Written by the Oppenheimer Lab team — Reviewed by Mohamed Arbi Jallali, Partner, Head of Production and Formulator
Published on
9 min read
A cosmetic claim is permitted when it meets the common criteria of Commission Regulation (EU) No 655/2013 and is proven in the PIF (Product Information File). Therapeutic promises and mentions of approval by an authority are excluded. This purely informative article offers a “can say / risky / avoid” grid designed for a Tunisian brand targeting the European Union, and refers to the official texts on EUR-Lex.
You will see the legal framework, the common criteria, the grid of wordings, then the method for building your evidence file before export and the question of responsibility.
What is a cosmetic claim and which text governs it?
A cosmetic claim is any statement, image or symbol that attributes a quality or an effect to a product. In the European Union, Article 20 of Regulation (EC) No 1223/2009 governs it, and Commission Regulation (EU) No 655/2013 sets the common criteria. These criteria apply only to products that meet the definition of a cosmetic.
The term covers more than the sentence printed on the label. A range name, a pictogram, a before/after photo, a product-sheet argument or a social media advertisement can constitute a claim as soon as it suggests a benefit. You must therefore examine all of your communication, not just the packaging.
The common criteria are the minimum rules, identical in all Member States, that a claim must meet to be used. Commission Regulation (EU) No 655/2013 establishes them, while Article 20 of Regulation (EC) No 1223/2009 lays down the principle of regulation.
Article 20 of Regulation (EC) No 1223/2009: product claims.
A clarification of scope is essential: these criteria apply only to a product that is genuinely a cosmetic. If a product falls rather under medicines or medical devices, this regime does not apply, and Member States decide case by case. A promise to treat or cure can therefore take your product out of the cosmetic category.
This article is informative and does not replace the official texts: consult them directly on EUR-Lex before settling your wordings.
What common criteria must every claim meet?
Commission Regulation (EU) No 655/2013 sets six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Each criterion is checked against the exact wording, the packaging and all of the brand’s communication, including online.
A common criterion is a requirement that every claim must fulfil, whatever the product or the Union country where it is sold. The six criteria form a checklist: a single failure is enough to weaken your wording.
- Legal compliance: the claim complies with the applicable regulations.
- Truthfulness: it describes a reality, without exaggeration.
- Evidential support: a documented element backs the announced effect.
- Honesty: it does not promise more than the product can deliver.
- Fairness: it does not disparage other products or other ingredients.
- Informed decision-making: it helps the user choose by understanding what they are buying.
Legal compliance and truthfulness
Legal compliance requires checking each statement against Article 20 of Regulation (EC) No 1223/2009 and Article 19 of the same regulation for labelling. Truthfulness is checked on substance: does the product really have the advertised quality? A generic formula such as “the best care” describes no verifiable fact; replace it with a precise property that you can demonstrate.
Evidence, honesty and fairness
The evidence criterion translates into a concrete document in your PIF: a use test, a study or data on an ingredient. It falls to the Responsible Person, within the meaning of Article 4 of Regulation (EC) No 1223/2009, to ensure that the wording matches the documents in the file. A result obtained on an isolated ingredient does not always prove the effect of the finished product: ask your laboratory to specify what each piece of evidence really demonstrates.
Honesty and fairness are judged on tone. Avoid presenting an ordinary advantage as an exclusive and devaluing competing products. Finally, reread each wording as a non-specialist consumer would: if they could understand something other than what you prove, reword it.
What can you say, what is risky, what should you avoid?
Three levels help you decide: what you can say with evidence to support it, what exposes you to risk for lack of substantiation, and what should be avoided because it is excluded. Promises of cure, official approval or an ordinary benefit belong to this last category.
This classification is a sorting tool, not an official list. It helps you spot, before your packaging is printed, the wordings that need in-depth checking. A “risky” claim is not prohibited: it becomes acceptable only if your file supports it.
Practical grid for your brand
A “risky” claim is a statement that is lawful in principle, but whose substantiation is demanding and easily challenged. The table below classifies common wordings. It illustrates a sorting method and replaces neither the official texts nor the advice of your Responsible Person.
| Level | Example wording | Why |
|---|---|---|
| Can say | “Moisturises the skin” or “light, non-greasy texture” | The effect is modest, measurable and documented by a use test or data on the formula, kept in the PIF. |
| Risky | “Free from” followed by an ingredient name | The statement must remain accurate for the complete formula, not be contradicted by an ingredient performing the same function, and not disparage lawfully used ingredients. Keep the composition evidence. |
| Risky | “Hypoallergenic” | Sensitive term: it must never suggest a total absence of allergy risk. It requires solid evidence and a careful reading of the official texts before use. |
| Risky | “Not tested on animals” | The statement must be justifiable for the finished product and for its ingredients. Check it with your laboratory and your Responsible Person. |
| Avoid | “Approved” or “authorised” by a Union authority | A notification or a compliant file is not official approval: suggesting otherwise is misleading. |
| Avoid | An advantage presented as exceptional when the law requires it of all products | Boasting about something that is a minimum requirement creates a particular benefit that does not exist. |
| Avoid | “Treats”, “cures”, “treats a disease” | These promises belong to a medicine or a medical device and take the product out of the cosmetic category. |
To use this grid, start from your most ambitious wording and ask yourself which PIF document supports it. If you find none, downgrade the wording to a more modest effect. This discipline is easier to maintain from the design stage, when you choose positioning and promises to create your cosmetic brand.
“Free from” and “hypoallergenic” claims: concrete examples
A “free from” claim is a claim that signals the absence of an ingredient or a family of ingredients. Three cases arise, and each calls for a different response.
- Prohibited ingredient: writing “free from” followed by a substance already excluded from all cosmetics presents as an advantage what is a general obligation. To be avoided.
- Ingredient with the same function: a “preservative-free” claim on a formula that contains an ingredient with a preservative function misleads the consumer, even if that ingredient is not presented as a preservative. Specify what you mean and check the wording with your Responsible Person.
- Ingredient absent from this type of product: pointing out the absence of a component that this type of formula never contains brings nothing to the consumer and may suggest a non-existent difference. It is better to highlight a real property of your formula.
“Hypoallergenic” calls for even more caution: the statement concerns the risk of allergy, which the consumer readily interprets as a guarantee. It requires specific evidence in the PIF and a human review. For all these wordings, consult the documents published by the European Commission on EUR-Lex and Article 20 of Regulation (EC) No 1223/2009.
Take a typical example: a Tunisian entrepreneur launches her first skincare brand sold online, with a single reference, a 50 ml light-textured facial moisturiser. She hesitates between “moisturises the skin”, “treats dry skin” and “preservative-free”. The first wording is modest: it relies on a use test kept in the PIF. The second implies a treatment and falls outside the cosmetic framework. The third would be inaccurate if the formula contains a preservative. She therefore chooses “moisturises the skin”, with the associated evidence.
These examples are indicative. Sensitive terms, including “hypoallergenic”, deserve a human review and a return to the official texts on EUR-Lex before anything is printed. This article remains informative.
How do you build an evidence file before exporting to the EU?
Each claim must point to evidence kept in the PIF (Product Information File): tests, studies or data on ingredients. The Responsible Person established in the European Union checks that the wording matches these documents. Manufacturing in Tunisia does not exempt you from the requirements of the destination market.
An evidence file is the set of documents that demonstrate, wording by wording, that what you state is accurate. It is built before the packaging is printed, not after. The Responsible Person, within the meaning of Article 4 of Regulation (EC) No 1223/2009, must be able to check each wording against the documents in the file. Without a matching document, the statement must be reworded or removed.
Linking each claim to the PIF
The PIF (Product Information File) is the file provided for in Article 11 of Regulation (EC) No 1223/2009. Oppenheimer Lab prepares PIFs and CPNP notifications. For claims, proceed in three steps:
- List all claims: label, carton, product sheet, advertisements and social media.
- Match evidence to each one: use test, study, ingredient data or composition.
- Validate the final wording with the Responsible Person, and reword any statement that the evidence supports only in part.
Keep the documents up to date and dated. If evidence changes, for example after a formula change, re-examine the wordings concerned.
Defining the countries of sale from the brief
We recommend defining the countries of sale from the brief, in order to prepare the corresponding supporting documents and packaging. For the European Union, you notably need to gather the following:
- a Responsible Person established in the EU;
- a PIF including a safety assessment (CPSR);
- a compliant composition;
- compliant labelling;
- a notification on the CPNP portal before placing on the market, provided for in Article 13 of Regulation (EC) No 1223/2009.
Note: CPNP notification is neither an authorisation nor a quality certification. It therefore never allows you to write that the product is “approved”. To frame your documents and timelines, you can request a quote. This article remains informative: refer to the official texts.
Who is responsible in the event of a misleading claim?
The Responsible Person, within the meaning of Article 4 of Regulation (EC) No 1223/2009, answers for the compliance of the claim. Inspections fall to the authorities of the Member States. Without matching evidence in the PIF, the statement is exposed; for the applicable penalties, consult the official texts and your legal adviser.
A misleading claim is a statement that suggests an effect, a guarantee or a quality that the product does not have, or that the file does not demonstrate. The decisive criterion is not the brand’s intention, but the impression the wording gives the consumer and the evidence you can present.
The Responsible Person is the entity designated by European regulation to guarantee the compliance of the product placed on the Union market. For a Tunisian brand, this means that a party established in the EU takes on this responsibility. It is therefore in their interest, as in yours, to accept only wordings backed by documents in the file. A disagreement over a statement is settled before the packaging is printed, not after an inspection.
The authorities of the Member States can examine your wordings on the packaging as well as in your online communication. The amounts and procedures for penalties depend on the country of sale and the situation. To find out more, refer to the official texts on EUR-Lex and to the authorities of the country concerned, or seek the advice of a specialist adviser.
On the manufacturing side, the documentary quality of your batches also supports your evidence. Oppenheimer Lab manufactures in line with cosmetic Good Manufacturing Practice (ISO 22716 / GMP). To frame GMP-compliant cosmetic manufacturing, define from the outset the target claims and the documents that will justify them. This article remains informative and does not replace the official texts.
Sources
- Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products, EUR-Lex (European Union), 10 July 2013
- Report from the Commission on cosmetic product claims (COM(2016) 580), EUR-Lex (European Commission), September 2016
- Made in Tunisia : révéler le potentiel cosmétique (in French), L’Économiste Maghrébin, 4 December 2025
Frequently asked questions
Can you say that a cosmetic treats or cures?
No, a promise to treat or cure should be avoided. It belongs to a medicine or a medical device and can take the product out of the cosmetic category, and therefore out of the scope of the common criteria. Favour modest, documented effects, and check your wordings in the official texts on EUR-Lex.
What is needed to use the “hypoallergenic” claim?
You need solid evidence filed in the PIF (Product Information File). The term implies a formula designed to minimise its allergenic potential and must never suggest a total absence of risk: the wording must match the documents in the file. Ask your laboratory what each test actually demonstrates, then have the claim reviewed by a person and by your Responsible Person.
Can you write “free from” followed by an ingredient name on a cosmetic?
Yes, but only if the claim is accurate for the complete formula, if the product contains no ingredient performing the same function, and if it does not disparage lawfully used ingredients. It must not disparage other products or present as an advantage something the law already requires of everyone. Keep the composition evidence in the PIF so you can produce it in the event of an inspection.
Who is responsible for substantiating a cosmetic claim?
It is the Responsible Person referred to in Article 4 of Regulation (EC) No 1223/2009. They ensure that the wording complies with the common criteria and matches the documents attesting the effect in the PIF (Product Information File). For the EU, they must be established in the Union.
Can a cosmetic manufactured in Tunisia carry the same claims in Europe?
Not automatically: manufacturing in Tunisia does not exempt you from the requirements of the destination market. For the European Union, wordings must meet the common criteria and be backed by the PIF, with a Responsible Person established in the EU and a CPNP notification before placing on the market.
