Progress in evaluation

Progress in evaluation

Article 54 of REACH requires ECHA to report on the progress made (over the previous year) in dossier and substance evaluation, by 28 February each year.

This reporting consists of numerical data on compliance checks, testing proposal examinations, follow-up assessments and substance evaluations carried out during the previous year.

Each year in spring, ECHA also publishes its Integrated Regulatory Strategy report which explains the impact of these outputs on chemical safety.

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

ECHA’s Integrated Regulatory Strategy brings together all REACH and CLP processes. Through this approach, substances are screened in groups or chemical families to accelerate data generation and the identification of substances of concern.  

If ECHA cannot conclude whether a substance is a high priority for regulatory risk management or currently low priority for further work, it will be selected for compliance check and/or substance evaluation. The data generated through these processes is then assessed to determine if the substance is hazardous or not. 

The REACH Evaluation Action Plan sets out an ambitious target for checking the compliance of the registration dossiers. Furthermore, according to the amended REACH Regulation, the Agency shall select, until 31 December 2023, a percentage of those dossiers no lower than 20 % of the total received by the Agency for registrations in tonnage bands of 100 tonnes or more per year. The Agency shall, until 31 December 2027, also select a percentage no lower than 20 % of the total received by the Agency for registrations in tonnage bands of less than 100 tonnes per year.  This means that all registered substances will go through a grouping and screening process and about 30 % of them will be checked for compliance. 

Compliance checks can either be full or targeted based on particular concern. A full compliance check focuses on the most relevant information requirements for identifying substances of concern. It covers, as a minimum: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproductive toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. 

Between 2009 and 2021, ECHA performed a full compliance check for 25 % of the substances registered in the highest tonnage band. 
 

Number of substances for which ECHA performed a full compliance check, 2009-2021  

Tonnage band (t/y) Registered substances* Substances subject to full compliance check* Percentage of registered substances (%)
≥1 000 2 342 589 25%
100 - 1 000 2 328 581 25%
10 - 100 2 725 231 8%
1 - 10 4 057 104 3%

* 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. 

Compliance checks have been performed primarily on the dossiers of lead registrants. These 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 checks the compliance of all relevant dossiers for a given substance and addresses its decisions to all relevant registrants (i.e. lead and co-registrants, opt-outs and individual 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. 

Between 2009-2021, ECHA checked the compliance (including full and targeted checks) of dossiers for more than 2500 substances. Among these, ECHA fully checked 1500 substances covering approximately 13000 registration dossiers, which corresponds to more than 13% of registered substances and 18% of submitted dossiers. 
 

 

Number of full compliance checks by tonnage band,
2009–2021

Tonnage band (t/a) Number of full compliance checks performed* Number of substances evaluated under full compliance check Number of dossiers checked for compliance
Concluded with further data requests Concluded without further data requests Substances with further data requests Substances with NO further data requests Total evaluated dossiers
(including JS members affected by evaluation outcome)
Registration dossiers** Percentage of registration dossiers checked for compliance (%)
≥1 000 542 121 455 112 3 223 20 665 15.6%
100 - 1 000 587 87 532 82 3 518 13 644 25.8%
10 - 100 246 36 234 36 3 166 15 024 21.1%
1 - 10 124 48 122 44 2 844 18 654 15.2%
Total 1 499 292 1 313 265 12 751 67 987 18.8%

* all comprehensive compliance checks performed, note it includes multiple evaluations on same dossiers over years
** dossiers registered by 31.12.2018, excluding intermediates and NONS

Follow-up to dossier evaluation

The dossier evaluation decision gives registrants deadline by when they need to submit the missing information to ECHA. Once submitted, the Agency assesses the information and verifies if it complies with the decision. 

If it does, ECHA notifies the European Commission and the Member State competent authorities about the conclusions made based on the received information. This could be, for example, that there is a need for further regulatory action. If the information received is non-compliant with the decision, national enforcement authorities are informed to consider enforcement actions. 

During 2013-2021, ECHA concluded assessments on 1975 substances which resulted in 2130 follow-up evaluations. There is a difference between the number of substances assessed and the number of follow-up assessments because a substance can be subject to several dossier evaluation processes (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 follow-up assessments, 171 substances were considered as possible candidates for a harmonised classification and labelling (CLH) proposal and three - for substance evaluation (SEv). In addition, four substances were selected for further clarification of endocrine-disrupting properties and four for further assessment of persistent, bioaccumulative and toxic (PBT) properties. 
 

Follow-up to dossier evaluation, 2013-2021

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 678 138 85 52 119 CLH
2 SEv
1 ED
1 PBT
Compliance check decisions 735 149 135 92 52 CLH
1 SEv
3 PBT
3 ED
Total 1 413 287 220 144 171CLH
3 SEv
4 PBT
4 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 that met REACH information requirements. 
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.
3Information 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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