Decree No. 372 / 2016 Coll.
Decree amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, 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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372
DECLARATION
of 25 October 2016
amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, as amended
According to Section 38 of Act No. 78 / 2004 Coll., on the Treatment of Genetically Modified Organisms and Genetic Products, as amended by Act No. 346 / 2005 Coll. and Act No. 371 / 2016 Coll.:
Decree No. 209 / 2004 Coll., on the closer conditions for the treatment of genetically modified organisms and genetic products, as amended by Decree No. 86 / 2006 Coll. and Decree No. 29 / 2010 Coll., is amended as follows:
1. Paragraph 1, including the title and footnote 1, reads as follows:
Subject matter
This decree implements the relevant provisions of the European Union1) and regulates the detailed conditions for the management of genetically modified organisms and genetic products by establishing:
(a) the models of the application for authorisation for the contained use of the third or fourth risk category, the application for authorisation for placing in the environment and the application for registration in the Marketing List;
(b) the particulars of the summary of the content of the application for authorisation for placing in the environment and for registration in the Marketing List;
(c) the formalities and procedures for risk assessment;
(d) threshold for the occurrence of additives;
(e) requirements for enclosed space and protective measures in the case of contained use;
(f) models of the notification of the contained use of the first or second risk category;
(g) a model of risk assessment for the contained use of the first category of risk referred to in Article 16a (4) of the Act;
(h) the manner and extent of documentation management;
(i) the model of the emergency plan and the scope of the Ministry's published information on the emergency plan;
(j) the elements of the evaluation report.
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. '
2. in Article 2, the following point (f) is inserted after point (e):
"(f) by a therapeutic vector of a non-cellular body, in particular plasmid or transpozone, containing hereditary material and capable of bringing such hereditary material into the cells of the treated organism to which it is applied for gene therapy;"
Points (f) to (j) shall be renumbered as points (g) to (k).
3. The heading of Section 3 reads "Models of notifications, applications and other documents."
4. Paragraph 3 (1) reads as follows:
"(1) Model
(a) the notification of the contained use is given in Part A of Annex 1 to this Order
1. in Part 1, if the contained use of the first risk category is concerned,
2. in Part 3, if the contained use of the second risk category is concerned,
3. in Episode 4, if the contained use of the second risk category is presented under Section 16a (5) of the Act,
(b) the risk assessment for the contained use of the first category of risk submitted under Section 16a (4) of the Act is set out in Part A of Annex 1 to this Decree in Part 2,
(c) the applications for authorisation for the contained use of the third or fourth risk category are set out in Part B of Annex No 1 to this Regulation;
(d) the procedures for assessing the risk of contained use are set out in Part C of Annex 1 to this Regulation;
(e) the application for authorisation for placing in the environment is set out in Annex No 2 to this Decree.
1. in Part A, Part 1, if it is a genetically modified organism other than a higher plant;
2. in Part A, Part 2, if it is a genetically modified organism which is a higher plant,
3. in Part B, if it is a genetically modified organism introduced into the environment for the purpose of clinical trial of medicinal products,
(f) the applications for registration in the Marketing List are set out in Annex 3 to this Order.
1. in Part A, if it is a genetically modified organism other than a higher plant or a genetic product other than containing a genetically modified higher plant,
2. in Part B, if it is a genetically modified organism which is a higher plant, or a genetic product containing a genetically modified higher plant. ';
5. In Article 3 (2), the words "risk assessment 'are inserted after the words" notification', the words "in accordance with paragraph 1 must be submitted in the Czech language 'are replaced by the words" submitted' and the words "by e-mail 'are replaced by the words" in electronic format'.
6. Paragraph 3 is deleted.
Paragraph 4 shall become paragraph 3.
7. In Article 3 (3), the words "it must be indicated 'are replaced by the words" it must be stated'.
8.
Forms of summary of the content of the application published
(K § 5 (4) of the Act)
The details of the summary of the content of the application for authorisation for placing in the environment and the application for registration in the Marketing List are set out in Annexes 2 and 3 to this Regulation. '
9. In Section 5, the text "paragraph 7 'is replaced by" paragraph 6'.
10. in Article 5 (8), the word 'Community' shall be replaced by 'European Union';
11. in § 5 (10) of the introductory part of the provisions, § 6 and § 10 (a) and (e), the words "put into circulation" are replaced by the words "to the market."
12. in Article 5, the following paragraph 11 is inserted after paragraph 10:
"(11) Furthermore, the risk assessment for placing genetically modified organisms in the environment for the purpose of clinical evaluation of medicinal products shall include:
(a) a description of the ways in which the genetically modified organism or parts thereof may spread from the tested body (human or animal) to the environment;
(b) the indication of the inclusion and elimination criteria for the selection of clinical trial subjects and the environmental risk impact of those criteria,
(c) the identification and evaluation of potential harmful effects in the event of an interaction of the genetically modified organism with a man who is not a clinical trial subject, carried out in accordance with the procedure referred to in paragraph 7. ';
Paragraph 11 shall become paragraph 12.
13. In Section 6, the text "paragraph 3 'is replaced by" paragraph 4'.
14. in Article 6, the text "paragraph 3" is replaced by "paragraph 4" and the words "or 2" are deleted;
15. in Article 8 (1) (a), the word "lodged" shall be deleted; the words "put into circulation" shall be replaced by the words "to the market or to extend its validity," the word "where appropriate" shall be deleted; and the words "2 or 3 of the law" shall be replaced by the words "3 or Article 16a (5) of the law, or the risk assessment submitted pursuant to Article 16a (4) of the law."
16. in Article 8 (1) (b), the text "Article 16 (10)" shall be replaced by "Article 16c (4)," the text "Article 17" shall be replaced by "Article 18," the text "Article 16 (5)" shall be replaced by "Article 16b (1)" and the words "or 35a" shall be inserted after "Article 35."
17. in Article 8 (6), the words "or, where appropriate, names, surnames" shall be deleted;
18. in Paragraph 8 (8) (h), the words "or names and surnames, as the case may be," shall be deleted.
19. in Paragraph 8 (8) (j), the words "or names and surnames, as the case may be," shall be deleted.
20.
Model of the emergency plan and scope of the Ministry published information on the emergency plan
(K § 20 (4) and (5) of the Act)
(1) The model of the emergency plan is set out in Annex 5 to this Order
(a) in Part A, if there is an emergency plan for contained use;
(b) in Part B, if there is an emergency plan for placing into the environment.
(2) Information on the emergency plan will be published by the Ministry to the extent of the information shown in Annex 5 to this Decree. '
footnotes 5 and 6 are deleted.
21. In Section 10, the text "§ 24 (17) 'is replaced by" § 24b (7)'.
22. In section 10 of the introductory part of the provision, the text "§ 24 (5) 'is replaced by the text" § 24a (2)'.
23. in Article 10 (e), the words "the European Communities" shall be replaced by the words "the European Union";
(24) Annexes 1 to 4, including footnotes 7 to 18, read:
"Annex No 1 to Decree No 209 / 2004 Coll.
Model of the notification of the contained use of the first risk category, model of the risk assessment for the contained use of the first risk category submitted under Section 16a (4) of the Act, model of the notification of the contained use of the second risk category, model of the notification of the contained use of the second risk category submitted under Section 16a (5) of the Act, model of the application for authorisation for the contained use of the third or fourth risk category and model of the procedure for the risk assessment of the contained use
Documents marked (+) shall be attached as a separate annex.
All attached documents shall bear the applicant's name or name (s).
MODEL NOTIFICATION OF THE INSTALLATION OF THE FIRST RISK CATEGORIES CLOSED IN ARTICLE 16a (4) OF THE LAW, MODEL NOTIFICATION OF THE INSTALLATION OF THE INSTALLATION OF THE SECOND RISK CATEGORIES CLOSED IN ARTICLE 16a (4) OF THE LAW, MODEL NOTIFICATION OF THE SECOND RISK CATEGORIES PRESENTED IN ARTICLE 16a (1) OF THE SAME NOTIFICATION 5 LAW
MODEL NOTIFICATION ON CLOSED LOAD OF FIRST RISK CATEGORIES
[Paragraph 16 (6) (a) of the Law]
Date of administration
1. Notification person (notifier)
1.1. Name or name or business name if the notifier is a natural person authorised to do business
1.2. Name or business name and legal form if the notifier is a legal person
1.3. Citizenship (for natural persons)
1.4. Address of residence and address of residence (for natural persons)
1.5. IČO (if assigned)
1.6. Names of persons who are members of the statutory body of the notifier, if the notifier is a legal person, indicating the manner in which the notifiers represent
2. Expert Advisor
(+) Evidence of educational attainment and the length of professional experience (if professional education or practice has been acquired in another Member State by a national of a Member State, this document means a decision on the recognition of professional qualifications under another legislation)
2.1. Name, academic title
2.2. Employment, possibly employer and job placement
2.3. Education
2.4. Professional courses
2.5. Practice
2.6. Address of residence
2.7. Telephone
2.8. E-mail
3. Contact person at the workplace if different from expert advisor
3.1. Name, academic title
3.2. Telephone
3.3. Email
4. Purpose of the contained use - nature of the activity to be carried out by the notifier (research, teaching, detection, production, etc.)
5. Workplace where the contained loading will take place
5.1. Workplace Address
5.2. Workplace description:
5.2.1. microbiological / molecular-genetic laboratory
5.2.2. semi-operation
5.2.3. manufacturing equipment
5.2.4. greenhouse / culture room
5.2.5. Animal breeding establishment
5.2.6. other (clearly identifying job description, e.g. handling spaces, means of transport)
(+) Plan of rooms, floors and premises
(+) Proof of accreditation under another legislation in the case of livestock breeding establishments 8)
6. GMO in use
| Příjemce / rodičovský organismus; případně skupina příjemců /rodičovských organismů | Dárce | Vkládaný gen / insert/ vyňatý gen; případně jejich skupina | Vektor |
|---|---|---|---|
For individual items (recipient / parental organism, donor, inserted gene / insert / excluded gene, vector), the whole group for which the risk assessment is identical may be indicated in case of undoubted classification in the first risk category of the contained use. In the case of recipients and donors, in particular strains of microbial species (e.g. "strains of Saccharomyces cerevisiae '), in the case of inserted genes / advertisers, where applicable their mutated and deleted variants, their groups (e.g." Bacillus subtilis genes and their mutated and delayed variants', "human genes'," mouse genes', "chromosome fragments of Corynebacterium glutamicum ') may be included as a group.
7. Quantity of genetically modified organisms
7.1. Approximate quantity of GMOs to be used per year (cultures, number of plants or animals)
(+) Project of an experiment under another legislation in the case of breeding establishments for animals 8)
8. Risk assessment
8.1. Summary of risk assessment according to Section 7 of the Act and Section 5 of this Ordinance on the management of genetically modified organisms referred to in point 5, prepared by completing the tables set out in Part C of this Annex.
8.2. Risk assessment result - risk classification
9. Assessment of the premises and facilities of the workplace according to the requirements for enclosed space and protective measures laid down for the risk category in Annex 4 to this Decree
(+) Correlation table of requirements for those workplaces
10. Waste management data for that site (waste water, other and hazardous waste)
11. Operating Regulations of the Institute
(+) Operating Regulations of the Institute according to Annex 4 to the Act
12. Observation of expert advisor
MODEL RISK ASSESSMENT FOR THE CLOSED TREATMENT OF THE FIRST RISK CATEGORIES SUBMITTED IN ACCORDANCE WITH ARTICLE 16a (4) OF THE LAW
(K § 16a (4) of the Act)
Date of administration
1. Reference to the notification submitted pursuant to Article 16 (3) of the Act
1.1. Reference number
1.2. Date of administration
1.3. Risk category
2. Newly used genetically modified organisms
| Příjemce / rodičovský organismus; případně skupina příjemců /rodičovských organismů | Dárce | Vkládaný gen / insert/ vyňatý gen; případně jejich skupina | Vektor |
|---|---|---|---|
3. Risk assessment
3.1. Summary of risk assessment of the contained treatment of newly used genetically modified organisms under Section 7 of the Act and Section 5 of this Decree, processed by completing the tables set out in Part C of this Annex
3.2. Risk assessment result - risk classification
4. Observation of expert advisor
MODEL NOTIFICATION ON CLOSED LOSSING OF THE SECOND RISK CATEGORIES
[Paragraph 16 (6) (b) of the Law]
Date of administration
1. Notification person (notifier)
1.1. Name or name or business name if the notifier is a natural person authorised to do business
1.2. Name or business name and legal form if the notifier is a legal person
1.3. Citizenship (for natural persons)
1.4. Address of residence and address of residence (for natural persons)
1.5. IČO (if assigned)
1.6. Names of persons who are members of the statutory body of the notifier, if the notifier is a legal person, indicating the manner in which the notifiers represent
2. Expert Advisor
(+) Evidence of educational attainment and the length of professional experience (if professional education or practice has been acquired in another Member State by a national of a Member State, this document means a decision on the recognition of professional qualifications under another legislation)
2.1. Name, academic title
2.2. Employment, possibly employer and job placement
2.3. Education
2.4. Professional courses
2.5. Practice
2.6. Address of residence
2.7. Telephone
2.8. E-mail
3. Contact person at the workplace if different from expert advisor
3.1. Name, academic title
3.2. Telephone
3.3. Email
4. Purpose of the contained use - nature of the activity to be carried out by the notifier (research, teaching, detection, production, etc.)
5. Workplace where the contained loading will take place
5.1. Workplace Address
5.2. Workplace description:
5.2.1. microbiological / molecular-genetic laboratory
5.2.2. semi-operation
5.2.3. manufacturing equipment
5.2.4. greenhouse / culture room
5.2.5. Animal breeding establishment
5.2.6. other (clearly identifying job description, e.g. handling spaces, means of transport)
(+) A plan of rooms, floors and areas indicating places of importance for limiting the consequences of a possible accident (main controls of energy supply and auxiliary media, storage sites of genetically modified organisms, safety features of space closure, location of means of deterrence or its consequences)
(+) Proof of accreditation under another legislation in the case of livestock breeding establishments 8)
6. GMO in use
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Regulation Information
| Citation | Decree No. 372 / 2016 Coll., amending Decree No. 209 / 2004 Coll., on closer conditions for the management of genetically modified organisms and genetic products, as amended |
|---|---|
| Regulation Type | Order |
| 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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