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Are your plans in place for the 2018 REACH Registration deadline?

May 31st, 2016

Are your plans in place for the 2018 REACH Registration deadline?

It is now three years since registrants were actively submitting documentation for the close date for registration of ‘phase-in’ substances in the 100-1000 t range (‘Phase 2’) in May 2013.

At that time, the deadline for low-volume (1 – 100 t, ‘Phase 3’) phase-in substances, 31 May 2018, seemed very distant – but that deadline is now only two years away.

Time is short!  If you have registration obligations and have not yet begun work, you should take action urgently. Consider:

  • You may require additional experimental evidence for inclusion in your registration data set. European Contract Research Organisations have high demand on laboratory capacity. Availability is likely to be pressed further once ECHA’s conclusions on Testing Proposals from the 2nd registration phase are finalised (at which time large numbers of higher-Annex studies will be commissioned).
  • If there is still uncertainty within your company about the appropriate tonnage range of a specific substance for your registration, a decision on this needs to be taken as soon as possible. Do not underestimate the difference in workload between preparing an Annex VII registration and an Annex VII-VIII registration, especially if your substance has many possible end uses. There are additional hazard and property endpoints that must be completed at Annex VIII and some of these can take a considerable amount of time to plan and conduct. Exposure assessment may require detailed research or consultation. 

Since the 2013 deadline, several important developments have been made (or are anticipated in the near future), including:

  • The fundamentally-important IUCLID 5 data management software is being replaced by a new version, IUCLID 6.
  • The exposure assessment tool CHESAR has been significantly developed between 2014-16 and a new version, CHESAR 3, is expected to be released in June. CHESAR (and some of the other tools available) can now populate IUCLID exposure scenario fields (in Chapter 3) and CSR and SDS documentation can be generated from it.
  • ECHA has released an important document on the read-across assessment framework (RAAF), setting out good practice for justifying read-across of data from one substance to another, which has clarified the nature of supporting evidence and explanations which ECHA expects to see.
  • ECHA has updated many of its guidance documents on information requirements and chemical safety assessment.
  • In vitro alternative testing techniques have continued to develop at OECD level and several in vitro methods are now fully adopted for the REACH and CLP contexts.
  • CLP for mixtures has fully replaced the former Dangerous Preparations Directive method.
  • Industry sector groups have made further advances with SPERCs and supporting documentation.

Prospective registrants should proceed without further delay to prepare for any remaining registrations at 1-10 t or 10-100 t per year, to ensure compliant and timely completion of the registration documents before the Phase 3 phase-in deadline.