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Food Supplements Risk and Safety Assessment

Risk Assessments for Food Supplements

Other Food Supplements Risk and Safety Assessment Resources

Format	Author(s)	Title / Description	Date added	Details
	Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion on Certain Bisglycinates as Sources of Copper, Zinc, Calcium, Magnesium and Glycinate Nicotinate as Source of Chromium in Foods intended for the General Population (including Food Supplements) and Foods for particular nutritional uses - Scientific Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food Opinion adopted on May22, 2008 regarding the safety of bisglycinate chelates of copper, zinc, calcium, magnesium, and of glycinate nicotinate as sources of the nutrient cations of respectively copper, zinc, calcium, magnesium and chromium and with the bioavailability of the nutrient cations from these sources. (more) Publication Date: Monday, June 9, 2008	Jun 11, 2008
	Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion on Mixed Tocopherols, Tocotrienol Tocopherol and Tocotrienols as Sources for Vitamin E Added as a Nutritional Substance in food Supplements - Scientific Opinion of the Panel on Food Additives, Flavourings, Processing aids and Materials in Contact with food (AFC) Opinion adopted on February 22, 2008 regarding the safety and bioavailability of three particular sources of vitamin E, intended for the general population, to be added in food supplements. (more) Publication Date: Monday, March 10, 2008	Mar 17, 2008
	Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Vanadium citrate, Bismaltolato Oxo Vanadium and Bisglycinato Oxo Vanadium Added for Nutritional Purposes to Foods for Particular Nutritional Uses and Foods (including Food Supplements) Intended for the General Population and Vanadyl Sulphate, Vanadium Pentoxide and Ammonium Monovanadate Added for Nutritional Purposes to Food Supplements Opinion adopted on January 29, 2008 regarding the safety of a number of vanadium compounds as sources of vanadium and with the bioavailability of vanadium from these sources added for nutritional purposes to foods for particular nutritional uses and foods (including food supplements) intended for the general population. (more) Publication Date: Tuesday, February 26, 2008	Mar 3, 2008
	Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Calcium Citrate Malate as Source for Calcium for Use in Foods for Particular Nutritional Uses and in Foods for the General Population (including Food Supplements) - Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) Opinion adopted on November 27, 2007 regarding the safety of Calcium citrate malate as source for calcium for use in foods for Particular Nutritional Uses and in foods for the general population. (more) Publication Date: Friday, December 21, 2007	Jan 18, 2008
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to the Use of Polyvinyl Alcohol as a Coating Agent for Food Supplements (Question No EFSA-Q-2005-0 Opinion adopted on December 5, 2005 resulting from a risk assessment of polyvinyl alcohol as a food additive used as film coating agent for food supplements. Summarizes the data from a variety of dietary toxicity studies. (more) Deadline: Tuesday, February 14, 2006 Publication Date: Tuesday, February 14, 2006	Feb 16, 2006
	Food and Drug Administration	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final rule regarding the use of vitamin D3 as a nutrient supplement in certain cheese and cheese products at levels up to 81 IU/30 g cheese. Includes discussion of the safety assessment. (more) Deadline: Friday, November 18, 2005 Publication Date: Wednesday, November 16, 2005	Nov 18, 2005
	Food and Drug Administration	Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final rule that amends the food additive regulations "to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other- type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight." Includes discussion of the safety assessment. (more) Publication Date: Wednesday, June 29, 2005	Jul 1, 2005
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel Related to D-α-tocopheryl Acid Succinate as a Source of Vitamin E in Foods Intended for the General Population, Food Supplements and Foods for Particular Nutritional Uses Opinion adopted on April 26, 2005 regarding the safety and bioavailability of D- α-tocopheryl acid succinate used as a source of vitamin E in foods for particular nutritional purposes, foods intended for the general population, and food supplements. (more) Publication Date: Friday, May 20, 2005	May 24, 2005
	Golden Rice Humanitarian Board	Golden Rice Project Project on the development of Golden Rice which has been genetically engineered to produce and accumulate beta-carotene in the grain. Includes background information for the risk/safety assessment. (more)	May 2, 2005
	Scientific Panel on Food Additives Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel on Magnesium Aspartate as a Mineral Substance in When Used as a Source of Magnesium in Dietary Foods for Special Medical Purposes Opinion adopted on January 7, 2005 regarding the bioavailability and safety of magnesium-L-aspartate for use as a source of magnesium in dietary foods for special medical purposes. (more) Publication Date: Monday, March 14, 2005	Apr 4, 2005
	United Kingdom Scientific Advisory Committee on Nutrition	Scientific Advisory Committee on Nutrition: Review of Dietary Advice on Vitamin A Draft of review of dietary advice on vitamin A. Comments are invited. There are eight annexes, including: "Current Legislation regarding food supplements and food fortification", "Tolerable Upper Intake Levels of preformed Vitamin A", "Human studies of retinol intake and bone health", "Comparison of diets in UK, US, and Sweden", "Adjustment of NDNS estimates of retinol intake using data from EPIC-Oxford", and "Percentage of consumers whose intakes fall above/below Guidance Level and LRNI under different scenarios". (more) Deadline: Friday, April 8, 2005 Publication Month: December 2004	Jan 11, 2005
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel Related to Calcium Sulphate as a Mineral Substance in Foods Intended for the General Population Opinion adopted on October 7, 2004 regarding the safety of calcium sulphate as a mineral substance in foods and in particular in water or water-based beverages. (more) Publication Date: Tuesday, November 23, 2004	Nov 30, 2004
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the AFC Panel Related to Calcium L-Methylfolate Opinion adopted on October 28, 2004 regarding the safety of synthetically obtained calcium L-5- methyltetrahydrofolate (L-5-MTHF-Ca) for use in foods for particular nutritional uses, food supplements, and other foods. (more) Publication Date: Tuesday, November 23, 2004	Nov 30, 2004
	Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 This document outlines FDA's strategies for monitoring and evaluating product and ingredient safety, quality assurance and CGMP, and monitoring and evaluating product labeling. (more) Publication Month: November 2004	Nov 5, 2004
	Scientific Committee, European Food Safety Authority	Botanicals and Botanical Preparations Widely Used as Food Supplements and Related Products: Coherent and Comprehensive Risk Assessment and Consumer Information Approaches Discussion paper adopted on June 23, 2004 that addresses issues related to risk assessment and consumer information on botanicals in food supplements. Includes discussion of quality and safety issues, related EC legislation, and potential future activities related to these products. (more) Publication Date: Tuesday, September 21, 2004	Sep 22, 2004
	Hathcock, John N.	Vitamin and Mineral Safety: 2nd Edition Safety evaluations that provide Upper Supplement Levels for supplemental intakes of vitamins, minerals, and trace elements. Includes an appendix table entitled "International Comparisons: CRN ULS, US FNB UL, EC SCF UL, UK EVM SUL or GL, and Japan UL". (more) Publication Year: 2004	Sep 16, 2004
	Cantox Health Sciences International	Safety Assessment and Determination of a Tolerable Upper Limit for Ephedra Assessment of safety and establishment of a safe upper intake level for ephedra/ephedrine alkaloids. Appendices include "Analysis of the Available Adverse Event Reports (AERs) for Ephedra," "Review of Published Case Reports," and "Boozer et al., (2000) Abstract and Analysis". (more) Publication Date: Tuesday, December 19, 2000	Sep 16, 2004
	Advisory Forum, European Food Safety Authority	EFSA Advisory Forum Event Berlin: Abstracts and presentations from this public event on topics related to the risk assessment process. Presentations include "Future perspectives in risk assessment: Key challenges and opportunities"/Jouve, Jean-Louis; "Future perspectives on risk assessment: key challenges and opportunities"/Feron, Victor J.; "Future perspectives on risk assessment: key challenges and opportunities"/Silano, Vittorio; "UK review of risks and benefits of fish consumption"/Benford, Diane; "Position of the French Committee of AFSSA on a risk/benefit analysis of GMOs"/Schwartz, Maxime; "Risk-benefit assessment of micronutrients - folic acid"/Flynn, Albert; and "Risk-benefit evaluation lessons for risk management and communication"/Renn, Ortwin. (more) Event Dates: Monday, November 8, 2004 - Tuesday, November 9, 2004 Publication Date: Friday, November 12, 2004	Aug 6, 2004
	Joint FAO/WHO Expert Committee on Food Additives	Joint FAO/WHO Expert Committee on Food Additives Sixty-third Meeting Geneva, 8-17 June 2004: Summary and Conclusions Summary and conclusions of this meeting held to evaluate certain food additives and ingredients, flavoring agents, and a natural consituent of food. Includes specifications information, acceptable daily intake values, and other toxicological recommendations for some food additives and ingredients, heavy metal (As, Pb, Cd, and Hg) limits for some food additives, safety evaluation results for certain flavoring agents, and toxicological recommendations for glycyrrhizinic acid. Annexes include a list of members, further information needs, and general considerations. (more) Publication Date: Thursday, June 17, 2004	Jun 24, 2004
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a Request from the Commission Related to the Use of Epoxidised Soybean Oil in Food Contact Materials. (Question No EFSA-Q-2003-073 Opinion adopted on May 26, 2004 regarding the risk to infants and other consumers from epoxidised soybean oil and its derivatives from baby food containers or other containers. Includes discussion of the assessment and recommendations. (more) Publication Date: Monday, June 7, 2004	Jun 7, 2004
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a Request from the Commission Related to Creatine Monohydrate for Use in Foods for Particular Nutritional Uses. (Question Number . . . Opinion adopted on February 17, 2004 regarding the safety and bioavailability of creatine monohydrate in foods for particular nutritional uses as a source of creatine. (more) Publication Date: Monday, April 26, 2004	Apr 26, 2004
	Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, European Food Safety Authority	Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a Request from the Commission Related to Ethyl Cellulose as a Food Additive. (Question Number EFSA-Q-2003-116) Opinion adopted February 17, 2004 regarding a safety evaluation for ethyl cellulose used as a food supplement. Publication Date: Monday, April 26, 2004	Apr 26, 2004
	Food and Nutrition Board, Institute of Medicine	Infant Formula: Evaluating the Safety of New Ingredients This report discusses issues related to the safety assessment of new ingredients in infant formulas. Appendices include "Acronyms and Glossary," "Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States," "Redbook Table of Contents," "Applying the Recommended Approaches," and "Biographical Sketches of Committee Members". (more) Publication Year: 2004	Apr 9, 2004
	Lindsey, Andrea T.	Dietary Supplements: Additional Resources for Professionals Bibliography of bibliographies and bibliographic databases, books, book chapters, and booklets, newsletters, web resources, and agencies and organizations that provide information on dietary supplements that would be of use to professionals. The bibliography is broken down into the categories of "General Information on Dietary Supplements," "Vitamins, Minerals and Antioxidants," "Herbs, Botanicals, Phytochemicals and Other Specific Dietary Supplements," "Ergogenic Aids," and "Safety and Consumer Protection". (more) Publication Month: July 2003	Nov 17, 2003
	Joint FAO/WHO Expert Committee on Food Additives	Joint FAO/WHO Expert Committee on Food Additives Sixty-First Meeting: Summary and Conclusions Rome, Italy: Summary and conclusions from this meeting to evaluate specific food additives and contaminants. Includes recommendations and specifications on "Food additives evaluated toxicologically," "Food additive considered for specifications only," "Revision of heavy metals limits for food additives," "Flavouring agents evaluated using the Procedure for the Safety Evaluation of Flavouring Agents Check for specs and conclusions," "Flavouring agents considered for specifications only," "Evaluation of a water-treatment agent" [sodium dichloroisocyanurate (NaDCC)], "Evaluation of a nutritional source for iron" [ferrous glycinate (processed with citric acid)], and "Contaminants" [cadmium and methyl mercury]. (more) Event Dates: Tuesday, June 10, 2003 - Thursday, June 19, 2003 Publication Date: Thursday, June 19, 2003	Jul 30, 2003
	Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences, Institute of Medicine, National Research Council	Proposed Framework for Evaluating the Safety of Dietary Supplements Proposed framework for evaluating the safety of dietary supplement ingredients that was developed for the FDA and is released for comment. Includes discussion of the proposed framework as well as discussion of approaches used by others. Appendices include "Other Approaches to Considering the Safety of Dietary Supplements," "Existing Frameworks of Systems for Evaluating the Safety of Other Substances," "Possible Combinations of Scores," "Table of Food and Drug Administration Actions on Dietary Supplements," "Presenters at the Open Sessions of the Project on the Framework for Evaluating the Safety of Dietary Supplements," and "Biographical Sketches of Committee Members". (more) Publication Year: 2002	May 21, 2003
	Taylor and Francis Group	Food Additives and Contaminants Monthly publication that publishes research related to food additive and contaminant analytical methodology, safety evaluation, regulatory control, surveillance, occurrence, and persistence. Access to full text online requires a subscription. (more)	Jan 16, 2003
	Scientific Committee on Food, Health and Consumer Protection Directorate-General, European Commission	Guidelines of the Scientific Committee on Food For the Development of Tolerable Upper Intake Levels for Vitamins and Minerals Guidance document that provides a framework for evaluating the adverse effects of micronutrients and for developing tolerable upper intake levels for vitamins and minerals. It outlines how the different steps in the risk assessment process relate to the process of defining an upper limit of intake. (more) Publication Date: Tuesday, November 28, 2000	Aug 13, 2002
	Woteki, Catherine	Nutrition, Food Safety, and Risk Assessment -- A Policy-Maker's Viewpoint Remarks prepared for delivery by Dr. Catherine Woteki, Under Secretary for Food Safety, before Purdue University, West Lafayette, IN, June 18, 1998. This speech describes the process of risk assessment, including how it fits into the risk analysis process and the strengths and limitations associated with risk assessment. Two examples of the application of risk assessment are given: development of tolerable upper intake levels for nutrients and risk assessment for Salmonella Enteritidis. (more) Publication Date: Thursday, June 18, 1998	Jul 11, 2002

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