Act No 371 / 2016 Coll.
Act amending Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended, and Act No. 252 / 1997 Coll., on Agriculture, as amended
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Effective from 01.01.2017
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01.01.2017
14.11.2016
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371
THE LAW
of 19 October 2016
amending Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended, and Act No. 252 / 1997 Coll., on Agriculture, as amended
Parliament has decided on this law of the Czech Republic:
Amendment of the act on the management of genetically modified organisms and genetic products
Act No. 78 / 2004 Coll., on the treatment of genetically modified organisms and genetic products, as amended by Act No. 346 / 2005 Coll., Act No. 124 / 2008 Coll., Act No. 227 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 18 / 2012 Coll., Act No. 279 / 2013 Coll. and Act No. 243 / 2016 Coll., is amended as follows:
1. Paragraph 1 (1), including footnotes 1 and 21, reads as follows:
"(1) This law implements the relevant European Union1), building on the directly applicable European Union21), and regulating the rights and obligations of persons and the powers of administrations in the management of genetically modified organisms and genetic products.
1) Directive 2001 / 18 / EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 / 220 / EEC. Directive 2009 / 41 / EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. Directive (EU) 2015 / 412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001 / 18 / EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) on their territory.
21) Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. 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 products produced from genetically modified organisms and amending Directive 2001 / 18 / EC. Regulation (EC) No 1946 / 2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms. ';
2. Paragraph 1 (4), including footnotes 2 and 22, reads as follows:
"(4) Where a genetically modified organism or a genetic product is a medicinal product subject to registration in accordance with a directly applicable European Union regulation governing procedures for the authorisation of medicinal products for human and veterinary use and the supervision of them (2) or a plant protection product for which authorisation is granted under the directly applicable European Union regulation on the placing of plant protection products on the market (22), Article 11 and the provisions of Part Four of this Act shall not apply.
(2) Regulation (EC) No 726 / 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
22) Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC. '
3. In Sections 2 (f), 3 (1) (a) to (c), 5, 5 (7) and 10, 6 (2), 7 (3) (a) and (c), 8 (1), (4) and (5), 9 (2) (d), 11 (3) and (4), 12 (1) of the introductory part of the provisions, 12 (1) (b), 12 (1) (c) and 12 (2), 13 (a) and (d), 17 (2), 28 (1) (g) and 37 (2) are replaced by "on the market."
4. in Article 3 (1) (a) and (b), "2" is replaced by "1."
5. In Article 4, the words "to 16c 'shall be added at the end of the text of paragraph 2.
6. Paragraph 4 (4), including footnote 23, reads as follows:
"(4) The marketing authorisation shall be issued on the date on which the decision on the placing on the market of a genetically modified organism or a genetic product is taken to take effect by the competent authority of another Member State of the European Union (hereinafter referred to as" the Member State ') or by an authorisation pursuant to the directly applicable European Union Regulation on genetically modified food and feed (23). Article 23 to 24c provides for more detailed conditions for this authorisation.
(23) Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council. "
7. Paragraph 5 (1) and (2) reads as follows:
"(1) Application for authorisation for contained use, authorisation for placing in the environment or registration in the Marketing List under this Act shall be submitted by the applicant to the Ministry
(a) via a data box;
(b) in electronic form, signed by a recognised electronic signature; or
(c) in paper form, provided that it is simultaneously supplied on the technical medium or sent in electronic form by means of a public data network.
(2) The applicant may refer in the application to data, information or results contained in previously submitted applications. The data, information or results contained in applications submitted by other applicants may be referred to only where such data, information or results are not subject to the protection provided for in Article 9 or where the applicant at whose request the reference is made has given written consent. ';
8. In Article 5 (4), the words "one copy of the application in paper form and also electronically 'are replaced by the words" application' and the words "and, at the same time, in accordance with Article 10 (b), the summary of the content of the application and the information on the initiation of the procedure, the information on the initiation of the procedure shall also be published in accordance with Article 10 (a) and (c) ';
9. In Article 5 (4), the first sentence is replaced by the following: "Information concerning the initiation of an authorisation procedure for placing in the environment or the registration procedure for the Marketing List shall be published by the Ministry in accordance with Article 10. A summary of the content of the application for authorisation for placing in the environment or for registration in the Marketing List shall be published by the Ministry in accordance with Article 10 (b). ';
10. in Article 5 (7), the words "in the case of an application for an authorisation for placing in the environment or entry into the List for putting into circulation" shall be deleted;
11. in Article 5 (12):
"(12) The same status as the ministries concerned shall be established in accordance with paragraphs 4, 5, 9 and 11, Article 16c (4) and Article 18 (7) of the Regional Office, in whose administrative district the treatment or placing into the environment is to take place immediately. '
12. in Articles 7 (3) (b), 9 (1), 20 (2) (b) and 22 (4) and (6), "2 or 3" is replaced by "3 or 16a (5)."
13. in Article 7 (3), the following point (c) is inserted after point (b):
"(c) the person authorised under this Act to dispose of the first category of risk in cases under Paragraph 16a (4),"
Points (c) and (d) shall be renumbered points (d) and (e).
14. in Article 7 (3), point (e) is deleted;
15. in Article 7, paragraph 5 is deleted;
Paragraphs 6 and 7 shall become paragraphs 5 and 6.
16. in Article 8 (4), the words "the European Communities (hereinafter referred to as the Member States)" shall be deleted;
17. in Article 8 (5), the words "consent or authorisation" shall be replaced by "written consent."
18. in Paragraph 8 (6) (c), the word "granted" shall be replaced by "written," the words "or" authorisation "shall be deleted and the words" authorisation granted "shall be replaced by" written. "
19. in Articles 9 (2) (b) and 18 (6) (a), the word "registered office" shall be replaced by "registered office" and "place of business" shall be replaced by "registered office";
20. In Sections 9 (2) (b), 18 (6) (a), 22 (5) (a) and 25 (7) (c) and (d), the word "persons" shall be inserted after the words "identification number."
21. In Articles 9 (2) (b), 18 (6) (a), 22 (5) (a) and 25 (7) (c) and (d), the words "or, where appropriate, names, surnames" shall be deleted.
22. in Paragraph 10 (b):
"(b) on its website,"
23. in Article 11 (1) and (2):
"(1) The person providing the genetically modified organism solely for the purposes of contained use or placing in the environment shall ensure that the words" Genetically modified organism 'are clearly indicated on the label or in the accompanying document of the genetically modified organism and that the designation of the genetically modified organism meets any additional labelling requirements resulting from the authorisation for contained use or placing in the environment.
(2) A person who, in the course of his business, places a genetically modified organism or a genetic product on the market must ensure that the words "This product contains genetically modified organisms" are indicated on the label or accompanying document of the genetically modified organism or genetic product. The designation of the genetically modified organism or genetic product shall also include:
(a) the trade name of the genetic product;
(b) the name of the genetically modified organism;
(c) the name and address of the registered office of the person established in the territory of one of the Member States responsible for marketing;
(d) an indication of where it is possible to obtain further publicly available information on this genetic product. ';
24. In Paragraph 11, the following paragraph 3 is inserted after paragraph 2:
"(3) In addition, the designation of a genetically modified organism or a genetic product placed on the market shall comply, where appropriate, with the additional labelling requirements resulting from the entry in the list of placing on the market or the written consent issued for placing on the market by the competent authority of another Member State or the authorisation issued under the directly applicable European Union Regulation on genetically modified food and feed (23). ';
Paragraphs 3 and 4 shall be renumbered paragraphs 4 and 5.
25. in Articles 11 (4) and 28 (1) (h), the words "the European Communities" shall be replaced by the words "the European Union."
26. in Paragraph 11 (4), "paragraph 2" is replaced by "paragraph 1" and "paragraphs 1 and 2" is replaced by "paragraphs 2 and 3."
27. in Article 13 (e), the words "or authorisation for placing into circulation by the competent authority of another Member State" shall be replaced by the words "for placing on the market by the competent authority of another Member State or for which authorisation has been granted under the directly applicable European Union Regulation on genetically modified food and feed (23)."
28. In Article 13, at the end of point (e), the dot is replaced by a comma and the following point (f) is added:
"(f) if the person entitled to the contained use does not submit a new notification in the cases referred to in Article 16b (2)."
29. in Article 15 (3), "Article 16" is replaced by "Article 16 to 16c."
30.
(1) Authorisations for the contained use may be granted only to a legal person or to a natural person authorised to do business.
(2) The authorisation for the contained use, which has been included in the first or second risk category on the basis of the outcome of the risk assessment provided for in Article 7, is a notification. The authorisation for the contained use, which, on the basis of the outcome of the risk assessment referred to in Article 7, has been placed in a third or fourth risk category, shall arise from the date on which the authorisation for the contained use is acquired.
(3) The notification or application for authorisation for contained use must be submitted to the Ministry before the first contained loading in a closed area pursuant to Paragraph 15 (2). The notification or application for authorisation for contained use may be submitted jointly for several enclosed spaces, if located in one building.
(4) The notification of the contained use of the first or second risk category and the application for authorisation for the contained use of the third or fourth risk category shall, in addition to the general requirements of the administrative rules, always contain:
(a) identification, contact and other details of the expert adviser and contact person at the workplace;
(b) information on genetically modified organisms;
(c) the purpose of the contained use;
(d) the address and description of the workplace on which the contained use will take place;
(e) an assessment of the premises and facilities of the workplace on which the contained use will be carried out with regard to compliance with the requirements for the closed space and protective measures laid down for the relevant risk category; and
(f) the opinion of the expert adviser.
(5) The application for authorisation for the contained use of a third or fourth risk category shall also include:
(a) a description of the contained use; and
(b) information on the duration of the contained use.
(6) The implementing act shall lay down in the form of a model of notification or application detailed content of:
(a) notification of the contained use of the first risk category;
(b) notification of the contained use of the second risk category;
(c) applications for authorisation for the contained use of a third or fourth risk category. "
31. The following Sections 16a to 16c are inserted after Section 16:
(1) Notification of the contained use of the first or second risk category by the notifier to the Ministry
(a) via a data box;
(b) in electronic form, signed by a recognised electronic signature; or
(c) in paper form, provided that they are simultaneously supplied on the technical medium or sent in electronic form via the public data network.
(2) The notifier may refer in the notification to data, information or results which are the content of the notifications previously submitted. The data, information or results contained in notifications submitted by other notifiers may only be referred to if such data, information or results are not subject to the protection provided for in Article 9 or if the notifier referred to has given written consent.
(3) The contained use of the first risk category may be initiated immediately after notification. The contained use of the second risk category may be initiated 45 days after the date of the notification, unless within that period the Ministry issues one of the decisions referred to in Paragraph 16b (1). With the agreement of the Ministry, the contained use of the second risk category may be initiated even before the end of that period; parts of the second and third administrative regulations shall not apply to the consent of the Ministry.
(4) Where, in a closed area notified under paragraph 1, genetically modified organisms which have not been listed in that notification are subsequently to be treated and the result of the risk assessment of the contained treatment of those organisms pursuant to paragraph 7 is its inclusion in the first risk category, the notifier shall only submit to the Ministry an appropriate risk assessment with reference to the previous notification submitted under paragraph 1. The contained treatment of these organisms may be initiated immediately upon submission of a risk assessment. The risk assessment for the contained use of the first risk category shall include, in addition to the reference to the previous notification, information on newly used GMOs and expert advice. The risk assessment model for such a case of contained use of the first risk category shall be established by implementing legislation.
(5) If it is subsequently to be handled in the restricted area notified under paragraph 1 with genetically modified organisms not mentioned in that notification and the result of the risk assessment of the contained treatment of those organisms pursuant to Article 7 is to be classified in the second risk category, the notifier shall be required to submit a new notification to the Ministry.
(6) The Ministry shall send the notifier a certificate of receipt of the notification referred to in paragraph 1 or 5 or of the acceptance of the risk assessment referred to in paragraph 4 within 5 working days of the date of submission of the notification. The Ministry shall be entitled to request from the notifier within 30 days of the date of submission of the notification, or from the submission of the risk assessment referred to in paragraph 4, further information or specification of the information specified in the notification or in the risk assessment.
(1) The Ministry may, on the basis of the notification, risk assessment, further information or specification of the data referred to in Article 16a (6) or the new information referred to in Article 8, require the notifier to make an adjustment to the conditions of the contained use set out in the notification, to include the contained use in another risk category or to suspend or terminate the contained use if necessary in terms of health or environmental protection. An appeal against a decision requiring the notifier to modify the conditions for the contained use set out in the notification, to include the contained use in another risk category or to suspend or terminate the contained use shall not have suspensory effect.
(2) A new notification must be submitted by the person entitled to the contained use if:
(a) adjust the enclosed space or contained use in a way that could have significant consequences for the risks associated with such handling; or
(b) obtain new information which could have significant consequences for the risks associated with such disposal.
(3) A certificate shall be issued by the Ministry on request of the notifier on the creation of an authorisation for the contained use pursuant to Article 16 (3) or Article 16a (4).
(1) The contained use of the third or fourth risk category may only be operated to the extent and under the conditions laid down in the authorisation for the contained use.
(2) The procedure for granting the authorisation for contained use shall be followed in accordance with Section 5.
(3) The authorisation for contained use contains:
(a) the name or name or business name, the address of the place of residence, the address of the registered office and the identification number of the person, if assigned, authorised, if he is a natural person authorised to do business, or the name or business name, the address of the registered office and the identification number of the person, if assigned, authorised, if he is a legal person;
(b) the specification of the genetically modified organism;
(c) the specification of the genetic modification;
(d) conditions of contained use taking into account health and environmental requirements;
(e) the risk category for which it was granted;
(f) the purpose of the contained use;
(g) any additional labelling requirements pursuant to Article 11 (1);
(h) the period of validity of the authorisation.
(4) The validity of authorisations for contained use must be limited in time. The Ministry may, at the request of the authorised person, not later than 60 days before the expiry date of the authorisation and after consulting the ministries concerned, extend the period of validity of the authorisation. The authorised person may continue the contained use to the extent and in accordance with the conditions laid down in the authorisation until a decision on the request for renewal has been taken.
(5) The authorisation for contained use is not transferable to another person. '
32. In Article 17, the following paragraphs 2 and 3 are inserted after paragraph 1:
"(2) The application for authorisation for placing in the environment shall, in addition to the general requirements of the application under the administrative rules, always include:
(a) name of the project;
(b) identification, contact and other details of the expert and contact person at the workplace;
(c) information on the genetically modified organism;
(d) information on the place where the placing into the environment will take place;
(e) the purpose and duration of the placing into the environment;
(f) a description of the management of the genetically modified organism;
(g) monitoring information;
(h) information on measures taken after the end of the placing into the environment and on waste management;
(i) information on the placing on the environment of the genetically modified organism in other States; and
(j) the opinion of the expert adviser.
(3) The implementing act shall lay down, in the form of a model application, the detailed content of the application for authorisation for placing in the environment in the case of a genetically modified organism which:
(a) higher plants;
(b) by an organism other than a higher plant;
(c) placed in the environment for the purpose of clinical trial of medicinal products. "
Paragraph 2 shall become paragraph 4.
33. In Paragraph 18 (2), the words "at the same time as the application or no later than 10 days after its submission 'are replaced by the words" on request'.
34. in Article 18 (6), the following point (d) is inserted after point (c):
"(d) the result of the risk assessment carried out in accordance with Article 7;"
Points (d) to (i) shall be renumbered as points (e) to (j).
35. in Paragraph 18 (6) (h), the words "in the case of field trials" shall be inserted after the words "to take place."
36. In Paragraph 18 (7), the last sentence shall be replaced by the sentence "The Ministry shall inform the Commission of the decision granting authorisation for placing in the environment or extending it."
37. in Article 19 (b), the words "including the operating rules of that place, the details of which are laid down in Annex 4 to this Act," and the words "10 years after the end of such disposal" shall be replaced by the words "5 years after the end of disposal in the case of contained handling and 10 years after the end of disposal in the case of placing in the environment and, on request, by the administrative authorities referred to in Article 27."
38. in Paragraph 19 (c):
"(c) send the Ministry, by 15 February of the calendar year, an overview of the genetically modified organisms, their quantities, their handling and comments on the review of the risk assessment for the previous calendar year,";
39. in Article 20 (2) (b), the words "on the contained use of the second risk category" shall be inserted after the words "submitting the notification."
40. In Articles 20 (2) (c) and (d) and 21 (1) and (2), the words "second and higher risk categories" shall be inserted after the words "loading."
41. in Article 20 (2) (c) and (d), the words "authorised person" shall be inserted after the words "or" authorised person. "
42. In Article 20 (3), the words "the applicant and 'shall be deleted and the words" the obligation' shall be replaced by the words "the obligation '.
43.Paragraph 20 (4) reads as follows:
"(4) The emergency plan shall be drawn up in accordance with the model laid down in the implementing act."
44. in Article 22 (3), the words "Paragraph 16 (9)" shall be replaced by the words "Paragraph 16c (3)" and the words "which are considered confidential" shall be replaced by the words "classified as business secrets."
45. in Article 22 (5) (a), the words "place of business" shall be replaced by the words "address of the registered office" and the words "seat" shall be replaced by the words "address of the registered office."
46. in Article 22 (5) (b):
"(b) the genetically modified organism for which authorisation has been granted to the user or the group of organisms referred to in the notification or risk assessment submitted pursuant to Article 16a (4);"
47. in Article 22 (7), "2 or 3" is replaced by "3 or Article 16a (5) or on the basis of a risk assessment submitted pursuant to Article 16a (4)."
48. The fourth part, including the title and footnotes No 24 and 25, reads:
MARKET INSPECTION
GENERAL PROVISIONS
(1) A genetically modified organism or genetic product may only be placed on the market if it has been entered in the Marketing List or if written consent has been given for placing on the market by the competent authority of another Member State or if an authorisation has been granted under the directly applicable European Union Regulation on genetically modified food and feed (23). The treatment of a genetically modified organism or genetic product authorised for placing on the market shall be limited to the extent of such registration, consent or authorisation and subject to the conditions laid down therein.
(2) Anyone who cultivates genetically modified organisms approved for placing on the market pursuant to paragraph 1 shall provide the Ministry with written information on their place of cultivation no later than 60 days after the start of their cultivation, in the event that they have not already done so under the Agricultural Act (20). The Ministry shall publish the sites of cultivation of GMOs on its website.
(3) The person entered in the Marketing List must ensure that monitoring and reporting of the results thereof are carried out in accordance with the requirements laid down in this Minutes. The Ministry is authorised to specify monitoring requirements on the basis of these reports after the first monitoring period. The results of the monitoring shall be made available to the public by the Ministry on its website.
(4) The reports on the results of the monitoring referred to in paragraph 3 shall be transmitted by the Ministry to the Commission and the competent authorities of the Member States.
PROCEDURE FOR THE MARKET INVESTIGATION LIST
(1) The procedure for registration in the Marketing List shall be followed in accordance with Section 5, unless otherwise specified. An application for registration may be submitted only by a legal person or a natural person authorised to do so.
(2) The application for registration in the Marketing List must, in addition to the general terms of the application under the administrative rules, always contain:
(a) the name of the genetic product;
(b) identification, contact and other details of the expert and contact person at the workplace;
(c) information on the genetically modified organism contained in the genetic product;
(d) information on the genetic product;
(e) the purpose and procedure for placing the genetically modified organism or genetic product on the market;
(f) information on previous placing in the environment and, where appropriate, on previous placing on the market;
(g) a proposal for the packaging of a genetic product and its labelling which complies with the requirements of Article 11 (2);
(h) monitoring plan;
(i) data on the provision of samples; and
(j) the opinion of the expert adviser.
(3) The implementing act shall lay down in the form of a model application the detailed content of the application for registration in the Marketing List in case of:
(a) a genetically modified organism which is a higher plant or a genetic product containing a genetically modified higher plant;
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Regulation Information
| Citation | Act No. 371 / 2016 Coll., amending Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended, and Act No. 252 / 1997 Coll., on Agriculture, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.11.2016 |
|---|---|
| Effective from | 01.01.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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