Full text of Act No. 434 / 2005 Coll.
Full text of Act No. 356 / 2003 Coll., on Chemicals and Chemicals and on the amendment of certain laws, as resulting from subsequent amendments
Valid
Declared full text
Text versions:
01.11.2005
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
HLAVA II
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
HLAVA III
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
§ 16
§ 17
§ 18
HLAVA IV
§ 19
§ 20
§ 21
§ 22
§ 23
HLAVA V
§ 24
§ 25
HLAVA VI
§ 26
HLAVA VII
§ 27
HLAVA VIII
§ 28
§ 29
HLAVA IX
§ 30
§ 31
§ 32
§ 33
§ 34
§ 35
§ 36
§ 37
HLAVA X
§ 38
§ 38a
§ 38b
§ 38c
§ 39
§ 39a
§ 39b
HLAVA XI
§ 40
§ 41
§ 42
ČÁST JEDENÁCTÁ
§ 52
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434
PRESIDENT OF THE GOVERNMENT
Announces
complete version of Act No. 356 / 2003 Coll., on Chemicals and Chemicals and on the amendment of certain laws, as is apparent from the amendments made by Act No. 186 / 2004 Coll., Act No. 125 / 2005 Coll. and Act No. 345 / 2005 Coll.
THE LAW
on chemicals and chemical preparations
Parliament has decided on this law of the Czech Republic:
CHEMICAL SUBSTANCES AND CHEMICAL PRODUCTS
GENERAL PROVISIONS
Subject matter of the regulation and scope of the law
(1) This Act regulates, in accordance with the law of the European Communities (1), the rights and obligations of legal persons established in the Czech Republic and of foreign legal persons with an organisational component located in the Czech Republic, and of commercial natural persons residing in the Czech Republic and of foreign commercial natural persons residing in the Czech Republic, the organisational component or the place of business (hereinafter referred to as "persons") in the classification and testing of dangerous properties, packaging and labelling, placing on the market or putting into circulation and the export and import of chemicals and chemical products, in the notification and registration of chemicals, and defines the scope of administrative authorities in the protection of health and the environment against the harmful effects of chemicals and chemical products.
(2) This Act does not apply to pharmaces2), feed (3), food and tobacco products4), cosmetic products 5), radionuclide radionuclide and nuclear material6), narcotic and psychotropic substances 7), medical devices 8), fertilisers, soil improvers, vegetable aid and substrates 9), mineral material10), veterinary products, with the exception of disinfections, desinsectionand deratitions11), in the form intended for final use, waste 11a), and for the transport and distribution of gas in the public interest of 12), do not provide for special legislation otherwise.
(3) Plant protection products and plant protection aids (13) are subject to the obligations laid down in this Act only to the classification, packaging, labelling, drawing up of safety data sheets and import and export obligations.
(4) This law does not apply to explosives (14) to the extent that this field is regulated by special legislation14).
(5) This Act does not apply to the transport of dangerous chemicals and dangerous chemicals in rail 15), road 16), inland waterway 17), air 18) and sea19) to transport and to the transport of dangerous chemicals and dangerous chemicals under customs regime transition20).
(6) The import and export of chemicals and chemical products are subject to customs legislation (20), unless otherwise provided for by this law or specific legislation.
Basic concepts
(1) Chemicals (hereinafter referred to as "substances") are chemical elements and their compounds in the natural state or obtained by a production process, including any additives necessary to preserve their stability and any impurities arising from the production process, with the exception of solvents which may be separated from substances without altering their composition or affecting their stability.
(2) Chemical preparations ("preparations") are mixtures or solutions composed of 2 or more substances.
(3) Polymer is a substance whose molecules consist of a chain of one or more types of monomer units containing more than half the weight of molecules with at least three monomer units associated with a covalent bond with at least another 1 monomer unit or other reactant and containing less than half the weight of molecules with the same molecular weight. The mass of the molecules of the substance is within a certain range, with the mass differences between the molecules mainly related to the differences in the number of monomer units. The monomer unit is a reacted form of monomer in a polymer molecule.
(4) Classification is a procedure for detecting the dangerous properties of a substance or preparation, for evaluating the identified properties and for subsequently classifying such a substance or preparation in individual hazard groups.
(5) Dangerous substances or dangerous preparations are substances or preparations which, under the conditions laid down by this Act, have one or more dangerous properties for which they are classified as:
(a) explosive; These are solid, liquid, pasty or gelatinous substances and preparations which can react externally even without air oxygen access, quickly releasing gases, and which, if in a partially enclosed space, detonate, burn or explode rapidly under defined test conditions,
(b) oxidising; substances and preparations which cause a highly exothermic reaction in contact with other substances, particularly flammable substances,
(c) extremely flammable; they are liquid substances and preparations having an extremely low flash point and a low boiling point, or gaseous substances and preparations which are flammable in contact with air at room temperature and pressure,
(d) highly flammable; are
1. substances and preparations which may self-heat and eventually ignite in contact with air at room temperature without any energy supply;
2. solids and preparations which can easily ignite after short contact with the ignition source and which continue to burn or burn after removal;
3. liquid substances and preparations having a very low flash point,
4. substances and preparations which, in contact with water or wet air, release highly flammable gases in dangerous quantities;
(e) flammable; they are liquid substances or preparations having a low flash point;
(f) highly toxic; these are substances or preparations which cause death or acute or chronic damage to health by inhalation, ingestion or skin penetration in very small quantities,
(g) toxic; these are substances or preparations which cause death or acute or chronic harm to health by inhalation, ingestion or skin penetration in small quantities;
(h) harmful health; they are substances or preparations which, by inhalation, ingestion or skin penetration, may cause death or acute or chronic harm to health;
(i) corrosive; they are substances or preparations which may destroy living tissues in contact with them,
(j) irritating; they are substances or preparations which, if in contact with skin or mucous membranes, may cause inflammation and have no corrosive effects,
(k) sensitising; substances or preparations which are capable of causing hypersensitivity by inhalation, ingestion or skin contact, thereby giving rise to a characteristic adverse effect on further exposure to the substance or preparation,
(l) carcinogenic; they are substances or preparations which, when inhaled or swallowed or penetrated through the skin, may cause or increase cancer,
(m) mutagenic; they are substances or preparations which, when inhaled or ingested or penetrated through the skin, may cause or increase hereditary genetic damage;
(n) toxic to reproduction; they are substances or preparations which, when inhaled or ingested or penetrated through the skin, may cause or increase the occurrence of uninherited adverse effects on the offspring or deterioration of male or female reproductive functions or abilities,
(o) hazardous to the environment; they are substances or preparations which, on entry into the environment, constitute or may present an immediate or later danger to one or more environmental compartments.
(6) For the purposes of this Act, the manufacturer shall be the person who produces or has only developed the substance or preparation which he intends to place on the market.
(7) For the purposes of this Act, the importer is the person who, at the time of import of the substance or preparation in the Czech Republic, is the recipient.
(8) For the purposes of this Act, the introduction of a substance or preparation from a country outside the European Communities into the territory of the Czech Republic into the customs procedure for free circulation, customs warehousing, inward processing, processing under customs supervision or temporary importation.
(9) By placing on the market in the Czech Republic (hereinafter referred to as "placing on the market"), for the purposes of this Act, any transfer of a substance or a preparation to the Czech Republic is their producer. Imports of a substance or preparation shall also be considered as placing on the market.
(10) The placing on the market in the European Communities for the purposes of this Act shall be the placing on the market and placing on the market in another Member State of the European Communities, the placing on the market in another Member State of the European Communities being any payment or free of charge of the transfer of a substance or preparation to the territory of another Member State of the European Communities by their manufacturer and the importation of substances and preparations into the territory of another Member State of the European Communities.
(11) For the purposes of this Act, the distributor shall be the person who puts the substance or preparation into circulation.
(12) For the purposes of this Act, the first distributor shall be the distributor who first circulates the substance or preparation which has been manufactured or imported into the territory of another Member State of the European Communities.
(13) By putting into circulation, for the purposes of this Act, the transfer of substances or preparations to another person in the Czech Republic after they have been placed on the market or acquired by the first distributor.
(14) For the purposes of this Act, proper laboratory practice is to ensure the quality system of the organisation process and the conditions under which non-clinical safety studies for health and the environment are planned, implemented, monitored, recorded, archived and reported.
(15) For the purposes of this Act, an intermediate product is a substance that is consumed or used in transformation into another substance or substance and is exclusively manufactured for that purpose.
GENERAL CLASSIFICATION AND CORRECT LABORATORY PRACTICE
General principles for the classification of substances and preparations
(1) The manufacturer or importer is required to carry out their classification before placing the substance or preparation on the market. The first distributor shall ensure that the substance or preparation which it acquires is classified in accordance with this Act and obtain the data used for its classification.
(2) The classification of a substance or preparation shall not take into account dangerous substances, mixtures or impurities classified in accordance with Paragraph 2 (5), the concentrations of which are lower than the minimum concentrations listed in Annex 1 to this Act, unless they are set out in the List of legally classified dangerous substances (hereinafter referred to as the List) for individual dangerous substances of a concentration lower.
(3) Substances are classified
(a) according to the List,
(b) if they are not listed in the List, according to the List of New Substances ("Elincs") published by the Ministry of the Environment ("the Ministry") at the Public Administration Portal,
(c) where they are not classified under (a) or (b) and are registered under Title III, according to their registration classification;
(d) in the case where they are not classified in accordance with points (a) to (c), in accordance with the general procedures for the assessment and labelling of dangerous properties of substances and preparations referred to in paragraph 7, on the basis of data on their dangerous properties derived from professional sources or on the basis of data obtained from testing pursuant to Article 8.
(4) Products shall be classified according to the procedures set out in Sections 4 to 6.
(5) The classification of the products referred to in paragraph 4 shall take into account all hazardous substances contained therein, except those referred to in paragraph 2.
(6) The persons referred to in paragraph 1 shall keep the data used for the classification of a substance or preparation for as long as they are placed on the market or put into circulation and for a further period of 3 years from the last placing on the market or putting into circulation and shall provide them to the competent administrative authorities on request for their administrative activities.
(7) The Ministry of Industry and Trade provides for implementing legislation
(a) the list and the manner in which it is used;
(b) general procedures for the evaluation and labelling of dangerous properties of substances and preparations;
(c) conventional calculation methods for assessing the hazardous properties of preparations based on the properties of physicochemical, health and environmental hazards.
Assessment of the hazards of preparations resulting from their physicochemical properties
(1) The assessment of the hazards of preparations resulting from their physico-chemical properties shall be carried out for the purposes of the classification provided for in paragraphs 2 (5) (a) to (e) by the procedures laid down in the implementing legislation referred to in paragraph 3 (7), on the basis of the determination of explosive, oxidising, extremely flammable, highly flammable or flammable properties by the methods set out in paragraph 8.
(2) The assessment of the hazards of the products referred to in paragraph 1 shall not be carried out where:
(a) none of the substances contained have the characteristics referred to in paragraph 1 and if, on the basis of the information available, the product does not present a risk of this kind;
(b) when changing the composition of the preparation of a known formulation, it is clear from scientific knowledge that a new determination of its hazards under paragraph 1 would not lead to a change in classification; or
(c) the product placed on the market or put into circulation in an aerosol dispenser complies with the requirements of specific legislation21).
(3) For plant protection products and auxiliary plant protection products, the evaluation shall be carried out in accordance with paragraph 1 only if other assessment methods are not laid down in the specific legislation13).
Assessment of the hazards of products for health
(1) For the purposes of the classification provided for in Article 2 (5) (f) to (n), the assessment of the hazards of the products for health resulting from their health effects shall be carried out:
(a) the conventional calculation method laid down in the implementing act referred to in Article 3 (7);
(b) the general procedures laid down in the implementing legislation referred to in Article 3 (7) on the basis of the determination of health-affecting properties by the methods referred to in Article 8.
(2) The procedure referred to in paragraph 1 (b) shall apply only if the health-affecting properties of the products cannot be determined by the method referred to in paragraph 1 (a) or on the basis of existing animal testing results.
(3) For plant protection products and auxiliary plant protection products, the evaluation shall be carried out in accordance with paragraph 1 only if other assessment methods are not laid down in the specific legislation13).
(4) Where the hazard of the product for health has been established in accordance with points (a) and (b) of paragraph 1, the results obtained in accordance with paragraph 1 (b) shall be used for the classification of the product, except for the determination of the carcinogenic, mutagenic or toxic property for reproduction in accordance with Article 2 (5), which shall always be followed in accordance with paragraph 1 (a).
(5) If the adverse effects of the product on human health identified from epidemiological studies, scientifically verified case studies or statistical data differ from those obtained from the assessment of the hazard of the product referred to in paragraph 1 or 3, the product shall be classified according to the identified effects on human health. The procedure for classification shall be laid down in the implementing legislation referred to in Article 3 (7) (b).
(6) Where it can be demonstrated that the hazard assessment of the product by the conventional calculation method referred to in paragraph 1 (a) could lead to a underestimation or overestimation of the actual hazard of the product as a result of an increase or decrease in its hazard due to the interaction of the constituents of the product, this influence shall be taken into account in the classification.
Evaluation of the hazards of environmental products
(1) For the purposes of the classification referred to in Article 2 (5) (o), the assessment of the hazards of environmental products resulting from their environmental performance shall be carried out:
(a) the conventional calculation method laid down in the implementing act referred to in Article 3 (7);
(b) the general procedures laid down in the implementing legislation referred to in Article 3 (7), on the basis of the determination of environmental performance by the methods set out in Article 8.
(2) For plant protection products and auxiliary plant protection products, the evaluation shall be carried out in accordance with paragraph 1 only if other assessment methods are not laid down in the specific legislation13).
(3) Where environmental hazards have been assessed under points (a) and (b) of paragraph 1, the results obtained under paragraph 1 (b) shall be used for the classification of the product.
Reassessment of product hazards
(1) The manufacturer or importer is required to carry out a new health or environmental hazard assessment for products of a known composition in accordance with the procedures set out in Section 5 or 6, provided that:
(a) the change in the initial concentration of one or more hazardous substances contained in a preparation classified in accordance with Article 2 (5) is greater than that specified in Annex 2 to this Act; or
(b) one or more substances are replaced or added.
(2) The manufacturer or importer shall not be required to carry out a re-evaluation of the hazards of the product if it is clear from scientific knowledge that changes in its composition will not cause a change in classification.
(3) The provisions of paragraph 1 do not apply to producers or importers of plant protection products and plant protection aids 13) evaluated in accordance with the provisions of § 5 (1) (b) or § 6 (1) (b).
(4) The first distributor shall ensure that a new health or environmental hazard assessment is carried out in accordance with paragraphs 1 to 3.
Testing of substances and preparations
(1) Testing of hazardous properties of substances or preparations for the purposes of this Act shall be carried out for substances and preparations in the state in which they are placed on the market or put into circulation.
(2) The person carrying out the testing of the hazardous properties of substances or preparations referred to in Article 2 (5) is required to use the basic methods set out in paragraph 5, while respecting the principles of good laboratory practice under Article 9 and the principles of animal protection under the specific legislation22).
(3) Where a basic method referred to in paragraph 5 is not established for testing a property, the method recommended by the Organisation for Economic Cooperation and Development (23) shall apply.
(4) Testing of the hazardous properties of products classified in accordance with § 2 (5) (f) to (o) in which laboratory animals are used may be carried out only if it is not possible to use the procedures under § 5 (1) (a) or § 6 (1) (a) to determine their hazardous properties.
(5) The basic methods for testing the dangerous properties of substances and preparations are laid down in the implementing act.
(a) Ministry of the Interior for the testing of hazardous properties of substances and preparations referred to in § 2 (5) (b) to (e);
(b) the Ministry of Health for the testing of hazardous properties of substances and preparations referred to in § 2 (5) (f) to (n);
(c) the Ministry of Testing for the Hazardous Characteristics of Substances and Preparations referred to in § 2 (5) (a) and (o) and for Testing of Other Physically-Chemical Characteristics of Substances and Preparations.
Good laboratory practice
(1) A person carrying out testing for the hazardous properties of substances or preparations pursuant to Article 2 (5) (f) to (o) must have a certificate of compliance with the principles of good laboratory practice (hereinafter referred to as "principles").
(2) The Ministry shall issue a certificate of compliance on the basis of a written request from a person after verification of compliance by that person. The Ministry may carry out verification of compliance with the Principles through the legal entity established by it.
(3) The person referred to in paragraph 1 shall be required to be subject to the verification of compliance with the Principles, to allow the control authorities to enter the land, premises and workplaces used for testing and to provide information on compliance with the Principles in accordance with the implementing legislation referred to in paragraph 10.
(4) The data established during the verification of compliance with the principles referred to in paragraph 3, other than the name of the laboratory, the quality of compliance with the principles and the dates of the checks carried out, shall be considered confidential and may only be provided to administrative authorities for the purposes of their administrative, control or sanction activities.
(5) The person referred to in paragraph 1 shall, when submitting the test results, confirm in writing that the tests have been carried out in accordance with the Principles.
(6) The Ministry shall withdraw a certificate of compliance with the Principles to the person referred to in paragraph 1, unless that person fulfils one of the conditions which the performance of which is necessary for the issue of the certificate or fulfils the obligations laid down in paragraphs 3 and 5.
(7) In the territory of the Czech Republic, a certificate of compliance issued by a Member State of the Organisation for Economic Cooperation and Development shall be considered equivalent if it can be established that the principles applied in that Member State on the basis of which the certificate was issued are identical to those laid down in this law.
(8) On the territory of the Czech Republic, a certificate of compliance issued by a Member State of the European Communities under the legislation of the European Community24 is considered equivalent.
(9) The Ministry keeps a list of holders of certificates of compliance and publishes it on 31 December of the calendar year in the Ministry of the Environment Bulletin.
(10) The principles, the procedure for verifying compliance with them, the procedure for issuing and withdrawing certificates and the procedure for checking compliance with the principles are laid down in the Ministry's implementing legislation.
MARKETING AUTHORISATION NUMBER
Basic conditions
(1) A person intending to place on the market in the European Communities a substance on its own or in a preparation shall, under the conditions laid down in this Act, request the Ministry of Health to register that substance. The registration shall include the information referred to in paragraphs 12, 13 or 18. If the application for registration complies with the conditions of Section 12, the Ministry of Health shall, within 60 days of the submission of the application, assign a reference number to the substance and enter it in the list of registered substances. If the application complies with the conditions laid down in Section 13, the Ministry of Health shall assign a reference number to the substance within 30 days of the application and enter it in the list of registered substances.
(2) If the application does not meet the conditions set out in Section 12, 13 or 18, the Ministry of Health shall, within the time limits referred to in paragraph 1, invite the applicant in writing to complete the application to the extent necessary.
(3) Where the applicant is requested in writing to complete the application, the proceedings shall be suspended on the day following the date of dispatch of the call for supplementary application. The proceedings shall continue on the day following the date on which the application was submitted to the Ministry of Health. In such a case, the Ministry of Health shall decide on the application within the time limits laid down in paragraph 1 calculated from the date of receipt of the completed application.
(4) If the suspension referred to in paragraph 3 persists for at least 360 days, the Ministry of Health may suspend the procedure.
(5) The Ministry of Health will publish the substances included in the list of registered substances on 31 December of the calendar year in the Ministry of Health Bulletin.
(6) In the case of a substance manufactured outside the territory of the European Communities, the person who places the substance on the market on its own or contained in the preparation or, where appropriate, the person who was the only person authorised to apply for the registration of the substance by the manufacturer.
(7) A person applying for a marketing authorisation pursuant to Article 12 may only place a substance on the market in the European Communities after 60 days of the submission of the application for a marketing authorisation or, where appropriate, of the addition of the application referred to in paragraph 2, if a reference number has been assigned to him.
(8) A person applying for a marketing authorisation under Paragraph 13 may only place a substance on the market in the European Communities after 30 days of submission of the application for a marketing authorisation or, where appropriate, of the addition of an application under paragraph 2, if a reference number has been assigned to him.
(9) The person who has placed on the market in the European Communities an unregistered substance or a preparation containing an unregistered substance shall be obliged to immediately withdraw such substance or preparation from the market and recall it. This is without prejudice to the provisions of Paragraph 38.
(10) The obligations of persons laid down in specific legislation25) are without prejudice to the provisions of this Title.
(11) The Ministry of Health sets out the implementing provisions
(a) applications for full registration of substances pursuant to Article 12 (1), requests for consent to submit a limited range of information pursuant to Article 12 (5) and applications for registration of an intermediate product with a limited range of information submitted pursuant to Article 12 (1) and (5);
(b) additional tests or studies for substances and intermediate products in accordance with Article 12 (2);
(c) applications for restricted registration of substances pursuant to Article 13 (1);
(d) applications for restricted registration of substances pursuant to Article 13 (2);
(e) applications for registration of polymers pursuant to Article 18.
Exemptions from registration
(1) Registration shall not be subject to:
(a) substances listed in the list of substances traded (hereinafter referred to as Einecs) or in the list of substances no longer considered as polymers (hereinafter referred to as Nlp) published by the Ministry at the Public Administration Portal;
(b) additives and substances for exclusive use in feedingstuffs (3) for animals;
(c) substances used exclusively as food additives and tobacco products4),
(d) substances which, prior to their placing on the market as such or as part of a preparation, must be submitted in accordance with the specific legislation11), 13), 26) identical to the requirements laid down in this Act; or
(e) substances manufactured outside the territory of the European Communities, registered in accordance with the provisions of the European Communities (27), in a Member State of the European Communities by a person having his registered office or permanent residence in the territory of another Member State of the European Communities, who has been authorised in writing as the sole manufacturer to apply for registration of a substance; or
(f) substances manufactured in the Czech Republic not intended for marketing in the European Communities.
(2) Furthermore, registration is not subject to:
(a) polymers, except those containing in sum 2 or more per cent of any substance not listed in Einecs or Nlp;
(b) substances placed on the market by one person in quantities of less than 10 kg per calendar year, provided that that person communicates the required information to the Ministry of Health; the information required by the Ministry of Health must not exceed the scope of Article 13 (1) (a) and (b);
(c) substances placed on the market by one person in quantities of less than 100 kg per calendar year which are intended solely for the purposes of scientific research and development carried out under controlled conditions; that person is obliged to register information on the identity, labelling, quantity and persons to whom the substance has been transferred and to provide it to the Ministry of Health upon request;
(d) substances placed on the market for the purposes of industrial research and development in the quantities necessary for applied research and development, for a period of 1 year from the first placing on the market, provided that the person who placed the substance on the market provides the Ministry of Health with information on the identification of the substance, the labelling and the quantity of the substance, the justification for that quantity and the list of persons to whom the substance has been provided, the research and development programme and meets all the conditions imposed by the Ministry of Health for that research and development. These conditions shall not exceed the requirements of the submission of information under Paragraph 13. In exceptional circumstances, the period of one year of exemption from the obligation to apply for a marketing authorisation may be extended for another year when the person who placed the substances on the market demonstrates to the Ministry of Health that such extension is justified. These substances may only be handled by workers of persons to whom substances have been provided and at the same time not supplied by the consumer (28), neither as substances themselves nor as part of the preparation. The Ministry of Health may extend the restrictions imposed by it due to an unacceptable risk to humans or the environment.
(3) A person who places on the market substances referred to in paragraph 2 which cannot be packed and labelled in full in accordance with the provisions of Sections 19 to 22, since he does not yet have the results of all tests in accordance with the implementing legislation referred to in Section 10 (11) (a), must ensure that the labelling of the substance contains, in addition to the labelling resulting from the tests already carried out, the warning "Caution - the substance is not yet fully tested."
(4) A person intending to place on the market, pursuant to paragraph 2, a hazardous substance classified in accordance with § 2 (5) as highly toxic, toxic, carcinogenic, mutagenic or toxic for reproduction shall be required to forward to the Ministry of Health all available information on the recommended treatment procedures, the recommended measures in the event of an accident and the recommended measures in the event of a threat to the health of persons in accordance with the implementing legislation referred to in § 10 (11) (a) and the acute toxicity data, if known.
Full registration
(1) A person applying for registration of a substance under Section 10 is required to submit the following written information to the Ministry of Health in the Czech language, with the exception of the technical documents referred to in point (c), which may be in the English language
(a) the identification of the manufacturer and the person applying for registration, that is the name or, where applicable, the name, surname, business name and place of business, if any, of the natural person authorised to do business, or the name or business name, legal form and registered office, if any, of the legal person;
(b) the identification of the substance for which registration is sought in accordance with the implementing legislation referred to in Article 10 (11) (a);
(c) technical documentation providing the information necessary to assess the foreseeable immediate or delayed risks of the substance to the environment and health; the technical documentation shall contain at least the information and results of the studies referred to in the implementing act referred to in Article 10 (11) (a), together with a full description of the studies carried out and a description of the methods or bibliographic references used;
(d) data on adverse effects of the substance on health and the environment, taking into account the intended use of the substance;
(e) the draft classification and labelling of a substance under this Act;
(f) for hazardous substances classified under § 2 (5), a draft safety data sheet under § 23 of this Act;
(g) where appropriate, a reasoned request for consent with the exception of the provision on the provision of test results on vertebrate animals to other persons referred to in Article 15 (3) applying for registration; the derogation may be granted for a maximum period of 1 year from the date of allocation of the reference number.
(2) Any person who has placed a substance on the market under Paragraph 10 (7) is required to notify the Ministry of Health without undue delay that:
(a) the quantity of the substance placed on the market by one manufacturer has reached 10 tonnes per calendar year or the total quantity of the substance placed on the market by one manufacturer has reached 50 tonnes; in this case, the Ministry of Health may require that some or all of the additional examinations or studies provided for in the implementing legislation provided for in Article 10 (11) (b) be carried out within a time limit set by it;
(b) the quantity of substance placed on the market by one manufacturer has reached 100 tonnes per calendar year or that the total quantity of substance placed on the market by one manufacturer has reached 500 tonnes; In this case, the Ministry of Health shall request additional examinations or studies provided for in the implementing legislation pursuant to Section 10 (11) (b). (b) as stage 1 within a time limit set by it, unless the person proves that the required tests or studies are not appropriate or proposes alternative scientific trials or studies;
(c) the quantity of the substance placed on the market by one manufacturer has reached 1 000 tonnes per calendar year or that the total quantity of the substance placed on the market by one manufacturer has reached 5 000 tonnes; in this case, the Ministry of Health shall draw up a programme of tests or studies in accordance with the implementing legislation referred to in Article 10 (11) (b) as Level 2 which the person must carry out within the time limit set by the Ministry of Health.
(3) The results of tests or studies carried out pursuant to paragraph 2, or without this obligation being imposed by law, shall be provided to the Ministry of Health.
(4) The person authorised under Article 10 (6) shall provide the Ministry of Health, when applying for registration, with a list of all persons in the territory of the European Communities for whom the authorised person operates, the estimated quantity of the substance to be marketed in the European Communities in total and the estimated quantities of the substance placed on the market in the European Communities by each person listed in the submitted list. Furthermore, the authorised person shall submit to the Ministry of Health the consent of the persons listed in the submitted list to carry out the activities of the authorised person and the declaration of the persons listed in the submitted list that they have been informed of the identity of the authorised person and that they will inform him of the quantity of the registered substance placed on the market in the European Communities.
(5) A person requesting the registration of an intermediate product may, prior to the submission of an application for registration pursuant to Article 10, request approval to submit a limited range of information referred to in paragraph 1 (c). At the same time, this person shall provide the Ministry of Health with evidence that the conditions laid down for intermediate products by implementing legislation pursuant to Section 10 (11) (a) are met.
Limited registration
(1) A person intending to place on the market in the European Communities a substance on his own or contained in a preparation of less than 1 tonne per calendar year from one manufacturer shall submit to the Ministry of Health, in the Czech language, with the exception of the technical documents referred to in point (c), which may be in the English language a registration containing the following information:
(a) the identification of the manufacturer and the person applying for registration, that is the name or, where applicable, the name, surname, business name and place of business, if any, of the natural person authorised to do business, or the name or business name, legal form and registered office, if any, of the legal person;
(b) the identification of the substance for which registration is sought in accordance with the implementing legislation referred to in Article 10 (11) (c);
(c) technical documentation providing the information necessary to assess the foreseeable immediate or delayed risks of a registered substance to health and the environment; the technical documentation shall contain at least the information and results of the studies referred to in Article 10 (11) (c), together with a complete description of the studies carried out and a description of the methods or bibliographic references used;
(d) all other information referred to in Articles 12 (1) (d) to (g) and 12 (4).
(2) Where the quantity of a substance placed on the market by one manufacturer is less than 100 kg per calendar year, the registrant may only submit in the registration application the information referred to in paragraph 1 (a), (b) and (d) and the information referred to in the implementing act referred to in Article 10 (11) (d).
(3) A person who places on the market a substance registered in accordance with paragraph 2 shall be required to submit to the Ministry of Health the additional information referred to in the implementing legislation referred to in Article 10 (11) (b). (c) before the quantity of a substance placed on the market by one manufacturer reaches 100 kg per calendar year or the total quantity of a substance placed on the market by one manufacturer reaches 500 kg.
(4) The person who has applied for registration and submitted the technical documentation referred to in paragraph 1 (c) must submit the technical documentation referred to in Article 12 (1) (c) before the amount of the substance placed on the market by one manufacturer reaches 1 000 kg per calendar year or before the total quantity of the substance placed on the market by one manufacturer reaches 5 000 kg. This person shall also be subject to the requirements of Section 12 (2).
(5) Where a substance registered in accordance with paragraphs 1 to 3 cannot be identified in full in accordance with the provisions of Sections 20 to 22, because the results of all tests necessary for its classification in accordance with this Act are not available, the labelling of the substance shall contain a warning in addition to that derived from the tests already carried out: "Caution - the substance is not yet fully tested '.
Further information
(1) The person who has been assigned the reference number of a substance pursuant to Article 10 (1) shall be required to inform the Ministry of Health in writing without undue delay of:
(a) changes in the annual or total quantities of that substance placed on the market of the European Communities by that person or by that person and by other persons, as the case may be, only by other persons, in respect of a substance manufactured outside the territory of the European Communities, the registration of which he has requested pursuant to Article 10 (6);
(b) new knowledge of the effects of the substance on health or the environment with which it has been introduced;
Contents
ČÁST PRVNÍ
HLAVA I
§ 1
§ 2
HLAVA II
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
HLAVA III
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
§ 16
§ 17
§ 18
HLAVA IV
§ 19
§ 20
§ 21
§ 22
§ 23
HLAVA V
§ 24
§ 25
HLAVA VI
§ 26
HLAVA VII
§ 27
HLAVA VIII
§ 28
§ 29
HLAVA IX
§ 30
§ 31
§ 32
§ 33
§ 34
§ 35
§ 36
§ 37
HLAVA X
§ 38
§ 38a
§ 38b
§ 38c
§ 39
§ 39a
§ 39b
HLAVA XI
§ 40
§ 41
§ 42
ČÁST JEDENÁCTÁ
§ 52
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Regulation Information
| Citation | Full version of Act No. 434 / 2005 Coll., Act No. 356 / 2003 Coll., on Chemicals and Chemicals and on the amendment of certain laws, as resulting from subsequent amendments |
|---|---|
| Regulation Type | Declared full text |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.11.2005 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
Legal Areas:
Health and safety at work
European law
European Community
Finance
Economic (State)
Commercial law
Fees
Labour law
Industrial rights
Governance of the national economic sectors
Administrative authorities
Administrative law
State (official) control
Constitutional (state) law
Territorial Authority
Fundamental human rights
Health
Eligibility for the pursuit of certain professions (activities)
The regulation text is for informational purposes only.
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