As required by the EU Cosmetics Regulation (EC No 1223/2009, Article 20), the acceptability of a claim made on a cosmetic product is determined by its compliance with the common criteria. Established by the EU Commission and the EU Member States, these six common criteria (namely Legal compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed decision-making) are reported in Regulation EU No 655/2013.1
The EU Commission and the EU Member States published a revised version of the guidelines for the application of the common criteria.2 This new version contains two additional annexes, one on ‘free from’ claims (annex III) and one on the ‘hypoallergenic’ claim (annex IV). In summary, these new annexes introduce the following changes in the management of cosmetic claims:
Annex III: ‘Free from’ claims
Type of ‘Free from’ claim | Status | Reasoning |
‘Free from’ + ingredient prohibited by the EU Cosmetics Regulation |
⊗ |
E.g. ‘Heavy metals free’
Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed. |
‘Free from’ + ingredient or ingredients category that are present in the product |
⊗ |
E.g. ‘Free from formaldehyde’ (if the product contains formaldehyde releasers)
If it is claimed on the product that it [does not] contain[s] a specific ingredient, the ingredient shall be deliberately [absent] present. |
‘Free from’ + ingredient not supposed to be present in the product |
⊗ |
E.g. ‘Preservative free’ (if the product is a fine fragrance containing high amounts of alcohol or bath salts, not expected to contain preservatives)
Claims shall not attribute to the product concerned specific characteristics if similar products possess the same characteristics. |
‘Free from allergenic / sensitizing substances’ |
⊗ |
A complete absence of the risk of an allergic reaction cannot be guaranteed and the product should not give the impression that it does.
“Free from” claims or claims with similar meaning should not be allowed when they imply guaranteed properties of the product, based on the absence of (an) ingredient(s), which cannot be given. |
‘Free from’ + ingredients category (e.g. fragrance, preservative, colorant) |
OK/⊗ |
E.g. ‘Preservative free’ is wrong if the product contains an ingredient, not in the official list of preservatives (Annex V) but having antimicrobial properties.
E.g. ‘Fragrance free’ is wrong if the product contains an ingredient that exerts a perfuming function, regardless of its other possible functions in the product. This claim is acceptable except if the product contains an ingredient having properties of this ingredients family as a side function. |
‘Free from’ + an ingredient or an ingredients family that are legally used |
⊗ |
E.g. ‘Parabens free’
Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used. |
‘Free from’ claims that allow an informed choice to a specific target group or groups of end users |
OK |
E.g. ‘Free from alcohol’ in a mouthwash intended as a family product.
E.g. ‘Free from animal-derived ingredients’ in Vegan products. Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice. |
Annex IV: ‘Hypoallergenic’ claim
The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. Evidence to support the claim must be available by verifying and confirming a very low allergenic potential of the product through scientifically robust and statistically reliable data (for example reviewing post-marketing surveillance data, etc.).
A product claiming to be ‘hypoallergenic’ will not contain known allergens or allergens precursors.
By making reference to the SCCS Memorandum SCCS/1567/15,3 these guidelines make useful clarifications about tests performed in healthy human volunteers such as the Human Repeated Insult Patch Tests (HRIPT). This version of the guidelines is less stringent than its initial draft and brings clarifications: hazard assessment of ingredients via HRIPTs is unethical and should be strictly prohibited. However, tolerance studies of a cosmetic product in humans are acceptable. Ideally, the use of Repeated Open Application Tests (ROAT) should be preferred to HRIPTs conducted on a finished cosmetic product.
The legal status of these guidelines was rather unclear and a legal review has been performed by Ms. Sylvie Gallage of Hogan Lovells LLP, a lawyer and specialist of this topic.
- On the one hand, it was confirmed that this document is a working document that has no legal status and, therefore, is not deemed legally-binding.
- On the other hand, these guidelines will be used by the National Authorities and Courts of Justice to determine on a case-by-case basis if a cosmetic product complies with Regulation EU No 655/2013.
Therefore, and to stay on the safe side, it is strongly recommended that cosmetic brands comply with these guidelines. Requirements laid down in Annex III and IV of these guidelines will start to apply in July 2019. While it is awkward to provide a deadline for a non-legally-binding document, the National Authorities and Courts of Justice will likely start to use these guidelines as a reference from this date.
References
- Regulation EU No 655/2013 [PDF]
- Technical document on cosmetic claims [PDF]
- SCCS Memorandum SCCS/1567/15
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Thank you for sharing this information. What if the product is made without using parabens, mineral oils and such can one say made without these ingredients on the packaging? As a consumer I would love to know what a product has in it and what it does not have. Love to hear your thoughts on this. Thank you
A cosmetic product that states “Paraben Free” on its packaging is not compliant with E.U. regulations. As the chart mentions, it’s “denigrating” and misleading to state that. Most parabens are safe, despite the hype. Here’s a blog post on that subject:
https://revivserums.com/blogs/serumscoop-tips-tricks-and-news/problems-for-preservatives
You can always check the INCI ingredients list on the packaging for the ingredients you’re concerned about.
You have stated that “A cosmetic product that states “Paraben Free” on its packaging is not compliant with E.U. regulations.”
Could you clarify why this statement isn’t compliant? The chart that you refer to is simply an annex to a technical document which clearly states that it is not legally binding, and your other reference is just a blog.
The article above suggests that a legal review has concluded that “it was confirmed that this document is a working document that has no legal status and, therefore, is not deemed legally-binding”
Can you direct me to the formal legislation that states that a “paraben-free claim is illegal?
As a cosmetic chemist who’s attended a number of regulatory symposiums in Europe on this issue, I can assure you it’s E.U. law and has been since 2013. Of course, that doesn’t stop some, and most are ignorant of this regulation since we all see such “free-from” claims on packaging pretty regularly.
It’s Regulation EU No 655/2013. The law is already cited in the Reference section above (the first citation link), and it’s related to Article No. 5. Fairness.
Is there a published standard for the Repeated Open Application Test? I’ve tried searching on the internet and have reached out to a few testing facilities, but none seem to be familiar with this particular test. Is this the definitive answer to hypoallergenic substantiation now?
Thanks for informing, useful article.
Would just like to clarify, if there is a claim for “free from mineral oil” or “free from alcohol” in a surfactant cleanser, that would be acceptable?
In most cases, mineral oils are not present in surfactant type cleansers. So is the claim still valid?
Dear Emily,
A ROAT is relatively common test in the EU that is relatively inexpensive (~300-400 € / product). You will find below a protocol of this test (recommended by the EU SCCS).
However, a test is not absolutely necessary to substantiate the claim hypoallergenic. It may be sufficient to show with no ambiguity that your product contains no substances classified skin sensitizer in the EU or allergen precursors or fragrance allergens in the sense of the EU Cosmetics Regulation.
Hope that it helps,
Fred (the author)
In patch testing the exposure is made under occlusion for 2 days. These exposure conditions are not comparable to actual exposures occurring in the daily life or working environment of the patient, which often involve long-term, repeated and low-dose contact with the allergen. However, procedures such as the repeated open application test (ROAT) or provocative use test much better reflect actual exposure by daily repeated open applications at relevant skin areas with solutions/product matrices of allergens in realistic concentrations (Johansen JD et al., 2015). Depending on the product type and allergen studied, the exposure can be 1-5 times daily usually for 2-3 weeks (Yazar K et al., 2015; Jorgensen PH et al., 2007; Nielsen NH et al., 1999). A standardised scale is used for assessing reactions (Johansen JD et al., 2015). The group size is 10-20 sensitised individuals (patch test positive eczema patients) and a similar number of nonsensitised control persons. The dose per area per application required to elicit a reaction in the ROAT is lower than the dose per area required to elicit a reaction in the patch test. A factor of around 30 between the dose in the patch test and the ROAT giving a response has been identified for two non-volatile allergens (Fischer LA et al., 2009). Safe levels identified with this method are directly relevant to exposures and disease. A negative test is a strong indication that the dose will be safe for most individuals concerning both induction and elicitation.
Check the bibliographical reference: Johansen JD, Aalto-Korte K, Agner T, Andersen KE, Bircher A, Bruze M, Cannavó A, Giménez-Arnau A, Gonçalo M, Goossens A, John SM, Lidén C, Lindberg M, Mahler V, Matura M, Rustemeyer T, Serup J, Spiewak R, Thyssen JP, Vigan M, White IR, Wilkinson M, Uter W. European Society of Contact Dermatitis guideline for diagnostic patch testing – recommendations on best practice. Contact Dermatitis. 2015 Oct;73(4):195- 221.
Dear Beatrice,
Thank you for the positive feedback.
Sometimes claims are just black or white. However, in many cases, this is a matter of interpretation and the right solution consists in making assumptions based on the common criteria of EU No 655/2013, the B2C Unfair Commercial Practices Directive (EC No 29/2005), the national provisions & jurisprudence in the countries of interest, what the market is doing and finally the common sense. This quite a tough job actually.
In practice, I think that the “alcohol free” can always be more or less acceptable, at least because some religious communities want to avoid alcohol in any form. You can then justify your decision buy the fact that you allow some groups of consumers to make a well-informed purchasing decision. Of course you cannot make such a claim if it appears that the product contains alcohol. Likewise “Sulfate free” in a shampoo looks ok because groups of consumers having long hair should better avoid sulfates (at least you can build a case). Identically, “Gluten free” in a lip balm sounds acceptable too because gluten-intolerant people would probably prefer this type of products and such a claim helps them to choose more easily.
However, “free from mineral oil”, in particular in a product not supposed to contain it, would be misleading. Indeed, you would breach common criterion 4 (Honesty) as you claim the absence (and try to make your product looks unique) of something that is not supposed to be present anyway. Furthermore, I believe that you also breach common criterion 5 (Fairness) as such a claim tends to denigrate the use of legal ingredients.
So, according to me, it would be yes, for the first one and no for the second one 🙂
Hope that it helps.
Fred
Hello,
I tend to agree with VG Nesbitt. The ‘free from’ guidance published at the EU level is ‘just’ an interpretation of the common criteria published in 2013 intended to harmonize the positions in the EU. In some cases, this interpretation has been made long ago by the Market Surveillance Authorities of some countries and regularly used for the evaluation of cosmetic claims in these countries.
I think that this guidance plays an important role nevertheless. A free-from claim breaching the common criteria was maybe somehow tolerated in some places and the EU Responsible Person could always say (somehow) “sorry, I didn’t know” in case of an inspection. Now, with this guidance, nobody will be able to pretend “I didn’t know”.
Hope that it helps.
Fred
Dear April,
Happy to help and thanks for the feedback.
With this regulatory change, the Authorities (and the industry somehow) want to say “we evaluated these ingredients, these ingredients are legal and safe and therefore there is no reason to try to avoid them”. The goal is mainly to prevent companies from denigrating useful ingredients. You may want to check this article: https://www.ulprospector.com/knowledge/6776/pcc-preservative-deep-dive-parabens-alternatives/
Now, I could understand that this is not what you want… but this is a different story. In the USA, people are relatively free to run their lives as they want provided that they are properly informed by the brand about what they buy (freedom to choose for its own life). Therefore, responsibility and consumer information plays there an important role. In the EU, the consumer is usually protected ‘by default’ (sometimes against its own consent) and what the Authorities accepted “is necessarily good for you”. I’m making a caricature of the situation but this is a bit the idea.
Hope that it helps.
Fred
VG, and Fred, thanks for feedback. I agree that Regulation EU No 655/2013 is indeed EU law, and thanks for highlighting this.
My point is that the Technical Document on Cosmetic Claims openly states that it only serves as a tool to support the legislation. Fred, as you suggest, this guidance does play an important role, but while the guidelines this document should probably be adhered to as examples of good practice, I would be wary of interpreting them as black letter law.
The document has its own disclaimer: “…The views expressed in this document are not legally binding; only the European Court of Justice can give an authoritative interpretation of Union law. This document cannot be regarded as reflecting the official position of the European Commission…”
Legally therefore, I would suggest this document is certainly persuasive, as it was drafted by the EU Working Group on Cosmetic Products which could be regarded as an arm of the EU, but not binding until endorsed by the ECJ (the ECJ might disagree with some of the examples given – after all, that is why cases end up in court – for judges to decide).
Does anyone have any information on test cases in this area?
Dear David,
Thank you for your message.
To my understanding, the disclaimer of this guidance document is intended to the EU Member States and not that much to the economic operators. This cautious wording aims to ensure that the Member States (who did not manage to find an agreement on these guidelines) are allowed to continue their own interpretation of the common criteria.
This is somehow confirmed by the disclaimer itself: “IT IS FOR THE NATIONAL COMPETENT AUTHORITIES AND NATIONAL COURTS TO ASSESS ON A
CASE-BY-CASE BASIS WHICH CLAIMS MADE IN RELATION TO COSMETIC PRODUCTS ARE ALLOWED.”
Hope that it helps.
Best regards,
Fred
As to Parabens and its Esters and its Chain Esters – it is banned in E.U
EU Regulation No.358/2014/9 of 9th April 2014
Hello
Thank you for this very informative article, very usefull.
Would you know if ‘Free from/NO Aluminium’ is acceptable to write on products?
A sweeping statement! Only some are banned by methyl parabens and ethyl parabens remain acceptable and propyl and butyl parabens are restricted to a total of 0.14% alone or in mixtures.
What will be a suitable/sensible 10 Free Claim for Nail Manicure Products since it seems that the consumer cannot move away from this marketing idea
What I dont understand is so many brands marketed at curly hair claim to be “sulphate, silicone, paraben free” – for example innersense, NYC curls, jessicurl, cantu etc etc, the first one especially claims to be formaldehyde free and propelyne glycol free, does. that mean they’re illegal selling?