Considerations on COM(2023)98 - Amendment of Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products

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(1) Annex III to Regulation (EU) 2019/1009 lays down the labelling requirements applicable to EU fertilising products. The information referred to in Annex III is to be provided on a label in a physical form attached to that 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 that packaging (‘physical label’). Products without a packaging are accompanied by a leaflet. The labelling requirements concern various parameters linked to the agronomic efficiency of EU fertilising products (e.g., content of nutrients in a fertiliser) and the content of such products (e.g., quantity). The labelling requirements also cover information needed for the protection of human health and the environment when using EU fertilising products (e.g., information needed for the correct application of Council Directive 91/676/EEC 23 ) and information needed for the correct handling and use of such products after purchase (e.g., 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.

(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, loud speakers or translation into other languages. In addition, digital labelling of EU fertilising products contributes to the ongoing progress with regard to digitalisation of the European agricultural sector and can facilitate the reporting obligations of farmers regarding the use of such products. Digital labelling can also lead to a more efficient management of the labelling obligations by economic operators, by facilitating the update of labelling information and permitting a more targeted information to users. In addition, digital labelling can contribute to reducing labelling costs all along the supply chain, given that the labels of EU fertilising products may be changed following a transaction between economic operators, before reaching end-users,

(4) However, digital labelling can also create new challenges for the vulnerable population groups, in particular persons with no, or insufficient, digital skills or persons with disabilities, and thus accentuate the digital divide. Therefore, digital labelling should be introduced in Regulation (EU) 2019/1009, under certain conditions, taking into account the need to ensure a high level of protection of human health and the environment, and the digital readiness.

(5) Economic operators should remain free to choose if to provide a digital or physical label. This will ensure that such economic operators have 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 digital labelling might be challenging, given the reduced volumes or types of EU fertilising products.

(6) The choice to provide a digital label lies primarily with manufacturers and importers, who are responsible for fulfilling the labelling requirements set out in Annex III to Regulation (EU) 2019/1009. Nevertheless, to maximise the use of digital labels and thereby improve the communication of information to users, distributors should also have the possibility to digitise the label of EU fertilising products that they make available on the market, based on the information already provided by the manufacturer. The extent of digital labelling should depend on two factors: if the EU fertilising products are made available to economic operators or to end-users and if the products are provided with or without a packaging.

(7) Economic operators should be allowed to provide all the labelling elements referred to in Annex III of Regulation (EU) 2019/1009 in a digital label only for the EU fertilising products supplied to other economic operators, with or without a packaging. The use of digital labels in such cases can reduce the labelling costs in the supply chain. Importers or distributors will have the possibility 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 in case of blending, packaging or re-packaging of EU fertilising products, since the products can be labelled with a physical label only once, before reaching end-users. As products are supplied to economic operators, the communication of information to end-users is not affected. Where the economic operators choose to provide, in addition to a digital label, a physical label, they should be free to decide which labelling elements to include in that physical label.

(8) Physical labels remain the preferred way of obtaining information for end-users as by being affixed to packaging such physical labels offer immediate access to information. In addition, the vast majority of EU fertilising products available on the market are used by professional users, such as farmers. While professional users are well accustomed with fertilising products and often rely on consultancy for their fertilisation plans, they tend to belong to more advanced age groups, with more reduced digital skills.

(9) Where economic operators opt for digital labelling of EU fertilising products supplied to end-users in a packaging, they should therefore ensure that a minimum set of information is also available on the physical label. In this context and with regard to other rules specific to products made available in a packaging, a packaging should contain no more than 1000 kg in coherence with Commission Regulation (EU) No 142/2011 24 . Products supplied in a packaging exceeding this limit should be considered as being supplied without a packaging for the purpose of Regulation (EU) 2019/1009. This will also address the challenges that vulnerable population groups may 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. 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 the protection of human health and the environment, as well as minimum information on the agronomic efficiency of the EU fertilising products and on their content and use, should always be provided on the physical label. Regulation (EU) 2019/1009 should clearly indicate which information may be provided only digitally.

(10) For EU fertilising products supplied without packaging, the economic operators are to provide the labelling elements in a leaflet. 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. Providing the same labelling elements in digital format would imply an adjustment of the way the information is retrieved without creating significant risks to users.  Economic operators should therefore be allowed to provide all the labelling elements referred to in Annex III of Regulation (EU) 2019/1009 in a digital label only for the EU fertilising products supplied without packaging. Where the economic operators choose to provide, in addition to a digital label, a physical label, they should be free to decide which labelling elements to include in that physical label. 

(11) To ensure a level playing field among economic operators making available EU fertilising products on the market, and to protect the end-users of such products, requirements for digital labelling should be laid down.

(12) In order to ensure that users receive all the 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 that label, even if they are also included on the physical label. The digital label should also contain information allowing end-users to identify and contact the manufacturer of the EU fertilising products, as this is an essential information and providing it digitally will facilitate the link between the product and the digital label. In addition, given that fertilising products are also placed on the market as non-harmonised products, it is important to include on the digital label the CE-mark and any corresponding reference to a notified body, so that end-users can deduce only from using the digital label 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 (more precisely, the batch number and the production date), the manufacturers should have the choice to provide the information either physically or digitally.

(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 digital labels. In addition, and in order to improve the chances that users will in practice retrieve the information, the information provided on the digital label should be easily accessible. Economic operators should not mix the information required by Regulation (EU) 2019/1009 with other information not requested by Regulation (EU) 2019/1009, such as marketing or commercial statements. Digital space has no space limitations typical for physical labels affixed to the packaging. It is therefore important to keep the labelling elements provided in accordance with Regulation (EU) 2019/1009 concentrated in one place, so that they are not difficult to find among various other information which economic operators might provide. Economic operators should also ensure that digital labels are presented in a way that takes into account the needs of vulnerable population groups, to further reduce the challenges such groups may face.

(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 5 years from the moment the EU fertilising product is placed on the market. 

(15) In order to reduce any potential risks caused by the unavailability of the digital label to vulnerable population groups, in particular as regards EU fertilising products supplied without packaging to end-users, where all the labelling elements may be provided digitally, economic operators should be responsible for providing the labelling elements by alternative means to end-users, upon request. Whenever the digital label is temporarily unavailable, the information should be provided even without a request.

(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. In addition, taking into account the possibility to provide only a digital label for EU fertilising products made available to blenders, 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. 

(17) In order to keep Regulation (EU) 2019/1009 up-to-date to 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 with regard to which labelling elements economic operators making available on the market EU fertilising products in a packaging to end-users may provide on a digital label only. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations are conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making 25 . 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 information needed.

(19) When deciding which labelling elements may be provided only digitally by economic operators making available on the market EU fertilising products in a packaging to end-users, 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 health and the environment.  

(20) Regulation (EU) 2019/1009 should therefore be amended accordingly.

(21) Given that this Regulation introduces the possibility of providing all or part of the labelling requirements in Annex III only in digital labels, its application should be deferred to provide for enough time for the development of the supplementing requirements concerning the digital labelling. 

(22) The specific 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, cannot be sufficiently achieved by the Member States. Since they 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, by introducing a possibility to use digital labelling for certain information, this Regulation does not go beyond what is necessary in order to achieve those objectives.