ECHA Prepares to Quadruple Number of REACH Dossier Compliance Checks
The European Chemicals Agency (ECHA) has reported that it plans to quadruple the number of reviews it performs on registrations for thousands of chemicals used in the European Union (EU). This decision comes in response to findings that a relatively small percentage of dossiers contain the proper information.
Why Compliance Checks?
A principal goal in conducting compliance checks for REACH registration dossiers is to assess the safety information and substance identity descriptions contained within them. While typically performed on chemicals listed in the Community Rolling Action Plan (CoRAP), the ECHA may exercise discretion to review the registrant-provided information in any dossier to verify that it is legally compliant.
Compliance checks typically focus on eight endpoints for substance of concern identification:
- bioaccumulation
- biodegradation
- carcinogenicity
- genotoxicity
- long-term aquatic toxicity
- pre-natal developmental toxicity
- repeated-dose toxicity
- reproduction toxicity
The significance of conducting dossier compliance checks is exemplified by recent findings from the ECHA. The ECHA has noted that of the approximately 2,700 REACH registration dossiers filed by companies during the decade-long period between 2008 and 2018, more than 65% of them are not fully compliant. This is due primarily to the presence of inaccurate data or a lack of necessary data.
| Total Registrations | 66,000 |
|---|---|
| Total Substancese | 16,500 |
| Registrations Reviewed | 2,700 |
| Substances Reviewed | >700 |
| Noncompliant Registrations | 66% |
Source: European Chemicals Agency
Addressing the Problem
Given its findings, the ECHA intends to increase the proportion of compliance checks it conducts to 20% of all registrations. This represents a four-fold change from its previous requirement to check only 5% of dossiers. For some larger-volume chemicals, the Agency is proposing to exceed 20% for compliance checks.
While the ECHA plans to do more to address the problem of checking for noncompliance, at the heart of the matter is the failure of many companies to initially provide the proper information. This issue is being acknowledged at the industry level as well. Marco Mensink, director general of the European Chemical Industry Council (Cefic), Europe’s principal chemical industry trade association, has noted “We take ECHA’s findings—that the quality of data in a number of REACH dossiers needs improvement—seriously”.
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