Progress in evaluation

Under Article 54 of REACH, ECHA is required to report on the progress made in dossier and substance evaluation by 28 February every year. The reporting contains a quantitative description of the generated outputs. A description of their impact and links to ECHA’s Integrated Regulatory Strategy will be included in the report on the implementation of the strategy to be published in April.

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

When examining the compliance of registrations, ECHA either chooses dossiers according to a potential hazard- or exposure-based concern, or selects dossiers at random. This regulatory check can lead to further data generation and helps to identify and address substances of concern.

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 2018, ECHA checked these information requirements in full for 24 % of the substances registered in the highest tonnage band. Across all tonnage bands, more than 1 000 substances were checked for compliance.

Number of substances for which ECHA performed a full compliance check, 2009-2018  

Tonnage band (t/a) Registered substances * Substances subject to full compliance check* Percentage of registered substances (%)
≥1 000 2 272 536 24 %
100 - 1 000 3 491 409 12 %
10 - 100 4 414 79 2 %
1 - 10 6 687 94 1.50 %

*As a substance can be registered in more than one tonnage band, the total number of substances across all tonnage bands is not calculated. Substances registered for intermediate use only and substances registered under the previous legislative regime (NONSs) are excluded from the count.

In addition, ECHA also performed compliance checks targeting specific concerns or substance identity, carrying out over 960 such checks for registrations above 100 tonnes per year.

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. By the end of 2018, a total of 2 140 dossiers had been checked.

The calculation of the overall percentage of the registrations checked for compliance is a dynamic process. After the last registration deadline the overall number of low tonnage registrations (1-100t/y) has almost tripled and the number of registrations in the higher tonnages has increased by around 2 000 in each higher tonnage band in comparison to last year. This explains the decrease of the overall percentage to 3.2% (compared to 4.6% in 2017).

Number of compliance checks by tonnage band, 2009–2018

Tonnage band (t/a) Number of unique compliance checks*  
  Concluded with draft decision Concluded without draft decision Total       Registration dossiers** 

Percentage of registrations
checked for compliance (%)

≥1 000 1 011 377 1 388 20 417 6.8 %
100 - 1 000 433 109 542 13 311 4.1 %
10 - 100 64 33 97 14 126 0.7 %
1 - 10 35 78 113 18 874 0.6 %
Total 1 543 597 2 140 66 728 3.2 %

* Unique compliance checks: 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 (NONSs) are excluded from the count.

In the future, ECHA will expand compliance checks by addressing all registrants in the joint submission. Based on the average size of joint submissions and on the number of lead dossiers currently checked under the ‘lead registrant’ approach (around 1 000 substances addressed in full), this expansion has been estimated to translate into approximately 5 500 dossiers being checked.

Follow-up to dossier evaluation

ECHA assesses the information submitted by the registrants and verifies whether it complies with the decision. If it does, ECHA notifies the Commission and the Member States competent authorities of the case and the conclusions made on the received information, for example a need for further regulatory action. In the case of non-compliance, national enforcement action will be initiated.

ECHA concluded on 1 548 follow-up evaluations. Based on these, 96 substances were considered as possible candidates for a proposal for harmonised classification and labelling (CLH) and 3 for substance evaluation (SEv).

Follow-up to dossier evaluation, 2013-2018

  Outcome
Decision type Compliant cases by the deadline Compliant cases after involving national enforcement authorities* Non-compliant cases still open** Non-compliant cases and a new decision was issued*** Candidates for further regulatory process
Testing proposal decisions 546 81 25 39 68 CLH
2 SEv
Compliance check decisions 676 92 37 52 28 CLH
1 SEv
Total 1 222 173 62 91 96 CLH
3 SEv
* No (or inadequate) information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions towards the registrant. This led to a dossier update with sufficient information.
** No (or inadequate) information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions towards the registrant. The requested information has not been provided yet.
*** Information has been provided, but the information requirement was not met.

 

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