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Law No. 178 Of 18 October 2000 (Republished) Relating To Cosmetic Products

Original Language Title:  LEGE nr. 178 din 18 octombrie 2000 (*republicată*) privind produsele cosmetice

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LEGE no. 178 178 of 11 April 2000 (* republished *) on cosmetic products
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 120 120 of 17 February 2011



------- Note * *) Republicated pursuant to art. III of Law no. 260/2010 for repeal art. 8 8 of Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 848 of 17 December 2010, giving the texts a new numbering. Law no. 178/2000 on cosmetics has been republished in the Official Gazette of Romania, Part I, no. 91 of 27 January 2005, and subsequently amended and supplemented by: - Law no. 469/2006 to amend and supplement Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 1.029 1.029 of 27 December 2006; - Government Ordinance no. 2/2010 for amendment Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 59 of 26 January 2010, approved by Law no. 159/2010 , published in the Official Gazette of Romania, Part I, no. 496 496 of 19 July 2010. + Chapter I General provisions + Article 1 This law regulates the conditions which must be respected in the manufacture and placing on the market of cosmetic products for human use. + Article 2 (1) For the application of this law the terms and phrases below signify as follows: a) cosmetic product-any substance or mixture 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 oral mucosa, for the sole or principal purpose of clean them, perfume them, modify their appearance and/or correct their body odors and/or protect them or maintain them in good condition; b) cosmetic dyes-substances that are added to cosmetic products for the purpose of colouring the product and/or parts of the human body; c) preservatives-substances that are added to cosmetic products, for the main purpose of inhibiting the development of micro-organisms in these products; d) ultraviolet filters-substances that are added to cosmetic products to filter certain ultraviolet radiation, in order to protect the skin from the undesirable effects of these radiation; e) batch of manufacture-a quantity defined in raw material, packaging material or finished product, manufactured in identical conditions by a process or a series of processes, so that it can be considered homogeneous; f) batch number of manufacturing-a distinctive combination of numbers and/or letters, which specifically identifies a batch; g) the date of minimum durability-the date until which a product, stored under appropriate conditions, continues to perform its initial functions and complies with the provisions of art. 5 5; h) notification-the administrative approach consisting in the transmission in written form to the Ministry of Health of the intention to put a cosmetic product on the market; i) principles of good manufacturing practice of cosmetic products-the set of rules grouping general principles, procedures, actions and checks on the manufacturing process of cosmetic products; j) label-any written material containing elements of product identification and, where appropriate, instructions for use for the consumer; k) primary packaging-material that comes into direct contact with the cosmetic product, used to maintain the prescribed characteristics of the product throughout the shelf life; l) secondary packaging-material used to protect the immediate packaging; m) 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. (2) For the application of art. 8 8 and art. 19, 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. 7, the following expression is defined as: -cosmetic ingredient-any chemical or mixture of synthetic or natural origin used in the composition of a cosmetic product, with the exception of fragrance and aromatization compositions. + Article 3 List of categories of cosmetic products, as defined in art. 2 2 para. ((1) lit. a), is set out in Annex no. 1. + Article 4 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. + Chapter II Conditions imposed on cosmetic products for consumer safety + Article 5 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 will not exempt any person, under any circumstances, to comply with other provisions of this law. + Article 6 The Ministry of 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 can be used in the composition of cosmetic products, with subsequent amendments and completions. + Article 7 (1) Without affecting the fulfilment 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 1, to 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 1, to 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 1, to 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 1, 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 1, 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 1, to 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 1, to Order of Health Minister no. 1.448/2005 , with subsequent amendments and completions. (2) The presence of traces of substances among those provided in par. ((1) lit. a) is allowed only if, from a technical point of view, it cannot be avoided under the conditions of good manufacturing practice and the provisions of art. 5. (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 to be used in cosmetic products. + Article 8 (1) Without affecting the fulfilment of the obligations provided for 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 Union, taking into account the evolution of the validation process in 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 Union 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, no later than the date on which these tests must be replaced by one or more of the validated methods provided for in Commission Implementing Regulation (EU) No 440/2008 of the Commission of 30 May 2008 laying down testing methods pursuant to Regulation (EC) No 1.907/2006 of the European Parliament and the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ((2) The methods set out in Annex no. IX "List of alternative validated methods for the replacement of animal experiments" Council Directive 76 /768/EEC COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products shall be governed by the order of the Minister of Health, as published in the Official Journal (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 9 (. 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 , with subsequent amendments and completions, within the limits and conditions imposed, until the date set out in that Annex. (2) 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, based on available scientific information or because they are no longer used. + Article 10 (1) By derogation from the provisions of art. 7, the Ministry of 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: a) the authorization must be limited to a maximum period of 3 years; b) to carry out an official verification of cosmetic products containing the substance or mixture 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). Simultaneously, it will communicate the documentation on which this request is based and indicate the uses to which the substance is intended. + Article 11 The manufacturer or his authorised representative or the beneficiary of the manufacture of the cosmetic product or the person responsible for the placing of cosmetic products on the European Union market shall notify the competent authority of the Member State where 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 placing them on the market. + Article 12 ((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 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 Health represents the competent authority in Romania for the notification of cosmetics + Article 13 ((. For the purpose of exercising control by the competent authorities, the manufacturer, his authorized representative, the beneficiary of the manufacture of the cosmetic product or the person responsible for placing on the market an imported cosmetic product must hold the following data on the label: a) the qualitative and quantitative composition of the product; information on the fragrant composition and fragrances are limited to the name and code number of the composition, as well as to the identity of the supplier; 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; c) method of manufacture in accordance with the rules of good manufacturing practice 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 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 cosmetic products are first imported; 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 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 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; f) the name and address of the qualified persons responsible for assessing 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, with subsequent amendments and completions; g) existing data on undesirable effects for human health caused by cosmetic products as a result of use; h) proof of the declared effect of the cosmetic product, if its nature justifies it; 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. (2) The National Authority for Consumer Protection is the competent authority in Romania for the verification of the data provided in par. ((1). ((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. Information on the quantitative composition referred to in paragraph 1. ((1) lit. a) will be limited to substances meeting the criteria for any of the following classes or categories of hazard set out in Annex no. I to Regulation (EC) No 1.272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67 /548/EEC and 1999 1999 /45/EC ,, as well as modification of Regulation (EC) No 1.907/2006 : a) hazard classes 2.1-2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A-F; b) hazard classes 3.1-3.6, 3.7-adverse effects on sexual function and fertility or on development, 3.8-effects other than narcotic effects, 3.9 and 3.10; c) hazard class 4.1; d) hazard class 5.1. (4) Safety assessment for human health, as provided in par. ((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 chemicals, with subsequent amendments and completions. + Article 14 The data provided in art. 13 will be compulsorily presented in Romanian, without excluding the presentation and in a language accepted by the competent authorities. + Article 15 After carrying out the verification action undertaken by the empowered representatives of the competent control bodies, the manufacturer, his authorised representative, the beneficiary of the cosmetic product manufacture or the person responsible for putting the market of an imported cosmetic product, as the case may be, is obliged to ensure their access to the data referred to in 13, no later than 72 hours after the request. + Article 16 (. 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 identified; c) country of origin for products manufactured outside the European Union; d) the nominal content at the time of packaging of the product, indicated by weight or by volume, excluding packaging containing less than 5 grams or less than 5 millilitres, free samples and single doses. With regard to packages in which products are marketed in a set of pieces and for which the indication of weight or volume is not significant, the content may not be indicated, but the number of pieces shall be indicated on the packaging; this term is not required when the number of parts is easy to determine from the outside or if the product is usually marketed as a unit; 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 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; g) the function of the cosmetic product, unless it results from the presentation of the product 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 mixture, but not found in the finished product; materials used in strictly necessary quantities as solvents or carriers 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. (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 on display for sale. (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 is published in the Official Gazette of Romania, Part I. + Article 17 The information provided in art. 16 16 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 times of the International Nomenclature for Cosmetic Products-INCI, displayed on the website of the Ministry of Health and of the European Union, or, as the case may be, the provisions contained in Government Decision no. 560/2001 *) on some measures to preserve the confidentiality of some ingredients in the composition of cosmetics, and the dyes will be registered according to the number in the color index-Colour Index. ------- Note * *) Government Decision no. 560/2001 has been repealed by Government Decision no. 562/2008 on certain measures to preserve the confidentiality of some ingredients in the composition of cosmetic products, published in the Official Gazette of Romania, Part I, no. 417 417 of 3 June 2008. + Article 18 (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. + Article 19 (. 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. ((2) The manufacturer or person responsible for placing on the European Union market 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 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/or have used any ingredient tested on animals of to third parties, for the purpose of formulating new cosmetic products. + Chapter III Sanctions + Article 20 Violation of the provisions of this law attracts material, civil, contravention or criminal liability, as the case may + Article 21 It constitutes contraventions and is sanctioned with fine the following facts: a) non-compliance with 13, 14 and 17, with a fine of 1,000 lei to 2,000 lei; b) non-compliance with 15, 16 and 19, with a fine of 2,000 lei to 3,000 lei; c) non-compliance with 5 5, 7, 8, 11, art. 18 18 para. ((2) and art. 23, with a fine of 5,000 lei to 10,000 lei. + Article 22 (1) The finding of contraventions and the application of sanctions provided in art. 21 are made by the authorized representatives of the National Authority for Consumer Protection and the Ministry of Health. (2) The competent control bodies according to par. ((1) may justify the temporary or definitive cessation of the manufacture and/or placing on the market of cosmetic products which do not meet the requirements of this law and which may affect the life or health of consumers. (3) The control bodies may take samples of cosmetic products which they deem necessary in order to carry out analyses. + Article 23 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 impose special conditions for its marketing on the Romanian territory. 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. + Article 24 The authorized representatives of the control bodies are obliged to respect the secret nature of the information contained in the documents provided in art. 13 or about which they became aware during the control actions. + Article 25 (1) The Ministry of Health shall be the competent national authority which shall transmit information to the European Commission on the 13, for publication in the Official Journal of the European Union. (2) The Ministry of Health shall ensure cooperation with the competent authorities of the Member States for the application of the provisions + Article 26 If the Ministry of Health has decided, according to art. 23, 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 can be applied. + Article 27 Provisions art. 21 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 , with subsequent amendments and completions. + Chapter IV Final provisions + Article 28 The Ministry of Health will establish, by December 31, 2006, the procedure by which some chemicals and chemical mixtures can be temporarily authorized, to be used in cosmetic products, the mechanism of access to information about substances used in the manufacture of cosmetic products necessary for the provision of appropriate medical treatments in case of health risk situations, which are approved by order of the Minister of Health. + Article 29 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 , with subsequent amendments and completions. + Article 30 (1) This law shall enter into force 60 days after its publication in the Official Gazette of Romania, Part I*). ------- Note * *) Law no. 178/2000 was published in the Official Gazette of Romania, Part I, no. 525 525 of 25 October 2000. (2) On the date of entry into force of this Law, it is repealed a) section 21 21 and 22 of Annex no. 2 2 to Government Decision no. 340/1992 on the import regime of waste and residues of any kind, as well as other dangerous goods for the health of the population and for the environment, republished in the Official Gazette of Romania, Part I, no. 201 of 18 August 1992, with subsequent amendments and completions; b) the provisions concerning the registration of cosmetic products art. 4 lit. b) of Government Ordinance no. 125/1998 on the establishment, organization and functioning of the National Medicines Agency, published in the Official Gazette of Romania, Part I, no. 329 of 31 August 1998, as amended; c) Government Decision no. 670/2001 for the approval of the Methodological Norms Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 422 422 of 30 July 2001; d) any other provisions to the contrary. + Article 31 Annexes no. 1-3 are an integral part of this law. + Annex 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. -Mixtures for bath and shower (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 + Annex 3 image NOTE: We reproduce below provisions that are not incorporated into the republished form of Law no. 178/2000 and which continue to apply as own provisions of the amending acts: 1. The mention of the transposition Law no. 469/2006 to amend and supplement Law no. 178/2000 on cosmetic products: "" 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. ' 2. Art. II and the mention of the transposition of Government Ordinance no. 2/2010 for amendment Law no. 178/2000 on cosmetic products, approved by Law no. 159/2010 : "" Art. II. -The provisions of this ordinance shall enter into force on June 1, 2010, except for the provisions of art. I section 2 2 and 3 which shall enter into force on 1 December 2010. * This ordinance transposes art. 1 1 " Changes in Directive 76 /768/EEC " of Directive 2008 /112/EC of the European Parliament and of the Council of 16 December 2008 amending Directives 76 /768/EEC , 88 88 /378/EEC , 1999 1999 /13/EC of the Council and Directives 2000 /53/EC , 2002 2002 /96/EC and 2004 2004 /42/EC of the European Parliament and of the Council, in order to adapt them to Regulation (EC) No 1.272/2008 1.272/2008 on the classification, labelling and packaging of substances and mixtures, published in the Official Journal of the European Union no. L 345 of 23 December 2008. ' 3. Art. I and II of Law no. 260/2010 for repeal art. 8 8 of Law no. 178/2000 on cosmetic products: " Art. I.-Article 8 of Law no. 178/2000 on cosmetic products, republished in the Official Gazette of Romania, Part I, no. 91 of 27 January 2005, as amended and supplemented, shall be repealed. Art. II In the normative acts, references to art. 8 8 of Law no. 178/2000 , republished, with subsequent amendments and completions, shall be construed as references to the provisions of art. 15 15 para. ((1) and (2) of Commission Implementing Regulation (EU) No 1.223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, published in the Official Journal of the European Union no. L 342 of 22 December 2009, as well as in art. 14, 31 and 32 of the same Regulation, if they are necessary for the application of the provisions of art. 15 15 para. ((1) and (2). ' -------