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WHAT'S NEW AT CANTOX
On 8-9 September 2003, Dr. Nestmann presented a talk entitled, "Identifying Potential Risks of Hepatotoxicity Associated With Botanical Dietary Supplements Prior to Marketing", at the
Hepatotoxicity Assessment for Botanical Dietary Supplements Conference in Bethesda, MD.
Dr. Ashley Roberts, Senior Scientific Consultant at Cantox, participated in the
European Health Claims Forum in Amsterdam, 18-19 September 2003, where he presented a talk entitled, "A Review and Comparison of Health Claims in the United States and Canada".
In Las Vegas, NV, Dr. David Bechtel, Senior Scientific Consultant at Cantox, presented a talk entitled, "Nutraceuticals: A United States and European Overview" at
WorldNutra 2003, held 28 September - 1 October 2003.
Dr. Nestmann, presented a talk entitled, "Safety Evaluation of Dietary Supplement Ingredients and Products" on 1 October 2003 at the
SupplySide West 2003 Conference and Tradeshow.
During the month of October, Dr. Hlywka was an invited speaker on 'Food Allergens' at several
Supply Chain Food Product Recall Workshops held across Canada. Dr. Hlywka also was an invited speaker at the
International Seminar on Transgenics, held in Sao Paulo, Brazil, 27-29 October 2003, where he presented a talk, "The Safety Assessment and Postmarket Monitoring of Foods Derived Through Agricultural Biotechnology".
Additionally, Dr. Hlykwa presented seminars on 'Allergens' at the
Importer Food Safety Workshops held on 13 November 2003 in Vancouver, BC, and on 24 November 2003 in Toronto, ON.
On 9-11 December 2003, Dr. Ian Munro, President of Cantox, participated in the
ILSI Southeast Asia Food Safety Standards Harmonization Workshop in Jakarta, Indonesia, where he presented talks on the Joint FAO/WHO (JECFA) Procedure for the Safety Evaluation Of Flavoring Substances and the U.S. Flavor and Extract Manufacturers' Association (FEMA) Generally Recognized As Safe (GRAS) Program for Flavors.
Dr. Larry McGirr, Senior Scientist at
Cantox, presented a talk entitled, "Intake Calculations in the JECFA Procedure for the Safety Evaluation of Flavoring Substances" at the
Food and Drug Administration (FDA) Office of Food Additive Safety (OFAS) Regulatory Grand Rounds Workshop
on Estimating Exposure, on 12 December 2003 in Washington, DC.
At the ILSI Project on Nutritional & Safety Assessment of Biotech Foods & Feeds
Workshop, 18-19 December 2003, in Paris, France, Dr. Munro presented talks on "The Feasibility of Postmarket Monitoring of Foods Derived Through Biotechnology to Identify Effects on Human Health" and "Safety Assessment of Nutritionally Improved Foods and Feeds Developed Through the Application of Modern Biotechnology".
PUBLICATIONS OF INTEREST
- Hlywka, J and Harwood, M. 2003. Ensuring the Safety of Dietary Supplements. In: Nutraceuticals World, October 2003. Rodman Publishing; Ramsey, NJ; pp. 50-53.
- Hlywka, JJ; Reid, JE; Munro, IC. 2003. The use of consumption data to assess exposure to biotechnology-derived foods and the feasibility of identifying effects on human health through post-market monitoring. Food and Chemical Toxicology 41:1273-1282.
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UPDATE ON FOOD FORTIFICATION
EUROPEAN UNION (EU)
On 10 November 2003, the European Commission published a Proposal for a EU regulation on the addition of vitamins and minerals and of certain other substances to foods. Currently, there are no Community rules on the voluntary addition of vitamins and minerals to foods, and rules on the fortification of foods vary widely between Member States. The goal of the proposal is to harmonize national rules governing these products. The proposed Regulation would allow for the voluntary fortification of foods for the purpose of restoration, nutritional equivalence of substitute foods, and/or fortification or enrichment. As proposed, the Regulation would provide a positive list of vitamins and minerals and their sources that could be added to foods at established maximum and minimum levels, and would outline a procedure for the evaluation by the European Food Safety Authority of certain other substances, such as amino acids, proteins, or herbal extracts. The proposal must pass review by the European Parliament and the Council before promulgation.
CANADA
Health Canada conducted a meeting for stakeholders to discuss issues related to a new food fortification policy on June 23, 2003. A revision of Canada's food fortification policy was initiated in 1998 in response to food industry and consumer concerns that the policies in place were too restrictive. The new policy, and the regulation to follow, are anticipated to recommend food fortification as a way to maintain and improve the nutritional quality of the food supply, to continue to use mandatory food fortification to correct or prevent nutritional deficiencies, to allow a wider range of fortified products, and to establish a new category of discretionary fortification and expand the category of special purpose foods. The new policy also is anticipated to use a new reference value, the Tolerable Upper Level of Intake (UL), to assess exposure of the population to intakes of nutrients that pose a health risk. Health Canada is anticipating that the new regulations will be published in the Canada Gazette Part I in January 2004.
SOUTH AFRICA
New legislation regarding the mandatory fortification of some food products was recently promulgated in South Africa. The government received a grant from the Global Alliance for Improved Nutrition, a foundation sponsored by the World Health Organization (WHO), to maintain a National Food Fortification Program over the upcoming 3 year-period. The new legislation requires millers to fortify white and brown bread flour and maize meal with various vitamins and minerals, which include folic acid, vitamin A, vitamin B6, thiamine, riboflavin, niacin, iron, and zinc. Previously, there were no regulations pertaining to the mandatory fortification of flours. The Department of Trade and Industry environmental health inspectors will enforce compliance with the new legislation.
OTHER REGULATORY UPDATES
UNITED STATES
Comments on Regulation of Qualified Health Claims (QHC)
On 25 November 2003, the U.S. FDA issued an advance notice of proposed rulemaking seeking comments on options for the regulation of QHC for conventional foods and dietary supplements. FDA is considering 3 regulatory options for QHC: (1) incorporate the interim procedures and evidence-based ranking system into a regulation under notice-and-comment rulemaking; (2) reinterpret the significant scientific agreement (SSA) standard to apply to the accuracy of the characterization of the evidence supporting the claim and subject QHC to notice-and-comment rulemaking; or (3) treat QHC as wholly outside the Nutrition Labeling and Education Act (NLEA) and regulate them solely on a post-market basis. In July 2003, the FDA's Task Force on Consumer Health Information for Better Nutrition provided criteria to rank scientific evidence relevant to substance/disease relationships that are the subject of QHC. A claim would be assigned: an "A" grade if it is supported by SSA, and is or could be authorized under the NLEA and regulations promulgated under the Food and Drugs Act; a "B" rating if the supporting data is good but not conclusive; a "C" grade if the evidence is limited and inconclusive; or a "D" grade if it is supported by little scientific evidence. The comment period on the regulatory options for QHC ends 26 January 2004.
CANADA
Revision of Guidelines for the Safety Assessment of Novel Foods
In June 2003, Health Canada published a revised version of its Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms. The Guidelines were originally published in 1994, prior to implementation of the Novel Foods Regulations in 1999. The revised Guidelines reflect the promulgation of the Novel Foods Regulations, which modified the definition of novel foods and required a mandatory pre-market notification process. The revised Guidelines provide more explicit guidance on the safety assessment data requirements for novel foods and the latest international developments with respect to the safety assessment of foods derived from biotechnology. A consultation document was issued in July 2003 to solicit comments on the revised Guidelines and the regulation of novel foods in Canada in general. Comments received by 30 September 2003 are being considered in finalizing the revised Guidelines.
EUROPEAN UNION
New Food Labeling Regulations
In September 2003, the European Council adopted new regulations requiring more detailed information on the labeling of food ingredients. Under the new regulations, all ingredients, including sub-ingredients of compound ingredients, must be declared on the label. Previously, sub-ingredients did not have to be declared if a compound ingredient made up less than 25% of the product. The new regulations will enable consumers with allergies to identify any allergenic ingredients that may be present, including soy, nuts, eggs, and milk and dairy products. Alcoholic beverages, previously exempt from ingredient labeling, also will be required to declare all ingredients on the list of allergens, including sulfites, which are commonly used as preservatives in wine, cider, and beer. The new regulations, which amend Directive 2000/13/EC, will be published in the Official Journal in late 2003 and will enter into force in 2005.
AUSTRALIA/NEW ZEALAND
Changes To Food Standards Code (FSC)
The Food Standards Australia New Zealand (FSANZ) published Amendment 68 to the FSC on 18 September 2003. The Amendment included the approval of the use of hexose oxidase as a processing aid and implementation of hazard analysis critical control point (HACCP)-based food safety programs in the production of uncooked comminuted fermented meat (UCFM) products. On 8 October 2003, FSANZ invited public comment on a number of possible changes to the FSC, including: the use of non-culinary herbs, nicotine and Nicotiana sp. in foods; the mandatory declaration of the presence of allergenic substances in food; a review on gluten claims; food derived from genetically modified insect-protected cotton; the use of Bacillus cereus in infant formula; updates on the provisions regulating wine; the recognition of polydextrose as a dietary fiber; a review of kava; and the derivation of maximum residue limits (MRLs) for certain agricultural and veterinary chemicals.
JAPAN
New Food Safety Law
Japan's New Food Safety Basic Law came into force this past summer. The law requires the Farm Ministry to set up a new food safety committee that will be charged with evaluating the safety of food products and monitoring the government's food safety policies. Members of the committee include one toxicologist, a microbiologist, a public health expert, and an expert in consumer psychology. In addition, subcommittees responsible for food additives, viruses, agricultural chemicals, and genetically modified food will be created. Additional changes to the existing food law include more severe penalties for false labeling and for illegal activity regarding residual agricultural chemicals
New GMO Law
The Japanese parliament enacted a bill regulating the use of genetically modified organisms (GMOs) in June 2003. Under the new law, GMO handlers must obtain approval from the Japanese government prior to conducting experiments or using GMOs outdoors. A submission detailing the use of the GMO and its impact on biodiversity will be required. For GMOs to be used indoors, handlers must take specific measures to ensure that GMOs will not escape into the environment. In addition to regulating the genetic engineering of farm products, the new law regulates the genetic map of microorganisms to be used for purposes such as cleaning up the environment or pest control.
CHINA
New Food Chemical and Food Labeling Standards
Following its obligations to the World Trade Organization (WTO), the People's Republic of China notified the WTO of its intention to create standards for the use of the agricultural chemicals, chlorpyrifos and glyphosate. China also advised the WTO of its intention to create a new standard requiring detailed labeling of all pre-packaged processed and unprocessed natural food, including basic labeling requirements and provisions for voluntary labeling, and mandatory labeling and exemptions.
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