abpi News
The European Commission last year issued a 'White Paper' on a future strategy for chemicals policy in the European Union. The proposals contained in the paper are extremely far reaching and if implemented as envisaged, will entail the testing of and, for some chemicals, authorisation for use. Previous EU legislation has required the notification of new substances – the White Paper envisages similar controls for all existing substances.
While the ensuing legislation may give derogations for certain types of chemicals regulated by specific legislation such as active pharmaceutical ingredients, the status of pharmaceutical intermediates remains open to debate. Not only that but any chemical used in the pharmaceutical supply chain is likely to be subject to the anticipated proposals for legislation.
The projected costs involved in the testing of individual compounds vary depending on the source but there is no doubt that there will be a significant cost factor, which may influence suppliers to look at the economic viability of certain compounds.
While the legislation is still in the developmental stage within the European Commission there is still scope to input positively to its development, but prudence suggests that companies may benefit from reviewing their supply chains to try to identify potential problem areas for the future.
The progress of the anticipated legislation will be monitored by all the interested trade associations, both in the UK and Europe, and you will be kept informed of developments, but in the meantime a review of supply chains may be worthwhile.