REACH / CLP

Achieving REACH compliance is demanding for manufacturers and importers of chemicals: the regulation asks for substance-specific data and for information from the supply chain and sets strict deadlines for the REACH registration of thousands of substances. Additionally, new tasks emerge from increased activities on authorization and substance evaluation. With our REACH services FoBiG supports companies in their efforts to comply with these requirements.

Our REACH expertise goes back to the very beginning of REACH (VCI projects on communication in the supply chain and on exposure-based waiving, the SPORT project, the VCI/Cefic Practical Guide on Exposure Assessment, the REACH Implementation Project (RIP) 4.1/4.2, the REACH Baseline study) and was applied in practice when working on a multitude of registration dossiers for many large European chemical companies.

FoBiG also gathered (as one of the first consultancies) experience in applications for authorization for substances in Annex XIV and provides scientific support for comments on restriction dossiers.

FoBiG provides the expertise in toxicological and ecotoxicological risk assessment to make use of the flexible instruments available in REACH: integrated testing strategies (e.g. category approaches and read-across), exposure-driven waiving arguments (e.g. according to Annex XI, no. 3, and documentation of strictly controlled conditions), substance-tailored exposure assessment and use of dose-response models for deriving DNELs.

REACH registration dossiers for phase-in and new substances:

• Support for SIEF- and consortium communication (phase in substances)
• Preparation of inquiry dossiers (new substances)
• Data search and data gap analysis
• Study monitoring
• Preparation of IUCLID files (physico-chemical, human health, and ecotoxicological data quality assured by „Good Evaluation Practice", classification and labeling, derivation of DNELs and PNECs)
• Preparation of chemical safety reports (including exposure assessment and risk characterisation – application of CHESAR)
• Applications for authorisation for substances listed in REACH Annex XIV
• Update and refinement of chemical safety reports
• Evaluation of alternative substances (in cooperation with our partner RPA) socio-economic analaysis (SEA)

Support for the communication in the supply chain and for downstream users’ REACH compliance:

• Support for extended safety data sheets (eSDS)
• Check of compliance with registered uses
• Evaluation of mixtures

Classification and labelling according to Regulation (EG) No. 1272/2008 (CLP) and DSD 67/548/EEC with outstanding expertise in the evaluation of:

• Physico-chemical hazards and respective test guidelines
• Toxicological hazards
• Environmental hazards