Residues of Veterinary Products 

This new Regulation aims to streamline and simplify the system of approving veterinary medicines and evaluating maximum residue limits of pharmacologically active substances in veterinary medicinal products.

Background

Regulation 2377/90/EEC established EU rules for maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as well as procedures to evaluate the safety of residues of pharmacologically active substances for human consumption. Directive 2001/82/EC regulated the authorisation of the use of veterinary medicinal products for food-producing animals if substances had been assessed as safe. The Commission felt however that the present system was so complex and slow that very few new products were being approved, threatening animal health. The new Regulation repeals and replaces Regulation EEC 2377/90 and amends Directive 2001/82/EC and establishes a new system for the approval of veterinary medicines and setting of residue limits.

Aim of the Regulation

The new Regulation aims to establish a new approval system for veterinary medicines that protects human health but at same time helps promote the number of veterinary products available. This entails:

• Expanding the role of the European Medicines Agency (EMA)
• Enabling the Commission to classify pharmacologically active substances in veterinary products
• Establishing new rules on the placing of pharmacologically active substances on the market

Authorisation Procedure

In order for a veterinary medicinal product containing pharmacologically active substances to be authorised, an application must first be made. An application can be submitted by a Member State or a private party. Applications are submitted to the EMA for an opinion. Final approval is then given by the Commission.

The Role of the European Medicines Agency (EMA)

The European Medicines Agency (EMA) will be responsible for advising the Commission on the maximum residue limits for veterinary medicinal products which may be accepted in food of animal origin. The opinion of the EMA must consist of two parts, a scientific risk assessment and risk management recommendations.

Scientific Risk Assessment

The scientific risk assessment must consider the type of residues and the amount which can be ingested by human beings over a lifetime without appreciable health risks. It also concerns the following factors:

• The type and amount of residue considered not to present a safety concern for human health
• The risk of toxicological, pharmacological or microbiological effects in human beings
• Residues that occur in food of plant origin or that come from the environment

Risk Management

Risk management recommendations must be based upon the scientific risk assessment whilst taking into account other factors such as:

• The availability of other substances for the treatment of relevant species
• The technological aspects of feed or food production and the feasibility of controls
• Whether a maximum residue limit or a provisional maximum residue limit should be established

If scientific data provided are insufficient to allow a safe limit to be identified or when a final conclusion cannot be established because of a lack of scientific information then no maximum residue limit may be recommended.

Opinions for the Member States and the Commission

An opinion of the EMA can also be requested by the Commission or a Member State in the following circumstances:

• Opinions for the Member States and the Commission
An opinion of the EMA can also be requested by the Commission or a Member State in the following circumstances:
• Where the substance is authorised for use in a veterinary medicinal product in a third country and no application for the establishment of a maximum residue limit has been submitted before
• If a substance is a medicinal product and no application for the establishment of a maximum residue limit has been submitted

The Role of the Commission

Under the new Regulation the Commission is responsible for the classification of pharmacologically active substances after receiving the opinion of the EMA. There are four classifications, three of which are positive:

 • Maximum residue limit – necessary for the protection of human health pursuant to either the opinion of the EMA or an uncontested decision of the Codex Alimentarius Commission
• Provisional maximum residue limit - where scientific data is incomplete but it is supposed there is no danger posed to human health. The provisional limit lasts for a maximum of 5 years and can be extended once for two further years
• Absence of the need to establish a maximum limit - for cases of no risk to human health

A fourth classification is negative:

• Prohibition of the substance being administered to food-producing animals – where any presence or residue of the pharmacologically active substance may pose a danger to human health or when no final conclusion can be drawn as to the potential effects of the substance in question

Further restrictions on the marketing and use of certain substances can be imposed be imposed by the Commission if necessary.  

Market Rules

Member States are not allowed to ban or impede the import or placing on the market of food of animal origin on grounds related to residue levels if the products have complied with the rules in the Regulation.

Analytical tests must be carried out regularly to determine whether there has been illegal administration of a prohibited or non-authorised pharmacologically active substance. If the investigations on products of the same origin identify a potential danger, the competent national authority must inform the Commission and the other Member States. There are penalties where appropriate.

In the case of products of third country origin the Commission can ask the competent national authority of the country or countries concerned requesting clarification as to the recurring presence of residues.

The Regulation was published in the EU’s Official Journal on 16 June, 2009 with the official legislative designation “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”.