Consumer Products

Cosmetics and Consumer Products

We offer consulting support in toxicology and for product safety assessment evaluations for cosmetics, personal care and household products.

We offer the following support:

Cosmetics and Personal Care Products:

The cosmetics and personal care industry is regulated under (EC) No. 1223/2009 Annex II to Annex VI, US FDA 21 CFR Title 21, Canada Hotlist, NICNAS etc. For these regulations we offer the following consultancy services:

  • Product pre-formulation and ingredient assessments and recommendations for re-formulation in order to avoid product recalls:
    • Annex II substance which may not be used
    • Annex III subtsance which may be used subject to certain conditions/restrictions
    • Annex IV Positive listing of colourants
    • Annex V Positive list of preservatives
    • Annex VI Positive list of  UV filters including nanomaterials
  • Product notification on the Cosmetic Product Notification Portal (CPNP) under Regulation (EC) No. 1223/2009
  • Preparation and maintenance of product information file (PIF) and Cosmetic Product Safety Report (CPSR) by a qualified safety assessor in line with (EC) No. 1223/2009 (Part A & B):
    • Preparation of toxicological profile
    • Risk assessment for ingredients and toxicological risk assessment report including exposure calculations i.e. determination of margin of exposure (MoS).
    • Label / artwork / packaging review
  • Assess the requirements of product claims substantiation and labelling as governed by various regulations such as the FDA Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labelling Act (FPLA) and (EC) No. 1223/2009:
    • Claims justification
    • Suitability of packaging
    • Label and artwork review
  • Design, arrange and manage safety evaluation and toxicology/clinical studies to meet industry standard and successful regulatory submissions:
    • In vitro testing for innovative cosmetic ingredients
    • Stability testing of the cosmetic products under reasonable foreseeable storage conditions
    • Microbiological analysis
    • Nitrosamine analysis
    • Nanomaterial characterization  
  • Manage compliance with cosmetic Good manufacturing Practice  (cGMP) according to ISO 22716
  • Responsible Person (RP) service to ensure compliance with (EC) No. 1223/2009


Consumer Products:

Consumer Products are regulated in the EU under the General Product Safety Directive (GPSD), 2001/95/EC, the Consumer Product Safety Act (CPSC) in the US, the Consumer Chemicals and Containers Regulations (CCCR) in Canada and the Australia Inventory of Chemical Substance (AICS) administered by NICNAS.  These regulations aims to ensure a high level of product safety for consumer products not covered by specific sector legislation. We provide the following support;

  • Conduct safety assessment of household chemical products are regulated by specific legislation, including biocides (under Regulation (EU) No. 528/2012) and detergents (under Regulation (EC) No. 648/2004)
  • Provide support with labelling of products under the FDA 16 CFR Part 500 & Federal hazardous Substances Act (FHSA) and the Classification, Labelling and Packaging (CLP) regulation (EC) No. 1272/2008
  • Product pre-formulation and ingredient assessments and recommendations for re-formulation in order to avoid product recalls


"We offer friendly, customer focused consulting services, making your regulatory obligations cost-effective."

Concy Aciro
Senior Consultant


29 Nov 2019

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