What changed between the plenary report and the adopted text

Recital 2: (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.

Recital 2 a (new): (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.

Recital 3: (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.

Recital 3 a (new): (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 technologically neutral manner, capable of evolving with future technological developments, and cover all forms of direct digital communication.

Recital 5: (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.

Recital 6: (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.

Recital 7 a (new): (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.

Recital 7 b (new): (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 than 0.9 mm. The European Chemicals Agency (ECHA) should update its guidance on formatting of labels and include clear examples of what constitutes acceptable and unacceptable examples of label formatting. The guidance should consider labelling formats from other relevant Union laws and take account of best practice on "accessible design" and accepted standards for readability, including acceptable as well as unacceptable colour combinations to ensure contrast. The guidance should assist enforcement by relevant national authorities, be developed in line with Better Regulation principles and informed by appropriate stakeholder consultation, support competitiveness by reducing unnecessary burdens, provide certainty for suppliers, and ensure fair competition on the internal market.

Recital 8: (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.

Recital 8 a (new): (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 advertisement or offer is made available, such as trade fairs, trade publications or digital platforms addressed to professional users. Similar provisions already exist under Union law.

Recital 9: (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 th…

Recital 10: (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.

Recital 12: (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.

Recital 12 a (new): (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.

Recital 14: (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.

Recital 17: (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.

Recital 18: (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.

Recital 19: (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.

Recital 21: (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 o…

Recital 22: (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.

Recital 23: (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.

Recital 25: (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 wo…

Recital 25 a (new): (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 1223/2009 and thereby contribute to fair competition and a high level of protection of human health. Furthermore, post-market surveillance should be strengthened, notably for online sales and imports, and cosmetic products identified as non-compliant through the Union rapid alert system (Safety Gate) should not be listed or offered for sale. To this end, online platforms should verify the identity of the responsible person before allowing products to be placed on the Union market, and the online sale, offering for sale and promotion, including via social media, of banned cosmetics, in particular mercury-added products, should be explicitly prohibited.

Recital 26: (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.

Recital 26 a (new): (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 products should not lower the levels of control on these products when they are entering the market, nor should it raise concerns regarding traceability, safety, and reputational impacts.

Recital 26 b (new): (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.

Recital 27: (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.

Recital 27 a (new): (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.

Recital 28: (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 i…

Recital 29 a (new): (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 mitigation measures included therein are largely derived from frameworks for feed hygiene and the prevention of feed fraud and do not always reflect the distinct exposure pathways and risk profiles of fertiliser products applied to the soil and water.

Recital 30: (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 …

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 1, Article 2 – point 42: 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;

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 1 a (new), Article 5 – paragraph 3 a (new): (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.’

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 2 – introductory part, Article 17 – paragraph 1 – point a: (2) Article 17(1) is amended as follows: / (a) point (a) is replaced by the following:

Regulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 2, Article 17 – paragraph 1 – point a: (a) the name, address, telephone number and digital contact of the supplier;