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EU chemicals approval process stifles safer alternatives


Analysis by ChemSec and ClientEarth shows the chemicals approval process gives undue influence to companies producing dangerous chemicals and stifles information on safer alternatives, limiting the market for companies that produce them.


Under EU chemicals law REACH, the most hazardous chemicals can only be used with a permit – a so-called authorisation.

The legal text is clear: if the risks of a substance cannot be controlled, authorisation should only be given when there are no safer alternatives – and if the benefits of continued use outweigh the risks.

But as the authorisation process has developed, it is clear that there are parts of it that are not implemented properly.

Analysis by ChemSec and ClientEarth shows the search for safer alternatives is left almost entirely to the companies that apply for permits. These are the very same companies that have a huge economic incentive to be granted an authorisation, which is only given if no alternatives are found.

Unsurprisingly, this has led to cases where an authorisation has been given, even when there are safer alternatives on the market.

Last year, for example, Gruppo Colle applied for authorisation to use Sodium dichromate in wool dyeing, without mentioning safer alternatives made by Huntsman and Dystar in its analysis. The Commission nevertheless granted the authorisation.

This case illustrates what the 10 years review of REACH (REACH REFIT), released by the Commission on March 5th, showed: the problem with REACH lies in its poor implementation. Our report explores how the authorisation process is particularly weakened by this issue which should be urgently addressed.

When an applicant’s analysis of alternatives is not checked by safeguard mechanisms, it creates a clear bias that is very likely to distort the chemicals market, to the detriment of companies producing safer substances.

Frida Hök, Policy Advisor at ChemSec, said: “Besides the obviously unnecessary use of some of the world’s nastiest chemicals, this undermines a level playing field for industry. Companies applying for authorisation are allowed to follow a business-as-usual approach, and virtuous competitors as well as alternative providers are left with the negative consequences of these decisions.”

In an effort to make sure no stone is left unturned in the search for safer alternatives, the European Chemicals Agency (ECHA) – which handles the authorisation process – holds public consultations where third parties can submit information.

But other chemical providers rarely hear about these consultations. When they do, they must weigh up the value of taking part against the potential risk to their business relationships with the companies applying for authorisation.

ClientEarth lawyer Alice Bernard said: “ECHA cannot work on the assumption that if an alternative exists, another provider will flag it in the public consultation – and that if there is no contribution from other providers, there is absolutely no alternative.

“ECHA needs to actively reach out and find these alternative providers. Our analysis shows that this can be done in many ways, creating a level playing field and boosting the business case for safer alternatives.”

These problems with the authorisation process are similar to another area of EU law.

Companies that apply for merger clearance might also be temped to present the market in a way that could best suit their interests. And competitors may have information that decision-makers need to decide whether to grant clearance.

To find this information, which safeguards the European market, the Commission developed active outreach – like conducting e-questionnaires and phone interviews – to help regulators get the full picture.

The Commission is currently considering a chemicals application from the company Ormezzano. It is very similar to last year’s application from Gruppo Colle, and could lead to the same error. The Commission and ECHA need to apply a new and improved analysis of alternatives on the market to on-going cases

Bernard added: “The chemicals authorisation process can be improved drastically by studying how the Commission acts in other areas of EU law. At the moment, companies that apply for a permit are marking their own homework. ECHA needs to proactively request the details of applicants’ main competitors, customers and suppliers check the reliability of their analysis.”

Read more: ChemSec and ClientEarth’s analysis of the authorisation process, along with solutions to make it better.