Authorization under REACH for the continued use of Annex XIV substances
Substances listed on Annex XIV of the REACH Regulation (ECHA) require authorization by the European Commission for their further use. This is because the Annex XIV substances are substances of very high concern. For example, they can cause cancer or damage the environment in the long term.
Sometimes a separate authorization is not required.
Perhaps you are lucky and your supplier has received approval for your use. Then you only need to continue buying from this supplier – without your own approval. Or you want to use the substance (exclusively) to synthesize another substance. This is because intermediate products are exempt from the authorization requirement.
The substances on Annex XIV are chemicals of very high concern. These can, for example, cause cancer or damage the environment in the long term. It is best to replace such a substance with a less hazardous one. If it works.
Analysis of alternatives and socio-economic assessment
Sometimes, however, there are no suitable alternatives, whether for technical or economic reasons, and you absolutely want/need to continue using the Annex XIV substance. Then you will not be able to avoid applying for a license, unless an exception exempts you.
Applications for approval are extensive and go into great detail. You do not only have to describe how you use the material. Above all, they must explain why the alternatives do not work. In many cases, this requires a socio-economic analysis in which you not only have to show that the use of the substance in question is indispensable for your company. They must demonstrate that it is beneficial for society as a whole to accept the risks in a controlled manner instead of doing without the substance. This whole discussion takes place more or less in public, and third parties can comment on your application.
Analysis, decision and, if necessary, implementation
The inclusion of a substance in Annex XIV does not happen overnight. It is announced many months in advance. You can comment against it, but you should have good reasons.
In any case, it is a good idea to find out in good time and prepare yourself: Do exceptions apply to you? Is the inclusion in Annex XIV justified? Do you have any alternatives to the material? Is it worth applying for a registration or should the business be discontinued?
It would be bad if you were surprised. And your competitor might not. But to prevent that, you are reading these lines right now.