What will failure to pre-register mean?
Failure to pre-register a substance that you place onto the European market will not entitle you to participate in the collective knowledge sharing process of registration, or be entitled to take advantage of the transitional periods for registration , placing on you the associated administrative and financial burdens required to register in full as an individual registrant.
What is pre-registration?
Pre-registration is a critical stage of the REACH process. Pre-registration requires manufacturers and importers, to provide a ‘postcard’ of information on the substances, in quantities of 1 tonne or more per year, they intend to register. Article 28 of REACH outlines the ‘postcard’ information requirements:
· The name of the substance plus its EINECS and CAS numbers;
· The name and address of the potential registrant (i.e. manufacturer, importer or person representing them);
· The name of the contact person;
· The envisaged deadline for the registration and the tonnage band;
· Any information that already exists regarding computer predictions of the toxicity of that substance (QSARs) or toxicological properties that are predicted by comparing the substance to ones with a similar chemical structure.
One month after the pre-registration phase has ended (1 January 2009) the European CHemicals Agency (ECHA), who is responsible for co-ordinating registration at community level, will publish on its website a list of the substances pre-registered. The list shall comprise only the names of the substances, including their EINECS and CAS number if available and other identity codes, and the first envisaged registration deadline.
Why should you pre-register?
Any manufacturer or importer who pre-registers can expect to rely on support from SIEFs (Substance Information Exchange Fora), which are formed by pre-registrants after the pre-registration phase ends. SIEFs, as outlined in Article 29 of the official text, allow groups of producers, importers and users of substances to join together and register a substance between them in a consorta (Article 11). This minimises the need for duplicate testing effort and facilitate the sharing of animal testing data which is mandatory under REACH. It also reduces the individual cost of registering substances.
Manufacturers and importers who fail to pre-register will not be entitled to take advantage of the transitional periods for registration. And will be required to register, in full, 12 months after REACH enters into force. Any manufacturer or importer who does not pre-register cannot expect to rely on support from SIEFs, making registration of a substance potentially both onerous and expensive. Pre-registered information will only be available to those who have pre-registered the same substance (i.e. SIEFs)
What should ‘downstream users’ do?
It is expected that some manufactures/importers may decide to withdraw substances from the market rather than undergo the burden of pre-registration/registration; other manufacturers/importers may have substances subject to an authorisation or restriction. For downstream users this may require seeking alternative supplier or substances for product use. If you are a downstream user it is vitally important that you communicate with your manufacturer and/or importer to ensure that they will register the substance(s) that they supply to you. Further information for downstream users is available from the download section of this page.