More than 90% of compliance checks on REACH registration dossiers during 2016 required further information, compared with 82% the year before.
Most of the dossiers chosen for evaluation were for high-volume substances with concerns related to carcinogenic, mutagenic or reprotoxic properties (CMRs) or persistence, bioaccumulation and toxicity (PBTs), in line with Echa’s regulatory compliance strategy.
As a result of these evaluations, 805 standard information requests were made in the draft decisions, Echa says in its 2016 evaluation report. Of these, 550 addressed the higher-tier endpoints. The results confirm that there are “important data gaps” in the dossiers of substances of potential concern.
The report also makes the point that the numbers cannot directly be used to assess the overall rate of compliance of all registration dossiers because they “reflect the effectiveness of screening and selection of dossiers”. But the figures clearly show, nonetheless, that for another year running the vast majority of dossiers chosen for evaluation were not in compliance.
Failure to update dossiers
In the report’s introduction, Echa executive director Geert Dancet notes that registrants are legally required by the REACH Regulation to update their dossiers “whenever there is a material change, or where new information comes to light”.
Last year Echa proposed that supplementary legislation is passed to strengthen the Regulation’s provisions regarding this obligation. Most of 2010 and 2013’s REACH registration documents have never been updated, says Echa. Many of those that have been were only updated after the registrants received a Decision or letter from the agency.
In 2016 the agency launched a targeted letter campaign on 270 shortlisted substances. This invited registrants to improve dossiers in advance of compliance checks or other processes that could follow the common screening. As a result, 40% of dossiers for substances on the shortlist were updated within four months.
Echa wants industry to take more active ownership of dossiers, including improving and updating information on uses and exposures, as this would help improve the agency’s screening programme.
Common areas of non-compliance relate to:
- prenatal developmental toxicity;
- short- and long-term aquatic toxicity;
- substance identification and composition;
- mutagenicity or genotoxicity; and
- issues related to the chemical safety report.
In addition to dossier compliance checks, the report updates the review of testing proposals and substance evaluation. It also includes recommendations for first-time registrants and companies updating their dossiers on how to ensure they are of sufficient quality.
During the past year, the agency issued 33 statements of non-compliance (Soncs) following a dossier evaluation decision and invited member states to consider enforcement action. At the end of 2016, there were 65 still unresolved Soncs that had been notified to member state authorities since 2012.
Echa’s key recommendations for registrants are:
- dossiers should be continuously updated to ensure safe use of the substance;
- the exposure assessment and risk characterisation must cover all hazards;
- registrants should read up on REACH requirements for skin corrosion or irritation, irritation and damage to eyes, acute dermal toxicity and skin sensitisation; and
- preparation is vital to meet the 2018 REACH Registration deadline.