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Food supplements are foods. These foods are concentrated sources of nutrients that is mineral and vitamins or other substances with a nutritional or physiological effect that are marketed in “dose” form such as, pills, tablets, capsules, and liquids in measured doses). A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to vitamins, minerals, amino acids, essential fatty acids, fibers, and various plants and herbal extracts.
Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic action. Therefore, their use is not intended to treat or prevent diseases in humans or to modify physiological functions. Food supplements have to meet different or additional requirements than food.
These additional requirements are set forth in Directive 2002/46/EC and country-specific regulations.
You must submit the following documentation based on the country in which you intend to sell your food supplements.
|Document type||Required documentation|
Global food Safety initiative (GFSI) or Hazard Analysis Critical Control Point (HACCP) certification for brand owner or manufacturer
Current GFSI certificate(s) or current HACCP certificate(s) for the manufacturer from an accredited third party certification body for the ASIN.
If you are contacted by us for compliance documents, complete the following steps to
submit the requested information:
It is your responsibility to comply with food safety legislation. The following material is not intended as legal advice. Amazon encourages you to consult your legal counsel if you have questions about the laws and regulations concerning your product.
For information on general requirements for food products, go to Food Information for Consumers Regulation for prepacked foods.
For food supplements, you must also comply with the following legal requirements:
Before selling food supplements, you must be sure your ASINs comply with pre-market notification requirements currently set forth under France, Italy, Spain, Poland, Germany regulations as well as in Turkey. If you are not the manufacturer, brand owner, or the importer into the EU for the ASINs, you can check that your ASINs have been registered with the local authorities by checking their online databases.
If the ASINs are not in the database, you need to contact the responsible company for the pre-market notification to obtain the required documentation. Only the manufacturer, brand owner, or the importer into the EU is allowed to register these ASINs with the local authorities. Here are the resources released by the authorities in these countries:
The following information is to be included on the labelling and detail page of any food supplement, in addition to the information required under Regulation 1169/2011 of Food Information for Consumers (FIC):
These requirements are applicable for the provision of information at both point of sale on the detail page and at point of delivery on the product label. If the mandatory requirements are not included in the image or detail page, your product will be removed from sale until compliant.
Novel foods and banned ingredients
Products for sale on Amazon cannot contain any unauthorized ingredients such as, unauthorized vitamins or minerals, additives or flavorings ,and novel foods or banned ingredients. Novel foods are foods that have not been consumed to a significant degree by humans in the EU before May 15, 1997. Novel food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU. A safety assessment must be conducted and pre-market authorisation must be given before a novel food can be marketed in the EU. The manufacturer must ensure that food supplements do not contain any ingredients that are considered unauthorized novel foods or other unauthorized ingredients according to European or applicable local legislation.
Safe upper limits
To ensure that food supplements are safe for consumption, the manufacturer must take account of the upper safe levels established by scientific risk assessment and data on vitamin and minerals intake from other foods, while also taking due account of what is considered an adequate vitamin and mineral intake for an average person. EFSA [European Food Safety Agency] has published scientific opinions about upper safe levels for various vitamins, minerals, and other substances. Some member states have legal maximum limits for vitamins and minerals, while others provide guidance only; such as the UK, which has Guidance on Upper Levels for Vitamins and Minerals from the Expert Group on Minerals and Vitamins.
If you do not provide all the documents required by Amazon, your food supplement will not be approved to sell in Amazon stores.
As part of our ongoing efforts to provide the best possible customer experience, starting August 4, 2021, Amazon is implementing additional requirements for food supplements.
You can raise an appeal in Seller Central by selecting "the requested documentation does not apply to me" in the documentation request in your Account Health dashboard.
You will receive an email notification from Amazon confirming the ASIN is approved and your Account Health dashboard will be updated.
Global Food Safety Initiative (GFSI) is an industry-driven, globally accepted set of food safety standards for vendors. Food manufacturer certified against the GFSI audit schemes are “GFSI-certified” and typically meet the requirements of most retailers.
HACCP stands for Hazard Analysis and Critical Control Point. It is an international standard defining the requirements for effective control of food safety. Food manufacturers certified against HACCP requirements by a 3rd party meet the Amazon food safety bar.