COMMISSION REGULATION (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance)

(1)

Regulation (EC) No 470/2009 provides that, except in cases where the Codex Alimentarius procedure applies, any pharmacologically active substance intended for use in the Union in veterinary medicinal products which are to be administered to food-producing animals shall be subject to an opinion of the European Medicines Agency (‘Agency’) on the maximum residue limits (‘MRLs’) of pharmacologically active substances used or intended to be used in veterinary medicinal products. The Agency's opinion should consist of a scientific risk assessment and risk management recommendations.

(2)

Regulation (EC) No 470/2009 empowers the Commission to adopt measures establishing the methodological principles for the risk assessment and risk management recommendations regarding the establishment of the MRLs of pharmacologically active substances.

(3)

In order to provide legal certainty, clarity and predictability with regard to the process of the establishment of MRLs, it is appropriate that the criteria against which the Agency appraise the applications are provided for in this Regulation.

(4)

The methodological principles for the risk assessment and risk management recommendations should aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.

(5)

Taking into account the requirements set out in Article 6 of Regulation (EC) No 470/2009, the detailed rules on the methodological principles for the scientific risk assessment part of the Agency's opinion should be laid down in this Regulation.

(6)

Taking into account the requirements set out in Article 7 of Regulation (EC) No 470/2009, the detailed rules on the methodological principles for the risk management recommendations part of Agency's opinion should be laid down in this Regulation. In the risk management recommendations, the Agency is also required to consider the availability of alternative substances and other legitimate factors, such as the technological aspects of food and feed production or the feasibility of controls. Therefore it is appropriate to lay down rules on that requirement.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

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‘major metabolites’ means metabolites comprising ≥ 100 μg/kg or ≥ 10 % of the total residue in a sample collected from the target animal species in the metabolism study,

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‘marker residue’ means a residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue,

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‘dairy starter cultures’ means prepared cultures of microorganism employed in the manufacture of a variety of dairy products including butter, cheese, yoghurt and cultured milk.