ECHA

ECHA checked 5% of the dossiers received for the 2010 registration deadline. That amounts to 1 130 compliance checks on registration dossiers.

Over one third of registered substances were covered by these dossier checks. In 69% of the evaluated cases, the dossiers did not comply with REACH requirements. In these cases, ECHA issued a draft decision, requesting more information from the registrants.

The Agency used a combination of two methods to select the dossiers - concern-based and random selection. For the selected dossiers, ECHA conducted either an overall compliance check (30% of the cases) or a targeted one (70% of the cases). Over one third of registered substances were covered by these dossier checks. In 69% of the evaluated cases, the dossiers did not comply with REACH requirements. In these cases, ECHA issued a draft decision, requesting more information from the registrants.

The annual Evaluation Report 2013 gives detailed information on dossier quality. Its specific recommendations target both the future registrants for the 2018 deadline and the existing registrants who need to update their dossiers.

The report will be published at the end of February 2014. The reports from previous years also include recommendations to registrants on how to improve their dossiers and those recommendations remain valid.

 

Compliance checks - how does ECHA do them? 

Dozens of scientific, legal and administrative staff work at ECHA evaluating dossiers. They work on compliance checks, go through proposals for testing and coordinate substance evaluation activities.

Marco Valentini and Katrin Halling are scientific officers at ECHA. Work on compliance checking was a priority for them in 2013. A compliance check requires ECHA to examine registration dossiers to verify if the submitted information complies with the legal requirements set out by the REACH Regulation.

Ms Halling and Mr Valentini explain the steps taken in the checks:

 

How do you choose dossiers for compliance check?

Marco Valentini: Our database now contains over 42 000 dossiers with information on more than 10 000 substances. For compliance checks, we select dossiers that cover elements necessary for the safe use of the chemical. Some dossiers are picked randomly, others because there are particular concerns. Examples of such concerns are dossiers using a large number of adaptations, using many read-across approaches for higher-tier endpoints or transported isolated intermediate registrations.

 

How do you do an overall check?

Katrin Halling: An overall check means that we assess all the relevant information contained in one single registration dossier. This can involve looking at thousands of data fields.

Mr Valentini: The hazard information of a substance is shared by all registrants in the joint submission and is pivotal for risk assessment. For each joint submission, ECHA selects the dossiers for checking from both the lead and member registrants.

A specialised team then starts working on the substance identity information. This ensures that the substance described in the dossier is in fact the substance being registered. In parallel, we go through all the information provided in the dossier that is relevant for the safe use of the chemical. In practice, experts with different backgrounds assess the hazard data on physico-chemical properties, human health and the environment in the technical dossier against the REACH information requirements.

After each expert has assessed the dossier in their area of expertise, the team decides whether a draft decision is needed.

Ms Halling: Let's not forget that the evaluation also includes the screening of the chemical safety report where it is required. Such a report can have several hundreds of pages. One check can result in more than one draft decision. This happens because, in many cases, it is more efficient to request information before continuing with the rest of the dossier. This is particularly the case for those dossiers where the substance identity is not clear.

 

Why do you also do targeted checks?

Ms Halling: Given that some endpoints are considered highly relevant for the safe use of chemicals, ECHA developed a strategy to focus on these. We screen the whole database for specific parts of the dossiers, based on particular concerns.

These can be for example: substance identity issues; endpoints that are considered highly relevant to risk management and chemical safety; chemicals that may in the near future be subject to substance evaluation; and dossiers submitted outside the joint submission with many adaptations for higher-tier toxicological endpoints - even though reliable data exists in the joint submission.

 

How do you do a targeted check?

Mr Valentini: A targeted compliance check on a certain endpoint, for example bioaccumulation in fish, means that we first search our database for those dossiers for which this endpoint is a standard information requirement.

Secondly, we perform an IT-based selection of those dossiers that do not seem to fulfil the legal requirements for the endpoint.

Thirdly, our experts verify whether the information for the endpoint complies with what the law requires.

***

If ECHA concludes that the information in the dossier does not comply with REACH requirements, the registrant receives a decision requesting that they provide further information.

Regarding the 2010 registrations, this has been the case for the majority of the dossiers. ECHA is continuing to check the compliance of the registrations received for the 2013 deadline: REACH requires ECHA to check 5% of the dossiers in each tonnage band.

ECHA targets the compliance checks to the endpoints which matter the most for the safety of chemicals.

	Type of compliance checks concluded
Year	Overall check	Targeted check	Total
2010	7	0	7
2011	42	80	122
2012	47	221	268
2013	225	508	733
Total number of concluded compliance checks	321	809	1 130

Concluded compliance checks considered as contributing to the 5% target.

 

Further information:

• Target met for 5% compliance checks of the 2010 registration dossiers, Press release 15 January 2014
• 5% Compliance checks of the 2010 registration dossiers - results

The Evaluation Report 2013 will be published on 26 February 2014.

Text by Tiiu Bräutigam
Top image: ECHA's scientific officers Marco Valentini and Katrin Halling explain how the compliance checks are done.