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Law No. 469 Of 12 December 2006 On The Modification And Completion Of The Law Nr. 178/2000 Relating To Cosmetic Products

Original Language Title:  LEGE nr. 469 din 12 decembrie 2006 pentru modificarea şi completarea Legii nr. 178/2000 privind produsele cosmetice

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LEGE no. 469 469 of 12 December 2006 to amend and supplement Law no. 178/2000 on cosmetic products
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 1.029 1.029 of 27 December 2006



The Romanian Parliament adopts this law + Article I Law no. 178/2000 on cosmetic products, republished in the Official Gazette of Romania, Part I, no. 91 of 27 January 2005, shall be amended and supplemented as follows: 1. in Article 2, points b), n) and o) shall be repealed. 2. In Article 2, two new paragraphs are inserted, paragraphs 2 and 3, with the following contents: " (2) For the application of art. 7 7 and art. 20, the following terms and expressions shall be defined as follows: a) 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; b) prototype-the first model or project of a cosmetic product that has not been manufactured in batches and from which the finished cosmetic product is copied or developed. (3) For the application of art. 6, the following expression is defined as: -cosmetic ingredient-any chemical or preparation of synthetic or natural origin used in the composition of a cosmetic product, with the exception of fragrance and aromatization compositions. ' 3. Article 5 shall read as follows: "" Art. 5. -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 concerning the preservation and use thereof, and of any other indication or information provided by the manufacturer, his authorised representative or any other person responsible for placing the product on the market. These indications or information shall not exempt any person, under any circumstances, from complying with other provisions of this law. " 4. After Article 5, a new article is inserted, Article 5 ^ 1, with the following contents: "" Art. 5 5 ^ 1. -The Ministry of Public Health takes all necessary measures to put on the market only those products that comply with the provisions of this law and of Order of Health Minister no. 1.448/2005 on the categories of cosmetic products and the lists of substances that may be used in the composition of cosmetic products, as amended and supplemented. " 5. In Article 6, paragraph 1 shall read as follows: "" Art. 6. -(1) Without affecting the performance of the obligations provided in art. 5, it is prohibited to put on the market cosmetic products in whose composition they are found: a) substances referred to in Annex no. II to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions; b) substances outside the limits of admissibility and the conditions set out in Annex no. III, Part I, at Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions; c) colouring agents other than those referred to in Annex no. IV, Part I, at Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, with the exception of cosmetic products intended to be used only in hair coloring; d) colouring agents set out in Annex no. IV, Part I, at Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, under conditions other than those specified, except for cosmetic products intended to be used only in hair coloring; e) preservatives, other than those established in Annex no. VI, Part I, to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions; f) preservatives, outside the limits of admissibility and the conditions imposed by Annex no. VI, Part I, to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, unless other concentrations are used, for specific purposes, resulting from the presentation of the product; g) UV filters other than those set out in Annex no. VII, Part I, at Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions; h) UV filters, used outside the limits of admissibility and the conditions imposed in Annex no. VII, Part I, at Order of Health Minister no. 1.448/2005 ,, as amended and supplemented; '. 6. in Article 6, after paragraph 2, a new paragraph (3) is inserted, with the following contents: " (3) The Order of the Minister of Industry and Resources and the Minister of Health and Family No. 309/729/2001 on the inventory for the ingredients used in cosmetic products have an indicative value, without constituting a list of substances authorised for use in cosmetic products. ' 7. In Article 7, paragraphs 1 and 2 shall read as follows: "" Art. 7. -(1) Without affecting the performance of the obligations provided in art. 5, shall be prohibited: a) the marketing of cosmetic products whose final formula, in order to meet the requirements of this law, has been tested on animals using a method, other than the alternative, after the latter has been validated and adopted at the level The European Community, taking into account the evolution of the validation process within the Organisation for Economic Cooperation and Development; b) the marketing of cosmetic products having ingredients or combinations of ingredients which, in order to meet the requirements of this law, have been tested on animals using a method, other than the alternative, after the date on which the latter been validated and adopted at European Community level, taking into account the evolution of the validation process in the Organisation for Economic Cooperation and Development; c) animal testing of finished cosmetic products, in order to meet the requirements of this law; d) animal testing of ingredients or combinations of ingredients, in order to meet the requirements of this law, after the date on which these tests must be replaced by alternative methods validated or established by the European Commission. (2) The alternative methods to those 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 , as amended and supplemented, shall be governed by order of the Minister of Public Health, as published in the Official Journal of the European Union. ' 8. In Article 8, paragraph 1 shall read as follows: "" Art. 8. -(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 concerning the classification, labelling and packaging of dangerous chemicals and preparations. ' 9. In Article 9, paragraph 1 shall read as follows: "" Art. 9. -(1) The marketing of cosmetic products containing: a) the substances listed in Annex no. III, Part 2, at Order of Health Minister no. 1.448/2005 , as amended and supplemented, within the limits and conditions imposed, by the date set out in that Annex; b) the colouring agents referred to in Annex no. IV, Part 2, to Order of Health Minister no. 1.448/2005 , as amended and supplemented, within the limits and conditions imposed, by the date set out in that Annex; c) preservatives set out in Annex no. VI, Part 2, to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, within the limits and conditions imposed, until the date set out in the Annex, unless other concentrations are used, for specific purposes, which emerge from the presentation of the product; d) UV filters set out in Annex no. VII, Part 2, at Order of Health Minister no. 1.448/2005 ,, as amended and supplemented, within the limits and conditions imposed, by the date set out in that Annex. " 10. In Article 9, after paragraph 1, a new paragraph (1 ^ 1) is inserted, with the following contents: "" (1 ^ 1) After the expiry of the date set according to (1), substances, colouring agents, preservatives and UV filters shall: a) definitively permitted; or b) definitively prohibited, by including in Annex no. II to Order of Health Minister no. 1.448/2005 , as amended and supplemented; or c) maintained, for the period provided for in Part 2 of the Annexes no. III, IV, VI and VII Order of Health Minister no. 1.448/2005 , as amended and supplemented; or d) remove, by repealing those positions in the Annexes to Order of Health Minister no. 1.448/2005 ,, with subsequent amendments and completions, on the basis of available scientific information or because they are no longer used. " 11. Article 9 (2) and (3) shall be repealed. 12. In Article 10, the introductory part of paragraph 1 shall read as follows: "" Art. 10. -(1) By derogation from the provisions of art. 6, the Ministry of Public Health may authorize 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: ". 13. Article 11 shall read as follows: "" Art. 11. -The manufacturer or his authorized representative or the beneficiary of the manufacture of the cosmetic product or the person responsible for placing cosmetic products on the European Community market shall notify the competent authority of the Member State where it manufactured the product or where it was imported for the first time the address of the place of manufacture or of the first import within the Community before their placing on the market. ' 14. Article 12 shall be repealed. 15. Article 13 shall read as follows: "" Art. 13. --(1) The notification shall be unique within the territory of the ((. The notification shall become effective from the moment of transmission. (3) Any modification of the information submitted to the Ministry of Public Health shall be notified within 30 days from the date of the change. (4) In accordance with the provisions of art. 11, the Ministry of Public Health is the competent authority in Romania for the notification of cosmetics. 16. in Article 14, points c), d) and e) of paragraph 1 shall read as follows: " c) the manufacturing method according to the rules of good manufacturing practice provided for in Order of Minister of Industry and Resources No. 308/2001 for the approval of the Guide on principles of good manufacturing practice for cosmetic products or in the regulations of other Member States; the provisions of the said order are applicable to cosmetics manufactured in Romania or imported from third countries, which are first introduced on the Community market through Romania; d) the name of the person responsible for the manufacture or import for the first time of a cosmetic product in the European Community; the person responsible must possess an appropriate level of professional qualification or experience, in accordance with the legislation and practice of the Member State of the European Community, where they are manufactured or where the cosmetic products are imported for e) safety assessment for the human health of the finished cosmetic product. For this, the 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 other Member States of the European Community, 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 the monitoring of the product or other control authorities, the manufacturer shall be obliged to specify the address to which the information is quickly accessible; '. 17. in Article 14, after paragraph 1, a new paragraph (1 ^ 1) is inserted, with the following contents: " (1 ^ 1) The National Authority for Consumer Protection is the competent authority in Romania for the verification of the data provided in par. ((1). ' 18. Article 14 (2) shall be repealed. 19. Article 15 shall read as follows: "" Art. 15. -The data provided in art. 14 will be compulsorily presented in Romanian, without excluding the presentation and in a language accepted by the competent authorities. " 20. in Article 17, points a), b), c), f), h) and i) of paragraph 1 shall read as follows: "" a) the name or name of the manufacturer or the person responsible for placing on the market established in the European Community or the abbreviation, if it permits the identification of b) the seat or address in the Member State of the European Community of the producer or person responsible for placing on the market, in the European Community, an imported cosmetic product or its abbreviation, as long as it is possible to identified; c) country of origin for products manufactured outside the European Community; .................................................................. f) special precautions for use, in particular those relating to the ingredients referred to in the column "Conditions of use and precautions to be mentioned on the label" of Annexes no. III, IV, VI and VII Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, and which must be inscribed on the packaging and on the container, 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, a label, an armband or a flyer that will contain 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; .................................................................. h) the batch number or an indication to enable the identification of the product. When the small size of the product does not allow, this information may appear only 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". Where, for practical reasons, this is not possible, the package leaflet, the label, the armband or the attached flyer must contain the information necessary for the consumer, in the abbreviated form or the symbol set out in Annex no. 3, to be marked on the packaging. Not considered as ingredients: impurities in the raw materials used; auxiliary technical materials used in the preparation, but not found in the finished product; materials used in strictly necessary quantities as solvents or carriers of perfume or aromatic compositions. The ingredients will be mentioned at a concentration of less than 1% without a specific order, after those whose concentration is greater than 1%. The dyes may be mentioned after the other ingredients, regardless of the order, according to the colour index number or the name set out in Annex no. VI to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions. 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 contained in Annex no. III to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions, 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. " 21. In Article 17, paragraph 2 shall read as follows: " (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 a flyer attached, 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. " 22. Article 18 shall read as follows: "" Art. 18. -The information provided in art. 17 17 para. ((1) lit. d)-f) and h) must be written in Romanian, except for the list containing the ingredients, where the names in the Order of the Minister of Industry and Resources and the Minister of Health and Family no. 309/729/2001 on the inventory for the ingredients used in cosmetic products or from the International Nomenclature for cosmetics-INCI, displayed on the website of the Ministry of Public Health and the European Union, or, as the case may be, apply the provisions of Government Decision no. 560/2001 on certain measures to preserve the confidentiality of some ingredients in the composition of cosmetic products, and the dyes will be registered according to the number in the color index-Colour Index. " 23. In Article 20, paragraph 2 shall read as follows: " (2) The manufacturer or person responsible for placing on the market of the European Community of the product may be used by the fact that he has not been tested on animals, by specifying on the packaging or on any other document, note, label, armband which accompanying or referring to the product, only if the manufacturer or its suppliers of raw materials did not or did not or did not request animal testing for the finished cosmetic product or on the prototype or did not use any of the ingredients tested on animals by third persons, for the purpose of formulating new cosmetic products. " 24. Article 25 shall read as follows: "" Art. 25. -The authorized representatives of the control bodies are obliged to respect the secret nature of the information contained in the documents provided in art. 14 14 or about which they became aware during the control actions. " 25. In Article 26, paragraph 1 shall read as follows: "" Art. 26. -(1) The Ministry of Public Health is the competent national authority that transmits information to the European Commission regarding the provisions 14, for publication in the Official Journal of the European Union. ' 26. Article 29 shall be repealed. 27. Article 31 shall read as follows: "" Art. 31. -The provisions of this Law shall not apply to products containing the substances listed in Annex no. V la Order of Health Minister no. 1.448/2005 ,, as amended and supplemented. " + Article II Throughout the whole Law no. 178/2000 on cosmetic products, the phrase "European Union" is replaced by the phrase "European Community" and the phrase "Ministry of Health" is replaced by the phrase "Ministry of Public Health". + Article III The Ministry of Public Health will develop and approve, by order of the Minister, the procedure for the notification of cosmetic products, within 30 days from the date of entry into force of this law, and will make public the list of cosmetic products notified. + 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 the provisions of art. I section 1, 2, 7, 12-16, 20-23 and 25, which takes effect on the date of Romania's accession to the European Union. + Article V Law no. 178/2000 on cosmetic products, republished in the Official Gazette of Romania, Part I, no. 91 of January 27, 2005, with the amendments and completions brought by this law, will be republished in the Official Gazette of Romania, Part I, giving the texts a new numbering. * This law transposes in full Council Directive 76 /768/EEC on the harmonisation of the laws of the Member States relating to cosmetic products published in the Official Journal of the European Communities no L/262 of 27 September 1976. 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 BOGDAN OLTEANU p. SENATE PRESIDENT, DORU IOAN TARACILA Bucharest, December 12, 2006. No. 469. -------