Do you manufacture or import chemical substances in quantities of more than one tonne per year (either in pure form or in mixtures)?
Or do you manufacture or import products that contain these substances, in circumstances where the substance may be released and is present in quantities of over a tonne per year?
If so, in order to continue manufacture or import in the EU, you should have either registered the substance with the European Chemicals Agency (ECHA), or pre-registered the substance with ECHA to obtain the benefit of an extended timescale for registration (the deadline being tonnage dependant).
Companies that have pre-registered and that manufacture or import in quantities of 100 tonnes per year or higher need to register with ECHA by 31 May 2013.
A considerable amount of work is needed before a substance can be registered with ECHA, so companies affected by the 2013 deadline should start preparations now.
What is REACH?
REACH is an EU Regulation relating to the Registration, Evaluation, Authorisation and Restriction of Chemicals. It came into force in 2007 and created a new regime for the regulation of chemicals in the EU.
Who must register under REACH?
Over time, there is a requirement for companies to register with ECHA where they:
- manufacture substances or preparations (mixtures of substances)
- manufacture articles (items that have a particular shape or design that determines function, for example a plastic toy) which contain substances that can be released from the articles under reasonable foreseeable conditions of use
- import substances, preparations or articles that contain substances which can be released from the products under reasonable foreseeable conditions of use
and where the substance is present in quantities of one tonne or more per year and no exemption or exclusion applies
When is the registration deadline?
Provided that a pre-registration has been made with ECHA, registration deadlines are:
- companies manufacturing or importing substances in quantities greater than 1,000 tonnes per year, or substances that are particularly harmful had to register by 30 November 2010
- companies manufacturing or importing substances in quantities greater than 100 tonnes per year have to register by 31 May 2013
- companies manufacturing or importing substances in quantities greater than one tonne per year have to register by 31 May 2018
What is pre-registration?
ECHA allowed companies to submit limited information by way of a 'pre-registration', and if they did so by 30 November 2008 the extended registration deadlines apply. Otherwise, the deadline for registration was 1 June 2008.
Late pre-registration can be made in certain circumstances.
Companies that pre-register have to join a Substance Information Exchange Forum (SIEF) for the substance, and are obliged to share data and jointly commission any new data that is needed. SIEF members then have to jointly register key technical data, using one company as a lead registrant.
What does registration involve?
Registration involves the submission of detailed technical dossiers containing information about the substance and its use. For substances manufactured or imported in quantities greater than 10 tonnes per year, a chemical safety report has to accompany the technical dossier.
What is the consequence of failing to register?
Failure to register means exclusion from the EU market. Substances cannot continue to be manufactured or imported.
What steps should I be taking to register by 31 May 2013?
If you have pre-registered and a dossier for the same substance has already been submitted in 2010, registration can be completed by buying a letter of access from the lead registrant of the SIEF.
You should check that the dossier covers your substance, your uses of the substance and the uses of your downstream users. You should then submit the dossier using REACH-IT, completing your company specific details.
If a dossier has not already been submitted for your substance, then, if you have not already done so you will need to:
- agree with other SIEF members that you are dealing with the same substance
- collect all available information on the substance, decide what (if any) new testing is required and agree a cost-sharing mechanism
- carry out a chemical safety assessment and, if applicable, a chemical safety report
- appoint a lead registrant
- submit the joint dossier well in advance of 31 May 2013
- submit your individual company registration via REACH-IT