Product Validation for Restricted Ingredients — Phoenix Compliance Services Skip to content
Product Validation for Restricted Ingredients

Product Validation for Restricted Ingredients

by Phoenix Compliance Services
£50.00 - £100.00
£50.00
£50.00 - £100.00
£50.00
Packages: Basic

Introduction

Before cosmetics containing certain ingredients can be sold in the UK or the EU, they must pass specific regulatory approvals. Colorants, preservatives, UV filters, and fragrance allergens must be regulated according to Law EC 1223/2009 and UK Cosmetic Regulation 2020 under Annexes III, IV, V, and VI.

Phoenix Safety Consultants have and still provide clients with validation of scoped and safety-controlled formulations. The validation of scoped and safety-controlled formulations means that a client's formulation conforms to the SCCS or IFRA safety standards, identifies the appropriate allowable concentration, and usage conditions with the UK and EU legislative market access provisions.

We strive to save our clients from the costly consequences of having to reformulate their formulations and from notified bodies such as the Office for Product Safety and Standards (OPSS) or EU competent bodies.

Scope of Restricted Ingredient Validation

Some ingredients can be used, but there are potential health and environmental impacts when they are over a certain threshold. Phoenix Safety Consultants determine compliance with concentration and use thresholds for all formulations in accordance with Regulation (EC) No 1223/2009, Annexes III–VI.

Validation scope for restricted ingredients includes:

  • Annex III – Restricted Substances: Review ingredients that are limited by concentration, product type, and risk phrases.
  • Annex IV – Colourants: Validation of approved colorants and dyes and compliance with purity specifications, limitations, and application of colorants and dyes, especially where use is restricted (e.g., around the eyes).
  • Annex V – Preservatives: Verification of antimicrobial, pH-dependency, and compatibilities for formulation pH and type.
  • Annex VI – UV Optical Filters: Verification of sun protection and active ingredients of the formulation for concentration and use category compliance.
  • Fragrance Allergen Compliance: Review of IFRA and SCCS levels of sensitising fragrance compounds for safety and legality.

This service also includes a cross-reference document. It includes the most recent SCCS scientific opinions, IFRA amendments, and ECHA substance classifications. This ensures the service reflects the most recent updates in the industry.

Legal Framework

The validation of products with restricted ingredients is based on the following:

  • Regulation (EC) No 1223/2009: Annexes III to VI describe the restrictions, concentration limits, and the conditions of use for colour additives, preservatives, and UV filters.
  • UK Cosmetic Regulation 2020 (SI 2020/1466): After Brexit, these regulations became retained and enforced under OPSS oversight.
  • SCCS Guidance and Opinions: Providing the toxicological rationale for the established concentration limits and conditions of safe use.
  • IFRA Standards and Amendments: The usage of fragrance allergens and components of essential oils is controlled.

The Responsible Person (RP) must ensure that none of the restricted materials exceed allowed limits and that any restricted material is used only under the conditions allowed. Phoenix Safety Consultants aids RPs, formulators, and brand owners by providing the validation data needed for CPSR (Annex I) and complying with the Product Information File (PIF) documentation.

Deliverables

The Restricted Ingredient Validation Report contains all the evidence needed for each ingredient to demonstrate that regulatory requirements have been met.

Deliverables include:

  • Compliance Summary: Annexes III–VI for each restricted or conditionally approved ingredient.
  • Concentration Limit Review: The limit is the legal maximum permitted concentration and is compared with the concentration of the ingredient in the formula.
  • Toxicological and MoS (Margin of Safety) Review: Calculation or verification against the reference data from the SCCS.
  • Fragrance and Allergen Validation: Certificates of compliance and allergen thresholds are reviewed.
  • CPSR and PIF Integration: Validation data is readily available to support Section A of the Cosmetic Product Safety Report and PIF documentation.
  • Regulatory Update Tracking: Tracking to note changes from the latest SCCS or IFRA changes that will impact compliance.

All reports include the necessary information to support safety assessments and audits. Your Responsible Person will have defensible compliance documentation.

Who Needs This Service

This service is vital for:

  • Cosmetic Brands and Private-Label Manufacturers working with restricted components like preservatives, UV filters, and color additives.
  • Formulators and Chemists working with or on IFRA-limited fragrance compounds.
  • Responsible Persons (RPs) needing technical validation support for the CPSR and PIF.
  • Distributors and Importers bringing cosmetic products to the UK or EU that were formulated outside these regions.

Validation is mandatory in the UK and EU for products with ingredients in Annex III to VI.

Process and Pricing

Our approach is designed to deliver on the regulatory timeframes and in the most efficient manner possible:

  • Data Submission: Client submits a full formulation with INCI names, percentage, supplier details, and any documentation.
  • Ingredient Screening: At this step, we cross-check every component against the limits of Annexes III–VI and relevant SCCS/IFRA documents.
  • Safety and Concentration Review: This step involves checking the MoS, route of exposure, and the toxicological relevance.
  • Validation Report Compilation: This involves compiling the summary of the report and including notes on the conclusion, compliance, and suggestions.
  • Final Delivery: We send the digital report within 2–4 working days, and it will be ready to be included in the CPSR.

Pricing: From £50 to £100, subject to complexity and how many restricted substances there are per product.

Ensuring restricted ingredient compliance protects your brand’s reputation, market access, and consumer safety. Before finalising your CPSR or launching your product, confirm that your formulation meets every requirement under Annex III–VI of the Cosmetic Regulations.

Protect your brand and comply with EU Annex requirements through Phoenix Safety Consultants’ restricted ingredient validation service.

→ Request Restricted Ingredient Validation
→ Learn About CPSR and PIF Compliance Services
→ Explore Formulation and Labelling Review Support

Frequently Asked Questions

What is a Cosmetic Product Safety Report (CPSR) and why do I need it?

A CPSR is a legal requirement under EU Regulation (EC) No 1223/2009. It confirms that your cosmetic product is safe for human use. Without a CPSR, your product cannot be sold legally in the EU.


Can I sell cosmetics in the EU without a Responsible Person?

No. Appointing an EU-based Responsible Person is mandatory to legally place cosmetic products on the EU market.


What happens if I don’t comply with EU cosmetic regulations?

Non-compliance can result in product withdrawal from the market, fines, or legal action. It can also damage your brand’s reputation.


What is an EU Responsible Person (RP)?

The RP is an individual or company based in the EU who acts as the main contact point for regulatory authorities. They are responsible for ensuring product compliance, safety, documentation, and CPNP notification.


What is the CPNP and what does registration involve?

The CPNP (Cosmetic Product Notification Portal) is an EU system for notifying authorities about cosmetic products. It involves submitting product details, safety assessments, and label info to comply with EU laws.


Who can act as my Responsible Person?

It can be an authorized company, consultancy, or distributor based in the EU — but they must have the expertise to handle compliance and regulatory responsibilities.