Substances listed in Annex XIV of the REACH Regulation require an authorisation for further use. The hurdles for an authorisation are high - but mostly conquerable.
The applicant has to demonstrate in his application for authorisation that the risks of the substance for his own use – and the use of his customers - are adequately controlled. In many cases, namely when CMR substances have no threshold for a safety level or it is a PBT-/vPvB-substance, the applicant has to prepare a socio-economic analysis. Therein he has to demonstrate that the benefits for the community outweigh the risks and that no suitable alternative substances or technologies are available.
An application for authorisation may relate to one or more uses of one substance. But it may also comprise a group of substances. The REACH authorisation has to be applied for by any company that wants to continue the use of this substance. The approval upstream of their own supply chain or through the direct customer is alternatively sufficient, if their use is covered.
Whether an authorisation under REACH is profitable, depends on various factors both economic and risk-based type. Collaboration with other companies for an application on authorisation can significantly reduce the costs for the preparation, but can lead to difficulties in case of an efflux of know-how. In addition, it is important to pay attention to the competition law. In this case, an independent third party (consultant) can be helpful.
Basically, every company has to ask the question what, if I can/ may not use my substance anymore? Are there simple alternatives or is it very difficult to replace the substance? In general the following question is crucial: Do the technical and economic benefits for my company in particular and for the European Union in general outweigh the risks arising from the previous use of the substance compared to a substitute?
The authorisation under REACH is a new instrument of the legislature, at which industry and trade as well as the authorities will broaden their knowledge. The most appropriate approach may be different for each company: Should one rely on the suppliers, should one merge with competitors for authorisation or does the own position on the market require a solo attempt - also to protect the confidential information?
Prosacon is specialised in advising and supporting companies and trading industry in the implementation of the REACH and CLP regulation. This includes advice in the context of an authorisation and the complete implementation of an application for authorisation. In addition Prosacon offers a full range of services for REACH registration, evaluation / assessment and restriction - both in terms of information / advice to our clients as well as for the implementation.
As authorisation is a complex process, it is recommended to early deal with the issue, for example as soon as ECHA announces the inclusion of a substance in Annex XIV as a draft or even when the substance was taken on the candidate list. Then, industrial or commercial side are able to check whether there are arguments why the inclusion in Annex XIV is inappropriate. Afterwards it is important to determine the position of your company and possibly collaborate with other companies. Prosacon advises you on your own implementation strategy and conducts the application for authorisation for you. Ways to contact us do you find here.
- Decision makers of the company
- Buyers of Annex XIV substances of the REACH regulation (import and EEA reference)
- Producers or users of substances in Annex XIV
- Sellers of Annex XIV substances
- Researchers and developers who plan to use Annex XIV substances
- Experts of product safety who deal with regulatory issues and need to advice the previously mentioned corporate functions
- Chemical industry
- Paints and varnishes
- Washing and cleaning
- Plastics processing industry
- Electrical industry
- Automotive and suppliers
- Machinery and equipment
- Import trade
- All users of substances of very high concern