REACH Processes | Chemicals covered | Methods and Tools | Actors |

Authorisation

Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation.

Substances of very high concern (SVHC)

Substances of very high concern include substances which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
• identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters

Why and how do they need to be regulated?

These substances have hazardous properties of very high concern. It is essential to regulate them because the effects they can have on humans and the environment are very serious and often irreversible. There is no tonnage threshold for a substance to be subject to authorisation.

The authorisation mechanism consists in an in-depth assessment. Its outcome is then thoroughly discussed before appropriate decisions are taken.

How will the authorisation process look like in practice?

The authorisation process consists of four steps. Industry has obligations in the third step. However, all interested parties have the opportunity to provide input in steps 1 and 2.

Step 1: Identification of substances of very high concern (by authorities)

Substances of very high concern can be identified on the basis of the criteria previously described. This will be done by Member State Competent Authorities or the Agency (on behalf of the European Commission) by preparing a dossier in accordance with Annex XV. Interested parties can comment on substances for which a dossier has been prepared. The outcome of this identification process is a list of identified substances, which are candidates for prioritisation (the “candidate list”). The list will be published and periodically updated by the Agency, probably not before end 2008.

Step 2: Prioritisation process (by authorities)

The substances on the candidate list are then prioritised to determine which ones should be subject to authorisation. Interested parties are invited to submit comments during this process. At the end of the prioritization process, the following decisions are taken:

• whether or not the substance will be subject to authorisation;
• which uses of the included substances will not need authorisation (e.g. because sufficient controls established by other legislation are already in place);
• the “sunset date” by when a substance can no more be used without authorisation.

Step 3: Applications for authorisation (by industry)

Applications for authorisation need to be made within the set deadlines for each use that is not exempted from the authorisation requirement. They must include among others:

• a chemical safety report covering risks related to those properties that caused the substance to be included in authorisation system (unless already submitted as part of the registration)
• an analysis of possible alternative substances or technologies including, where appropriate, information on research and development foreseen or already in progress to develop such alternatives.

If the analysis of alternatives reveals that a there is a suitable alternative, the applicant must submit a substitution plan, explaining how he intends to replace the substance by the alternative. The suitability of available alternatives is assessed taking into account all relevant aspects, including whether the alternative results in reduction of overall risks and is technically and economically feasible.

An applicant can include a socio-economic analysis in his application, but i n cases where he is not able to demonstrate adequate control of risks and where no suitable alternative exists, he needs to include one in his application.

A fee has to be paid for each application.

For all applications, the Agency will provide expert opinions. The applicant can comment on these opinions.

Step 4: Granting of authorisations (by the European Commission)

Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. The “adequate control route” does not apply for substances for which it is not possible to determine thresholds and substances with PBT or vPvB properties.

If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.

Downstream users may only use such substances for uses which have been authorised.

For this they must either:

• obtain the substance from a company that was granted an authorisation for that use. They must stay within the conditions of that authorisation. Such downstream users must notify the Agency that they are using an authorised substance.
• apply themselves for authorisations for their own uses.

Reviews

All authorisations will be reviewed after a certain time-limit which will be set on a case-by-case basis.