In this article
The short answer
Conditions in Part B mean the assessor has found your product safe within stated limits: an ingredient kept at or below a set level, a warning on the label, an age or user restriction, a pH range, a type of packaging or a shelf life. Each one should trace back to data in Part A. Some, such as Annex III maximums and the exact warnings those entries prescribe, are fixed by law. Others reflect the assessor's judgement and can sometimes move with better data, a reformulation or a more accurate product description. You can accept, reformulate or supply data. You cannot ignore a condition and still rely on the report.
Key takeaways
- A conditional Part B is normal. It defines the formula, use, users and label that make the product safe under Article 3.
- Every condition should be traceable to the reasoning in Part B and the data in Part A, usually the margin of safety, IFRA limits, irritation, pH or stability.
- Sort conditions into "set by law" (Annex III and V limits and their exact warnings) and "assessor's judgement" before you try to change any of them.
- Your options are accept, reformulate, or supply data such as a dermal absorption study that replaces the 50% default.
- Selling outside a condition, or applying it to one pack size but not another, leaves you without a valid safety assessment.
A brand owner rang us last spring, upset. She had paid for a safety report on her new rose and geranium face oil, and Part B had come back with three conditions: geranium oil capped below the level she used, "avoid contact with eyes" on the label, and no use on children under three. "So it failed," she said. It had not. Those three lines were the assessor telling her exactly what made the oil safe to sell, and two of them cost nothing beyond a label tweak. The third took one afternoon with her fragrance supplier.
That reaction is common, and it is worth getting past quickly. Under Annex I of the Cosmetics Regulation, Part B must contain a conclusion on safety, a statement on the warnings and instructions of use the label needs, the scientific reasoning behind both, and the assessor's credentials and signature. Conditions are simply what those first three sections look like when the assessor has done the work properly. If you want the structure of Part B first, our guide to CPSR Part B explained walks through all four sections. This article is about the next step: you have the report, it has conditions, and you need to decide what to do.
Why conditions exist at all
Article 3 requires a cosmetic to be safe "when used under normal or reasonably foreseeable conditions of use", taking account of its presentation, labelling and instructions. The assessor cannot sign off a product in the abstract. They sign off a specific formula, used in a specific way, by specific people, with specific words on the pack. Every condition pins down one of those variables.
That also tells you what happens if you ignore one. A face oil sold with more geranium than Part B allows, or marketed for babies when Part B says adults only, is no longer the product that was assessed. Strictly, you are selling something with no safety assessment behind it, and in Great Britain that is enforceable under the Cosmetic Products Enforcement Regulations 2013, mostly by Trading Standards.
The conditions we see most, and where they come from
Most conditions fall into a handful of types. The column that matters most is the third one, because a condition that comes straight from the law cannot be moved by anyone, while one that reflects the assessor's judgement on your data sometimes can.
| Condition in Part B | Where it usually comes from in Part A | Fixed by law or the assessor's call? | What you do |
|---|---|---|---|
| Maximum level for a fragrance or essential oil | Sensitisation and phototoxicity review against the IFRA Standard for the product's category; known sensitisers in the oil | Mostly the assessor, working from IFRA (an industry standard) and the toxicology | Keep every batch at or below the cap and keep the IFRA certificate in the PIF |
| Maximum level for an active or preservative | A margin of safety below 100 at the level you submitted, or an Annex III or V maximum | Annex limits are law. A lower cap from the margin of safety is the assessor's | Reduce the level, or supply better data (see below) |
| Exact warning such as "Not to be used for children under 3 years of age" | An Annex III entry, for example salicylic acid (entry 98) | Law. The wording is set in the annex | Print it word for word |
| "Avoid contact with eyes", "Discontinue use if irritation occurs" | Irritation data, the pH, or use near the face | The assessor's call (some Annex III entries also require eye warnings) | Print it as worded in Part B |
| Not for children under three, or adult use only | Exposure per kilogram is higher in small children; ingredients such as camphor, menthol or some essential oils | Usually the assessor; law where an annex entry says so | Label it and keep baby and toddler imagery out of the marketing |
| Sun protection advice | Exfoliating acids such as glycolic or lactic acid, or phototoxic citrus oils | The assessor, guided by the SCCNFP opinion on AHAs. No annex wording exists for AHAs | Print the advice; keep the acid level and pH within the assessed figures |
| pH to stay within a range | Acids, alkaline products, preservatives that only work at certain pH | The assessor, sometimes tied to an annex entry (for example sodium or potassium hydroxide) | Check pH on every batch and keep the record |
| Airless, pump or opaque packaging | Weak preservation in open jars, light sensitive ingredients | The assessor | The report only covers the product in that pack |
| Shelf life or period after opening | Stability data, challenge test, oxidation of oils | The assessor, applying Article 19(1)(c) | Never print a longer date or PAO than the report supports |
| Claim removed or limited | A claim that suggests a medicinal effect or that the data cannot support | Partly law (claims rules), partly the assessor | Change the pack, the listing and your social posts |
Two items people expect to find in that table are not really Part B conditions. Fragrance allergen declarations in the ingredient list follow from Annex III: in Great Britain, each listed allergen has to be named once it exceeds 0.001% in a leave on product or 0.01% in a rinse off product, and the EU has since added many more allergens to that list. A good assessor will flag them, but they are a labelling rule in their own right. Our guide to fragrance allergen labelling covers the EU changes. Likewise, "keep out of reach of children" is required by some annex entries and added by assessors for many products, but it is not automatic on every cosmetic.
How to read a condition before you react to it
Every condition should trace back to the reasoning section of Part B, and the reasoning should trace back to data in Part A. So when something hurts, go looking for its cause before you pick up the phone.
- A cap on an active or preservative. Find the margin of safety table in Part A, section 8. You should see the margin at the level you submitted and at the permitted level. If the margin was below 100 at your level, look at which inputs drove it: the NOAEL, the daily amount, the retention factor or the dermal absorption figure. Our explainer on the margin of safety shows how those numbers fit together, and our guide to exposure assessment explains where the daily amounts come from.
- A fragrance cap. Look for the IFRA category the assessor used and the constituent that set the limit. A body oil is assessed against a different IFRA category, with a different limit, from a lip balm or a soap.
- A warning. Check whether the reasoning cites an annex entry (fixed wording) or irritation, pH or use data (the assessor's judgement).
- An age restriction. Annex I demands a specific assessment for products intended for children under three, so the assessor will have considered the higher exposure per kilogram of body weight in small children. Our guide to cosmetics for under threes goes into this.
The cause tells you which response is realistic. A cap set by an Annex III maximum or by a sensitiser at its IFRA limit will not move. A cap set because the assessor had to assume worst case absorption might.
Three honest ways to respond
1. Accept it and build it into the product
This is the right answer most of the time, and usually the cheapest. Formulate at or below the permitted level, print the warnings as worded, carry the age or user restrictions into your website and social posts as well as the label, and record pH or packaging requirements in your batch documents. Then make sure the conditions are reflected in your Product Information File and that the label artwork is checked against Part B before anything goes to the printer.
2. Reformulate and have the report revised
Sometimes a condition guts the product. A fragrance cap so low the scent disappears, or an exclusion of the ingredient the whole product is built around. Then the formula has to change: swap the ingredient, reduce it, or change to a lower exposure format, and go back to the assessor for a revised report. Tell them what you are trying to keep. An experienced assessor will often know the fix, such as replacing cold pressed bergamot with a furocoumarin free (FCF) grade, or switching to a fragrance whose IFRA certificate allows a higher level in your category.
3. Supply data that changes the finding
Some conditions rest on cautious defaults used because data were missing. The clearest example is dermal absorption. Under the SCCS Notes of Guidance (12th revision), an assessor with no usable absorption data has to assume 50%. If your supplier holds a proper study showing, say, 5%, the systemic dose falls tenfold and the margin of safety rises with it. A passing challenge test can relax a preservation condition, and real time stability data can extend a shelf life. These routes cost time and sometimes lab fees, so ask the assessor first, in writing, exactly which data would change their conclusion.
A cheaper fix people miss: describe the product accurately
Sometimes a condition reflects how the product was described, not what is in it. An oil assessed as a whole body product may be capped harder than the same oil used only on hands and cuticles. A balm restricted because of an essential oil may sell perfectly well as an adult product. If the product really is used on a smaller area or by a different group, tell the assessor. They will need to revise the exposure sections and Part B, but that costs far less than a new formula. It only works if the new description is true and your marketing matches it.
What you cannot do
- Quietly ignore it. Selling above a permitted level, without a required warning, or to a restricted group means selling outside the assessment.
- Edit the report. Changing Part B, or showing a retailer an "unconditional" version, misrepresents a signed document and leaves you without a valid assessment.
- Apply conditions selectively. A warning on the 50 ml jar but not the 15 ml travel size, or "adults only" on the label while the Instagram shows a toddler, both put you outside the report.
- Assume a legal ingredient is fine at any legal level. Annex maximums are ceilings for every product in a category. Your product's exposure may justify less.
Taking the same formula to a second assessor is allowed, and genuine second opinions have their place, especially where a condition rests on judgement. But if the first assessor's finding was sound, a report that simply leaves it out is the weaker document, and it is the one an inspector or insurer may later question.
Conditional report or refusal to sign?
A conditional conclusion means the assessor can describe a safe version of your product. A refusal means they cannot, at least not without fundamental change. Refusals are much rarer than people fear, and they always come with a reason. The usual ones:
- A substance listed in Annex II (prohibited), or one used above an Annex III limit that cannot be lowered without losing the product.
- A substance classified as a carcinogen, mutagen or reproductive toxicant that is not permitted under Article 15. In Great Britain that means any category 1A, 1B or 2 CMR not listed in Annexes III to VI. See our article on CMR reclassification.
- A water based product with no workable preservation, or a failed challenge test that cannot be fixed.
- A fragrance or raw material whose supplier will not disclose enough composition or safety data.
- A product whose purpose or claims make it a medicine or a biocide rather than a cosmetic. Our guide to borderline products explains where that line sits.
When "no conditions at all" should worry you
A simple anhydrous balm with a well documented fragrance can genuinely come back with only standard warnings. A fragranced water based cream with several actives and essential oils, sold to a wide audience, almost never does. If a report like that has no maximum levels, no user restrictions and nothing beyond generic wording, it may not have engaged with the data. Retailers, marketplaces and insurers increasingly read Part B, and a report that found the issues and dealt with them is far more convincing than one that found nothing.
Ranges: conditions are set per variant
In a multiple variant CPSR, conditions belong to each variant. The lavender may carry an allergen declaration and a lower fragrance cap while the unscented version carries neither. Keep a simple matrix of variants against conditions; it stops the classic mistake of printing one scent's warnings on another's label. When you add a scent later, its addendum brings its own conditions. Our guide to CPSRs for variants covers how ranges are grouped.
A checklist for the day the report lands
- Read Part B in full, reasoning included, not just the first line of the conclusion.
- List every condition: levels, warnings, age or user limits, packaging, pH, shelf life, claims.
- Mark each one as "law" or "assessor's judgement" using the reasoning.
- Check each against the formula, the label, the website, marketplace listings and social posts.
- For any condition you cannot live with, ask the assessor in writing what would change it before spending money.
- Update artwork, have it checked against Part B, then print.
- File the report in the PIF with the batch records that show you meet the conditions.
Stuck on a Part B condition?
Send us the report and tell us which condition is the problem. We will trace it back to the finding in Part A, tell you honestly whether data, a reformulation or a clearer product description can move it, and check your label against Part B before you print.
Related reading
- CPSR Part B explained
- The margin of safety, explained simply
- Exposure assessment in a CPSR (Part A, sections 5 to 7)
- Cosmetic label warnings and mandatory statements
- Restricted ingredients: Annex III explained
- IFRA Standards and certificates explained
- pH in cosmetics: why the assessor asks
- What a CPSR is not
- All regulatory compliance articles
Myths we hear
- Conditions mean my CPSR failed. A conditional conclusion is a pass with the limits written down. A refusal to sign is the failure, and it is rare.
- A different assessor would remove the conditions. If the finding is sound, a report that ignores it is the weaker one. Second opinions help with judgement calls, not with annex limits.
- If an ingredient is legal, I can use it up to the legal maximum. Annex maximums are ceilings. Your exposure and margin of safety may justify a lower level.
- Warnings on the label are enough; the marketing can say what it likes. Restrictions apply to the whole presentation, including your website and social posts.
- Allergen declarations are something the assessor adds. They are a separate labelling rule from Annex III thresholds. The assessor may flag them, but they apply anyway.
What to do this week
- List every condition in your Part B and mark each as set by law or by the assessor's judgement.
- Check your label, website, marketplace listings and social posts against each condition.
- Confirm batch records show fragrance levels, actives and pH within the stated limits.
- For any condition that hurts the product, email your assessor asking what data or change would alter it.
- Ask your raw material suppliers whether they hold dermal absorption or other safety data you have not shared.
Frequently asked questions
Is it normal for a CPSR to come back with conditions?
Yes. Most reports for water based, fragranced or active containing products carry some conditions, such as a maximum fragrance level, an eye warning or an age restriction. They are the assessor stating the limits within which the product is safe, not a sign that it failed.
Which Part B conditions are set by law?
Maximum levels in Annexes III and V, and the exact warnings those annex entries prescribe, for example "Not to be used for children under 3 years of age" for salicylic acid. These cannot be negotiated. Most other warnings, caps and restrictions reflect the assessor's judgement on your data.
What happens if I sell my product without meeting a condition?
The product on sale is no longer the one that was assessed, so you are effectively selling without a valid safety assessment. In Great Britain this is enforced under the Cosmetic Products Enforcement Regulations 2013, mostly by Trading Standards, and it can also cause problems with retailers and insurers.
Can I get a Part B condition removed?
Sometimes. If it rests on a cautious default, such as the 50% dermal absorption figure the SCCS uses when no data exist, a proper study may change the result. Stability or challenge test data can also help. Ask the assessor in writing what evidence would change the conclusion before paying for any tests.
Do I need a new CPSR if I reformulate to meet a condition?
The report has to be revised to cover the new formula. Depending on the change, that may be an amended report or a fuller reassessment. Tell the assessor what you changed and why, and keep both versions in the PIF.
Why does my report say not for children under three?
Annex I requires a specific assessment for products intended for children under three, who have a higher skin area to body weight ratio than adults. Ingredients such as camphor, menthol, some essential oils, or salicylic acid, where the annex entry itself restricts use, often lead to this condition.
Is the AHA sun warning a legal requirement in the UK and EU?
There is no Annex III entry with set wording for glycolic or lactic acid. The sun protection advice comes from the safety assessment, guided by the EU scientific committee's opinion on AHAs, and becomes a Part B condition you must follow. The US FDA separately recommends a sunburn alert.
What is the difference between conditions and a refusal to sign?
With conditions, the assessor can describe a safe version of your product. A refusal means they cannot without fundamental change, for example because of a prohibited substance, a CMR that is not permitted, preservation that cannot work, or claims that make the product a medicine.
Official sources and legislation
- GB Cosmetics Regulation, Annex I: cosmetic product safety report, Part B (legislation.gov.uk)
- GB Cosmetics Regulation, Article 3: safety
- GB Cosmetics Regulation, Article 15: CMR substances
- GB Cosmetics Regulation, Article 19: labelling, including precautions in use
- GB Cosmetics Regulation, Annex III: restricted substances, limits and label warnings
- Regulation (EC) No 1223/2009, EU text as adopted (legislation.gov.uk)
- Commission Implementing Decision 2013/674/EU: guidelines on Annex I
- SCCS Notes of Guidance for the testing of cosmetic ingredients, 12th revision
- SCCNFP updated position paper on the safety of alpha hydroxy acids
- IFRA Standards library (International Fragrance Association)
- Cosmetic Products Enforcement Regulations 2013 (SI 2013/1478)
- OPSS: making cosmetic products available to consumers in Great Britain
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