REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) was written to ensure that all chemicals on the market in the European Union (EU) do not adversely affect human health or the environment. The REACH Regulation was enacted by the EU in June of 2007.
REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA).
Providing comprehensive REACH testing capabilities at our facilities located in Italy and French, we have been involved in a large amount of REACH registration dossiers that have been successfully submitted to ECHA.
The Scientific Staff at ERBC includes specialists in different regulatory disciplines. The following consultancy services are offered for the chemical industry:
- Evaluation of regulatory requirements, existing studies and literature for any product type
- Revision/evaluation of available toxicological data, SAR/QSAR evaluation, waiving strategies and testing proposal
- Design of complete testing programs, including cost and time evaluation
- Monitoring of outsourced studies (Physico-chemical properties and ecotoxicology studies)
- Preparation of scientific and regulatory dossier documents (IUCLID 6 files, Robust summaries, CSA/CSR, Technical dossier; US EPA/Japan METI dossier preparation)
- Risk assessment with evaluation of exposure scenarios and evaluation of safety procedures
- Direct contact and liaison with regulatory authorities
- Hazard classification and labelling proposal under GLP; preparation of PPORD and MSDS
Experimental Services for Reach
ERBC services cover all studies required for assessment of effects on human health described in Annexes VII to X of REACH Legislation.
ERBC can manage entire projects, by allocating and monitoring all the studies for the evaluation of physico-chemical and ecotoxicological properties to selected partner laboratories.
Examples of relevant studies performed by our team:
In Vitro Studies and Genetic Toxicology
- Bacterial gene mutation
- Mammalian cell gene mutation (HPRT, TK)
- In vitro and in vivo micronucleus test and metaphase analysis
- In vitro and in vivo UDS
- In vitro and in vivo comet assay
- Stand-alone methods alternative to animal testing (in vitro skin and eye irritation/corrosion)
- Toxicity in Balb 3T3 cell line
- Mechanistic studies for endocrine disruptors
- Photosafety studies
- Acute, subacute, subchronic/chronic, oncogenicity
- In vivo irritation and sensitisation studies
- Standard study designs according to OECD, OPPTS
- Specific studies: neurotoxicity studies in rats
- Species: rodents and non-rodents
Reproduction Toxicology Studies
- Full range of required protocols
- Standard study design according to OECD, OPPTS, METI including combined toxicity – reproduction/developmental toxicity tests
- Specific studies: uterotrophic assay in immature female rats
- Species: rats and rabbits
Drug Exposure Evaluation (non-radioactive)
With REACH Legislation, new testing programs and regulatory procedures have been set up. Strong attention was paid to intelligent testing strategies such as preference for in vitro tests, optimized in vivo tests, use of in silico methods (SARs, QSARs and biokinetic models), use of Thresholds of Toxicological Concern (TTC), grouping substances through read-across and chemical categories, exposure assessment or exposure-based waiving.