ECHA Report: 91% Of Evaluated Chemical Dossiers Came Up Short In 2016
This article was originally published in The Rose Sheet
Executive Summary
The European Chemicals Agency conducted 183 new compliance checks in 2016, yielding 168 requests for additional information to cover data gaps. The agency expects that the final REACH deadline for phase-in substances – May 31, 2018 – will generate the largest number of dossier submissions yet, including from many inexperienced SMEs, making its guidance and companies’ preparatory work all the more important.
Roughly 91% of chemical dossiers evaluated by the European Chemicals Agency last year lacked “crucial” information, according to ECHA’s 2016 Progress Report released Feb. 27.
Tasked with overseeing European chemicals programs including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), ECHA has been undertaking compliance checks on a targeted basis in recent years, focusing on substances with the greatest potential impact on humans and the environment.
The agency maintained this approach in 2016, conducting 184 new compliance checks, it says. Of those, 168 yielded requests for additional information to cover gaps in registrant dossiers.
“ECHA 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,” it notes in a same-day release.
Executive Director Geert Dancet encourages 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.”
According to ECHA’s report, 85% of its 2016 checks focused on dossiers for “high-priority substances,” representing a 50% increase over 2015 when it first began to target its evaluations strategically.
Registrant compliance in 2016 was down from 2015, when 150 of 183 compliance checks, or 82%, led to draft decisions highlighting areas where data were insufficient. (Also see "ECHA Advises Read-Across Know-How, Only 'Last Resort' Animal Testing" - HBW Insight, 7 Apr, 2016.)
Many of the issues observed in ECHA’s regulatory compliance work have plagued dossiers in past years. (Also see "ECHA Advises Read-Across Know-How, Only 'Last Resort' Animal Testing" - HBW Insight, 7 Apr, 2016.)
The agency urges existing and future registrants to refer to its previous progress reports for guidance, in addition to the newly issued report for 2016.
ECHA notes that December 2016 marked 10 years of the REACH regulation. According to findings released in June 2016, the majority of dossiers submitted under REACH and the Classification, Labeling and Packaging Regulation – which generally does not affect cosmetics – have never been updated.
The agency expects a deluge of new dossiers under the final REACH registration deadline for existing (phase-in) chemicals – May 31, 2018 – covering substances manufactured or imported in the EU in volumes of 1 ton to 100 tons annually.
The submission load could be three times greater than that seen across higher tonnage bands under previous phase-in deadlines, based on ECHA estimates. The agency also believes that a relatively greater number of inexperienced, small and medium-sized enterprises are subject to compliance with the 2018 deadline, making its guidance and companies’ preparatory work all the more important.
ECHA Zeroes In On High Priorities
ECHA initially performed regulatory compliance checks under REACH more or less at random, but the agency increasingly has been setting its sights on chemicals that could require substance evaluation or risk-management measures at the Member State level or EU-wide, based on its screening activities.
These include chemicals that show signs of being carcinogenic, mutagenic and reprotoxic (CMR) or (very) persistent, bioaccumulative and toxic (PBT/vPvB).
According to ECHA’s report, 85% of its 2016 checks focused on dossiers for such “high-priority substances,” representing a 50% increase compared with 2015 when it first began to target its evaluations strategically.
The agency notes that its 2016 work involved the evaluation of more than 1,200 higher-tier human health and environmental endpoints in total, and 550 of the 805 standard information requests it included in draft decisions pertained to such endpoints.
“These results confirm that there are important data gaps in the dossiers of substances of potential concern,” it says.
At the same time, ECHA stresses that compliance figures in 2016 reflect in large part the effectiveness of its screening program rather than registrants’ dossier quality overall.
The agency says it adopted decisions on 152 dossiers last year, largely based on draft decisions issued in 2015 for compliance checks that gave rise to 597 standard information requests overall. Those inquiries sought additional information on substance identification and composition, as well as pre-natal developmental toxicity and other safety concerns that informed similar requests in 2016.
In addition to assessing dossiers for data gaps, ECHA reviews new animal testing proposals and coordinates those efforts with the substance-evaluation arm of its regulatory program.
Its Progress Report includes updated recommendations for companies, particularly firms that will be subject to REACH registration for the first time in 2018. (Also see "REACH Registrants Should Bone Up On Alternative Test Requirements – ECHA" - HBW Insight, 27 Feb, 2017.)