REACHing the limit

In 2001, the EC published its White Paper on control of chemicals in the European Union. There has been a wide-ranging debate on the proposals since that time and this has culminated in the recently published proposals on the REACH (Registration, Evaluation Authorisation and Restriction of Chemicals) system.

Initial review of the proposals as they relate to the pharmaceutical industry suggests that there are good points in the draft which the Commission has recognised in terms of the control of active pharmaceutical ingredients (APIs). These include:

• substances used only in medicinal products are exempt on the basis that they are covered by equivalent legislation;

• the Commission will work with EMEA to agree new guidelines on Environmental Risk Assessment (these were discussed in last month's edition of Manufacturing Chemist);

• research uses are exempt from registration for five years, renewable to 10 years;

• the threshold for registration is one tonne per annum;

• non-isolated intermediates are exempt;

• testing requirements for other intermediates are limited.

Nonetheless, pharmaceutical manufacturers need to be aware of the potential for disruption of supply chains if the availability of chemicals becomes inhibited because of the necessity to comply with the REACH system. It is believed that at this stage this is a preliminary consultation by the Commission to look at the feasibility of a REACH-type system and it is not clear what the practical timescale for implementation may be. No doubt there will a lively debate in the next few months and ABPI will be involved and monitoring progress.