Dossier Evaluation (compliance check)

ECHA may examine any registration dossier to verify if the information submitted by registrants is compliant with the legal requirements. ECHA can pick dossiers for “overall” compliance checks that cover elements necessary for safe use throughout a dossier. ECHA either picks dossiers randomly or selects them using concern-driven criteria. ECHA can also carry out concern-driven “targeted” checks.

 

 

In the targeted compliance checks, ECHA only evaluates a specific part of the registration dossier (e.g. either specific endpoints in IUCLID or in the chemical safety report (CSR)) based on a specified concern. For targeted checking, ECHA uses intelligent selection strategies to screen the whole database, with the focus on the endpoints most relevant for safe use.

 

 

To increase the efficiency but also the transparency of the compliance checks, ECHA now publishes a list of substances which will be potentially subject to compliance check. This list is developed in accordance with ECHA's new Compliance Check Strategy and it is based on i.a. the results of the common screening approach that has been developed by ECHA together with the Member States. Please note that this list is updated a few times a year, please see http://echa.europa.eu/documents/10162/13628/substances_compliance_checks_2015_en.pdf

 

 

This list is only indicative and not exhaustive:  ECHA may at any time open a compliance check on any dossier to verify if the information submitted by registrants is compliant with the legal requirements.

 

 

In addition to the substances identified in this list, compliance checks are normally conducted on registration dossiers for substances which are on the Community Rolling Action Plan (CoRAP list).

 

 

Compliance check focuses on eight key endpoints which are outlined in the new compliance check strategy (see also  . These endpoints are key for identification of substances of concern and will allow concluding whether the criteria for substances of very high concern are likely to be fulfilled.

 

These key endpoints are:

·          Genotoxicity

·          Repeated-dose toxicity

·          Pre-natal developmental toxicity

·          Reproductive toxicity

·          Carcinogenicity

·          Long-term aquatic toxicity

·          Biodegradation and bioaccumulation

 

 

Grouping of substances and read-across is a commonly used alternative approach for filling data gaps in REACH registrations and has extensively been used by the metal sector. This approach uses relevant information from analogous (‘source') substances to predict the properties of ‘target' substances. For each standard information requirement that applies, registrants must indicate whether they are making an adaptation using read-across, and they must justify its use. However, registrants need to make sure that their approach falls within the conditions for using grouping and read-across approaches set out in Annex XI, section 1.5 of the REACH Regulation. A read-across approach can also support a conclusion for a REACH endpoint using a weight-of-evidence approach. In all cases, the grouping of substances and read-across approach needs to be adequately and appropriately documented (e.g. assumptions made, conclusions drawn).

 

 

When checking dossiers for compliance and evaluating testing proposals, ECHA will assess read-across based adaptations and the justifications. To ensure consistency and transparency in their evaluation, ECHA is using the Read-Across Assessment Framework (RAAF), which can be found here: http://echa.europa.eu/documents/10162/13628/raaf_en.pdf

 

 

The RAAF also provides insights for registrants making use of expertise in read-across on how to assess, and improve where they can, their explanations of why and how read-across can be used. It is recommended to consult it for new registrations and when read-across justifications are questioned in the context of a compliance check or testing proposal

 

 

The possible outcomes of the compliance check are

·          No action towards the registrant: there is no administrative action if the dossier is considered compliant with the information requirements provided in REACH. However, this does not necessarily mean that there are no shortcomings in the dossier. A new additional compliance check can still start at any time.

·          Quality observation letter: ECHA may identify shortcomings that are not necessarily related to a lack of information. For example, the risk management measures proposed by the registrant may be inadequate or the proposed classification and labelling may not reflect the reported study results.

·          Decisions to request additional information

 

More information on Evaluation and the outcomes of Compliance Checks are available on http://echa.europa.eu/regulations/reach/evaluation/compliance-checks  or http://echa.europa.eu/regulations/reach/evaluation/steps

 

 

Then, for each joint submission, ECHA may select dossiers to check from both lead and member registrants.

 

 

More information can be found here: http://echa.europa.eu/regulations/reach/evaluation/compliance-checks

 

 

Working Procedures for the Member State Committee (MSC) to process draft decisions under dossier evaluation - process description and tasks, including case-owner and stakeholder participation" (update adopted on 18 September 2014)

 

 

 

 

Latest update : 2 January 2016