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Law No. 360 Of 2 September 2003 (Republished) On The Status Of Dangerous Chemical Substances And Preparations)

Original Language Title:  LEGE nr. 360 din 2 septembrie 2003 (*republicată*) privind regimul substanţelor şi preparatelor chimice periculoase*)

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LEGE no. 360 360 of 2 September 2003 (* republished *) on the regime of dangerous chemicals and preparations *)
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 178 178 of 12 March 2014



______________ Note * *) Republicated pursuant to art. 248 248 of Law no. 187/2012 for the implementation of Law no. 286/2009 on the Criminal Code, published in the Official Gazette of Romania, Part I, no. 757 of 12 November 2012, corrected in the Official Gazette of Romania, Part I, no. 117 117 of 1 March 2013, giving the texts a new numbering. Law no. 360/2003 on the regime of dangerous chemicals and preparations was published in the Official Gazette of Romania, Part I, no. 635 of 5 September 2003 and subsequently amended and supplemented by: - Law no. 263/2005 to amend and supplement Law no. 360/2003 on the regime of dangerous chemicals and preparations, published in the Official Gazette of Romania, Part I, no. 899 899 of 7 October 2005; - Law no. 254/2011 for amendment art. 26 26 of Law no. 360/2003 on the regime of dangerous chemicals and preparations, published in the Official Gazette of Romania, Part I, no. 867 867 of 8 December 2011. + Article 1 This law establishes the general regulatory framework for effective control and effective supervision of the regime of dangerous chemicals and preparations, in order to protect the health of the population and the environment against the negative action of hazardous chemicals and preparations. + Article 2 The principles underlying activities involving hazardous chemicals and preparations are: a) the principle of precaution in the management of dangerous chemicals and preparations, in order to prevent damage to the health of the population and the environment; b) the principle of transparency towards consumers, ensuring access to information on the negative effects of dangerous chemicals and preparations; c) the principle of security of operations for the management of dangerous chemicals and preparations + Article 3 Dangerous chemicals and preparations, within the meaning of this Law, are those provided for in art. 7 of Government Emergency Ordinance no. 200/2000 ** **) on the classification, labelling and packaging of dangerous chemicals and preparations, approved with modifications by Law no. 451/2001 . _________ Note ** **) Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations, approved with amendments Law no. 451/2001 , published in the Official Gazette of Romania, Part I, no. 416 of 26 July 2001, as amended and supplemented, was repealed by Government Emergency Ordinance no. 145/2008 for repeal Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations, published in the Official Gazette of Romania, Part I, no. 754 of 7 November 2008, approved by Law no. 213/2009 , published in the Official Gazette of Romania, Part I, no. 369 369 of 11 June 2009. + Article 4 The list of dangerous chemicals and preparations is set out in Annex no. 2 to the methodological norms for the application Government Emergency Ordinance no. 200/2000 ,, approved by Government Decision no. 490/2002 .. * **) __________ Note *** ***) methodological rules for the application of Government Emergency Ordinance no. 200/2000 on the classification, labelling and packaging of dangerous chemicals and preparations approved by Government Decision no. 490/2002 , published in the Official Gazette of Romania, Part I, no. 356 of 28 May 2002, were repealed by Government Decision no. 1.408/2008 on the classification, labelling and packaging of dangerous substances, published in the Official Gazette of Romania, Part I, no. 813 813 of 4 December 2008. + Article 5 The provisions of this law refer to: a) the assessment and control of the risk that hazardous chemicals and preparations are for the health of the population and the environment; b) restrictions on the placing on the market and use of certain dangerous chemicals and preparations; c) control of the import and export of certain dangerous chemicals and preparations; d) substances that deplete the ozone layer; e) placing on the market of biocides; f) application of the principles of good laboratory practice (B.P.L.). + Article 6 In accordance with the legal provisions in force, the National Agency for Substances and Hazardous Chemicals * ***) has powers in the following areas: classification, packaging and labelling of dangerous chemicals and preparations, notification of hazardous chemicals and the application of the principles of good laboratory practice (B.P.L.). _________ Note **** ****) See art. 5 5 of Law no. 349/2007 on reorganization of the institutional framework in the field of chemical management, published in the Official Gazette of Romania, Part I, no. 840 of 7 December 2007, with subsequent amendments and completions. + Article 7 (. In order to ensure the protection of the environment and the health of the population, certain dangerous substances and preparations shall be restricted to the placing on the market and use. (2) Dangerous chemicals and preparations that are restricted to the placing on the market and use shall be determined by Government decision. (3) Manufacturers, importers, distributors and users are obliged to comply with all restrictions on the placing on the market and use of dangerous chemicals and preparations provided for in the normative acts specific to this Domain. + Article 8 The principles of the risk assessment that existing hazardous chemicals and preparations represent for the health of the population and the environment, the risk assessment of these substances, the reporting of risk assessment data, control the risk, the authorities responsible for the assessment and control of the risk and their duties shall be established by Government + Article 9 Experimental tests to be carried out to assess the risk that hazardous chemicals and preparations pose to the health of the population and to the environment shall be carried out in compliance with the principles of good laboratory practice (B.P.L.). + Article 10 In order to protect the environment and the health of the population, some dangerous chemicals and preparations that are prohibited in production and use or whose use is severely restricted by some countries are subject to special control when imported or exported by Romania. + Article 11 ((. The control of the import and export of certain dangerous substances and preparations shall be made in accordance with the provisions of the Convention on the prior informed consent procedure applicable to certain dangerous chemical products. and pesticides subject to international trade, adopted in Rotterdam on 10 September 1998, to which Romania acceded by Law no. 91/2003 , as well as with the Community provisions in this field. (2) The prior informed consent procedure for the control of the import and export of certain dangerous chemicals and preparations, hereinafter referred to as the PIC procedure, is hereby approved by the Government, within one year of the date of entry into force of this Law. + Article 12 The production, import, export, placing on the market, use, recovery, destruction and prevention of emissions into the atmosphere of substances that deplete the ozone layer are subject to the legal provisions specific to this field. + Article 13 The requirements to be fulfilled for the authorization of the placing on the market of biocides and the mutual recognition of this authorization shall be established by Government decision *), within 2 years from the date of entry into force of this Law. _________ Note * *) See Government Decision no. 956/2005 on the placing on the market of biocidal products, published in the Official Gazette of Romania, Part I, no. 852 852 of 21 September 2005, with subsequent amendments and completions. + Article 14 In the field of regulation of the regime of dangerous chemicals and preparations have responsibilities the following ministries and institutions: a) the Ministry of Environment and Climate Change; b) Ministry of Health; c) Ministry of Labour, Family, Social Protection and Elderly; d) Ministry of Economy * *), through the National Agency for Hazardous Substances and Chemicals. ________ Note ** **) See art. 1 1 of Law no. 349/2007 on reorganization of the institutional framework in the field of chemical management, published in the Official Gazette of Romania, Part I, no. 840 of 7 December 2007, as amended, whereby the National Environmental Protection Agency and the National Environmental Guard take over the duties and responsibilities of the National Agency for Hazardous Substances and Chemicals. + Article 15 For the assessment of the effects of hazardous chemicals and chemical preparations on the health of the population and the environment, the Scientific Advisory Committee for the Evaluation of Toxicity and Ecotoxicity of Substances shall be established. dangerous chemical, by Government decision * **), within one year from the date of entry into force of this Law. ___________ Note *** ***) See Government Decision no. 1.739/2004 on the establishment, organization and functioning of the Scientific Advisory Committee for the Evaluation of Toxicity and Ecotoxicity of Dangerous Chemicals, published in the Official Gazette of Romania, Part I, no. 996 996 of 28 October 2004. + Article 16 The Ministry of Environment and Climate Change has the following tasks: a) is the national competent authority for the application of the PIC procedure for the control of the import and export of certain dangerous chemicals and preparations; b) initiates, together with the other competent authorities, specific normative acts relating to the restriction of the placing on the market of certain dangerous chemicals and preparations; existing chemicals, control of import and export of certain hazardous chemicals and preparations; evaluate the placing on the market of biocides, except for products used in human health prophylaxis and activities relating to substances that deplete the ozone layer; c) store, hold and disseminate the specific information on substances that deplete the ozone layer; control and supervise the application on the territory of Romania of the provisions of the Convention on the protection of the ozone layer, adopted in Vienna on 22 March 1985, of the Protocol on substances that deplete the ozone layer, adopted in Montreal on 16 September 1987, and of the amendment to the Montreal Protocol, adopted in London on 27-29 June 1990, to which Romania joined by Law no. 84/1993 , as amended, as well as the application of the relevant internal legislation; d) inspect, through the personnel empowered under him, the way in which the legal provisions on dangerous chemicals and preparations are applied and observed, in order to prevent and combat environmental pollution; e) finds and sanctions non-compliance with the provisions on the regime of dangerous chemicals and preparations; f) organize, separately or together with other competent authorities, the training of subordinate personnel or other ministries and institutions involved in the application of legal provisions on dangerous chemicals and preparations. + Article 17 The Ministry of Health has the following a) is the national competent authority in collecting data, setting priorities and estimating the risk of dangerous chemicals and preparations in relation to human health; b) determine the strategies by which measures to limit the risks to the population exposed to dangerous chemicals and preparations that irreversibly affect human health are fulfilled; c) monitor the health of the population exposed to hazardous chemicals and preparations in the environment or professionally; d) carry out the database on the toxicological properties of dangerous chemicals and preparations; e) identify and evaluate dangerous chemicals and preparations affecting human health; f) ensures the secretariat of the Scientific Advisory Committee for the evaluation of the toxicity and ecotoxicity of hazardous chemicals, established under the provisions of art. 15 15; g) participate in the establishment of the principles for assessing the risk posed by chemical substances and preparations for the health of the population and for the environment; h) participate in the elaboration and promotion of normative acts related to the assessment of the effects that dangerous chemicals and preparations have on the health of the population and the environment; i) exercise control of compliance with the regime of dangerous chemicals and preparations, in order to prevent the health of the population; j) participate in the establishment of maximum permissible concentrations of hazardous chemicals in soil, water, air and food; k) coordinate, together with the Ministry of Environment and Climate Change, the training of specialists who carry out the risk assessment for health in relation to dangerous chemicals and preparations; l) inspect the observance of the principles of good laboratory practice (B.P.L.) in the case of testing of food additives, animal feed and pesticides, biological products, contaminants and biocides; m) initiates, together with the other competent authorities, specific rules for the regulation of the placing on the market of biocides in the category of those used in sanitary-human prophylaxis, disinfectants and sanitizers, microbiocides and condoms. + Article 18 The Ministry of Labour, Family, Social Protection and Elderly has the following tasks: a) initiates and promotes, together with the other competent authorities, specific normative acts relating to the protection of health and safety of employees who carry out activities or are in the workplaces where substances are present dangerous chemical preparations, as well as the assessment and control of the risk posed by humans and hazardous chemicals to humans and the environment; b) establish, together with the other competent authorities, regulations in the field of safety and health at work, policies to prevent accidents at work and occupational diseases due to dangerous chemicals and preparations; c) controls, through the Labour Inspection, how employers apply and comply with the necessary prevention measures in the case of presence in the work environment of dangerous chemicals and preparations. + Article 19 Manufacturers and importers shall, in particular, have the following duties and responsibilities: a) they document and/or carry out tests on the properties of existing dangerous chemicals and preparations, in order to assess the risk that these substances pose to the health of the population and to the environment; b) classify, label and package existing hazardous chemicals and preparations, in accordance with the provisions of the specific normative acts governing these activities; c) provide the Ministry of Environment and Climate Change, the Ministry of Health and the National Agency for Substances and Hazardous Chemical Preparations all information about the properties of hazardous chemicals and preparations that may endangers population health and the environment. + Article 20 Manufacturers and importers who place dangerous chemicals and preparations on the market, restricted to production and use in accordance with the provisions of specific normative acts, have the following obligations: a) not to produce or import, in order to place on the market and use, dangerous chemicals and preparations prohibited on the basis of specific normative acts; b) not to produce dangerous chemicals and preparations, the placing of which on the market and use are restricted, except for those uses for which the conditions for restriction in specific normative acts are provided. + Article 21 The placing on the market of dangerous chemicals and preparations that meet the legal provisions on classification, packaging, labelling and notification procedure cannot be prohibited, restricted or prevented. + Article 22 Users are required to use dangerous chemicals and preparations restricted to use only in compliance with the restriction conditions established by specific normative acts. + Article 23 Importers and exporters of dangerous chemicals and preparations whose import/export is controlled by the PIC procedure are obliged to carry out the import/export only on the basis of notification, according to this procedure. + Article 24 (1) Manufacturers, distributors, users, importers and exporters are required to allow personnel empowered under this law to carry out inspections of the manner in which they apply and comply with the regime regulations. hazardous chemicals and preparations. (2) Manufacturers, distributors, users, importers and exporters are obliged to provide the territorial labour inspectorate within which they operate, before its start, the list of substances and preparations dangerous chemicals they will own, with the specification of the category to which they belong, which can endanger the health of employees in the work environment. + Article 25 The inspection activity for compliance with the legal provisions on the regime of dangerous chemicals and preparations is made by the authorized personnel of the Ministry of Environment and Climate Change, the Ministry of Health, Ministry of Labour, Family, Social Protection and Elderly, Ministry of Internal Affairs and the National Agency for Hazardous Substances and Preparations, including the empowered personnel of the territorial structures of them. + Article 26 Manufacturers, distributors, users, importers and exporters who carry out activities with toxic and highly toxic substances and preparations are obliged to take appropriate measures to ensure and protect human health, animals and the environment, as well as for the prevention of any absconding of such substances and preparations or their diversion from the legal circuit. + Article 27 The way in which the territorial inspection activity is carried out and the presentation of the results of the inspections are established by joint order of the Minister of Environment and Climate Change, the Minister of Health, the Minister of Labour, the family, social protection and the elderly and the economy minister. + Article 28 (1) The following facts of natural or legal persons carrying out activities in the field of dangerous chemical substances and preparations shall be constituted: a) the supply by producers, importers, distributors and users of unreal or incomplete data on hazardous chemicals and preparations intended for the assessment of the risk they pose to the health of the population and the environment or whose placing on the market or use is prohibited or restricted; b) non-transmission or late transmission by producers, distributors and users of the data necessary for the assessment of the risk that hazardous chemicals and preparations are for the health of the population and for medium; c) preventing the access of authorized personnel, according to art. 25, in the premises of work or operations with toxic and highly toxic substances and preparations or the refusal to provide the control bodies with the data and documents requested, regarding the operations with them. (2) Contraventions provided in par. ((1) shall be sanctioned as follows: a) for individuals, with a fine of 5,000 lei to 10,000 lei; b) for legal entities, with a fine of 20,000 lei to 60,000 lei. + Article 29 Finding of contraventions and application of sanctions provided in art. 28 are made by the empowered staff of the Ministry of Environment and Climate Change, within the National Environmental Guard, as well as within the Ministry of Health and its territorial structures, within the Ministry of Labour, Family, Social Protection and Elderly, through Labour Inspection and territorial labour inspectorates, and by police officers and agents of the Ministry of Internal Affairs. NOTE: We reproduce below the provisions art. II of Law no. 263/2005 to amend and supplement Law no. 360/2003 on the regime of dangerous chemicals and preparations, published in the Official Gazette of Romania, Part I, no. 899 899 of 7 October 2005, which are not incorporated into the republished form of Law no. 360/2003 and which continue to apply as own provisions of the amending acts: "" Art. II. -On the date of entry into force of this Law, the Decree of the State Council no. 466/1979 on the regime of toxic products and substances, published in the Official Bulletin, Part I, no. 2 2 of 3 January 1980, as amended. ' _________