Toxicological Risk Assessment (TRA) for Fragrances

What's included in your fragrance TRA

Who a fragrance TRA is for

• Perfume and eau de parfum brands preparing a fragrance CPSR
• Body mist and hair mist launches
• Brands buying fragrance oils from a fragrance house
• Brands moving a fragrance into a new IFRA product category
• Not for launch on its own: a perfume on sale needs a full CPSR

What a fragrance TRA does not include

• The complete fragrance CPSR. The TRA supplies the toxicology, but a perfume still needs a full safety report before sale. Order a CPSR for fragrances when your formula is final.
• Creams, serums and other beauty products. Where fragrance is a minor ingredient, use our toxicological risk assessment for beauty products.
• An IFRA certificate. Your fragrance house issues the certificate; we check your finished product against it.
• A label review. We quantify the allergens; checking how they appear on your artwork is part of our allergen compliance check.

How it works

1. Fill our Product Information Document Tell us about the product and upload the fragrance documents listed below.
2. Component review We profile every aroma chemical, essential oil and natural extract against SCCS opinions, ECHA data and the Annexes.
3. Sensitisation, IFRA and allergens We assess sensitisation risk, apply IFRA category limits and quantify declarable allergens.
4. Exposure and Margin of Safety We account for cumulative, leave-on or rinse-off exposure and calculate MoS where systemic data exist.
5. Report issued Your signed fragrance TRA arrives within 72, 48 or 24 hours, depending on the delivery speed selected.

What is a fragrance toxicological risk assessment?

A fragrance toxicological risk assessment is a scientific evaluation of the aroma chemicals, essential oils and natural extracts in a perfume or fragrance compound, showing that each is safe at the level and in the way consumers use it. Fragrance materials carry risks that most other ingredients do not: skin sensitisation, declarable allergens and materials restricted by the IFRA Standards.

The assessment supplies the toxicology that a perfume's cosmetic product safety report (CPSR) must contain under Article 10 and Annex I of Regulation (EC) No 1223/2009 and its GB version. It is not a substitute for that report. Unlike a general ingredient TRA, it treats sensitisation as the primary endpoint and checks every component against IFRA limits and the Annex III allergen list.

How a fragrance TRA differs from a standard cosmetic TRA

Sensitisation first:

• Quantitative risk assessment (QRA): for a skin sensitiser, the expected dose per unit area of skin is compared with a level not expected to cause sensitisation. IFRA sets its limits for sensitising materials with this method (QRA2), and a Margin of Safety calculation does not address sensitisation.
• Hazard data as well: the SCCS Notes of Guidance do not treat QRA as a validated approach for skin sensitisation, so we also weigh SCCS opinions and Annex III restrictions for each sensitiser.
• Cumulative exposure: the same fragrance material often appears in several products a person uses each day, so repeat-use and leave-on exposure are taken into account.

IFRA and allergens:

• IFRA conformity: each restricted material is checked against the maximum level for your IFRA product category; fine fragrance, body lotion and rinse-off shower gel have different limits.
• Allergen quantification: Annex III fragrance allergens are calculated in the finished product. They must be named in the ingredient list above 0.001% in leave-on and 0.01% in rinse-off products. In the EU and Northern Ireland, Commission Regulation (EU) 2023/1545 adds further allergens: products placed on the market after 31 July 2026 must label them, and earlier stock may be sold until 31 July 2028.

Systemic safety:

• Component evaluation: identity, purity and toxicological profile of each material, checked against SCCS opinions, ECHA dossiers and Annexes II–VI.
• NOAEL, SED and MoS: where systemic toxicity data exist, MoS = NOAEL ÷ SED, and an MoS of at least 100 is generally accepted under the SCCS Notes of Guidance.

Fragrance TRA or full fragrance CPSR: which do you need?

A fragrance TRA on its own suits development work, such as comparing fragrance oils or dosage levels, or checking a fragrance before you move it into a new product category. To sell the perfume you need a full fragrance CPSR, which already includes this toxicology.

What to send for your fragrance TRA:

• Full fragrance composition with INCI names, CAS/EC numbers and concentrations
• IFRA certificate from your fragrance house
• Allergen breakdown from your fragrance supplier
• Product type and use: leave-on or rinse-off, and what the product is for

Legal framework

• Article 10 and Annex I, Regulation (EC) No 1223/2009 — every cosmetic, including perfume, needs a safety assessment and CPSR before it is placed on the market; Annex I Part A covers the toxicological profile of each substance, including skin sensitisation
• GB version — the same regulation as amended for Great Britain by Schedule 34 to SI 2019/696
• Annex III — fragrance allergens that must be named in the ingredient list above 0.001% (leave-on) or 0.01% (rinse-off)
• Commission Regulation (EU) 2023/1545 — expanded fragrance-allergen labelling in the EU and Northern Ireland; non-compliant products could be placed on the market until 31 July 2026 and may be made available until 31 July 2028
• SCCS Notes of Guidance (12th Revision) — toxicological evaluation, exposure and Margin of Safety
• IFRA Standards (51st Amendment) — the fragrance industry's self-regulatory standards prohibiting, restricting or specifying materials by product category; IFRA expects to notify the 52nd Amendment in January 2027

Official sources:

• Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
• Commission Regulation (EU) 2023/1545 on fragrance allergen labelling (EUR-Lex)
• IFRA notification of the 51st Amendment (IFRA)
• SCCS Notes of Guidance, 12th Revision (European Commission)

Why brands choose Phoenix for a fragrance toxicological risk assessment

• Fragrance-specialist toxicology — sensitisation, allergens and IFRA-restricted materials assessed together.
• Signed by a qualified Safety Assessor — ready to support your fragrance CPSR.
• Limits for the category you sell — IFRA levels applied to your actual product type.
• Regulator-ready or we revise it free — our compliance guarantee.
• Signed report in 72, 48 or 24 hours — useful when a fragrance house changes an oil close to launch.
• Trusted by 1,400+ brands over 14 years, including The Beard Struggle, The Essence Vault, Parfum Fabric and Junaid Jamshed.

Start your fragrance toxicological risk assessment today. Choose your delivery speed above, or message us on WhatsApp on +44 7346 009332 to check which documents your fragrance house needs to send.

Frequently asked questions