European Commission Report on claims

25/10/2016

Why are claims legally regulated?

The Cosmetics industry in Europe is a highly dynamic sector with 25% of cosmetic products on the market that are new. The European Union is the global leader in cosmetics, and for the sake of consumer safety this industry is highly regulated and monitored.

Claims that are made on the product should comply with regulation 655/2013. This regulation sets up the legal framework with six common criteria:

  • Legal compliance
  • Truthfulness
  • Evidential support
  • Honesty
  • Fairness
  • Informed decision-making

As stated by the recent report published by the European Commission « The common criteria apply to claims in the form of text, names, trademarks, pictures and figurative or other signs that explicitly or implicitly cover product characteristics or functions in the labeling making available on the market and advertising of cosmetic products. They apply to any claim, irrespective of the medium or type of marketing tool used, the products functions claims and the target audience».

Although claims are powerful marketing tools as they allow your brand to be distinguished from competitors, they have to be fair and not mislead consumers. The consumer must be able to make an informed decision based on these six common criteria. The legal framework of the claims regulation guarantees a high level of protection for consumers but also allows authorities for in-market control decisions.

Who monitors the European market?

European and national authorities are authorized to monitor the market.

In 2015, the European Advertising Standards Alliance (EASA) conducted a monitoring exercise across six countries: France, Hungary, Italy, Poland, Sweden and UK.

  • 1861 ads were controlled
  • 577 were on TV
  • 1824 were printed ads

Method and purpose used by the EC to carry out this report

Article 22 of the 1223/2009 Regulation states « Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.»

The EC invited all Member states to monitor their market during one calendar year (starting on July 2014). The scope set up by the EC was « the claims verified should cover all forms (text, signs, symbols, etc.) and vehicles (on-pack labels, television advertising, print advertising, etc.) for communicating claims. They should not be limited to on-pack text claims. »

The investigators checked all the communication support of the brand (from the packaging to the brochure and from the radio to the website.

Most samples used for the analysis represented products containing the following categories of claims:

  • «Claims characterizing ingredients (e.g. ‘anti-aging)
  • Claims related to the product’s efficacy (e.g. a skin cream with a sun protection factor)
  • Claims highlighting the absence of substance (e.g. ‘free from perfume’)
  • Claims addressing skin compatibility of the product (e.g. ‘hypoallergenic’, ‘for sensitive or atopic skin’);
  • Claims addressing health or additional benefits other than the cosmetic purpose (e.g. sunscreens or intimate hygiene products). »

Responsible Person, distributor, anti-poison center were involved and had to provide the Product Information File to verify the compliance of the claims with evidential support.

The results of the EC’s Claims Report

1- PRODUCT PERFORMANCE

Based on the common criteria ‘evidential support’ and ‘honesty’, 16 Member states found products on the EU market that were not compliant. Brand, distributor, and Responsible Persons could not provide sufficient evidential support or reliable scientific studies.

E.G.: Products claimed to have a sun protection effect or to not contain any allergens.

2- MEDICINAL PROPERTIES, CLAIMS OF TREATMENT ABILITY AND THERAPEUTIC EFFECTS

Based on the EC 655/2013 regulation on claims, 10 Member states found claims stating medicinal/therapeutic effects that were not compliant with the six commons criteria, especially: ‘honesty, ‘informed-decision making, ’evidential support’ or ‘legal compliance’.

Borderline products must be defined upstream to avoid misleading effects.

E.G.: Products, which are borderline with medical devices, medicines or biocidal products.

3- FREE FROM AUTHORIZED INGREDIENTS

Claims stating free from authorized ingredients are breaching the ‘fairness’ criteria.

« 20% of the monitored cosmetic had a ‘free from’ claim and many of them were ‘paraben free’. This claim is attractive for marketing purposes because of the media attention. However, Member Stated considered that it is against the ‘fairness’ criterion because it denigrates legally authorized ingredients. »

Nevertheless, the report pointed out that sometimes ‘free from’ claims could be authorized if they gave essential information to consumers especially for specific reasons such as religion or allergies

E.G.: Free from soap / alcohol / essential oils are compliant with the European Regulation.

4- FREE FROM BANNED INGREDIENTS

In rare cases, Member states found some products claiming free from « prohibited ingredients ». This claim breaches the ‘legal compliance’ criterion and is misleading for the consumer but also unfair to competitors.

5- HYPOALLERGENIC CLAIM

This claim is currently accepted as long as substantiated, i.e. in accordance with the common criterion ‘truthfulness’. Please note that this claim can only be used in the case where the cosmetic product has been designed to minimize its allergenic potential. The product shall not contain any allergens and there should be sufficiently robust and statistically reliable data to prove that the product has a very low allergenic potential.

However, this claim is not accepted by German authorities.

6- CLAIMS ON THE PRESENCE OF INGREDIENTS ALTHOUGH THEY WERE NOT FOUND IN THE PRODUCT

« 5 Member States reported cases of absence of ingredients mentioned in a product claim, which breaches the ‘truthfulness’ criterion »

7- ‘NOT TESTED ON ANIMALS AND THE RABBIT LOGO

Based on the common criterion «legal compliance », such claim could be interpreted as not allowed because « it conveys the idea that a product has specific benefit when this benefit is mere compliance with minimum legal requirements ». In fact, animal testing is totally banned since 2013 on all ingredients & finished products.

Member states found cases where the ‘evidential support’ criterion was not respected although products were claiming so (texts or symbols).

Corrective action in cases of non-compliance

Conclusions carried out by the report

  • 90% of analyzed cosmetic claims were found compliant with the common criteria set out in Regulation EC 655/2013
  • Borderlines products have to be better defined. The Member States could be the ones who regulate this point on a case-by-case basis.
  • Authorities encountered difficulties while verifying claims on cosmetic products especially for claims such as « hypoallergenic » and « free-from ‘authorized ingredient‘
  • There’s a need to clarify the points mentioned above and sub-working groups on claims would probably name to work on it.

Why are claims legally regulated?

The Cosmetics industry in Europe is a highly dynamic sector with 25% of cosmetic products on the market that are new. The European Union is the global leader in cosmetics, and for the sake of consumer safety this industry is highly regulated and monitored.

Claims that are made on the product should comply with regulation 655/2013. This regulation sets up the legal framework with six common criteria:

  • Legal compliance
  • Truthfulness
  • Evidential support
  • Honesty
  • Fairness
  • Informed decision-making

As stated by the recent report published by the European Commission « The common criteria apply to claims in the form of text, names, trademarks, pictures and figurative or other signs that explicitly or implicitly cover product characteristics or functions in the labeling making available on the market and advertising of cosmetic products. They apply to any claim, irrespective of the medium or type of marketing tool used, the products functions claims and the target audience».

Although claims are powerful marketing tools as they allow your brand to be distinguished from competitors, they have to be fair and not mislead consumers. The consumer must be able to make an informed decision based on these six common criteria. The legal framework of the claims regulation guarantees a high level of protection for consumers but also allows authorities for in-market control decisions.

Who monitors the European market?

European and national authorities are authorized to monitor the market.

In 2015, the European Advertising Standards Alliance (EASA) conducted a monitoring exercise across six countries: France, Hungary, Italy, Poland, Sweden and UK.

  • 1861 ads were controlled
  • 577 were on TV
  • 1824 were printed ads

Method and purpose used by the EC to carry out this report

Article 22 of the 1223/2009 Regulation states « Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.»

The EC invited all Member states to monitor their market during one calendar year (starting on July 2014). The scope set up by the EC was « the claims verified should cover all forms (text, signs, symbols, etc.) and vehicles (on-pack labels, television advertising, print advertising, etc.) for communicating claims. They should not be limited to on-pack text claims. »

The investigators checked all the communication support of the brand (from the packaging to the brochure and from the radio to the website.

Most samples used for the analysis represented products containing the following categories of claims:

  • «Claims characterizing ingredients (e.g. ‘anti-aging)
  • Claims related to the product’s efficacy (e.g. a skin cream with a sun protection factor)
  • Claims highlighting the absence of substance (e.g. ‘free from perfume’)
  • Claims addressing skin compatibility of the product (e.g. ‘hypoallergenic’, ‘for sensitive or atopic skin’);
  • Claims addressing health or additional benefits other than the cosmetic purpose (e.g. sunscreens or intimate hygiene products). »

Responsible Person, distributor, anti-poison center were involved and had to provide the Product Information File to verify the compliance of the claims with evidential support.

The results of the EC’s Claims Report

1- PRODUCT PERFORMANCE

Based on the common criteria ‘evidential support’ and ‘honesty’, 16 Member states found products on the EU market that were not compliant. Brand, distributor, and Responsible Persons could not provide sufficient evidential support or reliable scientific studies.

E.G.: Products claimed to have a sun protection effect or to not contain any allergens.

2- MEDICINAL PROPERTIES, CLAIMS OF TREATMENT ABILITY AND THERAPEUTIC EFFECTS

Based on the EC 655/2013 regulation on claims, 10 Member states found claims stating medicinal/therapeutic effects that were not compliant with the six commons criteria, especially: ‘honesty, ‘informed-decision making, ’evidential support’ or ‘legal compliance’.

Borderline products must be defined upstream to avoid misleading effects.

E.G.: Products, which are borderline with medical devices, medicines or biocidal products.

3- FREE FROM AUTHORIZED INGREDIENTS

Claims stating free from authorized ingredients are breaching the ‘fairness’ criteria.

« 20% of the monitored cosmetic had a ‘free from’ claim and many of them were ‘paraben free’. This claim is attractive for marketing purposes because of the media attention. However, Member Stated considered that it is against the ‘fairness’ criterion because it denigrates legally authorized ingredients. »

Nevertheless, the report pointed out that sometimes ‘free from’ claims could be authorized if they gave essential information to consumers especially for specific reasons such as religion or allergies

E.G.: Free from soap / alcohol / essential oils are compliant with the European Regulation.

4- FREE FROM BANNED INGREDIENTS

In rare cases, Member states found some products claiming free from « prohibited ingredients ». This claim breaches the ‘legal compliance’ criterion and is misleading for the consumer but also unfair to competitors.

5- HYPOALLERGENIC CLAIM

This claim is currently accepted as long as substantiated, i.e. in accordance with the common criterion ‘truthfulness’. Please note that this claim can only be used in the case where the cosmetic product has been designed to minimize its allergenic potential. The product shall not contain any allergens and there should be sufficiently robust and statistically reliable data to prove that the product has a very low allergenic potential.

However, this claim is not accepted by German authorities.

6- CLAIMS ON THE PRESENCE OF INGREDIENTS ALTHOUGH THEY WERE NOT FOUND IN THE PRODUCT

« 5 Member States reported cases of absence of ingredients mentioned in a product claim, which breaches the ‘truthfulness’ criterion »

7- ‘NOT TESTED ON ANIMALS AND THE RABBIT LOGO

Based on the common criterion «legal compliance », such claim could be interpreted as not allowed because « it conveys the idea that a product has specific benefit when this benefit is mere compliance with minimum legal requirements ». In fact, animal testing is totally banned since 2013 on all ingredients & finished products.

Member states found cases where the ‘evidential support’ criterion was not respected although products were claiming so (texts or symbols).

Corrective action in cases of non-compliance

Conclusions carried out by the report

  • 90% of analyzed cosmetic claims were found compliant with the common criteria set out in Regulation EC 655/2013
  • Borderlines products have to be better defined. The Member States could be the ones who regulate this point on a case-by-case basis.
  • Authorities encountered difficulties while verifying claims on cosmetic products especially for claims such as « hypoallergenic » and « free-from ‘authorized ingredient‘
  • There’s a need to clarify the points mentioned above and sub-working groups on claims would probably name to work on it.