International Aloe Science Council, Inc. News (January 2010)
International Update
| |
International Aloe Science Council, Inc. News (January 2010)
International Update |
| Home | Overview & Code of Ethics | Membership | Certification | Scientific Research | Certified Products | Links |
|
International Update To: IASC Members Please find below a list of current international and
US items which may be of relevance or interest to your business. As the
international organization representing the interests of suppliers, manufacturers,
distributors and growers of Aloe vera and its related products, we are
dedicated to maintaining a focus on the issues that may be of concern
to your business, including dietary supplement and other similar regulations. Best regards,
INTERNATIONAL DEVELOPMENTS CODEX KEY OUTCOMES FROM NUTRITION MEETING The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) met in November in Düsseldorf, Germany, and addressed the following key issues for the food supplement industry: * Dietary Fiber: following the adoption of the definition of dietary fiber, the CCNFSDU finalized an acceptable list of methods to identify each of the conditions of dietary fiber and addressed the key decision left to national governments about the inclusion of carbohydrates with monomeric units from 3 to 9. In the interests of national harmonization, most of the methods listed are AOAC, but the Englyst method was also listed as there are aspects for which further research is necessary before the complexities of the physiological role of fiber in the diet and its relation to health are fully understood. This list, which is supported by IADSA, is now forwarded for endorsement to the Codex Committee on Analysis and Sampling (March 2010) and final adoption by the Codex Alimentarius Commission (CAC), the decision-making body in Codex, which meets in July 2010. * Revision/Addition of nutrient reference values (NRVs) for vitamins and minerals: the general principles for establishing NRVs for vitamins and minerals for the general population were adopted at Step 5. They identify the general population as individuals older than 36 months, and the general population NRVs are determined by calculating the mean of the values for adult males (19 to 65 years old) and females (19 to 50 years old). In addition, a list of proposed NRVs calculated for each vitamin and mineral as described above was also addressed. Outstanding questions relate to the proposed NRVs themselves for certain nutrients, (e.g. retinol/vitamin A value was considered too low), terminology (e.g. folate and folic acid) and bio-availabilities (eg. iron). The general principles will now go forward for endorsement by the CAC, but the list with the numbers/values are retained at Step 3 for further discussion. Another key point agreed (and supported by IADSA), related to individual nutrient level 98, the daily nutrient intake value estimated to meet the nutrient requirement of 98 % of apparently healthy individuals - and the specific life stage and sex group. · Revision of Principles for the Addition of Essential Nutrients to Foods: the CCNFSDU agreed to start new work to amend the current Codex principles to address discretionary fortification, and as a part of that work, establish maximum levels for vitamins and minerals added to foods. In this context, the CCNFSDU asked FAO and WHO to organize an expert consultation to set upper levels of intake for vitamins and minerals. Although the majority of the principles on fortification do not apply to food supplements, setting these maximum levels will have an impact on potential future discussions on maximum levels for food supplements. However, the CCNFSDU has agreed that levels should be based on scientific risk assessment, as emphasized by IADSA and in accordance with the Nutritional Risk Analysis Principles agreed this year by Codex. IADSA will take part in the work of the electronic working group (eWG) established to draft the amendment to the principles for consideration next year by the CCNFSDU. For further information, contact: secretariat@iadsa.be
ASIA
JAPAN
AGENCY TO REVIEW HEALTH CLAIMS Japan’s Consumer Affairs Agency (CAA), has recently formed a committee to investigate health claims for health-oriented foods. The committee has until March 2010 to discuss current problems for all categories for health-oriented foods (FOSHU, FNFC and Dietary/Foods Supplements) and to make proposals their future management. Advertising issues for these products will also be discussed. Consumer groups are more strongly represented on this new committee than in previous similar investigations.
Source: AIFN
EFSA SIGNS COOPERATION AGREEMENT WITH JAPAN The European Food Safety Authority (EFSA) has recently signed a memorandum with Japan’s Food Safety Commission (FSC), which formalises their commitment to scientific cooperation and the sharing of information relating to current and emerging risks. The agreement is initially for five years, with a further clause to continue, if both parties so wish, until 2019. The aim of the agreement is to provide mutual support and cooperation on the collection and analysis of technical data. It is understood that nanotechnology and contaminants are amongst the issues likely to be discussed.
Source: JIHFS
EUROPE
EUROPEAN UNION
MAXIMUM LEVELS UPDATE A European Commission Working Group continues to discuss proposals (including, in particular, those put forward by the supplement trade associations EHPM and ERNA) for setting Maximum (and Minimum) permitted levels of Vitamins and Minerals under Directive 2002/46 on food supplements. The anticipated timings for the appearance of a draft proposal range from February to September, but the effect of the current changes in the European Commission will probably mean that the Commission’s proposal will not appear until late 2010. Source: EHPM
HEALTH CLAIMS UPDATE EFSA has published an updated briefing document aimed at Member States and the European Commission on Article 13.1 claims. It describes the procedures EFSA follows for the evaluation of Article 13.1 claims, including the use of uniform scientific criteria for substantiation of claims and for the characterization of foods. The update contains little new information, but makes it clear that EFSA assesses on a case-by-case basis whether clinical studies in a particular population group can be cited to support a claim for the general population. Information about the potential mechanisms of action or justification as to why the data can be extrapolated would be required as part of the submission. It would appear that there is no further opportunity to provide additional data to support those Article 13.1 claims which received negative results in the first batch of EFSA opinions released. Instead, a new submission under Article 13.4 (based on generally accepted scientific evidence) or 13.5 (based on newly developed scientific evidence and/or proprietary data), must be submitted. The next batch of between 4 – 500 opinions on Article 13.1 claims is scheduled for publication in February 2010, and will include substances such as plant extracts, carotenoids, probiotics and polyphenols. Recent opinions on Article 13.5 and 14 claims include a negative opinion on a disease risk reduction claim for Glucosamine hydrochloride and reduced rate of cartilage degeneration/reduced reduced risk of development of osteoarthritis. As with recently rejected Article 13 claims for glucosamine and joint health, EFSA’s view is that the evidence does not establish that patients with osteoarthritis are representative of the target population with regard to the status of joint tissues. EFSA points out that normal cells and tissues are genetically and functionally different from osteoarthritic cells/tissues, and therefore may respond differently to intervention exogenous substances. The Community Register of Claims has now been established and is available at: http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm Currently it lists positive and negative opinions for Article 13.5 and 14 (disease risk reduction) claims. Article 13.1 claims will be added once they have been through the full assessment process which requires scrutiny by the European Commission and the Parliament. Source: EHPM
NOVEL FOODS UPDATE EFSA recently held its 13th Scientific Colloquium with international experts to discuss the scientific information needed for applications on novel foods/ingredients. Discussion focused particularly on the history of safe use of traditional food from non-EU countries which would be considered ‘novel’ in the EU, on intake assessment, the toxicology and allergenicity of novel foods, and on data requirements for demonstrating the safety of novel foods made using nanotechnologies. Recent Novel Food approvals include a Norwegian manufactured omega-3 Krill Oil (the third such approval for krill), and for Chia (Salvia hispanica), an omega-3 and omega-6 rich grain. Source: EHPM
FOOD LABELLING UPDATE A robust report from Mrs Renate Sommer, Member of the European Parliament and Rapporteur on the Food Labeling (Food Information to the Consumer) legislation which is currently undergoing a first reading in the European Parliament, contains proposals for two particular points of importance to EHPM members: * No mandatory size
for labeling requirements. One particularly interesting comment from Mrs Sommer, which may also be applicable to other areas of contentious legislation such as Nutrition and Health Claims, notes "The proposed rules governing the indication of mandatory particulars smack of an effort to educate, not inform, consumers: the Commission wants to compel consumers by law to eat 'healthily’. The Commission proposal also displays substantive shortcomings. A number of requirements are based on assumptions about consumers' wishes and needs, and proposed reference amounts are of dubious quality. The aim of harmonizing labeling rules in keeping with internal market principles would be rendered absurd by the proposal to allow Member States to adopt special national provisions. Moreover, many of the Commission's proposals are liable to jeopardize the survival of SMEs. In this way, the Commission proposal contravenes the Small Business Act.” Source: EHPM
REGULATION ON FOOD SUPPLEMENT INGREDIENTS PUBLISHED
It entered into force on December 21 across all EU member states, which means that sources listed in Annexe II of the Regulation will not be allowed in food supplements manufactured after December 31st 2009. However, it is understood that informal agreement has been reached in the Netherlands and the Czech Republic to extend the derogation period for a further 12 months, and that for a period at least, some Member States may employ a flexible attitude to enforcement. Source: EHPM
NEW ADVICE FROM EFSA ON FOOD COLOURINGS The European Food Safety Authority (EFSA)’s expert panel on food additives and nutrient sources added to food (ANS) has updated its advice regarding the acceptable daily intake of three artificial food colors as part of an on-going review of all food colorings and additives currently approved for use in the European Union. · The Acceptable Daily Intake (ADI) for Quinoline Yellow has been halved, from 0 - 10mg/kg of bodyweight per day to 0 - 5mg/kg of bodyweight per day. · The ADI for Sunset Yellow (E110) was lowered from 0 - 2.25 to 0 - 1.0mg/kg of bodyweight per day. (This reduction is fixed for a trial period of two years because the Panel felt that the evidence was incomplete as it did not look at testes histopathology or sperm morphology and mobility.) · The ADI for Ponceau 4R (E124), has been lowered from 0 - 4 to 0.7 mg/kg of bodyweight per day. All the new ADIs were determined by looking at toxicity levels observed in animal studies but with large safety margins built in for humans. Although the ANS Panel concluded that there was no direct evidence to support the measure, the European Commission has now made it mandatory from July 2010 that products containing these colors carry a warning stating their potential link to hyperactivity in children. Source: EHPM
EFSA STAKEHOLDER MEETING
EHPM, ERNA and the European Botanical Forum (EBF) attended the recent meeting of the European Food Safety Authority (EFSA) Stakeholder Platform in Parma, Italy. The Platform, which was chaired by Andreas Varlamos of the EU consumer association BEUC, is made up of representatives of 24 European Union (EU) stakeholder organizations, including industry, consumers, environmentalists and animal rights defenders. The subjects discussed included the risk assessment of GMOs, EFSA’s approach on emerging risks and on nanotechnology – and, of particular interest to EHPM, the evaluation of the first series of Article 13 claims. EFSA showed little sign of changing its stringent approach to Article 13 claim assessment. However, it did acknowledge the need to improve dialogue with stakeholders and it was apparent that it was aware of EHPM’S key criticisms and of the volume of interest in health claims issues. Particular points commented on by EFSA included: * The differences
of the outcomes between vitamins/minerals and other substances is not
inconsistent, but related to the fact that for vitamins/Minerals there
is well-established consensus and for others there is not. The Stakeholder Platform work plan is currently open for comment and EHPM will advocate more technical stakeholder sessions in between Stakeholder meetings, particularly on claims. Source: EHPM
COMMITTEE RECOMMENDS VITAMIN D FOR THE ELDERLY
At a recent meeting the Standing Committee of European Doctors (CPME) issued the following statement calling on European Union institutions to include vitamin D deficiency in their health agendas: ‘Vitamin D supplementation (600 – 800 IU D3) plus calcium should be considered for elderly people (older than 75 years) with an increased fracture and/or fall risk, in particular people living in nursing homes’. IADSA’s Scientific Group has recently published an ‘Updated Risk Assessment of Vitamin D’, which recommends that scientists and policy makers review the safe upper level. For further details, contact: secretariat@iadsa.be Source: EHPM
EFSA OPINON ON HEALTH RISKS OF ARSENIC IN FOOD
Following receipt of data from 15 European Member States giving over 100,000 results on arsenic concentrations in various foodstuffs, the European Food Safety Authority’s (EFSA’s) panel on contaminants in the food chain (CONTAM) has published an opinion on the possible health risks. The Panel found that although data differentiating the concentrations and effects of the different species of arsenic were lacking, from the data that were available, its view was that exposure to inorganic arsenic should be reduced. Source: EHPM
EFSA HOLDS WORKSHOP ON BOTANICALS
At the end of November the European Food Safety Authority (EFSA) held a Workshop on the Safety Assessment of Botanicals intended for use as ingredients in Food Supplements. The aim of the meeting was to discuss EFSA’s recently released draft Safety Guidance proposals, the work of the European Safety Co-operative Group (ESCO) in using that guidance in practice, and its Compendium of botanicals of safety concern. About 50 representatives of national food safety authorities, risk assessors and industry representatives, including EHPM, ERNA and the European Botanical Forum (EBF) attended. While it was made clear that there would be no further formal consultation on the Guidance/Compendium, the following important issues/discussion points were amongst the outcomes of the meeting: * There is a communication
issue in relation to the objectives and usefulness of the Guidance document
and the Compendium and stakeholders were invited to provide EFSA with
examples of wrong interpretation and suggestions for clarification. These issues will be further discussed at the EBF’s forthcoming Annual Academic Workshop on Botanicals, which is attended by an invited audience of academics, regulators and industry representatives. Source: EHPM, ERNA
ILSI REPORT ON NUTRIENT INTAKE PUBLISHED
The International
Life Sciences Institute (ILSI) has recently published a long-awaited paper
on ‘Intake of selected nutrients from foods, from fortification
and from supplements in various European countries’. The authors of the study draw the following conclusions: * The major contributor
to intakes for all nutrients and in all countries is from foods in the
base diet. The paper’s findings will be taken into account by the European Commission and member states of the European Union in their forthcoming discussions on setting maximum levels for vitamins and minerals for both supplements and fortified foods. For further details of the ILSI paper, contact the EHPM Secretariat at: info@ehpm.be Source: EHPM
VICTORY IN VITAMIN C EUROPEAN COURT CASE
In 2007 the Greek competent authority, the National Organization for Medicines (EOF), prohibited the marketing of food supplements containing vitamin C (either alone or in combination with other vitamins/minerals) with a daily dose above 135mg and classified all such products as medicines. In 2004 Greece implemented Directive 2002/46/EC on food supplements into national law and included a table giving the maximum permitted level per day for vitamins and minerals as 3x the Recommended Daily Allowance (RDA) for water soluble vitamins, 1.5x RDA for fat soluble vitamins and 1x RDA for minerals. Following a call by EOF for the removal from the market of products with a daily dose of vitamin C above 135mg, the Greek Association for Health Food Product Manufacturers filed a case against the national competent authority regarding protection measures and arbitrary national practices. In November of this year, in Decision No 3274/2009, the Council of State, the High Court in Greece which manages cases concerning EU law, annulled the National Authority's decision, thus removing the ban on the sale of vitamin C above 135mg. The High Court’s ruling, which was based on precedent set by similar cases involving the European Commission against Germany and Austria, said that the National Authority's ruling had no scientific substantiation and there was no evidence from other Member States to support such a ruling, which also constituted a barrier to Community trade. Source: EHPM
FRANCE
AFSSA PROGRAMME TO MONITOR SUPPLEMENT INTAKE The French Food Agency, (AFSSA) recently launched a monitoring programme calling for health professionals to report observed side effects of several categories of foodstuffs, including food supplements. AFSSA’s website carries the statement that food supplements have ‘...no proven advantages especially given that studies are lacking to show that they are safe when taken regularly, and for an extended amount of time, …also several acute incidents have been reported. Although no evidence is offered to support these ‘acute incidents’, unfortunately this statement coupled with the misleading manner in which the programme was launched, resulted in a number of negative media stories which highlighted the potential dangers of food supplements. In response, the French Food Supplement association Synadiet has pointed out that it is not against a reporting system in itself, and indeed it supports any initiative to ensure that intake of supplements by consumers is done so safely. However, the association does take issue with AFSSA because they did not seek any industry views on their proposed action until shortly before its launch. In particular, Synadiet considers that any such scheme should be subject to the following conditions: · If there is a safety alert, AFSSA should inform the manufacturer(s) concerned · AFSSA should guarantee the transparency of the analytical methods used · AFSSA should verify the causality linkage between the problem reported and the food supplement to which it is attributed Now, Synadiet intends to hold a press conference in the New Year to put the record straight and to reassure consumers that food supplements are safe. Source: Synadiet
FINLAND ‘MIRACLE HERB’ BANNED The Finnish Food Safety Authority, Evira, has recently banned products based on the Thai herb Pueraria mirifica, mainly sold via the internet. The herb, which has a high concentration of phytoestrogens, is mainly used in breast enhancement products. Evira’s concerns are that it is not aware of a history of use for the herb in the European Union, there is insufficient information available about the safety of the herb and EU Novel Foods approval has not been sought. Source: LTLR
NO CONCERNS ABOUT TRANS FATS Following a recent examination of margarine products, Evira, the Finnish Food Safety Authority, has concluded that products containing trans fats that are currently on the Finnish market are not a matter of concern. Very low levels were found in the 18 samples analyzed as part of a broader research project aimed at developing methodology for analyzing fatty acids, and comparing the fatty acid content of ‘light’ products with those of ‘regular’ products. Source: LTLR
IRELAND IMB WARNING ON SUPPLEMENTS CONTAINING STEROIDS The Irish Medicines Board (IMB) has recently put out a warning about products being marketed as dietary supplements which are labeled as containing synthetic steroidal compounds, thus rendering them illegal medicinal products which have not been authorized for marketing in Ireland and cannot be regarded as safe. The US Food and Drug Administration has recently issued a recall notice relating to these products, and it is understood that Irish consumers have purchased them via the internet. Source: IHTA
SPAIN SPAIN TRANSPOSES FOOD SUPPLEMENT DIRECTIVE A new Spanish Royal Decree, No. 1487/2009 which transposes the EC Food Supplement Directive into Spanish national law has been published. The transposition has been made in a literal manner and, while the Decree currently only regulates vitamins and minerals, it foresees the possibility that other categories of food supplement ingredient may in the future be similarly regulated. Importantly, the transposition does not contain any proposals on maximum levels (previously the Spanish authorities had suggested that certain RDA-based levels should be set). Source: AFINUR
UNITED KINGDOM NEW ‘QUALITY MARK’ FOR TRADITIONAL HERBALS The UK Medicines and Healthcare products Regulatory Agency, (MHRA) has recently launched a new ‘quality mark’ for use on packaging by products which have been granted registrations under the EC Traditional Herbal Medicinal Products Directive. The intention of the ‘THR’ quality mark is to provide information to consumers that the product has been assessed by MHRA for quality and safety. It is understood that MHRA will be embarking on an information program for consumers to encourage understanding of the meaning and purpose of the mark. All herbal medicinal products in the European Union must be THR registered or otherwise market-authorized by the end of April 2011. Source: HFMA
NORTH AMERICA
CANADA REPRIEVE FOR NATURAL HEALTH PRODUCTS? Currently, Health Canada permits companies to sell unlicensed natural health products (a category which includes teas, vitamin and mineral supplements and herbal products), provided they have submitted a product license application with Health Canada’s natural health product directorate and the Department is not aware of any health risks associated with the products. Since 2004 Health Canada has received nearly 42000 product licenses applications, and has processed about 73% of these. The deadline for clearing the backlog is March 2010. However, according to Carl Carter, Director of Regulatory Affairs and Policy Development at the Canadian Health Food Association (CHFA), in response to intensive industry action, Health Canada officials have made it clear that the March date is an internal target, and that if a product does not have a compliance document by that date, it does not mean that it immediately has to come off the market. Instead, Health Canada intends to continue to work on their compliance policy during 2010, with enforcement taking effect in 2011. Source: CHFA
UNITED STATES NEW FOOD CODE PUBLISHED The US Food and Drug Administration (FDA) has announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The 2009 FDA Food Code is a key component of the US President’s overall public-health-focused food safety framework for maintaining a safe food supply and provides the basis licensing, inspection, and enforcement activity. Source: UNPA
NEW FDA GUIDANCE ON LIQUID DIETARY SUPPLEMENTS The Food and Drug Administration (FDA) has announced the availability of a draft guidance entitled “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.'' The draft guidance states that ‘We have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods’. It describes the factors that can be used to identify such products: ‘Liquid products that suggest through their serving size, packaging or recommended daily intake that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the US, are represented as beverages’ (and may not be marketed as food supplements). Manufacturers and distributors of beverages and other conventional foods, particularly those that contain novel ingredients, are also reminded about the requirements of the Federal Food, Drug, and Cosmetic Act regarding ingredients, (in particular unapproved additives) and labeling. Source: AHPA
FDA’S EXPANDED HEALTH INFORMATION INCLUDES SUPPLEMENTS The US Food and Drug Administration (FDA) has expanded its partnership with WebMD so as to give consumers a larger selection of timely information and multimedia tools. Initially launched in December 2008, over 150,00 consumers have accessed FDA’s destination on WebMD for health and wellness information, and it was used by FDA to increase the reach of its warning to consumers to stop using an over-the-counter weight loss product after reports of serious health problems associated with the product. Now, there will be five new sections containing personalized FDA information on subjects such as allergies, children’s health, diabetes, heart health and vitamins and supplements. Source: UNPA
FDA TO GET TOUGH ON FRONT OF PACK LABELLING CLAIMS The US Food and Drug Administration (FDA) has warned that it will consider using regulatory tools ‘If voluntary action by the food industry does not result in a common, credible approach to Front of Pack and shelf labeling….’ The problem is the plethora of different labeling systems now in use leading to questions whether they are helpful in providing consumers with useful and understandable nutrition information. FDA is already developing a proposal for a regulation to define the criteria for the use of on-pack nutrition symbols, with the aim of providing ...standardized, science-based criteria on which Front of Pack labeling must be based…’ Source: UNPA
USADA INITIATIVE AGAINST DANGEROUS SPORTS SUPPLEMENTS The United States Anti-Doping Agency (USADA), the body responsible for the testing and results management process in the US for Olympic and Paralympic athletes, in partnership with the US Olympic Committee and a number of national sports and health organizations has launched a new initiative, ‘Supplement Safety Now’. The aim of the project is to end the unscrupulous practices of ‘rogue’ manufacturers and eliminate dangerous products containing steroids or other drugs marketed as ‘safe and legal’ dietary supplements. |