TECHNICAL REPORT. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

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1 EFSA supporting publication 2014:EN-550 TECHNICAL REPORT Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/ European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Following a request from the European Commission, EFSA was asked to address the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (Vivatech) and from academia (Champy et al.). The comments received were related to the food which was the subject of the claim, the use of proprietary data, and the risks associated with the consumption of hydroxyanthracene derivatives. EFSA has reviewed and shared these comments with the chair of the NDA Panel and the chair of the NDA Working Group on Claims. In its Opinion adopted on 09 October 2013, the NDA Panel concluded that a cause and effect relationship has been established between the consumption of hydroxyanthracene derivatives and improvement of bowel function. The comments received do not require any change to the conclusions of the NDA Panel. European Food Safety Authority, 2014 KEY WORDS Transitech, hydroxyanthracene derivatives, bowel function, health claims, comments On request from the European Commission, Question No EFSA-Q , approved on 17 January Correspondence: nda@efsa.europa.eu Acknowledgement: EFSA wishes to thank: Ambroise Martin and Sean (J.J) Strain for the support provided to this output. Suggested citation: European Food Safety Authority, 2014; Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA supporting publication 2014:EN pp. Available online: European Food Safety Authority, 2014

2 TABLE OF CONTENTS Abstract... 1 Table of contents... 2 Background as provided by the European Commission... 3 Terms of reference as provided by the European Commission... 3 Consideration Introduction Food which was the subject of the claim Use of proprietary data Risks associated with the consumption of hydroxyanthracene derivatives... 5 Conclusions... 6 Documentation provided to EFSA... 6 References... 6 Abbreviations... 7 EFSA supporting publication 2014:EN-550 2

3 BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION Article 16(6) of Regulation (EC) No 1924/2006 on nutrition and health claims states that: "The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public. The applicant or members of the public may make comments to the Commission within 30 days from such publication. The Regulation does not foresee a consultation on the EFSA opinion. It does, however, allow for the applicant or members of the public to make comments to the Commission relating to the EFSA opinion. The Commission s services have established a practice for handling the comments provided by applicants and members of the public in order to allow their full consideration by the regulators in the health claims' authorisation process. More particularly, whenever the comments relate to the scientific assessment they are transmitted to EFSA for consideration. The Commission and the Member States await the EFSA response to the comments before proceeding with the final discussion and the vote in the Standing Committee on the Food Chain and Animal Health on the draft measure authorising or rejecting the health claims for which comments were made. The procedure briefly outlined above is in line with the procedure foreseen in Article 31 of Regulation (EC) No 178/2002, whereby the Authority may be requested by the Commission to provide scientific or technical assistance in any field within its mission, and when the matter does not require scientific evaluation by a Scientific Committee or a Scientific Panel. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION The Commission requests EFSA, within the framework of scientific and technical assistance to the Commission foreseen in Article 31 of Regulation (EC) No 178/2002, to evaluate the comments of a scientific nature received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 and to provide the Commission with a response. Relevant actions performed under this mandate will be carried out in good cooperation between the Commission and EFSA in accordance with the procedure set out in the Annex to the Mandate (to be found in the EFSA Register of Questions under mandate number M ). EFSA supporting publication 2014:EN-550 3

4 CONSIDERATION 1. Introduction On 09 October 2013, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted a Scientific Opinion on the scientific substantiation of health claims related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/ following an application for authorisation from Vivatech submitted via the Competent Authority of France (Claims serial number: 0392_FR, EFSA-Q ). In accordance with Article 16 of Regulation (EC) No 1924/2006, the applicants or members of the public may make comments to the European Commission on opinions published by the Authority pursuant to Articles 16 and 18 of the Regulation. On 23 December 2013, the European Commission requested EFSA to respond to the scientific comments received during the commenting period specified in Article 16 of the Regulation. Comments submitted to EFSA via the European Commission Services originated from the applicant (Vivatech) and from academia (Pierre Champy, Alexandre Maciuk (Université Paris-Sud), Sabrina Boutefnouchet (Université Paris René-Descartes), Thierry Hennebelle (Université Lille 2 Droit et Santé)). The comments received were related to the food which was the subject of the claim, the use of proprietary data, and the risks associated with the consumption of hydroxyanthracene derivatives. EFSA has reviewed and shared these comments with the chair of the NDA Panel, Prof Ambroise Martin, and the chair of the NDA Working Group on Claims, Prof Sean (J.J.) Strain. 2. Food which was the subject of the claim The applicant argued that the Panel failed to recognise the effect on bowel function of the specific combination of ingredients contained in Transitech, even though an effect on bowel function was observed in a human intervention study performed with Transitech and submitted by the applicant for the scientific substantiation of the claim. The applicant also argued that as the Panel attributed the effect on bowel function to only one of the ingredients contained in Transitech (i.e. hydroxyanthracene derivatives) there was no need for the applicant to characterise the food which was the subject of the claim, i.e. Transitech, with respect to all of its ingredients, as requested by the Panel. EFSA notes that the food which was the subject of the claim, and which was evaluated by the Panel, was Transitech. The applicant claimed that the constituents in Transitech responsible for the claimed effect were hydroxyanthracene derivatives derived from Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, and fructo-oligosaccharides derived from Althaea officinalis L. and Cynara scolymus L. The applicant also indicated that other ingredients in Transitech were added in order to prevent bloating, flatulence and spasms. In order for the Panel to evaluate the effect claimed by the applicant for the food, Transitech, the food needs to be characterised with respect to all of its ingredients and not only with respect to a single ingredient with a well-established role in the claimed effect (i.e. hydroxyanthracene derivatives). As detailed in the opinion, the human intervention study which investigated the effect of Transitech on bowel function was not designed to establish whether the combination of ingredients in Transitech exerts an effect on bowel function beyond the well-established effect of hydroxyanthracene derivatives or whether the use of Transitech would lead to a lower incidence of untoward effects of hydroxyanthracene derivatives. 4 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ L 404, , p EFSA supporting publication 2014:EN-550 4

5 In the comments submitted to EFSA via the European Commission, the applicant argues that the presence of reports or monographs on the traditional use of some of the ingredients in Transitech other than hydroxyanthracene derivatives in indications such as constipation or gastro-intestinal discomfort would be sufficient to establish that Transitech exerts an effect on bowel function beyond the effect of hydroxyanthracene derivatives, and that it leads to a lower incidence of abdominal pain and passage of liquid stools. EFSA notes that there is no scientific substance to this argument as no active control using hydroxyanthracene derivatives alone was used to compare with the effects of Transitech in the aforementioned study which was claimed as proprietary by the applicant. 3. Use of proprietary data The comments from the applicant also included a request to consider the study by Alexandre et al. (2011, unpublished, claimed as proprietary) conducted with Transitech as essential in establishing the conditions of use proposed by the Panel of 10 mg hydroxyanthracene derivatives per day. The applicant indicated that the monographs by the European Medicines Agency (EMA) and the World Health Organization (WHO) upon which the assessment of the Panel was based did not indicate a precise dose but a dose range, and therefore the study by Alexandre et al. (2011, unpublished) would have been needed to establish the conditions of use. EFSA notes that the study by Alexandre et al. (2011, unpublished) was neither used by the Panel to establish a cause and effect relationship between the consumption of hydroxyanthracene derivatives and improvement of bowel function nor used to establish conditions of use. The effect of hydroxyanthracene derivatives on bowel function is well established and the conditions of use were based on the lowest dose indicated to be effective either by EMA or by WHO. Moreover, the evaluation of the Panel was not restricted to Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids, as contained in Transitech, but extended to other sources of hydroxyanthracene derivatives with hydroxyanthracene derivative profiles different from Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids with a well established effect on bowel function. The applicant also agreed in the comments submitted to EFSA via the European Commission that the effect of these substances on bowel function was well established. 4. Risks associated with the consumption of hydroxyanthracene derivatives The comments received from academia related to the well known risks of hydroxyanthracene derivatives, such as impaired function of the intestine and dependence on laxatives, to the lack of a statement by the Panel on potential drug interactions, to the lack of a statement on a maximum daily dose, and to the lack of a statement on the use of hydroxyanthracene derivatives in different population groups, including children and pregnant women and to the legal classification of plants containing hydroxyanthracene derivatives as food supplements. EFSA notes that the assessment of the safety of the food which is the subject of a claim is outside the scope of the scientific evaluation carried out by EFSA within the framework of Regulation (EC) No 1924/2006, as is the determination of the legal classification of the substance. However, EFSA can propose restrictions of use, as was done for the scientific opinion to which this report relates. It is the task of risk managers to take into account in the authorisation process other legitimate factors relevant to the matter, such as the safety of a substance. EFSA supporting publication 2014:EN-550 5

6 CONCLUSIONS In its Opinion adopted on 09 October 2013, the NDA Panel concluded that a cause and effect relationship has been established between the consumption of hydroxyanthracene derivatives and improvement of bowel function. The comments received do not require any change to the conclusions of the NDA Panel. DOCUMENTATION PROVIDED TO EFSA Comments submitted to the European Commission by Vivatech, and by Pierre Champy, Alexandre Maciuk (Université Paris-Sud), Sabrina Boutefnouchet (Université Paris René-Descartes) and Thierry Hennebelle (Université Lille 2 Droit et Santé). REFERENCES Alexandre V, Bouchoucha M, Levy V and Benamouzig R, 2011, unpublished. Randomized doubleblind placebo-controlled trial to assess the efficacy of a food supplement on transit in participants presenting disturbed bowel movements and the persitence of such effect. EFSA supporting publication 2014:EN-550 6

7 ABBREVIATIONS EMA European Medicines Agency WHO World Health Organization EFSA supporting publication 2014:EN-550 7