CEPRA offers services related to the complex authorisation process of substances listed in Annex XIV of REACH.
The manufacture, import or use of substances listed in Annex XIV of REACH is prohibited unless a specific authorisation has been granted by the European Union.
The application for authorisation includes:
- a risk assessment (CSR – chemical safety report) demonstrating that the risk from the use of the substance is adequately controlled by applying appropriate risk management measures (RMM – risk management measures) and operational conditions (OC – operational conditions);
- a socio-economic analysis demonstrating that the socio-economic benefits of the use of the substance outweigh the risks and that there are no suitable (or impracticable) alternative substances or technologies;
- a substitution plan, i.e. a proposal, including a timetable, detailing the replacement of an Annex XIV substance with a suitable alternative substance or technology.
Our services for submitting an authorisation application
- Checking obligations and timelines
- Strategy development support
- We specialise in preparing risk assessments (CSR)
- Socio-economic assessment support
- Support in preparing a substitution plan
- Application preparation and submission
- Management of review phases
Our services for the user
- Regulatory framework
- Notification to ECHA
- Revision, if necessary, of prevention and protection measures
- Assessment of compliance with exposure scenarios
- Testing strategy for airborne substances as defined in the authorisation decision
- Environmental and personal sampling for exposure assessment
- Periodic data submission to ECHA and supplier
- Updating of chemical and/or carcinogenic/mutagenic risk assessment documents
THE AUTHORISATION PROCESS
The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
The route to authorisation starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.
Substances with the following hazard properties may be identified as SVHCs:
- Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
- Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.
- Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.
The SVHC identification process includes a 45-day public consultation. Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:
- supplying a safety data sheet
- communicating on safe use
- responding to consumer requests within 45 days and
- notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).