Order Approving The Deliberate Release Into The Environment Of Genetically Modified Organisms

Original Language Title: Bekendtgørelse om godkendelse af udsætning i miljøet af genetisk modificerede organismer

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Table of Contents
Chapter 1 Area and Definitions
Chapter 2 Test Phrase
Chapter 3 Marketing
Chapter 4 Consultation and information
Chapter 5 Entry into force and transitional provisions
Appendix 1 DIRECTIVE 2001 /18/EC OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC (OJ L 106, 17. in April 2001, s.1) as amended by the Commission Decision of 24. July 2002 (OJ L 200, 30. July 2002, s. Regulation (EC) No 22 of the European Parliament and of the Council. 1829/2003 of 22. September 2003 (OJ L 268, 18. October 2003, s. Regulation (1), Regulation (EC) No 1 of the European Parliament and 1830/2003 of 22. September 2003 (OJ L 268, 18. October 2003, s. Directive 24) and Directive 2008 /27/EC of the European Parliament and of the Council of 11. March 2008 (OJ L 81, 20. March 2008, s. 45).

Publication of the approval of the release into the environment of genetically modified organisms 1)

In accordance with section 9 a, section 13 (3). Paragraph 20, paragraph 20. 2, section 25, and section 27 (3). 1, in the area of the environment and gene technology, cf. Law Order no. 869 of 26. June 2010, as amended by law no. 1273 of 21. December 2011 :

Chapter 1

Area and Definitions

§ 1. The announcement shall implement the Directive 2001 /18/EC of the European Parliament and of the Council of 12. In March 2001, on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC, cf. Annex 1.

§ 2. For the purposes of this notice, genetically modified organisms shall mean genetically modified organisms : plants, animals, micro-organisms, cell cultures and viruses which present new composition of the genetic material, which do not occur naturally, cf. the species of 2.

§ 3. Approval shall not be granted to the test release or the placing on the market of genetically modified organisms, provided they contain genes which are resistant to antibiotics used in human or veterinary medical treatment.

Chapter 2

Test Phrase

§ 4. The application for approval for experimental treatment shall be considered in accordance with the procedure laid down in the Directive. 6 (2). 5. The application shall be submitted to the Environment Agency and shall include documented information on the conditions laid down in the Directive. 6 (2). 2-4.

Paragraph 2. The indicative notes referred to in Annex II of the Directive relating to environmental risk assessments and to the schedule for the purpose of the Directive in the Directive. 6 (2). (2) (a) (a) vii, mentioned compilation may be requested from the Environmental Management Board.

Paragraph 3. The Environment Minister may, in authorisations for the test statement, determine that the supervision of the approval must be carried out in specified periods of the study of the test statement.

Chapter 3

Marketing

§ 5. Application for authorisation for marketing shall be subject to the procedure laid down in the Directive. 13, paragraph 1. 1, species. Fourteen and species 15. The application shall be submitted to the EPA and must include documented information on the conditions laid down in the Directive. 13, paragraph 1. 2-4.

Paragraph 2. Guiding notes on environmental risk assessments and monitoring plans and schema to use it in kind. 13, paragraph 1. 2 (h) may be requested from the Environmental Management Board (s).

§ 6. An authorisation for placing on the market must contain the requirements of the Directive. 19 provided information.

§ 7. Where new information is provided on the risks to the environment, nature or health of the genetically modified organism, the recipient of approval shall notify the Environmental Management Board. The Recipient of the authorisation shall, at the same time, take the measures listed in the Directive. 13, paragraph 1. Six, and kind. 20.

§ 8. Applications for re-authorisation for placing on the market shall be submitted to the EPA within nine months prior to the expiry of the authorization requested.

Paragraph 2. The application must contain the requirements of the Directive. 17, paragraph 1. This information shall be indicated and dealt with in accordance with the procedure of the Directive. 17, paragraph 1. 2-8.

Paragraph 3. Where an application has been submitted, the original approval may be used until a final decision on the renewal of the authorisation has been made, cf. the species of 17, paragraph 1. 9.

Chapter 4

Consultation and information

§ 9. The Environmental Management Board shall carry out public consultation before a decision is taken on the subject of authorisation for trial or marketing, cf. § § 4 5, including the renewal of approvals, cf. § 8.

Paragraph 2. Consultation can be made entirely digitally on the Eco-Management website www.mst.dk.

§ 10. On its website, the Environmental Management Board shall establish a register of approvals for the test and marketing, including authorisations for the placing on the market of another EU Member State.

Paragraph 2. The one in paragraph 1. 1 the register must contain the following information in the case of test phrases :

1) The name and address of the applicant, the name and address of the person or the genetically modified organisms, the purpose of the statement and place of the release.

2) Summary of the environment, nature and health risk assessments, as well as the consultation responses.

3) The Environment Minister's assessment of the matter.

4) Terms and conditions for the execution of the test statement, cf. Section 16 of the law and conditions for reporting after completion of the statement, cf. the species of 10.

Paragraph 3. The one in paragraph 1. Paragraph 1 shall include, in the case of decisions concerning authorisation for placing on the market, the register must contain the provisions of the Directive. 19 provided information. In the case of decisions by the law, the following information shall

1) Changes or additions to an existing test subject approval, cf. the species of 8 (3). 2.

2) The minister's use of the safeguard clause in Article 17 (1) of the law. 5, in cases where there is justifiable reason to assume that an approval pursuant to Article 9 (9) of the law shall be granted. 2, no. Article 9 (2) or Section 9 (4). 5 pose a risk to the environment, nature and health, cf. the species of 23.

3) The results of the monitoring of the placing on the market of the Directive shall be Twenty, paragraph. 4.

4) Extreme from the Act of Title 9 (2). 1, cf. the species of 4 (4). 5.

Chapter 5

Entry into force and transitional provisions

§ 11. The announcement shall enter into force on 1. -February 2012.

Paragraph 2. Publication no. 1319 of 20. In November 2006, the approval of the testing and placing on the market of genetically modified organisms is hereby repealed.

The Ministry of Environment, the 19th. January 2012

Ida Auken

/ Michel Schilling


Appendix 1

DIRECTIVE 2001 /18/EC OF THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2001 /18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC (OJ L 106, 17. in April 2001, s.1) as amended by the Commission Decision of 24. July 2002 (OJ L 200, 30. July 2002, s. Regulation (EC) No 22 of the European Parliament and of the Council. 1829/2003 of 22. September 2003 (OJ L 268, 18. October 2003, s. Regulation (1), Regulation (EC) No 1 of the European Parliament and 1830/2003 of 22. September 2003 (OJ L 268, 18. October 2003, s. Directive 24) and Directive 2008 /27/EC of the European Parliament and of the Council of 11. March 2008 (OJ L 81, 20. March 2008, s. 45).

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION HAVE-

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee,

Acting in accordance with the procedure laid down in Article 251 of the Treaty, based on the joint text approved by the Conciliation Committee on 20 In December 2000, and in the following considerations :

(1) The Commission report on the review of Council Directive 90 /220/EEC of 23. April 1990 on the deliberate release into the environment of genetically modified organisms, which was adopted on 10. In December 1996, a number of areas in which there is a need for improvement are set.

(2) It is necessary to clarify the scope and definitions laid down in Directive 90 /220/EEC.

(3) Directive 90 /220/EEC has been amended. Since new changes are to be made to this Directive, the provisions in question should be recast in the interests of clarity and rationalisation.

(4) Living organisms exposed to the environment in larger or smaller quantities for experimental or commercial products may be reproduced in the environment and beyond the limits of national borders, thereby having consequences for other Member States. The consequences for the environment of such statements may be irreparable.

(5) The protection of human health and the environment requires special attention to be paid to the control of risks associated with the release into the environment of genetically modified organisms (GMOs).

(6) In accordance with the Treaty, Community measures on the environment must be based on the principle of preventive action.

(7) It is necessary to approximate the laws of the Member States relating to the release into the environment of GMOs, and to ensure that the development of industrial products for which GMOs are used is reassuring.

(8) In the form of this directive, the precautionary principle has been taken into account, and this principle will also be taken into account in the implementation of this directive.

(9) It is particularly important that ethical principles recognised in a Member State are respected ; Member States may take into account ethical aspects when GMOs are exposed to the environment or placed on the market as or in a product.

(10) To create a coherent and transparent legislative framework, it must be ensured that the public is consulted by either the Commission or the Member States when there are measures in preparation and that it is informed of the measures to be taken, shall be taken during the implementation of this Directive.

(11) The placing on the market also includes imports. Products which contain and / or be made out of GMOs covered by this Directive must not be imported into the Community if they do not comply with this Directive.

(12) The availability of GMOs for imports or handling as bulk goods, such as agricultural raw materials, should be considered to be marketed in accordance with this Directive.

(13) In this Directive, due account has been taken of international experience in the field and to international trade commitments, and it should respect the requirements of the Cartagena Protocol on Biosafety associated with the Biological Convention ; diversity. The Commission shall submit to the ratification of the Protocol as soon as possible and, at any event, before July 2001, the appropriate proposal for its implementation.

(14) The guidelines for the implementation of provisions on the definition of the placing on the market of this Directive should be drawn up by the Regulatory Committee.

(15) When genetically modified organisms are defined in the context of this Directive, human beings should not be regarded as organisms.

(16) The provisions of this Directive should not affect national legislation on environmental liability. There is a need for Community law in this area to be supplemented by rules imposing liability for different types of environmental damage throughout the European Union. To this end, the Commission has committed itself to tabling a legislative proposal on environmental liability before the end of 2001, which will cover damage caused by GMOs.

(17) This Directive should not apply to organisms made with certain techniques of genetic modification, which have traditionally been used in a number of applications, which have been certain for a long time.

(18) It is necessary to establish harmonised procedures and criteria for the assessment in the individual case of the potential risk of release into the environment of GMOs.

(19) A environmental risk assessment should always be carried out in each case before the release. Due account should also be taken of potential cumulative long-term effects related to the interaction with other GMOs and the environment.

(20) It is necessary to establish a common methodology for environmental risk assessment based on independent scientific advice. It is also necessary to establish common objectives for the monitoring of GMOs, in accordance with their release into the environment or on the market, as or in a product. Monitoring of potential cumulative long-term effects should be considered as a mandatory part of the monitoring plan.

(21) Member States and the Commission should ensure that systematic and independent research is carried out in the potential risks associated with the deliberate release or marketing of GMOs. The Member States and the Community must ensure, in accordance with their budgetary procedures, that the necessary funds are made available to such research and independent researchers should have access to all relevant material, as intellectuals ; property rights must be respected.

(22) The issue of genes expressing resistance to antibiotics should be taken into account in particular when the risk assessment of GMOs containing such genes is carried out.

(23) The release of GMOs in the research state is, in most cases, a necessary step in the development of new products derived from or containing GMOs.

(24) The transfer of GMOs into the environment should be carried out in a phased manner. This means that the indebtable of GMOs is limited and the scale of the statement is progressively increased, step by step, but only if the evaluation of the previous stages in terms of protecting human health and the environment shows that the next step can be taken.

(25) No GMOs which constitute or enter into products intended for release may be placed on the market without prior satisfactory testing in the field on the research and development stage of ecosystems, which might be affected by their use.

(26) This Directive should be implemented in close contact with the implementation of other relevant instruments, such as Council Directive 91 /414/EEC of 15. July 1991 on the marketing of plant protection products. The competent authorities within the Commission or in the Member States concerned with the implementation of this Directive and those instruments shall, in this context, coordinate their work as far as possible.

(27) This Directive should concern the environmental risk assessment in relation to part C, risk management, labelling, monitoring, informing the general public and the safeguard clause as the reference basis for GMOs that make up or enter into products. approved in accordance with other Community legislation, which should therefore include provisions for a specific environmental risk assessment to be carried out in accordance with the principles set out in Annex II and on the basis of the information set out in Annex III, subject to additional requirements in the abovementioned Community legislation, and lay down requirements, in the case of risk-handling, labelling, adequate monitoring, information to the general public and a safeguard clause, which is at least equivalent to the requirements of this Directive ; it is necessary to ensure that cooperation with those bodies is carried out, The Community and in the Member States referred to in this Directive in the context of its implementation.

(28) It is necessary to establish a Community authorisation procedure for the placing on the market of GMOs constituting or included in products when the intended use of the product includes the deliberate release into the environment of the organism (s) concerned.

(29) The Commission is requested to carry out a study to include an assessment of the various options for further improving the consistency and effectiveness of this regulatory framework, with particular emphasis on a centralized authorisation procedure ; in the case of the placing on the market of GMOs within the Community.

(30) In the case of vertical legislation, monitoring requirements may have to be adapted to the product concerned.

Part C of this Directive shall not apply to products covered by Council Regulation (EEC) No 2. 2309/93 of 22. July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary medicinal products and the establishment of a European Medicines Evaluation Agency, provided that the said Regulation comprises an environmental risk assessment ; corresponding to the one prescribed by this Directive.

(32) Anyone who imps the release into the environment of a GMO or the placing on the market of GMOs that make up or enter into products when the intended use of the product implies that it is exposed to the environment in advance shall file a notification in advance ; the competent national authority.

(33) This notification should include a technical file containing information, including a comprehensive environmental risk assessment, appropriate safety and contingency plans and, in the case of products, precise instructions and conditions for use and proposals ; labelling and packaging.

(34) After notification, the release of the GMOs must take place only when the competent authority is authorized.

(35) A notifier can withdraw his notification at any time in the administrative procedures provided for in this Directive ; the administrative procedure should be suspended when a notification has been withdrawn.

(36) Exposes a competent authority as a notification concerning the placing on the market of a GMO that composes or is included in a product, this should not affect the possibility of filing a notification relating to the same GMO to another competent authority.

(37) An agreement has been reached at the end of the conciliation period when there are no more objections.

(38) Rejection of a notification after a certified negative evaluation report should not affect future decisions based on the notification of the same GMO to another competent authority.

(39) With a view to ensuring that this directive works as intended, Member States should apply the different provisions on the exchange of information and experience before making use of the safeguard clause of this Directive.

(40) In order to ensure that the presence of GMOs in products containing or consisting of genetically modified organisms is appropriately identified, the terms of this product must be clearly stated on genetically modified organisms. a label or an accompanying document.

(41) An appropriate committee procedure should establish a system whereby GMOs are assigned a unique identifier, taking account of developments in the area of international fora.

(42) It is necessary to ensure the traceability of GMOs permitted in accordance with Part C of this Directive, at all stages of their marketing as or in a product.

(43) It is necessary in this Directive to introduce an obligation to implement a monitoring plan so that the direct or indirect effects of GMOs, immediate, delayed or unforeseen effects on human health or the environment may be introduced after they have been implemented ; placing on the market or in a product to be traced and identified.

(44) The Member States should be able to lay down additional measures in accordance with the Treaty with a view to the monitoring and control of GMOs on the market, for example, on the market or in a product.

(45) The possibility of facilitating the control of GMOs and their detection in the event of serious risk should be created.

(46) The comments of the general public should be taken into account in the draft measures presented to the Regulatory Committee.

(47) The competent authority should only give its authorisation after it has satisfied the release of the release is safe for human health and the environment.

(48) The administrative procedure for the communication of marketing authorisations for GMOs which is or part of a product should be made more efficient and transparent, and first-time permits should be given for a given period of time.

(49) For products subject to authorisation for a given period of time, a simplified procedure should be applied to renew the authorisation.

(50) Existing authorisations issued in accordance with Directive 90 /220/EEC shall be renewed in order to avoid any inequalities between authorisations issued in accordance with the said Directive and authorisations granted under this Directive and in order to take full account of account shall be taken of the conditions under which it is authorised under this Directive.

(51) A transitional period requires a transitional period during which existing authorisations granted under Directive 90 /220/EEC are not affected.

(52) When a permission is renewed, it should be possible to modify all the conditions of the original authorisation, including the conditions for monitoring and the time limit for the authorisation.

(53) There should be provision for consultation of one or more of the Scientific Committees set up by Commission Decision 97 /579/EC, on issues that could have consequences for human health and / or the environment.

(54) The arrangements for the exchange of information in the notifications introduced in accordance with Directive 90 /220/EEC has been useful and should be maintained.

(55) It is important that the development and the use of GMOs are followed closely.

(56) When a product containing a GMO that comprises or incorporates into products on the market and when this product has been duly approved in accordance with this Directive, a Member State may not prohibit, restrict or prevent the placing on the market of GMOs ; Whereas a safeguard procedure should be laid down in the event of the risk to human health or the environment.

(57) The European Group on Ethics in Science and New Technologies should be consulted with a view to consulting on ethical issues of a general nature, linked to the deliberate release or marketing of GMOs. Such consultations should not affect the competence of the Member States with regard to ethical issues.

(58) The Member States should be able to consult all the committees they have set up to give advice on the ethical aspects of biotechnology.

(59) The necessary implementing measures for this Directive should be adopted in accordance with Council Decision 1999 /468/EC of 28. In June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.

(60) The exchange of information pursuant to this Directive should also include the experience gained with the inclusion of the consideration of ethical aspects.

(61) In order to make the implementation of the provisions adopted pursuant to this Directive more effectively, rules should be adopted concerning the penalties to be applied by Member States, including in the case of the deliberate release or placing on the market, which are contrary to : the provisions of this Directive, in particular as a result of negligence.

(62) The Commission should in the report it emits every three years and in which it takes account of information from the Member States, in a separate chapter, account for the socio-economic benefits and disadvantages of each GMO category, marketing authorization, which takes account of the interests of farmers and consumers.

(63) The regulatory framework for biotechnology should be reviewed in order to further improve the coherence and effectiveness of this regulatory framework. The procedures may need to be adapted to improve efficiency, and all the possibilities that can lead to this result should be taken into account-

ISSUED THE FOLLOWING DIRECTIVE :

PART A

GENERAL PROVISIONS

ARTICLE 1

Objective

The purpose of this Directive is, in accordance with the precautionary principle, to approximate the laws, regulations and administrative provisions of the Member States, and to protect human health and the environment in the context of :

-WHAT? the deliberate release into the environment of genetically modified organisms for any other purposes other than marketing in the Community ;

-WHAT? the placing on the market of genetically modified organisms forming or forming part of the products in the Community.

ARTICLE 2

Definitions

For the purposes of this Directive :

1) organism : any biological entity that is capable of replicating or transferring genetic material ;

2) genetically modified organism (GMO) : an organism, other than humans, in which the genetic material has been altered in a manner that does not occur naturally by propagation and / or natural recombination.

Within the framework of this definition :

a) in the case of genetic modification, at least in the application of the techniques listed in Annex IA, Part 1

b) the techniques listed in Annex I A, part 2 are not considered to lead to genetic modification ;

3) ' release ` means any intended transfer to the environment of a GMO or a combination of GMOs for which no specific containment measures are used in order to limit the contact and safety of GMOs and to ensure a high level ; security level for the population and the environment ;

4) " placing on the market " means the availability of a third party against payment or non-remuntiate.

The following actions shall not be considered marketing :

-WHAT? the availability of genetically modified micro-organisms for activities covered by Council Directive 90 /219/EEC of 23. April 1990 on the containment of the use of genetically modified micro-organisms, including cultural collections

-WHAT? Whereas the availability of GMOs other than those referred to in the first indent are to be used exclusively for activities where appropriate strict containment measures are used in order to limit their contact with and to ensure a high level ; safety standards for the population and the environment ; whereas the measures should be based on the same principle of containment as laid down in Directive 90 /219/EEC;

-WHAT? the availability of GMOs solely for the use of herds which meet the requirements of Part B ;

5) notification : the submission of the information required pursuant to this Directive to the competent authority of a Member State ;

6) notifier : the person who notifides the notification ;

7) " product " means a preparation consisting of, or containing, a GMO or a combination of GMOs and marketed ;

8) the environmental risk assessment : assessment carried out in accordance with Annex II of the risks to human health and the environment, directly or indirectly, immediate or delayed, as the release or placing on the market of GMOs may include.

ARTICLE 3

Exclusions

1. This Directive shall not apply to organisms manufactured with the techniques of genetic modification listed in Annex I B.

2. This Directive shall not apply to the transport of genetically modified organisms by rail, by road, inland waterway, sea or air.

ARTICLE 4

General obligations

Member States shall ensure, in accordance with the precautionary principle, that all necessary measures are taken to prevent any adverse effects on human health and the environment as a result of the deliberate release or marketing of GMOs. GMOs may only be released or placed on the market in accordance with Part B or part C of the product.

2. Anyone intoption to file a notification according to Part B or part C shall carry out an environmental risk assessment. The information required to carry out the environmental risk assessment shall be indicated in Annex III. Member States and the Commission shall ensure that GMOs containing genes which express resistance to antibiotics used in human or veterinary medicine are taken into account, in particular, in the environmental risk assessment for the purposes of : identification and phasing out of antibiotic-resistant markers in GMOs which may have adverse effects on human health and the environment. This phasing out must take place before 31. In December 2004, in the case of GMOs placed on the market in accordance with Part C, and before 31. In December 2008, in the case of GMOs authorised under Part B.

Member States and, where appropriate, the Commission shall ensure that a strict assessment of the potential adverse effects on human health or the environment, which may be directly or indirectly caused by the transfer of the transfer of the Member States, in each case may be carried out in each case ; genes from GMOs to other organisms. This assessment shall be carried out in accordance with Annex II, having regard to the environmental impact according to the characteristics of the organism to which the product is exposed and the receiving environment.

Member States shall appoint the competent authority or authorities responsible for ensuring that the requirements of this Directive are met. The competent authority shall examine whether the notifications in accordance with the requirements of this Directive are in accordance with the requirements of this Directive and whether the notifications are in accordance with the requirements of this Directive. The assessment referred to in 2 is satisfactory.

5. Member States shall ensure that the competent authority shall exercise supervision and other appropriate controls to ensure that this Directive is complied with. In the case of the deliberate release or placing on the market of one or more GMOs constituting or incorporation into products for which no authorisation is granted, the Member State concerned shall ensure that the necessary measures are taken to restore the release ; or placing an end to the placing on the market, if necessary, to initiate remedial measures and to inform the public, the Commission and other Member States.

SHARE B

EXCEPTION OF GMOs IN ETHVERT ANOTHER ETHAN AN MARKET FOLLOWING

Article 5

Article 6-11 shall not apply to medicinal substances and medicinal products for human use consisting of, or containing, a GMO or a combination of GMOs, insofar as their release in any other than marketing is permitted under the conditions of marketing ; Community legislation, which

a) require a specific environmental risk assessment in accordance with Annex II, and on the basis of the type of information specified in Annex III, subject to additional requirements in accordance with the said legislation ;

b) calls for an explicit permit prior to postponement,

c) provide for a monitoring plan, in accordance with the relevant parts of Annex III, in order to identify the effects of GMOs or GMOs on human health or the environment ;

d) provide appropriate requirements for the processing of new information, information of the general public, information on the results of statements and exchanges of information, which are at least equivalent to the requirements of this Directive and in the measures that are : are made in accordance with this.

2. The assessment of the risks to the environment of such substances and preparations shall be carried out in cooperation with the authorities of the Member States and in the Community, as referred to in this Directive.

3. The procedures to ensure the conformity and equivalence of the specific environmental risk assessment and equivalence with the provisions of this Directive shall be defined in the said legislation, which shall refer to this Directive.

ARTICLE 6

Standard authorisation procedure

Without prejudice to Article 5, anyone who intends to carry out a release of a GMO or a combination of GMOs shall submit a notification to the competent authority of the Member State in which the release is to be carried out.

The second paragraph of paragraph 1. 1 notification of notification shall include :

a) A technical file containing the information specified in Annex III which is necessary to carry out the environmental risk assessment of the release of a GMO or a combination of GMOs, in particular :

i) general information, including information concerning staff and the training of staff ;

(ii) information on the GMO (s) concerned ;

(iii) information on the conditions of the release and the potential receiving environment ;

(iv) information on the interactions of the GMO (s) and the environment ;

(v) a monitoring plan, in accordance with the relevant parts of Annex III, in order to identify the effects of GMOs or GMOs on human health and the environment ;

We) information on controls, remediation methods, waste treatment and emergency plans ;

vii) a summary of the dossier.

b) The environmental risk assessment and the conclusions required in Annex II, point D, together with relevant bibliographic references and indications of the methods used.

3. The notifier may refer to data in or results of notifications previously filed by other notifiers, or provide additional information to the notifier, provided that such information, data and results are not available ; confidential or that such notifiers have given written consent thereto.

4. The competent authority may accept that the release of the same GMO or the combination of GMOs in the same place or in different places for the same purpose and within a limited period may be subject to a single notification.

5. The competent authority shall confirm the date of receipt of the notification and provides, where appropriate, taking into account comments from other Member States in accordance with Article 11, the notifier shall receive a written reply no later than 90 days after : the receipt of the notification, in which the competent authority is indicated :

a) it has found that the notification is in accordance with this Directive and that the release may be carried out, or

b) the release does not comply with the conditions laid down in this Directive and that the notification is therefore rejected.

6. for the calculation of the 90-day period referred to in paragraph 1. 5, do not include the period of time when the competent authority :

a) is pending further information requested by the notifier, or

b) carry out a public consultation in accordance with Article 9 ; this public consultation shall not extend the period of 90 days referred to in paragraph 1. Five, with more than 30 days.

7. Requesting the competent authority for new information, at the same time for reasons of such information.

8. The notifier must first make the statement after receiving the written consent of the competent authority and in accordance with the conditions attached thereto.

9. Member States shall ensure that no material derived from GMOs and which is subject to Part B shall be placed on the market unless it is done in accordance with Part C.

Article 7

Differentiated procedures

1. If sufficient experience has been obtained with the release of certain GMOs in certain ecosystems and the GMOs in question comply with the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal concerning the use of : differentiated procedures for such types of GMOs.

2. Within 30 days of receipt of a competent authority ' s proposal or on its own initiative, the Commission shall :

a) forward the proposal to the competent authorities, which may make comments within 60 days, and, at the same time,

b) make the proposal accessible to the public, which may make comments within 60 days, and

c) consult the relevant Scientific Committee, which may make a statement within 60 days.

Article 3 (3) shall, in accordance with the procedure laid down in Article 30, 2, a decision shall be taken on each proposal. The decision shall specify which of the technical information provided for in Annex III, which are at least necessary for the assessment of foreseeable risks of the release, in particular :

a) information on the GMO (s) concerned ;

b) information on the conditions of the release and the potential receiving environment ;

c) information on the interactions between the GMO (s) and the environment ;

d) the environmental risk assessment.

4. This decision shall be taken within 90 days of the date of the Commission ' s proposal or the date of receipt of the proposal by the competent authority. The period of 90 days shall not include the period in which the Commission is awaiting the comments of the competent authorities, the comments made by the public or the opinion of the Scientific Committees, cf. paragraph 2.

5. The decision taken pursuant to paragraph 1. 3 and 4 shall stipulate that the notifier must first make the statement when he has received the written consent of the competent authority. The notifier shall perform the release in accordance with the conditions laid down in the authorization.

The decision taken pursuant to paragraph 1. 3 and 4 may provide that the release of a GMO or a combination of GMOs in the same place or in different places for the same purpose and within a limited period may be subject to a single notification.

6. Commission Decision 94 /730/EC of 4. November 1994 laying down simplified procedures for the deliberate release into the environment of genetically modified plants pursuant to Article 6 (2). 5, in Council Directive 90 /220/EEC shall continue to apply, cf. however, paragraph 1 1-5 of this Article.

7. If a Member State is subject to the release of GMOs in its territory, the use of or not applying a procedure laid down in a decision in accordance with paragraph 1 shall be determined by a Member State. The Commission shall inform the Commission of 3 and 4.

ARTICLE 8

Processing of changes and new information

1. an alteration or an unintended transformation of the release of a GMO or a combination of GMOs which may have consequences in terms of the risks to human health and the environment after the competent authority has given its written written statement ; permit, or provide for new information on such risks, whether the notification is for the examination by the competent authority of a Member State or in accordance with the written consent, the notifier shall immediately :

a) take the measures necessary for the protection of human health and the environment ;

b) notify the competent authority prior to any changes, or as soon as the unintended change is known or the new information is available ;

c) revise the measures indicated in the notification.

2. If the one in paragraph 1 The competent authority referred to in paragraph 1 shall hold information which may have significant consequences in terms of risks to human health and the environment, or if they are in accordance with paragraph 1. In the circumstances described, the competent authority shall make an assessment of this information and make them publicly available. It may require the notifier to change the terms of the statement, put it in a bero or bring it to an end, and inform the public accordingly.

Article 9

Consultation of and information to the public

Without prejudice to Articles 7 and 25, Member States shall consult the public and, where appropriate, groups on the planned release. In this context, the Member States must determine the circumstances for such consultation, including a reasonable period of time, in order to give the public or the groups the opportunity to express their opinion.

Subject to Article 25 :

-WHAT? does the Member States make information on all part B-statements in their territory of GMOs available to the public ;

-WHAT? the Commission shall provide information contained in the system for the exchange of information pursuant to Article 11, publicly available.

Article 10

Reporting of statements by notifiers

When a statement is complete and then at the intervals laid down in the authorization on the basis of the results of the environmental risk assessment, the notifier shall notify the competent authority as a result of the release in respect of any risk to the health or environment of human beings, where appropriate, with particular reference to the types of products to which the notifier intends to report at a later date. A model for the presentation of this result shall be established in accordance with the procedure laid down in Article 30 (1). 2.

Article 11

Exchange of information between the competent authorities and the Commission

1. The Commission shall draw up a system for the exchange of information contained in the notifications. The competent authorities shall send the Commission a summary of each notification received pursuant to Article 6 within 30 days of receipt of the receipt. The model for this summary shall be drawn up and amended where necessary in accordance with the procedure laid down in Article 30 (3). 2.

2. The Commission shall transmit these to the other Member States within 30 days of receipt of the summary information, within 30 days, by means of the Commission or directly concerned. A Member State shall, upon request, have the right to a copy of the entire notification by the competent authority of the Member State concerned.

The competent authorities shall inform the Commission of the final decisions taken in accordance with Article 6 (1). 5, including, where appropriate, of their reasons for rejecting a notification and of the results of the statements they have received in accordance with Article 10.

4. As regards the release of GMOs as referred to in Article 7, Member States shall send to the Commission once a year a list of GMOs which have been refused, and a list of notifications that have been rejected for the Commission, the lists to the competent authorities of the other Member States.

PART C

THE MARKET OF MARKET OF GMOs OR INDUSTRY OR INDUSTRY IN PRODUCTS

Article 12

Vertical legislation

1. Articles 13 to 24 shall not apply to GMOs which constitute or enter into products as far as they are authorised under Community legislation, which in part contains requirements for a specific environmental risk assessment in accordance with the principles set out in Annex 1 II, and on the basis of information set out in Annex III, subject to additional requirements pursuant to the abovementioned Community legislation, lay down requirements for risk management, labelling, adequate monitoring, information to the public ; and the safeguard clause, which shall be at least equivalent to the requirements of this Directive.

2. For Council Regulation (EEC) No 2, Whereas Articles 13 to 24 of this Directive shall not apply to GMOs which constitute or enter into products as they have been approved in accordance with the said Regulation, provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II and on the basis of the type of information set out in Annex III, subject to other relevant risk assessment requirements, risk management, labelling, adequate monitoring, information to the public ; and the safeguard clause as laid down in Community legislation on medicinal products for : humane and veterinary use.

3. The procedures to ensure that risk assessment, risk management requirements, labelling, adequate monitoring, information to the general public and the safeguard clause correspond to what is laid down in this Directive for a Regulation, of the European Parliament and the Council Future sector-specific acts based on the provisions of that Regulation shall contain a reference to this Directive until the Regulation enters into force, GMOs which form or enter into products, provided that they are approved in under the terms of other Community legislation, only the placing on the market of the market in accordance with this Directive shall be placed on the market.

During the evaluation of applications for the marketing of the products referred to in paragraph 1. The bodies set up by the Community pursuant to this Directive and by the Member States for their implementation shall be consulted.

Article 12a

Transitional measures of unintended or technically unavoidable presence of genetically modified organisms for which a favourable risk assessment has been carried out ;

1. The placing on the market of GMOs or combinations of GMOs which appear as traces of products intended for direct use in food or feed or for processing are exemptable from Article 13-21 if they satisfy the conditions of Article 47 ; Regulation (EC) No, Regulation (EC) No, 1829/2003 on genetically modified food and feed.

This Article shall be valid for three years after the date on which Regulation (EC) No, 1829/2003 shall apply.

ARTICLE 13

Notification procedure

1. Before a GMO or a combination of GMOs constituting or forming part of a product, a notification shall be made to the competent authority of the Member State in which this GMO is to be marketed for the first time. The competent authority shall confirm the date of receipt of the notification and shall forward to the summary of the dossier of the dossier as referred to in paragraph 1 of this Article. (2) (h), to the competent authorities of the other Member States and to the Commission.

The competent authority shall examine immediately whether the notification is in accordance with paragraph 1. 2, and, if necessary, request the notifier for additional information.

When the notification is in accordance with paragraph 1, The competent authority shall send the competent authority no later than when it is subject to the provisions of Article 14 (1). A copy of the notification to the Commission, which shall transmit its assessment report to the Commission within 30 days of its receipt, shall forward it to the competent authorities of the other Member States within 30 days of its receipt.

2. The notification must include :

a) the information required in Annexes III and IV. This information shall take into account the diversity of the uses of GMOs which are or are part of a product, and shall include information on data and results from statements in research and development purposes in relation to the impact of the statement on human health and the environment ;

b) the environmental risk assessment and the conclusions required in Annex II, point D ;

c) the conditions for the placing on the market of the product, including special conditions for use and handling

d) a proposed period of validity for the authorization which should not exceed 10 years, cf. Article 15 (1). 4

(e) a plan for monitoring in accordance with Annex VII, which includes a proposal for the duration of the surveillance plan ; this duration may be different from the proposed period of validity of the authorization ;

(f) a proposal for labelling that must comply with the requirements set out in Annex IV. It must be clearly stated on the label that the product contains a GMO. The term This product contains genetically modified organisms either on a label or in an accompanying document

g) a proposal for packaging which must comply with the requirements set out in Annex IV ;

(h) a summary of the dossier. The modeling to the summary shall be laid down in accordance with the procedure laid down in Article 30 (1). 2.

Finds a notifier on the basis of the results of a statement declared under Part B, or on the basis of other essential, scientifically justified reasons, that the placing on the market and use of a GMO that constitutes or forming part of a product does not, In the interests of human health and the environment, the notifier may propose to the competent authority that he omits to provide a part or all of the information required in Annex IV (B).

3. The notifier must indicate in the notification data or results from statements of the same GMO (s) or the same combination of GMOs to which the notifier has previously reported and / or carried out or is in the process of reporting and / or taking place in or without for the Community.

4. The notifier may also refer to data or results from notifications previously filed by other notifiers, or provide additional information which he considers relevant, provided that such information, data and results are not available ; confidential or that these notifiers have given their written consent.

5. Should a GMO or a combination of GMOs be used for other purposes other than the one already indicated in a notification, a separate notification shall be filed.

6. If new information has been provided on the risks, the GMO for human health or the environment before written authorisation is granted, the notifier shall immediately take the necessary measures to protect human health and the environment and shall inform the competent authority accordingly. In addition, the notifier shall review the information and conditions indicated in the notification.

ARTICLE 14

Assessment Report

1. After receipt and confirmation of receipt of the notification in accordance with Article 13 (1), 2 shall examine the competent authority whether the notification is in accordance with this Directive.

2. Within 90 days of receipt of the notification, the competent authority shall :

-WHAT? prepare an assessment report and send it to the notifier. The notifier subsequently withdraws its notification does not preclube the submission of the notification in subsequent submission to another competent authority ;

-WHAT? in the one in paragraph 1. paragraph 3 (a) shall send this report together with the provisions referred to in paragraph 1. The information referred to in paragraph 4 and any other information to the Commission, which shall be forwarded to the Commission within 30 days of its receipt, shall forward the report to the competent authorities of the other Member States.

In the first paragraph, In the case of paragraph 3 (b), the competent authority shall send its report together with the information referred to in paragraph 1. 4 of the information referred to in paragraph 4 and any other information contained in its report shall be based to the Commission not less than 15 days after the assessment report has been sent to the notifier and within 105 days of receipt of the notification. The Commission shall transmit the report to the competent authorities of the other Member States within 30 days of receipt of the report.

3. In the assessment report,

a) the GMO (s) should be marketed and under which conditions, or

b) whether the GMO (s) concerned should not be marketed.

The assessment reports shall be drawn up according to the guidelines set out in Annex

For the calculation of the one in paragraph 1. The maximum period specified in 90 days shall not be included in the period during which the competent authority is awaiting further information as requested by the notifier. The competent authority shall justify any requests for further information.

Article 15

Standard procedure

Paragraph 1 of the provisions of Article 14 (1). The competent authority or the Commission may request further information, submit comments to or substantiated objections to the placing on the market of the GMO (s) concerned within 60 days of the date of the date of the date on which the date was taken ; the forwarding of the assessment report.

Remarks or reasoned objections and replies shall be sent to the Commission, which shall immediately forward them to all the competent authorities.

The competent authorities and the Commission may discuss any outstanding issues in order to reach an agreement within 105 days of the date of the transfer of the evaluation report.

For the purpose of calculating the final date of 45 days in order to reach an agreement, no account shall be taken of periods in which further information from the notifier is expected. Any request for further information shall be justified.

2. In the provisions referred to in Article 14 (1). The notification referred to in paragraph 3 (b) should be rejected if the competent authority, which produced the report, decides that the GMO (s) concerned should not be marketed. This decision shall be justified.

3. If the competent authority has drawn up the report, it shall decide that the product may be placed on the market if there are no reasoned objections from a Member State or from the Commission within 60 days of the date of the date of the date on which it was due ; the forwarding of the provisions referred to in Article 14 (1). The evaluation report (3) (a) shall be referred to or whose outstanding questions are resolved before the end of the period referred to in paragraph 1. The competent authority, which has produced the report, written authorisation for marketing, shall forward it to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

4. The authorisation shall be granted for a period of not more than 10 years from the date of its issue.

In the case of the approval of a GMO or its offspring solely for the purposes of the placing on the market of seeds in accordance with the relevant Community provisions, the period of validity of the first authorization shall expire within 10 years of the date on which the date of the sale of the seed, the first plant variety containing the GMO was recorded on an official national plant variety list of plant species in accordance with Council Directive 70 /457/EEC and 70 /458/EEC.

In the case of forest reproductive material, the period of validity of the first authorization shall expire no later than 10 years after the date on which the basic material containing GMOs was first recorded in a public national register ; basic material in accordance with Council Directive 1999 /105/EC.

Article 16

Criteria for and information on specified GMOs

In Article 13, a competent authority or the Commission may, on its own initiative, submit a proposal on criteria and requirements for information to be met by notification to the placing on the market of certain types of GMOs constituting or forming part of it ; products.

The provisions of paragraph 2 shall be fixed. 1 mentioned criteria and information requirements, as well as appropriate requirements for a summary of the dossier. These measures, which are intended to amend the non-essential provisions of this Directive by complementing it, shall be adopted after consulting the relevant scientific committee following the regulatory procedure with scrutiny in Article 30 (1). 3. The criteria and requirements for information must be such that they ensure a high level of safety for human health and the environment, and must be based on the scientific evidence available to this security and on experience gained ; the release of similar GMOs.

The requirements of Article 13 (1). the second paragraph shall be replaced by those adopted in accordance with the first subparagraph and the procedure laid down in Article 13 (1). 3, 4, 5 and 6, and Articles 14 and 15 shall apply.

3. before the regulatory procedure with scrutiny in Article 30 (1). 3, shall be opened with a view to a decision on the criteria and information requirements referred to in paragraph 1. 1, the Commission shall publish the proposal. The public has a deadline of 60 days to make comments to the Commission. The Commission shall send such comments together with an analysis to the Committee set up pursuant to Article 30.

Article 17

Renewal of a Permission

Paragraph 1 of Article 13, 14 and 15 shall apply to the procedure referred to in paragraph 1. 2-9

a) for the renewal of permits granted under Part C, and

b) before the 171. October 2006 for the renewal of authorisations prior to the 17th. In October 2002, in accordance with Directive 90 /220/EEC concerning the placing on the market of GMOs that make up or enter into products.

2. Not later than nine months prior to the expiry of a permit for authorisations referred to in paragraph 1. Paragraph 1 (a) and before 17. October 2006 in the case of authorisations referred to in paragraph 1. in Article 1 (b), the notifier shall, in accordance with this Article, submit to the competent authority which received the original notification, a notification which shall include :

a) a copy of the permit for the placing on the market of GMOs ;

b) a report on the results of the monitoring carried out in accordance with Article 20.

In the case of permits referred to in paragraph 1, In the case of surveillance, 1 (b) shall be presented when monitoring

c) all other new information on the risks of the product for human health and / or the environment ; and

d) where appropriate, a proposal for a change or alteration of the conditions of the original authorisation, inter alia the conditions for the future monitoring and the time limitation of the authorisation.

The competent authority shall confirm the date of receipt of the notification and, where the notification is in accordance with this paragraph, the competent authority shall forthwith send a copy of the notification and the assessment report to the Commission, as most recently : 30 days after receipt thereof, they shall forward them to the competent authorities of the other Member States. The competent authority shall also send its evaluation report to the notifier.

3. The assessment report shall indicate :

a) the GMO (s) should remain on the market and on what conditions, or

b) whether the GMO (s) concerned should not remain on the market.

4. The other competent authorities or the Commission may request further information, make comments, or to present reasoned objections within a period of 60 days from the date of the transfer of the evaluation report.

5. Any comments or reasoned objections and replies shall be sent to the Commission, which shall immediately forward them to all competent authorities.

For the first paragraph, paragraph 6. in the case of paragraph 3 (a), the competent authority which produced the report shall, where there are no justified objections from a Member State or from the Commission within 60 days of the date of the transfer of the assessment report, shall send : notifier the final written decision and notify the other Member States and the Commission thereof within 30 days. The validity of the authorization should not, as a general rule, exceed 10 years and may, where appropriate, be restricted or extended for specific reasons.

7. The competent authorities and the Commission may discuss any outstanding matter in order to reach an agreement no later than 75 days from the date of the re-entry of the evaluation report.

8. If the outstanding questions are resolved before the end of the item in paragraph 1. The competent authority responsible for drawing up the report shall submit its final written decision to the notifier and inform the other Member States and the Commission thereof within 30 days. The validity of the authorisation may, where appropriate, be restricted.

9. After submitting a notification for the renewal of a permit in accordance with paragraph 1. 2 the notifier may continue to market the GMO on the conditions laid down in the authorization until a final decision has been taken on the notification.

Article 18

Community procedure in the event of objections

If a competent authority or the Commission, in accordance with Articles 15, 17 and 20, shall make and maintain objections, the Commission shall, in accordance with the procedure referred to in Article 30 (1), shall, where appropriate, be 2, within 120 days shall be adopted and published a decision. This Decision shall contain the same information as provided for in Article 19 (1). 3.

In calculating the period of 120 days, no period shall be included where the Commission is awaiting further information requested by the notifier, or awaiting the opinion of a Scientific Committee, which has been consulted in accordance with Article 1 ; 28. The Commission must justify any request for further information and inform the competent authorities of its requests to the notifier. The period of time when the Commission is awaiting the opinion of the Scientific Committee shall not exceed 90 days.

The period during which the Council shall decide in accordance with the procedure laid down in Article 30 (1). Two, do not count.

2. If a positive decision has been taken, the competent authority which has prepared the report shall notify the notifier in writing to the notifier, forward it to the notifier and inform the others ; Member States and the Commission within 30 days of the publication or the notification of the decision.

Article 19

Permission

1. Only if written authorisation for the placing on the market of a GMO that constitutes or forms part of a product may be used without further notification throughout the Community, provided that the requirements of other Community legislation may be used without further notification in the Community, in so far as they are authorised ; specific conditions of use and of the requirements in terms of environments and / or geographical areas are strictly observed.

2. The notifier shall first start placing the placing on the market once he has received the written consent of the competent authority in accordance with Articles 15, 17 and 18, and in accordance with the conditions required for that authorisation.

The written consent referred to in Articles 15, 17 and 18 shall, in all cases, explicitly state :

a) the scope of the authorization, including the identity of the GMO (s) which constitute or enter into products and to be marketed, as well as their unique identifiable identifier ;

b) the period of validity of authorisation ;

c) the conditions for the placing on the market of the product, including any special conditions for use, handling and packaging of the product or GMOs constituting or forming part of products, and conditions for the protection of specific ecosystems / environments ; and / or geographical areas,

d) the notifier, subject to the application of Article 25, shall make auditing tests available to the competent authority ;

(e) labelling requirements in accordance with the requirements set out in Annex IV. Labelling must clearly indicate that the product contains a GMO. The term This product contains genetically modified organisms either on a label or in a document accompanying the product or other products containing the GMO (s) or GMOs ;

(f) surveillance requirements in accordance with Annex VII, including reporting obligations to the Commission and the competent authorities, the time period for the monitoring plan and, where applicable, all obligations incumlitiable to any person selling the product ; or any user in particular, in the case of cultivated GMOs, relating to an information-level information, considered appropriate, of the place where they are located.

4. Member States shall take all necessary measures to ensure that the written consent and, where appropriate, the decision referred to in Article 18 shall be made publicly available and that the terms of the written consent and the written consent and the conditions laid down in Article 1 of this Directive are made available ; the decision shall be complied with.

Article 20

Monitoring and processing of new information

1. Following the placing on the market of a GMO that composes or forms part of a product, the notifier shall ensure that monitoring is carried out, and shall report on the monitoring of the conditions laid down in the authorization. The reports on this monitoring shall be submitted to the Commission and the competent authorities of the Member States On the basis of these reports and in accordance with the authorization and within the framework of the monitoring plan laid down in the authorisation, the competent authority which received the original notification may adapt the surveillance plan ; after the first monitoring period.

If, after the written consent has been granted, new information from users or from other sources of risk to human health or the environment must be notified without delay, the notifier shall immediately take the necessary information ; measures to protect human health and the environment and inform the competent authority accordingly.

In addition, the notifier shall review the particulars and conditions indicated in the notification.

the competent authority in possession of information which may have consequences for the risks of the health or the environment of the GMO (s) of human health or the environment, or in the case of those referred to in paragraph 1, shall be provided. Where appropriate, the competent authority shall send the information to the Commission and the competent authorities of the other Member States without delay, and may, where appropriate, refer to the provisions of Article 15 (1). Article 17 (1) and Article 17 (1). 7 if the information has been obtained prior to the written consent.

Where the information is obtained after the authorisation was granted, the competent authority shall send its evaluation report within 60 days of receipt of the new information, stating whether or not the conditions of authorisation should be amended or its authorization shall be terminated to the Commission, which shall forward it to the competent authorities of the other Member States within 30 days of receipt thereof.

Remarks or reasoned objections to the continued marketing of the GMO (s) on the proposal to amend the conditions of the authorization shall be forwarded to the Commission within 60 days of the date of re-distribution of the evaluation report ; shall forward it to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues in order to reach an agreement no later than 75 days from the date of the transfer of the assessment report.

If there are no reasoned objections from a Member State or from the Commission no later than 60 days after the submission of the new information, or if outstanding questions are resolved within 75 days, the competent authority which has drawn up shall be that : the report, amend the authorisation as proposed, submit the amended authorisation to the notifier and inform the other Member States and the Commission thereof within 30 days.

4. In order to ensure transparency, the results of the surveillance in accordance with section C shall be made publicly available.

Article 21

Labelling

1. Member States shall take all necessary measures to ensure that labelling and packaging of market-derived GMOs, or included in products, in all stages of marketing are in accordance with the requirements of Article 15 (1). Article 17 (3). Article 18 (5) and (8). Article 19 (2) and Article 19 (1). 3, written consent.

2. For products intended for which unintended or technically unavoidable traces of authorised GMOs cannot be ruled out, a minimum threshold may be laid down in which these products do not have to be labelled in accordance with paragraph 1. 1.

The threshold values shall be determined taking into account the product concerned. These measures, which are intended to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with a view to the checks provided for in Article 30 (1). 3.

For products intended for direct processing, paragraph 1 shall apply. Paragraph 1 shall not apply to any traces of authorised GMOs where the proportion does not exceed 0,9% or lower thresholds, provided that these tracks are unintended or technically unavoidable.

Threshold values may be laid down as referred to in the first subparagraph. These measures, which are intended to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with a view to the checks provided for in Article 30 (1). 3.

Article 22

Free movement

Member States may not prohibit, restrict or prevent the placing on the market of GMOs that make up or enter into products and which comply with the requirements of this Directive, cf. however, Article 23.

Article 23

Safeguard clause

1. If a Member State as a result of new or supplementary information obtained after the authorisation is granted and which impacts on the environmental risk assessment or as a result of reassessment of existing information on the basis of new or additional information, Whereas scientific knowledge has justified grounds for the possibility of a GMO that constitutes or incorporates into products and has been duly notified and subject to written authorisation pursuant to this Directive constitutes a risk to human health ; the environment, this Member State may temporarily restrict or prohibit the use and / or sale of it ; the GMO (s) concerned as or in products in its territory.

The Member State shall ensure that, in the event of a serious risk, emergency measures, such as suspending or stopping for placing on the market, are being made, and the public is informed.

The Member State shall immediately inform the Commission and the other Member States of the measures taken pursuant to this Article and indicate the reasons for it, presenting its reassessment of the environmental risk assessment, indicating, whether the conditions for the authorisation shall be withdrawn or the licence, and how this is to be done and, where appropriate, the new or additional information on which the decision is based.

Within 60 days of the date of receipt of the information submitted by the Member State, a decision shall be taken on the measure taken by the Member State concerned in accordance with the regulatory procedure referred to in Article 30 (1). 2.In calculating the 60-day period of time, the Commission shall not count for further information requested by the notifier, or awaiting the opinion of the Scientific Committees who have been consulted. The period during which the Commission shall wait for the opinion of the Scientific Committees or the Scientific Committees shall not exceed 60 days.

Similarly, the time limit for which the Council shall apply shall not be taken into account under the regulatory procedure referred to in Article 30 (3). 2.

ARTICLE 24

Information to the public

1. After receiving a notification in accordance with Article 13 (1), 1, the Commission shall immediately do so in Article 13 (1). The summary information referred to in point 2 (h) shall be available to the public, cf. however, Article 25. The Commission shall also make the assessment reports available to the general public in the cases referred to in Article 14 (1). (3) (a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.

2. For all GMOs that make up or enter into a product and where marketing has been refused in accordance with this Directive, the assessment reports for these GMOs and opinions shall be the opinion of those GMOs ; from the scientific committees consulted, accessible to the public, cf. however, Article 25. For each product, clearly, the products contain and use the GMO (s), and its use.

SHARE D

FINAL PROVISIONS

ARTICLE 25

Confidentiality

1. The Commission and the competent authorities shall not disclose confidential information notified or exchanged in accordance with this Directive and shall protect the intellectual property rights which are linked to the received ; data.

2. The notifier may indicate which of the information in the notification pursuant to this Directive should be treated as confidential, because disclosure may prejudice the competitive position of the notifier. In this case, it shall be accompanied by a veritable certify reason.

3. The competent authority shall decide, after consultation with the notifier, the information which will be treated as confidential and shall notify the notifier of its decision.

4. The following information may in no way be treated as confidential when presented in accordance with Articles 6, 7, 8, 13, 17, 20 or 23 :

-WHAT? a general description of the GMO (s), the name and address of the notifier, the purpose of the statement and the place of the release and the intended use ;

-WHAT? methods and plans for the monitoring of the GMO (s) and the contingency plan ;

-WHAT? the environmental risk assessment.

If the notifier notifies his notification, regardless of the reason, the competent authorities and the Commission shall respect the confidential nature of the information.

Article 26

Labelling of GMOs referred to in Article 2 (2), 4, second subparagraph

1. GMOs to be made available to the acts referred to in Article 2 (2). The fourth subparagraph shall comply with the appropriate labelling requirements in accordance with the relevant paragraphs of Annex IV, in order to make it clear from a label or an accompanying document that GMOs have been used. The term This product contains genetically modified organisms either on a label or in an accompanying document.

2. the conditions for the implementation of paragraph 1. Paragraph 1 shall be established, by avoiding duplication or non-compliance with existing labelling provisions in the Community legislation in force. These measures, which are intended to amend non-essential provisions of this Directive by complementing it, shall be adopted in accordance with the regulatory procedure with a view to the checks provided for in Article 30 (1). In this respect, due account should be taken of the labelling provisions laid down by the Member States in accordance with Community legislation.

Article 26a

Measures to prevent the unintended presence of GMOs

1. Member States may take appropriate measures to prevent the unintended presence of GMOs in other products.

2. The Commission collects and coordinates information based on studies at Community level and national level, monitor developments in coexistence between genetically modified, conventional and organic crops in the Member States and establishes ; guidelines for this, based on this information and observations.

ARTICLE 27

Adaptation of the Annexes to technical progress

Adaptation of section C and D of Annex II, Annex III-VI and Section C of Annex VII, with the aim of changing non-essential provisions of the Directive, shall be subject to the regulatory procedure with a check referred to in Article 30 (1). 3.

Article 28

Consultation of one or more scientific committees

1. In cases where objections to the risks of GMOs for human health or the environment are submitted by a competent authority or the Commission, and shall be maintained in accordance with Article 15 (1). Paragraph 1, Article 17 (1). Article 20 (4). Whereas Article 23 (3) or Article 23 or, in the evaluation report referred to in Article 14, indicate that the GMO should not be placed on the market, the Commission shall, on its own initiative or at the request of a Member State, consult it or the relevant scientific committees ; on the objections.

The Commission may, on its own initiative or at the request of a Member State, consult it or the relevant scientific committees on all matters referred to in this Directive and which may have adverse effects on human health and the environment.

The administrative procedures provided for in this Directive shall not be affected by paragraph 1. 2.

ARTICLE 29

Consultation of one or more committees on ethical issues

Without prejudice to the competence of the Member States on ethical issues, the Commission shall, on its own initiative or at the request of the European Parliament or the Council, consult all the committees it has set up to advise on the ethical aspects of the case of biotechnology, such as the European Group on Ethics in Science and New Technologies, on ethical issues of a general nature.

This consultation may also take place at the request of a Member State.

2. This consultation shall be carried out in accordance with clear rules of transparency, transparency and public access. The results must be made available to the public.

The administrative procedures provided for in this Directive shall not be affected by paragraph 1. 1.

Article 30

Committee procedure

1. The Commission shall be assisted by a committee.

2. When reference is made to this paragraph, Articles 5 and 7 of Decision 1999 /468/EC shall apply, cf. its Article 8.

The period laid down in Article 5 (3). 6, in Decision 1999 /468/EC shall be set at three months.

Where reference is made to this paragraph, Article 5a (3) shall apply. 1-4, and Article 7 of Decision 1999 /468/EC, cf. its Article 8.

Article 31

Exchange of information and reporting

Member States and the Commission shall meet regularly and exchange information on the experience gained in the prevention of risks associated with the deliberate release into the environment and the placing on the market of GMOs. This exchange of information shall also include the experience gained in the implementation of Article 2 (2). 4, second subparagraph, environmental risk assessment, monitoring, and the question of consultation and information to the public.

The guidelines for the implementation of Article 2 (2), The fourth subparagraph may, if necessary, be determined by the Committee set up in accordance with Article 30 (1). 1.

The Commission shall establish one or more registers for the purpose of storing the information on genetic modification in GMOs referred to in Annex IV (A) (A). 7. Without prejudice to Article 25, the register / registers shall include a part that is accessible to the public. The detailed rules governing the operation of the register / registers shall be laid down in accordance with the procedure laid down in Article 30 (1). 2.

3. Without prejudice to paragraph 1, 2 as well as point A, no. 7, in Annex IV ;

a) Member States shall establish public registers with information on the placing on the market of GMOs under Part B of Part B ;

b) Member States shall also establish registers with information on the whereabouts of GMOs carried out in accordance with section C, in particular in order to monitor the possible effects of such GMOs on the environment in accordance with Article 19 (1). Paragraph 3 (f) and Article 20 (1). 1. Without prejudice to these provisions in Articles 19 and 20,

-WHAT? be notified to the competent authorities, and

-WHAT? be made publicly available

the manner in which the competent authorities consider appropriate, and in accordance with national rules.

Member States shall send to the Commission every three years a report on the measures taken for the implementation of this Directive. This report shall contain a brief factual statement of their experience with GMOs constituting or enter into products and placed on the market in accordance with this Directive.

5. The Commission shall publish a summary on the summary of the information referred to in paragraph 1 every three years. 4 reports.

6. The Commission shall forward to the European Parliament and the Council every three years in 2003 and, at every third year, a report on the experience of the Member States with GMOs placed on the market in accordance with this Directive.

7. When the Commission presents this report in 2003, it shall present a special report on how Part B and part C works, including an assessment of :

a) all the consequences of this, in particular with the aim of taking into account the diversity of European ecosystems, as well as the need to supplement the regulatory framework in this area ;

b) the feasibility of the various possibilities to further improve the coherence and effectiveness of this regulatory framework, including a centralised Community authorisation procedure and the provisions for final decision making by the Commission ;

c) where sufficient experience has been obtained with the implementation of the differentiated procedures referred to in Part B, that a provision for implicit authorisation in respect of these procedures may be justified, and with part C that it may be justified apply differentiated procedures ; and

d) the socio-economic impact of the deliberate release and the placing on the market of GMOs.

The Commission shall send a report to the European Parliament and the Council every year on the ethical questions referred to in Article 29 (1). 1 ; this report may, if appropriate, be accompanied by proposals for the purposes of amending the Directive.

ARTICLE 32

Implementation of the Cartagena Protocol on Biosafety

The Commission is requested, as soon as possible, and certainly before July 2001, to present a legislative proposal with a view to the implementation of the Cartagena Protocol on Biosafety. The proposal shall supplement and, where necessary, amend the provisions of this Directive.

2. This proposal shall include in particular appropriate measures for the implementation of the procedures laid down in the Cartagena Protocol and, in accordance with the Protocol, require the Community exporters to ensure that all the conditions in the prior authorisation procedure (Advance Informed Agreement procedure), cf. Articles 7 to 10, 12 and 14 of the Cartagena Protocol shall be complied with.

Article 33

Sanctions

Member States shall determine the penalties applicable to infringements of the national provisions adopted pursuant to this Directive ; these penalties must be effective, proportionate and dissuasive ; effect.

Article 34

Implementation of the Directive

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 17. October 2002. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 35

Notification during processing

1. concerning the placing on the market of GMOs which constitute or form part of a product received under Directive 90 /220/EEC, and in respect of which the procedures laid down in that Directive have not been completed by the date of the 17th. In October 2002, the provisions of this Directive are covered by this Directive.

Second latest on the 171. In January 2003, the notifiers shall have supplemented their notification in accordance with this Directive.

Article 36

Repeal

1. Directive 90 /220/EEC is hereby repealed on 17. October 2002.

2. References to the repealed Directive shall be construed as references to this Directive and shall be read in the correlation table in Annex VIII.

Article 37

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 38

This Directive is addressed to the Member States.

ANNEX I A

TECHNIKKER NÆVNT I DIREKTIKEL 2, Number 2

PART 1

Techniques for genetic modification, cf. Article 2 of the Directive, Point 2 (a) shall include, inter alia :

1) nuclear acid combination techniques, resulting in new combinations of genetic material when the introduction of nucleic coasts produced in any way outside of an organism in a virus, bacterial placards or other the vector system and its inference in a host body where they do not occur naturally, but where they are capable of reproacing

2) direct introduction into an organism of inherit materials which are prepared outside the organism, including microinjection, macro injection and microencapsulation

3) cell fusion (including protoplagers) or hybridization techniques, where live cells with new combinations of genetic material are formed by fusion of two or more cells by means of methods that do not occur naturally.

PART 2

Techniques which are not considered to lead to genetic modification, cf. Article 2 of the Directive, (b) 2 (b), provided that they do not involve the use of combinant nucleic coasts or genetically modified organisms produced with other techniques / methods other than those exempted in accordance with Annex I B :

1) in vitro fertilisation,

2) natural processes such as conjugation, transduction and transformation ;

3) the induction of polyploidi,

ATTACHMENT IN B

TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques / methods for genetic modification, resulting in organisms excluded from this Directive, provided that such techniques / methods do not involve the use of combinant nucleic cocyles or genetically modified organisms ; other than those made with one or more of the techniques / methods of the following :

1) mutagenesis,

2) cell fusion (including protoplagers fusion) of plant cells or organisms which may exchange genetic material by means of traditional processing methods.

ANNEX II

PRINCIPLES OF THE ENVIRONMENTAL RISK ASSESSMENT

This Annex contains a general description of the objectives to be achieved, the factors to be taken into account, and the general principles and methods to be followed in order to carry out the environmental risk assessment referred to in Articles 4 and 13. Technical guidance notes may be drawn up in accordance with the regulatory procedure referred to in Article 30 (1). 2, in order to facilitate implementation and understanding of this Annex.

In order to contribute to the common understanding of the terms directly, indirectly, immediate and delayed in the implementation of this Annex, without prejudice to further guidance in this respect, in particular with regard to the question of whether or not it can and the effects of indirect effects shall be described in such a way as to :

-WHAT? direct effects are intended to be the primary effects on human health or the environment, which is a result of the GMO itself and which cannot be attributable to a class chain of events ;

-WHAT? indirect effects are intended to affect human health or the environment, which may be attributable to a class chain of events by means of mechanisms such as interactions with other organisms, transfer of genetic material or changes in use ; or Handling.

Indirect effects are likely to be observed at a later time

-WHAT? immediate effects are aimed at the effects on human health or the environment, which are observed during the period during which the release of the GMO is being issued. Immedial effects may be direct or indirect ;

-WHAT? delayed effects are intended to affect human health or the environment, which are not observed during the period during which the release of the GMO is to occur, but which appears to be a direct or indirect effect either at a later date, or after the statement has been discharged.

Furthermore, a general principle of environmental risk assessment is that an analysis of the cumulative long-term effects associated with the release and marketing should be carried out. Cumulative long-term effects refer to the cumulative effect of the authoritasers on human health and the environment, including, inter alia, flora and fauna, soil fertility, soil degradation of organic material, food and feed chain, biological biological, biological and animal feed diversity, animal health and resistant problems in relation to antibiotics.

A. Measure

The purpose of an environmental risk assessment is by means of a specific assessment on a case-case basis, to demonstrate and assess the potential undesirable effects of the GMO, either directly, indirectly, immediate or delayed, on human health and the environment, which is being released in the environment or the placing on the market of GMOs may include. The environmental risk assessment must be carried out in order to demonstrate whether there is a need for risk management and, if so, what methods it is most appropriate to apply.

B. General principles

In accordance with the precautionary principle, the following general principles should be followed when an environmental risk assessment is carried out :

-WHAT? demonstrated the characteristics of the GMO and its use, which may cause adverse effects, to be compared with the properties of the non-modified organism from which the GMO is derived from, and its use in similar situations ;

-WHAT? the environmental risk assessment is carried out in a scientifically sound and transparent manner, on the basis of available scientific and technical data ;

-WHAT? the environmental risk assessment shall be carried out in a specific case from case to case, which means that the information required may vary according to the nature of the GMO (s) concerned, the intended use and the potential receiving environment, taking into account, inter alia, the case of : GMOs that are already in the environment

-WHAT? if new information on the GMO and its effects on human health or the environment is available, it may be necessary to repeat the environmental risk assessment for :

-WHAT? to establish whether the risk has been changed ;

-WHAT? establish whether there is a need to change the risk management accordingly.

C. Methods

C1. Characteristics of GMOs and the deliberate release into the environment

In the case of each case, the environmental risk assessment must take account of the relevant technical and scientific details relating to the characteristics of :

-WHAT? the recipient or parent organism (s),

-WHAT? the genetic modification, the introduction or the use of genetic material, and the relevant information on vector and donor ;

-WHAT? GMOs;

-WHAT? the intended release or use, including scopes,

-WHAT? the potential receiving environment ; and

-WHAT? the interactions of the interactions.

For the risk assessment, information on the release of similar organisms and organisms with similar traits and their interaction with similar environments may be used.

C.2. Steps in the environmental risk assessment

The following points should be taken into account when drawing conclusions for the environmental risk assessment provided for in Articles 4, 6, 7 and 13 of the Directive :

1. Demonstration of properties that may cause adverse effects

Characteristics of GMOs resulting from the genetic modification and which would cause adverse effects on human health or the environment must be identified. A comparison of the characteristics of GMOs with the non-modified organism under similar conditions by the release or use contributes to detecting the individual potential undesirable effects of the genetic modification. It is important not to ignore a potential undesirable effect even if it is considered improbable.

Potential adverse effects of GMOs will vary from case to case and may include :

-WHAT? disease for people, including allergenic or toxic effects (see, for example, paragraph A, point A, no. Paragraph 11, paragraph C, paragraph C, 2 (i) of Annex III A and point B (B), 7, in Annex III B),

-WHAT? disease for animals and plants, including toxic and possibly allergenic effects (see, for example, part A, point A, no. Paragraph 11, paragraph C, paragraph C, 2 (i) of Annex III A and point B (B), 7, and paragraph D, no. 8, in Annex III B),

-WHAT? effects on the dynamics of the populations of the receiving environment and the genetic diversity of each of these populations (see, for example, point IV, point B, no. 8, 9 and 12, in Annex III A)

-WHAT? changed susceptibility to pathogens which encourage the spread of infectious diseases and / or create new reservoirs or vectors ;

-WHAT? negative impact on prophylactic or therapeutic medical, veterinary or plant protection products, for example, by the transfer of genes which are resistant to antibiotics used in human medicine or veterinary medicine (see e.g. Paragraph 2, point A, no. paragraph 11 (e) and (b) (c) (c) (c) (c) 2 (i) no. i (iv) of Annex III A),

-WHAT? biogeochemical effects (biogeochemical circuits), in particular on carbon and nitrogen circuits, through changes to the soil degradation of organic material (see, for example, paragraph A, point A, no. paragraph 11 (f) and point IV (B), Paragraph 15 of Annex III A and point D (D). 11, in Annex III B).

Undesirable effects may arise directly or indirectly through mechanisms that may include :

-WHAT? the spread of the GMO (s) of the environment ;

-WHAT? transfer of the inserted genetic material to other organisms or the same organism, whether genetically modified or not,

-WHAT? fausaic and genetic instability,

-WHAT? interactions with other organisms,

-WHAT? changes in the management, including, where appropriate, in the case of agricultural practices.

2. Evaluation of the possible consequences of each undesirable effect, provided that it is entered ;

The extent of the possible consequences of any undesirable impact should be assessed. In this assessment, the starting point should be that such an undesirable effect will take place. The extent of the consequences will probably depend on the environment in which the GMO or GMOs are likely to be exposed and the conditions under which the release is being issued.

3. The evaluation of the likelihood that each of the possible adverse effects on the part of each of the detecting possible effects shall be included ;

An important factor in assessing the likelihood or the possibility of an undesirable impact shall be the characteristics of the environment in which the GMO (s) or GMOs are likely to be exposed and the conditions under which the release is being issued.

4. Evaluation of the risk, as shown by the GMO (s) of the GMO (s),

Whereas, in the light of the current scientific level, a estimation of the risk, as shown by a GMO to cause adverse effects on human health or the environment by combining it, should be carried out in the light of the current scientific level. the likelihood of the effect of the undesirable effect and the impact of the consequences if it enters into force.

5. Application of the risk management strategies for the deliberate release or placing on the market of the GMO (s) ;

The risk assessment may take risks that require management and the best way to handle the best possible handling and therefore a strategy for handling should be determined.

6. Determination of the overall risk of the GMO (s)

An assessment of the overall risk of the GMO or GMOs should be carried out taking into account the proposed risk management strategies.

D. Conclusions of the potential environmental impact of the release or marketing of the GMOs

On the basis of an environmental risk assessment carried out in accordance with the principles and methods outlined in points B and C, details of the points listed in sections (1) and (2) should be included in notifications, in particular, on the basis of the principles and methods set out in points (1) and (2). to draw conclusions about the potential environmental impact of the release or marketing of the GMOs :

D.1. In the case of GMOs other than high-standing plants,

1. Probability of GMOs becoming persistent and invasive in natural habitats under the conditions of the proposed release or statement.

2. Any selective advantage or the disadvantage of the GMOs and the likelihood of this being realised under the conditions of the proposed release or the proposed release.

3. Possibility of the transfer of genes to other species under the conditions of the proposed release of GMOs and any selective advantage or disadvantage to such species.

4. Possible immediate and / or delayed environmental impact as a result of direct and indirect interactions between the GMO and target organism (if applicable).

5. Possible immediate and / or delayed environmental impact as a result of direct and indirect interactions between GMOs and non-target organisms, including the impact of the population levels of competitors, prey, hosts, symbiotes, preclors, parasites and pathogens.

6. Potential immediate and / or delayed impact on human health resulting from potential direct and indirect interactions between the GMOs and persons working with or coming in contact with or are near or are near the person or persons concerned ; GMO statements.

7. Possible immediate and / or delayed impact on animal health and the effects on the food chain after the consumption of GMOs and products derived thermals where they are intended for animal feed.

8. Potential immediate and / or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions between the GMO and target organisms and non-target organisms near the GMO (s) in question.

9. Possible immediate and / or delayed direct and indirect environmental impact of the special techniques used to deal with GMOs when they are different from those used for non-GMOs.

D.2. In the case of genetically modified high-ranking plants (GMHPs)

1. Probability of GMHPs becoming more persistent than the recipient or the parent's replants in agricultural habitats or more invasive in natural habitats.

2. any selective benefit or disadvantage for the GMHPs.

3. The possibility of transmission of genes to the same or other cross-species compares to plant the GMHPs and any selective advantage or the disadvantage of these plant species.

4. Potential immediate and / or delayed environmental impact as a result of direct and indirect interactions between GMHPs and target organisms such as pre-dators, parasitoids and pathogens (if applicable).

5. Possible immediate and / or delayed environmental impact as a result of direct and indirect interactions between GMHPs and non-target organisms (e.g. taking account of organisms that are alternating with target organisms), including the effect of : the level of population levels of competitors, herbivores, symbiotes (if applicable), parasites and pathogens.

6. possible immediate and / or delayed impact on human health resulting from potential direct and indirect interactions between the GMHPs and persons working with or coming in contact with or near the person or persons concerned ; GMHA statements.

7. Possible immediate and / or delayed impact on animal health and effects on the food chain following the introduction of the GMHPs and products derived thermals where they are intended for animal feed.

8. Possible immediate and / or delayed direct and indirect environmental effects of the specific cultivation, handling and harvest techniques used for the GMHPs when they are different from those used for non-GMHPs.

9. Potential immediate and / or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions between the GMHPs and target organisms and non-target organisms in the vicinal of the GMHP release (s).

GUIDING NOTES ON OBJECTIVES, FACTORS, GENERAL PRINCIPLES AND METHODOLOGIES RELATING TO THE ENVIRONMENTAL RISK ASSESSMENT REFERRED TO IN ANNEX (II TO DIRECTIVE 2001 /18/EF

1. INTRODUCTION

Environmental risk assessment is Article 2 (2). Directive 8, in Directive 2001 /18/EC, as an assessment of the risks to human health and the environment, directly or indirectly, immediate or delayed, as the release or placing on the market of GMOs may include. As one of the general commitments contained in the directive, it is called Article 4 (2). 3, that the Member States and, where appropriate, the Commission shall ensure that potential adverse effects on human health or the environment which may be caused directly or indirectly, in each case, shall be assessed in each case, taking account of : the impact on the environment according to the properties of the organism exposed and the receiving environment. Environmental risk assessments shall be carried out in accordance with Annex II to the Directive and are also referred to in Part B and C of the Directive. Annex II contains a general description of the objectives to be achieved, the factors to be taken into account, and the general provisions of the Directive ; principles and methods to be followed in order to carry out an environmental risk assessment, taking into account the effects on human health and the environment, according to the properties of the organism being exposed and the receiving environment.

The notifiers shall file a notification containing an environmental risk assessment for the purposes of the release in accordance with Article 6 (2). 2, or an environmental risk assessment for placing on the market in accordance with Article 13 (1). 2.

This guide supplements Annex II to Directive 2001 /18/EC and describes the objectives, principles and methods of environmental risk assessment. The purpose of this is to assist the notifiers and the competent authorities, to make it easier to carry out a comprehensive and appropriate environmental risk assessment in accordance with Directive 2001 /18/EC and make the environmental risk assessment process transparent to the public.

The six steps in the environmental risk assessment are set out in 4.2.

2. TARGET

According to Annex II of Directive 2001 /18/EC, the purpose of an environmental risk assessment by means of a specific assessment on a case is to demonstrate and assess the potential undesirable effects of the GMO, either directly, indirectly, immediate or delayed, on human beings ; health and the environment, which the deliberate release into the environment or the placing on the market of GMOs may include. The environmental risk assessment must be carried out in order to demonstrate whether there is a need for risk management and, if so, what methods it is most appropriate to apply.

The environmental risk assessment therefore includes the release (part B) and the placing on the market (part C) as specified in Directive 2001 /18/EC. The placing on the market often involves, but not necessarily, deliberate release into the environment, but there are in any case the adventitive introduction on the market (e.g. agricultural products containing or consisting of GMOs exclusively for use as is intended for use only as : food and feed or for processing). In these cases, too, the notification must include an environmental risk assessment. Environmental risk assessments for release may generally differ from environmental risk assessments for marketing, for example, as a result of differences in the current data, the time frames and the scope of the relevant area.

In addition to this, these guide notes cover all GMOs, including micro-organisms, plants and animals. Until now, most of the exposed or market-led GMOs have been high-standing plants, but that can change in the future.

The environmental risk assessment will serve as a basis for identifying the need for risk management and, if so, the appropriate methods to be used, and for targeted monitoring (see. Chapter 3).

The General Case for Case assessment shall comprise the GMO (s) concerned (assessment of each GMO) and the environment or environments to which the GMO must be exposed (e.g. assessment of each location or region, if applicable).

As a result of the further developments in genetic modification, Annexes II and these indicative notes may be adapted to technical progress. A further differentiation of the information requirements for the various types of GMOs, such as single-celled organisms, fish or insects, or special use of GMOs, such as the development of vaccines, may be possible once sufficient experience has been obtained ; the statement of the release of specific GMOs in the Community (Annex III, point 4, and Chapter 6).

The risk assessment of the use of antibiotic-resistant marker genes is a very particular problem and additional guidance in this area may be necessary.

In Annex II to Directive 2001 /18/EC, different business categories for GMOs are described as far as human health and the environment are concerned. In order to ensure a common interpretation, the definitions set out in the Directive can be illustrated in the following way :

-WHAT? Direct effects are aimed at the primary effects on human health or the environment, which is a result of the GMO itself and which cannot be attributed to an annual chain of events (for example, the direct impact of the Bt toxin on target organisms or one ; The pathogenic effects of GM micro-organisms on human health).

-WHAT? Indirect effects are intended to affect human health or the environment, which may be attributable to a class chain of events through mechanisms such as interactions with other organisms, transfer of genetic material or changes in use ; or Handling. Indirect effects will probably only be observed later (for example, if a decrease in the target insect population affects the population of other insects, or if the development of multiple resistance or systemic effects will require an assessment of : long-term interaction ; however, some indirect effects such as a drop in pesticide consumption may occur immediately).

-WHAT? Immediate effects are intended to affect human health or the environment, which are observed during the period during which the release of the GMO is being made. Immediate effects may be direct or indirect (for example, lethal effects of insects eating the transgenic plants which possess the insetresist features, or the development of allergenicity of human beings as a result of exposure to a specific GMO).

-WHAT? The adverse effects on human health or the environment may not be observed during the course of the period in which the release of the GMO is to occur, but which appears to be a direct or indirect effect either at a later date, or after the release has been discharged (e.g. a GMO's establishment or invasion several generations after the release, which is very important if the GMO lives for a long time, such as genetically modified species or cross-feed, for example, of the immediate relatives of the transgenic species ; crops that are invasive in natural ecosystems).

In particular, it may be difficult to identify the delayed effects, especially if they are only in the long term. Appropriate measures such as monitoring (see below) may assist detecting these effects.

3. GENERAL PRINCIPLES

In accordance with the precautionary principle, the environmental risk assessment should be based on the following general principles :

-WHAT? Characteristically exposed properties of the GMO and its use, which may cause adverse effects, are compared with the properties of the non-modified organism from which the GMO is derived from, and its use in similar situations.

The access level of the receiving environment, including its organisms, their interaction and their known variations, should be mapped before the possible presence of the GMO (harmful) of the GMO (s). The exit mode serves as a reference point for which future changes can be compared. In the case of crops that multiply vegetative crops, the comparative analysis shall include the parent of the parent species used to generate the transgenic plant varieties. In the case of crops multiplying by gender propagation, appropriate isogenic plant varieties must be involved in the comparison.

In these cases, it is important that a comprehensive equivalence test is carried out with the most appropriate control measures in these cases and that the evaluation is not only carried out on the basis of comparison with it ; original parental material.

If the existing data is not sufficient, an initial mode of reference must be defined for other reference points so that a comparison can be made. The entry level will largely depend on the receiving environment, including biotic and abiotic factors (e.g., preserved natural habitats, farmland or contaminated land), or of a combination of different environments.

-WHAT? The environmental risk assessment should be carried out in a scientifically sound and transparent manner on the basis of available scientific and technical data.

The assessment of potentially harmful effects should be based on scientific and technical data and on a common methodology for identification, collection and interpretation of the relevant data. Data, measurements, and tests must be clearly described. Furthermore, the use of scientifically modelling modelling could provide missing data, which could be of use to the environmental risk assessment.

The environmental risk assessment must take into account different uncertaincertainfactors. Scientific uncertainty is usually due to the five characteristics of the scientific method : the selected variable, measurements, the samples taken, the models and causation of the causalities. Scientific uncertainty may also be due to disagreement over the data or the lack of relevant data. Uncertainty may be linked to qualitative or quantitative factors in the analysis. The extent of knowledge or data on the starting mode is reflected by the uncertainty that the notifier must indicate (the assessment of uncertainty, including lack of data, knowledge gaps, standard deviation, complexity, etc.) in relation to the uncertainty of the general ; scientific practice.

The environmental risk assessment will not, in all cases, provide conclusive answers to all the relevant questions due to the lack of data. In particular, for potential long-term effects, the data available to the available data can be very limited. In such specific cases, it is important to consider appropriate risk management (security measures) in accordance with the precautionary principle in order to prevent adverse effects on human health and the environment.

As a general principle, the environmental risk assessment should include relevant research findings on potential risks related to the release or placing on the market of GMOs, together with any, carefully documented, comparable experiences.

It may be useful to apply a step-by-step approach (i.e. all steps from the restoation of the release of the release over to the market). Data from each step should be collected as early in the procedure as possible. Simulated environmental conditions in an enclosed system could provide relevant results with regard to the release (e.g. microorganisms behaviour simulate in microcosmer, or if the behaviour of the plants can be simulated in greenhouses.)

In the case of GMOs to be placed on the market, relevant and accessible data should be obtained from statements in the environmental types in which the GMO in question will be marketed.

-WHAT? The environmental risk assessment shall be carried out by means of a specific case on a case-case basis, which means that the information required may vary according to the nature of the GMO (s) concerned, the intended use and the potential receiving environment, taking into account, inter alia, the case of : GMOs that are already in the environment.

The environmental risk assessment should be based on a case on a case basis, as a result of the individual characteristics of the various organisers (from GMO to GMO) and the differences in the environment (from place to place and from region to region).

There may be significant variations in the environmental effects of genetically modified micro-organisms (because they are small and their interplay is unknown), plants (e.g. high herbal plant species used for food and feed, or trees on land ; of their potential longevity, and animals (e.g. insects, for example, because they are small and are extremely capable of overcoming obstacles, or fish in salt water areas because of their extensive potential for expansion).

In addition, there may also be a wide range of environmental characteristics (location or region-specific) to be taken into account. As a case for review, it may be useful to classify regional data according to habitat areas where aspects of the recipient environment of GMOs are reflected (e.g., botanical data over the presence of wild relatives of GMOs-plants in different agricultural habitats or natural habitats in Europe).

The notifier shall also take into account the potential harmful interaction of GMOs which have previously been exposed or marketed, including repeated discards of the same GMO, such as the use of plant protection products. Repeated statements can lead to a discrepancies between individual statements over time, leading to a significant permanent background of the GMO as a permanent, permanent establishment in the environment.

If new information on the GMO and its effects on human health or the environment is produced, it may be necessary to repeat the environmental risk assessment ;

-WHAT? to establish whether the risk has been changed ;

-WHAT? establish whether there is a need to change the risk management accordingly.

Where new information is available, whether there is a need to take immediate measures or not, a new environmental risk assessment must be carried out with a view to the need to amend the conditions of approval of the release or the placing on the market of the GMO, or in order to adapt the risk-handling measures (see also Chapter 6). The new information could be derived from research, monitoring plans or relevant experiences from other sources.

Environmental risk assessment and monitoring are closely related. The environmental risk assessment is the basis of the monitoring plans, which focus on (negative) effects on human health and the environment. The monitoring requirements for the release of GMOs (part B in accordance with the relevant parts of Annex III) and the placing on the market of GMOs (part C in accordance with Annex VII) are different. Part C monitoring (including general monitoring) may also play an important role as a source of information on the potential of GMOs (potentially negative). The findings of monitoring results may confirm or lead to a review of the environmental risk assessment.

-WHAT? Furthermore, a general principle of environmental risk assessment is that there should be an analysis of decumulative long-term business relations with the release and marketing. Cumulative long-term effects refer to the cumulative effect of the authoritasers on human health and the environment, including, inter alia, flora and fauna, soil fertility, soil degradation of organic material, food and feed chain, biological biological, diversity, animal health and resistant problems in relation to antibiotics.

For the assessment of potential cumulative long-term effects, inter alia, the following topics shall be included in the environmental risk assessment :

-WHAT? the interactions between the GMO and the receiving environment in the long term ;

-WHAT? the characteristics of the GMO, which are significant in the long term ;

-WHAT? repeated statements or marketations over a long time ;

-WHAT? GMOs that are previously exposed or placed on the market.

Further information may be required in particular on long-term effects (e.g. multiple herbicide sistence) and adequate research must be available-partly within the framework of the surveillance plans-which may provide data of importance ; in the assessment of cumulative long-term effects. Further guidance in this area may be necessary.

4. METHODOLOGY

4.1. Characteristics of GMOs and non-phrases in the environment

The environmental risk assessment shall take account of the relevant technical and scientific details relating to the characteristics of :

-WHAT? the recipient or parent organism (s),

-WHAT? the genetic modification (s), whether it be the insertion or the presence of genetic material, and relevant information on vector and donor ;

-WHAT? GMOs;

-WHAT? the intended release or use, including scopes,

-WHAT? the potential receiving environment ; and

-WHAT? the interactions of the interactions.

For the risk assessment, information on the release of similar organisms and organisms with similar traits and their interaction with similar environments may be used.

In addition to the release of a GMO or a combination of GMOs in accordance with Part C of the Directive, the notifier shall submit the notifier to the competent authority of the Member State in which the release or marketing must take place on the first part of the Directive ; a notification containing the information provided for in Annex III A/B of the Directive (information on the GMO, donor, recipient, vector, outlet and the environment, interactions between the GMO and the environment and the monitoring of GMOs).

Such notifications shall include a technical information dossier, including a comprehensive environmental risk assessment pursuant to Article 6 (1) of the Directive. Article 13 (2) and 13 (3) 2. The level of information required to document a given question depends on the impact of the issue in the environmental risk assessment. Enrollers shall provide bibliographic references and guide the methods used.

The information which, according to the Annex III A/B of the Directive, must be given on the recipient, donor, vector, genetic modification and the GMO shall not depend on the environment of which the GMO is to be subjected to or placed on the market by the GMO in test sea and of the conditions. This information serves to identify potential harmful properties (potential hazards) on the GMO. Knowledge and experience obtained in connection with extractions of the same or similar GMOs may provide important information about the potential dangers of a given release.

The information which, according to the Annex III A/B of the Directive, shall be given on the proposed release, the receiving environment and the interconnection between the specific receiving environment for the release and release conditions, including its scope. This information ascertains the extent of potentially harmful characteristics of the GMO.

4.2. Steps in the analysis of the environmental risk assessment

When conclusions are drawn concerning the environmental risk assessment as referred to in Articles 4, 6, 7 and 13 of Directive 2001 /18/EC, the emphasis should be placed on the following fundamental steps in the environmental risk assessment.

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A hazard (harmful properties) is defined as the potential of an organism to inflict injury on or harmful effects on human health and / or the environment.

A risk is the combination of the scope of a father's consequences if it occurs, and the probability of its consequences will be a reality.

4.2.1. Step 1 : Demonstration of properties which may cause adverse effects

Characteristics of GMOs resulting from the genetic modification and which would cause adverse effects on human health or the environment must be identified. A comparison of the characteristics of GMOs with the non-modified organism under similar conditions by the release or use contributes to detecting the individual potential undesirable effects of the genetic modification. It is important not to ignore a potential undesirable effect even if it is considered improbable.

Potential adverse effects of GMOs will vary from case to case and may include :

-WHAT? sickness to people, including allergenic or toxic effects ;

-WHAT? disease for animals and plants, including toxic and, where appropriate, the allergenic effects ;

-WHAT? effects on the dynamics of the populations of the receiving environment and the genetic diversity of each of these populations ;

-WHAT? changed susceptibility to pathogens which encourage the spread of infectious diseases and / or create new reservoirs or vectors ;

-WHAT? negative impact on prophylactic or therapeutic or therapeutic medical, veterinary or plant protection products, e.g. by the transfer of genes resistant to antibiotics used in human medicine or veterinary medicine ;

-WHAT? Bio-chemical effects (biogeochemical circuits), in particular on carbon and nitrogen, through changes to the soil degradation of organic material.

Examples of potential adverse effects in Annexes III A and III B to Directive 2001 /18/EC have been given.

Most of the pernicious dangers (harmful properties) which may cause adverse effects are due to the effect or gene (s) inserted into the GMO, and the salted nature of their protein product (s). Further adverse effects such as pleiotropic effects could have been generated as a result of the method used to create the transgeners, as well as that of the GMO gene where the transgeners are inserted. Where more than one transgen is transferred to a recipient of a recipient or transgenic to a GMO, account must be taken of the potential interactions of the various transgenic transgenic transgenic agents, including the epizootic or regulatory nature of the transgenic ; effects.

It is important that the dangers are defined as accurately as possible, but in many cases it will be useful to review them following the points listed below, and then specify the danger that has been identified for the environmental risk assessment (s). For example, to detect potential adverse effects on human health, allergenicity and toxicity, these effects should be treated separately in the environmental risk assessment).

If the GMO is liable to be at risk, this will always be present and can be regarded as an intrinsic property. Farer may-with a given probability (step 3)-result in (negative) consequences, and these may again be of a different scale (stage 2). Finally, the individual dangers of GMOs must be brought up together.

At this stage of the environmental risk assessment, however, it is only necessary to examine the dangers that have been introduced as a result of genetic modification, which could cause undesirable effects. Steps 1 shall constitute the scientific basis for the following stages of the environmental risk assessment. Even at this stage, it is essential that each potential danger identifies the specific level of scientific uncertainty, so that this can be taken into account in a subsequent phase.

Undesirable effects may arise directly or indirectly through mechanisms that may include :

-WHAT? the dissemination of the GMO (s) of the environment ;

Propagation routes show the potential paths of the GMO (s) or potential fares to or in the environment (e.g. toxicity to humans : inhalation of toxic microorganisms or toxic proteins).

The potential of GMOs to be spread in the environment will depend on, inter alia :

-WHAT? its biological fitness (GMOs designed to improve performance of the environment in the environment through expulsion of properties that give them competitive advantages in the natural environment, or qualitative or quantitative change in ; the composition of the stocks, or GMOs of resistance to natural selections, or abiotic stress factors such as heat, cold, salt, or production of antimicrobials in micro-organisms),

-WHAT? conditions for the release or marketing (in particular the caret area and the extent of the statement in the form of the number of exposed GMOs),

-WHAT? the likelihood of placing on the market or placing on the market or the unintended release of GMOs into the environment (e.g., GMOs intended for processing) ;

-WHAT? life-saving routes for viable material (e.g., seeds, spores, etc.) with wind, water, animals, etc.

-WHAT? specific environmental considerations (location-or region-specific) : To support a specific assessment of the location or region, it may be beneficial to classify data according to habitat areas that reflect aspects of the receiving environment of relevance to the GMO (e.g., botanical data over the incidence of cross-combatant, wild relatives for GMO plants in different agricultural habitats or natural habitats in Europe).

It is also important to assess how long a given GMO or a given number of GMOs is generally expected to survive and how easy it is to spread and to be established in different habitats. The level of propagation, survival and rest forms shall be taken into account, including :

-WHAT? for plants : the survival capability of pollen, seeds and vegetative structures ;

-WHAT? for micro-organisms : the ability to survive, or the survival skills, but not cultibility.

The total dispersion capability may vary significantly (depending on the nature of the species, the genetic modification and the receiving environment, such as vegetation in the desert or fish farming in the sea),

-WHAT? transfer of the inserted genetic material to other organisms or the same organism, whether genetically modified or not,

A hazard may result in undesirable effects through retransfer within the same species or to other species (vertical or horizontal gene transfer). For example, the speed and extent of genetic transfer to other species (usually cross-combatant species when it is applicable to higher plants), for example, depends on :

-WHAT? the reproductive characteristics of the GMO itself, including the modified sequences ;

-WHAT? the conditions of release and certain environmental aspects such as climate (wind) ;

-WHAT? reproductive biological differences,

-WHAT? agricultural methods,

-WHAT? the presence of potential cross-partners,

-WHAT? transport and pollination vectors (e.g. insects or birds, animals in general) ;

-WHAT? the occurrence of hosts for parasites.

The occurrence of specific adverse effects resulting from genetic transfer may be linked to the number of exposed GMOs. Large fields of the transgenic plants may have a completely different retransfer potential in relation to small parcels than a proportional consideration. Furthermore, both qualitative and quantitative information on the occurrence of potential cross-species or recipients (among plants within an appropriate distance) is of major importance.

In the case of high-standing plants and animals, a distinction should be made between possible genetic transfer to the same species, to neighbouring species, to remote-related species and to unrelated species.

When it comes to micro-organisms, horizontal retransfer plays a more important role. Some types of gene material may be easily transmitted among near-related organisms (e.g. via plations or fager). As a result of rapid growth of the micro-organism, genetic transfer may take place more fairly than in the case of the right-wing organism.

Transfers of transgenetics may, in time, result in a mixed population of GMOs or lead to other gene / plant combinations, resulting in complex patterns of (undesirable) long-term effects. The complexity is growing, the more transgenic materials that are transferred to a population (e.g. the accumulation of repetition of stacking).

In some cases, the remodification method may change the retransfer potential of the retransfer potential, for example, by non-integrating plastering or viral vectors. The method by which the genetic modification is carried out may also reduce the potential for gene transfer (e.g. chloroplast-transformation).

In the form of genetic transfer, the inmate material may be persistent in natural populations. A GMO's ability to retransfer does not necessarily mean an inherent risk or a change in its survival or the ability to create undesirable effects. This will depend on the inserted gene material, the nature and the recipient environment, including the possible recipients ;

-WHAT? fausaic and genetic instability,

The extent to which genetic (u) stability can lead to fatheral (u) stability should be taken into account and is a danger. If the genetic modification is genetically unstable, in some cases, it may lead to reversion to the wild fatherotype. Other cases should be taken into account, including :

-WHAT? If transgenetics in a plant line containing more than one transgen in the subsequent division process are divided up by the offspring, there may be plants with fewer transgenic transgenetics, but with new faeca types.

-WHAT? Mutants as a result of instability (as a result of the design of the mutation in question) are being rerolled into a new one.

-WHAT? Transgenduplication leads to reinactivation (disengings silencing).

-WHAT? If the number of copies is very high.

-WHAT? The redeployment of the transitions results in new phenotypes as a result of inactivation of the transgenet at the insertion of mobile genelements.

-WHAT? If the level of transmission of the transgenome is important (e.g. a very low expulsion level of a toxic substance), the genetic instability of the instrument or regulator may lead to greater expulsion of the transgenome.

Typical instability may be caused by interactions with the environment in the context of cultivation, so that environmental and agricultural factors should be taken into account in the expansion of transgenic transgenic effects.

If the transgenic expansion is limited to a particular part of the GMO (for example, a particular plant tissue), the instability of the regulatory body can lead to the expansion of the transgenet throughout the organism. In this context, regulatory signals (for example, promoters) play an important role and should be taken into account.

The expulsion of the transgenship at a given moment in the life cycle of the organism or under special environmental conditions should also be taken into account.

Specific infertility transgenic genes may be inserted into the GMO to render it inferior (e.g. in order to prevent the transmission and dissemination of specific transgeners). If the fertility rates are unstable, it may lead to reactivation of the fertility of the plant and thus to the spread of transgeners, which may have undesirable effects.

The stability of the various transgeners not only in the main GMO but also in its offspring is of great importance, particularly for the long-term effects.

-WHAT? interactions with other organisms (other than the exchange of rematerials / pollen),

The possible interactions with other organisms, including other GMOs, must be carefully assessed, taking into account the complexity of multifairies. The following direct dangerous interactions can be mentioned, which could cause adverse effects :

-WHAT? exposure to human beings (e.g. farmers, consumers) ;

-WHAT? the exposure of animals,

-WHAT? competition for natural resources such as land, land, water and light ;

-WHAT? the protraction of natural populations of other organisms,

-WHAT? the marketing of toxic substances,

-WHAT? changed growth patterns.

If the genetic modification adds to the biological fitness, then the GM will be able to invade new environments and to suppress existing species. The appearance of certain undesirable effects is often proportional to the extent of the set ' s volume

-WHAT? changes in the management, including, where appropriate, agricultural practices ;

The relevance of changing the agricultural methods as an essential consequence of the deliberate release of the GMO must be assessed on the basis of the present agricultural methods. Changes in agricultural methods could include, for example :

-WHAT? sowing, planting, cultivation, harvest or transport of crops (e.g. planting of crops on small or large fields), choice of time ;

-WHAT? crop rotation (e.g. growing of the same plant each year or four years),

-WHAT? pest and pest control (e.g., type and dose of insecticides for plants or antibiotics for animals or alternative methods),

-WHAT? resistance handling (e.g. type and dose of herbicides for herbicide tolerant plants or changes in the use of biological suppression by Bt-proteins or virus),

-WHAT? insulation in terrestrial and aquatic cultivation and rearing systems (e.g. insulation distances in plant cultivation or improvement of the quality of the isolations system in fish farming),

-WHAT? agricultural methods (cultivation of GMOs and agriculture without the use of GMOs, including organic farming),

-WHAT? Handling outside of agriculture (e.g. isolation distances between natural habitats and GMO cultivation areas).

4.2.2. Step 2 : Evaluation of the possible consequences of each undesirable effect, provided that it is entered ;

The extent of the possible consequences of each undesirable impact should be assessed.

In addition to the probability that potential harmful properties will become a reality (see Point 4.2.3 (step 3) is an important factor in the risk assessment. The extent shall mean the extent to which the consequences of the potential hazards of the products exposed or marketed will become a reality.

The scope must be assessed in relation to the comparison base and will often be influenced by the following factors :

-WHAT? the redesign

-WHAT? each indesirable effect,

-WHAT? the number of exposed GMOs (scope),

-WHAT? the environment to which the GMO (s) or GMOs must be subjected ;

-WHAT? the conditions of release, including control measures ;

-WHAT? combinations of these factors.

For each individual inaction, the consequences of this shall be assessed for other organisms, populations, species and ecosystems that are exposed to the GMO. This requires in-depth knowledge of the environment to which the GMO must be deferred (e.g. location, region), and the release method. The consequences will result from insignificant or insignificant and self-limiting to significant or significant consequences which either have immediate and serious effects or, in the long term, can lead to lasting adverse effects.

The extent of the area should, if possible, be expressed in quantitative terms as significant, moderate, low or insignificant. In some cases, it is not possible to detect undesirable effects in a given environment. In such cases, the risk of the undesirable effect of the person concerned could be considered insignificant or insignificant.

The following qualitative examples can serve as illustration. They are neither definitive nor exhaustive, but must give a clue as to which account can be taken into consideration when weighing the consequences.

-WHAT? Significuous consequences could be significant changes in the number or species of other organisms, including endangered and useful species, in the short or long term. It may be a reduction or total eradication of any kind resulting from the negative consequences for the functional skill of the ecosystem and / or other related ecosystem. Such changes can often be irreparable, and possible re-establishment of the ecosystem will probably happen slowly.

-WHAT? Moderate consequences could be significant changes in the population density of other organisms, but not changes that could lead to a complete eradication of a species or have significant effects on endangered or useful species. Temporary and substantial population changes may be included in this category if they are presumed to be reversible. The long-term effects may also be included, provided that these are not serious adverse effects on the functioning of the ecosystem.

-WHAT? Poor consequences could be non-significant changes in the population density of other organisms, which do not lead to the complete eradication of a population or species of other organisms, and have no adverse effects on the ecosystem capability. Only non-endangered, non-useful species will be affected in the short or long term.

-WHAT? Unsignificant consequences mean no significant changes in populations in the environment or in the functioning of the ecosystem.

The examples above reflect the potential adverse effects of GMOs on populations, although, in some cases, it may be more appropriate to examine the likely effects on individual organisms. A given hazard may have more than one (unwanted) effect, and there may also be differences in the extent of the individual adverse effects. The undesirable effects of a given hazard may be of a different nature to human health and to agricultural habitats and natural habitats.

The potential consequences can be summed up in such a way that they include all the ecological elements that could be affected (such as species, populations, trophies and ecosystems), including the potential impact and uncertainty.

4.2.3. Step 3 : The evaluation of the likelihood that each of the possible adverse effects on the part of each of the detecting possible adverse effects shall be :

An important factor for the assessment of the likelihood or the possibility of an undesirable impact shall be the characteristics of the environment in which the GMO (s) are likely to be exposed and the conditions under which the release is being issued.

In addition to the extent of the consequences of the dangers (cf. Point 4.2.2, step 2) is also the likelihood of the entry into the risk of undesirable effects an important factor in the risk assessment. At this stage, the likelihood of the possibility of having undesirable effects will be assessed. In some cases, the probability and frequency of the frequency should be taken into account. As in step 2 (assessment of the potential consequences of each undesirable impact) are important factors in assessing the probability, in addition to the risk, the number of GMOs, the receiving environment and the conditions of release. Therefore, account must be taken of the climatic, geographical, soil-specific and demographic conditions and species of animals and plants in the potential receiving environment.

As far as the assessment of the survival capability is concerned, it is therefore appropriate to assess the size of the GMOs that may be expected to survive without taking into account the risk management measures that are proposed in connection with the release or The marketing. Where there is likely to be genetic transfer, account should be taken of the likely number or scope thereof. If the GMO has pathogenic or toxic properties, it should be assessed how much of the target organism in the environment is likely to be affected.

The likelihood of an effect of an effect will also depend on the relevant risk-handling measures, which may prevent such effects (e.g., the Pollen spread impossible as a result of destruction of the floral positions).

In the case of each individual undesirable, a qualitative assessment of the relative probability of the occurrence of the operation may not be possible, but the probability may be expressed as significant, moderate, poor or insignificant.

The examples above reflect the potential, adverse effects of GMOs on populations, although, in some cases, it may be more appropriate to examine the likely effects on individual organisms. A given hazard may have more than one (unwanted) effect so that there may also be differences in the likelihood that individual adverse effects occur. The undesirable effects of a given hazard may be of a different nature to human health and to agricultural habitats and natural habitats.

The likelihood can be summed up in such a way as to include all the ecological elements that could be affected (e.g. species, populations, trophies and ecosystems), including decoction measures, as well as the uncertainty level.

4.2.4. Step 4 : Evaluation of the risk which each identified as the presence of the GMO (s) involving the GMO (s) ;

Whereas, in the light of the current scientific level, a estimation of the risk, as shown by a GMO to cause adverse effects on human health or the environment, should be carried out, by combining. the likelihood of the effect of the undesirable effect and the impact of the impact on the impact of the impact.

On the basis of the conclusions of steps 2 and 3, an assessment of the risk of undesirable effects for each of the dangers identified at step 1 must be carried out. Here, too, it may be difficult to make a quantitative assessment. In the assessment of the individual hazards, the following shall be taken into account :

-WHAT? the scale of impact (significant, moderate, low or insignificant) ;

-WHAT? the likelihood that the adverse effect occurs (significant, moderate, low or insignificant),

-WHAT? if a hazard has more than one undesirable impact : the extent and probability of each of these effects.

Each GMO shall be treated on a case-case basis. Any attempt to quantify the above guidelines shall be carried out with a great deal of caution. If, for example, the extent of the consequences of an adverse effect in a given case is considered significant, while the probability of exposure to the effect of the operation is negligible, the risk could take into account the whole spectrum of significant proportions ; to insignificant. The result will depend on the circumstances and the weighting of certain factors by the notifier, which should be described and justifiably explained in the environmental risk assessment.

For each at risk, the total uncertainty must be described and whether possible, if possible, shall be documented, for example :

-WHAT? assumptions and extrapolations carried out at different levels in the environmental risk assessment ;

-WHAT? various scientific assessments and views ;

-WHAT? uncertainties

-WHAT? known restrictions on remedial measures,

-WHAT? conclusions that may be drawn from the data.

Although the environmental risk assessment should be based on quantifiable outcomes, many of the results of the environmental risk assessment may, in any cases, only be qualitative. However, although the final results of the environmental risk assessment are qualitative, they should necessarily be relative (for example, in comparison to a non-GMO reference).

4.2.5. Step 5 : Application of risk management strategies for the deliberate release or placing on the market of the GMO (s)

The risk assessment may take risks to which handling measures are required, and a handling strategy should be drawn up.

Before taking risk management, the prevention of the release should be considered as far as possible in such a way as to ensure that the risk becomes negligible. For example, in the reconstruction process, we should avoid using genetic elements which can cause adverse effects or which are unfamiliar. If this is not possible, the genetic elements in question should, if possible, be removed from the GMO at a later stage, but before the release or marketing.

This should be taken into account in stages 1 to 4. With risk management, it is aimed at controlling the exposed risk and taking into account uncertainties. The content rules should be proportionand to the level of risk and the level of uncertainty. When relevant data are provided at a later stage, risk management must be adapted to the new data.

Risk management measures must be clearly aimed at reducing the risk. For example, if there is a risk that a gene toxic to insects and pawn in a crop plant is transferred to related plant species, suitable control measures may consist of space or time isolation from the related species, or it may be possible to make the statement in another area in which the relevant risk (for example, plant species) is not present.

For example, the handling strategy may consist of isolation measures at all the appropriate stages of the handling and use of GMOs. It may also include a whole range of measures, such as different methods of propagation isolation, physical or biological barriers and cleaning of machinery or containers which have been in contact with GMOs, etc.

The detailed design of the risk-handling procedures will depend on :

-WHAT? the use of the type and extent of the GMO (statement or marketing) ;

-WHAT? type of GMO (e.g. genetically modified micro-organisms, higher one year old plants, higher plants and animals with longevity, GMO with one or more different kinds of GMOs),

-WHAT? type of habitat in general (for example, biogeochemical status, climate, incidence of cross-species within the same species and other species, origin centres, links between different habitats) ;

-WHAT? type of habitat type (e.g. agriculture, forestry, aquaculture, rural areas, the size, number of GMOs),

-WHAT? type of natural habitat (e.g. protected area mode).

It should be clearly stated what risk management involves in relation to the necessary adaptations of experiments, conditions for marketing and so on, and what a reduced risk is expected to be achieved.

4.2.6. Step 6 : Determination of the total risk of the GMO (s)

An assessment of the overall risk of the GMO (s) should be carried out taking into account the proposed risk management strategies.

On the basis of stage 4 and, where appropriate, step 5, a definitive evaluation of the overall risk, including the extent and probability of adverse effects of the GMO, should be carried out on the basis of the combination of the risks of the various undesirable substances ; effects, including cumulative effects of other GMOs. This final evaluation should be drawn up as a summary of the overall risks of the release or placing on the market and should also include the total uncertainties.

5. CONCLUSIONS CONCERNING THE POTENTIAL ENVIRONMENTAL IMPACT OF THE RELEASE OR MARKETING OF THE GMOS

On the basis of an environmental risk assessment carried out in accordance with the principles and methods outlined in paragraphs 3 and 4, details of the points listed in sections (1) and (2) of Annex II should be included in notifications, where appropriate in the notifications provided for in paragraphs 1 and 2 of Annex II ; to Directive 2001 /18/EC, so that conclusions may be drawn on this basis on the potential environmental impact of the release or marketing of the GMOs.

As a result of future developments, particularly for other GMOs other than plants, further instructions may be required for the information to be given in the notifications.

6. REVALUATION AND ADAPTATION

6.1. Revaluation and adaptation of an environmental risk assessment

An environmental risk assessment should not be regarded as terminatating. It should be periodically reviewed and updated, or may be amended to take account of relevant new data (in accordance with Articles 8 or 20 of Directive 2001 /18/EC). In the context of reassessments, consideration should be given to the effectiveness and accuracy of the environmental risk assessment and risk management taking into account data from research, from other extractions and from monitoring. This will also depend on the level of uncertainty laid down in the environmental risk assessment.

Following such a reassessment, the environmental risk assessment and risk management should be adapted or improved if necessary.

6.2. Assessment and adaptation of the environmental risk assessment guide

As a result of the further developments in genetic modification, Annexes II and these indicative notes may be adapted to technical progress. A further differentiation of the information requirements for the various types of GMOs, such as single-celled organisms, fish or insects, or special use of GMOs, such as the development of vaccines, may be possible once sufficient experience has been obtained ; the statement of the release of specific GMOs in the Community (Annex III, fourth subparagraph).

Where appropriate, the reassessment and adaptation of the environmental risk assessment guide should also take account of the need to adapt to technical progress and to develop further guidance on the basis of experience-where this is ; sufficiently, with the release of specific GMOs in specific ecosystems, in accordance with the criteria laid down in Article 7 (3) of this Directive. (1), as well as on the basis of experience and the scientific evidence available on the safety of human health and the environment in the marketing of certain GMOs (Article 16 (4)). 2).

ANNEX III

INFORMATION TO BE PROVIDED IN THE NOTIFICATION

A notification referred to in Part B of the Directive or C must contain the information provided in the sub-annexes, in so far as they are relevant.

Not all of the listed points apply in each case. A given notification is expected to address only those points that are relevant to the situation in question.

The need for a detailed response to the individual points may also vary according to the nature and scope of the proposed set.

Further developments in the genetic modification may make it necessary to adapt this Annex to the technical progress or to draw up indicative notes on this Annex. Additional differentiation of the information requirements for the different types of GMOs, such as single-celled organisms, fish or insects, or special use of GMOs, such as the development of vaccines, may be possible after recovery has been obtained ; in the case of notification of the release of special GMOs in the Community.

Dossigned must also contain a description of the methods employed or a reference to standardised or internationally recognised methods and the name of the bodies responsible for carrying out the investigations.

Annex III A applies to the release of all other types of genetically modified organisms other than high-level plants. Annex III B deals with the release of genetically modified high-ranking plants.

In the case of high-standing plants, nugseed and decoy seed plants (Gymnospermae and Angiospermae are understood).

ANNEX III A

INFORMATION TO BE GIVEN IN THE NOTIFICATION OF THE RELEASE OF OTHER GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGH-STANDING PLANTS

I. GENERAL INFORMATION

A. The name and address of the notifier (company or institution).

The name, skills and experience of the scientist or persons is being carried out.

C. Projectus's title.

II. INFORMATION ON THE GENETICALLY MODIFIED ORGANISM

A. Characteristics of (a) donor, (b) recipient (s) (if applicable) (if applicable) parent-organism organism (s)

1. Scientific name.

2. Taksonomy.

3. Other names (usual name, anceal name, etc).

Four, notytypic and genetic marklet.

5. The Graden of the blood relative between donor and recipient organism or between parental organisms.

6. Description of the identification and detection techniques.

7. Detextual and identification techniques sensitivity, reliability (quantitatively) and specificity.

8. Description of the geographical distribution and natural habitat of the organism, including information about natural predators, prey, parasites, rivals, symbionets and hosts.

9. Organisms to which it is known that under natural conditions transfer of genetic material is transferred.

10. Verification of the genetic stability and factors of the organism affected by this.

11. pathological, ecological and physiological features :

a) classification of risks in accordance with existing Community rules on the protection of human health and / or the environment ;

b) generation time in natural ecosystems, gender and ungenital reproduction cycles ;

c) information on survival, including seasonal phenomena and ability to form surviving structures ;

d) pathogenicity : infectivity, toxigenicity, virulence, allergenicity, disease bearing, potential vectors, host spectrum, including non-target organisms. Possibility of the activation of latent virus (victurus). Ability to colonize other organisms

(e) antibiotic resistance and possible use of these antibiotics for prophylax and therapy for humans and domestic animals ;

(f) participation in environmental processes : primary production, nutrient turnover, the breakdown of organic matter, respiration, and so on.

12. Supplies of endogenous vectors :

a) sequence

b) frequency of mobilisation,

c) specificity,

d) presence of genes resistant to resistance.

13. Description of previous genetic modifications.

B. Characteristics of the vector

1. the nature and origin of the vector.

2. The Sequence of the Codex, vectors and other non-coding genetic segments that are used for the construction of the GMO and for the introduction of the vector and insert to operate in the GMO.

3. Mobilisation frequency of the vector and / or ability to transfer genetic material and the methods used to determine it.

4. Information on the extent to which the vector is limited to the DNA required to carry out the intended function.

C. Characteristics of the modified organism

1. Information on the genetic modification :

a) methods used for the modification,

b) methods used to construct and introduce the insertion into the recipient or to delegate a sequence ;

c) description of the insert and / or vector design ;

d) the purity of the insert for any unknown sequence and indication of the extent to which the imported sequence is limited to the DNA required to perform the intended function ;

(e) methods and criteria used for selections,

(f) sequence, functional identity and the location of the altered / incorporated / incorporated nucleic acid segments concerned, with specific reference to any known harmful effects.

2. Information concerning the GMO produced :

a) description of genetic traits or phenotypic characteristics and, in particular, all new features and characteristics, which may be expressed or no longer expressed,

b) the structure and quantity of any vector and / or donor nucleic acid left in the final design of the modified organism ;

c) the stability of the organism in relation to genetic traits ;

d) Expedigression rate and level of the new genetic material. Mealey method and sensitivity

(e) the activity of the proteins expressed,

(f) description of identification and detection techniques, including identification and detection techniques, and vector detection techniques ;

g) sensitivity, reliability (expressed quantitatively) and specificity of detection and identification techniques ;

(h) description of earlier statements or the use of the GMO ;

i) aspects relating to human and animal health as well as plant health :

i) toxic or allergenic properties of the GMOs and / or their metabolites thereof ;

(ii) the pathogenicity of the modified organism, as compared to the donor, recipient or (where appropriate) parent-organism organism,

(iii) capacity for colonisation,

(iv) where the organism is pathogenic to humans who are immunocompetent :

-WHAT? caused diseases and the pathogenic mechanism, including the invasions and virulence ;

-WHAT? infectivity

-WHAT? contagious dose,

-WHAT? host spectrum, possibility of changes

-WHAT? the possibility of survival outside of human host,

-WHAT? presence of vectors or dispersal agents ;

-WHAT? biological stability,

-WHAT? antibiotic-resistant patterns

-WHAT? allergenicity,

-WHAT? disparity for suitable disease ;

(v) other product risks.

III. INFORMATION ABOUT THE RELEASE CONDITIONS AND THE RECEIVING ENVIRONMENT

A. Information about the release

1. Description of the proposed release, including the purpose (the objectives) and the expected products.

2. Scheduled times for the release and schedule for the trial, including frequency and duration of the release.

3. Process of the site before the release.

Four, the size of the place.

5. Method (s) to be used in the release.

6. The quantities of GMOs to be released.

7. Management of the site (crop and method, mining, irrigation or other activities).

8. Protective measures for the staff during the release.

9. Processing of the site after the release.

10. Techniques which are intended for disposal or inactivation of the GMOs at the end of the study.

11. Information on and results of earlier release of GMOs, especially in different scales and in different ecosystems.

B. Information about the environment (both about the place itself and about the surrounding environment)

The geographical location and the geographical location of the place or the site of the site (in the case of notifications under the Part C of the Directive) shall be the site of the site (s) of the proposed use of the product.

2. Physical or biological distance from humans or significant flora and fauna.

3. The state of major biotopes, protected areas or drinking water supplies.

4. The climatic characteristics of the area or areas likely to be affected.

5. Geographical, geological and paedophile characteristics.

6. Flora and fauna, including crops, livestock and migratory species.

7. Description of target decosystems and non-target cosystems that are likely to be affected.

8. A comparison of the natural habitat of the recipient of the recipient of the recipient (s) of the proposed outlets.

9. Any known plans for the development or changes in area use in the region in question, which could affect the impact of the statement on the environment.

LV. INFORMATION ON INTERACTIONS BETWEEN THE GMOS AND THE ENVIRONMENT

A. Characteristics affecting survival, propagation and dissemination

1. Biological features that affect survival, propagation and dissemination.

2. Known or expected environmental conditions that can affect survival, propagation and dissemination (wind, water, soil, temperature, pH, etc.).

3. Sensitivity to specific agents.

B. Vecsels with the environment

1. Projected habitat for the GMOs.

2. Studies concerning the behaviour and characteristics of GMOs, as well as their environmental impact or effect, performed in simulated natural environments, such as microcosm, growth chambers, greenhouse and so on.

3. Retransfer ability :

a) transfer, after the release, of genetic material from GMOs to organisms in affected ecosystems,

b) transfer, after the release, of genetic material from the living organisms living organisms to GMOs.

4. The probability of the selection of selections leading to expulsion of unexpected or undesirable characteristics of the modified organism.

5. Measures have been taken to ensure and verify genetic stability. The description of genetic properties that can prevent or reduce the spread of genetic material. Methods for verifying genetic stability.

6. The spread of biological diversity, known or potential forms of interaction with the diversion, including inhalation, ingestion, surface contact, ground and so on.

7. The description of ecosystems to which the GMOs could be spread.

8. Possibility of extraordinary population growth in the environment.

The competitive advantage of GMOs in relation to the non-modified recipient or parental organisms.

10. Identification and description of the target organisms, if applicable.

11, expected mechanism and result of interaction between the exposed GMOs and the target organisms, if applicable.

12. Identification and description of non-target organisms, which may be affected in the unwanted direction of the GMOs, and expected mechanisms for unwanted interactions.

13. Probability of changes to the biological interactions or in the host spectrum following the release.

14th known or prestigious interaction with non-target organisms in the environment, including competing organisms, barter, hosts, symbiotes, predators, parasites and pathogens.

15th known or expected participation in biogeochemical processes.

16. Other potential interactions with the environment.

V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND CONTINGENCY PLANS

A. Surveillance Techniques

1. Methods to track the GMO (s) and to monitor the effects.

2. The specificity of surveillance techniques (for identification of GMOs, and distinguishing them from donor, recipient or, where appropriate, parental organisms), sensitivity and reliability.

3. Techniques for the detection of the transfer of the imported genetic material to other organisms.

4. Duration and frequency of monitoring.

B. Control of the release

1. Methods and procedures to avoid and / or minimising the spread of GMOs outside the outlet or the chosen field of application.

2. Methods and procedures to protect the site against intrusions of unauthorised persons.

3. Methods and procedures to prevent other organisms from getting into the site.

C. Waste Treatment

1. The nature of the proclaimed species.

2. the expected quantity of waste.

3. Description of the intended treatment.

D. Contingency Plans

1. Methods and procedures for the control of GMOs in the event of unexpected dispersion.

2. Methods of decontamination of the affected areas, such as the eradication of GMOs.

3. Methods of disposal or purification of plants, animals, soil, etc., which have been exposed during or after dispersion.

4. Methods of isolation of the area affected by the spread.

5 Plans for the protection of human health and the environment in the event of undesirable effects.

ANNEX III B

INFORMATION TO BE GIVEN IN THE NOTIFICATION OF THE RELEASE OF GENETICALLY MODIFIED HIGH HERDS (GMHP) (GYMNOSPERMAE AND ANGIOSPERMAE),

A. GENERAL INFORMATION

1. the name and address of the notifier (company or institution).

The name, skills and experience of the scientist or persons shall be carried out.

3. The title of the project.

B. INFORMATION ABOUT (A) RECIPIENT OR B) (WHERE APPROPRIATE) PARENT (S)

1. Full name :

a) family

b) genus

c) species

d) subspecies

(e) variement/outward

(f) Trivial name.

2.

a) Information on reproduction :

i) reproduction method (s),

(ii) where appropriate, special factors of relevance to the reproduction capacity,

(iii) generation time

b) Compatibility compatibility with other cultivated or wild plant species, including the spread in Europe of the compatible species.

3. Conviviability :

a) ability to form structures that promote survival or growth hibernation

b) where appropriate, special factors of impact on survival of the survival of the fissure.

4. Spreading :

a) the extent to which the amount of viable pollen and / or seed takes distance, e.g. an estimate of the extent to which the quantity of viable pollen and / or seed is lashing.)

b) where appropriate, special factors of importance for dissemination.

5. the geographical distribution of the plant.

6. For plant species which are not normally grown in the Member State (s), the natural habitat of the plant, including information about natural predators, parasites, competitors and symbiotes is described.

7. Other potential interactions relevant to the GMO between the plant and other organisms in the ecosystem in which the commonly is grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

C. INFORMATION ABOUT THE GENETIC MODIFICATION

1. Description of the methods used for the genetic modification.

2. the nature and origin of the vector used.

3. Size, origin (name) of the donor organism (s) and the desired function of each constituent of the region to be inserted.

D. INFORMATION ABOUT THE GENETICALLY MODIFIED PLANT

1. Description of the characteristics and characteristics that have been introduced or modified.

2. Information about actual inserted / delegated sequences :

a) the size and structure of the insert and the methods used to characterize it, including information on any part of the vector imported into the GMHD, or whether any carrier of any foreign DNA left in the GMHP is returned ;

b) the size and function of the delegated regions in the event of the name or function of the Member

c) number of copies of the insertion

d) the location of the inserting into the plantecards (integrated into the chromosomes, chloroplaces, mitokondries or preserved in an unintegrated form) and methods for determining it.

3. The details of the expression ' s express expression :

a) information on the development of the insertion during the life cycle of the plant and the methods used to characterise it ;

b) parts of the plant where the insert is expressed (such as roots, stem, pollen, etc.).

4. The information on how the genetically modified plant differs from the recipient plant with regard to :

a) the conditions of reproduction and / or frequency ;

b) propagation,

c) survival skills.

5. The genetic stability of the Inseria and the phenotypic stability of the GMHP.

6. Change to the ability of the GMHP to transfer genetic material to other organisms.

7. Information on any toxic, allergenic or other harmful effects on human health, due to the genetic modification.

8. Information on the safety of the GMHP in relation to animal health, particularly with regard to any toxic, allergenic or other harmful effect caused by the genetic modification when the GMHP is to be used in animal feed.

9. Any interaction between the genetically modified plant and target organisms.

10. Potential changes to the interactions of GMHP with non-target organisms caused by the genetic modification.

11. Potential interactions with the abiotic environment.

12. Description of techniques for detecting and identifying the genetically modified plant.

13. details of any prior discards of the genetically modified plant.

E. INFORMATION ON THE STATEMENT OF THE SITE (ONLY APPLIES TO NOTIFICATIONS PURSUANT TO ARTICLES 6 AND 7 OF THE DIRECTIVE)

1. the location and size of the statement.

2. Description of the ecosystem of release site, including climate, flora and fauna.

3. Instance of cross-compatible related wild or cultivated plant species.

4. Distance to officially recognised biotopes or protected areas that will be affected.

FOR INFORMATION ON THE STATEMENT (APPLIES ONLY TO NOTIFICATIONS PURSUANT TO ARTICLES 6 AND 7 OF THE DIRECTIVE)

1. The purpose of the release.

2. The start date and duration of the statement.

3. The release method of genetically modified plants.

4. The procedure for preparation and treatment of the outlet, during and after the release, including animal and harvest practice.

5. Transitional number of plants (or plants per plant. m 2 ).

G. INFORMATION ON CONTROL, MONITORING AND TREATMENT AND WASTE MANAGEMENT PLANS (ONLY APPLIES IN ACCORDANCE WITH ARTICLES 6 AND 7 OF THE DIRECTIVE)

1. Trufn Precautions :

a) distance from cross-combines, both related wild plant species and crops ;

b) measures to reduce / avoid the spread of the reproductive organs of the GMHP (for example, pollen, seeds or knots).

2. Description of methods for post-execution post-processing methods.

3. Description of the methods of treatment, after the release, of the genetically modified plant, including waste.

4. Description of monitoring plans and techniques.

5. DESCRA Description of contingency plans.

6. Methods and procedures for the protection of the site.

ANNEX IV

ADDITIONAL INFORMATION

This Annex contains a general description of the additional information to be given in the marketing reviews and the information on labelling requirements relating to GMOs that make up or enter into products intended for the placing on the market and GMOs which are : exempted in accordance with Article 2 (2), 4), second subparagraph. Technical guidance notes, such as the description of the expected application, can be drawn up in accordance with the regulatory procedure referred to in Article 30 (1). 2, in order to facilitate implementation and understanding of this Annex. The requirements for the marking of the exempted organisms referred to in Article 26 are met by submitting appropriate recommendations and restrictions concerning the use :

In addition to the information specified in Annex III, a notification of the placing on the market of GMOs constituting or forming part of a product shall contain the following information :

1. Proposed commercial names of the products and names of GMOs contained therein, as well as all specific identifications, names or codes that the notifier uses to identify the GMO. After authorisation has been given, all new commercial names shall be communicated to the competent authority.

2. the name and full address of the person established in the Community and who is responsible for marketing, whether or not it is the manufacturer, the importer or the distributor.

3. Name and full address of the supplier / vendors of control samples.

4. Description of how the product and GMOs that make up or form part of a product are to be used. It should be highlighted how the use or handling of GMOs differs from the same non-genetically-modified products.

5. Description of the geographical area (s) and the environment types in which the product is expected to be used in the Community, including, where possible, the extent of the estimated application in each area.

6. Expected categories of users of the product, such as industry, agriculture, professional industries, alment human consumption.

7. Information on the genetic modification for one or more registers in one or more registers may lead to modifications to organisms which can be used to detect and identify special GMO products in order to facilitate checks on the market and The inspection. This information may include the deposit of samples of GMOs or their genetic material from the competent authority and detailed nucleotide sequences or other information necessary for the identification of the GMO product and its information ; offend, for example, the method of detection and identification of the GMO product, including experimental data for detection of the specificity of the method. Information which may not be entered in the publicly available section of the register shall be identified as confidential.

8. Proposal for labelling on a label or in an accompanying document. This must, at least in the form of a summary, include the commercial name of the product, this product contains genetically modified organisms, the name of the GMO and the information referred to in paragraph 2. It must be stated on the label how the information can be found ; is available in the publicly available part of the register.

In addition to the information referred to in point A, the following information shall be provided in the notification when appropriate, cf. Article 13 of the Directive :

1. Measures to be taken in the event of unintended release or misuse.

2. Specific instructions or recommendations for storage and handling.

3. Specific instructions concerning monitoring and reporting to the notifier and, if required, to the competent authority so that the competent authorities can effectively be informed of all the undesirable effects. These instructions shall be in accordance with point C of Annex VII.

4. A proposal for restrictions on the authorised use of the GMO, for example where the product may be used and for which purposes it may be used.

5, a proposal on packaging.

6, expected production and / or imports into the Community.

7. A proposal for additional labelling. This will include, at least in the form of a summary, the information referred to in point A, no. 4 and 5, and point B, no. One, two, three and four.

ANNEX V

CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7 OF THE DIRECTIVE)

The criteria referred to in Article 7 (2) of this Directive are to be applied. 1, follow below.

1. The taxonomic status and biology of the organism (e.g. reproduction and pollination, ability to cross with related species, pathogenicity) must be well known.

2. There must be sufficient knowledge of parental organisms, where appropriate, and the safety of the recipient of recipients in the release environment for human health and the environment.

3. Information on the interactions of particular relevance to the risk assessment, which includes the parent-organism, where appropriate, and the recipient organism and other organisms must be in the ecosystem of the test equipment.

4. There must be information showing that all the input of genetic material is accurately described. Information on the construction of vector systems or sequences of genetic material used with the lees ' DNA must be provided. When the genetic modification causes the presence of genetic material, information on the scope of the delegation must be provided. In addition, so much information must be provided on the genetic modification that the GMO and its offspring may be identified in a statement.

5. The GMO must not involve any additional or increased risk to human health or the environment than in the case of discards of the corresponding parents (where applicable) and recipient organisms. The ability to spread in the environment and penetrate foreign ecosystems and the ability to transfer genetic material to other organisms in the environment may not result in undesirable effects.

ANNEX WE

GUIDELINES FOR THE ASSESSMENT REPORTS

The evaluation reports provided for in Articles 13, 17, 19 and 20 of the Directive shall include in particular :

1. The indication of the characteristics of the recipient organism which is relevant to the evaluation of the GMO (s) concerned. Indication of known risks to human health and the environment as a result of the deliberate release into the environment of the non-modified recipient organism.

2. Description of the result of the genetic modification of the modified organism.

3. Assessment of whether the genetic modification has been sufficiently accurately described to enable an assessment of possible risks to human health and the environment.

4. Specifying all new risks to human health and the environment, as the release of the GMO (s) concerned may result in the release of the release or equivalent non-modified organisms based on the environmental risk assessment ; they are carried out in accordance with Annex II.

5. Conclusion as regards whether the GMO (s) should be marketed as a product or as a component of a product and on what conditions the GMOs should not be placed on the market or whether or not to obtain statements from others The competent authorities and the Commission on certain specific issues relating to the environmental risk assessment. These aspects must be mentioned. The proposed use, risk management and surveillance plan must be clearly stated in the conclusion. If it has been concluded that GMOs should not be placed on the market, then the competent authority must justify its conclusion.

ANNEX VII

MONITORING PLAN

This Annex contains a general description of the objectives to be achieved and the general principles to be followed in the preparation of the provisions of Article 13 (1). Article 19 (2) (2). Article 20 (3) and Article 20. Technical guidance notes may be drawn up in accordance with the regulatory procedure referred to in Article 30 (1). 2, in order to facilitate implementation and understanding of this Annex.

A. Measure

The purpose of the surveillance plan is

-WHAT? to confirm that assumptions in the environmental risk assessment on the occurrence and consequences of potential adverse effects of the GMO or its use are correct and

-WHAT? to demonstrate the presence of undesirable effects of the GMO or its use on human health or the environment, which was not foreseen in the environmental risk assessment.

B. General principles

Monitoring referred to in Articles 13, 19 and 20 of the Directive shall take place after authorisation for the placing on the market of a GMO.

The data collected at the monitoring should be interpreted in the context of other existing environmental conditions and activities. If any changes to the environment are observed, a further assessment must be considered to determine whether they are a result of the GMO or its use, since such changes may be a result of other environmental factors other than the marketing of the GMO.

Experience and data from the monitoring of testing of GMOs may be used in the definition of the monitoring system to be used after marketing, and which is required for the placing on the market of GMOs that make up or enter into products.

C. Expansion of the monitoring plan

The monitoring plan shall :

On a specific assessment from the case to the case, account shall be taken of the environmental risk assessment.

2. Taking into account the characteristics of the GMO, the properties and the scope of the intended use and the extent of the relevant environmental conditions in the place where the GMO is expected to be postponed.

3. Includes general monitoring of unforeseeable adverse effects and, where necessary, specific monitoring (in each case) focusing on the adverse effects detected in the environmental risk assessment :

3.1 specific monitoring shall be carried out during a period of sufficient time to demonstrate immediate and direct and, where appropriate, future or indirect effects of which have been identified in the environmental risk assessment ;

3.2 capable of monitoring, where appropriate, the use of already established routine monitoring methods, such as the monitoring of agricultural varieties, plant protection or medicinal products and veterinary medicinal products. In this context, a statement should be made on how the relevant information collected by means of established routine monitoring methods will be made available to the holder of the authorization.

In a systematic manner, it makes it easier to observe the release of a GMO in the receiving environment and to interpret these observations as to the safety of human health or the environment.

5. Identify who (notifiers, users) to perform the various tasks that the monitoring plan requires and who is responsible for ensuring that the monitoring plan is initiated and implemented in a proper manner and ensure that there is a way through which the holder of the authorisation and the competent authority will be informed of the adverse effects of adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring must be indicated.)

6. Take account of mechanisms for detecting and affirmation of the adverse effects on human health and the environment and make it possible for the holder of the authorisation or, where appropriate, the competent authority to take the measures which : are necessary in order to protect human health and the environment.

ANNEX VIII

COLLECTION TABLE

Directive 90 /220/EEC
This Directive
Article 1 (1). 1
ARTICLE 1
Article 1 (1). 2
Article 3 (1). 2
ARTICLE 2
ARTICLE 2
ARTICLE 3
Article 3 (1). 1
ARTICLE 4
ARTICLE 4
-
Article 5
Article 5
ARTICLE 6
Article 6 (1). 1-4
-
Article 6 (1). 5
Article 7
Article 6 (1). 6
ARTICLE 8
Article 7
Article 9
ARTICLE 8
Article 10
Article 9
Article 11
Article 10 (1). 2
Article 12
Article 11
ARTICLE 13
Article 12 (1). 1-3 and 5
ARTICLE 14
Article 13 (1). 2
Article 15 (1). 3
-
Article 15 (1). 1-2 and 4
-
Article 16
-
Article 17
Article 13 (1). 3 and 4
Article 18
Article 13 (1). 5 and 6
Article 19 (1). 1 and 4
Article 12 (1). 4
Article 20 (1). 3
ARTICLE 14
Article 21
Article 15
Article 22
Article 16
Article 23
-
Article 24 (1). 1
Article 17
Article 24 (1). 2
Article 19
ARTICLE 25
-
Article 26
Article 20
ARTICLE 27
-
Article 28
-
ARTICLE 29
Article 21
Article 30
Article 22
Article 31 (1). 1, 4 and 5
Article 18 (1). 2
Article 31 (1). 6
Article 18 (1). 3
Article 31 (1). 7
-
ARTICLE 32
-
Article 33
Article 23
Article 34
-
Article 35
-
Article 36
-
Article 37
ARTICLE 24
Article 38
Annex I A
Annex I A
Appendix I B
Appendix I B
-
Annex II
Annex II
Annex III
Annex IIA
Annex III A
Annex IIB
Annex III B
Annex III
Annex IV
-
Annex V
-
Annex VI
-
Annex VII
Official notes

1) The commotion contains provisions implementing Directive 2001 /18/EC of the European Parliament and of the Council of 12. In March 2001, on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90 /220/EEC, EC Official Journal 2001, nr. L-106, page one.