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Take Action Now on Substance Testing for REACH 2018

17 March 2015

There may seem to be plenty of time before the final REACH deadline in 2018, but companies should be taking action now if they need to undertake substances testing ahead of preparing the REACH dossier.

REACH registration in 2018 covers substances manufactured or imported into the European Union in volumes of 1-100 tonnes per annum. Substances termed Annex VII substances are those manufactured or imported in 1-10 tonnes per annum, while Annex VIII are manufactured or imported in 10-100 tonnes per annum.

Although REACH is sometimes thought of as an administrative process, this is only a small part of dossier preparation. Crucially, substances must be tested in accordance with the specifications of REACH and the results interpreted before compilation of the dossier can even begin.

For some substances, this work will have been done for the 2010 or 2013 deadlines. In  2010 approximately 3,400 substances were registered, with a 3,000 registered in 2013. However, the European Chemicals Agency expects that there will be considerably more substances to be registered for 2018; the current estimate is anywhere between 25,000 and 50,000 substances.

For some substances, this work will have been done for the 2010 or 2013 deadlines. In  2010 approximately 3,400 substances were registered, with a 3,000 registered in 2013. However, the European Chemicals Agency expects that there will be considerably more substances to be registered for 2018; the current estimate is anywhere between 25,000 and 50,000 substances.

This means that potential registrants of 2018 substances may have to perform a large number of studies before they can register for REACH.

Regardless of tonnage or whether a joint submission is to be made, each registrant must, as a minimum, ensure their substance is tested to confirm its identity. Substance identity testing can be performed in two to three weeks, depending on the availability of laboratory capacity.  However with 70,000 registrations anticipated for the 2018 deadline it is it not difficult to imagine that laboratories could become very busy in the coming months.

Registrants, Substance Information Exchange Fora, and Consortia preparing lead dossiers for 2018 face a much bigger task. Annex VII substances may require five to seven months to complete the testing process, while for Annex VIII substances it can take six to eight months.

However, testing itself is only part of the process. Firstly, existing data must be gathered and a strategy prepared, discussions with the test laboratory must take place, contracts signed and the test substances sent to the laboratory. Then the QA department must become involved and the relevant paper work completed.

The method development process can also take time. ReFaC’s advice is that 2018 registrants should aim to reach this stage as soon as possible. After this, the tests can be conducted and reports drawn up and finalised. Only then can dossier compilation and filing take place, a process that can take several months in itself.

From start to finish, it is estimated that the whole procedure can take up to 20 months for an Annex VII substance and 36 months for an Annex VIII substance. Bearing these timelines in mind and with the REACH 2018 deadline only three years away, it is advisable for preparations, such as an initial data gap assessment to determine testing needs, to begin as soon as possible.

ReFaC can assist with all aspects of REACH registration including dossier planning and the arrangement of suitable testing – contact us for more information.

With thanks to WIL Research and AMG Analytical Services.

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