If you make scented or skin products, sooner or later you will be told you need either a TRA or a CPSR, and quite often you will be told both by different people. The confusion is understandable. Both are safety assessments written by qualified scientists, both look at your ingredients and how people are exposed to them, and both end with a signed conclusion about whether the product is safe. But they sit under different laws and apply to different products. A cosmetic is governed by Regulation (EC) No 1223/2009 and, in Great Britain, the Cosmetic Products Enforcement Regulations 2013, enforced by the Office for Product Safety and Standards. A candle or a room spray is not a cosmetic at all, so those rules do not apply to it, and a different set of duties takes over.

This guide explains what each report is, which products need which, how to handle the borderline cases that trip people up, what each document contains, who is allowed to sign it, and what happens if you get the choice wrong. By the end you should be able to look at any product on your bench and say with confidence which assessment it needs.

What is a CPSR?

A Cosmetic Product Safety Report is the safety assessment that every cosmetic product must have before it is placed on the market in the UK or the EU. It is not optional and it is not a certificate you buy; it is a scientific document laid out in a legally defined format in Annex I of the Cosmetics Regulation. It comes in two parts. Part A gathers the safety information: the full quantitative formula, the physical and chemical characteristics, microbiological quality, impurities, packaging, normal and foreseeable use, exposure to the product and to each ingredient, the toxicological profile of every ingredient, and any data on undesirable effects. Part B is the assessment itself, where a qualified safety assessor weighs all of that evidence, calculates margins of safety where relevant, states the conclusion, sets any warnings and instructions that must appear on the label, and signs it with their credentials. Phoenix prepares these as single variant and multiple variant CPSRs.

The CPSR does not stand alone. It sits inside the Product Information File, the PIF, which the Responsible Person must keep for ten years after the last batch is placed on the market. The product must also be notified before sale, through SCPN in Great Britain or CPNP in the EU. So when someone says a cosmetic needs a CPSR, they are really describing a chain: CPSR, PIF, Responsible Person and notification. All four are required.

What is a TRA?

A Toxicological Risk Assessment is a safety assessment for a product that is not a cosmetic. There is no Annex I template for it, because it does not come from the Cosmetics Regulation. Instead, it is the expert evidence a maker uses to meet a broader legal duty: that any consumer product placed on the market must be safe. In Great Britain that duty comes from the General Product Safety Regulations 2005, and in the EU from the General Product Safety Regulation. Alongside it, if the product is a chemical mixture that meets hazard criteria, the CLP Regulation on classification, labelling and packaging requires hazard classification and the correct warning labels, and a Safety Data Sheet may be needed for the supply chain.

In practice a TRA identifies every substance in the product, gathers hazard data for each, works out how a person is realistically exposed (how much, how often, by what route, for how long), compares that exposure against safe thresholds, and concludes whether the product is safe as intended, with any restrictions or label warnings the maker must apply. Phoenix prepares TRAs for beauty and personal care adjacent products and for fragranced products such as candles, wax melts and diffusers.

A second meaning to be aware of. Toxicologists also use the phrase toxicological risk assessment for an assessment of a single ingredient, for example a new or unusual substance inside a cosmetic. That kind of TRA can feed into a CPSR, but it does not replace it. When makers ask TRA or CPSR, they almost always mean the product level question this article answers.

TRA vs CPSR at a glance

The deciding question: is it a cosmetic?

Everything turns on the legal definition of a cosmetic product. A cosmetic is any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, external genital organs) or with the teeth and the mucous membranes of the mouth, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Three things in that definition do the work: it must be applied to the body, it must be for a human, and its main purpose must be one of those listed functions.

Apply that test and most products sort themselves quickly. A bar of soap, a lip balm, a body butter, a shampoo, a perfume oil for the skin: all applied to the body, all for cleaning, perfuming or conditioning, all cosmetics, all need a CPSR. A candle, a wax melt, a reed diffuser, a room spray, a carpet freshener: none is applied to the body, so none is a cosmetic, and each needs a TRA and the general product safety and CLP duties instead. The product does not become a cosmetic because it smells nice or because it uses cosmetic grade ingredients. Intended use decides.

Which products need which: a working guide

The table below covers the products that generate the most questions. Use it as a starting point, not a substitute for assessment, because your claims and instructions can move a product across the line.

The borderline cases that catch people out

Massage candles

A massage candle looks like a candle, so makers assume it needs a TRA. But the whole point of the product is that the melted pool is poured onto skin, which makes it a cosmetic, and a CPSR is required. Because it also burns, the safety assessment must additionally cover the melt pool temperature and the wick, and the label needs both cosmetic information and burn safety instructions. It is one of the few products where the cosmetic framework and candle safety considerations genuinely overlap.

Room and linen mists

A mist sold purely for rooms and fabric, with no suggestion of use on the body, is not a cosmetic and needs a TRA and CLP labelling. The moment your product name, description or directions invite people to spray it on their skin, pillow next to their face or clothes they are wearing, it is being marketed as a cosmetic and needs a CPSR. Many makers deliberately choose to formulate a skin safe body and linen mist and assess it as a cosmetic, because that single product can then legally do both jobs.

Bath products

Bath bombs, bath salts and bath melts confuse people because they go into water rather than straight onto the body. They are still cosmetics: they are diluted for the purpose of contacting the skin while bathing, to clean, condition or perfume it. Bath products need a CPSR. A scented product designed only to fragrance a bathroom, not the bath water, would be a room fragrance and take the TRA route.

Wax melts using cosmetic butters and oils

Using shea butter or a skin safe fragrance in a wax melt does not turn it into a cosmetic. Nobody applies a wax melt to their body, so it is a home fragrance product assessed by TRA, with CLP classification for the fragrance load. Conversely, using candle grade fragrance in a body product does not make it a candle; it makes it a cosmetic with an ingredient that may fail its CPSR.

Products that are neither

Some products fall outside both frameworks. A hand sanitiser or antibacterial surface spray has a biocidal function and is regulated under the Biocidal Products Regulation. A balm that claims to treat eczema or heal a wound is making a medicinal claim and becomes a medicine. If your product's main purpose is to kill microbes or to treat a condition, neither a TRA nor a CPSR is the right answer, and you need specialist advice before going further.

What each report actually contains

Both assessments are built from the same raw material: a complete, quantitative formula with every ingredient's INCI or chemical name and percentage, the supplier Safety Data Sheets, the IFRA certificate and allergen statement for any fragrance, specifications for any raw material of variable composition, and a clear description of how the product is used. Where they differ is in structure and emphasis.

• CPSR Part A. Formula, physico chemical properties, stability, microbiological quality and challenge test data where relevant, impurities and traces, packaging compatibility, normal and foreseeable use, exposure calculations for the product and each substance, toxicological profiles, undesirable effects and any other supporting data.
• CPSR Part B. The assessor's reasoning, margin of safety calculations for substances of concern, the safety conclusion, the label warnings and instructions for use that must appear, and the assessor's name, address, proof of qualification and signature.
• TRA. Product description and intended use, full substance identification, hazard profile for each substance including sensitisation and phototoxicity for fragrance materials, realistic exposure scenarios (for a candle, inhalation of combustion and evaporation products in a room; for a diffuser, evaporation and accidental skin contact or ingestion), comparison of exposure against safe thresholds, an overall conclusion, and recommended warnings, usage restrictions and, where hazardous, the CLP classification and label elements.

Who is allowed to sign

For a CPSR the law is specific. Part B must be carried out by a person holding a diploma or other evidence of formal qualification awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent. A well meaning chemist without that qualification cannot sign your CPSR, however experienced. For a TRA there is no statutory list of qualifications, but the assessment is only worth anything if the person writing it is demonstrably competent in toxicology and product safety, because it is your evidence if a regulator or a court ever asks how you knew the product was safe. Both Phoenix reports are prepared and signed by qualified toxicologists and safety assessors, and you can review our client verifications.

What happens if you choose the wrong one

Selling a cosmetic on the strength of a TRA is the more serious mistake, because the cosmetic has then been placed on the market with no CPSR, no compliant PIF and usually no notification. Trading Standards and OPSS can require withdrawal or recall, marketplaces such as Amazon and Etsy will delist products that cannot show a CPSR on request, product liability insurers can decline a claim because the legal basics were missing, and the maker is personally exposed. It also means the assessment did not look at the things cosmetics law demands, such as exposure through the skin for every ingredient.

Assessing a candle or wax melt as if it were a cosmetic is less common but still wrong. The CPSR framework asks cosmetic questions and skips the ones that matter for a burned or evaporated product: combustion, inhalation, flammability, CLP hazard classification and the pictograms and hazard statements that must appear on the label. A maker in that position typically ends up paying twice: once for a report that does not fit, and again for the right one.

Cost, timing and what to prepare

A TRA is usually quicker and less expensive than a CPSR, not because the science is lighter, but because there is no PIF to compile, no notification to file and no Responsible Person chain to set up around it. A CPSR carries those obligations and its price often reflects the whole package. For both, the single biggest cause of delay is incomplete supplier documentation: a missing SDS, an IFRA certificate for the wrong product category, or a fragrance supplier who will not disclose allergen content. Gather these first.

Whichever route you need, send us the full formula with percentages, every supplier SDS, the IFRA certificate and allergen statement for each fragrance, your packaging details and a plain description of how the product is used. If you are not sure which assessment applies, that is exactly the question our regulatory consultation answers in a single call, and if you are launching a range that mixes cosmetics and home fragrance, we can scope both assessments together so nothing is duplicated.

A simple three question test

• Is it applied to the human body, including through bath water? If no, it is not a cosmetic. Think TRA, general product safety and CLP.
• Is its main purpose to clean, perfume, change the appearance of, protect, condition or deodorise the body? If yes to this and the first question, it is a cosmetic. Think CPSR, PIF, Responsible Person and notification.
• Does it claim to kill microbes or treat a condition? If yes, stop. It may be a biocide or a medicine, and neither assessment is the right one.

Run every new product through those three questions before you order packaging or book an assessment, and the TRA or CPSR question answers itself nine times out of ten. For the tenth, ask.

Related reading on the Phoenix blog

• CPSR for whipped soap
• CPSR for body mist
• CPSR for lip scrub
• All regulatory compliance articles

Phoenix services mentioned in this article

• Toxicological Risk Assessment for beauty and personal care products
• Toxicological Risk Assessment for fragranced products
• Cosmetic Product Safety Report, single variant
• Cosmetic Product Safety Report, multiple variants
• CPSR for fragrance products
• Safety Data Sheets for hazmat products, EU and UK
• All in one compliance pack: CPSR, PIF, SDS, SCPN
• Expert regulatory consultation
• Contact Phoenix

Official sources and legislation

• Regulation (EC) No 1223/2009 on cosmetic products (retained UK version)
• Cosmetic Products Enforcement Regulations 2013
• General Product Safety Regulations 2005
• Regulation (EU) 2023/988, the General Product Safety Regulation
• CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging
• HSE guidance on chemical classification and labelling
• Office for Product Safety and Standards
• Submit cosmetic product notifications (SCPN)

About the author

Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.