Cosmetic formula screening is the cheapest possible way to find out that a formula cannot be sold. It checks every ingredient, at your stated concentration and for your product type, against Annexes II to VI of Regulation (EC) No 1223/2009: the prohibited list, the restricted list, the permitted colorants, the permitted preservatives and the permitted UV filters.
It is not a safety report and it carries no assessor signature. What it does is answer the one question that determines whether the rest of your compliance spend is worth making: are these substances legal in the EU, in this product, at these levels? This guide explains what a screening covers, when to run it, and the three situations where skipping it is expensive.
Key takeaways
- A screening checks ingredients against Annexes II, III, IV, V and VI at your concentrations and for your product type.
- It is not a CPSR. There is no exposure calculation, no toxicological profile and no signed conclusion.
- Run it before stability testing, packaging orders and artwork, not after.
- Limits are product-type specific. The same substance can be fine rinse-off and prohibited leave-on.
- “Cosmetic grade” is a commercial description, not a regulatory status.
- The annexes are amended regularly. A formula cleared three years ago may not be compliant today.
- Screening catches problems while reformulation is still cheap, before a production run exists.
What the five annexes actually contain
Annex II: prohibited substances
More than a thousand entries that may not be used in cosmetic products at all. It includes whole classes of substances by CMR classification, so entries are added by every ATP to the CLP Regulation without anyone announcing it in cosmetic terms. Zinc pyrithione, the traditional anti-dandruff active, moved here after its CMR classification and forced a category-wide reformulation.
Annex III: restricted substances
Permitted, but conditionally. Each entry gives a maximum concentration, and frequently a product-type restriction and a mandatory label warning. This is the largest annex and the one where most screening findings land. Recent examples that caught brands out include the vitamin A limits set by Regulation (EU) 2024/996, the alpha-arbutin and arbutin restrictions in the same amendment, and the expanded fragrance allergen list under Regulation (EU) 2023/1545.
Annex IV: colorants
The permitted colorant list, with the Colour Index number, the product types each may be used in, the maximum concentration where one applies, and the purity criteria. Two conditions do most of the work: whether the colorant may be used near the eyes, and whether it may be used on the lips.
Annex V: preservatives
The permitted preservative list with concentration limits and product-type restrictions. Methylisothiazolinone, for example, is permitted in rinse-off products only, and MCI/MIT as the 3:1 mixture cannot be combined with MIT alone in the same product.
Annex VI: UV filters
Relevant the moment your product carries an SPF claim, and increasingly relevant when a UV filter is used purely to protect the formula. Nano forms carry their own approvals and require the (nano) suffix after the ingredient name.
A substance can appear in more than one annex over time. Several ingredients have moved from Annex III to Annex II as new toxicological data emerged, and others have had their Annex III conditions tightened. The annexes are living documents amended by Commission regulation, which is why a screening is a point-in-time check and worth repeating before a relaunch.
What screening will not tell you
This is where the honest limits matter. A screening is a legality check on ingredients. It is not a safety assessment, and it does not replace one.
| Question | Formula screening | Full CPSR |
|---|---|---|
| Is this ingredient permitted in the EU? | Yes | Yes |
| Is it permitted at my concentration? | Yes | Yes |
| Is it permitted in my product type? | Yes | Yes |
| Does it trigger a mandatory label warning? | Yes | Yes |
| What is the exposure and margin of safety? | No | Yes |
| Toxicological profile of each substance | No | Yes |
| Microbiological quality and stability assessment | No | Yes |
| Signed conclusion by a qualified assessor | No | Yes |
| Legally required before market placement | No | Yes |
| Prepares the INCI list | No | No |
| Reviews the label artwork | No | No |
Only the CPSR is legally required. Article 10 of Regulation (EC) No 1223/2009 demands it, and it must be held in the Product Information File and signed by a person with the qualifications set out in the regulation. Our guides to what a CPSR is and who can sign one cover that side.
When to run it
The value of a screening is entirely a function of timing. Run late, it tells you something you cannot act on cheaply. Run early, it is the highest-return spend in the whole compliance budget.
- At formulation sign-off, before the formula is locked with a manufacturer.
- Before stability and challenge testing. Testing a formula that has to be reformulated is money spent twice.
- Before packaging is ordered, because a mandatory warning changes the artwork area you need.
- Before the INCI list goes to a printer. Reprinting is the second most common avoidable cost after retesting.
- When you switch supplier or grade for a raw material, particularly a botanical or a pigment.
- Before relaunching an older product, because the annexes have almost certainly moved since it was first cleared.
Three situations where a screening pays for itself many times over: a formula developed outside the EU to another market’s rules, a private-label product where you did not choose the ingredients, and a natural or botanical formula where restricted substances arrive inside an essential oil rather than on the ingredient deck. In all three the brand usually has no visibility of the problem until an assessor finds it.
Why supplier assurances are not enough
The single most common finding in a screening is a raw material described by its supplier as suitable for cosmetics that is not permitted in the EU at the level intended, or in that product type. There is no bad faith in most cases. “Cosmetic grade” is a description of purity and manufacturing standard, not a statement of EU regulatory status, and a material entirely legal in the United States, South Korea or Türkiye may be restricted or prohibited here.
Compound raw materials make it worse. A “natural preservative blend” or a fragrance accord arrives as one line on your formula sheet and contains a dozen substances, several of which have their own Annex III entries. Screening works from what is actually in the formula, which is why we ask for the full composition of every compound raw material rather than the trade name.
Our article on essential oils in cosmetics covers the botanical version of this problem, and documents needed to order a CPSR covers what raw material documentation should look like.
What you get back
A screening report should be actionable, not a list of citations. What Lexora returns:
- A clear pass or fail per ingredient at your stated concentration, for your product type.
- For each restricted substance: the applicable limit, the product types it applies to, and any mandatory label warning it triggers.
- Substances that are compliant today but under active review flagged separately, so an amendment does not blindside you.
- For anything that fails, a note on whether a concentration reduction is enough or the substance has to come out.
That last point is the one brands find most useful. The difference between “reduce this from 0.6% to 0.3%” and “this substance cannot be in an EU cosmetic” is the difference between a small reformulation and starting again.
Bringing it all together
Compliance spending has a natural order, and most brands get it backwards. They commission testing, order packaging and print artwork, then discover at the safety assessment stage that an ingredient was never permitted. Every euro spent before that discovery is at risk.
Screening inverts the order for a fraction of the cost. It does not replace the CPSR, it does not prepare your INCI list and it does not review your label. It answers one question early enough for the answer to be useful.
Lexora offers cosmetic formula screening priced by the number of ingredients in your formula, with fast turnaround because it is designed to run before you commit budget elsewhere. When the formula is clear, the next steps are the Cosmetic Product Safety Report, the INCI list preparation and the label review.
Frequently asked questions
Is formula screening the same as a CPSR?
No, and the difference matters. A screening tells you whether your ingredients are permitted at your concentration for your product type. A CPSR adds the exposure assessment, the toxicological profile of every substance, the microbiological and stability evaluation, and a qualified assessor’s signed conclusion. Only the CPSR is legally required before you place a product on the market.
Can I use the screening report in my Product Information File?
It is useful supporting work and can sit in the file, but it does not satisfy the Article 10 requirement. The PIF needs the full safety report. Think of the screening as the check you run first so that you do not pay for a CPSR on a formula that cannot be made compliant.
What information do you need from me?
INCI names with exact percentages rather than ranges, the full composition of any compound raw material such as a fragrance or preservative blend, the intended product type, and whether the product is rinse-off or leave-on. The product type and use pattern matter because most Annex III and Annex V limits are specific to them.
My supplier says the ingredient is cosmetic grade. Is that enough?
No. “Cosmetic grade” describes purity and manufacturing standard, not EU regulatory status, and a raw material perfectly legal in another market may be restricted or prohibited under Regulation (EC) No 1223/2009. Inaccurate supplier descriptions are one of the more common things a screening surfaces.
How often do the annexes change?
Several times a year, through Commission regulations amending the annexes, plus indirect additions to Annex II whenever substances receive a CMR classification under the CLP Regulation. A formula cleared three years ago is not necessarily compliant now, which is why a re-screen before a relaunch is worth doing.
What happens if an ingredient fails?
The report tells you which annex it falls under, what the limit is, and whether reducing the concentration is enough or the substance has to be removed entirely. That distinction usually decides whether you are looking at a minor reformulation or a redesign, and knowing it before production is the whole point of screening.
Does screening cover my label or claims?
No. It identifies mandatory warnings triggered by restricted substances, which affects your artwork, but it does not prepare your INCI list, check your labelling against Article 19, or assess your marketing claims. Those are separate pieces of work: INCI list preparation, label review and a claims compliance check.
