Law No. 247 Of 30 June 2009 Approving Government Emergency Ordinance Nr. 43/2007 Concerning The Deliberate Release Into The Environment And Placing On The Market Of Genetically Modified Organisms

Original Language Title:  LEGE nr. 247 din 30 iunie 2009 pentru aprobarea Ordonanţei de urgenţă a Guvernului nr. 43/2007 privind introducerea deliberată în mediu şi introducerea pe piaţă a organismelor modificate genetic

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Law No. 247 of 30 June 2009 approving Government Emergency Ordinance nr. 43/2007 concerning the deliberate release into the environment and placing on the market of genetically modified organisms, published in PARLIAMENT ISSUING the OFFICIAL GAZETTE nr. 472 of 8 July 2009 the Romanian Parliament adopts this law.


The sole article approving Government Emergency Ordinance nr. 43 of 23 May 2007 concerning the deliberate release into the environment and placing on the market of genetically modified organisms, as published in the Official Gazette of Romania, part I, no. 435 of 28 June 2007, with the following amendments and supplements: 1. Title of the Emergency Ordinance is amended and shall read as follows: "EMERGENCY ORDINANCE concerning the deliberate release into the environment of genetically modified organisms" 2. In article 1 (4), b) and (f)) is amended and shall read as follows: "(b) the transport activity) genetically modified organisms by rail, on the road, inland waterway, sea or by air, except for the provisions concerning risk assessment and contingency plan;


f) authorization and placing on the market of medicinal products of transborder movement for human and veterinary use, containing GMOs or consisting of a genetically modified organism or a combination of genetically modified organisms, which are regulated by specific legislation; ".
  

3. In article 2 (1) in point 6, the introductory part shall be amended and shall read as follows: "6. the placing on the market-making available genetically modified organisms, whether for payment or free of charge to persons authorised to activities with genetically modified organisms deliberate release into the environment, representing the input which is subject to the requirements laid down in chapter II. III. For the purposes of this Ordinance, shall not be deemed to be placing on the market: ".
4. In article 2 (1), 12, 15 and 24 is amended and shall read as follows: ' 12. risk assessment for human health and the environment-the process meant to assess the risks of direct or indirect, immediate times delayed, which the deliberate introduction into the environment or the placing on the market of genetically modified organisms may have on human health and the environment and shall be in accordance with the annex. 2;

15. transboundary movement-the movement intended to genetically modified organisms, namely the introduction of the national territory, export outside the European Union border-border and transit;

24. control sample blank sample-according to art. 2 item 11 of Regulation (EC) No 1782/2003. Nr.1.829 decision 2003/of the European Parliament and of the Council of 22 September 2003 concerning food and feed, genetically modified, published in the official journal of the European Union no. L 268 of 18 October 2003. Shall be to certify the type of genetic modification; ".
5. In article 2, paragraph 1, point 25 shall be repealed.
6. In article 2, paragraph 1, point 26 is amended and shall read as follows: "26. location-the place where the deliberate introduction into the environment of genetically modified organisms; ".
7. In article 5, after paragraph 4, insert a new paragraph, paragraph (5) with the following content: "(5) a person referred to in paragraph 1. (1) is responsible for the accuracy of the information included in the notification and all documents submitted by the national authorities and the Community authorisation procedure. "
8. In article 6, paragraphs (3) and (4) is amended and shall read as follows: "(3) the Commission for biological safety examined from the point of view of the study on the scientific assessment of the risk to human health and the environment and shall issue a scientific opinion for deliberate release into the environment of genetically modified organism subject to the authorisation procedure.

(4) the competent authority shall inform and consult the public receives information from biological safety Commission and authorities involved and ensures transmission of information and/or decisions taken pursuant to this emergency Ordinance, as appropriate, to the authorities concerned, by the Commission for biological safety to the public and the notifier. "
  

9. In article 6, after paragraph 4, insert a new paragraph, paragraph (5) with the following content: "(5) the final decisions of the competent authority, in accordance with cap. II and III, shall be issued after consultation with the central public authority for environment protection. "
10. In article 7, paragraph (2) is amended and shall read as follows: "(2) in the case of the deliberate introductions into the environment times market of one or more genetically modified organisms or carry out a transboundary movement, in procuring supervisory body shall request the notifier or, if necessary, economic operator applying appropriate measures to stop such activities and If necessary, measures to remedy has adverse effects. This information is transmitted through the competent authority to the other authorities involved and to the public. Information on illicit cross-border movement is transmitted to the European Commission and the other Member States, through the central public authority for environment protection. "
11. Article 8 is amended and shall read as follows: Art. 8.-the competent authority and the control body shall publish on its internet address, no later than the end of the first quarter of each year, a report on the activities of the previous year. This report must be approved in advance by the central public authority for environment protection. "
12. In article 9, paragraph 5, shall be repealed.
13. In article 10, paragraph (2) is amended and shall read as follows: "(2) genetically modified organisms containing genes of resistance to antibiotics used in human or veterinary diseases treatment, which can have adverse effects on human health and the environment, as referred to in paragraph 1. (1) may not be placed on the market, in accordance with the provisions of cap. (III) if it is proved that they were inserted through genetic modification. "
14. In article 11, paragraph 2, introductory part and the letters d, e)) and j) is amended and shall read as follows: "(2) Central Public Authority for environment protection ensures the application of the precautionary principle, in order to avoid the potential adverse effects of genetically modified organisms on human health and the environment in the field of obtaining, use and sale of such undertakings as defined in article 2. 2. Central Public Authority for environmental protection has the following responsibilities: d) endorses annual reports of activity by the competent authority and the control body, in accordance with this Ordinance;
  

e) ensures, in conjunction with the competent authority, communicating with the European Commission and the other Member States, on the basis of information provided by the competent authority, in accordance with this Ordinance;
  



j) ensure that the provisions of article 7. 42 concerning the safeguard clause '.
  

15. In article 11 (3) (a)), points 6, 7 and 9 shall be amended and shall read as follows: "6. issuing/agreements under this emergency Ordinance, we review, we shall suspend or withdraw them;
7. inform the public about the authorities, revision, suspension or revocation of permits/agreements, as well as about any accidents;

9. cooperate with the national authorities and the community in the process of approval of genetically modified organisms for direct use as food or feed, or as medicines and products for human or veterinary use, as appropriate, if it requires an assessment of the environmental risk; ".
16. In article 11, paragraph 3, subparagraph (e)) is amended and shall read as follows: "s) and manages the national register regarding the information on genetic modifications in genetically modified organisms referred to in art. 48 para. (4), and the register regarding the locations for deliberate release into the environment, according to the head. And III referred to in article 1. 48 para. (5);".
17. In article 11, paragraph 4 shall be amended and shall read as follows: "(4) the competent authority shall consult the decision-making process and in emergency situations or in case of events with cross-border impact, where appropriate, the central public authority for environment protection, national experts or scientific community, national and international bodies, and may request the drafting of studies."
18. In article 11, paragraph 5, subparagraphs (d) and (e))) is amended and shall read as follows: "(d)) inform the competent authority of the results of control/inspection in the field of genetically modified organisms and on the measures taken and shall transmit, within a period not exceeding 15 days, a copy of the report containing the conclusions of the synthesis of control/inspection;

(e) the public authority) provide central to environmental data required for the participation of Romania in the international procedure and community information in the field of biosecurity approach (BCH) in accordance with Regulation (EC) No 1782/2003. 1.946/2003 and law No. 59/2003; ".
  

19. In article 11, paragraph 7, introductory part is amended and shall read as follows:

"(7) in order to meet the obligations according to this emergency Ordinance, the competent authority shall consult the Committee for biological safety. Powers of the Commission and the Organization and operation thereof are as follows: ".
20. In article 11, paragraph 7 (a)), the introductory words shall be repealed.
21. In article 11, paragraph 7 (a)), after paragraph 7, insert a new paragraph, paragraph 8, with the following content: "8. collaborates with similar bodies in other Member States, with national or international experts in the exercise of powers under this legislation."
22. In article 11, paragraph 7, subparagraph b) are repealed.
23. In article 11, paragraph 7, after the letter c) introduce six new letters, letters d-i)), with the following content: "d) bio-safety Commission consists of 12 members and four alternates, specializing in the areas covered by this emergency Ordinance, that have and/or academic titles and are dedicated to scientific personalities. Members of the Commission for biological safety come from the following institutions: 1.3. full members and an alternate member, from the Romanian Academy and/or its subordinate institutions flying;
2.3. full members and an alternate member, from the Academy of agricultural and forestry Sciences "Gheorghe Ionescu-Şişeşti and/or institutions contained in its subordination/coordination;
3.3. full members and an alternate member, of the Academy of medical sciences and/or placed under the control of the institutions/coordination;
4. full members and an alternate member, from universities and research institutes with biological profile, agriculture, medicine, environmental protection and other related areas;

e) bio-safety Commission for membership is determined on the basis of proposals submitted by the managers of the institutions referred to in d) and is approved by order of the central public authority for environmental protection;
  

f) bio-safety Commission operates legally in the presence of at least two thirds of all its members and issuing scientific opinions with at least two-thirds of the 12 votes;
  

g) bio-safety Committee operates in accordance with a regulation on the organisation and functioning of its own approved by a majority of votes of the members in its first session;
  

h) members of the Commission for biological safety are required to declare any conflict of interest situations. Participation in opinion is decided by the Commission;
  

I biological safety) the Panel may consult national experts, for a specified period, to address aspects of risk assessment and other legal tasks. To this end they shall establish a list of experts, who are potential collaborators. Payment of members of the Commission for biological safety, the experts and the technical activities administrative costs related to the operation of the Commission shall ensure that the competent authority of its own budget. The amount of the allowances for the members of the Commission and experts shall be fixed by order of the central public authority for environment protection. "
  

24. In article 11, paragraph 8, after the letter d) insert a new drive letter, letter e) with the following content: "e) in fulfilling the obligations of inspection and control, the control can collaborate on a contract basis, as appropriate, with national and international laboratories accredited for enforcement of determinations/specialized analyses. Payment for services will be ensured from own budget, with the exception of situations in which responsibility lies with the determinations of the notifier/consent holder agreement/operator, as required by law. "
25. In article 11, paragraph 10 is amended and shall read as follows: "(1) the competent authority may require the central public authority for environment protection, after consulting the Commission for biological safety and authorities involved, restrict or prohibit the use of provisional and/or the marketing of a genetically modified organism, or component of a product, on the national territory, through the application of the procedure governing the safeguard clause as provided for in art. 42. Furthermore, the competent authority shall ensure that the measures required in the event of major risks, in cooperation with the authorities concerned and the notifier, under powers. "
26. In article 12 (1), the introductory words shall be amended and shall read as follows: Art. 12. — (1) Art. 13-26 does not apply in the case of medicinal products for human use containing or consisting of a genetically modified organism or a combination of such organisms as defined under art. 2 (2). (1) where the deliberate release into the environment are placed, for purposes other than placing on the market, shall be authorised with the following requirements: ".
27. In chapter II, after the title of section 2 of the "notification shall introduce a new article, article 12 ^ 1 with the following content:" Art. 12 ^ 1. -Notifications relating to the deliberate release into the environment of genetically modified organisms, genetically modified higher plants representing, for purposes other than placing on the market, shall be transmitted for consultation and opinion by the competent authority only for bio-safety Commission and central public authority for agriculture. "
28. In article 13 (2) (c)), the 1-3 is amended and shall read as follows: "1. information of a general nature;
2. information on genetically modified organisms;
3. location/locations where they place the deliberate introductions/introduction/deliberate release into the environment;% quot%.
29. In article 13 (2) (c)), after paragraph 3, insert a new item 3 ^ 1 with the following content: "3 ^ 1. only data submitted by the notifier in art. 13(2). (2) section 3 with respect to location/locations of introduction of deliberate release into the environment can be made public, namely the location/locations with reference to administrative-territorial unit. Other data submitted by the notifier shall be considered confidential and may be made available to other authorities and to the public only upon written request and motivated; ".
30. In article 13 (2) (c)), the 4-6 is amended and shall read as follows: "4. information on the conditions and environment specific to each potential receiver locations referred to in section 3;
5. information on the interactions between genetically modified organisms and the environment;
6. a plan for monitoring in accordance with the relevant parts of the annex. 3 to identify the effects that genetically modified organisms may have on human health and the environment;% quot%.
31. In article 13, paragraphs (4) to (6) shall be amended and shall read as follows: "(4) the notification shall be transmitted to the competent authority in the Romanian language, in electronic form and on paper, in two originals, in the mail, with acknowledgement of receipt, or shall be lodged with the competent authority, who shall record the date of receipt of the notification. The summary of the notification and risk assessment shall be forwarded, binding, and in English. In the cases referred to in article 1. 25 para. (2) notification shall be transmitted to the Romanian and English languages, in electronic format.

(5) the additional information required is transmitted to the notifier subsequently, also in Romanian and English languages, in electronic format and on paper.
  

(6) the Notifier is required to ensure that the blank samples from the genetically modified organism, and the method of detection by the legal representative of the inspection body and/or the competent authority in order to carry out analyses, with the notification or at the latest within 5 days after the importation or placing on national territory. "
  

32. In article 15, paragraph (2) is amended and shall read as follows: "(2) if the notification is accepted, the competent authority shall enter the notification in the register provided for in article 4. 11(2). (3) (a). g), inform the notifier in writing and communicate the registration number of the notification, and the number of copies of the notification dossier, the necessary authorization process, which must submit to the competent authority not later than 7 days. Any delay in the transmission of documentation automatically lead to the extension of the duration of the delay of the other timelines. "
33. Article 16 is amended and shall read as follows: Art. 16. — (1) the Commission for biological safety and authorities concerned shall notify the competent authority if they need more information from the notifier and motivates their request.

(2) the competent authority shall require the notifier additional information any motivated. After receiving the additional information requested from the notifier, the competent authority shall forward them to the Commission for biological safety and/or authorities concerned. Any delay in the transmission of additional information by the notifier automatically lead to the extension of the duration of the delay of the other timelines.
  

(3) Commission for biological safety is kept informed about the comments made by the competent authority or by the other Member States, as well as about public comments.
  


(4) the competent authority may decide to suspend the time limit referred to in article flow. 18 paragraph 1. (1) during the period in which it is expected additional information transmission and shall notify the notifier, Commission for biological safety and/or authorities involved, where appropriate, the decision to suspend the flow.
  

(5) the authorities concerned will transmit their opinion to the competent authority within a period of 15 days from the date of receipt of the opinion of the Committee for biological safety.
  

(6) within 60 days after the date on which the procedure referred to in article 1. 15 para. (4) the Commission shall forward its opinion to be the basis of bio-safety at the competent authority and to each of the authorities involved. The competent authority shall transmit its opinion in Romanian language and in English. "
  

34. In article 17, paragraph 5 shall be amended and shall read as follows: "(5) within 10 days of the completion of consultation with the public, the competent authority shall prepare a summary of its observations, which it shall transmit to the central authority for environmental protection, the authorities involved and the Commission for biological safety."
35. In article 17, after paragraph 5, insert a new paragraph, paragraph (6) with the following content: "(6) the competent authority shall establish and apply, after consultation with the central public authority for environment protection, measures to ensure public participation in decision-making, in accordance with the legislation in force."
36. In article 18, paragraphs (1), (2) and (6) is amended and shall read as follows: Art. 18. — (1) no later than 90 days from the date of commencement of the proceeding, determined in accordance with article 4. 15 para. (4) the authorization to deliberate release into the environment, for purposes other than placing on the market, the competent authority shall take a decision on the basis of an opinion from the Scientific Committee based its bio-safety, permits the authorities involved, the synthesis of the consultation to the public, as well as on the basis of consultation with the Member States, in accordance with the provisions of art. 25. (2) for the purposes of calculating the period of 90 days referred to in paragraph 1. (1), shall not be taken into account while waiting for copies of the notification dossier, in accordance with art. 15 para. (2), and time periods in which the competent authority is awaiting further information from the notifier and provide consultation and public participation in decision making. The procedure for consultation and public participation must not exceed by more than 30 days the time limit of 90 days.
  



(6) the competent authority shall publish its address authorization on the internet and shall transmit a copy of the central public authority for environment protection, Commission for biological safety, control and body of each authority involved in the decision-making process, within 7 days from the date of payment by the notifier tariff. "
  

37. In article 18, paragraph 8, subparagraph g) is amended and shall read as follows: ") approved, indicating the locations of the areas for testing;".
38. In article 21, paragraphs (2) and (3) are repealed.
39. In article 22, paragraph (1) shall be amended and shall read as follows: Art. 22.-(1) not later than 15 December of each year during which a deliberate introduction into the environment of a genetically modified organism, or components of products authorized under this chapter, and thereafter, at any intervals laid down in the consent on the basis of the results of the risk evaluation on the environment and human health, the competent authority shall forward a report and result of introduction/Intros indicates If this is the case, any such bodies or components on which the notifier intends to notify at a later stage. "
40. In article 24, paragraphs (1) and (2) is amended and shall read as follows: Art. 24. — (1) the competent authority may suspend or withdraw the authorization concerning the deliberate release into the environment issued pursuant to this chapter, the following situation: the conditions imposed by the authorization are not or are no longer met and couldn't find any alternative solution to the suspension/withdrawal of authorisation by the competent authority. If necessary, ask for the opinion of the Committee for biological safety.

(2) Suspension/withdrawal is made after the notice, may grant a term for the performance of their obligations; during the period of suspension of activities is prohibited. "
  

41. Article 26 is amended and shall read as follows: Art. 26. — (1) the competent authority shall forward annually to the European Commission, in order to inform the competent authorities of other Member States a list of final decisions taken on the basis of requests for authorization under the register referred to in article 1. 11(2). (3) (a). (g)), including, where appropriate, the reasons for rejection notices, as well as the results, as intros. 22. (2) the competent authority shall forward annually to the European Commission, the central public authority for environmental protection, a list of genetically modified organisms which were deliberately introduced into the environment, simplified procedures have been implemented, according to this emergency Ordinance, as well as a list of notifications rejected under the same section, to be submitted to the competent authorities of the other Member States. "
  

42. The title of chapter III shall be amended and shall read as follows: "CHAPTER III deliberate release into the environment of genetically modified organisms, or parts of certain products for the purpose of placing on the market ' 43. In article 27, paragraphs (2) and (3) is amended and shall read as follows: "(2) Art. 29-42 does not apply to any genetically modified organism, or component of a medicine medicinal product for human use or for veterinary use. These are subject to the authorisation procedure under Regulation (EC) No 1782/2003. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures concerning the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, hereinafter Regulation No. (IMAGE) 726/2004.

(3) the procedure for authorisation referred to in paragraph 1. (2) it can be applied only to the drugs and genetically modified products or consisting of a genetically modified organism which has been issued by the competent authority concerning the deliberate release into the environment, a permit concerning the deliberate release into the environment for research and development purposes, in accordance with the provisions of cap. II. "
  

44. Article 28 shall be repealed.
45. In article 29, paragraph (1) shall be amended and shall read as follows: Art. 29. — (1) Any person who wishes to place on the market for the first time, a genetically modified organism or a combination of such organisms, or component of a product, it must send a notification to the competent authority, if Romania is the State where you intend to place on the market for the first time of this genetically modified organism, in order to obtain the authorization provided for in article 10. "". (1) the notification shall be transmitted. electronically, in Romanian and English languages, as well as on paper, in two originals, in the mail, with acknowledgement of receipt, or shall be lodged with the competent authority, who shall record the date of the notification. "
46. In article 29, paragraph 2, subparagraph (c)), section 6 is repealed.
47. In article 30, paragraph 5 (b)) is amended and shall read as follows: "(b) the summary of the notification); 29 para. (2) (a). (d)), in English, by the competent authorities of the other Member States and the European Commission. "
48. Article 32 is amended and shall read as follows: Art. 32. (1) within 5 days of the date of commencement of the authorisation procedure, the competent authority should trigger the consultation procedure and public participation in decision-making, in accordance with paragraph 1. (2) to (5) and in compliance with the legislation in force concerning consultation and public participation in decision making.

(2) within the time limit laid down in paragraph 1. (1) the competent authority shall publish on its website address: a summary of the notification); 29 para. (2) (a). d);
  

(b) information intended for the public) referred to in article 1. 29 para. (2) (a). k) (3) public can transmit its comments to the competent authority, for a period of 30 days, by e-mail or by post with advice of delivery and may consult the notice, with the exception of confidential data, on the basis of a submitted by the competent authority, in accordance with art. 43. (4) at the completion of set for the receipt of the comments of the public, the competent authority shall draw up a summary thereof, which shall be transmitted to the central public authority for environment protection in order to decide whether or not the Organization of public debates.
  

(5) the competent authority shall, after consultation with the central public authority for environment protection, provisions on public participation in decision-making, in accordance with the legislation in force. "
  

49. In article 33, paragraphs (1), (5) and (6) is amended and shall read as follows:

"Art. 33. — (1) no later than 90 days from the date of commencement of the authorisation procedure established in accordance with the provisions of art. 30 paragraph 2. (4) the competent authority shall, on the basis of the opinion of the Committee for biological safety, officials involved, public information and public consultation, synthesis; 32 para. (3) the risk management measures and after consulting the central public authority for environment protection, shall draw up an assessment report of the notification. The report shall be drawn up in the Dutch, Romanian and English.


(5) if the report determines that the modified organism/genetically modified organisms/may/can be inserted/introduced on the market, the competent authority shall transmit to the European Commission, in writing, within 90 days from the date of commencement of the proceeding, the evaluation report, together with any further information required, possibly from the notifier, and any other information that formed the basis of the report. The term transmission is established and in accordance with the provisions of paragraphs 1 and 2. 8. (6) where the report determines that the modified organism/genetically modified organisms/can't/can't be introduced/placed on the market no sooner than 15 days after sending the assessment report to the notifier and no later than 105 days from the date of commencement of the procedure, the competent authority shall transmit to the European Commission's evaluation report, possibly accompanied by the additional information requested from the notifier and any other information that formed the basis of the report. The term transmission is established and in accordance with the provisions of paragraphs 1 and 2. (8)."
  

50. In article 34, paragraphs (3), (5) and (9) shall be amended and shall read as follows: "(3) If you do not receive a reasoned objection from another Member State or of the European Commission, within the period of 60 days referred to in paragraph 1. (1), or if an agreement on any outstanding issues, within 105 days from the date of communication of the European Commission's assessment report, the competent authority shall issue a permit concerning the placing on the market, under the conditions laid down in article 21. 33 para. 1. In the case referred to in article 1. 33 para. (2) (a). to be received), if reasoned objection from another Member State or of the European Commission, within the period of 60 days referred to in paragraph 1. (1), and if you don't reach an agreement within 105 days from the date of communication of the evaluation report of the European Commission, where a competent authority of a Member State or the Commission has formulated and maintained an objection, apply Community procedures laid down in 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, as published in the official journal of the European Union no. L 106 of 17 April 2001, with subsequent amendments.
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(5) the competent authority shall inform the other Member States and the Commission, within 30 days, about the issue of the authorization. The competent authority shall forward a copy of the authorisation for Commission authorities involved, biological security and supervisory body, within 7 days from the date of paying the fare.
  

..

(9) The notification procedures initiated by the competent authorities of other Member States, the competent authorities of Romania shall examine such notification, and the evaluation report submitted by the European Commission and send them to the Commission for biological safety and, where appropriate, to the authorities concerned, in order to issue an opinion. The competent authority shall publish the assessment report on its own internet address, the date of receipt thereof. Within 60 days from the date of receipt of the assessment report, the competent authority, after consultation with the central public authority for driver protection, European Commission communicates the observations, reasoned objections or any additional information requests, also accompanied by a statement of reasons laid down by the authority, the Commission for biological safety or authorities involved. "
  

51. In article 36, the introductory words of paragraph (2) is amended and shall read as follows: "(2) no later than nine months before the expiry date of the authorisation issued under this chapter, if Romania is the Member State which received the original notification, the notifier must send to the competent authority a notification of renewal, under the following conditions:".
52. In article 37, paragraphs (1) and (3) is amended and shall read as follows: Art. 37. — (1) no later than 90 days from the date of commencement of the renewal procedure, the competent authority on the basis of the opinions received and the results of the public consultation and after consultation with the central public authority for environment protection, shall draw up an evaluation report, drawn up in accordance with the recommendations in the annex. 6..

(3) the competent authority shall transmit a copy of the report to the notifier, central public authority for environment protection, Commission for biological safety, as well as the European Commission. "
  

53. In article 37, paragraph (10) shall be repealed.
54. In article 38, paragraph 3, subparagraph g) is amended and shall read as follows: "g) monitoring requirements in accordance with annex 4. 7, the duration of the monitoring plan, including the obligation to report to the Commission and competent authorities of the Member States and, where appropriate, any obligations of the person selling or using the product, among other things, for genetically modified organisms, the appropriate information relating to the location; ".
55. In article 38, paragraph (4) is amended and shall read as follows: "(4) the competent authority shall issue an authorization in accordance with the provisions of cap. III if genetically modified organisms contain one or more genes of resistance to antibiotics used in human or veterinary medicine, which could have adverse effects on human health, animals and the environment, in accordance with the provisions of art. 10 para. (1)."
56. In article 42, paragraph (1) shall be amended and shall read as follows: Art. 42. — (1) where the competent authority has entered into possession of new or additional information that has become available since the issuance of the authorization and affecting human health risk assessment or reassess existing information environment, or on the basis of new or additional scientific data and has valid reasons to consider that a genetically modified organism, or component of a product that has been the subject of a notification of a valid and authorisation in a Member State, presents a serious risk to humans or the environment, after consulting the Commission for biological safety, it may ask the central public authority for environment protection limiting the validity of the authorization, restriction or prohibit the use of temporary and/or sale thereof, or component of a product national territory. The decision to initiate safeguard clause procedure shall be taken by the central public authority for environmental protection with the opinion of the authorities concerned. "
57. In article 42, paragraph 3 shall be repealed.
58. In article 43, paragraph 4, the introductory part shall be amended and shall read as follows: "(4) the following information shall not be confidential, submitted under article 22. 13-20, 22, 29, 36, 39 and 42: ".
59. In article 46, after paragraph 3, insert a new paragraph, paragraph (4), with the following contents: "(4) the procedures by which the European Commission Scientific Committee/committees/existing scientific/existing at european level, without prejudice to the administrative proceedings prescribed by this emergency Ordinance."
60. In article 47, paragraph (3) is amended and shall read as follows: "(3) the procedures by which the European Commission consults the Committee/ethics committees existing/existing at european level, without prejudice to the administrative proceedings prescribed by this emergency Ordinance."
61. Article 48, paragraph (6) is amended and shall read as follows: "(6) for the management of records referred to in paragraph 1. (5) (a). (b) central public authority), for agriculture, through its territorial structures, transmit to the competent authority the data concerning the growing of genetically modified higher plants required to be grown by farmers in order to begin monitoring plan nationally. "
62. In article 50, paragraph (3) is amended and shall read as follows: "(3) the import of products containing or consisting of a genetically modified organism or a combination of such organisms and which are the subject of this section is allowed only for products authorised under paragraph 1. (1) included in the official list, established at national level, in accordance with the provisions of art. 63 para. (3) the importation is made. compliance with the regime laid down in article 21. 53-56, as well as national and Community legislation on labelling and traceability. "
63. Article 63, paragraphs (1) and (3) is amended and shall read as follows:

"Art. 63. (1) the control carried out by the Customs Authority relating to customs operations with products subject to this emergency Ordinance, the documents to be submitted by the holders of the customs procedure, as well as their obligations shall be determined by order of the ruler of the central public authority for environmental protection and to the customs authority of the ruler on the import, export and transit of genetically modified organisms, to be published in the Official Gazette of Romania Part I. ..

(3) the common Order of paragraph (1) contains the list of goods in annex genetically modified to be tested according to paragraph 1. (1) specifying the tariff code. For updating, the head of the central public authority for environment protection shall forward the amended annexes ANV, for setting the tariff codes, for publication in the Official Gazette of Romania, part I. "
  

64. In article 69, paragraphs (2) and (3) is amended and shall read as follows: "(2) the competent authority shall charge fees, established by order of the central public authority for environmental protection, for any other required assessments of national and Community institutions, in the process of approval of products consisting of or containing genetically modified organisms, defined according to this emergency Ordinance.

(3) the equivalent amount of charges payable, directly and in a special account of the competent authority, to ensure the functioning of the Commission for biological safety. "
  

65. Article 70 is amended and shall read as follows: Art. 70. — (1) the following acts shall constitute offences and shall be imposed as follows: 1. failure to comply with the obligations laid down in article 21. 11(2). (7) (a). h), art. 22, art. 39 in paragraph 1. (2), art. 43 para. (1) by a fine from 10,000 to 30,000 lei lei;
2. failure to comply with the obligations laid down in article 21. "". (3), art. 5 para. (4), art. 9, art. 10 para. (2) and (3), art. 13(2). (6), art. 18 paragraph 1. (10), art. 20 paragraph 1. (1), art. 29 para. (7), art. 38 para. (2), art. 39 in paragraph 1. (4), art. 40, art. 44, art. 50-52, art. 55 paragraph 1. (2), art. 56, art. 57, art. and article 62. 65, with fine from 30,000 to 50,000 lei lei;
3. failure to comply with the obligations laid down in article 21. 3, art. "". (1), (2), (4) and (5), art. 5 para. (2), art. 7 para. (2), art. 24 para. (2), art. 29 para. (6), art. 54 paragraph 2. (1), art. 55 paragraph 1. (1) and art. 58-61 with fine from 50,000 to 80,000 lei lei.

(2) the finding of violations and sanctions shall be performed by authorized personnel of the National Guard. "
  

66. In article 72, paragraphs 1 to 5 shall be amended and shall read as follows: Art. 72. — (1) the amount of the charges levied by the competent authority shall be established by order of the central public authority for environment protection.

(2) Joint Order establishes the procedure for the control on the import, export and transit of genetically modified organisms; 63 para. (1) shall enter into force within 60 days from the date of entry into force of the law of this emergency Ordinance.
  

(3) the national register regarding the information on genetic modifications in GMOs is determined by order of the Minister of the environment.
  

(4) the national register regarding the locations of introduction into the environment of genetically modified organisms is determined by order of the Minister of the environment within 30 days of the entry into force of the law of this emergency Ordinance.
  

(5) the format of the authorisations relating to activities with genetically modified organisms, and import agreement format for genetically modified organisms shall be determined by the competent authority and shall be approved by order of the central public authority for environmental protection, within 30 days after the entry into force of the law of this emergency Ordinance. "
  

67. Article 74 is amended and shall read as follows: Art. 74.-the competent authority carries out and manages, under this emergency Ordinance, a computer system that provides the database according to the requirements of this legislation, including for the communication with the European Commission and the Member States in the process of approval and reporting on genetically modified organisms, as well as for communication with other authorities, the functioning of the Commission for biological safety, informing and consulting the public. "
68. At Annex 4. 1A, part 1, paragraph 3 is amended and shall read as follows: "3. cell fusion techniques (including protoplastelor fusion) or hybridisation techniques where live cells presenting new combinations of heritable genetic material are formed through the merger of two or more cells by means of methods that do not occur naturally."
69. At Annex 4. 1B, item 2 is amended and shall read as follows: "2. cell fusion (including protoplastelor fusion) of plant cells of organisms which can exchange genetic material through traditional methods of selection."
70. At Annex 4. 2, the title of section D is amended and shall read as follows: "d. Conclusions regarding the potential impact on the environment as a result of the deliberate release into the environment of a GMO."
71. At Annex 4. 2 section D, the introductory part shall be amended and shall read as follows: "based on an assessment of risk for human health and the environment carried out in accordance with the principles and methodology contained in sections B and C, notifications must include information on the points referred to in section D1 or D2, to conclude with respect to potential impacts on the environment as a result of the deliberate release into the environment of a GMO:. "
72. At Annex 4. 2 section D, paragraph 5 of section 2 shall be amended and shall read as follows: "5. The possible impact on the environment, immediate or delayed, and that you can have direct and indirect interactions between genetically modified higher plants and organisms-nonţintă (taking also into account the interactions of organisms with target organisms), including impact on population levels of competitors, herbivores, simbionţi (if applicable) , parasites and pathogens. "
73. At Annex 4. the 3rd paragraph of section III, paragraph 4 shall be amended and shall read as follows: "4. The size of the location, which for testing in the field of genetically modified plants, it is represented by the entire surface of the experimental field of the testing of genetically modified organisms."
74. At Annex 4. 3B the section B, point 1, letter e) is amended and shall read as follows: "e) cultivar/;".
75. At Annex 4. 3B the section B, item 4 shall be amended and shall read as follows: "4. Deliberate release into the environment: (a) ways and extent of dissemination) (e.g., an estimate of how the viability of pollen, seeds viable decreases with distance);
  

b) specific factors affecting dissemination in the environment, if any. "
  

76. At Annex 4. 3B the section D, point 4, point b) is amended and shall read as follows: "b) dissemination;".
77. At Annex 4. 4, introductory part the thesis I is amended and shall read as follows: "this annex describes in general terms the additional information to be provided in the case of notification for placing on the market and information for labelling requirements for genetically modified organisms, or parts of products, to be placed on the market of genetically modified organisms and exempted under article,. 2 (2). (1) section 6. "
78. At Annex 4. 4 section B, paragraph 3 is amended and shall read as follows: "3. specific instructions for realization of monitoring and drafting of the report by the notifier, so competent authority and/or the regulatory body can be effectively informed of any adverse effect. These instructions shall be in accordance with the annex. 7 section C; ".
This law was adopted in the Romanian Parliament, in compliance with the provisions of art. 75 and of art. 76 para. (2) of the Constitution of Romania, republished.
p. PRESIDENT CHAMBER of DEPUTIES SENATE DANIELA POPA, MIRCEA DAN GEOANA-Bucharest, June 30, 2009.
No. 247.
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