Cosmetic products consist of a wide array of products. They can be found in every home for different purposes and used by everybody in different forms. They include hair care, skin care, oral care, colour cosmetic, fragrances, soaps and shower gels, and sun care products. The global market for cosmetic product was put at over USD 532 billion in 2017 and expected to expand to over USD 805 billion by 2023.
Each product is developed for specific purpose and target market or end users. Manufacturers market their products with different claims expected to be supported with robust scientific data, which are often derived from expensive tests. The claims drive innovation and competition among producers of both the ingredients and the finished product.
Though there is increasing evidence of globalisation in rules and data set requirements, different global jurisdictions have their own set of rules aimed at protecting the end use, helping them make informed choices among multiple product claims and presentations. There are suspicions also that these rules contribute to market defence and protection.
The European Commission regulates cosmetic products sold in all member states with a set of rules under the Cosmetic Products Regulation 1223/2009/EU. All cosmetic products sold in the EU must meet the requirements of the regulation. A key requirement is to inform the end user not only about the composition of the product but also of the benefits generally referred to as claims and / or any potential harm.
The European Commission Regulation (EU) No 655/2013 provides common criteria to fulfill when presenting a cosmetic product claim to the consumer or an end user. The product claim should be useful, understandable and reliable to the end user and enable him or her to choose the best product for the intended use. In other words, claims should empower the end user to differentiate between the vast range of similar products, formats and claims in the market.
The European common criteria regulation set out some important definitions for manufacturers and those putting cosmetic products in EU markets. The key in the mind of a product manufacturer or supplier should include what are the things that should be in place in the character of a product before it is put before a consumer? What can be communicated and how might that be done without jeopardising the reputation of the business or the individual?
Broadly, there are six different legally binding areas and enforceable across EU member states since they are founded in directly applicable Regulation. They are namely: Legal compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed decision. As often with the law, the devil is in the detail.
The Commission also published guidance documents to facilitate interpretation and understanding. Ultimately, the responsibility and liabilities fall on the person placing the product on the market or the product manufacturer.
1. Legal compliance
- Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed
- The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is reasonably well-informed and reasonably observant and circumspect, take into account social, cultural and linguistic factors in the market in question
- 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.
- If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present
- Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has the same properties when it does not
- Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion reflects verifiable evidence
3. Evidential support
- Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments
- Evidence for claim substantiation shall take into account state of the art practices.
- Where studies are being used as evidence, they shall be relevant to the product and to the benefit claimed, shall follow well-designed, well-conducted methodologies (valid, reliable and reproducible) and shall respect ethical considerations
- The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for claims where lack of efficacy may cause a safety problem
- Statements of clear exaggeration which are not to be taken literally by the average end user (hyperbole) or statements of an abstract nature shall not require substantiation
- A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concentration
- Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge the end users
- Presentations of a product’s performance shall not go beyond the available supporting evidence.
- Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics.
- If the action of a product is linked to specific conditions, such as use in association with other products, this shall be clearly stated.
- Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used
- Claims for cosmetic products shall not create confusion with the product of a competitor
6. Informed decision-making
- Claims shall be clear and understandable to the average end user
- Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice
- Marketing communications shall into account the capacity of the target audience (population of relevant Member States or segments of the population, e.g. end users of different age and gender) to comprehend the communication.
- Marketing communications shall be clear, precise, relevant and understandable by the target
These are expected to have been implemented by manufacturers or suppliers since 2013. Implementation assists operators in cosmetic products supply chain to reduce or remove regulatory complexities and create level playing field in the market. While the regulation is directly binding, the guideline is not. Manufacturers and their representatives still have take responsibility for their actions or inaction in the market.
- Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
- Technical document on cosmetic claims Agreed by the Sub-Working Group on Claims (version of 3 July 2017)