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Risk Assessment & Regulatory Compliance

Duty of Care with Nanotechnology Risks

Checklist

Managing risk is part of everyday life and particularly crucial to businesses working at the cutting edge with novel materials and processes, where a need exists for reassurance that things are being done right, safely, and within the law, to minimise the barriers to market success and consumer acceptance.  Every employer and employee has duty-of-care responsibilities to assess and manage the risks presented in the workplace.

SAFENANO is a market-leading provider of risk assessment and regulatory compliance services, using recognised best-practice standards and a lifecycle-thinking approach to provide you with:

  • A basis for responsible stewardship of nanotechnologies and regulatory compliance;
  • Foresight of emerging issues along the supply chain;
  • Support for strategic decision-making, investment, market access, product developments & business risk management.

Our key services include:

Nanomaterial Risk Assessment

  • Risk assessments through integration of hazard and exposure evaluations, with recommendations on safe practice and appropriate control measures;
  • Reviews to scope, assess and interpret evidence and emerging issues;
  • Evidence appraisal to inform policy, guidance and standards development;
  • Development of in-house exposure limits;
  • Bespoke training to understand and manage risks.

Regulatory Support

  • Identifying and scoping international regulatory requirements (including reporting schemes) within key target markets;
  • REACH compliance management, including substance identification, development of registration dossiers and chemical safety reports, development of testing proposals, exposure assessment and identification of exposure scenarios;
  • Developing toxicological profiles for hazard classification and establishing Derived No Effect Levels (DNELs) and Risk Characterisation Ratios (RCRs) for human exposures;
  • Classification and labelling of substances and mixtures according to CLP/GHS.

Safety Data Sheet Preparation

  • Preparation of (extended)-safety data sheets (SDS) for substances and mixtures which are consistent with current best practice guidance for nanomaterials;
  • Identification and critical appraisal of information to fill data gaps.

Material Characterisation

  • Instrumental and microscopic analysis to provide hazard-relevant information on: number- and volume-rated particle size distributions (as per the EU Definition of a Nanomaterial), size-weighted respirable fractions (SWeRFs), dustiness, aerodynamic equivalent and lateral size of platelet-like materials, PAH and trace metal content.
For further information, download our service card and contact us to discuss how we can help you manage your risks and regulatory requirements.

These services complement the wider Chemical Risk and Regulation services provided by the IOM.

Did you know?

SAFENANO was established in 2006 as a Centre of Excellence in Nanosafety.