Decade of REACH dossier evaluation reveals 70% non-compliance, by Jairo Andrade Junior, C&J Consulting, Chemical Engineer, 2018-04-30

ECHA said that compliance checks on REACH registration dossiers from 2008 to the end of 2017 have shown that approximately seven in ten have failed to be compliant.

In its REACH evaluation progress report, published yesterday, the agency said that 69% of the 1,350 dossiers in the >1,000 tonnage band and 77% in the 100-1,000 tonnage band it checked contained data gaps.

By the end of last year, Echa had made 2,586 information requests.

Of these:

?          955 (37%) targeted human health hazards;

?          662 (26%) ecotoxicity and fate;

?          420 (16%) substance identification;

?          367 (14%) chemical safety reporting quality; and

?          178 (7%) physico-chemical properties.

Echa said also that the frequent non-compliances found when evaluating higher tonnage (>100 tonnes a year) dossiers "mean that we need to continue to address the inadequate adaptations and waiving statements in those dossiers and to request the missing data and that together with member states we can indeed further speed up and increase the impact of our joint evaluation work.

A large part of dossiers has not been updated since they were first submitted. This raises questions on the incentives (or lack of them) for complying with obligations regarding updates.

The agency is screening all dossiers and, together with member states, prioritizes those where they have reasons to suspect exposure and hazards are not being properly addressed.

ECHA said that the REACH 2018 deadline will bring new challenges for evaluation. In addition to examining the testing proposals in the last phase-in dossiers, Echa will have to select at least 5% of the dossiers for compliance checks also from the newly submitted low-tonnage registrations, which may mean over 3,000 dossiers.

During 2017, the ECHA performed 222 compliance checks on dossiers, 185 of which were done on substances of potential concern.

Overall, 151 dossiers were deemed non-compliant and draft decisions were issued to companies.

Echa adopted 139 compliance check decisions.

Altogether, 679 standard information requests were made in the ECHA’s decisions, with an average of five information requests per decision.

The most common non-compliances addressed in the compliance check decisions were:

?          pre-natal developmental toxicity, and mutagenicity/genotoxicity;

?          simulation testing (water, soil and sediment); and

?          long-term aquatic toxicity, reproduction toxicity, and repeated dose toxicity.

Fifty-eight testing proposal decisions were adopted; this comprises 127 requests for testing.

ECHA also concluded 327 dossier follow-up evaluations.

ECHA said that of the endpoints originally identified as being non-compliant with the information requirements or where a testing proposal was submitted, 639 (85%) are now compliant as a consequence of dossier evaluation.

For the remaining 117 (15%) endpoints, it sent a statement of non-compliance (SONC) for 109 endpoints and launched a new decision-making process according to Article 42(1) for eight endpoints.

Of the concluded follow-up evaluations, 67 cases were flagged as candidates for further regulatory processes.

Key recommendations for registrants

?          continuously update dossiers to ensure safe use of substances;

?          exposure assessment and risk characterization 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 sensitization; and

?          preparation is vital to meet the 2018 deadline.