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Allergens Review

Allergens Review

by Phoenix Safety Consuktants
£30.00 - £100.00
£30.00
£30.00 - £100.00
£30.00
Packages: Basic

1. Introduction

Allergens Reviews are essential components in assessing safety for cosmetic and fragrance products. It determines if the formulation works with allergenic materials and whether they meet the legal thresholds. Allergenic materials in fragrances are the most prevalent contributors to consumer sensitization, and their presence is legally required under UK and EU cosmetic law.

Phoenix Safety Consultants provides extensive Allergen Review Service, which involves scientifically documented assessments of fragrances and cosmetics for regulated allergens. This validates compliance with Regulation (EC) No 1223/2009, UK Cosmetic Regulation 2020, and IFRA Standards. Your products will be safe, transparent, and ready for the market across all jurisdictions.

2. Regulatory Context

The rules regarding allergens in cosmetics are primarily outlined in Annex III of Regulation (EC) No 1223/2009 and Schedule 34 of the UK Cosmetic Regulation 2020. These laws stipulate that fragrance-related allergens must be disclosed if they exceed specific concentrations:

  • 0.001% in leave-on products (creams, perfumes, lotions)
  • 0.01% in rinse-off products (shampoos, soaps, cleansers)

These limits are designed to protect consumers and ensure informed product use. The Scientific Committee on Consumer Safety (SCCS) continuously evaluates new allergenic ingredients, leading to updates to Annex III and potential expansions of the allergen list. The International Fragrance Association (IFRA) also imposes concentration restrictions and safe-use limits for certain fragrance components under the 49th Amendment.

All brands selling cosmetics or fragrance products in the UK, EU, or EEA must comply with both cosmetic and IFRA requirements.

3. Scope of Review

Phoenix Safety Consultants provides allergen reviews for both individual cosmetic products and complete fragrance compositions. The analysis identifies all regulated allergens and evaluates whether concentrations exceed reporting thresholds.

The review covers the 26 legally regulated fragrance allergens, including:

Limonene, Linalool, Citral, Geraniol, Coumarin, Cinnamal, Hydroxycitronellal, Eugenol, Benzyl Alcohol, Benzyl Salicylate, Amyl Cinnamal, Cinnamyl Alcohol, Benzyl Cinnamate, Isoeugenol, Farnesol, Anise Alcohol, Benzyl Benzoate, Hexyl Cinnamal, Alpha-Isomethyl Ionone, Evernia Prunastri Extract (Oakmoss), and Evernia Furfuracea Extract (Treemoss).

Each allergen is assessed for:

  • Presence in the formulation or fragrance compound
  • Concentration relative to product type (leave-on or rinse-off)
  • Cumulative exposure across multiple fragrance blends
  • IFRA classification and category restriction

Phoenix continuously monitors proposed allergen expansions under SCCS review to ensure fast compliance adaptation.

4. Phoenix Review Methodology

Phoenix Safety Consultants applies a multidisciplinary scientific approach combining toxicological evaluation and legal compliance assessment. The process includes:

Data Collection and Verification: obtaining Safety Data Sheets (SDS), IFRA certificates, and raw material specifications for all fragrance components, essential oils, and aromatic compounds.

Quantitative Allergen Assessment: calculating potential allergen concentrations using supplier data, formulation percentages, and IFRA category limits.

Regulatory Cross-Check: comparing allergen levels to the limits in Annex III of the EU Regulation and Schedule 34 of the UK Regulation.

IFRA Compliance Assessment: evaluating adherence to IFRA 49th Amendment restrictions and prohibitions.

Labeling Recommendations: issuing a summary identifying required disclosures, INCI names, ingredient order, and any precautionary or warning statements needed for consumer transparency.

All Phoenix reviews are scientifically robust, RP-verifiable, and defensible during regulatory audits.

5. Documentation and Output

Upon completion, Phoenix Safety Consultants delivers a compliance-ready Allergens Review Report containing:

  • Identified allergens with concentrations per product type (leave-on / rinse-off)
  • Annex III reference and applicable legal thresholds
  • IFRA category restrictions and relevant notes
  • Labelling requirements including INCI names and threshold indicators
  • Recommendations for reformulation, concentration adjustments, or labelling updates
  • Compliance summary covering EU Regulation 1223/2009, UK Cosmetic Regulation 2020, and IFRA standards

This document is designed to integrate seamlessly within both the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF), ensuring audit-ready traceability and technical integrity.

6. Integration with CPSR and PIF

Allergen review results are incorporated into both parts of the CPSR and referenced within the PIF:

  • Part A – Safety Information: verifies allergens remain within legal limits and are properly documented and declared.
  • Part B – Safety Assessment: strengthens the assessor’s toxicological judgment regarding sensitization and exposure.
  • Product Information File (PIF): provides official documentation for audits by competent authorities or the Office for Product Safety and Standards (OPSS).

Phoenix Safety Consultants ensures allergen data integrates seamlessly with CPSR and PIF records, forming a unified compliance dossier ready for SCPN or CPNP submission.

7. Benefits of the Allergens Review

  • Regulatory Compliance: ensures alignment with EU, UK, and IFRA allergen regulations.
  • Consumer Transparency: supports brand trust with clear and accurate allergen disclosure.
  • Risk Reduction: minimises risk of enforcement, recalls, or customer complaints.
  • Scientific Soundness: based on validated toxicological and compositional data.
  • Market Readiness: provides audit-ready CPSR, PIF, and CPNP/SCPN documentation.
  • IFRA Alignment: assures compliance with international fragrance safety standards.

8. Pricing

Service Range: £30 – £100 depending on product type, formulation complexity, and number of fragrance components reviewed.

Gain full regulatory confidence with Phoenix Safety Consultants’ Allergen Review Service — ensuring compliance with UK, EU, and IFRA allergen requirements for all cosmetic and fragrance formulations.

→ Get an Allergen Review Quote
→ Understanding IFRA and CPSR Integration
→ Product Safety Documentation Services

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.