CSR’s experience in the industrial chemical, agrochemical, biocide, biotechnology, and nanotechnology sectors allows it to offer a complete package of consultancy services for the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) No 1907/2006 - REACH. REACH entered into force on June 2007.
The CSR team provides project management to ensure product approval and registration, and to build support and defence packages for product portfolios. We compile supporting data packages, including literature searches, reviews, and risk assessments. The multi-disciplinary skills possessed by the members of CSR are essential to a cost-effective and timely product approval project. Today’s regulatory approvals hinge on the utilisation of multiple sources of information, resources, and skills.
CS Regulatory Ltd specialise in the EU REACH regulation, and can :
1) Overview of the chemical(s) that you work with:
A) Pre-registration (and “late” pre-registration) of phase-in substances.
B) Current regulatory status with respect to:
i Registration deadlines and process
ii) Identification of required documentation to support a registration (Expanded MSDS; Chemical Safety Reports as applicable)
iii) Applicability of authorisation / restriction to a particular substance based on known classification and labelling.
2) Assistance with Structured Information Exchange Format (SIEF) and/or Consortia participation:
i) Assistance with establishing “sameness” of substance for acceptable SIEF participation with other pre-registrants.
ii) Identification of data requirements for registration threshold level.
iii) Data gap analysis and identification of client specific requirements.
iv) Applicability of Quantitative Structural Activity Relationships (QSAR) and in silico modelling (if appropriate and applicable) in data gaps.
v) Provision of Expert Reports for ‘data waiving’ arguments.
vi) Advice on testing strategies, tests (including ‘alternative tests’) and approved laboratories.
vii) Interpretation of physico-chemical, toxicological and ecotoxicological data.
viii) Derive Classification and Labelling in accordance with CLP and DSD / DPD.
ix) Assistance with SIEF / Consortium participation (guidance on requirements and review of proposals provided by lead registrant / other pre-registrants).
3) Preparation of regulatory documentation and associated services:
i) Preparation of Article 26 Inquiry (for non-phase in substances)
ii) Dossier preparation in IUCLID 5 format (“Lead” or “Member” dossiers)
iii) Preparation of structural diagrams and associated information (SMILES, IUPAC name etc)
iv) Preparation of Chemical Safety Report and associated Exposure Scenarios if required.
v) Preparation of REACH format expanded MSDS if required.
vi) Subsequent submission
vii) Post-submission negotiations
viii) Preparation of Authorisation applications (if required and applicable).
ix) Associated with Authorisation, preparation of Socio-economic analysis
x) Recommendations for classification and labelling according to CLP (The Classification, Labelling and Packaging Directive) and GHS (Globally Harmonised System).