EU policy on REACH

I have at various times referred to the development of the EU's policy on chemicals following the consultation on its White Paper a couple of years ago and its subsequent internet consultation earlier this year.

On 29 October, the European Commission adopted a proposal for a new EU regulatory framework for chemicals subject to some minor text clarifications suggested by the Legal Linguists. Under the proposed new system called REACH (Registration, Evaluation and Authorisation of CHemicals), enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. The stated aims of the proposed new Regulation are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry.

In its covering note on the current proposal the Commission maintains that 'REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production.'

The Commission's formal proposal goes some way towards addressing some of the previously expressed concerns of industry - particularly in relation to intermediates - but there remain a number of residual concerns on the latest proposal. While there is also a derogation for APIs, there are still concerns regarding the effect of the proposal on the overall pharmaceutical supply chain.

There is obviously much debate to be gone through before the final legislation is agreed and ABPI will be following the progress of the proposal closely.