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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
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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
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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
presentationThe 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.
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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.
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: [email protected]
Web: www.eccromania.ro
www.facebook.com/ECC.Romania
https://twitter.com/eccromania/
Co-funded bythe European Union
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.
This infosheet is part of the action 670709 - ECC-Net RO FPA which has received funding under a grant for an ECC action from the European Union’s Consumer Programme (2014-2020).