Authorisation means that the European Commission has to approve your application so that you may continue to use the chemical. However, authorisation applies only to certain substances, i.e. those that are listed in Annex XIV of the REACH Regulation.
If you are fortunate, your supplier may already have been granted an authorisation for your use. You then only need to continue purchasing the substance from this supplier – you don’t need your own authorisation. Or will you use this substance (exclusively) for the synthesis of another substance? Here it’s good to know that intermediates are exempted from the authorisation requirements.
The substances listed in Annex XIV are of very high concern. For example, they can cause cancer or long-term environmental damage.
It is best if you can replace these substances by ones that are less harmful. But sometimes there are no suitable alternatives, for either technical or economical reasons, and you want to/must continue using the Annex XIV substance. In this case, you can’t avoid applying for authorisation, unless there are exemptions.
Applications for authorisation are extensive and go into considerable detail. Not only must you describe how you use the substance, you must also explain why the alternatives are not feasible. In many cases, a socio-economic analysis is required. Not only do you need to demonstrate that the substance is essential for your business, you must also show that the benefits to society outweigh the risks. This is more or less a public discussion, and third parties can comment on your application.
The inclusion of a substance in Annex XIV does not happen overnight. It’s a stepwise process that starts many months in advance. You can comment on this but must have good reasons for a non-inclusion.
In any case, it’s a good thing if you are well informed and prepared. Do exceptions apply in your case? Is the inclusion in Annex XIV justified? Are there alternatives to using this substance? Is it worth applying for authorisation, or should the business be given up?
You don’t want to be in for an unpleasant surprise. Especially if your competitors aren’t. But that’s why you are reading these lines – to prevent this very development from happening. ⇒ Contact