IADSA NEWSFLASH
JANUARY/FEBRUARY 2010
CONTENTS
CODEX: Work on food additives continues
SOUTH AFRICA: Association action on threat to CAMS
JAPAN: Commission considers capsule form unacceptable for FOSHU
EUROPEAN UNION: Parliament approves new European Commission
Revision to the upper levels for vitamins B6 and D?
European Court rulings relevant to supplements
Maximum levels for vitamins and minerals
Maximum levels for children
Health claims
Food Information (labelling)
Status of discussions on contaminants
Pan-European food consumption survey
Novel foods and nanotechnology update
CZECH REPUBLIC: Agency acts on problem supplements
FRANCE: French food safety agency to merge
Association takes prompt action on maximum levels
Proposal for a decree on nutrivigilance
ITALY: Draft decree on ‘other substances’
Association complains to the Ombudsman
UNITED KINGDOM: Revised guidance on nutrition and health claims
Watchdog acts on ‘herbal viagra’ advertisements
CANADA: Warning on slimming/unauthorised products
Advisory on products containing glucomannan
UNITED STATES: Introduction of new legislation amending the FFDCA
Strategic plan for supplements
FDA Guidance on liquid supplements/beverages
Herbal products and cardiovascular disease
Nanotechnology risk assessment bill
New rules for imports via ocean-going vessels
Court cases and fines for problem products
AUSTRALIA: Comment sought on regulatory change costs
Association comment on classification of tablets and capsules
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 more than 50 food 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 food 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 food 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.
INTERNATIONAL DEVELOPMENTS
CODEX
WORK ON FOOD ADDITIVES CONTINUES
The work of the Codex Committee on Food Additives (CCFA) on the adoption of food additives in the General Standard for Food Additives and their levels of use in food supplements, among other food categories, continues.
In view of the next meeting of the CCFA next month in Beijing, IADSA has developed a position on the basis of the responses of IADSA Members to the detailed questionnaire circulated to the membership on the food additives that will be considered by the CCFA this year. The IADSA position, which has been circulated to all members for further feedback, will form the basis of IADSA's negotiating position at the CCFA meeting.
For further information, contact the secretariat at:
Source: IADSA
AFRICA
SOUTH AFRICA
ASSOCIATION ACTION ON THREAT TO CAMS
The South African Health Product Association (HPA) has recently taken action on a government decision to rescind a decision made in 2002, which would effectively make about 15,000 Complementary and Alternative Medicine (CAM) products - herbals, amino-acids, etc. - illegal.
Following legal consultation, HPA lodged an official appeal which was delivered to the Minister of Health and the Registrar in November 2009. The appeal is based on a 7-year understanding that CAMS products could be sold, based on the submission of dossiers. There is also the expectation over many years that appropriate regulations would be published for CAMS products.
The procedure is that the Minister will now have to constitute a Committee of Appeal but to date no official response has been received.
Source: HPA
ASIA
JAPAN
COMMISSION CONSIDERS CAPSULE FORM UNACCEPTABLE FOR FOSHU
The Consumer Commission of the Japanese Cabinet Office that was established in last September has begun its examination of the FOSHU approval procedure and recently decided that it was not appropriate to approve a capsule-type product as FOSHU.
The active component of the product in question is wheat albumin and its safety and efficacy has been confirmed by the Food Safety Commission and the Ministry of Health, Labour and Welfare (MHLW), respectively. A product in the form of dried powder soup containing the same active component was also approved as FOSHU in 2003.
However, despite the fact that in Japan, shape regulation had been removed in 2001 and the government also decided to adopt capsule and tablet shapes into the FOSHU category, the new Commission considers that consumers would be bound to misunderstand the status of the product and would consider it to be a drug, because:
· It is in capsule form.
· It is packaged in a bottle.
· It carries the claim “Good for those concerned about blood glucose levels after meals”.
Source: JIHFS
EUROPE
EUROPEAN UNION
PARLIAMENT APPROVES NEW EUROPEAN COMMISSION
The European Parliament has now approved the new European Commission by a large majority, with the three largest political groups all giving the Commission their backing.
This means that the new Commissioners, including the Health and Consumer Commissioner, John Dalli - particularly relevant for food supplement issues - will now be able to take office. However, delays caused by the unacceptability of one candidate Commissioner, now replaced, means that the work schedule is four months behind schedule.
Mr Dalli’s legislative priorities are given as:
· Completing the European food chain strategy
· Developing effective and efficient healthcare systems in all Member States, leading to longer and healthier lives
· Keeping the consumer at the heart of the function of the internal market, including through the increased provision of information
In relation to innovation, Mr Dalli is quoted as saying, ‘…in this area the overarching principle remains ‘safety first’. This, however, does not mean zero risk, or that we should not take action to enhance growth and innovation’.
Source: EHPM
REVISION TO THE UPPER LEVELS FOR VITAMINS B6 AND D?
The European Federation of Associations of Health Product Manufacturers (EHPM) has recently received a response from the European Commission (EC) to a letter requesting consideration of the revision of the upper levels (ULs) for vitamins B6 and D.
In regard to vitamin B6, the EC has responded that considers that in order to keep a coherentapproach for all vitamins and minerals, they would not considersetting short term ULs as justified.
For vitamin D, however, before considering putting a request for the revision of the UL to the European Food Standards Agency, the EC is awaiting results of work carried out by EFSA on Recommended Reference Intake and also some work by the Institute of Medicine (IOM) work on the revision of the upper level for Vitamin D.
Source: EHPM
EUROPEAN COURT RULINGS RELEVANT TO SUPPLEMENTS
The Association of Importers and Manufacturers of Natural Products in Greece, a member of the European Federation of Health Product Associations (EHPM) has been successful in overturning national legislation limiting the amount of vitamin C that could be used in food supplements to 135 mg.
The judgmentconcluded that the risk to public health had not been demonstrated and thus that the prohibition was neither justified norproportionate in light of the free movement of goods (Mutual Recognition) rules, where there is now an increasing body of well-established European jurisprudence/case law.
In another ruling on national rules for food supplements in France, No C446/08, the Opinion of the Advocate General (AG) of the Court of Justice is supportiveof most of the arguments given by the companies, inparticular that:
· Pending harmonisation, Member States (MS) can set national levels, but in doing somust follow the principle of article 5 of the Food Supplements Directive.
· Levels that are fixed must not be based on the levels set for themost vulnerable population as their needs may not be sufficient tocover the average need of the rest of the population.
· If there is no Upper Safe Level (USL) set, MS cannot fix maximum levels. However if USLs are set, MS can set national maximum levels at areasonable lower level.
Although AG’s Opinion does not presume the final outcome of the case, it is a supportive reading of current legislation and important in view of the forthcomingdiscussion between the EC and member states on the setting ofmaximum levels for food supplements.
Another recent case heard by the European Court (Case333/08 of January 28, 2010), has condemned France on the basis of its non-application of mutual recognition principles in the area ofprocessing aids. Although not directly related to food supplements, this case illustrates the principles established in the case law of the Court, which now repeatedly finds in favour of plaintiffs in casesconcerning national restrictive rules.
Regulation for processing aids are not fully harmonised at the EU level and therefore the mutual recognition principle can apply. The Court’s conclusion was that “By laying down, for processing aids and foodstuffs whose preparation involved the use of processing aids fromother Member States where they are lawfully manufactured and/or marketed, a prior authorisation scheme not complying with the principle of proportionality, the French Republic has failed to fulfil its obligations under Article 28 EC.”
Source: EHPM
MAXIMUM LEVELS FOR VITAMINS AND MINERALS
The Institute of Life Sciences (ILSI), has recently published its latest report on intake data from food and food supplements in Europe. This data will be used to inform the discussions of the European Commission and Member States on the setting of maximum levels for vitamins and minerals - but the timescale for progress on this issue remains unclear pending further advice from DG SANCO and its new Commissioner, John Dalli.
For a copy of the ILSI report, contact the EHPM Secretariat at
Source: EHPM
MAXIMUM LEVELS FOR CHILDREN
Following a consultation with its member associations on a draft response to question from the European Commission (EC) on potential maximumlevels in food supplements for children, The European Federation of Health Product Associations (EHPM) has drafted a paper which offers a model and proposes levels. The paper explains all the factorswhich must be taken into account to derive the levels, and particularly the conservative requirement imposed by the EC and member states to use intake data for children of 4-6 year old as a basis for calculation.
The model is in line with EHPM’s current approach to the setting of adult levels, and proposes:
· No levels to be set for Group A nutrients (for which there is no ULas no risk of excess intake is identified).
· Specific levels for Group B nutrients based on safety considerationsand calculation on intake from other sources.
· Specific restrictive levels for group C nutrients taking into accountpotential risk of excessive intake by children.
For further information, contact the Secretariat at
Source: EHPM
HEALTH CLAIMS
Controversy still surrounds the assessment process for the 42,000 Article 13 health claims which were submitted for approval and which have been reduced to around 4,185 substance/health relationships for assessment by EFSA.
Of these around 1500 health claims have been accepted for assessment, with the first 500+ published in 94 opinions in October 2009. A further 417 claims in 31 opinions were completed by the end of January and are due to be published in February 2010. This latest tranche will include opinions on claims for probiotics, herbs and antioxidants as major categories of substances.
Information on all Health Claims being assessed by EFSA is available at: www.efsa.europa.eu/EFSA/ScientificPanels/NDA/efsa_locale-1178620753812_1178684448831.htm
The central EC Register of (approved and unapproved) Health Claims has now been published on the European Commission’s (SANCO) website at: http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm
It contains several disease risk reduction factor and claims for children’s products, but as yet no Article 13(1) (Generic) health claims.
Generic claims, and in particular claims for botanicals, did not fare well in the October 2009 tranche of claims, and expectations are not high for the next tranche. Once published in the Central Register of Health Claims, unapproved claims may no longer be used in the European Union.
In the face of this, European industry is carrying out an intensive lobbying campaign both nationally and in the EC aimed at ensuring that the criteria used by EFSA for the assessment of all article 13(1) claims are both proportionate and appropriate.
Source: EHPM
FOOD INFORMATION (LABELLING)
The proposed Regulation on Food Information for Consumers was published in February 2009 and since then has been the subject of intense discussion. The two most important issues for food supplements are the mandatory labelling font size and exemption from mandatory labelling for small packages. Industry has lobbied strongly for the deletion of mandatory font size labelling, proposing instead that the main criterion be legibility and is seeking amendment or exemption for small packages.
A final vote on the content of this Regulation is expected in the May plenary of the European Parliament.
Source: EHPM
STATUS OF DISCUSSIONS ON CONTAMINANTS
The current status of discussions between Member State experts and the European Commission (EC) on contaminants relevant to food supplements is as follows:
· Limits for non dioxin like PCBs - Consultation of stakeholdersexpected in April, with final adoption foreseen in spring 2010.
· Review of levels for dioxin like and non dioxin like PCBs -Consultation of stakeholders expected in April, with final adoptionforeseen in spring 2010.
· Review of legislation on fusarium toxins - EFSAopinion awaited - Consultation of stakeholders expected in the spring, withfinal adoption foreseen after summer 2010.
· Review of maximum levels for cadmium in foods - in progress but nodefined timeline yet for consultation of stakeholders - adoption expected by end 2010.
· Review of legislation on PAHs - in progress, waiting for furtheradvice from EFSA but no defined timeline yet for consultation ofstakeholders - adoption expected by end 2010.