Act No 345 / 2005 Coll.
Act amending Act No. 356 / 2003 Coll., on Chemicals and Chemicals and amending certain laws, as amended
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Law
Effective from 13.09.2005
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345
THE LAW
of 29 July 2005
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 on the amendment of certain laws, as amended by Act No. 186 / 2004 Coll. and Act No. 125 / 2005 Coll., is amended as follows:
1. In Article 1 (1), the words "legal persons and business natural persons" are replaced by the words "legal persons established in the Czech Republic and foreign legal persons with an organisational component located in the Czech Republic, and business natural persons residing in the Czech Republic and foreign commercial natural persons residing in the Czech Republic."
2. In Article 1 (2), the word "waste (11a) 'shall be inserted after the word" use'.
Footnote 11a reads:
"11a) Act No. 185 / 2001 Coll., on waste and on the amendment of certain other laws, as amended. '.
3. In footnote 1, "796 'is replaced by" 769'.
4. In Section 1, paragraph 6 is added:
"(6) The import and export of chemicals and chemical products shall be subject to customs legislation (20), unless otherwise provided for by this law or specific legislation. ';
5. Paragraph 2 (7) to (12) reads as follows:
"(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. '
6. In Article 2, the following paragraph 13 is inserted after paragraph 12:
"(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."
Paragraph 13 shall become paragraph 14.
7. In Article 2, the following paragraph 15 is added:
"(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 produced for that purpose. ';
8. In Article 3, at the end of paragraph 1, the sentence "The first distributor is required to ensure that the substance or preparation which he acquires is classified in accordance with this Act and to obtain the data used for its classification."
9. in Article 3 (3) (b), the word "issued" shall be replaced by the word "published" and the words "technical data carrier after notification in the Ministry of the Environment Bulletin" shall be replaced by "Public Administration Portal";
10.Paragraph 3 (6) reads as follows:
"(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 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. ';
11. in Article 7, the following paragraph 4 is added:
"(4) The first distributor shall ensure that a new health or environmental hazard assessment is carried out in accordance with paragraphs 1 to 3. ';
12. in Article 9 (1), the words "for classification purposes" shall be deleted and the words "points (f) to (o)" shall be inserted after the words "5."
13. In Paragraph 9, the sentence "The Ministry may carry out verification of compliance with the Principles through the legal entity set up by it 'is added at the end of paragraph 2.
14. In the first sentence of Article 10 (1), the word "first time 'is deleted and the words" in the European Communities' are inserted after the word "market '.
15. Paragraph 10 (6) reads:
"(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 submit the application for registration of the substance by the manufacturer. '
16. in Article 10 (7), (8), (9), Article 13 (1), Article 15 (1) and (2), the words "in the European Communities" shall be inserted after the words "market."
17. in Article 10 (11) (a), the word "chemical" shall be deleted and at the end of point (a) the words "request for consent to submit a limited range of information pursuant to § 12 (5) and an application for registration of an intermediate product with a limited range of information submitted pursuant to § 12 (1) and (5) shall be added;"
18. in Article 10 (11) (b), the words "for substances and intermediate products" shall be inserted after the words "studies."
19. in Article 10 (11) (c) and (d), the word "chemical" shall be deleted;
20. In Paragraph 11 (1) of the Introductory Part of the provision, the words "without registration may be placed on the market 'are replaced by the words" not subject to registration'.
21. In Paragraph 11 (1) (a), the words "issued by the Ministry on the technical data carrier following the notification in the Ministry of the Environment Bulletin" are replaced by the words "published by the Ministry at the Public Administration Portal."
22. in Article 11 (1) (e):
"(e) substances manufactured outside the territory of the European Communities registered in accordance with the provisions of the European Communities (27) in the 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 to register the substance as the sole producer; or"
23. in Article 11 (1), the following point (f) is added:
"(f) substances manufactured in the Czech Republic not intended for marketing in the European Communities."
24. in Article 12 (1), the comma at the end of (g) shall be replaced by a dot and (h) shall be deleted;
25. In Article 12, paragraphs 4 and 5 are added:
"(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 the implementing act referred to in Article 10 (11) (a) are met. '
26. in § 13 (1), § 15 (1) and (2), the word "first time" shall be deleted;
27. in Article 13 (1) (d), "h" is replaced by "g) and Article 12 (4)";
28. In Paragraph 14, at the end of paragraph 1, the dot is replaced by a comma and the following point (f) is added:
"(f) changes in the functional elements of the device in which the intermediate product is located and any other changes which may affect the effects of the intermediate product on humans or the environment.";
29. in Paragraph 15 (4):
"(4) The procedure referred to in paragraph 1 shall not apply where a person intends to place on the market a substance manufactured outside the territory of the European Communities which has been registered in the Czech Republic or in another Member State of the European Communities by a person who has been authorised by the manufacturer to submit an application for registration of a substance as the only one. ';
30. In Article 16, in the title, the words "the Czech Republic 'are replaced by the words" the territory of the European Communities'.
31. in Article 19 (1) and (4), the words' or put into circulation 'are replaced by' or the first distributor to put into circulation ';
32. In Article 19, the following paragraph 7 is added:
"(7) A distributor, with the exception of the first distributor which puts into circulation substances or preparations classified and packaged under this Act, is obliged to put them into circulation in the original packaging or newly packaged in accordance with this Act."
33. In Articles 20 (1), (2) and (3) and 21 (1) and (5), the words "or the first distributor to put into circulation" shall be inserted after the word "market."
34. in Article 20 (4) (b):
"(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, either the manufacturer or the importer. In the case of a substance transported to the territory of the Czech Republic from another Member State of the European Community, the indication of the data referred to in the first sentence shall be sufficient for a person resident or established in the territory of another Member State of the European Communities who is responsible for placing the substance on the market or putting it into circulation throughout the European Community, '.
35. in Article 20 (4) (c) and (5) (d) and Article 21 (8), the words "and the alphabetical indication of the hazardous properties of physicochemical and health or environmental hazards" shall be deleted;
36. in Article 20 (5) (b):
"(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 product on the market in the packaging, either the manufacturer or the importer. In the case of a product transported on the territory of the Czech Republic from another Member State of the European Community, it is sufficient that the particulars referred to in the first sentence are given to a person resident or established in the territory of another Member State of the European Community responsible for placing the product on the market or putting it into circulation throughout the European Community, '.
37. in Paragraph 20 (8), the words "or into circulation" shall be deleted;
38. in Sections 20 (8) and 23 (3), the reference to footnote 5 is replaced by footnote 28a:
"28a) Government Decree No 178 / 2001 Coll., laying down conditions for the protection of the health of workers at work, as amended."
39. in Paragraph 20 (9), "Person" is replaced by "Persons."
40. Paragraph 20 (10) reads:
"(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 as long as the substance or preparation is placed on the market or put into circulation and for a further 3 years and shall provide it to the administrative authorities, upon request, for the purposes of their administrative, control or sanction activities. ';
41. In Article 20, the following paragraph 11 is added:
"(11) A distributor, with the exception of the first distributor to put into circulation substances or preparations classified and labelled under this Act, is obliged to put them into circulation with the original designation or newly labelled in accordance with this Act; new labelling of substances or preparations may only be made by that distributor if the substance or preparations are put into circulation newly packaged in accordance with Article 19 (7). In the case of a new designation, each distributor, including the first distributor, shall be required to indicate on the packaging the particulars of his or her person mutatis mutandis in accordance with paragraph 4 (b) and paragraph 5 (b). ';
42. In Article 21, at the end of paragraph 5, the sentence "The fact that some of the particulars are contained in the package leaflet must appear on the package or label."
43. Paragraph 22 (2) is deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
44. in Paragraph 23 (1):
"(1) A person who places on the market a dangerous substance or a dangerous preparation classified in accordance with Paragraph 2 (5) or a preparation in accordance with paragraph 4 shall be required to ensure that a safety data sheet is drawn up in the Czech language. The safety data sheet shall be a summary of the identification details of the manufacturer or importer, which shall be the name or, where applicable, the name, surname, business name, place of business and telephone number, if any, the natural person authorised to do business, or the name or business name, legal form, seat and telephone number, if applicable, the legal person, the dangerous substance or preparation and the data needed for health and the environment. The manufacturer or importer may agree with the distributor who takes the substance or preparation from him to provide information on the distributor in the safety data sheet instead of the manufacturer or importer. ';
45. In Article 23, the following paragraph 2 is inserted after paragraph 1:
"(2) The first distributor shall ensure that a safety data sheet is drawn up for this substance or preparation in accordance with this law. In the safety data sheet, the first distributor shall indicate the data referred to in paragraph 1 in the second sentence of his or her person and, at the same time, the data relating to the manufacturer, importer or distributor established in the territory of another Member State of the European Communities from which the safety data sheet was taken over. A distributor who repackages a substance or a preparation in accordance with § 19 (7) or redenotes a substance or preparation in accordance with § 20 (11) shall be required to enter in the safety data sheet the information referred to in paragraph 1, second sentence, on his person. ';
Paragraphs 2 to 8 shall be renumbered paragraphs 3 to 9.
46. In the second sentence of Article 23 (3), the words "or export 'are deleted.
47. Paragraph 23 (5) reads:
"(5) Where a person who places on the market or puts into circulation dangerous substances or dangerous preparations as referred to in paragraph 3 or preparations as referred to in paragraph 4 finds new serious information on a dangerous substance or preparation, he shall be obliged to provide that information without delay to the recipient of a safety data sheet which has received a dangerous substance or preparation during the previous 12 months. New serious information on a dangerous substance or preparation, in particular on hazards to health or the environment, shall be provided in a new safety data sheet identified as revisions. This new safety data sheet shall clearly indicate the information which has been added, released or modified. ';
48. in Article 23 (7) and (8):
"(7) The persons referred to in paragraphs 1 and 2 shall keep the supporting documents used for drawing up the safety data sheets during the period of placing on the market or putting into circulation of the substances or preparations for which those safety data sheets have been drawn up and for the following 3 years and shall provide them to the administrative authorities on request for their administrative, control or sanction activities.
(8) Persons referred to in paragraphs 1 and 2 who place on the market or put into circulation dangerous substances or preparations classified under § 2 (5) (a) to (n) shall also be required to send a safety data sheet in electronic form within 30 days of the date on which they first placed the substance or preparation on the market to the Ministry of Health. '
49. in Paragraph 24 (1):
"(1) The Ministry of Health shall carry out a check on the completeness and correctness of the technical documents submitted in the registration of substances pursuant to Sections 12, 13 and 18 and assess the risk of substances to health. The Ministry of Health may entrust the inspection of technical documentation and risk assessment to a competent person, except for the person requesting the registration of the substance. The Ministry shall check the completeness and accuracy of the technical documents submitted in the registration of substances pursuant to Sections 12, 13 and 18 and assess the risk of substances to the environment. The Ministry may entrust the inspection of technical evidence and risk assessment to a competent person, except for the person requesting the registration of the substance. ';
50. In Article 24 (3), the words "or Article 10 (6) 'shall be inserted after the words" Paragraph 10 (1)'.
51. Paragraph 28 (10) reads:
"(10) The information referred to in the notifications referred to in paragraphs 1 and 4 shall be subject to the provisions on commercial secrecy laid down in Article 17. ';
52. in Paragraph 31 (1) (f):
"(f) assess the risk of environmental substances registered under Title III and substances in the national list of priority substances referred to in Article 29;"
53. In Paragraph 31 (1), the dot is replaced by a comma at the end of point (m) and the following points (n) and (o) are added:
"(n) carry out the functions of the competent authority referred to in Article 8 (1) of Regulation (EC) No 648 / 200431a),
(o) carry out the functions of competent authority pursuant to Article 15 of Regulation (EC) No 850 / 200431b.
31a) Regulation (EC) No 648 / 2004 of the European Parliament and of the Council on detergents.
31b) Regulation (EC) No 850 / 2004 of the European Parliament and of the Council on persistent organic pollutants and amending Directive 79 / 117 / EEC. '
54. in Article 32 (1) (c), the words "and giving consent" shall be inserted after the words "substances."
55. in Article 32 (1) (e) and (f):
"(e) ensure the collection of safety data sheets in accordance with Article 23 (8); another public health authority or a Toxicological Information Centre may be entrusted with the management of the relevant database;
(f) assess the risk of substances to health registered in accordance with Title III and substances in the national list of priority substances referred to in Article 29; ';
56. in Articles 33 (c) and 34 (1) (d), the words "specific legislation" are replaced by the words "implementing legislation pursuant to Article 26 (3)."
57. in § 33 (d) and § 34 (1) (e), "§ 38" is replaced by "§ 38 and 38a."
58. in § 35 (1) (a), "§ 23 (7)" is replaced by "§ 23 (8)";
59.In § 35 (1) (b), "§ 38" is replaced by "§ 38a."
60. In the first sentence of Paragraph 36 (a), the words "released across national borders" are replaced by the words "exported from the territory of the Czech Republic and imported into the territory of the Czech Republic," in the second sentence, "and" replaced by a comma, "the words" and the regional office, "the word" digital "is replaced by the word" remote, "and at the end of the text the words" via the Directorate-General of Customs. "
61. in Paragraph 36 (b), the word "ensure" shall be replaced by the word "do not release" and "inform the inspection without delay" and the second sentence shall be deleted;
62. In Paragraph 37 (3) (a), the words "the authority to carry out the inspection" shall be replaced by the words "the inspector's or the authorised officer's card."
63. The title of Title X shall read "REPEAL MEASURES AND ADMINISTRATIVE DEPARTMENTS."
64. In Paragraph 38, paragraphs 3 to 5 are deleted.
65. The following Sections 38a to 38c are inserted after Section 38:
(1) The manufacturer, importer or distributor commits an administrative offence by:
(a) they shall not indicate the substance or preparation referred to in Article 22 (1);
(b) not inform of the dangerous properties referred to in Article 22 (2);
(c) does not provide a safety data sheet or any new relevant information, although it is required to do so under Article 23 (2) to (4); or
(d) it shall place on the market or put into circulation a selected dangerous substance or a selected dangerous product without complying with the requirements of Article 26 (1).
(2) The manufacturer or importer shall further commit an administrative offence by:
(a) it does not classify substances or preparations or it does not comply with the procedures and conditions laid down in Articles 3 to 7 and 8 (1) before they are placed on the market or put into circulation;
(b) not to affix the substance or preparation with the packaging and closure provided for in Section 19;
(c) shall not indicate the substance or preparation in accordance with § 20 to 21 or § 11 (3) or § 13 (5);
(d) produce a safety data sheet in accordance with Article 23 (1);
(e) it does not keep documents or provide them on request pursuant to § 19 (4), § 20 (10) or § 23 (6);
(f) not provide the Ministry with information pursuant to § 24 (3) or § 25 (3);
(g) infringes the notification obligation or does not keep a record in accordance with § 28;
(h) to place a substance on the market without applying for its registration pursuant to Article 10 (1) or Article 15 (1);
(i) does not provide the Ministry of Health with information pursuant to § 11 (2) (c) and (d) and § 4, § 12 (1), § 13 (1) to (4), § 18 (2), § 24 (3) or § 25 (3);
(j) it shall place on the market the substance before the deadline referred to in Article 10 (7) or (8) or without the assigned reference number;
(k) does not withdraw from the market or circulation an unregistered substance or preparation containing the unregistered substance, in accordance with Article 10 (9);
(l) not to notify the Ministry of Health of the excess of the limit quantities and not to carry out the relevant additional tests or studies under § 12 (2) (a) to (c);
(m) does not provide the Ministry of Health with the results of tests or studies pursuant to § 12 (2) (a) to (c) and § 3;
(n) does not provide the Ministry of Health with any subsequent information pursuant to Paragraph 14 (1);
o) does not request information from the Ministry of Health pursuant to § 15 (3); or
(p) infringes the notification obligation under Article 23 (8).
(3) Furthermore, the importer commits an administrative offence by violating the obligation of information provided for in Article 14 (2).
(4) The distributor further commits an administrative offence by:
(a) put into circulation substances or preparations the packaging of which does not comply with Article 19 (7); or
(b) put into circulation substances or preparations the labelling of which does not comply with Article 20 (11).
(5) The first distributor further commits an administrative offence by:
(a) does not ensure classification or obtain data in accordance with the second sentence of Article 3 (1);
(b) shall not provide for a new evaluation in accordance with Article 7 (4);
(c) not to affix the substance or preparation with the packaging and closure provided for in Section 19;
(d) it does not keep documents or provide them on request in accordance with § 19 (4), § 20 (10) or § 23 (6);
(e) does not ensure the labelling of a substance or preparation in accordance with Sections 20 to 22;
(f) does not ensure that a safety data sheet is drawn up in accordance with Article 23 (1); or
(g) infringes the notification obligation under Article 23 (8).
(1) A person carrying out a test of dangerous properties of substances or preparations for the purposes of this Act shall commit an administrative offence by:
(a) does not apply the basic methods for testing the hazardous properties of substances and preparations in compliance with the principles and principles of animal protection in accordance with § 8 (2) to (4);
(b) it does not have a certificate of compliance with the principle of Article 9 (1);
(c) not confirm in writing, when submitting the results of the tests, that the tests have been carried out in accordance with the principles laid down in Article 9 (5); or
(d) does not provide information on compliance with the Principles under Paragraph 9 (3).
(2) The person responsible for applying for a marketing authorisation pursuant to Article 10 (6) shall commit an administrative offence by:
(a) does not provide information to the Ministry of Health pursuant to Articles 11 (2) (c) and (d) and 4, 12 (1), 13 (1) to (4), 18 (2) or 24 (3),
(b) not to notify the Ministry of Health of the excess of the limit quantities and not to carry out the relevant additional tests or studies in accordance with § 12 (2) (a) to (c);
(c) does not provide the Ministry of Health with the results of tests or studies pursuant to § 12 (2) (a) to (c) and § 3;
(d) does not provide the Ministry of Health with any subsequent information pursuant to Paragraph 14 (1);
(e) require no information from the Ministry of Health pursuant to Article 15 (3); or
(f) does not provide the Ministry with information pursuant to § 24 (3).
(3) A person commits an administrative offence in breach of the rules of the European Communities
(a) not notify the Ministry in due time of the export of the substance referred to in Part 1 and of the products containing the substances listed in Parts 2 and 3 of Annex I to Regulation (EC) No 304 / 2003 in conjunction with Article 14.1 of Regulation (EC) No 304 / 200330,
(b) they shall not notify the Ministry in due time of the first export of a substance pursuant to Article 7.1 of Regulation (EC) No 304 / 200330;
(c) inform the Ministry in good time of the quantity of the substance listed in Annex I to Regulation (EC) No 304 / 2003 (EC) exported during the calendar year referred to in Article 9.1 of Regulation (EC) No 304 / 200330;
(d) inform the Ministry in due time of the quantity of the substance listed in Annex I to Regulation (EC) No 304 / 2003 imported during the calendar year referred to in Article 9.1 of Regulation (EC) No 304 / 200330;
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Regulation Information
| Citation | Act No. 345 / 2005 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 | 13.09.2005 |
|---|---|
| Effective from | 13.09.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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