REACH requires from companies that substances on their own, in mixtures or (in certain cases) in articles are not manufactured or placed on the market in the Community, unless they have been registered. The principle “no data, no market” applies(Title II, Article 5).
Registration is required for quantities of one tonne or more per year placed on the market per manufacturer or importer (for exemptions see Articles 2 and 9 REACH). A registration needs to be submitted to ECHA by:
- EU manufacturers or importers of a substance, or
- EU producers and importers of articles under certain circumstances (Article 7), or
- Only representatives established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers (Article 8).
A registration dossier contains a variety of information on a substance and is submitted electronically by the registrant. The dossier is divided in two parts:
1. The technical dossier (IUCLID dossier) contains the information requirements and possible adaptations as set out in the Annexes VI to XI REACH and has to be submitted for every registration.
2. The Chemical Safety Report: According to Article 14 REACH, registrants who manufacture or import a substance at ten or more tonnes per year must conduct a chemical safety assessment to define the conditions of use under which the risks can be controlled.
Registration is based on the "one substance, one registration" principle, i.e. manufacturers and importers of the same substance have to submit their registration jointly.
For an overview of the REACH registration process see also our thematic newsletter on registration.
In principle, the registration of a substance must be submitted immediately once the 1 tonne/year threshold is reached by a manufacturer/importer. However, for so-called phase-in substances that have been pre-registered before 1 December 2008, transitional arrangements apply (Article 23). For pre-registered phase-in substances the following registration deadlines did apply:
- 1 December 2010: >1000 t/a, CMR Substances > 1 t/a, Very toxic to aquatic organism > 100 t/a
- 1 June 2013: 100-1000 t/a
- 1 June 2018: 1-100 t/a
REACH 2018 – Steps to go
Substances manufactured or imported in quantities of over one tonne up to 100 tonnes per year, and which have already been pre-registered, are subject to the REACH registration deadline of 31 May 2018. The respective data requirements are defined in Annex VII and VIII REACH. A chemical safety report (CSR) is only necessary for quantities of more than ten tonnes per year.
Companies should follow six steps in the preparation of their registration (see also ECHA’s REACH2018 webpage):
Check your portfolio to identify the substances which are subject to the registration obligation. Have you ever done an inventory of the chemicals and articles you buy?
The REACH&CLP Helpdesk Luxembourg offers you its REACH Excel Tool, which can help a company to gather relevant information to make an inventory of chemicals in the company and to identify possible registration obligations.
All co-registrants for the same substance are part of a cooperation group called a substance information exchange forum (SIEF). Potential (new) registrants have to enquire with ECHA, whether a registration has already been submitted for the substance in question or not. Registered substances are listed on the ECHA website.
The substance information exchange forum is open to any company in order to exchange substance data with other registrants. In case there are several registrants for the same substance, REACH requires registrants to jointly submit a registration (Article 11).
REACH requires the submission of information on physico-chemical properties, mammalian toxicity, ecotoxicity and environmental fate, including abiotic and biotic degradation. If manufacturing or importing is above 10 tonnes per year, a chemical safety assessment (CSA) is required to assess if the potential risks arising from the substance and its use are adequately controlled (Article 14).
It is the responsibility of the registrant to update his registration when needed. According to Article 22, the registrant must immediately inform ECHA or update his dossier upon its own initiative or due to decisions by ECHA or the Commission, when new and relevant information regarding the substance or the registration is available.