REACH: A new regulation for chemical substances

The REACH regulation will today enter the final stage of the EU decision-making process through the Council of Ministers and the European Parliament. The regulation will ensure that industry generates and provides information on the properties of several thousand chemical substances and on the risks involved in using them. It will also call for the progressive substitution of the most dangerous substances and will, therefore, establish a system that, over time, would greatly improve health and environmental protection in the European Union.

European consumers expect that the chemicals contained in products such as textiles, beauty products, cleaning products, electrical appliances and other goods, are harmless. That might be the case for the 3,000 "new" chemical substances placed on the EU market since 1981 as they are subject to strict notification procedures, but not for some 100,000 substances that were on the market in the EU prior to that date. The chemical substances still found in countless products make their way to the environment and inside our own bodies, while for the majority of them we do not have sufficient information on the consequences for our health or the environment.

This is why the European Commission prepared new legislation which, on the one hand, will make for a better knowledge of the way chemical substances interact with human health and the environment and, on the other, obliges producers to use the safest substances wherever possible. This legislation will be formally agreed by the European Parliament today and by the Council on Monday through the so-called co-decision procedure.

REACH stands for Registration, Evaluation and Authorisation of Chemicals, the three stages of the process.

Registration: For each substance produced or imported into the EU beyond one tonne, manufacturers and importers must submit a registration to a new independent agency to be established in Helsinki. They will have to identify risk management measures and share this information with all actors in the supply chain. This will happen over a period of 11 years, with the highest volumes and most dangerous substances having to register first, after three-and-a-half years and others after six and 11 years respectively.

Evaluation: For chemical substances not causing specific concerns, registration will suffice. Substances suspected to be more problematic must undergo an in-depth evaluation by the national authorities on the basis of the registration data.

The result of such an evaluation can generate information that will be useful for other legislation (for instance water, waste) or can lead to further measures under authorisation or restriction.

Authorisation of the most dangerous substances represents the third pillar of REACH. It concerns substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) as well those that are persistent, bio-accumulative or toxic (PBT) and those substances that are very persistent or very bioaccumulative (vPvB).

For some substances, authorisations will only be granted to companies if they can demonstrate that the risks from the use of the substance can be adequately controlled. If a safer alternative exists that is technically and economically feasible, the applicant has to submit a substitution plan, which will determine the period in which the authorisation will be reviewed.

For PBTs, vPvBs and other substances that cannot be adequately controlled, authorisation may only be granted if no safer alternative exists (as above) and if, in addition, it is demonstrated that the socio-economic benefits of the use of the substances outweigh the risks for health and environment.

More information is available from Forum Malta fl-Ewropa on 2590 9192 or via e-mail at foruminfo@gov.mt.

Mr Vella is consultation coordinator, Forum Malta fl-Ewropa.

cleavon.vella@gov.mt