Gerald Renner Cosmetics Europe Cosmetic product claims Regulatory framework and the common criteria Gerald Renner Cosmetics Europe

Contents Introduction The EU regulatory framework for cosmetic product claims The scope of the Common Criteria The 6 Common Criteria with examples Guidance References

1. Introduction Claims are text, names, trade marks, pictures and figurative or other signs that convey explicitly or implicitly product characteristics or functions in the labelling, making available on the market and advertising of cosmetic products. Product claims are marketing tools that are essential to: - help consumers/users choose a product; - foster competition; - promote innovation.

1. Introduction (continued) Cosmetic product claims are subject to a multiple set of rules that may apply concurrently. In the EU, claims may be controlled by a diversity of national authorities, including non-governmental bodies, on the basis of “private” codes of practice. Rules applicable to claims generally pursue 2 main objectives: - consumer protection (against misleading practices); - fair competition. Focus on the cosmetic legislation i.e. the “lex specialis” for claims related to the characteristics and functions of cosmetic products.

2. The EU Regulatory Framework Horizontal legislation: Directive 2005/29/EC on unfair commercial practices Directive 2006/114/EC on misleading and comparative advertising Cosmetic-specific legislation: Directive 76/768/EC - Articles 6(3) and 7a.1(g) / to be replaced by Articles 20 and 11(2)(d) Regulation 1223/20009 in July 2013 Commission recommendation on claims related to the absence of animal tests Commission recommendation on the labelling and efficacy of sunscreen products

Directive 76/768/EC Article 7a (1)(g): “Member States shall take all measures necessary to ensure that, in the labelling, putting up for sale and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs are not used to imply that these products have characteristics which they do not have”. Article 7a (1)(g): The Product Information (PIF) must include “the proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product”.

Regulation 1223/2009: what has changed? Article 20 amends Article 6(3) of the Directive but the basic principles remain the same: Art.20 (1): “In the labelling, making available on the market and advertising of cosmetic products, texts, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have”. Art.11(2)(d): The PIF must include, “where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product”.

Regulation 1223/2009: what has changed? (continued) In the future more harmonization in enforcement policies New Article 20(2): “(….). After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products (…), taking into account of Directive 2005/29/EC. By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria (…). If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States.”

3. The scope of the common criteria Aim principally to protect end users (i.e. consumers and professionals) of cosmetic products from misleading claims They will be mandatory and will supersede conflicting national requirements (including codes of practice) They will apply to any claim within the scope of the Regulation, irrespective of the medium or type of marketing tool used, of the product functions claimed, and of the target audience

3. The scope of the common criteria (continued) Cosmetic claims concerned are claims made in relation to the characteristics or the function(s) of a cosmetic product as defined in Article 2(1)(a) of the Regulation The criteria are not meant to help the classification of a “borderline” product as a cosmetic product – They apply to products that qualify as “cosmetics” (including primary and secondary functions if any) The Responsible Person is responsible for ensuring compliance with the criteria – Distributors may also be liable if they modify the claims

4. The 6 Common Criteria Legal compliance Truthfulness Evidential support Honesty Fairness Informed decision-making

Legal compliance A claim must comply with all legal requirements and must not mislead the consumer or any other end user; Relevant self-regulatory regimes should also be taken into account by the Responsible Person; A claim is to be assessed on the basis of the expectations of the “average consumer” i.e. a consumer “who is reasonably well informed and reasonably observant and circumspect”; The benefits claimed for a product must go beyond mere compliance with legal requirements.

Legal compliance - examples Examples of claims not allowed: “this skin cream does not contain hydroquinone”; “this product complies with the EU cosmetics legislation”.

Truthfulness The presentation or claims made in relation to a product must not be based on false or irrelevant information; If a product claims to be containing a specific ingredient, the ingredient must be deliberately present; Ingredient claims referring to the cosmetic properties of a specific ingredient should not imply that the finished product has the same properties when it does not.

Truthfulness - examples Examples of claims not allowed: “silicone-free” (if the product contains silicone) “48-hour hydration” (if the set of evidence only supports a shorter period of hydration) “contains honey” (if product only contains honey flavour, but no honey) “contains moisturising aloe vera” (if the product itself has no moisturising effect)

Evidential Support Product claims must be supported by adequate and appropriate evidence (exceptions: hyperboles or clear exaggerations); The types of evidence may vary depending on the nature of the claim and the general knowledge; Subject to control by the authorities, it is the responsibility of the Responsible Person to determine the appropriate supporting evidence.

Evidential Support (continued) If studies are used, they must be relevant to the product and the benefit claimed; Experimental studies and consumer perception tests must be conducted in accordance with best practices; Supporting evidence (when required) for efficacy claims must be available as part of the PIF; Weight of evidence approach, taking into account all studies, data and information available.

Honesty Presentation of the product performance must not go beyond the available supporting evidence; The presentation of the product or claims made for the product must not imply, by action or by omission, that the product has characteristics or functions that it does not have; Claims about improved properties of a new formulation should reflect the actual improvement and should not be overstated; Products must not presented as having unique characteristics if similar products have the same characteristics; If the action of the product is linked to specific conditions, this must be explicitly stated.

Honesty - examples Examples of claims not allowed: « one million consumers prefer this product » (if based only on the sales figure of one million units) Claims based on electronically manipulated « before / after » images (if the display is misleading as to the product performance » « this fine fragrance does not contain preservatives » (if the alcohol content is such that preservation is not necessary) If the claimed performance of a shampoo is based on the combined use of that shampoo with a hair conditioner, this must be communicated.

Fairness Claims must be objective and must not denigrate the competition; Neither shall they denigrate ingredients legally and safely used in cosmetics; Claims must not create confusion with the product of a competitor; Claims can be comparative as long as they comply with Directive 2006/114/EC on misleading and comparative advertising, and with national rules implementing it.

Fairness - examples Examples of claims not allowed: « contrary to product X, this product does not contain ingredient Y which is known to be irritating » « well-tolerated, as it does not contain mineral oils » « low in allergens because free of preservatives » « this deodorant is as effective as an anti-perspirant »

Informed decision-making Claims must contain information allowing end users to make an informed choice; Messages must be clear, precise, relevant and understandable by the target audience; The presentation of the characteristics and the function of the product shall include the information needed by the average consumer to take an informed decision.

5. Guidance The Commission has drafted Guidelines on the application of the common criteria. These should be published at the same time as the latter. In addition, specific claim areas are currently under discussion: Absence of an ingredient/class of ingredients (« X-free») Reduced risk of allergy (e.g. hypoallergenic) Natural / organic (ISO standard in preparation) It is expected that guidance on how to apply the common criteria to these specific types of claims will be developed.

6. References Directive 76/768/EC consolidated version http://ec.europa.eu/consumers/sectors/cosmetics/regulatory-framework Regulation 1223/2009 of the European Parliament and of the Council on cosmetic products, OJEC L 342, 22.12.2009, p.59. Commission recommendation 2006/406/EC on the use of claims referring to the absence of tests on animals, OJEC L 158, 10.6.2006, p.18. Commission recommendation 2006/647/EC on the efficacy of sunscreen products and the claims made relating thereto, OJEC L 265, 26.9.2006, p. 39.