Dancet: Better Authorisation Application Quality Will Improve Certainty

Improving the information and quality of REACH authorisation applications is a key challenge that needs to be addressed, Echa head Geert Dancet has said.

Speaking at an agency conference on the implementation of authorisation in Helsinki this week, Mr Dancet said this will allow the European Commission to shorten the time it takes to decide on an application. "It will also increase credibility of the system and certainty for industry and market operators," he added.

A year ago, Chemical Watch reported that the Commission had recommended that Echa did not allow an authorisation application to pass its 'conformity check', until the agency's committees adopted their draft Opinion on the dossier.

But, at the time, Echa said it wished to avoid situations where applicants do not know if their applications are in conformity or not, "as this would create business uncertainty".

In late 2015, NGO the European Environmental Bureau (EEB) urged Echa to reject, at the conformity check stage, applications not complying with REACH information requirements. This includes those for broad uses, and missing fundamental information on exposure scenarios, alternatives and/or socio-economic assessments.

It also said a review of the conformity check procedure was "critically needed", because the agency only checks if an application includes all the necessary documents and is complete, rather than the quality of the information.

At this week’s conference, Mr Dancet also said there is a need to improve the way upstream applications are prepared and managed. He said he hoped that "further refinements of acceptance criteria" for such applications could be concluded.

The conference heard how Echa’s Risk Assessment and Socio-economic Analysis Committees (Rac and Seac) have difficulties with use description in the application, which is often considered too broad.

Mr Dancet said information from downstream user notifications continues to be "a very important source of knowledge to help authorisation holders improve their description of uses and narrow down their authorisation needs".

Predictability is "essential" for business, he added, and regulators should ensure the authorisation system delivers this. "I am relieved the Commission finally decided to add 12 new substances to the authorisation list this year," he said. Updating the list "regularly allows us to continually harvest the benefits of the authorisation system".

There are currently 174 SVHCs on the REACH candidate list, of which 43 are on the authorisation list.

Alternatives
One key benefit of authorisation is the stimulation of substitution, but this can only be achieved if providers of alternatives get more involved, the conference heard.

Mark Schwagler from Germany's federal ministry for the environment said that in some cases "it is not clear" for Seac whether alternatives exist. "More rigorous examination of alternatives is required," he added. And alternatives that are deemed "not feasible" for the applicant but available on the market "should be taken into account".

Dolores Romano from EEB said the system is "not working". The REACH legal text says applicants have to demonstrate alternatives are not available, but where it is known they are the authorisation is still granted, she said.

Finn Pedersen from the Danish competent authority said there have been cases where other industries have already started using other "less problematic" substitutes for some of the substances for which an authorisation is being sought. "We need a better explanation as to why it is not possible for [the applicants] to find alternatives," he said.

And Frida Hök, from NGO ChemSec, said the Opinions of Echa committees are "killing the incentive" to switch to safer alternatives. Alternatives providers find it "painful" to take part in the process, she added.