Free From Claims: the assessor’s position

Free From Claims

In the realm of cosmetics, it is imperative that product labels encompass a comprehensive array of mandatory information, ensuring transparency and consumer awareness. Serving as a crucial link of communication, these labels elucidate essential details about the cosmetic product to the end user. Beyond mere formality, adhering to these label requirements reflects a commitment to regulatory standards and consumer safety.

These requirements are outlined in the Regulation 655/2013, which establishes a structured framework that mandates the inclusion of specific information on cosmetic labels, encompassing details related to ingredients, usage instructions, precautions, and more.

Amongst the product labelings and claims, one of the most discussed and of importance for the end user is the “free from” claim. Specifically, these are claims used in cosmetics to boast the absence of an ingredient or an entire class of ingredients, often “harmful” (or thought to be harmful by the general public) to people and/or the environment. These types of claims are often thorny, because they are not always allowed, but constitute a big part of the marketing strategy for cosmetic products.

How are these claims applied?

Annex III of the Technical Document on Cosmetic Claim (7/2017) is the guidance document that establishes guidelines for the application of claims. As with any Commission guidelines, these are not legally binding texts, but only guidance documents. The contents of this document apply from 1 July 2019.

As for “free from” claims, they should not be used when referring to an ingredient prohibited by Regulation 1223/2009. Likewise, boasting the absence of ingredients or classes of ingredients permitted by Regulation 1223/2009 is not considered correct.

Let’s take a look at some examples:

  1. The claim “without parabens” is not permitted as it is denigrating to the entire class of parabens which are permitted and included in Annex V of Regulation 1223/2009. Nevertheless, this claim is present on a lot of packages! The same principle is applicable for other preservatives such as Phenoxyethanol and Triclosan.
  2. The claim “cruelty free” does not make much sense to exist because in 2004 the European Union banned the testing of cosmetic products on animals, in 2009 it banned the testing of cosmetic ingredients on animals, and in 2013 it banned the sale of products cosmetics that contain ingredients tested on animals.
  3. The claim “without allergenic/sensitizing substances” is not permitted. In fact, the complete absence of the risk of allergic reaction cannot be guaranteed and the product should not give such an illusion. Therefore, the use of the hypoallergenic claim does not guarantee a complete absence of risk. The product should undergo testing confirming very low allergenic potential and the presence of known allergens or allergen precursors should be avoided completely.
  4. The claim “no alcohol” is permitted when it allows the product to be differentiated from another, as in the case of mouthwashes intended for use by the whole family. However, it is not permitted if the claim is disparaging towards competitors or if it suggests that alcohol is a harmful ingredient.
  5. For perfumes, which usually contain a high quantity of ethanol such as to make the additional use of preservatives superfluous, the claim “without preservatives” is not permitted because, given the high quantity of ethanol which by its nature plays a preservative action, it would be unfair to point out that the perfume does not contain preservatives.

As the amount of claims to be included in labels is broad, a standardized approach was introduced by regulation (EU) 655/2013, establishing common criteria that guide the appropriate use of descriptors. These criteria, designed to enhance clarity and accuracy, encompass the following:

  • compliance with standards;
  • truthfulness;
  • evidentiary support;
  • honesty;
  • correctness;
  • informed decisions.

The main objective of adopting these six common criteria is to ensure a high level of protection for end users, in particular against misleading claims about cosmetic products. Given that these products play an important role in the lives of end users, it is important to ensure that the information provided with these declarations is useful, understandable and reliable, allowing end users to make informed decisions and choose the products best suited to their needs and expectations.

The common criteria apply to:

  • all cosmetic claims;
  • all forms of advertising (texts, names, brands, designs, images etc.);
  • all means of communication (product labels, TV, press, internet, etc.).

In the realm of cosmetics, the veracity of product claims plays a pivotal role in building and maintaining consumer trust. Truthful claims, especially in marketing, establish a foundation of credibility that resonates with consumers. When cosmetic brands provide accurate information about the efficacy, ingredients, and benefits of their products, it fosters a sense of transparency and reliability. This transparency not only enhances brand credibility but also strengthens the bond of trust between consumers and the brand. In an industry where perception is paramount, the authenticity of claims becomes a cornerstone for establishing enduring relationships with consumers based on honesty and integrity. Misleading or inaccurate assertions can not only jeopardize consumer safety but also erode trust in the broader market. Therefore, compliance with Regulation 655/2013 becomes a cornerstone in maintaining the integrity of the cosmetic industry, ensuring that manufacturers prioritize transparency and accuracy in their product representations.

Now, let’s talk about some common misconceptions:

Preservatives have been one of the most demonized products of our times in all products, not only in cosmetics. What people do not realize, is that preservatives allow us to have products that are safe from a microbiological point of view throughout their use! Precisely due of their bactericidal and preservative action, their safety has sometimes been questioned.

Nevertheless, Annex V of Regulation 1223/2009 guarantees the harmlessness of preservatives used in cosmetic products, containing the list of preservatives that can be used in cosmetics and their permitted quantities. Furthermore, for preservatives, the SCCS proposes a cumulative daily exposure limit considering the set of all cosmetic products that a person can use in a day and this value must be used to calculate the Margin of Safety.

Another controversial trend  in the cosmetic industry involves the incorporation of botanicals in products. Consumers often perceive these substances as “cleaner” and “natural,” contributing to formulations that are free of chemical ingredients and, consequently, perceived as safer for both health and the environment.

However, the general public is not aware that sometimes “natural” or “biological” ingredients and products could have more critical issues than products of “synthetic” origin. Moreover, many cosmetic products are presented as “natural” or “bio” but sometimes contain only minimal quantities of substances well identified in this sense. Apart from a few exceptions (e.g. oils, butters, essential oils, aromatic distilled waters) it is difficult to create 100% natural cosmetics. The composition of most “natural” products is made up of chemically modified substances of natural origin, often accompanied by ingredients of synthetic origin (preservatives, emulsifiers, perfumes, etc.)

A claim that accentuates the concept of safety linked to the presence of natural substances, for example “safer for your skin” is not permitted. Natural does not mean greater safety! In fact, a toxicologist can run into pitfalls when evaluating the safety of ingredients of natural origin.

In conclusion, the fundamental requirement is that all cosmetic products comply with the Cosmetic Regulation 1223/2009. Their ingredients must comply with any restrictions or prohibitions provided for by this Regulation. Given that the cosmetic market is not as strictly regulated as the medical device industry, claims are often not thoroughly scrutinized, except through occasional “random checking.” This is why it is essential for both companies and consumers to exercise diligence and responsibility in ensuring the accuracy and safety of cosmetic products. Consumers are encouraged to make informed choices, while companies should uphold high standards of transparency and compliance to build trust in the marketplace.



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.

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30  November 2009 on cosmetic products.

SCCS (Scientific Committee on Consumer Safety) – The Sccs Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th Revision, 2023.

TECHNICAL DOCUMENT ON COSMETIC CLAIM – Agreed by Sub-Working Group on Claims (version of 3 July 2017).


Article Issued by Maria Labianca

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