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Law No. 379 28 September 2004 Amending And Supplementing Law No. 178/2000 On Cosmetic Products

Original Language Title:  LEGE nr. 379 din 28 septembrie 2004 pentru modificarea şi completarea Legii nr. 178/2000 privind produsele cosmetice

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LEGE no. 379 379 of 28 September 2004 to amend and supplement Law no. 178/2000 on cosmetic products
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 901 901 of 4 October 2004



The Romanian Parliament adopts this law + Article I Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 525 of 25 October 2000, as amended and supplemented, shall be amended and supplemented as follows: 1. In Article 2, the letter a) shall read as follows: "" a) cosmetic product-any substance or preparation to be put in contact with various external parts of the human body, such as skin, hair, nails, lips, external genitals or with teeth and mouth, for the sole or principal purpose of to clean them, to perfume them, to modify their appearance and/or to correct their bodily odors and/or to protect them or to maintain them in good condition; " 2. in Article 2, after letter k), three new letters, letters l), m) and n) are inserted, with the following contents: "" l) finished cosmetic product-the cosmetic product in its final formula, as it is placed on the market and offered to the final consumer, or its prototype; m) prototype-the first model or design of a cosmetic product that has not been manufactured in batches and from which the finished cosmetic product is copied or developed; n) the period after opening-the period of time when a finished cosmetic product can be used safely, calculated from the first opening of the immediate packaging and the start of the use of the product. " 3. Article 3 shall read as follows: "" Art. 3. -List of categories of cosmetic products, as defined in art. 2 lit. a), is set out in Annex no. 1 1. " 4. After Article 3, a new article is inserted, Article 3 ^ 1, with the following contents: "" Art. 3 3 ^ 1. -The Ministry of Health represents the competent national authority for regulating the marketing of cosmetic products, their notification in the preparation and administration of the database, inspection and market control, information of the population, registration of reported cases of adverse effects on the population caused by cosmetic products, reporting to the European Commission. " 5. Article 4 shall read as follows: "" Art. 4. -The cosmetic products placed on the market must not endanger human health when used under normal or reasonably foreseeable conditions of use, taking into account, in particular, the presentation of the product, the labelling, the instructions on its use and removal, as well as any other indication provided by the manufacturer, its authorised representative or any other person responsible for the placing on the market of the product. These indications shall not exempt any person, under any circumstances, from complying with other provisions of this law. " 6. After Article 5, Articles 5 ^ 1 and 5 ^ 2 are inserted with the following contents: "" Art. 5 5 ^ 1. -(1) Without prejudice to the fulfilment of the obligations deriving from art. 4 4, shall be prohibited: a) the placing on the market of cosmetic products in relation to the final formula and those containing ingredients or combinations of ingredients which, in order to meet the requirements of this law, have been tested on animals, using one method, another than the alternative, after the date on which the latter was validated and adopted at the level of the European Union, taking into account the evolution of the validation process in the Organisation for Economic Cooperation and Development; b) animal testing of finished cosmetic products, in order to meet the requirements of this law; c) animal testing of ingredients or combinations of ingredients, in order to meet the requirements of this law, starting with the date on which these tests must be replaced by alternative methods validated or established by the European Commission. Alternative methods are set out in Annex no. 3 to the methodological norms for the application Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations approved by Government Decision no. 490/2002 . (2) The Ministry of Health shall ensure, by order of the Minister, the takeover of new alternative methods, in accordance with the progress made in the validation and their adoption by the European Commission, in accordance with the following deadlines: 11 March 2009, for the testing of ingredients or combinations of ingredients, and 11 March 2013, for repeated dose toxicity tests, reproductive toxicity and toxicokinetics. (3) In exceptional circumstances, when there is a good reason for the safety of an existing cosmetic ingredient, the Ministry of Health may request the European Commission to grant a derogation from the provisions of par. ((1). The request for a derogation shall contain an assessment of the situation and indicate the necessary measures. On the basis of the application and after consulting the Scientific Committee on Cosmetics and Non-Food Products, the European Commission may authorise the derogation by reasoned decision This authorisation shall contain the conditions under which the derogation was granted, the specific objective, the duration and the reporting of the results. ((. Derogation may be granted only if: a) the ingredient is used frequently and cannot be replaced by another ingredient with similar function; b) the specific human health problem is substantiated and the need to resort to animal testing is justified and supported by a detailed research protocol, proposed as an evaluation basis. Article 5 ^ 2. -(1) The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic to reproduction, of categories 1, 2 and 3, as set out in Annex no. 2 to the methodological norms for the application Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations. (2) A substance classified in category 3 may only be used in cosmetic products if it has been evaluated by the Scientific Committee for Cosmetics and Non-Food Products of the European Commission and has been accepted for use in products cosmetics. " 7. Article 6 shall be inserted after Article 6, with the following contents: "" Art. 6 6 ^ 1. -(1) By derogation from the provisions of art. 5 and without prejudice to the provisions of the Order of the Minister of Industry and Resources and the Minister of Health and Family 309/729/2001 on the inventory for the ingredients used in cosmetics, published in the Official Gazette of Romania, Part I, no. 756 of 28 November 2001, the Ministry of Health may authorise the use on the territory of Romania of substances not provided for in the list of substances allowed for certain cosmetic products, under the following conditions: a) the authorization must be limited to a maximum period of 3 years; b) an official verification of cosmetic products containing the substance or preparation the use of which has been authorised; c) the cosmetic product thus manufactured must bear a distinct indication, which will be specified in the authorization. (2) The Ministry of Health must inform the European Commission and the Member States about the authorization decision taken according to par. ((1), within two months from the date of entry into force of the authorization. (3) Before the expiry of the 3-year term, provided in par. ((1) lit. a), the Ministry of Health may submit to the European Commission an application for the inclusion on the list of permitted substances of the substance that received the national authorization, ((1). It will communicate the documentation on which this request is based and indicate the uses to which the substance is intended. " 8. In Article 8, the introductory part shall read as follows: "" Art. 8. -The notification shall consist of the following data in the written and/or electronic form of the following data: " 9 paragraphs 1 and 3 of Article 9 shall read as follows: "" Art. 9. -(1) The notification of a cosmetic product that is placed on the market on the territory of Romania is made at the Ministry of Health, by sending in written and/or electronic form the notification form. The Ministry of Health records the notification, communicates to the person who transmitted it the number of notification and makes public the list of ............................................................................................. (3) Any modification of the information submitted to the Ministry of Health, according to the 8, will be notified to him within 30 days of the date of the change. " 10. In Article 10 (1), letters b), d), e) and f) shall read as follows: " b) the physico-chemical and microbiological specifications for the raw materials and the finished product and the purity and microbiology control criteria for the cosmetic product; ............................................................................................. d) the name of the person responsible for the manufacture or import for the first time of a cosmetic product in the European Union; the person responsible must possess an appropriate level of professional qualification or experience, in accordance with the legislation and the practice of the Member State of the European Union where they are manufactured or where the cosmetics are first imported e) risk assessment for the human health of the cosmetic product. For this manufacturer will take into account the general toxicological profile of the ingredients used, their chemical structure and the level of exposure, in particular the specific exposure characteristics of the area where the product will be applied or the population to which it is intended; for products intended for children under 3 years of age, and for those intended exclusively for external intimate hygiene, there must be a specific safety assessment for human health. If the product is manufactured in different localities on the territory of Romania or the Member States of the European Union, the manufacturer may choose a single location/place, where the information on the product is available. In this regard, at the request of the competent authorities for monitoring the product or other authorities with control powers, the manufacturer shall be obliged to specify the address to which the information is quickly accessible; f) the name and address of the qualified persons responsible, who assessed the product from the point of view of safety for human health; the persons responsible for the assessment must have the diploma of higher education in the specialties: pharmacy, toxicology, dermatology, medicine or a similar specialty as defined in the Law no. 200/2004 on the recognition of diplomas and professional qualifications for regulated professions in Romania. " 11. in Article 10 (1), the following shall be inserted after point h): "" i) information on any animal testing, carried out by the manufacturer, its agents or suppliers, related to the development of the product or the assessment of the safety of the cosmetic product or its ingredients, including any animal testing, carried out in order to comply with national regulations in non-member countries of the European Union. ' 12. in Article 10, after paragraph 2, paragraphs 3 and 4 are inserted as follows: "" (3) Without prejudice to the protection of trade secrets and intellectual property, the manufacturer, his authorized representative, the beneficiary of the manufacture of the cosmetic product or the person responsible for placing a cosmetic product on the market imported will ensure that the information provided in par. ((1) lit. a) and g) be accessible to the public in any format, including electronically; the information provided in par. ((1) lit. a), which will be accessible to the public, will be limited to the quantitative information of dangerous substances regulated by Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations, approved with amendments and additions by Law no. 451/2001 . (4) Safety assessment for human health, as provided for in art. 10 10 para. ((1) lit. e), will be carried out in accordance with the principles of good laboratory practice provided by Government Decision no. 63/2002 on the approval of the principles of good laboratory practice, as well as the inspection and verification of their compliance with the tests carried out on chemical substances. ' 13. In Article 13, the introductory part of paragraph 1, points a), b), c), e), f) and i) and paragraph 2 shall read as follows: "" Art. 13. --(1) Cosmetic products may be placed on the market only if the following information is marked visibly, legibly and with non-sterile characters on the container and on the packaging; in respect of the information referred to in point (a). i), they can only be marked on the packaging. The following data will be indicated: a) the name or name of the manufacturer or of the person responsible for placing on the market established in the European Union or the abbreviation, if it allows b) the seat or address in the Member State of the European Union of the manufacturer or of the person responsible for placing on the market in the European Union an imported cosmetic product or its abbreviation, as long as it is possible to identify; c) country of origin for products manufactured outside the Member States of the European Union; ............................................................................................ e) the minimum durability date indicated by the phrase "To be used preferably before ...", followed by the date or indication of the place on the packaging where it is inscribed this date. The date must be clearly mentioned, indicating, in order and with Arabic figures, either the month and the year, or the day, month and year. If necessary, this information will be supplemented by an indication of the conditions to be met in order to guarantee the sustainability asserted. The indication of the durability date shall not be mandatory for cosmetic products whose minimum durability exceeds 30 months. For these the terms shall be supplemented by the indication of the period, after the opening of the cosmetic product, in which it can be used safely by consumers. This information will be given by the symbol set out in Annex no. 2, followed by the period of use expressed in months and/or years; f) special precautions for use, in particular those relating to the ingredients referred to in the lists provided for in art. 6 6 para. ((1) and approved by order of the Minister of Health and which must be inscribed on the packaging, as well as the special warning information for cosmetic products for professional use, especially those for hairdressing. If this is not possible for practical reasons, a prospectus will be joined, an armband or a card containing the information necessary for consumers, either abbreviated or by the use of the symbol set out in Annex no. 3, which must appear on the container and on the packaging; ........................................................................................ i) the list of ingredients forming part of the composition of the cosmetic product, in descending order of weight at the time of their incorporation; this list is preceded by the word "ingredients". If, for practical reasons related to space, this is not possible, a prospectus will be joined, an armband or a card that must contain the information necessary to the consumer and will be inscribed on the container or on the packaging. information abbreviated or the symbol provided for by order of the Minister The ingredients will be mentioned at a concentration of less than 1%, without a specific order, after those whose concentration is greater than 1%. Dyes can be mentioned after the other ingredients. For decorative cosmetic products marketed in several colors/shades, all colouring agents used are mentioned, preceded by the phrase "may contain" or the symbol "+/-". The fragrance or aromatization compositions and their raw materials will be mentioned by the word "perfume", respectively "aroma". Substances included in the lists presented in art. 6 6 para. ((1) lit. a) and approved by order of the Minister of Health, for which there is the mention of being inscribed on the packaging, will be included on the list of ingredients, regardless of the function they have in the cosmetic product. (2) Where, for practical reasons related to the size or shape of the containers or packaging, it is not possible to burn the information provided in par. ((1) lit. f) and i), they shall be entered on a label, an armband, a prospectus or a leaflet which is joined by the product. In the case of soap, bath balls or other small-sized products, where it is practically impossible, for reasons of size or shape, to write the information provided in par. ((1) lit. i) on a prospectus, a label, an armband, a leaflet or an attached card, this information will be written on a leaflet placed in the immediate vicinity of the container in which the cosmetic product is displayed for sale. " 14. in Article 13, after paragraph 2, paragraph 3 is inserted as follows: " (3) For cosmetic products that are not prepackaged and which are packed at the point of sale at the request of the buyer or which are prepacked for immediate sale, the detailed rules for the way of indicating the information provided in par. (1) is approved by order of the Minister of Health, which shall be published in the Official Gazette of Romania, Part I. " 15. Article 14 (1) shall be inserted after Article 14: "" Art. 14 14 ^ 1. -(1) The Ministry of Health may not prohibit, restrict or impede the placing on the market of cosmetic products that meet the requirements of this Law. (2) In order to ensure prompt and appropriate medical treatment in case of health risk situations, at the request of the Ministry of Health, the manufacturer, importer or person responsible for placing on the market must ensure providing the necessary and appropriate information on the substances used in cosmetic products. (3) The Ministry of Health is the competent national authority that ensures the transmission of the information provided ((2) to any of the Member States of the European Union, at their request, taking the necessary measures for the information to be transmitted only for the purpose of applying appropriate medical treatment. " 16. Article 15 shall read as follows: "" Art. 15. -(1) In the labelling, the presentation for sale or the promotion of the product shall be prohibited from the use of the texts, names, marks, images or other insignia which attribute to the products characteristics which they do not have. ((. The manufacturer or the person responsible for placing the product on the market may, on the packaging or on any other document, note, label, armband accompanying or referring to the product, that the product has not been tested on animals, only if the manufacturer or its supplier of raw materials has not carried out animal testing for the final product or for the prototype or has not used any animal-tested ingredient by third parties for the purposes of the formulation of new cosmetic products. ' 17. In Article 17, the introductory part and letter c) shall read as follows: "" Art. 17. -Constitutes contraventions and is sanctioned with fine the following facts: ............................................................................................ c) non-compliance with 4, 5, 5 1, 5 2, 7, art. 14 14 1 para. ((2) and art. 19, with a fine of 50,000,000 lei to 100,000,000 lei. " 18. Article 19 shall read as follows: "" Art. 19. -If the Ministry of Health finds, on the basis of good evidence, that a cosmetic product, although complying with the requirements of this law, poses a health hazard, may provisionally prohibit the marketing of that product or may impose special conditions for its marketing on the territory of Romania. In this case it will immediately inform the European Commission and the Member States of the European Union of this decision and of the reasons for this decision. " 19. After Article 20, Articles 20 ^ 1 and 20 ^ 2 shall be inserted as follows: "" Art. 20 20 ^ 1. -(1) The Ministry of Health is the competent national authority, which shall transmit information to the European Commission regarding the provisions 8 and 10 for the purpose of publication in the Official Journal of the European Communities. (2) The Ministry of Health shall ensure cooperation with the competent authorities of the Member States for the application of the provisions Article 20 ^ 2. -If the Ministry of Health has decided, according to art. 19, the provisional prohibition or restriction of the marketing of a cosmetic product, it shall inform in writing, within 72 hours, the interested party/involved about the measure, indicating the reasons for the decision and the recommended remedial measures, in accordance with existing legal regulations, as well as the deadline by which they may be applied. " 20. Article 21 shall read as follows: "" Art. 21. --provisions art. 17 is completed with the provisions of Government Ordinance no. 2/2001 on the legal regime of contraventions, approved with amendments and additions by Law no. 180/2002 ,, as amended. " 21. After Article 22, Articles 22 ^ 1 and 22 ^ 2 are inserted with the following contents: "" Art. 22 22 ^ 1. -The Ministry of Health will determine, by December 31, 2006, the procedure by which some chemicals and preparations can be temporarily authorized, to be used in cosmetic products, the access mechanism to information about substances used in the manufacture of cosmetic products necessary for the provision of appropriate medical treatments in the case of health risk situations, which are approved by order of the Minister of Health. Article 22 ^ 2. -The provisions of this law do not apply to products containing substances set out in Annex no. 6 6 to Order of the Minister of Health and Family 1.031/2002 for the approval of the lists containing the substances that can be used in the composition of cosmetics, published in the Official Gazette of Romania, Part I, no. 17 17 of 14 January 2003, as amended. '; 22. Article 25 shall be repealed. 23. Article 26 shall be inserted after Article 25: "" Art. 26. -Annexes no. 1-3 are an integral part of this law. " 24. Annexes no. 1 and 2 will have the following contents: "" ANNEX No 1 LIST comprising the categories of cosmetic products -Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.) -Face Masks (excl. products that act as superficial abrasives of the skin by chemical) -Nuanced bases (liquids, pasta, powders, etc.) -Makeup powders, pudding after bath, hygienic powders, etc. -Toilet soaps, deodorant soaps, etc. -Perfumes, toilet waters, colony waters, etc. -Bath and shower preparations (salts, foams, oils, gels, etc.) -Troubleshooting --Deodorants and antiperspirants -Hair care products: -nuanters and discoloration; -products for curling, straightening and fixing; -products for arrangement (decoration); -cleaning products (lotions, powders, shampoos, etc.); -conditioning products (lotions, creams, oils, etc.); -styling products (lotions, lakes, briantine, etc.) -Laughing products (creams, foams, lotions, etc.) -Products for makeup and removing it from the face and eyes -Products for use on the lips -Products for the care of teeth and mouth -Products for nail care and their decoration -Products for external intimate hygiene -Products for sunbathing (beach) -Products for sun-free tanning -Skin whitening products -anti-wrinkle products. "" Annex 2 image 25. After Annex no. 2 2 insert Annex no. 3 3 with the following contents: "" ANNEX No 3 image + Article II The limits of competence in carrying out the market control of cosmetic products shall be established by joint order of the Minister of Health and of the President of the National Authority for Consumer Protection, within 180 days of publication this law. + Article III This law transposes Council Directive no. 76 76 /768/EEC relating to cosmetic products, published in the Official Journal of the European Communities no. L053 of 25 February 1977, as amended and supplemented, including those brought by Directive no. 2003 2003 /15/EC ,, published in the Official Journal of the European Communities no. L066 of 11 March 2003. + Article IV The provisions of this Law shall enter into force 3 days from the date of publication in the Official Gazette of Romania, Part I, except: a) provisions of art. I section 8 8 and 9, which takes effect 180 days from the date of publication of the law; b) provisions of art. I section 6, 7 and 10-19, which enters into force on the date of Romania's accession to the European Union. + Article V Law no. 178/2000 on cosmetic products, with subsequent amendments and completions, as well as with those brought by this law, will be republished in the Official Gazette of Romania, Part I, giving the texts a new numbering. This law was adopted by the Romanian Parliament, in compliance with the provisions of art. 75 75 and art. 76 76 para. (2) of the Romanian Constitution, republished. CHAMBER OF DEPUTIES PRESIDENT VALER DORNEANU SENATE PRESIDENT NICOLAE VACAROIU Bucharest, September 28, 2004. No. 379. ------------