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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

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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LEGE no. 247 247 of 30 June 2009 for approval Government Emergency Ordinance no. 43/2007 on the deliberate introduction into the environment and placing on the market of genetically modified
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 472 472 of 8 July 2009



The Romanian Parliament adopts this law + Article UNIC Approval Government Emergency Ordinance no. 43 43 of 23 May 2007 on the deliberate introduction into the environment and the placing on the market of genetically modified organisms, published in the Official Gazette of Romania, Part I, no. 435 of 28 June 2007, with the following amendments and additions: 1. The title of the emergency ordinance shall be amended and shall read as follows: " EMERGENCY ORDINANCE on the deliberate introduction into the environment of genetically modified organisms ' 2. Article 1 (4), (b) and (f) shall be amended and shall read as follows: " b) the transport activity of genetically modified organisms by rail, public roads, inland waterway, sea or air, with the exception of the provisions on risk assessment and contingency plan; ........................................................................ f) authorising the placing on the market and the transboundary movement of medicinal products for human and veterinary use, containing genetically modified organisms or consisting of genetically modified organisms or a combination of genetically modified organisms, which are regulated by specific legislation; '. 3. In Article 2 (1) (6), the introductory part shall be amended and shall read as follows: "" 6. placing on the market-the making available of genetically modified organisms, for a fee or free of charge, to persons authorised for activities with genetically modified organisms, representing deliberate introduction into the environment subject to the requirements The head. III. For the purposes of this emergency ordinance, it is not considered to be placed on the market: 4. in Article 2 (1), points 12, 15 and 24 shall be amended and shall read as follows: " 12. assessment of the risk to human health and the environment-the process aimed at assessing direct or indirect, immediate or delayed risks, 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 which are carried out in accordance with Annex no. 2 2; ........................................................................ 15. transboundary movement-the intentional movement of genetically modified organisms, namely the introduction into the national territory, the export outside the European Community and the transit-border transit; ........................................................................ 24. control sample, sample-witness-according to art. 2 2 section 11 of Regulation (EC) No 45/ 1.829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed published in the Official Journal of the European Union no. L 268 of 18 October 2003. It is taken for the certification of the type of genetic modification; ". 5. Article 2 (1) shall be repealed. 6. In Article 2 (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 takes place; ". 7. in Article 5, after paragraph 4, a new paragraph (5) is inserted, with the following contents: " (5) The person referred to in par. ((1) is responsible for the accuracy of the information included in the notification and in all documents submitted to the national and Community authorities in the authorisation procedure. ' 8. In Article 6, paragraphs 3 and 4 shall be amended and shall read as follows: " (3) The Committee on Biological Security shall scientifically examine the study on the risk assessment for human health and the environment and issue a scientific opinion for the deliberate introduction into the environment of the genetically modified organism subject to the authorisation procedure. (. The competent authority shall inform and consult the public, receive the information from the Commission for biological security and the authorities concerned and ensure the transmission of the information and/or decisions taken in the application of this ordinance emergency, as appropriate, to the authorities involved, to the Commission for biological security, to the public and to the notifier. " 9. in Article 6, after paragraph 4, a new paragraph (5) is inserted, with the following contents: " (5) Final decisions of the competent authority in accordance with the head. II and III shall be issued after consulting the central public authority for environmental protection. " 10. In Article 7, paragraph 2 shall be amended and shall read as follows: " (2) In the event that deliberate introductions occur in the environment or on the market of one or more genetically modified organisms or a cross-border movement thereof is carried out, the control body shall, after all, request its notifier, after the economic operator shall apply the measures necessary to stop such activities and, where appropriate, order the measures to remedy the adverse effects. This information shall be transmitted through the competent authority to the other authorities involved and to the public. Information on the illicit trans-border movement shall be transmitted to the European Commission and to the other Member States through the central public authority for environmental protection. " 11. Article 8 is amended and shall read as follows: "" Art. 8. -The competent authority and the public control body on its own internet address, at the latest at the end of the first quarter of each year, a report on the activities of the previous year. This report should be endorsed in advance by the central public authority for environmental protection. " 12. Article 9 (5) shall be repealed. 13. In Article 10, paragraph 2 shall be amended and shall read as follows: " (2) genetically modified organisms containing antibiotic resistance genes, used in the treatment of human or veterinary diseases, which may have adverse effects on human health and the environment, provided in par. (1), may not be placed on the market, in accordance with the head provisions. III, if it is proven that they were inserted by genetic modification. " 14. In Article 11 (2), the introductory part and letters d), e) and j) shall be amended and shall read as follows: " (2) The central public authority for environmental protection shall ensure the application of the precautionary principle to avoid the potential adverse effects of genetically modified organisms on human health and the environment in the field of obtaining, the use and marketing of these bodies defined in accordance with Article 2. The central public authority for environmental protection has the following responsibilities: ........................................................................ d) endorse the annual activity reports prepared by the competent authority and the control body, in accordance with this emergency ordinance; e) ensure, together with the competent authority, communication with the European Commission and the other Member States, on the basis of the information provided by the competent authority, in accordance with this Emergency Ordinance; ........................................................................ j) ensure the application of art. 42 42 on the safeguard clause; '. 15. in Article 11 (3) (a), points 6, 7 and 9 shall be amended and shall read as follows: " 6. issue the permits/agreements according to this emergency ordinance, review them, suspend or withdraw them; 7. informs the authorities, the public about the revision, suspension or withdrawal of permits/agreements, as well as possible accidents; ........................................................................ 9. collaborates with national and Community authorities in the authorisation process of genetically modified organisms for direct use as food or feed or as medicinal products and products for human or veterinary use, as appropriate, if they require an environmental risk assessment; '; 16. Article 11 (3), letter e) shall be amended and shall read as follows: " e) performs and manages the National Register on information about genetic changes in genetically modified organisms, provided in art. 48 48 para. (4), and the Register on locations for deliberate introduction into the environment, according to the head II and III, provided for in art. 48 48 para. ((5); '. 17. In Article 11, paragraph 4 shall be amended and shall read as follows: " (4) The competent authority shall consult in the decision-making and emergency situations or in the case of events with transboundary impact, where appropriate, the central public authority for environmental protection, national or community experts, bodies national and international scientific and may require the development of specialized studies. " 18. In Article 11 (5), points d) and e) shall be amended and shall read as follows: "" d) inform the competent authority of the results of the control/inspection in the field of genetically modified organisms and of the measures adopted and transmit, no later than 15 days, a copy of the summary report containing the conclusions control/inspection; e) provide to the central public authority for environmental protection the data necessary for Romania's participation in the international and community information procedure in the field of biosecurity (BCH), in accordance with Commission Implementing Regulation (EU) No 1.946/2003 and Law no. 59/2003 ;; ". 19. In Article 11 (7), the introductory part shall be amended and shall read as follows: "" (7) For the fulfilment of obligations under this emergency ordinance, the competent authority shall consult the Commission on biological security. The tasks of the Commission and its organisation and functioning shall be as follows: '. 20. In Article 11 (7) (a), the introductory part shall be repealed. 21. in Article 11 (7) (a), a new point shall be inserted after point 7, paragraph 8, with the following contents: "" 8. collaborate with similar bodies in other Member States, with national or international experts in the exercise of their duties under this normative act. " 22. Article 11 (7), point b) shall be repealed. 23. In Article 11 (7), after letter c), six new letters, letters d)-i) are inserted, with the following contents: " d) The Committee on Biological Security shall consist of 12 full members and 4 alternate members, specialised in the fields covered by this Emergency Ordinance, who hold academic and/or university titles and are scientific personalities consecrated. The members of the Committee on Biological Security shall come from 1. 3. full members and an alternate member, from the Romanian Academy and/or from the institutions subordinated to it; 2. 3. full members and an alternate member, from the Academy of Agricultural and Forestry Sciences "Gheorghe Ionescu-Sisesti" and/or from the institutions subordinated to/coordinating it; 3. 3. full members and an alternate member, from the Academy of Medical Sciences and/or institutions subordinated to/coordinating it; 4. 3. full members and an alternate member, from universities and research and development institutes with biological, agricultural, medical, environmental protection and other related fields; e) the composition of the Committee on Biological Security shall be established on the basis of proposals submitted by the heads of d) and is approved by order of the central public authority for environmental protection; f) The biological security commission shall carry out its legal activity in the presence of at least two thirds of its members ' totality and shall issue scientific opinions with a minimum of two thirds of the 12 votes; g) The biological security commission shall carry out its activity after a regulation of its own organization and functioning approved by the majority of the votes of the members, at its first meeting; h) the members of the Committee on Biological Security are obliged to declare any conflict of interest situations. Participation in endorsement shall be decided by the Commission; i) The Committee on Biological Security may consult national experts, for a specified period, for the settlement of risk assessment and other legal duties. For this purpose it establishes a list of experts, who are potential collaborators. The payment of the members of the Commission for biological security, experts and the costs of the technical-administrative activities relating to the functioning of the Commission shall be ensured by the competent authority of its The amount of allowances for members of the Commission and experts shall be determined by order of the head of the central public authority for environmental protection. 24. In Article 11 (8), a new letter is inserted after point d), with the following contents: " e) in carrying out the obligations of inspection and control, the control body may collaborate on the basis of contract, as the case may be, with national and international laboratories, accredited for the execution of specialized determinations/analyses. Payment of services shall be ensured from the own budget, except where the responsibility of the determinations lies with the notifier/holder of the authorization, the agreement/operator, according to the legislation in force. 25. Article 11 (10) shall be amended and shall read as follows: " (10) The competent authority may request the central public authority for environmental protection, after consulting the Commission for biological security and the authorities concerned, provisional restriction or prohibition of use and/or the marketing of a genetically modified organism, as such or the component of a product, on the national territory, by applying the Community procedure on the safeguard clause provided for in art. 42. The competent authority shall also ensure the application of the necessary measures in the event of major risks, in collaboration with the notifier and the authorities concerned, according to the powers 26. In Article 12 (1), the introductory part shall be amended and shall read as follows: "" Art. 12. -(1) Article 13-26 shall not apply to medicinal products and products for human use, consisting of or containing genetically modified organisms or a combination of such organisms as defined in accordance with art. 2 2 para. ((1), if their deliberate introduction into the environment, for purposes other than that of placing on the market, is authorised to meet the following requirements: ". 27. In Chapter II, after the heading of the 2nd section " Notification is inserted a new article, Article 12 ^ 1, with the following contents: "" Art. 12 12 ^ 1. -The notifications concerning the deliberate introduction into the environment of genetically modified organisms, representing genetically modified higher plants for purposes other than placing on the market, shall be submitted for consultation and opinion by the Authority competence only for the Commission for biological security and central public authority for agriculture. " 28. In Article 13 (2) (c), points 1 to 3 shall be amended and shall read as follows: " 1. general information; 2. information on genetically modified organisms; 3. the locations/locations where the deliberated/deliberate introduction/introductions take place in the environment; ". 29. in Article 13 (2) (c), after point 3 a new point is inserted, point 3 ^ 1, with the following contents: "" 3 ^ 1. only the data submitted by the notifier to art. 13 13 para. ((2) 3 regarding the location/locations of the deliberate introduction into the environment can be made public, namely the location/locations with reference to the administrative-territorial unit. The other data submitted by the notifier shall be considered confidential and may be made available to the other authorities and the public only at their written and reasoned request; '. 30. In Article 13 (2) (c), points 4 to 6 shall be amended and shall read as follows: " 4. information on the conditions of introduction and the potential receptor environment, specific to each location referred to in point 3 3; 5. information on interactions between genetically modified organisms and the environment; 6. a monitoring plan, in accordance with the relevant parts of Annex no. 3, to identify the effects that genetically modified organisms can have on human health and the environment; ". 31. In Article 13, paragraphs 4 to 6 shall be amended and shall read as follows: "" (4) The notification shall be sent to the competent authority in Romanian, in electronic form, as well as on paper, in two original copies, by post, with acknowledgement of receipt, or submitted to the competent authority, which records notification on the date of receipt The summary of the notification and the risk assessment shall be transmitted in English. In the situations provided in art. 25 25 para. (2), the notification is transmitted in Romanian and English, in electronic format. (5) The additional information, subsequently requested by the notifier, shall also be transmitted in Romanian and English, in electronic format, as well as on paper. ((6) The notifier is obliged to provide evidence-witness from the genetically modified organism, as well as the method of detection to the legal representative of the control body and/or the competent authority, in order to carry out analyses, with notification or at the latest within 5 days of the import or introduction into national territory. '; 32. In Article 15, paragraph 2 shall be amended and shall read as follows: " (2) If the notification is accepted, the competent authority shall register the notification in the register provided for in art. 11 11 para. ((3) lit. g), inform the notifier in writing and communicate the registration number of the notification, as well as the number of copies of the notification file, required in the authorization process, which they must submit to the competent authority within not more than 7 days. Any delay in the transmission of the documentation shall automatically lead to the extension of the other deadlines. ' 33. Article 16 is amended and shall read as follows: "" Art. 16. -(1) The biological security commission and the authorities concerned shall notify the competent authority if they need additional information from the notifier and shall state their reasons. (. The competent authority shall require the notifier to provide any additional information After receiving the additional information requested from the notifier, the competent authority shall transmit it to the Commission for biological security and/or the authorities concerned Any delay in the submission of additional information by the notifier automatically leads to the extension of the other deadlines during the delay. (. The Commission on Biological Security shall be informed of the observations made by the competent authority or by the other Member States and of the comments of the public. (. The competent authority may decide to suspend the period referred to in art. 18 18 para. ((1) during the period in which the submission of additional information is expected and shall inform the notifier, the Commission for biological security and/or the authorities concerned, as the case may be, of the decision to suspend the term. ((. The authorities concerned shall submit their opinion to the competent authority within 15 days from the date of receipt of the opinion of the Commission on biological security ((6) Within 60 days from the date of commencement of the procedure provided for in art. 15 15 para. ((. The Commission for Biological Security shall transmit the scientific substantiated opinion to the competent authority and to each of the authorities concerned. For the competent authority the opinion shall be transmitted in Romanian and in English. " 34. Article 17 (5) shall be amended and shall read as follows: "" (5) Within 10 days following the conclusion of the public consultation, the competent authority shall draw up a summary of its observations, which it shall submit to the central public authority for the protection of the environment, the authorities concerned and the Commission biological security. " 35. in Article 17, after paragraph 5, a new paragraph (6) is inserted, with the following contents: "(6) The competent authority shall determine and apply, after consulting the central public authority for environmental protection, measures to ensure public participation in the decision, in accordance with the legislation in force." 36. In Article 18, paragraphs 1, 2 and 6 shall be amended and shall read as follows: "" Art. 18. -(1) Within no more than 90 days from the date of commencement of the procedure, established according to art. 15 15 para. ((4), concerning the authorisation of deliberate introduction into the environment for purposes other than placing on the market, the competent authority shall take a decision on the basis of the scientific substantiated opinion of the Committee on Biological Security, the opinions of involved, the synthesis of the public consultation, as well as on the basis of the consultation of the Member States, in accordance with 25. (2) In order to calculate the 90-day period, provided in par. (1), the period in which the copies of the notification file are expected shall not be taken into account, according to art. 15 15 para. ((2), and the periods of time during which the competent authority expects the additional information from the notifier and shall ensure consultation and participation of the public in the decision. The procedure for the consultation and participation of the public shall not exceed 90 days by more than 30 days. ........................................................................ (. The competent authority shall publish the authorisation on its website and shall transmit a copy to the central public authority for environmental protection, to the Commission for biological security, to the control body and to each authority involved in the the decision-making process, within 7 days from the date of payment of the tariff by the notifier. " 37. In Article 18 (8), letter g) shall be amended and shall read as follows: " g) approved locations, with exact indication of surfaces for testing; '. 38. Article 21 (2) and (3) shall be repealed. 39. In Article 22, paragraph 1 shall be amended and shall read as follows: "" Art. 22. --(1) No later than 15 December of each year during which there is a deliberate introduction into the environment of a genetically modified organism, as such or components of certain products, authorised under this Chapter and subsequently to any intervals provided for in the authorisation, based on the results of the environmental and human health risk assessment, the notifier shall submit to the competent authority a report containing the result of the introduction/introductions and indicate, any such bodies or components that the notifier intends to notify subsequently. " 40. In Article 24, paragraphs 1 and 2 shall be amended and shall read as follows: "" Art. 24. -(1) The competent authority may suspend or withdraw the authorization for the deliberate introduction into the environment issued in accordance with this chapter, in the following situation: the conditions imposed by the authorization are not or are no longer fulfilled and could not be found no alternative solution to the suspension/withdrawal of the authorisation by the competent authority. Where appropriate, the opinion of the Committee on Biological Security shall be required in advance. (2) The suspension/withdrawal of the authorization is made after a prior notification, by which a deadline for fulfilling the obligations can be granted; during the suspension period the activities are prohibited. " 41. Article 26 is amended and shall read as follows: "" Art. 26. -(1) The competent authority shall transmit to the European Commission, for the purposes of informing the competent authorities of the other Member States, the list of final decisions taken on the basis of the applications for authorisation in accordance with the register 11 11 para. ((3) lit. g), including, if applicable, the reasons for the rejection of the notifications, as well as the results of the introductions, according to the 22. ((2) The competent authority shall transmit to the European Commission, with the opinion of the central public authority for environmental protection, a list of genetically modified organisms which have been deliberately introduced into the environment for which the procedures have been applied. simplified, in accordance with this emergency ordinance, as well as a list of notifications rejected in accordance with the same section, to be transmitted to the competent authorities of the other Member States. " 42. The title of Chapter III is amended and shall read as follows: "" CHAPTER III Deliberate introduction into the environment of genetically modified organisms as such or components of products for the purpose of placing on the market " 43. In Article 27, paragraphs 2 and 3 shall be amended and shall read as follows: " (2) Article 29-42 shall not apply to any genetically modified organism, as such or component of a medicinal product or medicinal product for human or veterinary use. They shall be subject to the authorisation procedure under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, continue Regulation no. ((EC) 726/2004 . (3) The authorization procedure provided for in par. ((2) may apply only to medicinal products and products genetically modified or consisting of a genetically modified organism for which it has been issued, by the competent authority concerning the deliberate introduction into the environment, an authorisation for the introduction Deliberate in the environment for research and development purposes, according to the provisions of the head. 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 legal person, who wishes to place on the market, for the first time, a genetically modified organism or a combination of such organisms, as such or component of a product, must give prior notification to the the competent authority, if Romania is the state where it is intended to place on the market, for the first time, this genetically modified organism, to obtain the authorization provided for in art. 4 4 para. ((1). The notification shall be sent electronically, in Romanian and English, and on paper, in two original copies, by post, with acknowledgement of receipt, or submitted to the competent authority, which shall record the notification to the date of submission 46. in Article 29 (2) (c), point 6 shall be repealed. 47. In Article 30 (5), letter b) shall be amended and shall read as follows: " b) the summary of the notification provided for in art. 29 29 para. ((2) lit. d), in English, to the competent authorities of the other Member States and to the European Commission. " 48. Article 32 is amended and shall read as follows: "" Art. 32. -(1) Within 5 days from the date of commencement of the authorization procedure, the competent authority shall trigger the procedure for consultation and participation of the public in the decision, according to the provisions of ((2)-(5) and in compliance with the legislation in force on consultation and public participation in the decision. (2) Within the deadline set out in par. (1), the competent authority shall publish on its internet address: a) summary of notification, according to art. 29 29 para. ((2) lit. d); b) information intended for the public, provided in art. 29 29 para. ((2) lit. k). ((. The public may submit its observations to the competent authority for 30 days by e-mail or by post with acknowledgement of receipt and may consult the notification file, except for confidential data, on the basis of an address transmitted to the competent authority, according to 43. ((. At the end of the duration set for the reception of public comments, the competent authority shall draw up a summary thereof, which shall be transmitted to the central public authority for the protection of the environment in order to decide public debates. (5) The competent authority shall, after consulting the central public authority for environmental protection, apply the provisions on public participation in the decision, in accordance with the legislation in force. " 49. In Article 33, paragraphs 1, 5 and 6 shall be amended and shall read as follows: "" Art. 33. -(1) Within no more than 90 days from the date of commencement of the authorization procedure, established according to the provisions of art. 30 30 para. ((4), the competent authority, on the basis of the opinion of the Committee on Biological Security, the authorities involved, the information intended for the public and the summary of the public consultation 32 32 para. ((3), of risk management measures and after consulting the central public authority for environmental protection, shall draw up a report assessing the notification. The report shall be drawn up in Romanian and English. ........................................................................ ((5) Where the report establishes that the genetically modified/modified organism (s) may be introduced/placed on the market, the competent authority shall transmit to the European Commission, within 90 days of the start of the procedure, the report evaluation, accompanied by additional information, possibly requested from the notifier, and any other information that was the basis of the report. The deadline for transmission is also established in accordance with the provisions of para. ((8). ((6) If the report determines that the genetically modified/modified organism/organisms cannot/cannot be introduced/placed on the market, no earlier than 15 days after the submission of the evaluation report to the notifier and no later than 105 days from the start of the procedure, the competent authority shall submit the assessment report to the European Commission, together with the additional information requested from the notifier and any other information which was the basis of the report. The deadline for transmission is also established in accordance with the provisions of para. ((8). ' 50. In Article 34, paragraphs 3, 5 and 9 shall be amended and shall read as follows: "" (3) If reasoned objections are not received from another Member State or the European Commission within the 60-day period referred to in paragraph 1. ((1), or if an agreement on possible unresolved problems is reached, within the period of 105 days from the date of submission of the evaluation report to the European Commission, the competent authority shall issue a marketing authorisation under the conditions of provided in art. 33 33 para. ((1). In the case provided in art. 33 33 para. ((2) lit. a), if reasoned objections are received from another Member State or the European Commission, within the 60-day period provided for in par. ((1), and if no agreement is reached within the period of 105 days from the date of submission of the evaluation report to the European Commission, if a competent authority of a Member State or the European Commission has formulated and maintained an objection, it shall be apply the Community procedure laid down 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, published in the Official Journal of the European Union no. L 106 of 17 April 2001, with subsequent amendments. .......................................................................... (. The competent authority shall inform the other Member States and the European Commission within 30 days of the issuing of the authorisation. The competent authority shall send a copy of the authorisation to the authorities concerned, to the Commission for biological security and to the control body, within 7 days from the date of payment of the tariff. .......................................................................... ((9) In the framework of the notification procedures initiated by the competent authorities of other Member States, the competent authority of Romania shall review that notification and the evaluation report submitted by the European Commission and send them to the Commission for biological security and, where appropriate, the authorities concerned, with a view to issuing an opinion. The competent authority shall publish the assessment report on its own website at the time of its receipt. Within 60 days from the date of receipt of the assessment report, the competent authority, after consulting the head of the central public authority for environmental protection, shall communicate to the European Commission the observations, reasoned objections or possible requests for additional information, also accompanied by a statement of reasons, made by the Authority, by the Commission on Biological Security or by the authorities concerned. '; 51. In Article 36, the introductory part of paragraph 2 shall be amended and shall read as follows: "" (2) At the latest 9 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 shall submit to the competent authority a notification of renewal, under the following conditions: '. 52. In Article 37, paragraphs 1 and 3 shall be amended and shall read as follows: "" Art. 37. --(1) No later than 90 days after the date of commencement of the renewal procedure, the competent authority shall, on the basis of the opinions received and the results of the public consultation and after consulting the central public authority for environmental protection, draw up an evaluation report, which shall be drawn up in accordance with the recommendations of Annex no. 6. ......................................................................... (. The competent authority shall transmit a copy of the report to the notifier, to the central public authority for environmental protection, to the Commission on biological security and to the European Commission. 53. Article 37 (10) shall be repealed. 54. In Article 38 (3), letter g) shall be amended and shall read as follows: "" g) monitoring requirements in accordance with Annex no. 7, the duration of the monitoring plan, including the obligation to report to the Commission and the competent authorities of the Member States and, where applicable, any obligations of the person marketing or using the product, inter alia, for Genetically modified organisms cultured, appropriate location information; '. 55. In Article 38, paragraph 4 shall be amended and shall read as follows: " (4) The competent authority shall not issue the authorization in accordance with the provisions of III, if genetically modified organisms contain one or more antibiotic resistance genes that are used in human or veterinary medicine, which could have adverse effects on human, animal health and the environment, according to Art. 10 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 taken possession of new or additional information which has become available after the issuance of the authorisation and which affects the assessment of the risk of human health or the environment, or information on the basis of new or additional scientific data and has reasonable grounds to consider that a genetically modified organism, as such or component of a product, which has been the subject of a valid notification and authorisation issued in a Member State, presents a risk to human health or the environment, after consultation of the Committee on Biological Security, may require the central public authority for environmental protection to limit the validity of the authorisation, restrict or temporarily prohibit the use and/or sale it, as such or component of a product, on the national territory. The decision on the initiation of the safeguard clause procedure shall be taken by the central public authority for environmental protection with the opinion of the authorities concerned. " 57. Article 42 (3) shall be repealed. 58. In Article 43 (4), the introductory part shall be amended and shall read as follows: " (4) The following information is not confidential, transmitted according to art. 13-20 13-20, 22, 29, 36, 39 and 42: ". 59. in Article 46, after paragraph 3, a new paragraph (4) is inserted, with the following contents: "" (4) The procedures by which the European Commission consults the existing/existing scientific/scientific committees/committees at European level shall be without prejudice to the administrative procedures provided for by this Emergency Ordinance. " 60. In Article 47, paragraph 3 shall be amended and shall read as follows: "" (3) The procedures by which the European Commission consults the existing/existing ethics committee/committees at European level shall be without prejudice to the administrative procedures provided for by this Emergency Ordinance. " 61. In Article 48, paragraph 6 is amended and shall read as follows: " (6) For the management of the registers provided in par. ((5) lit. b), the central public authority for agriculture, through its territorial structures, shall transmit to the competent authority the data on the crops of genetically modified upper plants requested to be grown by farmers, in order to start development of the monitoring plan at national level. " 62. In Article 50, paragraph 3 shall be 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 shall be permitted only for products authorised under par. ((1), included in the official list, established at national level, in accordance with the provisions of art. 63 63 para. ((3). Import is made in compliance with the regime established in art. 53-56, as well as the provisions of national and Community legislation on their labelling and traceability. " 63. In Article 63, paragraphs 1 and 3 shall be amended and shall read as follows: "" Art. 63. --(1) The control carried out by the customs authority on customs operations with the products covered by this emergency ordinance, the documents to be submitted by the holders of the customs procedure and their obligations shall be established by joint order of the head of the central public authority for the protection of the environment and the head of the customs authority on the import, export and transit of genetically modified organisms, which shall be published in the Official Gazette of Romania I. ......................................................................... (3) The common order provided in par. ((1) contains in the Annex lists of genetically modified goods, subject to control according to par. (1), specifying their tariff code. To update the lists, the head of the central public authority for environmental protection shall transmit the amended annexes to the National Customs Authority, for the establishment of tariff codes, for publication in the Official Gazette of the Romania, Part I. " 64. In Article 69, paragraphs 2 and 3 shall be amended and shall read as follows: " (2) The competent authority shall charge tariffs, established by order of the head of the central public authority for environmental protection, for any other assessments required by national and community institutions, in the process of authorization of products consisting of or containing genetically modified organisms as defined under this emergency ordinance. ((. The charge shall be paid directly and in full in a special account of the competent authority in order to ensure the functioning of the Commission on biological security. " 65. Article 70 is amended and shall read as follows: "" Art. 70. -(1) The following acts constitute contraventions and shall be sanctioned as follows: 1. non-compliance with the obligations provided 11 11 para. ((7) lit. h), art. 22 22, art. 39 39 para. ((2), art. 43 43 para. (1), with a fine of 10,000 lei to 30,000 lei; 2. non-compliance with the obligations provided 4 4 para. ((3), art. 5 5 para. ((4), art. 9 9, art. 10 10 para. ((2) and (3), art. 13 13 para. ((6), art. 18 18 para. ((10), art. 20 20 para. ((1), art. 29 29 para. ((7), art. 38 38 para. ((2), art. 39 39 para. ((4), art. 40 40, art. 44 44, art. 50-52 50-52, art. 55 55 para. ((2), art. 56 56, art. 57 57, art. 62 62 and art. 65, with a fine of 30,000 lei to 50,000 lei; 3. non-compliance with the obligations provided 3 3, art. 4 4 para. ((1), (2), (4) and (5), art. 5 5 para. ((2), art. 7 7 para. ((2), art. 24 24 para. ((2), art. 29 29 para. ((6), art. 54 54 para. ((1), art. 55 55 para. ((1) and art. 58-61, with a fine of 50,000 lei to 80,000 lei. (2) The finding of contraventions and the application of sanctions shall be carried out by the authorized personnel of the National Environmental Guard. " 66. In Article 72, paragraphs 1 to 5 shall be amended and shall read as follows: "" Art. 72. -(1) The amount of tariffs charged by the competent authority shall be determined by order of the head of the central public authority for environmental protection. (2) The common order establishing the control procedure on the import, export and transit of genetically modified organisms, provided for in art. 63 63 para. ((1), shall enter into force within 60 days from the date of entry into force of the law approving this emergency ordinance. (3) The national register on information about genetic changes in genetically modified organisms shall be established by order of the Minister of Environment. (4) The national register on the locations of the introduction into the environment of genetically modified organisms shall be established by order of the Minister of the Environment, within 30 days from the entry into force of the law approving this emergency ordinance. ((5) The format of authorisations for activities with genetically modified organisms and the format of the import agreement for genetically modified organisms shall be established by the competent authority and approved by order of the head of the public authority central to the protection of the environment, within 30 days from the entry into force of the law approving this emergency ordinance. " 67. Article 74 is amended and shall read as follows: "" Art. 74. -The competent authority shall carry out and manage, on the basis of this emergency ordinance, a computer system, which provides the database as required by this normative act, including for communication with the European Commission and the Member States in the authorisation and reporting process for genetically modified organisms, as well as for communication with other authorities, the functioning of the Commission on biological security, information and consultation of the public. " 68. Annex no. Part 1, point 3 is amended and shall read as follows: "" 3. cell fusion techniques (including the fusion of protoplastics) or hybridation techniques in which living cells presenting new combinations of hereditary genetic material are formed by merging two or more cells, using methods that do not produce naturally. " 69. Annex no. 1B, paragraph 2 is amended and shall read as follows: "2. cell fusion (including the fusion of protoplastics) of plant cells from organisms that may change genetic material using traditional selection methods." 70. Annex no. 2, the title of Section D is amended and shall read as follows: "" D. Conclusions on the potential impact on the environment as a result of the deliberate introduction into the environment of a GMO. " 71. Annex no. 2 section D, the introductory part changes and will read as follows: " Based on a risk assessment of human health and the environment carried out in accordance with the principles and methodology contained in Sections B and C, the notifications shall include information on the points referred to in Section D1 or D2, in order to be able to conclude on the potential impact on the environment as a result of the deliberate introduction into the environment of a GMO: '. 72. Annex no. 2 section D, paragraph 5 of section D. 2 is amended and shall read as follows: "" Five. Possible impact on the environment, immediately and/or delayed, that direct and indirect interactions between genetically modified higher plants and non-target organisms may have (also taking into account the interactions of organisms with Target body), including impact on the level of populations of competitors, herbivores, symbionts (if applicable), parasites and pathogens. ' 73. Annex no. 3A point III, Section A, point 4 is amended and shall read as follows: "" Four. The size of the location, which for field testing of genetically modified plants, is represented by the entire surface of the experimental field in which the testing of genetically modified organisms takes place. " 74. Annex no. 3B, Section B, point 1, letter e) is amended and shall read as follows: "" e) cultivar/linie; '. 75. Annex no. 3B section B, paragraph 4 is amended and shall read as follows: "" Four. Deliberate release into the environment: a) the paths and extent of the dissemination (e.g. an estimate of how the viability of pollen and viable seeds decreases by distance); b) specific factors affecting the dissemination in the environment, if any. " 76. Annex no. 3B section D, paragraph 4, letter b) is amended and shall read as follows: " b) dissemination; '; 77. Annex no. 4 the introductory part, sentence 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 on the labelling requirements of genetically modified organisms as such or components of some products, to be placed on the market and genetically modified organisms, exempted, according to art. 2 2 para. ((1) pt. 6 6. " 78. Annex no. 4 section B, point 3 is amended and shall read as follows: "" 3. the specific instructions for carrying out the monitoring and drawing up the report by the notifier, so that the competent authority and/or the control body can be effectively informed of any adverse effect. instructions must comply with Annex no. 7 7 section C; '. This law was adopted by the Romanian Parliament, in compliance with the provisions art. 75 and ale art. 76 76 para. (2) of the Romanian Constitution, republished . p. CHAMBER OF DEPUTIES PRESIDENT, DANIELA POPA SENATE PRESIDENT MIRCEA-DAN GEOANA Bucharest, June 30, 2009. No. 247. __________