EC Publishes Discussion Paper on Maximum/Minimum Levels
European Commission has now published its 'Discussion paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs' in view of its future proposal on maximum levels that is expected to be available this year.
The paper sets out the regulatory background to setting levels, and gives examples of five existing risk assessment models prepared by:
- AFFSA - the French Food Safety Agency
- The Danish Institute of Food and Veterinary Research
- BfR - the German Federal Institute for Risk Assessment
- ILSI - the International Life Sciences Institute
- ERNA/EHPM - the European Responsible Nutrition Alliance and the European Federation of Associations of Health Product Manufacturers.
The questions the paper poses include:
- How maximum permitted levels (MPLs) may be set (if at all) where there are no Upper Safe Levels (ULs) proposed by the Scientific Committee for Food/The European Food Safety Authority
- How to apportion MPLs between fortified foods and food supplements
- How to deal with varying needs for supplementation in different Member States
- To what extent Population Reference Intakes/Recommended Daily Allowances (PRI/RDAs) should be taken into account when setting MPLs
- Whether minimum levels should be set and on what basis.
The Commission has asked for comment by end September 2006. The full document can be accessed on http://ec.europa.eu/food/food/labellingnutrition/supplements/discus_paper_amount_vitamins.pdf.
Novel Foods Regulations to be Simplified?
The Novel Foods Regulation originally came into force in 1997. ('Novel Foods' are defined as products not consumed 'to a significant degree' in the EU prior to May 1997). Since then the European Commission has had further consultation with industry and regulators and an independent review of the legislation, resulting in various policy options.
The Commission believes that a revision of the Regulation is necessary in part to reflect the fact that genetically modified foods no longer fall under its scope, but also to create a more favourable legislative environment for innovation in the food industry and to better facilitate both internal and external trade.
Now, the Commission is inviting interested stakeholders to complete a questionnaire on the impact assessment of the changes to the current legislation. In particular, it is noted that the Commission seeks feedback on the creation of a more streamline authorisation procedure, which can take into account, for example, the particular requirements of traditional exotic foods from third countries which are the subject of applications covering several food uses.
The on-line questionnaire can be found on:
TheThe closing date for comment is 1 August. Responses to the questionnaire will be taken into account by the Commission when it finalises its proposals for amendment to the Novel Food legislation—expected to be issued in the first half of 2007.
Guidance on Qualified Health Claims
The US Food and Drug Administration (FDA) has prepared some 'Guidance for Industry on its implementation of "Qualified Health Claims" i.e. those where there is a relationship between the products and health, but the standard of scientific substantiation is not yet absolute.
The Guidance, which is in Question and Answer form and covers the background and regulatory procedures applicable to this type of claim and how a petition for a qualified health claim should be submitted. The full document is available on http://www.cfsan.fda.gov/~dms/qhcqagui.html.
5-Year Rule for American Ginseng Restored
The US Fish and Wildlife Service (FWS) has recently announced that the export of wild American ginseng (Panax quinquefolius) roots that are at least 5 years old '…will not be detrimental to the survival of the species'.
The outcome of this ruling, which re-establishes the '5 year rule' which had been set aside in favour of a requirement that limited export to plants of at least 10 years of age, is that wild American ginseng can be exported from states that maintain ginseng programmes during the years 2006 - 2008.
New Objectives for Self-Regulation
The Health Product Association of Southern Africa (HPA) is continuing to negotiate with the Department of Health (DoH) to implement acceptable and appropriate regulations for complementary medicine.
In parallel, it is developing plans to set up a self-regulatory structure that will both assist the DoH and protect the industry from unethical practices and unscrupulous marketers. Several meetings with industry have been held to determine the objectives and scope of the project, and names for the initiative are being sought, one possibility being 'The Consumer Health Product Protection Authority'.
Further meetings are planned to discuss industry concerns about the costs and complexity of the project, which may result in some revision of the objectives of the project.