REACH

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The information that Concawe provides on its Website represents opinions and is intended for guidance only. Whilst the information is provided in utmost good faith and has been based on the best information currently available, it is to be relied upon at the user’s own risk. No representations or warranties are made with regards to its completeness or accuracy and no liability will be accepted for damages of any nature whatsoever resulting from the use of, or reliance on, the information.

Documents published by Concawe are based on interpretations of Regulation (EC) 1907/2006 (REACH Regulation) and Regulation (EC) 1272/2008 (CLP Regulation) as well as guidance provided by and information obtained from the European Chemicals Agency (ECHA).

Background

What is REACH?

REACH is the European Regulation (EC) No 1907/2006, on the Registration, Evaluation, Authorisation and Restriction of Chemicals.

The REACH Regulation was adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the European Union (EU) chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

REACH entered into force in 2007, and shifted the responsibility from public authorities to industry with regards to assessing and managing the risks posed by chemicals and providing appropriate safety information for their users.

How is REACH evaluation progressing?

Initial registrations for substances with higher volumes, manufactured or imported in the EU were made in time to meet two deadlines (2010 and 2013). The third and final REACH registration deadline of 31 May 2018 is for substances with lower volumes (1-100 tonnes per year).

As the Registration phase nears completion, the Evaluation phase of REACH will gather momentum. This phase is likely to carry on through the 2020s.

The submitted registration dossiers may be subjected to compliance checks by European Chemicals Agency (ECHA).

• Compliance checks are to ensure that the information required is sufficient for the regulators to properly evaluate the substance and its uses. Should the regulators identify that there are gaps in the information, registrants are given notice and a deadline to generate the missing information and update their dossiers.

• ECHA also evaluates any testing proposals included in the registration dossiers to confirm the proposed studies will effectively generate sufficient data for the assessment of the substance, but also to check that the studies will not result in unnecessary testing, especially on animals.

Once ECHA have completed compliance checks, local competent authorities (Member State) may select substances for substance evaluation.