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Law No. 508 Of 12 July 2002 On The Amendment Of Law No. 178/2000 Relating To Cosmetic Products

Original Language Title:  LEGE nr. 508 din 12 iulie 2002 pentru modificarea şi completarea Legii nr. 178/2000 privind produsele cosmetice

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LEGE no. 508 508 of 12 July 2002 to amend and supplement Law no. 178/2000 on cosmetic products
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 582 582 of 6 August 2002



The Romanian Parliament adopts this law + Article 1 Law no. 178/2000 on cosmetic products, published in the Official Gazette of Romania, Part I, no. 525 of 25 October 2000, shall be amended and supplemented as follows: 1. Article 1 shall read as follows: "" Art. 1. -This law regulates the conditions which must be respected in the manufacture and placing on the market of cosmetic products for human use. " 2. In Article 2, letters a), b) and h) shall read as follows: "" a) cosmetic product-any substance or preparation to be put in contact with various external parts of the human body (skin, eyes, nails, lips, external genitals, hair on the head and body, etc.) or with teeth and mouth, with the exclusive or main purpose of cleaning them, perfecting them, modifying their appearance and/or correcting their bodily odors and/or protecting them or keeping them in good condition; b) cosmetic ingredient-any substance or preparation of synthetic or natural origin used in the composition of a cosmetic product, with the exception of impurities in the raw materials used, auxiliary technical materials used in the preparation of the product final, but not present in it, and the materials used in strictly necessary quantities as solvents or perfume carriers or aromatic compositions; ............................................................... h) 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. 4 4. " 3. In Article 2, after letter h) the letters h ^ 1 and h ^ 2 are inserted) with the following contents: " h ^ 1) notification-the administrative approach consisting in the transmission in written form to the Ministry of Health and Family of the intention to put a cosmetic product on the market; h ^ 2) 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; " 4. Articles 3 to 9 will read as follows: "" Art. 3. -The exemplifying list of the functions of the products that are considered cosmetic products, according to the definition provided in art. 2 lit. a), is set out in the Annex which forms an integral part of this Law. Article 4. -The cosmetic products placed on the market must not endanger human health when used under normal or reasonably foreseeable conditions of use, taking into account in particular the presentation of the products, the labelling, the instructions on the preservation, storage, use and removal thereof and of any other indication provided by the manufacturer, his authorised representative or any other person responsible for placing the product on the market. Article 5. -(1) It is prohibited to put on the market cosmetic products in whose composition they are found: a) substances prohibited by the Ministry of Health and Family for use in the composition of cosmetic products; b) substances outside the limits of admissibility and conditions imposed by the Ministry of Health and Family; c) colouring agents, other than those established by the Ministry of Health and Family, except for cosmetic products intended to be used only in hair coloring; d) colouring agents used outside the limits of admissibility and the conditions imposed by the Ministry of Health and Family, except for cosmetic products intended to be used only to dye hair; e) preservatives, other than those established by the Ministry of Health and Family; f) preservatives, outside the limits of admissibility and conditions imposed by the Ministry of Health and Family, unless other concentrations are used, for specific purposes, which emerge from the presentation of the product; g) UV filters, other than those established by the Ministry of Health and Family; h) UV filters used outside the limits of admissibility and conditions imposed by the Ministry of Health and Family. (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. 4. Article 6. -(1) The lists of substances that may be used in the composition of cosmetic products are established by order of the Minister of Health and Family and include: a) substances used in admissibility limits and under the conditions imposed by the Ministry of Health and Family; b) colouring agents, except those to be used only in hair coloring, preservatives that can only be used under certain permissible conditions and limits, UV filters that can only be used under certain conditions and limits allowable; c) preservatives; d) UV filters. ((2) The lists of prohibited substances, as well as substances not subject to this law shall be established by order of the Minister of Health and Family. (3) The lists referred to in par. (1) and (2) will be updated according to technical progress, by order of the Minister of Health and Family. Article 7. -The cosmetic products may be placed on the market on the territory of Romania only if the manufacturer, his authorized representative, the beneficiary of the cosmetic product manufacture or the person responsible for placing on the market the imported cosmetic registered legally in Romania and notified the Ministry of Health and Family of the intention to put cosmetic products into circulation. Article 8. -The notification shall consist in the written form of the following data: a) the name/name of the manufacturer, his authorized representative, the beneficiary of the manufacture of the cosmetic product and the registration number at the trade register of the manufacturer and his authorized representative; b) the headquarters in Romania of the manufacturer or his authorized representative; c) country of origin for the cosmetic product manufactured outside the territory of Romania; d) trade name of the cosmetic product; e) function of cosmetic product; f) the declaration of conformity whereby the manufacturer, his authorized representative, the beneficiary of the manufacture of the cosmetic product or the person responsible for placing on the market the imported cosmetic product assumes the responsibility of Cosmetics manufactured/imported with the provisions of this Law. Article 9. -(1) The notification of a cosmetic product that is placed on the market on the territory of Romania is made at the Ministry of Health and Family, through the county public health department or the city of Bucharest in whose territorial area the address indicated on the label of the cosmetic product, the address of the cosmetic product file. ((2) The notification becomes effective from the moment of transmission of the data provided in 8. (3) Any modification of the information transmitted to the territorial public health authorities, according to the provisions of 8, will be notified to them within 30 days of the date of the change. " 5. Paragraph 1 of Article 10 shall read as follows: "" Art. 10. -(1) 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; the information on the fragrance 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 details for the raw materials and the finished product and the purity and microbiological control criteria for the cosmetic product; c) method of manufacture in accordance with the rules of good manufacturing practice of cosmetic products in force d) the name of the person responsible for the manufacture or import of a cosmetic product; it must have adequate training or experience in the field; e) the risk assessment for the human health of the cosmetic product, which is based on the general toxicological profile of the ingredients used and/or the evaluation in a laboratory, in compliance with the principles of good laboratory practice, and present in the form of the human health risk assessment document, signed by the person responsible for assessing the cosmetic product from this point of view; f) the name and address of the laboratory and/or persons responsible for the assessment of the cosmetic product in terms of safety for human health; the persons responsible for the evaluation must have the diploma of higher education of specialty in pharmacy, toxicology, medicine, chemistry, biology or similar discipline; 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. " 6. Articles 11 to 14 shall read as follows: "" Art. 11. -The data provided in art. 10 will be presented in Romanian or in an international language. Article 12. -After carrying out the verification action taken by the authorized representatives of the competent control bodies, the manufacturer, his authorized 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 10, no later than 72 hours after the request. Article 13. -(1) Cosmetic products may be placed on the market only if the information is visibly, legibly and indelibly marked on the container and/or on the packaging, indicating the following data: a) the company name or its abbreviation; b) the establishment in Romania of 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 or his abbreviation, as long as it is possible to identify; c) country of origin for import products; 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 date of minimum durability, marked by the phrase "To be used preferably before", followed by the date or details on the place where it is inscribed this date, expressed by month and year, in this order and with Arabic figures. If necessary, this information will be supplemented by an indication of the conditions to be met in order to guarantee the sustainability asserted. Where cosmetic products have a durability of more than 30 months, the indication of the date of minimum durability shall not be mandatory; f) the instructions for use and special warning to be brought to the attention of cosmetic products, including those for professional use, in particular those for hairdressing, containing ingredients from the lists provided for in art. 6 6 para. ((1) lit. b) and approved by order of the Minister of Health and Family and for which warning conditions are provided to be inscribed on the label. If this is not possible for practical reasons, a prospectus will be attached, an armband or a card containing the information necessary to the consumer or on the container of the product will be inscribed the necessary information abbreviated or the symbol provided in the list established by order of the Minister of Health and Family, as specified in the lists approved by order of the Minister of Health and Family g) the function of the cosmetic product, unless it results from the presentation of the product h) the batch number, marked on the container or on the packaging, as the case may be, or an indication allowing the identification of the product; i) the list of ingredients forming part of the composition of the cosmetic product, in descending order of weight at the time of their incorporation. This list is preceded by the word "ingredients". If, for practical reasons related to space, this is not possible, a prospectus will be attached, an armband or a card that must contain the information necessary to the consumer or will be inscribed on the container or on the packaging. the abbreviated information or the symbol provided in the lists presented in 6 6 para. ((1) lit. b) and approved by order of the Minister of Health and Family. The ingredients will be mentioned at a concentration of less than 1%, without a specific order, after those whose concentration is greater than 1%. Dyes can be mentioned after the other ingredients. The colouring assembly used in several colour shades will be indicated on the label, preceded by "+/-". The fragrance or aromatization compositions and their raw materials will be mentioned by the word "perfume", respectively "aroma". (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 attached to the product. In the case of soap, bath balls or other small products where it is practically impossible, for reasons of size or shape, the information provided in par. ((1) lit. i) on a prospectus, a label, an armband, a leaflet or an attached card, this information will be written on a leaflet placed in the immediate vicinity of the container in which the cosmetic product is displayed for sale. Article 14. -The information provided in art. 13 13 para. ((1) lit. d)-f) and h) must be written in Romanian, except for the list containing the ingredients, where the names of the International Nomenclature for Cosmetic Products will be used-INCI, and the dyes will be written according to the number in the Index colors-Colour Index. " 7 7. The letter b) of Article 17 shall read as follows: " b) non-compliance with 12, 13 and 15, with a fine from 20,000,000. lei to 30,000,000 lei; " 8. Articles 18 and 19 shall read as follows: "" Art. 18. -(1) The finding of contraventions and the application of sanctions provided in art. 17 are made by the authorized representatives of the National Authority for Consumer Protection and the Ministry of Health and Family. (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 19. -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 is obliged to stop the deliveries, respectively to withdraw from the market or from beneficiaries of cosmetic products to which the bodies empowered by law or their own specialists have found that they can affect the life, health or safety of consumers and bring to the public's knowledge this fact. " 9. Article 22 shall read as follows: "" Art. 22. -The opinion of the cosmetic product, issued by the Ministry of Health and Family prior to the entry into force of this Law, is valid until 31 December 2002 only if the information communicated on the occasion of obtaining the opinion has not Amended. ' 10. Article 23 shall be repealed. 11. Paragraph 2 of Article 24 shall read as follows: " (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. " 12. The title of the annex will read: "" LIST exemplifying the functions of cosmetic products " + Article 2 Law no. 178/2000 on cosmetic products, 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 was adopted by the Senate at its meeting of 23 May 2002, in compliance with the provisions of art. 74 74 para. (2) of the Romanian Constitution. p. SENATE PRESIDENT, DORU IOAN TARACILA This law was adopted by the Chamber of Deputies at its meeting on June 27, 2002, in compliance with the provisions of 74 74 para. (2) of the Romanian Constitution. CHAMBER OF DEPUTIES PRESIDENT VALER DORNEANU Bucharest, July 12, 2002. No. 508. --------------