In 2016 it was estimated that the European cosmetic market was worth €77 billion and that about 25% of all cosmetics placed on the market each year are new.1 Product claims and advertising play an important part in persuading customers to purchase cosmetic products.
In this article we will take a closer look at the common criteria, experimental studies, consumer perception tests and published information. We have also included an insight into how user trials work based on our experience with First Beauty.
What is a claim?
According to article 20 of regulation (EC) 1223/2009 cosmetic claims can be text, names, trademarks, pictures and figurative or other signs that convey the product’s characteristics or function. These claims can be in the form of labelling, advertising or how the product is made available on the European market. Cosmetic products cannot claim to have characteristics and functions that they do not have.
European Commission report on claims
Article 20 of the regulation (EC) 1223/2009 required the European Commission to establish a list of common criteria for claims made by cosmetic products. The European Commission established the common criteria in Commission Regulation (EU) No 655/2013. The common criteria are legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision making. The European Commission was also required by 11 July 2016 (3 years after the full implementation of regulation (EC) 1223/2009) to submit a report to the European Parliament and Council on whether claims made comply with the requirements of the common criteria. The European Commission asked Member States to carry out market surveillance on claims made for cosmetic products. Market surveillance by competent authorities in 21 member states of the European Union in 2014 and 2015 found that out of 38995 cosmetic claims analysed, 3730 (10%) were non compliant.1 In some member states the majority of noncompliant claims were found to be online rather than on the actual product or in brochures.
The common criteria prohibit claims that a product has been “authorised or approved by a competent authority” within the European Union or meets the “minimum legal requirements” required for cosmetic products placed on the market within the European Union.2 Cosmetic products are not permitted to claim that they do not contain ingredients which are prohibited by European cosmetic legislation. Claims that the product has been made following good manufacturing practice are not permitted as it is a requirement of the cosmetic regulation (EC) 1233/2009 that all products are made following good manufacturing practice.
The common criteria also state that acceptability of the 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 taking into account social, cultural and linguistic factors.”2 Member States found that claims that stated that products did not contain alcohol, essential oils or soap were compliant with the common criteria as it enabled consumers to avoid these ingredients for specific reasons such as religion or allergy.1
The common criteria require that all claims are truthful. If it is claimed that a product contains a certain ingredient then the ingredient must be “deliberately present”.2 Claims that an ingredient has certain properties cannot be claimed for the finished product if the finished product does not have those properties. Expressions of opinion should not be presented as verified claims, in marketing communications unless there is verifiable evidence. In the European Commission report, five Member States reported cases of ingredients not being present that were mentioned in a product claim.1
Claims can be explicit or implicit but in either case they must be substantiated with adequate verifiable evidence. Where studies are used to verify claims the studies must be relevant to the product and claim being made. Studies should follow “well designed, well conducted methodologies (valid, reliable and reproducible) and shall respect ethical considerations.”3 Current and up-to-date test methods and practices should be used.
The amount of evidence required to substantiate a claim must be consistent with the type of claim being made. It is especially important for products such as sunscreens where lack of efficacy could cause a safety issue. Statements of clear exaggeration such as hyperbole which will not be taken seriously by the consumer do not require substantiation.
The common criteria permits claims to be made for a product based on the properties of an ingredient. The claim must be substantiated with evidence and the ingredient must be in the product at an effective concentration. It may be necessary to test the product to determine the concentration of the ingredient. When assessing the acceptability of a claim a weight of evidence approach should be taken when considering information, data and evidence from all studies. The nature of the claim and the expectation and understanding of the claim by the target user should also be taken into consideration.
Four Member States reported cases of non-compliance with the requirements for evidential support when the rabbit logo was used for the “not tested on animals” claim.1 The responsible person was unable to provide evidence for all the ingredients. Article 20 of regulation (EC) 1223 / 2009 permits the “not tested on animals” claim to be made providing the manufacturer of the product and the ingredient suppliers have not tested or commissioned any tests on animals and none of the ingredients have been tested on animals for “the purpose of developing new cosmetic products” by others. There has been a complete ban on testing cosmetic products and ingredients on animals for the purposes of regulation (EC) 1223/2009 since 2013.
Member States also reported cases where a function for a product could not be substantiated due to a lack of evidence.1 The responsible person was unable to provide evidence that an ingredient was in a product at a sufficient concentration for the product to have the function claimed. Some of the products that the competent authorities looked at made a sun protection claim or claimed that they did not contain any allergens. The claims for these products were found to lack evidential support and were considered to be dishonest.
A claim would be considered to breach the honesty criteria if it goes beyond the available supporting evidence. Claims cannot be made for a particular function of a product if all products of that type have the same function. The guidelines give the example of a preservative free claim being made for a fine fragrance.3 Preservatives are normally not used in fine fragrances as they contain a high level of alcohol and are not required. If a claim is made for a product based on it being used with another product then this must be clearly stated. An example of this would be a claim for the performance of a shampoo that was dependent on it being used with a conditioner.3
According to the common criteria claims must be objective and not denigrate a competitor or ingredients which are permitted to be used in cosmetic products.2 Ten Member States raised the issue of the fairness criterion being breached with the “free from” claim. They considered that the “free from paraben” and “free from aluminium” claims denigrated these ingredients.1
Informed decision making
Claims must be clear and understandable by the end user and must allow the user to make an informed decision. Any marketing information should take into consideration the capacity of the target audience to understand the marketing information and must be “clear, precise, relevant and understandable by the target market”.2 Products intended for professional use may use technical terms and language if they will be easily understood by the target market.3
There is no universally accepted definition for ‘hypoallergenic’. The intention with hypoallergenic products is to reduce the allergenic potential of the product by using ingredients that are not skin irritants, eye irritants or skin sensitisers or by limiting their use and concentration so that the allergenic potential of the product is reduced. Seven Member States reported cases of hypoallergenic claims being made without supporting evidence.1 Some national authorities were concerned that hair dye products which claimed to reduce the risk of allergy or offer protection from skin problems during the colouring process underestimated the risk of allergic reaction and prevented the consumer from making an informed choice. The hair dye products were found to contain resorcinol and para-phenylenediamine which are well known allergens.
Claims are often substantiated by experimental studies, consumer perception tests or published information or by a combination of all three. The guidelines to the common criteria considers what is best practice for all three of these.3
The number and type of experimental studies that can be used to substantiate claims is wide ranging but they should have the following features in common. They should be well designed and use scientifically valid methodology following best practice. They should take into consideration relevant guidelines and international standards.
The criteria used to evaluate a product’s performance should be carefully chosen and accurately defined and relevant to the claim being made. The experimental studies should include a sufficient number of samples or subjects so that the data collected has statistical significance. Studies should be capable of reaching scientifically and statistically valid conclusions. Interpretation of the data from experimental studies must be fair and not go beyond the limits of the test. Data presentation should be clearly explained and not overstate the results of the study. Validated protocols and operating procedures should be used and the study should be conducted by a person who has appropriate qualifications, training and experience in the type of study being conducted. The study should be carried out ethically and with professional integrity.
Products tested on human volunteers must be assessed as being safe. Studies shall be conducted on the target population and there should be strict criteria for including or excluding people from the study. Studies on humans should follow ethical principles such as those stated in the Declaration of Helsinki.
The types of claims that can be made using experimental studies include “tested under medical supervision”, “dermatologically tested”, “clinically tested” and sun protection factors.
Consumer perception tests
Consumer tests evaluate cosmetic products based on the consumer’s perception of the product. The testing is subjective and relies on what a person can observe or feel. Consumer tests should be designed so that the study achieves scientifically robust conclusions. An awareness of statistical analysis is important to ensure that a sufficient number of subjects and test samples are tested.
For consumer user tests the wording of the questionnaire is very important. The questions and proposed answers should be presented in a very clear way and be capable of being unequivocally understood by the people taking part in the consumer test. If an answer scale is used there should be the same number of positive and negative answers to choose from. The range of answers that a participant is able to choose from should not be capable of influencing the answer that they give.
Appropriate statistical analysis of the data from the consumer trial should be performed. Interpretation of the data must be fair and should not go beyond the limits of the test’s significance. Complex data should be presented and explained in a clear manner. The report should include the identification of the project and establish a link to the product being placed on the market. The report should include the objectives of the study, test schedule, test protocol, presentation and interpretation of results and data, and signature of the person in charge of the study.
User trials can be a vital aspect of product development and marketing, demonstrating the safety, efficacy and user perception of a product and justifying and enhancing the claims being made. The user trial report offers a statistical overview of results that enable a better understanding of the optimum product positioning and likely success of a product when it comes to market.
In the past, panellists for user trials were recruited through face to face interviews but now with most people having access to the internet this process can be done online. We have found that the process of recruitment is important in establishing a wide reaching demography and a high standard of feedback on user trial reports. The types of information that a panellist will be asked for when registering to become a panellist can include date of birth, gender, ethnicity, skin type, hair type, relationship status, methods of transportation, education, income levels, expenditure and buying habits. The panellist may be asked to take part in a validation user trial first.
Engaging with panellists and ensuring that they are ready for user trials is important. To do this ‘Heartbeats’ can be used. Heartbeats can include: ad-hoc question campaigns and games; beauty blogs and marketing; special offers; client trial ‘shout outs’; additional validation trials; and rewards. Social media is playing a more prominent part in engaging and communicating with panellists.
For companies commissioning user trials, an online user trial platform enables them to have more involvement in designing the user trial questionnaire and allows them to follow the progress of the trial in real time. However it is also important to have the support of experts who can help with the wording of the questionnaire and the claims being substantiated. As user trial platforms become more integrated with social media the parameters that can be used to select panellists will become more diverse.
Published information can include scientific publications and market data. Scientific publications can be used to substantiate claims for ingredients or combinations of ingredients providing that the data is relevant to the type of cosmetic product and the claim being made.3 Articles that have been peer reviewed prior to publication and that are open to scrutiny by the scientific community may carry more weight than articles that have not been peer reviewed. Market data such as a company’s market share in a particular country can be used to substantiate claims where relevant. The data would need to be supported by sales data from a reputable source such as an independent third party market research company.
The responsibility for ensuring that claims made for a product comply with the requirements of the common criteria lies with the responsible person. Enforcement of the common criteria is the responsibility of the competent authority of each Member State. If a product is found to breach the requirements of the common criteria the competent authority can insist that corrective actions are taken by the responsible person to ensure that their product is compliant. Corrective actions can include prohibiting the sale of the product until it is compliant; requiring modification to the claims made in advertisements, in the media and online; requiring the responsible person to retrospectively test their product to substantiate a claim; and correcting labelling. In some Member States the responsible person can face a financial penalty if they are found to be in breach of regulation (EC) 1223/2009 and the common criteria.
1. Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics, Brussels, 199.2016 COM(2016) 580 final
2. Regulation (EU) 655/2013
3. Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
4. Declaration of Helsinki, adopted by 18th World Medical Assembly, Helsinki, Finland, 1964 and its subsequent amendment
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