‘Free From’ Claims in Cosmetic Products
Consumers are increasingly demand simple, 'clean', sustainable cosmetics and their interest on the composition of products is growing. 'Free from' or similar claims are usually appreciated and are currently a trend in the market. Nevertheless, not all 'free from' claims should be used or are allowed in cosmetic products placed in the European Union market.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate


Claims can be in the form of texts, names, trademarks, pictures and figurative or other signs that convey explicitly or implicitly product characteristic or functions in the labelling, marketing and advertising of cosmetic products.

The Commission Regulation (EU) No 655/2013 lays down common criteria for the justification of claims in relation to cosmetic products. It applies to any cosmetic product claim, irrespective of the medium or type of marketing tool used, the product functions claimed and the target audience.

The six common criteria laid down by the Commission Regulation (EU) No 655/2013 are: Legal Compliance; Truthfulness; Evidential Support; Honesty; Fairness; and Allowing Informed Decisions. A cosmetic product cannot contain or imply false or irrelevant information and its claims should be supported by adequate and verifiable evidence (i.e., nothing should be claimed that cannot be supported). Overall, cosmetic products claims must be clear, true, objective, understandable and give enough information to allow consumers to make informed decisions. (see previous post)

A Technical document on cosmetic claims was prepared by the Sub-Working Group on Claims and then endorsed by the Working Group on Cosmetic Products. It serves as a ‘tool’, providing guidance for the application of the Commission Regulation on cosmetic claims. However, the views expressed in the document are not legally binding and only the European Court of Justice can give an authoritative interpretation of Union law.


Annex III of the Technical document on cosmetic claims provides guidance for the application of the common criteria established by the Commission Regulation (EU) No 655/2013 to ‘free from’ claims. It includes illustrative and non-exhaustive examples of this type of claims, with the aim of helping the industry to correctly use them.

Cosmetic products can not indicate that they are ‘free from’ a substance which is prohibited for use in cosmetics (according to Regulation (EC) No 1223/2009), as it is a mere compliance with minimum legal requirements. For example, “free from heavy metals” is not allowed, since the intended presence of heavy metals is prohibited in cosmetic products.

Free from parabens‘ is another trendy claim in the cosmetic industry. Nevertheless, such claim should not be use. Certain parabens are safe when used according to the European Cosmetics Regulation, and the use of these type of claims is denigrating the entire group of parabens (authorized substances).

Another very common example of this type of claims is the “fragrance free” (or similar). These have to be evaluated in a case-by-case basis and are intrinsically dependent on the ingredients present and the respective function they can have in the final product.

However, there are several ‘free from’ claims or similar claims that are permitted as they allow an informed decision to a specific target group or groups of end users. One example is the claim “free from acetone” in a nail polish, for users wishing to avoid its particular smell, or the claim “free from animal-derived ingredients” in products intended for vegans.

If you need further information or advice on which claims can be made for your cosmetic products and their proper substantiation, feel free to contact us at info@criticalcatalyst.com.


  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Commission Regulation (EU) No 655/2013 of 10 July 22013 laying down common criteria for the justification of claims used in relation to cosmetic products.
  3. Technical document on cosmetic claims. Agreed by the Sub-Working Group on Claims. 2017. European Commission.


medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »