On the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products

(COM(2025)0531 – C100143/2025 – 2025/0531(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2025)0531),

– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100143/2025),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 23 October 2025,

– having regard to Rule 60 of its Rules of Procedure,

– having regard to the opinion of the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on the Environment, Climate and Food Safety and the Committee on the Internal Market and Consumer Protection (A100000/2026),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment 1

Proposal for a regulation

Recital 3

Or. en

Justification

The proposal makes the inclusion of a digital contact voluntary, in line with the proposed amendments to Article 17(1) of Regulation (EC) No 1272/2008.

Amendment 2

Proposal for a regulation

Recital 3 a (new)

Or. en

Justification

This recital is aligned with the Article 1(1), 1(2) and the Council's position.

Amendment 3

Proposal for a regulation

Recital 5

Or. en

Amendment 4

Proposal for a regulation

Recital 6

Or. en

Amendment 5

Proposal for a regulation

Recital 7

Or. en

Amendment 6

Proposal for a regulation

Recital 7 a (new)

Or. en

Amendment 7

Proposal for a regulation

Recital 8

Or. en

Justification

The amendment clarifies that the requirements on advertisements and distance sales offers should apply only to products intended for the general public. This approach is consistent with the objectives of reducing unnecessary burdens on industry while ensuring the free movement of substances and mixtures within the internal market. For professional and industrial users, Regulation (EC) No 1907/2006 already establishes comprehensive obligations on information flows through the safety data sheet, which guarantees that these users receive all necessary safety information. Aligning the text accordingly avoids duplication of requirements and ensures legal coherence with existing Union legislation. The last part of the amendment adds clarification on what constitutes advertising.

Amendment 8

Proposal for a regulation

Recital 8 a (new)

Or. en

Amendment 9

Proposal for a regulation

Recital 9

Or. en

Justification

The amendment introduces flexibility for suppliers in conveying the invitation to read the label and product information in advertisements. Given the diversity of advertising formats, prescriptive requirements would create unnecessary burdens without improving safety. Allowing flexibility ensures proportionality while maintaining the objective of informing consumers before use. The newly introduced sentence ‘Always read the label and product information before use.’ must be used in this specific form, without variations that may require duplication of this requirement under CLP and the wording already in use under BPR.

Amendment 10

Proposal for a regulation

Recital 10

Or. en

Amendment 11

Proposal for a regulation

Recital 12 a (new)

Or. en

Justification

The proposed derogation from Articles 17(1), 25(6), 31(1b) and 34(a) would apply to technical containers inserted into other equipment/systems, such as inkjet printer cartridges, where the contents do not exceed 150 ml and where the full CLP hazard information is provided on outer packaging. Printers and cartridges are designed as a system and the available space and locations for labels on the cartridges is limited by the design requirements of the cartridge and printer. Fold out labels cannot be attached to the cartridge because they would interfere with the insertion into and then the functioning of the printer. As a result, unlike types of packaging for which a fold-out label is possible, the CLP Regulation does not offer a multi-language solution for cartridges.

Amendment 12

Proposal for a regulation

Recital 16

Or. en

Amendment 13

Proposal for a regulation

Recital 16 a (new)

Or. en

Amendment 14

Proposal for a regulation

Recital 18

Or. en

Amendment 15

Proposal for a regulation

Recital 18 a (new)

Or. en

Justification

The development of guidance to promote consistency and predictability in the assessment of alternatives is a welcome step. The reference to “these terms” lacks precision, and the guidance should not be limited to explaining criteria for economically and technically feasible and viable alternatives, but should instead provide clarity on all applicable conditions.

Amendment 16

Proposal for a regulation

Recital 20

Or. en

Amendment 17

Proposal for a regulation

Recital 21

Or. en

Amendment 18

Proposal for a regulation

Recital 22

Or. en

Justification

To ensure legal certainty and workability especially for SME, an extension to 18 and 36 months is suggested.

Amendment 19

Proposal for a regulation

Recital 23

Or. en

Amendment 20

Proposal for a regulation

Recital 24 a (new)

Or. en

Justification

This recital clarifies the rationale for not introducing separate or additional safety requirements for nanomaterials in Annex I. The existing framework already obliges manufacturers to assess all relevant physicochemical and toxicological properties of ingredients, ensuring a high level of consumer safety without creating disproportionate administrative burden. By confirming that Annex I fully covers nanomaterial safety, the recital ensures coherence with the deletion of Article 16(3) and supports the simplification objective of the Omnibus Regulation.

Amendment 21

Proposal for a regulation

Recital 25

Or. en

Justification

The Commission proposes to delete Article 33 and change article 19 to enable businesses and competent authorities to rely on the internationally recognised nomenclature of labelling cosmetic products and facilitate the product's international acceptability. The proposed text deletes the published ‘paper’ glossary and replaces this by a requirement for ingredient labelling to be “in accordance with the internationally recognised nomenclature”. However, the proposal does not specify what this nomenclature is. The Commission proposal should be complemented with the confirmation introduced by the Council in its general approach in Recital 25 that this should be interpreted as the International Nomenclature of Cosmetics Ingredients (INCI).

Amendment 22

Proposal for a regulation

Recital 26

Or. en

Justification

This amendment clarifies that digital solutions for providing the EU declaration of conformity remain optional, in line with the proportionality principle, while ensuring full system coherence where a Digital Product Passport is required under other Union legislation. In such cases, the Digital Product Passport should serve as the single access point, avoiding duplication and unnecessary administrative burden for economic operators, in particular SMEs.

Amendment 23

Proposal for a regulation

Recital 27

Or. en

Justification

This clarification ensures that the identification of shortcomings in the current positive list system is not interpreted as questioning its continued validity. It confirms that the existing listing-based approach under Annex II remains in place, while allowing complementary assessment pathways to address delays and better reflect scientific progress, thereby improving innovation without undermining legal certainty or safety standards.

Amendment 24

Proposal for a regulation

Recital 27 a (new)

Or. en

Justification

This recital reflects the extensive scientific knowledge and practical experience regarding the use of Bacillus spp. and Paenibacillus spp. in agriculture. It provides an evidence-based context for their inclusion in CMC 7, grounded in documented agronomic functionality and existing lawful use, without implying automatic safety for all individual strains.

Amendment 25

Proposal for a regulation

Recital 27 b (new)

Or. en

Justification

This recital addresses safety concerns by clarifying that the inclusion of Bacillus spp. and Paenibacillus spp. is grounded in extensive scientific knowledge enabling strain-level risk assessment. It explicitly excludes pathogenic, toxigenic or antimicrobial-resistant strains and confirms that existing Union safety obligations continue to apply, thereby ensuring a high level of protection while enabling innovation.

Amendment 26

Proposal for a regulation

Recital 28

Or. en

Justification

The amendment clarifies that, when developing the criteria and methodology for the assessment of micro-organisms, the Commission should take into account relevant technical studies commissioned in the context of this Regulation. This ensures that the delegated acts are informed by existing scientific and technical evidence, supports regulatory coherence and efficiency, and avoids unnecessary duplication of work, while preserving the Commission’s discretion and flexibility to further refine or adapt the methodology as appropriate.

Amendment 27

Proposal for a regulation

Recital 28 a (new)

Or. en

Amendment 28

Proposal for a regulation

Recital 29

Or. en

Amendment 29

Proposal for a regulation

Recital 31

Or. en

Justification

This clarification ensures that the transitional provision is not interpreted as implying a future obligation to use digital solutions. It confirms that only mandatory digital requirements are subject to deferral, while preserving the possibility for economic operators to use digital tools on a voluntary basis, in line with proportionality and the professional nature of fertilising products.

Amendment 30

Proposal for a regulation

Recital 32 a (new)

Or. en

Justification

The proposed amendment ensures that the labelling of substances and mixtures is based on the hazardous properties they present. It prevents the illogical outcomes in which different requirements for labelling apply depending on the function a substance plays in mixture rather than the hazard presented by the substance. The omission of information from the packaging as already permitted under CLP where the conditions in 1.5.2.4 are met (i.e., involving circumstances where the contents do not exceed 10 ml) should apply equally to products in scope of Regulation 528/2012 concerning the making available on the market and use of biocidal products ("BPR"), to resolve the inconsistency created by 1.5.2.5 in Annex I of CLP. There is no clear explanation, in any recitals to the legislation or in any guidance, as to why products in scope of BPR are not able to benefit from the labelling derogations explained above. BPR relies on CLP for labelling purposes, with regards to the communication of information on hazards. BPR also contains its own separate and additional labelling requirements for biocidal products (contained in Article 69) and treated articles (contained in Article 58), which concern the communication of certain specific information. The application of section 1.5.2.5 results in a significantly more restrictive approach being taken with regards to biocidal products and treated mixtures when compared with other non-BPR substances and mixtures which present the same hazardous properties. There is no risk-based reason to justify this approach, and it results in illogical and confusing outcomes when applied in practice with substances or mixtures presenting the same hazard being labelled differently under CLP Regulation.

Amendment 31

Proposal for a regulation

Article 1 – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Article 2 – point 42

Or. en

Justification

The amendment specifies that the digital contact must be not only up-to-date and accessible but also freely accessible. This ensures that users can reach suppliers without incurring costs or facing barriers, thereby improving transparency and ease of communication in line with consumer protection principles.

Amendment 32

Proposal for a regulation

Article 1 – paragraph 1 – point 2 – introductory part

Or. en

Amendment 33

Proposal for a regulation

Article 1 – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – point a

Or. en

Justification

This amendment ensures consistency with the updated Regulation on detergents and surfactants while addressing the needs of SMEs. It allows suppliers to retain a telephone number on product labels as a primary contact option and makes the provision of a digital contact voluntary, thereby reducing unnecessary burdens while maintaining effective communication channels.

Amendment 34

Proposal for a regulation

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

Regulation (EC) No 1272/2008

Article 17 – paragraph 1 – subparagraph 1 a (new)

Or. en

Amendment 35

Proposal for a regulation

Article 1 – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Article 25 – paragraph 6 – subparagraph 3

Or. en

Justification

In addition, to keep this requirement proportionate and avoid relabelling and repackaging (with the associated waste) just to include a digital contact, it is important that businesses retain flexibility to introduce the digital contact as soon as feasible and in alignment with their regular label-update cycles. This avoids triggering premature or standalone reprinting of labels solely to add new contact information, which would be unnecessarily costly and operationally disruptive. Ensuring that the digital contact can be integrated as part of broader, planned label updates maintains the provision’s effectiveness while allowing companies to implement it efficiently and proportionately.

Amendment 36

Proposal for a regulation

Article 1 – paragraph 1 – point 4 – introductory part

Or. en

Amendment 37

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 1

Or. en

(32008R1272)

Amendment 38

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2

Or. en

Amendment 39

Proposal for a regulation

Article 1 – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Article 29 – paragraph 2 a (new)

Or. en

Justification

The amendment introduces a specific provision for packaging up to 75 ml, allowing the reduction of label elements in line with section 1.5.2.4 of Annex I. This ensures proportionality and practicality for small packaging, where space constraints make full labelling difficult, while maintaining safety and compliance. In new 2(a), the proposed derogation would apply to technical containers inserted into other equipment/systems, such as inkjet printer cartridges, where the contents do not exceed 150 ml and where the full CLP hazard information is provided on outer packaging. Printers and cartridges are designed as a system and the available space and locations for labels on the cartridges is limited by the design requirements of the cartridge and printer. Fold out labels cannot be attached to the cartridge because they would interfere with the insertion into and then the functioning of the printer. As a result, unlike types of packaging for which a fold-out label is possible, the CLP Regulation does not offer a multi-language solution for cartridges.

Amendment 40

Proposal for a regulation

Article 1 – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Article 30 – paragraph 1

Or. en

Justification

Updating labels following changes in classification or the addition of new hazard classes requires a realistic and predictable transition period. The redesign of artwork alone commonly takes around 12 months, in addition to the time needed to identify, generate and evaluate new data or conduct any reformulation work. To avoid repeated and burdensome relabelling cycles, we should also allow the flexibility to align updates with companies’ existing production and labelling schedules. A longer and clearly defined update period, such as 18 months, together with a staged approach for different actors in the supply chain would better reflect operational realities and reduce unnecessary disruption.

Amendment 41

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Article 48 – paragraph 1

Or. en

Justification

A general statement such as required in the Biocidal Products Regulation, (EU) No 528/2012, has already proven successful in effectively communicating on hazards of products, when the label elements are not available at the point of purchase. The sentence ‘Always read the label and product information before use.’ must be used in this specific form, without variations that may require duplication of this requirement under CLP and the wording already in use under BPR. In the second part of the amendment, online sales communications should also be excluded from these requirements. In the context of an online sale, the full set of safety information, product details, and mandatory labelling elements is already available directly on the website in a structured and easily accessible format. It is also unclear whether online product listings constitute “advertising” within the meaning of the provision, given that they function primarily as part of the transactional interface rather than promotional material. Therefore, we should clearly exclude online sales from this provision, as search results or internal references on an online store that guide customers elsewhere on the site should not be treated as advertisements. Product thumbnails are essential for helping customers compare items during the initial discovery phase, especially on search results pages. Applying Article 48 to online sales would lead to redundant warning tags that risk diluting the effectiveness of hazard communication, create inconsistencies.

Amendment 42

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

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

Or. en

Justification

A general statement such as required in the Biocidal Products Regulation, (EU) No 528/2012, has already proven successful in effectively communicating on hazards of products, when the label elements are not available at the point of purchase. The sentence ‘Always read the label and product information before use.’ must be used in this specific form, without variations that may require duplication of this requirement under CLP and the wording already in use under BPR. In the second part of the amendment, online sales communications should also be excluded from these requirements. In the context of an online sale, the full set of safety information, product details, and mandatory labelling elements is already available directly on the website in a structured and easily accessible format. It is also unclear whether online product listings constitute “advertising” within the meaning of the provision, given that they function primarily as part of the transactional interface rather than promotional material. Therefore, we should clearly exclude online sales from this provision, as search results or internal references on an online store that guide customers elsewhere on the site should not be treated as advertisements. Product thumbnails are essential for helping customers compare items during the initial discovery phase, especially on search results pages. Applying Article 48 to online sales would lead to redundant warning tags that risk diluting the effectiveness of hazard communication, create inconsistencies.

Amendment 43

Proposal for a regulation

Article 1 – paragraph 1 – point 7

Regulation (EC) No 1272/2008

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

Or. en

Justification

A general statement such as required in the Biocidal Products Regulation, (EU) No 528/2012, has already proven successful in effectively communicating on hazards of products, when the label elements are not available at the point of purchase. The sentence ‘Always read the label and product information before use.’ must be used in this specific form, without variations that may require duplication of this requirement under CLP and the wording already in use under BPR. In the second part of the amendment, online sales communications should also be excluded from these requirements. In the context of an online sale, the full set of safety information, product details, and mandatory labelling elements is already available directly on the website in a structured and easily accessible format. It is also unclear whether online product listings constitute “advertising” within the meaning of the provision, given that they function primarily as part of the transactional interface rather than promotional material. Therefore, we should clearly exclude online sales from this provision, as search results or internal references on an online store that guide customers elsewhere on the site should not be treated as advertisements. Product thumbnails are essential for helping customers compare items during the initial discovery phase, especially on search results pages. Applying Article 48 to online sales would lead to redundant warning tags that risk diluting the effectiveness of hazard communication, create inconsistencies.

Amendment 44

Proposal for a regulation

Article 1 – paragraph 1 – point 8

Regulation (EC) 1272/2008

Article 48a

Or. en

Justification

The label information is not relevant at point of purchase such as how to store the product and how to act in case of accidents. It is an administrative burden for companies to keep this information up to date and therefore the information should be limited to the most relevant and provide companies some flexibility. Regarding the second paragraph (2), requiring distance-sales offers to clearly and visibly display the label elements referred to in Article 17 should not apply to industrial or professional settings and would be disproportionate, particularly in a website setting, as a substantial number of B2B transactions take place online. Purchasing via B2B online platforms and apps is generally restricted to verified business users, requiring registration and verification. Consumers cannot access or purchase chemicals through these systems. In such B2B environments, the SDS is already mandatorily provided under REACH and is generally readily accessible online, ensuring that all relevant hazard information is available without duplicating the label elements at the point of purchase. Extending these obligations to closed professional platforms would therefore add administrative and technical burdens without improving safety, and would hinder the efficiency of digital procurement channels that are essential in modern B2B operations.

Amendment 45

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point a

Regulation (EC) No 1272/2008

Article 61 – paragraph 8

Or. en

Justification

Commission Proposal 2025/0526, endorsed by both the Council of the European Union and the European Parliament (though not yet published in the Official Journal), introduces amendments that postpone certain obligations by one year compared to Regulation (EU) 2024/2865. This proposed amendment ensures alignment with those newly endorsed provisions. The extension of requirements under Article 18(3) to include new hazard classes such as PBT, vPvB, PMT, vPvM and endocrine disruptors significantly increases the complexity of compliance. A longer transition period until 1 January 2030 is necessary to allow industry sufficient time to adapt to these expanded obligations.

Amendment 46

Proposal for a regulation

Article 1 – paragraph 1 – point 9 – point b

Regulation (EC) No 1272/2008

Article 61 – paragraph 9

Or. en

Justification

In both cases, Commission Proposal 2025/0526, endorsed by both the Council of the European Union and the European Parliament (though not yet published in the Official Journal), postpones certain obligations compared to Regulation (EU) 2024/2865. This proposed amendment ensures alignment with those newly endorsed provisions.

Amendment 47

Proposal for a regulation

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

Regulation (EC) No 1223/2009

Article 13 – paragraph 1 a (new)

Or. en

Justification

With the deletion of Article 16(3), the notification under Article 13 becomes the sole notification mechanism for nanomaterials. This amendment clarifies that no parallel or additional notification requirements exist, ensuring the simplified system functions as intended.It eliminates duplication, reduces burden for companies, and ensures that all relevant information for identifying potential risks is provided through a single, coherent mechanism, without compromising consumer safety.

Amendment 48

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

Or. en

Justification

Under the current Cosmetic Products Regulation (CPR), there is no formal legal deadline for submitting a request for derogation from the ban on CMR substances. This new deadline clarifies when the derogation process starts, linking it to the new harmonized classification rather than after the publication of the RAC opinion - which is not per se legally binding. A 6 months’ timeline would offer a more workable and proportionate period for preparing such requests, particularly for SMEs. This timeframe allows for the preparation of a robust evidence-based dossier that directly addresses the specific concerns and outcomes identified in the RAC opinion.

Amendment 49

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

Or. en

Justification

The Omnibus proposal fully maintains the strict consumer safety standards of the Cosmetic Products Regulation (CPR). CMR are banned by default in cosmetics products and cannot be allowed without a robust safety assessment that takes account aggregated exposure conditions.To preserve efficiency, it should be possible to request a derogation for more than one specific cosmetic use, provided that they are listed according to product category/ categories and a detailed exposure scenario is proved for each use.

Amendment 50

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

Or. en

Amendment 51

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

Or. en

Amendment 52

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

Or. en

Justification

Any derogation system under art 15.2 should be mainly driven by the SCCS assessment on whether the use of the CMR substance in specific cosmetic products is safe. The obligation to replace such safe substance with a suitable alternative, when available, does not enhance consumer protection but reflects a policy of replacing hazard-classified substances whenever possible, irrespective of the actual risk they pose.The criterion on replacing as safe substance suitable alternatives criterion does not enhance consumer protection. Within the current Omnibus proposal, where the suitable alternatives criterion is still maintained, useful clarifications are provided on the application of this criterion. They can, however, be complemented with additional guidance without undermining the risk-based safety assessment The conditions on risk reduction to human health and the environment do not create alignment issues with SCCS processes (human health) and REACH (environmental health).

Amendment 53

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

Or. en

Amendment 54

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

Or. en

Justification

The objective should be to clarify that the ingredient is not affected by limitations on its placing on the market. While ingredients must be registered under REACH, access to a substance may in practice be constrained by the applicable tonnage band under which it is registered. Where a substance is not registered at a tonnage band allowing for the required volumes, manufacturers may not have access to sufficient quantities. Moreover, any increase to a higher tonnage band entails compliance with additional registration requirements, a process that can take several months, or in some cases even years.

Amendment 55

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 a (new)

Or. en

Amendment 56

Proposal for a regulation

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

Or. en

Amendment 57

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 a (new)

Or. en

Justification

Under the Cosmetic Products Regulation (CPR), after a substance is classified as a Carcinogenic, Mutagenic, or Toxic for Reproduction (CMR) under CLP, the European Commission must update the CPR Annex to reflect this development. Currently, the European Commission must complete the update of the CPR Annex within 15 months after the "inclusion" of the substance in the CLP Annex. The term "inclusion" is not a precise legal term, and today's interpretation has been to equate it with the "entry into force" of the CLP Annex’ amendment. This timing is genuinely short. In fact, if a derogation dossier is submitted, this timeline often does not allow enough time for a proper assessment of the dossier. Consequently, an update of the CPR Annex might be made based on a partial or unclear evaluation of the derogation dossier, potentially leading to the need for corrigenda (corrections) to the CPR Annex update later. Therefore, a 15-month period for the European Commission to update the CPR Annex, starting from the "date of application" of the CLP Annex as amended as proposed by the European Commission, is essential. This extended period is crucial because it must cover numerous steps: the Commission’s compliance check on the derogation request, the Commission's mandate to the Scientific Committee on Consumer Safety (SCCS), the SCCS's scientific evaluation (which alone typically requires up to 12-15 months), the evaluation of suitable alternatives criteria by the Commission and Member States authorities, the preparation of the Commission proposal for a ban or derogation, a vote by the Standing Committee for Cosmetic Products (MS competent authorities), WTO notification, the European Parliament scrutiny period, adoption by the College of Commissioners, translation, and final publication in the Official Journal of the EU.

Amendment 58

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 5

Or. en

Justification

This amendment clarifies and improves the wording, while maintaining the same objective. It states that if a Carcinogenic, Mutagenic, or Toxic for Reproduction (CMR) classification is linked only to oral (ingestion) or inhalation exposure, then the ban will apply only to cosmetic products that expose consumers to that substance via ingestion or inhalation. The classified substance can be used in cosmetic products producing exposure via ingestion or inhalation, only if the Scientific Committee on Consumer Safety (SCCS) has evaluated and confirmed its safety for those specific uses.

Amendment 59

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 6

Or. en

Justification

Article 15.2 CMR rules were designed for individual substances intentionally added to cosmetics, not for constituents of Natural Complex Substances (NCS) such as essential oils or plant extracts. Constituents may be present at different levels and vary naturally, and their properties cannot be equated with those of the whole ingredient. The Omnibus VI proposal ensures a risk-based evaluation by SCCS, focusing on actual exposure in finished products. This avoids unnecessary bans of safe natural ingredients, provides legal certainty, and maintains high consumer protection.

Amendment 60

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Or. en

Justification

Knowing that in all cases, products on the market have an up-to-date CPSR (Cosmetic Product Safety Report) showing that the product is safe, the introduction of transitional periods for the industry to implement the regulatory changes is needed. This would avoid unnecessary disruption of the market and product destruction. A 18-month period for placing on the market, and 36 months for making available, provide needed time for businesses to identify alternatives, reformulate products, and complete safety testing while maintaining full consumer protection.Extending the default transitional periods does not compromise safety. In case of an urgent safety issue, CPR 15.2 already foresees that the Commission may use the urgency procedure referred to in article 32(4) of CPR, which would allow shorter transition times.In certain limited cases, substances fulfilling a specific and technically critical function in cosmetic formulations may require slightly longer adaptation periods to allow for the development, validation, and approval of safe and compliant alternatives. Introducing an enabling provision allowing the Commission, to determine longer transitional periods, duly justified on technical or scientific grounds, would provide the necessary flexibility to manage such exceptional situations. This approach reinforces legal certainty and avoids product shortages or market disruptions.

Amendment 61

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7 – subparagraph 1 a (new)

Or. en

Justification

Knowing that in all cases, products on the market have an up-to-date CPSR (Cosmetic Product Safety Report) showing that the product is safe, the introduction of transitional periods for the industry to implement the regulatory changes is needed. This would avoid unnecessary disruption of the market and product destruction. A 18-month period for placing on the market, and 36 months for making available, provide needed time for businesses to identify alternatives, reformulate products, and complete safety testing while maintaining full consumer protection.Extending the default transitional periods does not compromise safety. In case of an urgent safety issue, CPR 15.2 already foresees that the Commission may use the urgency procedure referred to in article 32(4) of CPR, which would allow shorter transition times.In certain limited cases, substances fulfilling a specific and technically critical function in cosmetic formulations may require slightly longer adaptation periods to allow for the development, validation, and approval of safe and compliant alternatives. Introducing an enabling provision allowing the Commission, to determine longer transitional periods, duly justified on technical or scientific grounds, would provide the necessary flexibility to manage such exceptional situations. This approach reinforces legal certainty and avoids product shortages or market disruptions.

Amendment 62

Proposal for a regulation

Article 2 – paragraph 1 – point 3 a (new)

Regulation (EC) No 1223/2009

Article 16 – paragraph 4

Or. en

Justification

The wording proposed by the Commission (“where the Commission has concerns”) is overly broad, lacks objective criteria and risks re-establishing routine SCCS reviews similar to those previously triggered under the deleted Article 16(3). Such an approach creates regulatory uncertainty, leads to disproportionate administrative burden, and undermines the simplification objective of this Regulation.This amendment introduces a clear, risk-based trigger for SCCS assessments: a review is initiated only where information submitted under Article 13, or other scientifically substantiated evidence, indicates a potential risk. This ensures that SCCS resources are focused on cases where safety concerns are supported by evidence, while avoiding unnecessary duplication and maintaining a high level of consumer protection.The amendment preserves the procedural timelines proposed by the Commission but places them in a proportionate and transparent framework aligned with science-based decision-making.

Amendment 63

Proposal for a regulation

Article 2 – paragraph 1 – point 8

Or. en

Justification

The Commission's proposal to include specific requirements for nanomaterials (chemical name, descriptors, size, properties, toxicological profile, and exposure conditions) within Annex I, Part A, point 2 of the CPR creates unnecessary duplication and administrative burden. This information is already covered and required under existing regulations. Specifically, article 13 of the CPR already mandates the notification of nanomaterial specifications and other sections of Annex I (e.g., paragraphs 6 to 8) already require detailed exposure and toxicological information for all ingredients, including nanomaterials, as part of the Cosmetic Product Safety Report (CPSR). Therefore, the deletion of these specific nanomaterial requirements from Annex I, Part A, point 2, as proposed in the amendment proposal avoids redundant paperwork, and reduces administrative costs for businesses without compromising safety, as robust review mechanisms for nanomaterials remain in place elsewhere in the CPR.

Amendment 64

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) No 2019/1009

Article 2 – paragraph 1 – point 15a

Or. en

Justification

The amendment specifies that the digital contact must be not only up-to-date and accessible but also freely accessible. This ensures that users can reach suppliers without incurring costs or facing barriers, thereby improving transparency and ease of communication in line with consumer protection principles.

Amendment 65

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point a – point i

Regulation (EU) No 2019/1009

Article 6 – paragraph 2 – subparagraph 2

Or. en

Justification

The amendment enables the EU declaration of conformity to be drawn up and made available in electronic form, without making this mandatory. It reflects the professional nature of EU fertilising products and the role of the declaration as a compliance tool, while ensuring flexibility and proportionality and avoiding unnecessary administrative burden for economic operators, in particular SMEs.

Amendment 66

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point a – point ii

Regulation (EU) No 2019/1009

Article 6 – paragraph 2 – subparagraph 2 a (new)

Or. en

Justification

The amendment clarifies that manufacturers must provide information on how the EU declaration of conformity can be accessed, while allowing flexibility as to the means used. By using an illustrative approach, such as an internet address or a data carrier, it enables digital solutions without imposing mandatory digital channels, ensuring legal clarity and proportionality.

Amendment 67

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point c

Regulation (EU) No 2019/1009

Article 6 – paragraph 6 – subparagraph 1

Or. en

Justification

Replacing ‘reached’ with ‘engaged’ shifts the requirement from passive accessibility to active interaction. It ensures the single point of contact is functional and capable of responding to inquiries from authorities or users. This aligns with EU market surveillance goals to eliminate "shell" addresses, ensuring that the manufacturer is not just locatable, but effectively contactable and ready to provide technical or safety-related support when prompted.

Amendment 68

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point a

Regulation (EU) No 2019/1009

Article 8 – paragraph 2 – subparagraph 1

Or. en

Justification

The amendment clarifies the obligation of importers to verify that information on access to the EU declaration of conformity accompanies the product, while allowing flexibility as to the means used. By referring to examples such as an internet address or a data carrier, it enables digital solutions without making them mandatory, ensuring proportionality and legal clarity in line with the professional use of fertilising products.

Amendment 69

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point b

Regulation (EU) No 2019/1009

Article 8 – paragraph 3

Or. en

Justification

Consistency in the supply chain is crucial for market surveillance. Applying the term ‘engaged’ to importers ensures they remain actively accountable for the products they place on the EU market. It mandates a functional communication channel, preventing the use of unresponsive "letterbox" addresses. This allows authorities to effectively initiate inquiries or safety actions, ensuring that the importer is capable of a meaningful response rather than just having a passive physical presence.

Amendment 70

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point c

Regulation (EU) No 2019/1009

Article 8 – paragraph 8 – subparagraph 1

Or. en

Justification

The amendment introduces a targeted administrative simplification for importers of blends containing components from two or more third countries by allowing the electronic storage of declarations of conformity. It reflects current business practices, reduces unnecessary administrative burden, and improves efficiency, while fully preserving the ability of market surveillance authorities to access the required documentation upon request.

Amendment 71

Proposal for a regulation

Article 3 – paragraph 1 – point 5 – point a

Regulation (EU) No 2019/1009

Article 9 – paragraph 2 – subparagraph 1

Or. en

Justification

The amendment clarifies that distributors must verify that information on how to access the EU declaration of conformity accompanies the product, while preserving flexibility as to the means used. By referring to examples such as an internet address or a data carrier, it enables digital solutions without imposing mandatory digital requirements, ensuring proportionality, legal clarity and consistency with the professional use of fertilising products.

Amendment 72

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Regulation (EU) No 2019/1009

Article 16 – paragraph 5 – subparagraph 1

Or. en

Justification

The amendment removes the additional requirements on the format of the digital EU declaration of conformity in order to remain consistent with Omnibus IV and avoid disproportionate administrative burden. While accessibility is important, the declaration of conformity is not intended for consumer use, and requirements such as the use of an open format go beyond what is necessary. Removing this provision supports simplification without affecting compliance or access to the information.

Amendment 73

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Regulation (EU) No 2019/1009

Article 16 – paragraph 6

Or. en

Justification

This amendment ensures administrative efficiency by preventing the duplication of digital tools. By requiring the full EU declaration of conformity (rather than just compliance information) to be integrated into the Digital Product Passport (DPP) when one exists, it creates a single point of truth for regulators and users. This aligns with the new requirements of Article 16, ensuring that the legally binding document is centrally accessible within the product's digital ecosystem.

Amendment 74

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) No 2019/1009

Article 42 – paragraph 4a – point f

Or. en

Justification

The amendment clarifies the requirement on susceptibility to antimicrobial agents by specifying that it should cover at least two classes of relevant agents, excluding intrinsic resistance. This ensures consistency with the requirements for micro-organisms used as low-risk active substances in plant protection products and guarantees the availability of effective control tools in the unlikely event of infection, without introducing disproportionate regulatory requirements.

Amendment 75

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) No 2019/1009

Article 42 – paragraph 4a a (new)

Or. en

Justification

The amendment requires that updates to the list of micro-organisms and to the criteria and methodology be adopted within a reasonable timeframe and based on publicly available scientific evidence. It addresses past delays in updating Annex II, strengthens legal certainty, supports innovation, and facilitates timely market access for safe micro-organisms while maintaining high safety standards, in line with the objectives of Omnibus.

Amendment 76

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) No 2019/1009

Article 42 – paragraph 4a b (new)

Or. en

Justification

The amendment introduces horizontal criteria and a methodology for assessing innovative component materials other than micro-organisms, addressing regulatory gaps caused by closed CMC lists. It provides a transparent, science-based market access pathway, strengthens legal certainty, reduces delays, and enables the rapid uptake of safe and sustainable materials without the need for repeated legislative amendments.

Amendment 77

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 1

Or. en

Amendment 78

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 2

Or. en

Amendment 79

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 3

Or. en

Amendment 80

Proposal for a regulation

Article 4 – paragraph 2

Or. en

Amendment 81

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Or. en

Justification

Ensuring label legibility through a balanced combination of formatting rules, to be further clarified by ECHA through guidance, is essential to avoid excessive obligations that increase packaging size and conflict with PPWR circularity objectives. Coupling these elements provides legal certainty while ensuring that forthcoming criteria remain workable and reflect business realities, supported by proper stakeholder consultation. To strike the right balance between effective on-label communication, compliance with other regulatory frameworks and the avoidance of duplicative requirements, we should include these provisions and enable ECHA to develop clear, practical guidance. For industrial and professional uses, where SDSs already provide comprehensive hazard information, additional labelling obligations would not enhance safety. This approach maintains high readability while reducing unnecessary burdens and supporting competitiveness.

Amendment 82

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Or. en

Justification

The signal word was introduced the CLP revision in 2024 and based on analysis the ‘signal word’ it does not bring a considerable change in the hazard communication since the hazard pictogram is still part of the requirements. The amendment also ensures allowing suppliers to retain a telephone number on product labels as a primary contact option and makes the provision of a digital contact voluntary, thereby reducing unnecessary burdens while maintaining effective communication channels.

Amendment 83

Proposal for a regulation

Annex I – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4

Or. en

Justification

Alignment with proposed Article 29, paragraph 2: the amendment introduces a specific provision for packaging up to 75 ml, allowing the reduction of label elements in line with section 1.5.2.4 of Annex I. This ensures proportionality and practicality for small packaging, where space constraints make full labelling difficult, while maintaining safety and compliance.

Amendment 84

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1

Or. en

Justification

Alignment with proposed Article 29, paragraph 2: the amendment introduces a specific provision for packaging up to 75 ml, allowing the reduction of label elements in line with section 1.5.2.4 of Annex I. This ensures proportionality and practicality for small packaging, where space constraints make full labelling difficult, while maintaining safety and compliance. Raising the threshold to 75 ml provides a more practical and proportionate solution that avoids unnecessary packaging, supports circular-economy goals, and maintains safety through hazard information available on the outer packaging or, where relevant, via digital labelling.

Amendment 85

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3. – point a

Or. en

Justification

Alignment with proposed Article 29, paragraph 2: the amendment introduces a specific provision for packaging up to 75 ml, allowing the reduction of label elements in line with section 1.5.2.4 of Annex I. This ensures proportionality and practicality for small packaging, where space constraints make full labelling difficult, while maintaining safety and compliance.

Amendment 86

Proposal for a regulation

Annex I – paragraph 1 – point 7 a (new)

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.5.a (new)

Or. en

Justification

The proposed derogation would apply to technical containers inserted into other equipment/systems, such as inkjet printer cartridges, where the contents do not exceed 150 ml and where the full CLP hazard information is provided on outer packaging.Printers and cartridges are designed as a system and the available space and locations for labels on the cartridges is limited by the design requirements of the cartridge and printer. Fold out labels cannot be attached to the cartridge because they would interfere with the insertion into and then the functioning of the printer. As a result, unlike types of packaging for which a fold-out label is possible, the CLP Regulation does not offer a multi-language solution for cartridges.

Amendment 87

Proposal for a regulation

Annex I – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Annex I – section 1.6 – point b a (new)

Or. en

Justification

This amendment expands the scope of information that may be included on a digital label under Section 1.6 of Annex I to Regulation (EC) No 1272/2008. As currently drafted, the Commission proposal allows only supplemental information and supplier details to be provided digitally. However, for many sectors, including the fertilising products sector, the physical label is highly constrained due to multilingual requirements and a large volume of mandatory information stemming from both CLP and sectoral legislation. Allowing non-hazard-related information, such as instructions for use, recommended application rates, and storage conditions, to be placed on a digital label significantly reduces pressure on the physical label while preserving full access to essential safety information. This improves label readability, prevents packaging expansion driven by space constraints, and complements the simplification objectives of the Chemicals Omnibus VI. The amendment maintains a clear distinction between hazard communication, which must remain on the physical label, and operational information that does not affect classification or hazard perception. It therefore enhances proportionality, supports multilingual labelling practices, and aligns with the broader EU goal of enabling digital product information without compromising safety or enforceability.

Amendment 88

Proposal for a regulation

Annex I – paragraph 1 – point 9

Regulation (EC) No 1272/2008

Annex I – part 5 – point b

Or. en

Justification

There are technical and practical constraints for the labels on the pumps as there is limited space on the fuel pumps to include all the required elements:• CLP Art 18.3 (b) requires to mention on the label, the substances responsible for major health hazards classified as CMR, STOT, aspiration hazard, severe eye damage, etc and driving the classification of a mixture• Changing composition (e.g. changes in sourcing of components in the mixture) or increased fraction of renewable components e.g. methanol or ethanol, would require to change the labels while the hazard classification of the products would not change (e.g. changes in UFI without changes in the classification)• In some Member States, other mandatory labelling elements are required in addition to the CLP elements and multiple languages are sometimes needed• Several labels would be needed to cover multiple fuel types distributed from each pump. The most important driver for the requirements in Annex II.5, is to communicate to the customer the necessary information to allow for a safe use of the products, whether the fuel is pumped directly in the fuel tank or in a portable receptacle.Therefore, it is proposed a simplified label on or near the pumps in fuel service stations with as elements: simplified product identifier, hazard pictogram, hazard and precautionary statements and the signal word. The UFI and the nominal quantity do not need to be provided. The other CLP label elements referred to in Art 17.1 (c) – (h) shall be provided either digitally or on or near the pump.

Amendment 89

Proposal for a regulation

Annex II – paragraph 1

Regulation (EC) No 1223/2009

Annex I – Part A – point 2

Or. en

Amendment 90

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point e a (new)

Regulation (EC) No 1223/2009

Annex II – Part II – CMC 7

Or. en

Justification

The amendment adds Bacillus spp. and Paenibacillus spp. to CMC 7 to reflect their widespread use as microbial plant biostimulants with well-established safety and agronomic performance. Their inclusion ensures regulatory consistency across EU frameworks, removes unjustified regulatory barriers, and enables timely market access for safe and effective microbial products.

Amendment 91

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point f

Regulation (EC) No 1223/2009

Annex II – Part II – CMC 8: NUTRIENT POLYMERS

Or. en

Justification

The amendment clarifies that polymers used under CMC 8 may also perform secondary stabilising or structural functions, provided these do not affect product safety or the controlled-release function. It ensures legal certainty, prevents overly restrictive interpretations by authorities, and reflects the technological reality of polymer-based nutrient design, in line with the principle of proportionality.

Amendment 92

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point l a (new)

Regulation (EU) No 2019/1009

Annex II – Part II – CMC 15 a (new)

Or. en

Justification

The amendment introduces a new CMC category allowing the use of component materials that comply with the horizontal criteria and methodology adopted pursuant to Article 42(4c), without requiring individual listing in Annex II. It provides a transparent, science-based and flexible market access pathway, strengthens legal certainty, reduces regulatory delays, and supports innovation while maintaining a high level of safety.

Amendment 93

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point a – point i

Regulation (EC) No 1223/2009

Annex IV – part II – Module A – point 4.2

Or. en

Justification

The change from ‘shall’ to ‘may’ aims to protect manufacturers, particularly SMEs, from excessive administrative burdens of mandatory digitalization. Following the proportionality principle, it allows flexibility in choosing between paper or electronic formats, preventing market exclusion of smaller actors. Simultaneously, the obligation to provide documents electronically upon request (e.g., as scans) ensures effective market surveillance without mandating permanent investments in digital infrastructure.

Amendment 94

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point b – point ii

Regulation (EC) No 1223/2009

Annex IV – part II – Module A 1 – point 5.2

Or. en

Justification

The change from ‘shall’ to ‘may’ aims to protect manufacturers, particularly SMEs, from excessive administrative burdens of mandatory digitalization. Following the proportionality principle, it allows flexibility in choosing between paper or electronic formats, preventing market exclusion of smaller actors. Simultaneously, the obligation to provide documents electronically upon request (e.g., as scans) ensures effective market surveillance without mandating permanent investments in digital infrastructure.

Amendment 95

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point c – point ii a (new)

Regulation (EC) No 1223/2009

Annex IV – part II – Module B – point 8.3

Or. en

Justification

Replacing ‘copy’ with ‘electronic form’ aligns the text with the digital transition goals. It ensures that authorities receive documentation in a modern, transferable format, streamlining administrative cooperation and reducing costs. This amendment provides legal certainty immediately, avoiding the need for future delegated acts. It maintains consistency with other digital requirements in the Regulation, ensuring efficient market surveillance and faster data exchange between Member States.

Amendment 96

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point c – point ii b (new)

Regulation (EC) No 1223/2009

Annex IV – part II – Module B – point 9.1

Or. en

Justification

Replacing ‘copy’ with ‘electronic form’ modernizes archiving for notified bodies. It ensures certificates and technical files are stored in a format allowing immediate digital transmission to authorities or the Commission. This increases efficiency, reduces physical storage costs, and aligns the certification process with digital transformation goals. It ensures faster data exchange between Member States while maintaining the integrity of the conformity assessment records.

Amendment 97

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point c – point ii c (new)

Regulation (EC) No 1223/2009

Annex IV – part II – Module B – point 9.2

Or. en

Justification

Requiring manufacturers to keep documentation in electronic form is vital for effective market surveillance. It ensures they can immediately fulfill obligations to provide documents upon a reasoned request in a digital format. This change eliminates ambiguity surrounding the term ‘copy’, reduces paper archiving burdens, and ensures consistency with the digital labeling framework. It allows for rapid verification of compliance without mandating expensive physical storage systems.

Amendment 98

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point d – point i

Regulation (EU) No 2019/1009

Annex IV – part II – Module C – point 3.2

Or. en

Justification

The change from ‘shall’ to ‘may’ aims to protect manufacturers, particularly SMEs, from excessive administrative burdens of mandatory digitalization. Following the proportionality principle, it allows flexibility in choosing between paper or electronic formats, preventing market exclusion of smaller actors. Simultaneously, the obligation to provide documents electronically upon request (e.g., as scans) ensures effective market surveillance without mandating permanent investments in digital infrastructure.

Amendment 99

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point e – point ii

Regulation (EU) No 2019/1009

Annex IV – part II – Module D 1 – point 7.2

Or. en

Justification

The change from ‘shall’ to ‘may’ aims to protect manufacturers, particularly SMEs, from excessive administrative burdens of mandatory digitalization. Following the proportionality principle, it allows flexibility in choosing between paper or electronic formats, preventing market exclusion of smaller actors. Simultaneously, the obligation to provide documents electronically upon request (e.g., as scans) ensures effective market surveillance without mandating permanent investments in digital infrastructure.

EXPLANATORY STATEMENT

The Chemical Omnibus contributes to the objectives of simplification and reducing administrative burdens by streamlining rules, improving coherence, and supporting a more competitive and resilient industrial base, while maintaining high levels of protection.

These amending Regulations were examined by the European Parliament in accordance with Rule 59 (Joint committee procedure) of the Rules of Procedure. Reflecting the cross-cutting nature of the subject matter, the co-rapporteurs worked together throughout the process on the preparation and assessment of the draft report.

The original Regulations (EC) No 1272/2008 and (EC) No 1223/2009 were examined by ENVI, given their focus on the protection of human health and the environment and the regulation of hazardous substances, while duly taking into account internal market considerations. The original Regulation (EU) 2019/1009 was examined by IMCO, reflecting its core objective of harmonising product rules and ensuring the functioning of the internal market through CE-marking and conformity assessment, with ENVI contributing on environmental and safety aspects, and AGRI on agricultural use and impacts.

Amendments to Regulation (EC) No 1272/2008

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) requires economic operators to classify, label and package hazardous chemicals before they are placed on the market. The proposed initiative aims to simplify and introduce greater flexibility to the labelling requirements, in particular regarding formatting rules such as minimum font sizes and line spacing, which have been identified as disproportionately burdensome for industry. It clarifies derogations for small packages and the rules applicable to fuel pumps and seeks to limit the provisions on advertisements and distance sales to products intended for the general public, given that REACH already ensures information flows in professional supply chains. The initiative also streamlines advertising obligations by reducing unnecessary mandatory information, removes the fixed six-month deadline for label updates in favour of a more proportionate “without undue delay” requirement, and expands the possibility for digital labelling to accommodate additional information.

The co-rapporteurs welcome the Commission’s proposals to modernise and streamline labelling obligations under the CLP Regulation, recognising that clearer, more flexible rules can improve the functioning of the internal market while maintaining high levels of protection. The introduction of a “digital contact” as a formal means of communication is an important and timely step. It ensures that supplier information remains easily accessible, up to date and freely available, while reducing the pressure on physical label space, particularly for products with multiple languages or complex supply chains. Allowing the omission of a telephone number when this information is accessible through the digital contact is a proportionate and technologically neutral measure that reflects current communication practices.

The co-rapporteurs also support the differentiated approach to labelling in cases where full compliance would be impractical or disproportionate without weakening safety requirements. The possibility to reduce label elements for small packaging, packaging up to 75 ml, and technical containers integrated into equipment provides needed flexibility. The updated rules on label revision, requiring updates without undue delay and no later than 18 months per actor in the supply chain, strike a balanced compromise between ensuring the timely communication of hazard information and acknowledging operational realities across diverse industrial sectors.

Furthermore, the co-rapporteurs consider the proposed changes on advertisements and distance sales to be balanced and coherent. By focusing obligations on communications targeted at the general public and exempting professional users and online sales channels under specific conditions, the proposal strengthens consumer protection while reducing unnecessary administrative burden. The clearer rules on distance sales offers also ensure that essential hazard information remains visible at the point of purchase, thereby supporting informed decision-making and market transparency.

Overall, the co-rapporteurs consider that these targeted amendments contribute meaningfully to simplification, enhance regulatory clarity, and support competitiveness, without compromising the protection of human health and the environment.

Amendments to Regulation (EC) No 1223/2009

The co-rapporteurs welcome the targeted amendments to the Cosmetic Products Regulation, which preserve the EU’s high level of consumer safety while improving clarity and reducing unnecessary administrative burdens for businesses and authorities. Establishing a clearer and more efficient procedure for approving colorants, preservatives and UV filters will accelerate the safe introduction of new cosmetic ingredients. The refinement of the derogation process for CMR substances reflects over a decade of practical experience and enhances legal certainty. The digitalisation of the glossary of ingredient names will support accurate labelling and reduce compliance risks. Moreover, the removal of redundant pre-notification requirements for products containing nanomaterials, along with simplified reporting obligations, will streamline processes without compromising safety.

The co-rapporteurs support the proposed amendments to Article 15, which significantly enhance the clarity, coherence and scientific robustness of the framework governing the use of CMR substances in cosmetic products. The revised derogation procedure introduces a clearer and more predictable system, ensuring that derogation requests are submitted within a defined timeline following a new CMR classification and assessed on the basis of stringent, transparent criteria. The co-rapporteurs consider the strengthened requirements for analysing alternatives, focusing on real risk reduction, equivalent performance, technical feasibility and economic viability, to be essential for ensuring that substitutions are meaningful, safe and achievable at industrial scale.

The co-rapporteurs also welcome the explicit alignment of derogations with SCCS safety evaluations, which must consider exposure from all relevant sources and population groups. The new provisions addressing classifications with specified routes of exposure bring regulatory practice closer to scientific evidence, ensuring that prohibitions apply proportionately to the intended use of cosmetic products. Likewise, the dedicated rules for plant-derived substances containing CMR constituents introduce much-needed clarity, establishing a science-based mechanism for SCCS review and timely regulatory follow-up where a potential risk is identified.

The updated transitional periods for placing and making available products on the market, combined with the possibility of extension where necessary, provide legal certainty for industry and help ensure a smooth adaptation to new regulatory requirements. The co-rapporteurs further support the deletion of outdated provisions, the modernisation of ingredient nomenclature rules, and the consequential updates to Annexes II–VI, which together improve regulatory coherence and reduce unnecessary administrative burden.

Overall, the co-rapporteurs consider that these targeted amendments strike a balanced and forward-looking approach: they reinforce consumer safety, enhance predictability for operators, and reflect more than a decade of practical experience and scientific progress, while supporting innovation and maintaining the high standards of the EU cosmetics sector.

Amendments to Regulation (EC) No 1223/2009

Regulation (EU) 2019/1009 laying down rules on the making available on the market of EU fertilising products establishes harmonised requirements to ensure a high level of protection of human health and the environment, while supporting the functioning of the internal market. The proposed initiative seeks to improve the proportionality, competitiveness and innovation capacity of the Fertilising Products Regulation, in particular with regard to the needs of small and medium-sized enterprises, which form the backbone of the EU fertilising products sector.

The co-rapporteurs welcome the Commission’s proposal to remove the specific extended REACH registration requirement set out in the Fertilising Products Regulation, so that standard REACH provisions apply to substances used in EU fertilising products. This change enhances legal clarity, avoids unnecessary duplication and ensures a coherent application of Union chemicals legislation, while maintaining high safety standards.

The co-rapporteurs also support empowering the Commission to introduce criteria and a methodology for the assessment of micro-organisms by manufacturers and notified bodies. This measure strengthens legal certainty, facilitates consistent implementation and supports innovation in biological fertilising products without weakening safety requirements.

Furthermore, the co-rapporteurs consider the removal of the unbundling clause in Article 43 to be justified and proportionate. By avoiding the need for separate delegated acts for each component material category, the proposal allows for a more flexible and efficient regulatory framework, better adapted to technological progress. In this context, the introduction of an optional component material category, CMC X, provides a future-proof tool that offers economic operators, in particular SMEs, a clearer and more predictable route to market for safe and innovative products.

The co-rapporteurs consider the proposed approach to digitalisation to be balanced. By enabling, but not mandating, digital solutions such as electronic EU declarations of conformity, the amendments preserve flexibility for economic operators and avoid imposing disproportionate burdens on SMEs. At the same time, the proposal ensures coherence with broader Union digital policies by providing that, where a Digital Product Passport is required under other Union legislation, the EU declaration of conformity shall be made available through that passport.

Overall, the co-rapporteurs consider that the proposed amendments strengthen proportionality, enhance regulatory clarity and support innovation and competitiveness in the EU fertilising products sector, without compromising the protection of human health and the environment.

ANNEX: DECLARATIONS OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declare that they included in their report input on matters pertaining to the subject of the file that they received, in the preparation of the draft report, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

The list above is drawn up under the exclusive responsibility of the rapporteurs.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteurs declare that they have submitted to the natural persons concerned the European Parliament’s Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.