PHARMACOLOGICALLY ACTIVE SUBSTANCES IN FOODS: COMMISSION PAVES THE WAY FOR SETTING MRLS

EU Commission finally has come out with Regulation (EU) No 2017/17, a new implementing measure setting the form and the content of the applications for the establishment of maximum residue limits (MRL) in foodstuffs of animal origin, in accordance with Regulation (EC) No 470/2009.

This regulation aims at avoiding unreasonable barriers to the free movement of foods of animal origin by enhancing a harmonised approach to the scientific assessment of residues.

Maximum residue limits (MRLs) and reference values for pharmacologically active substances present in food obtained from animals are the outcome of a procedure according to which scientific risk assessment is carried out by the European Medicines Agency (EMA). Then, EU Commission, acting as the risk manager, adopts a regulation setting the MRL.

In order to improve the objective of the Regulation, the Commission felt the need to adopt an implementing measure with the aim of outlining a common-format for submitting applications and for the organisation of the information to be presented in order to substantiate a well-structured application.

According to the implementing measure, applicants shall be required to submit by electronic means a request for the establishment of maximum residue limits to the Agency; the information and details accompanying an application shall be shaped accurate on the basis of the scientific information available and taking into account scientific guidance issued by EMA concerning the safety of residues.

Any significant data for the evaluation of the safety of residues, whether favourable or unfavourable to the substance, shall be included in the application or request. In particular, applicant shall disclose all relevant details concerning any incomplete or abandoned test or trial related to the active substance.

As application, can be extended to other animal species or other foodstuff, EMA is allowed to claim safety data if the risk assessment performed with regard to the establishment of the existing MRL is not applicable to the extension proposed.

Furthermore, the Commission has announced its intention to work o other implementing measures in order to improve the objective of Regulation (EU) No 470/2009.

2017-02-09