First Directive derogations granted in the UK

April 30, 2005

2 Min Read
First Directive derogations granted in the UK

Fifteen nutrients have been granted a stay of execution after the UK?s Food Standard?s Agency (FSA) announced receipt of Europe?s first scientific dossiers supporting nutrients not currently permitted by the European Union?s Food Supplements Directive.

The 15 nutrient sources, plus any others that have dossiers submitted by July 12, may continue to be sold on the UK market until a decision is made on their safety by the Italy-based European Food Safety Authority (EFSA). Dossiers must first be submitted to member state agencies before being handed to EFSA for assessment.

While technically the FSA derogations only apply to the UK, the chairman of the European Health Product Manufacturers Association and the Natural and Health Products Association of the Netherlands, Peter van Doorn, said agreements were being sought that would reduce the costly and time-consuming process of companies having to submit dossiers to each member state individually.

?We can?t assume all states will grant derogations,? he said. ?It?s not clear how things will go, but we are pleased the dossiers are starting to come in.?

Van Doorn said the Netherlands, the UK and Finland have indicated they will grant derogation based on a dossier submitted in another member state, but other states such as the Czech Republic, Luxembourg and Greece had indicated they will not allow any derogations, preferring to wait for EFSA positive decisions on nutrients before reinstating them. Italy has eschewed the dossier process altogether by legalising the ongoing use of more than 100 nutrients and sources omitted from the Directive?s positive lists.

Some of the nutrient sources granted derogations in the UK include a range of amino acid chelates (submitted by Albion), boric acid (Solgar UK), sodium borate (Wassen International), calcium ascorbate/threonate (Zila Nutraceuticals), chromium picolinate (Nutrition 21), chromium polynicotinate and zinc L-monomethionine (Inter-Health Nutraceuticals), selenium-enriched yeast (Wassen UK, Lallemand and Lesaffre), and calcium sulphate (UK Health Food Manufacturers Association).

?With the FSA?s agreement that chromium picolinate is safe and its approval for continued sale, we are confidently moving forward with our plans for international expansion,? said Gail Montgomery, president and CEO of Nutrition 21.

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