In this article
The short answer
To write Part A of your CPSR, your safety assessor needs a full quantitative formula with INCI names and exact percentages totalling 100%, an SDS plus specification or CoA for every raw material, the IFRA certificate and allergen declaration for each fragrance or essential oil, primary packaging details, a clear description of how and by whom the product is used, your label draft and claims, and any stability or microbiological data you already hold. Incomplete packs — especially missing fragrance paperwork — are what stall most reports.
Key takeaways
- Part A of the CPSR is built from documents you supply; the assessor adds toxicology, exposure maths and the Part B conclusion.
- The quantitative formula must total 100% with exact figures (not ranges), with blends broken down and fragrance named with supplier code.
- Every raw material needs a current SDS and a specification or certificate of analysis; every fragrance and essential oil needs IFRA plus an allergen statement.
- How the product is used, by whom and how often drives exposure — and therefore every margin of safety — as much as what is in the jar.
- Annex I of Regulation (EC) No 1223/2009 sets ten Part A headings; a tidy submission pack lets the assessor start on day one instead of chasing gaps for a week.
Most of the delay in getting a Cosmetic Product Safety Report has nothing to do with the assessor's toxicology. It sits in the submission pack: percentages rounded to whole numbers, a fragrance with no allergen declaration, a missing Safety Data Sheet, or a product described as a rinse-off cream when it is actually a leave-on balm. Article 10 of Regulation (EC) No 1223/2009 requires a safety assessment before the product is placed on the market. Annex I sets out ten headings of safety information that Part A must contain, and the assessor cannot invent them. In Great Britain the same duties sit in the retained Cosmetics Regulation, enforced through the Cosmetic Products Enforcement Regulations 2013 by the Office for Product Safety and Standards.
This guide turns those ten Part A headings into a practical CPSR checklist: what to send, in what form, where makers commonly fall short, and how to organise the pack so work can start on day one. It is written for makers commissioning a single-variant or multiple-variant CPSR, but any qualified assessor will ask for the same documents.
Why the submission pack matters so much
A CPSR is an evidence-based document. Part A collects the safety information about the product; Part B is the assessor's judgement. The assessor supplies toxicological profiles, exposure calculations and margins of safety, but everything else in Part A describes your product, ingredients, packaging and customers. When a pack is incomplete the assessor either chases gaps for days or weeks, or makes conservative assumptions that usually tighten Part B more than the formula needs. A complete pack produces a faster report and, often, a fairer one. Once signed, the report sits in the Product Information File under Article 11 with the supplier documents it relies on.
The ten Part A headings and what you provide for each
| Part A heading (Annex I) | What the assessor needs from you |
|---|---|
| A1 Composition | Full quantitative formula, INCI and trade names, supplier, function, exact % totalling 100; for fragrances: name, code and supplier |
| A2 Physical/chemical characteristics and stability | Appearance, odour, pH where relevant, viscosity if measured, packaging type, any stability data, intended shelf life / PAO |
| A3 Microbiological quality | Water activity / water-based ingredients, preservative system, challenge-test or microbial-count results where relevant |
| A4 Impurities, traces, packaging | Specifications or CoAs, impurity statements, packaging material description and any compatibility data |
| A5 Normal and reasonably foreseeable use | Product type, site and amount of use, frequency, leave-on or rinse-off, target and foreseeable users |
| A6 Exposure to the product | Calculated by the assessor from A5 — your use description must be accurate |
| A7 Exposure to the substances | Calculated by the assessor from A1 and A6 |
| A8 Toxicological profile | Built by the assessor; supplier tox summaries help for unusual ingredients |
| A9 Undesirable effects and SUEs | Any complaints or reactions on file, including serious undesirable effects, and how you record them |
| A10 Information on the cosmetic product | Claims evidence, volunteer or clinical data, relevant published assessments |
If you want the structure of Part A itself rather than the documents behind it, see CPSR Part A explained.
A1: preparing the quantitative formula
This is the foundation of the report and the most common source of delay. The assessor needs every ingredient by INCI name, trade name and supplier where it is a blend or proprietary material, its function, and its exact percentage by weight in the finished product. Percentages must total one hundred. Ranges, approximations and recipes in grams without a batch total are not usable, because every exposure calculation and margin of safety depends on concentration.
- Blended raw materials. An emulsifying wax, preservative blend or botanical extract in glycerin is itself a mixture. Provide the supplier's composition breakdown so each component can be assessed and correctly placed in the INCI list.
- Fragrances and essential oils. Annex I asks for the name and code number of the composition and the identity of the supplier. In practice, attach the IFRA certificate and allergen declaration as well so constituents can be assessed for sensitisation and labelling.
- Water. State it, including water contributed by aloe juice, hydrosols and extracts.
- Soap and processed systems. Give the oils, lye and water as formulated, plus superfat, so saponification can be assessed.
- Colours. INCI name and CI number, plus confirmation the colour is permitted for the intended use (especially lips and the eye area).
Keep percentages exact and consistent. The formula in Part A must match what you manufacture and the INCI list on the label. If you round to whole numbers for the assessor and then make the product to two decimal places, the report and the product have already diverged.
Raw material documents: SDS, specifications and certificates
For every raw material the assessor wants the Safety Data Sheet and either a specification or a certificate of analysis. The SDS gives hazard classification and often a toxicological summary; the specification or CoA supports identity, purity and impurity limits for A4. For botanical oils and butters, a technical data sheet with fatty-acid profile helps. For actives, a supplier dossier with use levels, stability and any safety or efficacy data shortens A8 and A10. Name files by material and supplier, and check each document is current — a multi-revision-old SDS will be queried.
Fragrance and essential oil documents
These are the documents most often missing and most often decisive. For each fragrance oil send the IFRA conformity certificate for your product category, the allergen declaration against the applicable expanded allergen list, and the SDS. For each essential oil send the SDS and a constituent or allergen breakdown, ideally batch-specific because natural oils vary. Without them the fragrance cannot be assessed for sensitisation and phototoxicity, allergen labelling cannot be set, and the report cannot be signed. If a supplier will not provide them, change supplier before you submit; an allergen review can help decode thin paperwork.
Packaging
Describe the primary packaging in contact with the product: material, closure, any pump, dropper or airless system, and fill volume for each size. The assessor uses this for A4 (migration and compatibility), A2 (protection from light and air) and A3 (how the consumer accesses the product and the contamination risk). A wide-mouthed jar and an airless pump can lead to different preservation conclusions for the same formula. Include packaging-supplier compatibility data if you have it, and list every pack size you sell.
How the product is used: the information behind A5 to A7
Exposure cannot be calculated without a clear use description. State the product type in plain terms, where on the body it is applied, roughly how much per use, how often, whether it is left on or rinsed off, and who uses it — including whether children under three, pregnant users or people with compromised skin are intended or foreseeable. Note any professional or salon use. Be honest about foreseeable secondary exposure: a lip product will be partly ingested, a body oil will reach the face, a bath product can contact the eyes. That description drives which standard exposure values the assessor applies.
Stability and microbiological information
Annex I expects microbiological specifications and, where relevant, results of a preservation challenge test. If you hold accelerated or real-time stability data, include method and results. If you hold a preservative efficacy (challenge) test or microbial counts for a water-containing product, include the laboratory report. If you have neither, say so; the assessor will advise what the product type needs. For genuinely anhydrous products the report usually documents why a challenge test is not required rather than inventing one. Stating intended shelf life and period-after-opening helps the assessor confirm or adjust them. Related service detail sits under stability and compatibility testing.
Label draft and claims
Send current label artwork or, if it does not yet exist, the intended name, on-pack and online claims, and directions for use. The assessor checks ingredient-list order, allergen declarations, warnings that Part B will require, and whether any claim strays into medicinal territory that no CPSR can support. Supplying this at the start avoids the familiar sequence of receiving the report, printing labels, then discovering B2 required a warning that is not on them.
Undesirable effects and other information
Annex I A9 covers undesirable effects and serious undesirable effects (SUEs). For a new product, state that none have been reported and describe how you will record complaints and reactions. For an existing product, summarise any reactions received, including severity. Under A10, include claims evidence (supplier substantiation, consumer trials, published data on similar formulations). The section is short for most small brands, but it should not be blank.
How to organise the submission
- One folder per product, named with the product and variant.
- A cover sheet with product name, variants, your details, Responsible Person, market (GB, EU or both), and a document index.
- The formula as a spreadsheet: INCI, trade name, supplier, function, percentage, with a total row of 100.
- A raw-material subfolder: SDS and specification per ingredient, named consistently.
- A fragrance subfolder: IFRA certificate, allergen statement and SDS per fragrance or essential oil.
- Packaging, use, label and claims as short documents or a completed questionnaire.
- Any test data: stability, challenge test, microbial counts, with laboratory reports.
Assessors who receive this structure begin toxicology immediately. Assessors who receive a recipe in an email and a link to a supplier website spend the first week asking questions.
Common submission failures
- Percentages that do not total 100, or grams without a batch weight.
- Blended materials listed as single ingredients with no breakdown.
- Fragrance with no IFRA certificate or allergen statement — still the single most common cause of a stalled report.
- Wrong product category (leave-on described as rinse-off, body product described as hand-only), which changes exposure.
- No packaging description, forcing a worst-case assumption.
- Claims withheld until after the report is signed, then medicinal wording appears on the label.
- Out-of-date documents: superseded SDS or an IFRA certificate against an old amendment.
What happens after you submit
A good assessor acknowledges the pack, reviews it for completeness within a day or two, and raises queries in one batch. Toxicology and calculations then proceed; you may get interim questions on use or claims. The signed report arrives with Part B setting out the conclusion, required label warnings and any conditions. File it, with the supplier documents it references, in the Product Information File. If you are also having the PIF built and the notification made, the same pack feeds all three.
The all-in-one compliance pack uses one submission for the CPSR, PIF and SCPN notification. A pre-submission consultation is worthwhile for a first product or an unusual formula.
Myths we hear
- A CPSR is a lab test you order once. A CPSR is a written safety assessment by a qualified assessor under Article 10 and Annex I. Lab tests (stability, challenge, microbes) support Part A; they do not replace the report.
- You only need a CPSR if you sell in the EU. Great Britain requires a CPSR under the retained Cosmetics Regulation as well. Separate notification portals (CPNP vs SCPN) do not remove the safety report.
- Ranges on the formula are fine if they are "about right". Exposure and margin-of-safety calculations need exact finished-product percentages. Ranges, rounded guesses and recipes in grams without a batch total are not usable as submitted.
- Once the assessor has signed, the CPSR never changes. Update it when the formula, key raw materials, packaging, claims, target users or the applicable rules change — and keep the revised report in the Product Information File.
- Fragrance can go in as "parfum 2%" with no paperwork. Annex I asks for the fragrance name, code and supplier, and in practice the assessor also needs the IFRA certificate and allergen declaration before Part A/B can be finished.
What to do this week
- Build one spreadsheet formula per variant: INCI, trade name, supplier, function, exact % — total must equal 100.
- File a current SDS and specification or CoA for every raw material, named by material and supplier.
- Attach IFRA conformity certificates and allergen declarations for every fragrance oil and essential oil.
- Write a one-page use description (site, amount, frequency, leave-on/rinse-off, users) and describe primary packaging.
- Send the label draft and planned claims with the pack, then keep the signed CPSR inside your PIF under Article 11.
Frequently asked questions
What documents do I need for a CPSR Part A?
A full quantitative formula with INCI names and exact percentages totalling 100%, a current SDS and specification or CoA for every raw material, IFRA certificate and allergen declaration for each fragrance or essential oil, primary packaging details, a use-and-users description, your label draft and claims, and any stability or microbiological data you hold. That pack is what Annex I Part A is built from.
Can I submit my recipe in grams instead of percentages?
Only if you also give the batch total so percentages can be derived. The assessor works in finished-product percentages because every exposure and margin-of-safety calculation depends on them. A spreadsheet with exact percentages totalling 100% is the correct form.
Do I need an SDS for every ingredient?
Yes for practical Part A work — or a supplier technical data sheet where a material is not classified as hazardous. Identity, purity and hazard information support A1 and A4, and the documents are filed with the CPSR in your Product Information File under Article 11.
What fragrance documents does the safety assessor need?
Annex I requires the fragrance name, code number and supplier. In practice also send the IFRA conformity certificate for your product category, the allergen declaration against the applicable expanded list, and the SDS. For essential oils, send the SDS and a constituent or allergen breakdown, ideally batch-specific.
Why does the assessor need to know how the product is used?
Because exposure — and therefore every margin of safety — depends on where and how much product is applied, how often, whether it is left on, and who uses it. The same formula assessed as a hand cream and as a body lotion produces different results.
Do I need a challenge test before I submit for a CPSR?
Include whatever microbiological and stability data you already hold. Annex I expects challenge-test results where preservation efficacy evidence is relevant, which for most water-containing products means a preservative efficacy test will be required before the report can be signed. Genuinely anhydrous products usually justify why a challenge test is not required.
How long does a CPSR take once the document pack is complete?
With a complete submission, typically a few days to a couple of weeks depending on formula complexity and workload. Missing fragrance or raw-material documents remain the usual cause of longer delays — not the toxicology itself.
What do I supply for Part A versus what the assessor writes in Part B?
You supply the product facts behind Part A: composition, physico-chemical and stability information, microbiology inputs, impurities and packaging, normal and foreseeable use, undesirable-effect history, and claims evidence. The assessor derives exposure (A6–A7), builds toxicological profiles (A8), and writes Part B — conclusion, labelled warnings and scientific reasoning — then signs.
Official sources and legislation
- Regulation (EC) No 1223/2009, Article 10 (safety assessment)
- Regulation (EC) No 1223/2009, Article 11 (Product Information File)
- Regulation (EC) No 1223/2009, Annex I (Cosmetic Product Safety Report)
- Cosmetic Products Enforcement Regulations 2013
- Scientific Committee on Consumer Safety (SCCS), Notes of Guidance
- Office for Product Safety and Standards (OPSS)
- Submit cosmetic product notifications (SCPN, Great Britain)
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