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

Original Language Title:  LEGE nr. 178 din 18 octombrie 2000 privind produsele cosmetice

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Law No. 178 of 11 April 2000 (republished) concerning cosmetic products published in PARLIAMENT ISSUING the OFFICIAL GAZETTE nr. 120 of 17 February 2011--Note *) Republished pursuant to art. III of law No. 260/2010 for the repeal of art. 8 of law No. 178/2000 relating to cosmetic products, as published in the Official Gazette of Romania, part I, no. 848 on December 17, 2010, posing a new texts.

Law No. 178/2000 on cosmetic products was also republished in the Official Gazette of Romania, part I, no. 91 of 27 January 2005, and subsequently was amended and supplemented by:-Law No. 469/2006 modifying and completing law No. 178/2000 relating to cosmetic products, as published in the Official Gazette of Romania, part I, no. of 27 December 2006 1,029;
-Order No. 2/2010 for amendment of law No. 178/2000 relating to cosmetic products, as published in the Official Gazette of Romania, part I, no. 59 of 26 January 2010, which was approved by law No. 159/2010, published in the Official Gazette of Romania, part I, no. 496 of 19 July 2010.


Chapter I General provisions Article 1 this law regulates the conditions that must be complied with in the manufacture and placing on the market of cosmetic products for human use.


Article 2 (1) For the purposes of this law the following terms and expressions below signify as follows: a) cosmetic product-any substance or mixture to be put in contact with the various external parts of the human body, such as skin, hair, nails, lips, or external genitalia with the teeth and the mucous membrane of the mouth, with the sole purpose or primary to clean them perfuming them, changing them the appearance and/or correcting body odours them and/or protecting them or keeping them in good condition;
  

b colouring agent)-substances which are added to cosmetic products for the purposes of the case of the product and/or parts of the human body;
  

c) preservatives-substances which are added to cosmetic products in order to inhibit the development of main microorganisms in these products;
  

d) ultraviolet filters-substances which are added to cosmetic products to filter certain UV radiation, in order to protect the skin from the effects of such radiation;
  

e) manufacturing batch-a quantity defined in raw material, packaging material or finished product, manufactured in identical conditions in a process or series of processes so that it can be considered homogeneous;
  

f) manufacturing batch number a distinctive combination of numbers and/or letters that specifically identifies a batch;
  

(g) the minimum durability date)-the date by which a product, stored under appropriate conditions, continues to fulfil its initial functions and complies with the provisions of art. 5;
  

h) notification-administrative approach that consists of the transmission in written form to the Ministry of health has the intention of marketing of a cosmetic product;
  

I) principles of good manufacturing practice of cosmetic products-rule Assembly which groups the General principles, procedures, and checks what actions shall be exercised on the process of manufacturing of cosmetic products;
  

j) label-any written material which contains the particulars of the product and, where appropriate, instructions for use for the consumer;
  

k) primary packaging-material that comes into direct contact with the product, used to maintain the prescribed characteristics of the product throughout the period of validity;
  

l) secondary packaging-material used to protect the primary packaging;
  

m) after opening period-the period of time during which a finished cosmetic product can be safely used, calculated from the first openings of primary packaging and commencement of use of the product.
  

(2) pursuant to the provisions of article 7. 8 and of article 23. 19, the following terms and expressions shall be defined as follows: a) the finished cosmetic product-the cosmetic product in its final formulation, as placed on the market and offered to the final consumer, or its prototype;
  

b) prototype-first model or design of a cosmetic product that has not been produced in batches, and from which the finished cosmetic product is copied or developed.
  

(3) pursuant to the provisions of article 7. 7, the following expression is defined as follows:-cosmetic ingredient-any chemical substance or mixture of synthetic origin used in times of a natural cosmetic product, with the exception of flavouring and fragrance compositions.


Article 3 the list of categories of cosmetic products, as defined in art. 2 (2). (1) (a). a), it is provided in the annex. 1. In article 4 the Ministry of health the competent national authority for the regulation of the marketing of cosmetic products, the notification of their preparation and data base administration, inspection and monitoring of the market, informing the population, recording cases reported concerning adverse effects on the population, caused by cosmetics, reporting to the European Commission.


Chapter II Conditions imposed for the safety of cosmetic products consumers Article 5 cosmetic products placed on the market must not endanger human health when used under normal or reasonably foreseeable use, bearing in mind, in particular, the presentation of the product, labeling, instructions concerning the keeping and use thereof, and any other indication or information provided by the manufacturer , his authorized representative or any other person responsible for the placing on the market of the product. These guidelines or information will not relieve any person, under no circumstance, to comply with the other provisions of this law.


Article 6 the Ministry of health will take all measures needed to be put on the market only products which comply with the provisions of this law and of the order of the Minister of health no. 1.448/2005 relating to the categories of cosmetics, and lists those substances which may be used in the composition of cosmetic products, as amended and supplemented.


Article 7 (1) without prejudice to compliance with the obligations laid down in article 21. 5, prohibit the placing on the market of cosmetic products whose composition can be found: a) the substances referred to in annex 4. To the Minister of Health Order No. 1.448/2005, as amended and supplemented;
  

b) substances beyond the limits and the conditions for admissibility laid down in the annex. III, part 1, by order of the Minister of health no. 1.448/2005, as amended and supplemented;
  

c) colouring agents other than those listed in the annex. IV, part 1, by order of the Minister of health no. 1.448/2005, amended and supplemented, except for cosmetic products intended to be used only to hair dye;
  

d) colouring agents listed in the annex. IV, part 1, by order of the Minister of health no. 1.448/2005, amended and supplemented, under conditions other than those specified, with the exception of cosmetic products intended to be used only to hair dye;
  

e) preservatives other than those set out in the annex. Vi, part 1, by order of the Minister of health no. 1.448/2005, as amended and supplemented;
  

f) preservatives, beyond the limits of admissibility and the conditions imposed by the annex. Vi, part 1, by order of the Minister of health no. 1.448/2005, with amendments and additions thereto, unless other concentrations are used for specific purposes, resulting from the presentation of the product;
  

g) UV filters other than those set out in the annex. VII, part 1, by order of the Minister of health no. 1.448/2005, as amended and supplemented;
  

h) UV filters, used outside the limits of admissibility and the conditions imposed in the annex. VII, part 1, by order of the Minister of health no. 1.448/2005, with subsequent amendments and additions.
  

(2) the presence of traces of the substances listed in paragraph 1. (1) (a). a) is allowed if, from a technical point of view, cannot be avoided under conditions of good manufacturing practice and shall comply with the provisions of art. 5. (3) the provisions of the order of the Minister of industry and resources and the Minister of health and family no. 309/729/2001 on the inventory of ingredients used in cosmetic products have indicative value, without imposing a list of substances authorized for use in cosmetic products.
  


Article 8 (1) without prejudice to the fulfilment of the obligations laid down in article 21. 5, the following shall be prohibited: (a)) marketing of cosmetic products where the final formulation, in order to meet the requirements of this law has been tested on animals by using a method other than an alternative method after the latter has been validated and adopted at EU level, taking into account the evolution of the validation process within the Organization for economic cooperation and development;
  

b) marketing of cosmetic products having the ingredients or combinations of ingredients which, in order to meet the requirements of this Act, have been tested on animals by using a method other than an alternative, after the date on which the latter has been validated and adopted at EU level, taking into account the evolution of the validation process within the Organization for economic cooperation and development;
  

c) testing on animals of finished cosmetic products in order to meet the requirements of this Act;
  


d) animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Act, not later than the date on which such tests should be replaced by one or more validated methods referred to in Regulation (EC) No 1782/2003. 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1782/2003. 1.907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals (REACH).
  

(2) the methods described in annex 4. (IX) "list of validated alternative methods to replace animal experiments" to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products are regulated by order of the Minister of health, as it has been published in the official journal of the European Union.
  

(3) in exceptional circumstances, when there is a compelling reason in terms of safety of an existing cosmetic ingredient, the Ministry of health may request the European Commission to grant a derogation from the provisions of paragraph 1. 1. Request for a derogation shall contain an assessment of the situation and to indicate the measures necessary. Upon request and after consulting the Scientific Committee on cosmetics and non-food products, the European Commission may authorise derogation by means of a reasoned decision. This authorization must contain the conditions under which the exemption has been granted, the specific objective, duration and reporting results.
  

(4) a derogation may be granted only if: (a)) is used in ingredient frequently and cannot be replaced by another ingredient with similar function;
  

(b) human health) problem is specific and substantiated the need for resorting to animal testing is justified and supported by a detailed research protocol proposed as the basis for the assessment.
  


Article 9 (1) shall be permitted the marketing of cosmetic products containing: (a) the substances referred to in annex II) No. III, part 2, by order of the Minister of health no. 1.448/2005, amended and supplemented, within the limits and conditions imposed by the date fixed in that annex;
  

b colouring agents) referred to in annex 4. IV, part 2, by order of the Minister of health no. 1.448/2005, amended and supplemented, within the limits and conditions imposed by the date fixed in that annex;
  

c) preservatives listed in annex No. Vi, part 2, by order of the Minister of health no. 1.448/2005, amended and supplemented, within the limits and conditions imposed by the date fixed in the annex hereto, unless other concentrations are used for specific purposes, arising from the presentation of the product;
  

d) UV filters listed in annex No. VII, part 2, by order of the Minister of health no. 1.448/2005, amended and supplemented, within the limits and conditions imposed by the date fixed in that annex.
  

(2) after the final date laid down pursuant to paragraph 1. (1) substances, colouring agents, preservatives and UV filters shall be: a) definitively permitted; or b) be definitively, by inclusion in the annex. To the Minister of Health Order No. 1.448/2005, as amended and supplemented; or c) kept, for the period specified in part 2 of annexes II nr. III, IV, VI and VII to the Minister of Health Order No. 1.448/2005, as amended and supplemented; or d) you want to remove, by repealing the respective positions of the annexes by order of the Minister of health no. 1.448/2005, as amended and supplemented on the basis of available scientific information or because they are no longer using.
  


Article 10 (1) by way of derogation from the provisions of art. 7, Health Ministry may authorise the use of Romanian territory which are not listed in the list of substances permitted for certain cosmetic products under the following conditions: a) the authorisation should be limited to a maximum period of 3 years;
  

(b)) to perform a formal verification of the cosmetic products containing the substance or the mixture use of which has been authorized;
  

c) cosmetic product thus manufactured must bear a distinctive indication which will be specified in the authorization.
  

(2) the Ministry of health shall inform the European Commission and the Member States about the authorization decision taken pursuant to paragraph 1. (1) within two months from the date of entry into force of the authorization.
  

(3) before the expiry of three years referred to in paragraph 1. (1) (a). the Ministry of health), may submit an application to the European Commission for inclusion in the list of permitted substances for which he was awarded the national authorization, in accordance with para. 1. Simultaneously, will communicate the documentation on this application and shall indicate the uses for which it is intended for the substance.
  


Article 11 the manufacturer or his authorised representative or the beneficiary of the manufacture of the cosmetic product, or the person responsible for putting cosmetic products to the EU market will notify to the competent authority of the Member State where the product was manufactured or where it was imported for the first time address of manufacturing or first import into the community before placing them on the market.


Article 12 (1) the notification is unique within the European Union.
  

(2) the notification shall become effective from the moment of data transmission.
  

(3) any changes to the information submitted by the Ministry of health shall be informed thereof within 30 days from the date of the occurrence of the change.
  

(4) In accordance with the provisions of art. 11, the Ministry of health in Romania means the competent authority for the notification of cosmetic products.
  


Article 13 (1) for the purposes of exercising supervision by the competent authorities, the manufacturer, his authorised representative, the manufacture of the cosmetic product, or person responsible for the placing on the market of cosmetic product imported must have the address specified on the label, the following information: a) the qualitative and quantitative composition of the product; information on the composition of perfumed fragrances and are limited to the name and the code number of the composition and the identity of the supplier;
  

b) physico-chemical specifications and microbiological checks on the raw materials and the finished product and the purity criteria for control and microbiology for cosmetic product;
  

c) manufacturing method in accordance with the rules of good manufacturing practice referred to in the order of the Minister of industry and resources no. 308/2001 for approval of the Guide on the principles of good manufacturing practice of cosmetic products, or in the rules of the other Member States; the provisions of the order mentioned are applicable to cosmetic products manufactured in Romania or imported from third countries, which are being introduced for the first time on the Community market by Romania;
  

(d) the name of the person responsible for) the manufacture or importation for the first time of a cosmetic product in the European Union; the responsible person must possess an appropriate level of professional qualification or experience, in accordance with the legislation and practice of the Member State of the European Union where are manufactured wherever there are for the first time imported cosmetic products;
  

e) safety for human health of the finished cosmetic product. To do this, the manufacturer will take into account the general toxicological profile of the ingredients, their chemical structure and the level of exposure, especially of the specific exposure characteristics of the product will be applied or of the population for whom it is intended; for products intended for children under 3 years of age, as well as for those intended exclusively for external intimate hygiene there should be an assessment of the safety for human health. Where the product is manufactured in different localities within the territory of Romania or of Member States of the European Union, the manufacturer may choose a single location (place), where product information is available. In this regard, at the request of the competent authorities to monitor the product or other authorities with powers of inspection, the manufacturer shall state the address from which the information is quickly accessible;
  

f) names and addresses of persons qualified in charge who rated product in terms of safety to human health; persons responsible for assessment should have post-graduate diploma in specialities: Pharmacy, toxicology, dermatology, medicine or a similar specialty as defined in the law. 200/2004 concerning the recognition of diplomas and professional qualifications for regulated professions from Romania, as amended and supplemented;
  

g) existing data with respect to the effects on human health caused by cosmetic products as a result of the use;
  

h) proof of the effect of the cosmetic product, where its nature justify it;
  

I) information relating to any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product of the cosmetic product, or its ingredients, including any animal testing performed for the purpose of compliance with the national regulations of countries that are not members of the European Union.
  

(2) the national authority for consumer protection is the competent authority in Romania to verify the data provided for in paragraph 1. (1).
  


(3) Without prejudice to the protection of commercial secrecy and of intellectual property, the manufacturer, his authorised representative, the manufacture of the cosmetic product, or person responsible for placing on the market of imported cosmetic product will ensure that the information referred to in paragraph 1. (1) (a). a) and g) to be made accessible to the public in any format, including electronic. Information relating to the quantitative composition referred to in paragraph 1. (1) (a). a) will be limited to those substances meeting the criteria for any of the following hazard classes or categories set out in annex 4. I to Regulation (EC) No 1782/2003. 1,272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1782/2003. 1.907/2006: a) danger 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) the assessment of the safety for human health, as referred to in paragraph 1. (1) (a). (e)), will be carried out in accordance with the principles of good laboratory practice laid down by Government Decree No. 63/2002 approving the principles of good laboratory practice, as well as their inspection and verification in the case of tests carried out on chemical substances, as amended and supplemented.
  


Article 14 the data specified in article 1. 13 will be presented in the Romanian language, without however excluding the presentation and in a language accepted by the competent authorities.


Article 15 action in the verification undertaken by representatives of supervisory agencies empowered by the manufacturer, his authorised representative, the manufacture of the cosmetic product, or person responsible for the placing on the market of imported cosmetic product, where applicable, be required to provide access to data referred to in article 1. 13 not later than 72 hours after the request.


Article 16 (1) cosmetic products may be marketed only if the container and packaging the following information shall be marked visibly, legibly and with characters that are not deleted; with regard to the information referred to in I), these can be written only on the packaging. Indicate the following data: (a) name or business name of the manufacturer), or the person responsible for placing on the market established within the European Union or the abbreviation, if it permits identification of data subjects;
  

(b) the address or headquarters) the Member State of the European Union by the producer or of the person responsible for placing on the market in the European Union, of a cosmetic product imported times abbreviation thereof, so long as it is possible to identify;
  

c) country of origin for products manufactured outside the European Union;
  

(d) the nominal content at the time) packaging, shown by weight or volume, except for packages containing less than five grams or less than 5 millilitres, free samples and single doses. In terms of packaging in which products are marketed in a number of pieces for which the indication of weight or volume is not significant, the content may not be shown, but it will be noted on the package number of pieces; This is not required when the number of pieces is easily determined from the outside or if the product is usually marketed as a unit;
  

(e) the date of minimum durability) as indicated by the phrase "to be used preferably before" followed by the date or place of the indication on the whereabouts of the package appears. The date shall be clearly mentioned, with an indication, in order and with Arabic numerals, either the month and year or the day, month and year. If necessary, this information shall be supplemented by an indication of the conditions which must be met in order to ensure the sustainability of affirmed. Indication of the date of durability shall not be mandatory for cosmetic products the minimum durability of which exceeds 30 months. For these particulars shall be supplemented by an indication of the period, after the opening of the cosmetic product, it can be used safely by consumers. This information will be presented by the symbol given in annex No. 2, followed by the period of use expressed in months and/or years;
  

f special precautions for use), in particular regarding the ingredients mentioned in the column "conditions of use and precautions that need to be mentioned on the label" in the appendices. III, IV, VI and VII to the Minister of Health Order No. 1.448/2005, amended and supplemented, and which must be marked on the package and on the container, as well as special information warning for use in cosmetics, especially those for hairdressers. Where this is not possible for practical reasons, will be joined by an enclosed leaflet, label, an armband or a flyer that will contain the necessary information to consumers, be abbreviated by using either the symbol given in annex No. 3, which must appear on the container and packaging;
  

g) function of the cosmetic product, except where it results from the presentation of the product;
  

h) the batch number of manufacture or an indication enabling identification of the product. When the small size of the product do not allow, this information may occur only on the packaging;
  

I) the list of ingredients that are part of the composition of the product, in descending order of weight at the time of incorporation; This list is preceded by the word "ingredients". Where, for practical reasons, this is not possible, the leaflet, label, band or the attached flyer should contain the necessary information to the consumer, in abbreviated form or the symbol given in annex No. 3, to be marked on the packaging. Are not considered as ingredients: impurities in the raw materials used; auxiliary technical materials used in the mix, but not present in the finished product; the materials used in strictly necessary quantities as solvents or as carriers for perfume times aromatic compositions. Will mention the ingredients in concentrations of less than 1% without a specific order after those whose concentration is higher than 1%. Colours can be listed after the other ingredients, regardless of the order in accordance with the color index number or designation set out in the annex. Vi to the Minister of Health Order No. 1.448/2005, with subsequent amendments and additions. For decorative cosmetic products marketed in several colour shades, all stated/advertisers use, staining of the phrase "may precede contains" or the symbol "+/-". Fragrance compositions or flavouring and their raw materials shall be referred to by the word "perfume" and "flavour." Substances listed in the annex. (III) the order of the Minister of health no. 1.448/2005, with subsequent amendments and additions to the entry to be written to the package, will be included on the list of ingredients, regardless of the function in the cosmetic product.
  

(2) where, for practical reasons relating to the size or shape of the containers or packaging, it is not feasible to information referred to in paragraph 1. (1) (a). f) and i), they are part of a label, an armband, a leaflet or a folder which is joined to the product. In the case of SOAP, bath balls and other small products where it is virtually impossible, for reasons of size or shape, to be written information referred to in paragraph 1. (1) (a). I) on an enclosed leaflet, label, an armband, a folder or a flyer attached, this information will be written to a folder put the container in which the cosmetic product is exposed for sale.
  

(3) For cosmetic products which are not pre-packaged and are packed at the point of sale at the request of the purchaser or are prepackaged for immediate sale, detailed rules for the indication of the information referred to in paragraph 1. (1) is approved by order of the Minister of health, to be published in the Official Gazette of Romania, part I.
  


Article 17 information referred to in article 1. 391. (1) (a). d)-f) and h) must be written in the Romanian language, with the exception of the list containing the ingredients, where they use the names in the order of the Minister of industry and resources and the Minister of health and family no. 309/729/2001 or international Nomenclature cosmetic-INCHES, displayed on the website of the Ministry of health and that of the European Union, or, if necessary, applies the provisions contained in Government Decree No. 560/2001) concerning measures to preserve the confidentiality of certain ingredients from cosmetics, and colours will be registered according to the colour index-number from Colour Index.
— — — — — — — * Note) Government decision No. 560/2001 has been repealed by Government Decree No. 562/2008 on measures to preserve the confidentiality of certain ingredients from cosmetics, published in the Official Gazette of Romania, part I, no. 417 on June 3 2008.


Article 18 (1) the Ministry of health may not prohibit, restrict or impede the placing on the market of cosmetic products which meet the requirements provided for in this law.
  


(2) in order to ensure prompt and appropriate medical treatment in the event of situations with risk to health, at the request of the Ministry of health, the manufacturer, the importer or the person responsible for placing on the market must ensure that the necessary and adequate information on substances used in cosmetic products.
  

(3) the Ministry of health is the competent national authority, which shall ensure the transmission of the information referred to in paragraph 1. (2) by any of the EU Member States, at their request, by taking the necessary measures to ensure that the information to be transmitted solely for the purpose of applying the appropriate medical treatment.
  


Article 19 (1) in the labelling, presentation for sale or promotion it is prohibited to use texts, names, trade marks, images or other insignia that assigns products features that they do not have them.
  

(2) the manufacturer or the person responsible for placing on the market of the product in the European Union can make use of the fact that it has not been tested on animals, by specifying the package or any other document, notice, label, the band accompanying or referring to a product, only if the manufacturer or its suppliers of raw materials has not been carried out or not/has/have requested tests on animals for finished cosmetic product times prototype or has/have used no ingredient tested on animals by third persons, for the purpose of formulating new cosmetics.
  


Chapter III Sanctions the violation of Article 20 of this law shall entail liability, civil, administrative or criminal, as appropriate.


Article 21 shall constitute offences and fines shall be imposed on the following facts: (a) failure to satisfy the requirements of article.) 13, 14 and 17, with fine from 1,000 to 2,000 lei lei;
  

(b) failure to meet the requirements of article.) 15, 16 and 19, with fine from 2.000 to 3,000 lei lei;
  

(c) failure to comply with the provisions of article 1.) 5, 7, 8, 11, art. 18 paragraph 1. (2) and article 3. 23, with fine from 5,000 to 10,000 lei lei.
  


Article 22 (1) Finding contraventions and penalties provided for in article 10. 21 are carried out by the National Authority empowered representatives you have consumer protection and the Ministry of health.
  

(2) the authorized control bodies pursuant to paragraph 1. (1) may provide for any valid temporary or definitive halt manufacturing and/or placing on the market of cosmetic products which do not meet the requirements of this Act and which may affect the life or health of consumers.
  

(3) the control bodies may take samples of cosmetic product which it deems necessary to carry out the analysis.
  


Article 23 where the Ministry of health, on the basis of evidence, that a cosmetic product, although complying with the requirements of the present law, represents a hazard to health, it may provisionally prohibit the marketing of that product or may impose special conditions for its marketing in Romania. In this case, it shall immediately inform the European Commission and EU Member States over this decision and of the reasons which underlie this decision.


Article 24 Representatives empowered bodies are obliged to respect the confidential nature of the information contained in the documents referred to in article 1. 13 or of which they become aware during control actions.


Article 25 (1) the Ministry of health is the competent national authority which transmits information to the European Commission relating to the provisions of article 4. 13 for the purpose of publication in the official journal of the European Union.
  

(2) the Ministry of health ensures cooperation with the competent authorities of the Member States, pursuant to the provisions of this law.
  


Article 26 where the Ministry of health decided, under art. 23, provisional ban or restrict the marketing of a cosmetic product, it shall notify, in writing, within 72 hours, the person concerned/involved about such measure, indicating the reasons for its decision and recommended remedial action, in accordance with the existing legal regulations, as well as the deadline by which they can be applied.


Article 27 the provisions of art. 21 shall be supplemented by the provisions of Ordinance No. 2/2001 on the legal regime of contraventions, approved with amendments and completions by law No. 180/2002, as amended and supplemented.


Chapter IV final provisions Article 28 the Health Ministry will establish, no later than 31 December 2006, the procedure by which some chemical substances and mixtures may be authorised temporarily to be used in cosmetics, the mechanism for access to information about the substances used in the manufacture of cosmetic products required to ensure appropriate medical treatment in the event of situations with risk to health which is approved by order of the Minister of health.


Article 29 the provisions of this law shall not apply to products containing the substances set out in annex 4. V the Minister of health order No. 1.448/2005, with subsequent amendments and additions.


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 has been published in the Official Gazette of Romania, part I, no. 525 of 25 October 2000.

(2) on the date of entry into force of this law shall be repealed: a) point 21 and 22 of annex 4. 2 the Government decision nr. 340/1992 on the arrangements for the import of wastes and residues of any kind, as well as other dangerous goods for the population's health and the environment, republished in the Official Gazette of Romania, part I, no. 201 of 18 august 1992, as amended and supplemented;
  

(b) provisions relating to registration) cosmetic products covered by article 1. 4A. b) of 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, with subsequent amendments;
  

c) Government Decree No. 670/2001 for approval of methodological Norms for the application of law No. 178/2000 relating to cosmetic products, as published in the Official Gazette of Romania, part I, no. 422 of 30 July 2001;
  

(d) any other provisions to the contrary).
  


Article 31 appendices. 1-3 are an integral part of this law.


Annex 1 list of categories of cosmetics-creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.)-face Masks (with the exception of products that act as Abrasives on skin superficial chemical way)-nuanţatoare Bases (liquids, pastes, powders etc.)-make-up Powders, after-bath powders, hygienic powders after bath etc.-toilet Soaps, deodorant soaps, etc.-perfumes, toilet waters , Eau de Cologne, etc.-Mixtures for bath and shower (salts, foams, oils, gels, etc.)-hair removal-deodorants and antiperspirants-hair care products:-nuanţatoare and decolorante;
-products for waving, straightening and fixing;
-products for setting (decoration);
-cleaning products (lotions, powders, shampoos etc.);
-conditioning products (lotions, creams, oils etc.);
styling products (lotions, lacquers, brilliantines, etc.);
-Shaving products (creams, foams, lotions etc.) for your makeup and remove him from his face and eyes-products intended for application on the lips-teeth care products and mouth-products for nail care and decoration-products for external intimate hygiene products for sunbathing (Beach)-sunless tanning products-products-skin whitening anti-wrinkle Products.


Annex 2 Annex 3 Note: we present below provisions are not incorporated in the form of law No. republished 178/2000 applies, hereinafter referred to as ' own provisions modifying documents: 1. the indication of transposition of the law nr. 469/2006 modifying and completing law No. 178/2000 on cosmetic products: "this Act transpose in full Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, as published in the official journal of the European Communities No. L/262 of 27 September 1976. "
2. Art. II and the Government from implementing the Ordinance. 2/2010 for amendment of law No. 178/2000 relating to cosmetic products, approved by law No. 159/2010: "Art. II.-the provisions of this Ordinance shall enter into force on 1 June 2010, except for the provisions of article 3. I, point 2 and 3, which shall enter into force on 1 December 2010.
* This Ordinance to transpose art. 1 «amendments to Directive 76/768/EEC» of Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC of the Council and directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1782/2003. 1,272/2008 on classification, labelling and packaging of substances and mixtures, as 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 the repeal of art. 8 of law No. 178/2000 on cosmetic products: "Art. -Article 8 of law No. 178/2000 on cosmetics, republished in the Official Gazette of Romania, part I, no. 91 of 27 January 2005, with amendments and additions thereto, is hereby repealed.
Art. (II)

The normative reference to art. 8 of law No. 178/2000, republished, with subsequent amendments and additions shall be construed as references to the provisions of art. 15 para. (1) and (2) of Regulation (EC) No 1782/2003. 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 at art. 14, 31 and 32 of the same regulation, where these are necessary for the implementation of the provisions of art. 15 para. (1) şi (2)."
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