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. |