Product Formulation Review

Introduction 

1.Why a Formulation Review Is a Legal Prerequisite Before CPSR

In the UK and EU, compliance for cosmetic products begins with the rigorous Product Formulation Review, not the Cosmetic Product Safety Report (CPSR). This pre-assessment step determines whether every ingredient in a cosmetic formulation is legally allowed, justified scientifically, and within legally safe limits before proceeding with the safety evaluation. Under UK Cosmetic Regulation 2020 (SI 2020/1466) and EU Regulation (EC) N0 1223/2009, no cosmetic products are permitted to advance to the CPSR stage or be sold in the market unless their entire composition has been reviewed according to Annex II (prohibited substances), Annex III (restricted substances), and all other applicable annexes pertaining to colourants, UV filters, preservatives, and other parts.

Phoenix Safety Consultants offers a scientifically grounded and evidence-based evaluation for formulation reviews. This service includes verification of the legality, compliance with concentration, and category suitability of cosmetic products intended for the UK and EU markets. This review assists in assessing compliance with safety formulation guidelines for skin creams, shampoos, lip balms, fragrances, and hair dyes so that only compliant formulations which are assessable advance to CPSR preparation.

Reviewing a formulation helps keep manufacturers and Responsible Persons from expensive rework or rejection during the safety assessment. Non-compliant ingredients, including those that exceed SCCS-advised limits, those that use outdated INCI nomenclature, or those that are non-compliant for other reasons, will likely cause unnecessary delays or worsen a situation with regulations. Having a professional review minimizes these risks at the earliest stages, so the product formulation will comply with SCCS Notes of Guidance (12th Edition), the traceability and record accuracy provisions of ISO 22716 Good Manufacturing Practice, and the standards of IFRA 51st Amendment for fragranced items.

2. Scope of Assessment – Ingredient, Category, and Safety Verification

Phoenix Safety Consultants looks at each formulation from all sides. Assessments focus on regulatory and scientific components and include data cross verification from various authoritative sources.

Ingredient Verification and Classification: Each ingredient is evaluated under Annex II and Annex III of Regulation (EC) No 1223/2009 to check banned and restricted substances for cosmetic use. This involves examination of impurities, purity and the presence of trace materials and natural extracts or essential oils.

Concentration and Exposure Assessment: For every active component, concentration levels are compared to the SCCS Notes of Guidance. Cost analysis and frequencies for dermal exposure, product category, and use frequencies are within the accepted safety margins. For instance, an ingredient allowed at 1% in rinse-off formulations may be limited to 0.3% in leave-on applications. Such nuances are validated during the review.

Allergen and Fragrance Assessment: For the fragranced products, Phoenix uses the IFRA 51st Amendment rules to cut levels of permitted fragrance category (e.g. Category 4 leave-on or category 9 rinse-off). Also cross-checked are the allergens under Annex III for correct declaration thresholds (0.001% in leave-on and 0.01% in rinse-off).

Regulation and Testing for Preservatives, UV Filters and Colourants: The appropriate functions, maximum limitations, and specified purity criteria of the components detailed in Annexes IV, V, and VI are cross-checked. The presence of outdated or unnecessary additives, such as prohibited parabens and dyes, is reported for removal or substitution.

Validation of Toxicological References: The Ingredient Safety documents are validated alongside Risk Assessments and published documents from sources such as ECHA, the SCCS, PubChem, CosIng, and others. Each constituent is thus validated as having adequate documented toxicological proof.

This check is done to ensure the formulation of the product not only meets the legal provisions but is also scientifically warranted with regard to toxicology and the safety of the user.

3. Legal Framework – The Role of Regulation and the Responsible Person

According to Article 3 of Regulation (EC) No 1223/2009, all marketed cosmetic products must be safe for human health under normal or, any reasonable foreseeable use conditions. This responsibility must be borne by the Responsible Person (RP) under the law, who ensures the product undergoes complete regulatory evaluation prior to any product launch.

The Product Formulation Review assists part of this legal obligation by:

• Confirming if all the product's ingredients comply with the legal annexes and any restrictions therein.
• Confirming if the toxicological justification is consistent with the SCCS Notes of Guidance.
• Drafting validated compositional data for the CPSR and Product Information File (PIF).
• Flagging non-compliant materials that will need to be reformulated before the assessment.

Not verifying that all the ingredients comply will result in the rejection of the CPSR, cause delays in launching the product, or trigger regulatory action from enforcement bodies such as the UK Office for Product Safety and Standards (OPSS) or the competent bodies in the EU member states.

For all Responsible Persons and formulators, Phoenix Safety Consultants drafts the documentation to be submitted during the CPSR phase and ensures that it is aligned with the regulatory requirements.

4. Deliverables – Comprehensive Compliance Documentation

At the end of the project, clients receive a set of structured and regulator-ready documents which help integrate it into the compliance portfolio of the product. These include:

• Formulation Compliance Summary Sheet: A comprehensive table containing all INCI names, CAS/EC numbers, the role and function of the ingredients, permitted concentration, and the regulatory position of the UK/EU on the legislation.
• Annex II/III Cross-Reference Table: A matrix of identifying prohibited and restricted ingredients with the applicable conditions and concentration ceilings.
• Allergen and IFRA Review Summary: If there are fragrances or essential oils, a summary of the allergen levels and the determination of the compliance category with IFRA is provided.
• CPSR-Ready Ingredient Data File: Consolidated technical data which includes the identity of the ingredient, chemical and physical parameters, percentage composition, and others which is structured to be included in the CPSR Part A.
• Recommendations Report: An expert commentary identifying areas of non-compliance, suggested reformulations, and possible substitutions grounded on SCCS or IFRA.

These documents assure that the Responsible Person or cosmetic safety assessor can move directly to the CPSR phase without additional reformulation or clarification after the pack is sent out.

5. Who Needs This Service – Target Users and Regulatory Context

The Product Formulation Review service is particularly suited for:

• Cosmetic brand owners developing new formulations or modifying existing ones;
• Private-label producers manufacturing under multiple brand names;
• Formulators and laboratories seeking independent validation of compliance;
• Responsible Persons and regulatory consultants requiring pre-assessment data for inclusion in CPSR and PIF documentation.

Even established companies benefit from independent verification when reformulating products, incorporating new raw materials, or transitioning from EU to UK compliance frameworks post-Brexit. The review is also essential for brands preparing to sell across both regions, as subtle variations exist between EU Annexes and UK retained regulations for example, ingredient approval timelines, IFRA adoption, or specific colourant authorisations.

Review Process and Pricing Structure

At Phoenix Safety Consultants, each stage of the process has clear deliverables along with documentation and evidence.

• Information Collection: The customer submits the detailed product formulation, including INCI names, the exact percentage of ingredients, fragrance composition (if any), and the product type (e.g., face cream, shampoo, body lotion).
• Initial Regulatory Review: Each product component is screened and cross-checked against Annex II, III, IV, V, and VI as well as the CosIng and ECHA databases.
• Doc Review and Scientific Assessment: Toxicological and functional data, according to SCCS Notes of Guidance, are assessed to ensure the product poses no health risk at the claimed concentrations.
• Allergen & IFRA Assessment: For scented products, the allergens and fragrance ingredient limits are checked against the IFRA criteria of the 51st Amendment.
• Compliance Report: A detailed summary is produced, documenting which ingredients are compliant and which need revision or replacement.
• Final Report: The documentation is dispatched electronically within 3–5 working days and is provided in editable and printable forms.
• Pricing: Each formulation is charged between £75 and £100, based on the product type, ingredients, and complexity (e.g., multi-phase emulsions, SPF products, and variations with fragrance).

This structure ensures regulatory confidence and provides documentation continuity from the initial assessment to the final Cosmetic Product Safety Report.

Advantage of Reviews by Phoenix Safety Consultants

• Early identification of non-compliant ingredients, which helps avoid a CPSR or PIF review stage rejection.
• Regulatory and compliance assessments that save time and money since safety testing and toxicological evaluations are performed after reformulation.
• Regulatory assurance as a result of consistent compliance across UK and EU markets.
• Scientifically-based compliance due to reliance on SCCS, IFRA, and ECHA.
• Peace of mind for Responsible Persons and assessors that submitted formulations are compliant and fully traceable.

The review also enhances a brand’s compliance position, especially for audits or when documentation is requested by authorities, distributors, or ecommerce platforms, like Amazon UK and EU.

Request Professional Review

A compliant formulation is an essential first step for every compliant cosmetic product, which is why a comprehensive Product Formulation Review is a necessary step in regulatory due diligence. Validating exclusion checks, including ingredient, concentration, and regulatory compliance, is crucial before preparing the CPSR. This greatly helps in avoiding expensive reformulation costs, document rejection, and market withdrawal.

Prior to CPSR submission, ensure your cosmetic formulations comply with UK and EU legislation. Contact Phoenix Safety Consultants to request compliance.

To provide you with a solid basis for the Clinical Product Safety Report (CPSR), Product Information File (PIF), and market notification, our experts conduct a thorough examination and check the legality, IFRA standards, and toxicological appropriateness of every component.

Comprehensive. Evidence-Based. Regulation-Aligned.