Regulation (EU) 2024/2516 of the European Parliament and of the Council of 18 September 2024 amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products (Text with EEA relevance)

Official Journal EN of the European Union L series 2024/2516 30.9.2024 REGULATION (EU) 2024/2516 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 September 2024 amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Annex III to Regulation (EU) 2019/1009 of the European Parliament and of the Council (3) lays down the labelling requirements applicable to EU fertilising products. The information referred to in that Annex is to be provided on a label in a physical form attached to the packaging or, for the labelling elements that cannot be provided on the label due to the packaging being too small, in a separate leaflet accompanying the packaging (‘physical label’), while products without packaging are accompanied by a leaflet. The labelling requirements concern parameters linked to the agronomic efficiency of EU fertilising products, such as their nutrient content, as well as other parameters linked to such products, such as their quantity. The labelling requirements also cover information necessary for the protection of human health and the environment when using EU fertilising products, such as information necessary for the correct application of Council Directive 91/676/EEC (4) and information necessary for the correct handling and use of such products after purchase, for example information on storage conditions. (2) The form in which EU fertilising products are labelled in accordance with Regulation (EU) 2019/1009 should be adapted to technological and societal changes in the field of digitalisation. This should be done without compromising the quality or accessibility of information and with a view to providing better information, while taking account of the impacts on and benefits for economic operators and end-users. (3) Providing information on a label in a digital form (‘digital label’) has clear benefits. Digital labelling can improve the communication of labelling information both by avoiding overcrowded physical labels and by allowing users to rely on various reading options available only for digital formats, such as increased font, automatic search, loudspeakers or translation into other languages. In addition, digital labelling of EU fertilising products can contribute to the ongoing progress with regard to the digital and green transformation of the European agricultural sector by reducing packaging waste and facilitating the reporting obligations of farmers regarding the use of such products. Digital labelling can also lead to more efficient management of the labelling obligations by economic operators by facilitating the update of labelling information and allowing for the provision of more targeted information to users. While the use of digital labels could overcome space limitations compared to physical labels by allowing the information to be traced and could reduce fertiliser prices due to the lower labelling costs, irrelevant or unnecessary information should be avoided in order to ensure the best quality of essential information for users. In addition, digital labelling can contribute to reducing labelling costs all along the supply chain, given that the labels of EU fertilising products can be changed following a transaction between economic operators, before reaching end-users. (1) OJ C 293, 18.8.2023, p. 108. (2) Position of the European Parliament of 12 March 2024 (not yet published in the Official Journal) and decision of the Council of 22 July 2024. (3) 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). (4) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1). ELI: http://data.europa.eu/eli/reg/2024/2516/oj 1/13EN OJ L, 30.9.2024 (4) However, digital labelling can also come with new challenges. It is possible, for example, that digital labelling will create problems for vulnerable groups, in particular for persons with no, or insufficient, digital skills or access to digital devices necessary to retrieve the digital labels, and for persons with disabilities. Digital labelling could make it more difficult for those groups to easily access essential information on the agronomic efficiency of EU fertilising products, as well as instructions for safe use and the protection of human, animal and plant health and the environment, and thus ultimately accentuate the digital divide. Digital labelling should therefore be introduced in Regulation (EU) 2019/1009 under certain conditions and digital labels should be easily understandable and accessible to vulnerable groups and persons with disabilities, taking into account the need to ensure a high level of protection of human, animal and plant health and the environment, as well as digital readiness, without increasing costs excessively. It is vital that user safety not be compromised in the process of making labelling more user-friendly through digital means and that the possibilities and skills of small and medium-sized enterprises to digitalise the labels be taken into account. (5) Economic operators should remain free to choose whether they want to provide a digital or physical label. That will ensure that they have the flexibility to opt for the rules most appropriate to their situation. It is particularly important not to create unjustified costs for small and medium-sized enterprises, for which, given the reduced volumes or types of EU fertilising products that they are handling, digital labelling might be challenging. It is also important to provide support in the form of guidance and training programmes in order to enable such enterprises to develop the skills and capabilities necessary to comply with this Regulation. (6) The choice to provide a digital label lies primarily with manufacturers and importers responsible for fulfilling the labelling requirements set out in Annex III to Regulation (EU) 2019/1009. This is important to ensure that they can make informed decisions that are tailored to their product range and intended customers. Nevertheless, to maximise the use of digital labels and thereby improve the communication of information to users, distributors should also be able to digitalise the labels of EU fertilising products that they make available on the market, on the basis of the information provided by the manufacturer. The use of digital labels should ensure a consistent flow of accurate information throughout the supply chain. The extent of digital labelling should depend on two factors: whether the EU fertilising products are made available to economic operators or to end-users and whether the products are provided with or without packaging. (7) Economic operators should be allowed to provide all the labelling elements referred to in Annex III to Regulation (EU) 2019/1009 in a digital label only for the EU fertilising products supplied to other economic operators, with or without packaging. The use of digital labels in such cases can reduce waste and labelling costs in the supply chain. Importers or distributors will be able to affix a physical label to the EU fertilising product directly in the official languages needed for their specific situation. In addition, labelling costs can be avoided where EU fertilising products blended, packaged or repackaged, since the products can be labelled with a physical label only once, before reaching end-users. As such products are supplied to economic operators, the communication of information to end-users is not affected by using digital labels only. Where the economic operators choose to provide a physical label in addition to a digital label, they should be free to decide which labelling elements to include in that physical label in accordance with Regulation (EU) 2019/1009. (8) Physical labels remain a preferred way for end-users to obtain key information about the use of EU fertilising products because they offer immediate reliable access to information by being affixed to packaging. In addition, the vast majority of EU fertilising products available on the market are used by professional users, such as farmers and agricultural contractors. While professional users are well accustomed to fertilising products and often rely on consultancy for their fertilisation plans, they tend to belong to more advanced age groups, with a lower level of digital skills and might encounter difficulties in accessing the digital labels. In addition, less-developed rural regions might face fluctuating access to internet in the field or on the farm. (9) Where economic operators opt for digital labelling of EU fertilising products supplied to end-users in packaging, they should ensure that a minimum set of key information about the agronomic efficiency and use of the product is also available on the physical label. In this context and with regard to other rules specific to products made available in packaging, packaging should contain no more than 1 000 kg in line with Commission Regulation (EU) No 142/2011 (5) in order to ensure that larger quantities, typically used in industrial settings, are treated differently (5) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1). 2/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 from packages normally provided to consumers. Products supplied in packaging exceeding this limit should be considered to be supplied without packaging for the purposes of Regulation (EU) 2019/1009. That will also address the challenges that vulnerable groups could face. The specific information that economic operators should be allowed to provide only on a digital label should therefore reflect the current state of the digitalisation of the society and the particular situation of the users of EU fertilising products and should acknowledge the diversity of the user base. In order to enable all end-users to make informed choices before buying EU fertilising products and to ensure the safe handling and use of such products by all groups of end-users, labelling information concerning safety and the protection of human, animal, plant health and the environment, as well as minimum information on the agronomic efficiency of the EU fertilising products and on their content and correct use, should always be provided on the physical label. Digital labels could also include information on greenhouse gas emissions related to the production process, the environmental impact of the fertiliser, including its production process and the agroecological efficiency. Regulation (EU) 2019/1009 should clearly indicate which information can be provided only digitally. (10) For EU fertilising products supplied without packaging, the economic operators are to provide the labelling elements in a leaflet in order to ensure that, even without direct packaging, essential information is still accessible to the user, including those lacking basic literacy skills. The leaflet, contrary to physical labels, has no physical link to the product itself and therefore does not offer immediate access to the information relevant to the product when handling it. The leaflet should therefore serve as a bridge between the product and the user, ensuring that vital details are not lost. Providing the same labelling elements in digital format would involve an adjustment of the way the information is retrieved. Such an adjustment would be justified once the risks to users are properly addressed and mitigated. The digital format should be flexible, harmonised and updated in real time, ensuring that users can access the most recent information. Economic operators should therefore be allowed to provide all the labelling elements referred to in Annex III to Regulation (EU) 2019/1009 in a digital label only for the EU fertilising products supplied without packaging. Where the economic operators choose to provide a leaflet in addition to a digital label, they should be free to decide which labelling elements they want to include in that leaflet. (11) To ensure a level playing field among economic operators making EU fertilising products available on the market, and to protect the end-users when handling such products, harmonised requirements for digital labelling should be laid down. (12) In order to ensure that users receive all the necessary labelling elements on the digital label and will not need to compile the information both from a physical and a digital label, economic operators using a digital label should be required to include all such labelling elements in the digital label, even if they are also included on the physical label to ensure a one-stop source for all necessary information. Since information allowing end-users to identify and contact the manufacturer and the importer of the EU fertilising products is essential information, digital labels should also contain such information, since it is necessary to have a direct communication line to enhance trust and transparency and providing it digitally will facilitate the creation of a link between the product and the digital label as well as between the manufacturer or importer and the end-user. In addition, given that fertilising products are also placed on the market as non-harmonised products, it is crucial to include on the digital label the CE mark and any corresponding reference to a notified body, so that end-users can deduce from the digital label alone that the product is marketed in accordance with Regulation (EU) 2019/1009. However, to facilitate the update of certain information to be provided by the manufacturers, which changes frequently and is not used on a daily basis by end-users, in particular the batch number and the production date, the manufacturers should have the option to provide the information either physically or digitally. Such flexibility should lead to prompter and more accurate updates. Economic operators should also have the option not to include the quantity on the digital label if already provided in a physical form, given that that element could change along the supply chain or could vary with each transaction in the case of products supplied without packaging. It is recalled that it is also essential for the end-user to have the necessary information referred to in Regulation (EU) 2023/988 of the European Parliament and of the Council (6) in order to be able to identify and contact the responsible person for products placed on the Union market. (6) Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1). ELI: http://data.europa.eu/eli/reg/2024/2516/oj 3/13EN OJ L, 30.9.2024 (13) Since digital labels, similarly to physical labels, are a means of providing mandatory information on EU fertilising products to users, economic operators should ensure free access to a digital label for a period of 10 years from the date that the EU fertilising product concerned was placed on the market. In addition, and in order to improve the chances that users will retrieve the information, the information provided on the digital label should be easily accessible to end-users in the Union through widely used digital technologies compatible with all major operating systems and browsers, the access to the label should be ensured without any password, registration or specific application and the needs of vulnerable groups should be taken into account. The data carrier should lead directly to the digital label, without the need to register in advance, to browse a website, to download or install applications or to provide a password, and the access to the information should not be conditioned by the geographical area within the territory of the Union. Economic operators should not mix the information required by Regulation (EU) 2019/1009 with other information not requested by that Regulation, such as marketing or commercial statements. As digital labels have no space limitations typical for physical labels affixed to the packaging, it is important to keep the labelling elements provided in accordance with Regulation (EU) 2019/1009 concentrated in one place instead of placing them together with other information provided by economic operators, which would make it difficult to find them. To further reduce the challenges that vulnerable groups, in particular persons with disabilities, could face, economic operators should also ensure that digital labels are presented in a way that takes into account the needs of such groups. At the same time, the fact that digital labels do not have space limitations also provides an opportunity to provide additional information regarding the use of the EU fertilising product, such as recommendations and best practices to limit nutrient losses. Economic operators should therefore be able to provide such information in the digital label. (14) Taking into account both the interest of users to have access to information about EU fertilising products with a relatively long shelf life and the interest of economic operators to avoid unnecessary costs, economic operators should ensure that the digital label is available for a period of 10 years from the date that the EU fertilising product was placed on the market. (15) In order to reduce any potential risks that unavailability of the digital label to vulnerable groups can cause, in particular as regards EU fertilising products supplied without packaging to end-users, where all the labelling elements can be provided digitally, economic operators should be responsible for providing the labelling elements to end-users by alternative means, upon request. Potential end-users should have the right, irrespective of a purchase, to receive information by alternative means in order to take an informed decision. Whenever the digital label is temporarily unavailable, the information should be provided by alternative means even without a request. In addition, for products supplied to end-users without packaging and with a digital label only, the labelling information provided in accordance with Annex III to Regulation (EU) 2019/1009 should also be in a visible place at the point of sale on the premises. That will help to ensure that potential end-users are properly informed and enable them to make an informed purchase. It would also ensure direct access to information relevant for the protection of human, animal and plant health and the environment, such as information on the content of nitrogen required for the implementation of the national rules transposing Council Directive 91/676/EEC. (16) The requirements for the technical documentation set out in Annex IV to Regulation (EU) 2019/1009 should be adjusted to take into account the introduction of digital labels. Given the evolving nature of digital platforms and the need for consistent accessibility, those adjustments should be periodically reviewed. In addition, taking into account the possibility to provide only a digital label for EU fertilising products made available to blenders, in order to facilitate market surveillance, the technical documentation of fertilising products blends should include a specimen of the information provided under Annex III to Regulation (EU) 2019/1009 on the component EU fertilising products to ensure that all stakeholders have a clear understanding of the product’s components and their respective origins. (17) In order to keep Regulation (EU) 2019/1009 in line with technical progress, new scientific evidence and the evolution of the digitalisation of the society, 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 supplementing the requirements for digital labelling and amending Annex III to that Regulation with regard to which labelling elements economic operators making EU fertilising products available to end-users on the market in packaging can provide on a digital label only. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). It is also of (7) OJ L 123, 12.5.2016, p. 1. 4/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 particular importance that the Commission takes into account the views of all stakeholders during its preparatory work. 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. (18) When setting out more detailed rules for digital labelling, the Commission should pay particular attention to other Union rules on the provision of information about products or substances and mixtures in a digital format. It should be possible to access all the information requested by various Union rules in one digital space, so that the users have easy access to all the necessary information. That would simplify the user experience and encourage trust in digital information sources. Furthermore, it would provide a more comprehensive and user-friendly interface, promoting consumer transparency and informed decision-making. (19) When deciding which labelling elements can be provided only digitally by economic operators making EU fertilising products available to end-users on the market in packaging, the Commission should take into account the level of digital readiness among users of EU fertilising products and the need to keep the use of such products safe for human, animal and plant health and the environment, as well as the need to ensure availability of the digital label for a period of 10 years from the date the EU fertilising product was placed on the market. In addition, consideration should be given to the evolving digital landscape, ensuring that digital labelling remains accessible and user-friendly, in line with technological progress. It is crucial to assess the feedback from end-users and stakeholders to ensure that the digital labelling system meets their needs and addresses any emerging concerns. (20) Regulation (EU) 2019/1009 should therefore be amended accordingly. (21) Since this Regulation introduces the possibility of providing all or part of the labelling requirements set out in Annex III to Regulation (EU) 2019/1009 only in digital labels, its application should be deferred to provide enough time for the development of the supplementing requirements concerning the digital labelling. (22) Since the objectives of this Regulation, namely to improve the readability of the labels of EU fertilising products and to facilitate the management of such labels by the economic operators in order to guarantee the functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: Article 1 Regulation (EU) 2019/1009 is amended as follows: (1) Article 2 is amended as follows: (a) the following point is inserted: ‘(10a) “packaging” means a sealable receptacle holding not more than 1 000 kg;’; (b) the following point is inserted: ‘(16a) “data carrier” means a linear bar-code symbol, two-dimensional symbol or other automatic identification data capture medium that can be read by a device;’; (2) Article 6 is amended as follows: (a) in paragraph 5, the following subparagraph is added: ‘The information referred to in the first subparagraph shall be provided physically on the packaging or the accompanying document, digitally, or both. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’; (b) in paragraph 6, the following subparagraph is added: ‘The information referred to in the first subparagraph shall be provided physically on the packaging or the accompanying document or both physically on the packaging or the accompanying document and digitally. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’; ELI: http://data.europa.eu/eli/reg/2024/2516/oj 5/13EN OJ L, 30.9.2024 (c) paragraph 7 is replaced by the following: ‘7. Manufacturers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form as set out in Article 11a. Those labelling elements shall be: (a) in a language which can be easily understood by end-users, as determined by the Member State concerned; (b) clear, understandable, accurate, intelligible and prominently placed on the packaging; (c) accessible for inspection purposes when the EU fertilising product is made available on the market.’; (3) in Article 8, paragraph 4 is replaced by the following: ‘4. Importers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form set out in Article 11a. Those labelling elements shall be: (a) in a language which can be easily understood by end-users, as determined by the Member State concerned; (b) accessible for inspection purposes when the EU fertilising product is made available on the market.’; (4) the following articles are inserted: ‘Article 11a Forms of labelling 1. Where EU fertilising products are made available to economic operators on the market in packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form: (a) on a label in a digital form (“digital label”); or (b) on a label in a physical form attached to the packaging or, for the labelling elements that cannot be provided on the label due to the packaging being too small, in a separate leaflet accompanying the packaging (“physical label”). 2. Where EU fertilising products are made available to economic operators on the market without packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form: (a) on a digital label; or (b) in a leaflet accompanying the EU fertilising product. 3. Where EU fertilising products are made available to end-users on the market in packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form: (a) on a physical label; or (b) on a digital label and duplicated on a physical label. By way of derogation from point (b) of the first subparagraph, the labelling elements marked with an asterisk in Annex III do not have to be duplicated on the physical label. 4. Where EU fertilising products are made available to end-users on the market without packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form: (a) on a digital label; or (b) in a leaflet accompanying the EU fertilising product. 5. Where economic operators provide a digital label in accordance with this Article, they shall ensure consistent labelling in the case of duplication and shall comply with the requirements set out in Articles 11b and 11c. Article 11b Requirements for digital labels 1. The digital label shall include: (a) the information required pursuant to Article 6(6) and Article 8(3); (b) the CE marking and, where applicable, the identification number of the notified body, in accordance with Articles 17 and 18; (c) all the labelling elements required under Annex III, with the exception of the production date and quantity where those elements have been provided on the physical label. 6/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 2. The digital label may include recommendations and best practices for the use of the EU fertilising product. 3. The information referred to in paragraph 1 shall be provided together in one place and separated from information under paragraph 2 and from any information not provided under this Regulation. 4. The digital label shall be: (a) accessible free of charge; (b) easily and directly accessible through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all potential users in the Union; (c) searchable; (d) presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access by those groups, in particular those consisting of persons with disabilities; (e) available for a period of 10 years from the date that the EU fertilising product concerned was placed on the market, including in the event of the insolvency, liquidation or cessation of activity in the Union of the economic operator that created it. Where the digital label is available in more than one language, the choice of languages shall not be dependent on the geographical location. 5. The data carrier used for a digital label shall be printed or placed physically on the packaging or, where the EU fertilising products are made available on the market without packaging, on the accompanying document or leaflet, in a way that it is externally visible, legible, and accessible to vulnerable groups, including persons with disabilities, and that allows that data carrier to be processed automatically by digital devices. Article 11c Obligations of economic operators providing a digital label 1. Economic operators providing a digital label shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the relevant information digitally. 2. At the request of end-users and independently of a purchase, or without such a request where the digital label is temporarily unavailable at the time of purchase, economic operators making EU fertilising products available to such end-users on the market shall provide the information included on the digital label by alternative means and free of charge; 3. Where EU fertilising products are made available on the market with a digital label in accordance with Article 11a(4), point (a), the economic operator supplying them to end-users shall post the labelling information referred to in Article 11b(1) in a visible place at the point of sale.’; (5) in Article 42, the following paragraphs are added: ‘9. By 1 May 2027, the Commission shall adopt delegated acts in accordance with Article 44 to supplement Articles 11b and 11c by laying down specific requirements for the digital labelling of EU fertilising products and conditions for fulfilling the obligations of economic operators providing a digital label. Those requirements shall establish, in particular, the types of electronic technical solutions which economic operators can use for providing the digital label, and the alternative means for providing the information referred to in Article 11c(2). When adopting the delegated acts, the Commission shall: (a) ensure consistency with other relevant Union acts; (b) encourage innovation and the use of state-of-the-art technology; (c) ensure technological neutrality by not limiting the choice of technology or equipment, within the bounds of compatibility and interference avoidance; (d) ensure that the digital labelling does not compromise the safety of the end-user and the environment; (e) ensure that any modification of the digital label does not compromise the ability of market surveillance authorities to verify the content of the label which existed prior to that modification; (f) take into account the level of digital readiness among end-users of EU fertilising products; (g) take into account the requirement set out in this Regulation to provide the information for a period of 10 years from the date that the EU fertilising product was placed on the market; ELI: http://data.europa.eu/eli/reg/2024/2516/oj 7/13EN OJ L, 30.9.2024 (h) take into consideration the enhancement of the free movement of EU fertilising products in the internal market; (i) take into consideration the needs and the capacity of small and medium-sized enterprises to comply with such requirements. 10. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Annex III, as regards the labelling information which economic operators choose to provide on a digital label only in accordance with the derogation set out in Article 11a(3), second subparagraph, in order to adapt that Annex to technical and scientific progress or to the level of digital readiness among end-users of EU fertilising products. When adopting those delegated acts, the Commission shall take into account the need to ensure safety and a high level of protection of human, animal and plant health and the environment.’; (6) the following article is inserted: ‘Article 49a Evaluation By 21 October 2031, the Commission shall carry out an evaluation of the digital labelling of EU fertilising products as introduced by Regulation (EU) 2024/2516 of the European Parliament and of the Council (*). As part of that evaluation, it shall assess in particular: (a) the impact of digital labelling of EU fertilising products on the proper functioning of the internal market, the level of consumer protection and impact of digital labelling of EU fertilising products on businesses, in particular micro, small and medium-sized enterprises; (b) the impact of Article 11a and in particular the extent to which economic operators opted for the use of a digital label. The Commission shall draw up a report on the main findings and submit it to the European Parliament, the Council and the European Economic and Social Committee. Member States shall provide the Commission with the information necessary for the preparation of that report. The report shall be accompanied, where appropriate, by a legislative proposal. (*) Regulation (EU) 2024/2516 of the European Parliament and of the Council of 18 September 2024 amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products (OJ L, 2024/2516, 30.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2516/oj).’ (7) Annex III is amended in accordance with Annex I to this Regulation; (8) Annex IV is amended in accordance with Annex II to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 May 2027. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 18 September 2024. For the European Parliament For the Council The President The President R. METSOLA BÓKA J. 8/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 ANNEX I Annex III to Regulation (EU) 2019/1009 is amended as follows: (1) Part I is amended as follows: (a) point 1 is amended as follows: (i) point (d) is replaced by the following: ‘(d) instructions for intended use concerning application rates, timing and frequency, and target plants or mushrooms;’; (ii) the following point is inserted: ‘(da) other instructions for intended use than those listed in point (d);*’; (iii) point (h) is replaced by the following: ‘(h) a list of all ingredients above 5 % by product weight or volume, or in the case of products in liquid form by dry weight, in descending order of magnitude;*’; (iv) the following points are added: ‘(i) an identification in accordance with Article 18 of Regulation (EC) No 1272/2008 of any ingredient in the list referred to in point (h) that is a substance or a mixture;* (j) the designations of the relevant CMCs as referred to in Part I of Annex II for each ingredient listed in point (h).*’; (v) the following paragraph is added: ‘Naturally occurring substances may, in addition to the information requested in point (i), be identified by their mineral names.’; (b) the following points are added: ‘12. Where economic operators provide a digital label in accordance with Article 11a(1) and (2), the data carrier used for that digital label shall be accompanied by the warning: “A physical label must be provided in accordance with Regulation (EU) 2019/1009 before the product is made available to end-users on the market in packaging containing up to 1 000 kg” or by a similar warning. 13. Where economic operators provide a digital label in accordance with Article 11a(3), second subparagraph, the data carrier used for that digital label shall be accompanied by the statement “More comprehensive information on the product is available online. You can ask your supplier to provide that information by other means.” or by a similar statement. 14. Where economic operators provide a digital label in accordance with Article 11a(4), the data carrier used for that digital label shall be accompanied by the statement “Information on the agronomic efficiency and the safe handling of the product is available online. You can ask your supplier to provide that information by other means.” or by a similar statement.’; (2) Part II is amended as follows: (a) the section ‘PFC 1(A): ORGANIC FERTILISER’ is amended as follows: (i) in point (d), sub-points (v) and (vi) are replaced by the following: ‘(v) organic carbon (C );* org (vi) dry matter;*’; ELI: http://data.europa.eu/eli/reg/2024/2516/oj 9/13EN OJ L, 30.9.2024 (ii) points (e) and (f) are replaced by the following: ‘(e) the ratio of organic carbon to total nitrogen (C /N);* org (f) production date;*’; (b) the section ‘PFC 1(B): ORGANO-MINERAL FERTILISER’ is amended as follows: (i) in point 1(d) sub-points (v) and (vi) are replaced by the following: ‘(v) organic carbon (C );* org (vi) dry matter;*’; (ii) in point 5 sub-point (ca) is replaced by the following: ‘(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’; (c) the section ‘PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER’ is amended as follows: (i) point 2 is replaced by the following: ‘2. The granulometry of a solid inorganic macronutrient fertiliser shall be indicated, expressed as % by mass of the product passing through a determined sieve.*’; (ii) point 4 is amended as follows: — the introductory sentence is replaced by the following: ‘For coated solid inorganic macronutrient fertilisers, the following shall be indicated:’; — the following points (-a) and (-aa) are inserted: ‘(-a) the name of the coating agents; (-aa) the percentage of fertiliser coated by each coating agent;*’; (iii) in point 8, sub-point (ca) is replaced by the following: ‘(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’; (d) the section ‘PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER’ is amended as follows: (i) point 1 is replaced by the following: ‘1. The label shall indicate whether the liquid inorganic macronutrient fertiliser is in suspension or in solution.*’; (ii) in point 6 sub-point (ca) is replaced by the following: ‘(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’; (e) the section ‘PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER’ is amended as follows: (i) point 1 is replaced by the following: ‘1. For inorganic micronutrient fertilisers, the following shall be indicated: — the declared micronutrients listed by their names and chemical symbols of the declared micronutrients, in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn); — the names of their counter-ions when the declared micronutrients are intentionally added.*’; (ii) point 2a is replaced by the following: ‘2a. Where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability shall be indicated.*’; (f) in the section ‘PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER’, point 1 is replaced by the following: ‘1. The label shall indicate the relevant typology, as referred to in the table under PFC 1(C)(II)(a) in Part II of Annex I.*’; 10/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 (g) in the section ‘PFC 2: LIMING MATERIAL’, the fifth indent is replaced by the following: ‘— reactivity and method of determination of reactivity, except for oxide and hydroxide limes.*’; (h) the section ‘PFC 3(A): ORGANIC SOIL IMPROVER’ is amended as follows: (i) the first indent is replaced by the following: ‘— pH;*’; (ii) the fifth indent is replaced by the following: ‘— the ratio of organic carbon to total nitrogen (C /N).*’; org (i) the section ‘PFC 4: GROWING MEDIUM’ is amended as follows: (i) the second indent is replaced by the following: ‘— pH;*’; (ii) the fourth, fifth, sixth and seventh indents are replaced by the following: ‘— nitrogen (N) extractable by CaCl/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; “CAT-so- 2 luble”), if above 150 mg/l;* — phosphorus pentoxide (PO) extractable by CaCl/DTPA (calcium chloride/ diethylenetriaminepentaacetic 2 5 2 acid; “CAT-soluble”), if above 20 mg/l;* — potassium oxide (KO) extractable by CaCl/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 2 2 “CAT-soluble”), if above 150 mg/l;* — production date.*’; (j) the section ‘PFC 5: INHIBITOR’ is replaced by the following: ‘PFC 5: INHIBITOR 1. All ingredients shall be declared by product weight or volume in descending order of magnitude.* 2. The content of the inhibiting compound(s), expressed as % by mass or volume shall be declared.* 3. The use instructions referred to in point 1(da) of Part I of this Annex shall contain information on: (a) the types of EU fertilising products with which the inhibitor may be mixed*, in particular: (i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) forms ammonium (NH+) 4 and urea (CHNO);* 4 2 (ii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) form urea (CHNO);* 4 2 (b) the minimum and maximum recommended concentration of inhibiting compound(s) when mixed with a fertiliser prior to its use: (i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH+) and urea nitrogen (CHNO); 4 4 2 (ii) for the denitrification inhibitor referred to in PFC 5(B) in Part II of Annex I, expressed as a % by mass of the nitrate (NO-) present; 3 (iii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH NO).’; 4 2 (k) the section ‘PFC 6: PLANT BIOSTIMULANT’ is replaced by the following: ‘PFC 6: PLANT BIOSTIMULANT The following information shall be provided: (a) physical form; (b) production date;* ELI: http://data.europa.eu/eli/reg/2024/2516/oj 11/13EN OJ L, 30.9.2024 (c) expiry date; (d) application method(s);* (e) effect claimed for each target plant;* and (f) any relevant instructions related to the efficacy of the product, including soil management practices, chemical fertilisation, incompatibility with plant protection products, recommended spraying nozzles size, sprayer pressure and other anti-drift measures.*’; (l) in section ‘PFC 7: FERTILISING PRODUCT BLEND’, the second paragraph is replaced by the following: ‘Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the concentration of each plant biostimulant in the blend shall be indicated in g/kg or g/l at 20 oC.*’. 12/13 ELI: http://data.europa.eu/eli/reg/2024/2516/ojEN OJ L, 30.9.2024 ANNEX II Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows: (1) in the section ‘MODULE A – INTERNAL PRODUCTION CONTROL’, point 2.2. is amended as follows: (a) point (c) is replaced by the following: ‘(c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’; (b) point (e) is replaced by the following: ‘(e) a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’; (2) in the section ‘MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING’, point 2.2. is amended as follows: (a) point (c) is replaced by the following: ‘(c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’; (b) point (e) is replaced by the following: ‘(e) a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’; (3) in the section ‘MODULE B – EU-TYPE EXAMINATION’, point 2.2 is amended as follows: (a) point (c) is replaced by the following: ‘(c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’; (b) point (e) is replaced by the following: ‘(e) a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’; (4) in the section ‘MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS’, point 2.2. is amended as follows: (a) point (c) is replaced by the following: ‘(c) the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’; (b) point (e) is replaced by the following: ‘(e) a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’. ELI: http://data.europa.eu/eli/reg/2024/2516/oj 13/13