Compliance Tier One:

Services to Cosmetic Brands.

We offer the complete range of UK and EU mandatory cosmetic regulatory and testing services plus a bespoke range of support packages including comprehensive product recall procedures and borderline claims advice.

Our Service Offering.

  • Compliance review with 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.

  • 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 review 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).

  • Cosmetic Product Toxicological Safety Assessment in accordance with Regulation (EC) 1223/2009 and Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and in accordance with Annex I of the EU Cosmetic Products Regulation (EC) 1223/ 2009.

  • Submit product notification and upload formula and pack details if placing onto the UK market.

  • Submit product notification and upload formula and pack details if placing on to the EU market.

  • 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.

  • 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.

  • Preservative Efficacy Testing (PET Challenge Testing) studies.

    Dermatological Irritation Potential Patch Testing Studies- normal & sensitive skin test subjects.

    In vitro UVA PF and Critical Wavelength Assessment to ISO 24443;2021 Protocol.

    In vivo SPF testing to ISO 24444:2019 Protocol.

    Antiaging and moisturisation claims substantiation clinical study protocols.

    Accelerated Stability Studies.

    Packaging Compatibility and functionality testing studies.

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