Botanical extracts \ Ingredients - N°64 and-see strategy been emerging. This procedure is applicable if •Hydroxyanthracene Derivatives (HAD): HADs a substance is added to a food and may pose are found in various plants, such as rhubarb, aloe a potential risk to the consumer. The European vera, senna. EFSA delivered its opinion on 23 Commission can then request EFSA to assess its January. An opinion that is not positive since it safety and then decide, based on the conclusions concludes that “the current datado not elimi- of its opinion, to include it in one of the parts of nate the risks for these substances,” except for Annex III to Article 8. Annex III of Article 8 allows rhein. Nevertheless, the European Commission for substance classifi cation into three categories, was notifi ed that EFSA’s evaluation has certain Prohibited Substances (Part A), Restricted Subs- shortcomings: lack of consideration of plant spe- tances (Part B), and Substances under Com- cifi cities (matrix effect) and of the non-equiva- munity Scrutiny (Part C). When the Commission lence of HADs, as the evaluation had been mainly includes a substance in Part C, operators have performed on danthrone. 18 months to provide further data and thereby As EFSA’s opinion has been issued, the EC must allow for a re-evaluation by EFSA. now take a stand as to these substances and decide whether or not to place them under the A few opinions scope of Article 8 (a substance that is prohibited or restricted or under community scrutiny). The Since its enactment, EFSA has received fi ve European Commission was to present its position reports asking the agency to carry out safety to the Member States on 22 June. The Member evaluations. Four evaluations have already led States will then vote to validate or not the decision to published opinions and an evaluation is still of the Commission. ongoing: •Green tea catechins: EFSA issued its opinion •Ephedra: EFSA has issued an opinion and the on their safety evaluation on 18 April, concluding 109 European Commission has included the plant in that the consumption of catechins (between 90 Part A of Annex III: Prohibited Substances. and 300 mg of EGCG) from infusions is safe. The •Yohimbine: EFSA concluded that it did not have experts concluded that there was no indication enough data to carry out an evaluation, the plant of liver injury for doses below 800 mg of EGCG/ was therefore included in Part C: Under Commu- day. Nevertheless, the panel cannot conclude on nity Scrutiny, a call for data was then launched a safe dose of EGCG from dietary sources. In but no new data has been transmitted to EFSA, France, the Decree on Plants frames this ingre- so that the plant will surely be included in Part dient with a maximum content of 300 mg EGCG A, namely Prohibited Substances. and labelling mentions. EFSA considers the dose News on Functional & Health Ingredients \ N°64 \ July - August - September 2018 \ ■