amending Regulation (EU) 2017/625 as regards official controls on animals and products of animal origin exported from third countries to the Union to ensure compliance with the prohibition of certain uses of antimicrobials

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•Reasons for and objectives of the proposal

Regulation (EU) 2019/6, which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)). Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law, but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’). For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation.

However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, it would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation.

The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly.

Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation.

Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.

2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•Legal basis

The legal bases of this proposal are Article 43(2), Article 114 and Article 168(4)(b) of the Treaty on the Functioning of the European Union.

•Subsidiarity (for non-exclusive competence)

Imports of animals and products of animal origin from third countries have been comprehensively regulated at Union level. Therefore, it would not be possible to address the issue at national level.

•Proportionality

Amending the Official Controls Regulation to cover verification of compliance with Article 118(1) of Regulation (EU) 2019/6 is the only effective way of ensuring that Article 118(1) of that Regulation is complied with in relation to imports of animals and products of animal origin from third countries. Regulation (EU) 2019/6 itself does not have the necessary basic provisions to make this possible. The empowerment in Article 118(2) of Regulation (EU) 2019/6 would not allow the Commission to adopt the necessary rules on official controls for animals and products of animal origin similar to those set out in the Official Controls Regulation. The amendment is indispensable in order to allow the Union’s official control system for animals and products of animal origin to apply to verification of compliance with Article 118(1) of Regulation (EU) 2019/6.

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

From a Better Regulation perspective, a roadmap, stakeholder consultation or impact assessment are not necessary, as the proposal is a technical measure, necessary to ensure implementation of Article 118 of Regulation (EU) 2019/6. The proposal, when adopted, will allow for official controls in accordance with the Official Controls Regulation and thus not introduce any significant burden on economic operators and on Member States. The proposal needs to be adopted ahead of the entry into application of Regulation (EU) 2019/6 in January 2022 and in good time to allow for the preparation of implementing acts specifying the modalities for official controls in relation to Article 118 of Regulation (EU) 2019/6 before that date.

4.BUDGETARY IMPLICATIONS