REACH discussed with health sector

The second of three working groups on the REACH (Registration, Evaluation and Authorisation of Chemicals) legislation was held with the collaboration of MSA Foodstuffs, Chemicals and Cosmetics Directorate Director Martin Seychell. This follows the brainstorming and briefing session held for FOI members in March.

The aim of these working groups is to enable business operators to air their concerns and put forward their suggestions on how best this new legislation can be implemented and enforced locally, as well as the identification of local training requirements and how best to address these requirements.

Although the forthcoming REACH legislation will exclude from its provisions any substance used in medicinal products (active ingredients and excipients), this new regulation may still directly affect the pharmaceutical and health-related business operators, depending on set annual thresholds and actual use of the chemical or substance.

In fact, all substances that do not eventually end up forming part of the medicinal product, as well as those substances purchased that do not form part of the manufacturing process (including lubricants from machinery, disinfectants, and reagents) all fall under the provisions of REACH.

In view of this, for the second working group meeting, which was held at the FOI last Monday, chaired by FOI executive Cecilia Vella, the FOI invited pharmaceutical and health-related manufacturers, as well as those involved in the manufacture of cosmetics.

The two main areas of focus during this meeting were a clarification of the various exemptions, as well as the issue of confidentiality. In addition to the areas of application listed above, Mr Seychell explained various sections within Article 2 of the REACH proposal, particularly that relating to worker risk protection.

He said that exposure scenarios would be recorded with the logging of the exposure duration of each employee to any substance termed as critical in the production process. The MSA official also highlighted the exemption relating to product and process-orientated research and development (R&D), as well as scientific R&D, for five years under Article 7 of the REACH proposal.

When referring to Articles 114-116 of the EU proposal, Mr Seychell briefly outlined the information that has to be disclosed to consumers; information that would only be made available on request and details that, as a general rule, would be kept confidential.

The protection of confidential uses of the substances and the collective sharing of information, as well as the situation when suppliers are located in non-EU countries, were also discussed.

The discussion ensued on aspects like the co-ordination between the various government authorities for the local enforcement of REACH; possible withdrawal of substances; post-registration surveillance; and the treatment of polymers and nanomaterials. Before the meeting ended, Mr Seychell recommended that all business operators appoint a REACH contact person (possibly the official responsible for H&S, environment or purchasing in the company) who should become familiar with REACH and its consequence to the company, particularly in view of pre-registration, registration and other REACH processes.

The REACH official would study how REACH would need to be administered within the firm and how new procedures in the handling of confidential information and exposure scenarios would need to be implemented. It is also recommendable that the REACH official would also seek the support of the company's suppliers of substances, particularly in view of the company's specific uses of the chemicals/substances, as well as rating these suppliers and assessing the portfolio of the substances purchased.