EU Commissioner Bieńkowska Calls for Authorisation Simplification

The REACH authorisation process should be simplified for those applications that "do not raise major concerns", according to European Commissioner Elżbieta Bieńkowska (pictured).

In a rare speech on chemicals policy, the internal market, industry, entrepreneurship and SMEs commissioner, said that for substances added to the authorisation list, the Commission must ensure the procedures are "fit for purpose".

Speaking at this week's Helsinki Chemical Forum Ms Bieńkowska said feedback on the second REACH review had identified improving the REACH authorisation process as a priority.

One possible way forward, she said, is to build "on the success of existing risk management option analysis (RMOA)" as this would allow "discussion at a very early stage" about the best regulatory route.

And if the main concern is protection of workers there could be "authorisation, restriction or action under the occupational safety and health (OSH) legislation."

Frustration

The current process has frustrated companies that have already substituted substances subject to authorisation, she said. But while industry says authorisation is too costly and lacks legal certainty, NGOs feel more could be done and that more substances should be restricted.

And the European Parliament, several member states and NGOs think some applications for authorisation should have been rejected because they are insufficient, Ms Bieńkowska told the Forum.

The question, the commissioner said, is how to keep the benefits of the process, such as improved protection to human health and the environment while – for industry – reducing the costs and "uncertainty" created by the process.

Alternative

Bjørn Hansen, head of DG Environment's chemicals unit, said that as the authorisation process is still relatively new it can be difficult to say what can be done.

"The Commission makes mistakes like everyone else," he told the Forum, adding that it has questioned too late what 'alternative' means – whether it is an alternative for the chemical itself or the functionality of the article in which the chemical is used. He said the discussion needs to quickly come to a close "in order to start gaining efficiencies in what we see as being procedurally a piece of legislation that is working".

There is no alternative to REACH, he said "so let’s roll up our sleeves and make it more efficient".

Impact on innovation

Industry complains that the authorisation process has little effect on innovation, Ms Bieńkowska said. REACH "drains resources" from innovation for which there is no standard cycle – companies apply for review periods of four to 15 years or more. She said the Commission will "better reflect" these realities when addressing individual applications for authorisation.

And Andrea Paetz, director of regulatory policy at Bayer, said the authorisation process does not promote innovation. This is something companies "always do […] to improve their portfolio. I don't see stimulation of innovation by substitution. We are willing to do it, but often it is not possible."

Authorisation and restriction are "two sides of the coin", she added, and restriction is a "better way" to proceed as a threshold is set across the EU that everybody must follow. "I think it is the easiest way" as it does not phase out a substance, she said.

ClientEarth lawyer Vito Buonsante said authorisation and restriction "can live together at same time". Authorisation is a huge driver for substitution, he said, and inclusion on the candidate list can make substitution happen "overnight when it's an easy substitution".

The European Commission's report on the second REACH review is due to be published after the summer.