(fra kommisjonsforordningen)

(1) Commission Regulation (EU) No 547/2011 contains requirements for the labelling of plant protection products, including standard phrases for special risks to human or animal health and safety precautions for the protection of human or animal health or of the environment as well as the attribution criteria for those standard phrases and safety precautions. 

(2) The labelling requirements for substances and mixtures set out in Regulation (EC) No 1272/2008 of the European Parliament and of the Council have been amended by Commission Delegated Regulation (EU) 2023/707 and Regulation (EU) 2024/2865. In order to facilitate the implementation and enforcement of Regulation (EC) 1107/2009 and Regulation (EU) 2017/625 of the European Parliament and of the Council, certain elements of the labelling requirements for plant protection products should be aligned to the new labelling requirements applicable under Regulation (EC) No 1272/2008. 

(3) Pursuant to Article 65(3) of Regulation (EC) No 1107/2009, Member States must notify to the other Member States and the Commission the additional national labelling phrases necessary to protect human or animal health or the environment in their territories. The Member States have notified additional phrases requiring personal protective equipment and specific technical equipment for specific tasks. In addition, the Member States have notified phrases that contain risk mitigation measures to address their specific environmental or agricultural circumstances pursuant to Article 36(3) of Regulation (EC) No 1107/2009. The Commission has compiled the additional phrases as notified by the Member States and considered them for inclusion in this Regulation. 

(4) The attribution criteria of some of the standard phrases of Regulation (EC) No 547/2011 were not linked to the outcome of the risk assessment. In order to facilitate the work of the risk managers in the Member States, standard phrases should be assigned to the label of plant protection products for which the risk assessment shows that restrictions of use or specific risk mitigation measures should be applied to protect human health (operators, workers, bystanders and residents) or the environment. Additionally, other phrases that aim to communicate specific good agricultural practices when using fumigants, rodenticides or products for seed treatment are also categorised. At the same time, the Member States should provide supplementary precisions related to the risk mitigation measures identified by the risk managers when authorising a plant protection product pursuant to Article 36(3) of Regulation (EC) No 1107/2009, in spaces or placeholders placed in those standard phrases for that purpose. 

(5) For certain categories of plant protection products, specific precautionary phrases and good agricultural practices should be systematically attributed, independently of the outcome of the risk assessment. 

(6) Digital labels could improve the communication of the potential risks of plant protection products and could offer users advantages like larger fonts, auto-search, voice assistance or translation into other languages. Moreover, digital labels on plant protection products could enhance the transition to digital agriculture and the uptake of precision application techniques, enabling the transfer of the authorised conditions of use to the application machinery, local maps, or weather stations, as well as simplifying the reporting in line with Commission Implementing Regulation (EU) 2023/564. Therefore, it is appropriate to require a digital label for plant protection products, in addition to the physical label, and to lay down requirements concerning the digital labels. 

(7) The physical and digital label of a plant protection product should as a rule contain the same elements, reflecting the content of the authorisation granted, with some limited flexibility during grace periods pursuant to Article 46 of Regulation (EC) No 1107/2009. 

(8) It is appropriate to allow the use of fold-out labels for plant protection products, as well as, for small packages, the possibility to provide the label in a leaflet format accompanying the package. For fold-out labels, the rules applicable to the presentation of fold-out labels under Regulation (EC) No 1272/2008 should apply. 

(9) Following the entry into force of Commission Regulation (EU) 2024/1487 safeners and synergists on the market will become subject to approval at Union level under Regulation (EC) No 1107/2009. It is therefore appropriate that the name of the safener(s) and synergist(s) approved under that Regulation contained in a plant protection product as well as their respective concentration is indicated in the label. 

(10) Pursuant to Article 55 of Regulation (EC) No 1107/2009, proper use of a plant protection product must include the application of the principles of integrated pest management. Therefore, to remind users about the obligation to apply the principles of integrated pest management, a specific standard phrase should be included on the label of plant protection products authorised for professional users. 

(11) The label of the product should inform professional users about the conditions of use of the authorised plant protection product, including the possibility of using precision application techniques. These techniques allow users to apply the authorised plant protection products in a more precise and accurate manner compared to conventional application equipment. They allow a reduction of the plant protection product applied per hectare while maintaining the authorised application rate on the target surfaces. Precision application techniques may contribute to an overall reduction of the environmental exposure to plant protection products and may encourage a more efficient, targeted, and sustainable use. 

(12) To prevent waste from the disposal of the plant protection products’ packaging, and not only from the disposal of the plant protection products themselves, standard phrases for their safe disposal should be established. 

(13) To improve the communication to the user about plant protection products potentially hazardous to bees, a specific phrase and pictogram should be established. 

(14) In compliance with Commission Regulation (EU) No 283/2013 and the uniform principles set out in Commission Regulation (EU) No 546/2011, all micro-organisms are to be regarded as potential sensitisers until validated tests for assessing their sensitisation are available. Therefore, a specific precautionary sentence to warn about the potential of micro-organisms to cause sensitising reactions should be established.

(15) End users of treated seeds must be informed about the potential risks that may come from the sowing of treated seeds, caused by the plant protection product(s) which have been used to treat the seeds. As the end user of treated seeds does not always have access to the label of the plant protection product(s) with which the seeds are treated, certain standard phrases to communicate risk mitigation measures when handling or sowing the treated seeds should be included both on the label of the plant protection product(s) and on the label and documents accompanying the treated seeds in accordance with Article 49(4) of Regulation (EC) No 1107/2009. 

(16) To provide Member States adequate tools to combat the trade of illegal plant protection products, it is appropriate to establish a specific labelling requirement for plant protection products subject to a parallel trade permit granted under Article 52 of Regulation (EC) No 1107/2009. In line with the judgment of the European Court of Justice in Case C-830/21, Syngenta Agro, it should be clarified that the batch number of the formulation concerned allocated by the initial manufacturer, the permit number and the name and address of the permit holder should be included on the label of a parallel traded product. 

(17) Pursuant to Article 54 of Regulation (EC) No 1107/2009, plant protection products can be used for research or development purposes. Considering that these products do not require an authorisation and to provide researchers with safety instructions, certain requirements concerning the labelling of plant protection products which are to be used for such purposes should be maintained. 

(18) To ensure that competent authorities, authorisation holders, suppliers and professional or non-professional users have enough time to adapt to the new requirements set out in this Regulation, its date of application should be deferred. 

(19) In addition, a transitional measure should be introduced to ensure a gradual implementation of the new requirements set out in this Regulation on the occasion of new authorisations and renewals of authorisations of plant protection products. Since a draft label must be submitted in applications for such authorisations or renewals, this transitional measure should apply where the respective application was submitted before the date of application of this Regulation. However, where the label of such plant protection products must be amended or is updated, some of the new requirements set out in this Regulation should apply to the amended label without waiting for the next renewal of the authorisation. 

(20) Due to the high number of amendments and in the interest of clarity, it is appropriate to repeal Regulation (EU) No 547/2011 and replace it by a new Regulation. 

(21) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.