Act No. 356 / 2003 Coll.

Law on chemicals and chemical preparations and amending certain laws

Valid Law Effective from 01.05.2004
356
THE LAW
of 23 September 2003
on chemicals and chemical preparations and amending certain laws
Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

CHEMICAL SUBSTANCES AND CHEMICAL PRODUCTS

HLAVA I

GENERAL PROVISIONS
§ 1
Subject matter of the regulation and scope of the law
(1) This Act incorporates the relevant provisions of the European Community1) and regulates the rights and obligations of legal persons and business individuals (hereinafter referred to as "persons") in the manufacture, classification, testing of dangerous properties, packaging, labelling, placing on the market, use, export and import of chemicals (hereinafter referred to as "substance") or substances contained in preparations or articles, and in the classification, testing of dangerous properties, packaging and labelling of chemical products (hereinafter referred to as "product") in the territory of the Czech Republic and defining the competence of the administrative authorities in ensuring the protection of health and environmental effects of substances and preparations.
(2) This Act does not apply to pharmaceuticals, 2) feed, 3) food and tobacco products, 4) cosmetic products, 5) radionuclide radionuclide and nuclear materials, 6) narcotic and psychotropic substances, 7) medical devices, 8) mineral materials, 10) veterinary preparations, except disinfectant, disinfectant and derative11) in the form intended for final use, waste 11a), and to the transport and distribution of gas in the public interest, 12) unless specific legislation provides otherwise.
(3) Plant protection products, plant protection aids (13) and biocides (13a) are subject only to the requirements of classification, packaging, labelling and import and export obligations under this Act.
(4) This law does not apply to explosives (14) to the extent that this field is regulated by a specific legislation. 14)
(5) This Act does not apply to the transport of dangerous substances and dangerous preparations in railway, 15) road, 16) inland waterway, 17) air 18) and sea19) transport and the transport of dangerous substances and dangerous preparations under customs transit procedure. 20)
(6) Import and export of substances and preparations are subject to customs legislation (20), unless otherwise provided for by this law or specific legislation.
§ 2
Basic concepts
(1) 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.
(2) Dangerous substances or dangerous preparations are substances or preparations which, under the conditions laid down in 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.
(3) 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.
(4) For the purposes of this Act, the first beneficiary shall be the first person to place on the market a substance or preparation which has been manufactured or placed on the market in the territory of another Member State of the European Communities and which operates in the territory of the Czech Republic in accordance with other legislation.
(5) For the purposes of this Act, the contractor shall mean a person with his registered office, organisational structure, residence or place of business in the territory of the European Communities who produces or has only developed the product.
(6) The definitions set out in Article 3 of Regulation (EC) No 1907 / 20061a apply to the other basic terms in this Act.

HLAVA II

GENERAL CLASSIFICATION AND CORRECT LABORATORY PRACTICE
§ 3
General principles for the classification of substances and preparations
(1) The manufacturer, contractor or importer must ensure that their classification is carried out before the substance or preparation is placed on the market. The first beneficiary shall not place on the market in the Czech Republic substances or preparations which are not classified in accordance with this Act.
(2) The classification of a substance or preparation shall not take into account dangerous substances, mixtures or impurities classified in accordance with Paragraph 2 (2), 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 mandatory classification of dangerous substances (hereinafter referred to as "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) in the case where they are not classified in accordance with (a) or (b), 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 obtained from professional sources or on the basis of data obtained from testing in accordance with 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) 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 and for a further period of 10 years from the last placing on the market and shall provide them, on request, to the competent administrative authorities for the purposes of 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.
§ 4
Assessment of the hazards of preparations resulting from their physicochemical properties
(1) The assessment of the hazards of the preparations resulting from their physico-chemical properties shall be carried out for the purposes of the classification referred to in paragraphs 2 (2) (a) to (e) of Article 2 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 in an aerosol dispenser complies with the requirements of specific legislation. 21)
(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 provided for in a specific legislation. 13)
§ 5
Assessment of the hazards of products for health
(1) The assessment of the hazards of the products for health resulting from their health effects for the purposes of the classification referred to in Article 2 (2) (f) to (n) 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 provided for in a specific legislation. 13)
(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 referred to in paragraph 2 (2), for which the determination must always be carried out 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 a 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 shall be taken into account in the classification.
§ 6
Evaluation of the hazards of environmental products
(1) For the purposes of the classification referred to in Article 2 (2) (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 provided for in a specific legislation. 13)
(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.
§ 7
Reassessment of product hazards
(1) The contractor or importer is obliged to carry out a new health or environmental hazard assessment for products of a known composition in accordance with the procedures set out in Sections 5 or 6, provided that:
(a) the change in the initial concentration of one or more hazardous substances contained in the preparation classified in accordance with Article 2 (2) is greater than that specified in Annex 2 to this Act; or
(b) one or more substances are replaced or added.
(2) The contractor or importer shall not be required to carry out a reassessment of the hazard of the product if it is clear from scientific knowledge that changes in its composition will not cause a change in classification.
(3) Paragraph 1 shall not apply to contractors or importers of plant protection products and plant protection aids (13) assessed 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.
§ 8
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 produced or placed on the market.
(2) A person carrying out the testing of the hazardous properties of substances or preparations referred to in Article 2 (2) is required to use the basic methods set out in paragraph 5 and to comply with the principles of good laboratory practice (hereinafter referred to as "principles") and animal protection under a specific legislation when testing the dangerous properties of substances or preparations referred to in paragraphs 2 (2) (f) to (o). 22)
(3) Where no basic method is established for testing a property in accordance with paragraph 5, the method recommended by the Organisation for Economic Co-operation and Development shall be used. 23)
(4) Testing of the dangerous properties of products classified in accordance with § 2 (2) (f) to (o) in which laboratory animals are used may only be carried out if it is not possible to use the procedures under § 5 (1) (a) or § 6 (1) (a) to determine their dangerous properties.
(5) The basic methods for testing the dangerous properties of substances and preparations are laid down in the directly applicable regulation of the European Community23a).
(6) Testing of substances is carried out in accordance with the requirements of the directly applicable Regulation of the European Communities (1a).
§ 9
Good laboratory practice
(1) A person who, in accordance with this Act, carries out testing for hazardous properties of substances or preparations in accordance with § 2 (2) (f) to (o) must have a certificate of compliance with the 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) In 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 Communities shall be considered equivalent. 24)
(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.

HLAVA IV

PACK, MARKING AND SECURITY LIST
§ 19
Packaging of substances and preparations
(1) The manufacturer, importer or contractor who places on the market substances or preparations classified as hazardous in accordance with § 2 (2) or preparations which may present a specific health or environmental hazard provided for in the implementing legislation under § 20 (7) are required to ensure that such substances and preparations are provided with packaging and seals which comply with these requirements.
(a) the packaging and closure must be so designed and constructed that the contents of the packaging cannot escape; This requirement does not apply where special safety measures are prescribed,
(b) materials used for the manufacture of packaging and sealing shall not be disturbed by the content and shall not form hazardous compounds with it;
(c) the packaging and closure must be so manufactured as to ensure that they resist and do not release the pressure and deformations resulting from normal treatment;
(d) the packaging intended for re-use must be so designed and constructed that it can be re-sealed without leakage of contents.
(2) The manufacturer, importer or contractor who places on the market dangerous substances or substances contained in products classified in accordance with Article 2 (2) shall be required to provide them with packaging and seals in accordance with this Law and, in the case of substances which have been registered in accordance with Title II of Regulation (EC) No 1907 / 20061a, also in accordance with the information obtained pursuant to Articles 12 and 13 of this Regulation.
(3) The first beneficiary will not place substances or preparations on the market of the Czech Republic whose packaging does not comply with the requirements of this Act.
(4) The packaging of substances or preparations referred to in paragraph 1 intended for sale to the consumer (28) must satisfy these requirements in addition to the requirements referred to in paragraph 1.
(a) the packaging containing a substance or preparation which is labelled as highly toxic, toxic or corrosive must have a child-resistant closure and a tangible warning for the blind,
(b) packaging containing a substance or preparation which is labelled as harmful, extremely flammable or highly flammable shall bear a tangible warning for the blind; This requirement does not apply to preparations in an aerosol dispenser classified and labelled only as extremely flammable or highly flammable,
(c) the packaging containing the substance or preparation must not be such as to mislead the consumer or confuse the product with toys, 5), 8)
(d) the packaging containing the substance or preparation must not have the design or labelling used for foodstuffs, drinking water, feed, medicinal products or cosmetic products.
(5) The Ministry of Industry and Trade provides for additional requirements for packaging of dangerous substances and dangerous preparations intended for sale to the consumer by means of implementing legislation. 28)
(6) A person who places substances or preparations on the market as referred to in paragraph 4 shall keep evidence of compliance with the packaging requirements laid down in paragraph 4 (a) and (b) and in the implementing legislation referred to in paragraph 5 for the period of their placing on the market and for 10 years after the last placing on the market and shall provide them to the administrative authorities on request for their administrative, control or sanction activities.
(7) Packaging of dangerous substances or dangerous preparations classified in accordance with Paragraph 2 (2) carried out in accordance with the conditions for the transport of dangerous goods in international transport15), 16) and requirements for the transport of dangerous goods in rail, 15) road, 16) inland waterway, 17) air (18) and maritime transport19) comply with the requirements of paragraph 1.
(8) The obligations of persons when packing substances or preparations provided for in specific legislation25) are without prejudice to the provisions of this Title.
(9) A distributor who places on the market substances or preparations classified and packaged under this Act is obliged to place them on the market in the original packaging.
§ 20
Labelling of substances and preparations
(1) A manufacturer or importer who places on the market dangerous substances classified in accordance with Article 2 (2) shall ensure that their labelling complies with the requirements of this Act and, for substances registered in accordance with Title II of Regulation (EC) No 1907 / 20061a, that their labelling complies with the information obtained in application of Articles 12 and 13 of this Regulation.
(2) Importers or contractors who place on the market dangerous products classified in accordance with § 2 (2) are required to ensure that labelling of packaging complies with the requirements of paragraph 5 and the implementing legislation referred to in paragraph 7.
(3) Importers or contractors who place on the market products which may present a specific risk to health or the environment, as provided for in the implementing act referred to in paragraph 7, are required to ensure that their labelling complies with the requirements of paragraph 5 (a), (b) and the implementing act referred to in paragraph 7.
(4) The packaging of the dangerous substance referred to in paragraph 1 shall bear the following particulars clearly, legibly and indelibly in the Czech language:
(a) the chemical name of the substance in the form of one of the names listed in the List; if the substance is not listed in the List, the chemical name of the substance shall be indicated in accordance with internationally accepted nomenclature;
(b) the name and, where applicable, the name, surname, name or business name, place of business (registered office) and the telephone number of the person responsible for placing the substance on the market in the packaging;
(c) the warning symbols laid down in the implementing legislation referred to in paragraph 7;
(d) standard risk phrases (R-phrases) laid down in the implementing legislation referred to in paragraph 7;
(e) the standard precautionary statements (sentence) laid down in the implementing legislation referred to in paragraph 7;
(f) EC number according to Einecs, Elincs or Nlp,
(g) the words "EC designation" as regards substances listed in the List.
(5) The packaging of the dangerous product referred to in paragraph 2 shall bear the following particulars clearly, legibly and indelibly in the Czech language:
(a) the trade name of the preparation,
(b) the name and, where appropriate, the name, surname, name or business name, place of business (registered office) and the telephone number of the person responsible for placing the product on the market;
(c) the chemical name of the dangerous substance or substances present in the preparation in the form of one of the names listed in the List and in accordance with the implementing legislation referred to in paragraph 7. If the substance is not listed in the List, the chemical name of the substance or substances shall be indicated in accordance with internationally accepted nomenclature,
(d) the warning symbols provided for in the implementing act referred to in paragraph 7;
(e) standard risk phrases (R-phrases) laid down in the implementing legislation referred to in paragraph 7;
(f) the standard precautionary statements (SDS) laid down by the implementing legislation referred to in paragraph 7; if these instructions cannot be placed on the label or on the packaging, they shall be accompanied by the packaging;
(g) weight or volume if the products are intended for sale to the consumer. 28)
(6) The designation of plant protection products and plant protection aids (13) under this Act must be accompanied by the indication "Follow the instructions for use in order to avoid risks to humans and the environment."
(7) The Ministry of Industry and Trade provides for implementing legislation
(a) particulars of the labelling of dangerous substances, dangerous preparations and preparations which may constitute a specific risk to health or the environment;
(b) warning symbols and letters of dangerous properties of physicochemical and health or environmental hazards;
(c) standard risk phrases (R-phrases);
(d) the standard precautionary statements (World theorem).
(8) The contractor or importer who places dangerous products on the market may, on the basis of the approval of the Ministry in their designation, use the names identifying the most important functional chemical groups or alternative names instead of the name of certain hazardous substances present in the preparation. Where the contractor or importer of a dangerous product wishes to replace the name of certain hazardous substances present in the preparation with the name identifying the most important functional chemical groups or an alternative for reasons of commercial secrecy, he shall be obliged to justify this in a written request. This procedure may not be used if an acceptable exposure limit or maximum allowable concentration for the workingenvironment is established for the substance (28a). The content of the application and the principles of naming shall be laid down in the implementing legislation. The Ministry of Health and the competent authorities of the European Communities and the Member States of the European Communities shall send a copy of the consent opinion on the use of this name.
(9) Persons referred to in paragraphs 1 to 3 may not place on the labelling of packages of substances and preparations referred to in paragraphs 1 to 3 placed on the market signs such as "non-toxic '," harmless', "non-polluting '," organic', "eco 'or any other information indicating that the substance or preparation is not dangerous or that may lead to an underestimation of the hazard of the substance or preparation.
(10) Persons referred to in paragraphs 1 to 3 shall keep the data used for the labelling of a substance or preparation referred to in paragraphs 1 to 3 for the period during which that substance or preparation is placed on the market and for an additional 10 years and shall provide them to administrative authorities on request for their administrative, control or penalty activities.
(11) A distributor who places on the market substances or preparations classified and labelled under this Act is obliged to place them on the market with the original label.
§ 21
(1) The manufacturer, importer or contractor who places on the market substances or preparations classified as dangerous under § 2 (2) in packages of which the content does not exceed 125 ml shall comply with the implementing legislation provided for in § 20 (7).
(2) In the event that the particulars required under Paragraph 20 indicate on the label the space on the packaging, the label shall be firmly attached to one or more sides of the packaging so that the particulars can be read in the position in which the packaging is normally stored. The dimensions of the label and the area of the packaging to be indicated under this Act are specified in the implementing legislation referred to in Section 20 (7). The packaging or label for labelling under this Act is intended only for the provision of the information required by this Act or additional health and safety information as appropriate. (29) This provision shall not affect the presentation of further information on packaging under specific legislation29).
(3) The label is not required if the particulars are clearly indicated on the packaging.
(4) The information given on the packaging or label referred to in § 20 (1) to (6) must appear clearly from its background and must be of such size and layout as to be easily legible. The colour and execution of the marking shall be such that the warning symbol and its background clearly stand out.
(5) The manufacturer, importer or contractor who places on the market dangerous products classified in accordance with § 2 (2) as defined by the implementing legislation referred to in § 20 (7) intended for sale to the consumer, 28) are required to provide instructions for use and instructions for pre-medical first aid, which may be indicated instead of the packaging or label in the package leaflet. The fact that some of the information is contained in the package leaflet must appear on the package leaflet or label.
(6) The obligation to indicate packaging in the Czech language does not preclude the possibility of parallel labelling in other languages.
(7) The Ministry may, at the written request of a manufacturer, importer or contractor who places a dangerous substance or a dangerous preparation classified in accordance with Article 2 (2) on the market, allow exemptions from the labelling requirements for such substances or preparations
(a) the packaging of substances and preparations referred to in Article 20 (1) to (3) which are too small or otherwise unsuitable for labelling pursuant to paragraphs 2 and 3 may be marked by other appropriate means;
(b) the packaging of dangerous substances not classified as explosive, highly toxic or toxic in accordance with § 2 (2) may not be marked or labelled differently from the requirements of § 20 (4) and paragraphs 1 to 6, provided that they contain such small quantities of dangerous substances as they do not pose a danger to persons handling them or to other persons;
(c) packaging of dangerous substances classified as explosive, highly toxic or toxic in accordance with § 2 (2) may be marked differently from the requirements of § 20 (4) and paragraphs 1 to 6, provided that they contain such small quantities of dangerous substances as to not pose a danger to persons handling them or to other persons;
(d) the packaging of dangerous products classified as harmful, extremely flammable, highly flammable, flammable, irritating or oxidising, in accordance with Article 2 (2), may not be marked or marked differently from the requirements laid down in Article 20 (5) and paragraphs 1 to 6, provided that they contain such small quantities of the dangerous product that they do not pose a risk to persons handling them or to other persons;
(e) the packaging of dangerous products classified as hazardous to the environment in accordance with Article 2 (2) may not be marked or labelled differently from the requirements set out in Article 20 (5) and paragraphs 1 to 6, provided that they contain such small quantities of a dangerous product that they do not pose a risk to the environment;
(f) packaging of dangerous products not referred to in points (d) and (e) may be marked by other appropriate means, provided that the packaging is too small for labelling in accordance with the requirements set out in Article 20 (5) and paragraphs 1 to 6 and that there is no reason to fear danger for persons handling such products or for other persons.
(8) A person who has been granted a derogation from the labelling requirements referred to in paragraph 7 is required to use the warning symbols, the risk-specific standard phrases (R-phrases) and the standard precautionary statements (S-phrases) provided for by the implementing legislation pursuant to Article 20 (7).
(9) The Ministry provides for implementing legislation
(a) the particulars of the application for the use of the name identifying the most important groups or the alternative name of the dangerous substance in the labelling of the dangerous product, the details of its formation and the list of specified groups of substances and preparations;
(b) the procedure and method for granting exemptions from labelling requirements for dangerous substances and preparations.
(10) The first beneficiary will not place substances or preparations on the market of the Czech Republic whose designation does not comply with the requirements of this Act.
§ 22
(1) For the purposes of this Act, the manufacturer, importer or contractor who places substances or preparations on the market shall comply with the labelling requirements for dangerous substances and dangerous preparations classified in accordance with Article 2 (2).
(a) where the outer packaging contains one or more internal packaging, where the outer packaging is marked in accordance with the conditions for the transport of dangerous goods in international transport laid down by the international treaty, which is binding on the Czech Republic (15), 16) and which has been published in the Collection of Laws or in the Collection of International Contracts, and the inner packaging is labelled in accordance with this law,
(b) where they are provided with a single package, where such packaging is marked in accordance with the conditions for the transport of dangerous goods in international transport laid down by the international treaty, which is binding on the Czech Republic (15), (16), and which has been declared in the Collection of Laws or the Collection of International Contracts, and in accordance with § 20 (4) (a), (b), (d), (e) and (f), if applicable, of dangerous substances, (a), (b), (c), (e) and (f); hazardous substances or preparations classified as hazardous to the environment shall also be labelled in accordance with § 20 (4) (c) or § 20 (5) (d);
(c) where they bear a specific type of packaging, such as gas cylinders, provided that such packaging is labelled in accordance with the specific requirements laid down in the implementing legislation referred to in Article 20 (7).
(2) The manufacturer, importer, contractor or distributor, when advertising or offering a dangerous substance classified in accordance with Paragraph 2 (2), are required to inform at the same time about the hazardous properties of the substances in accordance with this Act. When advertising or offering a dangerous product classified in accordance with Paragraph 2 (2) which allows the purchase of the product without the buyer having the opportunity to see the designation of the product before the conclusion of the contract, persons must inform the buyer of the dangerous properties of the product at the latest when the contract is concluded.
(3) The designation of the exported hazardous substances or dangerous preparations classified in accordance with Paragraph 2 (2) shall be given in the language required by the importing country. The requirements of the importing country for the labelling of these substances or preparations may be met only if they include all the information referred to in § 20 (4) and (5).
(4) The contractor or importers who place on the market products classified as hazardous under § 2 (2) (a) to (n) are required to provide the Ministry of Health with information on their health effects, including information on their composition and physical-chemical properties, in electronic form using the Chemical and Product (CHLAP) programme, made available on the Ministry of Health website, within 30 days of the date of first placing on the market. This information shall be kept confidential by the Ministry of Health and may be used only for medical purposes and for public authorities under Section 32 (1) (b).
(5) The Ministry of Health shall, by means of implementing legislation, determine the details of the provision of the information referred to in paragraph 4, the form of its electronic form and the data interface.
§ 24
(1) The manufacturer or importer of detergents (1c) placing on the market liquid detergents intended for sale to consumers shall not use graphic pictures of fruit on packaging which may mislead the consumer. The first beneficiary does not place liquid detergents on the market of the Czech Republic intended for sale to consumers with a graphical picture of fruit on the packaging.
(2) The manufacturer or importer of detergent 1c) or surfactant 1d) which places detergents or surfactants on the market shall be required to provide the Ministry of Health with the information referred to in Article 22 (4) and (5) within 30 days of the date on which these substances or preparations were first placed on the market.

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Regulation Information

CitationAct No. 356 / 2003 Coll., on Chemicals and Chemicals and on the Amendment of Certain Acts
Regulation TypeLaw
Author-
CollectionCode of Laws
Date of Promulgation29.10.2003
Effective from01.05.2004
Effective until-
Status Valid
The regulation text is for informational purposes only.
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