Introduction
In the UK and the EU, having a cosmetic product formulation review is a required part of the due diligence process before you assess product safety, prepare documentation, and submit it for market approval. For the safety assessment, every ingredient and formulation must meet standards set out in the European Cosmetic Regulation (EC) No 1223/2009 and the UK Cosmetic Regulation 2020 (SI 2020/1466).
At Phoenix Safety Consultants, our formulation validation specialists conduct a review of your entire ingredient list in relation to the legal annexes, banned and restricted ingredient lists, and concentration limits. This protects your brand from non-compliance risks and ensures you are ready to submit your product for CPSR, PIF, and CPNP/SCPN.
What Is a Product Formulation Review
A Product Formulation Review involves assessing a cosmetic formulation on analytical and regulatory levels while also ensuring it aligns with the legal obligations of ingredients and concentration requirements. Each cosmetic value is ascertained using its INCI name, CAS/EC number, and functional role, ensuring legislative compliance with the UK and EU legislative requirements for cosmetics.
In this step, we determine:
- Whether the ingredients have been prohibited or restricted in the cosmetics annexes.
- If the concentrations are within the legal allowable limits defined by the SCCS (Scientific Committee on Consumer Safety).
- Whether the compositions of the ingredients cause additional labeling or safety tests.
- That all material possesses supporting documentation (SDS, purity data, allergens, preservatives, and colourants).
The aim is to deliver a formulation that is defensible from a technical compliance standpoint so it can easily reach the stage of market notification and toxicology evaluation.
Regulatory Compliance and Legal Basis
Under Regulation (EC) No 1223/2009 and the UK Cosmetic Regulation 2020, all ingredients used in cosmetic products must comply with specific annexes of the law:
- Annex II – List of Prohibited Substances
- Annex III – List of Restricted Substances (conditions of use, maximum limits, and warnings)
- Annex IV – Permitted Colourants
- Annex V – Permitted Preservatives
- Annex VI – Permitted UV Filters
With every update in the Official Journal of the European Union and the amendments in UK SIs, we report and cross-reference every ingredient used in the formulation with the annexes and applicable SCCS opinions, with the formulation also being assessed against REACH and CLP regulations, allergen labelling, cosmetic product safety assessment, and the overall formulation safety assessment.
What We Provide
The Phoenix Safety Consultants formulation validation service is intended to provide safety evaluation and documentation support, both technical and regulatory.
Service Deliverables:
- Full Ingredient Verification: Identification and assessment of INCI ingredient identity, purity, and regulatory status.
- Compliance Review Against Annex II–VI: Review of banned, restricted, and function-specific substances.
- Concentration and Exposure Validation: Validation of ingredient levels against SCCS and legislative limits.
- Functional and Synergistic Analysis: Analysis of ingredient functions and interactions Preservatives, UV filters, colourants, etc.
- Reformulation Recommendations: Recommendations to guide exceeding limits that require concentration adjustments or substitutions.
- Documentation Support: Summarization of documentation to support inclusion of data in CPSR Part A, PIF and Responsible Person files.
Reports contain complete compliance matrices with regulatory status and required action or confirmation. Each ingredient and reference annex is listed.
Who Needs This Service
This service is for anyone who is responsible for putting cosmetic items on the market in the UK or EU, including:
- Cosmetic brand owners who are creating new formulations or reformulating products.
- Private label manufacturers and contract formulators who supply third party products.
- Importers and distributors who are adapting formulations for entry into the UK or EU legally.
- Product developers and chemists needing independent verification prior to CPSR submission.
Independent verification of cosmetic formulations guarantees that any formula submitted for safety assessment is compliant with the legislative levels, standards, and documentation requirements.
Why It Matters
Non-compliant formulations submitted for safety assessment or market notifications can lead to punishment, withdrawal of the product, or loss of brand reputation. Regulatory bodies, for instance, the UK Office for Product Safety and Standards and EU Competent Authorities, do random checks and ask for compliance documents at any time.
The benefits of receiving a formal formulation review include, first and foremost, legal reassurance before one commences investment on production or packaging. Secondly, they will have filed documents of due diligence under Article 3 of the Cosmetics Regulation (safety obligation). Thirdly, they will have a reviewed document upon which the Cosmetic Product Safety Report (CPSR) will be built. And finally, the risk of having to reformulate a product or recall it due to having prohibited ingredients will be substantially decreased.
By having compliance documents certifications, brands will avoid pricey reworks and have compliance documents for an easier assessment process, Responsible Person sign-off, and CPNP/SCPN submission.
Process & Turnaround
This process works for speed and accuracy.
- Formulation Submission: The client submits a complete ingredient list with percentages and available SDS.
- Ingredient Verification: Each ingredient is checked against Annex II–VI, SCCS opinions, and any current updates on regulations.
- Risk Classification & Documentation Review: The functional purpose, exposure category, and concentration are verified against and is used to crosscheck.
- Compliance Report Provided: A formal written review is provided, where all non-conformities are spelled out and any recommendations for correction are noted.
This is completed within a 3–5 day period. This period is not inclusive of holidays. For urgent CPSR or PIF submissions, this is prioritized.
Pricing and Deliverables
Indicative Pricing: £50 – £100 per product (Based on how complex the formulation and the number of ingredients is)
Deliverables:
- Formulation Compliance Report
- Annex II–VI Status Table
- Regulatory Compliance Summary
- Reformulation Approval Recommendations or Reformulation Recommendations
Final Deliverables: All documents are ready for compliance submission to your Responsible Person or for your Product Information File (PIF).
Before you assess the safety of your products and launch them on the market, make sure your cosmetic formulations comply with the law. Phoenix Safety Consultants will ensure that each one of your ingredients and their concentrations will be validated against the UK and EU law, thus certifying and reviewing them as Responsible Persons with confidence.
Before the safety assessment and market launch, make sure your cosmetic formulations comply with both UK and EU legislation, and contact Phoenix Safety Consultants for a comprehensive compliance review.
→ Request Formulation Validation
→ Learn About CPSR and PIF Services
→ Explore UK and EU Cosmetic Compliance Support
