EU REACH Dossier Improvement

EU REACH Dossier Improvement

Keeping your REACH registration dossiers up-to-date


EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation requires EU manufacturers and importers to assess their chemicals and document their findings in a registration dossier which is then evaluated by the European Chemicals Agency (ECHA).

In 2019, ECHA and the European Commission (EC), having identified the need to significantly improve the quality of information provided in REACH dossiers1, published a REACH Evaluation Joint Action Plan to address the lack of compliance with the information requirements in dossiers and increased the number of compliance checks. 

In response to the action plan, the European Chemical Industry Council (Cefic) has already taken action to encourage its members to proactively reassess and update the data in their dossiers in a systematic and stepwise manner. Cefic members can find what to do next here.

As part of NCEC’s REACH dossier service, our experts can review your dossiers to identify and fill data gaps, strengthen justifications for adaptations and help establish if all appropriate information has been gathered, to reduce the likelihood of ECHA requesting further information. We have extensive experience with standard and non-standard approaches to assessing physicochemical, ecotoxicological and environmental fate endpoints. We can also conduct read-across, quantitative structure-activity relationship models (QSARs) and weight-of-evidence approaches to minimise costs and testing. 

Action plan numbers and timeline

By 2027, ECHA will have screened all registration dossiers submitted by the 2018 deadline and will perform a compliance check for all substances where data gaps prevent from concluding whether the substance is of concern or whether it is of low priority for further regulatory action.  – REACH Evaluation Joint Action Plan

When evaluating dossiers, ECHA checks that the available data complies with the standard information requirements outlined in REACH or is included in a testing proposal. ECHA and the EC aim to increase the target for compliance checks from 5% to 20% of registration dossiers in each tonnage band, representing 30% of all registered chemicals. The division of checks will depend on tonnage bands:

  • By 2023: tonnage band >100 tonnes/year (from Annex IX) 
  • By 2027: tonnage bands 1-100 tonnes/year (from Annex VII)

Why you need to update your REACH dossiers urgently:

Keeping your registration dossiers up to date is a legal obligation under REACH. A proactive approach to dossier compliance is highly valuable as it ensures dossiers contain high-quality information which reduces the risk of further costs of compliance and regulatory action on substances. 

Should ECHA find a compliance failure, it could lead to problems with your REACH registration and subsequent market access. Non-compliance can also lead to insufficient or inadequate risk management measures where protection of human and environmental health is not optimised. This could have important impacts on other chemical regulations and could also lead to dysfunction of the chemical industry internal market.

As part of Cefic’s dossier improvement action plan, CEFIC members can sign up to declare their intent to re-evaluate and update their dossiers in-line with the joint action plan. As of 31 Dec 2021, 198 companies had signed up to the Cefic Action Plan, representing 1436 legal entities (registration holders). Businesses that are signed up are urgently recommended to start updating their REACH dossiers.

It is important to note that CEFIC does not have access to registration dossiers and all updates need to be done by individual companies.

How can NCEC help?

Our regulatory team is highly experienced in the preparation of REACH dossiers and the use of IUCLID, and can support you with a comprehensive review and analysis of the different sections of your dossier. We will scrutinise your data, identify the data gaps and areas for improvement, and provide recommendations and solutions on how to improve the quality of your dossier. Our aim is to make your dossiers robust enough to pass the checks and prevent further evaluation and additional testing, reduce the risks of non-compliance and the potential impact on your business reputation. 

Our services include:

  • Assessing physical and chemical properties, environmental fate, toxicological and ecotoxicological endpoints

We will review and analyse the data provided for the physico-chemical endpoints, environmental fate, toxicological and ecotoxicological sections and improve your dossier’s quality of data, the relevance of the test methods used and the coherence of the results in relation to the rest of the dossier. With experience in assessing complex and difficult chemicals, our teams can provide technical expertise in reviewing substances with challenging properties (e.g. poorly soluble, volatile, substance of unknown or variable composition, complex reaction products or biological materials (UVCB), etc). 

  • Reviewing compositional and analytical data on IUCLID

As part of the dossier review, we will examine compositional information (used for substance sameness), check that analysis and testing is up to date and that the dossier clearly and adequately demonstrates identification and quantification purity of the substance using the current methodology described in the Substance Identity Profile (SIP). If any of the substances are UVCBs, analysis and composition will be detailed as accurately as possible based on the complex nature of these substances. 

  • Standard information

In addition to a more detailed review of endpoint and study data, NCEC will conduct a generalised review of standard information. For example, we can help to keep the substance classification information consistent across the latest revisions of classification, labelling and packaging (CLP) of substances and mixtures Annex VI harmonised classifications and the lead dossier, as well as checking that tonnage and use information is up to date. 

NCEC experts can conduct a review of the chemical safety report (CSR) if required, so that all listed uses within the dossier have corresponding exposure scenarios. We have legal entities throughout UK and EU and can act as your Only Representative. You can find all our UK and EU REACH services here.

If you need support with updating your REACH dossiers to reduce the risk of non-compliance and minimise the risks of increased costs and business disruption, please contact us using the form on the side or at [email protected].

In 2018, the German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA) found that, only one-third of the approximately 3,800 REACH registered dossiers that were investigated met the information requirements. (REACH Evaluation Joint Action Plan, 2019)