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<BR>Human food<BR>Home,Anses,News,Press room,Agenda,Our topics,Food,Animal health and nutrition,Environmental health,Occupational health,Plants,Opinions and publications,Last opinions and reports,Food opinions and reports,Animal health and nutrition opinions and reports,Environmental and occupational health opinions and reports,Plants opinions,Opinions and reports in English,Bulletins and periodicals,Other publications,Subscribe to Anses newsletter,Research and reference,Research program,Laboratories and reference activities, + ,Job opportunities,Public procurement contracts,Our websites,Partners,Extranet / ExpertNet,Kid's area,Legal notice,Contact, ,<BR>> La plaquette de présentation du dispositif<BR>National nutritional vigilance scheme<BR><BR><BR><BR>Implementation of the national nutritional vigilance scheme was entrusted to ANSES in July 2009 by the French Act on Regional Health Governance (Loi Hôpital, Patients, Santé et Territoires).<BR><BR>The aim of the scheme is to improve consumer safety by rapidly identifying any potential adverse effects associated with consumption of:<BR><BR>- food supplements <BR>- foods and beverages fortified with substances for nutritional or physiological purposes (vitamins, minerals, micronutrients, plant extracts, etc.) <BR>- novel foods and new ingredients <BR>- products intended for consumption by specific populations (infants, athletes, individuals with food intolerances, etc.)<BR><BR>Several factors have prompted the setting up of a nutritional vigilance scheme, including the availability of an increasing number of non-traditional novel foods and new ingredients in Europe, the globalisation of trade and the emergence of new food consumption habits with a rise in the consumption of food supplements and fortified foods and beverages. In addition, adverse effects potentially linked to consumption of some of these products have been reported.<BR><BR>After a pilot vigilance phase targeting food supplements conducted in 2009 and 2010, ANSES has now extended the scheme to all food products. The pilot phase report is available here (in French). The presentation of the scheme to the press, held on 9 December 2010, is available on the website of the Foreign Press Center - Paris.<BR><BR>Manufacturers and distributors participate in the scheme through their product safety obligations(1). <BR><BR>Télédéclaration<BR>Accéder au formulaire<BR>Find out more...<BR>>News<BR><BR>>How to file a declaration?<BR><BR>- Who can file a declaration? <BR><BR>Health professionals (physicians, pharmacists, dietitians, etc.) capable of identifying adverse effects in their patients.<BR>Other people wishing to file a declaration on their own behalf should contact a health professional. <BR><BR><BR>- Where can declarations be filed? <BR><BR>On the ANSES web site by filling out the online declaration form. The online form is a fast and reliable way to file a nutritional vigilance declaration.<BR>A declaration form can also be downloaded, filled out and sent to ANSES by e-mail, fax or regular mail. <BR><BR><BR>- What is a food-related adverse effect? <BR><BR>It's a harmful reaction occurring either under the normal conditions of use of a product or resulting from improper use of the product. <BR>It is important to fill out the declaration form as precisely as possible in order to provide the most complete description of the adverse effect.<BR><BR><BR>- How are declarations processed? <BR><BR>All declarations registered by ANSES fully ensure consumer anonymity. <BR><BR>The declarations are analysed by the nutritional vigilance unit of ANSES with the support of the French Health Products Safety Agency (AFSSAPS), the French Institute for Public Health Surveillance (InVS), the Toxicant and Poison Control Centres (CAP-TV) and the French Anti-Doping Agency (AFLD).<BR><BR>After consultation with the Agency's Expert Committees (CES), the conclusions of these analyses are sent to the relevant ministries to enable them to implement the appropriate management measures. <BR><BR><BR><BR>(1) articles L221-1 and L221-1-3 of the consumer code: "Under normal conditions of use or under other conditions reasonably foreseeable by professionals, products and services must provide a legitimately expected level of safety and must not be harmful to the health of individuals." Should "a manufacturer or distributor be aware that a product they have placed on the market for use by consumers does not fulfill these requirements, the manufacturer or distributor must inform the competent authorities."<BR><BR><BR><BR><BR>October 2010<BR><BR><A HREF='PNF8I0.htm'>Anses</A>
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Implementation of the national nutritional vigilance scheme was entrusted to ANSES in July 2009 by the French Act on Regional Health Governance (Loi Hôpital, Patients, Santé et Territoires).
The aim of the scheme is to improve consumer safety by rapidly identifying any potential adverse effects associated with consumption of:
- food supplements - foods and beverages fortified with substances for nutritional or physiological purposes (vitamins, minerals, micronutrients, plant extracts, etc.) - novel foods and new ingredients - products intended for consumption by specific populations (infants, athletes, individuals with food intolerances, etc.)
Several factors have prompted the setting up of a nutritional vigilance scheme, including the availability of an increasing number of non-traditional novel foods and new ingredients in Europe, the globalisation of trade and the emergence of new food consumption habits with a rise in the consumption of food supplements and fortified foods and beverages. In addition, adverse effects potentially linked to consumption of some of these products have been reported.
After a pilot vigilance phase targeting food supplements conducted in 2009 and 2010, ANSES has now extended the scheme to all food products. The pilot phase report is available here (in French). The presentation of the scheme to the press, held on 9 December 2010, is available on the website of the Foreign Press Center - Paris.
Manufacturers and distributors participate in the scheme through their product safety obligations(1).
Health professionals (physicians, pharmacists, dietitians, etc.) capable of identifying adverse effects in their patients. Other people wishing to file a declaration on their own behalf should contact a health professional.
- Where can declarations be filed?
On the ANSES web site by filling out the online declaration form. The online formis a fast and reliable way to file a nutritional vigilance declaration. A declaration form can also be downloaded, filled out and sent to ANSES by e-mail, fax or regular mail.
- What is a food-related adverse effect?
It's a harmful reaction occurring either under the normal conditions of use of a product or resulting from improper use of the product. It is important to fill out the declaration form as precisely as possible in order to provide the most complete description of the adverse effect.
- How are declarations processed?
All declarations registered by ANSES fully ensure consumer anonymity.
The declarations are analysed by the nutritional vigilance unit of ANSES with the support of the French Health Products Safety Agency (AFSSAPS), the French Institute for Public Health Surveillance (InVS), the Toxicant and Poison Control Centres (CAP-TV) and the French Anti-Doping Agency (AFLD).
After consultation with the Agency's Expert Committees (CES), the conclusions of these analyses are sent to the relevant ministries to enable them to implement the appropriate management measures.
(1) articles L221-1 and L221-1-3 of the consumer code: "Under normal conditions of use or under other conditions reasonably foreseeable by professionals, products and services must provide a legitimately expected level of safety and must not be harmful to the health of individuals." Should "a manufacturer or distributor be aware that a product they have placed on the market for use by consumers does not fulfill these requirements, the manufacturer or distributor must inform the competent authorities."
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