ASSOERBE
Fondata nel 1981, ASSOERBE è l’unica associazione nazionale di categoria che rappresenta le aziende italiane che operano nel settore delle piante medicinali, aromatiche e da profumo, delle spezie, degli estratti vegetali, degli oli essenziali e dei loro derivati per l'impiego in alimenti, integratori, cosmetici, farmaci, dispositivi medici e mangimi.
ID: 558397412572-26
Lobbying Activity
21 Apr 2020
ASSOERBE's response to the initiative promoted by the European Commission as regards extracts containing hydroxyanthracene derivatives.
Founded in 1981, ASSOERBE is the Italian trade association that includes among its members: growers, collectors, manufacturers, importers, exporters and traders of medicinal, aromatic and perfume plants, spices, extracts, essential oils and derived products such as: food and feed, food supplements, cosmetics, medicinal products, medical devices and biocides.
ASSOERBE is pleased to have the opportunity, provided by the European Commission, to comment on the draft Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards extracts containing hydroxyanthracene derivatives.
ASSOERBE is certainly critical whenever natural substances of a millenary tradition of use in foods and not only, risk to be prohibited on the base of an uncertain risk assessment without take into account the complex interactions between phytochemicals, the actual exposure and the more recent scientific evidences.
However, we are deeply aware that EFSA’s conclusion, although considered reasonable at the time of evaluation, may prove to be incorrect. We feel it is our duty to contribute submitting to the Commission more appropriate research and comprehensive scientific data. But we need more time to take up this challenge fielding our experience and involving eminent scientific experts.
Consideration
The proposal of the European Commission subject to public consultation provides in Art. 1(1) that the following products: 'aloe-emodin and all extracts in which this substance is present'; 'emodin and all extracts in which this substance is present'; 'extracts from the leaf of Aloe species containing hydroxyanthracene derivatives'; "danthron and all extracts in which this substance is present" are included in Annex III part A of REGULATION (EC) No. 1925/2006.
The EFSA scientific opinion adopted on 22 November 2017 (EFSA Journal 2018; 16 (1): 5090), to which the proposal is clearly inspired, pointed out, as clearly reported in the conclusions (EFSA Journal 2018; 16 (1): 5090 - page 69) the persistent uncertainty regarding the adverse health effects of hydroxyanthracene derivatives.
Article 8 (b) of REGULATION (EC) No. 1925/2006 provides clear indications that where scientific uncertainty exists, substances should be included in Annex III, Part C. This decision will enable, as provided in Article 8 (4), food business operators to develop studies and produce scientific data demonstrating the safety of the substances under scrutiny, and submit them for evaluation taking into account the provision of the Article 8 (5).
Considering the above, ASSOERBE recommends to place the substances and extracts listed in the article 1 (1) of the European Commission proposal ('aloe-emodin and all extracts in which this substance is present'; 'emodin and all extracts in which this substance is present'; 'extracts from the leaf of Aloe species containing hydroxyanthracene derivatives'; ‘danthron and all extracts in which this substance is present’) in Part C of the Annex III of Regulation (EC) No 1925/2006.
ASSOERBE
Via Francesco Ferrucci 22-20145 Milano (Italy)
Tel. +39.02.8130508
email assoerbe@assoerbe.eu
Web www.assoerbe.eu
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