REACH Authorisation

Ecotox Centers are offering consultation services focused on REACH legislation, Management of SVHC substances, communication in supply chain and support for EU chemicals legislation compliance.

 We do have done several projects in terms of:

  • REACH Authorisation applications – development of whole REACH Authorisation documentation.
  • Downstream users compliance – Internal Documentation for REACH Authorisation Compliance (IDRAC).

  If you have questions please contact us:

phone +421 2 45943712 / e-mail ekotox(at)ekotox.eu

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REACH Authorisation Services:

  1. REACH Authorisation Application

Whole management, coordination and elaboration of the Application for REACH Authorisation:

  • Development of application strategy;
  • Chemical Safety Report;
  • Analysis of Alternatives;
  • Socio-economic Analysis;
  • Substitution Plan.
  1. REACH Authorisation/SVHCs Screening/Audit

Companies (producers / importers) now need to understand the status of SVHCs use in their products portfolio – mixtures and products (articles) entering EU market. That means also to check the suppliers for their compliance with EU chemicals legislation.

  • Inventory of SVHCs use and their status;
  • SVHCs analysis for general requirements, SCIP and more;
  • Development of the „corporate“ strategy;
  • Internal rules and application manuals development;
  • Communication Strategy;
  • SVHCs Application Plan.
  1. Downstream User Compliance Screening/Audit

Companies (downstream users) are under the preasure of the additional requirements to understand the status of SVHCs use. Having SVHCs in their products portfolio means the risk of additional administrative burden as well as rising prices of supplies affected by REACH authorisation. Additional costs for REACH authorisation complience as well as risk that such a material disapear are quite challenging.

  • Inventory of SVHCs use and their status;
  • Annex XIV substances use and their status;
  • Development of the – Internal Documentation for REACH Authorisation Compliance (IDRAC);
  • Communication and Implementation Strategy;

REACH Authorisation Process

The authorisation process is described in the scheme below:

Link to ECHA: https://echa.europa.eu/substances-of-potential-concern

REACH Authorization is related to substances listed in the Annex XIV of the REACH regulation – “Authorisation list”.
In fact it means a complete ban on the use of chemical substances except “Authorised 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.

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 and more.


Please contact us:

phone +421 2 45943712 / e-mail ekotox(at)ekotox.eu

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Twitter: Ekotox Centers
Linkedin: Ekotox


Authorisation:

Candidate List

Authorisation list

Substance of very high concern