Etiqueta: CPSR

Reliability of toxicological data in a CPSR: what the SCCS guidance says

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The reliability of toxicological data decides what a cosmetic product safety report is worth. A margin of safety can be calculated to three decimals and still be wrong if the value it starts from comes from a study nobody checked, or from a summary table that never named its source. This article goes through what Regulation (EC) No 1223/2009 and the SCCS Notes of Guidance say about that starting value, and what the person reading a CPSR (a Responsible Person, a brand owner, a buyer’s quality team) can reasonably ask of it.

What the Regulation says about the reliability of toxicological data

Three provisions carry most of the weight. Annex I, Part A, point 8, asks for the toxicological profile of each substance and for a margin of safety (MoS) based on the no observed adverse effect level (NOAEL); leaving out the MoS has to be duly justified. The same point adds two sentences that matter here: any read-across between substances must be documented and justified, and the source of the information must be clearly identified. Article 10(1)(b) makes the responsible person ensure that an appropriate weight-of-evidence approach is used to review data from all existing sources. And Article 10(3) requires the non-clinical safety studies referred to in the safety assessment and carried out after 30 June 1988 to assess the safety of a cosmetic product to comply with EU legislation on good laboratory practice (GLP) in force when the study was run, or with other international standards that the Commission or ECHA recognises as equivalent.

There is no scoring scale in the Regulation, no ranking of study types and no rule for choosing between two conflicting NOAELs. The Regulation sets the frame and leaves the choice inside it to the safety assessor, which is where a weak CPSR and a strong one part ways.

What the SCCS Notes of Guidance are, and what they are not

The Notes of Guidance (SCCS/1647/22, 12th revision) were written for the safety dossiers on Annex substances that companies submit to the SCCS. Their introduction says they were not written for substances outside the Annexes, that they can nevertheless be of practical use when compiling the Product Information File of a finished product, and that they are not a prescriptive procedure. We use them in that spirit: as a detailed technical reference on how the Committee looks at data quality, not as a requirement of the Regulation. Where a point below is professional judgement and not the text of the guidance or of the Regulation, we say so.

The starting value: NOAEL, LOAEL or BMDL

The guidance calls the value from which extrapolation to low doses begins the point of departure (PoD) and notes that in most SCCS opinions it has been a NOAEL. For substances with a threshold it can also be a LOAEL, the lowest observed adverse effect level, or a BMDL, the lower limit of a benchmark dose. For its own opinions the SCCS considers the benchmark dose (BMD) approach preferable where usable in vivo data exist: it uses the whole dose-response curve and allows the uncertainty to be quantified. A CPSR built on a NOAEL is not wrong for that reason, since Annex I itself names the NOAEL. What is wrong is a bare figure: a value in mg/kg/day with no study, no endpoint and no document behind it.

Age and origin matter too. The guidance recalls that the ban on testing finished cosmetic products has applied since 11 September 2004 and the ban on testing ingredients since 11 March 2009, with the marketing ban applying from 11 March 2009, or from 11 March 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics. It also says that animal data generated before those dates, or for other legislation such as food, medicines or biocides, may still support the assessment of a cosmetic ingredient. Many values in circulation therefore come from studies run for another purpose, so ask where a given value was obtained.

Scoring the quality of a study

To assess the quality of a toxicological study, the guidance says the Klimisch score could be used, for example, and points to ToxRTool, a software tool developed by the EU Reference Laboratory for the Validation of Alternative Methods (EURL ECVAM) that determines the Klimisch score in a systematic way and also works for in vitro studies. The guidance names the score but does not reproduce its scale, which comes from the 1997 paper it cites. It also says that when data are taken from the scientific literature, a systematic search and review following pertinent standards (PRISMA is the example given) should be performed and documented: search engine, key words, and the reason each study was included or excluded.

A CPSR does not need a full systematic review for every ingredient. The underlying idea is the best answer to the question «how do you know there is no better study?»: a search that another person could repeat. Two further points are our own criteria, not rules. A study scored as unreliable should not, on its own, carry a signed margin of safety. And because Article 10(3) applies to studies run after 30 June 1988 to assess the safety of a cosmetic product, the report should state how compliance with good laboratory practice was checked, and not leave the reader to assume it. On deviations from GLP, the guidance is explicit for the data it receives: they must be indicated, explained and scientifically justified.

Read-across and in silico predictions: support, not substitute

Models are useful and the guidance is demanding about them. A (Q)SAR model is considered appropriate for regulatory use only if it was developed under the OECD validation principles: a defined endpoint, an unambiguous algorithm, a defined applicability domain, appropriate measures of goodness-of-fit, robustness and predictivity, and, where possible, a mechanistic interpretation. The QSAR Model Reporting Format (QMRF) exists to summarise that information for each model. The guidance also quotes the 2014 report of the International Cooperation on Cosmetics Regulation (ICCR), which concluded that in silico approaches for cosmetic ingredients were largely limited to internal decision-making and not yet a mainstream alternative to testing.

Read-across gets similar treatment. Structural similarity alone is not enough: the guidance, citing ECHA, asks that similarity in physicochemical properties, toxicokinetic and toxicodynamic behaviour and toxicological effects also be considered, and that analogues be selected impartially and not by picking a few on personal judgement. Put next to Annex I, Part A, point 8, the practical reading is that a prediction or an analogue is one piece of the weight of evidence, documented and justified, and not the only foundation of a margin.

Four questions to put to any CPSR

The reliability of toxicological data in a report comes down to whether, for each substance with a calculated margin of safety, you can answer four things. Which value was used and of what type: NOAEL, LOAEL or BMDL. Which document exactly it comes from, because «SCCS» on its own is not a source and Annex I asks for the source to be clearly identified. How reliable the study was judged to be and by what method. And what the position on good laboratory practice is. That value is then set against the systemic exposure the intended use produces, which Article 10(1)(a) requires to be taken into account, and Annex I, Part B, point 3, asks for the margins of safety, where relevant, to be assessed and discussed in the reasoning. An error in the input travels through all of it without any formula noticing. If there is no valid value at all, the report has to justify the absence, and that is a different thing from filling the gap with the number of a similar substance.

Frequently asked questions

Does the SCCS guidance apply to my CPSR?

Not as a legal requirement. It is written for SCCS dossiers, and it describes itself as an approach to adapt case by case. It is nonetheless a detailed public account of how the Committee weighs data, so it is a sound benchmark for the reliability of toxicological data in a report signed by a safety assessor.

Can I use the NOAEL of a similar substance?

Only as support inside a weight-of-evidence analysis, with the similarity justified and the source identified. The assessor should not present it as the value of the substance being assessed.

What if a REACH registration dossier lists several studies?

Then the report should say which study carries the assessment and why, instead of defaulting to the first one found. Which one to choose is a professional judgement; the Regulation only asks that it be justified.

When does a value need to be revisited?

When new relevant information appears. Article 10(1)(c) requires the safety report to be kept up to date with information generated after the product is placed on the market, and a new SCCS opinion on an ingredient is exactly that.

Who answers for the value chosen?

The responsible person ensures the safety assessment is done (Article 10(1)), and Part B is carried out by a person with the qualifications set out in Article 10(2), whose name, proof of qualification, date and signature appear in the report (Annex I, Part B, point 4).

If you place cosmetics on the EU market and want to check the reliability of toxicological data behind your safety report, write to us through our contact page. You can also read our guide to the Cosmetic Product Safety Report, our note on the Responsible Person for cosmetics, our cosmetics advisory service, or the Spanish version of this article.

Allowed ingredients do not make a safe product: what comes after the formula

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A formula built from allowed ingredients is where cosmetic development starts, not where it ends. A brand checks every INCI name against the prohibited list, finds nothing in Annex II, keeps each restricted substance under its limit, and concludes that the product can go on sale. The Regulation does not follow that logic, and it says so itself: Article 14(1), the provision that bans the listed substances, opens with the words «without prejudice to Article 3», the requirement that the product as a whole be safe. After almost twenty years assessing the safety and conformity of cosmetics and food supplements, this is an assumption we meet often, and it is costly when it surfaces late.

What allowed ingredients means in Regulation (EC) No 1223/2009

Article 14(1) draws the line in five places. A cosmetic product may not contain substances listed in Annex II, restricted substances in Annex III that are not used within their restrictions, or colourants, preservatives and UV filters other than those listed in Annexes IV, V and VI, nor listed ones used outside the conditions of those annexes. The logic differs by annex. Annex II is a negative list: what is not on it is not banned on that ground. Annexes IV, V and VI are positive lists: a colourant, preservative or UV filter that is not on the relevant list cannot be used in that function. Article 15 adds its own rules for substances classified as carcinogenic, mutagenic or toxic for reproduction.

These lists move. Regulation (EU) 2026/909, adopted in April 2026, amended the rules on the use of several substances, and we cover it separately in our article on the 2026/909 amendment (in Spanish). The point of this article is different: even a formula that matches today’s lists exactly is only the input to the product.

The test is the finished product, not the ingredient list

Article 3 states that cosmetic products made available on the market must be safe for human health under normal or reasonably foreseeable conditions of use, taking into account in particular the presentation, the labelling, the instructions for use and disposal, and any other indication given by the responsible person. Every item on that list describes the product as sold and used, not its raw materials. The last sentence closes a common shortcut: the presence of warnings does not exempt the operators concerned from the other obligations of the Regulation.

So the question is not whether each ingredient is allowed, but whether these allowed ingredients, in this pack, used this way, add up to a safe product. Four things separate the two questions. The first is exposure. Annex I asks for the place and area of application, the amount applied, the duration and frequency of use, the routes of exposure and the target population, and calculates the margin of safety on the NOAEL, with any omission duly justified. Article 10(1)(a) speaks of the anticipated systemic exposure to the individual ingredients of the final formulation. The same substance at the same percentage is not the same exposure in a leave-on face cream and a rinse-off shampoo.

The second is interaction and impurities. Annex I directs attention to the impurities of the substances and raw materials used and to the interaction of the substances, and Article 17 tolerates trace amounts of a prohibited substance only if technically unavoidable in good manufacturing practice and compatible with Article 3. The third is stability and microbiological quality: the report covers stability under reasonably foreseeable storage conditions and the results of the preservative efficacy test. A preservative from Annex V used within its conditions does not show that this product resists contamination; the test does. The fourth is the packaging, whose relevant characteristics, in particular purity and stability, belong to the same assessment.

The safety assessment turns a formula into a product

Article 10(1) requires, before a cosmetic product is placed on the market, a safety assessment based on the relevant information and a cosmetic product safety report drawn up under Annex I. Part A collects the data described above. Part B is the assessor’s conclusion, with the reasoning, the statement on the warnings and instructions the label must carry, and due account of how stability affects safety. It has to be carried out by a person with a university qualification in pharmacy, toxicology, medicine or a similar discipline, or studies recognised as equivalent by a Member State (Article 10(2)), and it carries the assessor’s name, proof of qualification, date and signature. At ASC that step is carried out and signed by a qualified safety assessor. The structure of the report is explained in our guide to the cosmetic product safety report.

Nor does the report end at launch: Article 10(1)(c) requires it to be updated with relevant information generated after the product reaches the market.

Made under good manufacturing practice

Article 8 requires cosmetic products to be manufactured in line with good manufacturing practice (GMP), and presumes conformity when manufacture follows the relevant harmonised standards published in the Official Journal. The Commission lists EN ISO 22716 among the harmonised standards under the Regulation. Its scope is production, control, storage and shipment, and it expressly excludes research and development and the distribution of the finished product. Development work on the formula therefore sits outside the standard, which starts at production. The product information file must contain a description of the manufacturing method and a declaration of conformity with GMP (Article 11(2)(c)). If a contract manufacturer makes the product, ask how it applies the standard: ISO 22716 has a chapter on subcontracting.

Labelled and notified before it is sold

Article 19(1) lists what must appear on the container and packaging, among others: the name and address of the responsible person, with the country of origin for imported products; the nominal content; the batch number; the function; the list of ingredients; and the precautions for use, at least those set out in Annexes III to VI. Two items depend directly on the safety assessment. The date of minimum durability is the date until which the product, stored under suitable conditions, keeps fulfilling its initial function and complying with Article 3, so it has to be consistent with the stability data in the report; and Part B of the report states which warnings the label needs. Under Article 19(5), the language of several of these mentions is set by the law of each Member State where the product is made available to the end user.

Notification is the last gate. Under Article 13, before the product is placed on the market, the responsible person submits electronically to the Commission, in practice through the Cosmetic Products Notification Portal, the product category and name, the name and address of the responsible person, the country of origin for imports, the Member State of introduction, a contact person, the presence of nanomaterials, any CMR substances of categories 1A or 1B, and a framework formulation for prompt medical treatment. Those data should be consistent with what the file and the label say.

Someone in the Union has to answer for it

Article 4(1) allows only products for which a natural or legal person within the Union is designated as responsible person. For an imported product the importer holds that role, and may designate by written mandate another person established in the Union who accepts it in writing (Article 4(5)). Article 5(1) makes the responsible person answerable for compliance with, among others, Articles 3, 8, 10, 11 and 13, and Article 11(1) requires the product information file to be kept for ten years after the last batch was placed on the market. What the role involves in practice is covered in our guide to the responsible person.

A working order before you call the formula finished

Once the formula meets the annexes, settle the intended use and target population; confirm the packaging the product will be filled in; obtain stability and preservative efficacy results for the product in that packaging; have a qualified assessor complete Parts A and B; check that the manufacturer works to GMP; write the label from the assessor’s warnings and the stability data; and appoint the responsible person before notifying.

Questions we are asked

If my formula only uses allowed ingredients, do I still need a safety report?

Yes. Article 10(1) applies to every cosmetic product before it is placed on the market. The composition of the formula does not create an exemption.

Can a warning on the label cover a doubtful formula?

No. The last sentence of Article 3 says that the presence of warnings does not exempt the operators concerned from the remaining obligations.

Can I rely on my supplier’s safety data instead of an assessment?

Supplier data are an input, not a substitute. Annex I requires the toxicological profile of each substance, with the source clearly stated, and Article 10(1)(b) requires a weight-of-evidence approach across all existing sources, in the safety assessment of the product.

If your formula is settled and the rest of the file is not, write to us through our contact page and tell us the product, the pack and the markets you plan to sell in. If what you still need is the formula itself, our cosmetic formulation service covers that step only: the safety report, the label and the notification are separate services.

Who answers for a new cosmetic formula in the EU

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Every new cosmetic formula involves several people: the brand that wants the product, the chemist who balances the ingredients, the plant that runs the first batch, the professional who signs the safety assessment. Regulation (EC) No 1223/2009 does not ask who wrote the formula. It asks a different question, about the finished product: who answers for it in the Union? For a brand outside the EU, or an importer launching its first product, the answer is less obvious than it looks, and it is cheaper to settle before the formula is fixed than after the first batch.

Who is who around a new cosmetic formula

The Regulation defines roles by what a party does with the product, not by who designed it. The manufacturer under Article 2 is whoever makes a product, or has it designed or made, and markets it under its own name or trademark. A brand that commissions a laboratory to develop the formula and a plant to produce it is therefore the manufacturer for legal purposes, while for a contract plant that only produces for the brand the definition is not something to assume: settle in the contract, in writing, who acts as the manufacturer and who as the responsible person.

The importer is a person established in the Union who places a product from a third country on the market; the distributor is any other party in the supply chain that makes the product available. Around them sit the Responsible Person and the safety assessor, two further roles that are often confused with the others.

Whose name goes on the label when the brand is outside the EU

Article 4(1) allows a cosmetic product on the market only if a natural or legal person has been designated as its Responsible Person in the Union. The rest of the article tells you who that is. If the product is made in the EU and not exported and re-imported, the manufacturer established in the EU is the Responsible Person, and it may designate someone else by written mandate that the other accepts in writing. If that manufacturer is established outside the EU, Article 4(4) obliges it to designate, by written mandate, a person established in the EU who accepts in writing. For imported products, Article 4(5) makes each importer the Responsible Person for the specific product it places on the market, with the same option of a written mandate. A distributor becomes the Responsible Person if it places a product on the market under its own name or trademark, or modifies one in a way that could affect compliance; translating the product information is expressly not such a modification.

Take a concrete case. A brand based outside the EU commissions the formula and the production from an EU laboratory. The brand is the manufacturer under Article 2 and it is established outside the Union, so Article 4(4) applies: it needs a written mandate to a person in the EU, accepted in writing. The laboratory does not become the Responsible Person by default. Change one fact, production in Asia and import by a Spanish company, and the importer is the Responsible Person by default. Our guide to the Responsible Person covers the role in full.

The safety obligation and the person who assesses it

Article 3 sets the standard: a cosmetic must be safe for human health under normal or reasonably foreseeable conditions of use, taking into account its presentation, labelling, instructions and any other information the Responsible Person provides. Warnings on the label do not relieve anyone of the other obligations in the Regulation.

Article 10 turns that standard into work. Before the product is placed on the market, the Responsible Person must ensure that a safety assessment has been carried out and that a safety report has been drawn up in line with Annex I. The assessment has to take into account the intended use and the anticipated systemic exposure to the individual ingredients of the final formulation, which is why it cannot be closed on a draft. Article 10(2) requires the assessment to be carried out by a person holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline, or a qualification a Member State recognises as equivalent.

Annex I sets the content. Part A covers composition, stability, microbiological quality, impurities, exposure, the toxicological profile of the substances with the margin of safety, and undesirable effects. Part B holds the conclusion, the warnings the label needs, the reasoning, and the assessor’s name, address, proof of qualification, date and signature. The assessor signs Part B; Article 10(1) puts the duty to make sure the assessment exists, and is updated with information generated after launch, on the Responsible Person. The Cosmetic Product Safety Report is that document.

The file and the notification that carry the formula

Under Article 11 the Responsible Person holds a Product Information File for ten years after the last batch was placed on the market. It contains a description of the product, the safety report, a description of the method of manufacture with a declaration of compliance with good manufacturing practice, proof of the claimed effect where justified, and data on animal testing. It must be available to the competent authority of the Member State where it is kept, at the address on the label, in a language the authority can readily understand.

Before launch, Article 13 requires the Responsible Person to notify the Commission electronically. The notification carries the category and name, the Responsible Person’s name and address, the country of origin for imports, any nanomaterials, the CMR substances of categories 1A and 1B, and the framework formulation that allows rapid medical treatment if something goes wrong. Changes must be updated immediately. Article 19(1)(a) puts the Responsible Person’s name and address on the packaging, plus the country of origin for imports. Our CPNP notification guide walks through the Commission’s portal.

The plant, good manufacturing practice and what the contract covers

Article 8 requires manufacture under good manufacturing practice and presumes conformity when it follows the relevant harmonised standards published in the Official Journal. The Commission lists EN ISO 22716:2007, the good manufacturing practice guidelines for cosmetics, among the harmonised standards for the Regulation, and two points from its text matter to a brand commissioning a new cosmetic formula. Its scope is production, control, storage and shipment; research and development, and distribution of the finished product, are outside it, so a plant’s GMP evidence tells you how the product is made, not whether the formula is safe. And clause 12 on subcontracting expects a written contract that specifies the respective duties of contractor and subcontractor. That contract is worth having, but Article 5(1) lists Article 8 among the provisions the Responsible Person must guarantee.

What a contract cannot move

You can move three things by contract: the manufacture, the assessment and the Responsible Person role itself, the last only by the written mandate Article 4 describes, accepted in writing by a person established in the Union. What you cannot do is leave the product without a Responsible Person, or push the duties of Article 5 onto the formulator, the plant or the assessor while the Responsible Person stays a name on the label.

Article 5 is specific. The Responsible Person guarantees compliance with Articles 3, 8 and 10 to 18, parts of Article 19, and Articles 20, 21, 23 and 24. If it has reason to think a product on the market does not comply, it must take corrective measures at once and, where there is a risk to human health, inform the national authorities immediately. On a reasoned request it must hand over the documentation showing conformity, in a language the authority understands, and Article 23 adds immediate notification of serious undesirable effects.

A supply agreement with your formulator or plant, including indemnities, allocates cost and recourse between the parties. It does not change the party the Regulation names to the authority. Nor does a warning on the label, as Article 3 says, and nor does the assessor’s signature. After almost twenty years assessing the safety and conformity of cosmetics and food supplements, we see three problems repeatedly: a brand that believes the contract plant is its Responsible Person because the plant issues the invoices; a formula adjusted at the plant after the assessment was signed; and a label that shows an address where nobody keeps the file.

A sensible order of decisions

Decide first who will be the Responsible Person and put the mandate in writing. Then choose the manufacturer, ask for its GMP evidence and agree the subcontracting terms. Fix the formula and give the assessor the final version. Only then build the file, notify and finalise the label; every later change of composition goes back to the assessor.

If you still need the formula itself, our cosmetic formulation service delivers the formula only: the ingredient list with percentages, checked against the annexes of the Regulation. Labelling, claims and the safety report are separate services.

Frequently asked questions

Can my contract manufacturer be my Responsible Person?

Yes, if it is established in the Union and accepts the role in writing under the mandate Article 4 describes. Accepting the role means accepting the Article 5 duties.

Next step

If you are about to launch a new cosmetic formula in the EU and are not sure who in your chain holds which role, write to us through our contact page before the first production order, and a technician at ASC will go through it with you.

How to commission a cosmetic formula: what to prepare and what you receive

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If you are going to commission a cosmetic formula for the EU market, the brief you write decides most of what follows: which ingredients are possible, what a manufacturer can produce and what the safety assessment will have to cover. Brands that arrive with a clear brief get a formula they can take straight to a manufacturer. Brands that arrive with “a good face cream” get a round of questions first. Here is what to have decided, what a formula delivery contains and leaves out, and what has to happen before you can sell.

What to have decided before you commission a cosmetic formula

Type of product and intended use. Regulation (EC) 1223/2009 defines a cosmetic by its purpose: a substance or mixture meant to be put in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the mouth, with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours (Article 2(1)(a)). Name your product in those terms. A shampoo, a body lotion and a lip balm are different formulas, because the same ingredient can be allowed up to one limit in one product type and be subject to another limit, or to extra conditions, in another: Annex III, the list of restricted substances, sets its conditions by product type and by part of the body.

Who will use it, and how. The safety assessment is built on use. Annex I asks for the place and area of application, the amount applied, the duration and frequency of use, the routes of exposure and the target population, and its microbiological section singles out products used around the eyes, on mucous membranes or on damaged skin, and use by children under three, older people and people with an altered immune response. Adults or children, daily or occasional, face or body: settle it now, because the formula is designed for that use and the assessor will start from it (Article 10(1)(a)).

Presentation and characteristics. Cream, gel, serum, stick, powder or spray; texture, colour, fragrance or none. Presentation changes the exposure: Annex I tells the assessor to consider the unintended inhalation of aerosols and the effect of particle size, so a spray raises questions that a cream does not. Describe the product you want, not the promises you plan to print on the box: what you may say about a cosmetic is governed by Article 20, which forbids attributing to a product characteristics or functions it does not have, and it is a separate question from the formula.

Markets. Name the EU countries where you intend to sell. The notification records the Member State where the product is placed on the market (Article 13(1)(d)), and the language of several mandatory label particulars is set by the law of each Member State where the product reaches the end user (Article 19(5)). The formula is checked against EU rules; other markets keep their own lists of permitted ingredients and would need their own check.

What you receive when you commission a cosmetic formula

A formula proposal for the product you described: the list of ingredients, the percentage of each and the function each one performs. Before delivery, every ingredient is checked against the annexes of the Regulation: Annex II (prohibited substances), Annex III (substances allowed only with restrictions) and Annexes IV, V and VI, which list the admitted colourants, preservatives and UV filters. That is what our cosmetic formulation service delivers, and only that.

The first item of Annex I, Part A, the section every safety report must contain, is the qualitative and quantitative composition, with the chemical identity of each substance (INCI name, CAS number where possible) and its intended function. A formula with percentages and functions is the starting point of that section. You take it to your manufacturer, in the EU or in a third country, and ask for a quotation and a first sample. Who owns the formula and under what conditions you may use it are settled in our quotation, before you accept it.

What a formula does not include

A formula is a design on paper. Several things that brands assume come with it do not, and each has a different owner.

The label and the claims. Article 19 lists what must appear on the container and the packaging, among other particulars the name and address of the Responsible Person, the nominal content, the durability information and the ingredient list (which may appear on the packaging alone; small and unpackaged products have their own rules). Whatever you say about the product must be true, and when its nature or effect justifies it, the product information file must hold the evidence of the effect claimed (Article 11(2)(d)). Both are separate services.

The safety report (CPSR). Under Article 10(1), before a cosmetic is placed on the market the Responsible Person must make sure it has undergone a safety assessment and that a report has been drawn up in accordance with Annex I. A formula built on permitted ingredients is not, by itself, a safe product: the assessment looks at exposure, at the toxicological profile of each substance and at the margin of safety, and it must be carried out by a person holding a degree in pharmacy, toxicology, medicine or a similar discipline (Article 10(2)). Our guide to the cosmetic product safety report explains the document.

Stability, packaging compatibility and the challenge test. Annex I, Part A asks for the stability of the product under reasonably foreseeable storage conditions, its microbiological quality, including the result of the preservation efficacy test (the challenge test), and the relevant characteristics of the packaging material. All of it is measured on the real product in its real pack, so it can only exist once your manufacturer has made a sample. It stays with you and your manufacturer, and the results go into the safety report.

What comes after the formula

The order matters. First, a manufacturer that works to good manufacturing practice: Article 8 requires it, and in practice manufacturers show it through EN ISO 22716, so ask for evidence before you place an order. Second, the samples and the tests above. Third, the safety report on the final formulation, before any batch is sold. Fourth, the product information file that Article 11 requires the Responsible Person to hold, containing among other things the safety report, a description of the method of manufacture and a statement of good manufacturing practice. It is kept for ten years after the last batch was placed on the market (Article 11(1)).

Then the person and the portal. Only cosmetics for which a Responsible Person has been designated within the Union may be placed on the market (Article 4(1)). Who that is depends on where the product is made and who brings it in: the manufacturer established in the EU, the importer when the product is imported, or another person established in the EU designated by written mandate and accepting it in writing (Article 4(3) to (5)). If you have a product designed or made for you and sell it under your own name or trademark, the Regulation treats you as the manufacturer (Article 2(1)(d)). Our guide to the Responsible Person for cosmetics in the EU covers the role.

Before the product is placed on the market, the Responsible Person notifies it electronically through the Cosmetic Products Notification Portal (CPNP): category and name, name and address of the Responsible Person, country of origin for imports, Member State, a contact person and the frame formulation that allows rapid and appropriate medical treatment, among other data (Article 13(1)). The step-by-step CPNP guide walks through it.

Mistakes we see when brands commission a cosmetic formula

The most expensive is placing the production order before the safety assessment. A first batch is made, and only then does someone ask for the report. If the assessment finds that an ingredient level or a use does not hold up, the change means a new sample and, often, new stability tests. Assess first, produce second.

The second is a silent substitution. A raw material cannot be sourced, an equivalent takes its place and nobody tells the brand. A change of ingredient can change what the Regulation allows and the composition on which the safety report rests, so every substitution should come back for a check before it goes into production.

The third is a brief too vague to design from. “A moisturiser for sensitive skin” leaves open the use, the population, the presentation and the markets, which are exactly the questions above. Each one you leave open becomes a round of emails later.

Frequently asked questions

Do I need a manufacturer before I ask for a formula?

No. The formula does not depend on where it is made. Have your manufacturer review it before you place the order, because they confirm whether they can produce it with their equipment.

Can I change an ingredient after I receive the formula?

Any change in composition is handled as a new proposal: we tell you what it involves before we do it. It also changes the composition that the safety report and the notification are based on.

If you are planning a cosmetic for the EU market, tell us what product you have in mind through our contact page and we will send you a quotation for the formula, with ownership and conditions of use spelled out.

Fiabilidad de los datos toxicológicos en el CPSR: qué dice el SCCS

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La fiabilidad de los datos toxicológicos decide lo que vale un informe de seguridad cosmético. Se decide en un punto que casi nadie mira desde fuera: de dónde sale el valor con el que se calcula el margen de seguridad, y qué garantías tiene el estudio que lo produjo. Un informe es tan sólido como los datos toxicológicos que lo sostienen.

El punto de partida de la evaluación

Las Notes of Guidance del SCCS (SCCS/1647/22, duodécima revisión) están pensadas para los dosieres de ingredientes que se presentan al SCCS; aquí las usamos como referencia técnica de buenas prácticas, no como requisito del Reglamento. Llaman «punto de partida» (PoD) al punto de la relación dosis-respuesta desde el que arranca la extrapolación a dosis bajas, y señalan que en la mayoría de sus opiniones se ha usado el NOAEL, la dosis sin efecto adverso observado. El Anexo I, parte A, punto 8, del Reglamento pide precisamente que el margen de seguridad se calcule basado en el NOAEL. La guía añade que, para los dictámenes del SCCS, considera preferible expresar la dosis como BenchMark Dose (BMD) cuando hay datos in vivo utilizables, porque aprovecha toda la curva dosis-respuesta y permite cuantificar la incertidumbre. Que un CPSR use NOAEL no es un error; que no diga cuál usa ni de dónde sale, sí lo es.

Cómo se valora la fiabilidad de los datos toxicológicos

La guía indica que, para evaluar la calidad de un estudio toxicológico, puede usarse la puntuación de Klimisch, y menciona la herramienta ToxRTool, desarrollada por el laboratorio de referencia europeo para métodos alternativos (EURL ECVAM), que calcula esa puntuación de forma sistemática y sirve también para estudios in vitro. La escala clásica de Klimisch et al. (1997) va de 1, fiable sin restricciones, a 4, no asignable; esa escala no figura en el texto de la guía, que solo cita el método. Lo que sigue es criterio profesional, no norma: un estudio puntuado como no fiable no debería ser, por sí solo, el fundamento de un margen de seguridad firmado.

Buenas prácticas de laboratorio y valor de la evidencia

El Reglamento (CE) 1223/2009 pone dos condiciones adicionales. El artículo 10.1.b obliga a usar un enfoque apropiado sobre el valor de la evidencia para examinar los datos de todas las fuentes existentes: no basta con el primer valor que aparezca. Y el artículo 10.3 exige que los estudios no clínicos de seguridad realizados después del 30 de junio de 1988 cumplan la legislación comunitaria sobre buenas prácticas de laboratorio, o normas internacionales reconocidas como equivalentes por la Comisión o por la ECHA.

El papel de los modelos in silico y de las referencias cruzadas

Los modelos QSAR y las técnicas de extrapolación entre sustancias parecidas son útiles, pero la guía es exigente: un modelo solo se considera apropiado para uso regulatorio si se ha desarrollado conforme a los principios de validación de la OCDE, con un objetivo definido, un algoritmo sin ambigüedades, un dominio de aplicabilidad delimitado y medidas de ajuste, robustez y capacidad predictiva. Existe además un formato normalizado (QMRF) para resumir y comunicar la información de cada modelo. La guía recoge también la conclusión de un informe del ICCR de 2014, según la cual el uso de estos métodos en la evaluación de seguridad de ingredientes cosméticos se limitaba en gran medida a la toma de decisiones interna. El Anexo I, parte A, punto 8, añade que cualquier enfoque comparativo mediante referencias cruzadas estará debidamente documentado y justificado, y que la fuente de información se indicará claramente. En la práctica, una predicción sirve como apoyo dentro del conjunto de la evidencia y no como único fundamento.

Cómo se convierte en un margen de seguridad

El punto de partida no vale por sí solo: se compara con la dosis de exposición sistémica (SED) que resulta del uso real del producto. El Anexo I, parte B, punto 3, pide que, cuando proceda, los márgenes de seguridad se evalúen y analicen dentro del razonamiento científico de la evaluación. Si el punto de partida es débil, el margen, por bien calculado que esté, lo es también: un error en el valor de entrada se propaga a todo el informe sin que ninguna fórmula lo detecte.

Qué exigir sobre la fiabilidad de los datos toxicológicos de un CPSR

Un informe defendible permite responder cuatro preguntas para cada sustancia con margen de seguridad: qué valor se ha usado y de qué tipo es (NOAEL, LOAEL o BMDL), de qué documento concreto procede —«SCCS» a secas no es una fuente, y el Anexo I exige indicarla claramente—, qué fiabilidad tiene el estudio y si cumple buenas prácticas de laboratorio. Cuando no hay dato válido, lo honesto es dejar ese margen abierto y explicar qué se pide al proveedor, y no rellenarlo con un valor de otra sustancia parecida.

Preguntas frecuentes

¿Sirve el NOAEL de una sustancia parecida?

Solo como apoyo dentro de un análisis de valor de la evidencia y con la justificación de la similitud, porque el Anexo I exige documentar y justificar el enfoque comparativo; el evaluador no debería tomarlo como valor de la sustancia evaluada sin más.

¿Qué hago con un expediente de registro REACH?

Un dossier de registro puede contener varios estudios de dosis repetidas con valores distintos. La regla de práctica que seguimos es usar el valor que el registrante identifica como clave en su resumen, no el primero que aparece. Es una regla de trabajo, no un requisito del Reglamento.

¿Cuándo hay que revisar el valor?

Cuando aparece información nueva: el artículo 10.1.c exige actualizar el informe con la información pertinente que se genere tras la introducción del producto en el mercado, y una opinión nueva del SCCS sobre la sustancia es exactamente eso.

¿Quién decide qué valor se usa?

El evaluador de seguridad que firma la parte B. El Reglamento exige que sea una persona con la cualificación del artículo 10.2 y que su nombre, cualificación, fecha y firma consten en el informe.

Si tu empresa comercializa cosméticos y quieres saber de qué datos toxicológicos depende tu informe de seguridad, escríbenos antes de la próxima revisión de tu expediente y te presupuestamos el análisis de una referencia. Puedes ver nuestros servicios de consultoría regulatoria o leer cómo se aplica el informe de seguridad de producto cosmético (en inglés). El texto del Reglamento de cosméticos está en EUR-Lex.

Tipos de ensayos de uso en cosméticos: requisitos esenciales para un Cosmetic Product Safety Report (CPSR) conforme

Posted on by adminarya

La comercialización de cualquier producto cosmético en la Unión Europea exige la elaboración previa del Cosmetic Product Safety Report (CPSR), tal como establece el Reglamento (CE) 1223/2009. Este informe técnico, obligatorio para acceder al mercado, evalúa la seguridad del producto antes de su puesta en circulación.

Uno de los pilares fundamentales del CPSR son los ensayos de uso, que permiten verificar la compatibilidad cutánea, tolerancia, eficacia y ausencia de efectos adversos. Estos ensayos no solo son necesarios para garantizar la protección del consumidor, sino que también proporcionan evidencia científica que respalda las declaraciones del producto (claims).

A continuación, analizamos los principales tipos de ensayos de uso utilizados para elaborar el CPSR y su relevancia en el marco normativo actual.

¿Qué es un ensayo de uso y por qué es obligatorio?

Un ensayo de uso es un estudio realizado en condiciones reales o simuladas de aplicación del producto cosmético sobre personas voluntarias. Estos ensayos permiten observar su tolerancia, eficacia o posibles reacciones adversas. La persona responsable del producto debe asegurar que se ha generado evidencia suficiente para justificar la seguridad de uso prevista en el público objetivo.

El toxicólogo evaluador que firma el CPSR utilizará estos datos en la Parte B del informe para emitir su dictamen de seguridad final.

Principales tipos de ensayos de uso en cosmética

1. Patch test (test de irritación cutánea o test epicutáneo cerrado)

  • Objetivo: Evaluar la tolerancia cutánea básica del producto.
  • Metodología: Se aplica el producto bajo un apósito oclusivo durante 24–48 horas en la espalda de voluntarios.
  • Resultado esperado: Ausencia de irritación o reacciones inflamatorias.

Es el ensayo más básico e imprescindible para cualquier producto cosmético que se aplique sobre la piel.

2. Uso repetido bajo condiciones normales (in-use test)

  • Objetivo: Comprobar la tolerancia del producto en condiciones reales durante un periodo determinado.
  • Aplicación: El producto se usa siguiendo las instrucciones habituales (por ejemplo, crema facial dos veces al día durante 28 días).
  • Control: Puede incluir observación médica o autovaloraciones del usuario.

Ideal para productos de uso frecuente (corporales, faciales, capilares).

3. Pruebas bajo control dermatológico

  • Objetivo: Validar la seguridad del producto en voluntarios, con seguimiento por parte de un dermatólogo.
  • Valor añadido: Permite incorporar en el etiquetado la mención “Testado bajo control dermatológico”.
  • Documentación: Se debe disponer del informe clínico firmado por el profesional sanitario responsable del estudio.

En muchos casos, estas pruebas se realizan junto con el patch test o el uso prolongado.

4. Pruebas de uso en grupos específicos (pediatría, piel atópica, piel sensible)

  • Necesarias si: El producto está destinado a niños, pieles sensibles, pieles con condiciones dermatológicas o mucosas.
  • Requiere: Evaluación en una muestra representativa de la población objetivo, con consentimiento informado y supervisión médica.
  • Regulación: El evaluador de seguridad debe justificar la elección de la población y su adecuación al uso previsto.

5. Evaluaciones de eficacia y claims

Aunque no forman parte estricta de la seguridad, son relevantes para validar el contenido del CPSR cuando se alegan beneficios como:

  • “Hidrata durante 24h”
  • “Reduce visiblemente las arrugas”
  • “Anticaspa”, “Antimanchas”, etc.

Este tipo de ensayos se basan en estudios instrumentales (corneometría, sebumetría, análisis de imagen), test de uso subjetivos o ensayos clínicos controlados.

6. Ensayos oftalmológicos y de uso en mucosas

  • Para productos aplicados cerca de los ojos (delineadores, máscaras, cremas oculares) o en mucosas (labios, genitales), es necesario:
    • Estudio de irritación ocular (ensayo clínico).
    • Validación de uso en condiciones específicas.
    • Certificados o estudios adicionales de pH, osmolaridad, etc.

¿Qué ensayos son obligatorios y cuáles opcionales?

  • Obligatorios: Al menos un test de tolerancia cutánea (patch test) y evidencia de uso seguro en las condiciones previstas.
  • Altamente recomendables: Estudios de uso prolongado, bajo control dermatológico, y específicos si el producto lo requiere (zonas sensibles, menores, uso oral).
  • Opcionales pero estratégicos: Ensayos de eficacia o marketing claims, útiles para reforzar la posición del producto en el mercado.

Conclusión: un CPSR conforme empieza con ensayos clínicos bien diseñados

La seguridad de los productos cosméticos no puede basarse en suposiciones. El CPSR exige datos objetivos que demuestren que el producto es seguro para su uso previsto. En este sentido, los ensayos de uso clínico, controlados y documentados son una herramienta imprescindible.

En ASC Services colaboramos con laboratorios autorizados, CROs y toxicólogos expertos para garantizar que tus productos cosméticos cumplen con los estándares regulatorios más exigentes desde el primer momento.

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