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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LAW no. 360 of 2 September 2003 (republished)
on the regime of dangerous chemical substances and preparations)
Issued



PARLIAMENT Published


Official Gazette no. 178 of March 12, 2014
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Note


*) Republished under art. 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, as corrected in the Official Gazette of Romania, Part I, no. 117 of 1 March 2013, the texts shall be renumbered.

Law. 360/2003 on the regime of hazardous chemical substances and was published in the Official Gazette of Romania, Part I, no. 635 5 September 2003 and subsequently been amended by:
- Law no. 263/2005 amending and supplementing Law no. 360/2003 on the regime of dangerous chemical substances and preparations, published in the Official Gazette of Romania, Part I, no. 899 of 7 October 2005;
- Law no. 254/2011 for the amendment of Art. 26 of Law no. 360/2003 on the regime of dangerous chemical substances and preparations, published in the Official Gazette of Romania, Part I, no. 867 of 8 December 2011.

Article 1


This law establishes general legislative framework for effective control and effective supervision regime of hazardous chemical substances and to protect human health and the environment from the negative action of dangerous substances and preparations.

Article 2


Principles underlying the activities involving dangerous substances and preparations are

A) the precautionary principle in the management of dangerous chemical substances and preparations in order to prevent damage to health and the environment;


B) the principle of transparency to customers, ensuring access to information regarding the adverse effects that may generate hazardous chemical substances and preparations;


C) principle of management operations and hazardous chemical substances.


Article 3


Dangerous substances and preparations, within the meaning of this law are those set out in Art. 7 of the Government Emergency Ordinance no. 200/2000 **) on classification, labeling and packaging of substances and chemical preparations, approved by Law no. 451/2001. _________


Note

**
) Government Emergency Ordinance no. 200/2000 on the classification, labeling and packaging of substances and chemical preparations, approved by Law no. 451/2001 published in the Official Gazette of Romania, Part I, no. 416 of 26 July 2001 with subsequent amendments, was repealed by Government Emergency Ordinance no. 145/2008 for the repeal of the Emergency Government Ordinance no. 200/2000 on the classification, labeling and packaging of substances and chemical 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 of 11 June 2009.

Article 4


List of dangerous substances and preparations listed in Annex no. 2 The rules for the application of Government Emergency Ordinance no. 200/2000, approved by Government Decision no. 490/2002. ***) __________


Note


***) Methodological Norms for the application of Government Emergency Ordinance no. 200/2000 on the classification, labeling and packaging of substances and chemical preparations, approved by Government Decision no. 490/2002 published in the Official Gazette of Romania, Part I, no. 356 of 28 May 2002, it was repealed by Government Decision no. 1408/2008 on classification, labeling and packaging of dangerous substances, published in the Official Gazette of Romania, Part I, no. 813 of 4 December 2008.

Article 5


This law refers to:

A) risk assessment and control of chemical substances and preparations that it is dangerous to human health and the environment;


B) restrictions on the marketing and use of certain dangerous substances and preparations;


C) control the import and export of certain dangerous substances and preparations;


D) ozone depleting substances;


E) the marketing of biocides;


F) the principles of Good Laboratory Practice (GLP).


Article 6



According to legal provisions, the National Agency for Dangerous Chemical Substances ****) has responsibilities in the following areas: classification, packaging and labeling of dangerous substances and preparations, the notification of hazardous chemicals and applying the principles of good practice laboratory (BPL). _________


Note


****) See art. 5 of Law no. 349/2007 regarding the reorganization of the institutional framework for chemicals management, published in the Official Gazette of Romania, Part I, no. 840 of 7 December 2007, as amended and supplemented.

Article 7


(1) In order to protect the environment and human health, and hazardous chemical substances restricting the placing on the market and use.


(2) dangerous chemical substances and preparations that are restricted to the marketing and use shall be established by Government decision.


(3) Manufacturers, importers, distributors and users are required to comply with all restrictions on the marketing and use of dangerous chemical substances and preparations stipulated in the regulations in this area.


Article 8


Risk assessment principles that existing dangerous chemical substances and preparations they pose to human health and the environment, risk assessment of these substances, the data regarding risk assessment, risk control authorities responsible for assessing and controlling risk and powers shall be established by Government Decision.

Article 9


Experimental tests that are done for assessing the risk of dangerous chemical substances and preparations they pose to human health and the environment is carried out with respect for the principles of good laboratory practice (GLP).

Article 10


In order to protect the environment and human health, some hazardous substances and chemicals that are banned from 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


(1) control the import and export of certain dangerous substances and preparations shall be in accordance with the Convention on the Prior Informed Consent procedure for concerned for Certain Hazardous Chemicals and Pesticides in International Trade, adopted in Rotterdam September 10, 1998, to which Romania adhered by the Law no. 91/2003 and with the Community provisions in this area.


(2) prior informed consent procedure for the issue to control the import and export of certain dangerous substances and preparations, 'the PIC procedure, approved by Government Decision within one year of the entry into force of this law.


Article 12


Production, import, export, marketing, use, recovery, destruction and prevent atmospheric emissions of substances that deplete the ozone layer is governed by the laws in this area.

Article 13


Requirements to be met for the marketing authorization of biocidal products and 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 of 21 September 2005, as amended and supplemented.

Article 14


The regulatory regime of hazardous chemical substances and responsibilities following ministries and institutions:

A) The Ministry of Environment and Climate Change;


B) Ministry of Health;


C) Ministry of Labor, Family, and Social Protection;


D) The Ministry of **), the National Agency for Dangerous Chemical Substances.

________


Note


**) See art. 1 of Law no. 349/2007 regarding the reorganization of the institutional framework for chemicals management, published in the Official Gazette of Romania, Part I, no. 840 of 7 December 2007, as amended by the National Agency for Environmental Protection and the National Environmental Guard take over the duties and responsibilities of the National Agency for Dangerous Chemical Substances.


Article 15


To assess the effects of hazardous chemical substances and preparations have on the health and environment inter-ministerial committee was established to assess scientific advisory toxicity and ecotoxicity of dangerous chemicals, by Government decision ***) within one year the entry into force of this law. ___________


Note


***) See Government Decision no. 1739/2004 on the establishment, organization and functioning of the Interministerial Committee Scientific Assessment Advisory toxicity and ecotoxicity of dangerous chemical substances, published in the Official Gazette of Romania, Part I, no. 996 of 28 October 2004.

Article 16


Ministry of Environment and Climate Change shall:

A) the competent national authority for application of the PIC procedure for controlling the import and export of certain dangerous substances and preparations;


B) initiate, together with other competent authorities, specific laws relating to restrictions on the marketing of certain dangerous substances and preparations; assess control risk to humans and the environment, represented by existing chemical substances, control imports and exports of certain dangerous substances and preparations; assesses the marketing of biocides, except for products used in human health and prevention activities on substances that deplete the ozone layer;


C) store, hold and disseminate specific information on substances that deplete the ozone layer; control and supervise the application in Romania of the Convention on the Protection of the Ozone Layer, adopted in Vienna on 22 March 1985 Protocol on Substances that Deplete the Ozone Layer, adopted in Montreal on 16 September 1987 and the Amendment to the Protocol Montreal, adopted in London on 27 to 29 June 1990, to which Romania adhered by the Law no. 84/1993, as amended, and the application of national legislation specific to this field;


D) inspected by personnel authorized under its orders, how they are applied and complied with legal provisions on dangerous substances and preparations in order to prevent and combat environmental pollution;


E) Notes and compliance on provisions relating to the dangerous substances and preparations;


F) organizes itself or together with other competent authorities, training subordinate staff or other ministries and institutions involved in the legal provisions concerning dangerous substances and preparations.


Article 17


Ministry of Health shall:

A) the competent national authority in data collection, priority setting and risk assessment of chemicals and chemical preparations in relation to human health;


B) establish strategies which meet the risk mitigation measures for people exposed to hazardous substances and chemicals that irreversibly affect human health;


C) monitors the health of the population exposed to dangerous substances and preparations or professional environment;


D) creates a database on toxicological properties of dangerous chemical substances and preparations;


E) identify and assess hazardous substances and preparations affecting human health;


F) provide the secretariat of the Interministerial Committee Scientific Assessment Advisory toxicity and ecotoxicity of dangerous chemicals, set up pursuant to art. 15;


G) participate in establishing principles for assessment of risk posed dangerous substances and preparations for human health and the environment;


H) participates in developing and promoting legislative acts concerning the assessment of the effects of hazardous chemical substances and preparations have on human health and the environment;


I) exercising control and compliance regime of hazardous chemical substances in order to prevent damage to health;


J) participate in establishing maximum permissible concentrations of dangerous chemicals in soil, water, air and food;


K) coordinate with the Ministry of Environment and Climate Change, training of professionals conducting health risk assessment in relation to dangerous substances and preparations;



L) inspects the principles of good laboratory practice (GLP) where testing food additives to the feed and pesticides, biological products, contaminants and biocides;


M) initiate, together with other competent authorities, specific rules to regulate the marketing of biocides in the category of used prophylaxis human health, disinfectants and sanitized, microbicides and condoms.


Article 18


Ministry of Labor, Family, and Social Protection shall:

A) initiate and promote, together with other competent authorities, specific legislation relating to health and safety of employees engaged or are in jobs that are hazardous chemical substances present times, and the assessment and control risk it poses to human health and environment hazardous chemical substances and preparations;


B) establish, together with other competent authorities, health and safety regulations at work, policies to prevent work accidents and occupational diseases due to dangerous substances and preparations;


C) controls by the Labour Inspectorate how employers apply and comply with the necessary preventive measures in case of presence at the workplace of hazardous chemical substances and preparations.


Article 19


Manufacturers and importers mainly the following duties and responsibilities:

A) documented and / or perform tests on the properties of substances and chemical preparations available to assess the risk that these substances pose to human health and the environment;


B) classified, labeled and packaged existing hazardous substances and preparations in accordance with specific legal provisions governing such activities;


C) provide the Ministry of Environment and Climate Change, Ministry of Health and the National Agency for Dangerous Chemical Substances all information about the properties of substances and chemical preparations that may endanger public health and the environment.


Article 20


Manufacturers and importers placing on the market of dangerous substances and preparations, restricted to the production and use in accordance with the provisions of legal acts, shall:

A) not to manufacture or import, the placing on the market and use, hazardous chemical substances and preparations on the basis of legal acts prohibited;


B) does not produce dangerous substances and preparations whose marketing and use is restricted only to those uses which sets out the conditions restricting the specific normative acts.


Article 21


The marketing of dangerous chemical substances and preparations that meet the legal provisions on classification, packaging, labeling and notification procedure can not be prohibited, restricted or prevented.

Article 22


Users are required to use dangerous substances and preparations restricted to use only by observing the restrictions established by specific normative acts.

Article 23


Importers and exporters of dangerous substances and preparations whose import / export is controlled by the PIC procedure are required to undertake import / export-only notification under this procedure.

Article 24


(1) producers, distributors, users, importers and exporters are obliged to allow authorized personnel to carry out inspections under this law on how to implement and comply with regulations on the regime of dangerous chemical substances and preparations.


(2) The manufacturers, distributors, users, importers and exporters are obliged to provide territorial labor inspectorate within whose jurisdiction it operates, before it begins the list of dangerous chemical substances and preparations that they will hold, stating category to which they belong, which can endanger the health of employees in the work environment.


Article 25



Inspection activity for compliance with legal provisions concerning the dangerous chemical substances and preparations is made by the authorized staff of the Ministry of Environment and Climate Change, Ministry of Health, Ministry of Labor, Family, and Social Protection, Ministry of Interior and National Agency for Dangerous Chemical substances, including personnel authorized within their territorial structures.

Article 26


Manufacturers, distributors, users, importers and exporters operating substances and preparations toxic and highly toxic substances are required to take appropriate measures to ensure and protect the health of humans, animals and the environment and to prevent any such theft substances and preparations or their diversion from the legal circuit.

Article 27


The way in which the inspection work at the local level and presenting the results of inspections shall be determined by order of the Minister of environment and climate change, the Minister of Health, Minister of Labour, Family, Social Protection and the elderly and the Minister of Economy.

Article 28


(1) The following deeds of individuals or legal entities engaged in dangerous substances and preparations:


A) the provision by manufacturers, importers, distributors and users of incomplete or false data about hazardous chemical substances and preparations that are being considered for assessing the risk they pose to human health and the environment or whose entry market or use is prohibited or restricted;


B) the failure to transmit or late submission by producers, distributors and users of the data necessary for assessing the risk of dangerous chemical substances and preparations they pose to human health and the environment;


C) preventing access to authorized personnel, according to Art. 25, work spaces or where operations with substances and preparations toxic and very toxic or refusal to provide data and control bodies requested documents relating to operations with them.


(2) The provisions of par. (1) shall be sanctioned as follows:


A) for individuals with a fine of 5,000 lei to 10,000 lei;


B) legal entities, with a fine of 20,000 lei to 60,000 lei.


Article 29


Ascertained and the penalties provided in Art. 28 are made by the authorized staff of the Ministry of Environment and Climate Change of the National Environmental Guard and the Ministry of Health and its territorial structures of the Ministry of Labor, Family, and Social Protection, the Labour Inspection and labor inspectorates, and the police officers and agents from the Interior Ministry.
NOTE:
below the provisions of art. II of Law no. 263/2005 amending and supplementing Law no. 360/2003 on the regime of dangerous chemical substances and preparations, published in the Official Gazette of Romania, Part I, no. 899 of 7 October 2005, which are not incorporated in the republished Law no. 360/2003 and applicable further as provisions of modifying documents:
"Art. II. - On the effective date of this law, the Decree no. 466/1979 regarding the products and toxic substances, published in the Official Gazette, Part I, no. 2 of January 3, 1980, as amended. "
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