Sittings · Document

Draft report (COM(2025)0531 – C90424/2023 – 2025/0531(COD)) 2026-02-24

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

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

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Amendment 270

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

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

Or. en

Justification

The amendment ensures consistency with the revised Detergents and Surfactants Regulation by preserving flexibility in supplier contact options. Allowing the use of a telephone number on labels and keeping digital contacts voluntary avoids disproportionate burdens, particularly for SMEs, while ensuring effective communication for consumers and competent authorities under Regulation (EC) No 1272/2008.

Amendment 271

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

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

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

Or. en

Justification

By allowing suppliers to retain a telephone number on product labels and keeping the provision of a digital contact voluntary, it avoids imposing unnecessary or disproportionate obligations, in particular on smaller operators. At the same time, it preserves effective and reliable communication channels for consumers and enforcement authorities, ensuring that regulatory objectives are met without undermining accessibility or creating avoidable administrative burdens under Regulation (EC) No 1272/2008.

Amendment 272

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

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier or suppliers of the mixture and/or the telephone number, unless the latter is immediately available through the digital contact. The inclusion or change to the digital contact may be implemented without undue delay, or in alignment with the supplier’s regular label-update cycles;

Or. en

Amendment 273

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

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address, digital contact of the suppliers of the mixture or the telephone number, unless this telephone number is immediately available through the digital contact.;

Or. en

Justification

This amendment aligns with the revised Detergents and Surfactants Regulation by preserving flexibility in supplier contact details. It allows a telephone number to remain on labels while keeping digital contact optional, avoiding disproportionate obligations, especially for SMEs. At the same time, it ensures consumers and authorities retain effective communication channels, supporting transparency and enforcement under Regulation (EC) No 1272/2008 without unnecessary administrative burden.

Amendment 274

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address, digital contact of the suppliers of the mixture or the telephone number, unless this telephone number is immediately available through the digital contact.

Or. en

Amendment 275

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address, digital contact of the suppliers of the mixture or the telephone number, unless this telephone number is immediately available through the digital contact;

Or. en

Justification

Amendment 276

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

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address, telephone number and digital contact of the supplier of the mixture;

Or. en

Amendment 277

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

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact of the supplier of the mixture.;	The label shall also include the product identifier referred to in Article 18 and the name, address and digital contact or telephone number of the suppliers of the mixture.;

Or. en

Amendment 278

Klara Dostalova

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Text proposed by the Commission	Amendment
	The following information shall, notably for reasons of public health and safety, be provided exclusively on the physical label on supplementary information on the label: (a) instructions for use; (b) recommended application doses and dosage information; (c) storage conditions; (d) safety warnings and precautionary statements; (e) first aid measures; (f) any other information essential to ensuring safe and proper use of the product.

Or. en

Justification

The information listed in points (a) to (c) falls within the scope of supplementary label information as defined in Article 25 of Regulation (EC) No 1272/2008 and is essential for safe use, thereby requiring physical accessibility.

Amendment 279

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2

Text proposed by the Commission	Amendment
2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.;	2. 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 of Article 31 for a 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) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.;

Or. en

Amendment 280

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2

Text proposed by the Commission	Amendment
2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.;	2. 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 of Article 31 for a label in the languages of the Member State in which the substance or mixture is placed on the market, the label information may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.

Or. en

Amendment 281

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

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2

Text proposed by the Commission	Amendment
2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.;	2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.
	For packaging not exceeding 100 ml, the label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2.4 of Annex I.;

Or. en

Amendment 282

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2

Text proposed by the Commission	Amendment
2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2 of Annex I.;	2. The label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2.4 of Annex I.;

Or. en

Amendment 283

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
	2a. By way of derogation from Articles 17(1) and 25(6), the labelling of technical containers forming an integral part of a system of equipment may include reduced label elements, in accordance with the rules set out in Annex I, section 1.5.2.5a.

Or. en

Justification

The amendment introduces a specific provision for packaging of up to 75 ml, allowing reduced label elements in line with Annex I, section 1.5.2.4, to ensure proportionality for small packaging. New point 2(a) extends this derogation to technical containers integrated into equipment, such as inkjet printer cartridges up to 150 ml, where full CLP information is provided on the outer packaging. Due to design constraints, labels or fold-out labels cannot be applied to cartridges without interfering with their insertion or operation.

Amendment 284

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
	2a. For packaging where the contents do not exceed 10 ml, the label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2.4 of Annex I.

Or. en

Amendment 285

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
	2a. For packaging up to and including 10 ml, the label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2.4 of Annex I.

Or. en

Amendment 286

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
	2a. For packaging up to and including 75 ml, the label elements set out in Article 17(1) may be reduced in accordance with the rules set out in section 1.5.2.4 of Annex I.;

Or. en

Amendment 287

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 b (new)

Text proposed by the Commission	Amendment
	2b. By way of derogation from Article 17(1) and Article 25(6), for the labelling of technical containers that operate as an integral part of a system of equipment, and where technical constraints limit the available labelling surface area, the label elements may be reduced in accordance with the rules set out in section 1.5.2.5a of Annex I.

Or. en

Amendment 288

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

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
(5) in Article 30, paragraph 1 is replaced by the following:	deleted
‘1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;’

Or. en

Justification

Establishment of a max 6-month timeline for label updates following classification changes is critical for consumer protection and can’t be extended without creating significant safety risks. When a substance or mixture receives a new hazard classification or more severe rating, this reflects newly discovered or confirmed dangers to human health, safety, or the environment. Every day that consumers, workers, and end-users interact with improperly labelled products represents potential exposure to inadequately communicated risks.

Amendment 289

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
(5) in Article 30, paragraph 1 is replaced by the following:	deleted
‘1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;’

Or. en

Amendment 290

Majdouline Sbai

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;	1. 'No later than by 15 January of every year, the Agency shall compile and publish a list of the changes regarding the self-classification or 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. Suppliers of such a substance or mixture shall ensure that the label is updated at the latest by 15 July of the subsequent year. Suppliers should have the possibility to apply the new or updated self-classifications, and to adapt the labelling accordingly, on a voluntary basis before the date provided above to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers.'

Or. en

Justification

The current system of updating labels in case of new hazard classes or more severe classifications based on self-classification follows an archaic linear chain of communication from one supplier to another. That is not appropriate in 21st century. This is particularly problematic as supply chains can easily involve three or more actors. The delays created by such communication from one to another defeat the purpose of timely communication of the new or more severe classifications and do not serve anyone. This is made worse by the EC proposal to delete the clear maximum time per supplier for the update. Requiring updates "without undue delay" creates major problems for enforcement (the meaning is unclear and is likely to be applied differently in different Member States), leading to an unlevel playing field. Instead, a system should be created in analogy to what is applicable in case of harmonised classifications. Every year, the EC adopts the new harmonised classifications based on the RAC opinions of the penultimate year. The new classifications are then applicable 18 months after their entry into force for all suppliers. A similar approach should be established for relevant changes in self-classification. Instead of each individual self-classification triggering a supplier after supplier update requirement, all relevant changes in self-classification in one calendar year should be grouped by the ECHA into one document at the beginning of the next calendar year. All suppliers should then have 18 months to update their label. Annual grouping of such updates with a clear periodicity for all suppliers would truly simplify issues, instead of unclear periods that can be triggered at any moment and that are virtually impossible to enforce in light of the complexities of supply chains. And it would leave ample time for suppliers for the update.

Amendment 291

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;	1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 24 months per actor in the supply chain and sequentially scheduled after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;

Or. en

Amendment 292

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;	1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months per actor in the supply chain and sequentially scheduled after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;

Or. en

Justification

Classification changes require sufficient time to be translated into compliant labels. The redesign of label artwork alone can take up to 12 months, in addition to the time needed for data generation or reformulation. Allowing updates to align with existing production cycles and providing a clear 18-month update period, with a staged application across the supply chain, would better reflect operational realities and avoid unnecessary disruption.

Amendment 293

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

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;	1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 24 months per actor in the supply chain and sequentially scheduled after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;

Or. en

Amendment 294

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Text proposed by the Commission	Amendment
1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;	1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 9 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;

Or. en

Amendment 295

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

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) No 1272/2008

Article 31 – paragraph 3

Text proposed by the Commission	Amendment
(6) in Article 31, paragraph 3 is replaced by the following:	deleted
‘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 a size and be spaced in such a way as to be easily read.;’

Or. en

Justification

Maintaining mandatory requirements for label characteristics, including background colour, line spacing, single font usage, and letter spacing, is essential to ensure uniformity, legibility, and effective hazard communication across all chemical products. Standardized formatting requirements guarantee that safety information remains legible regardless of the producer's design preferences.

Amendment 296

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) No 1272/2008

Article 31 – paragraph 3

Text proposed by the Commission	Amendment
(6) in Article 31, paragraph 3 is replaced by the following:	deleted
‘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 a size and be spaced in such a way as to be easily read.;’

Or. en

Amendment 297

Majdouline Sbai

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) No 1272/2008

Article 31 – paragraph 3

Text proposed by the Commission	Amendment
(6) in Article 31, paragraph 3 is replaced by the following:	deleted
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 a size and be spaced in such a way as to be easily read.;

Or. en

Justification

The sole purpose of the Commission's amendment of this paragraph is to delete the requirements for labelling as laid down in Annex I point 1.2.1.5. This is not appropriate. The Annex should be retained - not only to set out general criteria on readability, as also done by the rapporteur and the Council - but also to ensure clear requirements with regard to line spacing (in general) and to minimum font size for B2C communication. The deletion of the Commission of Annex I point 1.2.1.5. by replacing this paragraph should therefore be deleted.

Amendment 298

Nikola Minchev

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) No 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 a size and be spaced in such a way as to be easily read.;	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 a size and be spaced in such a way as to be easy to read at the point of purchase and during use. They shall be formatted in accordance with section 1.2.1.5 of Annex I.;

Or. en

Amendment 299

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 6

Regulation (EC) No 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 a size and be spaced in such a way as to be easily read.;	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 a size and spacing be spaced in such a way as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.

Or. en

Amendment 300

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

Proposal for a regulation

Article 1 – paragraph 1 – point 6 a (new)

Regulation (EC) No 1272/2008

Article 36 – paragraph 1

Present text	Amendment
	(6a) in Article 36(1), points (e) to (j) are deleted;

Or. en

Justification

This article should not list hazard classes that are only now discussed at UN-GHS level. It is premature to include them at EU level for prioritisation before their adoption at UN level to ensure global harmonisation.

Amendment 301

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 6 a (new)

Regulation (EC) No 1272/2008

Article 37 – paragraph 4

Present text	Amendment
	(6a) 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. This opinion shall take account of the proposal submitted pursuant to paragraphs 1 or 2, the views of interested parties and the relevant scientific information provided to the Agency until the RAC opinion is adopted. The Agency shall forward this opinion and any comments to the Commission, who, based on the information received, shall decide and justify if the entry to Annex VI to CLP would be appropriate and/or needs to be modified according to Art 37 (5).

Or. en

Justification

Any new scientific data emerging during the harmonised classification process, including after ECHA’s public consultation, should be evaluated by RAC before the classification is included in Annex VI of the CLP Regulation.

Amendment 302

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 6 b (new)

Regulation (EC) No 1272/2008

Article 37 – paragraph 5

Text proposed by the Commission	Amendment
	(6b) in Article 37, paragraph 5 is replaced by the following:
5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.	5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it may adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI. Where the Commission decides not to adopt a delegated act, or where the delegated act does not take the opinions or specific parts of the opinions from the Committee for Risk Assessment into account for a specific substance, classification and/or the specific concentration limits, M-factors or acute toxicity limits or modifies the entry by adding specific notes, the Commission shall provide a detailed explanation of the reasons for the differences.
Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

Or. en

Justification

Where justified, the Commission should be able to refrain from advancing harmonised hazard classifications or depart from ECHA RAC opinions. This flexibility would allow consideration of downstream impacts, including effects on substance uses. Similar discretion already exists under REACH restrictions and EU pharmaceutical legislation.

Amendment 303

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

Proposal for a regulation

Article 1 – paragraph 1 – point 6 b (new)

Regulation (EC) No 1272/2008

Article 37 – paragraph 7

Text proposed by the Commission	Amendment
	(6b) In Article 37, paragraph 7 is deleted.

Or. en

Justification

UN GHS (Globally Harmonised System) is an internationally recognised system to harmonise hazard criteria globally. CLP implements UN GHS principles at EU level. However, in 2023 criteria for new hazard classes were inserted to CLP Regulation. Given that these criteria are not adopted yet at UN level but only discussed, they should be removed from CLP Regulation.

Amendment 304

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 6 c (new)

Regulation (EC) No 1272/2008

Article 40 – paragraph 1 – subparagraph g

Text proposed by the Commission	Amendment
	(6c) (g) where applicable and supported by the best available science, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;

Or. en

Justification

Diverging (self-)classifications should be explained where possible and based on the best available scientific evidence (e.g. substance identity, impurities, data availability).

Amendment 305

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 6 d (new)

Regulation (EC) No 1272/2008

Article 40 – paragraph 1 – subparagraph h

Text proposed by the Commission	Amendment
	(6d) (h) where applicable and supported by the best available science, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42;

Or. en

Justification

Diverging (self-)classifications should be explained where possible and based on the best available scientific evidence (e.g. substance identity, impurities, data availability).

Amendment 306

Nikola Minchev, Jeannette Baljeu

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’
	In addition, any advertisement presented in a visual form to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall also include at least one of the following:
	a) the applicable hazard pictograms;
	b) the relevant signal word in accordance with Article 20.

Or. en

Amendment 307

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

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. When advertising a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II, the advertisement shall only be made if the advertisement includes at least one of the following:
	a) the applicable hazard pictograms;
	b) the relevant signal word in accordance with Article 20, followed by the sentence: ‘Always read the label and product information before use.’;

Or. en

Justification

The amendment aims at preventing misleading advertisements that would only display effects of chemicals, but not hazards pictograms and relevant signal words, which can be decisive for buyers who should be able to make an informed decision.

Amendment 308

Majdouline Sbai

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall indicate, as applicable, the hazard pictograms and the signal words. Any advertisement for such a substance or mixture for sale to the general public shall, in addition, state: ‘Always read the label and product information before use.’.

Or. en

Justification

Advertisement seek to promote the purchase of a product. It is not appropriate to delete all hazard labelling in case of substance or mixtures that are classified as hazardous. Advertisement, whether for professionals or for the general public, should always include the hazard pictograms as well as the signal words. It is acceptable to add the statement "Always read the label and product information before use.’ only in advertising for the general public.

Amendment 309

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall include the sentence: ‘Always read the label and hazard information before purchasing.’

Or. en

Justification

A general statement, as required under the Biocidal Products Regulation (EU) No 528/2012, has proven effective where label elements are unavailable at purchase. The sentence “Always read the label and product information before use.” must be used unchanged. Online sales should be excluded, as full safety and labelling information is already clearly available on websites, and listings function as transactional tools rather than advertising.

Amendment 310

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall indicate, as applicable, the hazard pictograms and signal words, and include the sentence: ‘Always read the label and product information before use. See detailed hazard information at point of purchase’.

Or. en

Justification

In order not to clutter advertisements or make them impractical, while remaining informative to alert potential users to the hazardous nature of the product before the purchase, as a minimum the advertisements in general should include elements that provide immediate visual recognition of the nature and severity of the hazard, namely hazard pictograms and signal words, whilst also requiring advertisements to invite customers to read the label and product information before use

Amendment 311

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall indicate the hazard pictograms and signal words and shall include the sentence: ‘Always read the label and product information before use.’.

Or. en

Amendment 312

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

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’ without any permitted modification of its wording.

Or. en

Amendment 313

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

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Text proposed by the Commission	Amendment
1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’.	1. Any advertisement to the general public for a substance or a mixture classified as hazardous or a mixture containing substances referred to in Part 2 of Annex II shall include the sentence: ‘Always read the label and product information before use.’ without modifying its wording.

Or. en

Amendment 314

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	Online sales communications shall be exempted from these requirements. The first subparagraph shall not apply to advertisements to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, provided that the advertisement is not targeted at consumers.

Or. en

Justification

Amendment 315

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	Online sales communications shall be exempted from these requirements. The first subparagraph shall not apply to advertisements to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, provided that the advertisement is not targeted at consumers.

Or. en

Amendment 316

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1 – subparagraph 1 b (new)

Text proposed by the Commission	Amendment
	The first subparagraph shall not apply to advertisements to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, provided that the advertisement is not targeted at consumers.

Or. en

Justification

Amendment 317

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 2

Text proposed by the Commission	Amendment
2. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not allowed to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).’	2. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not allowed to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).’ The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited.

Or. en

Amendment 318

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 2

Text proposed by the Commission	Amendment
2. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not allowed to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).’	2. When advertising a substance or a mixture classified as hazardous, the advertisement shall only be made if the advertisement does not contain statements that are not allowed to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).’

Or. en

Amendment 319

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a

Text proposed by the Commission	Amendment
(8) Article 48a is replaced by the following:	deleted
‘Article 48a
Distance sales offers
When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’

Or. en

Justification

The distinction between general public and professional user is inherently fluid and difficult to enforce in distance sales. Online marketplaces, e-commerce platforms, and mail-order suppliers cannot effectively verify the professional status of buyers. If labelling requirements differ based on intended user category, suppliers could strategically classify hazardous products as "professional use only" to circumvent more stringent consumer labelling requirements, while still making the products readily accessible to general consumers through online channels

Amendment 320

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1

Text proposed by the Commission	Amendment
When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’	1. When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the:
	(a) name of the suppliers;
	(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;
	(c) product identifiers as specified in Article 18, and where applicable
	(d) where applicable, hazard pictograms in accordance with Article 19;
	(e) where applicable, signal words in accordance with Article 20;
	(f) where applicable, hazard statements in accordance with Article 21;
	2. Paragraph 1 also applies to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is targeted at the general public or if it allows a member of the general public to conclude a distance contract as defined in Article 2, point (7) of Directive 2011/83/EU;

Or. en

Amendment 321

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1

Text proposed by the Commission	Amendment
When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’	When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the following:
	(a) name of the suppliers;
	(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;
	(c) product identifiers as specified in Article 18, and where applicable;
	(d) where applicable, hazard pictograms in accordance with Article 19;
	(e) where applicable, signal words in accordance with Article 20;
	(f) where applicable, hazard statements in accordance with Article 21.
	This also applies to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is targeted at the general public or if it allows a member of the general public to conclude a distance contract as defined in Article 2, point (7) of Directive 2011/83/EU.;

Or. en

Justification

This amendment clarifies the information that must be clearly provided in distance sales offers for hazardous substances or mixtures made available to the general public. Ensuring that key hazard information is available prior to purchase strengthens consumer protection and informed decision-making, while extending these requirements to publicly accessible professional products prevents circumvention and ensures consistent protection across online sales channels.

Amendment 322

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

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1

Text proposed by the Commission	Amendment
When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’	1. When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the:
	(a) name of the suppliers;
	(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;
	(c) product identifiers as specified in Article 18, and where applicable (d) where applicable, hazard pictograms in accordance with Article 19; (e) where applicable, signal words in accordance with Article 20;
	(f) where applicable, hazard statements in accordance with Article 21;
	2. Paragraph 1 also applies to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is targeted at the general public or if it allows a member of the general public to conclude a distance contract as defined in Article 2, point (7) of Directive 2011/83/EU.;

Or. en

Justification

This amendment clarifies which hazard information must be clearly shown in distance sales offers when hazardous substances or mixtures are made available to the general public. It requires key elements such as product identifiers, hazard pictograms, signal words and hazard statements to be provided before purchase, supporting consumer protection and informed decisions online. Extending these rules to professional or industrial products accessible to the public prevents circumvention and ensures consistent protection across online sales.

Amendment 323

Nikola Minchev

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1

Text proposed by the Commission	Amendment
When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’	When substances or mixtures are placed on the market for the general public through distance sales, the offer shall clearly and visibly indicate the following:
	(a) name of the supplier;
	(b) the nominal quantity of the substance or mixture in the package;
	(c) relevant product identifiers in accordance with Article 18;
	(d) relevant hazard pictograms in accordance with Article 19;
	(e) relevant signal words in accordance with Article 20;
	(f) relevant hazard statements in accordance with Article 21.

Or. en

Amendment 324

Majdouline Sbai

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	The first subparagraph shall also apply to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is made on a website or a mobile application, unless the website or mobile application is closed to the general public and only professional users are able to complete purchases.

Or. en

Justification

It should be clarified that online sales offers for professional users also have to comply with Article 17 in case these offers are also open for the general public.

Amendment 325

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission	Amendment
	Paragraph 1 also applies to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is made on a website or a mobile application, unless the website or mobile application is closed to the general public and only professional users are able to complete purchases.

Or. en

Justification

The amendment ensures that the safeguards for online sales for the general public are applicable in any case and to avoid gaps in case of mobile applications or websites targeted to professionals, but used by general public to purchase classified substances and mixtures.

Amendment 326

Nikola Minchev

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48 – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	Paragraph 1 shall also apply to distance sales offers to professional users, where the offer is made available on a website or a mobile application that is open to the general public and allows the general public to conclude a distance contract as defined in Article 2, point (7) of Directive 2011/83/EU.;

Or. en

Amendment 327

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1 a (new)

Text proposed by the Commission	Amendment
	Paragraph 1 also applies to distance sales offers to professional users for substances or mixtures intended for use in the course of their industrial or professional activities, if the offer is made on a website or a mobile application.

Or. en

Amendment 328

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Article 48a – paragraph 1 b (new)

Text proposed by the Commission	Amendment
	When substances or mixtures falling under a harmonised classification pursuant to Regulation (EC) No 1272/2008, in particular category 1A, 1B or 2 CMR and endocrine disrupting substances and category 1 respiratory sensitisers, are offered for sale to professional users, distance sales offers shall display, prior to purchase, clear and visible information on their hazard classification and occupational risks.
	Digital presentation of such information shall not replace or weaken the obligation to ensure harmonised classification and labelling for these substances.

Or. en

Amendment 329

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 1 – paragraph 1 – point 9

Regulation (EC) No 1272/2008

Article 61 – paragraphs 8 and 9

Text proposed by the Commission	Amendment
(9) Article 61 is amended as follows:	deleted
(a) paragraph 8 is replaced by the following:
‘8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’ ;’
‘9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 36 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 60 months after entry into force of this Regulation].’ ;’

Or. en

Amendment 330

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Text proposed by the Commission	Amendment
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’	8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1. of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’

Or. en

Amendment 331

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

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Text proposed by the Commission	Amendment
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’	8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’

Or. en

Justification

Amendment 332

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Text proposed by the Commission	Amendment
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’	8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) Article 31(3) and section 1.2.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 January 2028 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2030.’

Or. en

Justification

Commission Proposal 2025/0526 provides for the postponement of certain obligations by one year compared to Regulation (EU) 2024/2865. Alignment with these proposed provisions is necessary, as the extension of Article 18(3) to additional hazard classes significantly increases compliance complexity. A transition period until 1 January 2030 is therefore warranted.

Amendment 333

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Text proposed by the Commission	Amendment
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’	8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2030.’

Or. en

Amendment 334

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

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Text proposed by the Commission	Amendment
8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2029.’	8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3) as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2030.

Or. en

Amendment 335

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

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EC) No 1272/2008

Article 61 – paragraph 9

Text proposed by the Commission	Amendment
9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 36 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 60 months after entry into force of this Regulation].’	9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 48 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 72 months after entry into force of this Regulation].’

Or. en

Amendment 336

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EC) No 1272/2008

Article 61 – paragraph 9

Text proposed by the Commission	Amendment
9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 36 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 60 months after entry into force of this Regulation].’	9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 24 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 48 months after entry into force of this Regulation].’

Or. en

Amendment 337

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EC) No 1272/2008

Article 61 – paragraph 9

Text proposed by the Commission	Amendment
9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 36 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 60 months after entry into force of this Regulation].’	9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 24 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 48 months after entry into force of this Regulation].’

Or. en

Justification

The Commission is going beyond what was agreed in the "stop the clock" proposal (COM(2025)526 - Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2024/2865 as regards dates of application and transitional provisions), which is already reflected in paragraphs 7 and 8 of this Article.

Amendment 338

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EC) No 1272/2008

Article 61 – paragraph 9

Text proposed by the Commission	Amendment
9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 36 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 60 months after entry into force of this Regulation].’	9. Substances and mixtures which have been labelled in accordance with Article 17(1), Article 25(6) and section 1.5.1.2 and section 1.6 of Annex I as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation] and which were placed on the market before [OP: please insert 48 months after entry into force of this Regulation] shall not be required to be labelled in accordance with this Regulation as amended by [OP: please add reference to this Regulation] until [OP: please insert 72 months after entry into force of this Regulation].

Or. en

Amendment 339

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

Proposal for a regulation

Article 1 – paragraph 1 – point 9 a (new)

Regulation (EC) No 1272/2008

Article 61 – paragraph 10 (new)

Text proposed by the Commission	Amendment
	(9a) In article 61, the following paragraph is added:
	‘10. Substances and mixtures which have been labelled in accordance with Article 31(3) and section 1.2.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1° January 2028 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865, Regulation (EU) 2025/2439 and by [OP: please add reference to this Regulation] until 1° January 2030.’

Or. en

Amendment 340

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

Proposal for a regulation

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

Regulation (EC) No 1272/2008

Article 5 – paragraph 5

Text proposed by the Commission	Amendment
	Article 5, paragraph 5 is amended as follows:
	5. For the evaluation of a substance 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 or very persistent, very bioaccumulative properties’ and ‘persistent, mobile and toxic or very persistent, very mobile properties’ 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 and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents in the substance. Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met:
	(a) the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation.
	(b) the information supports the conclusions based on the relevant available information on the constituents in the substance.
	Relevant information available on the substance containing more than one component, and as such demonstrating the absence of the properties referred to in point (a) or the existence of less severe properties cannot take precedence over relevant information available on the components of the substance in the event that conclusive scientific experimental data demonstrate that the component is not bioavailable and/or that there is a risk of synergistic or antagonistic effects between the constituents of the substance.

Or. fr

Justification

In accordance with the Globally Harmonized System and the rules applicable to mixtures. If a complex substance is tested for its effects on the environment, these test data must prevail and take precedence over a theoretical assessment based on the individual constituents of the complex substance.

Amendment 341

Martin Hojsík, Sigrid Friis, Michal Wiezik, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used in cosmetic products exceptionally if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B, and the Commission grants the derogation from the general prohibition laid out in subparagraph 1. The Commission shall grant the derogation where all of the following conditions are fulfilled:

Or. en

Amendment 342

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

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

Text proposed by the Commission	Amendment
	(-1) In Article 2, paragraph 1, the following point (ka) is inserted:
	(ka) ‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3 -) or methylene (-CF2 -) carbon atom (without any H/Cl/Br/I attached to it);

Or. en

Justification

For the application of the prohibition of PFAS, a clear definition should be provided. The definition is identical to the one in Regulation (EU) 2025/2509 of 26 November 2025 on the safety of toys.

Amendment 343

Per Clausen, Anja Hazekamp

Proposal for a regulation

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

Regulation (EC) No 1223/2009

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

Text proposed by the Commission	Amendment
	(-1) In Article 2, paragraph 1, the following point is added:
	(sa) ‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Or. en

Amendment 344

Inese Vaidere

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 10 – paragraph 1

Present text	Amendment
	-1 In Article 10, paragraph 1, the following subparagraph is inserted at the end:
CHAPTER III	"Safety assessment
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION	Exemptions must be foreseen for the cosmetic products that are produced in small quantities by using traditional methods, are handmade and made from locally sourced natural ingredients and not intended for medical purposes. In these cases the producer can be exempted or partly exempted from the requirements set out in the Annex I, Part B - from Cosmetic Product Safety Report (CPSR); Product registration (CPNP); Good Manufacturing Practice (GMP) and need for specialist and expert services."
Article 10

Or. en

(The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).)

Justification

The amendment provides for a simplification for small-scale homemade artisanal naturally produced cosmetics products not intended for medical purposes. It is based on existing exceptions set out in the US, Canada, Australian legislation.

Amendment 345

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 13 – paragraph 1 – point g

Present text	Amendment
	-1a Article 13, paragraph 1, point (g) is replaced by the following:
(g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;	"(g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, and of substances classified as endocrine disruptors for human health, category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;"

Or. en

(Regulation (EC) No 1223/2009)

Justification

Endocrine disruptors for human health category 1 should also be notified to the Commission, just like CMR substances category 1A and 1B.

Amendment 346

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

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 14 – paragraph 1 – point e a (new)

Text proposed by the Commission	Amendment
	-1 in Article 14, in paragraph 1, the following point (ea) is added:
	(ea) intentionally added per- and polyfluoroalkyl substances (PFAS) that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Or. en

Justification

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

Amendment 347

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

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 2 – paragraph 1 – point g

Present text	Amendment
	-1. In Article 2, paragraph 1 point (g) is replaced by the following:
(g) ‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;	"(g) ‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge excluding the professional use of a cosmetic product by persons in the exercise of their professional activity;"

Or. en

Justification

To ensure consistency with Union product law and the Commission’s Blue Guide, Regulation (EC) No 1223/2009 should clarify that “making available on the market” excludes the professional use of cosmetic products by professionals in the exercise of their professional activity. The Blue Guide distinguishes market placement from use solely in a service context, a distinction not explicitly reflected in the Regulation, leading to legal uncertainty and inconsistent application of the rules.

Amendment 348

Nikola Minchev

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Regulation (EC) No 1223/2009

Article 14a – paragraph 2

Text proposed by the Commission	Amendment
2. After receiving the request referred to in paragraph 1, the Commission shall seek an opinion of the SCCS on the safety of the substance for use in cosmetic products without undue delay.	2. After receiving the request referred to in paragraph 1, the Commission shall request the opinion of the SCCS on the safety of the substance for use in cosmetic products without undue delay.

Or. en

Amendment 349

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Regulation (EC) No 1223/2009

Article 14a – paragraph 3

Text proposed by the Commission	Amendment
The SCCS shall transmit its opinion to the Commission within 12 months after receiving the request from the Commission referred to in paragraph 2. The Commission may extend that deadline if additional evidence is required.’	The SCCS shall transmit its opinion to the Commission within nine months after receiving the request from the Commission referred to in paragraph 2. The Commission may extend that deadline if additional evidence is required.’

Or. en

Justification

The SCCS will be shifted to ECHA in the context of the ECHA Basic Regulation. At ECHA, comparable work is done by the Risk Assessment Committee (RAC). Pursuant to REACH, RAC has nine months to prepare opinions on restrictions of chemicals. Such restrictions can have very broad scope. A scientific opinion on the safety of a colorant, preservative or UV-filter is rather limited in comparison. It is therefore difficult to see why the SCCS should have more time for such opinions as compared to RAC for chemical restrictions. It is appropriate to align the timeline for the SCCS to that for RAC.

Amendment 350

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – title

Text proposed by the Commission	Amendment
	-a The title of Article 15 is amended as follows:
	Article 15
	Substances classified as CMR substances or as endocrine disruptors for human health

Or. en

Amendment 351

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – Title

Present text	Amendment
	"The Title of Article 15 is replaced by the following:
Substances classified as CMR substances	Substances classified as CMR substances or as endocrine disruptors for human health"

Or. en

(Amendment linked to the amendment proposing to extend the ban of CMR substances to endocrine disruptors in paragraph 2)

Amendment 352

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

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – title

Present text	Amendment
	-aa The title of Article 15 is replaced by the following:
Substances classified as CMR substances	"Substances classified as CMR substances or as endocrine disruptors for human health"

Or. en

(32009R1223)

Justification

Endocrine disrupting chemicals can interfere with the normal functioning of the hormone system and have been linked, even at low doses, to adverse health effects. Given the direct and repeated nature of exposure to cosmetic products, the presence of endocrine disrupting substances in cosmetics should therefore be strictly prohibited and be subject to possible exemptions as CMRs. The endocrine disruptors fall under the generic ban in the recently revised Toy Safety Regulation

Amendment 353

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

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 1

Present text	Amendment
	-a paragraph 1 is amended as follows:
The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.	"the first paragraph is replaced by the following:
	The use in cosmetic products of substances classified as CMR substances, of category 2, or as endocrine disruptors for human health, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation."

Or. en

(32009R1223)

Justification

Amendment 354

Per Clausen, Anja Hazekamp

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 1

Text proposed by the Commission	Amendment
	(-a) Paragraph 1 is replaced by the following:
	1. The use in cosmetic products of substances classified as CMR substances or endocrine disruptor for human health, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.

Or. en

Amendment 355

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 1

Text proposed by the Commission	Amendment
	-aa The first paragraph of Article 15 is amended as follows:
	1. The use in cosmetic products of substances classified as CMR substances, of category 2, or as endocrine disruptors for human health, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.

Or. en

Amendment 356

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 1

Text proposed by the Commission	Amendment
	-i The first subparagraph is replaced by the following:
	2. The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B, or as endocrine disruptors for human health, of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

Or. en

Amendment 357

Per Clausen, Anja Hazekamp

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 1

Text proposed by the Commission	Amendment
	(-i) Paragraph 2, first subparagraph is replaced by the following:
	2. The use in cosmetic products of PFAS substances and substances classified as CMR substances, of category 1A or 1B, or as endocrine disruptor for human health, of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

Or. en

Amendment 358

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

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 1

Present text	Amendment
	"the first subparagraph is replaced by the following:
The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.	‘The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B, or as endocrine disruptors for human health, of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited."

Or. en

(32009R1223)

Justification

Amendment 359

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 1

Present text	Amendment
	-i the first subparagraph is replaced by the following:
The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.	"'the use in cosmetic products of substances classified as CMR substances of category 1A or 1B and of endocrine disruptors of category 1 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited."

Or. en

(Regulation (EC) No 1223/2009)

Justification

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

Amendment 360

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, CMR or endocrine disrupting substances may in exceptional and time-limited cases be used in cosmetic products if a justified derogation request is granted by the Commission. Such a derogation request shall be submitted to the Commission at the latest one month after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B or as endocrine disruptor for human health of category 1. The Commission may grant the derogation only where all of the following conditions are fulfilled:

Or. en

Amendment 361

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used in cosmetic products by way of exception, where subsequent to a derogation request submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B or as endocrine disruptor for human health of category 1, the Commission grants the derogation from the general prohibition laid out in subparagraph 1. The Commission may grant the derogation where all of the following conditions are fulfilled:

Or. en

Amendment 362

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used for particular uses in particular cosmetic product categories if a derogation request is submitted to the Commission at the latest one month after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B or as an endocrine disruptor for human health category 1. The Commission shall grant the derogation for particular uses in particular cosmetic product categories where all of the following conditions are fulfilled:

Or. en

Justification

The scope of the derogation should be aligned with the scope of the SCCS assessment, namely the assessment of particular uses of particular cosmetic product categories. It makes sense to link the deadline to the date of entry into force of the classification. The Commission makes annual updates of CLP based on the RAC opinions with regard to CLP classifications of the penultimate year. In the last five years, the annual updates have taken taken at least 14 months after the last RAC opinion of the penultimate year. The Commission normally follows the RAC opinion. As such, companies will already have had at least fourteen months to prepare a derogation from the date of adoption of the RAC opinion. Thus derogations can be submitted very quickly after the entry into force of the classification. EDC category 1 substances should be treated like CMR 1A and 1B substances, thus also allowing for derogation requests.

Amendment 363

Kristian Vigenin

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used in cosmetic products by way of exception, where subsequent to a derogation request submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B, the Commission grants the derogation from the general prohibition laid out in subparagraph 1. The Commission shall grant the derogation where all of the following conditions are fulfilled:

Or. en

Amendment 364

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may by way of exception be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B or as endocrine distruptor for human helath, of category 1, and provided that all of the following conditions are fulfilled:

Or. en

Amendment 365

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest six months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:

Or. en

Amendment 366

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission	Amendment
2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest three months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:	2. However, such substances may be used in cosmetic products if a derogation request is submitted to the Commission at the latest six months after at the date of entry into force of the amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance as CMR substance of category 1A or 1B. The Commission shall grant the derogation where all of the following conditions are fulfilled:

Or. en

Justification

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

Amendment 367

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – point a

Text proposed by the Commission	Amendment
(a) there are no suitable alternative substances available as documented in an analysis of alternatives;	(a) there are no suitable alternatives available to the presence of such substances in the cosmetic products, including via alternative production processes, as documented in a thorough analysis of alternatives;

Or. en

Justification

Limiting substitution assessments to one-to-one chemical replacement creates an artificially narrow framework that overlooks safer, more innovative solutions and may inadvertently perpetuate hazardous exposures through supposedly "safer" alternatives. By considering combinations of less hazardous substances or entirely different technological approaches, evaluators can escape the cycle of sequential substitutions within the same chemical family and identify genuinely safer pathways

Amendment 368

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 2 – point b

Text proposed by the Commission	Amendment
(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups..	(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and any additional known hazards arising from simultaneous exposure to other substances, and of vulnerable population groups. When assessing the safety, SCCS shall also consider occupational safety and health and safety of chemicals, in particular Directives 89/391/EEC, 98/24/EC and 2004/37/EC.

Or. en

Amendment 369

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – point b

Text proposed by the Commission	Amendment
(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups..	(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and any known additional hazards from co-exposure with other substances, as well as of vulnerable population groups..

Or. en

Amendment 370

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – point b

Text proposed by the Commission	Amendment
(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups..	(b) the substances have been evaluated and found safe by the SCCS for one or more particular uses of one or more cosmetic product categories, considering exposure from the uses in those product categories, overall exposure from sources other than cosmetics and of vulnerable population groups.

Or. en

Justification

It should be clarified that it a derogation may be granted for one or more particular uses in one or more product categories. However, exposure should continue to be assessed both for the specific uses and product categories concerned, as well as exposure from other sources.

Amendment 371

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point i

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 2 – point b

Text proposed by the Commission	Amendment
(b) the substances have been evaluated and found safe by the SCCS for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups..	(b) the substances have been evaluated and found safe by the SCCS for particular uses in of the cosmetic product categories, considering overall exposure to those products, as well as from sources other than cosmetics and of vulnerable population groups.

Or. en

Justification

The Omnibus proposal maintains the stringent consumer safety standards established under the CPR, as CMR substances remain prohibited unless supported by a robust safety assessment based on aggregated exposure. The amendment further clarifies that the SCCS shall assess substances for specific uses across cosmetic product categories, taking into account exposure arising from cosmetics, other sources and vulnerable population groups, thereby ensuring a comprehensive risk assessment while streamlining the derogation process.

Amendment 372

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 3 – introductory part

Text proposed by the Commission	Amendment
For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative if it fulfils all of the following conditions:	For the purpose of the second subparagraph, point (a), a substance, a combination of substances, or where relevant, an alternative method or technology, that replaces the need for the substance shall be considered a suitable alternative if it fulfils all of the following conditions:

Or. en

Amendment 373

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – introductory part

Text proposed by the Commission	Amendment
For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative if it fulfils all of the following conditions:	For the purpose of the second subparagraph, point (a), a substance, a combination of substances, or where relevant, an alternative production process, that replaces the need for the substance shall be considered a suitable alternative if it fulfils all of the following conditions:

Or. en

Justification

Amendment 374

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – introductory part

Text proposed by the Commission	Amendment
For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative if it fulfils all of the following conditions:	For the purpose of the second subparagraph, point (a), a substance, a combination of substances, or where relevant, an alternative technology, that replaces the need for the substance shall be considered a suitable alternative if it fulfils all of the following conditions:

Or. en

Justification

REACH reflecting that alternative does not necessarily have to be a substance, but combination of substances or alternative technologies. The Commission proposal would narrow down the pool of alternative options, making it difficult for industry to consider other possibilities than 1:1 substitution. ECJ in the past confirmed that the analysis of the absence of suitable alternative by the Commission has to include not only substances, but also alternative technologies, i.e. that the Commission cannot narrow down the analysis to 1:1 substitution.

Amendment 375

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – introductory part

Text proposed by the Commission	Amendment
For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative if it fulfils all of the following conditions:	For the purpose of the second subparagraph, point (a), a substance, a combination of substances, or where relevant, an alternative technology that replaces the need for the substance shall be considered a suitable alternative if it fulfils all of the following conditions:

Or. en

Justification

The assessment of alternatives to CMR 1A or 1B substances (and of endocrine disruptors to human health category 1) in cosmetics should go beyond the mere substance level. It may well be possible to replace such substances via a combination of other substances or another technology (e.g. replacing a preservative by a different kind of packaging). If there are such alternatives, they should also be assessed whether they are suitable. This is in line with Article 60(4) of REACH, which also considers alternative technologies as an alternative to a substance of very high concern.

Amendment 376

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – introductory part

Text proposed by the Commission	Amendment
For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative if it fulfils all of the following conditions:	For the purpose of the second subparagraph, point (a), a substance shall be considered a suitable alternative only if such substance, by itself, fulfils all of the following conditions:

Or. en

Justification

Derogations granted under Article 15(2) should be grounded primarily in the SCCS assessment of the safety of a CMR substance for specific cosmetic uses. The amendment clarifies that suitable alternatives must demonstrably reduce overall risk, provide the same function and performance, be technically feasible at industrial scale, economically viable for sustained production, and not be subject to existing or forthcoming restrictions, thereby ensuring that alternatives are genuinely superior and practical.

Amendment 377

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products is safe for human health;

Or. en

Justification

It is important to underline that any alternative must be deemed safe for human health and not only reduce overall risks to human health. If we focus only on risk reduction, we may perpetuate hazardous exposures through supposedly “safer” alternatives.

Amendment 378

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products is safe for human health, including when considering occupational health and safety, and it does not pose unacceptable risks to the environment;

Or. en

Amendment 379

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products does not present risk to human health and the environment;

Or. en

Amendment 380

Nikola Minchev

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products is safe to human health and the environment;

Or. en

Amendment 381

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products demonstrably results in reduction of overall risk to human health and the environment compared to the substance it is intended to replace;

Or. en

Amendment 382

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products demonstrably results in reduction of overall risk to human health and the environment compared to the substance it is intended to replace;

Or. en

Amendment 383

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – pargraph 2 – subparagraph 3– point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products results in reduced overall risk to human health and the environment when assessed against the substance it is intended to replace

Or. en

Amendment 384

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products results in reduced overall risk to human health and the environment compared to the substance it is intended to replace;

Or. fr

Amendment 385

Beatrice Timgren

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products demonstrably results in reduction of overall risk to human health and the environment compared to the substance it is intended to replace;

Or. en

Amendment 386

Vytenis Povilas Andriukaitis

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products results in reduced overall risk to human health and the environment, compared to substance it is intended to replace;

Or. en

Amendment 387

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products demonstrably results in a reduction of overall risk to human health and the environment;

Or. en

Justification

Amendment 388

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point a

Text proposed by the Commission	Amendment
(a) its use in cosmetic products results in reduced overall risk to human health and the environment;	(a) its use in cosmetic products results in reduced overall risk to human health;

Or. en

Justification

The environmental risk of cosmetic ingredients is regulated under REACH, not under the Cosmetics Regulation. For that reason, there are no provisions in the Cosmetics Regulation with regard to the environmental impacts of cosmetics. It thus seems odd that such considerations should be introduced in the context of the assessment of an alternative to a CMR 1A or 1B substance (or endocrine disruptor to human health category 1). It is unclear how this should be operationalized in the absence of environmental provisions of the Cosmetics Regulation.

Amendment 389

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides a similar function to the classified substance, in a finished cosmetic product with a comparable effect and level of efficacy, or it replaces the need for that function;

Or. en

Amendment 390

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides an identical functional performance to the classified substance, in a finished cosmetic product with equivalent effect and the same level of efficacy;

Or. en

Amendment 391

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides the same function as the classified substance, in a finished cosmetic product with the same effect and the same level of efficacy and performance;

Or. en

Amendment 392

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides the same function as the classified substance, in a finished cosmetic product with the same effect and the same level of efficacy and performance;

Or. en

Justification

Amendment 393

Beatrice Timgren

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides the same function as the classified substance, in a finished cosmetic product with the same effect and the same level of efficacy and performance;

Or. en

Amendment 394

Radan Kanev

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides the same function as the classified substance, in a finished cosmetic product with the same effect and the same level of efficacy and performance

Or. en

Justification

CMR-classified substances that the SCCS has deemed safe should not be banned solely because another substance on the market produces a similar effect. To ensure the quality of the finished cosmetic product, any replacement must be a suitable alternative that delivers the same function, the same effect, and the same level of efficacy and performance as the classified substance. Otherwise, the outcome would be a different cosmetic product.

Amendment 395

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides a similar function to the classified substance, in a finished cosmetic product with a comparable effect and sufficient level of efficacy;

Or. en

Justification

The purpose of this assessment is to see whether an alternative to a CMR substance (or endocrine disruptor for human health) is suitable for use in cosmetics. For an alternative to be suitable, when it comes to function, effect and efficacy, it should be enough to prove that it fulfils a similar function with comparable effect and that it has sufficient level of efficacy as compared to the CMR substance (or the endocrine disruptor). Otherwise, this criterion would be far too restrictive and would thus defeat the purpose of seeing whether there is a suitable alternative.

Amendment 396

Nikola Minchev

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides the same function as the classified substance, in a finished cosmetic product with the same effect and the same level of efficacy;

Or. en

Amendment 397

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides a comparable function to the classified substance, in a finished cosmetic product with a comparable effect and level of efficacy;

Or. en

Justification

Mandating that alternatives achieve the same or equivalent effect and efficacy as the hazardous substance being replaced creates an insurmountable barrier to meaningful risk reduction and prioritizes marginal performance gains over fundamental health and safety protections. The "equivalent efficacy" requirement assumes that the current performance level of a substance represents an essential, non-negotiable standard. Many applications have evolved to exploit the maximum performance characteristics of available chemicals without questioning whether such extreme performance is actually necessary

Amendment 398

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission	Amendment
(b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a similar effect and the same level of efficacy;	(b) it provides similar function to the classified substance, in a finished cosmetic product with a comparable effect and level of efficacy;

Or. en

Justification

The Commission proposal narrows down substantially the definition of alternatives that shall be considered. Assessment of alternatives should not look at 1:1 substance substitution, which may be difficult, but also on combination of substances or alternative technologies.

Amendment 399

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) is technically feasible.

Or. en

Amendment 400

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) is technically feasible at industrial scale and economically viable, provided that costs and supply conditions allow sustained production;

Or. en

Justification

Amendment 401

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) it is technically practicable and economically attainable;

Or. en

Amendment 402

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) is technically and economically feasible;

Or. en

Amendment 403

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) is technically and economically feasible;

Or. en

Amendment 404

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point c

Text proposed by the Commission	Amendment
(c) is technically feasible and economically viable;	(c) is technically and economically feasible;

Or. en

Justification

The criterion of economic viability is not only very vague, but also highly subjective. The wording should be aligned with that applicable pursuant to Article 60(5)(b) of REACH with regard to suitable alternative substances or technologies, which refers to technical and economic feasibility of alternatives.

Amendment 405

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point d

Text proposed by the Commission	Amendment
(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’	deleted

Or. en

Amendment 406

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point d

Text proposed by the Commission	Amendment
(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’	(d) it is either available on the market at scale, in quantities large enough to meet current and expected demand or demonstrates potential to achieve production volumes sufficient to satisfy current and expected demand within a reasonable timeframe.'

Or. en

Justification

Alternatives demonstrating credible scale-up potential can be effectively available, they simply require the market certainty that substitution mandates provide to trigger capacity deployment. Safer alternatives may exist at pilot scale but lack commercial production facilities. Producers may not want to invest in scale-up without guaranteed demand. Without regulatory mandate, market demand remains insufficient to justify investment, thus keeping hazardous substances in use indefinitely despite viable alternatives existing

Amendment 407

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point d

Text proposed by the Commission	Amendment
(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’	(d) it is not restricted and is either available on the market in quantities and scale sufficient to meet current and expected demand or if potential that it can meet expected demand in reasonable timeframe is demonstrated.

Or. en

Amendment 408

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point d

Text proposed by the Commission	Amendment
(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’	(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current demand, or likely to be available in sufficient quantities within a reasonable timeframe.’

Or. en

Justification

Demand of cosmetics depends on the product category and marketing practices of the industry. It is impossible to objectively foresee future demands. Moreover, the availability of alternatives may well increase with demand. It is therefore inappropriate to require that an alternative would only be suitable if it was available at quantities to meet "expected demand". However, it can be assessed whether sufficient quantities may become available within a reasonable timeframe, so this should be added.

Amendment 409

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point ii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 – point d

Text proposed by the Commission	Amendment
(d) it is not restricted, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’	(d) it is not subject to restriction, not protected by exclusive rights, and is available on the market at scale, in quantities large enough to meet current and expected demand.’

Or. en

Justification

The purpose of this amendment is to clarify that the ingredient is not subject to limitations on its placing on the market. Although substances must be registered under REACH, market availability may be constrained by the applicable tonnage band. Where higher volumes are required, moving to a higher tonnage band entails additional registration obligations, which may take several months or years to complete.

Amendment 410

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 3 a (new)

Text proposed by the Commission	Amendment
	(iia) The following subparagraph is inserted after the third subparagraph:
	'The Commission shall consult relevant stakeholders for the purpose of the second subparagraph, point (a) and for the purpose of the third subparagraph.'

Or. en

Justification

It is important that stakeholders are consulted with regard to the availability and suitability of an alternative. This is necessary to ensure an impartial assessment.

Amendment 411

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii – introductory part

Text proposed by the Commission	Amendment
(iii) the following subparagraph is inserted after the fourth subparagraph:	(iii) the following subparagraphs are inserted after the fourth subparagraph:

Or. en

Amendment 412

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii – introductory part

Text proposed by the Commission	Amendment
(iii) the following subparagraph is inserted after the fourth subparagraph:	(iii) the following subparagraphs are inserted after the fourth subparagraph:

Or. en

Amendment 413

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 –subparagraph 5

Text proposed by the Commission	Amendment
The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into application of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;	The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into force of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B. Where a derogation request referred to in the second subparagraph of paragraph 2 has been submitted for CMR substances of category 1A or 1B or for endocrine disruptors for human health category 1, this deadline shall be extended by six months.

Or. en

Justification

Cosmetics legislation bans the use of CMR 1A and 1B substances, subject to the possibility to grant derogations. In the current legislation, the deadline for including such CMR substances into the annexes so as to apply the ban is fifteen months after inclusion into CLP (i.e. date of entry into force). The Commission proposal seeks to postpone that deadline by 18 months by linking it to the date of application of the CLP classification, instead of the date of entry into force. Delaying the application of CMR bans in cosmetics by 18 months is not compatible with Recital 2, according to which the simplification of this law should maintain the SAME level of protection of human health and of the environment. An 18-month-delay would be particularly problematic where there is not even a derogation request. In case of derogation requests, it would be justified to extend the deadline by six months so as to allow for enough time for the scientific assessment and the Commission decision, but not by eighteen months. The same should apply for endocrine disruptors.

Amendment 414

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 5

Text proposed by the Commission	Amendment
The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into application of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;	The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into force of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B or as endocrine disruptor for human health of category 1.
	Where a derogation request referred to in the second subparagraph of paragraph 2 has been submitted, this deadline may be extended by 9 months.

Or. en

Amendment 415

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 5

Text proposed by the Commission	Amendment
The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into application of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;	The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into force of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B or 2 or as endocrine disruptor for human health of category 1 or 2.;

Or. en

Amendment 416

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 5

Text proposed by the Commission	Amendment
The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into application of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;	The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into force of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B or as endocrine disruptor for human health of category 1.:

Or. en

Justification

The Commission proposal would delay the effect of regulatory measures for all CMR substances by 18 months, also where no derogation request has been submitted. This is not proportionate and would weaken consumer protection e.g. in situation where the SCCS identifies health concerns related to a CMR ingredient. Given the severity of the hazard and the potential for widespread consumer exposure including of vulnerable groups, the current 15-months implementation period should therefore be maintained.

Amendment 417

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 5

Text proposed by the Commission	Amendment
The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into application of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;	The deadline laid down in the fourth subparagraph of this paragraph shall start on the date of entry into force of the relevant amendments to Part 3 of Annex VI to Regulation (EC) No 1272/2008 classifying the substance concerned as CMR substance of category 1A, or 1B.;

Or. en

Amendment 418

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 5

Text proposed by the Commission	Amendment
	The Commission may, where necessary, extend the period referred to in this subparagraph, in accordance with the regulatory procedure referred to in Article 32(3).

Or. en

Justification

Under the CPR, classification of a substance as CMR under the CLP requires the Commission to update the relevant Annex. The current 15-month deadline, calculated from the entry into force of the amended CLP Annex, is too short and risks decisions based on incomplete derogation assessments. Starting this period from the date of application of the amended CLP Annex is necessary to allow proper SCCS evaluation, with transparency ensured through a published revised timeline where needed.

Amendment 419

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point a – point iii

Regulation (EC) No 1223/2009

Article 15 – paragraph 2 – subparagraph 6

Text proposed by the Commission	Amendment
	Where a derogation request referred to in the second subparagraph of paragraph 2 has been submitted, this deadline may be extended by six months.’

Or. en

Amendment 420

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b – introductory part

Text proposed by the Commission	Amendment
(b) the following paragraphs 5, 6 and 7 are added:	(b) the following paragraphs 6 and 7 are added:

Or. en

Amendment 421

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b – introductory part

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
(b) the following paragraphs 5, 6 and 7 are added:	(b) the following paragraphs 6 and 7 are added:

Or. en

Amendment 422

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b – introductory part

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
(b) the following paragraphs 5, 6 and 7 are added:	(b) the following paragraphs 6 and 7 are added:

Or. en

Justification

Amendment linked to the deletion of paragraph 5 as proposed by the same author.

Amendment 423

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	deleted

Or. en

Amendment 424

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	deleted

Or. en

Justification

Exposure to CMR harmonized substances via oral or inhalation of cosmetics happens on daily basis, including in case of vulnerable groups such as kids, that tend to lick lipsticks of their mothers or use their parfums. Excluding from the ban substances classified due the oral or inhalation route of exposure, would decrease the level of consumer´s protection and underestimate the risk of exposure to hazardous chemicals from different sources.

Amendment 425

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	deleted

Or. en

Justification

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

Amendment 426

Jessica Polfjärd, Niels Flemming Hansen

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	deleted

Or. en

Amendment 427

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	deleted

Or. en

Justification

Cosmetics are applied directly to skin, often over large body surface areas and for extended periods. Many CMRs readily penetrate skin barriers and enter systemic circulation. Exempting substances simply because their harmonized classification specifies oral or inhalation routes ignores that. The provision acknowledges risks from "incidental ingestion or inhalation" but treats them as exceptional circumstances requiring separate SCCS review - lip products are systematically ingested, inhalation exposure via sprays, powders, aerosols is routine, hand-to-mouth transfer occurs constantly and children's exposure is even higher

Amendment 428

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Text proposed by the Commission	Amendment
5. The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance where the oral or inhalation route of exposure for CMR harmonised classification has been explicitly indicated in the ‘Hazard statement Code(s)’ column under the ‘Classification’ in Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from cosmetic products containing such substance due to incidental ingestion or inhalation, the Commission shall request an SCCS opinion on the safety of the substance concerned in those specific product types without undue delay.	5. Where the harmonised classification of a CMR substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 specifies a route of exposure in the ‘Hazard statement Code(s)’ column, the prohibition referred to in paragraphs 1 and 2 subparagraph 1 of this Article shall apply only to cosmetic products entailing exposure by that specified route of exposure. The classified substance may be used in such cosmetic products when it has been evaluated by the SCCS and found safe.

Or. en

Justification

This amendment improves the formulation without altering the underlying objective. It provides that where a CMR classification is based exclusively on oral (ingestion) or inhalation exposure, the prohibition applies only to cosmetic products that give rise to exposure through those routes. Use of the classified substance in cosmetic products involving oral or inhalation exposure is permitted only where the Scientific Committee on Consumer Safety (SCCS) has assessed and confirmed its safety for the relevant uses.

Amendment 429

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	deleted

Or. en

Amendment 430

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 or as an endocrine disruptor for human health of category 1 or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.
	Where a constituent of such a substance is classified as CMR category 1A, 1B or 2 or as an endocrine disruptor for human health of category 1 or 2, the Commission shall, without delay, mandate the SCCS to evaluate the safety of that substance for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and any known additional hazards from co-exposure with other substances, as well as of vulnerable population groups.
	The SCCS shall deliver its opinion within 12 months of the Commission’s request. The Commission may extend that deadline by six months if additional evidence is required. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.
	Taking into account the opinion of the SCCS, and where a potential risk to human health arises from the use in cosmetic products of a substance referred to in the first subparagraph containing a constituent classified as CMR category 1A, 1B or 2 or as an endocrine disruptor for human health of category 1 or 2, including when there is insufficient data, the Commission shall, without delay, amend the Annexes to this Regulation.

Or. en

Amendment 431

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2, or as endocrine disruptor for human health of category 1 or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008.
	Where a constituent of such a substance is classified as CMR category 1A, 1B or 2 or as endocrine disruptor for human health of category 1 or 2, the Commission shall, without delay, mandate the SCCS to evaluate the safety of this constituent present in that substance for a particular use of the cosmetic product category, considering exposure to those products, overall exposure from sources other than cosmetics and of vulnerable population groups.
	The SCCS shall deliver its opinion within 12 months of the Commission’s request. The Commission may extend that deadline by six months if additional evidence is required. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.
	Taking into account the opinion of the SCCS, and where a potential risk to human health arises from the use in cosmetic products of a substance referred to in the first subparagraph containing a constituent classified as CMR category 1A, 1B or 2 or as endocrine disruptor for human health of category 1 or 2, including when there is insufficient data, the Commission shall, without delay, amend the Annexes to this Regulation.

Or. en

Justification

Plant-based ingredients such as essential oils can contain several CMR constituents, often in significant concentrations. They are widely used across all cosmetic products – and as such represent a significant potential source of consumer exposure to CMR substances. To ensure effective and systematic scrutiny of such substances, the procedural steps to be followed by the Commission should be specified similar to Article 16 on nanomaterials. This will ensure a high level of consumer protection where a constituent of a plant-based ingredient is classified as CMR while also enhancing legal certainty for all actors involved

Amendment 432

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to substances extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. As a potential risk to human health arises from the use in cosmetic products of a substance containing a constituent classified as CMR category 1A, 1B or 2, the Commission shall without undue delay request the SCCS to give its opinion on the safety of the CMR-constituents present in the substance for a particular use of the cosmetic product category, as part of the exposure assessment.
	The SCCS shall deliver its opinion within 6 months of the Commission’s request. The Commission may extend that deadline by 6 months if additional evidence is required. The SCCS shall deliver its final opinion within 6 months of submission of additional data. The opinion of the SCCS shall be made publicly available. Taking into account the opinion of the SCCS, where needed the Commission shall, without delay, amend the Annexes to this Regulation.

Or. en

Justification

The amendment sets clear deadline for the SCCS to deliver its opinion on the safety of CMR-constituents present in cosmetics products.

Amendment 433

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Art 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.
	The opinion shall seek to avoid an overly restrictive or disproportionate approach based on the automatic prohibition of complex natural substances as such, which could lead to the withdrawal from the market of widely used cosmetic products, including products of natural or biological origin, without bringing a real and proven benefit for consumer safety. It should therefore be ensured that the application of this Regulation does not unjustifiably impede the availability of those products on the Union market.

Or. fr

Amendment 434

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to substances extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. As a potential risk to human health arises from the presence of such constituents in such substances in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of such substances for use in cosmetic products without undue delay. The SCCS shall deliver its opinion within 9 months of the Commission's request. In case the SCCS considers the natural substance containing a CMR constituent not to be safe, the Commission shall take regulatory action in accordance with Article 31(1) of this Regulation.

Or. en

Justification

In case substances extracted from plants contain one or more CMR constituents, the Commission should be obliged to request an opinion by the SCCS on the safety of such substances to be delivered within 9 months. In case the SCCS finds the substance not to be safe, the Commission should be obliged to amend the relevant Annexes to this Regulation within six months.

Amendment 435

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 shall not apply to substances extracted from plants or plant parts that have not been chemically modified, as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, and that contain more than one constituent, at least one of which is classified as a CMR substance of category 1A, 1B or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the presence of such a constituent in cosmetic products, the Commission shall, without undue delay, seek an opinion from the Scientific Committee on Consumer Safety (SCCS) on the safety of that constituent for its presence in cosmetic products. For the purposes of this paragraph, “plants” means living or dead organisms from the kingdoms Plantae and Fungi, including algae, lichens and yeasts.

Or. en

Justification

This amendment clarifies the wording while preserving its objective by specifying that the SCCS opinion concerns the presence of the constituent substance in cosmetic products. This removes any ambiguity as to whether the Scientific Committee on Consumer Safety (SCCS) would assess the entire natural complex substance, and instead focuses the evaluation on the specific CMR constituent that is the actual source of potential risk.

Amendment 436

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

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such constituent substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that constituent substance for its present use in cosmetic products without undue delay.

Or. en

Amendment 437

Nikola Minchev

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. When a potential risk to human health arises from the presence of such constituent in such substance in cosmetic products, the Commission shall request an opinion of the SCCS on the safe use of that substance in cosmetic products without undue delay.

Or. en

Amendment 438

Radan Kanev

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Text proposed by the Commission	Amendment
The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. If a potential risk to human health arises from the use of such substance in cosmetic products, the Commission shall seek an opinion of the SCCS on the safety of that substance for its use in cosmetic products without undue delay.	The prohibition referred to in paragraphs 1 and 2 of this Article shall not apply to a substance extracted from plants or plant parts and not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, containing more than one constituent, at least one of which has been classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008. When a potential risk to human health arises from the presence of such constituent in such substance in cosmetic products, the Commission shall request an opinion of the SCCS on the safe use of that substance in cosmetic products without undue delay

Or. en

Justification

Adding the notion of “presence” clarifies that the substance is intentionally added to cosmetic formulations, whereas a CMR constituent occurs naturally within a complex natural ingredient (a “Natural Complex Substance”). Nevertheless, the SCCS should assess the safety of the NCS itself, since that is the material used in the cosmetic product and because the consumer’s actual exposure is to the substance as a whole, not to an individual CMR constituent.

Amendment 439

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2, or as endocrine disruptor for human health category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 and for which no derogation was applied or containing such substance not compliant with a restriction shall be withdrawn from the market within one month of the entry into force of the relevant amendments to the relevant Annexes to this Regulation.
	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2, or as endocrine disruptor for human health category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 and for which a derogation was applied for, but not granted because of safety concerns by the SCCS, or containing such substance not compliant with a restriction shall be withdrawn from the market within one month after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.
	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2, or as endocrine disruptor for human health category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products due to the availability of a suitable alternative may continue to be placed on the market for 6 months and be made available on the market for 12 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Justification

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

Amendment 440

Majdouline Sbai

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 15 – paragraph 7a

Text proposed by the Commission	Amendment
	(ba) the following paragraph 7a is added:
	'7a. Any derogation granted under this Article shall be without prejudice to the application of Union legislation on occupational safety and health and safety of chemicals, in particular Directives 89/391/EEC, 98/24/EC and 2004/37/EC.'

Or. en

Justification

The cosmetics product legislation seeks to ensure the safety of consumers. It does not deal with the safety of workers. It should be clarified that the derogations that can be granted are without prejudice to the application of EU occupational health and safety legislation.