Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplements

Aloe Jaume is a producer and processing company for the raw material of Aloe Vera with more than 30 years of experience. Europe is one of our main markets and we are very concerned about the recent opinion of the European Commission on the products of Aloe Vera.

Filed in Spanish · English published by the European Commission

We support the European Commission's intention to regulate potentially harmful substances in the context of food as consumer protection. is a goal that we share and support. Unfortunately, the EFSA opinion (EFSA Journal 2018;16(1):5090)) does not take all of the available information concerning the safety of hydroxyanthracene derivatives (HADs) into account.

The Vis Medicatrix naturae s.r.l. appreciates the opportunity given by the European Commission to participate in the consultation on the draft regulation proposing the amendment of Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species and extracts from Aloe containing derivatives that contain anthracenic derivatives (HAD).

Filed in Italian · English published by the European Commission

Forever Living entities (“Forever”) has commercialized beverages based on the inner juice of the Aloe vera leaf for over 35 years. Given that Aloe vera juice is not an “extract” according to normal standards of food processing and EU law, we understand that our products are not covered by this draft Regulation.

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…

SUMMARY OF COMMENTS INSTITUT KURZ GmbH, based in Cologne, on behalf of the company LR Health & Beauty headquartered in Ahlen, is pleased to have the opportunity to contribute to the European Commission’s feedback consultation on the Commission's draft regulation which proposes the modification of Annex III of the regulation (EC) n.

The Association of the European Self-Care Industry (AESGP) appreciates the opportunity provided by the 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 botanical species containing hydroxyanthracene derivatives (HAD).

Food Supplements Europe represents the sector of Food Supplements in the EU. We welcome the opportunity to comment on this proposal. However, this consultation comes at a moment where companies are highly affected by the COVID-19 outbreak, which has made it difficult to gather all relevant information within the short timeframe of this consultation.

Arbeitskreis Nahrungsergänzungsmittel (AK NEM) is part of Food Federation Germany (Lebensmittelverband Deutschland e. V.) and represents the German food supplement sector. AK NEM’s membership includes the leading brand and contract manufacturers, raw material suppliers and legal and scientific advisors to the sector. AK NEM is concerned about the proposed prohibition of all foods containing extracts of Aloe spp.

As one of the largest German law firms specialised in food law, we comment on the draft Regulation amending Annex III of Regulation (EC) No 1925/2006. For our client LR Health & Beauty Systems GmbH we have analysed the legality of the planned law act.

On behalf of LR Health & Beauty Systems GmbH, a major producer of food products from Aloe vera, I take the opportunity to submit comments to the draft Regulation. As a summary we conclude that EFSA based its risk assessment on an exposition with hydroxyanthracene derivatives, which differs from the amount of hydroxyanthracene derivatives that can be found in Aloe vera gels from the inner leaf fillet, which contains…

On behalf of its members, the International Aloe Science Council (IASC) appreciates the opportunity to provide feedback to the European Commission’s March 4, 2020 announcement of the draft regulation titled “Amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives.” Based on the detailed comments provided…

We deliver the Commission for the opportunity to give our feedback on the Draft amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council regarding Botanical species containing hydroxy anthracene derivatives. Our comments are detailed below.

Filed in French · English published by the European Commission

The European Federation of Associations of Health Product Manufacturers EHPM, EU stakeholder registered on the EU Transparency Register (No. 65512466920-96) would like to submit its contribution in the context of the consultation on the proposed draft Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing Hydroxyanthracene…

Dear Madam, Dear, Oxyslow is a company active in the field of plant extracts and food supplements. The company was developed on the basis of this research on crop extracts rich in polyphenols of interest, which enabled natural ingredients to be identified which concentrate on active ingredients which could have positive effects on health. In particular, Oxyslow has developed a characterised grenade extract.

Filed in French · English published by the European Commission

We are a Belgian company importing granulated herbal extracts from Taiwan since 1989. In our catalog we carry various species containing hydroxyanthraquinones (HA) like Rheum palmatum, Aloe vera, Cassia senna and Polygonatum or Fallopia spp. Every batch is being tested to secure the content and conformity standard of the concentrated polar extraction, as traditionally required.

Dear Madam, Sir, We would like to ask you to follow up on the proposal for the revision of Annex III to Regulation (EC) No 1925/2006 concerning hydroxyanthracenic derivatives contained in certain botanical species. We are concerned that this impact will have an impact on the activities of the companies with which we are working, but also on our own activities if clarifications are not provided.

Filed in French · English published by the European Commission

Comments by Pharmos Natur Green Luxury GmbH, Bernried am Starnberger See, Germany, on supplementing the following regulation: Amending Annex III to Regulation EC No 1925/2006 of the European Parliament and of the Council as regards Botanical species containing hydroxyantrhacene derivatives The European Commission’s draft on the ban on Aloe Vera is based on an EFSA opinion.

Filed in German · English published by the European Commission

Coswell S.p.A. is an Italian company established in 2006 out of the long experience of Guaber S.p.A., a company founded in 1961, to provide consumers high-quality products for personal care and well-being. The company operates in three main branches: toiletries, oral care and food to develop unique and innovative brands based on Nature, Science and Tradition, combined together for a modern wellbeing.

As a company we absolutely support any action taken to ensure consumer safety, however we are concerned that the wording of proposal is too broad and could inadvertently sweep up widely used, well established supplements and foods containing negligible amounts of HAD. The proposal in its present form is therefore potentially disproportionate and may have consequences beyond those intended

The EFSA opinion on HAD from 2017, including the inclusion of HAD in Annex III, Part A to Regulation (EC) No 1925/2006, is based on incomplete and unreliable data. The introduction of a total ban would not be the least restrictive measure at this point in time.

Filed in German · English published by the European Commission

LR Health & Beauty Systems GmbH welcomes the opportunity to participate in the Feedback Consultation process opened the 4th of March 2020 by the European Commission on a proposal amending Annex III to Regulation (EC) 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods.

Herbalife Nutrition values the European Commission’s (EC’s) attention to potential health concerns associated with foods and food supplements containing high levels of hydroxyanthracene derivatives (HAD). However, we have serious concerns about the draft proposal effectively prohibiting all preparations of Aloe spp.

AOAC INTERNATIONAL is a globally recognized, 501(c)(3), independent, third party, not-for-profit association and voluntary consensus standards developing organization. Founded in 1884, AOAC INTERNATIONAL provides a forum for finding appropriate science-based analytical solutions - principally the development of microbiological and chemical method performance standards - when needs arise within a food safety/food…

The European Flavour Association (EFFA) is the voice of the European flavour industry in Europe, leading a Europe-wide strategy to the benefit of the flavour industry, its customers and consumers alike. Our members are Flavour Houses and National Flavour Associations from across Europe, representing 12 European countries.

The Council for Responsible Nutrition UK (CRN UK) is a trade association based in the United Kingdom (UK), whose members market food supplements, functional foods and their ingredients in the UK, across the whole of the European Union (EU) and globally. CRN UK and its members consider the safety of consumers to be paramount when placing products on the market.

The National Association of the Food Supplements Industry (Asociación Nacional de la Industria de Suplementos Alimenticios: ANAISA) was created on September 20, 2011, to promote the growth of the food supplement industry.

The Latin American Alliance for Responsible Nutrition -ALANUR- is the main regional association of the food supplements sector in Latin America. It was founded in 2011 with the purpose of contributing to the development of regulatory frameworks that ensure the responsible access of food supplements and ingredients in the region.

The Council for Responsible Nutrition (CRN) appreciates the opportunity to provide input on amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (HAD).

AFEPADI is the first business association of food supplements and dietary products in Spain, who represents the Companies operating in the Spanish market whose activity is directly related to food supplements and dietary products, both in their manufacturing, distribution and related services.

We welcome and support the European Commission consistent prioritisation of health and well-being of consumers in its actions, and we support the Commission work by applying new legal requirements. In view of the ongoing consultation, we would like to point to some concerns related to the recent proposal of the Commission Regulation Amending Annex III to Regulation (EC) No 1925/2006 as Regards Botanical Species…

Equilibra Srl, Italian company operating in the food supplements market and leader in Italy in the Aloe gel-based products, through the Feed-back mechanism regarding the Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplement submits to this Commission the TEFARCO INNOVA - National Inter-University Consortium of Innovative Pharmaceutical Technologies - paper.

The American Botanical Council (ABC) is an independent, international nonprofit research and education organization which provides reliable science-based information about the safe and responsible use of medicinal plants, phytomedicines, and related natural plant- and fungal-based ingredients and their products to researchers, educators, government agencies, healthcare professionals, industry, the media, and the…

Independent Retail Europe is the voice of groups of independent retailers in the food as well as non-food sectors at EU level. We welcome that the European Commission is consistently prioritising the health and well-being of consumers in all of its actions. The retail sector is its powerful ally in this pursuit.

Unione Italiana Food represents 450 companies, more than 20 food categories, with 35 billion euros of turnover, including 10 billion euros of export turnover, and 65.000 employees. - The impact of the ban envisaged in the proposal is very extensive if we consider that derivatives of Aloe spp.

Veracetics is a Spanish company, a pioneer in the development of Aloe vera products and with an R&D department that has allowed it to develop Aloe vera products with low aloin content. However, we believe that: - Aloe vera is beneficial for health as proven by research carried out by this company and corroborates existing bibliography. - Aloin banning is only found in specific research and is not generalized.

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…

From a literature[1] search, it is evident that aloe-emodin and emodin (belonging to anthraquinones, a class of naturally occurring phenolic coumpounds) are present in many plant families, genera and species. The lack of validated analytical methods able to assess the content of individual anthranoids, does not allow to evaluate the impact of the proposal on many plants and products that are regularly traded in the…

ICADA, the international association for cosmetic products, cosmetic devices and food supplements, representing over 600 global small and medium size enterprises We are against a ban on aloe vera products on the European market. Products based on the inner aloe vera gel and products based on the whole leaf both decolorized contain aloin level ≤ 5 ppm.

Follow up to “Brief commentary on the Scientific Opinion Safety of hydroxyanthracene derivatives for use in food" A follow up to what had been prepared for the European Commission and circulated by the Italian Ministry of Health among Member States months ago (https://sitox-site.s3.eu-central-1.amazonaws.com/allegati/Commentary+HADs.pdf) to renew the appeal to consider the need to apply scientific robust evidences…

As a company active in mining, we wish to draw your attention to the fact that the text is not sufficiently precise and that it could have far-reaching consequences for our sector if it were published as such. We would like to draw your attention to 4 critical aspects of this proposal: 1. A need to clarify the situation in relation to the Emodin and Aloe-emodin components.

Filed in French · English published by the European Commission

The Commission’s intervention is requested in order to provide a clearer legal framework since, as things stand, the proposal for a regulation is almost inapplicable. The Commission should make it clear which plants and parts of plants will be prohibited, so as to ensure that operators in the sector do not behave in a scattered manner.

Filed in Italian · English published by the European Commission

Our laboratory has been selling the Abbé Perdrongeon contract since 1879 and therefore has extensive history of use. The product has existed since 1859, giving it more than 160 years of use on millions of users. Since that date and until 1998, this herbal medicinal product containing, inter alia, aloe, has been sold and used in two external and internal uses. In 1998, as a medicine, only external use was retained.

Filed in French · English published by the European Commission

Elsenborn, the 16/04/2020 REF : Feed-back mechanism regarding the Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplements Dear Madam, Sir As all SMEs in Europe and in the world, we are currently strongly affected by the global Covid-19 health crisis.

Proposed Art.8.HAD DRAFT (EC) No 1925/2006 EC — amending Annex III to Regulation (EC) No 1925/2006 EC — amending Annex III to Regulation (EC) No SANTE/10860/2018 is likely to interfere with the free movement of goods and to restrict certain consumers in a discriminatory manner, in breach of, inter alia, Article 26 (2), Article 36, last sentence, Article 37, Article 67 (1), Article 169 of the Treaty on the…

Filed in Czech · English published by the European Commission

Česká asociace pro speciální potraviny/Czech Association for Special Foods (CASP) is the interest association of natural persons as food operators that was established in year 2 000 and it is representing the common interests of its members, mainly manufacturers and distributors of Food Supplements at national and international level.

It would be our utmost wish to take the chance and comment the intended changes concerning the use of botanical species containing hydroxyanthracene derivatives in food products. Even though we are a pharmaceutical industry association we suspect that herbal medicinal products may be affected by the classification of herbal substances and their preparations to be used in food products.

Na Group, composed by Nova Argentia SPA and AEFFE Farmaceutici S.r.l., is a pharmaceutical company committed on the development and manifacture of several pharmaceutical products, food supplements, medical devices.

Naturae is a food industry. It is aware of this new legal situation that directly affects products with aloe vera and it wants to show our point of view to the European Commission: 1.The EFSA reevaluation is inconclusive on the following points: a.It has obviated to evaluate the risk of the majority products on the market (aloe vera juices purified or made exclusively with the inner gel (without rind).

Aboca is an Italian healthcare company based in Sansepolcro, province of Arezzo, Tuscany. Aboca was established 40 years ago with the aim of searching for human health solutions in natural substances, based on scientific evidence and developed according to the Systems Medicine and the Systems Biology approach. The company has more than 1500 and the products are sold in 16 Countries, in and outside Europe.

Public comment by Korea Health Supplements Association As the only trade association for the health functional food industry in Korea, the Korea Health Supplements Association (KHSA) would like to produce contrary evidences against the EFSA’s scientific conclusion on the safety of aloe, and hereby submit our comment on the EC draft amendment to prohibit the use of aloe in food and food supplements. 1.