Legal regulation regarding cosmetics.
While cosmetics are not treated and regulated in such a deep way like for example medicines, there are some legal frames which have to be obeyed during the promotion and sale process. There are certain conditions to fulfil in order to admit cosmetics to internal European market, features of labelling and information which can or should be given about these products. The basic acts are of European Union origin. Having in mind they have a status regulations being directly in force in Poland, they do not need to be implemented into national legal system.
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
- Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
- Cosmetics Act of 30 March 2001 (Journal of Law from 2013, item 475).
Describing the frame legal aspects regulating cosmetic products it is crucial to start with the Regulation No 1223/2009. This act establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure a high level of protection of human health. Thus, it defines, what is a cosmetic, who is responsible for the product launched into the market, what are the duties and obligations of distributors, required documentation, procedure of notification, sampling and analysis, what are the limitations regarding some substances or testing on animals. From customer’s point of view the important provisions relate to the information about the products – labelling, product claims and an access to the information for the public. This act also regulates aspects in respect to market surveillance and administrative cooperation between member states and European Commission in the field.
The main points of the Regulation No 1223/2009 are:
- cosmetic product’ means 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 and 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;
- only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market; For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation;
- labelling: the container and packaging of cosmetic products have to bear the following information: the name and the address of the responsible person, the nominal content at the time of packaging, date of minimum durability, particular precautions to be observed in use, the function of the cosmetic product, the batch number of manufacture, a list of ingredients;
- in the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.
Another European law, Commission Regulation (EU) No 655/2013 – refers to criteria for the justification of claims used in relation to cosmetic products. It applies to claims in the form of texts, names, trademarks, pictures and figurative or other signs that convey explicitly or implicitly product characteristics or functions in the labelling, the making available on the market and advertising of cosmetic products. Hence, the role of these provisions is to take care about the interest and safety of the products end users. There are six areas described by the act:
1. Legal compliance:
a) Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed;
b) 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.
a) If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present;
b) 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;
c) Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion reflects verifiable evidence.
3. Evidential support:
a) Claims for cosmetic products shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments;
b) Where studies are being used as evidence, they shall be relevant to the product and to the benefit claimed and shall respect ethical considerations;
a) Presentations of a product’s performance shall not go beyond the available supporting evidence;
b) Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics;
a) Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used;
b) Claims for cosmetic products shall not create confusion with the product of a competitor.
6. Informed decision-making:
a) Claims shall be clear and understandable to the average end user;
b) Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice;
c) Marketing communications shall take 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 audience.
Polish internal law also provides with some rules in the field. Major act in the field is Cosmetics Act of 30 March 2001. It establishes requirements regarding contents, labelling and conditions of cosmetics turnover in Poland. Definitions are derived from quoted European legislation. There are bans on using dangerous substances and testing on animals. Moreover, according to the act packaging has to contain among others: trade name, name and address of the producer, nominal amount of the cosmetics, expiry date, function of the cosmetics and the list of ingredients. Additionally the regulation determine sanctions and penalties for violating the existing law.