Following a review of the operation of the REACH chemicals regulation since its commencement in June 2007, the European Commission has concluded in a recently published report that it is delivering its objectives and functions well. A number of changes are identified as being required in the future, however, as well as the need to revise the regime to reduce its effect on small and medium sized enterprises (SMEs). The perennial issue of lack of effective enforcement of the regime by member states also cropped up.

The key conclusion of the Commission’s report is that REACH fulfils its aims, and the use of chemicals in the EU has become safer since its entry into force five years ago. Other conclusions were:
  • the Commission believes that some adjustments to the legislation are needed (although does not spell out what these are), but balancing this need against the need for legislative stability and predictability precludes any changes to the REACH regulation for the time being;
  • enforcement under the REACH regime could be improved. Enforcement is the responsibility of member states, and the report recommends member states aim to improve the co-ordination of enforcement efforts among themselves;
  • the financial and administrative burden of the regulation on SMEs is too heavy. The report suggests methods to try and reduce this burden, including reducing the registration fees for SMEs in the near future. Part of the reason for this focus is that thousands of SMEs will need support complying with the next phase of REACH – the deadline for registration of substances that are manufactured or marketed in the EU in quantities of 100 tonnes or more per year falls at the end of May – and a survey discovered that REACH is considered one of the top 10 most burdensome pieces of European legislation for SMEs.

The report also highlights that the Commission is continuing to develop a scheme to identify and list all substances of very high concern (SVHCs) by 2020. It plans to develop a roadmap for this purpose shortly.

Issues also arose with the quality of registration dossiers, some of which have been found to be only partially complete. The Commission wants to improve the quality of these, and plans to encourage companies to improve the use of safety data sheets (SDSs) as a central risk-management tool.

The Commission also wants to see issues with cost sharing within the substance information exchange forums (SIEFs) addressed, particularly with a view to reducing the burden on SMEs. SIEFs are formed to enable companies that intend to register the same phase-in substance to collaborate to share data on the intrinsic properties of the relevant substance and to avoid the duplication of studies.

Finally, the Commission has said that it envisages amending the REACH annexes to clarify the position on nanomaterials and how to manage their type-specific risks. There have been suggestions that tonnage thresholds for application for REACH should be lowered to ensure nanomaterials are captured, and this would require that the annexes be amended. An impact assessment is to be carried out, possibly leading to a proposal to amend the regulation later this year.