PLENARY MEETING OF THE SCIENTIFIC PANEL ON DIETETIC PRODUCTS, NUTRITION AND ALLERGIES HELD ON 30 SEPTEMBER & 1-2 OCTOBER 2008

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1 Panel on Dietetic products, Nutrition and Allergies 2 October 2008 MINUTES OF THE 22 ND PLENARY MEETING OF THE SCIENTIFIC PANEL ON DIETETIC PRODUCTS, NUTRITION AND ALLERGIES HELD ON 30 SEPTEMBER & 1-2 OCTOBER 2008 PARTICIPANTS Panel members: Jean-Louis Bresson, Albert Flynn Marina Heinonen Karin Hulshof Hannu Korhonen Pagona Lagiou Martinus Løvik Rosangela Marchelli Ambroise Martin Andreu Palou Hildegard Przyrembel Sean (J.J.) Strain Stephan Strobel Inge Tetens Henk van den Berg Hendrik van Loveren Hans Verhagen EFSA staff: Juliane Kleiner Wolfgang Gelbmann Leng Heng Emanuela Turla Silvia Valtueña Martínez Reinhard Ackerl Janusz Ciok European Commission: Sabine Osaer 1 Christophe Didion 1 1 DG Health and Consumer Protection Page 1 of 7

2 1. WELCOME, APOLOGIES FOR ABSENCE The Chair welcomed all participants to the plenary meeting. Apologies for absence were received from Bevan Moseley and Seppo Salminen. Members welcomed Reinhard Ackerl and Janusz Ciok as new scientific officers in the NDA Panel support unit. 2. ADOPTION OF THE AGENDA The agenda was adopted with changes in the order of items discussed. 3. Declarations of interest In relation to the draft opinion on Evolus (agenda item 12.1), Hannu Korhonen declared his involvement in the past with Valio and refrained from the discussion for this agenda item. In relation to the draft opinion on plant stanols (agenda item 12.2), Marina Heinonen declared her involvement in the certification of the similar substance for Raisio and refrained from the discussion for this agenda item. The other participants had no additional interest, other than those already declared in their annual DOI. 4. FEEDBACK FROM EFSA SCIENTIFIC COMMITTEE AND OTHER EFSA PANELS The Chair reported back from last meeting of the Scientific Committee (SC). Members were informed that EFSA will organise next year some training sessions on systematic review and interested Panel members may apply to this training. 5. GENERAL INFORMATION BY EFSA ON MATTERS RELATING TO THE PANEL The Secretariat informed the Panel that EFSA will be launching shortly an Experts satisfaction survey. The survey will focus on three domains of support provided by EFSA to the Panels and experts, i.e. scientific, administrative and communication. The Panel was also informed about the call for renewal of the membership for the EFSA s Scientific Committee and Scientific Panels. The call was launched on 23 October 2008 and will be closed on 7 January The short-listed candidates will be selected by the EFSA Management Board. Panel members were invited to re-apply online ( _JoinEFSAScientificCommitteeorPanels.htm). The mandate of EFSA s existing NDA Panel expires in July Page 2 of 7

3 6. ARTICLE 13 HEALTH CLAIM S LIST Members were informed about the status of the Article 13 claims consolidated list and discussed strategies on how to handle the high number of claims (see also: A draft list of health claims together with the Terms of Reference was received from the Commission in July The list contained 2,870 main entries and around 7000 similar health relationships Many health claims have multiple health relationships. For conditions of use and references EFSA needs to take into account the information provided in the similar health relationships. EFSA is expecting to receive a revised list of Article 13 claims by end of October including new claims and additional information to existing claims, like conditions of use or references. In order to streamline the evaluation process, members discussed criteria to pre-screen the list in order to send claims back for which more clarification or information is needed (the prescreening criteria were adopted by written procedure on 8 October 2008). The Panel will start evaluating the health claims which were sent to EFSA in July 2008t and which passed the prescreening step and is targeting to finalise those by July NEW REQUESTS FOR SCIENTIFIC OPINIONS 7.1 Safety of Lycopene cold water dispersible (CWD) products from Blakeslea trispora. A new request for opinion was received from the European Commission asking EFSA to carry out additional assessment related to the Safety of Lycopene cold water dispersible (CWD) products from Blakeslea trispora, submitted in accordance with the Novel Foods Regulation 258/97/EC. 7.2 Food ingredients likely to trigger adverse effects (allergy or intolerance) Colours used in food A request was received from the European Commission for a scientific opinion on the appropriateness for inclusion in the list of food allergens set up in Annex IIIa of Directive 2000/13/EC concerning ten azo colours. Members were informed that the Panel on food additives and nutrient sources added to food (ANS) is currently reviewing the five azo colours used in the Southampton study by June 2009 and the five other colours by March It was proposed that the NDA Panel will prepare an opinion based on the re-evaluation work currently undertaken by the ANS Panel on the 10 azo colours, which includes also consideration on the allergenicity and potential intolerance of these 10 colours. 8. STATUS OF APPLICATIONS UNDER ARTICLE 14/13(5) HEALTH CLAIMS Article 14 claims Up to 1 October, EFSA has received 229 Article 14 applications (90% referring to children s health and development and 10% referring to reduction of disease risk claims); 43 applications are under evaluation and 8 were adopted. For many of the applications, additional information is currently being requested from the applicants. For Page 3 of 7

4 some of the applications, EFSA went back to the respective National Competent Authority and the Commission seeking clarification on whether the application would fall in the scope of EC 1924/2006 Health Claims Regulation. Article 18 claims - EFSA has received 7 applications under Article 18 (claims based on newly developed science and/or which include a request for the protection of proprietary data): 4 are under evaluation, 1 was adopted and 2 were withdrawn. 9. NOVEL FOODS 9.1 Draft opinion on Vitamin K2 at: _Opinions465.htm. 9.2 Draft opinion on Morinda citrifolia (Noni) fruit puree and concentrate as a food ingredient Related to the application of Noni Puree and concentrate, the Panel was given information received from the Finnish Food Safety Authority on two recent cases of hepatotoxicity that have been suspected to be related to the consumption of a Noni Juice product from an unidentified source. It was agreed to request additional data from the Finnish Authority. 10. INFANT FORMULA 10.1 Draft Opinion on Lutein at: _Opinions465.htm 11. DIETARY REFERENCES VALUES 11.1 Draft opinion on Carbohydrates Due to time constraints this agenda item was postponed to next plenary meeting. 12. APPLICATIONS PURSUANT TO ARTICLE 14 OF REGULATION (EC) NO 1924/ Evolus reduces arterial stiffness at: Plant Stanol Esters by actively lowering/reducing LDL cholesterol reduce the risk of (coronary) heart disease Page 4 of 7

5 at: Calcium and bone growth at: Vitamin D and bone growth at: Calcium and Vitamin D and bone strength at: Animal protein and bone growth The draft opinion was discussed and a revised version taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 31 October The Dairy fresh cheese and bone growth Adoption of this opinion was postponed to the next plenary meeting Xylitol and tooth decay The draft opinion was discussed and a revised version taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 30 October The Regulat.pro.kid BRAIN and mental and cognitive development of children at: Page 5 of 7

6 12.10 LGG MAX and reduce gastro-intestinal discomfort The draft opinion was discussed and a revised version taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 30 October The LACTORAL and a) normal functioning of the alimentary tract; b) improve the general immunity; c) build the natural intestinal barrier; d) maintain natural intestinal microflora during travel; e) contains living probiotic bacteria The draft opinions were discussed and revised versions taking into account the comments made Post meeting notes: the opinions were formally adopted by the Panel on 28 October The _Opinions465.htm I omega kids / Pufan 3 kids and calming at: I omega kids / Pufan 3 kids and serenity at: I omega kids / Pufan 3 kids and thinking capacity The draft opinions was discussed and revised versions taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 24 October The I omega kids / Pufan 3 kids and concentration The draft opinion was discussed and revised versions taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 24 October The I omega kids / Pufan 3 kids and vision Page 6 of 7

7 at: I omega kids / Pufan 3 kids and learning ability The draft opinion was discussed and revised versions taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 24 October The I omega kids / Pufan 3 kids and mental development The draft opinions was discussed and revised versions taking into account the comments made Post meeting notes: the opinion was formally adopted by the Panel on 24 October The ANY OTHER BUSINESS The Plenary meeting initially scheduled on 2-4 December 2008 was changed to: 1-4 December Post meeting notes: The Plenary meeting initially scheduled on 9-11 July 2009 was changed to: - For the existing Panel: 29 June to 2 July For the inaugural meeting of the new NDA Panel: 2 July to 3 July ADOPTION OF THESE MINUTES These minutes were adopted by written procedure on 4 December Page 7 of 7