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IADSA NEWSFLASH FEBRUARY 2009 CONTENTS INTERNATIONAL DEVELOPMENTS Additives committee meeting Resolution on traditional medicine ASIA CODEX: WHO: INDIA: Food supplements or Ayurvedic medicines? EUROPE EUROPEAN UNION: IRELAND: UNITED KINGDOM: Maximum levels update Update on annex II of the EU food supplement directive Health claims update ESCO working groups report Opinions on supplement ingredients Clarification on status of POM vitamins Ireland and maximum Levels Survey calls for more research on metals New register of practitioners launched NORTH AMERICA UNITED STATES: FDA says Pyridoxamine is not a dietary supplement CISPI rejects trans fat advice INDEX OF ASSOCIATION CONTRIBUTORS KEY EVENTS IADSA The International Alliance of Dietary /Food Supplements Associations was founded in 1998 to address the globalization of dietary supplement markets and increasing regulatory challenges. IADSA brings together 55 dietary supplement associations with the aim of building a sound legislative and political environment for the development of the dietary supplement market worldwide. IADSA serves its worldwide network of associations and companies by: Providing a fast flow of regulatory and policy information on dietary supplements, ensuring that there is an awareness and understanding of new developments. Coordinating strategy and action on global regulatory issues, particularly in relation to Codex Alimentarius initiatives. Widening and deepening the network of associations around the world by helping the establishment of new dietary supplement associations and supporting existing national associations. Organizing global and regional events to promote dialogue on the scientific and regulatory issues underpinning the dietary supplement market. February 2009 1 INTERNATIONAL DEVELOPMENTS CODEX ADDITIVES COMMITTEE MEETING The Codex Committee on Food Additives will be considering next month the levels of use of a number of key food additives in food supplements. An electronic working group (eWG) has reviewed the use in food supplements of aspartame-acelsufame salt and 3 bulking agents; sorbates, phosphates and sucroglycerides. While the eWG is recommending a lower level of use of 200 mg/kg for aspartame-acesulfame salt, it is requesting more information to address the level for phosphates and has not suggested yet a level for sucroglycerides when in Codex a fixed level has to be set. The eWG’s recommendations will be considered by the Committee next month. In addition, the Committee will consider the adoption of a number of aluminium containing additives and of key colours. These additive provisions were either not considered by the Committee last year or not resolved. The eWG has not reviewed them, although the Committee would welcome any additional information that it is provided. In fact, if more information is not provided these additives run the risk of being removed from the Codex list. Although IADSA has provided over the past few years to the Additives Committee information to justify the use of these key colours, it is requested to members provide any further technological information to justify the use of these colours in food supplements. An IADSA delegation will be participating at the next Committee meeting in Shanghai. For more information, please contact the Secretariat: [email protected]. WHO RESOLUTION ON TRADITIONAL MEDICINE The Executive Board of the World Health Organisation (WHO) has recently adopted a draft Resolution on Traditional Medicine which will be submitted to the World Health Assembly in May of this year. Based on the ‘Beijing Declaration’, prepared by 12 countries at last year’s WHO Congress on Traditional Medicines, the Resolution calls on Governments to integrate traditional medicines into their national health systems, and to promote further research and innovation in line with the resolution adopted at the 2008 WHO Assembly on ‘Global strategy and plan of action on public health, innovation and intellectual property’. For more information, please contact the Secretariat: [email protected]. ASIA February 2009 2 INDIA FOOD SUPPLEMENTS OR AYURVEDIC MEDICINES? An Indian herbal manufacturing company has recently challenged a sectoral tribunal ruling which held that its products, which are registered as ayurvedic proprietary medicines, did not cure any disease, and were thus liable to pay higher excise duty. The Indian Supreme Court will now decide whether the products in fact have “preventative and curative properties” and therefore, as medicines, qualify for lower excise duty. Source: HADSA EUROPE EUROPEAN UNION MAXIMUM LEVELS UPDATE The European Commission (EC) is currently working with a small group of Member States (Denmark, France, German, Ireland, Portugal, United Kingdom, Norway) to test the model provided by EHPM/ERNA for food supplements and Professor Albert Flynn's model on fortification, provided by the food industry. The results of this exercise are currently awaited. In parallel the food industry is still working to agree acceptable levels of use because the theoretical levels presented by Prof. Flynn on the basis of his model are unlikely to be acceptable to Member States. Some Member States have also raised the issue of intake for children, in particular in relation to fortified foods. So far, the EC has been supportive of the application of the EHPM/ERNA model for food supplements, and continues to request that no level be set for nutrients where there is no safety concern. It also remains keen to avoid an arbitrary division of levels between fortified foods and supplements. At a recent hearing of the European Parliament Petition Committee, the EC reiterated its wish to establish levels based on safety risk assessment conducted by the European Food Safety Authority (EFSA), and stated that the Directive does not intend to restrict the choice of consumers but rather to allow them access to safe products across Europe. The EC indicated it still hopes to be able to come forward with a proposal for maximum levels of vitamins and minerals in food supplements by March of this year. Source: EHPM, ERNA UPDATE ON ANNEX II OF THE EU FOOD SUPPLEMENT DIRECTIVE The European Commission presented a proposal for discussion and vote at this month’s Standing Committee meeting of Member States for a Regulation to update the sources listed in Annex II of the Food Supplement Directive (Directive 2002/46/EC) on the basis of February 2009 3 the first EFSA favourable opinions, as well as Annexes of various other pieces of legislation regarding PARNUTS and fortified foods (Directives 2001/15/EC, 2006/125/EC and Regulation (EC) 1925/2006) It is important to point out that the Commission's proposal did not yet take into account the most recent EFSA positive nutrient source opinions, as for example, the opinion regarding zinc mono-L-methionine sulphate. Moreover, not all EFSA nutrient source evaluations have yet been completed. EFSA has indicated in its 2009 Management Plan that it intends to evaluate 147 nutrient substance dossier applications in 2009 (with 5 still ongoing at the end of 2009). This means, that the European Commission will most likely table further amendments to the Annexes later this year/beginning next year, to include potential additional positive EFSA nutrient substance evaluations of 2009. An additional draft Commission Regulation to include these opinions as a follow-up is therefore likely to be issued during course of 2009. It is to be noted that EFSA has recently also released a number of opinions indicating the impossibility to assess the safety of the proposed nutrient sources due to lack of data in the provided dossiers. These concerned in particular dossiers on: Selenium amino acid chelate, and chromium and copper ethanolamine phosphate. EFSA also released an opinion on calcium L-methionate and magnesium L-methionate as sources for calcium and magnesium expressing a very precautionary approach.The EFSA opinion concludes that there could be a safety concern if these were used at tolerable upper intake levels. The content of the above mentioned proposal has not raised particular questions from members states although the legal form of the text is still under discussion with the legal services. The issue of whether selenium yeast was to be considered as another substance or a mineral was raised by one member stated and it was agreed that it was a mineral source. In addition, the EC indicated that once a choice is made on the legal form of this text, currently proposed as a Regulation covering the amendment of several acts including the Annex II of the Food Supplement Directive, the proposal will be presented again to member states with a view of its adoption, possibly at the Standing Committee at the end of April or June. Furthermore, EFSA has delivered further opinions on the dossiers it has received on: - Monomethylsilanetriol added for nutritional purposes to food supplements - safety cannot be established - Ferrous phosphate added for nutritional purposes to food supplement - safe - Inositol hexanicotinate (inositol hexaniacinate) as a source of niacin (vitamin B3) added for nutritional purposes in food supplements - safe but concerns on proposed levels - Iron (II) taurate, magnesium taurate and magnesium acetyl taurate as sources of iron or magnesium added for nutritional purposes in food supplements - safe - Choline-stabilised orthosilicic acid added for nutritional purposes to food supplements - no safety concern provided that the upper level for choline is not exceeded. February 2009 4 More details on the above EFSA nutrient source opinions can be found on the following web page: http://www.efsa.europa.eu/EFSA/ScientificPanels/ANS/efsa_locale1178620753812_OpinionsANS.htm Source: EHPM HEALTH CLAIMS UPDATE The consolidated list of proposed Article 13 claims was published on the EFSA website in mid January – see: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_article13.htm It contains over 4185 health claims. The database details comments from EFSA’s screening process and the agreed deadline for the opinion. EFSA’s criteria for returning health claims to the Commission for further clarification on the scope or for information to be added, is: • • • • • • where clarification on scope is needed (e.g. claims referring to risk reduction or referring to children’s development and health, or medicinal claims) General 'well-being' claims where the health relationship is not clear, e.g. “Compound X supplementation sustains vitality while aging” Claims that are too vague (claim effect not specified/measurable), e.g. Compound X is “necessary to maintain energy and general vitality” Foods which are not sufficiently characterised or conditions of use are not sufficiently specified Combination constituents that are not sufficiently defined Claims in other languages than English (to be returned for translation). . Currently about 1000 claims have a deadline for review of 31st July 09, and a further 470 have a deadline of 30 November 09. That leaves about 2700 claims, including about 1000 for botancials currently without a deadline for review. EFSA has now delivered 47 opinions on Article 14 and 13.5 claims. These include 34 children’s claims, 8 disease risk reduction claims, and 5 Article 13.5 claims (on 'new scientific evidence'). 7 of the 47 scientific opinions are favourable and further 3 were concluded to show cause and effect, but because intakes of the substances (animal protein and omega-6 fatty acids) are not inadequate in European diets, it remains to be seen whether these claims will be given final approval. The European Commission issued its revised draft proposals for the adoption/rejection of a first list of Article 14 and 13.5 claims. It is to be noted that, whereas previously the proposals were for a Regulation and a Decision, both texts have now been issued in the form of Regulations. Both texts have been adopted by the Member States at this month’s Standing Committee meeting. The texts had been slightly changed based upon comments received and further changes have been included during the meeting. The proposals will now go to the European Parliament for scrutiny. February 2009 5 Source: EHPM ESCO WORKING GROUPS REPORT The Plenary meeting of the European Food Safety Authority (EFSA) Scientific Committee recently reported on the activities of its Scientific Cooperation (ESCO) Working Groups: Botanicals: in an interim report the Group said that in 2008 EFSA had published a draft guidance document which proposed a two-level approach for the safety assessment of botanicals. This approach was now being tested by the ESCO Group with a selected number of examples. The Group was also working on enlarging the information in its compendium of botanicals reported to contain toxic, addictive, psychotropic or other substances of concern. Good progress was being made, and the Group expected to deliver its final report to EFSA’s Executive Director by May of this year. Emerging Risks: the ESCO Working Group has identified 11 indicators of possible emerging risks in the areas of chemical microbial and nutritional hazards, as well as key resources of information and best practices for data collection and exchange. Its final report will be available soon. Folic acid: the ESCO Group working on ‘Analysis of Risks and benefits of Fortification of Food with Folic Acid’ presented a compilation of the situation regarding folic acid in different European countries, together with statistics on neural tube defects, and data on food supplementation, whether voluntary or mandatory. Harmonisation of Risk Assessment approaches in Member States: a comprehensive questionnaire was developed which asked Member States to describe possible discrepancies in their risk assessment approaches from existing EFSA guidance documents. One particular outcome was the recommendation to address the further harmonisation of risk assessment approaches within specific scientific areas. The Group’s final report will now be submitted to EFSA’ s Executive Director. Source: ERNA OPINIONS ON SUPPLEMENT INGREDIENTS To date 49 nutrient source ingredients have been given a positive opinion by EFSA and a further 127 positive opinions are possible from those yet to be assessed which would result in a maximum of 176 possible additions to Annex II. The remaining 241 ingredients listed on the Commission website and granted derogation until 31st December 2009 will not be allowed to be used in food supplements from January 2010. Most recently, EFSA has published positive opinions on: • • • • • Sodium monofluorophosphate as a source of fluoride in food supplements Calcium fluoride as a source of fluoride in food supplements Copper aspartate as a source of copper in food supplements Zinc aspartate as a source of zinc in food supplements Zinc mono-methionine as a source of zinc in food supplements There was insufficient evidence to prove safety of: • Silver hydrosol as a source of silver in food supplements (considered to be nanotechnology) February 2009 6 • • • • • • Calcium aspartate Magnesium aspartate Potassium aspartate Chromium (poly)nicotinate Calcium methionate Magnesium methionate Source: EHPM IRELAND CLARIFICATION ON THE STATUS OF POM VITAMINS The Irish Medicines Board (IMB) has recently published a clarification on the medicinal status of certain products containing vitamins which are subject to their Prescription and Controls of Supply (POM) regulations. The notification reiterates the current practice that while in general any substance restricted by the prescription regulatons is considered automatically to be a prescriptiononly medicine, products in oral form containing the following vitamin substances, which do not make medicinal claims, and are subject to the maximum daily doses stated below, may be presented as food supplements and marketed in accordance with the European Community Food Suppplements Directive: • • • • • • Folic acid 500 microgram Vitamin A 7,500 IU (2.25mg) Vitamin D (ergocalciferol; cholecalciferol) 300 IU (75 microgram) Vitamin B6 50mg Vitamin B12 25 microgram Phytomeniadione (Vitamin K1) any dose. However, while the IMB reserves the right to review the status of any product and determine the approriate prescription status, the notification goes on to say that following advice received from the Irish Department of Health and Children, the IMB understands that products containing vitamins exceeding the dosage levels above may also be marketed as food supplements, providing no medicinal claim is made. Source: IHTA IRELAND AND MAXIMUM LEVELS A recent meeting of the Irish Food Standards Authority (FSAI) Consultative Council was devoted to the subject of food supplements, and particularly on maximum levels for vitamins and minerals. Speakers included Dr Mary Flynn, who represents Ireland in maximum levels discussions in the European Union Expert Group meetings, Dr Alan Ruth, Chief Executive of the Irish Health Trade Association (IHTA) and Basil Mathioudakis of the European Commission. . In response to a reminder from Dr Flynn that the current FSAI policy was that Food Supplements should not contain more than 1 x RDA, Dr Ruth pointed out that this did not accord with European Court of Justice (ECJ) case law. This was supported by Mr Mathioudakis, who explained that nutritional need was not the basis for setting maximum February 2009 7 levels and that the EC did not intend to limit levels to multiples of RDA. Instead, the EC approach follows the criteria laid out in the Food Supplement Directive, adopted by the European Parliament and the Member States, and is based on evaluating the risk, taking into particular account the European Food Safety Authority (EFSA) opinions on Upper Safe Levels. Mr Mathioudakis confirmed that for those nutrients where no Upper Levels were set because there were no identified risk at high intakes, the EC’s view was that no levels were necessary. He also re-affirmed that it was the EC’s intention that the levels to be proposed should allow a wide choice of safe supplements for consumers across Europe. Source: IHTA UNITED KINGDOM SURVEY CALLS FOR MORE RESEARCH ON METALS A recently released study carried out by the Food Standards Agency (FSA) Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) has indicated that while levels of most metals in foods are falling, more information on the bioavailability of barium and manganese was desirable, as was clarification of the reasons for the large variations of aluminium found in foods. The aim of the project was to estimate dietary exposures of the elements for UK consumers. 24 elements - including metals - were studied, from samples of 20 different food groups bought in 24 randomly selected towns in the UK. Source: HFMA NEW REGISTER OF PRACTITIONERS LAUNCHED A new Register has recently been launched, aimed at providing the public with reassurance as to the status of complementary practioners/businesses. The Complementary and Natural Healthcare Council (CHNC) will not judge whether clinics or therapies are effective, but will only accept onto their Register those practitioners and/or businesses which can demonstrate that they operate in a professional and safe manner. Source: HFMA NORTH AMERICA UNITED STATES February 2009 8 FDA SAYS PYRIDOXAMINE IS NOT A DIETARY SUPPLEMENT Following an on-going debate between the manufacturer, the US Council for Responsible Nutrition (CRN) and the US Food and Drug Administration (FDA), the FDA has finally ruled that pyridoxamine dihydrochloride, a B6 compound, cannot be used in dietary supplements. The basis for FDA’s decision is that the ingredient was authorised for investigation as a new drug before it was marketed as a food supplement. This is despite the fact that the supplement industry and CRN had produced evidence to show that the product had been on the market as a food supplement prior to the enactment of the 1994 Dietary Supplement and Health Education Act – and that its continued marketing as a food supplement was therefore covered by a ‘grandfathering’ clause. There is industry concern that FDA’s decision might set a precedent for other supplement ingredients, and CRN has warned its members to ensure that they keep records of when products were first placed on the market. Source: CRN US CISPI REJECTS TRANS FAT ADVICE The US Centre for Science in the Public Interest (CISPI) has recently challenged the advice of the Trans Fat Task Force in Pennsylvania that a mandatory ban could, from a health perspective, do more harm than good. The conclusions of the Task Force, set up to find ways to reduce trans fat consumption in Pennsylvania, were that a public education programme plus industry encouragement to make the switch, was preferable to a total ban. CISPI has countered this view by pointing out that acceptable alternatives to trans fats are much more readily available than they were, say, ten years ago, and hence an outright ban was a far better solution. Source: UNPA INDEX OF ASSOCIATION CONTRIBUTORS CRN (US) (Council for Responsible Nutrition): [email protected] EHPM (European Federation of Associations of Health Product Manufacturers): [email protected] ERNA (European Responsible Nutrition Alliance): [email protected] HADSA (India) (Health & Dietary Supplements Association): [email protected] HFMA (UK) (Health Food Manufacturers’ Association): [email protected] IHTA (Irish Health Trade Association): [email protected] UNPA (US) (United Natural Products Alliance): [email protected] KEY EVENTS: February 2009 9 Date Conference Place March 04 - 05 Nutracon www.nutraconference.com/nutracon09/public/ent er.aspx Anaheim, CA, United States March 05 - 08 Natural Products Expo West/ Supplyexpo http://expowest.com/ew09/public/enter.aspx Anaheim, CA, United States March 16 - 20 Codex Committee on Food Additives www.codexalimentarius.net Beijing, China March 23 - 27 Codex Committee on Contaminants in Foods www.codexalimentarius.net Rotterdam, The Netherlands March 25 - 27 WorldFood Uzbekistan www.worldfood.uz/en/2009/ Tashkent, Uzbekistan March 30 April 04 Codex Committee on General Principles www.codexalimentarius.net Paris, France April 02 - 05 CHFA Expo West 2009 www.chfa.ca Vancouver, Canada April 02 - 06 Cosmoprof/Cosmopack www.cosmoprof.com/en/index.asp Bologna, Italy April 27 - 29 SupplySide East www.supplysideshow.com/east/2009/ Secaucus, NJ, United States May 04 - 08 Codex Committee on Food Labelling www.codexalimentarius.net Calgary, Canada May 05 - 07 Vitafoods International www.vitafoods.eu.com Geneva, Switzerland Date Conference Place February 2009 10 May 08 -10 Cosmofarma 2009 www.cosmofarma.com/ Bologna, Italy May 12 - 13 IADSA Annual General Meeting (AGM) www.iadsa.org Cancun, Mexico June 15 - 16 Health Ingredients South America Summit 2009 www.hi-events.com.br/ingles.html São Paulo, Brazil June 23 - 25 Food Ingredients Asia-China/Health Ingredients China/Natural Ingredients China 2009 http://asiachina2008.fievents.com/content/default.aspx Shanghai, Chin June 23 - 26 Executive Committee of the Codex Alimentarius www.codexalimentarius.net Rome, Italy June 29 - July 04 Codex Alimentarius Commission www.codexalimentarius.net Rome, Italy Prepared by the INTERNATIONAL ALLIANCE OF DIETARY/FOOD SUPPLEMENT ASSOCIATIONS rue de l’ Association 50 B-1000 Brussels Tel: (00) (32) (2) 209 11 55; Fax: (00) (32) (2) 223 30 64, E-mail: [email protected] - Website: www.iadsa.org IADSA endeavours to check the veracity of information covered in the Newsflash, but cannot be held responsible for any inaccuracies in the articles published. Where available, IADSA provides links to other World Wide Web sites as a convenience to users, but cannot be held responsible for the content or availability of these sites February 2009 11