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EU & UK regulatory
Product labelling and claims
Product labelling and marketing claims are key elements of cosmetic regulatory compliance. Every market has its own requirements regarding the information that must appear on product labels, the language in which it must be presented, and the types of claims that may be made.
In the following sections, we outline the requirements applicable to the EU and the UK. For information on labelling and claims requirements in other markets, please refer to the dedicated pages for those jurisdictions.
Compliance requirements
EU and UK cosmetics labelling requirements
The open book symbol indicates that some information about the product can be found elsewhere.
Compliance requirements
EU and UK cosmetics labelling requirements
Just as attractive labelling is one of the most important features of the product when it comes to sales, so is correct labelling essential for the compliance of the cosmetic product with the cosmetics Regulation 1223/2009/EC and the UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, as labelling is an important part of the product information file.
The regulation contains various cosmetic labelling requirements and very specific rules regarding labelling, which have to be followed and are described in article 19 of the regulation. The notification of cosmetic products is not possible without the compliant product labels.
Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering… (EU Regulation 1223/2009, Article 19.1)
According to the regulation, the container and the outer packaging of cosmetic products have to bear the following information in indelible, easily legible and visible lettering:
- The name and address of the EU responsible person or UK responsible person
- The country of origin if the product is imported from countries outside of the EU/UK
- Nominal content of the product at the time of packaging, given by weight or volume
- Date of minimum durability or period after opening
- Precautions for use
- Batch number of manufacture or the reference for identifying the cosmetic product
- Function of the cosmetic product, unless it's clear from its presentation
- List of ingredients (which may be indicated on the outer packaging alone)
Some of these elements may also be mentioned on an enclosed or attached leaflet, label, tape, tag or card if it's impossible to list them on the labels. In that case an open book symbol should be placed on the label, which indicates that some information about the product can be found elsewhere.
EU & EFTA countries
Required languages for cosmetic labels
The EU consists of 27 different countries and the cosmetic labelling laws require certain information on the labels to be translated into different languages. Some countries have more than one official language, which further complicates things and requires that certain information appear in more than one language on the labels.
Our process
How our review works
01
Submit Materials
Send us your artwork and marketing materials.
02
Compliance Review
We review the labels against EU and UK requirements.
03
Issue Identification
We identify any compliance issues.
04
Artwork Updates
You update the artwork.
05
Final Verification
We perform the final compliance check.
Regulation 655/2013
Cosmetic product claims
Regulation 655/2013
Cosmetic product claims
Every claim that appears on the cosmetic product label, on the website where the cosmetic product is presented, in TV commercials etc. has to be substantiated unless it's a clear exaggeration or it's obvious for the type of the cosmetic product. It is a responsible person's task to ensure that all of the claims made regarding the product are substantiated.
In the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have. (EU Regulation 1223/2009, Article 20)
The EU published a separate regulation (Regulation 655/2013), which deals specifically with cosmetic product claims and is laying down 6 common criteria for the justification of claims used in relation to cosmetic products:
- Legal compliance
- Truthfulness
- Evidential support
- Honesty
- Fairness
- Informed decision-making
These common criteria are set in order to assess whether or not the use of a claim is justified. Regulation 655/2013 also provides guidance on the use of "free from claims" and hypoallergenic claims.
Additionally, there are also a number of guidelines for the so-called borderline products, which can also help determining which claims can be made for cosmetic products (as opposed to medical devices, biocides…) or how they should be phrased if the product is to be classified as a cosmetic.
Claim substantiation
How to prove cosmetic product claims
Claim substantiation
How to prove cosmetic product claims
All cosmetic claims must be supported by adequate and verifiable evidence. The type of evidence required depends on the nature of the claim, the product, and the expectations created for consumers. The supporting evidence should be robust enough to demonstrate that the claim is truthful, fair, and can be justified if requested by the competent authorities.
Best practices for claim substantiation evidence are also described in the Regulation 655/2013. Evidence for substantiating claims:
- Experimental studies (in silico, in vitro, ex-vivo, with instrumental or biochemical methods, sensory evaluations, etc.)
- Consumer perception tests
- Evidential support
- Use of published information
Where a claim is based on scientific research or testing, that work should have been conducted in accordance with best practice (consult independent experts).
CE.way offers a range of efficacy testing services to support cosmetic claim substantiation. Our regulatory specialists can advise which studies are appropriate for your product and intended claims, helping you generate evidence that meets regulatory expectations while avoiding unnecessary testing.
Related services
Related services
CE.way can offer various services related to product labelling and claims. We can offer:
Client reviews
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