What, when and how to register?

The core of this new European Regulation is that companies who produce, process or pass on chemical substances to clients must supply information about the substances and their use to their clients and suppliers to stimulate safe use. To achieve this they must:

• Know the risks of all the substances;
• Indicate measures to manage the risks and
• Also implement these measures at their own company.

For substances not previously sold or produced in the European Union – the non-phase-in substances – the registration obligation applies from 1 June 2008.

For substances already marketed or produced in the EU – the phase-in substances - the transitional periods for registration are three, six or eleven years depending on the production volumes. A condition is that these substances are preregistered.

Substances of which notification was submitted under the Dangerous Substances Directive 67/548/EEC and that are included on the ELINCS list of new substances are given the status of registered substances under REACH. A file is already available for these substances. This is adopted by REACH.

What is the impact of REACH on your company? What are the different parts of REACH on which you must work to be able to continue producing, importing and distributing your products?

The answers to these questions follow. If you want more information about a specific part, click on the name of that part in the text.

Before ultimate registration, companies must carry out a number of activities that can be summarised as follows:

• Determining of the scope, roles and obligations (see who is REACH for and what are the obligations)
• Preregistration
• Cooperation and information exchange
• Submission of the registration file (registration)
• If applicable, submission of an application for a licence (authorisation)
• Management of the file

After the role has been determined companies must decide if a substance must be registered, which activities they carry out with a substance that must be registered, and what the obligations are in that case. They can preregister phase-in substances between 1 June 2008 and 1 December 2008. With preregistration these companies automatically become compulsory participants of the Substance Information Exchange Forum (SIEF). Exchanging information avoids work having to be done repeatedly and unnecessary testing on animals for the actual registration of a substance. For all substances produced or imported in volumes of at least 1 ton a year, manufacturers and importers must prepare a registration file to submit to the European Chemicals Agency. Final registration can take place no sooner than 1 June 2008.

The first year after coming into force will mainly be devoted to setting up the new ECHA in Helsinki, to the approval of the application modalities and the review of certain annexes. The task of the industry consists of the collecting and preparation of the information. The period (3, 6 or 11 years after the coming into force of REACH, see figure) and the required information for the file depend on the tonnage category and dangers involved with the substances. Besides this information about the substances, individual use identified by downstream users from the whole supply chain as well as the risk assessments associated with their use and the associated safety measures must also be specified. The table shows the test requirements per tonnage category. After registration companies must keep the registration file up to date. This means that all new information about a substance, but also address changes, must be notified to the European Chemicals Agency (ECHA). Registration forms the basis of two other stages (evaluation and authorisation). Evaluation consists of two aspects: the assessment of the files and the substances. An authorisation or licence will be required for each use of a substance belonging to the specific group of so-called ‘substances of very high concern’. After 1 January 2009 the European Chemicals Agency will publish a list of substances of very high concern for which a licence must be requested. If the risk - associated with a certain use of a substance - cannot be effectively controlled, the Commission or a Member State may submit a proposal for a restriction or limitation of the marketing and use of a substance. The decision about this proposal is taken by the Commission in consultation with the Member States. The Commission can therefore take account of the socio-economic elements in deciding to prohibit the use of certain products or use by certain clients. The Commission can also fully prohibit substance. The restriction comprises the safety net of the new legislation.