Compliance Tier Two:

Services to Cosmetic Brands.

We provide a full product portfolio review for the range of products being sold to ensure consumer safety and regulatory compliance. We can assist to avoid any regulatory non-conformances and plan for future changes to your existing product ranges.

We can support in generating retailer specific ingredient ethos strategies and scientific  justification of any restricted ingredients.

Our Service Offering.

  • Full range compliance review in accordance to Regulation (EC) 1223/2009 and Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (UK Cosmetics Regulation) and EU Cosmetic Products Regulation (EC) 1223/ 2009.

  • Full range compliance review and regulatory status of ingredients in the following territories:

    Europe - Great Britain, The European Union – 27 Member States, Switzerland.

    North America - USA (including California Prop 65 list), Canada.

    Middle East – Turkey, Israel, United Arab Emirates.

    Asia - China, Hong Kong, Japan, Taiwan, South Korea, ASEAN – 10 Member States.

    Oceana – Australia, New Zealand.

  • Claims and mode of action reviews in accordance with the MHRA Guidance Note 8 (Guidance to What Is a Medicinal Product, and in accordance with the Working Group on Cosmetic Products (Sub-group on Borderline Products) Art.2(1)(A) to ensure no infringements of borderline claims for the product portfolio.

  • Support and guidance for Facility Registration, Product Listing, Labelling (including Fragrance Allergen Rule), Safety Substantiation and Adverse Event reporting in the USA as defined under section 607 of the Food Drug and Cosmetic Act (FD&C Act).

  • Full written recall procedure and accordance with PAS7100 Recall guidance and the UK Government Business notification of unsafe and noncompliant products notification process.

    Annual mock recall carried to evaluate the procedure and satisfy the requirements of ISO 22716:2007.

  • Ensure product specification and parameters are being adhered to by your product manufacturers. We can carry out independent analysis of your products, taken off the shelf, to check for:

    Preservative Efficacy (PET Challenge Test) in pack.

    pH value, Viscosity value, Emulsion Homogeneity, Relative Density.

    Proof of effect checking: In vitro SPF screening to check claimed SPF value is viable.

    Antibacterial efficacy claim testing, hydration effect, Dermal Irritation potential to check suitability for sensitive skin claims.

  • Collation and maintenance of the Product Information File (PIF).

    Ensure your products are manufactured in accordance with Good Manufacturing Practices (GMP).

    Cover any legislative amendments to the OPSS product notification data base and PIF file.

    Post market Surveillance including undesirable effects (UE) and Serious Undesirable Effects (SUE).

    Management and reporting of any SUE to the OPSS using the Trading Standards notification process.

    Update the CPSR with any UE/SUE data.

  • Collation and maintenance of the Product Information File (PIF) Ensure your products are manufactured in accordance with Good Manufacturing Practices (GMP).

    Cover any legislative amendments to the CPNP European Cosmetic product notification Portal data and PIF file.

    Post market Surveillance including undesirable effects (UE) and Serious Undesirable Effects (SUE).

    Management and reporting of any SUE to the Competent Market Authorities.

Please get in touch to discuss your cosmetic regulatory needs, we’d love to hear from you.