Ecotox Centers are offering consultation service focused on REACH legislation, Management of SVHC substance as such or substance included in mixture and articles used in your company, communication in supply chain and effect of chemical legislation on individual articles and products ….
If you have questions please contact us by phone +421 2 45943712 or by e-mail ekotox(at)ekotox.sk
Content of service:
- Identification of SVHC substances as such or included in mixture in your company in order to submit an application for authorization to European Chemical Agency (ECHA) ;
- Elaboration of application for authorisation including needed documentation under REACH regulation ;
- Assessment whether the risk from the use of a substance or in mixtures in your business is adequately and sufficiently confined ;
- Ensuring communication with ECHA.
If you order our services for REACH authorisation, we will provide:
- The List of chemical substances selected based presence of SVHC substances (Substance of Very High concern) – PDF document;
- The List of chemical substances selected based presence of CMR substances (carcinogenic, mutagenic and toxic for reproduction ) – PDF document ;
- Elaborated documentation for submittion of application fo authorisation (Chemical Safety Report, if is not already submitted as part of the registration, analysis of Alternative substances and Technologies…) – PDF documents ;
- Assessment Report whether the risk from the use of a substance or in mixtures in your business is adequately and sufficiently confined – PDF documents ;
- Authorization is related to substances listed in the “Authorisation list”. In fact it means a complete ban on the use of chemical substances except “Authorises use”. Decision on authorisation issued by the European Commission.
- Authorisation process require the preparation and submission of documentation proving that the use is safe or that it currently cannot be replaced. Specific dates are determined for submission of documentations as well as sunset day for application.
Manufacturers, importers or downstream users can apply for an authorisation for the placing on the market or the use of a substance on the Authorisation List.
Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. If not, an authorisation may still be granted when it is proven that the socio-economic benefits of using the substance outweigh the risks and there are no suitable alternative substances or technologies.
The application will include a chemical safety report, an analysis of the possible alternatives and a plan to substitute the substance if suitable alternatives are available. It may also include a socio-economic analysis.
Upon receiving the application and the fee payment, ECHA’s Risk Assessment Committee (RAC) and the Committee for Socio-Economic Analysis (SEAC) prepare their opinions on the application. They first check whether the application conforms to the information requirements of REACH (Article 62). If it does not, the Committees may request additional information.
Authorisation is a risk management measure for chemicals. Its aim is to protect health and the environment from substances with *CMR,*PBT and *vPvB properties of substances for which there is scientific evidence of probable serious effects to human health or the environment. These substances should be replaced by less hazardous substances.
*CMR (carcinogenic, mutagenic or toxic for reproduction) – substances that meet the criteria for classification in category 1 and 2 according to Directive 67/548/EEC.
*PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative) – substances that meet the criteria set out in Annex XIII of the REACH Regulation.
*Substances for which there is scientific evidence of probable serious effects to human health or the environment, which give rise to the same level of concern as listed substances (i.e. substances with endocrine disruptors or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not meet the criteria in Annex XIII of the REACH Regulation.
4 steps of Authorisation process:
- step: Identification of substance of very high concern – SVHC
Identification of substance of very high concern – SVHC, mainly CMR, PBT a vPvB substances under REACH regulation. Competent Body of Member States and ECHA shall submit documentation according to Annex XV REACH regulation. Before submission a proposal, Member States have to confirm interest in submitting a proposal and the substance will get into the “Registry of Intentions”. Prepared documentation according to Annex XV REACH regulation shall be submitted for public comment, which will approve Candidate list.
ECHA selects (prioritizes) substances of the “Candidate list” to “Authorisation list”. The selection shall be preceded by a public comment on the results of the substances included in the Authorisation list. Authorisation list shall determine the use of the substance and the sunset date “sunset date“, from which it is possible to use the substance without authorisation.
3.step: Request for authorisation
An applicant submits the request for authorisation based on legislation to ECHA. The request shall include:
- The Chemical Safety Report, if is not already submitted as part of the registration and,
- Analysis of Alternative substances and Technologies
- step: Granting of authorisation
Commission grand the Authorisation, applicant has to prove, that:
- Risk of the substance use is adequately and sufficiently restricted ,or
- Although the risk is not sufficiently restricted, socio-economic benefits exceed the risk of substance use and there are no available appropriate alternative substances or technologies. Base on mentioned above the Authorisation is granted/ is not granted.
A downstream user may use a substance only in accordance with the authorization granted, the substance must be taken from the company which has been granted authorization, comply with the conditions of authorization and notify ECHA the uses of this substance. A downstream user may also apply for grant of authorization for his use.
Authorisation is relatively lengthy process and requires enough time to decide on issues of communication, cooperation, information sharing…
Please contact us: ekotox(at)ekotox.sk