Analysis of substance identity (SID) and substance sameness of complex substances in REACH - expert study
Call for data
- Based on the results of the project, actions can be taken to clarify the issues and the most demanding and challenging aspects related to substance identity and substance sameness prior to the 2018 REACH registration deadline.
- It is therefore in best interest of all parties to share their experience with substance identity and to discuss related issues faced in the registration process.
Context and aim of the project
- Identifying a substance is the central task in REACH registration process (registration in accordance with Regulation (EC) No 1907/2006). In the REACH Review report and corresponding working document of the European Commission published in 2013, the Commission states that determining substance identity and sameness has proven to be a complex task, the definition of substance identity and the determination of sameness of substances are some of the most challenging aspects of REACH and many registration dossiers have been found to be non-compliant, including with regard to substance identity, as reported by the European Chemicals Agency (ECHA). Especially in case of substances of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB substances), but also for specific well-defined substances in terms of REACH, clear identification poses objective challenges.
- The European Commission has therefore decided to start a project to analyse major difficulties faced by registrants in assessing substance identity and substance sameness and to identify good practices and areas of concern requiring further attention. The results of the project shall provide consolidated information in the field to allow the Commission and ECHA to take effective actions to facilitate the process of identifying substances prior to the 2018 registration deadline.
Outputs of the project
- Comprehensive study on substance identity and substance sameness in REACH related to complex substances, i.e. substances for which the application of the substance identification provisions of REACH and the rules and conventions of the SID guidance pose challenges.
- Sector-specific factsheets providing key information and best practices in identification of complex substances in selected industry sectors.
- To perform the project, a consortium of TECHEM CZ and VUOS has been selected in an open call for tender announced by DG Enterprise and Industry in August 2013.
- VUOS (Research Institute of Organic Syntheses) provides professional services in research and development in chemistry and chemical technologies, chemical analytics, toxicological and eco-toxicological testing of chemicals and complex services in implementing REACH and CLP. The company is also a manufacturer of specialty chemicals.
- The REACH SIDC project is performed by the specialized Centre for Ecology, Toxicology and Analytics (CETA). CETA is a major provider of toxicity and ecotoxicity testing of chemicals and of chemical analytics services. Accredited laboratories of CETA certified as laboratories adhering to conditions of Good Laboratory Practice are equipped with modern instruments for mass spectrometry, liquid and gas chromatography, thermogravimetry, elemental analysis, supercritical extraction, multinuclear magnetic resonance, absorption and emission spectrometry and other methods of measurement of various physico-chemical properties of chemicals.
- For further information on activities of VUOS, visit www.vuos.com.
TECHEM CZ (www.techemcz.cz)
- TECHEM CZ is a private consultancy company providing technological, environmental and regulatory consultancy services to enterprises of chemical and pharmaceutical industry.
- The activities of the company are focused to three major fields – implementing national and European chemical and environmental legislation (especially risk assessment of chemicals), managing and participating in projects of applied research in the fields of chemistry and environmental sciences, and providing professional information services in chemistry and natural sciences (literature and patent search, software development, data mining).
- For further information on activities of TECHEM CZ, visit www.techemcz.cz.
The REACH SIDC project is funded by the European Commission, DG Enterprise and Industry, however this website was developed and is operated by the consortium performing the project. The information provided within this website is therefore presented by the consortium performing the project and the Commission cannot be held responsible for any use which may be made of the information contained therein.