Cosmetics
Cosmetics Cosmetics are products with an essential role in each person's life. In this category, besides traditional cosmetics, such as make-up products and perfumes, are also included personal hygiene, such as dental products, shampoos and soaps. How can one separate a cosmetic from other products? May the cosmetics be regarded as medicines? Separating cosmetics from other products involves an analysis of both the cosmetics' definition and the legal rules regarding other categories of products, which due to their nature may be mistaken as cosmetics. According Regulation EC CE 1223/2009 regarding cosmetic products, a product is regarded as cosmetic if is used in contact with different external human body parts, such as skin, hair, nails, lips, genitals, teeth and mouth, with the exclusive or main goal to clean, perfume, modify their aspect and/or correct the body odors and/or maintain or keep them in good state. Also, to be regarded as a cosmetic, a product must be delivered under the form of a substance or mixture. However, there are certain products which, although they are not cosmetic due to their nature, are regarded as cosmetics, due to the fact they liberate or make the human body absorb the substance or mixture contained within. It is the case of make-up removal tissues, perfumed tissues or temporary tattoos. Permanent tattoos cannot be regarded as cosmetics due to the fact they come in contact with internal organs of the body. The same rules apply also to products indicated or recommended as having therapeutically or prophylactic properties. Even if these correspond to the definition of cosmetics, they cannot be regarded as such, due to their destination to ensure protection against illness. Be careful! The European Court of Justice has decided that a product indicated or recommended as having therapeutic or prophylactic properties must be regarded as a medicine due to its presentation, even if it is known that it has no therapeutically effect. Instead, are regarded as cosmetics anti-dandruff shampoos, anti-bacterial soaps etc., due to the fact their main function corresponds to the cosmetic products definition, to protect and maintain in good state. However, for these products the declared effect of the products must be proved. Regarding the separation between cosmetics and medicines, the provisions of Directive 2004/27/EC on the establishment of a community code for human use medicines show that in case of doubt, where a product, taking into account all its characteristics, can be regarded as both a medicine and another product regulated by other community laws, the directive dispositions should apply. This means that, if a product, due to its presentation and function corresponds to both the definition for the medicine and that for the cosmetic, its placement on the market should be made according the rules on human use medicines. So, these products cannot be regarded as cosmetics. As conclusion, the evaluation of each product should be made, case by case, according objective criteria, such as its presentation and usual functions. Cosmetics labelling Cosmetics can be placed on the market only if on the container and on the packaging the following 1
information are inscribed in a visible, readable way and with characters that cannot be easily erased: 1. The identification details of the person responsible with placing the product on the market: ü name or commercial name of the person responsible with placing the product on the market, when established in the European Union; ü headquarters or address of the person responsible with placing a cosmetic on the market; ü origin country for products manufactured outside EU. Be careful! The address can be inscribed using an abbreviation for the city, district, county or country, similar to that used by the postal services. A full postal code can be regarded as sufficient information. In the case of products manufactured in EU member states and placed on the Romanian market, the legislation does not require mentioning on the label of a Romanian address. The responsible person, according Regulation EC 1223/2009 regarding cosmetics, can be: ü the manufacturer, when the product is manufactured in the Community and is not exported and then imported back into the Community; the manufacturer established inside the Community or outside can designate, through a written mandate, a person established inside the Community as the responsible person, who must accept it in written; ü the importer, when placing on the market an imported product; the importer can designate, through a written mandate, a person established inside the Community as the responsible person, who must accept it in written; ü the distributor, when placing on the market a cosmetic under his name or mark or when modifying an already marked placed product, in a way the conformity with the applicable rules is affected; the translation of information regarding a cosmetic already placed on the market is not regarded as a modification of that product. 2. The nominal contents in the moment of packaging, indicated in weight or volume, except for packages containing less than 5 g or 5 ml, free samples and single dosages. For pre-packages products sold, usually, as a number of articles for which the indication of weight or volume is not of significance, the content is not necessary to be provided, on the condition the number of articles appears on the package. Be careful! The mention on nominal contents is not necessary when the number of articles can be easily determined from exterior or if the product is usually sold by piece. 3. Minimum durability period the period until the cosmetic product, stored in adequate conditions, fulfills its initial function. The minimum durability period or the details regarding its placement are preceded by the symbol or by the syntagm To be used preferably before.... The date must be clearly mentioned, by indicating in order the month and the year or the day, month and year. If it is necessary, this information should be supplemented by an indication of the conditions that must be fulfilled in order to guarantee the durability. The information regarding the minimum durability period is important to be mentioned this is different for cosmetic products having a durability period shorter or longer than 30 months. Therefore, the syntagm To be used preferably before..., followed by the date or indication of its placing on the package, is specific for cosmetics with a minimum durability period shorter than 30 months, due to the fact the product is susceptible to deteriorate during these 30 months since the moment of its manufacture and it cannot satisfy the general safety requirements and cannot fulfill its functions. Be careful! For cosmetic products with a minimum durability period longer than 30 months the indication of the minimum durability period is not compulsory. However, for this type of products the syntagm Period after opening is used, representing the moment since when a cosmetic product 2
ceases to satisfy the safety requirements and it is materialized by the symbol of a recipient with an opened lid, followed by the period in months and/or years specified through a number inscribed in the interior or near the symbol. The European Commission and the Member States have agreed to use the letter M for months, but on the symbol for year there was no agreement. At the level of the European Union the use of the number of months has been agreed, to illustrate the period after the opening. Therefore, when the period after opening is half a year, one year, 2 years etc., the symbol will be 6 M, 12 M or 24 M etc. In the case of cosmetics used in specialized unit by professionals, it is important that the date of opening to be inscribed on the product, so that the minimum durability period can be verified. Important! For cosmetics sold in Romania, the minimum durability period must be specified in Romanian on both the primary and secondary packaging. 4. Special cautions for use, mainly those referring to compulsory ingredients to be mentioned on the label Special cautions for use, such as special warning information must be inscribed on the packaging or on the container. Where this is not possible for practical reasons, a flyer, label etc. will be placed near the product, which will contain the necessary information for consumers, in abbreviation or by using the following symbol which must be placed on the container or the packaging 5. The function of the cosmetic product, except the case where this clearly results from its presentation The function will be mentioned on both the label of the secondary exterior packaging (box) and the primary packaging (container), except the case where it results clearly from the presentation. For example, the function of a lipstick or toilet soap is obvious, but a hair spray must be distinguished from a deodorant, case where the function must be mentioned. 6. Lot production number or an indication that would allow for its identification The lot production number must be inscribed on both the primary packaging (container) and on the secondary packaging (box) under the form of a code which would allow the manufacturer or the distributor to identify the lot of the product. If the product is not manufactured in lots, then a code is applied, through which the place and date of manufacture can be identified. In the case of a product aggregate ( a product which includes in a secondary packaging several products in primary packages see the example of the hair dyes) the lot numbers of the products can be different, under the condition the manufacturer to have an exact identification system, both for each product in the aggregate and the aggregate itself. A good practice allowing for an identification for a lot or a series as exact as possible, has the advantage that when a problem arises, the product quantities for which the authorities or the manufacturer have decided to recall, to be limited. Be careful! Where the reduced size of the product do not allow the inscription of the code on both packaging, primary and secondary, the inscription of the code only on the exterior (secondary) packaging is accepted. 7. The list of ingredients which are part of the cosmetic composition, in the decreasing order of their weight in the moment of their incorporation; this list is preceded by the word ingredients. If, for practical reasons, the list of ingredients is not possible to be put on the packaging, the flyer, label, etc. must contain all the necessary information. 3
Be careful! For soap, bath pearls or other small products, where, for practical reasons, the list of ingredients cannot be inscribed on the label, this must be shown on a flyer placed near the container. Impurities from materials used in the product, from technical auxiliary materials, and which cannot be found in the final product, materials used in strictly necessary quantities as solvents or perfumes or aromatic compositions are not ingredients. However, ingredients such as colorants, perfume and aromatization compositions and their composing materials must be mentioned on the label, with the mentioned that ingredients with a concentration lower than 1% can be mentioned without a prescribed order, but only after the ingredients with a higher concentration than 1%. Also, colorants can be mentioned after the other ingredients, no matter in which order, according their index color number. For decorative cosmetics sold in several colors all the coloring agents must be mentioned, preceded by the syntagm may contain or the symbol "+/ -". The perfume and aromatization compositions and their materials will be mentioned by the use of the word perfume or aroma. Liability for cosmetics safety Cosmetics can only be placed on the market if they are safe, in order not to affect human health. The liability for cosmetic safety regarding composition, packaging and information pertains to the manufacturer or importer. Be careful! A product must be safe not only in normal conditions of use, but also in rational predictable use conditions. In order to determine the rational predictable use conditions one must take into consideration all circumstances, including the product presentation (which includes the warning), use or removal instructions and any other indication. The safety requirements do not include a misuse of the product (except the case where such a misuse is predictable). For example, a hair dye for general use contains clear instructions along warnings for the safe use of the product, such as Not to be used for eyebrows or eyelashes dying, Rinse immediately in case the product comes into contact with the eyes. Through these warnings the manufacturer recognizes the fact the product may affect the eyes and warned the consumer not to apply it near the eyes. But if the product is so irritant that affects in any circumstance the eyes, without coming into contact with them and the consumer used the product according the instructions, it is possible the manufacturer to be held liable for affecting consumer's health. 4
Centrul European al Consumatorilor din România Str. Maior Aviator Ștefan Sănătescu nr. 44 Et. 1, Ap. 2, Sector 1, București, 011478 Tel/fax: +40.21.315.71.49 E-mail: office@eccromania.ro Web: www.eccromania.ro www.facebook.com/ecc.romania https://twitter.com/eccromania/ Co-funded by the European Union Acest infosheet este parte a acțiunii 670709 - ECC-Net RO FPA care a primit finanțare pentru un grant în cadrul Programului pentru Consumatori al Uniunii Europene (2014-2020). Conținutul acestui material reprezintă doar punctul de vedere al ECC Romania și este doar responsabilitatea acestuia; nu poate fi interpretat în niciun caz ca reflectând punctul de vedere al Comisiei Europene și/sau al Agenției Executive pentru Consumatori, Sănătate, Agricultură și Alimente sau al oricărei alte instituții a Uniunii Europene. Comisia Europeană și Agenția nu își asumă nicio răspundere pentru niciun fel de utilizare a informațiilor din acest material.