Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 10 March 2021
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Commission consultation: EU rules on official controls - update to allow controls of imports for the use of certain antimicrobials A copy of this draft Regulation is available on this site (click on image). For more details, see Commission consultation page. Note that the consultation is open until 5th May 2021. |
The following is the intial 'Context of the Proposal' section of the draft document:
Reasons for and objectives of the proposal
Regulation (EU) 2019/6 [see Note 1 below], 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 [see Note 2 below], but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) [see Note 3 below]. 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 [see Note 4 below]. 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 poverall 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.
Notes
