REACH Dossier Review and ECHA Decision letters

REACH Dossier updates – ECHA Decision letters and CoRAP

For various reasons, registrations already completed and submitted may need to be updated.  Officially, there are two forms and these are spontaneous (ie at the initiative of the registrant) or enforced (request by ECHA).  

In the case of changes to data or classification, only the lead registrant need make an update; the Lead Registrant will need to consult with other Joint Registration holders before doing so, and if there are (agreed) costs involved, then these costs need to be shared.

It if the registration is being updated to include new uses or changes in substance identity, this will be needed by all registrant holders affected.

Why do a spontaneous update?

There is a legal obligation to update a Registration dossier (EU and GB) if new data becomes available and especially if that new data results in an amendment to the classification and if changes are needed to recommend safe use. These updates will go in hand with updates to SDS and labelling.

Sometimes, when looking back at data, or more importantly waivers or use of read-across to avoid unnecessary testing, you may notice that the dossier fails to meet expected requirements. Dossiers passing ‘technical completeness checks (TCC) with IUCLID 5 in 2010 would not pass the requirements of current IUCLID validation; some of this cosmetic and formatting changes, but the IUCLID data sets are getting more difficult to pass validation as new checks are made

An absence of comments from ECHA since original Registrations were made back in 2010 may not mean it is a perfect dossier and as more checks are made, ECHA may come back to you for further requirements to enhance the data set.

If you are aware of short-comings in the dossier, it is better to fix these early and bring the dossier up to an acceptable standard.

Decisions from ECHA

Enforced updates are needed when requested by ECHA in response to questions raised after review of the dossier.  

It is perhaps best to understand the process of dossier review and the sifting process following submissions, but as a summary:

1          Computer (enhanced) quality validation post-submission

2          Human check on computer quality validation

3          Subsequent dossier reviews

4          Community Rolling Action Plan (CoRAP) for review of substances of concern

5          Other targeted reviews based on consumer use, or grouping of substances of concern

1          Failures in the dossier not picked up by the IUCLID validation tool – there is a disclaimer in the validation tool that further checks will be made and the tool offers no guarantee of acceptance. Some of these checks are trivial and are sometimes linked to the ‘quality errors’ in the validation (and a good reason to minimise the quality errors prior to submission).  Examples have been when stating work is done by Good Laboratory Practice, the name of the testing facility is not included in data source.  A more common error is when the uses in Section 3.5 of IUCLID do not exactly match the uses described in the CSR.

This enhanced check will flag up the use of waivers and read-across as well as the quality errors

2          Check by humans – staff will spend very little time make a human check and priority is set by the computer; effectively, the computer check puts dossiers in three piles; one is a major alert with many waivers using ‘other’ as the reason, many quality errors etc. This ‘red list’ is the first to be checked by humans.  They are pushed for time and can only look at the dossier so if a waiver is based on what you think is blindingly obvious school-level chemistry (such as ionic solutions dissociating in water), back this up with evidence that is cross-referenced from the waiver.

These errors may be identified within days or few weeks of submission and a reasonable period of time is provided to get the dossier amended. 

The second ‘amber list’ will be checked when there is time and there is no back-log of red-list dossiers.  This may be months after submission and can be more serious in terms of the quality of the data set.

Those on the low concern ‘green’ list are put to one side for later reviews as part of longer-term reviews.

Of course, if the process ends up with your dossier on the long-term ‘green list’, you are not congratulated and told your dossier is good. 

3          Longer-term checks – there is a commitment by ECHA to review the back-log of dossiers not picked up in initial sifts and these may result from classification checks on similar substances, concerns from similar substances etc.

The first you will know of this will be a ‘draft decision letter’ from ECHA.  This is typically e mailed to all Registration holders.  In the past, only the Lead Registrant got this and it caused problems if they failed to act on it or did not consult with other Registration holders.  Now, everyone should get a copy.

The draft decision will allow consultation, but give a deadline for comments (which ECHA rarely seem to consider).  A formal decision letter will be received weeks or months (or even longer) with a deadline to make updates to the parts of the dossier considered incomplete.

[See below on what to do next]

4          CoRAP Process – every year or so, a small number of substances are added to this list and allocated to a Member State for review.  Typically, a couple of years is given for the review, but if new data is needed, this can be extended.  To be on this list, there needs to be some concern regarding possible candidates for ‘Substance of Very High Concern’ (SVHC) or high exposure to consumers or the environment. (opens on new page)

In many cases the concerns are based on limited data in the REACH submission; for example, failure to biodegrade and a low water solubility could point towards very Persistent and very Bioaccumulative (vPvB) or limitations on mutagenicity data could point to concerns to be classified as Carcinogen or Mutagen.

In many cases, re-examination of existing data will provide answers; this is good reason to check old dossiers and make spontaneous updates to answer the questions before they are asked.  Sometimes, poorly prepared CSRs fail to demonstrate controlled exposure.

However, it is very likely that some new data will be needed; either higher level biodegradation or higher level mutagenicity, for example. This is not always tonnage related and low tonnage substances may need expensive new testing – or you remove the substance from the market.

If new data fail to remove concerns, expect the next step to go on the Candidate List and then ultimately, enforced controls and restrictions.

Denehurst can help with data review and targeted new testing to minimise costs for maximum data output.

5          Other reviews – different processes occur in the EU with reviews such as PACT (Public Activities Coordination Tool) looking at high exposure substances and generic concerns such as skin or respiratory sensitisation. These rarely result in new information being needed by Registration holders, but will put the data set into focus meaning that ECHA will no doubt ask some questions.

For GB REACH, there is no direct equivalent to these processes, but there is a promise to return to ‘risk based’ assessment of chemicals where those of highest exposure and highest hazard are assessed for ‘science’ and that checks will not be just for form-filling errors.

ECHA Decision Letters

Many know the dread of receiving a ‘decision letter’ from ECHA.  The first is a ‘draft decision’ which comes in two parts – one outlining the legal process and the other technical letter telling you why your dossier is not good enough. To be fair, these do spell out the issues in specific parts of the dossier and suggest ways to resolve the dossier quality. 

Many of the observations are valid, but some are just beyond belief in terms of basic chemistry or toxicology – examples have included providing better quality partition coefficient information in case of bioaccumulation on a substance found in every living cell and another to enhance justification to use read-across between potassium and sodium salts.

ECHA cannot legally demand new testing – this is a fallacy.  ECHA can only ask to enhance or improve a dossier and while new testing is an obvious way to achieve this, other options are open, including improved read-across or waiver justifications. 

An obvious way forward to prove read-across is to perform some more chemistry to show bio-transformation or environmental dissociation etc.  A few thousand spent in better chemistry can save tens of thousands on other laboratory costs.

Experience has shown that trying to fight these decisions on a legal or procedural basis achieved nothing other than annoying those who work ECHA.  Scientific engagement is needed, even if doing basic chemistry or other tests to explain the obvious.  New animal testing must only be considered as a very last resort.

ECHA rarely change their mind after a draft decision.  After a period of time (weeks or months) a final letter will be sent and this will give a firm deadline to complete the dossier updates.  The time given is usually generous, but make full use of the time.  Exceptionally, when it can be shown that problems arose during testing (which started promptly, of course), extensions will be given.  If you are going to run out of time, tell ECHA immediately.

Denehurst provides support in this area and will offer free advice in attempts to prevent animal testing.