Introduction
Regulation (EC) No. 1907/2006 (REACH) regarding the Registration, Evaluation, Authorisation and restriction of Chemicals entered into force on the 1st of June 2007. The European Chemicals Agency (ECHA) based in Finland is coordinating the implementation of REACH in the EU. The registration obligation applies for substances manufactured or imported above 1 ton/year. A transitional period applied for phase-in substances that could be pre-registered until 1 December 2008 or one year before the respective registration deadline. For those substances depending on the tonnage band three registration deadlines apply: 30 November 2010, 31 May 2013 and 31 May 2018. The Regulation includes also some exemptions that companies should check including Annex IV and V.
Registration
The registration is based on the “one substance, one registration” principle. Manufacturers and importers of the same substance have to prepare a joint registration. This avoids the duplication of testing and data sharing is promoted. Companies that pre-registered and need to register the same substance communicate in SIEFs (Substance Information Exchange Forum) but may also organize in Consortia. The SIEF choses a Lead Registrant that will coordinate the preparation of the so called Lead Dossier for submission to the ECHA. This dossier will include common information on classification & labelling, physical-chemical, toxicological and ecotoxicological properties. Usually a joint Chemical Safety Report is also included in the Lead Dossier. The Substance Information Profile and uses are agreed among all members of the SIEF. Costs are equally shared among the members of the SIEF that need to buy a Letter of Access to the Lead Dossier.
Each member of the SIEF has to prepare and submit a co-registration dossier which will include information about the company and own substance including spectral data and analytical data. Registration dossiers are prepared using the IUCLID 5 and submission to the ECHA is done through the online platform REACH-IT. Registrants must be aware that the registration process does not end with receiving the registration number as updating obligations may apply, further information may be requested by the ECHA under dossier evaluation. This also means that additional costs with possible updates must also be considered as well as testing included in test proposals or further requested by the ECHA. Until January 2015, the total number of registrations received by the ECHA was 40791 corresponding to 6127 substances in joint submissions. Industry faces now a big challenge with the 31 May 2018 registration deadline that unlike the previous deadlines in 2010 and 2013 will affect mainly SMEs with lower know-how and resources needed to achieve a successful registration. Start of registration process should start not later than 2016 to ensure that a registration may be submitted before the deadline.
Downstream Users
Companies that do not manufacture substances neither import them on their own or in mixtures are still affected by obligations under REACH. Most important are related with Safety Data Sheets including Exposure Scenarios and Risk Management Measures.
Carlos Miguel Fazendeiro
Director Regulatory Affairs at REACh ChemAdvice GmbH
carlos.fazendeiro@reach-chemadvice.com
