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Commission Consultation, 13 February 2019
COMMISSION DELEGATED REGULATION (EU) …/... of XXX supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances.
A copy of this draft is available on this site (click on image). A draft Annex is also available. For more details, see the consultation page at: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-645516_en. Consultation closes 13 March 2019.
The following are the recitals from the draft regulation:
Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States to verify compliance with Union legislation inter alia in the area of food safety at all stages of production, processing and distribution. It provides for specific rules on official controls in relation to substances whose use may result in residues in food and feed.
Articles 137 and 138 of Regulation (EU) 2017/625 respectively lay down obligations of the competent authorities as regards actions to be taken in case of suspicion of non-compliance and list actions and measures to be taken in the event of established non-compliance.
Regulation (EU) 2017/625 repeals Directive 96/23/EC [see Note 1 below] with effect from 14 December 2019. That Directive currently lays down measures to monitor certain substances and residues thereof in live animals and animal products and specifically defines the enforcement measures to be taken by the competent authorities in cases of suspected or established non-compliance related to substances and residues within its scope.
The rules set out in Directive 96/23/EC ensure the harmonised enforcement of the EU food safety legislation related to the use and residues of pharmacologically active substances. In order to rationalise and simplify the overall legislative framework, the rules applicable to official controls in specific areas of the agri-food chain legislation have been integrated into the framework for official controls defined by Regulation (EU) 2017/625. In order to ensure a continued and harmonised enforcement, the rules of Directive 96/23/EC related to the follow-up to non-compliances, should be integrated in the new legal framework under Regulation (EU) 2017/625.
The rules laid down in this Regulation should ensure, within the framework of Regulation (EU) 2017/625, a continuation of the requirements on the follow-up of suspected or established non-compliance with the rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances, in particular as laid down in:
– Regulation (EC) No 470/2009 [see Note 2 below] laying down rules for the establishment of residue limits of pharmacologically active substances in food of animal origin and for placing on the market food of animal origin containing residues of pharmacologically active substances;
– Regulation (EU) No 37/2010 [see Note 3 below], which classifies pharmacologically active substances in light of their prohibition or the maximum residue limits applicable to them;
– Regulation (EU) No 1831/2003 [see Note 4 below], which lays down rules for the authorisation of certain veterinary medicinal products as feed additives and the legal acts adopted on this basis, define the authorisations of specific substances and their maximum residue limits in food of animal origin;
– Regulation (EC) No 1950/2006 [see Note 5 below], which lays down a list of substances essential for the treatment of equidae;
– Commission Regulation (EC) No 124/2009 [see Note 6 below], which sets maximum levels for the presence of coccidiostats or histomonostats in foods resulting from the unavoidable carry-over of these substances in non-target feed on the basis of Council Regulation (EEC) No 315/93 laying down Community procedures for contaminants in food. [see Notes 7 and 8 below],
– Directive 96/22/EC [see Note 9 below], which prohibits the use in stockfarming of certain substances having a hormonal or thyreostatic action and of ß-agonists.
Where, on the basis of the Union rules referred to Recital 5, prohibited or unauthorised substances are discovered in the possession of non-authorised persons, thereby creating a suspicion of illegal treatment and a possible impact on food safety, the measures for official detention and investigations, as provided for in Regulation (EU) 2017/625 and in this Regulation should apply.
Directive 2001/82/EC [see Note 10 below], establishes the regulatory framework for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products. Pharmacologically active substances, which are not authorised in veterinary medicinal products, are not to be used on food-producing animals, with the exception of the use of substances essential for the treatment of equidae, as laid down in Commission Regulation (EC) No 1950/2006. Follow-up on established or suspected non-compliances related to the use of veterinary medicinal products which have a suspected or established impact on food safety falls within the scope of Regulation (EU) 2017/625 and of this Regulation.
By 28 January 2022 Directive 2001/82/EC is repealed and replaced by Regulation (EU) 2019/6 of the European Parliament and the Council on veterinary medicinal products (the new VMP Regulation) [see Note 11 bleow]. As part of the rules for veterinary medicinal products Regulation (EU) 2019/6 restricts the use in animals of antimicrobial veterinary medicinal products. On this basis, the Commission may establish a list of antimicrobials which shall not be used or may only be used subject to certain conditions, and illegal treatment with such products shall also be covered by the present act.
In light of the fact that diverging enforcement practices could lead to an uneven protection of human and animal health, to disruptions of the internal market and to distortions of competition, Regulation (EU) 2017/625 should be supplemented by specific rules for the performance of official controls on animals and goods at any stage of production, processing, distribution and use in relation to suspected or established non-compliances related to the relevant substances and for action to be taken following those official controls.
In view of the specificities of the actions and controls to be taken in case of suspected or established non-compliance with Union rules applicable to the use of pharmacologically active substances on food-producing animals and to their residues, and in order to ensure an Union-wide uniform application of enforcement actions, the cases where the measures listed in Articles 137 and 138 of Regulation (EU) 2017/625 are to be taken should be specified to tailor them to this sector.
Pursuant to Article 79(2)(c) of Regulation (EU) 2017/625, costs generated by mandatory fees or charges for official controls taken under this Regulation, should be borne by the operator responsible for the animals and goods.
Article 50 of Regulation (EC) No 178/2002 [see Note 12 below] requires Member States to notify a direct or indirect risk to human health deriving from food or feed via the network, which has been put in place for this purpose. Non-compliances related to residues of pharmacologically active substances and constituting such risks should therefore be notified accordingly. In addition, where the non-compliances are identified in relation to animals or products of animal origin originating from another Member State, the authorities of the Member State having identified the non-compliance and the Member State of origin should make use of the provisions on assistance set out in Regulation (EU) 2017/625 and take the appropriate follow-up measures, as defined in the present Regulation.
As the rules laid down in Directive 96/23/EC for the follow-up of specific cases of established non-compliance or suspected non-compliance related to the substances and residues within its scope are repealed by 14 December 2019, this Regulation should apply from that date onwards.