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Parliamentary questions
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23 October 2018
Question for written answer P-005391-18
to the Commission
Rule 130
Simona Bonafè (S&D) , Nicola Danti (S&D)

 Subject:  Monacolin assessment
 Answer in writing 

Food supplement products containing monacolin K in red yeast have been used in the EU for many years by millions of consumers for cholesterol management. The Italian authorities continue to support the use of monacolin K and many experts consider that any safety issues are in fact identified by setting a dosage level of 10 mg for a health claim (as defined in the EFSA opinion), whereas previously the dosage level prescribed by the Italian authorities was 3 mg. In this context, can the Commission clarify the following points?

When EFSA delivers an opinion on the safety of an ingredient that contradicts national authorities which have been regulating use for years without any safety issues, in which ways does the Commission take into account the national authorities’ decisions during the risk management procedure?

Are the principles of proportionality and subsidiarity being taken into account in the Commission’s current implementation of Regulation (EC) No 1925/2006, given that many national authorities clearly do not hold the same views as EFSA on the safety of the ingredients being assessed?

Will the Commission support the idea of ensuring that in future the EFSA panels that produce scientific opinions contain a balance of expertise from different Member States?

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