Authorisation process

ChemSec’s position: The authorisation process

The authorisation process constitutes the heart of REACH, in itself manifesting many of the principles that make REACH uni­que. The process is designed to drive substitution of Substances of Very High Concern (SVHCs) and to identify the specific uses where substitution is not yet possible.

The authorisation process is a step­wise approach starting with Candidate Listing. We already know that the Candidate List, along with the SIN List, are drivers for innovation in the chemi­cal manufacturing industry. This driving force is dependent on the continu­ing process leading to restrictions or bans. If authorisations are given in all cases, the in­centive to innovate will obviously be reduced.

In many recent cases there have been discussions around how to evaluate different authorisation applications. For example, what can be considered as a specific use, and is there really no alternatives to a certain substance? And what if one company stopped using a certain chemical, but another one wants to use it and claims that there is no alternative? As you can imagine, granting authorisation could lead to unfair market advantages and disfavour companies that put a lot of effort towards getting rid of a certain harmful substance.

At ChemSec, we consider a well-functioning authorisation process to be one of the most important issues of REACH, and we are determined to advocate and push for the many progressive companies that are working hard to get rid of harmful substances in their products.

ChemSec concerns

> Available alternatives

Authorisation are sometimes granted even though there ap­pears to be available alternatives on the European market. This can cause an economic disadvantage to companies who have already invested substantial resources in substituting these SVHCs. Moreover, it gives an unclear message to companies whether or not SVHCs should be substituted when possible.

> Disfavoring third parties

The current imbalance be­tween taking into account the interest of the applicant for authorisation and the interest of third parties, including alternatives producers and users. This imbalance is partly built into the process when it comes to incentives to provide information and the access to key background information. Unfortunately this has also been made obvious in how the supplied third party informa­tion is assessed and weighted in the ECHA committees. This imbalance, or gap, particularly concerns the socioeconomic aspects of authorisation and the suitability of alternatives. At present, the applicant’s perspective seems to be the only perspective considered for the opinions. Instead, the positive implications for the producers of alternatives and societal bene­fits need to be included in the evaluation more efficiently.

> Wider socioeconomic assessments needed

Assessments in the authorization process need to consider more factors. The use of hazardous chemi­cals is often accompanied by additional costs, including employee health measures and handling of hazardous waste, to name a few. And while there may be a negative economic impact for a company that has to substitute a substance it is dependent on, there are also opportunities and potential financial benefits for other companies, for example producers of alternatives and progressive competitors that have already made the substitution. A proper assessment should include and analyse all extra charges surrounding hazardous chemicals and the costs and benefits for all involved parties, including society as a whole. Failing to include these aspects in the assessment may lead to the wrong conclusion and in the end regulation that counteracts its purpose of driving innovation.

Read more in ChemSec’s publication The Bigger Picture

> Follow up information about alternatives more closely

When alternatives are assessed, the applicant for authorisation and the producer of alternatives will most likely have different views regarding the technical feasibility of the alternatives. The applicant, however, having initiated the specific authorisation process is far more likely to contribute with extensive docu­mentation supporting their case than the alternative producer. The alternatives producer may also lack important information, such as specific uses, to contribute with relevant information. To make sure authorisations are not given when alternatives are available the ECHA committees need to be prepared to put effort into following up more in depth the information on alternatives provided through public consultations.