24 April, 2017

Start your REACH journey before it's too late

By Kate Newell

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Starting your registration for REACH Phase 3 can seem a daunting task. Here’s how to beat the ticking clock, and spare yourself some major EU headaches.

REACH so far
Phase 3 of REACH is in progress now. The deadline for Phase 3 is June 1, 2018. The deadline for pre-registration is even sooner - 31 May 2017.

It’s almost ten years since the European Union (EU) established its REACH (Registration, Evaluation and Authorisation of Chemicals) regulations. Broadly speaking, REACH’s Phase 1 in 2010 covered chemical substances of very high concern. This phase dealt mainly with larger volume suppliers. Phase 2 of REACH followed in 2013. Now it included companies that manufactured or imported chemical substances in quantities between 100 and 1,000 tpa. Phases 1 and 2 are now complete. Between them thousands of chemical substances have been registered.

What should I know about Phase 3?
Phase 3 will encompass many low-volume registrations. Regulators expect three-to-ten times the number of registrations for the first two phases combined. Unlike the first two phases, Phase 3 is almost guaranteed to put some companies in a difficult situation. This is for three main reasons:

1) The fast-approaching June 1 2018 deadline
2) The massive number of low-volume substances to be registered
3) The limited capacity at testing facilities worldwide

This could spell bad news for companies whose chemical substances will be in high demand beyond the 2018 deadline, and who rely on these substances commercially.

How much work will be involved?
There is a surprisingly large amount of time of effort involved in preparing the required dossier. Please don’t underestimate what Phase 3 involves. Planning appropriately is important, but especially those organizations with no data. Remember, it can take up to a year to complete the 28-day repeat dose and reproductive toxicity screenings.
Click the links below for more details on what you’ll need to do regarding:

Substance identification
Lead registration

Advice on your pre-registration
Pre-registered already?
Continue collating tonnages and calculating three year averages. This will determine your registration deadline, and the level at which you need to register.

Not pre-registered yet?
You must pre-register your substance within six months of first import occurring, and before 31 May 2017. Your three year averages must be below 100 tpa. And the substance should not be classified as a carcinogenic, mutagenic or reproductive (CMR) toxins.

What are my options for registration?
This depends on if you have a lead registrant (LR).

YES: I have a lead registrant
You’ll need to contact your LR for LOA the conditions, costs and substance profile (SIP). You’ll also need to prepare analytical information to establish audience sameness and correct SEF.

NO: A lead registrant is not available
Firstly, ask yourself: “Do I want to support the market?” If your answer’s “yes”, then ask yourself: “Am I willing to be the LR?”. Your obligations as an LR will vary depending on volumes. To explore these volumes in greater detail, please click here.

How can I make sure my REACH registration is successful?
There are a number of technical and business challenges facing companies pursuing Phase 3 registration. It is vital to understand what these are and what you must do to meet them. Due to the tight deadline and complexity of Phase 3, it is understandable why so many companies are bringing in specialist assistance. A CRO will be able to provide a wide range of knowledge and expertise to assist you with every aspect of pre-registration and registration for REACH.

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Category // Chemical, REACH