Act No 371 / 2008 Coll.
Act amending Act No. 356 / 2003 Coll., on Chemicals and Chemicals and amending certain laws, as amended
Valid
Law
Effective from 01.11.2008
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371
THE LAW
of 18 July 2008
amending Act No 356 / 2003 Coll., on Chemicals and Chemicals and amending certain laws, as amended
Parliament has decided on this law of the Czech Republic:
Act No. 356 / 2003 Coll., on Chemicals and Chemicals and amending certain laws, as amended by Act No. 186 / 2004 Coll., Act No. 125 / 2005 Coll., Act No. 345 / 2005 Coll. and Act No. 222 / 2006 Coll., are amended as follows:
1. Paragraph 1 (1), including footnotes 1 and 1a to 1d, reads as follows:
"(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" the 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.
1) Council Directive 67 / 548 / EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, as amended. Directive 1999 / 45 / EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, as amended. Council Directive 76 / 769 / EEC on the approximation of laws, regulations and administrative provisions relating to restrictions on the marketing and use of certain dangerous substances and preparations, as amended. Directive 2004 / 9 / EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice. Directive 2004 / 10 / EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their use in chemical testing.
(1a) Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, establishing a European Chemicals Agency, amending Directive 1999 / 45 / EC and repealing Council Regulation (EEC) No 793 / 93, Commission Regulation (EC) No 1488 / 94, Council Directive 76 / 796 / EEC and Commission Directives 91 / 155 / EEC, 93 / 67 / EEC, 93 / 105 / EC and 2000 / 21 / EC.
(1b) Regulation (EC) No 304 / 2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals, as amended.
(1c) Regulation (EC) No 648 / 2004 of the European Parliament and of the Council of 31 March 2004 on detergents, as amended.
(1d) Regulation (EC) No 850 / 2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79 / 117 / EEC, as amended. ';
2. In Article 1 (2), the words "fertilisers, soil improvers, plant aids and substrates, 9) ', including footnote 9, are deleted.
3. In Article 1 (3), the words "and to plant protection aids 13) 'are replaced by the words", plant protection aids 13) and biocidal products 13a)' and the words ", the preparation of safety data sheets' are deleted.
Footnote 13a reads:
"13a) Act No. 120 / 2002 Coll., on the conditions for the placing on the market of biocidal products and active substances and amending certain related acts, as amended. '.
4. In Article 1 (5) and (6), the words "chemical 'are deleted.
5. In Article 2, paragraphs 1 to 3, 6 to 13 and 15 are deleted.
Paragraphs 4, 5 and 14 shall become paragraphs 1, 2 and 3.
6. In Article 2, paragraphs 4 to 6 are added:
"(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 in Article 3 of Regulation (EC) No 1907 / 20061a shall apply to the other basic terms in this Act. '.
7. Paragraph 3 (1) reads as follows:
"(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. '
8. In § 3 (2), § 4 (1), § 5 (1) and (4), § 6 (1) of the introductory part of the provision, § 7 (1) (a), § 9 (1), § 19 (1) of the introductory part of the provision and § 5, § 20 (2), § 21 (1), (5) and (7) (b) and (c), § 22 (1) of the introductory part of the provision and § 2 and § 26 (3), "5" is replaced by "2."
9. in Article 3 (3), point (c) is deleted;
Point (d) shall be renumbered (c).
10. in Article 3 (3) (c), "to (c)" is replaced by "or (b)";
11. in Article 3 (6), "3" is replaced by "10."
12. in § 3 (6), § 4 (2) (c), § 8 (1), § 20 (9) and (10) and § 26 (2), the words "or into circulation" shall be deleted;
13. in Article 7 (1) and (2), the word "Manufacturer" shall be replaced by the word "Developer" and in Article 7 (3), the word "Manufacturer" shall be replaced by "Developer."
14. in Article 8 (1), the words "produce or" shall be inserted after the words "produce."
15. in Sections 8 (2) and (4), 21 (7) (d) and (e) and 22 (3), "§ 2 (5)" is replaced by "§ 2 (2)";
16. in Article 8 (2), the words "with respect to the principles of good laboratory practice in accordance with § 9 and the principles" shall be replaced by the words "and, when testing the dangerous properties of substances or preparations in accordance with § 2 (2) (f) to (o), the principles of good laboratory practice (hereinafter referred to as" principles ") and the principles."
17. in Paragraph 8 (5), including footnote 23a:
"(5) The basic methods for testing hazardous properties of substances and preparations are laid down in the directly applicable regulation of the European Community23a).
23a) Commission Regulation (EC) No 444 / 2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals. ';
18. In Article 8, paragraph 6 is added:
"(6) The testing of substances is carried out in accordance with the requirements of the directly applicable Regulation of the European Communities (1a)."
19. in Article 9 (1), the words "in accordance with this law" and the words "principles of good laboratory practice (hereinafter referred to as" principles ")" shall be replaced by "principle."
20. In Part One, Title III, including the headings and footnotes 25 to 28, is deleted.
21. In Article 19 (1) of the Introductory Part of the Provisions and Article 21 (1) and (5), the words "The person placing on the market or the first distributor putting into circulation" shall be replaced by "The manufacturer, importer or contractor placing on the market."
22. In Paragraph 19 (1) of the Introductory Part of the provision, the words "is required to procure these substances and preparations' are replaced by the words" are required to ensure that such substances and preparations are procured '.
23. In Paragraph 19, the following paragraphs 2 and 3 are inserted after paragraph 1:
"(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 Act 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 shall not place on the market of the Czech Republic substances or preparations the packaging of which does not comply with the requirements of this Act. '
Paragraphs 2 to 7 shall be renumbered paragraphs 4 to 9.
24. In Article 19 (5), the words "substances and dangerous' shall be inserted after the words" dangerous'.
25. Paragraph 19 (6) reads:
"(6) The person placing on the market substances or preparations 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 from the last placing on the market and shall provide them to the administrative authorities, upon request, for the purposes of their administrative, control or sanction activities. ';
26. in Paragraph 19 (9):
"(9) A distributor who places on the market substances or preparations classified and packaged under this Act shall be obliged to place them on the market in the original packaging."
27. in Paragraph 20 (1):
"(1) The 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. ';
28. in Article 20 (2) and (3), the words "The person who places on the market or the first distributor who puts into circulation" shall be replaced by the words "Importer or contractor who places on the market."
29. in Articles 20 (2) and (3), 21 (5) and 26 (2), the words "is required" shall be replaced by the words "are required."
30. in Articles 20 (4) (b) and 20 (5) (b), the words "either producer or importer" shall be deleted;
31. in Articles 20 (4) (b) and 20 (5) (b), the second sentence shall be deleted;
32. Paragraph 20 (8), including footnote 28a, reads as follows:
"(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.
28a) Government Decree No. 361 / 2007 Coll., laying down conditions for health protection at work. '
33.In Paragraph 20 (10), the words "another 3 years" are replaced by the words "another 10 years."
34. in Paragraph 20 (11):
"(11) A distributor who places on the market substances or preparations classified and labelled under this Act shall be obliged to place them on the market with the original designation."
35. in Article 21 (4), the word "symbol" shall be replaced by "warning symbol."
36. in Paragraph 21 (7), the introductory part of the provision reads:
"The Ministry may, at the written request of the manufacturer, importer or contractor who places a dangerous substance or a dangerous product classified in accordance with Paragraph 2 (2) on the market, authorise exemptions from the labelling requirements for such substances or preparations'.
37. in Article 21 (8), the words "packaging and" shall be deleted;
38. in Paragraph 21 (9) (b), the words "on packaging and" shall be replaced by the words "from requirements on."
39. In Article 21, the following paragraph 10 is added:
"(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. '
40. in Paragraph 22 (1), the words "The person who places on the market or puts into circulation" shall be replaced by "The manufacturer, importer or contractor who places on the market."
41. in Paragraph 22 (2), the word "Persons" shall be replaced by the words "Manufacturer, importer, contractor or distributor" and the word "obliged" shall be replaced by "obliged."
42. In Paragraph 22, paragraphs 4 and 5 are added:
"(4) The contractor or importers who place on the market products classified as dangerous under § 2 (2) (a) to (n) shall be required to provide the Ministry of Health with information on their health effects, including information on their composition and physico-chemical properties, in electronic form, using the Chemicals and Products (CHLAP) programme, made available on the Ministry of Health website, within 30 days of the date they first placed 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, lay down the details of the provision of information referred to in paragraph 4, the form of their electronic form and the data interface. ';
43. Article 23 shall be deleted, including the title.
44. In Part One of Title V, "CONDITIONS OF DETERGENTS AND SUPERVISORY ACTIVE SUBSTANCES ON THE MARKET '.
45.
(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 detergents1c) or surfactant 1d) placing 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. '
46. Paragraph 25 shall be deleted, including the title.
47. In Part One, Title V, including the title, is deleted.
48. In Part One of Title VI, "LIMITATION OF CERTAIN DANGEROUS SUBSTANCES AND DANGEROUS MARKET PRODUCTS '.
49. In Paragraph 26 (1), the words "put into circulation 'are deleted and the words" the person who places on the market or puts into circulation' are replaced by the words "the persons referred to in paragraph 2 who place on the market or use '.
50. in Article 26 (2), the words "The person who places the product on the market" shall be replaced by "The manufacturer, importer, contractor, downstream user or distributor who places the product on the market."
51. in Article 26 (3), the words "and the Ministry of Agriculture" shall be deleted and the words "put into circulation" shall be replaced by the words "sales to consumers."
52. In Part One, Titles VII and VIII, including footnotes 30 and 31, are deleted.
53. In Section 30 of the Introductory Part of the Provisions, the words "substances and preparations on the market and put into circulation 'are replaced by the words" substances or substances contained in preparations and articles, placing on the market'.
54. in Article 30, the following point (c) is inserted after point (b):
"(c) Ministry of Industry and Trade,"
Points (c) to (f) shall be renumbered (d) to (g).
55. in Paragraph 26 (4), the words "special legislation" are replaced by the words "special legislature25";
footnote 25:
"25) For example Act No. 86 / 2002 Coll., on Air Protection and on the amendment of certain other laws (Air Protection Act), as amended."
56. in Paragraph 30, point (e) is deleted;
Points (f) and (g) shall become points (e) and (f).
57.
"(1) Ministry
(a) is the central administration in the field of environmental protection against the harmful effects of substances or substances in preparations and articles and preparations (1a);
(b) exercise the highest level of national supervision in the field of environmental protection against the harmful effects of substances or substances contained in preparations or articles and preparations (1a) manufactured, placed on the market or used;
(c) publishes Einecs, Elincs and Nlp on the public administration portal;
(d) grant and withdraw certificates of compliance with the Principles;
(e) keeps a list of holders of certificates of compliance and publishes them in the Ministry of the Environment Bulletin;
(f) carry out the function of designated national authority for the import and export of dangerous substances or substances contained in preparations or articles referred to in Article 4 of Regulation (EC) No 304 / 20031b;
(g) agree to exemptions in the labelling of substances and preparations;
(h) agree to use a name identifying the most important functional chemical groups or using an alternative name of the substance present in the preparation;
(i) carry out the functions of competent authority pursuant to Article 121 of Regulation (EC) No 1907 / 20061a);
(j) establish a central contact point pursuant to Article 124 of Regulation (EC) No 1907 / 20061a to provide advice to manufacturers, importers, downstream users and other interested parties on their obligations and responsibilities under this Regulation;
(k) inform the general public of the risks of substances referred to in Article 123 of Regulation (EC) No 1907 / 20061a);
(l) carry out the functions of competent authority referred to in Article 8 (1) of Regulation (EC) No 648 / 20041c;
(m) carry out the functions of the competent authority referred to in Article 15 of Regulation (EC) No 850 / 20041d. ';
58. in Articles 31 (2) and (3) and 32 (2) and (3), the words "and preparations" shall be replaced by "or substances contained in preparations and articles and preparations (1a)."
59. Paragraph 32 (1) reads as follows:
"(1) Ministry of Health
(a) is the central administration on the public health protection section against the harmful effects of substances or substances contained in preparations and articles and preparations (1a);
(b) ensure the collection of information pursuant to Articles 22 (4) and 24 (2) and allow remote access to it to the Toxicological Information Centre and to other public authorities pursuant to Article 30, the Ministry of the Interior and the Fire Rescue Corps of the Regions;
(c) cooperate with the Ministry in the performance of the duties of the competent authority pursuant to Article 121 of Regulation (EC) No 1907 / 20061a);
(d) inform the public of the risks to the public of substances or substances contained in preparations and articles dangerous to human health under Article 123 of Regulation (EC) No 1907 / 20061a within its scope. ';
60. The following Section 32a is inserted after Section 32:
Ministry of Industry and Trade
Ministry of Industry and Trade
(a) cooperate in providing information to manufacturers, importers, downstream users and other interested parties on their obligations and responsibilities under Article 124 of Regulation (EC) No 1907 / 20061a;
(b) inform the general public of the risks of substances referred to in Article 123 of Regulation (EC) No 1907 / 20061a within its scope. ';
61. Paragraph 33, including the title, reads:
Inspections
(1) Inspections
(a) checks that manufacturers, contractors, importers, downstream users, distributors and the first recipients of substances, preparations and articles comply with the provisions of this Act, the legislation issued for its implementation, the directly applicable provisions of the European Communities (1b), (1d), (1e) and administrative decisions under this Act, with the exception of the items under the control of the Regional Sanitary Station;
(b) lay down the conditions and time limits for the correction, if the checks referred to in (a) reveal defects;
(c) order measures to eliminate the illegal situation in the field of the placing on the market of substances, preparations or articles; where there is a risk of damage to health or a threat to human life, to the environment, or if it has already occurred, it may order the disposal of a dangerous substance, preparation or article at the expense of its owner or, if the owner is not known, the owner;
(d) impose fines and corrective measures under this law;
(e) to encourage the Ministry to exercise national supervision over the harmful effects of substances or substances contained in preparations or articles and preparations (1a) manufactured, marketed or used;
(f) cooperate with regional hygienes5), customs and administrative authorities on the fire protection, population protection and integrated rescue systemand provide them with technical assistance.
(2) The scope of the inspection referred to in paragraph 1 in the armed forces shall be exercised by its authorities by the Ministry of Defence. "
62. Paragraph 34 shall be deleted, including the title and footnote 32.
63. Paragraph 35 (1), including footnote 33, reads as follows:
"(1) Regional Sanitation Station 5)
(a) checks compliance with the provisions of this Act, the legislation adopted for its implementation, the directly applicable provisions of the European Communities (1a), (1c) and the decisions of the administrative authorities issued under this Act, provided that they regulate the content of substances in articles intended to come into contact with food, toys, cosmetic products, products for children under the age of 3 years (hereinafter referred to as "the subject of normal use") and in products intended to come into direct contact with drinking, hot or raw water during its collection, collection, transport, treatment, distribution, assembly, measurement of supplies and other similar purposes (hereinafter referred to as "the product coming into direct contact with water");
(b) in accordance with the procedure laid down in the Act on the Protection of Public Health (33), impose fines and corrective measures for infringements of the obligations laid down by that Act, the laws adopted for its implementation, the directly applicable provisions of the European Communities (1a), (1c) and the decisions of administrative offices issued under that Act, provided that they regulate the content of substances in articles of common use or products in direct contact with water;
(c) cooperate with the inspection and customs authorities and provide them with professional assistance.
33) Sections 84 and 92 of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended. '
64. In Paragraph 35, the following sentence is added at the end of paragraph 2: "In carrying out the checks referred to in paragraph 1 (a), public health authorities shall proceed in accordance with the provisions of the Public Health Protection Act governing the exercise of national health surveillance. According to the Public Health Protection Act, the rights and obligations of the Public Health Protection Authority and the controlled persons in the exercise of the control referred to in paragraph 1 (a) shall also be assessed. ';
65. Paragraph 36, including the title, reads:
Customs office
Customs office
(a) keeps records of all consignments of substances and preparations classified in accordance with § 2 (2) exported from the Czech Republic and imported into the Czech Republic. This register will allow Ministry, Inspection, State Plant Health Administration and Regional Health Stations to view, extract, copy or copy thereof, including the possibility of remote transmission through the Directorate-General for Customs,
(b) they shall not release dangerous substances or substances contained in products the importation of which is prohibited under Article 26 (3), except for substances imported for scientific, research or supervisory purposes;
(c) controls the import and export of substances in accordance with the provisions directly applicable to the European Communities (1b);
(d) checks that the packaging and labelling of substances and preparations on importation and export comply with the requirements of Sections 19 to 22;
(e) checks that the safety data sheet of the substance or preparation on import and export complies with the requirements of Article 31 of Regulation (EC) No 1907 / 20061a);
(f) when carrying out checks under other legislation, checks the fulfilment of the obligations laid down in paragraphs 19 to 22;
(g) to encourage the Ministry to exercise supreme state control over the import and export of substances and preparations;
(h) initiate an inspection to initiate proceedings where there are reasonable grounds for suspecting a breach of the obligations referred to in (c) to (f). ";
66. In Section 37 (1) of the Introductory Part of the provision, the words "the responsibility in the field of health and environmental protection against the harmful effects of substances and preparations shall be" replaced by "the supervisory activity" and the words "are" inserted after the word "the law."
67.In Paragraph 37 (1) (b):
"(b) in the event of suspected infringement of this law or of the provisions directly applicable to the European Communities, take samples of substances, preparations or articles in order to establish their composition and carry out or analyse them." For samples taken, compensation shall be granted to the person checked at the price at which the substance, preparation or article is sold on the market at the time of removal. The right to reimbursement shall not arise in respect of a substance, preparation or article which does not meet the requirements of this Law or of the directly applicable provisions of the European Communities, '.
68. In Paragraph 37 (1) (f), the words "have submitted a written report within the time limit laid down on the elimination of the deficiencies identified" shall be replaced by the words "have corrected the deficiencies identified, their causes and the harmful consequences identified, or have immediately implemented the necessary measures to eliminate them and to report on them and their results within the time limit laid down on them."
69. in Paragraph 37 (1), the following points (g) and (h) are added:
'( g) suspend or prohibit the placing on the market of a dangerous substance or substance contained in a preparation or article or preparation (1) in the event of a serious risk to the health or safety of persons, property or the environment, or decide to withdraw it from the market;
(h) notify the State Plant Health Administration without delay if it finds a breach of obligations concerning plant protection products or plant protection aids. ";
70. In Paragraph 37 (3) of the Introductory Part of the Provisions, the words "and preparations' are replaced by the words" or substances contained in preparations and articles and preparations (1) '.
71. In Part One, Title X, including the title and footnote 35:
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Regulation Information
| Citation | Act No. 371 / 2008 Coll., amending Act No. 356 / 2003 Coll., on Chemicals and Chemical Products and amending certain laws, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.10.2008 |
|---|---|
| Effective from | 01.11.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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