![]() The EU and the UK define c ollagen as “the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of ” (Regulation (EC) 853/2004). The EU and the UK define gelatin as “natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals” (Regulation (EC) 853/2004). establishments that appear on the EU lists. establishments are only eligible to be included on the EU lists for collagen and gelatin if they manufacture collagen and gelatin in the United States or if they use collagen or gelatin sourced from U.S. Generally, the EU’s listing requirements will apply to establishments that produce collagen or gelatin, establishments that use collagen or gelatin as an ingredient in products for export to the EU, and establishments that package and ship products containing collagen or gelatin to the EU. The EU’s listing requirements apply to establishments involved in the preparation and dispatch of consignments containing products of animal origin, unless one of the exemptions in Article 6 of Regulation (EU) 2019/625 applies. Please note that FDA does not have a separate application process for the UK lists establishments that wish to export to the UK should apply for the relevant EU list in the ELM. Please visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions. ![]() Industry may apply for inclusion on these lists via the Export Listing Module (ELM). export of collagen and gelatin products to the European Union (EU) and the United Kingdom (UK) are subject to establishment listing requirements as a precondition for market access. ![]()
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