Name of law
Law amending the Law on Genetically Modified Organisms




Name Bill
Bill amending the Law on Genetically Modified Organisms





Date of adoption
18/03/2010



Number / year Official Gazette
25/2010








DECREE № 82 Pursuant to Art. 98 pt. 4 of the Constitution of the Republic of Bulgaria
DECREE:
To be published in the "Official Gazette" Law amending the Law on Genetically Modified Organisms adopted by HLI National Assembly on March 18, 2010 | || Released in Sofia on March 25, 2010
President of the Republic, Georgi Parvanov
stamped with the state seal.
Minister of Justice Margarita Popova

Law amending the Law on Genetically Modified Organisms (prom. SG. 27 of 2005 .; amend., SG. 88 and 99 of 2005 SG. 30 of 2006, No. 31 of 2007, pcs. 36, 43 and 54 of 2008, pcs. 74, 80 and 82 of 2009)
§ 1. In Art. 2 made the following amendments:
1. In para. 1:
a) in the text before item. 1 after the word "through" add "at least one";
B) in Item. 1, 'recombinant DNA technology, which includes "are replaced by" recombinant techniques using nucleic acids that include "words" nucleic acid molecules "are replaced by" nucleic acid molecules "and then the words "capable" insert "permanently";
C) t. 3, after the words "fusion" insert "(including protoplast fusion)."
2. Paragraph 2 is amended as follows:
"(2) This Act shall not apply to:
1. the contained use of GMOs, obtained by one or more of the following techniques and / or methods:
a) mutagenesis;
B) cell fusion (including protoplast fusion) of prokaryotic species that can exchange genetic material by known physiological processes;
C) cell fusion (including protoplast fusion) of cells from any eukaryotic species, including production of hybridomas or fusions of plant cells;
D) self-cloning, when it is unlikely that the resulting microorganism to cause disease in humans, animals and plants; for the purposes of the cloning can be used with recombinant vectors long history of safe use in certain microorganisms,
provided they do not involve the use of recombinant molecules of nucleic acids or GMOs produced by techniques and / or methods other than those listed under letters "a" - "d";
2. the release and marketing of GMOs or products consisting of or containing GMOs, obtained by one or more of the following techniques and / or methods:
a) mutagenesis;

B) fusion of eukaryotic species (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods,
provided they do not involve the use of recombinant nucleic acid molecules acids or GMOs produced by techniques and / or methods other than those listed under letters "a" and "b"; 3
. marketing, import, export and transit of:
a) genetically modified organisms for use in / or food, genetically modified foods, foods containing ingredients produced from GMOs are regulated by the Food Act;
B) genetically modified organisms for use in / or feed, genetically modified feed, feed containing ingredients produced from GMOs which are governed by the Law on feed and Veterinary Practices Act;
C) veterinary medicinal products consisting of or containing GMOs or a combination of GMOs or is produced from GMOs are regulated by the Veterinary Practices Act;
4. contained use, release into the environment, marketing, import, export and transit of medicinal products for human use, which consist of or contain GMOs or a combination of GMOs or is produced from GMOs which are governed by the Law on Medicinal Products in human medicine;
5. storage, culture, transport, destruction, treatment as waste or the use of genetically modified micro-organisms (GMM) that have been authorized for marketing in accordance with the requirements of Chapter Four, Section III or other normative order requiring performance of a specific evaluation risk similar to that set out in Chapter IV, section III, provided that work with those contained use is in accordance with the conditions specified in the authorization for marketing as such are defined in it. "
3. In para. 3, 'ordinance for dealing with GMOs adopted by the Council of Ministers "are replaced by" ordinance under para. 4 ".
4. A new paragraph. 4:
"(4) The Council of Ministers adopted an ordinance on the use of genetically modified organisms in controlled conditions."
5. Former para. 4 becomes para. 5.
§ 2. In the first chapter creates art. 2a:
"Art. 2a. It is believed that do not lead to genetic modification, the following techniques and / or methods:
1. in vitro fertilization;
2. natural processes such as conjugation, transduction and transformation; 3
. polyploidy induction,
provided they do not involve the use of recombinant molecules of nucleic acids or GMOs made by techniques and / or methods other than those specified in Art. 2 para. 2. "

§ 3. In art. 13 be made the following amendments:
1. In para. 2, second sentence finally put a comma and added "except when considering confidential information under Chapter Six".
2. Paragraph 3 is amended as follows:
"(3) The Commission shall submit a written statement of the Minister of Environment and Water and / or the Minister of Agriculture and Food filed under this Act requests, as well as other matters within its competence in their request. "
third. In para. 5 after the words "stored" insert "of the unit under Art. 12 ".
§ 4. In art. 16 be made the following amendments:
1. In para. 2 pt. 4 the word "impact" is replaced by "seriousness".
2. A new paragraph. 3:
"(3) In carrying out the risk assessment takes into account the waste management work with GMOs and, where appropriate, to provide the necessary protective measures to protect human health and the environment. "
third. Former para. 3 becomes para. 4 and in it the words "and keep" insert "for a period of 10 years."
§ 5. In art. 17 be made the following amendments:
1. The previous text becomes para. 1 and in it:
a) in the text before item. 1 abbreviation "GMO" is replaced by "genetically modified micro-organisms (GMM) ';
B) in Item. 1 the word "minimum" is replaced by "insignificant";
C) in item. 3 the word "risk" is deleted and after the word "activities" added "moderate risk";
D) in Item. 4 the word "subprime" is deleted and after the word "activities" added "high risk".
2. A par. 2:
"(2) Based on the risk assessment of persons under Art. 16 para. 1 classify the contained use of GMOs other than GMM as follows:
1. Class A - activities where the risk is not increased in comparison with non-genetically modified organism and which is appropriate to the level of protection of human health and the environment;
2. Class B - activities where the risk is increased in comparison with non-genetically modified organism and which, depending on the case is appropriate protective measures corresponding to the second level or a higher level of protection of human health and the environment . "
§ 6. Article 18 is amended as follows:
" Art. 18. In case of doubt to which class risk to refer work with GMOs apply protective measures for the higher class except when there is a written consent of the Minister of Environment and Water, based on submitted by the applicant enough evidence to justify the application of safeguards for the lower class risk. "
§ 7. Article 19 is repealed.
§ 8. Article 20 is repealed.
§ 9. Article 21 is amended as follows:

"Art. 21. The criteria for classifying work with GMOs, conditions and procedures for assessing the risk of working with GMOs, as well as preventive and protective measures for the class to work with GMOs are defined by the ordinance under Art. 2 para. 4. "
§ 10. In art. 22 in the text before item. 1 after the words "every two years or" insert "immediately".
§ 11. In art. 23, para. 2 words "para. 3 "are replaced with" para. 4 ".
§ 12. In art. 24 be made the following amendments:
1. In para. 2:
a) in item. 1 the words "BULSTAT" are replaced by "and unified identification code or BULSTAT";
B) pt. 5 words "para. 3 "are replaced with" para. 4 ';
C) point 8 is repealed.
2. Paragraph 3 is amended as follows:
"(3) The application for registration of premises for working with GMOs applies document for paid fee determined by the tariff under Art. 15 for foreign entities - a document certifying the legal status of the applicant, issued in accordance with national legislation up to three months before submitting the application. "
Third. A par. 4:
"(4) In the case of the first of class 1 to class A GMM and use of GMOs other than GMM contained use, the application under par. 2 apply:
1. a summary of the risk assessment under the terms and conditions laid down in accordance with Art. 2 para. 4;
2. information on waste management. "
§ 13. In art. 25 be made the following amendments:
1. Create a new paragraph. 3, 4 and 5:
"(3) The Ministry of Environment and Water through the Regional Inspectorates of Environment and Water (RIEW) performed an initial inspection of the premises of art. 23, para. 1 to establish the adequacy of safeguards.
(4) Based on the inspection RIEWs prepare a protocol and, if necessary propose specific changes to the precautions to be taken into account in preparing the opinion under par. 7.
(5) The Protocol under par. 4 shall provide the Commission within 14 days of submission of the application. "
2. Former para. 3 becomes para. 6 and there before the word "precision" insert "including" the words "and the adequacy of safeguards" are deleted. 3
. Former para. 4 becomes para. 7.
4. Former para. 5 becomes para. 8 and the words "para. 4 "are replaced with" para. 7 '.
§ 14. In art. 26 para. 2 is amended as follows:
"(2) The Minister of Environment and Water issued a registration certificate, which confirms the class of contained use, in accordance with the examination committee of art. 25, para. 6. "
§ 15. In art. 27 para. 3 after the words "para. 2 "is added" and 4 ".
§ 16. In art. 29 be made the following amendments:
1. Create a new paragraph. 3 and par. 4:

"(3) Class 1 operation GMM and class work with GMOs other than GMM in a room that is registered under section II, is done without permission under par. 1.
(4) In the cases under par. 3 persons of art. 16 stored performed risk assessments and submit them to the Ministry of Environment and Water in starting work or RIEWs on demand on the job. "
2. Former para. 3 becomes para. 5.
§ 17. In art. 30 be made the following amendments:
1. In para. 2:
a) in the text before item. 1 after the word "application" shall be added "to perform the first and subsequent class 2 contained use of GMOs";
B) in Item. 1 the words "registration" is replaced by "and unified identification code or code";
C) in item. 2 before the words "registration number" insert "date of filing the application under Art. And 24 ';
D) pt. 5 after the word "vector" a comma and added "when it is used";
E) p. 10 words "contained use" shall be replaced with "the protection and preventive measures", a finally put a comma and added "and the description of the parts of the plant - for contained use GM classes 3 and 4 ";
E) in Item. 12 the word "summary" is replaced by "copy" and the words "for grades 1 and 2 or a copy of the risk assessment for grades 3 and 4" is replaced by "made pursuant to the terms and conditions set in accordance with Art. 2 para. 4 ".
2. Create a new paragraph. 3 and 4:
"(3) The stated under par. 1 work can begin immediately after application, when will be carried out in a room which has been authorized for class 2 or class work with GMM and met all its conditions. The applicant may request written permission from the Minister of Environment and Water, which shall be issued within 45 days of application.
(4) The stated under par. 1 work could begin 45 days after submission of the application or earlier with the written consent of the Minister of Environment and Water, as will be done in a room that has no authorized Class 2 or higher class work with the GMM. "
third. Former para. 3 becomes para. 5 and is amended as follows:
"(5) The application to perform first and subsequent Class 3 and 4 work with GMM and Class B use of GMOs other than GMM contain the information specified in par. 2 pt. 1-11, and:
1. culture volume that will be used;
2. description of the different parts of the room; 3
. information about plans for preventing accidents and plans for emergency response, if required, incl .:
a) the specific risks arising from the location of the installation;
B) safeguards applied such as safety equipment, alarm systems and methods;
C) the procedures and plans for verifying the effectiveness of preventive measures;

D) a description of information provided to persons working with GMOs in controlled conditions;
E) information about those responsible for oversight of the implementation of safety measures identified in the plan (name, responsibilities, telephone number, email address). "
4. Created al. 6, 7 and 8:
"(6) Work with the contained use of class 3 and 4 and Class B use of GMOs other than GMM can not begin until authorized by the Minister of Environment and Water .
(7) As a result of the risk analysis has found that the violation of protective measures can lead to serious, immediate or delayed danger to people outside registered for work with GMOs room and / or the environment to application for working with GMOs apply:
1. Plans for accident prevention and emergency response;
2. confirmation by the applicant that the information of plans for accident prevention and emergency response is provided without prior request to all authorities and organizations likely to be affected in the event of an accident.
(8) The information under par. 7, p. 1:
1. periodically updated every five years and be made publicly available by the applicant;
2. be submitted promptly by the Ministry of Environment and Water of the relevant authorities in other countries - EU member states likely to be affected in case of emergency. "
5. Former para. 4 becomes para. 9.
6. Former para. 5 becomes para. 10 and amended as follows:
"(10) The application under par. 2 and 5 apply document for paid fee determined by the tariff under Art. 15 for foreign entities - a document certifying the legal status of the applicant, issued in accordance with national legislation up to three months before submitting the application. "
§ 18. In art. 31 be made the following amendments:
1. A new paragraph. 3:
"(3) The Ministry of Environment and Water Regional Inspectorate carried out through an initial inspection of the premises of art. 30 para. 3, 4 and 6 for establishing the adequacy of safeguards. "
2. Paragraphs 4 and 5 are amended as follows:
"(4) The Commission verifies developed a plan for emergency response in handling GMOs, when a breach of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and / or environmental environment.
(5) Based on the inspection RIEWs prepare a protocol and, if necessary propose specific changes to the precautions to be taken into account in preparing the opinion under par. 8. The record is submitted to the Commission within 14 days of application. "
3
. Former para. 3 becomes para. 6 and the words "adequate safeguards" are deleted.
4. Former para. 6 becomes para. 7 and is amended as follows:
"(7) Upon completion of inspections under par. 1, 3 and 6, the Minister of Environment and Water on the advice of the Commission may:
1. require the applicant:
a) to provide additional information;
B) to modify the conditions of the proposed contained use;
C) to amend the class of risk contained use;
D) to postpone the start of the requested work to authorization on the basis of the information or changed conditions in letters "a" - "c";
E) to suspend work in cases where it has already begun to authorization on the basis of the information or changed conditions in letters "a" - "c";
2. lay down additional conditions to work. "
5. Former para. 7 becomes para. 8 and is amended as follows:
"(8) The Commission shall prepare an opinion and submit it to the Minister of Environment and Water to:
1. thirty days of the filing of an application for Class 2;
2. thirty days of the filing of an application for Classes 3, 4 or B when the work will be carried out in premises which have previously authorized for use of GMOs in Classes 3, 4 or B and any conditions therein are met; 3
. sixty days of the filing of an application for Classes 3, 4 or B when the work will be done in a room that has no previously authorized for use of GMOs in Classes 3, 4 or B. "
§ 19. An article . 31a:
"Art. 31a. (1) After preparing the opinion of art. 31, para. 8 pt. 2 and 3 the Minister of Environment and Water launched a public consultation to be held no later than:
1. thirty days of preparing the opinion of art. 31, para. 8 pt. 2;
2. Forty-five days of preparing the opinion of art. 31, para. 8 tons. 3.
(2) The public consultation presented the summary of the technical dossier, a copy of the risk assessment under Art. 30 para. 2 pt. 12 and the opinion of the Committee on Art. 31, para. 8 pt. 2 and 3.
(3) can not be discussed information designated as confidential pursuant to Chapter Six.
(4) Not later than 30 days before the date of the discussion in a central daily by the local media by placing advertisements in the relevant municipalities in the area of ​​whereabouts of room to work with GMOs from risk class 3, 4 or B, as well as on the website of the information system under Art. 4 para. 2 announced the subject of public discussion and where relevant information is made available to interested parties. The notice shall announce the date and place where the public consultation.

(5) Any person may submit an opinion on the subject of discussion in writing or in electronic form.
(6) To participate in the public discussion and invite the applicant or his representatives and committee members.
(7) public consultation and protocol attached to the authorization. "
§ 20. In art. 32 made the following amendments:
1. Paragraph 1 shall be amended as follows:
"(1) Based on the opinion of the Committee and the public consultation, the Minister of Environment and Water authorizes the use of GMOs within:
1. Forty-five days of submission of the application for Class 2;
2. forty-five days from the submission of the Class 3, 4 or B when the work will be carried out in premises which have previously authorized for use of GMOs in Classes 3, 4 or B and any conditions therein are met; 3
. sixty days of the filing of the application for Classes 3, 4 or B when the work will be done in a room that has no previously authorized for use of GMOs in Classes 3, 4 or B. "
2. In para. 2:
a) in item. 2 the words "para. 6 "is replaced with" para. 7 ';
B) the item. 3:
"3. while holding a public discussion of art. 31a, in which case the term under par. 1 can not be extended by more than 30 days. "
Third. Paragraph 3 is amended as follows:
"(3) permit under par. 1 to approve the final classification of the contained use and specifying requirements under which the work is performed, including requirements related to the transportation of GMOs. "
§ 21. In art. 34, para. 1 the words "for a period not exceeding five years" are replaced by "for the period specified in Art. 30 para. 2 pt. 11 ".
§ 22. In art. 37 be made the following amendments:
1. A new paragraph. 1:
"(1) Before work under controlled conditions to begin, the Minister of Environment and Water provide information under Art. 30 para. 5 pt. 3 of the competent authorities of the Member - States of the European Union are likely to be affected in the event of an accident, and consult with them on the implementation of the proposed emergency plans. "
2. Former para. 1 becomes para. 2.
third. Former para. 2 becomes para. 3 and there in the text before item. 1 the words "under par. 1 "is replaced by" under par. 2 ".
4. A par. 4:
"(4) In the cases under par. 2 Minister of Environment and Water:
1. ensure implementation of all necessary measures to protect both the applicant and the competent authorities;
2. immediately inform the competent authorities of the Member - States of the European Union are likely to be affected by the accident; 3
. informed as soon as possible the European Commission for each of an accident and provides information on:
a) the circumstances in which the accident occurred;

B) the type and quantities of the GMOs;
C) the measures taken to protect and their effectiveness;
D) an analysis of the causes of accidents and measures to prevent them in the future and to limit their consequences. "
§ 23. In art. 38 word "level" is replaced by "degree".
§ 24. In art. 39 made the following amendments:
1. In para. 1 after the word "science" is added "and another".
2. In para. 2 the words "or to cease" are replaced by "to suspend or terminate".
§ 25. A Art. 40a:
"Art. 40a. Minister of Environment and Waters sent to the European Commission:
1. by 31 December of the current year - a report on the stated year activities contained use of classes 3 and 4, including description, purpose and risks of these activities;
2. every three years - a report on the experience gained in implementing the requirements of Chapter Three. "
§ 26. In art. 41 after the words "fee" a comma and added "determined by the tariff under Art. 15 ".
§ 27. In art. 42, para. 1, 'any natural or legal person shall "be replaced by" the applicant shall. "
§ 28. In art. 45 after the words "GMO on the market" insert "terms and conditions for the coexistence of genetically modified crops with conventional and organic farming."
§ 29. In art. 46, a new paragraph. 3:
"(3) The Minister of Environment and Waters may authorize the release of the same GMO or combination of GMOs in one place or in different places, but with the same goal with a permission set in a period when provided that it is carried out a risk assessment for each site and subject to the procedure laid down in Art. 47 - 52. "
§ 30. In art. 47 be made the following amendments:
1. In para. 1 m are created. 3 and 4:
"3. summary of the application in accordance with the format specified in accordance with the ordinance of art. 45;
4. economic impact analysis of Bulgarian agriculture release into the environment of genetically modified species of economic importance for the country. "
2. In para. 2:
a) t. 1, letter "a" word "registration" is replaced by "and unified identification code or code";
B) pt. 6 the words "remediation methods" are replaced by "techniques for removal or inactivation of GMOs after the operation." 3
. Paragraph 5 shall be amended as follows:
"(5) The application under par. 1 shall apply:
1. document for paid fee determined by the tariff under Art. 15 for foreign entities - a document certifying the legal status of the applicant, issued in accordance with national legislation up to three months before submitting the application;

2. declaration of consent by the owners when the applicant is not the owner and a declaration of agreement on GMO cultivation by the landlord when the applicant is not the owner. "
4. A par. 6:
"(6) Areas necessary to comply with clearances under this Act shall be provided by the applicant, which provides a declaration that circumstance."
§ 31. In art. 48, para. 1 the word "persons" is replaced by "applicants" and the words "or to the relevant authorities of other countries" are deleted.
§ 32. In art. 49 be made the following amendments:
1. Create a new paragraph. 3 and 4:
"(3) The Minister of Environment and Water shall send the Commission a summary of the application under Art. 47, para. 1 pt. 3 within 30 days of filing the application under Art. 46, para. 2.
(4) At the request of a Member - State of the Union Minister of Environment and Water shall forward all information contained in the application under Art. 46, para. 2. "
2. Former para. 3 becomes para. 5 and in it the word "adequacy" is deleted and the words "remediation methods" are replaced by "techniques for removal or inactivation of GMOs after completion of the action." 3
. Former para. 4 and 5 become par. 6 and 7.
§ 33. In art. 50 be made the following amendments:
1. In para. 1 the words "para. 5 "is replaced with" para. 7 "and the words" 45 days "shall be added" to draw up the opinion. "
2. In para. 2 words "para. 5 "is replaced with" para. 7 '.
§ 34. In art. 51 made the following amendments:
1. Paragraph 1 shall be amended as follows:
"(1) Based on the Commission's economic analysis of art. 47, para. 1 pt. 4, the results of the public consultation, comments made by other Member - States of the European Union, and after consultation with the Minister of Agriculture and Food Minister of Environment and Water within 14 days from the date of the public hearing prepare a draft permit for the release of GMOs or a combination of GMOs into the environment and submit it for approval by the Cabinet. "
2. Create a new paragraph. 2 and 3:
"(2) The Council of Ministers shall make a decision within 14 days of receipt of materials under par. 1.
(3) Within 90 days of submission of the application, the Minister of Environment and Water:
1. authorizing the release of GMOs or a combination of GMOs into the environment in a positive decision of the Council of Ministers;
2. refuse to issue a permit at its own discretion based on the information under par. 1 or a negative decision of the Council of Ministers. "
Third. Former para. 2 becomes para. 4 and in it t. 2 the words "para. 4 "are replaced with" para. 6 '.
4. Former para. 3 becomes para. 5.
5. Former para. 4 becomes para. 6 is amended as follows:

"(6) The authorization under par. 3 pt. 1 defines the term and conditions under which the release of GMOs into the environment, including mandatory clearances of the area planted with genetically modified plants from:
1. areas with the traditional way of production - not less than those specified in Annex № 2;
2. area under organic production - not less than 7 km; 3
. stationary apiaries registered under the Act beekeeping - not less than 10 kilometers. "
6. A par. 7:
"(7) The material derived from GMOs after their release into the environment can be launched only after authorization under section III of this chapter."
§ 35. In art . 52 is amended as follows:
1. Paragraph 2 is amended as follows:
"(2) The Minister of Environment and Water shall refuse to grant permission for the release of GMOs into the environment in case of field with traditional methods of production, located distances smaller than those specified in Annex № 2, and on the field with organic production and stationary apiaries registered under the Act beekeeping located at distances smaller than those specified in Art. 51, para. 6 pt. 2 and 3. "
2. In para. 3 words "and 2" are deleted.
§ 36. In art. 54, para. 3 after the word "science" is added "and another".
§ 37. created art. 56a and 56b:
"Art. 56a. (1) Where another Member - State of the Union, sent to the Ministry of Environment and Water summary of the application for release of GMOs on its territory, it is available immediately to the Commission.
(2) The Minister of Environment and Waters may ask the state - member of the European Union to provide all information contained in the application under par. 1.
(3) Within 21 days of receipt of the summary Commission prepare an opinion and submit it to the Minister of Environment and Water.
(4) Within 30 days of receipt of the summary Minister of Environment and Water, based on the opinion of the Commission and after consultation with the Minister of Agriculture and Food may send the European Commission comment on the application.
Art. 56b. (1) The Minister of Environment and Waters informed the European Commission of any decision taken under this section, including the reasons for refusal of permits, and the results of the exemptions pursuant to Art. 55.
(2) The Minister of Environment and Water shall send to the European Commission every three years a report on the experience gained in implementing the requirements of this section. "
§ 38. In art. 57, para. 1 pt. 2 before the word "area" is added "location and size."
§ 39. In art. 58 after the words "fee" a comma and added "as defined in the tariff of art. 15 ".

§ 40. In art. 59 para. 1, 'non-food and food ingredients under the Food Act "are deleted.
§ 41. In art. 60 be made the following amendments:
1. In para. 1:
a) t. 1, letter "b" word "registration" is replaced by "unified identification code or code";
B) point 8 is amended as follows:
"8. proposal for the duration of the authorization to market a maximum of 10 years; "
c) t. 12 after the word "file" a comma and add "in accordance with the format specified in accordance with the ordinance of art. 45 ';
D) the item. 12:
"12a. declaration providing the required clearances under this Act by the applicant. "
2. Paragraph 3 is amended as follows:
"(3) The application under par. 1 proof of payment fee determined by the tariff under Art. 15 for foreign entities - a document certifying the legal status of the applicant, issued in accordance with national legislation up to three months before submitting the application. Applications shall include a declaration of consent for the cultivation of GMOs by the landlord when the applicant is not the owner. "
Third. A new paragraph. 4:
"(4) After receiving the application, the Minister of Agriculture and immediately forward the summary of the dossier under par. 1, p. 12 of the European Commission and other Member - States of the European Union. "
4. Former para. 4 and 5 become par. 5 and 6.
§ 42. A Art. 60a:
"Art. 60a. Minister of Agriculture and Food published immediately on the website of the information system under Art. 4 para. 2:
1. summary of the application;
2. report under Art. 66, para. 1; 3
. information on the possibility of public participation in the procedure for public discussion that takes place at EU level. "
§ 43. Article 64 is repealed.
§ 44. In art. 65 in the text before item. 1 after the word "science" is added "and another".
§ 45. In art. 66 is amended as follows:
1. Paragraph 1 shall be amended as follows:
"(1) Based on the opinion of the Committee and after consultation with the Minister of Environment and Water within 90 days of receiving the application, the Minister of Agriculture and Food prepared and sent to the applicant evaluation report the application. The report contains the information specified in Annex № 3. "
2. In para. 2 t. 3 is repealed. 3
. Paragraph 3 shall be repealed.
§ 46. A Art. 66a:
"Art. 66a. (1) Where the report under Art. 66, para. 1 states that GMOs may be available, the Minister of Agriculture and send it to the European Commission together with the additional information under Art. 63, para. 4 and any other information taken into account in drawing it up within 90 days of receipt of the application.

(2) After sending the report under Art. 66, para. 1 of the European Commission, the Minister of Agriculture and Food provides the public summary of the dossier and the report for discussion by the website of the information system under Art. 4 para. 2. The discussion will be held within 30 days. Minister of Agriculture and Food summarizes the remarks and comments and send them to the European Commission.
(3) The Minister of Agriculture and Food authorizes the placing on the market when:
1. within 60 days after the report is not forthcoming motivated objections or issues be raised by the European Commission or the Member - States of the European Union;
2. the issues raised by the European Commission or the Member - States of the European Union are permitted within 105 days after submission of the report.
(4) The term under par. 3 shall be suspended until the applicant to provide additional information requested by the Commission or by the Member - States of the European Union.
(5) If within the period under par. 3 pt. 2 submitted objections or issues raised by the European Commission or the Member - States of the European Union shall not be permitted, the Minister of Agriculture and Food granted only when a positive decision from the European Commission or the Council of the European Union.
(6) The permission marketing is sent to the applicant within 30 days after the expiry of the terms under par. 3 or after the promulgation of the decision of the European Commission.
(7) In the period under par. 6 Minister of Agriculture and Food shall notify the European Commission and Member - States of the European Union, issued permission. "
§ 47. In art. 67 is amended as follows:
1. Paragraph 3 is amended as follows:
"(3) The permit shall be issued for a maximum period of 10 years."
2. In para. 4 words "Official Variety List pursuant to the Seeds and Seedlings" are replaced by "common catalog of varieties of agricultural plant species and the common catalog of varieties of vegetable species."
§ 48. In art. 68 be made the following amendments:
1. Paragraph 1 shall be amended as follows:
"(1) The Minister of Agriculture and Food, on the basis of the report under Art. 66, para. 1 reasoned refusal to issue a permit for placing on the market when:
1. opinion of the Committee is that there are risks to human health or the environment and that the measures taken for protection are inadequate or ineffective;
2. the applicant fails to cure the deficiencies or inaccuracies in the application in term of art. 63, para. 2. "
2. Create a new paragraph. 2 and 3:
"(2) The applicant shall be notified of the refusal of permission in term of art. 66.

(3) Upon refusal of permission Minister of Agriculture and send the report under Art. 66, para. 1 of the European Commission together with the additional information under Art. 63, para. 4 and any other information considered in its preparation, not earlier than 15 days after notifying the applicant and not later than 105 days from the submission of the application. "
Third. Former para. 2 becomes para. 4.
§ 49. In art. 69 is amended as follows:
1. Paragraph 1 shall be amended as follows:
"(1) The Ministry of Agriculture and Food is created and maintained in electronic public register of:
1. authorizations for placing GMOs on the market;
2. information on the genetic modification in order to facilitate the control and surveillance after placing on the market of GMOs as or in products. "
2. In para. 2 words "electronic register" and "is" are replaced by "electronic records" and "are." 3
. Paragraph 3 is amended as follows:
"(3) The information to be entered in the registers shall be decided in accordance with Art. 45. "
4. In para. 4 the word "register" is replaced by "registers".
§ 50. In art. 70 be made the following amendments:
1. In para. 1 a second sentence: "The Minister of Agriculture and Food reports sent to the European Commission and the Member - States of the European Union."
2. In para. 2 the word "period" is replaced by "stage".
§ 51. In art. 71 be made the following amendments:
1. In para. 1 after 'placing on the market "insert" of the European Union. "
2. Paragraph 3 is amended as follows:
"(3) Persons who grow genetically modified plants under par. 1 are obliged to comply with the terms and conditions for the coexistence of genetically modified crops with conventional and organic farming determined in accordance with Art. 45, as well as mandatory clearances under Art. 51, para. 6. "
third. A par. 6:
"(6) Areas necessary to comply with clearances under par. 3 shall be provided by the applicant, which provides a declaration that circumstance, and a declaration of agreement on GMO cultivation by the owners of the land where the applicant is not the owner. "
§ 52. In art. 72 be made the following amendments:
1. In para. 1 in the text before item. 1 after the word "science" is added "and another".
2. Paragraph 3 is amended as follows:
"(3) In the cases under par. 1 and 2, the Minister of Agriculture and Food on the advice of the commission report on the need to change the conditions for marketing or to terminate the marketing of GMOs. The report is completed and sent to the European Commission within 60 days of receipt of new information. "
Third. A par. 4:

"(4) The Minister of Agriculture and Food change the terms or terminate the authorization for marketing as:
1. within 60 days after the submission of the report is not forthcoming motivated objections or issues be raised by the European Commission or the Member - States of the European Union;
2. the issues raised by the European Commission or the Member - States of the European Union are resolved within 75 days after the report. "
4. Created al. 5 and 6:
"(5) If within the period under par. 4 pt. 2 submitted objections or questions issues by the European Commission or the Member - States of the European Union shall not be permitted, the Minister of Agriculture and Food change the terms or terminate the authorization to place on the market a positive decision from the European Commission or the Council the European Union.
(6) The Minister of Agriculture and Food shall notify the applicant, the European Union and its Member - States of the European Union's decision under par. 4 or 5 within 30 days of its issuance. "
§ 53. In art. 73 be made the following amendments:
1. In para. 1 the words "extend" shall be replaced with "renewed."
2. In para. 2:
a) t. 1, letter "b" word "registration" is replaced by "unified identification code or code";
B) in item. 3 the words "extension" are replaced by "renewal". 3
. In para. 3 word "apply" is replaced by "applied" and the words "copy of the authorization for placing GMOs on the market and" shall be deleted.
4. Paragraph 4 is amended as follows:
"(4) The Minister of Agriculture and Food on the advice of the committee shall prepare and send the applicant a report on the renewal of the authorization within 60 days of submission of the application."
5. Create a new paragraph. 5 and 6:
"(5) The Minister of Agriculture and Food immediately send the report together with the application of the European Commission and the competent authorities of the Member - States of the European Union.
(6) The Minister of Agriculture and Food renew the authorization when:
1. within 60 days after the submission of the report is not forthcoming motivated objections or issues be raised by the European Commission or the Member - States of the European Union;
2. the issues raised by the European Commission or the Member - States of the European Union are resolved within 75 days after submission of the report. "
6. Created al. 7-9:
"(7) When the term under par. 6 pt. 2 submitted objections or issues raised by the European Commission or the Member - States of the European Union are not solved, the Minister of Agriculture and Food renew the authorization for marketing in a positive decision from the European Commission or the Council of the European Union.

(8) The term of validity of the authorization under par. 1 is 10 years. Minister of Agriculture and Food may shorten or extend the presence of specific reasons, stating the reasons therefor.
(9) The Ministry of Agriculture and Food shall notify the applicant, the Commission and the Member - States of the European Union, its decision concerning the renewal of the authorization under par. 1 within 30 days of its issuance. "
7. Former para. 5 becomes para. 10 and the words "para. 4 "are replaced with" para. 6 '.
8. Former para. 6 becomes para. 11 and the words "extension" are replaced by "renewal".
§ 54. In art. 74 is amended as follows:
1. Paragraph 2 is amended as follows:
"(2) A product label must be displayed information as defined in Regulation (EC) № 1830/2003 of the European Parliament and Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from GMOs and amending Directive 2001/18 / EC. The size of the letters in the designation of GMO content in products under Art. 4, paragraph 6 of the Regulation must be twice as large compared to the rest of the inscription with color and font other than the primary. "
2. In para. 3:
a) in item. 1 the word "minimum" shall be deleted;
B) Section 2 is repealed.
§ 55. Article 75 is amended as follows:
"Art. 75. (1) The Minister of Agriculture and Food, after consultation with the Minister of Environment and Water and the Minister of Health may propose to the Council of Ministers provisionally restrict or prohibit the use or sale of GMOs as or in products for which has been authorized for marketing when there are reasons to believe that this GMO constitutes a risk to human health and the environment based on:
1. new or additional information made available since the issuance of the permit, which affects the risk assessment or
2. reassessment of existing information based on new or additional scientific knowledge.
(2) In the cases under par. 1 at a risk to human health and the environment minister of Agriculture and apply all necessary measures to protect and inform the public immediately of the measures taken and the reasons for them.
(3) In the cases under par. 1 Commission review the risk assessment at the request of the Minister of Agriculture and Food.
(4) The Minister of Agriculture and Food submit to the Cabinet information under par. 1 together with the revised risk assessment for a decision on the application of the prohibition under par. 1.

(5) In the case of a prohibition under par. 1, the Minister of Agriculture and Food shall immediately inform the European Commission and Member - States of the European Union, undertaken under par. 2 measures and the reasons for them as presents:
1. revised risk assessment stating what conditions and how to modify the authorization for marketing or permit to be revoked;
2. information under par. 1, p. 1.
(6) The appeal of the decision of the Council of Ministers under par. 4 does not stop its execution. "
§ 56. A Art. 77a:
"Art. 77a. Minister of Agriculture and Food of every three years sent the European Commission a report on the experience gained in implementing the requirements of this section. "
§ 57. In art. 78 after the words "for issuing" insert "or renewal" after the word "charge" a comma and added "determined by the tariff under Art. 15 ".
§ 58. Article 80 is amended as follows:
"Art. 80. prohibited breeding and release into the environment of GMOs, including pursuant to Section II and Section III of Chapter IV of this Act in the following areas:
1. within the boundaries of protected areas in the Protected Areas Act and within the protected areas of the National Ecological Network under the Law on Biological Diversity;
2. a distance less than 30 kilometers from the borders of the territories under p. 1; 3
. a distance less than 10 km from stationary apiaries registered under the Act beekeeping;
4. a distance of less than seven kilometers from the area of ​​organic production of agricultural products;
5. at distances less than those specified in Annex № 2 in respect of areas with traditional production methods. "
§ 59. Article 82 is amended as follows:
" Art. 82. (1) For banned in another Member - State of the Union based on the safeguard clause, the Minister of Agriculture and Food, citing information received, it shall proceed under Art. 75.
(2) The Minister of Agriculture and Food and the Minister of Environment and Water apply the safeguard clause and traditional kinds of great economic importance for Bulgaria as defined in § 1, p. 40 of the Additional Provisions. "
§ 60. Articles 84, 85 and 86 are canceled.
§ 61. A Art. 86a:
"Art. 86a. (1) With regard to exports and unintentional transboundary movements of GMOs Regulation (EC) № 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms.
(2) The competent authority under Regulation (EC) № 1946/2003 is:
1. Minister of Environment and Water when GMOs - subject to export or unintentional transboundary movements are intended for release into the environment;

2. Minister of Agriculture and Food as GMO - subject to export or unintentional transboundary movement intended to be placed on the market. "
§ 62. Articles 87, 88 and 89 are canceled.
§ 63. In Chapter Five Section III shall be repealed.
§ 64. In Chapter Five Section IV is repealed.
§ 65. In Chapter V Section VI is repealed.
§ 66. In art. 104 make the following additions:
1. In para. 2 after the word "command" insert "after consultation with the applicant."
2. A par. 4:
"(4) The information under par. 2 is treated confidentially and the withdrawal of the application by the applicant. "
§ 67. In art. 105 is amended as follows:
1. In item. 1, letter "a" word "performance" is replaced by "common characteristics".
2. In item. 2, letter "a" word "description" is replaced by "common characteristics".
§ 68. In art. 106 words "DNA sequences" are replaced by "nucleotide sequences".
§ 69. In art. 108 par. 1 is amended as follows:
"(1) The Minister of Environment and Water Regional Inspectorate carried out by control:
1. the observance of this law on the implementation of preventive and protective measures determined for each class of working with GMOs;
2. on the release of GMOs into the environment. "
§ 70. In art. 112, para. 1, p. 2, 'art. 87 or "are deleted.
§ 71. In art. 114 words "at least twice a year" are replaced by "in accordance with the requirements and conditions of the permit under Art. 32, para. 1, Art. 51, para. 3 pt. 1, Art. 67, para. 1 and Art. 73, para. 1 ".
§ 72. In art. 115 new para. 6:
"(6) Until January 31 officials submit to the Minister of Environment or the Minister of Agriculture and Food reports on the previous year inspections under par. 1 and the results thereof. "
§ 73. In art. 120 after the words "violation of Art. 29 "insert" or in violation of Art. 30 para. 3 and 4 ".
§ 74. Article 133 is repealed.
§ 75. Article 134 is amended as follows:
"Art. 134. Whoever violates the provisions of Art. 79 or Art. 80 or does not fulfill an obligation under Art. 82 shall be punished by a fine or a pecuniary penalty of 500,000 to 1 million lev. "
§ 76. Article 136 is amended as follows:
" Art. 136. Whoever violates imposed by the Council of Ministers prohibition of art. 75 para. 1 is punishable by fine or a pecuniary penalty in the amount of 500 000 to 1 million lev. "
§ 77. In art. 141 words "Chapter Five, Section II" are replaced by "Regulation (EC) № 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms."
§ 78. Article 142 is repealed.
§ 79. Article 143 is amended as follows:
"Art. 143. (1) The acts for establishing the offenses shall be issued by the respective officials of art. 115.
(2) The penalty shall be issued by the competent authority or by an authorized officer, as defined in Chapter Seven powers.

(3) Establishment of violations, issuance, appeal and execution of penalty decrees shall follow the procedure of the Administrative Violations and Penalties Act.
(4) The administrative sanction under Art. 134 is imposed by the Supreme Administrative Court. Administrative violation is established by a report of a commission appointed by the Prime Minister, who is sent to court.
(5) The Supreme Administrative Court heard the case on the merits and issue a decision imposing an administrative penalty or stating that there is no administrative violation.
(6) The decision under par. 5 subject to cassation appeal under the Administrative Code.
(7) The amounts of the fines and penalties for violations of this law shall go to the budgets of relevant ministries depending on the competent authority issued the punitive decree. "
§ 80. A Chapter Nine of art. 144 and 145:
"Chapter Nine

CIVIL LIABILITY Art. 144. (1) Whoever, GMO-free, causes another person harm contamination of crops grown in neighboring properties with those GMOs, or genes used for the gene modification and / or with accompanying marker genes, including the established horizontal transfer genes is obliged to compensate him.
(2) Liability under par. 1 covers loss of earnings as a result of this contamination.
(3) Crops of genetically modified plants grown in violation of this Act shall be destroyed at the expense of the offender.
Art. 145. The injured parties under Art. 144 can bring an action against the infringer to cease the infringement and to eliminate the effects of pollution. "
§ 81. In additional provisions be made the following amendments:
1. In § 1:
a) in item. 3, second sentence finally put a comma and added "and the organism obtained through techniques and / or methods listed in Art. 2a ';
B) point 9 shall be amended as follows:
"9. "Clone" is excision of nucleotide sequences from a cell of an organism which may or may not be followed by a reverse insertion of all or a portion of this nucleotide sequence or a corresponding synthetic equivalent (with or without prior enzymatic or physical treatment) into cells the same or phylogenetically close species which can exchange genetic material naturally. "
C) t. 25 the second sentence is deleted;
D) in Item. 26 after the words "which used" add "specific precautions, such as" and, finally, a comma and added "as well as ensuring a high level of safety";
E) paragraph 33 shall be repealed;
E) points 34, 35 and 36 are amended as follows:

"34. "Export" is an export within the meaning of Regulation (EC) № 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms.
35. "Exporter" is an exporter within the meaning of Regulation (EC) № 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms.
36. "Transboundary movement" transboundary movement within the meaning of Regulation (EC) № 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms. "
G) m is created. 38, 39, 40, 41 and 42:
"38. "Applicant" means any natural or legal person who applies.
39. "Application" is written submissions to the competent authority under Art. 3 in accordance with the requirements of this law.
40. "Traditional kinds of great economic significance" are tobacco, vine, rose oil, wheat, and all vegetable and fruit crops.
41. "Safeguard clause" procedure provided for in Art. 23 of Directive 2001/18 / EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release of genetically modified organisms into the environment and repealing Council Directive 90/220 / EEC.
42. "Horizontal gene transfer" is a transfer of genetic material from a genetically modified organism into another organism carried by viruses without human intervention. "
2. Paragraph 2 is repealed. 3
. A § 4a:
"§ 4a. This law introduces the requirements of Directive 90/219 / EEC of 23 April 1990 regarding the use of genetically modified organisms in controlled conditions, as last amended by Directive 98/81 / EC of 26 October 1998, and Directive 2001/18 / EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release of genetically modified organisms into the environment and repealing Council Directive 90/220 / EEC. "
§ 82. Paragraph 8 of the transitional and final provisions are repealed.
§ 83. Application № 2 to art. 51, para. 4 and art. 71, para. 3 is amended as follows:
"Application № 2 to art. 51, para. 6, Art. 52, para. 2, Art. 71, para. 3
Distance of the area planted with genetically modified plants from areas with traditional production methods





Plants


Minimum distance (m)




I.


Cereal










barley


150







oats


150







rice



150







millet


150







Sudan grass


150







rye


1000







triticale


200







corn


800







Canary grass


800




II.


Leguminous










chickpeas


150







Field beans


200







other varieties of










Ph.coccineus L.


2000




III.


Oil and fiber










Peanut


100







mustard


400







hemp


3000







cotton


400







Safflower, caraway, cumin










Italian


400







soya


200







rape


400







sunflower


3000







Len, oleaginous and fiber


200







ricin


1000







sesame


1000








Mack


400




IV.


Feed crops


1000




V.


potatoes


400






"
§ 84. An application № 3 to Art. 66, para. 1:
"Application № 3 to Art. 66, para. 1
Instructions for making an assessment report
assessment report pursuant to Art. 66, para. 1 shall include at least the following information:
1. Identification of the characteristics of the recipient organism which are relevant to the assessment of the proposed GMO.
2. Identification of any known risks to human health and the environment resulting from the release into the environment of genetically modified recipient organism. 3
. Description of the results of genetic modification in the GMO.
4. Assessment of whether the genetic modification has been characterized sufficiently to determine the risks to human health and the environment.
5. Identification of any new risks to human health and the environment from the release of the requested GMOs into the environment in comparison with the release of the corresponding non-genetically modified organism into the environment based on a risk assessment under Chapter Four, Section I.
6. Reasoned conclusion that:
a) applied for GMOs to be marketed as a product or a product and the conditions under which to perform this release or
b) requested GMOs should not be placed on the market;
C) requested an opinion from the Member - States of the European Union and the European Commission on specific issues relating to risk assessment.
Conclusion clearly states proposed:
- use of GMOs requested;
- Risk management;
- Monitoring plan. "
Final provisions
§ 85. In the Law on Seeds and Seedlings (prom. SG. 20 of 2003 .; amend., SG. 27 of 2005 . No.. 30 and 97, 2006, and pcs. 36 and 43 of 2008) § 3 of the transitional and final provisions are repealed.
§ 86. In Veterinary Medicine Act (prom. SG. 87 of 2005 .; amend., SG. 30, 31, 55 and 88, 2006, issue. 51 and 84 of 2007 ., No. 13, 36 and 100 of 2008, pcs. 27, 35, 74, 95 and 102 of 2009) the following amendments:
1. In art. 395:
a) in para. 1 p. 9 is repealed;
B) paragraph 2 shall be amended as follows:
"(2) The competent authority shall exercise control over:
1. feed materials, feed additives containing, consisting of or produced from genetically modified organisms;
2. in doubt - water intended for animals as a source of environmental contamination or transmission of pathogens and / or products of their vital activity. "

2. In § 1 of the Supplementary Provisions shall be created item. 125:
"125. "Genetically modified feed" genetically modified feed within the meaning of Regulation (EC) № 1829/2003 of the European Parliament and Council of 22 September 2003 on genetically modified food and feed. "
§ 87. In the Law on Food ( prom. SG. 90 of 1999 .; amend. pcs. 102 of 2003, SG. 70 of 2004, pcs. 87, 99 and 105 of 2005, pcs. 30, 31, 34, 51, 55, 80 and 96 of 2006, pcs. 31, 51 and 53 of 2007, pcs. 36 and 69 of 2008, pcs. 23, 41, 74, 82 and 93 of 2009 .) Art. 10, para. 1 a second sentence: "The size of the letters in the designation of GMO content in products under Art. 4, paragraph 6 of Regulation (EC) № 1830/2003 of the European Parliament and Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from GMOs and amending Directive 2001/18 / EC should be twice as large compared to the rest of the inscription with color and font other than the primary. "
law was adopted by the 41 th National Assembly on March 18, 2010 and was affixed with the official seal of the National Assembly.
Chairman of the National Assembly Tsetska Tsacheva
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