Sittings · Document

Draft report (COM(2022)0748 – C9-0433/2022 – 2022/0432(COD)) 2023-05-16

Amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

Committee on the Environment, Public Health and Food Safety

Official HTML ↗ PDF DOCX

AM_Com_LegReport

Amendment 58

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision, together with requirements in Regulation (EU) No xxx/xxx [reference to adopted act to be inserted] on General Product Safety, Regulation (EU) No 2022/2065, and Regulation (EU) 2019/1020 would improve compliance with and enforcement of the Regulation (EC) No 1272/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

Or. en

Amendment 59

Anja Hazekamp

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human and animal health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

Or. en

Amendment 60

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore necessary to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision should improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

Or. en

Amendment 61

Andrey Novakov, Asim Ademov, Andrey Kovatchev, Emil Radev, Eva Maydell, Alexander Alexandrov Yordanov, Radan Kanev, Ivo Hristov, Tsvetelina Penkova, Petar Vitanov, Elena Yoncheva, Atidzhe Alieva-Veli, Ilhan Kyuchyuk, Iskra Mihaylova, Angel Dzhambazki, Andrey Slabakov, Cristina Maestre Martín De Almagro, Salvatore De Meo, Dolors Montserrat, Lucia Vuolo, Clara Aguilera, Juan Ignacio Zoido Álvarez, Francisco José Millán Mon, Cristian-Silviu Buşoi, Massimiliano Salini, Isabel Benjumea Benjumea, Lara Comi, Agnès Evren, Tomislav Sokol, Daniel Buda, Anne Sander, Sunčana Glavak, Francesca Peppucci

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

deleted

_________________

39 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).

Or. en

Justification

We propose to delete the definition of 'multi-constituent substance' as there is a lack of clarity and alignment with the definition of 'multi-constituent substance' under the ECHA Guidance for identification and naming of substances under REACH and CLP. In order to ensure complementarity and legal certainty, 'multi-constituent substance' should be defined under REACH and classified under CLP. Substances with more than one constituent (multi-constituent substances) should be considered as single substances and not mixtures. The provision for mixtures is neither adequate, nor usable in the case of natural complex substances (NCSs) - essential oil, plant extract, absolute and so on. In that case, all constituents are integral and inseparable part of the substance. Therefore, the toxicological properties are defined by the entirety of the substance, not by its individual constituents. The composition of the NCSs is complex and often includes a multitude of constituents. The composition of a natural complex substance depends on nature. It is not an intentional addition of ingredients like a real mixture and this is why the classification criteria for intentional mixtures may fail to provide the correct classification for natural complex substances.

Amendment 62

Anna Zalewska

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Justification

Natural multicomponent substances should remain classified as 'substances', according to the current REACH and CLP regulation. Mixtures may contain thousands of components that are inherent in the substance. Their composition varies according to geographical origin, season, climatic conditions and method of production. It would therefore be inappropriate to classify natural complex substances under the rules for mixtures with very low component limits and ignoring available data on the entire complex/multicomponent substance.

Amendment 63

Nicola Procaccini, Pietro Fiocchi

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Amendment 64

Irène Tolleret, Max Orville, Giuseppe Ferrandino, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Justification

Essential oils and plant extracts are natural complex substances composed by hundreds of constituents. Natural complex substances are regulated as substances under REACH and CLP regulations and should continue to be considered as substances and not as mixtures. A change of approach, classifying natural complex substances as mixtures, would endanger the use of these substances in consumer products and undermine the whole sector of essential oils and plant extracts production.

Amendment 65

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituentsubstances.

(2) From a toxicological point of view, substances with more than one constituent are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on substances containing more than one constituentis to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, substances containing more than one constituentshould be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those substances containing more than one constituenton the basis of sufficient and reliable scientific argumentation. Such derogations would be warranted where using data on constituents and calculation rules would result in a less appropriate classification of the complexsubstances than by using data on the substance itself. This could be the case for example when a complex substance like essential oil contains only structurally similar constituents or when there is proof of antagonistic effects among constituents. The Committee for Risk Assessment of the Agency set up pursuant to Article 76/1/(c) of Regulation (EC) no 1907/2006 should provide an assessment of the derogations when needed.This regulatory approach should contribute to the objectives of the EU Chemical Strategy for Sustainability to better protect citizens and the environment and to boost innovation for safe and sustainable chemicals by ensuring implementation of existing legal provisions of Regulation 1272/2008 and corresponding Guidance on the Application of the CLP criteria.

_________________

Or. en

Justification

Article 10(1) and 11(1) of Regulation 1272/2008 set principles of classification for substances with more than one constituent. Guidance document from ECHA on the Application of the CLP Criteria (see paragraphs 1.1.6.1. and 1.1.7.2. https://echa.europa.eu/documents/10162/2324906/clp_en.pdf/58b5dc6d-ac2a-4910-9702-e9e1f5051cc5) furthermore provides assistance to industry in complying with their obligations under the CLP Regulation. The changes in the Regulation to the paragraph 5(3) are done in order to help harmonized implementation of the already existing rules and guidance and enforcement. In other words, the article 5(3) effectively equals to codification of provisions of Regulation 1272/2008 and the corresponding Guidance.

Amendment 66

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituentsubstances.

(2) From a toxicological point of view, substances containing more than one constituent are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, substances containing more than one constituentshould be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those substances. Specific provisions could be provided into Annex I on the basis of adequate and reliable scientific argumentation. Such derogations would be needed for cases where using data on constituents and calculation rules would result in a less appropriate classification of a substance with more than one constituent than by using data on the substance itself. This could be the case for example when a substance with more than one constituent contains constituents interacting with each other. Such interactions could have an impact on the hazard of the whole substance, notably when antagonistic effects occur. The scientific criteria to derogate to the mixture rule should be established by the Risk Assessment Committee. This committee should also be consulted for specific cases where appropriate.

_________________

Or. en

Amendment 67

Jutta Paulus

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limitanimal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for aspecific provision for those multi-constituentsubstances.

(2) From a toxicological point of view, substances with more than one constituent are normally no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to minimiseanimal testing, data on substances with more than one constituentis to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, substances containing more than one constituentshould be evaluated and classified following the same classification rules as mixtures. However,specific provisions should be provided into Annex I forsubstances containing more than one constituent on the basis of robust scientific argumentation for cases where using data on constituents and calculation rules could result in a false classification as compared to using data on the substance containing more than one constituent as a whole. This could be the case for example when there is proof of antagonistic effects among constituents. At the same time, it must be ensured that any such differences are not due to dilution effects. In such cases, the Commisson should ask the Risk Assessment Committee for an opinion.

_________________

Or. en

Justification

Clear indications for the derogation to Article 5(3) via Annex I should be provided.

Amendment 68

Anja Hazekamp

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limitanimal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to phase out, through replacement, reduction and refinement of animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

_________________

Or. en

Amendment 69

Pietro Fiocchi

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituentsubstances.

(2) From a toxicological point of view, and in accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council3, aimed to limit animal testing, data on substances with more than one constituent is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on the substance with more than one constituent is not available and where relevant data on individual constituents is available, these substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those substances.

_________________

Or. en

Amendment 70

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituentsubstances.

(2) From a toxicological point of view, and in accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on substances is to be generated under the same conditions as data on any other substance with more than one costituent, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on the substance with more than one constituent is not available and where relevant data onindividual constituents is available, thesesubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those substances.

_________________

Or. en

Amendment 71

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

(2) From a toxicological point of view, substances with more than one constituents for which the information is available for this constituent are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data is to be developpedon substances, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

_________________

Or. en

Justification

Alignment to definition REACH Regulation since REACH and CLP apply the same definition of a substance. The new definition on "multi-constituent substances" creates confusion and is unnecessary as it is at odds with how multi-constituent substances have been identified under REACH

Amendment 72

Agnès Evren

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) Whereas the European Parliament resolution of 14 December 2022 on the implementation of the new European agenda for culture and the EU strategy for international cultural relations (2022/2047(INI)) noted that the EU must ensure that Europe’s cultural heritage is safeguarded and insists that upholding the required level of protection for human health and the environment does not conflict with the preservation of European heritage, avoiding the closure of many craft enterprises and any negative impact on the restoration, maintenance and conservation of the vast heritage of the EU. European institutions should consult and involve the heritage sector in all discussions related to regulatory or legislative changes with a direct impact on their activities. Products such as essential oils and natural complexes made from plants and landscapes, which are part of a cultural heritage, must be preserved.

Or. fr

Amendment 73

Martin Hojsík, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) Essential oils are derived from various sections of plants and are obtained by distillation, steam distillation or expression. They are complex substances that should warrant a tailored approach to their identification, including by providing for scientifically justified derogations from the rules applicable to the substances with more than one constituent under Article 5(3) of this Regulation. The European Commission and the Agency should assist the sector, particularly micro and small companies, that intends to benefit from the derogation, including by ensuring expeditious assessment of the dossier. This Regulation does not regulate safe use of essential oils in consumer products.

Or. en

Amendment 74

Eric Andrieu, Nora Mebarek, Sylvie Guillaume

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) The development of safe and sustainable products by design should contribute to achieving Green Deal objectives. In this context, natural and renewable products, which are inherently sustainable, could play a key role in the development of a circular and sustainable economy.

Or. fr

Justification

It is of paramount importance to ensure consistency between European policies and ambitions in the context of the EU Green Deal. One of these is the EU Bioeconomy Strategy, which aims to shift the European economy towards a wider and more sustainable use of renewable resources.

Amendment 75

Cristian-Silviu Buşoi, Aldo Patriciello, Salvatore De Meo

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) The development of products that are safe and sustainable by design must help to achieve the objectives of the green deal. In that context, the products of natural and renewable origin, by essence sustainable, could play a key role in facilitating the development of a circular and sustainable economy.

Or. en

Amendment 76

Eric Andrieu, Nora Mebarek, Sylvie Guillaume

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

(2b) Essential oils are natural, renewable products of agricultural and plant origin, made up of heterogeneous components that cannot be formulated or pre-calibrated. An essential oil cannot be chemically reproduced by combining its individual components. An essential oil is therefore intrinsically a substance, like vegetable oils, and not a mixture of ingredients, since the identification of an essential oil is incomplete if the ingredients are considered separately. In addition, the scientific evidence on essential oils shows that specific ingredients considered in isolation may have hazardous properties that are not expressed when naturally present in an essential oil assessed as a whole substance.

Or. fr

Justification

A natural substance (essential oil, plant extract, etc.) is a ‘complex substance’, generally composed of many different constituents. The mixture-based approach is not suitable for such substances. Their constituents together determine their toxicological properties. Studies have shown that, in toxicological terms, a complex natural substance tested as a whole may give different results than one or more of its constituents when tested as individual chemicals.

Amendment 77

Cristian-Silviu Buşoi, Aldo Patriciello, Salvatore De Meo

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

(2b) Essential oils are natural and renewable products, of agricultural and plants origin, of heterogeneous components that cannot be formulated or dosed. An essential oil cannot be reproduced chemically by the addition of its individual components. An essential oil is therefore intrinsically a substance, similarly to vegetal oils, and not a mixture of ingredients, that taken separately could not enable its full identification. In addition, scientific evidences on essential oils show that specific ingredients considered in isolation can have hazardous properties that are not expressed when they are naturally present in an essential oil assessed as a whole substance.

Or. en

Amendment 78

Cristian-Silviu Buşoi, Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 2 c (new)

Text proposed by the Commission

Amendment

(2c) Considering that the European Parliament resolution of 14 December 2022 on the implementation of the New European Agenda for Culture and the EU Strategy for International Cultural Relations (2022/2047(INI)) recalled that the EU must ensure that Europe’s cultural heritage is safeguarded and insisted on the fact that upholding the required level of protection for human health and the environment does not conflict, where appropriate, with the preservation of European heritage, avoiding the closure of many craft enterprises and any negative impact on the restoration, maintenance and conservation of the vast heritage of the EU. The European institutions should consult and involve the heritage sector in all discussions related to regulatory or legislative changes with a direct impact on their activities. The products such as essential oils and natural complex substances, obtained from plants and landscapes, which are part of a cultural heritage, should be preserved.

Or. en

Amendment 79

Nicola Procaccini, Pietro Fiocchi

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi-constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi-constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those cases.

deleted

Or. en

Amendment 80

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) For the assessment of endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties both whole substance data and data for the individual constituents of the substance with more than one constituent, impurity or additive should be used as the basis for hazard classification of those substances.

Or. en

Amendment 81

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture on the basis of data on that mixture. The data for the individual substances of the mixture should therefore normally be used as the basis for hazard identification of those mixtures.

Or. en

Justification

References to 'multi-constituent substances' are deleted.

Amendment 82

Irène Tolleret, Max Orville, Giuseppe Ferrandino, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

Or. en

Justification

Amendment 83

Anna Zalewska

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Under the current state of science, it may be difficult to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the substance should therefore normally be used as the basis for hazard identification of those substances or mixtures. However, in certain cases, data on those substances themselves may also be relevant.

Or. en

Amendment 84

Jutta Paulus

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a substance containing more than one constituent on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the substance containing more than one constituent should therefore normally be used as the basis for hazard identification of those substances containing more than one constituent or mixtures. However, in certain cases, data on mixtures or on substances containing more than one constituent may also be relevant. This is the case in particular for the one plant protection product or the one biocidal product relevant for approval decisions of the corresponding active substance, or where data on mixtures or on substances containing more than one constituent demonstrate endocrine disrupting properties for human health and the environment, or persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on mixtures or on substances containing more than one constituent are taken into consideration in those cases.

Or. en

Justification

It is well known that plant protection products as a whole are often more toxic than the active substance they contain. This is not surprising, as plant protection products are a deliberate mixture to achieve a specific toxic effect. Assessing a plant protection product merely on the basis of its constituents is highly likely to underestimate the hazards of it. It should therefore be clarified that for the plant protection product that is relevant for the approval of the active substance, data on the mixture as a whole also needs to be considered. The same should apply to biocides in analogy.

Amendment 85

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a substance containing more than one constituent on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the substance containing more than one constituent should therefore normally be used as the basis for hazard identification of those substances containing more than one constituent or mixtures. However, in certain cases, data on those substance containing more than one constituent themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on substances containing more than one constituent are used in those cases.

Or. en

Amendment 86

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a substance containing more than one constituent on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi-constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those substances containing more than one constituent themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on substances containing more than one constituent are used in those cases.

Or. en

Amendment 87

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or a substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the substance should therefore normally be used as the basis for hazard identification of those substances or mixtures. However, in certain cases, data on those substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents or substances in the mixture. Therefore, it is appropriate that data on substances or mixtures are used in those cases.

Or. en

Justification

Alignment with REACH definition on a substance. New definition as proposed in CLP is confusing and unnecessary as it is at odds with how multi-constituent substances have been identified for multi-constituent substances.

Amendment 88

Marian-Jean Marinescu

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out.

(4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. Commission shall provide detailed guidance regarding adjusted calculation method for special mixture. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out.

Or. en

Amendment 89

Nicola Procaccini, Pietro Fiocchi

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7a) Disposable electronic cigarettes and single use cartridges may contain a nicotine-containing mixture classified as having acute oral and/or acute dermal toxicity properties. However, the mixtures contained in these products cannot directly be ingested or touched. Therefore, it is appropriate to provide for labelling exemptions for these products, unless the mixtures contained are classified as having acute inhalation toxicity and/or respiratory sensitisation properties. This is without prejudice to specific EU and national legislation on the marketability of the mixtures contained.

Or. en

Amendment 90

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 6 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at maximum6 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

_________________

40 Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)

Or. en

Justification

6 months deadline should be respected mainly when a more severe hazard class is established in order to protect consumers.

Amendment 91

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 6months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 3months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

_________________

Or. en

Amendment 92

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while durability and good readability of all physical labels should be ensured, including by laying down minimum font size, using optimal typesets and contrasts between the print and the background and other formatting requirements. In order to ensure compatibility between bigger flexibility and minimum consumers safety, the front page of a fold-out label should display at least signal words, precautionary statement and hazard pictograms.

Or. en

Justification

Minimum font sizes proposed by the Commission in Annex I should allow for easy readibility by consumers, who should be able to consult critical information on labelling when applying the product. Hence, durability of labels should be considered as well. Existing ECHA´s Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 should serve as minimum standard for fold-out labels: https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf

Amendment 93

Pietro Fiocchi

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels.

Or. en

Amendment 94

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by adding more examples of label in the Guidance on Labelling and Packaging.

Or. en

Amendment 95

Pietro Fiocchi

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by adding more examples of label in the Guidance on Labelling and Packaging.

Or. en

Amendment 96

Sirpa Pietikäinen

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary digital labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment.

Or. en

Amendment 97

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 98

Stanislav Polčák

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary mandatory digital labelling supplementing, but not replacing, the existing physical labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment.

Or. cs

Amendment 99

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and a high level of protection of human health and the environment.

(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among different population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, ensuring high level of protection of human health and the environment and sufficient information on chemicals that the citizens are exposed to.

Or. en

Amendment 100

Anja Hazekamp

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

Or. en

Amendment 101

Stanislav Polčák

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Regulation (EC) No 1272/2008 does not lay down rules on the labelling of chemicals supplied to the general public without packaging except for ready mixed cement and concrete in a wet state. In order to enhance legal clarity and ensure a better protection of citizens, it is appropriate to provide for the labelling elements of other chemicals, such as fuels supplied at filling stations and intended to be pumped into receptacles from where they are normally not intended to be removed.

(16) Regulation (EC) No 1272/2008 does not lay down rules on the labelling of chemicals supplied to the general public without packaging except for ready mixed cement and concrete in a wet state. In order to enhance legal clarity and ensure a better protection of citizens, it is appropriate to provide for the labelling elements of other chemicals supplied without packaging, such as fuels supplied at filling stations and intended to be pumped into receptacles from where they are normally not intended to be removed.

Or. cs

Amendment 102

Stanislav Polčák

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) As the new hazard classes and criteria introduced by Commission Delegated Regulation 41 allow for the harmonised classification and labelling of substances of the highest concern with regard to health and environment, they should normally be subject to harmonised classification and labelling and added to the list of hazard classes which includes respiratory sensitisation, germ cell mutagenicity, carcinogenicity and reproductive toxicity. Sub-categorisation of the hazard class for respiratory sensitisation in sub-category 1A or 1B should be performed where sufficient information to classify in those hazard sub-categories is available, in order to avoid over- or under-classification. In view of the rapid development of scientific knowledge and the long-standing expertise of the European Chemicals Agency (the ‘Agency’) and the European Food Safety Authority (the ‘Authority’) on the one hand, and the limited resources of Member States’ competent authorities to develop harmonised classification proposals on the other, the Commission should have the right to request the Agency and the Authority to develop a harmonised classification and labelling proposal.

(17) As the new hazard classes and criteria introduced by Commission Delegated Regulation allow for the harmonised classification and labelling of substances of the highest concern with regard to health and environment, they should normally under normal circumstances be subject to harmonised classification and labelling and added to the list of hazard classes which includes respiratory sensitisation, germ cell mutagenicity, carcinogenicity and reproductive toxicity. Sub-categorisation of the hazard class for respiratory sensitisation in sub-category 1A or 1B should be performed where sufficient information to classify in those hazard sub-categories is available, in order to avoid over- or under-classification. In view of the rapid development of scientific knowledge and the long-standing expertise of the European Chemicals Agency (the ‘Agency’) and the European Food Safety Authority (the ‘Authority’) on the one hand, and the limited resources of Member States’ competent authorities to develop harmonised classification proposals on the other, the Commission should have the right to request the Agency and the Authority to develop a harmonised classification and labelling proposal.

_________________

41 [Commission Delegated Regulation amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures, OJ XX of XX p XX.]

Or. cs

Amendment 103

Marian-Jean Marinescu

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17a) The process of classification of a substance or mixture under this Regulation should identify, assess and communicate the regulatory links between this Regulation and the relevant EU legislation.

Or. en

Amendment 104

Anna Zalewska

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on scientific justification (taking into account all available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, allows for similar classification of all substances in the group. The grouping process should be scientifically robust, coherent and transparent for all stakeholders. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group. The similarity of a group of substances should be given for the specific endpoint and the severity of the effect, which results in the same classification for the respective hazard class. To ensure that all submitters of dossiers for harmonised classification and labelling apply the same scientific principles to justify the grouping approach, there is a need for ECHA to develop guidance clarifying the principles from which a harmonised classification for a group of substances can be derived.

Or. en

Amendment 105

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group. Where it is scientifically justified and possible, proposals for classification should prioritise groups of substances rather than individual substances.

Or. en

Amendment 106

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group. The grouping approach to harmonsied classification should therefore be used by default, whenever possible and scientifically justified.

Or. en

Amendment 107

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on a scientific evidence approach and justification allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

Or. en

Amendment 108

Anja Hazekamp

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and should cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group and can thereby reduce the use of animals.

Or. en

Amendment 109

Marian-Jean Marinescu

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities.

(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Stakeholders should have better acces to CARACAL and the platform should provide a higher transparency. to include among others meeting minutes, discussions and decisions related to CLP classification proposals. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. The proposals should be based on socio-economic assessments. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities.

Or. en

Amendment 110

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

Or. en

Amendment 111

Stanislav Polčák

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) As the criteria for substances to qualify as endocrine disruptor for human health or the environment included in sections 3.6.5. and 3.8.2. of Annex II to Regulation (EC) No 1107/2009 and in Commission Delegated Regulation (EU) 2017/2100, and those to qualify as endocrine disruptor for human health or the environment included in Annex I to Regulation (EC) No 1272/2008, are equivalent, substances which qualify as meeting the criteria for endocrine disruptor properties in accordance with Commission Regulation (EU) 2018/605 and Commission Delegated Regulation (EU) 2017/2100 should be included as endocrine disruptors category 1 for human health or endocrine disruptors category 1 for the environment in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(21) (Does not affect the English version.)

Or. cs

Amendment 112

Anja Hazekamp

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation.

(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human and animal health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation, and the Agency should be entitled to delete obsolete classifications. Furthermore, divergent classifications should be harmonised within 12 months to the most severe classification per hazard class.

Or. en

Amendment 113

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

Or. en

Amendment 114

Anja Hazekamp

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, certain information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, all information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

Or. en

Amendment 115

Stanislav Polčák

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ fulfilment of their duty to come to an agreed notification of data to be listed for the same substance, certain information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. That information should include the identity of the notifiers also as, knowing whom to contact, would facilitate the objective of coming to an agreed entry of data to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

Or. cs

Amendment 116

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.

(29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of human health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.

Or. en

Amendment 117

Stanislav Polčák

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) Regulation (EC) No 1272/2008 does not explicitly refer to offers, let alone to distance sales offers. Consequently, it does not address specific problems arising from distance sales, such as online sales. Whereas advertisements is understood as being at the pre-stage of offers, notably as information designed to promote messages of a natural or legal person, whether or not against remuneration, offers are understood as invitations by a natural or legal person to conclude a purchase contract. This differentiation should justify the requirement of providing more hazard information in offers than in advertisements. In order to keep pace with technological development and new means of sale, the compliance by design obligations laid down for providers of online marketplaces in Article 31 of Regulation (EU) 2022/2065 of the European Parliament and of the Council 44 should apply for the purpose of labelling information required by Article 17 of Regulation (EC) No 1272/2008. The enforcement of those obligations is subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065.

(30) Regulation (EC) No 1272/2008 does not explicitly regulate offers, let alone distance sales offers. Consequently, it does not address specific problems arising from distance sales, such as online sales. Whereas advertisements is understood as being at the pre-stage of offers, notably as information designed to promote messages of a natural or legal person, whether or not against remuneration, offers are understood as invitations by a natural or legal person to conclude a purchase contract. This differentiation should justify the requirement of providing more hazard information in offers than in advertisements. In order to keep pace with technological development and new means of sale, the compliance by design obligations laid down for providers of online marketplaces in Article 31 of Regulation (EU) 2022/2065 of the European Parliament and of the Council [1] should apply for the purpose of labelling information required by Article 17 of Regulation (EC) No 1272/2008. The enforcement of those obligations is subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065.

_________________

44 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).

Or. cs

Amendment 118

Stanislav Polčák

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) Apart from providing industry with technical and scientific tools on how to comply with Regulation (EC) No 1272/2008, the Agency should also provide competent authorities with such tools, for example databases, in order to foster implementation. Regulation (EC) No 12727/2008 should more in detail set out the Agency’s remit in this regard. Furthermore, the Agency, acting as a body appointed by a Member State competent authority for receiving information for emergency health response, should provide the relevant national appointed body of that Member State access to that information.

(31) Apart from providing industry with technical and scientific tools on how to comply with Regulation (EC) No 1272/2008, the Agency should also provide competent authorities with such tools, for example databases, in order to foster its implementation. Regulation (EC) No 12727/2008 should more in detail set out the Agency’s remit in this regard. Furthermore, the Agency, if it acts as a body appointed by a Member State competent authority for receiving information for emergency health response, should provide the relevant national appointed body of that Member State access to that information.

Or. cs

Amendment 119

Stanislav Polčák

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council 47, it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council [1], it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, such as in vitro tests (using cells or tissues), computational models and high-throughput screening methods, which offer many advantages, including being faster, cheaper and often more accurate, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.

_________________

47 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. cs

Amendment 120

Anja Hazekamp

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without unduedelay.

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals, with a view to stop using animals for testing as soon as possible. Implementation of Regulation (EC) No 1272/2008 should be based on the promotion, development anduse of New Approach Methodologies (NAM), suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be supported,monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without delay.

_________________

47 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. en

Amendment 121

Jutta Paulus

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods, including new approach methodologies,should be monitored and systematically and periodicallyevaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods, including new approach methods,in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.

_________________

47 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. en

Justification

New approach methods can contribute significantly to reducing tests on vertebrate animals and should therefore also be considered. It is of key importance that the Commission regularly evaluates the progress with regard to the development of new approach methods and non-animal methods and updates the Annex, if relevant. Any advances at UN level need to be reflected in CLP in a timely manner.

Amendment 122

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 35 a (new)

Text proposed by the Commission

Amendment

(35a) Where the Agency deems it necessary, it should provide further guidance for the application of the provisions associated with the revision of this Regulation.

Or. en

Amendment 123

João Albuquerque, Sara Cerdas

Proposal for a regulation

Recital 35 b (new)

Text proposed by the Commission

Amendment

(35b) The revision of this regulation expands the tasks and remit of the Agency. In order to provide adequate expertise, support, and thorough scientific evaluations, a sustainable funding for the Agency should be ensured under the framework of the upcoming ECHA Founding Regulation.

Or. en

Amendment 124

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) To ensure that suppliers of substances and mixtures have time to adapt to rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.

Or. en

Amendment 125

Stanislav Polčák

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) To ensure that suppliers of substances and mixtures have time to adapt to new rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.

Or. cs

Amendment 126

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 37 a (new)

Text proposed by the Commission

Amendment

(37a) An assessment of the costs incurred by micro, small and medium-sized enterprises, especially producers of essential oils, in implementing this regulation should be carried out by the European Commission. This should be carried out with a view to providing financial support to these entities, if necessary.

Or. fr

Amendment 127

Stanislav Polčák

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

(38a) In line with the new tasks that will arise for the Agency as a result of the amendment of Regulation (EC) No 1272/2008, it is essential that the Agency is provided with additional resources to enable it to fully carry out these new tasks.

Or. cs

Amendment 128

Stanislav Polčák

Proposal for a regulation

Recital 38 b (new)

Text proposed by the Commission

Amendment

(38b) Following the adoption of this Regulation, the Agency should explore ways to further simplify the notification procedure, in particular taking into account the needs of small and medium-sized enterprises, so that they are not disproportionately burdened by new obligations.

Or. cs

Amendment 129

Marian-Jean Marinescu

Proposal for a regulation

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

Regulation (EC) 1272/2008

Article 1 – paragraph 1

Present text

Amendment

-1 In Article 1, paragraph 1 is replaced by the following:

Article 1 Purpose and Scope 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006;

"1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006; (iv) the Commission to ensure, prior to introducing new hazard classes or classification criteria, that such classes or criteria can be fully satisfied with existing data aligned with the EU’s goal of using alternative test methods, and thus avoiding animal testing where feasible."

Or. en

(Regulation 1272/2008)

Justification

References and definitions in REACH and CLP should be identical, to avoid confusion.

Amendment 130

Anja Hazekamp

Proposal for a regulation

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

Regulation (EC) 1272/2008

Article 1 – paragraph 1

Present text

Amendment

(-1) In Article 1, paragraph 1 is replaced by the following:

The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:

"The purpose of this Regulation is to ensure a high level of protection of human and animal lives and health, protection of the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:"

Or. en

(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)

Amendment 131

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

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

Regulation (EC) 1272/2008

Article 1 – paragraph 5 – point c

Present text

Amendment

(1a) In Article 1, paragraph 5, point c is replaced by the following:

"(c) cosmetic products as defined in Directive 76/768/EEC for human health hazard classes;"

Or. en

(32008R1272)

Justification

The amendment keeps the derogation for cosmetic products´ human health hazard classes in the original Regulation

Amendment 132

Jutta Paulus

Proposal for a regulation

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

Regulation (EC) 1272/2008

Article 1 – paragraph 5

Present text

Amendment

(1a) In Article 1, paragraph 5 is replaced by the following:

This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:

"This Regulation shall not apply to human health hazard classes for substances and mixtures in the following forms, which are in the finished state, intended for the final user:'"

Or. en

(Regulation (EC) 1272/2008)

Justification

All the listed laws only deal with the health effects of chemicals therein, not with the environmental effects. As such, they should only be exempted from CLP with regard to human health hazard classes, but not for environmental hazard classes.

Amendment 133

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008

Article 2 – point 7a

Text proposed by the Commission

Amendment

(a) the following point is inserted:

deleted

‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’

Or. en

Justification

The new definition for multi-constituent substances should be deleted, as it is not in line with ECHA guidance. There is no need for a definition of multi-constituent substances to be able to address them by CLP.

Amendment 134

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008

Article 2 – point 7a

Text proposed by the Commission

Amendment

(a) the following point is inserted:

deleted

‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 2 point 7a (new))

Amendment 135

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008

Article 2 – paragraph 7a

Text proposed by the Commission

Amendment

(a) the following point is inserted:

deleted

‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’

Or. en

Amendment 136

Anna Zalewska

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008

Article 2 – point 7a

Text proposed by the Commission

Amendment

(a) the following point is inserted:

deleted

‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’

Or. en

Amendment 137

Irène Tolleret, Max Orville, Giuseppe Ferrandino, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008

Article 2 – paragraph 7a

Text proposed by the Commission

Amendment

(a) the following point is inserted:

deleted

‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’

Or. en

Justification

The new definition of "multi-constituent substances" that is proposed is different from the definition used under REACH regulation. This create legal uncertainty, especially for the essential oils' sector, and puts at risk essential oils and plant extracts production chain.

Amendment 138

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008

Article 2 – paragraph 7a

Text proposed by the Commission

Amendment

7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.

deleted

Or. en

Justification

Amendment 139

Martin Hojsík, Irène Tolleret, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008

Article 2 – paragraph 7a

Text proposed by the Commission

Amendment

7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.

deleted

Or. en

Amendment 140

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008

Article 5 – paragraph 7a

Text proposed by the Commission

Amendment

7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.

deleted

Or. en

Amendment 141

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008

Article 2 – point 7a

Text proposed by the Commission

Amendment

7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.

7a. ‘substance’ means a substance that contains more than one constituent.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 2, point 7a)

Amendment 142

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point b a (new)

Regulation (EC) 1272/2008

Article 2 – paragraph 1 – point 38 a (new)

Text proposed by the Commission

Amendment

(ba) In Article 2, the following point 38 a is added:

'38a. refill’ means an operation by which a consumer or a professional user fills its own container, which fulfils the packaging function, with a hazardous substance or mixture offered by a supplier in the context of a commercial transaction;'

Or. en

Amendment 143

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – point b b (new)

Regulation (EC) 1272/2008

Article 2 – paragraph 1 – point 38 b (new)

Text proposed by the Commission

Amendment

(bb) In Article 2, the following point 38 b is added:

'38b. refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be purchased through refill;'

Or. en

Amendment 144

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 2 a (new)

Regulation (EC) 1272/2008

Article 3 – paragraph 1

Present text

Amendment

(2a) In Article 3, paragraph 1 is replaced by the following:

A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.

"A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex. Gender differences with regard to the susceptibility to chemicals shall be taken into consideration, where relevant."

Or. en

(Regulation (EC) 1272/2008)

Justification

There are important physiological and biological differences between the genders, leading to different susceptibility to chemicals (eg, body fat, metabolism, hormonal system). Hormones are well-known to have gender-specific consequences. In the hazard assessment under CLP, such differences should be considered, where relevant.

Amendment 145

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

CLP revision proposes a similar classification approach to be applied for multi-constituent substances as for mixtures. The provision for mixtures is neither adequate, nor usable in the case of natural complex substances (NCSs) - essential oil, plant extract, absolute and so on. In that case, all constituents are integral and inseparable part of the substance. Therefore, the toxicological properties are defined by the entirety of the substance, not by its individual constituents. The composition of the NCSs is complex and often includes a multitude of constituents. The composition of NCSs is also variable and it depends on a number of factors such as the part of the plant, the geographical origin, the season and climate conditions (humidity, sun intensity), the extraction techniques and more. In this regard, it is important that the legislation considers the specificities of NCSs, incl. their character as UVCB substances (with variable composition and concentration) for their classification as single substances and not mixtures. Based on the above, a full deletion of Article 5 par. 3 is necessary, as NCSs are not intentional mixtures but substances. The deletion of Article 5 par. 3 guarantees that the current complementary approach for the classification of NCSs, would continue to apply. Keeping the current approach reduces the risk of over classification of NCSs, which would undermine the production and the market placement of currently safe for use natural substances. Legal certainty would require that the CLP lays down clear criteria and a transparent procedure for a derogation in Annex I, while the latter should take place through a targeted amendment to the regulation. It is worth noting that the burden of these requirements will largely fall on the distilleries, predominantly made up of SMEs and family-owned businesses.

Amendment 146

Nicola Procaccini, Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 147

Anna Zalewska

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Amendment 148

Irène Tolleret, Max Orville, Giuseppe Ferrandino, Atidzhe Alieva-Veli, Iskra Mihaylova, Ilhan Kyuchyuk

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Amendment 149

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

A multi-constituent substance containing at least one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

A substance containing more than one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance.

(The first part of this amendment is a horizontal amendment: all references in the Commission proposal to "multi-constituent substance(s)" - other than the deletion of the definition - should be replaced with the wording provided here)

Or. en

(This amendment is linked to amendments by the same author to the fourth and seventh sub-paragraph of this paragraph.)

Justification

The reference to the possibility for a specific provision is misplaced here. It should be moved to the fourth and seventh sub-paragraph of this paragraph.

Amendment 150

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

A substance containing at least one constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Justification

To avoid confusion and discrepancies with practices under REACH, text modifications are proposed to remove references to the definition of multi-constituent substances which the Commission proposes to introduce and instead use the already existing terminology in the REACH and CLP Regulations. The text is further simplified by referring to the sections in Annex I rather than subsections. ’Hazardous to the aquatic environment’ is moved to the first part of the new Art 5.3 to combine hazard classes in the 2 parts of the text according to how classification is carried out. For ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’ and ‘hazardous to the aquatic environment’ if no data on constituents are available, whole substances are tested. For ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes, also whole substances are tested, but the effects take de facto place at constituent level. The property ‘rapid degradability of organic substances’ (Annex I Section 4.1.2.9) part of the ‘hazard to the aquatic environment’ hazard (Annex I Section 4.1) is different from the property ‘persistence (degradation’ part of the hazards ‘Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties’ (Annex I Section 4.3) and ‘Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties’ (Annex I Section 4.4).

In alignment with the current approach under the CLP and under the UN-GHS, all available and reliable information on constituents as well as whole substance data are used to assess the hazards.

Amendment 151

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 5 §3 (new))

Amendment 152

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

A substance containing at least one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

Or. en

Amendment 153

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

Substances containing more than one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.

Or. en

Amendment 154

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 155

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

For the evaluation of multi-constituent substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

For the evaluation of substances containing more than one constituent pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Or. en

Amendment 156

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

For the evaluation of these substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, and ‘hazardous to the aquatic environment’ referred to in sections 3.5., 3.6., 3.7., and 4.1 and 4.2.3.1. of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents, impurities and additives in the substance.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 5 §3 (new))

Amendment 157

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

For the evaluation of substances containing more than one constituent pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Or. en

Amendment 158

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

For the evaluation of these substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’ and ‘hazardous to the aquatic environment’ referred to in sections 3.5, 3.6, 3.7 and 4.1 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents, impurities and additives in the substance.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art, 5 - paragraph 3 (new))

Justification

Amendment 159

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 3

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:

Relevant available information on the substances containing more than one constituent itself shall be taken into account where one of the following conditions are met, unless Annex I lays down a specific provision:

Or. en

Amendment 160

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 3

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:

Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

Or. en

Amendment 161

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 3 – point b a (new)

Text proposed by the Commission

Amendment

(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.

Or. en

Amendment 162

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 4

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.

Relevant available information on the substance containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance, unless Annex I lays down a specific provision.

Or. en

Justification

The essential oil industry holds that their oils as a whole, even when containing a CMR substance as a constituent, do not show these properties. The Commission has therefore proposed that a derogation from the application of the mixing rules that are applicable for mixtures can be granted for substances containing more than one constituent. This possibility of a derogation needs to be explicitly referred to in this subparagraph.

Amendment 163

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 4

Text proposed by the Commission

Amendment

Relevant available information on the substance containing more than one constituent itself showing absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

Or. en

Amendment 164

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 4

Text proposed by the Commission

Amendment

Relevant available information on the substances containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.

Or. en

Amendment 165

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EU) 1272/2008

Article 5 – paragraph 3 – point 4

Text proposed by the Commission

Amendment

Or. cs

Amendment 166

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 5

Text proposed by the Commission

Amendment

For the evaluation of multi-constituent substances pursuant to Chapter 2 in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

For the evaluation of these substances pursuant to Chapter 2 in relation to the ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.3 and 4.4 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents, impurities or additives in the substance

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 5 - paragraph 3 (new))

Justification

Amendment 167

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 5

Text proposed by the Commission

Amendment

For the evaluation of substances containing more than one constituent pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Or. en

Amendment 168

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 5

Text proposed by the Commission

Amendment

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 5 §3 (new))

Amendment 169

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 5

Text proposed by the Commission

Amendment

For the evaluation of substances containing more than one constituent pursuant to Chapter 2 in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.

Or. en

Amendment 170

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 6

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:

deleted

(a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties.

(b) the information supports the conclusions based on the relevant available information on the constituents in the substance.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 5 §3 (new))

Amendment 171

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 6

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:

Or. en

Amendment 172

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 6

Text proposed by the Commission

Amendment

Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:

Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

Or. en

Amendment 173

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 6 – point a

Text proposed by the Commission

Amendment

(a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties.

(a) the information demonstrates lack of biodegradation, or persistence, mobility or bioaccumulation properties.

Or. en

Justification

Correction of an obvious mistake in the Commission proposal. Relevant available information on the substance containing more than one constituent should be taken into account about in case of lack of biodegradation, not in case of biodegradation. And the properties should be considered each in their own right and not only if all of them are fulfilled.

Amendment 174

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 6 – point a

Text proposed by the Commission

Amendment

(a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties.

(a) the information demonstrates persistence, mobility and bioaccumulation properties, or lack of biodegradation

Or. en

Amendment 175

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 6 – point b a (new)

Text proposed by the Commission

Amendment

(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.

Or. en

Amendment 176

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 7

Text proposed by the Commission

Amendment

deleted

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Art 5 §3 (new))

Amendment 177

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 7

Text proposed by the Commission

Amendment

Or. en

Justification

The possibility of a derogation from this rule via Annex I should also apply for the properties referred to in subparagraph 5.

Amendment 178

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 – subparagraph 7

Text proposed by the Commission

Amendment

Relevant available information on the substance containing more than one constituent itself showing absence of the properties referred to in (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

Or. en

Amendment 179

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 7

Text proposed by the Commission

Amendment

Or. en

Amendment 180

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 53 in order to amend Annex I to lay down derogation criteria referred to in paragraph 3, subparagraphs 3(ba) and 5(ba) on the basis of the opinion of the Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006. The opinion of the Committee for Risk Assessment shall be based on reliable and updated scientific information, particularly when it demonstrates the occurrence of antagonistic effects among constituents impacting the hazard of the substance.'

Or. en

Amendment 181

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Max Orville, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'The European Commission shall, where appropriate and scientifically justified, amend Annex I in accordance with the procedure referred to in Article 53, to lay down specific provisions granting derogation from the criteria set out in this Article for a substance containing more than one constituent.

The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall, where necessary, adopt an opinion on the scientific argumentation for a derogation from the rules for substances containing more than one constituent provided under this article.'

Or. en

Amendment 182

Eric Andrieu, Nora Mebarek, Sylvie Guillaume

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, paragraph 3a is added as follows:

‘For substances which occur in nature, as defined in Article 3(39) of the REACH Regulation, and substances obtained directly from plants of renewable origin such as essential oils, the determination of classification should be based solely on data obtained from an analysis of the substance as a whole and not from an analysis of its components taken separately.’

Or. fr

Justification

For natural products, in particular those obtained by distillation of plants, the classification must be based on the complex natural substance as a whole and not by extrapolation of the classification of each of its components. This amendment ensures continued alignment with the internationally agreed approach and maintains the competitiveness of European industry.

Amendment 183

Cristian-Silviu Buşoi, Salvatore De Meo, Aldo Patriciello

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'Substances which occur in nature, as defined under article 3.39 of REACH, as well as substances obtained directly from plants occurring from renewable origin, intrinsically sustainable, justify that the determination of the classification can take into account data obtained on the whole substance.'

Or. en

Justification

Substances which occur in nature, as defined under article 3.39 of REACH, renewable origin, intrinsically sustainable, justify that the determination of the classification can take into account data obtained on the whole substance.

Amendment 184

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 – subparagraph 7 a (new)

Text proposed by the Commission

Amendment

In Article 5, paragraph 3, the following subparagraph 7a is added:

'The Commission shall use the procedure in Article 53 to lay down specific provisions in Annex I.'

Or. en

Justification

An explicit reference should be provided in this Article for the adoption of the specific provision in Annex I.

Amendment 185

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'3a. Paragraph 3 shall not apply to UVCB substances of biological origin.'

Or. en

Justification

It should be considered that UVCB substances cannot be identified well enough by their chemical composition because they contain a large number of constituents and the composition is often largely unknown, variable or difficult to predict. Other types of information are required to identify them, such as origin/source and manufacturing process, and any significant change to the source or process may result in a different substance and thus the need for new tests. This group presents a real scientific and analytical challenge in respect to the analysis of the composition and structure of different constituents. We also would like to emphasize that UVCB include very different substances, such as polymers, petroleum products, essential oils and others with varying properties and hazard and risk profiles, which are very different from the core MCS group. In most cases UVCB encompass hundreds to thousands of different unknown constituents, which makes the analysis unpractical, unworkable and technically and economically unfeasible. Given the nature of these substances, in practice the proposed principle would be difficult to apply to them. The classification of UVCB substances of the biological material type as CMR, ED, PBT/vPvB, PMT/vPvM, will have a significant negative effect on their use and will lead to the restriction and ban of traditional and widely used products such as Essential oils. Given the existing EU legislative requirements for the use of CMR substances in cosmetic products, detergents, biocides, plant protection products, toys, etc. the application of the MCS concept will impose restrictions on the use of UVCB substances of biological origin in different products and the need to replace them, without it being clear whether safe alternatives exist. Classification and labeling are essential ways to communicate the hazards of substances and mixtures related

Amendment 186

Petar Vitanov, Tsvetelina Penkova, Ilhan Kyuchyuk, Iskra Mihaylova, Atidzhe Alieva-Veli, Radan Kanev, Eva Maydell, Andrey Kovatchev, Andrey Novakov, Emil Radev, Asim Ademov

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Or. en

Justification

The classification of UVCB substances of the biological material type as CMR, ED, PBT/vPvB, PMT/vPvM, will have a significant negative effect on their use and will lead to the restriction and ban of traditional and widely used products such as Essential oils. Given the existing EU legislative requirements for the use of CMR substances in cosmetic products, detergents, biocides, plant protection products, toys, etc., the application of the MCS concept will impose restrictions on the use of UVCB substances of biological origin in different products and the need to replace them, without it being clear whether safe alternatives exist. Classification and labelling are essential ways to communicate the hazards of substances and mixtures related to human health and the environment and, in this sense, the designation of natural Essential oils as hazardous will inevitably affect the consumer and the trust in preferred products, which has been proven to be safe over time.

Amendment 187

Andrey Slabakov, Andrey Novakov, Angel Dzhambazki, Emil Radev, Andrey Kovatchev, Tsvetelina Penkova, Atidzhe Alieva-Veli, Ilhan Kyuchyuk, Iskra Mihaylova, Radan Kanev, Petar Vitanov, Alexander Alexandrov Yordanov

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Or. en

Amendment 188

Radan Kanev, Emil Radev, Andrey Novakov, Andrey Kovatchev, Asim Ademov, Petar Vitanov, Angel Dzhambazki

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Or. en

Justification

Amendment 189

Billy Kelleher, Ilhan Kyuchyuk, Iskra Mihaylova, Atidzhe Alieva-Veli

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 5, the following paragraph 3a is added:

'Paragraph 3 shall not apply to UVCB substances of biological origin.'

Or. en

Justification

The classification of UVCB substances of the biological material type as CMR, ED,PBT/vPvB, PMT/vPvM, will have a significant negative effect on their use and will lead to the restriction and ban of traditional and widely used products such as Essential oils. Given the existing EU legislative requirements for the use of CMR substances in cosmetic products, detergents, biocides, plant protection products, toys, etc. the application of the MCS concept will impose restrictions on the use of UVCB substances of biological origin in different products and the need to replace them, without it being clear whether safe alternatives exist. Classification and labelling are essential ways to communicate the hazards of substances and mixtures related to human health and the environment and, in this sense, the designation of natural Essential oils as hazardous will inevitably affect the consumer and the trust in preferred products, which has been proven to be safe over time.

Amendment 190

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

For the evaluation of mixtures pursuant to chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself .

For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself .

Or. en

Amendment 191

Marian-Jean Marinescu

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) 1272/2008

Article 6 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

In Article 6, paragraph 4a is added:

'The Agency shall develop robust and timely guidance to support the above mentioned evaluations. All guidance should be adopted before the entry into force of this Regulation.'

Or. en

(See paragraph 4, Article 6, Regulation 1272/2008)

Justification

As a principle, guidance for regulations, should be adopted before the entry into force of the regulation, rather than after, to avoid unnecessary implementation challenges.

Amendment 192

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) 1272/2008

Article 6 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

However, where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, that data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

However, for the one plant protection product or the one biocidal product for which the approval criteria of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 need to be met, respectively, for the approval of the corresponding active substance, or where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, data on the mixture as a whole shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Or. en

Justification

Amendment 193

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. For the evaluation of mixtures pursuant to Chapter 2 in relation to the ‘biodegradation, persistency, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’, ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ;

4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistency, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’, ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ;

However, where the available test data on the mixture itself demonstrates persistent, mobile, or bioaccumulation properties which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, that data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Or. en

Amendment 194

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EU) 1272/2008

Article 6 – paragraph 4a (new)

Text proposed by the Commission

Amendment

4a. However, where available test data on the mixture itself demonstrate biodegradability, persistence, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Or. cs

Amendment 195

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 5 a (new)

Regulation (EU) 1272/2008

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

(5a) Article 7, paragraph 1 is replaced by the following:

1. Where new tests are carried out for the purposes of this Regulation, animal testing within the meaning of Directive 2010/63/EU shall only be carried out if there are no other alternatives providing adequate reliability and quality of data at the time they are carried out. These tests should gradually be fully replaced by alternative methods in accordance with the current state of scientific knowledge.

Or. cs

Amendment 196

Marian-Jean Marinescu

Proposal for a regulation

Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008

Article 7

Present text

Amendment

(5a) Article 7 is replaced by the following:

Article 7

"Article 7

Article 7 Animal and human testing 1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/ 609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible. 2. Tests on non-human primates shall be prohibited for the purposes of this Regulation. 3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.

Or. en

(Regulation 1272/ 2008)

Justification

References and definitions in REACH and CLP should be identical, to avoid confusion.

CLP should follow REACH’s wording: “use of alternative test methods” rather than “non animal test methods”.

Amendment 197

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008

Article 7

Present text

Amendment

(5a) Article 7 is replaced by the following:

Animal and human testing

"'New Approach Methodologies, animal and human testing

1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible.

1. Where new tests are carried out for the purposes of this Regulation, New Approach methodologies (NAM) shall be used as the norm. Tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where it is demonstrated that no other alternatives, which provide adequate reliability and quality of data, exist.

2. Tests on non-human primates shall be prohibited for the purposes of this Regulation.

2. Tests on non-human primates shall be prohibited for the purposes of this Regulation, as well as the use of data derived from tests on non-human primates.

3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.

3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.'"

Or. en

(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)

Amendment 198

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 5 a (new)

Regulation (EC) 1272/2008

Article 7 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

(5a) In Article 7, the following paragraph 1a is added:

'1a. Tests using new approach methodologies shall also be considered'.

Or. en

Justification

New approach methods can contribute significantly to reducing tests on vertebrate animals and should therefore also be considered.

Amendment 199

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) 1272/2008

Article 9 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.

3. Where the criteria referred to in paragraph 1 cannot be applied directly to all available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(in Article 9, paragraphs 3 and 4 are replaced by the following:)

Justification

Building an assessment on all available data is a fundamental scientific practice, for some hazard classes a classification can only be decided on a Weight of Evidence basis, as clearly stated in UN GHS section 1.3.2.4.9.

Especially where a hazard classification will be based on the evaluation of several criteria as in PBT/vPvB (persistent, bioaccumulative and toxic) and PMT/vPvM (persistent, mobile and toxic) assessment, it is crucial to consider all available information to assess if a classification is really warranted.

Amendment 200

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 10 a (new)

Text proposed by the Commission

Amendment

(7a) The following Article 10 a is added:

The proposed classification of a substance or mixture shall be accompanied by a socio-economic impact assessment. The assessment shall evaluate potential social and economic impacts associated with the proposed classification. This report is to be conducted by the party submitting the classification proposal and by the industry whose substance is subject to classification. The socio-economic impact assessment shall include, but not be limited to, the following:

a) Economic implications, including potential effects on jobs, the competitive position of the EU industry, and the cost of compliance with the proposed classification and who will bear such cost.

b) Social implications, including potential effects on consumer/industry access to goods and services, job loss and competitivity.

A third party shall review the socio-economic impact assessment as part of the classification process for a comprehensive and neutral review. Parts of the socio-economic impact assessment could be made publicly available, subject to the protection of confidential business information (CBI).

Or. en

Amendment 201

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008

Article 10 b (new)

Text proposed by the Commission

Amendment

(7b) The following Article 10 b is added:

In the process of classifying a substance or mixture under CLP regulation, it shall be necessary to identify, assess, and clearly communicate the regulatory links between the CLP Regulation and other relevant pieces of EU legislation. This is to ensure consistent and effective risk management across all relevant regulatory contexts and prevent double regulation. The downstream impact assessment shall take into account case-specific factors. For example, in cases where a substance is present as an impurity in other substances or mixtures, the impact assessment should consider the socio-economic implications for industries relying on the recycling of these substances or mixtures. This is specially relevant for special mixtures such as metals and inorganics. The European Chemicals Agency (ECHA), in cooperation with relevant national authorities, shall ensure that the consequences of proposed classifications, including the regulatory links and downstream impacts, are clearly communicated to all relevant stakeholders to prevent classifications from existing in a vacuum disconnected from the other pieces of legislation affecting the substance or mixture in question. The assessment of regulatory links and downstream impacts, and the communication of these links and impacts, shall be regularly reviewed and updated as part of the continuous evolution of the CLP regulation and in light of new scientific evidence or changes in socio-economic conditions.

Or. en

Amendment 202

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 7 c (new)

Regulation (EC) 1272/2008

Article 10 c (new)

Text proposed by the Commission

Amendment

(7c) The following Article 10 c is added:

When calculating the concentration of a classified substance in a special mixture, such as those containing metals and other inorganic substances, specific considerations shall apply. This is in recognition of the fact that these mixtures may have distinct properties and behaviours compared to mixtures of organic chemical substances. Rather than calculating the concentration of a classified substance in a special mixture using the full mixture weight, a different method shall be employed. This method shall be based on a scientifically valid approach that considers the specific physical, chemical, and toxicological properties of the classified substance and the nature of the special mixture.

The European Chemicals Agency (ECHA) and steered by the Commission shall provide detailed guidance on the adjusted calculation method for special mixtures. This guidance shall be developed in consultation with relevant scientific experts and industry stakeholders, steered by the European Commission, and shall be regularly reviewed and updated in light of new evidence. The adjusted calculation method for special mixtures, and the associated guidance from ECHA, shall be taken into account when implementing and enforcing other relevant pieces of EU legislation, including but not limited to the SEVESO Directive. This is to ensure a consistent and fair approach to the classification and management of special mixtures across all regulatory contexts.

Or. en

Amendment 203

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 7 d (new)

Regulation (EC° 1272/2008

Article 10 d (new)

Text proposed by the Commission

Amendment

(7d) The following Article 10 d is added:

The Competent Authorities for REACH and CLP (CARACAL) platform shall enhance its transparency beyond meeting agendas. This includes making meeting minutes, including discussions and decisions related to CLP classification proposals, publicly available. All such information shall be made accessible in a user-friendly manner to facilitate understanding by non-expert stakeholders. In recognition of the specific interests and expertise of industry stakeholders, special measures shall be taken to ensure their informed participation in the CLP classification process. This includes, but is not limited to, providing clear and comprehensive information on the classification process and its implications for industry, and facilitating industry representation in CARACAL discussions.

Or. en

Amendment 204

Marian-Jean Marinescu

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272

Article 17

Present text

Amendment

(7a) Article 17 is replaced by the following:

1. A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:

"1. A substance or mixture classified as hazardous and contained in packaging shall bear a label or fold-out label including the following elements:

(a) the name, address and telephone number of the supplier(s);

(b) the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;

(d) where applicable, hazard pictograms in accordance with Article 19;

(d) where applicable, hazard pictograms and signal words in accordance with Article 19 and 20;

(e) where applicable, signal words in accordance with Article 20;

(f) where applicable, hazard statements in accordance with Article 21;

(g) where applicable, the appropriate precautionary statements in accordance with Article 22;

(h) where applicable, a section for supplemental information in accordance with Article 25.

(h) where applicable, section for a statement indicating that supplemental information in accordance with Article 25, and other sector specific labelling information, can be found online.

2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.

Suppliers may use more languages on their labels or fold-out labels than those required by the MemberStates, provided that the same details appear in all languages used. The information in paragraph 1 (e), (f), (g) and (h) may be provided on the inner pages of a fold-out label. For multilingual fold-out labels, the languages shall be ordered in a logical way, e.g. alphabetically. The Commission shall develop clear guidance to outline further the details of the criteria in this article prior to the entry into force of this Regulation."

Or. en

(32008R1272)

Justification

Article 17 rules should be adjusted to allow for a more ambitious approach to digital labelling, with supplemental information, and other labelling text going online.

In addition, the text should be clarified so that the signal work accompanies pictograms on the outer label, while also possible to add to the inner label, where applicable

Finally, as a principle, guidance for regulations, including this one, should be adopted before the entry into force of the regulation, rather than after, to avoid unnecessary implementation challenges.

Amendment 205

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 17 – paragraph 1

Present text

Amendment

(7a) In Article 17, paragraph 1 is replaced by the following:

1. A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:

"1. A substance or mixture classified as hazardous and contained in packaging shall bear a label or fold-out label including the following elements:"

Or. en

(Regulation 1272/2008)

Amendment 206

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 17 – paragraph 1 – point (i) (new)

Text proposed by the Commission

Amendment

(7a) In Article 17, paragraph 1, the following point (i) is added:

'(i) where relevant, the species and number of animals used in tests;'

Or. en

Amendment 207

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008

Article 17 paragraph 1 – point a

Present text

Amendment

(7b) In Article 17, in paragraph 1, point a is replaced by the following:

(a)the name, address and telephone number of the supplier(s);

"(a) the name, address and telephone number of the supplier(s); distributers who do not change the product or packaging may use the provided label unchanged."

Or. en

(Regulation 1272/2008/EC)

Amendment 208

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008

Article 17 – paragraph 2

Present text

Amendment

(7b) In Article 17, paragraph 2 is replaced by the following:

2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.

"2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.Suppliers may use more languages on their labels or fold-out labels than those required by the Member States, provided that the same details appear in all languages used."

Or. en

(Regulation 1272/2008)

Amendment 209

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 18 – paragraph 3 – point b

Present text

Amendment

(7a) In Article 18, paragraph 3, point (b) is replaced by the following:

(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.

"‘(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties.’;"

Or. en

(Regulation 1272/2008)

Amendment 210

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 18 – paragraph 3 – point b

Present text

Amendment

(7a) In Article 18, paragraph 3, point b is replaced by the following:

"(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM)."

Or. en

(32008R1272)

Justification

The amendment only corrects omission of the EC that forgot to add the new hazard classes to the Article 18.

Amendment 211

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008

Article 18 – paragraph 3 – point b

Present text

Amendment

(7a) In Article 18, paragraph 3, point (b) is replaced by the following:

the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.

"the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT), aspiration hazard, endocrine disruption for human health, endocrine disruption for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, or very persistent and very mobile properties."

Or. en

(Regulation (EC) 1272/2008)

Justification

This is correcting an oversight by the Commission. The recently adopted delegated act introduced new hazard classes (for endocrine disruption, and PBT/vPvB, PMT/vPvM). These may contribute to the classification of the mixture with regard to these classes. They should obviously also be listed here.

Amendment 212

Nicola Procaccini, Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation 1272/2008

Article 23 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

In Article 23, the following point ea is added:

'(ea) disposable electronic cigarettes, single use cartridges and refill containers as defined in Directive 2014/40/EU.'

Or. en

Amendment 213

Alexander Bernhuber

Proposal for a regulation

Article 1 – paragraph 1 – point 9

Regulation (EC) 1272/2008

Article 25 – paragraph 8

Present text

Amendment

In Article 25, paragraph 8 is replaced by the following:

In the case of a bespoke paint for which no submission in accordance with Annex VIII has been made and no corresponding unique formula identifier has been created, the unique formula identifiers of all the mixtures contained in the bespoke paint in a concentration exceeding 0,1 % which themselves are subject to notification under Article 45 shall be included in the supplemental information on the label of the bespoke paint, located together and listed in descending order of the mixtures’ concentration in the bespoke paint, in accordance with the provisions of Section 5 of Part A of Annex VIII. In a case falling within the first subparagraph, where the concentration of a mixture with a unique formula identifier in the bespoke paint exceeds 5 %, the concentration of that mixture shall also be included in the supplemental information on the label of the bespoke paint next to its unique formula identifier, in accordance with Section 3.4 of Part B of Annex VIII. For the purposes of this paragraph, ‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.

"In the case of a bespoke paint or an on-site formulated mixture for which no submission in accordance with Annex VIII has been made and no corresponding unique formula identifier has been created, the unique formula identifiers of all the mixtures contained in the bespoke paint or the on-site formulated mixture in a concentration exceeding 0,1 % which themselves are subject to notification under Article 45 shall be included in the supplemental information on the label of the bespoke paint or the on-site formulated mixture, located together and listed in descending order of the mixtures’ concentration in the bespoke paint or the on-site formulated mixture, in accordance with the provisions of Section 5 of Part A of Annex VIII. In a case falling within the first subparagraph, where the concentration of a mixture with a unique formula identifier in the bespoke paint or the on-site formulated mixture exceeds 5 %, the concentration of that mixture shall also be included in the supplemental information on the label of the bespoke paint or the on-site formulated mixture next to its unique formula identifier, in accordance with Section 3.4 of Part B of Annex VIII. For the purposes of this paragraph, ‘bespoke paint’ means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing and ‘on-site formulated mixture’ means a mixture that is formulated in a volume less than 10 ml on a tailor-made basis for an individual consumer or professional user at the point of supply."

Or. en

(Regulation (EU) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.Art. 25, para. 1)

Amendment 214

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 9

Regulation (EC) 1272/2008

Article 25 – paragraph 2 and 3

Present text

Amendment

In article 25, paragraph 2 and 3 are replaced by the following:

2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EEC.The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation.

"2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 .The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation.

3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1 and 2, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.

3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1, 2 and 7, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements."

Or. en

(Regulation 1272/2008)

Amendment 215

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 10 a (new)

Regulation (EC) 1272/2008

Article 25 – paragraph 6

Present text

Amendment

(10a) In Article 25, paragraph 6 is replaced by the following:

6. Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture.

"6. Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture. Distributers who do not change the product or its packaging may use the provided label unchanged."

Or. en

(Regulation 1272/2008/EC)

Amendment 216

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 11 – point a

Regulation (EC) 1272/2008

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member State in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.;

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member States in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.;

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 29 paragraph 1)

Justification

Analogy with recital 11, where more flexibility for the use on regular basis the fold-out labels is provided.

Amendment 217

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 11 – point a

Regulation (EC) 1272/2008

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.;

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 29 - paragraph 1)

Justification

Alternative means of labelling are especially crucial for SMEs, for the professional sector and for the ability to place on the market of multiple Member States.

Alternative means of labelling (tie-on tags or outer packaging) have important benefits where the shape, form or size do not support a label or fold-out label and can facilitate the free movement of goods in the Single Market and allow more users to receive safety information in their own language.

Amendment 218

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EU) 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure that the label is updated within 6 months after the results of the new evaluation referred to in Article 15(4) were obtained. Where the supplier is a micro, small or medium-sized enterprise within the meaning of the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises, it shall ensure that the label is updated within 12 months of receiving the results of the reassessment referred to in Article 15(4).

Or. cs

Amendment 219

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 30 - paragraph 1)

Justification

It is critical to grant sufficient time for all actors in the supply chain to update their labels and to sustainably exhaust their stocks. The reason for a label update has absolutely no influence on the efforts required to update label artwork. Downstream users are in the middle of the supply chain and depend on their suppliers for classification information.

The proposed six-month transition period is impossible for manufacturers to meet and would create scrappage, product-rework/relabel and unnecessary transport of goods which contradicts the objectives of the Green Deal. This should be aligned with the 18 months given under paragraph 2 and the typical transition period for delegated acts under paragraph 3 for harmonised classification.

Amendment 220

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 221

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 222

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 223

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months after the results of the new evaluation referred to in Article 15(4) were obtained.

2. The supplier shall ensure that the label is updated within 18 months after the supplier has received the new evaluation referred to in Article 15(4).

Or. en

Justification

Alignment with current rules for a label update following the timeline for ATP's when CLH becomes mandatory for specific substances.

Amendment 224

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 12 months after the results of the new evaluation referred to in Article 15(4) were obtained.

Or. en

Amendment 225

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008

Article 30 – paragraph 3a new

Text proposed by the Commission

Amendment

3a. Paragraphs 1 and 2 shall not be applicable to distributers who do not modify the product, its packaging or label.

Or. en

Amendment 226

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 13

Regulation (EC) 1272/2008

Article 31– paragraph 3

Text proposed by the Commission

Amendment

3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such size and spacing as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.;

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 31- paragraph 3Justification)

Justification

As noted in the ECHA Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 Version 4.2 March 2021 – “Readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.”

Overly prescriptive additional requirements regarding font size, distance between two lines and background colour are not justified and severely limit the flexibility of suppliers . It is sufficient if the label or fold-out label is easily readable and clearly stands out from the background. In fact, the additional requirements would hinder the free movement of products in the Single Market, which in turn would entail an adjustment of logistics.

Amendment 227

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 13

Regulation (EU) 1272/2008

Article 31 – paragraph 3

Text proposed by the Commission

Amendment

3. The label elements referred to in Article 17(1) must be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such size and spacing as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.’

Or. cs

Amendment 228

Christian Doleschal, Christine Schneider, Dennis Radtke

Proposal for a regulation

Article 1 – paragraph 1 – point 13 a (new)

Regulation (EC) 1272/2008

Article 31 – title

Present text

Amendment

(13a) In Article 31, the title is changed as following:

General rules for the application of labels

"General rules for the application of labels and fold-out labels"

Or. en

(Regulation 1272/2008)

Amendment 229

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 14

Regulation (EC) No 1272/2008

Article 32 – paragraph 6

Text proposed by the Commission

Amendment

(14) in Article 32, paragraph 6 is deleted;

(14) in Article 32, paragraph 6 is deleted and replaced by the following;

´6. Where the label elements referred to in Article 17(1) is provided by means of a fold-out label, the front page shall contain at least the information provided in accordance with Article 17(1)(e) in all languages of the label along with a reference to the additional information provided on the inside page(s).'

Or. en

Amendment 230

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008

Chapter 3 - header

Text proposed by the Commission

Amendment

Formats of the labelling

(Does not affect the English version.)

Or. cs

Amendment 231

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008

Article 34a – paragraph 1 – point a)

Text proposed by the Commission

Amendment

(a) on a label in a physical form (‘physical label’); or

(a) on a label in a physical form (‘physical label’); and

Or. cs

Amendment 232

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008

Article 34a – paragraph 1 – point b)

Text proposed by the Commission

Amendment

(b) both on a physical label and on a label in a digital form (‘digital label’).

(b) on a label in a digital form (‘digital label’).

Or. cs

Amendment 233

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EC) No 1272/2008

Article 34a – paragraph 2a (new)

Text proposed by the Commission

Amendment

2a. In Article 34a, the following paragraph 2a is added:

'The Commission shall document in full transparency the decision process to determine what information is not instrumental for the safety of the user or the protection of the environment.'

Or. en

Amendment 234

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008

Article 34b – paragraph 1

Text proposed by the Commission

Amendment

1. The digital label for substances and mixtures shall satisfy the following general rules and technical requirements:

1. The digital label for substances and mixtures must satisfy the following general rules and technical requirements:

Or. cs

Amendment 235

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EU) 1272/2008

Article 34b – paragraph 1 – point d)

Text proposed by the Commission

Amendment

(d) the digital label shall be accessible free of charge, without the need to register, download or install applications, or to provide a password;

(d) the digital label shall be accessible free of charge, without the need to register, download or install applications, or to provide a password, in a user-friendly and harmonised format;

Or. cs

Amendment 236

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008

Article 34b – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the digital label shall be accessible free of charge, without the need to register, download or install applications, or to provide a password;

(d) the digital label shall be accessible free of charge, without the need to register, download or install specific applications, or to provide a password;

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 34)

Justification

A general reference not to download or install application could de facto also prevent the use of a QR code reader app, as some people may need to install it on their mobile.

Amendment 237

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008

Article 34b – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) the information on the digital label shall be accessible with no more than two clicks;

deleted

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 34)

Justification

Accessing the information for differing language versions, esp. in MS with more than one official language may require more than two clicks and should be covered by guidance.

Amendment 238

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008

Article 34b – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) when the digital label is available in more than one language, the choice of language shall not be conditioned on the geographical location;

(h) when the digital label is available in more than one language, the choice of language shall not be restricted by geographical location;

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 34)

Justification

Clarification

Amendment 239

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 16

Regulation (EC) No 1272/2008

Article 35 – paragraph 2a

Text proposed by the Commission

Amendment

2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled.;

This paragraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).;

Or. en

Amendment 240

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 16

Regulation (EU) 1272/2008

Article 35 – paragraph 2a

Text proposed by the Commission

Amendment

2a. Hazardous substances or mixtures may be supplied to consumers and subsequent users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled.’;

Or. cs

Amendment 241

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 16 a (new)

Regulation (EC) 1272/2008

Title V

Present text

Amendment

HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE CLASSIFICATION AND LABELLING INVENTORY

"HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND MIXTURES AND THE CLASSIFICATION AND LABELLING INVENTORY"

(Horizontal amendment that should apply throughout the text.)

Or. en

(Regulation (EC) 1272/2008)

Justification

Harmonised classification should also be possible for mixtures.

Amendment 242

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008

Article 37 – paragraph 1 – first subparagraph

Text proposed by the Commission

Amendment

A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.

A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances or a mixture and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.

Or. en

Justification

Recital 18 explicitly refers to group approaches for classification and labelling. This should also be reflected in the operative part. Competent authorities should not only be allowed to submit proposals for harmonised classification for substances, but also for groups of substances. The use of group approaches can facilitate the work, improve protection of human health and the environment, save animal tests and increase consistency and predictability.

Amendment 243

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008

Article 37 – paragraph 1

Text proposed by the Commission

Amendment

The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling 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 Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances where a harmonised classification could be necessary to protect human and animal health and the environment.

Or. en

Amendment 244

Sirpa Pietikäinen

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) No 1272/2008

Article 37 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling 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. Whenever considered scientifically justified and possible by a competent authority or the European Commission, proposals for classification should prioritise groups of substances rather than individual substances.

Or. en

Amendment 245

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008

Article 37 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

(Linked to the amendment on the first subparagraph of this Article by the same author.)

Justification

Amendment 246

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) 1272/2008

Article 37 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The proposals 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.

The proposals for harmonised classification and labelling of a substance and also groups 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.

Or. en

Justification

This amendment provides for better understanding of this Article and of the preferred transition towards using the grouping approach, where scientifically justified, as default approach in order to alleviate the burden on the competent authorities, increase efficiency, decrease costs and improve the overall effectiveness of the Regulation.

Amendment 247

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point a

Regulation (EC) No 1272/2008

Article 37 – paragraph 1 – subparagraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 37, the following subparagraph 3a is added:

'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling should prioritise groups of rather than individual substances.'

Or. en

Amendment 248

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point c

Regulation (EC) 1272/2008

Article 37 – paragraph 2a – subparagraph 2

Text proposed by the Commission

Amendment

Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).

Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter, as well as scientific data, studies and other information supporting the proposal. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).

Or. en

Amendment 249

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point d a (new)

Regulation (EC) 1272/2008

Article 37 – paragraph 4

Present text

Amendment

(da) In Article 37, paragraph 4 is replaced by the following

4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.

"4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.

The Agency may provide further guidance on the development of harmonised classification proposal for group(s) of substances and take into consideration the complexity of the proposal to allow sufficient time for the relevant stakeholders to provide comments."

Or. en

(32008R1272)

Justification

Article 50 of Regulation 1272/2008 "Tasks of the Agency" requests that the Agency´s Secretariat "(a) provide industry with technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation; (b) provide competent authorities with technical and scientific guidance and tools on the operation and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44." The following amendment therefore gives the Agency room for manoeuvre.

Amendment 250

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008

Article 37 – paragraph 5

Text proposed by the Commission

Amendment

The Commission shall adopt without undue delay, delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

The Commission shall adopt within 6 months after the adoption of an opinion by the Committee for Risk Assessment of the Agency in accordance with paragraph 4, delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Or. en

Amendment 251

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008

Article 37 – paragraph 5

Text proposed by the Commission

Amendment

The Commission shall within nine months following the receipt of the opinion of the Committee for Risk Assessment adopt delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances or mixtures together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Or. en

Justification

There should be a clear deadline for the Commission to take decisions on CLP. In Article 71(9) of the recently agreed revision of the Batteries Regulation, a deadline of nine months was adopted for the Commission to adopt a delegated act with regard to the restriction of substances following the receipt of the opinion of the relevant committee. The same deadline should be included here to ensure timely decision-making to protect human health and the environment and to provide certainty for economic operators.

Amendment 252

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008

Article 37 – paragraph 6

Text proposed by the Commission

Amendment

6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market. The manufacturer, importer or downstream user that has, after refusal of submission to adapt classification to a less severe hazard class or category by a competent authority in one of the Member States, resorted to submitting the proposal to a competent authority in another Member States, shall be rejected and contribute with a fee to compensate for the costs borne by the competent authorities;

Or. en

Justification

The amendment aims at deterring submitters from attempts to overcome one Member States authority when seeking unjustified de-classification of substance or group of substances.

Amendment 253

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) 1272/2008

Article 37 – paragraph 6

Text proposed by the Commission

Amendment

A proposal of a manufacturer, importer or downstream user for a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI to a less severe harmonised classification and labelling shall be accompanied by the fee determined by the Commission in accordance with the procedure referred to in Article 54(2);

Or. en

Justification

According to paragraph 3 of the Article 37, manufacturers, importers and downstream users who would like to propose a harmonised classification shall pay a fee. The same should be required by such economic operators who have new information. A fee should however only be required if the new information might lead to a less severe classification, so as to avoid a disincentive for economic operators to provide new data that could lead to a more severe classification.

Amendment 254

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point e

Regulation (EC) No 1272/2008

Article 37 – paragraph 6

Text proposed by the Commission

Amendment

Any proposal referred to in the first subparagraph shall be accompanied by a fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2) of this Regulation.

Or. en

Amendment 255

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008

Article 37 – paragraph 7

Text proposed by the Commission

Amendment

The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative together with relevant classification and labelling elements where, on … [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. delegated act on the new hazard classes - reference to be added once adopted], those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative, as persistent, mobile and toxic or as very persistent, very mobile, together with relevant classification and labelling elements where, on … [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. delegated act on the new hazard classes - reference to be added once adopted], those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

Or. en

Amendment 256

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008

Article 37 – paragraph 7

Text proposed by the Commission

Amendment

By 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic, as very persistent and very bioaccumulative, as persistent, mobile and toxic, or very persistent and very mobile together with relevant classification and labelling elements where, on 1 January 2025, those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

Or. en

Justification

Under REACH 22 endocrine disrupters and 49 persistent chemicals (PBT/vPvB) have been identified to date. A clear date should be set for those to be added to Annex VI of CLP following the adoption of the new hazard classes. Assuming entry into force of the revised CLP Regulation in summer 2024, it is appropriate to set a deadline for the amendment of the Annex by the end of 2025. This should apply for all corresponding substances on the candidate list one year before. This should include also any PMTs and vPvM, which are also substances of very high concern pursuant to Article 57(f) of REACH.

Amendment 257

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008

Article 37 – paragraph 8

Text proposed by the Commission

Amendment

The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI by inclusion of substances together with relevant classification and labelling elements where, on … [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. the delegated act on the new hazard classes - reference to be added once adopted] those substances have not been approved, under Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 or have been approved with derogation in accordance with the relevant provisions of those Regulations, due to either of the following characteristics:

By 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI by inclusion of substances together with relevant classification and labelling elements where, on 1 January 2025 those substances have not been approved, under Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 or have been approved with derogation in accordance with the relevant provisions of those Regulations, due to either of the following characteristics:

Or. en

Justification

A deadline should also be set for the Commission to include the classification of substances that have not been approved under the Plant Protection Products Regulation and the Biocidal Regulation.

Amendment 258

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008

Article 37 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

In Article 37, the following paragraph 8a is added:

'8a. Without prejudice to paragraphs 1 to 5, in the case that additional classification criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I, are integrated to this regulation, new data in relation to those criteria and available to manufacturers, importers and downstream users, not having been previously submitted for evaluation under the processes of Regulation (EC) No. 1107/2009 or Regulation (EU) No 528/2012 or Regulation (EU) No 2017/2100, shall be evaluated at minimum through a simplified process by the Risk Assessment Committee of the Agency before inclusion in Table 3.2 of Part 3 of Annex VI of conclusions on classification and labelling relating to the criteria concerned.'

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Justification

In order to ensure the robustness and alignment of all classifications contained in CLP annex VI, to consider all additional information now available and not previously taken into account and to allow the possibility of a harmonized categorisation, substances should be reviewed by ECHA Risk Assessment Committee (RAC) before their inclusion in CLP annex VI.

In particular, for active substances in plant protection products, there is a risk that new data might be available after the decision made by EFSA, which would need to be taken into account to ensure the harmonized classification according to CLP principles is granted during this transfer of regulatory decisions across regulations.

Amendment 259

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 20 a (new)

Regulation (EC) 1272/2008

Article 41

Present text

Amendment

(20a) The Article 41 is replaced by the following:

Agreed entries

"Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. In case where notifiers and registrants cannot come to an agreed entry because of divergences about the level of scientific evidence supporting a classification and labelling of the same substance, the most protective classification shall prevail.'"

Or. en

(32008R1272)

Amendment 260

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 20 a (new)

Regulation (EC) 1272/2008

Article 41

Present text

Amendment

(20a) Article 41 is replaced by the following:

Agreed entries

"Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. If after 6 months no agreement has been reached, the most severe hazard classification will apply for all concerned entries, and the Agency will change them accordingly."

Or. en

(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)

Amendment 261

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008

Article 42 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

(21) in Article 42(1), the third subparagraph is replaced by the following:

deleted

‘The following information shall be made publicly available free of charge online:

(a) information referred to in Article 40(1), point (a), except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party;

(b) in the case of group notifications, the identity of the importer or manufacturer submitting the information on behalf of the other members of the group;

(c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006.

The Agency shall grant access to the information in the inventory that concerns a substance and is not referred to in the first subparagraph to other parties subject to Article 118 of Regulation (EC) No 1907/2006.;’

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Justification

Companies contacting each other for agreement on hazard classification of substances without a defined institutional framework (like SIEFS under REACH) is not in line with competition law. Therefore, making notifiers names publicly available should be opposed.

Amendment 262

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EU) 1272/2008

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

The following information shall be made publicly available free of charge online:

The following information shall be made publicly available free of charge online in a user-friendly format:

Or. cs

Amendment 263

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008

Article 42 – paragraph 1 – subparagraph 3 – point (a)

Text proposed by the Commission

Amendment

(a) information referred to in Article 40(1), point (a);

Or. en

Amendment 264

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EU) 1272/2008

Article 42 – paragraph 1 – point a)

Text proposed by the Commission

Amendment

(a) information referred to in Article 40(1), point (a);

Or. cs

Amendment 265

Alexander Bernhuber

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008

Article 42 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In the Article 42, the following paragraph 3a is added:

'The Agency shall remove inactive entries from the inventory. An entry is considered inactive, when the notifier has not updated the entry within 2 years and after this period has not reacted on a request of the Agency to confirm the correctness of the entry.'

Or. en

Amendment 266

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008

Article 42 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

In Article 42, the following paragraph 3a is inserted:

3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall delete the corresponding entry from the inventory after having informed the notifier .

Or. en

Amendment 267

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008

Article 42 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

In Article 42, paragraph 2, the following subparagraph 1a is added:

'The Agency may, where appropriate, delete obsolete and out-of-date information from the inventory;'

Or. en

Amendment 268

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 21 a (new)

Regulation (EC) 1272/2008

Article –43 (new)

Text proposed by the Commission

Amendment

(21a) The following Article -43 is added:

Article -43 – Right to request action from competent authorities and the Commission

1. Any natural or legal person, individually or in association, shall be entitled to submit substantiated evidence to competent authorities as referred to in Article 43 or the Commission, such as peer reviewed studies, human biomonitoring data, or environmental monitoring data, on the hazardous properties of a substance(s) or mixture(s) showing that hazardous properties of a substance(s) or mixture(s) may not have been sufficiently considered in the classification or labelling process.

2. The competent authorities or the Commission shall diligently and impartially assess the information submitted in accordance with paragraph 1, integrating the evidence submitted to all other available evidence using a weight of evidence approach.

3. Where the evidence submitted shows non-compliance with one or several of the requirements on the classification, labelling and packaging of substances and mixtures, enforcement measures shall be initiated in accordance with Article 47.

4. Where the assessment has showed that the substance(s) meets the criteria for classification in any of the hazard classes referred to in Article 36(1), the competent authority or the Commission shall initiate a process of harmonised classification and labelling. Where the assessment has showed a wide dispersive use of and/or consumer exposure to the substance or mixture concerned, the competent authority or the Commission shall initiate a risk management process under Article 59, Article 69, or Article 68(2) of Regulation (EU) No 1907/2006. Where the assessment has showed a lack of information on the risk to health or the environment posed by a hazardous substance or mixture, the competent authority or the Commission shall require companies or any other relevant actor to provide more information, with a view to take risk management measures under Titles VI, VII or VIII of Regulation (EU) 1907/2006, where necessary.

5. Where the evidence submitted should have been included in the registration dossier submitted under Regulation (EU) No 1907/2006 but was omitted by the registrant, enforcement measure should be initiated under Article 126 of Regulation (EU) No 1907/2006 against registrants which registration is non-compliant.

6. The competent authority or the Commission, shall, within 6 months, inform the natural or legal persons referred to in paragraph 1, of its opinion on the evidence and concerns so submitted, and of any steps it plans to take to address these concerns, providing the reasons for both the opinion reached and the steps proposed.

7. Competent authorities and the Commission shall publish an annual report on the requests received and their treatment.

Or. en

Amendment 269

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 21 a (new)

Regulation (EC) 1272/2008

Article 42 – paragraph 2

Present text

Amendment

(21a) Article 42, paragraph 2 is amended as follows:

The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

"The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

The Agency shall delete entries which it considers obsolete. "

Or. en

(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32008R1272)

Amendment 270

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 21 b (new)

Regulation (EC) 1272/2008

Article –43 a (new)

Text proposed by the Commission

Amendment

(21b) The following Article -43a is added:

Article -43a – Access to justice

1. Any natural or legal person which has submitted substantiated concern in accordance with Article -43a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant competent authority under this Regulation.

2. Member States shall ensure access to administrative or judicial procedure to review their decisions, acts and omissions, in accordance with national legislation or practice. Decisions, acts and omissions by the Commission shall be submitted to review according to the provisions of Regulation EU (No) 1367/2006.

3. Any such procedure shall be fair, equitable, timely and not prohibitively expensive as well as provide adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Or. en

Amendment 271

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 22 a (new)

Regulation (EC) 1272/2008

Article 46a (new)

Text proposed by the Commission

Amendment

(22a) The following Article 46a is added:

Article 46a

Access to justice

1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection, the protection of human or animal health or animal welfare, and meeting any requirements under national law shall be deemed to have sufficient interest.

2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Or. en

Amendment 272

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008

Article 48

Text proposed by the Commission

Amendment

(23) Article 48 is replaced by the following:

deleted

‘Article 48

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.’

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 48)

Justification

The Commission proposal is a significant widening of the scope of the regulation. It is a disproportionate measure to include all types of advertisements with likely mixed results in terms of protection of human health and environment.

The current regulation ensures sufficient information is available at point of sale. Advertisement is more appropriately covered by other legislation and digital labels will provide consumers with additional information.

Amendment 273

Marian-Jean Marinescu

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

1. Any advertisement of a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements and request the user to always read and follow product label information.

Or. en

Amendment 274

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;

Or. en

Amendment 275

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EU) 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

1. Any advertisement for a substance classified as hazardous must indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

Or. cs

Amendment 276

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008

Article 48 – paragraph 2

Text proposed by the Commission

Amendment

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;

Or. en

Amendment 277

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 23

Regulation (EU) 1272/2008

Article 48 – paragraph 2

Text proposed by the Commission

Amendment

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) must indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.

Or. cs

Amendment 278

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 24

Regulation (EC) 1272/2008

Article 48 a

Text proposed by the Commission

Amendment

(24) the following Article 48a is added:

deleted

‘Article 48a

Distance sales offers

Suppliers placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to in Article 17.;’

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 48 a)

Justification

This is not required, the original text of Article 48 is sufficient. Advertisement is more appropriately covered by other legislation and digital labels will provide consumers with additional information.

Amendment 279

Stanislav Polčák

Proposal for a regulation

Article 1 – paragraph 1 – point 24

Regulation (EU) 1272/2008

Article 48a

Text proposed by the Commission

Amendment

Suppliers placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to in Article 17.

Suppliers placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to in Article 17 as part of the offer of these substances or mixtures.

Or. cs

Amendment 280

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 25 a (new)

Regulation (EC) 1272/2008

Article 53 – paragraph 1

Present text

Amendment

(25 a) In Article 53, paragraph 1 is replaced by the following:

The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.

"'The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases, and to adopt specific provisions in Annex I for substances containing more than one constituent."

Or. en

(Regulation (EC) 1272/2008)

Justification

The empowerment in Article 53 needs to be modified to explicitly allow for the introduction of specific provisions for substances containing more than one constituent - a derogation foreseen in Article 5(3) - as this goes beyond the adaptation to technical and scientific progress.

Amendment 281

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point -a (new)

Regulation (EC) 1272/2008

Article 53 – paragraph 1– subparagraph 1 a (new)

Text proposed by the Commission

Amendment

(-a) In Article 53, paragraph 1, the following subparagraph 1a is added:

'The Commission shall, no later than 2025, adopt delegated acts in accordance with Article 53a to propose the development of hazard criteria for immunotoxicity and neurotoxicity;'

Or. en

Amendment 282

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point a

Regulation (EC) 1272/2008

Article 53 – paragraph 1a

Text proposed by the Commission

Amendment

1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6. of Annex I in order to adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among all population groups in the Union. When adopting those delegated acts, the Commission shall take into account the societal needs and a high level of protection of human health and the environment;

1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6. of Annex I in order to adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among different population groups in the Union. When adopting those delegated acts, the Commission shall ensure high level of protection of human health and the environment and take into account the societal needs. The Commission shall make sure that information which is critical to protect human health and environment shall remain easily accessible on physical label;

Or. en

Justification

Transition towards digital labelling needs to be implemented in a way that no societal and age group is left behind. Insufficient information could, moreover, lead towards decreased trust and demand of consumers, causing subsequent economic losses to EU businesses.

Amendment 283

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point a

Regulation (EC) 1272/2008

Article 53 – paragraph 1b – point d

Text proposed by the Commission

Amendment

(d) take into account the level of digital readiness among all population groups in the Union;

(d) take into account the level of digital readiness among all population groups in the Union, as well as readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

Or. en

Amendment 284

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point b

Regulation (EC) 1272/2008

Article 53 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well as alternative test methods at the level of the UN.;

2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well the development of criteria for immunotoxic and neurotoxic substances and as well as alternative test methods, including new approach methods and in particular non-animal methods at the level of the UN to address existing and emerging hazard classes.

Or. en

Justification

In the Chemical Strategy for Sustainability, the Commission committed to assess the need to address chemicals with immunotoxic and neurotoxic properties under CLP. It would be appropriate to promote this also at UN level. It is important that the Commission and Member States also promote the use of non-animal methods including new approach methods at the UN level.

Amendment 285

Jutta Paulus

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008

Article 53 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

3. The Commission shall evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, including new approach methods and in particular non-animal test methods, at least every two years, and update Annex I of this Regulation to reflect such technical progress, if relevant. The Commission shall update Annex I of this Regulation no more than six months after non-animal data are taken up into harmonised criteria for classification and labelling at the level of the UN.

Or. en

Justification

It is of key importance that the Commission regularly evaluates the progress with regard to the development of new approach methods and non-animal methods and updates the Annex, if relevant. Any advances as UN level need to be reflected in CLP in a timely manner.

Amendment 286

Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008

Article 53 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

3. The Commission shall promote and at least every two years evaluate the development of New Approach Methodologies, including those referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

No later than six months after new harmonised criteria based on available NAM are included in UN GHS, the Commission shall adopt Delegated Acts in accordance with Article 53a to update Annex I of this Regulation.

Or. en

Amendment 287

João Albuquerque, Sara Cerdas

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) No 1272/2008

Article 53 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

Where validated alternative test methods are not available for the endpoint in discussion, the expert judgement of competent authorities on the type of data necessary to decide on the classification of substances and mixtures shall prevail.

Or. en

Amendment 288

Martin Hojsík, Billy Kelleher, María Soraya Rodríguez Ramos, Michal Wiezik, Susana Solís Pérez

Proposal for a regulation

Article 1 – paragraph 1 – point 26 – point c

Regulation (EC) 1272/2008

Article 53 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. In Article 53, the following paragraph 3a is added:

'The Commission shall by December 2024 assess hazard criteria for immunotoxicity and neurotoxicity and, where appropriate, adopt delegated acts in accordance with Article 53;'

Or. en

Justification

The Commission committed in the Chemical Strategy for Sustainability to assess the need for specific criteria for immunotoxicity and neurotoxicity, currently under the hazard endpoints ‘Specific target organ toxicity’ and ‘reproductive toxicity’, and amend them if necessary. Nevertheless, in the IA it only states that the scale of the problems caused by these hazards need further investigation, before deciding on the best way to tackle the problems linked. This amendment therefore requests from the EC to properly assess this issue and come up with a proposal if appropriate.

Amendment 289

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008

Article 61 – paragraph 7

Text proposed by the Commission

Amendment

Substances and mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

Substances which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third subparagraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 61 – paragraph 7))

Justification

Amendment 290

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008

Article 61 – paragraph 7

Text proposed by the Commission

Amendment

Substances which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 61 – paragraph 7))

Amendment 291

Pietro Fiocchi

Proposal for a regulation

Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008

Article 61 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

In the Article 61, the following paragraph 7a is added:

‘7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII, Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 36 months [VC1] after the date of entry into force of this Regulation] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].’

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Justification

Differentiated dates for substances and mixtures should be introduced in this paragraph. As the classification of mixtures depends on the classification of substances, the provisions for the classification of mixtures should only be applied after the reclassification of all substances. Moreover, in order to avoid unnecessary burdens on enterprises, substances and mixtures which are already in the supply chain when the labelling provisions of this Regulation become applicable to them may continue to be placed on the market without relabelling for a certain period of time. A reasonable timeline for the application of these new provisions would be: 24 months for substances and 42 months for substances already placed in the market; 36 months for mixtures and 60 months for mixtures already placed in the market. Such timeline is consistent with CLP Regulation and the recent delegated act for hazard classes- Commission Delegated Regulation (EU) 2023/707.

Amendment 292

Danilo Oscar Lancini, Silvia Sardone, Matteo Adinolfi, Rosanna Conte, Gianantonio Da Re, Gianna Gancia, Maria Veronica Rossi, Aurélia Beigneux, Elisabetta De Blasis

Proposal for a regulation

Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008

Article 61 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

In Article 61, the following paragraph 7a is added:

'7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII, Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 36 months [VC1] after the date of entry into force of this Regulation] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 60 months after the date of entry into force of this Regulation].'

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

(Article 61 – paragraph 7 a (new))

Amendment 293

Pietro Fiocchi

Proposal for a regulation

Article 2 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The following provisions shall apply from [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

2. The following provisions shall apply to substances from [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

Or. en

Amendment 294

Pietro Fiocchi

Proposal for a regulation

Article 2 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 36 months after the date of entry into force of this Regulation]:

(a) Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) and (24);

(b) points (2), (3), (7), (9) and (10) of Annex I;

(d) points (1)(c), (2), (3) and (4) of Annex III.

Or. en

Amendment 295

Pietro Fiocchi

Proposal for a regulation

Article 2 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date = the day before the date of entry into force of this Regulation], substances and mixtures may until … [OP: please insert the date = the last day of the month following 17 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:

3. By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date = the day before the date of entry into force of this Regulation], substances and mixtures may until … [OP: please insert the date = the last day of the month following 17 months after the date of entry into force of this Regulation] and mixture may until … [OP: please insert the date = the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:

Or. en