WCA | REACH Regulation

REACH (Registration, Evaluation, Authorisation and restriction of CHemicals), is the European Union programme for the regulation of both new and existing chemical substances on the European market.

Coming into force in 2007, with staggered deadlines through to 2018, depending on tonnage and hazard class, the REACH regulation covers all substances manufactured in or imported into the EU in tonnages of 1 tonne per year or more.

With the passing of the final registration deadline for phase-in substances of 31 May 2018, it is vital to keep registrations up to date and respond to any requests from ECHA during the evaluation phase, in addition to registering any new substances that become relevant to your business. If you have a previous NONS registration you may also need to upgrade this to a full REACH dossier if you intend to increase your tonnage, for example.

wca provide the following REACH services for our clients:

Support with all aspects of dossier preparation for new registrations and updates to existing registrations.
Response to Compliance Check and Substance Evaluation requests from ECHA and Member States, and technical advocacy.
Development and refinement of exposure assessments, including site-specific assessments.
Assessment of read across approaches and preparation of read across justification reports following ECHA’s Read Across Assessment Framework.
Preparation of inquiry dossiers for new substances without a pre-registration.
Cost calculations for Letters of Access, following the Data Sharing Regulation.

Our personal and tailored approach means that we are able to provide support for all aspects of REACH, on behalf of companies both large and small. Please contact us for further details.

Preparation of registration dossiers

Our staff have been involved in hundreds of registrations for the 2010, 2013 and 2018 registration deadlines. These have included registration of complex UVCB substances, inorganics and difficult to test substances. We understand that every registration has unique challenges and work with out clients to identify appropriate solutions. We have provided tailored support and guidance, for companies large and small, to help them complete their company-specific dossier sections and submit dossiers via REACH IT. Following registration, we work with clients during Substance Evaluation and support them when responding to Decision Letters from ECHA.

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Substance identity analysis

Representative substance identity profiles (SIPs) are required for demonstrating substance sameness and are used as the basis for assessing read across potential and for determining representative samples for testing of UVCB substances. As such, registrants must ensure that they provide clear and accurate substance identity information in their REACH dossiers. ECHA have indicated that substance identity is a particular focus when dossiers are reviewed, and this section is targeted in ECHA’s manual completeness checks, as complete substance identity information is crucial for evaluating other sections of REACH dossiers.

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Design of testing strategies

Fulfilling the information requirements for REACH will usually require the conduct of some new testing. Additional testing can also be requested as part of Substance Evaluation, and this testing can sometimes be complex and non-standard.

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Risk assessment

In order to assess whether chemicals pose a risk to humans or the environment, risk assessment is a crucial part of the REACH process. This includes the derivation of predicted no effect concentrations (PNECs) and derived no effect levels (DNELs) as a way of assessing safe levels of a particular substance. Our staff have extensive experience of deriving both of these under REACH and other regulatory regimes.

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Cost sharing and consortia management

‘One substance, one registration’ is one of the underlying principles of REACH and this necessitates joint registration dossiers to be submitted, containing all available data. Contributions to the costs of joint registrations must be fair and transparent and follow ECHA’s guidance on data sharing, which was updated in 2017. Cost calculations can be complex, but wca have helped both consortia and single companies to negotiate this difficult task.

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