Around 1500 substances of very high concern may become subject to authorisation, including:
- CMRs (substances that are carcinogenic, mutagenic or toxic to reproduction), category 1 and 2,
- PBTs (substances with persistent, bio-accumulative and toxic properties),
- vPvBs (substances that are very persistent, very bio-accumulative).
- Substances identified from scientific evidence as causing probable serious effects to human health and the environment equivalent to those of the other categories mentioned above, for example certain endocrine disrupting substances (substances disturbing the body’s hormone system). These will be identified on a case by case basis.
The authorisation system is intended to ensure that such substances will be progressively replaced wherever they cause unacceptable risks for human health and the environment or where there are no other reasons that justify carrying on using them.
In particular, there may be applications where exposure to human beings or the environment is very limited and where risks can be adequately controlled. In other cases, the use of such substances can create substantial socio-economic benefits that outweigh the risks associated with the use (e.g. ensuring safety of equipment for cases where there is no suitable alternative). For these uses, special rules for authorisation have been defined.
For certain substances that are carcinogenic, mutagenic or toxic to the reproductive system (CMR substances), an authorisation will be granted if the producer or importer can show that risks from the use in question can be adequately controlled. This means that scientists can agree on a "safe threshold" below which a substance does not create negative effects to the human body or the environment. For other CMR substances and substances with persistent, bio-accumulative or toxic properties (PBT, vPvB substances), where adequate control is not possible, an authorisation will only be granted if no safer alternative exists and if the socio-economic benefits of the use of the substance outweigh the risks.