Act No. 346 / 2005 Coll.
Act amending Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products
Valid
Law
Effective from 13.09.2005
Text versions:
13.09.2005
346
THE LAW
of 29 July 2005
amending Act No 78 / 2004 Coll., on the Management of Genetically Modified Organisms and Genetic Products
Parliament has decided on this law of the Czech Republic:
Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, is amended as follows:
1. in Article 3 (1) (a) and (b), the words "entered into circulation in the List of Products" shall be replaced by the words "approved for circulation in accordance with Article 23 (2)";
2. in Article 3 (1) (c):
"(c) the placing into circulation of genetically modified organisms or genetic products (hereinafter referred to as" putting into circulation "), which shall be deemed to have been handed over to another person, whether or not for the sole purpose of being disposed of or put into the environment, to the person entitled to such disposal."
3. In Paragraph 4 (4), at the end of the first sentence, the words "or on the basis of written consent or authorisation to put it into circulation issued by the competent authority of another Member State 'shall be added.
4. In Article 5 (4), the words "publish the summary of the content of the application in accordance with Article 10 (b) and the information on the initiation of the procedure 'are replaced by the words" publish the summary of the content of the application and the information on the initiation of the procedure, as well'.
5. In Article 5, the following paragraph 12 is added:
"(12) The same status as the ministries concerned shall be established in accordance with paragraphs 4, 5, 9 and 11, Article 16 (10) and Article 18 (7) of the counties in whose territory the treatment or placing into the environment is immediately closed. ';
6. In Article 9 (1), the word "confidential 'shall be replaced by" business secrets 7)' and the words "disclosure of confidential information would in fact be detrimental to competition, otherwise such data cannot be classified as confidential 'shall be replaced by the words" its trade secrets are its trade secrets'.
7. In Paragraph 9 (2) of the introductory part of the provision, the words "confidential data cannot 'are replaced by the words" business secrets cannot be covered by this Act'.
8. In Section 9 (3) of the introductory part of the provision, the word "confidential 'is replaced by" business secrets'.
9. Paragraph 9 (4) reads as follows:
"(4) Unless otherwise provided for in this Act, the collection, storage, publication and other processing of personal data carried out in connection with the management of genetically modified organisms and genetic products shall be carried out in accordance with the Specific Act (8). ';
10. In Article 9, paragraphs 5 to 7 are deleted.
11. In Article 11, at the end of paragraph 2, the sentence "Where a genetically modified organism or genetic product is put into circulation for which written consent or authorisation for placing into circulation has been given by the competent authority of another Member State, the person putting it into circulation in the course of his business shall ensure that the labelling and packaging also complies with the relevant requirements specified in that consent or authorisation. ';
12. Paragraph 11 (3), including footnote 8a, reads as follows:
"(3) For products for which random or technically unavoidable additives of genetically modified organisms approved for circulation pursuant to Article 23 (2) cannot be excluded, the Ministry shall, in accordance with European Community law (8a), set a threshold for the presence of such additives by implementing legislation. Where the values for the occurrence of additives in a product are lower than the threshold, the product may no longer be marked in accordance with paragraphs 1 and 2.
(8a) Article 21 (2) of Directive 2001 / 18 / EC of the European Parliament and of the Council, as amended by Regulation (EC) No 1830 / 2003 of the European Parliament and of the Council of 22 September 2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed produced from genetically modified organisms and amending Directive 2001 / 18 / EC. "
13. in Article 13, at the end of point (d), the dot is replaced by a comma and the following point (e) is added:
"(e) the expiry of the period for which the written consent or authorisation for placing into circulation has been issued by the competent authority of another Member State or by the withdrawal of such consent or authorisation.";
14. in Article 16 (4), "within 15 days" is replaced by "within 30 days."
15. Paragraph 20 (5) reads:
"(5) Information on the emergency plan shall be published by the Ministry in accordance with Article 10 (b) and (c). The scope of this information shall be determined by implementing legislation. '.
16. In Article 20 (6), the words "emergency plan 'are replaced by the words" emergency plan information'.
17. Paragraph 23 (3) reads as follows:
"(3) Any person who grows genetically modified organisms approved for putting into circulation in accordance with paragraph 2 shall provide the Ministry with written information on their place of cultivation no later than 60 days after the start of their cultivation. The Ministry shall communicate this information to the public on the basis of evidence of reasonable interest. ';
18. In Article 24, paragraph 18 is added, including footnote 11a:
"(18) Paragraphs 1 to 17, 11 (1) and (2), 23, 25 and 26 shall not apply to the putting into circulation of genetic products intended for direct use as food or feed or for processing, provided that they comply with the conditions laid down in the relevant directly applicable regulation of the European Communities (11a).
11a) Article 47 of Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. Article 12a of Directive 2001 / 18 / EC of the European Parliament and of the Council, as amended by Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. ';
19. In Article 25 (6), the words "and, in the case of pharmaceuticals, the State Institute for Drug Control 'are replaced by the words" and in the case of medicinal products for human use, the State Institute for Drug Control and, in the case of veterinary medicines, the Institute for State Control of Veterinary Bioprafts and Medicines'.
20. In Article 28, the dot is replaced by a comma at the end of paragraph 1 and the following point (h) is added, including footnote 13a:
"(h) exercise the competence of the contact point and the competent administrative authority in accordance with the directly applicable European Communities Regulation on the cross-border movement of genetically modified organisms 13a).
13a) Article 17 of Regulation (EC) No 1946 / 2003 of the European Parliament and of the Council of 15 July 2003 on the movement of genetically modified organisms across borders. '
21. In Paragraph 28 (2), the words "appoint and revoke with their consent" shall be replaced by "appoint and revoke with their consent."
22. in Article 35 (2) (h), the words' for the previous calendar year 'shall be replaced by' on time ';
23. In Article 35, at the end of paragraph 2, the dot is replaced by a comma and the following point (i) is added:
"(i) fail to comply with the conditions for the export, import or other cross-border movement of genetically modified organisms laid down in Article 25 and the relevant directly applicable European Communities16a).
16a) Regulation (EC) No 1946 / 2003 of the European Parliament and of the Council of 15 July 2003 on the movement of genetically modified organisms across borders. ';
24. in § 35 (3) (g), the words "although required under § 11 (1) and (2)" shall be replaced by "and the relevant directly applicable regulation of the European Communities (16b)."
Footnote 16b reads:
"(16b) Article 4 (6) of Regulation (EC) No 1830 / 2003 of the European Parliament and of the Council of 22 September 2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed produced from genetically modified organisms and amending Directive 2001 / 18 / EC."
25. in Article 35 (3), the following point (h) is inserted after point (g):
"(h) fails to comply with the traceability and labelling requirements for products consisting of or containing genetically modified organisms set out in the directly applicable Regulation of the European Communities (16c);
16c) Article 4 (1) to (4) of Regulation (EC) No 1830 / 2003 of the European Parliament and of the Council of 22 September 2003. "
Points (h) to (m) shall be renumbered as points (i) to (n).
26. in Paragraph 38 (h):
"(h) the requirements of the emergency plan (§ 20 (4)) and the scope of the Ministry's published information on the emergency plan (§ 20 (5)),"
27. in Paragraph 38, at the end of point (i), the dot is replaced by a comma and the following point (j) is added:
"(j) particulars of evidence of legitimate interest.";
28. in Article 40 (2), the words "Article 11 (3)," shall be deleted;
29. In Article 40, the following paragraph 3 is added:
"(3) Paragraph 24 (18) shall expire on 18 April 2007."
Efficacy
This Act shall take effect on the day of its publication.
Zaoralek v. r.
Klaus v. r.
Paroubek v. r.
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Regulation Information
| Citation | Act No. 346 / 2005 Coll., amending Act No. 78 / 2004 Coll., on the Management of genetically modified organisms and genetic products |
|---|---|
| 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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