Chemicals

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).

Services for REACH

Toxicology suite
Surgical rooms
Data center
Analytics lab
Animal facilities (dedicated facilities for each specie)

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

Toxicology 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)

Toxicokinetics

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.