REACH Technical Dossier Services
Intertek offers a single-source solution for completing a technical dossier for the EU REACH registration process.
The chemical industry is faced with the huge challenge of complying with the European Union’s REACH Regulation (Registration, Evaluation, and Authorization of Chemical Substances - EC1907/2006). REACH Registration with the European Chemicals Agency (ECHA) is a mandatory obligation for chemical producers and importers for continued sales of chemicals and products in the EU. The REACH Registration deadline for substances depends on the volume of the substance produced or imported per year.
One component of the complex and time-consuming REACH Registration process is the creation and submission of a technical dossier to the European Chemicals Agency (ECHA). There are two kinds of registration: individual submission and joint submission. The registration dossier should include: physicochemical, toxicological, ecotoxicological properties of substances, human and environmental exposure, intended uses, classification and labelling, and proposed risk management measures.
The REACH registration dossier should be prepared through the IUCLID 5 and REACH-IT programs, used for data collection and registration dossier submission. Once submitted, the ECHA then assigns a registration number and a registration date to each registration dossier.
REACH Registration Technical Dossier Services
Intertek’s global regulatory, scientific, technical and administrative experts have extensive experience providing REACH Registration Dossier Support Services to assist companies successfully complete the complex requirements of individual and joint dossier submissions.
- REACH Technical Dossier data gap analysis:
- Perform literature searches to locate available data on substances of interest
- Evaluate existing study reports and rate according to Klimisch criteria
- Analyze available data against the REACH requirements to identify key studies and any gaps
- Confirm key studies and prepare robust and endpoint summaries for IUCLID
- Develop Derived-No-Effect-Levels (DNELS)
- Fill any gaps using scientific strategies that may include the use of:
- REACH testing (substance identification, sameness testing, physicochemical property determination, toxicological, ecotoxicological, etc.)
- Exposure Scenarios
- waiver arguments
- (Q)SARs and extrapolation
- read-across data
- Creation of IUCLID 5 Dossier
- Submission of completed REACH Registration Dossier to ECHA
- SIEF and Consortia Management when needed
- Consulting support from Intertek REACH Specialists
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