Simplification of certain requirements and procedures for chemical products (Omnibus VI)

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Proposal for a regulation · Recital 2
   Current text

   (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment. _________________ 2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competit…

   Amendment

   (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083, (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary administrative and regulatory burdens should be removed, while maintaining a high level of consumer protection, protection of human health and of the environment. _________________ 2 2024 report by Mario Draghi on the future of European competitiveness: https://co…

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2. Amendment 2Proposal for a regulation · Recital 2 a (new)
   Amendment

   (2a) Fertilising products covered by Regulation (EU) 2019/1009 directly affect farmers’ production costs, incomes, safety and competitiveness, while regulatory requirements and administrative burdens on producers are transmitted along the supply chain. As competitiveness of the Union depends, inter alia, on its capacity to innovate, the regulatory framework should support innovation and technical progress by remaining proportionate and avoiding unnecessary burdens, while ensuring the objectives of that Regulation are achieved.

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3. Amendment 3Proposal for a regulation · Recital 3
   Current text

   (3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between economic operators and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures is necessary to enhance the effectiveness of official controls and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, b…

   Amendment

   (3) In line with the Commission’s objective to promote the ‘digital by default’ principle to support digital transformations and in order to facilitate communication between suppliers and individuals and between suppliers and national authorities responsible for enforcement, the indication of a digital contact on the label of hazardous substances and mixtures contributes to enhancing the effectiveness of official controls, traceability, accountability and enforcement and to expedite the process of detecting substances and mixtures that do not comply with the requirements of Regulation (EC) No 1272/2008, as well as to ensure consumers have a quick and direct contact in case of an emergency or…

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4. Amendment 4Proposal for a regulation · Recital 3 a (new)
   Amendment

   (3a) The digital contact should allow consumers and authorities to contact suppliers directly and swiftly, and should be accessible free of charge, and without the need to provide any personal data, the download or use of an application or an obligation to register solely for the purpose of contacting the supplier. Such digital contact could include, for example, an email address or a contact form on a website. However, it should not be understood as encompassing automatic replies to queries, chatbots or fax numbers. The term ‘digital contact’, similarly to the term ‘electronic address’ in Regulation (EU) 2023/988 of the European Parliament and of the Council, should be understood in a techn…

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5. Amendment 5Proposal for a regulation · Recital 5
   Current text

   (5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. However, further simplifications are needed with regard to the application of this derogation in cases where these packages are subject to the supplementary hazard statement EUH 208. It is also necessary to clarify the requirements for inner and outer packaging in cases where the 10 ml derogation is applied. _________________ 6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances an…

   Amendment

   (5) Regulation (EU) 2024/2865 of the European Parliament and of the Council6 introduced exemptions from labelling and packaging requirements for packages containing less than 10 ml. It introduced a possibility to omit label elements from such inner packaging under certain conditions. However, it is necessary to simplify these provisions and clarify which cases require labelling elements to be presented on the outer packaging in cases allowing for these elements to be fully omitted. In addition, the Commission should carry out an assessment on whether further specific reductions of mandatory label elements should apply to packages between 10 and 125 ml. _________________ 6 Regulation (EU) 202…

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6. Amendment 6Proposal for a regulation · Recital 6
   Current text

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

   Amendment

   (6) With regard to the updating of labels in case of new or more severe self-classification, suppliers should inform their direct downstream users about the results of the new evaluation without undue delay. In order to provide sufficient time for all suppliers of substances and mixtures, in particular, for small and medium-sized enterprises who often outsource label printing services and to facilitate the preparation and the production of fold-out labels, which is significantly longer than the production of the standard labels, it is necessary to extend the fixed six months relabelling deadline to eighteen months, while continuing to require the labels to be changed without undue delay afte…

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7. Amendment 7Proposal for a regulation · Recital 7
   Current text

   (7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and burden for industry8 , it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. Economic operators and enforcement authorities must remain responsible for ensuring that the labels are legible in accordance with the legal requirements. _________________ 7 Detailed analysis of costs associate…

   Amendment

   (7) Regulation (EU) 2024/2865 laid down rules on mandatory requirements for label formatting. New information7 pointed to excessive administrative burden and costs, associated with these requirements. To balance the need for label information to be clearly understood by consumers with the need to reduce market barriers and unjustified burden for industry8, in particular for small and medium-sized enterprises, it is necessary to simplify the current formatting obligations without reducing the level of protection of human health and the environment. The new measures should maintain a high level of consumer protection and ensure the proper functioning of the internal market. Suppliers must rema…

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8. Amendment 8Proposal for a regulation · Recital 7 a (new)
   Amendment

   (7a) The label serves as a primary and often single source of hazard information and safe-use guidance readily available to consumers, while professional and industrial users are also informed about the hazards associated with a particular substance or mixture prior to use through safety data sheets and safety training. Therefore, it is indispensable that a label is easily readable not only under normal conditions, but also in exceptional circumstances such as accidents.

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9. Amendment 9Proposal for a regulation · Recital 7 b (new)
   Amendment

   (7b) To ensure that a label has an appropriate degree of readability, it should at least have a clear contrast of the text of the label to the background, a suitable typeface, an appropriately sized font, appropriate line and letter spacing, overall label design and other relevant formatting elements. In particular, for substances or mixtures made available on the market for the general public, the label elements referred to in Article 17(1) should use a font size where the x-height is equal to or greater than 1.2 mm. However, when the contents of the package do not exceed 125 ml, the label elements referred to in Article 17(1) might use a font size where the x-height is equal to or greater…

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10. Amendment 10Proposal for a regulation · Recital 8
    Current text

    (8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures. _________________ 9 Regulation (EC) No 1907/2006 of the European Parliament and of the…

    Amendment

    (8) To alleviate the burden on industry and to improve the free circulation of substances and mixtures in the internal market it is appropriate to amend Regulation (EC) No 1272/2008 as regards the rules on advertisements and distance sales offers, taking advantages of existing provisions in other Union legislation with the same objectives. In this regard, requirements for advertisements and distance sales offers should be limited to products placed on the market for the general public, as Regulation (EC) No 1907/20069 already provides clear obligations on information flows in supply chains for substances and mixtures. _________________ 9 Regulation (EC) No 1907/2006 of the European Parliamen…

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11. Amendment 11Proposal for a regulation · Recital 8 a (new)
    Amendment

    (8a) Professional and industrial users are generally better informed about the hazards associated with substances and mixtures than consumers. It is therefore appropriate to differentiate information requirements with respect to advertisement depending on whether products are intended for professional and industrial use or for consumers or directly made available to them. When assessing whether an advertisement is targeted at consumers or made available to them, competent authorities should take into account objective elements, including whether it is clearly indicated that the substance or mixture is intended exclusively for professional use, as well as the context in which the advertisemen…

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12. Amendment 12Proposal for a regulation · Recital 9
    Current text

    (9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the prod…

    Amendment

    (9) Before the amendments introduced by Regulation (EU) 2024/2865, Regulation (EC) No 1272/2008 required the advertisements for hazardous mixtures, for which a member of the general public is allowed to conclude a contract for purchase without first having sight of the label, to mention the type or types of hazards indicated on the label, and required advertisements for substances to mention the hazard classes or hazard categories concerned. Regulation (EU) 2024/2865 introduced a new requirement for all distance sales of hazardous substances and mixtures to include all labelling information in the offer, thus ensuring that the buyer is always informed about the hazards before buying the prod…

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13. Amendment 13Proposal for a regulation · Recital 10
    Current text

    (10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate to use the same requirement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products. _________________ 10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of…

    Amendment

    (10) As Regulation (EC) No 1107/2009 of the European Parliament and of the Council10 and Regulation (EU) No 528/2012 of the European Parliament and of the Council11 require advertisements for authorised plant protection products and biocidal products to use the statement ‘Always read the label and product information before use’, it would be appropriate for the advertisers to use the same statement for advertisements of hazardous substances and mixtures to ensure consistency, especially in cases where advertised hazardous substances and mixtures are also authorised plant protection products or biocidal products. _________________ 10 Regulation (EC) No 1107/2009 of the European Parliament and…

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14. Amendment 14Proposal for a regulation · Recital 12
    Current text

    (12) Regulation (EU) 2024/2865 introduced the possibility to include certain labelling elements in the digital label only. To ensure broader use of technology and to allow a simpler and more flexible approach to labelling, suppliers should be allowed to place contact details of any additional suppliers on the digital label only. Inclusion of the digital contact would also be appropriate where contact details of additional suppliers are provided in the digital label.

    Amendment

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

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15. Amendment 15Proposal for a regulation · Recital 12 a (new)
    Amendment

    (12a) Inkjet cartridges (≤150 ml) (supplied in outer packaging and designed to be installed in a printer by a consumer or professional user) have very limited usable surface area for labelling and cannot benefit from the fold out label option enabling multilanguage solutions. In this case suppliers should be permitted to reduce hazard label information under certain conditions.

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16. Amendment 16Proposal for a regulation · Recital 14
    Current text

    (14) In line with the transitional provisions of Regulation (EC) No 1272/2008, suppliers should have the possibility of applying the new classification, labelling and packaging provisions introduced by this Regulation on a voluntary basis before the date of the deferred application of these provisions.

    Amendment

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

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17. Amendment 17Proposal for a regulation · Recital 17
    Current text

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

    Amendment

    (17) The conditions allowing for exemptions from the ban of use of such substances in cosmetic products should be streamlined without lowering the high level of human health and safety and consumer protection, and their scope should be set out in more detail. In addition, compliance with food safety requirements is not compatible with the scientific and technical developments that allow the development of new substances for use in cosmetic products that are not used or found in food. The compliance with food safety requirements does not necessarily enhance the safety of cosmetic products as both categories of products are inherently different. It is, therefore, appropriate to abolish this co…

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18. Amendment 18Proposal for a regulation · Recital 18
    Current text

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

    Amendment

    (18) Furthermore, the elements to be considered under the availability of suitable alternatives condition should be outlined. In particular, it should be provided that the use of any alternative substance to replace the classified substance is safe for human health. The alternative should provide an equivalent function and comparable level of efficacy and performance and should be available on the market in sufficient quantities, or likely to be available in sufficient quantities to meet current demand and has the demonstrated potential to meet expected demands in a reasonable timeframe. Its use should be technically and economically feasible for businesses and especially for SMEs to allow s…

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19. Amendment 19Proposal for a regulation · Recital 19
    Current text

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

    Amendment

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

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20. Amendment 20Proposal for a regulation · Recital 21
    Current text

    (21) Often a substance can also be a constituent of natural complex substances, for example essential oils. In such cases, the prohibition of use in cosmetic products under Article 15 of Regulation (EC) No 1223/2009 is relevant only to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. This means that natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except if that natural complex substance is itself listed as CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent may raise concerns as to the sa…

    Amendment

    (21) Substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006, are often referred to as natural complex substances, or ‘NCS’. They might contain one or more constituents classified as CMR substances, while the overall natural complex substance is not itself classified as a CMR substance. A high level of consumer protection must apply to such substances and should be based on scientific knowledge and the actual conditions of exposure arising from their use in cosmetic products. The prohibition of use in cosmetic products under Article 15 of Regulatio…

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21. Amendment 21Proposal for a regulation · Recital 22
    Current text

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

    Amendment

    (22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate, test and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Accordingly, if no derogation request was submitted, a period of 6 months for placing and 15 months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided. In case a request for derogation…

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22. Amendment 22Proposal for a regulation · Recital 23
    Current text

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

    Amendment

    (23) To reduce compliance and administrative burden on businesses active in the cosmetic sector, notifications of the cosmetic products to the Commission should be required before placing them on the Union market. To maintain vigilance on nanomaterials in cosmetic products, it should be required that this notification includes the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI, and the specification of the nanomaterial including size of particles, physical and chemical properties, intended to be placed on the market per year. This is necessary so that a safety assessment can be requested…

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23. Amendment 23Proposal for a regulation · Recital 25
    Current text

    (25) Cosmetics are globally traded goods. It is therefore important that the ingredient names present on their labels reflect the current state of scientific and technological development. The use of internationally recognised cosmetic ingredient’ names is an important factor promoting transparency and facilitating cross-border trade in cosmetics. This Regulation should enable internationally recognised names to be used on the labelling of cosmetic products without any additional regulatory action from the Commission. As a glossary of common ingredient names adopted by the Commission would slow down the process of uptake of the new names, the provision requiring the Commission to adopt such…

    Amendment

    (25) Cosmetics are globally traded goods and it is therefore essential that the ingredient names present on their labels reflect the current state of scientific and technological development in a timely manner. The use of internationally recognised nomenclature, such as the International Nomenclature of Cosmetic ingredient (INCI) names is an important factor promoting ingredients transparency for consumers, ensures consistency across jurisdictions, and facilitates cross-border trade in cosmetics. INCI names are maintained by the Personal Care Products Council (PCPC) as an international industry standard and are widely recognised by regulators and stakeholders worldwide. This Regulation shoul…

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24. Amendment 24Proposal for a regulation · Recital 25 a (new)
    Amendment

    (25a) In order to ensure a high level of protection of human health, all operators placing cosmetic products on the Union market, whether offline or online, should be subject to equivalent obligations and effective enforcement. This is particularly important given the growing sales of cosmetics via online marketplaces, including products originating from third countries that are not subject to the same health and safety requirements. Therefore, it is necessary to require certain labelling information referred to in Article 19 to be clearly and visibly indicated in case of distance sales, including via online marketplaces. This requirement will simplify enforcement of Regulation (EC) No 1223/…

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25. Amendment 25Proposal for a regulation · Recital 26
    Current text

    (26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be reached, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide authorities, upon request, with all relevant information and documentation in electronic form. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products…

    Amendment

    (26) In line with the Commission’s objective to rationalise and simplify reporting requirements and to promote the ‘digital by default’ principle to support digital transformations, economic operators dealing with EU fertilising products in accordance with Regulation (EU) 2019/1009 should provide a digital contact through which they can be contacted by competent authorities and end-users so as to adequately answer any queries from those, draw up the EU declaration of conformity in electronic form and make it accessible via an internet address or data carrier, and provide competent authorities, upon request, with all relevant information and documentation in a swift manner in electronic form.…

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26. Amendment 26Proposal for a regulation · Recital 26 a (new)
    Amendment

    (26a) Fertiliser products covered by Regulation (EU) 2019/1009 are subject to regulatory requirements and administrative burdens which, when increased, may widen the gap between agricultural production costs in the Union and those in third countries. The revision of this Regulation should therefore provide for regulatory simplification for EU fertiliser producers and benefit EU farmers making it easier for operators to enter the EU market and operate beyond national markets to the benefit of the Single Market. Therefore, it should not undermine a high level of consumer, health, environmental protection and risk management. Furthermore, easing sector-specific requirements for fertilising prod…

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27. Amendment 27Proposal for a regulation · Recital 26 b (new)
    Amendment

    (26b) Digitalisation of declarations of conformity and technical product information may offer certain advantages. Due regard should be given to cybersecurity, effective and swift enforcement oversight, the availability and interoperability of digital infrastructure, the potential costs of introducing and operating such systems and the diversity of economic operators and national systems.

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28. Amendment 28Proposal for a regulation · Recital 27
    Current text

    (27) Under Regulation (EU) 2019/1009, only micro-organisms listed on a positive list in Annex II to that Regulation may be used as component material in microbial plant biostimulants. The Commission is empowered to add new micro-organisms or strains of micro-organisms to that list after an assessment concluding that none of the strains presents a risk to human, animal or plant health, to safety or to the environment and that it ensures agronomic efficiency. Given the large number of micro-organisms on the market, the assessment and subsequent inclusion of new micro-organisms or strains of micro-organism to the positive list are lagging scientific progress. The current mechanism slows down th…

    Amendment

    (27) Under Regulation (EU) 2019/1009, only micro-organisms listed on a positive list in Annex II to that Regulation may be used as component material in microbial plant biostimulants. The Commission is empowered to add new micro-organisms or strains of micro-organisms to that list after an assessment concluding that none of the strains presents a risk to human, animal or plant health, to safety or to the environment and that it ensures agronomic efficiency. Given the large number of micro-organisms on the market, the assessment and subsequent inclusion of new micro-organisms or strains of micro-organism to the positive list are lagging scientific progress. The current mechanism slows down th…

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29. Amendment 29Proposal for a regulation · Recital 27 a (new)
    Amendment

    (27a) Given the rapid pace of innovation in agricultural biotechnology, it is important that existing regulatory procedures, including the updating of Annexes by the Commission, are applied in a timely and science-based manner, making full use of the possibilities already provided for under Regulation (EU) 2019/1009. This should facilitate the timely assessment of new strains, while ensuring that only those meeting Union safety requirements are allowed on the market.

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30. Amendment 30Proposal for a regulation · Recital 28
    Current text

    (28) In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria and the methodology should allow manufacturers and notified bodies to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not p…

    Amendment

    (28) The wider use of microbial plant biostimulants can improve nutrient-use efficiency and soil health, thereby fostering the development of sustainable while highly productive agriculture. In order to accelerate the assessment of micro-organisms and to open the single market for more microbial plant biostimulants, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of Annex II, Part II, component material category (CMC) 7, to Regulation (EU) 2019/1009 to allow the Commission to introduce general criteria and a methodology for the assessment of micro-organisms. Those criteria should re…

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31. Amendment 31Proposal for a regulation · Recital 29 a (new)
    Amendment

    (29a) Regulation (EU) 2019/1009 aims to facilitate the placing on the internal market and free movement of safe fertilising products, while supporting the recycling of nutrients and the circular use of raw materials and ensuring a high level of protection for human, animal and plant health and the environment. The effective application thereof depends, among other things, on the recognition of end points for constituent materials derived from animal by-products within the meaning of Regulation (EC) No 1069/2009. Delegated Regulation (EU) 2023/1605 has established certain end points for animal by-products intended for fertiliser applications. However, the processing parameters and risk mitiga…

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32. Amendment 32Proposal for a regulation · Recital 30
    Current text

    (30) Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 1 tonne per company per year, need to be registered in accordance with Regulation (EC) No 1907/2006, with information requirements depending on the actual volume. Regulation (EU) 2019/1009, going beyond the requirements of Regulation (EC) No 1907/2006, requires that all substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, are registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together…

    Amendment

    (30) Regulation (EU) 2019/1009 introduced additional registration requirements for substances used in EU fertilising products, going beyond those set out in Regulation (EC) No 1907/2006. In order to ensure proportionality while maintaining a high level of protection of human health and the environment, it is appropriate to align the registration requirements for substances used in EU fertilising products with those set out in Regulation (EC) No 1907/2006, taking into account the relevant tonnage thresholds and information requirements. At the same time, for substances with particularly hazardous properties, including those classified under Regulation (EC) No 1272/2008 as carcinogenic, mutage…

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33. Amendment 33Proposal for a regulation · Article 1 – paragraph 1 – point 1 · Regulation (EC) No 1272/2008 · Article 2 – point 42
    Current text

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

    Amendment

    42. “digital contact” means any up-to-date easily and freely accessible online communication channel such as email addresses or a weblink through which a supplier can be contacted without the need to register or to download or use an application;

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34. Amendment 34Proposal for a regulation · Article 1 – paragraph 1 – point 1 a (new) · Regulation (EC) No 1272/2008 · Article 5 – paragraph 3 a (new)
    Amendment

    (1a) In article 5, the following paragraph is inserted: ‘3a. By 18 months from the date of the entering into force of this Amending Regulation, the Commission shall carry out an assessment on whether further specific reductions of mandatory label elements should apply to packages between 10 and 125 ml.’

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35. Amendment 35Proposal for a regulation · Article 1 – paragraph 1 – point 2 – introductory part · Regulation (EC) No 1272/2008 · Article 17 – paragraph 1 – point a
    Current text

    (2) in Article 17(1), point (a) is replaced by the following:

    Amendment

    (2) Article 17(1) is amended as follows: (a) point (a) is replaced by the following:

    official amendment document ↗
36. Amendment 36Proposal for a regulation · Article 1 – paragraph 1 – point 2 · Regulation (EC) No 1272/2008 · Article 17 – paragraph 1 – point a
    Current text

    (a) the name, address and digital contact of the suppliers;;

    Amendment

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

    official amendment document ↗
37. Amendment 37Proposal for a regulation · Article 1 – paragraph 1 – point 2 a (new) · Regulation (EC) No 1272/2008 · Article 17 – paragraph 1 – subparagraph 1 a (new)
    Amendment

    (2a) in Article 17(1) the following subparagraph is added: ‘The telephone number in point (a) of the first subparagraph may be omitted from the label if such telephone number is directly available through the digital contact.’

    official amendment document ↗
38. Amendment 38Proposal for a regulation · Article 1 – paragraph 1 – point 3 · Regulation (EC) No 1272/2008 · Article 25 – paragraph 6 – subparagraph 3
    Current text

    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.;

    Amendment

    The label shall also include the product identifier referred to in Article 18 and the name, address, digital contact of the supplier(s) of the mixture and the telephone number, unless this telephone number is directly available through the digital contact. Without prejudice to the deadline established in Article 61(8), the inclusion or change to the digital contact may be added or updated at any time or during the supplier’s regular label update cycles;

    official amendment document ↗
39. Amendment 39Proposal for a regulation · Article 1 – paragraph 1 – point 4 – introductory part · Regulation (EC) No 1272/2008 · Article 29 – paragraph 2
    Current text

    (4) in Article 29, paragraph 2 is replaced by the following: 1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements of Article 31 for a label in the languages of the L 353/18 EN Official Journal of the European Union 31.12.2008 Member State in which the substance or mixture is placed on the market, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with section 1.5.1 of Annex I.

    Amendment

    (4) in Article 29 paragraphs 1 and 2 are replaced by the following: "1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in 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) shall be provided in accordance with section 1.5.1 of Annex I.;"

    official amendment document ↗
40. Amendment 40Proposal for a regulation · Article 1 – paragraph 1 – point 4 · Regulation (EC) No 1272/2008 · Article 29 – paragraph 2
    Current text

    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.;

    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. where: a) the content of the packaging of a substance or a mixture does not exceed the quantities indicated in section 1.5.2. of Annex I; and b) the packaging is either in such a shape or form or is too small in size to allow for a full reference to all the elements referred to in Article 31 in all the languages of the Member State in which the substance or mixture is placed on the market.”

    official amendment document ↗
41. Amendment 41Proposal for a regulation · Article 1 – paragraph 1 – point 4 a (new) · Regulation (EC) No 1272/2008 · Article 29 – paragraph 2 a (new)
    Amendment

    (4a) In article 29, the following paragraph is inserted: 2a. By way of derogation from Article 17(1) and Article 25(6), the label elements of ink cartridges may be reduced in accordance with the rules set out in 1.5.2.5a of Annex I. For the purpose of this paragraph, ‘ink cartridge’ means a replaceable unit that holds ink and which must be inserted into a printer during printing.

    official amendment document ↗
42. Amendment 42Proposal for a regulation · Article 1 – paragraph 1 – point 5 · Regulation (EC) No 1272/2008 · Article 30 – paragraph 1
    Current text

    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.;

    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 and in any event no later than eighteen months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier. With a view to complete the changes to the labelling without undue delay, suppliers shall cooperate in accordance with Article 4(9) and inform their…

    Excerpt — full text in the official PDF.
    official amendment document ↗
43. Amendment 43Proposal for a regulation · Article 1 – paragraph 1 – point 6 · Regulation (EC) No 1272/2008 · Article 31 – paragraph 3
    Current text

    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.;

    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 spacing as to be easy to read. They shall be formatted in accordance with section 1.2.1 of Annex I.;

    official amendment document ↗
44. Amendment 44Proposal for a regulation · Article 1 – paragraph 1 – point 7 · Regulation (EC) No 1272/2008 · Article 48 – paragraph 1
    Current text

    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.’.

    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 always include the sentence: ‘Always read the label and product information before use.’, and shall also include one of the following: a) the applicable hazard pictogram(s); or b) the relevant signal word in accordance with Article 20.

    official amendment document ↗
45. Amendment 45Proposal for a regulation · Article 1 – paragraph 1 – point 7 · Regulation (EC) No 1272/2008 · Article 48 – paragraph 1 – subparagraph 1 a (new)
    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 or directly made available to the general public.

    official amendment document ↗
46. Amendment 46Proposal for a regulation · Article 1 – paragraph 1 – point 8 · Regulation (EC) No 1272/2008 · Article 48a
    Current text

    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.’

    Amendment

    Article 48a Distance sales offers 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 label elements referred to in Article 17; 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 allows a member of the general public to conclude a distance contract as defined in Article 2, point (7) of Directive 2011/83/EU;’

    official amendment document ↗
47. Amendment 47Proposal for a regulation · Article 1 – paragraph 1 – point 9 – point a · Regulation (EC) No 1272/2008 · Article 61 – paragraph 8
    Current text

    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.’

    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. Substances and mixtures which have been classified, labelled and packaged 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 ac…

    Excerpt — full text in the official PDF.
    official amendment document ↗
48. Amendment 48Proposal for a regulation · Article 2 – paragraph 1 – point 1 · Regulation (EC) No 1223/2009 · Article 14a – paragraph 2
    Current text

    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.

    Amendment

    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.

    official amendment document ↗
49. Amendment 49Proposal 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
    Current text

    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:

    Amendment

    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 may grant the derogation where all of the following conditions are fulfilled:

    official amendment document ↗
50. Amendment 50Proposal 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
    Current text

    (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..

    Amendment

    (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 overall exposure from the uses in those products categories as well as from sources other than cosmetics and of vulnerable population groups.

    official amendment document ↗
51. Amendment 51Proposal 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
    Current text

    (a) its use in cosmetic products results in reduced overall risk to human health and the environment;

    Amendment

    (a) its use in cosmetic products is safe and results in reduction of overall risk to human health, when assessed against the substance it is intended to replace;

    official amendment document ↗
52. Amendment 52Proposal 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
    Current text

    (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;

    Amendment

    (b) it provides an equivalent function to the classified substance, in a finished cosmetic product with a comparable effect, level of efficacy and performance;

    official amendment document ↗
53. Amendment 53Proposal 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
    Current text

    (c) is technically feasible and economically viable;

    Amendment

    (c) is technically feasible and economically feasible provided costs and supply conditions allow sustained production;

    official amendment document ↗
54. Amendment 54Proposal 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
    Current text

    (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.’

    Amendment

    (d) it is not restricted and is either available on the market at scale and in quantities sufficient to meet current demand or has the potential to meet current or expected demand in a reasonable timeframe.

    official amendment document ↗
55. Amendment 55Proposal 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)
    Amendment

    (ii a) 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.'

    official amendment document ↗
56. Amendment 56Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point a – point iii – introductory part · Regulation (EC) No 1223/2009 · Article 15 – paragraph 2 – subparagraph 5
    Current text

    (iii) the following subparagraph is inserted after the fourth subparagraph:

    Amendment

    (iii) the following subparagraphs are inserted after the fourth subparagraph:

    official amendment document ↗
57. Amendment 57Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point a – point iii · Regulation (EC) No 1223/2009 · Article 15 – paragraph 2 – subparagraph 5
    Current text

    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.;

    Amendment

    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.

    official amendment document ↗
58. Amendment 58Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point a · Regulation (EC) No 1223/2009 · Article 15 – paragraph 2 – subparagraph 5 a (new)
    Amendment

    5a. Where a derogation request referred to in the second subparagraph of paragraph 2 has been submitted for CMR substances of category 1A, or 1B, this deadline may, where relevant, be extended by twelve months.

    official amendment document ↗
59. Amendment 59Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point b · Regulation (EC) No 1223/2009 · Article 15 – paragraph 5
    Current text

    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.

    Amendment

    deleted

    official amendment document ↗
60. Amendment 60Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point b · Regulation (EC) No 1223/2009 · Article 15 – paragraph 6
    Current text

    6. 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.

    Amendment

    6. 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 constituent classified as CMR category 1A, 1B or 2 in such substances in cosmetic products, the Commission shall without delay request an opinion of the SCCS on the safety of that constituent for its presence in cos…

    Excerpt — full text in the official PDF.
    official amendment document ↗
61. Amendment 61Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point b · Regulation (EC) No 1223/2009 · Article 15 – paragraph 7
    Current text

    7. 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.’

    Amendment

    7. 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 and for which no derogation request was submitted in accordance with paragraph 2 or such substance is not compliant with a restriction may continue to be placed on the market for 6 months, and be available on the market for 15 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 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from us…

    Excerpt — full text in the official PDF.
    official amendment document ↗
62. Amendment 62Proposal for a regulation · Article 2 – paragraph 1 – point 3 · Regulation (EC) No 1223/2009 · Article 16 – paragraph 3
    Current text

    (3) In Article 16, paragraphs 3 and 7 are deleted;

    Amendment

    (3) In Article 16, paragraphs 3 is replaced by the following: 3. In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means prior to being placed on the market. The first subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III. The information notified to the Commission shall contain at least/ (a) the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI, and (b) the specification of the nanomate…

    Excerpt — full text in the official PDF.
    official amendment document ↗
63. Amendment 63Proposal for a regulation · Article 2 – paragraph 1 – point 4 a (new) · Regulation (EC) No 1223/2009 · Article 19 – paragraph 6 a (new)
    Amendment

    (4a) In Article 19, the following paragraph is added: ‘6a. When cosmetic products are made available on the market through distance sales, the offer shall clearly and visibly indicate the information referred to in paragraph 1.’

    official amendment document ↗
64. Amendment 64Proposal for a regulation · Article 2 – paragraph 1 – point 8
    Current text

    (8) Annexes II to VI are amended in accordance with Annex III this Regulation.

    Amendment

    deleted

    official amendment document ↗
65. Amendment 65Proposal for a regulation · Article 3 – paragraph 1 – point 1 · Regulation (EU) No 2019/1009 · Article 2 – paragraph 1 – point 15a
    Current text

    ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’

    Amendment

    “digital contact” means any up-to-date and freely accessible online communication channel through which a economic operator can be contacted without the need to register, download or use additional applications specific to the economic operator;’

    official amendment document ↗
66. Amendment 66Proposal for a regulation · Article 3 – paragraph 1 – point 2 – point a – point ii · Regulation (EU) No 2019/1009 · Article 6 – paragraph 2 – subparagraph 2a
    Current text

    Manufacturers shall ensure that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed.;

    Amendment

    Manufacturers shall ensure that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be directly accessed.;

    official amendment document ↗
67. Amendment 67Proposal for a regulation · Article 3 – paragraph 1 – point 2 – point c · Regulation (EU) No 2019/1009 · Article 6 – paragraph 6 – subparagraph 1
    Current text

    Manufacturers shall indicate on the packaging of the EU fertilising product their name, registered trade name or registered trademark as well as their postal address and digital contact or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.’

    Amendment

    Manufacturers shall indicate on the packaging of the EU fertilising product their name, registered trade name or registered trademark as well as their postal address and digital contact or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address and digital contact shall indicate a single point through which the manufacturer can be contacted in a swift manner.’

    official amendment document ↗
68. Amendment 68Proposal for a regulation · Article 3 – paragraph 1 – point 4 – point a · Regulation (EU) No 2019/1009 · Article 8 – paragraph 2 – subparagraph 1
    Current text

    They shall ensure that the manufacturer has drawn up the technical documentation, that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).’

    Amendment

    They shall ensure that the manufacturer has drawn up the technical documentation, that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be directly accessed and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).’

    official amendment document ↗
69. Amendment 69Proposal for a regulation · Article 3 – paragraph 1 – point 4 – point c · Regulation (EU) No 2019/1009 · Article 8 – paragraph 8 – subparagraph 1
    Current text

    Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

    Amendment

    Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available in a swift manner to those authorities, upon request.

    official amendment document ↗
70. Amendment 70Proposal for a regulation · Article 3 – paragraph 1 – point 4 – point c · Regulation (EU) No 2019/1009 · Article 8 – paragraph 8 – subparagraph 2
    Current text

    On request, importers shall make the EU declaration of conformity available to other economic operators in electronic form.’

    Amendment

    On request, importers shall make the EU declaration of conformity available to other economic operators in electronic form in a swift manner.

    official amendment document ↗
71. Amendment 71Proposal for a regulation · Article 3 – paragraph 1 – point 5 – point a · Regulation (EU) No 2019/1009 · Article 9 – paragraph 2 – subparagraph 1
    Current text

    Before making an EU fertilising product available on the market, distributors shall verify that it is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed and, where appropriate, by other required documents, including the information referred to in Article 6(7) or Article 8(4) provided in the manner specified therein, in a language which can be easily understood by end-users in the Member State in which the EU fertilising product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.’

    Amendment

    Before making an EU fertilising product available on the market distributors shall verify that it is accompanied by the internet address or data carrier through which the EU declaration of conformity can be directly accessed, and where appropriate, by other required documents, including the information referred to in Article 6(7) or Article 8(4) provided in the manner specified therein, in a language which can be easily understood by end-users in the Member State in which the EU fertilising product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.

    official amendment document ↗
72. Amendment 72Proposal for a regulation · Article 3 – paragraph 1 – point 7 · Regulation (EU) No 2019/1009 · Article 16 – paragraph 5 – subparagraph 1
    Current text

    The EU declaration of conformity shall be provided in a machine-readable and open format as defined in Article 2, points (13) and (14), of Directive (EU) 2019/1024 of the European Parliament and of the Council* and meet the requirements for digital labels set out in Article 11b(4), points (a) to (d).

    Amendment

    The EU declaration of conformity shall be provided in a machine-readable format through which it can be directly accessed.

    official amendment document ↗
73. Amendment 73Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b · Regulation (EU) No 2019/1009 · Article 42 – paragraph 4a – introductory part
    Current text

    The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

    Amendment

    The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if a manufacturer demonstrates and the notifying bodies verify the compliance with those criteria in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow a notified body to verify that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

    official amendment document ↗
74. Amendment 74Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b · Regulation (EU) No 2019/1009 · Article 42 – paragraph 4 aa (new)
    Amendment

    The following paragraph 4aa is inserted: ‘4aa. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to establish general criteria and a methodology for the assessment of materials and processing methods other than those already listed in Annex II, excluding micro-organisms, which may be used as component materials in EU fertilising products where compliance with those criteria is demonstrated in the conformity assessment. The criteria and methodology shall, as a minimum, provide for the consideration of scientific or technical information supporting safe sourcing, processing and use of the material.’

    official amendment document ↗
75. Amendment 75Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b · Regulation (EU) No 2019/1009 · Article 42 – paragraph 4 ab (new)
    Amendment

    The following paragraph 4 ab is inserted: 4 ab. By [12 months after the date of entry into force of this amending Regulation] the Commission shall adopt a delegated act to establish the criteria and methodology and upon assessment to create a corresponding new category for materials and processing methods other than those already listed in Annex II, excluding micro-organisms, which may be used as component materials in EU fertilising products provided that compliance with those criteria is demonstrated in the conformity assessment. The criteria and methodology shall aim to ensure safe sourcing, processing and use of the material. This new category shall be established without prejudice to th…

    Excerpt — full text in the official PDF.
    official amendment document ↗
76. Amendment 76Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b a (new) · Regulation (EU) No 2019/1009 · Article 42 – paragraph 5 a (new)
    Amendment

    (b a) The following paragraph is inserted ‘5a. For the purposes of this Regulation, products derived from animal by-products that are used solely as component materials in EU fertilising products may be made available on the market only where they originate from animal by-products or derived products that have reached an end point in the manufacturing chain in accordance with Article 5(2) of Regulation (EC) No 1069/2009. When determining such end points for derived products intended for use in EU fertilising products, the Commission shall ensure that: a) the processing and safety criteria, as well as any necessary risk-mitigation measures, are proportionate and sufficient to ensure a high le…

    Excerpt — full text in the official PDF.
    official amendment document ↗
77. Amendment 77Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b b (new) · Regulation (EU) No 2019/1009 · Article 42 – paragraph 8 a (new)
    Amendment

    (b b) The following paragraph is added: ‘8a. The Commission shall adopt the first delegated act pursuant to paragraph 4a by ... [18 months after the entry into force of this Regulation].’

    official amendment document ↗
78. Amendment 78Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b c (new) · Regulation (EU) No 2019/1009 · Article 49 a (new)
    Amendment

    (b c) ‘Article 49a Review The Commission shall periodically assess whether the requirements governing the treatment of materials intended for use in fertilising products remain appropriate and, where necessary, adapt them in light of scientific and technical advances, taking into account national practices, and the objectives of Regulation (EU) 2019/1009. This review shall be carried out for the first time no later than two years after the date of application of this amending Regulation.’

    official amendment document ↗
79. Amendment 79Proposal for a regulation · Article 3 – paragraph 1 – point 9 – point b d (new) · Regulation (EU) No 2019/1009 · Article 49 aa (new)
    Amendment

    (b d) By [insert date: 12 months after entry into force], the Commission shall submit a report to the European Parliament and the Council assessing the requirements for fertilising product blends where the primary component is one or more growing media belonging to PFC 4. The report shall, in particular, evaluate the conditions for adjusting nutrient content, pH value or biological activity, updated labelling requirements, and appropriate conformity assessment procedures for such blends and it may accompany, where appropriate, amendments to this Regulation.

    official amendment document ↗
80. Amendment 80Proposal for a regulation · Annex I – paragraph 1 – point 2 · Regulation (EC) No 1272/2008 · Annex I – section 1.2.1.5
    Current text

    (2) in Annex I, section 1.2.1.5 is deleted;

    Amendment

    (2) in Annex I, section 1.2.1.5 is replaced by the following: The text on the label shall be legible. For the purpose of this section, a label shall be considered legible if the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background. It shall have at least the following characteristics: (a) printed in a contrasting colour compared to the background; (b) a single typeface that is easily legi…

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81. Amendment 81Proposal for a regulation · Annex I – paragraph 1 – point 3 · Regulation (EC) No 1272/2008 · Annex I – section 1.5.1.2
    Current text

    1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;

    Amendment

    1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, the name, the digital contact and the telephone number of the suppliers of the substance or mixture unless this telephone number is directly available through the digital contact;

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82. Amendment 82Proposal for a regulation · Annex I – paragraph 1 – point 5 · Regulation (EC) No 1272/2008 · Annex I – section 1.5.2.4.1 – point (b)
    Current text

    (b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II, and is not classified in any of the following hazard classes and categories:

    Amendment

    (b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:

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83. Amendment 83Proposal for a regulation · Annex I – paragraph 1 – point 7 · Regulation (EC) No 1272/2008 · Annex I – section 1.5.2.4.3 – point (b)
    Current text

    (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II;

    Amendment

    (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II;

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84. Amendment 84Proposal for a regulation · Annex I – paragraph 1 – point 7 a (new) · Regulation (EC) No 1272/2008 · Annex I – section 1.5.2.4.3a (new)
    Amendment

    (7 a) in Annex I, section 1.5.2.4.3a is added: 'Where section 1.5.2.4.3 applies, the label on the packaging shall contain the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and, where applicable, the hazard pictograms ‘GHS01’ or ‘GHS05’;’

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85. Amendment 85Proposal for a regulation · Annex I – paragraph 1 – point 7 b (new) · Regulation (EC) No 1272/2008 · Annex I – section 1.5.2.5.a (new)
    Amendment

    (7 b) in Annex I, section 1.5.2.5a is added: Labelling of ink cartridges where the contents do not exceed 150 ml. 1.5.2.5a1: The label elements required by Article 17 may be reduced in accordance with 1.5.2.5a.2 and 1.5.2.5a.3 where: (a) the contents of the ink cartridge do not exceed 150 ml (b) the outer packaging complies with the provisions laid out in Article 17.; and (c) keep the hazard information on the outer packaging is kept with the printer 1.5.2.5a.2: Where 1.5.2.5a.1 applies the label on the ink cartridge and any intermediate packaging shall contain at least: (a) the product identifier in accordance with Article 18(2) for substances and Article 18(3) for mixtures; (b) where appli…

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86. Amendment 86Proposal for a regulation · Annex I – paragraph 1 – point 8 · Regulation (EC) No 1272/2008 · Annex I – section 1.6 – point (b a) new
    Amendment

    (b a) The telephone number for the supplier(s) required according to Article 17(1), point (a), and where relevant the third subparagraph of Article 25(6) and section 1.5.1.2 of Annex I’;

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87. Amendment 87Proposal for a regulation · Annex I – paragraph 1 – point 9 · Regulation (EC) No 1272/2008 · Annex I – part 5 – point b
    Current text

    (b) For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the copy of the label elements referred to in Article 17, points (c) to (h) shall be provided on a visible place on the respective pump. The unique formula identifier referred to in Article 25(7) does not need to be provided.

    Amendment

    (b) For a substance or a mixture supplied at a fuel service station the copy of the following label elements referred to in Article 17.1, points (c) to (h) shall be provided on a visible place on or next to the respective pump: The unique formula identifier referred to in Article 25(7) does not need to be provided.

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88. Amendment 88Proposal for a regulation · Annex IV – paragraph 1 – point 2 – point a · Regulation (EU) No 2019/1009 · ANNEX II – Part II – VIRGIN MATERIAL SUBSTANCES AND MIXTURES
    Current text

    (a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is deleted;

    Amendment

    (a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is replaced as follows: a) Substances classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the following hazard classes or categories: - Germ cell mutagenicity, category 1A or 1B; - Carcinogenicity, category 1A or 1B; - Reproductive toxicity, category 1A or 1B; - Specific target organ toxicity, repeated exposure, category 1 - Endocrine disruptor for human health, category 1; - Endocrine disruptor for the environment, category 1; and - Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties whose actual quantities placed on the market are lower than 10 tonnes per year, intention…

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89. Amendment 89Proposal for a regulation · Annex IV – paragraph 1 – point 2 – point f · Regulation (EU) No 2019/1009 · Annex II – Part II – CMC 8: NUTRIENT POLYMERS
    Current text

    1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in point 1 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.;

    Amendment

    1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in point 1 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances. The polymer may additionally perform other functions, provided that this does not alter the safety characteristics of the product nor compromise the controlled-release function;

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90. Amendment 90The LeftProposal for a regulation · Citation 5 a (new)
    Amendment

    The European Parliament rejects the Commission proposal.

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91. Amendment 91The LeftProposal for a regulation · Recital 15 a (new)
    Amendment

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

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92. Amendment 92The LeftProposal for a regulation · Recital 15 b (new)
    Amendment

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

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93. Amendment 93The LeftProposal for a regulation · Recital 22
    Current text

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

    Amendment

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

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94. Amendment 94The LeftProposal for a regulation · Article 1 – paragraph 1 – point 5
    Current text

    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.;

    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 and in any event no later than three months after the results of the new evaluation referred to in Article 15(4) are published.;

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95. Amendment 95The LeftProposal for a regulation · Article 2 – paragraph 1 – point 2 – point a a (new)
    Amendment

    (aa) The following paragraph is inserted after the second paragraph: 2a. The use in cosmetic products of substances classified as endocrine disruptor for human health of category 1A or 1B, or category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

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96. Amendment 96The LeftProposal for a regulation · Article 2 – paragraph 1 – point 2 – point b
    Current text

    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.’

    Amendment

    Where a CMR substance of category 1A, 1B, or 2 or an endocrine disruptor for human health of category 1 or 2, classified under Part 3 of Annex VI to Regulation (EC) No 1272/2008, following a derogation request made in accordance with paragraph 1 or paragraph 2, second subparagraph, is prohibited or further restricted from use, cosmetic products containing that substance or not compliant with a restriction may continue to be made available on the market for 6 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

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97. Amendment 97The LeftProposal for a regulation · Article 2 – paragraph 1 – point 2 – point b
    Amendment

    The following paragraph is inserted after the seventh paragraph: Where cosmetic products containing a substance prohibited from use in cosmetic products or such substance not compliant with a restriction are placed or made available on the market during the set transition period, they shall bear a clear notice on the front of the packaging indicating the presence of the concerned substance and its classification, including the relevant signal word and hazard pictogram, ensuring that it is clear to the consumers that these substances pose risks to human health.

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98. Amendment 98PfEProposal for a regulation · Recital 2 a (new)
    Amendment

    (2 a) Agricultural producers in the Union are increasingly exposed to international competition from third countries where regulatory, environmental and safety requirements are less stringent. This situation creates significant distortions of competition and places Union farmers at a disadvantage. In this context, it is essential that regulatory framework affecting fertilising products and agricultural inputs do not further increase production costs for Union farmers, while at the same time enhance their competitiveness, innovation and resilience.

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99. Amendment 99PfEProposal for a regulation · Article 2 – paragraph 1 – point 2 – point b
    Current text

    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.

    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, taking into account real-life exposure conditions. Union chemical legislation shall be based…

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100. Amendment 100Verts/ALE, The LeftProposal for a regulation · Recital 22 a (new)
     Amendment

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

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101. Amendment 101Verts/ALE, The LeftProposal for a regulation · Article 2 – paragraph 1 – point 2 a (new)
     Amendment

     (2 a) The following Article is inserted: Article 15a Per- and polyfluoroalkyl substances (PFAS) 1. The intentional use of per- and polyfluoroalkyl substances (PFAS) shall be prohibited in cosmetic products. ‘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. 2. Paragraph 1 shall apply as of [OP: please insert the date of 18 months after entry into force of this Regulation]. 3. Restrictions or prohibitions on the use of PFAS laid down in accordance with Regulation (EC) No 1907/2006 or (EU) 2019/1021 of the European Parliament and of the Council shall take precedence over paragraph 1.

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102. Amendment 102Verts/ALEProposal for a regulation · Recital 15 a (new)
     Amendment

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

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103. Amendment 103Verts/ALEProposal for a regulation · Recital 22
     Current text

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

     Amendment

     (22) When a substance is prohibited or restricted from the use in cosmetic products, the manufacturers, importers, distributors and responsible persons should be given appropriate time to take necessary measures to reformulate, test and relabel their products, withdraw from the distribution and destroy the unsold products not complying with the new requirements. Accordingly, if no derogation request was submitted, a period of three months for making available on the market of cosmetic products containing the substance concerned following the entry into force of the respective amendments to Regulation (EC) No 1223/2009 should be provided. Where a request for derogation has been submitted and…

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104. Amendment 104Verts/ALEProposal for a regulation · Article 2 – paragraph 1 – point 2 – point -a (new)
     Current text

     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.

     Amendment

     (-a) paragraph 1 is replaced by the following "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." (in case of adoption, Article 13(1), the title of Article 15, Article 15(2) second subparagraph and subparagraph 4a, Article 15(7) and Recital 22 should be modified accordingly)

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105. Amendment 105Verts/ALEProposal for a regulation · Article 2 – paragraph 1 – point 2 – point b
     Current text

     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.’

     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 and for which no derogation request was submitted in accordance with paragraph 2 or such substance is not compliant with a restriction may continue to be made available on the market until three 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 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products and for whic…

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106. Amendment 106ESNProposal for a regulation · Recital 2
     Current text

     (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment. _________________ 2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competit…

     Amendment

     (2) The findings of the 2024 Draghi report2 indicated that the increasing number and complexity of rules risks limiting room for manoeuvre for Union businesses and preventing them from remaining competitive. Against this background, certain procedures and requirements laid down in Regulations (EC) No 1272/20083 , (EC) No 1223/20094 and (EU) 2019/10095 of the European Parliament and of the Council should be simplified and unnecessary regulatory burdens should be removed, while maintaining the same level of protection of human health and of the environment. All measures introduced under this Regulation should remain proportionate, science-based, and limited to what is strictly necessary. _____…

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107. Amendment 107ESNProposal for a regulation · Recital 22
     Current text

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

     Amendment

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

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108. Amendment 108ESNProposal for a regulation · Article 1 – paragraph 1 – point 2
     Current text

     (a) the name, address and digital contact of the suppliers;;

     Amendment

     (a) the name and address of the supplier;

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109. Amendment 109ESNProposal for a regulation · Article 1 – paragraph 1 – point 4
     Current text

     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.;

     Amendment

     2. Where the packaging of a substance or mixture does not exceed 125 ml, the label elements referred to in Article 17(1) may be limited to those strictly necessary to ensure safe use, taking into account the nature of the hazard and the conditions of use.

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110. Amendment 110ESNProposal for a regulation · Article 1 – paragraph 1 – point 5
     Current text

     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.;

     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 no later than 36 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.;

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111. Amendment 111ESNProposal for a regulation · Article 1 – paragraph 1 – point 6
     Current text

     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.;

     Amendment

     3. Label elements shall be clearly and indelibly marked and easily readable. Detailed formatting requirements shall not impose disproportionate administrative or technical burdens on economic operators.

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112. Amendment 112ESNProposal for a regulation · Article 2 – paragraph 1 – point 2 – point a – point i
     Amendment

     2 a. The assessment of substances under this Article shall explicitly take into account the relevant routes of exposure. Substances classified as hazardous solely for routes of exposure not relevant to the intended use of the cosmetic product shall not be subject to automatic restriction or prohibition.

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113. Amendment 113ESNProposal for a regulation · Article 2 – paragraph 1 – point 2 – point a – point i
     Amendment

     2 b. The assessment of alternatives shall remain proportionate and shall not lead to de facto prohibition where safe use of the substance has been established.

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114. Amendment 114Proposal for a regulation · Recital 22 a (new)
     Amendment

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

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115. Amendment 115Proposal for a regulation · Recital 22 b (new)
     Amendment

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

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116. Amendment 116Proposal for a regulation · Article 2 – paragraph 1 – point -1
     Amendment

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

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117. Amendment 117Proposal for a regulation · Article 2 – paragraph 1 – point 2 – point a – point i a (new)
     Amendment

     (i a) 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 or 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

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