Roche vitamin E fits Dutch regulations

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Related tags: Netherlands, European union

Swiss pharmaceuticals company Roche yesterday said its vitamins and
fine chemicals unit, recently sold to DSM, fully complies with new
requirements for vitamin E issued this month by the Netherlands.

Swiss pharmaceuticals company Roche yesterday released a statement that its vitamins and fine chemicals unit, recently sold to DSM, fully complies with new requirements for vitamin E issued this month by the Netherlands.

On 6 February, the Dutch Food and Product Safety Authority issued a Rapid Alert for Food and Feed (pursuant to Regulation (EC) Nr: 178/2002 - Art. 50), advising other EU members of the limits it has imposed on benzo(a)pyrene in natural vitamin E for use both in food supplements and food. The Authority added that certain forms of natural-source vitamin E, namely d-alpha-tocopherol, d-alpha-tocopheryl acetate and d-alpha tocopheryl succinate, may contain high contamination levels of polycyclic aromatic hydrocarbons (PAH).

Benzo(a)pyrene (BaP) is considered to be mutagenic and potentially carcinogenic in animals. The Dutch authorities have limited BaP levels to a maximum of 1 ppb in consumer products. BaP belongs to the category of PAH, which result from incomplete combustion of organic substances, or are formed during industrial processes.

Roche, one of the leading suppliers of natural-source vitamin E, said that it only supplies d-alpha-tocopheryl acetate and does not produce d-alpha-tocopherol or d-alpha-tocopheryl succinate. Analytical results have shown that the d-alpha-tocopheryl acetate produced for Roche complies fully with the recent limits imposed by the Dutch authorities, according to the company.

In 2001, Roche's vitamins and fine chemicals division recorded sales of more than SF3.5 billion. Its sale to the Dutch life sciences group DSM was confirmed this week, but is still awaiting merger approval.

Related topics: Drug Delivery