NEWS - April 2010:
International
Update
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NEWS - April 2010: International
Update |
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International Update 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.
CODEX FOOD ADDITIVES ADOPTIONS CONTINUE
The Codex Commission, the highest decision-making body in Codex, will consider at its July meeting whether to endorse the CCFA's decision and to finally adopt these additives. In addition, the CCFA discussed also the use of steviol glycosides in food supplements and the three different maximum levels that were proposed: 5,500 mg/kg / 2,000 mg/kg (supported by the Philippines) / 50 mg/kg (supported by Australia and Mexico). The CCFA’s view was that the reporting basis should be on the actual steviol content as the glycosides have varying molecular weights. In the light of the wide disparity in the levels proposed for food supplements (50 - 50,000 mg/kg), a good technological justification is required on realistic usage levels in food supplements based on the steviol content. An electronic working
group, led by the USA, was also established to address the food additives
that are pending for discussion, including the technological justification
for steviol glycosides and for Erythrosine, which was returned last year
for further discussion by the CCFA.
For further details, contact: secretariat@iadsa.be
AFRICA
SOUTH AFRICA
NEW FOOD LABELING AND ADVERTISING REGULATIONS
These recently published regulations cover a wide range of topics:
· Technical topics: methods of analysis, sampling for analysis, etc. · Commercial topics: including misleading claims (based on UK food industry criteria) and categorisation of names that may be considered comparative but are not comparative.
The publication of these regulations is the result of South Africa’s commitment in implementing the World Health Organisation (WHO) Global Strategy on Diet, Physical Activity and Health. They will apply to both locally manufactured and imported products, and come into effect in March 2011.
Source: HPA
ASIA
INDIA
GROWTH IN SUPPLEMENT MARKET ANTICIPATED
Regulations resulting from the passage into law of India’s Food Safety and Standards Act of 2006 are due to come into force during 2010.
Growth in India’s food supplement market is anticipated as a result of the additional regulatory clarity that these new rules are expected to bring, particularly for ‘life-style’ products, memory loss, vision enhancement, blood sugar levels, and disease-risk prevention.
Source: HADSA
JAPAN
SAFE LEAD CONCENTRATION LEVELS
The Chemical Substances and Contaminants Expert Committee for lead of the Japanese Safety Committee (JSC) have published their interim report for safe blood Pb levels.
From the several epidemiological studies for the relationship between blood Pb level and neurological outcome, they decided on two separate safe blood Pb levels, one for high risk groups and other for other adults:
· High risk group (infants, children, women under pregnancy and lactation and women who have some possibility to be pregnant):4µg/dL · Other adult group:10µg/dL
Regarding the setting of an upper level of Pb, the committee postponed their conclusion due to the uncertainty of current Pb intake data.
Source: AIFN
EUROPE
EUROPEAN UNION
HEALTH CLAIMS UPDATE
Meeting with the European Commission: Industry associations, including the European Federation of Associations of Health Product Manufacturers (EHPM), the European Responsible Nutrition Alliance (ERNA), and the European Botanical Forum (EBF), were recently invited to meeting with the European Commission to discuss article 13 ‘generic’ health claims.
It emerged that despite objections from industry and from some Member States, political decisions have been taken to publish the European Food Safety Authority (EFSA)’s health claim opinions in batches up to 2011. Additionally, despite strong representations from industry about the feasibility of the ruling, a transition period of not more than 6 months will be allowed for rejected claims. More positively, it is understood that the Commission will not propose blank prohibitions for botanical claims based on traditional use. Instead, there will be discussion between EFSA and the European Medicines Agency (EMA) to ensure a consistent approach for medicinal products and food supplements. A contributory factor to this decision is that EMA now falls under the responsibility of DG SANCO, (as do food supplements), making it difficult to defend the rejection of claims based on traditional use for botanical food supplements whilst allowing them for traditional medicinal products.
As requested by the Commission, since the meeting the food industry associations, including EHPM, ERNA and the EBF, have written a joint letter to the Commission, further underlining the problems the implementation of the Regulation is causing the industry, and seeking further clarity on a number of the points discussed. For further information contact secretariat@ehpm.be
Meeting with the NDA Panel: EFSA has recently announced that it is to host a meeting between its Panel on Dietetic Products, Nutrition and Allergies (NDA) and stakeholders on the subject of health claims. This meeting, which will offer a rare opportunity for stakeholders to put their views to the Panel, will be held in May, at EFSA’s headquarters in Parma, Italy.
Additionally, there is no agreement between Member States (MS) as to how to treat claims which EFSA considers to be substantiated, but for which it has indicated there is no known deficient intake or dietary need for the substance. Some MS have proposed a mandatory label warning statement, but the European Commission (EC) is strongly opposed to this idea.
Publication of the Register of approved/rejected claims: The EC intends to produce a first draft of lists of the approved/rejected claims by April, with final publication of the first batches probable after September of this year.
Publication of the second batch of opinions on submissions under Article 13.1: EFSA has now published its second batch of opinions. Only 8 of the 416 claims covered are positive. The remainder are negative, according to EFSA primarily due to “the poor quality of the information provided’, for example:
· Lack of information to identify the substance on which the claim is based, e.g “probiotics”; · Lack of evidence that the claimed effect is beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”); · Lack of human studies with reliable measures of the claimed health benefit.
The opinions, which can be found at http://www.efsa.europa.eu/en/ndatopics/topic/nutrition.htm under the section “Scientific Documents”, cover 34 botanicals, primarily relating to claims for anti-oxidant activity, joint health and glucose metabolism.
Source: EHPM, ERNA
WORKING GROUP DISCUSSES EVIDENCE FOR BOTANICAL CLAIMS
At a recent meeting of the Working Group on Nutrition and Health Claims on Foods, the European Commission used a flowchart to initiate a discussion about the role of evidence of traditional use in the substantiation of health claims on botanicals and about the role of evidence from sick people in the substantiation of health claims aimed at the normal population.
Many Member States took the view that it was reasonable to use evidence of traditional use as part of the evidence submitted in support of a botanical health claim and that it could be weighed by EFSA during the assessment process. The relevance of that information would then have to be considered on a case-by-case basis. In response, EFSA said that it would look at all the evidence but if this evidence did not include scientific conclusions then it cannot be taken into account.
On the question of whether evidence from sick people could be used in substantiating a claim aimed at the normal population, most Member States considered that this needed to be considered on a case-by-case basis.
Source: EHPM
COMMITTEE ADOPTS FOOD INFORMATION PROPOSALS
After 18 months of debate, the European Parliament’s Environment Committee has finally voted on their report on the Food Information to Consumers Regulation which sets out new harmonised rules for food labelling across the EU.
Key points of the report, which was adopted by an overwhelming majority, include:
- Additional nutrition information on proteins, fibre, natural and trans fats should be added to labels and all mandatory nutrition information should be given on the front of pack. Energy content should be especially visible and specific rules to guarantee this were adopted. - Traffic light front of pack colouring across the European Union is rejected. General rules on how information should be displayed were agreed but a specific system for their display is left up to national authorities. - Information should be clearly legible and the European Commission (EC) was asked to draw up guidelines to ensure this; the Commission’s proposed requirement that information be given in a minimum font size of 3mm was rejected. - Members of the European Parliament (MEPs) agreed with the Commission that information on energy and nutrients should be given in relation to 100g or per 100ml and possibly also per portion. They also endorsed the idea of making comparisons with reference intake for energy but added the caveat that these reference intakes may differ from person to person. - MEPs also voted to delete nutrient profiling from the Nutrition and Health Claims Regulation.
One amendment of potential concern to the food supplement industry concerns the requirement for origin labelling for products composed of a single ingredient. This may be of concern for some food supplements composed of a single ingredient such as fish oil capsules, etc. The European Federation of Associations of Health Product Manufacturers (EHPM) is seeking feed-back from its members on this point. The report will now go before the full European Parliament for adoption, probably in late May. Agreement will then have to be reached with the Council, who are also currently considering the proposal, and a second reading of the proposal may then be necessary.
Source: EHPM
‘RED RICE’ AND NOVEL FOOD STATUS
The European Food Safety Authority’s (EFSA) Standing Committee on the Food Chain and Animal Health recently concluded that ‘fermented red yeast rice when used in or as food supplement, should not be considered as subject to the novel food Regulation.
The Committee’s ruling was in response to enquiries from Belgium to other European Union Member States as to the status of the ingredient. Italy was able to confirm that products containing red yeast rice were on the Italian market before May 1997, the date when the EU Novel Food Regulation came into effect.
Source: EHPM
NO SAFETY CONCERNS FOR FOOD SUPPLEMENT COATING
The European Food Safety Authority (EFSA) Panel on food additives and nutrient sources added to food (ANS) has recently concluded that the use of basic methacrylate polymer (BMC) has no safety concerns when used as a glazing agent in food supplements at the levels of use proposed.
In the opinion of the Panel, BMC is a stable high-molecular compound, virtually not absorbed from the gastro-intestinal tract after oral administration.
Source: EHPM
EFSA OPINION ON HERB EXTRACTS AS FOOD ADDITI VES
Following a request from the European Commission, EFSA’s Panel on food additives and nutrient sources added to food (ANS) has delivered its scientific opinion on the safety of oregano and lemon balm extracts when used as food additives.
The Panel noted that the specifications proposed are not in line with what would be expected for a botanical/botanical preparation, and that the presence of compounds of concern such as estragole, carvacrol and thymol are not specified. In addition, data on genotoxicity, reproductive and developmental and long-term toxicity of the extracts was lacking.
For these reasons, the Panel concluded the safety at the proposed uses (in foodstuffs and in teas), at the proposed levels could not be assessed.
Source: EHPM
FRANCE
NEW FRENCH RDAs FOR LIPIDS AND FATTY ACIDS
The French food safety agency AFSSA has recently announced new Recommended Daily Amounts (RDAs) for lipids and fatty acids. See full details on: http://www.afssa.fr/
The main changes are : • The part of lipids in the total daily amount of energy: 35 to 40% instead of 30-35% • AFSSA distinguishes essential fatty acids (because they cannot be synthesised) from others • The three essential fatty acids are: - Linoleic acid (C18 :2 n-6) => RDA's = 4% of the total daily amount of energy. - Alpha-linolenic aid (C18 :3 n-3) => RDA's = 1% of the total daily amount of energy. - DHA (C22:6 n-3) => RDA's = 250 mg. • AFSSA creates distinctions between different types of saturated fatty acids
Some specific RDA's are fixed for infants and young children, children, teenagers, pregnant and breastfeeding women
Source : SDCA
ITALY
PROGRESS ON DRAFT DECREE ON ‘OTHER SUBSTANCES’
The Italian draft decree on the use of other substances (including botanicals), reported in last month’s Newsflash, has now been discussed by the Member States (MS) of the European Union. Several MS, in particular Belgium, expressed concerns that the mandatory labelling statement for botanicals would be contrary to the Nutrition and Health Claims on Food Regulation. However, the Italian authorities have stated they would take EFSA's opinions on health claims into account when they become available.
Belgium has also indicated that the legislation proposed in the draft decree should apply to the Italian market only and should not be subject to mutual recognition amongst other EU Member States. Taking into account such comments, the European Commission is now expected to deliver its views in April 2010.
UNITED KINGDOM
NOVEL FOODS AND TECHNOLOGIES WORKSHOP
Under the original novel foods regulation, foods and food ingredients that have no history of safe use in the EU before 15 May 1997 may not be placed on the market before they have gone through an approval process. Once the first approval has been granted, subsequent applicants can apply for approval on the grounds of substantial equivalence.
The regulation is now being revised as some new and emerging technologies, such as nanotechnology, need to be taken into consideration. Also, the regulation has come in for criticism since approvals can take a long time to come through, which can impact on the competitiveness of the European food sector. It has been proposed that the updated regulation should contain a system for assessing foods that already have a safe history of use outside the EU.
The UK Food Standards Agency’s Advisory Committee on Novel Foods and Processes (ACNFP) is to hold a Workshop where, as well as updating delegates on the progress of the amendments, the agenda will includes the adding of novel biological active substances in food and food supplements, public attitudes to innovation and risk, and how novel foods might help promote sustainability of the food supply.
Source: CRN UK
COMPLAINTS ABOUT CHANNEL ISLAND SUPPLEMENT CLAIMS
The UK Advertising Standards Authority has recently warned two companies based in the Channel Islands (CIs), (islands in the English Channel that runs between the UK and France) that the claims they are currently making for Ginkgo, Ginseng and Bilberry products conform with neither UK and European Union legal requirements for food supplements, nor those for traditional herbal medicinal products.
Such product claims made by some companies based in the CIs have long been a source of concern to the mainland UK food supplement industry. However, in this instance it is understood that the companies concerned are now amending the advertising for their products to conform with UK/EU legislation.
Source: HFMA
NORTH AMERICA
CANADA
FOOD COLOURINGS CONSULTATION
In response to concerns about food colourings and, in particular, behavioural response in children, Health Canada is consulting on a proposal to change the regulations on how food colourings should be listed on product labels.
Currently, the word ‘colour’ can refer to one or more colours in a product, and individual listing of colours contained in the product is optional. Now, Health Canada is proposing to improve food colour labelling to require that ‘…many, if not all’ colours are listed, so as to ‘…enable consumers to make more informed choices which could contribute to the reduction of adverse reactions’.
Source: CHFA
RECOMMENDATIONS FOR ADVERSE EVENT REPORTING
A report recommending the closer monitoring of adverse reactions to Herbal Medicinal Products (HMPs) has been welcomed by the Canadian food health association.
The report recommends five particular actions to protect public health: Using Poison Control
Centre data to augment available reports suspected to be linked to HMPs
Source: CHFA
UNITED STATES
NEW GUIDANCE ON HEALTH CLAIM SUBSTANTIATION?
It is understood that the U.S Federal Trade Commission is currently in the process of initiating change to its guidance of the substantiation of health claims. Specific changes which are likely to have a major impact on the supplement industry are the requirements for at least two adequate and well-controlled Random Control Trial human studies of the exact formula for the product in question (or a substantially similar product), conducted by different experts, independently of each other. The Guidance is also likely to specify that the trials must conform to acceptable designs and protocols, and deliver results that, when considered in the light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the claims made for the product. Source: CRN US
REPORT SEEKS IMPROVEMENT TO OVERSIGHT OF GRAS According to a new report from the US Government Accountability Office (GAO), the Food and Drug Administration (FDA) needs to improve its oversight of GRAS (Generally Recognized As Safe) food ingredients. The Food and Drug Administration (FDA) no longer ‘approves’ food ingredients as GRAS, but it does review their safety if a company submits a research dossier including the findings of an independent scientific panel. The FDA can then issue a letter of no objection, leading to what is commonly referred to as FDA GRAS. However, the company remains responsible for ensuring the ingredient is safe and that it complies with all regulatory requirements. Alternatively, a company can self-affirm GRAS after conducting all necessary research and forming an independent panel to determine its safety. To self-affirm, the company needs to be confident that it could defend the safety of its ingredient based on this process. However, the report notes that “FDA is not systematically ensuring the continued safety of current GRAS substances. While, according to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, the agency has not systematically reconsidered GRAS substances since the 1980s.” In relation to a current area of concern, nanotechnology, FDA has previously stated that in terms of safety assessment, it would not view products that contain nanotech materials any differently from others, in that regardless of the technology used to make them, companies are responsible for ensuring the safety of all ingredients: “While a single definition for nanomaterials for all FDA-regulated products may have a certain utility, the key issue for safety evaluation is not whether a bright line on the nano-scale has been crossed but whether the modification at the nano-scale creates new properties that require testing to ensure safety under intended conditions of use.” It is understood that in response to the report, FDA now intends to develop guidance to help food manufacturers understand how the GRAS process applies. Source: CRN US
FDA ACTS ON LABELLING VIOLATIONS
In a recent open letter to industry, the U.S. Food and Drug Administration (FDA) has notified 17 food manufacturers that the labelling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.
The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg, M.D., encouraging companies to review their labelling to ensure that they were in compliance with FDA regulations, and were truthful and not misleading.
Source: NPA
SENATORS REACH AGREEMENT ON SUPPLEMENT LEGISLATION
It is understood that as a result of a letter from Senator Orrin Hatch, a long-time supporter of the food supplement industry, Senator John McCain will withdraw his support for certain elements of the legislative proposal he introduced in February of this year, ‘The Dietary Supplement Safety Act of 2010’ (S3002). As reported in last month’s Newsflash, the US supplement industry have specifically expressed concern that the bill would negatively affect the dietary supplement industry and American consumers’ access to a broad range of supplements.
In his letter, Senator Hatch states his intention to work with McCain “on calling for the full enforcement of existing laws … so Americans will have uninterrupted access to safe dietary supplements and bad actor companies are removed from the market immediately.”
Source: AHPA, NPA
FITNESS TRAINER SUED FOR FALSE HEALTH CLAIMS
A celebrity fitness trainer is currently being sued for the second time in a class action over claims made for a weight loss supplement which makes up a major part of her fitness programme.
The product, which promises ‘Maximum Strength Calorie Control’, is described in the action as ‘worthless’ and a ‘deception’.
Source: UNPA
FDA WARNS ON WEBSITE CLAIMS
The US Food and Drug Administration (FDA) recently wrote a warning letter to a marketer of a Green Tea product in relation to claims made on a website linked to the company’s main website and presented as ‘educational material’. Examples include:
• "Anticancer
effects of green tea and the EGCG level of the green tea used in cancer
Source: AHPA
SUPPLEMENT PROVISIONS SURVIVE IN HEALTH CARE REFORM BILL
The health care reform bill signed into law this month by President Barack Obama, the Patient Protection and Affordable Care Act, includes several provisions that address complementary and alternative medicine (CAM), and one focused on certain dietary supplements. These details primarily serve to better incorporate alternative practitioners into the U.S. health care system.
Among the provisions included in the final law, section 4206 would have a direct effect on those dietary supplements for which there are FDA-approved health claims by setting up a pilot program for "wellness plans," which can now include those few supplements with "health claims approved by the Secretary." Currently approved health claims include, for example, claims for calcium and osteoporosis; soluble fiber and coronary heart disease; and folic acid and neural tube birth defects. The full list can be found on the Food and Drug Association (FDA) web site: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/default.htm
The new health care law is a starting point for a broader inclusion of CAM within the U.S. healthcare system. If managed properly, greater inclusion of alternative practitioners in health care should open a pathway for increased acceptance of the dietary supplement products they provide.
Source: AHPA
SOUTH WEST PACIFIC
AUSTRALIA
CONSULTATION ON FOOD LABELLING LAW AND POLICY REVIEW
The trade association “Complementary Healthcare Council of Australia” (CHC) is seeking comment from its members on an Australian Government Issues Consultation Paper on Food Labelling Law and Policy Review. http://www.foodlabellingreview.gov.au/internet/foodlabelling/publishing.nsf/Content/pubsreports
The background to the consultation is that various reviews of the food regulation system in Australia have suggested that food labelling is an area of concern for food industry, consumers and government. Issues raised include: Difficulties consumers
have in understanding and using information on labels; In particular, CHC is seeking feedback on member’s views of the key roles of food labelling which questions the evidence for health claims and questions the practical implications and consequences of aligning the regulations relating to health claims on foods and complementary medicine products. The paper also seeks comment on presentation of labels for foods and the issues around enforcement of food labelling.
Source: CHC
Prepared
by the
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.
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