(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.

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2 2024 report by Mario Draghi on the future of European competitiveness: https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059

3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).

4 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).

5 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj).

(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 accident. Currently, suppliers are required to indicate their address and telephone number on the label of the packaging of hazardous substances or mixtures, but this is not always sufficient to ensure that authorities responsible for enforcement can establish rapid contact. It is therefore necessary to require suppliers to also provide a digital contact, which should be any up-to-date, easily and freely accessible online communication channel with the supplier, and allow for the storage of information on a durable medium. Where a digital contact is provided, the telephone number can be made directly available through that digital contact.

(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.

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6 Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj).

(6)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 after new data was obtained by or communicated to a supplier.

(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 remain responsible for ensuring that the labels are legible in accordance with the legal requirements.

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7 Detailed analysis of costs associated with new formatting requirements is provided in the Staff Working Document Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products, SWD(2025) 531, p. 14.

8 As outlined in the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions The Single Market: our European home market in an uncertain world, A Strategy for making the Single Market simple, seamless and strong, COM(2025) 500 final, p. 10, available at: https://single-market-economy.ec.europa.eu/document/download/d92c78d0-7d47-4a16-b53f-1cead54bcb49_en?filename=Communication%20-%20Single%20Market%20Strategy.pdf.

(8)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.

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9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj).

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

(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.

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10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).

11 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj).

(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.

(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.

(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 condition.

(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 sustained production. To assess economic feasibility, the economic aspects, such as costs of reformulation and comparative contribution to overall production costs, as relevant factors in the analysis of the suitability of alternatives, can be considered.

(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.

(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 Regulation (EC) No 1223/2009 only applies to the substance as it appears in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Natural complex substances that contain a CMR classified constituent are not subject to the prohibition, except where the natural complex substance itself is classified as a CMR substance of category 1A, 1B or 2 in Part 3 of Annex VI to the Regulation (EC) No 1272/2008. Nevertheless, since the harmonised classification of a constituent raises concerns about the use and safety of the natural complex substances when used in cosmetic products, the Commission should without delay mandate the SCCS to assess the safety of such substances and, where necessary, take appropriate regulatory action in accordance with Article 31(1) of Regulation (EC) No 1223/2009. The assessment of the SCCS should be timely to ensure predictability for the industry.

(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 has been submitted and the SCCS has found that the substance is not safe, those deadlines should be shortened to a period of 3 months for placing and 12 months for making available on the market. In case a request for derogation has been submitted and the SCCS has found that the substance is safe, but the request has been refused due to the availability of suitable alternatives, those deadlines should be extended to a period of 24 months for placing and 48 months for making available on the market, under the condition that an up-to-date Cosmetic Product Safety Report (CPSR) remains available at all times.

(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 by the Commission in case of concerns. It should also be explicitly required that specific information on nanomaterials used in a cosmetic product is provided in the Cosmetic Products Notification Portal (CPNP) notification and in the cosmetic product safety report that are both accessible to the competent authorities and can be consulted by the competent authorities, where concerns over the potential risk to human health arise from the use of a particular nanomaterial in cosmetic products.

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

(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. Documents and correspondence to and from notified bodies related to conformity assessments of EU fertilising products should also be provided in electronic form in a swift manner. Where a digital label is used, manufacturers should use the same data carrier used for the digital label to provide access to the EU declaration of conformity, to avoid the presence of multiple data carriers on the same product. Where a Digital Product Passport is required for EU fertilising products under other EU legislation, the digital labelling information and the EU declaration of conformity should be provided in that Digital Product Passport.

(27)Under Regulation (EU) 2019/1009, only micro-organisms listed on a positive list in Annex II to that Regulation may be used as component material in microbial plant biostimulants. The Commission is empowered to add new micro-organisms or strains of micro-organisms to that list after an assessment concluding that none of the strains presents a risk to human, animal or plant health, to safety or to the environment and that it ensures agronomic efficiency. Given the large number of micro-organisms on the market, the assessment and subsequent inclusion of new micro-organisms or strains of micro-organism to the positive list are lagging scientific progress. The current mechanism slows down the development of microbial plant biostimulants and delays farmers’ access to those innovative fertilising products. A proactive monitoring of the scientific developments and updating of the list of micro-organisms or strains of micro-organisms, as well as of the relevant criteria and methodology is necessary on a continuous basis. Furthermore, all updates should be implemented swiftly. At the same time, the regulatory framework should ensure that the use of traditional and natural fertilisers remains a viable and accessible option, recognising their role alongside microbial solutions, so as not to undermine competitiveness or agricultural production within the Union.

(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 reflect the most recent scientific developments and allow manufacturers and notified bodies, to demonstrate and verify that micro-organisms used in microbial plant biostimulants, other than those listed in CMC 7, do not present a risk to human, animal or plant health, to safety or to the environment and ensure agronomic efficiency while taking into account EU competitiveness and production. Verifying compliance of micro-organisms with the criteria and methodology set under this Regulation requires specific competences, scientific and technical knowledge from the conformity assessment bodies. Those competences should be therefore scrutinized by the national bodies in charge of accreditation and notification, as well as aspects such as independence, objectivity, impartiality and professional integrity. In order to refine and validate the criteria and methodology to be introduced, it is of particular importance that the Commission involves the relevant scientific bodies, in particular the European Food Safety Agency, the JRC and the ECHA, to review and contribute, and also carry out appropriate consultations during its preparatory work, including at expert level. It is essential that the Commission preserves strong interinstitutional cooperation, while engaging in those consultations, which should be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making13. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

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13 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2016/512/oj.

(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, mutagenic, toxic for reproduction, endocrine disrupting or persistent, bioaccumulative and toxic, specific information requirements should apply even where such substances are used in low quantities in fertilising products. This approach ensures that safety-relevant information is available, while avoiding unnecessary burdens for substances presenting lower risks. The information provided should be based on available data, including the use of alternative methods and adaptations in accordance with Regulation (EC) No 1907/2006, and should, wherever relevant and in last resort, avoid unnecessary testing, in particular on vertebrate animals. Chemical safety assessments should be limited to relevant exposure scenarios related to the agronomic use of fertilising products and the environment. Such an approach ensures a balanced framework that supports innovation and market access, while safeguarding a high level of protection and legal certainty for operators.

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;

(2)Article 17(1) is amended as follows:

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

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;

(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.;"

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.”

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 direct downstream users about the results of the new evaluation as referred to in subparagraph 1 in accordance with the applicable requirements of Regulation (EC) 1907/2006. Suppliers may apply the new or updated classifications and adapt the labelling accordingly on a voluntary basis before the expiry of the eighteen months period, in order to ensure a high level of protection of human health and the environment and to provide sufficient flexibility;

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.;

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.

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;

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 accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council until 1 January 2030.’

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.

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:

(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.

(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;

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

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

(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.

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

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.

deleted

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 cosmetic products. The SCCS shall deliver its opinion within 12 months of the Commission’s request. The Commission may extend that deadline by six months if additional evidence is required. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available. Taking into account the opinion of the SCCS, and where a potential risk to human health arises from the use of a substance referred to in the first subparagraph in cosmetic products containing a constituent classified as CMR category 1A, 1B or 2 for human health, the Commission shall, without undue delay, amend the Annexes to this Regulation. For the purposes of this paragraph, “plants” means living or dead organisms from the kingdoms Plantae and Fungi, including algae, lichens and yeasts.

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 use in cosmetic products and for which a derogation request was submitted in accordance with paragraph 2, but not granted due to safety concerns by the SCCS or such substance not compliant with a restriction may continue to be placed on the market for 3 months, and be available on the market for 12 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 or such substance not compliant with a restriction and for which a derogation request was submitted in accordance with paragraph 2, but not granted due to the availability of a suitable alternative, may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation, and where needed updated the cosmetic product safety report (CPSR) remains available.

(3)In Article 16, paragraphs 3 is replaced by the following:

deleted

“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;’

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.;

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.’

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).’

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.

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

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.

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

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:

(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 legible and without serifs shall be used; (c) appropriate letter spacing for the selected typeface to be easily legible; (d) appropriate line spacing for the selected typeface to be easily readable and to ensure that lines of text do not overlap; (e) an appropriate font size with regard to the size of the label and the required label elements and the intended user. For substances or mixtures made available on the market for the general public, the label elements referred to in Article 17(1) shall use a font size where the x-height is equal to or greater than 1.2 mm. However, where the contents of the package do not exceed 125 ml, the label elements referred to in Article 17(1) may use a font size where the x-height is equal to or greater than 0.9 mm. These characteristics shall be further clarified in the ECHA guidance on legibility and label presentation to be developed under this Regulation. Compliance with this section shall be assessed on the basis of the overall legibility of the label and applied in a manner compatible with the physical characteristics and technical limitations of the packaging, including size as well as the intended user.

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;

(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:

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

(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.

(a)in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is replaced as follows:

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;