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FAQ Natural food and Products - Frequently Asked Questions - Organic Link - ITC(10)

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     Which regulations are relevant for export of natural products to international markets?

     Regulatory frameworks may set standards for proof of safety, efficacy and quality; determine the scope of claims made about products, the information included on labels, and the content of advertisements. Natural products are used in end-products marketed within different industries, including food, pharmaceuticals, herbal or botanical medicine, chemicals, cosmetics, veterinary products, etc. Different regulations may apply to different end-products marketed in different countries. Products marketed in international markets must comply with the regulatory requirements in the relevant market for the particular type of product. However, most natural products are exported as raw or semi-processed plant material. Usually, the importer and manufacturer will be responsible for the compliance with relevant regulations in relevant markets. Therefore, close contact should be maintained with importers so that detailed information may be obtained on which standards to comply with at export level. For example, natural products sold as ingredients in pharmaceuticals in the European markets would have to be produced in line with Good Manufacturing Practices (GMP), and ingredients for food products would have to be produced in line with Hazard Analysis Critical Control Points (HACCP). Most countries have implemented the conventions on International Trade in Endangered Species of Wild Fauna and Flora (CITES) http://www.cites.org/ and the International Plant Protection Convention (IPPC), www.ippc.int which then must be complied with (see above). The Novel Food Regulation (European Parliament and Council Regulation 258/97) lays down detailed rules for the authorization of novel foods and novel food ingredients. It defines novel foods as foods and food ingredients that were not used to a significant degree in the EU before May 15, 1997, which fall into the following specific categories: · with a new intentionally modified primary molecular structure, or · consisting of or isolated from plants or animals, except for foods and food ingredients obtained by traditional propagating or breeding practices with a history of safe use, or · to which a production process not currently used has been applied, where that process changes the composition or structure of the food or food ingredient significantly Novel foods must undergo a safety assessment before they can be placed on the EU market. This has led to the Regulation being described as a trade barrier since foods and food ingrediants that have been consumed in developing countries but not exported to Europe since 1997 require prohibitively expensive safety assessment before exports to Europe are authorized.