ECHA and EU Member States evaluate the information submitted by companies to REACH to examine the quality of the registration dossiers and the testing proposals, and to establish if a given substance constitutes a risk to human health or the environment.
In 2016, ECHA says it focused its dossier evaluation activities on substances with the greatest potential to negatively affect people and the environment: substances produced in high volumes – over 100 tonnes per year – and with a potential concern.
The agency has now released a report on these checks, and it outlines that most of the the evaluated registration dossiers had data gaps and need updating. It also covers other measures to improve data quality, and offers recommendations for registrants.
Examining the data
Last year, 184 new compliance checks were concluded, most of them on selected substances of potential concern. In 168 cases, important information was missing.
ECHA says that it asked registrants to provide more data on their substances, mostly related to pre-natal developmental toxicity, mutagenicity/genotoxicity, reproduction toxicity and long-term aquatic toxicity.
To encourage registrants to update their dossiers before compliance checks or risk management actions take place, ECHA says it sent letters to the registrants of 270 substances of potential concern, highlighting the deficiencies in their dossiers. The agency notes that it also regularly published a list of substances that may be chosen for compliance checks.
The registration process, in particular the completeness check, was revised to improve the availability of high-quality information in the incoming registrations – both on new ones or existing ones. It now includes manual checks for information that cannot be automatically assessed, ensuring that all information intended by REACH has been included in the dossier.
If the companies do not react by the deadline stipulated by ECHA, their registration will be revoked, the agency asserts.
ECHA’s Executive Director Geert Dancet says: “Our evaluation report shows that crucial data is still missing for most substances subject to compliance check. I encourage companies to take stock of our recommendations and update their dossiers especially when their substance is shortlisted for regulatory action.
"Authorities need the data to conclude whether further risk management is required on these substances.”
Key findings
Altogether in 2016, ECHA examined 164 new testing proposals and sent 133 draft decisions to registrants. To promote alternatives to animal testing, ECHA now requests
registrants submitting testing proposals to provide their considerations on alternatives as part of the registration dossier. New supporting materials on alternative methods were also published.
A large majority of registrants update their dossiers in line with ECHA’s decisions on compliance checks or testing proposals, providing the missing information. Only in 33 of 355 examined cases, information was still missing or inadequate and ECHA invited the Member State authorities to consider national enforcement actions on these registrants.
In substance evaluation, ECHA took 26 decisions based on evaluations from previous years.
In preparation of further decisions, Member States evaluated 48 substances in 2015-2016 and concluded that 32 required further information from registrants to clarify the suspected concerns.
Furthermore, 20 substance evaluation conclusions were published. 11 of them concluded that the risks are sufficiently controlled with existing measures, and 9 concluded that EU-wide risk management measures are necessary.
The report also gives specific recommendations for future and existing registrants. Further information can be found here