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REACH 2018: Assess your substance to show safe use

ECHA/PR/16/09

Companies registering the same substance must work together to compile and share information on the uses, hazards and risks of their substance to demonstrate safe use. If new data involving animal testing needs to be generated, alternatives must always be considered first. All information should be reported in a registration dossier and submitted to ECHA by 31 May 2018.

Helsinki, 19 July 2016 – Companies registering the same substance need to gather all available information on their substance, identify data gaps and decide how to fill them in the substance information exchange forum (SIEF)*. This work is the most important part in preparing for REACH registration as companies use the information to demonstrate the safe use of their substance for human health and the environment. Assessing the hazards and risks of substances is the fourth phase of ECHA's REACH 2018 Roadmap.

Companies should, as soon as possible, start compiling the information they need. They should first study what information is relevant for their registration. This depends on the substance properties and the volume of manufacture or import - the bigger the volume, the more information is needed. They can then identify information gaps, which have to be filled by sharing existing data or by generating new.

Before any new tests involving vertebrate animals are commissioned, full use of alternative approaches must be made first. Any adaptation to standard information requirements must be adequately justified in the registration dossier.

Practical advice on information requirements for low-tonnage chemicals, how to avoid unnecessary testing on animals and on ways to gather information is now available on ECHA's website. ECHA also publishes a new practical guide on REACH information requirements for SME managers and REACH coordinators.

A webinar on the fourth phase of the REACH 2018 Roadmap will take place on Wednesday 20 July at 11:00 (Helsinki time). It will give companies an understanding of the type of data they need to collect for the tonnage they want to register. It will also highlight what registrants should do before generating any new data for their substance. Finally, it will give practical tips on how to fill in data gaps and how co-registrants are involved in this common activity. Participants will have the opportunity to ask questions from ECHA's experts.

*A SIEF is a specific group that registrants and pre-registrants of the same substance are part of. They share data for the REACH registration in the SIEF.
 

Background

The last REACH registration deadline will be on 31 May 2018. This deadline concerns companies that manufacture or import chemical substances in low volumes, between 1-100 tonnes per year. ECHA's REACH 2018 Roadmap splits the registration into seven phases and describes the milestones of each phase and support that the Agency plans to give to registrants. Companies should start their preparations early enough. ECHA's REACH 2018 web pages serve as a one-stop-shop for all material to help companies prepare.
 

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