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Safety of hydroxyanthracene derivatives
European Commission requests EFSA assessment
In 2013, the European Food Safety Authority (EFSA) issued a positive scientific opinion on a health claim application for authorization related to hydroxyanthracene derivatives and improvement of bowel function. The application was based on a food supplement containing a blend of botanical ingredients and micro-organisms.
In their opinion, the EFSA Panel concluded that a cause and effect relationship was established between consumption of the substance and the claimed beneficial effect, but that in order to bear the health claim 10 mg hydroxyanthracene derivatives per day from the named botanical sources should be taken for the target population of adults.
Furthermore, some restrictions of use were noted by EFSA, as these were considered necessary. Namely, that stimulant laxatives should not be consumed continually for periods longer than 1–2 weeks without medical supervision and that long-term use of stimulant laxatives should be avoided, and these should only be used if their effect cannot be achieved by a change of diet or the administration of so-called bulking agents. However, as is the case for all health claims applications, EFSA opinions and subsequent authorizations cannot be construed as marketing authorizations, positive safety assessments or decisions on classification as a foodstuff of the concerned substance, as this is not foreseen in the framework of the Nutrition and Health Claims Regulation.
Although it was the first favourable EFSA outcome for a health claim for substances derived from botanicals, the Scientific Opinion was considered somewhat controversial and during the risk management phase related to the authorization of the health claim, concerns were repeatedly raised by certain EU Member States.
The medicinal character of these substances was evoked during the European Commission (EC) meetings, as was the importance of setting appropriate conditions of use that would fully take account of the restrictions of use concerning stimulant laxatives stated in the EFSA opinion. Following lengthy discussions in the EC working group on claims, early this year two options were discussed to resolve the issue, either to reject the claims or use the so-called Article 8 procedure to address potential safety concerns.
The EC, on their own initiative, therefore decided to request an EFSA Scientific Opinion on the safety of hydroxyanthracene derivatives under Article 8 of Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. This procedure provides for the potential prohibition, restriction or placing under Community scrutiny, of substances other than vitamins or minerals when added to or used in the manufacture of foods, where these represent a risk to consumers.
EFSA has indicated a deadline of 30 June 2017 to deliver their opinion, and have just initiated discussions to identify the necessary expertise to conduct the assessment and establish a dedicated Working Group. The outcome of this assessment will determine if hydroxyanthracene derivatives will be added to Annex III of Regulation 1925/2006, and therefore be subject to prohibition, restrictions or scrutiny for use in foods including food supplements in the EU.