Cosmetics are very popular consumer products in daily life of every individual, their production and sale are subject to specific rules.
Cosmetic products are “substances and preparations, different from drugs, intended to be placed on external surfaces of human body (epidermis, hair system, nails, lips and external genital organs) or of teeth and mucous membranes of mouth, with the scope of cleaning, perfuming, changing their appearance, correcting body odors, protecting them or keeping them in good condition”.
In Italy cosmetics production and sale are governed by Law 713, 11 October 1986 and subsequent amendments. La legge ha recepito la direttiva comunitaria 76/768/CEE e ss.mm.ii. The above law has implemented EU directive 76/768/EEC and subsequent amendments in order to make uniform EU rules on production and sale of cosmetics.
Law 713/86 disciplines the aspects relating to composition of cosmetic products, presentation (labelling, packaging and any other form of external representation of product) and steps necessary to start production, sale and import of cosmetics.
Cosmetics composition is regulated by EU Directive 76/768/EEC. Lists are continuously updated as result of technical committee’s indications in field. Law 713/86 is therefore constantly updated according to directives issued by European Commission.
Qua.Ser. LTD offers assistance with the following activities:
– Labelling evaluation and mandatory compliance with requirements;
– Technical dossier drafting or assessment;
– Notification of required documentation drafting to Ministry of Health and Region/Autonomous Province of competence;
– Documentation drafting to request certificate of free sale;
– Supply instructions on payments;
– Delivery the documents to Ministry of Health;
– Assistance to Ministry of Health if requested.
Companies intending to produce or manufacture their own and/or for third parties cosmetic products should transmit a notification at least 30 days before starting production and/or packaging to Ministry of Health and to Region/Autonomous Province.
The notification must be submit with revenue stamp, signed by legal representative who must attach his ID; the notification must contain, mainly, owner’s data, workshop production and/or packaging data, description of workshops and equipment production, trade name of cosmetic category (according to Annex I of Law 713/86), full list of ingredients listed under INCI name, address of the place where Company stored technical documentation, etc..
If the activity ends, then producers must notify Ministry of Health and Region of it within 60 days (Article 10, paragraph 12-a).
We’d like remind of:
– Cosmetic products must be conform to Ministerial Decree of May 10, 2004 (no phenol or phenol ethoxylate);
– Presentation of cosmetic product (form, packaging, labelling and advertising) must be in accordance with Legislative Decree 23 January 1992, No. 73 implementing Directive 87/357/EEC and to Legislative Decree 6 September 2005, No 206, bearing Consumer Code
Before marketing, Companies must transmit a notification to Ministry of Health and to Regional/Autonomous Province at least 30 days before release.
The notification must be stamped, and signed by legal representative who must attach his ID card. The notification should contain following information: owner’s data, workshop production and/or packaging data, trade name of cosmetic membership category (in accordance with Annex I of Law 713/86), full list of ingredients indicated in accordance with INCI name, address of place where Companies stored technical documentation, etc..
Any change to above data should be subject to new advance notice to be transmitted following the above instructions (Article 10, paragraph 7).
The notification must also be made by manufacturer, following instructions in the reference section (link).
IMPORTATION OF COSMETICS FROM EU MEMBERS
Anyone into Europe intends start cosmetic products marketing on national territory must transmit a notification to Ministry of Health and to Region/Autonomous Province at least 30 days before introduce products into national territory.
The notification must be stamped, and signed by legal representative who must attach his ID card. The notification should contain following information: Company’s data, workshop production and/or packaging data, trade name of cosmetic membership category (according to Annex I of Law 713/86), full list of ingredients in accordance with INCI name, address of technical documentation, etc…
IMPORTATION OF COSMETICS FROM MEMBERS OUTSIDE EU
Anyone out of Europe intends start on national territory must transmit a notification to Ministry of Health and to Region/Autonomous Province at least 30 days prior introduce products into national territory.
The paragraph 3-bis of Article 10 of Law 713/86 states:
“The importation of cosmetic products from countries out of European Union must be under responsibility of an expert with requirements of paragraphs 1 and 2; he is required to assess the used method of product manufacturing”
Importing Companies, or manager appointed by European manufacturers, shall appoint and assumes an expert to evaluate method of manufacture of individual products. He is the Technical Director, responsible for proper execution of manufacturing operations and packaging. He should have a degree in chemistry, industrial chemistry or in chemistry and pharmacy, pharmaceutical chemistry and technology, chemical engineering, pharmacy, life science and he should be put on the professional register or in possession of equivalent title of university discipline in EU country.
The notification must be stamped and signed by legal representative who must attach his ID card; the notification shell contain following information: owner’s data, workshop production and/or packaging data, trade name of cosmetic membership (in accordance with Annex I of Law 713/86), full list of ingredients indicated in accordance with INCI name, data of Office of maritime health, air and border – USMAF/customs entry, address of technical documentation, address of manufacture or first importation into European Union (Article 10-ter, paragraph 6); country of the cosmetic products (Law 713/86, Art. 8, paragraph 1, letter f); if different from country where cosmetic products are manufactured, data on qualifications of the expert responsible for import (L. 713/86, art. 10, paragraph 3 a), etc..
To clear through customs manager director should submit a copy of sent notification to Office of maritime health, air and border and a copy of receipt notification (or the acceptance official seal of Ministry).
COSMETICS FREE SALE
Free sale certification of cosmetics outside European Union, already subject to communications at Ministry of Health, needs of application with revenue stamp to Ministry of Health. The application should contain following information: owner’s data, workshop production data, product name, category, list of ingredients (INCI name), address where technical documentation is kept, countries of destination (maximum 5).
Certificate may be issued in Italian, English or Spanish.
Department costs consist of fixed fee for each required certificate plus revenue stamp duty costs (amount to be determined case by case).
CONFIDENTIALITY OF COSMETIC INGREDIENTS
Manufacturer or person placing on Community market may request to not show one or more ingredients of product list that must appear on container or outer. (Law 713/86 art. 8 bis and Annex VII).
After request for confidentiality, ingredient list on packaging will be replaced by a registration number allocated by Ministry.
Ministry places a 7-digit number composed of:
– first two digit correspond to year of approval of confidentiality; – first two digit below represent code assigned to each Member State:
– 01 France
– 02 Belgium
– 03 The Netherlands
– 04 Germany
– 05 Italy
– 06 United Kingdom
– 07 Ireland
– 08 Denmark
– 09 Luxembourg
– 10 Greece
– 11 Spain
– 12 Finland
– 13 Austria
– 14 Sweden
– last three digits are assigned by competent authority.
Cosmetic products advertising is not subject to prior authorization from Ministry of Health; however it must adhere to specific provisions.
Advertisements for cosmetic products must conform to general principles of advertising, set out in Code of consumption, required by Law 229 of 2003 and approved by Legislative Decree 206 of 2005.
The Code prohibits misleading advertising, defined as any form of advertising that might mislead consumers by influencing them choices through statements, presentations and false images of product or ambiguous on characteristics and effects”.
The Article 9 of Law 11 October 1986, 713, that takes in the Directive 76/768/EEC on cosmetic products production and marketing, forbids using texts, names, logos, pictures or other signs, figurative or otherwise, that give characteristics different from reality, under Article 1 of the same Law.
Accordingly, in messages referring to cosmetic products, whether contained in label or other printed texts, or of advertising nature, cannot be attributed to them for purposes other than cleaning, perfuming, changing appearance, protect or maintain in good condition exterior surfaces of human body.
Consequently, presentation and name of cosmetics should not lead consumers to confuse the products for cosmetics and personal care with medication.
Above provisions have objective of safeguarding public health, through pursuit of accurate information