Sittings · Document

Draft report (COM(2025)0531 – C90424/2023 – 2025/0531(COD)) 2026-02-06

Amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products

Committee on the Environment, Climate and Food Safety Committee on the Internal Market and Consumer Protection

Amendment 100

Per Clausen, Anja Hazekamp

Proposal for a regulation

Title 1

Text proposed by the Commission	Amendment
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products (Text with EEA relevance)	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 1272/2008, (EC) No 1223/2009, (EU) 2019/1009, (EC) 1107/2009 and (EU) No 528/2012 as regards simplification of certain requirements and procedures for chemical products (Text with EEA relevance)

Or. en

Amendment 101

Idoia Mendia, Kristian Vigenin, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido, Christel Schaldemose

Proposal for a regulation

Recital 1

Text proposed by the Commission	Amendment
(1) High quality and safety requirements for products on the Single Market ensure a high level of protection of human health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade products manufactured in the Union can create an advantage for Union companies.	(1) High quality and safety requirements for products on the Single Market ensure a high level of protection of human health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade and safe products manufactured in the Union can create an advantage for Union companies.

Or. en

Amendment 102

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 1

Text proposed by the Commission	Amendment
(1) High quality and safety requirements for products on the Single Market ensure a high level of protection of human health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade products manufactured in the Union can create an advantage for Union companies.	(1) High quality and safety requirements for products on the Single Market ensure a high level of protection of health and the environment and contribute to a fair and sustainable economy. In international competition, the reputation of high-grade products manufactured in the Union can create an advantage for Union companies.

Or. en

Amendment 103

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission	Amendment
	(1a) The competitiveness of the European Union depends in particular on its capacity to innovate. Simplifying the regulatory framework represents a key lever in this regard. Initiatives aimed at achieving technical progress and innovation must not be obstructed or compromised by an accumulation of regulatory constraints, but should instead be recognised as instruments contributing to the European Union’s competitiveness and economic viability.

Or. fr

Amendment 104

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 2

Text proposed by the Commission	Amendment
(2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment.	deleted
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2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).
5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj).

Or. en

Amendment 105

Proposal for a regulation

Recital 2

Text proposed by the Commission	Amendment
(2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment.	(2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council could be simplified and unnecessary administrative burdens should be removed, while maintaining a high level of consumer protection, protection of human health and of the environment.
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2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059	2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).	3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).	4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).
5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj).	5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj).

Or. en

Amendment 106

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission	Amendment
	(2a) The political guidelines of the European Commission emphasize the need to step up action on preventive health and to ensure the effective implementation of the European Beating Cancer Plan. In light of this priority, any amendments to existing legislation should be fully aligned with, and contribute to, the objectives of the European Beating Cancer Plan, ensuring the highest level of protection of human health, strengthening the fight against all forms of cancer, and placing prevention at the center of Union action.

Or. en

Amendment 107

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. Suppliers may provide a digital contact, together or in the place of the phone number, which could be any up-to-date and accessible online communication channel with the supplier. To reduce the space required on labels, suppliers may provide the telephone number exclusively on the digital label or through a digital contact. Where a digital contact is used, the telephone number might be made available, for example, via an automated email reply or on a dedicated webpage. To allow sufficient time for adaptation, the obligation to provide a digital contact should apply to substances and mixtures placed on the market three years after the entry into force of this Regulation. Products placed on the market before that date should be allowed to remain available without relabelling for a further two years. During this transitional period, the existing requirements, including the obligation to provide a telephone number on the label, should continue to apply. Suppliers should also be permitted to apply the new provisions on a voluntary basis immediately after the entry into force of this Regulation.

Or. en

Justification

While digital tools can support enforcement and information exchange, making a digital contact voluntary provides coherence with the revised Detergents and Surfactants Regulation, avoids undue burdens on SMEs, preserves accessibility for all users, and allows gradual uptake where digital solutions enhance compliance under Regulation (EC) No 1272/2008.

Amendment 108

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date, free of charge, and accessible online communication channel with the supplier. The digital contact should allow consumers and competent authorities to contact economic operators directly, without the need to provide any personal data, download or use additional applications specific to the economic operator. It should not oblige consumers or competent authorities to register solely for the purpose of contact economic operators. Such digital contact might include inter alia, an email address or a contact form on a website, be interpreted in a technologically neutral manner, and enable the saving of the information on a durable medium. However, it should not be understood as implying automatic replies to queries, chatbots, fax numbers or telephone lines. In order to allow persons with disabilities to use the digital contact point, accessibility requirements should be set in line with Directive (EU) 2019/882.

Or. en

Amendment 109

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations without leaving anyone behind and in order to facilitate expeditious communication between suppliers and individuals, and between suppliers and national authorities, the indication of a digital contact, as well as a direct telephone number, on the label of hazardous substances and mixtures is for example necessary to enhance the effectiveness of official controls, traceability, accountability and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008, as well as to ensure consumers have a quick and direct contact in case of an emergency or accident. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to also provide a digital contact, which should be an up-to-date, easily and freely accessible online communication channel with the supplier which allows for the storage information on a durable medium.

Or. en

Amendment 110

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between suppliers and national authorities responsible for enforcement, as well as between suppliers and consumers, the indication of a digital contact on the label of hazardous substances and mixtures is necessary. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and freely accessible online communication channel with the supplier, without the need for registering or downloading of an application. Through digital contact, suppliers should provide all relevant means of contacting them, including a telephone number. This should also enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008.

Or. en

Amendment 111

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact or telephone number, which could be any up-to-date and accessible online communication channel with the supplier.

Or. en

Amendment 112

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures could allow to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. Suppliers might provide a digital contact, together or in the place of the phone number, which could be any up-to-date and accessible online communication channel with the supplier.

Or. en

Amendment 113

Aurelijus Veryga

Proposal for a regulation

Recital 3

Text proposed by the Commission	Amendment
(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to provide a digital contact, which could be any up-to-date and accessible online communication channel with the supplier.	(3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures could allow to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. Suppliers might provide a digital contact, together or in the place of the phone number, which could be any up-to-date and accessible online communication channel with the supplier.

Or. en

Amendment 114

Majdouline Sbai

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission	Amendment
	(3a) The digital contact should allow consumers and authorities to contact suppliers directly, and should be accessible free of charge, without the need for providing any personal data, downloading or using additional applications specific to the supplier or the obligation to register solely to contact the supplier. Such digital contact might include, for example, an email address or a contact form on a website. However, it should not be understood as encompassing automatic replies to queries, or chatbots or fax numbers. The term ‘digital contact’, similarly to the term ‘electronic address’ in Regulation (EU) 2023/988 of the European Parliament and of the Council, should be interpreted in a technologically neutral manner, capable of evolving with future technological developments, and should cover all forms of direct digital communication.

Or. en

Justification

Amendment to align with amendment 34 of the rapporteur, allowing that the telephone number may be provided as part of the digital contact.

Amendment 115

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission	Amendment
	(3a) The digital contact should allow individuals and authorities to contact suppliers directly and swiftly. It should be free of charge, easily accessible in a clear and prominent manner, allowing contact on a durable medium, without requiring an account or registration and without requiring the provision of any personal data, downloading or using applications or another software or hardware to contact the suppliers. Such digital contact may include, for example, an email address or a contact form on a website. However, it should not include automatic replies to queries, chatbots, fax numbers or telephone lines.

Or. en

Amendment 116

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission	Amendment
	(3a) In order to ensure effective and direct communication, the digital contact should allow consumers and competent authorities to contact suppliers directly. Such digital contact should be accessible free of charge and without requiring the provision of personal data, the downloading or use of applications specific to the supplier, or registration solely for the purpose of contacting the supplier. The digital contact should include, for example, an email address or a contact form on a website. It should not be understood as encompassing automatic replies to queries, chatbots or fax numbers.

Or. en

Justification

Clarifies that a digital contact should constitute a genuine, direct and free means of communication, without conditions such as the collection of personal data or registration, excludes automated or obsolete systems, and ensures that digitalisation supports effective enforcement and consumer protection.

Amendment 117

Aurelijus Veryga

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission	Amendment
	(3a) The digital contact should allow consumers and authorities to contact suppliers directly, and should be accessible free of charge, without the need for providing any personal data, downloading or using additional applications specific to the supplier or the obligation to register solely to contact the supplier. Such digital contact might include, for example, an email address or a contact form on a website. However, it should not be understood as encompassing automatic replies to queries, chatbots or fax numbers.

Or. en

Amendment 118

Proposal for a regulation

Recital 4

Text proposed by the Commission	Amendment
(4) Regulation (EC) No 1272/2008 laid down the exemptions from labelling and packaging requirements for packaging of specific shapes, forms or sizes. Those exemptions can only be triggered if all required label elements do not fit on the outer packaging or on a tie-on tag. To simplify the use of those exemptions, it is appropriate to allow the existing exemptions to be applied to smaller packages without the need to prove the impossibility of using the outer packaging or tie-on tag.	deleted

Or. en

Amendment 119

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. It is necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.
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6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).	6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Amendment 120

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, it is appropriate to extend the scope of those exemptions to packages of up to 75 ml and to further simplify their application where such packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the applicable requirements for inner and outer packaging where the derogation for packages of less than 10 ml is applied.
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6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).	6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Justification

Ensures alignment with the proposed amendments to Article 29(2) of Regulation (EC) No 1272/2008 by introducing a specific provision for packaging of up to 75 ml, allowing reduced labelling elements in accordance with Annex I, section 1.5.2.4. This enhances proportionality and practicality for small packaging with space constraints, while maintaining a high level of safety and regulatory compliance.

Amendment 121

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, it is appropriate to further expand the scope to packages not exceeding 100 ml and further simplify the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 100 ml derogation is applied.
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6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).	6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Amendment 122

Aurelijus Veryga

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, it is appropriate to further expand the scope to 75 ml and further simplify application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 75 ml derogation is applied.
_________________
6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Amendment 123

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. It introduced a possibility to omit label elements from such packaging under certain conditions. It is necessary to clarify cases that require labelling elements to be included on the inner and outer packaging and cases allowing for those elements to be fully omitted.
_________________	_________________
6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).	6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Amendment 124

Majdouline Sbai

Proposal for a regulation

Recital 5

Text proposed by the Commission	Amendment
(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied.	(5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. It introduced a possibility to omit label elements from such inner packaging under certain conditions. However, it is necessary to amend these provisions and clarify cases that require labelling elements to be presented on the outer packaging in cases allowing for these elements to be fully omitted.
_________________	_________________
6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).	6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

Or. en

Justification

Skin sensitisation is a serious health hazard. The corresponding label requirement EUH 208 "Contains (name of sensitising substance). May produce an allergic reaction" should not be allowed to be omitted from the inner packaging of small packages.

Amendment 125

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	deleted

Or. en

Amendment 126

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	deleted

Or. en

Amendment 127

Majdouline Sbai

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	(6) In order to provide clear and enforceable rules for all suppliers with regard to the updating of labels in case of new or more severe self-classifications and to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to establish a system for the updating of such labels in analogy to what is done in case of harmonised classifications. Every year, the Agency should publish a list of the new or more severe classifications of the preceding year and suppliers of such a substance or mixture should update their label accordingly within a clear timeframe applicable to all.

Or. en

Justification

The updates of hazard labels in case of changes in self-classification should follow a structure as applicable for such updates in case of changes of harmonised classification. Instead of each individual self-classification triggering a supplier after supplier update requirement, all relevant changes in self-classification in one calendar year should be grouped by the ECHA into one document at the beginning of the next calendar year. All suppliers should then have 18 months to update their label. Annual grouping of such updates with a clear periodicity for all suppliers would truly simplify issues, instead of unclear periods that can be triggered at any moment and that are virtually impossible to enforce in light of the complexities of supply chains. And it would leave ample time for suppliers for the update.

Amendment 128

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to extend the fixed six months relabelling deadline to twenty four months per actor, while continuing to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.

Or. en

Amendment 129

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	(6) In order to provide more time for suppliers of substances and mixtures, particularly for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to extend relabelling deadline from 6 to 9 months after new data was obtained by or communicated to a supplier.

Or. en

Amendment 130

Aurelijus Veryga

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to extend the fixed six months relabelling deadline to twenty four months per actor, while continuing to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.

Or. en

Amendment 131

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 6

Text proposed by the Commission	Amendment
(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to remove a fixed six months relabelling deadline and to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.	(6) In order to provide the flexibility for suppliers of substances and mixtures, to create equal conditions for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to extend the fixed six months relabelling deadline to 24 months, while continuing to require the labels to be changed without undue delay after new data was obtained by or communicated to a supplier.

Or. en

Justification

Experience shows that a six-month deadline for updating labels is unworkable in complex supply chains and risks causing errors, disruption and unnecessary waste. A 24-month transition period for each supply-chain actor is therefore a necessary and proportionate alternative, allowing for accurate and orderly implementation, reducing compliance risks, preventing the premature disposal of labels and products, and ensuring coherence with sustainability and packaging legislation.

Amendment 132

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8, it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.	deleted
_________________
7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.
8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

Or. en

Amendment 133

Nikola Minchev

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.	(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8, particularly for SMEs, it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Introduced measures should maintain a high level of consumer protection and ensure the proper functioning of the internal market. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements, and easy to read at the point of purchase and during use. For a label to be considered easy to read, it should present a clear contrast between the text of the label and the background, an appropriate font size, and line and letter spacing, and other formatting elements that ensure the necessary level of readability.
_________________	_________________
7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.	7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.
8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.	8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

Or. en

Amendment 134

Majdouline Sbai

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.	(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New provisions with regard to line spacing are universally applicable and should thus remain. New information7 pointed to undue administrative burden and costs, associated with some of these requirements for business to business communication. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to amend the current formatting obligations without reducing the level of protection of human health and the environment of consumers. To ensure proper readability of labels for substances and mixtures sold to the general public, and to facilitate enforcement, requirements with regard to minimum font size should be retained. Suppliers must remain responsible for ensuring other elements of legibility in accordance with the legal requirements.
_________________	_________________
7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.	7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.
8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.	8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

Or. en

Justification

A basic requirement of good readability is line spacing. Unfortunately, proper line spacing is not always respected. For that reason, the recently revised CLP Regulation introduced the generic requirement of 120% line spacing in all cases. This should be maintained. When it comes to font sizes, it is important to distinguish between B2B and B2C. While relevant arguments have been put forward that flexibility is needed for B2B labelling, not least in light of the availability of material safety data sheets for business operators, minimum font size should clearly be established for products for sale to the general public to ensure proper readability of hazard information. It is of paramount importance to ensure that consumer are properly informed of the hazards of a substance or a mixture. That requires that the obligation of minimum font size as established in the latest revision is retained for B2C.

Amendment 135

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.	(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations in case that chemicals are provided in the course of professional or industrial activities in direct business to business relationship, without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements .
_________________	_________________
7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.
8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.	8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

Or. en

Justification

To allow authorities to enforce the formatting and fulfil its duties, and to ensure fair conditions for economic operators on the internal market, labelling and formatting rules have to be clear.

Amendment 136

Proposal for a regulation

Recital 7

Text proposed by the Commission	Amendment
(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.	(7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and unjustified burdens for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health, and safety and the environment. Suppliers and authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements.
_________________	_________________
7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.	7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.
8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.	8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at:https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

Or. en

Amendment 137

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission	Amendment
	(7a) The labelling of chemical products intended for supply to the general public serves as the primary, and often sole, source of hazard communication and safe-use guidance for consumers who lack specialised training in chemical safety. It is therefore essential that such labels present critical safety information in a manner that ensures immediate legibility and comprehension. Consumers may encounter chemical products in diverse circumstances, including suboptimal lighting conditions, emergency situations requiring rapid response, or environments where individuals with varying degrees of visual acuity, literacy levels, and linguistic competence may access the products. Furthermore, consumer settings frequently involve vulnerable populations, including children, elderly persons, and individuals with sensory impairments, who may be exposed to inadequately labelled products. In contrast, professional users operate within structured regulatory frameworks that mandate comprehensive safety training, ensure access to safety data sheets and technical documentation, require the use of personal protective equipment, and provide institutional oversight of chemical handling procedures. Professional users therefore benefit from multiple layers of safety information beyond product labelling alone. Consequently, it is necessary to establish minimum font size requirements for labels on chemical products in packaging of up to 10 litres, which are generally supplied to consumers, but also to professional users such as hairdressing and beauty salons, which do not necessarily have access to higher levels of training as regards the use of hazardous substances, thereby ensuring that critical hazard warnings, precautionary statements, and emergency response instructions are prominently displayed and readily accessible to all members of the general public, regardless of age, visual capacity, or technical knowledge, while maintaining proportionate requirements for professional contexts where additional safety mechanisms are already in place.

Or. en

Amendment 138

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission	Amendment
	(7a) A product’s label may constitute the sole source of information readily available to users. It is therefore indispensable that the label is easily readable under normal conditions and in exceptional circumstances, such as accidents. For a label to be considered readable, a combination of features should be taken into account, including clear contrast between the text and the background, a suitable typeface, an appropriately sized font, appropriate line and letter spacing, overall label design and other relevant formatting elements, which together ensure the appropriate degree of readability.

Or. en

Justification

The recital clarifies that consumers rely primarily on labels for hazard information, while professional users have access to additional sources, such as safety data sheets and training. It emphasises that label readability depends on factors including layout, contrast, font and spacing, and notes that references to ECHA guidance are unnecessary, as these aspects are already covered by Article 50(2) of Regulation (EC) No 1272/2008.

Amendment 139

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione, Yvan Verougstraete

Proposal for a regulation

Recital 8

Text proposed by the Commission	Amendment
(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.	(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures. Consumers are increasingly buying substances and mixtures via distance sales, such as online selling via webshops, online marketplaces or mobile applications. Therefore, information appearing on the label should be made available in the form of an image or as part of the product description, except for distance sales to professional or industrial users. Where the website or mobile application intended for professional or industrial users allows the general public to purchase substances or mixtures, suppliers should be also required to provide labelling information at the time of distance sale.
_________________	_________________
9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).	9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

Or. en

Amendment 140

Proposal for a regulation

Recital 8

Text proposed by the Commission	Amendment
(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.	(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, it should be noted that Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.
_________________	_________________
9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).	9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

Or. en

Amendment 141

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 8

Text proposed by the Commission	Amendment
(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.	(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance sales offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance sales offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/2006 already provides clear obligations on information flows in supply chains for substances and mixtures for professional and industrial users through the safety data sheet.
_________________
9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

Or. en

Amendment 142

Aurelijus Veryga

Proposal for a regulation

Recital 8

Text proposed by the Commission	Amendment
(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.	(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance sales offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance sales offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/2006 already provides clear obligations on information flows in supply chains for substances and mixtures for professional and industrial users through the safety data sheet.
_________________
9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

Or. en

Amendment 143

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 8

Text proposed by the Commission	Amendment
(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.	(8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance sales offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance sales offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures.
_________________	_________________
9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).	9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

Or. en

Justification

The amendment clarifies that requirements for advertisements and distance sales apply only to products intended for the general public. This reduces unnecessary burdens for industry while safeguarding the free movement of goods within the internal market. Professional and industrial users are already covered by Regulation (EC) No 1907/2006 through safety data sheets, thereby avoiding duplication and ensuring legal coherence.

Amendment 144

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission	Amendment
	(8a) Professional and industrial users are generally better informed about the hazards associated with substances and mixtures than consumers. It is therefore appropriate to differentiate information requirements according to whether products are intended for consumer use or for professional and industrial use. An advertisement or distance sales offer should be regarded as targeted at consumers on the basis of objective elements, including whether it is clearly indicated that the substance or mixture is intended exclusively for professional use and the context in which the advertisement or offer is made available, such as trade fairs, trade publications or digital platforms addressed to professional users.

Or. en

Justification

This amendment introduces objective criteria for determining when advertisements or distance-sales offers are directed at consumers. It enhances legal certainty for operators and authorities, particularly in online contexts, while maintaining a high level of consumer protection.

Amendment 145

Aurelijus Veryga

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission	Amendment
	(8a) Professional and industrial users are generally better informed about the hazards associated with substances and mixtures than consumers. It is therefore appropriate to differentiate information requirements depending on whether products are intended for consumer or for professional and industrial use. An advertisement or a distance sales offer is targeted at consumers, based on objective elements, including whether it is clearly indicated that the substance or mixture is intended exclusively for professional use, as well as the context in which the advertisement or offer is made available, such as trade fairs, trade publications or digital platforms addressed to professional users.

Or. en

Amendment 146

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label.	(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to focus on those elements that provide immediate visual recognition of the nature and severity of the hazard, namely hazard pictograms and signal words, whilst also requiring advertisements to invite customers to read the label and product information before use, but not to duplicate all hazard information from the label. This approach ensures that advertisements remain sufficiently informative in alerting potential users to the hazardous nature of the product without imposing requirements that would make advertisements cluttered, difficult to interpret, or commercially impractical.

Or. en

Amendment 147

Martin Hojsík, Michal Wiezik, Pascal Canfin, Jeannette Baljeu, Grégory Allione, Yvan Verougstraete

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label.	(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use accompanied by relevant signal word or to include the pictogram, but not to duplicate all hazard information from the label. Given the many different forms of advertisements, suppliers should be provided a degree of flexibility on how this information should be conveyed in advertisements.

Or. en

Amendment 148

Aurelijus Veryga

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label.	(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label. Given the many different forms of advertisements, suppliers should be provided a degree of flexibility on how this information should be conveyed in advertisements.

Or. en

Amendment 149

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label.	(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label. Given the many different forms of advertisements, suppliers should be provided a degree of flexibility on how this information should be conveyed in advertisements.

Or. en

Amendment 150

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 9

Text proposed by the Commission	Amendment
(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to invite customers to read the label and product information before use, but not to duplicate the hazard information from the label.	(9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the product. That Regulation also expanded requirements for advertisements, requiring them to indicate the hazard pictograms, signal words, hazard statements and supplemental statements and, in addition, to invite general public to follow the information on the product label. Advertisements are means of promoting the sale or use of chemical products, and at the moment of sale the label on the packaging of the substance or mixture or the label information in the distance offer provides full information about the hazards associated with that substance or mixture. It would therefore be appropriate to require advertisements to indicate the hazard pictograms and signal words, and to invite the customers to read the label and product information before use, but not to duplicate all hazard information from the label.

Or. en

Amendment 151

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission	Amendment
	(9a) Regulation (EU) 2024/2865 introduced new hazard classes that have not yet been adopted at UN level, namely endocrine disruptors (ED), persistent, bioaccumulative and toxic substances (PBT), very persistent and very bioaccumulative substances (vPvB), persistent, mobile and toxic substances (PMT), and very persistent and very mobile substances (vPvM). These hazard classes are currently under discussion within the framework of the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS), which constitutes the internationally recognised system for the global harmonisation of hazard classification criteria. Considering that the Union should refrain from implementing these hazard classes prior to their formal adoption at UN level, Commission Delegated Regulation (EU) 2023/707 should therefore be repealed, in order to safeguard global regulatory harmonization and prevent potential losses of competitiveness for Union industry.

Or. en

Amendment 152

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.	(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to only use the statement ‘Always read the label and product information before use’, it would be appropriate to amend that Regulation to ensure the same requirement for advertisements of hazardous substances and mixtures to ensure consistency in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.
_________________	_________________
10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).	10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).
11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).	11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

Or. en

Amendment 153

Aurelijus Veryga

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.	(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate for the advertisers to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.
_________________	_________________
10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).	10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).
11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).	11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

Or. en

Amendment 154

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.	(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate for the advertisers to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.
_________________	_________________
10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).	10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).
11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).	11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

Or. en

Amendment 155

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.	(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate for the advertisers to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.
_________________	_________________
10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).	10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).
11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).	11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

Or. en

Amendment 156

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 10

Text proposed by the Commission	Amendment
(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.	(10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate for the advertisers to use a similar statement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products.
_________________	_________________
10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).	10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).
11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).	11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

Or. en

Justification

A general statement, as required under Regulation (EU) No 528/2012, has proven effective in communicating product hazards where label elements are not available at the point of purchase. The wording “Always read the label and product information before use.” should therefore be used by advertisers in this exact form, avoiding variations and preventing duplication between CLP requirements and the established Biocidal Products Regulation wording.

Amendment 157

Proposal for a regulation

Recital 12

Text proposed by the Commission	Amendment
(12) Regulation (EU) 2024/2865 introduced the possibility to include certain labelling elements in the digital label only. To ensure broader use of technology and to allow a simpler and more flexible approach to labelling, suppliers should be allowed to place contact details of any additional suppliers on the digital label only. Inclusion of the digital contact would also be appropriate where contact details of additional suppliers are provided in the digital label.	(12) Regulation (EU) 2024/2865 introduced the possibility to include certain labelling elements in the digital label only. To ensure broader use of technology and to allow a simpler and more flexible approach to labelling, suppliers should be allowed to place contact details of any additional suppliers on the digital label only. Inclusion of the digital contact would also be appropriate where contact details of additional suppliers are provided in the digital label. In order to ensure the possibility for rapid contact which is essential in certain situation such as in cases of emergency, the presence of a digital contact should not exclude the provision of a telephone number.

Or. en

Amendment 158

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission	Amendment
	(12a) Certain technical containers (≤150 ml), such as inkjet cartridges (supplied in outer packaging and designed to be installed in a device by a consumer or professional user), are part of a wider system and have very limited usable surface area for labelling and cannot benefit from the fold out label option enabling multilanguage solutions. In these cases suppliers should be permitted to present hazard label information in accordance with Annex I section 1.5.2.5a.

Or. en

Justification

The proposed derogation would apply to small technical containers, such as inkjet printer cartridges under 150 ml. Full CLP hazard information would be provided on the outer packaging. Because cartridges and printers are designed to work as a single system, there is very limited space for labels on the cartridge, and fold-out labels cannot be used as they would interfere with installation and operation. As a result, cartridges cannot accommodate multilingual CLP labels.

Amendment 159

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission	Amendment
	(12a) Certain technical containers, such as inkjet and toner printer cartridges, have only a limited surface area available for labelling. The use of fold-out labels is not feasible, and incorrect labelling could result in damage to the cartridge or the equipment. In such cases, suppliers should be permitted to present hazard label information in accordance with section 1.5.2.5a of Annex I.

Or. en

Amendment 160

Proposal for a regulation

Recital 14

Text proposed by the Commission	Amendment
(14) In line with the transitional provisions of Regulation (EC) No 1272/2008, suppliers should have the possibility of applying the new classification, labelling and packaging provisions introduced by this Regulation on a voluntary basis before the date of the deferred application of these provisions.	(14) In line with the transitional provisions of Regulation (EC) No 1272/2008, suppliers should have the possibility of applying the new classification, labelling and packaging provisions introduced by this Regulation on a voluntary basis before the date of the deferred application of these provisions and national authorities should encourage them to do so.

Or. en

Amendment 161

Inese Vaidere

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission	Amendment
	(15a) Regulation (EC) No 1223/2009 imposes very strict requirements for product registration, safety assessment and production quality assurance. While these requirements are important for consumer safety and market transparency, they often become a significant obstacle for small home producers and artisans who want to produce and legally market handmade, fully natural organic cosmetic products. Such requirements significantly limit the opportunities for small and artisanal producers to develop and offer their products to consumers, creating not only unfavourable conditions for business, but also losses for local culture, the sustainability of natural resources, and economic diversity.

Or. en

Amendment 162

Majdouline Sbai

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission	Amendment
	(15a) Given the essential role of the endocrine system during human development, exposure to endocrine disruptors during critical periods of development, such as perinatal life, childhood and puberty can lead to adverse effects even at very low doses and affect health at a later stage of life. The use of cosmetic products can lead to direct and long-lasting exposure. Given the special risks that substances classified as endocrine disruptors for human health category 1 pursuant to Part 3 of Annex I to Regulation (EC) No 1272/2008 may entail for human health, their use in cosmetic products should be prohibited.

Or. en

Justification

Endocrine disrupters for human health pose a special threat to human health. Already in 2012, WHO and UNEP considered them a global threat, see https://wedocs.unep.org/rest/api/core/bitstreams/0561a697-6b8e-4c8f-a724-7bab3e18c953/content They can have serious and irreversible adverse effects during critical periods of development at very low levels of exposure. In the context of REACH, they are considered to be of equivalent concern to CMR substances. CMR substances are prohibited in cosmetics since 2003. It is long overdue that the same prohibition applies to endocrine disruptors. This is further corroborated by the Union ban of endocrine disrupters for human health in toys (adopted last year). The same should be done for cosmetics, given in particular the high exposure that can be created by cosmetic products.

Amendment 163

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission	Amendment
	(15a) In the Chemical Strategy for Sustainability, the Commission committed to ensure that consumer products, including cosmetics do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative.

Or. en

Amendment 164

Inese Vaidere

Proposal for a regulation

Recital 15 b (new)

Text proposed by the Commission	Amendment
	(15b) Regulation 1223/2009 does not provide for cases where individual entrepreneurs or start-ups are using natural products and preparing extracts, macerates, ointments and hydrolates from them - products that have a high value in local culture and contribute to the sustainable use of natural resources. The current regulatory system does not allow these traditional extracts and artisanal products to be easily used in cosmetic production and sold on the legal market requires a thorough, expensive and time-consuming product safety assessment, including laboratory tests, which are often not financially affordable for small manufacturers; requires full product registration on the European Commission’s Cosmetic Product Notification Portal (CPNP) with all documentation and testing; requires strict GMP (Good Manufacturing Practice) requirements, and a requirement for an expert services which are not suitable and practical for artisanal and small-scale production;

Or. en

Amendment 165

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 15 b (new)

Text proposed by the Commission	Amendment
	(15b) Endocrine disrupting chemicals are increasingly linked to diseases acting via the hormonal system. Their use represents a serious risk to human health as well as creating an economic cost for society. As hormones control brain development and growth, exposure to endocrine-disruptors during foetal development and puberty can lead to irreversible effects, some being detected only many years later. Endocrine-related disorders impact in particular the functioning of the thyroid, the immune system, the reproduction system and the overall human metabolism. Cosmetics should not contain endocrine disrupting chemicals.

Or. en

Amendment 166

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 15 c (new)

Text proposed by the Commission	Amendment
	(15c) Per- and polyfluoroalkyl substances (PFAS) constitute a large group of more than 10,000 synthetic chemicals. Since they were first introduced in the late 1940s, PFAS have been increasingly used in a wide variety of consumer products. Exposure to the most extensively studied PFAS has been linked to numerous negative health effects, including thyroid disorders, liver damage, diabetes, reduced effectiveness of routine vaccinations, and an increased risk of breast, kidney and testicular cancer. Cosmetics should not contain per- or polyfluoroalkyl substances (PFAS).

Or. en

Amendment 167

Majdouline Sbai

Proposal for a regulation

Recital 16

Text proposed by the Commission	Amendment
(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest three months after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.	(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest one month after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.

Or. en

Justification

The Commission makes annual updates of CLP based on the latest RAC opinions with regard to CLP classifications. The updates take on average 18 months until they enter into force, and another 18 months until they are applicable. The Commission normally follows the RAC opinions, which are publicly available. It makes sense to link the deadline to the date of entry into force of the classification. However, given the current working methods, companies already had on average at least 18 months to prepare a derogation from the date of adoption of the RAC opinion. Thus derogations can be submitted very quickly after the entry into force of the classification.

Amendment 168

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 16

Text proposed by the Commission	Amendment
(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest three months after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.	(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest one month after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.

Or. en

Amendment 169

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 16

Text proposed by the Commission	Amendment
(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest three months after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.	(16) Regulation (EC) No 1223/2009 provides the possibility to use in cosmetic products substances classified as CMR substances of category 1A and 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 under certain conditions. A request for derogation should be submitted to the Commission at the latest six months after the entry into force of the respective changes to Part 3 of Annex VI to Regulation (EC) No 1272/2008. As the relevant opinion of the Committee for Risk Assessment proposing the substances for the harmonised classification is made publicly available several months before the Commission follows with the regulatory measure, such deadline is sufficient.

Or. en

Justification

Under the CPR, the classification of a substance as CMR under the CLP leads to a rapid prohibition in cosmetic products, leaving insufficient time for industry to prepare a defence dossier. The Commission proposal allows continued use where a derogation request is submitted within a defined timeframe. Extending this period to six months is therefore essential to enable companies, including SMEs, to assess the classification, gather relevant data, define the uses to be defended and prepare robust, evidence-based dossiers, thereby ensuring a more proportionate and predictable regulatory framework.

Amendment 170

Majdouline Sbai

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission	Amendment
	(16a) The prohibition of the use of CMR substances in cosmetic products should be applied as swiftly as possible. At the same time, sufficient time needs to be granted to assess whether the criteria for a derogation are fulfilled. The assessment of the fulfilment of the derogation criteria requires multiple consultations and deliberations. The assessment of the Scientific Committee on Consumer Safety (SCCS) of the safety of the substance for human health requires nine months, the assessment of the compliance with other derogation criteria require consultations with experts and discussions with the Member States and industry representatives concerned. Once the draft measure is prepared by the Commission it is subject to notification under the WTO Technical Barriers to Trade (TBT) procedure for a minimum of two months. The draft Commission measure falls under the obligatory scrutiny by the European Parliament and the Council which lasts three months before its final adoption and publication in the Official Journal. The analysis of the fulfilment of the derogation criteria and the obligatory sequential steps which must be followed by the Commission while adopting a regulatory measure require that sufficient time is accorded to the Commission for the adoption of the measure from the submission of the request for derogation, without granting any undue delays.
	(Text as in Council mandate, only changing the timeline for SCCS opinion)

Or. en

Justification

The top priority is that cosmetic products are safe. As such, the prohibition of CMR substances needs to be applied as fast as possible. Nine months are enough for the work of the SCCS. When it comes to the safety of nanomaterials, it has to give an opinion in six months in current legislation. The SCCS will be shifted to ECHA in the context of the ECHA Basic Regulation. At ECHA, work that is comparable to that of the SCCS is done by the Risk Assessment Committee (RAC). RAC has nine months to prepare opinions on restrictions of chemicals. Such restrictions can have very broad scope. A scientific opinion on the safety of a specific CMR substance in cosmetics is rather limited in comparison. It is therefore difficult to see why the SCCS should have more time for such opinions as compared to RAC for chemical restrictions. It is appropriate to align the timeline for the SCCS to that for RAC. The Commission should enact the restrictions as swiftly as possible without undue delays.

Amendment 171

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission	Amendment
	(16a) The assessment of the fulfilment of the derogation criteria requires multiple consultations and deliberations. The assessment by the Scientific Committee on Consumer Safety (SCCS) of the safety of the substance for human health requires a minimum of twelve months, the assessment of the compliance with other derogation criteria require consultations with experts and discussions with the Member States and the industry representatives. Once the draft measure is prepared by the Commission it is subject to notification under the WTO Technical Barriers to Trade (TBT) procedure for a minimum of two months. The draft Commission measure falls under the obligatory scrutiny by the European Parliament and the Council which lasts three months before its final adoption and publication in the Official Journal. The analysis of the fulfilment of the derogation criteria and the obligatory sequential steps which must be followed by the Commission while adopting a regulatory measure require that sufficient time is accorded to the Commission for the adoption of the measure from the submission of the request for derogation.

Or. en

Amendment 172

Proposal for a regulation

Recital 17

Text proposed by the Commission	Amendment
(17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined, and their scope should be set out in more detail. In addition, compliance with food safety requirements is not compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements does not enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this condition.	(17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined without lowering the high level of human health and, safety and consumer protection, and their scope should be set out in more detail. In addition, compliance with food safety requirements is in contrast to the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. At the time, this condition was introduced as a gatekeeping criteria to reduce the number of CMR substances in cosmetic products and to contribute to ensuring that the Scientific Committee on Consumer Safety (SCCS) has the capacity to conduct its duties. The compliance with food safety requirements does not necessarily enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this condition.

Or. en

Amendment 173

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy, Yvan Verougstraete

Proposal for a regulation

Recital 17

Text proposed by the Commission	Amendment
(17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined, and their scope should be set out in more detail. In addition, compliance with food safety requirements is not compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements does not enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this condition.	(17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined, and their scope should be set out in more detail. In addition, compliance with food safety requirements may not be compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements may not always enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to reconsider the application of this condition, while working towards maximum possible safety for consumers from cosmetic products containing CMR substances or substances affecting their endocrine system.

Or. en

Amendment 174

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 17

Text proposed by the Commission	Amendment
(17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined, and their scope should be set out in more detail. In addition, compliance with food safety requirements is not compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements does not enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this condition.	(17) The conditions allowing for exemptions from the ban of use of CMR substances and endocrine disrupting chemicals in cosmetic products and their scope should be set out in more detail. In addition, compliance with food safety requirements is not compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements does not enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this condition.

Or. en

Amendment 175

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be outlined. In particular, the key criteria to confirm the safe use of a substance in cosmetics is the assessment by the Scientific Committee for Consumer Safety (SCCS), a complete toxicological assessment which considers all exposure routes. This provides additional robust scientific knowledge that establishes it as a safe and a preferred option for the consumer. In addition, it should be provided that any alternative substance considered to replace the need for classified substance has a demonstrably reduced risk for human health and the environment. The alternative substance should provide the same function and the same level of efficacy and performance, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs to allow sustained production. In addition, access to the substance should not be restricted by patents or raw material restrictions. In particular, to assess economic feasibility, the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives, should be considered.

Or. en

Amendment 176

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, the elements to be considered under the availability of suitable alternatives condition should be outlined. In particular, the key criteria to confirm the safe use of a substance in cosmetics is the assessment by the Scientific Committee for Consumer Safety (SCCS) - a complete toxicological assessment which considers all exposure routes. This provides additional robust scientific knowledge that establishes it as a safe and a preferred option for the consumer. In addition, it should be provided that any alternative substance considered to replace the need for the classified substance has a demonstrably reduced risk for human health and the environment. The alternative should provide the same function and the same level of efficacy and performance, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs to allow sustained production. In addition, access to the substance should not be restricted by patents or raw material restrictions. In particular, to assess economic feasibility, economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives, should be considered.

Or. en

Amendment 177

Beatrice Timgren

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, the elements to be considered under the availability of suitable alternatives condition should be outlined. In particular, the key criteria to confirm the safe use of a substance in cosmetics is the assessment by the Scientific Committee for Consumer Safety (SCCS) - a complete toxicological assessment which considers all exposure routes. This provides additional robust scientific knowledge that establishes it as a safe and a preferred option for the consumer. In addition, it should be provided that any alternative substance considered to replace the need for the classified substance has a demonstrably reduced risk for human health and the environment. The alternative should provide the same function and the same level of efficacy and performance, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs to allow sustained production. In addition, access to the substance should not be restricted by patents or raw material restrictions. In particular, to assess economic feasibility, economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives, should be considered.

Or. en

Amendment 178

Raúl de la Hoz Quintano, Dolors Montserrat, Esther Herranz García, Susana Solís Pérez, Pablo Arias Echeverría

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, the primary basis for establishing the safe use of a substance in cosmetic products should be a scientific risk assessment carried out by the Scientific Committee on Consumer Safety (SCCS), based on a complete toxicological evaluation covering all relevant exposure routes. This assessment provides a robust scientific foundation for considering the substance safe and suitable for consumers. it should be provided that the use of alternative substance should result in demonstrably reduced risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 179

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance, combination of substances or alternative methods and technology that replaces the need for the substance should be harmless for human health and should not pose unacceptable risks to the environment. Occupational safety and health should also be thoroughly taken into account, including the assessment of worker exposure scenarios.

Or. en

Amendment 180

Vytenis Povilas Andriukaitis

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, the key criteria to confirm the safe use of a substance in cosmetics is the assessment by the Scientific Committee for Consumer Safety (SCCS) - a complete toxicological assessment which considers all exposure routes. In addition, it should be provided that any alternative substance considered to replace the need for the classified substance has a demonstrably reduced risk to human health and the environment. The alternative should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 181

Heléne Fritzon, Christophe Clergeau, Adnan Dibrani, Annalisa Corrado

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance, a combination of substances, or, where relevant, an alternative technology that replaces the need for the substance, should be safe for human health and should provide a similar function and level of efficacy in a cosmetic product, comparable to the classified substance, be available on the market in sufficient quantities or likely to be available within a reasonable timeframe, so that it can be technically and economically feasible for businesses and especially for SMEs. The consideration of suitable alternatives should not be limited to alternatives providing 1:1 substitution. Economic aspects, such as costs of reformulation and comparative contribution to overall production costs, could also be considered as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 182

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance or combination of substances should be safe for human health and should provide a comparable or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 183

Idoia Mendia, Kristian Vigenin, Elisabeth Grossmann, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Marta Temido

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance, a combination of substances, or, where relevant, an alternative production process that replaces the need for the substance, should be safe for human health and should provide a similar function and level of efficacy in a cosmetic product comparable to the classified substance, be available on the market in sufficient quantities or likely to be available within a reasonable timeframe, so that it can be technically and economically feasible also for businesses and especially for SMEs. Economic aspects, such as costs of reformulation and comparative contribution to overall production costs, could also be considered as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 184

Sirpa Pietikäinen

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, satisfy consumer needs, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 185

Majdouline Sbai

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of an alternative substance, a combination of substances, or, where relevant, an alternative technology that can replace a CMR substance should result in reduced overall risk to human health. The alternative should provide a similar function and sufficient level of efficacy in a cosmetic product, be available on the market in sufficient quantities, or likely to be available in sufficient quantities within a reasonable timeframe, so that its use can be technically feasible for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions.

Or. en

(This amendment is linked to several amendments by the same author to the operative part of the text.)

Justification

The recital should be aligned to the proposed changes in the operative part. It should not set out provisions that are not in the operative part, such as costs of reformulation and comparative contribution to overall costs.

Amendment 186

Nikola Minchev

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should be safe for human health and the environment, should provide same function in a cosmetic product, and should be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.

Or. en

Amendment 187

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 18

Text proposed by the Commission	Amendment
(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be specified. In particular, it should be provided that the use of alternative substance should result in reduced overall risk to human health and the environment and the substance should provide an equivalent or similar function in a cosmetic product, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs. In addition, access to the substance should not be restricted by patents or raw material restrictions. It should also be possible to consider the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives.	(18) Furthermore, elements to be considered under the availability of suitable alternatives condition should be outlined. In particular, it should be provided that the use of an alternative substance that replaces the need for the substance, is safe for human health and the environment. The alternative should provide, the same function and the same level of efficacy and performance, be available on the market in sufficient quantities, so that it can be technically feasible and economically viable for businesses and especially for SMEs to allow sustained production. In assessing economic feasibility, relevant economic factors such as reformulation costs and the relative contribution of a substance to overall production costs should be taken into account when evaluating the suitability of alternatives.

Or. en

Justification

Any derogation under Article 15(2) should be primarily based on the Scientific Committee on Consumer Safety (SCCS) assessment of the safety of CMR substances in specific cosmetic uses. Furthermore, the amendment clarifies that suitable alternatives must demonstrably reduce overall risk, deliver the same function and performance, be technically feasible at industrial scale, economically viable for sustained production, and not be subject to existing or forthcoming restrictions.

Amendment 188

Majdouline Sbai

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission	Amendment
	(18a) Regarding the assessment of alternatives, the words “similar” and “comparable” refer to all possible alternatives available, and not only alternatives providing 1:1 substitution. “Technically feasible” highlights that it has to be possible to apply the alternative with technologies and methods generally available.

Or. en

Justification

It is important that a broad concept of alternatives is applied, not just 1:1 substitution. Several of the terms in the operative part should be better explained.

Amendment 189

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission	Amendment
	(18a) Regarding the assessment of alternatives, the applicant shall demonstrate that no 1:1 substitution exists for the classified ingredient. In view of the widespread and diverse reformulations in which the ingredient would require replacement, a proportionate approach to the burden of proof shall be applied.

Or. en

Justification

The development of guidance to promote consistency and predictability in the assessment of alternatives is welcome. However, further clarification is required, as the reference to “these terms” lacks precision. Moreover, the guidance should not be limited to explaining criteria for economic and technical feasibility and viability, but should clarify all applicable conditions.

Amendment 190

Beatrice Timgren

Proposal for a regulation

Recital 19

Text proposed by the Commission	Amendment
(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, (i.e., namely specific use in particular product category), therefore, a separate criterion is redundant.	(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, therefore, a separate criterion is redundant.

Or. en

Amendment 191

Vytenis Povilas Andriukaitis

Proposal for a regulation

Recital 19

Text proposed by the Commission	Amendment
(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, (i.e., namely specific use in particular product category), therefore, a separate criterion is redundant.	(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, therefore, a separate criterion is redundant.

Or. en

Amendment 192

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Recital 19

Text proposed by the Commission	Amendment
(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, (i.e., namely specific use in particular product category), therefore, a separate criterion is redundant.	(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, therefore, a separate criterion is redundant.

Or. en

Amendment 193

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 19

Text proposed by the Commission	Amendment
(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, (i.e., namely specific use in particular product category), therefore, a separate criterion is redundant.	(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, therefore, a separate criterion is redundant.

Or. en

Justification

In Recital 19, removing the bracketed text would eliminate redundancy with earlier statements in the same recital.

Amendment 194

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Recital 19

Text proposed by the Commission	Amendment
(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, (i.e., namely specific use in particular product category), therefore, a separate criterion is redundant.	(19) In addition, in order to streamline the derogation procedure, the condition that the derogation request is made for a particular use of a product category with a known exposure should become part of the SCCS assessment criterion. Currently, the scientific committee is already assessing the safety of the substance considering its hazard properties and exposure, therefore, a separate criterion is redundant.

Or. en

Amendment 195

Idoia Mendia, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission	Amendment
	(19a) The communication of the Commission of 14 October 2020 on Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (CSS) called for simplifying and strengthening the legal framework on chemicals. In particular, the Communication commits to strengthen Regulation (EC) No 1223/2009 with respect to risks from endocrine disruptors. Endocrine disrupting chemicals may interfere with the normal functioning of the hormone system and have been linked, even at low doses, to adverse health effects including effects on reproductive health, metabolic disorders, and developmental impacts. Given the direct and repeated nature of exposure to cosmetic products, the presence of endocrine disrupting substances in cosmetics should be specifically addressed. For reasons of consistency and to ensure the same high level of protection across different product categories, it is therefore necessary to extend the scope of the generic ban in Article 15 of Regulation (EC) No 1223/2009 to substances classified as endocrine disruptors for human health, category 1 and 2, pursuant to Regulation (EC) No 1272/2008.

Or. en

Amendment 196

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy, Yvan Verougstraete

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	deleted

Or. en

Justification

The proposal contradicts the conclusions of the Scientific Committee on Cosmetic Products (2001) and its recommendation to prohibit the use of all CMR substances in cosmetic products. The proposal would, furthermore, lead towards increased complexity and uncertainty for cosmetic producers, which contradicts the sole nature of an omnibus (aiming to achieve simplification), in terms of Art. 15 and considering and determining of exposure routes.

Amendment 197

Idoia Mendia, Kristian Vigenin, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	deleted

Or. en

Amendment 198

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	deleted

Or. en

Amendment 199

Majdouline Sbai

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	deleted

Or. en

Justification

The Commission proposal would effectively undo to the existing CMR ban in cosmetics for substances that are CMR by inhalation or by ingestion. Many cosmetics are inhaled (e.g. perfumes), and some may be ingested (e.g. tooth paste). Undoing such bans flies against the stated objective to maintain the same level of protection of human health (see Recital 2). The real but unstated motivation for the COM amendment is to create a lex specialis for ethanol in anticipation of a possible classification as CMR for oral use. However, the issue of ethanol has already been explicitly addressed in the recast of the Regulation in 2009. In the context of that recast, the possibility for a derogation from the CMR ban was introduced - explicitly to deal with a possible classification of ethanol. It is not acceptable that the Commission is now trying to tacitly insert a lex specialis for ethanol. In case of classification of ethanol as CMR, it should follow the same rules with regard to derogations as other substances.

Amendment 200

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to a route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Such substances are still subject to the prohibition under Article 15 of Regulation (EC) No 1223/2009 when used in cosmetic products entailing that specified route of exposure but should follow the procedure for CMR in category 2 in case a derogation is needed and do therefore not have to fulfil the criteria regarding alternative assessment.

Or. en

Amendment 201

Susana Solís Pérez, Esther Herranz García, Raúl de la Hoz Quintano, Pablo Arias Echeverría, Dolors Montserrat

Proposal for a regulation

Recital 20

Text proposed by the Commission	Amendment
(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of human body (for example epidermis, hair system, nails, external genital organs) and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under the Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to specific routes of exposure or when they are assigned explicitly to the dermal route of exposure. Where the CMR classification of a substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled). Therefore, such substances should not be subject to a prohibition under Article 15 of Regulation (EC) No 1223/2009. However, the fact that a substance used in oral or sprayable cosmetic products is classified as CMR due to its oral or inhalation route of exposure, may raise concerns for human health. In such cases, the Commission should mandate the SCCS to assess the safety of such substances when used in cosmetic products and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(20) Due account should be taken of the specific exposure of cosmetic products, which are mainly placed in contact with the external parts of the human body (for example epidermis, hair system, nails, external genital organs), and of the actual conditions of exposure arising from their use, and that they are not ingested, inhaled, injected or implanted into the human body. The prohibition triggered by Article 15 of Regulation (EC) No 1223/2009 should cover the substances with CMR harmonised classification under Regulation (EC) No 1272/2008, where the CMR hazards are not assigned to a route of exposure or when they are assigned explicitly to the dermal route of exposure.Where the CMR classification of a substance or of a constituent of a natural complex substance is only associated with oral or inhalation routes of exposure, its use in cosmetic products does not result in the same level of risk for end-users, provided that a scientific assessment of realistic exposure scenarios confirms its safety, since oral and inhalation exposure are incidental (for example, cosmetic products used on lips, teeth or mucous membranes of the oral cavity or cosmetic products used in spray are not intended to be ingested or inhaled).Such substances are still subject to the prohibition under Article 15 of Regulation (EC) No 1223/2009 when used in cosmetic products entailing that specific route of exposure, but their safety should be assessed in accordance with the procedure for CMR substances of category 2, based on an independent scientific evaluation by the Scientific Committee on Consumer Safety, and do therefore not have to fulfil the criteria regarding alternative assessment.

Or. en

Amendment 202

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	deleted

Or. en

Amendment 203

Susana Solís Pérez, Esther Herranz García, Raúl de la Hoz Quintano, Pablo Arias Echeverría, Dolors Montserrat

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(21) Article 5 of Regulation (EC) No 1272/2008 provides a specific rule for the identification and examination of available information when evaluating the hazardous properties of substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006. Such substances, often referred to as natural complex substances (NCS), might contain one or more substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), while the overall natural complex substance is not itself classified as a CMR substance.A high level of consumer protection must apply to such substances and should be based on scientific knowledge of their composition, their behaviour as a whole, and the actual conditions of exposure arising from their use in cosmetic products. The prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 applies to the constituent concerned. Natural complex substances that contain a CMR-classified constituent are not subject to the prohibition, except where the natural complex substance itself is classified as a CMR substance of category 1A, 1B or 2 and listed as such in Part 3 of Annex VI to Regulation (EC) No 1272/2008, based on data relating to the natural complex substance itself, where available.When a constituent of a natural complex substance is classified as a CMR substance (categories 1A, 1B or 2), this may raise concerns regarding its safe use in cosmetic products. In such cases, the Commission should mandate the Scientific Committee on Consumer Safety to assess the safety of the natural complex substance, taking into account relevant exposure scenarios and routes of exposure. Where necessary, regulatory action should be taken under Article 31(1) of Regulation (EC) No 1223/2009.

Or. en

Amendment 204

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(21) Article 5 of Regulation (EC) No 1272/2008 provides a specific rule for identification and examination of available information when evaluating the hazardous properties of substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006. Such substances, often referred to as ‘of Natural complex substances’, or ‘NCS’ may contain one or more substances classified as CMR substances, for example essential oils. In such cases, while the overall Natural complex substance is not itself classified as a CMR substance. The prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 only applies to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Natural complex substances are not subject to the prohibition, except if that Natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. When a constituent of a Natural complex substance is classified as a CMR (categories 1A, 1B or 2), this raises concerns about its safe use in cosmetics. In such cases, the Commission should systematically and promptly request the SCCS to assess the safety of such constituents and, where necessary, take regulatory measures in accordance with action under Article 31(1) of Regulation (EC) No 1223/2009. The assessment of the SCCS should be timely to ensure predictability for the industry.

Or. en

Amendment 205

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(21) Article 5 of Regulation (EC) No 1272/2008 provides a specific rule for identification and examination of available information when evaluating the hazardous properties of substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006. Such substances, often referred to as natural complex substances, may contain one or more substances classified as CMR substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 applies only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent raises concerns about the use and safety of the natural complex substances when used in cosmetic products, the Commission should without delay mandate the SCCS to assess the safety of such constituents and, where necessary take appropriate regulatory action in accordance with Article 31(1) of Regulation (EC) No 1223/2009.

Or. en

Amendment 206

Majdouline Sbai

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(21) Substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006 are referred to as natural complex substances. Natural complex substances might contain one or more constituents classified as CMR. While mixtures of substances are classified as CMR when containing CMR substances above a certain concentration, natural complex substances containing CMR constituents are exempt from such classification pursuant to Article 5 (6) of that Regulation. However, when a constituent of a Natural Complex Substance is classified as a CMR (categories 1A, 1B or 2), this raises concerns about its safe use in cosmetic products. In such cases, the Commission should request the SCCS to assess the safety of such substances, and, where necessary, take regulatory action under Article 31(1) of Regulation (EC) No 1223/2009.

Or. en

Justification

The legal situation should be described properly. In case a natural complex substance used in cosmetics contains a constituent that is classified as CMR, the Commission should be obliged to request an opinion from the SCCS about the safety of it. If it is found not to be safe, the Commission should take the necessary regulatory action.

Amendment 207

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 21

Text proposed by the Commission	Amendment
(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the safety of the natural complex substances when used in cosmetic products, the Commission should mandate the SCCS to assess the impact of such constituent on the safety of natural complex substances, if a safety concern arises, and is to follow up with the appropriate regulatory measures in accordance with Article 31(1) of Regulation (EC) No 1223/2009.	(21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the constituent(s) of such substance, as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008, based on the data of the natural complex substance itself if they exist. When a constituent of a natural complex substance is classified as a CMR (categories 1A, 1B or 2), this may raise concerns about its safe use in cosmetics. In such cases, the Commission should systematically request the SCCS to assess such constituents and, where necessary, take regulatory action under Article 31(1) of Regulation (EC) No 1223/2009.

Or. en

Amendment 208

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Recital 21 a (new)

Text proposed by the Commission	Amendment
	(21a) The specific characteristics of complex natural substances, such as essential oils and vegetable oils, must be taken into account so as not to disproportionately penalise a sector composed mainly of SMEs and family businesses. An open and proportionate approach, with appropriate compliance deadlines, is necessary to safeguard these traditional industries, foster their competitiveness and promote production based on local expertise.

Or. fr

Amendment 209

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures. To enable manufacturers of cosmetic products amongst others to secure the suitable alternative substances, to carry out tests as part of reformulation process and to proceed with the safety assessment of the final products and their re-labelling and mandatory notifications, they should be provided with appropriate adjustment period. During this period distributors and retailers continue to receive cosmetic products containing the substance subject to regulatory measures. Therefore, they need additional time to withdraw such products from the distribution chain and to destroy the unsold products not complying with the new requirements. These actions impact the existing contractual arrangements and require substantial logistical efforts. Accordingly, a period of 24 months for placing and 48 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided. An up-to-date Cosmetic Product Safety Report (CPSR) must remain available at all times.

Or. en

Amendment 210

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures. To enable manufacturers of cosmetic products amongst others to secure the suitable alternative substances, to carry out tests as part of reformulation process and to proceed with the safety assessment of the final products and their re-labelling and mandatory notifications, they should be provided with appropriate adjustment period. During this period distributors and retailers continue to receive cosmetic products containing the substance subject to regulatory measures. Therefore, they need additional time to withdraw such products from the distribution chain and to destroy the unsold products not complying with the new requirements. These actions impact the existing contractual arrangements and requires substantial logistical efforts. Accordingly, a period of 24 months for placing and 48 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Justification

Under the CPR, the absence of formal transitional periods following a ban or restriction leads to the immediate withdrawal of products from the market, even where they are demonstrably safe, resulting in unnecessary waste and economic loss. The Omnibus proposal therefore rightly introduces transitional arrangements. These should be set at 24 months for placing on the market and 48 months for making available, where a valid Cosmetic Product Safety Report (CPSR) exists, allowing sufficient time for reformulation without compromising consumer safety. Urgent risks would continue to be addressed through existing emergency procedures, while limited flexibility to grant longer periods in duly justified, technically complex cases would further enhance legal certainty and prevent avoidable market disruption.

Amendment 211

Majdouline Sbai

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products due to safety concerns, manufacturers, importers, distributors and responsible persons should withdraw the products concerned very swiftly. When a substance is prohibited or restricted from the use in cosmetic products due to the existence of suitable alternatives, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures. Therefore, in such cases, it is justified to give additional time to withdraw such products from the distribution chain and to destroy the unsold products not complying with the new requirements. Therefore, in case a suitable alternative exists, a period of 6 months for placing on the market and of 12 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Justification

It is important to distinguish between two different cases that can confirm the ban of CMR substances in cosmetics: lack of safety or existence of a suitable alternative. In case of safety problems, the products should be withdrawn from the market swiftly. It would be irresponsible to allow the placing on the market of cosmetic products that are unsafe because they contain a CMR substance to continue for another year, and the sale even for yet another year. A grace period may only be granted in case of existence of a suitable alternative. A grace period of 6/12 months is sufficient.

Amendment 212

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 24 months for placing and 48 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Amendment 213

Raúl de la Hoz Quintano, Dolors Montserrat, Esther Herranz García, Susana Solís Pérez, Pablo Arias Echeverría

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 24 months for placing and 48 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Amendment 214

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, a period of 6 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Amendment 215

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy, Yvan Verougstraete

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time, after submitting their request for derogation, to take necessary measures to withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, period of 6 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Justification

A limited transition period should be provided to economic operators after classification of CMR substances in existing cosmetic products to achieve their orderly withdrawal from the market. No new products should, however, be allowed on the market after CMR classification to prevent lock-ins and stranded investments and to protect citizens, including children and other vulnerable groups.

Amendment 216

Proposal for a regulation

Recital 22

Text proposed by the Commission	Amendment
(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, periods of 12 months for placing and 24 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.	(22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Therefore, a period of maximum 12 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided.

Or. en

Amendment 217

Idoia Mendia, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission	Amendment
	(22a) Per- and polyfluorinated alkyl substances (PFAS) are a large family of more than 10 000 man-made chemicals. PFAS have been used in an increasingly wide range of products, including consumer products. Due to their exceptional stability, water-repellent properties, and film-forming capabilities, PFAS have been used in cosmetic products as emulsifiers, stabilizers, and film-forming agents, particularly in long-wear foundations, waterproof mascaras, hair styling products, and sunscreens. Scientific evidence has demonstrated that exposure to PFAS poses significant risks to human health, including potential carcinogenic effects, liver damage, immune system suppression, thyroid dysfunction, and developmental issues in children. Studies have indicated that even low-level exposure may result in adverse health outcomes, with particular concern for vulnerable populations. While some individual PFAS substances are already prohibited in cosmetic products under Annexes II and III of Regulation (EC) No 1223/2009 due to their classification as carcinogenic, mutagenic, or toxic to reproduction (CMR), or following safety assessments demonstrating unacceptable risks to human health, the fragmented regulation of individual PFAS substances is insufficient to address the risks posed by this large group of structurally related chemicals. Moreover, evidence demonstrates that technically and economically feasible alternatives to PFAS in cosmetic applications already exist and are available on the market, including silicon-based compounds, biodegradable polymers, and natural waxes. The cosmetics industry has successfully formulated products without intentionally added PFAS, demonstrating that viable substitutes can maintain product performance and quality. A harmonized Union-wide approach is necessary to ensure a level playing field for economic operators, prevent market fragmentation, and provide consistent protection for all Union consumers. A comprehensive prohibition of PFAS in cosmetic products is therefore necessary as the most effective regulatory option to minimize human exposure and environmental contamination from this source.

Or. en

Amendment 218

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy, Yvan Verougstraete

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission	Amendment
	(22a) Per- and polyfluorinated alkyl substances (PFAS) are a large family of more than 10 000 man-made chemicals. PFAS have been used in an increasingly wide range of products, including consumer products. A core concern is the persistency of all PFAS leading to increasing environmental concentrations. Exposure to the most studied PFAS has been associated with a range of adverse health effects. The intentional use of PFAS in cosmetics and its ingredients should be prohibited.

Or. en

Justification

Some PFAS, e.g. PFHxA and PFHxA-related substances are already banned in cosmetics. EC announced the intention to ban all PFAS in cosmetics, as in case of toys. France has in absence of EU-wide measure banned cosmetics products containing all intentionally added PFAS as of January 2026 (with 12-month transition period for products placed on the market before this date). To prevent barriers on the internal market for the cosmetics industry, dual standards in protection, and to ensure that the CPR will not have to be opened again soon, the ban of PFAS is already reflected in this proposal.

Amendment 219

Majdouline Sbai

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission	Amendment
	(22a) Per- and polyfluorinated alkyl substances (PFAS) are a large family of more than 10 000 man-made chemicals. PFAS have been used in an increasingly wide range of products, including cosmetic products. A core concern is the persistency of all PFAS leading to increasing environmental concentrations. However, exposure to the most studied PFAS has also been associated with a range of adverse health effects. The use of PFAS in cosmetics should be prohibited.

Or. en

Justification

PFAS are banned in France in cosmetics since January 2026. In 2025, the EU banned PFAS in toys. In 2024, the EU banned PFAS in food contact packaging. In 2023, four Member States and Norway proposed a universal restriction of PFAS, including for cosmetics. They made a clear case for prohibiting PFAS in cosmetics. About 1% of cosmetic products contain PFAS. An analysis of the market share of PFAS-containing products showed that most occurred in the product category decorative cosmetics (3.7%), followed by skin care, hair care and toiletries (0.78, 0.65 and 0.27% respectively). There is sufficiently strong evidence that technically and economically feasible alternatives exist. There is no evidence of a shortage in supply of alternatives. The costs of a restriction within 18 months are assessed to be low. They proposed a restriction applicable within 18 months after entry into force. In October 2024, EVP Séjourné committed the following in his written responses to the European Parliament: "I will seek to ban the use of PFAS in consumer uses, like cosmetics, food contact materials and outdoor clothing." However, in the meantime, the Commission has made clear that it will not take any action until ECHA's scientific committees have given their opinion. Their opinions are expected for the end of 2026. So it will take at least until mid-2027 before the Commission will take any restrictive action against PFAS in cosmetics. Given the clear case for a restriction already made three years ago, we cannot afford to wait any longer. We should seize the opportunity of the chemical omnibus to also improve protection of human health and the environment. A ban of PFAS in cosmetics should be applicable within 18 months. As co-legislator we are entitled to adopt such a ban, there is no need to wait for ECHA's opinions as confirmed in the judgment by the ECJ in Case T 745/20.

Amendment 220

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission	Amendment
	(22a) The Chemicals Strategy for Sustainability called for simplifying and strengthening the legal framework on chemicals. In particular, the strategy commits to strengthen the Cosmetic Products Regulation with respect to risks from endocrine disruptors and from possible combination effects of chemicals.

Or. en

Amendment 221

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Recital 22 b (new)

Text proposed by the Commission	Amendment
	(22b) Given the essential role of the endocrine system during human development, exposure to endocrine disruptors can lead to adverse health effects even at very low doses. Chemicals that affect the endocrine system should therefore be specifically addressed in cosmetic products. In particular, the requirements for such substances need to be simplified and strengthened by extending Article 15 of Regulation (EC) No 1223/2009 to substances classified as endocrine disruptors for human health, category 1 and 2, pursuant to Regulation (EC) No 1272/2008.

Or. en

Amendment 222

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 23

Text proposed by the Commission	Amendment
(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. The conditions of such notification should apply in a non-discriminatory way to cosmetic products containing nanomaterials and to those cosmetic products which do not contain them. To maintain vigilance on nanomaterials, it should be required that the specific information on nanomaterials used in a cosmetic product is provided in the cosmetic product safety report so that it can be consulted by the competent authorities where the concerns over the potential risk to human health arise from the use of a particular nanomaterial	deleted

Or. en

Amendment 223

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 23

Text proposed by the Commission	Amendment
(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. The conditions of such notification should apply in a non-discriminatory way to cosmetic products containing nanomaterials and to those cosmetic products which do not contain them. To maintain vigilance on nanomaterials, it should be required that the specific information on nanomaterials used in a cosmetic product is provided in the cosmetic product safety report so that it can be consulted by the competent authorities where the concerns over the potential risk to human health arise from the use of a particular nanomaterial	(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. The conditions of such notification should apply in a non-discriminatory way to cosmetic products containing nanomaterials and to those cosmetic products which do not contain them. Vigilance on nanomaterials is ensured through the existing requirements that the specific information on nanomaterials used in a cosmetic product used in a cosmetic product is provided in the Cosmetic Products Notification Portal (CPNP) notification and in the cosmetic product safety report that are both accessible to competent authorities where concerns over the potential risk to human health arise from the use of a particular nanomaterial, these can be appropriately addressed with the restriction process for ingredients established under this Regulation, where necessary following the urgency procedure referred to in Article 32(4) of this regulation.

Or. en

Justification

The proposal to introduce specific nanomaterial requirements in Annex I, Part A, point 2 of the CPR would create unnecessary duplication and additional administrative burdens. The same information is already required under existing provisions, notably Article 13 and other relevant parts of Annex I of the Cosmetic Product Safety Report (CPSR). Removing these provisions would avoid redundant documentation and reduce costs without compromising safety, as robust mechanisms for the assessment of nanomaterials remain in place elsewhere in the CPR.

Amendment 224

Proposal for a regulation

Recital 23

Text proposed by the Commission	Amendment
(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. The conditions of such notification should apply in a non-discriminatory way to cosmetic products containing nanomaterials and to those cosmetic products which do not contain them. To maintain vigilance on nanomaterials, it should be required that the specific information on nanomaterials used in a cosmetic product is provided in the cosmetic product safety report so that it can be consulted by the competent authorities where the concerns over the potential risk to human health arise from the use of a particular nanomaterial	(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, notifications of the cosmetic products should only be required before placing them on the Union market. To maintain vigilance on nanomaterials, specific information on nanomaterials used in a cosmetic product should continue to be provided by the responsible persons through the existing process before the product is placed on the market.

Or. en

Amendment 225

Majdouline Sbai

Proposal for a regulation

Recital 23

Text proposed by the Commission	Amendment
(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. The conditions of such notification should apply in a non-discriminatory way to cosmetic products containing nanomaterials and to those cosmetic products which do not contain them. To maintain vigilance on nanomaterials, it should be required that the specific information on nanomaterials used in a cosmetic product is provided in the cosmetic product safety report so that it can be consulted by the competent authorities where the concerns over the potential risk to human health arise from the use of a particular nanomaterial	(23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, only one notification of the cosmetic products should be required before placing them on the Union market. To maintain vigilance on nanomaterials in cosmetic products, it should be required that this notification includes specific information on the nanomaterials concerned to be provided by the responsible persons through the existing process before the product is placed on the market. This is necessary so that a safety assessment can be requested by the Commission in case of concerns. It should also be required that the specific information on nanomaterials used in a cosmetic product is provided in the cosmetic product safety report so that it can be consulted by the competent authorities where concerns over the potential risk to human health arise from the use of a particular nanomaterial in cosmetic products.

Or. en

Justification

Safety of cosmetic products is top priority. Nanomaterials in cosmetics raise potential safety concerns. Both the Commission and Member States should be able to address any such safety concerns. It is therefore necessary to maintain the existing notification of specific risk information with regard to nanomaterials to the Commission. Including it in the general notification means that the notification is delayed by six months compared to current law, but this could be accepted with a view to simplify procedures while maintaining responsibility of the Commission to act in case of concerns. At the same time, it makes sense to include this information also in the cosmetic product report, so that it is also available to Member States.

Amendment 226

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Recital 25

Text proposed by the Commission	Amendment
(25) Cosmetics are globally traded goods. It is therefore important that the ingredient names present on their labels reflect the current state of scientific and technological development. The use of internationally recognised cosmetic ingredient’ names is an important factor promoting transparency and facilitating cross-border trade in cosmetics. This Regulation should enable internationally recognised names to be used on the labelling of cosmetic products without any additional regulatory action from the Commission. As a glossary of common ingredient names adopted by the Commission would slow down the process of uptake of the new names, the provision requiring the Commission to adopt such a glossary should be abolished.	(25) Cosmetics are globally traded goods and it is therefore essential that the ingredient names present on their labels reflect the current state of scientific and technological development in a timely manner. The use of internationally recognised nomenclature, such as the International Nomenclature of Cosmetic ingredient (INCI)’ names is an important factor promoting Ingredients transparency for consumers, ensures consistency across jurisdictions, and facilitates cross-border trade in cosmetics. INCI names are maintained by the Personal Care Products Council (PCPC) as an international industry standard and are widely recognised by regulators and stakeholders worldwide. This Regulation should enable the direct use of internationally recognised names nomenclature, such as INCI, to be used on the labelling of cosmetic products without any additional further regulatory action from the Commission. Where a common ingredient name is not available in INCI, other generally accepted nomenclature should be used, for example names established in recognised international chemical or pharmacopoeia references, or in other authoritative sources commonly relied upon by industry and regulators. This approach ensures flexibility, avoids unnecessary administrative burden, and guarantees that ingredient names used on cosmetic product labelling remain up to date, internationally coherent, and easily understandable to consumers. As a glossary of common ingredient names adopted by the Commission would slow down the process of uptake of the new names, the provision requiring the Commission to adopt such a glossary should be abolished.

Or. en

Justification

The Commission proposes deleting Article 33 and amending Article 19 to rely on internationally recognised nomenclature for cosmetic labelling, replacing the existing terminology list. However, it does not specify which nomenclature should apply. The proposal should therefore be complemented, as in the Council’s general approach (Recital 25), by clarifying that this refers to the International Nomenclature of Cosmetic Ingredients (INCI).

Amendment 227

Proposal for a regulation

Recital 25 a (new)

Text proposed by the Commission	Amendment
	(25a) In order to ensure a high level of protection of human health, all operators placing cosmetic products on the Union market, whether offline or online, should be subject to equivalent obligations and effective enforcement. This is particularly important given the growing sale of cosmetics via online marketplaces, including products originating from third countries that are not subject to the same health and safety requirements. Therefore, it is necessary to require the labelling information referred to in Article 19 to be clearly and visibly indicated in case of distance sales, including via online marketplaces. This requirement will simplify enforcement of Regulation (EC) No 1223/2009 and thereby contribute to fair competition and a high level of protection of human health. Furthermore, post-market surveillance should be strengthened, notably for online sales and imports, and cosmetic products identified as non-compliant through the Union rapid alert system (Safety Gate) should not be listed or offered for sale. To this end, online platforms should verify the identity of the responsible person before allowing products to be placed on the Union market, and the online sale, offering for sale and promotion, including via social media, of banned cosmetics, in particular mercury-added products, should be explicitly prohibited.

Or. en

Amendment 228

Sander Smit

Proposal for a regulation

Recital 26

Text proposed by the Commission	Amendment
(26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be reached, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products should also be provided in electronic form. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.	(26) Digital solutions for the EU declaration of conformity should remain voluntary and do not affect the nature of the declaration as an internal compliance document; these are to be made available to competent authorities and relevant economic operators upon request in accordance with Regulation (EU) 2019/1009.

Or. nl

Amendment 229

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 26

Text proposed by the Commission	Amendment
(26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be reached, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products should also be provided in electronic form. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.	(26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be contacted by users and competent authorities so as to adequately answer any queries from those, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products should also be provided in electronic form. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.

Or. en

Amendment 230

Proposal for a regulation

Recital 26

Text proposed by the Commission	Amendment
(26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be reached, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products should also be provided in electronic form. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.	(26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be reached, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form in a swift manner and without undue delay. Documents and correspondence to and from notified bodies, national authorities or EFSA related to conformity assessments of EU fertilising products should also be provided in electronic form. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.

Or. en

Amendment 231

Proposal for a regulation

Recital 26 a (new)

Text proposed by the Commission	Amendment
	(26a) While simplification aims to reduce administrative burdens and can facilitate market access for fertiliser traders, making it easier for operators to enter the EU market and operate beyond national markets to the benefit of the Single Market, it should not undermine a high level of consumer, health and environmental protection or risk management. Easing sector-specific requirements for fertilising products may increase the risk of chemicals subject to lower levels of control entering the market, raising concerns regarding traceability, safety, and reputational impacts. Shifting obligations back to the general chemicals framework, notably REACH, may create uncertainty regarding registration, notification, and labelling requirements, making it essential to ensure continued alignment with horizontal chemicals, environmental, and safety legislation.

Or. en

Amendment 232

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Recital 26 a (new)

Text proposed by the Commission	Amendment
	(26a) Fertiliser products covered by Regulation (EU) 2019/1009 account for a significant proportion of agricultural production costs and impinge directly upon farmers’ incomes and competitiveness. The increase in regulatory and administrative burdens on producers has knock-on effects throughout the supply chain, increasing costs for farmers and widening the gap between agricultural production costs in the Union and those in third countries. Any revision of Regulation (EU) 2019/1009 should therefore prioritise regulatory simplification for EU fertiliser producers, with direct benefits for EU farmers.

Or. fr

Amendment 233

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 26 a (new)

Text proposed by the Commission	Amendment
	(26a) The European Parliament has called for the Union and its Member States not to grant patents on biological material. Hence, processes that are essentially biological, as well as species or organisms, including micro-organisms, parts thereof, genetic information and the process features they contain should not be subject to patent legislation.

Or. en

Amendment 234

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Recital 27

Text proposed by the Commission	Amendment
(27) Under Regulation (EU) 2019/1009, only micro-organisms listed on a positive list in Annex II to that Regulation may be used as component material in microbial plant biostimulants. The Commission is empowered to add new micro-organisms or strains of micro-organisms to that list after an assessment concluding that none of the strains presents a risk to human, animal or plant health, to safety or to the environment and that it ensures agronomic efficiency. Given the large number of micro-organisms on the market, the assessment and subsequent inclusion of new micro-organisms or strains of micro-organism to the positive list are lagging scientific progress. The current mechanism slows down the development of microbial plant biostimulants and delays farmers’ access to those innovative fertilising products which may stimulate plant nutrition processes and thereby reduce the use of traditional fertilisers.	(27) Under Regulation (EU) 2019/1009, only micro-organisms listed on a positive list in Annex II to that Regulation may be used as component material in microbial plant biostimulants. The Commission is empowered to add new micro-organisms or strains of micro-organisms to that list after an assessment concluding that none of the strains presents a risk to human, animal or plant health, to safety or to the environment and that it ensures agronomic efficiency. Given the large number of micro-organisms on the market, the assessment and subsequent inclusion of new micro-organisms or strains of micro-organism to the positive list are lagging scientific progress. The current mechanism slows down the development of microbial plant biostimulants and delays farmers’ access to those innovative fertilising products. The use of traditional fertilisers must remain a viable and accessible option so as not to affect competitiveness and production within the EU.

Or. fr

Amendment 235

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies, in consultation with the relevant national authorities, the EFSA and the JRC, to thoroughly demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. This assessment requires independence, objectivity, impartiality, professional integrity and special expertise for which conformity assessment bodies will need to be specifically accredited and notified. The national bodies responsible for accreditation and notification should carefully verify the conformity assessment bodies’ technical and scientific competence in the assessment of micro-organisms and that they meet the stringent requirements for notified bodies set out by the Regulation, including independence, objectivity, impartiality and professional integrity. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission invite EFSA and the JRC as independent scientific bodies, to review, contribute, and carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 236

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers to document and demonstrate compliance and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. Verifying compliance of micro-organisms with the criteria and methodology set under this Regulation will require specific competences and technical knowledge from the conformity assessment bodies, requiring therefore accreditation and notification in line with Regulation (EU)765/2008. Those competences should be therefore scrutinized by the national bodies in charge of accreditation and notification, as well as aspects such as independence, objectivity, impartiality and professional integrity. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission involves the relevant scientific and independent bodies, in particular the European Food Safety Agency and the ECHA, in its preparatory work and also carry out appropriate consultations during its preparatory work , including at expert level. Those consultations should be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 237

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms taking into account technical studies contracted by the European Commission in the context of this Regulation.. Those criteria and the methodology should define specific data protection disposals for test and study reports on micro-organisms and allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. This empowerment should complement, and be without prejudice to, the existing listing based approach for micro-organisms under CMC 7 of Annex II.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 238

Sander Smit

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. In order to ensure legal certainty and effective implementation, the criteria-based procedure for the assessment of new materials should be carried out through the delegation of powers laid down in Article 42(1) of Regulation (EU) 2019/1009.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. nl

Amendment 239

Daniel Buda

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms and for ensuring common minimum criteria throughout the EU. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations, together with a scientific body such as EFSA or the JRC, and to which experts are also invited, during its preparatory work, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. ro

Amendment 240

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, are compliant and do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and with the JRC, ECHA and the European Food Safety Authority (EFSA), and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. en

Amendment 241

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Recital 28

Text proposed by the Commission	Amendment
(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.	(28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency without impinging upon EU competitiveness and production. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
_________________	_________________
13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.	13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

Or. fr

Amendment 242

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 29

Text proposed by the Commission	Amendment
(29) Where the Commission makes use of its empowerment to amend the component material categories in Annex II to Regulation (EU) 2019/1009, it may currently only do so via separate delegated acts in respect of each component material category. Considering the need to introduce additional materials to the various component material categories in the future and the constant technical and scientific progress in the fertilising product sector, there is a frequent need to amend the different component material categories. In some cases, for instance where a new raw material may be allowed in multiple CMCs, the Commission would introduce the same change in all relevant CMCs, each of them covered by a different delegated act. To speed up the adoption of the respective delegated acts, the Commission should be allowed to amend several component material categories by one delegated act.	deleted

Or. en

Amendment 243

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 29

Text proposed by the Commission	Amendment
(29) Where the Commission makes use of its empowerment to amend the component material categories in Annex II to Regulation (EU) 2019/1009, it may currently only do so via separate delegated acts in respect of each component material category. Considering the need to introduce additional materials to the various component material categories in the future and the constant technical and scientific progress in the fertilising product sector, there is a frequent need to amend the different component material categories. In some cases, for instance where a new raw material may be allowed in multiple CMCs, the Commission would introduce the same change in all relevant CMCs, each of them covered by a different delegated act. To speed up the adoption of the respective delegated acts, the Commission should be allowed to amend several component material categories by one delegated act.	deleted

Or. en

Amendment 244

Proposal for a regulation

Recital 29

Text proposed by the Commission	Amendment
(29) Where the Commission makes use of its empowerment to amend the component material categories in Annex II to Regulation (EU) 2019/1009, it may currently only do so via separate delegated acts in respect of each component material category. Considering the need to introduce additional materials to the various component material categories in the future and the constant technical and scientific progress in the fertilising product sector, there is a frequent need to amend the different component material categories. In some cases, for instance where a new raw material may be allowed in multiple CMCs, the Commission would introduce the same change in all relevant CMCs, each of them covered by a different delegated act. To speed up the adoption of the respective delegated acts, the Commission should be allowed to amend several component material categories by one delegated act.	(29) Where the Commission makes use of its empowerment to amend the component material categories in Annex II to Regulation (EU) 2019/1009, it may currently only do so via separate delegated acts in respect of each component material category. To speed up the adoption of the respective delegated acts, the Commission should be exceptionally allowed to amend several component material categories by one delegated act in a timely manner and without undue delay in two cases, to introduce or remove the same raw material, or to introduce, amend or remove the same requirements. It is essential the Commission preserves strong interinstitutional cooperation and consultation, in full compliance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

Or. en

Amendment 245

Sander Smit

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission	Amendment
	(29a) Regulation (EU) 2019/1009 aims to facilitate the placing on the internal market and free movement of safe fertilising products, while supporting the recycling of nutrients and the circular use of raw materials and ensuring a high level of protection for human, animal and plant health and the environment. The effective application thereof depends, among other things, on the recognition of end points for constituent materials derived from animal by-products within the meaning of Regulation (EC) No 1069/2009. Delegated Regulation (EU) 2023/1605 has established certain end points for animal by-products intended for fertiliser applications. However, the processing parameters and risk mitigation measures included therein are largely derived from frameworks for feed hygiene and the prevention of feed fraud and do not always reflect the distinct exposure routes and risk profiles of fertiliser products applied to the soil. The application of processing standards or risk mitigation measures designed for feed applications to fertiliser products may therefore create unnecessary barriers to the marketing of safe fertiliser products without providing additional protection for human or animal health or the environment. Where appropriate processing has eliminated the relevant risks, taking into account the conditions of use of fertilising products and the conformity assessment requirements under Regulation (EU) 2019/1009, the lack of compliance with feed-related processing standards should not in itself prevent an end point from being recognised.

Or. nl

Justification

Since the adoption of Delegated Regulation (EU) 2023/ 1605, competent authorities increasingly treat these as an exhaustive list of permitted fertilisation methods, even though Article 5 of Regulation (EC) No 1069/2009 is based on the principle of risk elimination rather than closed lists. This recital restores legal clarity, prevents unnecessary blocking of safe materials and supports the effective application of the regulation on fertilising products without lowering safety standards.

Amendment 246

Proposal for a regulation

Recital 30

Text proposed by the Commission	Amendment
(30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product, in accordance with Article 14 of that Regulation. Those extensive information requirements might prevent manufacturers, especially small and medium-sized enterprises, from using substances that are not yet registered according to those requirements or force them to place their products only on national markets according to national rules. For the sake of proportionality, and considering the general obligation of manufactures and importers of substances and EU fertilising products under Regulation (EC) No 1907/2006 and Regulation (EU) 2019/1009, respectively, to ensure the safety of the products that they place on the market, registration of substances used in EU fertilising products should only follow the requirements, including the relevant gradations, set out in Regulation (EC) No 1907/2006.	deleted

Or. en

Amendment 247

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 30

Text proposed by the Commission	Amendment
(30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product, in accordance with Article 14 of that Regulation. Those extensive information requirements might prevent manufacturers, especially small and medium-sized enterprises, from using substances that are not yet registered according to those requirements or force them to place their products only on national markets according to national rules. For the sake of proportionality, and considering the general obligation of manufactures and importers of substances and EU fertilising products under Regulation (EC) No 1907/2006 and Regulation (EU) 2019/1009, respectively, to ensure the safety of the products that they place on the market, registration of substances used in EU fertilising products should only follow the requirements, including the relevant gradations, set out in Regulation (EC) No 1907/2006.	(30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product, in accordance with Article 14 of that Regulation.

Or. en

Amendment 248

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 30

Text proposed by the Commission	Amendment
(30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product, in accordance with Article 14 of that Regulation. Those extensive information requirements might prevent manufacturers, especially small and medium-sized enterprises, from using substances that are not yet registered according to those requirements or force them to place their products only on national markets according to national rules. For the sake of proportionality, and considering the general obligation of manufactures and importers of substances and EU fertilising products under Regulation (EC) No 1907/2006 and Regulation (EU) 2019/1009, respectively, to ensure the safety of the products that they place on the market, registration of substances used in EU fertilising products should only follow the requirements, including the relevant gradations, set out in Regulation (EC) No 1907/2006.	(30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product, in accordance with Article 14 of that Regulation.

Or. en

Amendment 249

Per Clausen, Anja Hazekamp

Proposal for a regulation

Recital 33

Text proposed by the Commission	Amendment
(33) Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 should therefore be amended accordingly,	(33) Regulations (EC) No 1272/2008, (EC) No 1223/2009, (EU) 2019/1009, (EC) 1107/2009 and (EU) No 528/2012 should therefore be amended accordingly,

Or. en

Amendment 250

Andrea Wechsler, Stefan Köhler, Christine Schneider, Norbert Lins, Jens Gieseke, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point -1 (new)

Regulation (EC) No 1272/2008

Article 12

Present text	Amendment
	-1. Article 12 is replaced by the following:
Specific cases requiring further evaluation Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:	‘Specific cases requiring further evaluation Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:
(a) adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests;	(a) adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests; (b) conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;
(b) conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;	(c) adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture;
(c) adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture.	(d) where reliable scientific information demonstrates that the potential hazards cannot occur under realistic and intended conditions for use because the substance would not be biologically available, would be physically bound or would have to be absorbed by non-relevant routes of exposure.’

Or. de

(https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02008R1272-20200501#tocId1)

Justification

The proposed amendments to Article 12 provide a clear legal basis for hazard classifications to be carried out only if the hazards can actually occur under realistic conditions of use.

Amendment 251

Andrea Wechsler, Stefan Köhler, Christine Schneider, Norbert Lins, Jens Gieseke, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point -1 a (new)

Regulation (EC) No 1272/2008

Article 36 – paragraph 1

Present text	Amendment
	-1a. in Article 36, paragraph 1 is replaced by the following:
(1) A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:	(1) A substance that fulfils the criteria set out in Annex I for the following shall, taking into account the specific cases set out under Article 12 and provided that a relevant route of exposure exists under realistic conditions for use, normally be subject to harmonised classification and labelling in accordance with Article 37:
(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4);	(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4);
(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);	(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);	(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7);	(d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7);
(e) endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11);	(e) endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11);
(f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2); (g) persistent, bioaccumulative and toxic (Annex I, section 4.3);	(f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2); (g) persistent, bioaccumulative and toxic (Annex I, section 4.3);
(h) very persistent, very bioaccumulative (Annex I, section 4.3);	(h) very persistent, very bioaccumulative (Annex I, section 4.3);
(i) persistent, mobile and toxic (Annex I, section 4.4);	(i) persistent, mobile and toxic (Annex I, section 4.4);
(j) very persistent, very mobile (Annex I, section 4.4);	(j) very persistent, very mobile (Annex I, section 4.4)’;

Or. de

(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-20250901&qid=1769779965164)

Justification

The additions to Article 36 ensure that harmonised classifications are not triggered automatically but are subject to a prior relevance check based on real world data and practically significant exposure scenarios. Furthermore, it is ensured that the decision on the need for harmonised classification of plant protection and biocidal active substances remains at the discretion of the competent authorities and the Commission, as it was prior to amending Regulation (EU) 2024/2865.

Amendment 252

Andrea Wechsler, Stefan Köhler, Christine Schneider, Norbert Lins, Jens Gieseke, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point -1 b (new)

Regulation (EC) No 1272/2008

Article 36 – paragraph 2

Present text	Amendment
	-1b. In Article 36, paragraph 2 is replaced by the following:
Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.	‘Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall be subject to harmonised classification and labelling only if the competent authorities, after consulting the Agency, determine that a harmonised classification is necessary and proportionate for the protection of health and the environment. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.’

Or. de

(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-20250901&qid=1769779965164)

Justification

Amendment 253

Andrea Wechsler, Stefan Köhler, Christine Schneider, Norbert Lins, Jens Gieseke, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point -1 c (new)

Regulation (EC) No 1272/2008

Article 37 – paragraph 1

Present text	Amendment
	-1c. in Article 37, paragraph 1 is replaced by the following:
(1) A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for a revision thereof. The Commission may request the Agency or the European Food Safety Authority (the ‘Authority’) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency. The proposals for harmonised classification and labelling of a substance or a group of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.	‘(1) A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits or M-factors or a proposal for a revision thereof.
	The Commission may request the Agency or the European Food Safety Authority (the ‘Authority’) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.
	Before submitting a proposal, the competent authority shall systematically verify: (a) whether the available toxicological and ecotoxicological information is relevant to the actual and intended use of the substance or mixture;
	(b) whether there is at least one realistic and quantitatively relevant route of exposure (oral, dermal and/or inhalation) for the relevant hazard category, considering in particular whether the amount, concentration and duration of anticipated exposure are sufficient to cause the effects described in the toxicological data.
	(c) whether scientific findings from poison centres, occupational health examinations, market surveillance data or epidemiological studies provide evidence of a hazard relevance in a real-life use context.
	In the event that this verification shows that no relevant route of exposure exists, or that the hazard characteristics cannot occur under the intended conditions, no proposal for harmonised classification shall be made.
	The proposal of the Authority shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

Or. de

(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-20250901&qid=1769779965164)

Justification

The additions to Article 37 ensure that harmonised classifications are not triggered automatically but are subject to a prior relevance check based on real world data and practically significant exposure scenarios. Furthermore, it is ensured that the decision on the need for harmonised classification of plant protection and biocidal active substances remains at the discretion of the competent authorities and the Commission, as it was prior to amending Regulation (EU) 2024/2865.

Amendment 254

Majdouline Sbai

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel such as email addresses or a weblink through which a supplier can be contacted without the need to register or to download or use an application. Digital contact shall allow users and competent authorities to engage in a dialogue with the economic operators and exclude the use of automatic means or replies such as chatbots or automatic replies;

Or. en

Justification

It should be clarified that a digital contact should serve to all allow users and competent authorities to engage in a dialogue with the economic operators, and that it should exclude the use of automatic means or replies such as chatbots or automatic replies.

Amendment 255

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which an economic operator can be contacted without the need to register or to download or use additional applications specific to the economic operator.;

Or. en

Amendment 256

Daniel Buda

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;	42. ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached directly, without the need for any intermediate step, such as registering any data or downloading an application;

Or. ro

Amendment 257

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date, easily and freely accessible online communication channel through which a supplier can be contacted without the need to register or to download or use an application.;

Or. en

Amendment 258

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;

Or. en

Justification

The amendment clarifies that a “digital contact” must be up to date, accessible and free of charge, thereby preventing financial, technical or procedural barriers. It ensures that consumers and competent authorities can contact suppliers without costs, registration or the use of proprietary applications, strengthening transparency and accountability while aligning the use of digital tools with consumer protection principles under Regulation (EC) No 1272/2008.

Amendment 259

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;

Or. en

Amendment 260

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;

Or. en

Amendment 261

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;

Or. en

Amendment 262

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Text proposed by the Commission	Amendment
42. “digital contact” means any up-to-date and accessible online communication channel through which a supplier can be reached or engaged without the need to register or to download an application.;	42. “digital contact” means any up-to-date and freely accessible online communication channel through which a supplier can be reached without the need to register or to download an application.;

Or. en

Amendment 263

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1272/2008

Article 2 – paragraph 42a

Text proposed by the Commission	Amendment
	42a. ‘placing on the market’ means the first making available on the market of a product.

Or. en

Justification

CLP does not distinguish between “placing on the market” and “making available on the market.” When a new classification applies, companies must relabel both new products and those already in the supply chain, causing logistical burdens such as recalls, relabeling, added costs, and increased waste.

Amendment 264

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk

Proposal for a regulation

Article 1 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – point 4

Text proposed by the Commission	Amendment
	(1a) Article 5(3)(4) is amended as follows:
	For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disruption for human health’ and ‘endocrine disruption for the environment’ hazard classes referred to in sections 3.5., 3.6., 3.7., 3.11. and 4.2. of Annex I, the manufacturer, importer and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents.
	Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met:
	(a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;
	(b) the information supports the conclusions based on the relevant available information on the constituents in the substance.
	Relevant information available on the substance containing more than one component, and as such demonstrating the absence of the properties referred to in point (a) or the existence of less severe properties cannot take precedence over relevant information available on the components of the substance in the event that conclusive scientific experimental data demonstrate that the component is not bioavailable and/or that there is a risk of synergistic or antagonistic effects between the constituents of the substance.

Or. fr

Justification

Under the Globally Harmonised System and the rules applicable to mixtures, it should be possible to demonstrate the absence of bioavailability or the presence of antagonistic/synergistic effects in accordance with the provisions of Article 12 on mixtures. If a complex substance is tested for its effects on health, these test data should prevail and take precedence over a theoretical assessment based on the individual constituents of the complex substance.

Amendment 265

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1272/2008

Article 2 – paragraph 42b

Text proposed by the Commission	Amendment
	(1a) ‘making available on the market’ means any supply of a product for distribution or use in the course of a commercial activity, whether in return for payment or free of charge.

Or. en

Justification

Amendment 266

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) the name, address and digital contact of the suppliers;;	(a) the name, address and digital contact or the telephone number of the suppliers;;

Or. en

Amendment 267

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) the name, address and digital contact of the suppliers;;	(a) the name, address, telephone number and/or digital contact of the suppliers;

Or. en

Amendment 268

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) the name, address and digital contact of the suppliers;;	(a) the name, address, telephone number and digital contact of the suppliers;

Or. en

Amendment 269

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

Text proposed by the Commission	Amendment
(a) the name, address and digital contact of the suppliers;;	(a) the name, address telephone number or digital contact of the suppliers;;

Or. en