On 30 September 2024, the EU published 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, which aims at promoting the use of digital labelling for fertilising products in the EU, improving the readability of labelling and simplifying suppliers’ labelling obligations. This article provides an overview of the EU’s legal framework on the labelling of fertilising products, the digital labelling requirements introduced under Regulation (EU) 2024/2516, and the implications for businesses, as well for end-users.
The EU’s legal framework for the labelling of fertilising products
In the EU, the labelling of fertilisers is regulated by Regulation (EU) 2019/1009 of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products. Article 2(1) of Regulation (EU) 2019/1009 defines ‘fertilising product’ as “a substance, mixture, micro-organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency”. According to Article 2(2) of Regulation (EU) 2019/1009, ‘EU fertilising product’ means “a fertilising product which is CE marked when made available on the market”.
Article 4(1) of Regulation (EU) 2019/1009 provides that EU fertilising products are to be labelled in accordance with the labelling requirements defined in Annex III to the Regulation. Annex III includes general labelling requirements, including: 1) The designation of the Product Function Category (PFC); 2) The quantity of the EU fertilising product; 3) The iinstructions for intended use, including application rates, timing and frequency; 4) TheThe recommended storage conditions; 5) Any relevant information on measures recommended to manage risks to human, animal or plant health, to safety, or to the environment; and 6) A list of all ingredients above 5% by product weight or volume.
The extensive labelling requirements set out in Regulation (EU) 2019/1009 mean that labels tend to be overloaded with information. While the provision of such detailed information caters to the appropriate use of products characterised by innovative components, as well as to the growing interest in their environmental and health impacts, it also has an impact on the labels’ readability. In 2020, the European Commission (hereinafter, Commission) published its report on the ‘fitness check’ of the EU’s most relevant chemicals legislation, including Regulation (EU) 2019/1009. Among its conclusions, the Commission noted that not all the opportunities to improve and simplify the communication of chemical hazards and safety information to consumers had yet been seized, including those presented by digital technologies (see Trade Perspectives, Issue No. 22 of 4 December 2023).
The new digital labelling rules for EU fertilising products
Regulation (EU) 2024/2516 amends Regulation (EU) 2019/1009 by providing the option for voluntary digital labelling of EU fertilising products. In doing so, Regulation (EU) 2024/2516 presents businesses placing EU fertilising products on the market with an opportunity to make the most of digital solutions without compromising the objectives of protecting public health and the environment. In July 2024, following the conclusion of the legislative process for Regulation (EU) 2024/2516, the Council of EU noted that “digital labels are QR codes or bar codes that redirect the user to a web page where the information of the label is stored”.
Regulation (EU) 2019/1009, as amended by Regulation (EU) 2024/2516, contains new provisions concerning, inter alia, the forms of labelling, the requirements for digital labels, obligations of economic operators providing a digital label, and the evaluation of the digital labelling of EU fertilising products. Article 11a(1) of Regulation (EU) 2019/1009 on “Forms of labelling” provides for two main forms of labelling of EU fertilising products: 1) A label indigital form (“digital label”); or 2) A label in physical form (“physical label”). The decision to use a digital label will be informed by 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.
Articles 11a(1) and (2) of Regulation (EU) 2019/1009 allows all labelling elements referred to in Annex III to Regulation (EU) 2019/1009 to be provided in a digital label only for the EU fertilising products supplied to economic operators, with or without packaging. Article 2(15) of Regulation (EU) 2019/1009 defines economic operator as “the manufacturer, the authorised representative, the importer and the distributor”. Regarding end-users, Article 11a(3) of Regulation (EU) 2019/1009 specifies that, when EU fertilising products are made available to end-users in packaging and the provider uses a digital label, its content must be duplicated on the physical label. Article 11(a)(4) of Regulation (EU) 2019/1009 provides for an exception concerning products made available on the market to end-users without packaging. For such cases, as an alternative to the leaflet accompanying the product, a digital label may be used. Recital 8 of Regulation (EU) 2024/2516 notes that “physical labels remain a preferred way for end-users to obtain key information about the use of EU fertilising products”, that, “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”, and that there is a higher possibility of unreliable internet access in rural areas.
Article 11(b) of Regulation (EU) 2019/1009 spells out the ‘Requirements for digital labels’ in terms of content, accessibility and usability. Notably, the digital label must digitally provide the manufacturers’ and importers’ name, registered trade name or trademark, and a contact postal address; the CE marking; and all labelling elements required in Annex III. Article 11b(4) of Regulation (EU) 2019/1009 requires a digital label to be easily accessible free of charge, searchable, available for 10 years after the product is placed on the EU market, and “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”, as well as “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”. Pursuant to Article 11b(5), the data carrier, such as QR code, used for the digital label, must be physically printed or placed on the product packaging or on an accompanying document if the product is sold without packaging, “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 of Regulation (EU) 2019/1009 on ‘Obligations of economic operators providing a digital label’ requires economic operators providing a digital label not to “track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the relevant information digitally”. When EU fertilising products are supplied to end-users without packaging and the required information is provided through a digital label, the economic operator must display the manufacturer’s and importer’s details visibly at the point of sale.
Finally Article 42 of Regulation (EU) 2019/1009, as amended, requires the Commission, by 1 May 2027, to adopt delegated acts supplementing the requirements for digital labelling and the obligations for economic operators on issues such as the approved “electronic technical solutions” for providing the digital label, and the alternative means for providing the necessary information in case of the ilitytemporary unavailability of the digital label.
A trend towards digital labels and digital product passports
In recent times, the EU has adopted similar legislation introducing either digital labelling for specific products or legal obligations for product-specific information to be accessible digitally. Notable examples include the requirement for a ‘digital battery passport’ for industrial batteries, light means of transport (LMT) batteries, and electric vehicle (EV) batteries, that provides information on a wide range of aspects, including battery manufacturing carbon intensity, repair and recycling processes, as well as a ‘digital product passport’ setting out sustainability-related performance and information conditions (i.e., the so-called ‘ecodesign requirements’)for almost all categories of goods (see Trade Perspectives, Issue No. 7 of 11 April 2022). Digital labelling rules are also in place for medical devices, and are under preparation for, inter alia, detergents, hazardous chemicals, and packaging and packaging waste.
From a regulatory coherence perspective, in July 2023, in its paper calling for digital labelling for food and drink products, FoodDrinkEurope, an association representing the European food and drink industry, had argued that the growing number of digital labelling regulations across various consumer products creates a fragmented and disjointed system in the internal market. FoodDrinkEurope further contended that, without “a horizontal and harmonised approach to digital labelling, the EU is facing an impermeable web of digital labelling that differs across different sectors and products, to the detriment of the consumer”.
A cost-effective solution for large and small businesses?
The deployment of digital solutions, such as QR codes, allows the provision of comprehensive information while decreasing labelling complexities and costs, simplifying content updates, and increasing the accessibility and readability of the information. Notably, the quantity and quality of the information that can be access through a digital label can be much higher compared to a physical label. Emphasising the cost saving advantage of digital labelling, the Council of the EU notes that digital labelling is expected to reduce annual costs by, on average, EUR 57,000 for a large company and EUR 4,500 for a small and medium-sized enterprise. Beyond the EU market, studies also show that digital labelling would “avoid multiple compliance marks for products designed for the global market” especially in countries where such labelling is already allowed, thereby, facilitating trade across borders.
Preparing to harness digital labelling
Regulation (EU) 2024/2516 will enter into force on 20 October 2024, but, pursuant to Article 2 thereof, it will only start applying after two years and seven months, namely from 1 May 2027. Businesses interested in placing fertilising products on the EU market, and interested in utilising digital labels, should expect further requirements and obligations, such as the alternative means for providing information in case of the temporary unavailability of the digital label, to be set through delegated acts and should seek professional advice to ensure compliance with the requirements for digital labelling and the obligations for economic operators.
