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Risk assessment

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To obtain approval, register or market a new substance or a new chemical formulation you must complete, where applicable, in compliance with specific regulatory requirements, the risk assessment resulting from the use of your product for:

  • human health (consumer, professional or non-professional applicator, worker, etc.),
  • non-target animal species,
  • the environment.

The Staphyt Regulatory team advises and accompanies you in carrying out these risk assessments.

You need to

  • Identify any critical missing parameter such as: Henry’s law constant, n-octanol/water partition coefficient or Atkinson’s tropospheric half-life using Quantitative Structure-Activity Relationship (QSAR)
  • Define endpoints for :
    • human (Toxicity Reference Values (TRVs) such as AOEL, ADI, ARfD, MRL or dermal absorption values according to EFSA 2017, etc.)
    • environment (Koc, DT50 according to EFSA 2014, biodegrability, etc.)
    • non-target organisms (LD50, LC50, NOEC, etc.)
  • Prepare and/or refine risk assessments according to European or national models for plant protection products for:
    • the operator / applicator, the workers, the bystanders and residents,
    • consumers,
    • environmental fate and behaviour,
    • non-target organisms.
  • Prepare and/or refine risk assessments according to European models for biocidal products for :
    • applicators, consumers and animals, including livestock,
    • environmental compartments (surface water, groundwater, sediment, soil, air),
    • non-target organisms.
  • Prepare and / or refine risk assessments according to European models for chemicals products and substances for:
    • people exposed to products through an environmental exposure,
    • consumers exposed to the chemicals contained in the formulations and articles,
    • workers and professionals exposed to chemicals,
    • environmental compartments (surface water, groundwater, sediment, soil, air).
  • Carry out the safety assessments of a cosmetic product.
  • Prepare and / or refine environmental risk assessments for human and veterinary medicines.
  • Assess the risks of cross-contamination in the manufacture of your medicines.
  • Assess the PBT, vPvB and POP potential of your substances.
  • Assess the hazards of a chemical substance.
  • Establish exposure studies for operators, workers, consumers and the environment (OPEX).

Our expertise

  • For Plant Protection Product, prepare risk assessments according to European or national models:
    • AOEM and other usual models for the operator/applicator, workers and bystanders,
    • PRIMo models (EFSA), or WHO model for consumers exposed to residues,
    • PEC calculation, Mackay model, FOCUS GW modeling with PEARL, PELMO et MACRO, FOCUS SW modeling with SWASH, Hardspec, for environmental fate and behaviour,
    • Volatilization calculation with EVA,
    • TER calculation or PEC/PNEC for the exposure of non-target organisms to a product,
    • FROGS, SWAN, EPAT, HC5 calculations for the refinement of risk assessments.
  • For Biocidal Products, prepare risk assessments according to European or international models:
    • BEAT, ConsExpo, ECETOC TRA and other standard models for professionals and consumers exposed to biocidal products,
    • ESD (Emission Scenario Documents) for the calculation of emissions into the environment,
    • EUSES, Simple Treat, FOCUS modeling, MAMPEC, Mackay model, for the calculation of PECs and the environmental fate and behaviour of active substances and metabolites,
    • calculation of PEC / PNEC for the exposure of non-target organisms to a product,
    • Guidelines “Technical Notes for Guidance on Human Exposure” and “Guidelines on Risk characterization and assessment of Maximum Residue Limits (MRLs) for biocides” for humans exposed to biocidal products,
    • Guideline “Technical Notes for Guidance in Estimating Livestock Exposure to Active Substances used in Biocidal Products” for livestock exposed to biocidal products.
  • For chemical substances and products, prepare risk assessments according to European or national models:
    • CHESAR, EASE, ECETOC TRA, Riskofderm, Stoffenmanager for workers and professionals exposed to chemical products and substances,
    • EUSES for the environment and the humans exposed to products through an environmental exposure,
    • Carry out the Chemical Safety Report (CSR) with CHESAR.
  • For cosmetics, prepare safety assessments of your products including:
    • the determination of the normal and reasonably foreseeable use of the product,
    • the establishment of the exposure to cosmetic products and substances,
    • the bibliographic research to establish the toxicological profile of the formulants and the NOAELs to be used,
    • the calculation of the substances’ Margins of Safety,
    • the drafting of the safety assessment of cosmetic product on human health (validated by an ERT toxicologist).
  • For human and veterinary medicines, prepare environmental safety assessments including:
    • the module 1.6 of the marketing authorisation application (MAA) for human medicines,
    • the ERAs for veterinary medicines,
    • the determination of environmental compartments potentially at risk and the quantification of emissions in these compartments,
    • the definition of acceptable levels of exposure for ecosystems (PNEC calculation),
    • the assessment and, if necessary, refinement of the risk for all environmental compartments.
  • Calculate the PDE (Permitted Daily Exposure) necessary to assess the risks of cross-contamination during the manufacture of medicines.
  • Conduct assessments of PBT, vPvB, POP for any kind of substance.
  • Propose alternatives to laboratory testing by performing:
    • hazard assessments of a chemical substance using RSA(Q) models (QSAR Toolbox, Toxtree, EpiSuite),
    • expert statements for the chemical hazards of your substances and products,
    • bibliographic research on components (EndNote software) or hazard assessment (CLP classification) according to the data or by calculation.
  • Develop customized risk assessments based on your product’s characteristics and use and / or refinement if the risks are considered unacceptable.
  • In the framework of risk assessment studies for operators, workers, consumers and the environment, ensure the realization of GLP multi-site studies in all Northern and Southern regulatory areas of the European Union for plant protection products on all crops and implement specific studies to assess exposure to biocidal products (OPEX).

All services

Registration dossiers for substances and products
Risk assessment
Strategy, advice and regulatory watch
Field and laboratory studies management
Classification, SDS, labelling
Alternative to laboratory studies: QSAR, expert statement, literature search
Regulatory training