Getting a balm safety assessed: the dossier, the assessor and the margin of safety

What goes into Annex I Part A and Part B, the documents your safety assessor will ask for, a worked margin of safety calculation, and realistic costs and turnaround.

A safety report is a document somebody else signs about your formula, on the strength of a data pack you assemble. Almost all of the money and nearly all of the delay sit in the pack, not the signature. This page sets out what the assessor needs from you, what they add themselves, and how the margin of safety arithmetic actually falls out for a lip balm.

• Article 10, Regulation (EC) No 1223/2009
• Lip exposure: 57 mg/day
• Margin of safety target: 100
• Assessor: degree level qualification
• PIF retained 10 years

Which rule this is, and where it bites

Article 10 of Regulation (EC) No 1223/2009 says a cosmetic product may not be placed on the market until a safety assessment has been carried out and a cosmetic product safety report drawn up in accordance with Annex I. Annex I sets the structure. Commission Implementing Decision 2013/674/EU adds official guidelines on how to fill it in, and is the most useful free document in the whole system for a small maker who wants to know what "adequate" means.

Great Britain applies the same text, retained after exit as the UK Cosmetics Regulation and carried by Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The obligations are the same in substance: a Responsible Person established in the UK, a signed report, a product information file at a UK address in English. Northern Ireland stays under the EU instrument. The wider pre-market machinery, including notification, is set out under selling balms in the UK and EU.

Nothing equivalent exists in the United States. Under MoCRA a responsible person must keep records adequately substantiating safety, but no signed report by a person holding a named qualification is required, and there is no template. Canada asks for a cosmetic notification form rather than an assessment. So the report is an EU, UK and Northern Ireland cost, and its scope is per product formula: one recipe sold in ten sizes and two label designs is one report, while two recipes are two.

Annex I Part A, heading by heading, and who produces it

Part A is the data set. It is not a form you fill in on the day: most of it is supplier paperwork you should already hold, plus a small amount of arithmetic and observation that only you can do. The assessor will not chase your suppliers for you, and every missing document is a day added to the turnaround.

Two headings do most of the damage to a timetable. A3 stalls when a maker assumes anhydrous means exempt, which it is not: microbiological quality has to be characterised for every product, and the reasoning behind a water activity argument is worth understanding before the conversation starts, as set out under do balms need preservatives. A4 stalls when a supplier turns out to have no specification at all, which is a sourcing problem rather than a regulatory one and is easier to avoid than to fix, as argued under sourcing ingredients.

Part B, and who is allowed to sign it

Part B is the assessment proper: the conclusion that the product is safe under Article 3, the warnings and instructions that have to appear on the label, the reasoning that connects the Part A data to the conclusion, and the assessor's name, address, qualification and signature.

Article 10(2) sets the qualification test. The assessor must hold a diploma or other evidence of formal qualifications 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 by a member state. That is a hard gate. Twenty years of formulating, a diploma from a private cosmetic science course and a chemistry A level are all outside it. If you do not hold the qualification you cannot sign your own Part B, and no amount of care in Part A changes that.

The Regulation sets a qualification test rather than a nationality test, so an assessor does not have to sit in the same country as your Responsible Person. What does matter is language: a competent authority can ask for the file in a language it accepts, which means English for Great Britain and often the market language in the EU. Before you engage anyone, ask to see the qualification they are relying on, ask whether the report is written for GB, the EU or both, and ask what their professional indemnity position is. An assessor who signs carries real liability, which is why a good one refuses a thin dossier rather than guessing.

The per ingredient document pack

The single biggest predictor of a cheap, fast assessment is whether you can hand over a complete folder per raw material on day one. Build it as you buy, not when you decide to sell.

Essential oils generate more paperwork than everything else combined, because each one is a mixture whose constituents carry their own limits. If your range uses eleven oils you have eleven document sets to keep current, and every supplier change resets them. The formulation side of that trade is covered under essential oils in balms, and the labelling arithmetic under fragrance allergen labelling. Ingredient list order and naming, which the assessor will check against the label artwork, can be built with the INCI list builder.

The margin of safety, worked on a lip balm

The margin of safety is the number at the centre of Part B for any substance with a threshold effect. It compares the dose known to produce no adverse effect in animal studies against the dose your product delivers to a human, and it must reach 100.

The arithmetic runs in three steps. First, the daily amount of product. The SCCS Notes of Guidance give an estimated daily exposure of 57 mg a day for lip products, a figure that already assumes the product stays on and is partly ingested, so no further retention factor is applied. Second, the amount of the substance in that product, which is the 57 mg multiplied by the concentration. Third, the systemic exposure dosage, or SED, which is that amount divided by the SCCS default body weight of 60 kg, adjusted by the fraction absorbed.

Take an ingredient used at 2.0 percent in a lip balm, with no measured absorption data, so absorption is taken as 100 percent:

1. Substance applied per day. 57 mg multiplied by 0.02 gives 1.14 mg a day.
2. Systemic exposure dosage. 1.14 mg divided by 60 kg gives 0.019 mg per kg of body weight per day.
3. Margin of safety. If the point of departure is a no observed adverse effect level of 20 mg per kg per day, then 20 divided by 0.019 gives a margin of about 1,050.

That passes comfortably. The threshold of 100 is not arbitrary: it is a factor of 10 for the difference between test species and humans, multiplied by a factor of 10 for variation between individual humans. Turning the calculation around gives the more useful number, which is the concentration at which a substance would stop passing.

The last column is the one that surprises people. The same ingredient is roughly 137 times more constrained in a body balm than in a lip balm, because a body application is about 7.82 g a day against 57 mg. A face balm sits near 1.54 g a day and a hand balm near 2.16 g. Small print matters here: those applied amounts come from the SCCS exposure tables and are revised between editions, so an assessor works from the current revision rather than from a figure quoted on a website.

Where the margin of safety calculation stops

Four limits are worth knowing before you argue with an assessor about a number.

Sensitisers are not handled this way. Skin sensitisation is a local effect at the point of contact, so a systemic dose calculation misses it. Fragrance allergens are controlled through IFRA Standards and Annex III thresholds instead, which is why a material can pass the margin of safety at 2 percent and still be capped at 0.1 percent. Substances without a threshold have no NOAEL at all, so genotoxic or mutagenic materials cannot be handled by this arithmetic and are simply excluded. Aggregate exposure is a live question. If a customer uses your lip balm, your hand balm and your body balm, the same essential oil is delivered three times, and the assessor may aggregate across your own range. And children under three trigger a separate assessment under Annex I, which catches nappy balms, baby balms and children's lip balms, a boundary discussed under balms for babies.

The specific Annex III entries that bite hardest on balms, including the tight lip limits on methyl salicylate and salicylic acid, are tabulated on the UK and EU selling page. Materials with pharmacological reputations, such as menthol and camphor, attract both a numeric limit and a claims problem at the same time, which is a good reason to settle wording against cosmetic versus drug claims before the report is drafted rather than after.

Grouping shades and scents to cut the cost per variant

The report is per formula, so a naive range of twelve scents on one base is twelve formulas and twelve fees. Assessors will usually treat a family as a single assessment with variants, provided the base is genuinely identical and only a defined component changes. Two structures work.

• Colour

  One base, a pigment matrix

  Identical base at a fixed percentage, with iron oxides and micas varying within a stated envelope, for instance a total pigment load never exceeding 4 percent. The assessor evaluates the worst case shade at the maximum load, and the remaining shades follow from it.

• Scent

  One base, a fragrance slot

  Identical base with a fixed fragrance percentage, and a list of the specific oils or compounds that may occupy that slot. Each oil needs its own allergen and IFRA documentation, but the base is assessed once.

Design the range this way from the start and you keep the option. Design it as twelve unrelated recipes with different wax loads and you have thrown it away. The commercial logic is that assessment is a fixed cost per formula, so it lands hardest on the maker with many recipes and low volume, which is worth modelling alongside the rest of your costing and pricing. Ask your prospective assessor how they price variants before you finalise the range, because their answer changes what your range should look like.

What it costs and how long it takes

UK quotes gathered in 2026 sit in a band of roughly 120 to 400 pounds per formula, with variants under a range assessment typically charged at a fraction of that, and turnaround of 5 to 20 working days from a complete dossier. The spread is wide because the work is not the same job twice.

The clock only starts when the dossier is complete. In practice the six weeks people report is usually four weeks of chasing a supplier for a specification and ten days of assessment. Sort the paperwork first and the quoted turnaround becomes the real one.

The product information file, and the ten year clock

Article 11 requires the Responsible Person to keep a product information file accessible at the address given on the label. It holds a description of the product, the safety report itself, a description of the manufacturing method with a statement that it complies with good manufacturing practice, proof of any claimed effect where the claim justifies it, and data on animal testing. It is not lodged with anyone: you hold it, and you produce it when a competent authority asks.

The retention period is ten years from the date the last batch was placed on the market, not ten years from the date of the report. That clock restarts every time you make the product again, so a formula you produce for six years is kept for sixteen. Batch records, retained samples and the manufacturing method feed straight into it, which is the practical reason to keep batch records properly from the first sale rather than reconstructing them later. The GMP statement is satisfied by working to ISO 22716, which at small scale looks like the routine described under workshop hygiene. Stability observations that support the durability date belong here too, gathered as described under shelf life testing, with the accelerated protocols under accelerated ageing used as a screen rather than as proof.

What this page cannot decide, and the order to do things in

Trebalm cannot assess your formula, cannot tell you whether a specific percentage is safe in a specific product, and cannot stand in for a qualified assessor. Nothing here is a safety assessment and nothing here substitutes for the current text of the rules where you sell, a limit set out in full on the disclaimer. The arithmetic on this page is published so that you can follow the assessor's reasoning and prepare for it, not so that you can perform it.

The decision rule is about sequence. Finish the formula before you commission the report, because changing a supplier grade or a percentage afterwards may reopen it. Gather every document before you request quotes. Design the range as a base plus variants rather than as a set of unrelated recipes. Assess one product properly and sell it before commissioning five more, since the cost is fixed per formula and unrelated to how many units you sell. And treat any offer to write both Part A and Part B for a fee that looks too low with suspicion, because the qualification behind the signature is the only part of the transaction you cannot audit yourself. Once the report is signed, the remaining steps are notification and labelling, covered under cosmetic notification portals and labelling cosmetics in the UK.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.