Supporting Publications 2013:EN-423 TECHNICAL REPORT OF EFSA 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 monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006 1 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 review 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 monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (Nutraveris Sarl on behalf of Sylvan Bio Europe BV). The comments received indicated that the conditions of use for the claim set by the NDA Panel did not take into account evidence of a potential effect on blood LDL-cholesterol of concentrations of monacolin K below a daily dose of 10 mg. EFSA has reviewed the comments and shared them with the chair of the NDA Panel and the chair of the NDA Working Group on Claims. In its opinion adopted on 24 January 2013, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that a cause and effect relationship has been established between the consumption of monacolin K in red yeast rice preparations, which include SYLVAN BIO red yeast rice, and maintenance of normal blood LDL-cholesterol concentrations. The Panel considered that in order to obtain the claimed effect, 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily. The comments received do not change the conclusions of the NDA Panel. European Food Safety Authority, 2013 KEY WORDS Red yeast rice, Sylvan Bio, monacolin K, LDL-cholesterol, health claims, comments 1 2 3 On request from the European Commission, Question No EFSA-Q-2013-00366, approved on 08 May 2013. Correspondence: nda@efsa.europa.eu Acknowledgement: EFSA wishes to thank: Ambroise Martin and Sean (J.J.) Strain for the support provided to this technical report. Suggested citation: European Food Safety Authority, 2013; 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 monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA supporting publication 2013:EN-423. 5 pp. Available online: http://www.efsa.europa.eu/publications. European Food Safety Authority, 2013
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... 4 1. Introduction... 4 2. Comments related to the conditions and restrictions of use... 4 Conclusions... 5 Documentation provided to EFSA... 5 References... 5 EFSA Supporting Publications 2013:EN-423 2
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-2011-0063). EFSA Supporting Publications 2013:EN-423 3
CONSIDERATION 1. Introduction On 24 January 2013, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted a Scientific Opinion on the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006 4 (EFSA NDA Panel, 2013) following an application for authorisation from Sylvan Bio Europe BV submitted via the Competent Authority of the Netherlands (Claims serial number: 0361_NL, EFSA-Q-2012-00736). 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 15 April 2013, the European Commission requested EFSA to respond to the scientific comments received during the commenting period specified in Article 16 of the Regulation. EFSA has reviewed the comments and shared them 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. Comments related to the conditions and restrictions of use The comments received indicated that the conditions of use for the claim set by the NDA Panel did not take into account evidence of a potential effect on blood LDL-cholesterol of concentrations of monacolin K below a daily dose of 10 mg. It should be noted that three (Heber et al., 1999; Lin et al., 2005; Bogsrud et al., 2010) of the five human intervention studies referred to in the comments were not part of the evaluation of the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations. The two remaining studies showed an effect of monacolin K in SYLVAN BIO red yeast rice on blood LDL-cholesterol concentrations at doses of about 9 mg per day (Myers et al., 2006, unpublished) and of about 10 mg per day (Becker et al., 2009). As already stated in the opinion, this is in the range of the doses used in the two human intervention studies (Heber et al., 1999; Lin et al., 2005) which were evaluated by the Panel to set conditions of use of 10 mg monacolin K per day for a claim on monacolin K from red yeast rice preparations in general and maintenance of normal blood LDLcholesterol concentrations (EFSA NDA Panel, 2011). It is also argued in the comments that in the Panel s previous opinion on monacolin K from red yeast rice preparations in general (EFSA NDA Panel, 2011), the conditions of use should have been based on the human intervention study in which a statistically significant effect of 7.2 mg/day of monacolin K in red yeast rice preparation on blood LDL-cholesterol concentrations was observed. In this respect, it should be noted that also when setting conditions of use, the Panel takes into account and weighs the totality of the available scientific evidence. In this specific case, the Panel took into account the evidence provided by two human intervention studies (Heber et al., 1999; Lin et al., 2005) at doses of around 7.5 and 11.5 mg/day monacolin K, as well as the lowest dose of lovastatin (pure monacolin K) which has been shown consistently to reduce LDL-cholesterol concentrations in the target population (i.e. 10 mg/day). 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, 30.12.2006, p. 9 25. EFSA Supporting Publications 2013:EN-423 4
CONCLUSIONS In its opinion adopted on 24 January 2013, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that a cause and effect relationship has been established between the consumption of monacolin K in red yeast rice preparations, which include SYLVAN BIO red yeast rice, and maintenance of normal blood LDL-cholesterol concentrations. The Panel considered that in order to obtain the claimed effect, 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily. The comments received do not change the conclusions of the NDA Panel. DOCUMENTATION PROVIDED TO EFSA Comments submitted to the European Commission by Nutraveris Sarl. REFERENCES Becker DJ, Gordon RY, Halbert SC, French B, Morris PB and Rader DJ, 2009. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Annals of Internal Medicine, 150, 830-839, W147-839. Bogsrud MP, Ose L, Langslet G, Ottestad I, Strom EC, Hagve TA and Retterstol K, 2010. HypoCol (red yeast rice) lowers plasma cholesterol - a randomized placebo controlled study. Scandinavian Cardiovascular Journal, 44, 197-200. EFSA NDA Panel (EFSA Panel on Dietetic Products Nutrition and Allergies), 2011. Scientific Opinion on the substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations (ID 1648, 1700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 9(7):2304, 16 pp. EFSA NDA Panel (EFSA Panel on Dietetic Products Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(2):3084, 13 pp. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM and Go VL, 1999. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. American Journal of Clinical Nutrition, 69, 231-236. Lin CC, Li TC and Lai MM, 2005. Efficacy and safety of Monascus purpureus Went rice in subjects with hyperlipidemia. European Journal of Endocrinology, 153, 679-686. Myers SP, Cheras PA, Brooks L and O'Connor J, 2006, unpublished. Study on the Safety and Efficacy of Sylvan Red Yeast Rice in Adults with Primary Hypercholesteremia (claimed as proprietary by the applicant). EFSA Supporting Publications 2013:EN-423 5