Why You Need to Maintain Chemical Dossier Quality Even Though the REACH Registration Has Passed

October 25, 2018 | Insights,

The REACH numbers:

  • 13,620 European companies submitted information to ECHA
  • Almost 90,000 dossier registrations for chemicals manufactured in or imported to the EU and European Economic Area at over one tonne/year.

The European Chemicals Agency – ECHA – now holds the most comprehensive public database on chemicals in the world. The aim of this database is to protect human health and the environment from the risks posed by chemicals not just in Europe, but with a wider global view.

To provide some background: the database was ‘completed’ on 31st May 2018 when the third and final deadline for the REACH registration passed, signalling the end of the 10-year registration period for existing chemicals.


What’s next for REACH?

We’re sure many companies first thoughts after the 10-year deadline passed was: ‘Phew, that’s it!’ On further reflection, there are many actions that now follow on, including dossier compliance and quality.

ECHA’s priority is to now start the mammoth task of evaluating all the data submitted. The initial completeness checks performed upon submission by ECHA have only brushed the surface of their review of the data.

The REACH Regulation requires ECHA to check at least 5% of registrations per tonnage band to be evaluated for compliance using both a concern-based (targeted) approach and random selection. Potentially, any registration could be examined to verify if the information submitted by registrants is compliant with the legal requirements.

Changes to how ECHA evaluates dossiers

In a recent move, ECHA has announced major changes to its dossier evaluation processes to increase compliance and improve dossier quality. From January 2019, the Agency is proposing to send all draft evaluation decisions to all the registrants rather than just the lead registrants.

In addition, once a draft decision has been issued, no routine dossier updates or informal interactions with ECHA will be allowed. It is therefore in your best interest to update information, especially if your volumes radically change downwards, otherwise upon receiving the draft decision you’ll be required to pay for any work needed at the higher tonnage band.

The compliance check has two possible outcomes:

  1. No action towards the registrant
  2. Decision to request further information

If further information is requested, ECHA may conclude that additional testing or other information is needed.  A deadline will be provided to ultimately update their dossier.

What information does my business need to update?

ECHA is therefore urging companies to take a proactive role and update dossiers before the revised evaluation process is kicked off in 2019.

New studies – when new studies or literature on the substance become available then these should be considered and included in the dataset, particularly any new research conducted in the field of toxicology or ecotoxicology.

Current production volumes – plus new uses should also be included in any update.

Quality of analytical data – Good quality analytical data is essential to accurately identify your substance. Good quality means that your data fulfils the legal requirements stated in the REACH Regulation and is specific enough for ECHA to be confident about the identity of your substance.

Why it’s important not to underestimate quality analytical data?

We have experience of ECHA being rigorous in their assessment of analytical data and therefore this area should be treated with the upmost importance. A large number of inquiry and co-registrant dossiers have been sent back for further work by ECHA for their lack of quality analytical data.

If you manufacture or import organic or inorganic substances into EU, it is recommended that you ensure that a complete set of spectral analyses has been submitted to confirm the identity of the substance.  More importantly, and lacking from many registrations, the spectra data should provide full details of the analysis and interpretation of the spectra to prove that the substance you are manufacturing or importing is the one which has been registered – keeping in mind that ECHA’s experts who review this data may not have an intimate knowledge of your substance and how it is manufactured.

For Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Materials (UVCBs), we’ve already seen the introduction of the requirement to provide a description of the manufacturing process to confirm sameness. Registrants of UVCBs pre-2017 should ensure they update their registration with this information.

As the compliance checks take place, it will also be interesting to see ECHA’s views on the analytical data submitted for UVCB substances. Many co-registrants failed to submit adequate compositional data since they were unable to develop a suitable method even with the help of external laboratories. It will be interesting to see whether ECHA will encourage the sharing of full method details for a suitable remuneration for the analysis of complex substances.

Enter the new era for chemical management

Now that the final phase-in deadline has passed, we’ve entered a new era for chemical management. One which will ensure the safe use of chemicals throughout the EU from the manufacture of the substance through to its end use. We now have in our hands the most comprehensive public database on chemicals in the world and every registrant must ensure they actively review and seek to update their registration, so the status of this database can be maintained.

Anthesis’ experienced team of sustainable chemists can support you on three main areas:

  • Help review dossiers before the compliance check to highlight potential areas of improvement.
  • Offer guidance on which analytical tests are required and review spectral data to ensure compliance.
  • Support you to review and form a robust response to the draft decision if further information is requested by ECHA after a compliance check
  • Help obtain laboratory quotes and monitor studies if further testing is requested. We can then help with updating the dossier with the new information.


About the Author

Karen Cooksey – With a PhD in Organic Chemistry, Karen is an expert on REACH-related issues and chemistry & analytical methods. She was heavily involved in the preparation and updating of registrant dossiers before the REACH deadline.

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