At the time of going to press it seemed as though the final form of the much awaited European Union REACH regulation was close to being agreed. The European Commission and Council had agreed with representatives of the European Parliament compromise positions on a number of thorny issues - particularly that of substitution. The compromise proposal awaited approval at the Regulation's second reading in the European Parliament and also by the Council of Ministers in mid-December - both approvals appeared likely. If, as expected, these votes were in favour of the proposed regulation then it would remain on its intended course for publication and entry into force in April 2007.
This now opens the way for member states and industry to begin preparing in detail for application of the regulation. In the UK it was announced in October that the Health & Safety Executive has been nominated as the Competent Authority to oversee the application of the provisions of the REACH regulation in the UK.
In respect of the pharmaceutical industry, there are exemptions in the scope of REACH for chemicals, in so far as they are used in medicinal products. However, there will be a need for producers of medicinal products to ensure that suppliers of those ingredients used in their products are sure that the up-stream materials used in the production of their products are in compliance with REACH where appropriate.'
The implementation of REACH is going to be complicated and time-consuming and a topic that no doubt this column will return to at regular intervals over the coming years.