Toxicological Risk Assessment (TRA) for Beauty Products

What's included in your toxicological risk assessment

Who a cosmetic TRA is for

• Brands checking a draft formula before ordering the full CPSR
• Formulators testing whether a higher ingredient level is still safe
• Skincare, haircare and make-up brands selling in the UK or EU
• Not for launch on its own: a product on sale needs a full CPSR

What a cosmetic TRA does not include

• The rest of the safety report. A TRA covers exposure and toxicology only. Stability, microbiological quality, impurities and packaging, and the signed Part B conclusion belong to the full CPSR.
• Perfumes and fragrance compounds. Fine fragrances, body mists and fragrance oils need sensitisation, IFRA and allergen work, covered by our fragrance toxicological risk assessment.
• Laboratory testing. We assess the data you send; we do not run stability, microbiological or preservative challenge tests.
• Notification and a Responsible Person. A TRA does not register your product. Great Britain needs an SCPN notification and a UK Responsible Person; the EU needs a CPNP notification and an EU Responsible Person.

How it works

1. Fill our Product Information Document Give us your product details and upload your formula and raw-material data.
2. Ingredient data review We profile each ingredient using SCCS opinions, ECHA dossiers, supplier data and Annexes II–VI.
3. Exposure and Margin of Safety We model exposure for your product type and calculate SED and MoS for each relevant ingredient.
4. Signed report delivered You receive the signed TRA within the 72, 48 or 24 hours of the delivery option you chose.

What is a toxicological risk assessment for cosmetics?

A toxicological risk assessment for cosmetics (TRA) is the scientific evaluation of whether each ingredient in a product is safe at the concentration used and in the way consumers are exposed to it. It identifies each ingredient's hazards, estimates how much reaches the body, and compares the two using the Margin of Safety.

A TRA is one part of the cosmetic product safety report (CPSR), not a substitute for it. Annex I of Regulation (EC) No 1223/2009, in both its EU and GB versions, requires the CPSR to cover exposure to the product and its substances and the toxicological profile of each substance, including the Margin of Safety. The TRA supplies exactly that evidence, which the safety assessor then relies on for the Part B conclusion.

How we assess each ingredient: NOAEL, SED and Margin of Safety

• Identity and data: chemical identity, purity, function and toxicological profile, cross-referenced against SCCS opinions, ECHA registration dossiers, supplier SDS and Annexes II–VI.
• Toxicological endpoints: acute and repeated-dose toxicity, skin and eye irritation, skin sensitisation, mutagenicity, carcinogenicity, reproductive toxicity and dermal absorption.
• Dermal exposure assessment: the amount applied, application area, frequency and contact time for your product type. A leave-on product usually gives a higher exposure than a rinse-off product at the same concentration.
• Margin of Safety: the Systemic Exposure Dose (SED) is compared with the ingredient's No Observed Adverse Effect Level (NOAEL). MoS = NOAEL ÷ SED. Under the SCCS Notes of Guidance, an MoS of at least 100 is generally regarded as acceptable for systemic effects; a lower figure calls for a lower concentration or further justification.
• Safety conclusion: a consolidated judgement on whether the formula is safe for its intended use.

We follow the SCCS Notes of Guidance (12th Revision) and draw on data from studies run to OECD test guidelines.

TRA or full CPSR: when is a TRA alone enough?

A standalone TRA is enough when you need the toxicology but are not yet placing the product on the market:

• During formulation, to check a draft formula before you commit to a CPSR
• For a specific ingredient question, such as whether a higher concentration or a substitute ingredient is still safe

A TRA is never enough to sell a cosmetic. Article 10(1) requires the Responsible Person to make sure, before a product is placed on the GB or EU market, that it has had a safety assessment and that a CPSR has been set up in line with Annex I. That report also covers stability, microbiological quality, impurities and packaging, and ends with the assessor's signed Part B conclusion. Our full CPSR already includes the toxicology, so if your formula is final, order a CPSR for a single beauty product instead.

What to send us:

• Full INCI list with the percentage of each ingredient (% w/w)
• Safety Data Sheets and technical data for every raw material
• Product category and intended use, e.g. face cream, eye serum or hand lotion
• Leave-on or rinse-off, physical form, application area and frequency

Stability, microbiological and preservative challenge test results are optional but strengthen the assessment.

Legal framework

• Article 10(1) and Annex I, Regulation (EC) No 1223/2009 — before a cosmetic is placed on the market it must have a safety assessment and a CPSR; Annex I Part A covers exposure to the substances and their toxicological profile, including the Margin of Safety based on a NOAEL
• Article 10(2) — the safety assessment must be carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline
• Article 3 — a cosmetic must be safe for human health under normal or reasonably foreseeable conditions of use
• GB version — Regulation (EC) No 1223/2009 as amended for Great Britain by Schedule 34 to SI 2019/696
• Annexes II–VI — prohibited and restricted substances, colourants, preservatives and UV filters
• SCCS Notes of Guidance (12th Revision) — the accepted method for toxicological evaluation, exposure calculation and Margin of Safety

Official sources:

• Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
• Article 10: Safety assessment, GB version (legislation.gov.uk)
• Annex I: Cosmetic product safety report, GB version (legislation.gov.uk)
• SCCS Notes of Guidance, 12th Revision (European Commission)

Why brands choose Phoenix for a toxicological risk assessment

• Signed by a qualified Safety Assessor — ingredient toxicology your CPSR can rely on.
• Margin of Safety for each relevant ingredient — NOAEL, SED and MoS shown in one table.
• Built around your CPSR — matches the exposure and toxicology sections of Part A.
• Regulator-ready or we revise it free — our compliance guarantee.
• Delivery in 72, 48 or 24 hours — choose Standard, Fast or Priority Delivery.
• Trusted by 1,400+ brands over 14 years, including The Beard Struggle, The Essence Vault, Parfum Fabric and Junaid Jamshed.

Start your toxicological risk assessment today. Choose your delivery speed above, or message us on WhatsApp on +44 7346 009332 if you are unsure whether you need a TRA or a full CPSR.

Frequently asked questions