Società italiana di scienze applicate alle piante officinali ed ai prodotti per la salute
SISTE
Informazione e formazione di carattere tecnico, scientifico e regolatorio.
ID: 871764312574-04
Lobbying Activity
Response to Food safety – restrictions on the use of monacolins from red yeast rice in foods
16 Jun 2021
Italian Association of science applied to Botanicals and Health products (SISTE), a scientific and no-profit organisation of operators of the Botanicals sector as well as experts and scientific research groups, would like to use the opportunity provided by the Commission to submit comments on the draft Commission Regulation (EU) …/… of XXX amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice.
The proposed amendment is intended to restrict the use of monacolins from red yeast rice to ensure this substance is used safely in foods and food supplements on the base of the European Food Safety Authority’s scientific opinion on the safety of monacolins in red yeast rice which reports of adverse effects linked to the use of products containing such rice.
We would like to point out that the institutional aims of our association are to encourage the use of natural substances in health products, but only where there are solid scientific evidences to prove their efficacy and safety, and that it bases its opinions on correct knowledge of the substances and scientific rigour.
Only through rigour and precision on rules of this kind can the correct application and legal certainty and thus consumer safety be guaranteed.
In the light of the above, we would like to point out 3 aspects of this measure that we consider to be lacking in rigour and which could become an obstacle to the correct application of the rules and consequently a problem for consumer safety.
The main aspects of the measure on which we want to make our contribution are:
1. Products covered by the restrictions;
2. Maximum levels admitted;
3. Warnings for consumers.
Read full response23 Apr 2020
Italian Society of science applied to Botanicals and Health products (SISTE), a scientific and no-profit organisation of operators of the Botanical sector as well as experts and scientific research groups, would like to use the opportunity provided by the Commission to submit comments on the draft Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (HADs).
The proposed amendment which provide for the prohibition of aloe-emodin, emodin and extracts from the leaf of Aloe species containing hydroxyanthracene derivatives in Part A, and for the introduction in Part C (Substances under Community scrutiny) of botanical extracts containing hydroxyanthracene derivatives, is based on the evaluation done by EFSA on HADs safety published in 2018, actually not thoroughly shared by most of the risk assessors who deal with hazard identification and hazard assessment.
SISTE, respectfully requests that a sufficient period of time be available to in order to submit the results of some experiments that could be able to fill some uncertainties raised by the same Authority.
Attached our considerations.
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