06 December, 2018

ECHA decision letters - all you need to know

By Naheed Rehman

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The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances, and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out.

Where have we got to with dossier evaluation?

Periodic table

With the REACH deadlines complete, ECHA has ramped up its focus on dossier evaluation. Dossier evaluation involves compliance checks and assessment of testing proposals, and a ECHA can be asked for more information on either of these. According to the 2017 ECHA progress report, 300–350 follow-up evaluations are carried out annually, with approximately 55% resulting from compliance checks and 45% from testing proposal decisions.

In 2017, 83% of compliance checks carried out were on substances of potential concern, such as CMRs (substances classified as carcinogenic, mutagenic, or toxic for reproduction). On average there were five information requests per compliance check decision. In terms of testing proposals in 2017, 58 were adopted, out of a total of 197 dossiers.

The most common endpoint gaps for both are listed in the table.

   Evaluation
  Most common information needed
 
    Human health endpoints
    Environmental endpoints
   Compliance
   checks


  • Pre-natal developmental toxicity
  • Mutagenicity/genotoxicity
  • Reproductive toxicity
  • Repeated dose toxicity
  • Simulation testing (water, soil and
    sediment)
  • Long-term aquatic toxicity
      
   Testing proposals

  • Pre-natal developmental toxicity
  • Sub-chronic 90-day toxicity 

  • Short- and long-term effects on terrestrial organisms
  • Long-term aquatic toxicity


It is also worth noting that between 2012 and 2017, 72% of active substances in the
community rolling action plan (CoRAP) required further information to clarify suspected concerns.

Read this e-book on new product registration to gain further insight into what happens after REACH submission.

What to expect from a dossier decision letter

ECHA issues decision letters for both compliance checks and test proposal follow-up evaluations. For compliance checks, the letter flags up data gaps and identifies the studies needed to ‘complete’ the dossier. This is not just a tick box exercise, substantial scrutiny is applied with an increased demand for higher-tier testing that reflects the evolving scientific and regulatory environment created by REACH.

Learn more about the ECHA evaluation process.For testing proposals, the initial draft decision letter lists new studies or study modifications and describes, in detail, the scientific and regulatory rationale behind ECHA’s decision. Registrants can challenge this within a set time frame. The registrant’s response is returned to the Member State Competent Authority who reviews it and elicits feedback from other Member States. A final – binding – decision letter is issued, which the registrant must action.

83% of compliance checks carried out were on
substances of potential concern

 

Common themes are evolving in ECHA requirements

It’s clear we are entering a new era of enhanced integration between regulation and science. The decision letters that have been hitting inboxes to date relate to dossiers submitted for the 2010 and 2013 REACH deadlines, however since then there has been significant development in many scientific approaches.

This is evidenced by some key themes appearing in decision letters.

  • Rejection of waivers: read-across approaches based on existing data for similar substances or substances with similar physiochemical properties are being questioned

  • Greater consideration of exposure-related risk: as the database grows, new uses for each chemical are being identified, tonnages/volumes may increase demanding new exposure scenarios and risk assessments. This, in turn, is feeding into categorisation and labelling

  • Scrutiny of quantitative structure–activity relationship (QSAR) models: the sophistication of QSAR modelling has significantly improved in the last decade with increasing data generated and scientific knowledge. Early dossiers using limited QSARs may no longer be perceived as robust enough scientifically or technically.

Read this ebook on QSARs to find out how to optimize predictions with expert-led scientific approaches.

To address some of these issues, ECHA’s Integrated Regulatory Strategy has initiated a pilot to enhance the use of read-across grouping approaches for priority substances.

What next?

The REACH evaluation process is evolving as the chemical safety and usage dataset grows. So, when that dossier decision letter arrives, be prepared to think creatively and combine scientific and regulatory thinking in innovative ways.

The third and final May 2018 deadline for REACH registration has past, however this deadline is not the end, it just the final step in data gathering. As Geert Dancet the previous chairman of ECHA stated “May 2018 is only the beginning”. So what’s next? Read this new product registration e-book to gain further insight into what happens after REACH submission. 

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About the author

Naheed is Business Lead Consultant for Chemicals, and provides Envigo with the leadership and direction in terms of future scientific and regulatory developments, particularly in the innovations space and potential impact with emerging global regulations.

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Category // REACH, Chemical, higher tier testing, Naheed Rehman