WHAT IS THE AIM OF THE REGULATION?
It lays down rules on maximum residue limits1 for pharmacologically active substances used in veterinary medicine, such as antibiotics, in food of animal origin – including meat, fish, milk, eggs and honey – in order to ensure food safety.
In this regard, it sets out:
- the procedures for establishing maximum residue limits
- the reference point for action2 in cases where a maximum residue limit has not been calculated.
KEY POINTS
- The applicant for a marketing authorisation for a veterinary medicinal product in which any pharmacologically active substance is used must submit an application to the European Medicines Agency. The agency must give an opinion consisting of a scientific risk assessment and risk management recommendations.
- The agency decides whether to apply established maximum residue limits for a particular food or species. The European Commission sets out rules on the conditions regarding this calculation of residue limits.
- The risk assessment must determine whether the type and amount of residue assessed presents a safety concern for human health.
- Risk management recommendations must assess a variety of factors, including the availability of alternative substances for the treatment of the relevant species.
- The Commission classifies the pharmacologically active substances that have already been subject to an opinion from the agency. It can establish reference points for action for residues of pharmacologically active substances that are not classified.
- In certain cases, the Commission or an EU Member State may submit a request for an opinion on maximum residue limits to the agency. Such cases include circumstances where the substance in question is authorised for use in a non-EU country.
- A number of substances are excluded from the scope of this regulation, including substances covered by the EU’s Regulation (EEC) No 315/93 on contaminants in food (see summary).
- In January 2017, the Commission adopted an implementing act, Implementing Regulation (EU) 2017/12. This regulation lays down the form and content of applications and requests to the European Medicines Agency for the establishment of maximum residue limits.
- In June 2017, the Commission adopted Regulation (EU) 2017/880. This regulation lays down rules on the extrapolation of maximum residue limits, that is:
- using a maximum residue limit established for a pharmacologically active substance in one foodstuff for another foodstuff derived from the same species; and
- using a maximum residue limit established for a pharmacologically active substance in one or more species for another species.
- In May 2018, the Commission adopted Regulation (EU) 2018/782 laying down the methodological principles for the risk assessment and risk management recommendations to be applied by the European Medicines Agency when preparing opinions on the maximum residue limits of pharmacologically active substances that may be permitted in food of animal origin.
FROM WHEN DOES THIS REGULATION APPLY?
It has applied since 6 July 2009.
BACKGROUND
Scientific and technological progress in relation to refined detection methods led to a decrease in the availability of medicines for food-producing animals and required an adjustment of EU rules. This regulation was introduced to ensure both consumer safety and the availability of veterinary medicines to treat specific diseases.
For further information, see:
KEY TERMS
- Maximum residue limit (MRL). The maximum concentration of a residue of a pharmacologically active substance that may be permitted in food of animal origin.
- Reference point for action. The level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down. The reference points for action are established in consultation with official control laboratories.
MAIN DOCUMENT
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, pp. 11–22).
RELATED DOCUMENTS
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 (OJ L 132, 30.5.2018, pp. 5–30).
Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, pp. 1–5).
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, pp. 1–7).
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, pp. 1–72).
Successive amendments to Regulation (EU) No 37/2010 have been incorporated in the original text. This consolidated version is of documentary value only.
Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, pp. 1–3).
See consolidated version.
