New European legislation could disrupt the supply of up to one-in-ten medicines, according to a report in Chemistry & Industry, a magazine published by the Society of Chemical Industry.

The law known as REACH - Registration, Evaluation and Authorisation of Chemicals – may be, according to the BBC’s website, the most important EU legislation for 20 years. REACH, which could come into force in April 2007, requires businesses to show that the chemicals it uses are safe; aims to encourage companies to replace hazardous chemicals with safer alternatives; and intends to stimulate R&D, the BBC comments.

REACH ascribes the highest priority to hazardous chemicals, such as carcinogens or mutagens, and high volume chemicals. Active pharmaceutical ingredients are largely exempt. However, REACH covers many solvents and intermediates used in medicines manufacture. Chemistry & Industry reports that 5% to 10% of drug syntheses depend on hazardous or high-volume chemicals.

The article cites comments made by David Vosvenieks, REACH issue manager at AstraZeneca who told an SCI meeting that the legislation “poses a serious threat to supplies of large numbers of intermediates and raw materials used in drug manufacture.” Two companies supplying important intermediates required for the manufacture of two AstraZeneca drugs warned AZ that they might not be able to guarantee supplies.

Pfizer told Chemistry & Industry that they were “in discussions with suppliers over REACH, but declined to say whether any particular products were affected.” A GSK spokesperson told the journal that they had not encountered any issues arising from REACH.

Chemistry & Industry notes that changing supplier would mean resubmitting for regulatory approval. Depending on the complexity of the change, reauthorisation could take 30 to 60 days, raising the prospect of interruptions to supplies.