TECHNICAL REPORT APPROVED: 14 April 2015 PUBLISHED: 17 April 2015 Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006 Abstract European Food Safety Authority 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 a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (Oy Karl Fazer AB). The comments received were related to the claimed effect evaluated in the opinion, the food considered by the Panel, and the conditions of use which could not be established for the claim. EFSA has reviewed the scientific 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 19 September 2014, the NDA Panel concluded that a cause and effect relationship has been established between the consumption of almost any food and a reduction of post-prandial blood glucose responses as compared with glucose. However, the Panel considered that solid foods (including high-fibre sourdough rye bread) are generally not considered as an alternative to glucose solutions. In this context, conditions of use could not be established for this health claim. The comments received do not require any change to the conclusions of the NDA Panel. European Food Safety Authority, 2015 Key words: high-fibre sourdough rye bread, post-prandial glycaemic responses, blood glucose, health claims, comments Requestor: European Commission Question number: EFSA-Q-2015-00014 Correspondence: nda@efsa.europa.eu www.efsa.europa.eu/publications EFSA Supporting publication 2015:EN-796
Response to comments on the Scientific Opinion of a health claim related to high-fibre sourdough Acknowledgements: EFSA wishes to thank: Ambroise Martin and Sean (J.J) Strain for the support provided to this output. Suggested citation: EFSA (European Food Safety Authority), 2015. Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA supporting publication 2015:EN-796. 7 pp. European Food Safety Authority, 2015 www.efsa.europa.eu/publications 2 EFSA Supporting publication 2015:EN-796
Table of contents Abstract... 1 1. Introduction... 4 1.1. Background as provided by the European Commission... 4 1.2. Terms of Reference as provided by the European Commission... 4 2. Consideration... 4 2.1. Claimed effect evaluated in the opinion... 5 2.2. Food considered by the Panel... 5 2.3. Conditions of use for the claim... 6 3. Conclusions... 6 Documentation provided to EFSA... 7 References... 7 www.efsa.europa.eu/publications 3 EFSA Supporting publication 2015:EN-796
1. Introduction 1.1. 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. 1.2. 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). 2. Consideration On 19 September 2014, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted a Scientific Opinion on the scientific substantiation of a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses (EFSA NDA Panel, 2014) pursuant to Article 13(5) of Regulation (EC) No 1924/2006 1 following an application for authorisation from Oy Karl Fazer AB submitted via the Competent Authority of Finland (Claim serial number: 0405_FI, Question No EFSA-Q-2014-00012). 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 22 December 2014, 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 (Oy Karl Fazer AB). The comments received were related to the claimed effect evaluated in the opinion, the food considered by the Panel, and the conditions of use which could not be established for the claim. In line with the Terms of Reference as provided by the European Commission, EFSA addressed the comments which were of a scientific nature. EFSA has reviewed the scientific comments and shared them with the chair of the NDA Panel, Professor Ambroise Martin, and the chair of the NDA Working Group on Claims, Professor Sean (J.J.) Strain. 1 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. www.efsa.europa.eu/publications 4 EFSA Supporting publication 2015:EN-796
2.1. Claimed effect evaluated in the opinion The applicant commented that the proposed wording for the claim for which authorisation was sought was consumption of high-fibre sourdough rye bread contributes to the reduction of glycaemic responses accompanied with a decreased insulin response after a meal. The applicant also stated that it was not intended to seek a claim solely based on post-prandial glycaemic responses, but viewed together ( accompanied ) with a decreased insulin response. The applicant concurred that it might be correct that numerous foods do have glycaemic responses lower than glucose, as the NDA Panel indicated, but claims that the same is not true as regards to a reduced glycaemic response accompanied by a decreased insulin response. In its Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations (EFSA NDA Panel, 2012a), the NDA Panel indicated that claims on the reduction of post-prandial blood glucose responses refer to the ability of a food/constituent to reduce the blood glucose rise after consumption of a food or meal rich in digestible carbohydrates (i.e. in comparison to a reference food or meal). This ability may be considered a beneficial physiological effect (e.g. for subjects with impaired glucose tolerance) as long as insulin responses are not disproportionally increased. Therefore, claims on the reduction of post-prandial blood glucose responses as effected by a food/constituent are always considered in combination with the insulin responses elicited by the food/constituent (as far as the totality of the evidence is concerned). This was also stated in section 2 of the scientific opinion, i.e. the Panel considers that a reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionately increased) might be a beneficial physiological effect. It is noted that many carbohydrate-containing foods which induce a reduction of post-prandial blood glucose responses compared with glucose, e.g. by delaying the absorption of glycaemic carbohydrates, could reasonably be expected to also induce a reduction of post-prandial insulinaemic responses compared with glucose, which has already been recognised by the NDA Panel in previous opinions on this health relationship (EFSA NDA Panel, 2011b, c, 2012b). It is also noted that foods containing low amounts of carbohydrates or no available carbohydrates will also induce lower postprandial insulinaemic responses when compared with glucose. The comments received do not require any change to the considerations of the NDA Panel. 2.2. Food considered by the Panel The applicant commented that the submitted claim was for high-fibre sourdough rye bread, and not for other foods, that the submitted studies had been carried out with high-fibre sourdough rye bread and that EFSA was not requested to establish whether the claimed effect would also be applicable to other foods. It is noted that in the application high-fibre sourdough rye bread was proposed as the food to be considered as the subject of the health claim. However, for the substantiation of the claim, studies were submitted which assessed the ability of such breads to reduce post-prandial blood glucose responses in comparison with a glucose reference drink. In the opinion, the Panel noted that the consumption of high-fibre sourdough rye bread induced a significant reduction of post-prandial blood glucose responses when compared with glucose. Considering generally accepted scientific evidence, the Panel also noted that when comparable amounts of available carbohydrates from different carbohydrate-containing foods are tested, almost any carbohydrate-containing food (see also Atkinson et al., 2008) would induce a reduction of postprandial blood glucose responses compared with the blood glucose responses elicited by the consumption of glucose. In addition, the Panel noted that foods containing low amounts of carbohydrates or no available carbohydrates will also induce lower post-prandial blood glucose responses when compared with glucose. Therefore, the Panel concluded that the consumption of almost any food would lead to a reduction of post-prandial blood glucose responses as compared with glucose. www.efsa.europa.eu/publications 5 EFSA Supporting publication 2015:EN-796
In this context it is also noted that specificity is one of the essential aspects considered by the Panel in the scientific assessment of a cause and effect relationship between the consumption of a food/constituent and the claimed effect (EFSA NDA Panel, 2011a), which is in line with Regulation (EU) No 1169/2011 2 on the provision of food information to consumers, and in particular Article 7.1. Food information shall not be misleading, particularly by: (c) suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics, in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients. The comments received do not require any change to the conclusions of the NDA Panel. 2.3. Conditions of use for the claim The applicant indicated that in the studies which were submitted for the substantiation of the claim glucose was used as a reference food rather than as a comparator for a claim. The applicant also indicated that this methodological aspect related to the substantiation of the applied claim should not be seen as an obstacle to define the conditions of use for the applied claim. Furthermore, the applicant proposed as conditions of use for the claim 100 g of high-fibre sourdough rye bread (as specified in the application) to be consumed daily, which, according to the applicant, is in agreement with the dose ranges used in the submitted studies. During the scientific evaluation of the proposed health claim the applicant was informed that claims on the reduction of post-prandial blood glucose responses refer to the ability of a food/constituent to reduce the blood glucose rise after consumption of a food or meal rich in available carbohydrates in comparison with a reference food or meal, and that, therefore, such claims are considered comparative claims (EFSA NDA Panel, 2011a). The applicant was also informed that, in presenting such claims, applicants should take into account the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for the use of comparative claims 3, which specifies that a comparison may only be made between foods of the same category, that the notion of food category should also take account of the occasion of consumption and/or the purpose of the consumption, and that the reference product should be explicitly mentioned. In this context, the applicant was requested to specify and characterise the food/constituent that is the subject of the health claim and the food/constituent that is being used as the comparator (reference). In reply, the applicant indicated that glucose was the reference food with which the high-fibre sourdough rye bread should be compared in relation to the claimed effect. In its opinion, the Panel concluded that a cause and effect relationship has been established between the consumption of almost any food and a reduction of post-prandial blood glucose responses as compared with glucose. However, the Panel also considered that solid foods, including high-fibre sourdough rye bread, are generally not considered as an alternative (i.e. to be consumed on similar occasions and/or for the same purpose) to glucose solutions. In this context, the Panel could not establish conditions of use for this claim. The comments received do not require any change to the conclusions of the NDA Panel. 3. Conclusions In its opinion adopted on 19 September 2014, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that a cause and effect relationship has been established between the consumption of almost any food and a reduction of post-prandial blood glucose responses as compared with glucose. However, the Panel considered that solid foods, including high-fibre sourdough rye bread, are generally not considered as an alternative to glucose solutions. In this context, conditions of use could not be established for this health claim. The comments received do not require any change to the conclusions of the NDA Panel. 2 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. OJ L 304, 22.11.2011, p. 18 63. 3 Guidance on the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods Conclusions of the Standing Committee on the Food Chain and Animal Health, 14 December 2007. www.efsa.europa.eu/publications 6 EFSA Supporting publication 2015:EN-796
Documentation provided to EFSA 1. Comments submitted to the European Commission by Oy Medfiles Ltd on behalf of the applicant Oy Karl Fazer AB. References Atkinson FS, Foster-Powell K and Brand-Miller JC, 2008. International tables of glycemic index and glycemic load values: 2008. Diabetes Care, 31, 2281-2283. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011a. General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal 2011;9(4):2135, 24 pp. doi:10.2903/j.efsa.2011.2135 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011b. Scientific Opinion on the substantiation of health claims related to arabinoxylan produced from wheat endosperm and reduction of post-prandial glycaemic responses (ID 830) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6):2205, 15 pp. doi:10.2903/j.efsa.2011.2205 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2011c. Scientific Opinion on the substantiation of health claims related to beta-glucans from oats and barley and maintenance of normal blood LDL-cholesterol concentrations (ID 1236, 1299), increase in satiety leading to a reduction in energy intake (ID 851, 852), reduction of post-prandial glycaemic responses (ID 821, 824), and digestive function (ID 850) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(6):2207, 21 pp. doi:10.2903/j.efsa.2011.2207 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012a. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal 2012;10(3):2604, 11 pp. doi:10.2903/j.efsa.2012.2604 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2012b. Scientific Opinion on the substantiation of health claims related to alpha-cyclodextrin and reduction of post-prandial glycaemic responses (ID 2926, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2012;10(6):2713, 17 pp. doi:10.2903/j.efsa.2012.2713 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to high-fibre sourdough rye bread and reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2014;12(10):3837, 11 pp. doi:10.2903/j.efsa.2014.3837 www.efsa.europa.eu/publications 7 EFSA Supporting publication 2015:EN-796