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 relevant 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. According to ECHA’s Integrated Regulatory Strategy, all registered substances will go through a grouping and screening process and overall about 30 % of them will be checked for compliance. 

Compliance checks can either be full or targeted based on a 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 2023, ECHA performed a full compliance check for 29 % of the substances registered in the highest tonnage band. 
 

Number of substances for which ECHA performed a full compliance check, 2009-2023  

* 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 2009-2023, ECHA checked the compliance (including full and targeted checks) of dossiers for more than 2 740 substances. Among these, ECHA fully checked approximately 2000 substances covering approximately 14 800 registration dossiers, which represents more than 17 % of registered substances and 21 % of submitted dossiers. 
 

Number of full compliance checks by tonnage band,
2009–2023

* all comprehensive compliance checks performed, note it includes multiple evaluations on same dossiers over years
** dossiers registered by 31 December 2018, excluding intermediates and NONS
*** note it is not a sum of each tonnage band entry, as the same substances can be registered and compliance checked under different tonnages; total counts each

Follow-up to dossier evaluation

The dossier evaluation decision gives registrants a 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 2013-2023, ECHA conducted follow-up evaluations on 2 228 substances.

Based on ECHA’s follow-up assessments, 230 substances were considered as possible candidates for a harmonised classification and labelling (CLH) proposal and ten for substance evaluation (SEv). In addition, ten substances were selected for further clarification of endocrine-disrupting properties and six for further assessment of persistent, bioaccumulative and toxic (PBT) properties. 

Follow-up to dossier evaluation, 2013-2023

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 Information has been provided, but the information requirement was not met.

³The cumulative number of substances proposed as candidates for further regulatory processes is partially biased due to the changes of monitoring systems in June 2018.