discussion on the need/challenge to improve the Registration dossiers

The REACH registration dossiers quality is a long term issue repeatedly criticised by different authorities, NGOs… Lack of credibility of information was identified also by a project which assessed more than 3,800 registration dossiers for substances that were produced or imported into the EU at tonnages of at least 100 tons per year (tpa).

The REACH Compliance project was a joint project of the BfR and the German Environment Agency (UBA). It investigates the availability of human health and environmental data in the REACH registrations of chemicals regarding their compliance with the requirements on toxicological and eco-toxicological information as laid down in REACH.

The project, ongoing since 2014, found that – related to the endpoints assessed and considering that the evaluation work has not been fully completed at the date of the workshop – the current average rate of “compliance” was :

  • 31 % for substances registered at 1000 tpa;
  • more and 44 % for substances at tonnages between 100 and 1000 tpa.

The option to deviate from standard testing requirements and to provide justifications for such deviations was commonly used by registrants – for the assessed endpoints on average of about 70 % (range 50-93 %). However, alternative data (e. g. using read-across to other substances) or justifications for data waiving or adaptations were often not sufficient. For example:

  • 32 % of the dossiers for substances at tonnage levels of 1000 tpa and more were found to be “noncompliant” with REACH requirements on average over the assessed endpoints
  • the average rate of “non-compliance” was at 19 % for substances at 100-1000 tpa.

It should be noted that the evaluation methodology did not allow deciding for all dossiers whether they were in compliance with the REACH requirements: Therefore for both tonnage bands, averaged over the assessed endpoints about 37 % of the dossiers remained without conclusion.

The outcome of the project indicates that increased efforts by industry and authorities are needed to achieve a higher rate of compliance for the chemical dossiers.

On 28 February 2019 ECHA has published its annual evaluation report, delivering updated statistics on evaluated substances and registration dossiers, and giving advice to registrants on how to improve the information they provide on chemicals.

In 2018, ECHA checked the compliance of 286 registrations, most of which focused on substances of potential concern. ECHA verifies key information requirements which allow authorities to identify if the substance is carcinogenic, mutagenic and reprotoxic; or persistent, bioaccumulative and toxic. In 211 cases, the Agency has asked registrants for further information to show that the substance is used safely. ECHA has also examined 198 testing proposals. Altogether, the Agency adopted 274 final decisions, in which 888 different information requests were asked.

The numbers show a similar picture to previous years – in the majority of registration dossiers that ECHA checks, important safety information is missing. After ECHA’s request, most registrants update their dossiers with compliant information. Based on the evaluation outcomes and observations, ECHA has published recommendations on how registrants can improve their dossiers. Different activities by the Commission, ECHA  and industry were initiated.

We want to discuss the way forward having the Commission contribution on the Implementation Act on updates; ECHA speeding up of the Compliance checks; or NGO’s view on the data quality; Industry: work on up-dates as well as structural and pro-active approach on updating registration files. Registrants should have their say as well.


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