The topic is short and compact
Regulation (EU) No 655/2013 establishes six common criteria that every claim must meet.
"Free-from" claims have been heavily restricted since July 1, 2019, because they disparage permitted ingredients.
Evidence is generated from testing: twelve weeks of stability and the preservative efficacy test according to ISO 11930.
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The basis is Article 20 of Regulation (EC) No 1223/2009. According to this, text, names, trademarks, images, and other signs may not be used to suggest features or functions that the product does not possess.
The regulation applies to every communication channel, not just the label. It covers packaging, website, advertisements, and statements in retail alike. For development, this means that the product claim cannot be decided at the end of the packaging design process, but rather co-determines the scope of testing.
Applies to all channels, from packaging to advertisement.
The product claim determines which evidence must be provided.
The decision belongs at the beginning of development.
The legal framework: Article 20
The basis is Article 20 of Regulation (EC) No 1223/2009. According to this, text, names, trademarks, images, and other signs may not be used to suggest features or functions that the product does not possess.
The regulation applies to every communication channel, not just the label. It covers packaging, website, advertisements, and statements in retail alike. For development, this means that the product claim cannot be decided at the end of the packaging design process, but rather co-determines the scope of testing.
Applies to all channels, from packaging to advertisement.
The product claim determines which evidence must be provided.
The decision belongs at the beginning of development.
The six common criteria
Regulation (EU) No 655/2013 substantiates Article 20 through six binding criteria that every claim must meet before being placed on the market.
They are interconnected and cover different aspects: compliance with applicable law, the truthfulness of the claim, its supportability, fairness towards competitors, the honesty of the presentation, and the ability of consumers to make an informed decision on this basis.
Legal compliance: statutory obligations must not be advertised as a unique selling proposition.
Truthfulness: do not claim an effect that the product does not have.
Supportability: every claim requires verifiable evidence.
Fairness and honesty: no disparagement of permitted substances or competitors.
Informed decision: the information must be clear and not misleading.
"Free-from" claims: what is no longer allowed since 2019
For a long time, cosmetic advertising relied on negative claims to suggest purity or safety. With Annexes III and IV of the Technical Document on Cosmetic Claims, applicable since July 1, 2019, this has been significantly restricted.
The core principle: A claim must not disparage approved and safely usable substances in a general way. Formulations like "paraben-free" are therefore considered inadmissible because they disparage a legally usable preservative. Similarly, "preservative-free" is inadmissible if multifunctional raw materials in fact ensure microbiological stability.
No disparagement of approved substances, for example through "paraben-free".
No "preservative-free" claims if multifunctional substances have a preserving effect.
No "free-from" claims for substances that are already unusual in this product category.
The effect of a raw material is not the same as the effect of the finished product
A common mistake is applying raw material data to the finished product. An active ingredient manufacturer may present studies showing an effect in vitro or in an isolated carrier solution. These results do not automatically apply to the finished formulation.
The Annex to Regulation (EU) No 655/2013 clarifies that a claim about the properties of an ingredient must not suggest that the finished product has the same properties unless this is true. Anyone drawing conclusions about product efficacy from the raw material efficacy needs their own verifiable evidence for this, such as proof of an effective concentration in the final product.
Studies from the raw material supplier do not prove the efficacy of the formulation.
The concentration used must match the claimed efficacy.
Separate proof is required for transferring this to the finished product.
What checks the documents provide
Evidence is created in the laboratory, not in the copy department. Before any claim is made, the formulation must prove that it physically, chemically, and microbiologically delivers what the label promises.
This includes accelerated stability testing at approximately 40 degrees Celsius over twelve weeks, during which phase separation, viscosity drift, color and odor changes, as well as the active ingredient content are monitored. The effectiveness of the preservation is proven by the preservation efficacy test according to ISO 11930, in which the inoculated samples are evaluated after 7, 14, and 28 days.
Accelerated stability testing over twelve weeks at elevated temperature.
Preservation efficacy test according to ISO 11930 with evaluation after 7, 14, and 28 days.
Efficacy claims additionally require proof on the finished product.
The scope of testing is described in Stability and safety testing.
Product Information File and Safety Report
Before being placed on the market, a product information file must be available for each product. It bundles the formulation, manufacturing description, test reports, labelling, and proof of the claims.
The core is the safety report required by Article 10 of the Regulation according to Annex I. Part A contains the safety-relevant data including exposure assessment, Part B the assessment by the qualified person. The evidence for advertising claims expressly belongs in this dossier.
Product information file with formulation, test reports and evidence of claims.
Safety report with Part A and Part B according to Annex I.
The evidence for each claim is part of the file.
A cosmetic product may only be placed on the market if a responsible person established in the Union has been designated. Article 4 of the Regulation governs the designation, Article 5 the responsibility of this person, including for compliance with the rules on advertising claims pursuant to Article 20 and for keeping the product information file.
Prior to placing on the market, notification is made via the European Commission's CPNP portal. This involves depositing the product category, formulation details, packaging design and emergency contacts. Without this notification, sale in retail stores is not permitted.
Designate a responsible person established in the EU.
CPNP notification with formulation details and artwork prior to placing on the market.
The responsible person is also liable for the advertising claims.
The procedure is described in EU Cosmetics Regulation, CPNP and PIF.
More useful links
FAQ
Which law applies to advertising claims for cosmetics?
The basis is Article 20 of Regulation (EC) No. 1223/2009, according to which no characteristics may be suggested that the product does not possess. This is specified by Regulation (EU) No. 655/2013 with six common criteria for each claim.
What are the six common criteria?
Legal compliance, truthfulness, substantiability, honesty, fairness, and the possibility of an informed decision. Every statement must satisfy all six before the product is placed on the market.
Why are "free-from" claims problematic?
Because they denigrate substances that are approved and safe to use. Since July 1, 2019, Annexes III and IV of the Technical Document have applied to this. A statement such as "paraben-free" denigrates a legally usable preservative and is therefore inadmissible.
Can a product be advertised as preservative-free?
Not if multifunctional raw materials ensure microbiological stability. The statement would then be neither truthful nor honest, because the product is in fact preserved, only with substances that are not formally listed as preservatives.
How are efficacy claims proven?
Via laboratory tests and, in the case of efficacy claims, via studies on the finished product. The standard tests are the accelerated stability test over twelve weeks at approximately 40 degrees Celsius and the challenge test according to ISO 11930 with evaluation after 7, 14, and 28 days.
Can I use the raw material supplier's study?
Not directly. The annex of Regulation (EU) No. 655/2013 clarifies that properties of an ingredient may not simply be attributed to the finished product. Separate proof is required, for example regarding the effective concentration in the final product.
