Progress in evaluation

ECHA has to report on the progress made in dossier and substance evaluation by 28 February each year according to Article 54 of REACH.

The reporting gives the numbers for each of the outputs.

A description of their impact will be included in the report on ECHA’s integrated regulatory strategy, which is due to be published in April 2020.

Compliance checks aim to ensure information on chemicals is compliant with REACH

Since 2015, ECHA’s integrated regulatory strategy has brought together all REACH and CLP processes. As a result of this approach, substances are screened in groups or chemical families to accelerate data generation and speed up the identification of substances of concern 

Those substances for which ECHA cannot conclude whether they are high priority for regulatory risk management or currently low priority for further work are selected for compliance check.

In 2019, to speed up the work under this integrated regulatory strategy, ECHA has worked together with the European Commission to prepare the REACH Evaluation Joint Action Plan. This plan sets out a more ambitious approach to scrutinising all registered substances, identifying those that need risk management and obtaining overall compliance within a timeline of nine years. According to this plan, at least 20 % of all registration dossiers in each tonnage band will be checked for compliance by 2027. Overall, this will mean that about 30 % of all registered substances will be checked. 

A full compliance check focuses on the most relevant information requirements for identifying substances of concern. Such checks cover, as a minimum: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. 

Between 2009 and 2019, ECHA fully checked these information requirements for 20.5 % of the substances registered in the highest tonnage band. 

Across all tonnage bands, more than 1 000 substances underwent a full check for compliance. 

Number of substances for which ECHA performed a full compliance check, 2009-2019  

Tonnage band (t/a) Registered substances * Substances subject to full compliance check* Percentage of registered substances (%)
≥1 000 2 361 494 21 %
100 - 1 000 2 332 428 18 %
10 - 100 2 658 108 4 %
1 - 10 4 465 52 1 %

* Each substance is counted once (i.e. only at the highest tonnage band it was registered for). Substances registered for intermediate use only and substances registered under the previous legislative regime (NONS) are excluded from this count.

In addition, ECHA also performed targeted compliance checks to address specific concerns only (e.g. substance identity). Over 1 400 such checks for registrations above 100 tonnes per year have been carried out so far.

Compliance checks have been performed primarily on the dossiers of lead registrants, which should contain the standard and safe use information required under REACH on the substance for all co-registrants of the joint submission.

Since 1 January 2019, ECHA has started checking the compliance of all relevant dossiers for a given substance and addressing its decisions to all registrants (i.e. lead and co-registrants) with non-compliant dossiers. Similarly, the Agency started addressing its decisions on testing proposals to all those registrants intending to rely on the proposed tests to fulfil their information requirement.

By the end of 2019, ECHA performed more than 2 400 compliance checks (including full and targeted checks) corresponding to more than 11 000 registration dossiers. The difference between the number of checks and number of dossiers is because ECHA is checking the dossiers of all members of the joint registration (e.g. substance identity and uses) and opt-outs (if applicable). 

Number of compliance checks performed and corresponding number of dossiers processed by tonnage band,
2009–2019

Tonnage band (t/a) Number of compliance checks (CCHs) performed* Number of registration dossiers checked
CCHs concluded with
draft decision
CCHs concluded
without draft decision
Total evaluated
dossiers (including
joint submission
members affected
by evaluation
outcome)
Registration
dossiers**
Percentage of
registrations
checked for
compliance (%)
≥1 000 1 081 366 2 859 21 047 13.6 %
100 - 1 000 550 147 3 027 14 184 21.3 %
10 - 100 105 40 2 649 15 965 16.6 %
1 - 10 66 88 2 657 21 222 12.5 %
Total 1 802 641 11 192 72 418 15.5 %

* The overall numbers of dossiers processed by compliance check depends on the number of companies that have jointly registered. It can vary significantly depending on whether the substance is a commodity or a specialty (i.e. the size of a joint submission varies from several hundred to only a few members). If there was more than one compliance check on the same registration dossier, it is counted only once.
** Dossiers of substances registered for intermediate use only and of substances registered under the previous legislative regime (NONS) are excluded from the count.

Follow-up to dossier evaluation

ECHA assesses the information submitted by registrants and verifies whether it complies with the decision. If it does, ECHA notifies the Commission and the Member State competent authorities about the case and of the conclusions made on the received information, for example, if there is a need for further regulatory action. For cases of non-compliance, national enforcement actions will be started.

ECHA concluded assessments on 1 568 substances which were covered by 1 715 follow-up evaluations. The difference between the number of substances and the number of follow-up evaluations is because a substance can be subject to several compliance checks (e.g. clarification of the substance identity through a targeted compliance check followed by examination of a testing proposal) leading to several assessments at follow-up stage.

Based on ECHA’s assessments, 111 substances were considered as possible candidates for a harmonised classification and labelling (CLH) proposal and three for substance evaluation (SEv). In addition, one substance was selected for further clarification of endocrine-disrupting properties and one for further assessment of persistent, bioaccumulative and toxic (PBT) properties.

However, at the end of 2019, 76 other substances were still under assessment by the Endocrine Disruptor Expert Group and 84 substances were under PBT assessment. These substances were stemming, for example, from substance evaluation, proposals by Member States, or selected through other processes.

Follow-up to dossier evaluation, 2013-2018

Decision type Outcome
Substances compliant with decision by the deadline Substances compliant with decision after involving national enforcement authorities1 Substances non-compliant with decision, assessments still open2 Substances non-compliant with the decision, a new decision issued3 Substances proposed as candidates for further regulatory processes4
Testing proposal decisions 560 97 41 44 76 CLH
2 SEv
Compliance check decisions 607 105 52 62 35 CLH
1 SEv
1 PBT
1 ED
Total 1 167 202 93 106 111 CLH
3 SEv
1 PBT
1 ED
1 No (or inadequate) information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. This led to a dossier update with sufficient information.
2 No (or inadequate) information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. The requested information has not yet been provided.
3 Information has been provided, but the information requirement was not met.
4 The cumulative number of substances proposed as candidates for further regulatory processes is partially biased due to the changes of monitoring systems in June 2018.

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