CODE OF ETHICS
IN ADVERTISING
Warsaw, June 25th 2019
INDUSTRY CODES
Appendix no 1 – Beer Advertising Standards
Scope of Application
Article 1
This Appendix shall govern all advertising related to beer publicized within the Republic of Poland or addressed to Polish beer consumers.
The scope of the marketing message of the beer advertising is determined by the definitions of advertising , comparative advertising and sponsoring contained in art. 3 a) – c) of the (further: “advertising” or “beer advertising”)
Requirements regarding the contents and form of advertising
Article 2
- All advertising shall abide by laws and regulations effective in the territory of the Republic of Poland.
- Beer advertising should follow the rules contained in the Code of Ethics in Advertising and the provisions of this appendix.
- The provisions of chapter IV of the Code of Ethics in Advertising do not apply to beer advertising.
Article 3
- Beer advertising may not use images, symbols, persons and topics, which can be regarded as offensive, derogatory or humiliating.
- Beer advertising may not cause offence to prevalent religious norms.
Article 4
Beer advertising may not encourage aggressive or anti-social behaviour.
Article 5
Beer advertising may not use or promote sexual promiscuity, consent to sex or nudity, nor suggest that beer consumption can have a positive influence on sexual performance.
Article 6
Beer advertising may not create the image of beer as a means of overcoming life’s problems.
Article 7
Beer advertising may not present beer consumption in circumstances which are commonly regarded as irresponsible, inappropriate or in breach of law, in particular before or during any course of action which requires sobriety.
Article 8
Beer advertising may not:
- present or encourage irresponsible or excessive consumption of beer;
- present intoxicated people or in any way suggest that state of intoxication is a state socially approved;
- encourage consumers to prefer a given beverage due to its ability to create intoxication;
- suggest that consumption of beer with lower alcohol content does not lead to alcohol abuse;
- present refusal to consume alcohol or consumption in moderate quantities in a negative light.
Protection of Children
Article 9
Beer advertising may not be addressed at people under the age of 18 years, in any way whatsoever, be it through its contents or the method of publicizing. In this context, it does not apply to beer advertising the content of chapter IV “Advertisement addressed to children and young people”.
Article 10
Neither beer producers, nor their representatives, nor their agencies may make any payments or provide any benefits whatsoever for advertising which is mainly aimed at persons under the age of 18 years and is meant to be publicly distributed in the Republic of Poland. This provision shall apply also to messages and product placement contained in films.
Article 11
Beer advertising may not:
- contain images of people who are less than 25 years old;
- use images of people or figures which influence minors in a special way;
- suggest that beer is essential to becoming an adult or to achieve success in work or areas of social activity.
Protection of Health
Article 12
Beer advertising may not:
- suggest that beer has healing properties or prevents illnesses;
- suggest that beer has properties of a stimulating, anaesthetic or sedative drug;
- present pregnant women or breastfeeding women.
Appendix no 2 Standards of Food Advertising aimed at children
Article 1
Food advertising may not be aimed directly at children under 12 years of age.
Article 2
Restrictions on food advertising do not apply to products which meet certain nutritional criteria based on accepted scientific evidence and/or national and international nutrition recommendations contained, in particular, in Appendix 2a to the Code of Ethics in Advertising “Nutrition Criteria to the Self-Regulation Concerning Food Advertising Aimed at Children under 12 Years of Age in Poland”.
Article 3
Any type of advertising is considered to be aimed at children if, in the planned target group in the media used, children under 12 years of age represent at least 35 percent of the group.
Article 4
Food advertising may not be carried out in any form in primary schools.
Article 5
No type of food advertising aimed at children may:
a) promote or present unhealthy eating habits or unhealthy lifestyle in the form of eating and drinking in an immeasurable, excessive or coercive manner, or promote a sedentary lifestyle,
b) discredit the importance of healthy eating habits, a varied and balanced diet and physical activity,
c) contain direct exhortations to children to purchase the advertised products through the use of such phrases as: “buy now”, “you must have it”,
d) appeal to the child to persuade the child’s parents to buy the advertised product,
e) mislead as to the characteristics of the promoted product and the benefits of its use,
f) imply that the product in question has some special dietary characteristics if all similar products have similar characteristics,
g) arouse fear by providing descriptions of violence or overly aggressive elements,
h) encourage the use of the food product in an inappropriate or unsafe manner.
Article 6
Within the meaning of this Code, advertising is not the use of a company or product name, logo of the company or product in educational campaigns aimed at promoting healthy eating habits and physical activity among children and young people. The content of such campaigns must comply with national and/or international recommendations on nutrition and physical activity. Such campaigns at school may only be conducted with the consent of the school authorities.
Appendix no 2a to Code of Ethics in Advertising
Introduction
This document defines the criteria for nutritional voluntary initiative on the principles for food and beverage advertising, targeting children under the age of twelve, published in media in Poland.
The proposed criteria were approved by the Institute of Food and Nutrition – Poland’s leading research institution, with which competence includes issues related to food, nutrition and their impact on health.
According to the Institute, it is necessary to take action to reduce the intake of fat, saturated fatty acids, trans-fatty acids, sugars and salt, by restricting the advertising of certain foods aimed at children under 12 years of age and to promote reformulation of food composition.
In the opinion of the Institute, criteria established for the nutritional assessment of food products in terms of the possibility of advertising to children under 12 years of age, as a voluntary initiative of food producers, is valuable. This initiative fits perfectly into the current activities to reduce overweight and obesity among the youngest part of the Polish public and to promote proper nutrition.
According to the overarching principle expressed in the Polish Code of Advertising Standards (Annex 2 Standards of food advertising to children), advertising of food products cannot be addressed directly to children who have not attained the age of 12, assuming that these children account for 35% or more of the audience of the broadcast. This rules do not apply to products that meet certain nutritional criteria based on accepted scientific evidence and/or national and international dietary recommendations .
Nutritional criteria have been developed in order to clarify the criteria by which food products are to be advertised to children under the age of 12. Criteria will allow both advertisers and broadcasters to easily assess products for compliance with the self-regulation. Nutritional criteria are based on an approach on the distribution of food products in the categories using the threshold values for key nutrients. Such an approach reflects better the role that different categories of foods and beverages play in the average diet, than the use of a universal profile. This approach also introduces a distinction between different food products within a given category, and thus allows it to achieve the fundamental objective to limit the types of food and beverage products advertised to children, while promoting competition in the development of healthier options through innovation and change recipes.
Nutritional criteria contain ten defined categories of products produced or sold on the Polish market. Selection of categories is dictated by the need to maintain a balance between the simplicity and a consistent treatment of similar products on the one hand, and on the other – the need to avoid creating categories so broad that only a relatively mild nutritional criteria could be applied to all kinds of products falling within this category. In order to ensure both the reliability of the system, as well as fair treatment, it was necessary to create subcategories within most of these ten categories.
Common nutritional criteria are based on a set of “nutrient ingredients that need to be limited” and “ingredients which presence should be promoted ” (nutrients and categories of food). The system takes into account both criteria and is consistent with the fundamental goal of self-regulation, that is the promotion of innovation, change recipes and competition in order to bring a change for advertising of healthier options – than a system based solely on “nutrient demanding constraints” .
“Nutrients requiring limitations” – sodium, saturated fats and sugars – were selected on the basis of publicly available evidence that they are important from a public health perspective because their average consumption in the population often exceeds the recommended or desirable for health. What is important – in the criteria adopted nutritional “components whose presence should be promoted” do not constitute a counterweight to the “nutrient demanding limitations”: to be able to advertise the product to children under twelve years of age , the product must contain the required amount of “ingredients whose presence must be promoted “and also lower than the threshold value “of nutrients requiring constraint” and have the energy value lower than the maximum fixed for each category.
In developing nutrition criteria , the recommendations of the World Health Organization ( WHO) were taken into consideration to determine the nutrient profiles. In line with these recommendations, nutritional criteria should be subject to appropriate adjustment to the new research. Accordingly, an update in the future, will possibly also take into account categories of products that are not currently represented in nutritional criteria.
In the framework of the guidelines, there are categories of food products for which does not provide any criteria for advertising to children under 12 years of age.
This applies to the following categories of food:
1. Sugar and sugar-based products, comprising:
– Chocolate and chocolate products,
– Jam or marmalade,
– Non-chocolate candy and other sugar products
2. Non-alcoholic drinks;
3. Potato chips and potato-based snacks, including products made from dough;
This reflects the existing voluntary commitments of food industry and is a confirmation that such products will not be advertised to children under 12 years of age.
The proposed criteria do not apply to food intended for particular nutritional uses, composition of which is regulated by the Regulation of the Minister of Health of 16 September 2010 on foodstuffs intended for particular nutritional criteria based on accepted scientific evidence. Children under the age of 3 are not recipients of advertising, and their dietary habits are shaped by parents in consultation with specialists in the field of nutrition and care of infants and young children .
11. Categories of food products for which criteria, for advertising to children under 12 years of age when they are more than 35% of the broadcast audience, were not provided:
1. Sugar and sugar-based products, comprising:
– Chocolate and chocolate products,
– Jam or marmalade,
– Non-chocolate candy and other sugar products
2. Non-alcoholic drinks;
3. Potato chips and potato-based snacks, including products made from dough;
Appendix No 3
Charter for the protection of children in advertising
( Self-regulatory act – annex 3 to code of ethics in advertising )
Chapter 1
SELF-REGULATION GOALS
Article 1 The purpose of the Charter is to specify terms that should be met in order to properly protect the interest of children, in particular those up to 12 years old, in marketing communication. The terms are in line with the Broadcasting Act of 29 December 1992 [Dz.U. (Journal of Laws) of 1993 No. 7, item 34 as amended], hereinafter referred to as the Act, in particular with Article 18(1), (3) and (5) of the Act.
Article 2 The signatories of the Charter are aware of the fact that an advertising message may provide children with new knowledge and skills, positive values as well as convictions about the world and people, but it can also pose certain threats, the more so as:
- using Internet contents and watching TV, including advertising messages, is one of the main activities performed by children in their free time,
- using an image of a child in order to enhance the effectiveness of an advertisement can increase the probability of exposing young advertising audience to risks associated with both messages addressed directly to them as well as commercials using child images, but addressed to adults,
- the use of child actors in commercials intensifies their impact, especially on children.
Article 3 Signatories of the Charter will strive to protect children as addressees of advertising messages, as well as limit unnecessary exposure of child actors starring in commercials that are not related to the nature of a product or the concept of an advertising message.
Chapter 2
ADVERTISING PRODUCTS OR SERVICES WHERE CHILDREN MAY BE INDIRECT RECIPIENTS
Article 4 The signatories of the Charter shall do their best to ensure that advertising messages addressed to children and advertising messages that are not addressed directly to them, but, due to their form, place and manner of presentation, are watched by children, do not include contents that might have a negative impact on their development.
Article 5 Signatories of the Charter, acting in accordance with the provisions of Article 16b(2)-(5), which prohibit broadcasting of commercial messages
- that encourage children to sustain pressure on parents or other persons in order to persuade them to purchase the advertised products or services;
- that take advantage of children’s confidence in parents, teachers and other people;
- showing children in dangerous situations unreasonably;
- having a hidden impact on the subconscious.
Declare that commercials addressed to children due to their contents, form, communication channel and manner of presentation will not contain, in particular:
- contents that may pose a threat to their health or safety,
- scenes showing physical or mental abuse,
- scenes showing family problems (e.g. neglecting a child, a child acting as an adult, a negative attitude of a child towards adults, including parents),
- a message that directly or indirectly undermines the authority of parents and legal guardians as well as their effort put in exercising the parental authority or taking care of children, in particular that depicts the exercise of the authority or custody as a negative phenomenon, contrary to the child’s welfare.
- scenes encouraging conflicts in any form (child-peers, child-parents and child-institutions),
- scenes showing threat (e.g. dangerous games or accidents), unless the purpose of the presentation is to promote the protective function of a product,
- a motif of excessive consumption and a consumerist lifestyle as a key value in life, taking into account the nature of a message such as a TV commercial,
- a message that suggests, directly or indirectly, that fun and entertainment does not involve any responsibility and limitations or precludes such responsibility or limitations.
- discriminatory contents, in particular due to race, sex, nationality, religious beliefs or disability,
- a message that uses, directly or indirectly, sexual innuendoes, including the use of sexual jokes and a hidden sexual meaning of individual words, or presents a false picture of sex and a sexual relationship, exclusively as an element of fun and entertainment,
- an image of a child persistently extorting shopping and other decisions on adults,
- promotion of negative models of generally unacceptable behaviour
- promotion of products that do not meet the criteria of other self-regulations of broadcasters, in particular the “Agreement between TV broadcasters on the principles of distributing commercials and sponsor references concerning food products or drinks containing ingredients whose presence in excessive amounts in a daily diet is not recommended”.
Chapter 3
CHILD ACTORS IN COMMERCIALS
Article 6 The signatories of the Code undertake to obey, at all stages of creating and distributing advertising messages, the following principles:
- the use of a child image in commercials advertising products or services that are not associated with children’s everyday life and activities should be limited by means of a thorough analysis of legitimacy
- children starring in a commercial should be presented in a friendly social environment, especially family and peers
- a child image cannot be treated in a commercial like an object in order to tout products and suggest other children or their parents that they should buy it.
Article 7 The signatories of the Charter shall do their best to ensure that child characters do not appear in commercials in the following contexts:
- acceptance of social stigmatization of a person and taunting as a model of socialization,
- contents debatable in terms of education (associations with alcohol consumption, references to sex life etc.),
- extreme fetishization of a product as the only remedy for a child’s problems and vital needs,
- imitating adults’ behaviours that are not appropriate from the point of view of children’s development needs.
Article 8 The following shall be avoided in the process of producing commercials with child actors:
- any threats to their health or safety
- their exposure to severe stress
- using a model character in the narrative of a commercial that might ridicule a child actor
- exposure to contents inappropriate at a given development phase
- situations leading to a distorted perception of the reality, e.g. if very young children star in commercials having an extremely fantastic plot
- situations causing fears, typical for social commercials warning against dangerous situations.
Appendix No 4
Technical document on cosmetic claims
Agreed by the Sub-Working Group on Claims
( Version of 3 July 2017 )
PLEASE NOTE: THIS TECHNICAL DOCUMENT WAS PREPARED BY THE SUB-WORKING GROUP ON CLAIMS AND THEN ENDORSED BY THE WORKING GROUP ON COSMETIC PRODUCTS. IT IS NOT A EUROPEAN COMMISSION DOCUMENT.
THIS DOCUMENT SHALL ONLY SERVE AS “TOOL” AND IS A COLLECTION OF BEST PRACTICE FOR THE CASE-BY-CASE APPLICATION OF UNION LEGISLATION BY THE MEMBER-STATES. 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.
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. IT REMAINS A WORK IN PROGRESS SUBJECT TO MODIFICATIONS.
ON 3 JULY 2017, ANNEXES III AND IV WERE ADDED TO THIS DOCUMENT. MEMBERS OF THE WORKING GROUP ON COSMETIC PRODUCTS AGREED THAT THE NEW ELEMENTS CONTAINED THEREIN SHOULD BE APPLICABLE AS OF 1 JULY 2019.
The purpose of this document is to provide guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
Based on Article 20 of Regulation (EC) No 1223/2009 on cosmetic products (‘CPR’), Commission Regulation (EU) No 655/2013 established EU harmonised common criteria in order to assess whether or not the use of a claim is justified.
Article 20 of the CPR applies to products that fall within the definition of a cosmetic product under Article 2 of the CPR . The common criteria only come into play when it has been assessed that the product in question is indeed a cosmetic product. It is for the national competent authorities and national courts to decide on a case-by-case basis which regulatory framework applies.
In order to ensure harmonisation across the single market as regards qualification of products, various guidance documents have been produced by the European Commission on the delimitation between cosmetic products and other product categories (e.g. between cosmetics and medicines , between cosmetics and biocidal products , and between cosmetics and other products ) in order to determine whether the product falls within the definition given in Article 2. In particular, the presentation of the product (including all communication mediums) and the manufacturer’s intended purpose should ensure that the cosmetic product falls within the definition laid down in Article 2 of the CPR.
The Commission adopted recommendations on the efficacy of sunscreen products and related claims which were inspired by the same principles as those illustrated in Commission Regulation (EU) No 655/2013.
In accordance with Article 5 of the CPR, the responsible person should ensure compliance with Article 20 of the CPR and with the common criteria set out in Commission Regulation (EU) No 655/2013.
According to Article 6(1) of the CPR, distributors also have a duty to act with due care, in the context of their activities. Distributors should translate any claim provided by the responsible person in a way that keeps the essence of the claim, otherwise they become the responsible person under Article 4(6) of the CPR.
For this purpose, close cooperation between the responsible person and distributor should be encouraged. Whilst ensuring that the same principles are respected throughout the EU, the common criteria are not aimed at defining and specifying the wording that can be used for cosmetic product claims. Nevertheless, the responsible person has a duty to ensure that the wording of the message communicated is in compliance with the common criteria and is consistent with the documentation in his possession for supporting the claim. If a company adapts a claim to the extent that the primary function of the notified product is changed, it should be considered as a different product.
In accordance with Article 22 of the CPR, Member States’ competent authorities should monitor compliance with Commission Regulation (EU) No 655/2013 via in-market controls of the cosmetic products made available on the market, including the appropriateness and relevance of the supporting evidence for justifying the use of claims. A common approach at Union level will facilitate administrative cooperation between the competent authorities of the Member States and prevent distortions in the internal market.
In specific cases, where the common criteria may not provide an adequate and sufficiently detailed framework for the protection of consumers and professionals from misleading claims, additional common criteria for specific types of claims should be elaborated.
Annex I to this document provides a detailed description of the common criteria established by Commission Regulation (EU) No 655/2013, including illustrative and non-exhaustive examples of claims.
Annex II to this document provides for best practices specifically related to the type of evidential support used for the justification of cosmetic claims.
Annex III to this document provides guidance for the application of the common criteria established by Commission Regulation (EU) No 655/2013 to “free from” claims, including illustrative and non-exhaustive examples of “free from” claims.
Annex IV to this document provides guidance for the application of the common criteria established by Commission Regulation (EU) No 655/2013 to the specific type of claim “hypoallergenic”.
ANNEX 1
Common criteria for claims used in relation to cosmetic products
According to Commission Regulation (EU) No 655/2013 claims on cosmetic products should conform to the following common criteria:
- Legal compliance
- Truthfulness
- Evidential support
- Honesty
- Fairness
- Informed decision-making
These common criteria are of equal importance and are further elaborated in the table below.
ANNEX 2
Best practice for claim substantiation evidence
Different types of evidential support can be used to substantiate claims. It is usual to substantiate claims by using either experimental studies or consumer perception tests and/or published information or, indeed, a combination of these.
The aim of this annex is to define best practices specifically related to the type of support used.
Best practices applying to experimental studies
Experimental studies include (but are not limited to) studies in silico, in vitro, ex-vivo, with instrumental or biochemical methods, studies conducted on volunteers, investigator evaluations, sensory evaluations, etc. Different types of experimental studies can be used to provide data on the performance of cosmetic products. It is useful to take into consideration existing relevant guidelines, e.g. guidelines relating to instrumental clinical techniques, other European or international guidelines or standards (e.g. CEN, ISO, etc.).
Such studies should comprise methods which are reliable and reproducible. The studies should follow a well-designed and scientifically valid methodology according to best practices. The criteria used for evaluation of product performance should be defined with accuracy and chosen in accordance with the aim of the test.
The experimental aspect of studies calls for reliance on knowledge and awareness of statistical principles in the design and analysis of the study, e.g. in terms of number of subjects, test samples, etc. This is necessary in order to ensure that the studies achieve scientifically and statistically valid conclusions.
A study protocol should be drawn up and validated in order to enable the study to be conducted and monitored appropriately, thereby ensuring its quality. Whatever the type of study, it is important that the person conducting the study:
- has the appropriate qualifications;
- has training and experience in the field of the proposed study; and
- has high ethical qualities standards and professional integrity.
Test facilities should maintain a quality assurance system, including standardised operating procedures.
A monitoring system should be set up for each study in order to ensure that the protocol and the operating procedures are correctly followed.
Data processing and the interpretation of results should be fair and should not overstep the limits of the test’s significance. Data recording, transformations and representation in tabular or graphical form should be transparent or clearly explained, if complex. It should not be designed to overstate the effect(s) measured. Appropriate statistical analysis of the data should be performed.
Ex vivo/in vitro tests should be conducted under standardised conditions and their protocols should refer to published and/or ‘in house’ validated methods. Clear descriptions of the methodology will be documented, as well as the statistical analysis of the data. These tests should be conducted in a controlled environment. To be used as evidence, such tests should be predictive of an action or representative of an in vivo effect, but studies on humans should validate these predictive effects if necessary.
Studies conducted on volunteers should follow ethical principles and products tested should have been assessed as safe. Human studies should be conducted on the target population where necessary, and be defined by strict inclusion/exclusion criteria.
Products may bear claims that relate to the nature of experimental studies. Consumer expectations regarding these claims may vary depending, in particular, upon the presentation of the claim and its specific context. However, in all circumstances, consumers will expect that such claims are made only when the effects tested are favourable.
The claim “tolerance tested” means that the product underwent tests under the supervision of a scientifically qualified professional intended to study its tolerance on a target group and that the results of those tests show that the product was well tolerated by this group.
The claim “tested under medical supervision” indicates that the product underwent tests conducted under the supervision of a medically qualified professional, such as a medical doctor or a dentist. Depending on the presentation of the claim, it may, for example, refer to a specific efficacy of the product or to skin tolerance.
The claim “dermatologically tested” implies that the product was tested on humans under the supervision of a dermatologist. Depending on the presentation of the claim, it may, refer to a specific efficacy or tolerance of the product. Consumer self-perceptions studies are not appropriate to support such claims. The same logic would apply to a claim referring to any other medical discipline.
The claim “clinically tested” refers to expertise, process or conditions under which the tests were carried out. “Clinically tested” means that the product was tested on humans under the supervision of a medically qualified professional or another scientifically qualified professional according to a clinical protocol or in a clinical setting.
A report should be prepared which includes clear identification of the product, enabling establishment of a link to the product available on the market. This report should also include the study’s objective, test schedule and test protocol, presentation of results and their interpretation, statistics, and signature of the person in charge of the study.
Best practice applying to consumer perception tests
Such tests evaluate consumers’ perception of product efficacy and cosmetic properties based on parameters that they can observe or feel.
The experimental aspect of studies calls for reliance on knowledge and awareness of statistical principles in the design and analysis of the study, e.g. in terms of number of subjects, test samples, etc. This is necessary in order to ensure that the studies achieve scientifically valid conclusions.
A study protocol should be drawn up and validated in order to enable the study to be conducted and monitored appropriately, thereby ensuring its quality.
Studies conducted on consumers should follow ethical principles16 and products tested should have been assessed as safe. Human studies should be conducted on a statistically representative sample of the target population, defined by strict inclusion/exclusion criteria including a clear definition of socio-demographic criteria.
A critical point for the validity of consumer tests is the wording of the questionnaire.
The questions and proposed answers should be clear enough to be unequivocally understood by participants. The answers scale should be well balanced (e.g. same number of positive and negative answers (a nominal, ordinal or visual analogical notation scale may be used)) and not capable of influencing the answer.
Special attention should be paid to the wording of questions for which responses will be used to substantiate the claim: the claim should be directly substantiated by the results related to the relevant question without any questionable interpretation.
Data processing and the interpretation of results should be fair and should not overstep the limits of the test’s significance. Data recording, transformations and representation in tabular or graphical form should be transparent or clearly explained if complex. It should not be designed to overstate the effect(s) measured. Appropriate statistical analysis of the data should be performed.
A report should be prepared which includes clear identification of the product, enabling establishment of a link to the product available on the market. This report should also include the study’s objective, test schedule and test protocol, presentation of results and their interpretation, statistics, and signature of the person in charge of the study.
Best practice applying to the use of published information
Published information may include scientific publications, scientific state-of-the-art and market data.
Reference to scientific publications on ingredients or combinations of ingredients to substantiate a claim is acceptable provided that they are relevant to the cosmetic product and the claim made. Particular weight can be given to articles that have been peer-reviewed before being published in the scientific literature where they are open to scrutiny by the scientific community at large.
Market data (e.g. a company’s market share within a specific product category in a specific country) may be a legitimate source of information to substantiate claims. Such data should be relevant to the claim made and representative of the market in question.
For example, the claim to be the best selling toothpaste in Europe may be supported by sales data from a reputable source such as a third party market research company.
ANNEX 3
Free from claims
In the case of “free from claims”, more guidance is needed for the application of the common criteria to provide an adequate and sufficient protection of consumers and professionals from misleading claims.
ANNEX 4
Hypoallergenic claim
The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. The responsible person should have evidence to support the claim 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.). This assessment should be updated continuously in light of new data.
If a cosmetic product claims to be hypoallergenic, the presence of known allergens or allergen precursors should be totally avoided, in particular of substances or mixtures:
- identified as sensitizers by the SCCS or former committees assessing the safety of cosmetic ingredients;
- identified as skin sensitizers by other official risk assessment committees;
- falling under the classification of skin sensitizers of category 1, sub-category 1A or sub-category 1B, on the basis of new criteria set by the CLP Regulation ;
- identified by the company on the basis of the assessment of consumer complaints;
- generally recognized as sensitizers in scientific literature; or o for which relevant data on their sensitizing potential are missing.
The use of the claim “hypoallergenic” does not guarantee a complete absence of risk of an allergic reaction and the product should not give the impression that it does.
Regarding the use of human data in risk assessment of skin sensitisation, including ethical aspects, reference should be made to the SCCS “Memorandum on use of Human Data in risk assessment of skin sensitisation”, SCCS/1567/15, 15 December 2015.
The companies should consider whether consumers, in the respective country, understand the claim “hypoallergenic”. If necessary, further information or clarification regarding its meaning should be made available.
Przypisy:
1 The Working Group is chaired by the European Commission and is composed of representatives of all Member States of EU and EFTA, the European Consumer Organisation (BEUC), The Personal Care Association (Cosmetics Europe), the European Federation for Cosmetic Ingredients (EFfCI), the International Fragrance Association (IFRA), the European Organisation of Cosmetic Ingredients Industries and Services (Unitis), the European Association of Craft, Small and Medium-sized Enterprises (UEAPME), the International Natural and Organics Cosmetics Association (Natrue), and the European Cosmetics Responsible Person Association (ERPA).
2 According to Article 2 of the CPR a cosmetic product is ‘any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’.
3 Guidance document on the demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83/EC as agreed between the Commission services and the competent authorities of the Member States.
4 Guidance document of the Commission services and the competent authorities of the Member States on the borderline between Directive 98/8/EC concerning the placing on the market of biocidal products and Directive 76/768/EEC concerning cosmetic products, Version 2002/2003, revision 1 of 24 May 2004.
5 Manual on the scope of application of the Cosmetic Products Directive 76/768/EEC (Art. 1(1) of the Directive) Version 5.0, June 2009.
6 See also Directive 87/357/EEC on products which, appearing to be other than they are, endanger the health or safety of consumers.Zalecenie Komisji 2006/647/WE z dnia 22 września 2006 r.
7 Commission Recommendation 2006/647/EC of 22 September 2006.
8 Notified according to Art. 13(1) of Regulation 1223/2009.
9 See Annex II
10 See Articles 4 and 5 of Regulation (EC) No 1223/2009.
11 See Article 11(2) of Regulation (EC) No 1223/2009, listing the information to be included in the product information file (11(2)(d): ‘where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product’).
12 See Recommendation 2006/647/EC of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto, OJ L 265, 26.9.2006, p. 39.
13 See Article 5 of Directive 2005/29/EC (‘(…) the common and legitimate advertising practice of making exaggerated statements or statements which are not meant to be taken literally is not considered as an unfair practice’).
14 See Article 6 of Directive 2005/29/EC and Article 4 of Directive 2006/114/EC.
15 See Article 5 of Directive 2005/29/EC: commercial practices which are likely to distort the behaviour of a clearly identifiable group of consumers in a way which a trader could reasonably be expected to foresee should be assessed from the perspective of the average member of that group.sach krajowych.
16 For instance, the principles as stated in the Declaration of Helsinki, adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, and its subsequent amendments, or national requirements.
17 The use of the claim “dermatologically tested” for cosmetic products was assessed by the European Court of Justice in Case C-99/01. In its decision, the Court clarified that the average consumer’s expectation of such a claim is that the product underwent tests intended to study its effects on the skin and that the results of those tests were positive and showed that the product was well tolerated.
18 Section 3.4.2.2. (Skin sensitisers) of Commission Regulation (EU) N° 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, available at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:083:0001:0053:EN:PDF