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Parliamentary questions
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5 December 2018
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: P-005391/2018

In 2013, the European Food Safety Authority (EFSA), in the context of a scientific assessment of a health claim, established a cause and effect relationship between the consumption of 10mg/day of monacolin K and the claimed effect on cholesterol levels. During the discussions on the claim authorisation, Member States raised safety concerns for monacolins on the basis of scientific opinions and reports by national risk assessment bodies, leading the Commission to initiate the procedure under Article 8 of Regulation (EC) No 1925/2006(1).

This is a harmonised procedure which allows the Commission to prohibit, restrict or place under scrutiny a substance for which safety concerns have been raised. The Commission services are currently preparing a risk management measure on the basis of EFSA’s safety assessment. The draft measure will be discussed with the Member States and their opinion will be sought in the Standing Committee on Plants, Animals, Food and Feed. The Member States are therefore actively involved in the risk management process.

The Fitness Check of General Food Law identified as a shortcoming of EFSA’s capacity to maintain a high level of scientific expertise the dependence on a small number of Member States that provide more than two thirds of the EFSA Scientific Panels’ experts(2). To address this, the Commission adopted a Proposal for a regulation on the transparency and sustainability of the EU risk assessment in the food chain(3), which, amongst others, should ensure greater Member States involvement in nominating Scientific Panel experts, so as to achieve the broadest possible geographical distribution in the final appointments of experts in the EFSA Scientific Panels.

(2)Commission Staff Working Document, ‘The REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002)’, SWD(2018)38, 15.1.2008.
(3)Proposal for a regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EU) No 2015/2283 [on novel foods], COM(2018) 0179 final, dated 11.4.2018.

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