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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Overview (table of contents)

Chapter 1

Scope and definitions


Chapter 2

Pilot release


Chapter 3

marketing


Chapter 4

Consultation and information


Chapter 5

Commencement and transitional provisions


Appendix 1

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 of 17 April 2001, p.1) as amended by Commission Decision of 24 July 2002 (OJ L 200 of 30 July 2002, p. 22), the European Parliament and Council Regulation (EC) no. 1829/2003 of 22 september 2003 (OJ L 268 of 18 October 2003, p. 1) European Parliament and Council Regulation (EC) no. 1830/2003 of 22 september 2003 (OJ L 268 of 18 October 2003, p. 24) and European Parliament and Council Directive 2008/27 / EC of 11 . March 2008 (OJ L 81 of 20 March 2008, p. 45).


The full text
Order approving the deliberate release into the environment of genetically modified organisms1)
In accordance with § 9, § 13 paragraph. 1, § 20 paragraph. 2, § 25 and § 27 paragraph. 1 of the Act on Environment and Genetic Engineering, cf.. Legislative Decree no. 869 of 26 June 2010 as amended by Act no. 1273 of 21 December 2011, provides:

Chapter 1

Scope and definitions

§ 1. The Order implements the European Parliament and Council Directive 2001/18 / EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220 / EEC See Appendix 1.

§ 2. In these Regulations, genetically modified organisms: plants, animals, microorganisms, cell cultures and viruses, which occur new combinations of genetic material that does not occur naturally, see. Art. 2.

§ 3. Approval shall not be granted for experimental release or marketing of genetically modified organisms, if they contain genes that confer resistance to antibiotics used in human or veterinary medical treatment.

Chapter 2

Pilot release

§ 4. Application for approval for experimental release to the procedure of art. 6 pieces. 5. The application submitted to the Environmental Protection Agency and must include evidence on the matters set out in art. 6 pieces. 2-4.

PCS. 2. in Annex II said guidance notes on environmental risk assessment and scheme for it in art. 6 pieces. 2, point a, no. Vii, above summary may be obtained from the Environmental Protection Agency.

PCS. 3. The Minister may in approvals for trial release determine that supervision of compliance with the authorization shall be made in certain periods of the experimental release process.

Chapter 3

Marketing

§ 5. Application for marketing approval to the procedure of art. 13 paragraph. 1, Art. 14 and Art. 15. The application submitted to the Environmental Protection Agency and must include evidence on the matters set out in art. 13 paragraph. 2-4.

PCS. 2. Guidance notes for environmental risk assessments and monitoring plans and scheme for it in art. 13 paragraph. 2, point h, required summary can be obtained from the Environmental Protection Agency.

§ 6. A market authorization shall include the art. 19 provided information.

§ 7. If new information on the risks of the genetically modified organism poses to the environment, nature or health, the recipient of the authorization shall inform the Environmental Protection Agency. The recipient of the approval shall simultaneously with the take the measures set out in art. 13 paragraph. 6, and kind. 20

§ 8. Application for re-approval for marketing shall be submitted to the Environmental Protection Agency no later than nine months before the expiry of the approval to be renewed.

PCS. 2. The application must include the in art. 17 paragraph. 2 information listed and treated in accordance with art. 17 paragraph. 2-8.

PCS. 3. When an application is submitted, the original approval exercised pending a final decision on the renewal of the authorization under. Art. 17 paragraph. 9.

Chapter 4

Consultation and information

§ 9. Environmental Protection Agency conducts public hearing before making a decision on approval for experimental release or marketing meaning. §§ 4-5, including the renewal of authorizations referred to. § 8.

PCS. 2. Consultation may take place entirely digitally on the EPA website www.mst.dk.


§ 10. The Environmental Protection Agency set up on its website www.mst.dk a register of approvals for trial releases and marketing, including approvals for marketing granted by another EU member state.

PCS. 2. in paragraph. 1 that register should, as far as experimental releases, include the following information:

1) Name and address, description of the genetically modified organisms, purpose of the release and location of release.

2) summary of the environmental, natural and health risk assessments and consultation responses.

3) Environment Minister's assessment of the case.

4) Conditions for the implementation of the experimental release, see. Act § 16, and conditions on reporting after the release is complete, see. Art. 10.

PCS. 3. in paragraph. 1 that register should, as far as decisions on approval for marketing, shall include in art. 19 provided information. For decisions under the act are also published the following information:

1) Changes or additions to an existing approval for experimental releases, see. Art. 8 pcs. 2.

2) The Minister's use of the safeguard clause in the Act § 17 paragraph. 5, in cases where there are legitimate grounds for believing that an authorization pursuant to § 9 paragraph. 2, no. 2, or § 9 paragraph. 5, carries a risk for the environment, nature and health see. Art. 23

3) The results of monitoring of releases for marketing according to art. 20 pcs. 4.

4) Violation of the Act § 9 paragraph. 1, see. Art. 4 pcs. 5.

Chapter 5

Commencement and transitional provisions

§ 11. This Order shall enter into force on 1 February 2012.

PCS. 2. Order no. 1319 of 20 November 2006 approving the experimental release and marketing of genetically modified organisms repealed.

Ministry of the Environment, January 19, 2012
Ida Auken
/ Michel Schilling



Appendix 1

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 of 17 April 2001, p.1) as amended by Commission Decision of 24 July 2002 (OJ L 200 of 30 July 2002, p. 22), the European Parliament and Council Regulation (EC) no. 1829/2003 of 22 september 2003 (OJ L 268 of 18 October 2003 , p. 1), the European Parliament and Council Regulation (EC) no. 1830/2003 of 22 september 2003 (OJ L 268 of 18 October 2003, p. 24) and European Parliament and Council Directive 2008/27 / EC of 11 March 2008 (OJ L 81 of 20 March 2008, p. 45).
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION -
Having regard to the Treaty establishing the European Community, and in particular Article 95
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee,
according to the procedure laid down in Article 251 on the basis of the Conciliation Committee on 20 december 2000, and Whereas:
(1) 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 december 1996, identified a number of areas where improvements are needed.
(2) It is necessary to clarify the scope and definitions of Directive 90/220 / EEC.
(3) Directive 90/220 / EEC has been amended. Now that made new amendments to this directive, the provisions concerned should be recast for reasons of clarity and rationalization.
(4) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers, thereby affecting other Member States. Environmental impact of such releases may be irreversible.
(5) Protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs).
(6) Under the Treaty, Community environmental measures based on the principle of preventive action.
(7) It is necessary to approximate the laws of Member States concerning the deliberate release of GMOs and to ensure that the development of industrial products utilizing GMOs, performed in a satisfactory manner.
(8) The design of this Directive takes into account the precautionary principle, and there will also be taken into account this principle in the implementation of this Directive.

(9) It is particularly important that the ethical principles recognized in a Member State is respected; Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in a product.
(10) In order to create a coherent and transparent legislative framework, to ensure that the public is consulted by either the Commission or the Member States when there are measures being prepared, and that they are informed of the measures taken during the implementation of this Directive.
(11) Marketing also covers import. Products containing and / or consisting of GMOs covered by this Directive can not be imported into the Community if they do not comply with this Directive.
(12) Making GMOs available to be imported or handled in bulk quantities, for example. agricultural commodities, should be regarded as marketing under this Directive.
(13) This Directive is duly takes into account international experience in this field and international trade commitments and should respect the requirements of the Cartagena Protocol on Biosafety attached to the Convention on Biological Diversity. The Commission shall, in connection with the ratification of the Protocol as soon as possible and in any case before July 2001, appropriate proposals for its implementation.
(14) Guidance on the implementation of the provisions on the definition of the market in this Directive should be provided by the Regulatory Committee.
(15) When genetically modified organisms are defined in relation to this Directive, human beings should not be considered as organisms.
(16) This Directive should not affect national legislation on environmental liability. There is a need for Community legislation in this area complemented by rules covering liability for different types of environmental damage throughout the European Union. Commission to this end have committed to submit a legislative proposal on environmental liability before the end of 2001, which will also cover damage from GMOs.
(17) This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications, which have long safety record.
(18) It is necessary to establish harmonized procedures and criteria for assessment in each case of the potential risk associated with the deliberate release of GMOs.
(19) There should always be an environmental risk assessment in each case prior to a release. It should also take due account of potential cumulative long-term effects associated with 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 after their deliberate release or the market as or in a product. Monitoring of potential cumulative long-term effects should be considered as a compulsory part of the monitoring plan.
(21) Member States and the Commission should ensure that systematic and independent research on the potential risks of the deliberate release or marketing of GMOs. Member States and the Community in accordance with their budgetary procedures to ensure that the necessary resources are made available for such research and the independent researchers should be given access to all relevant material, while respecting intellectual property rights, however, must be respected.
(22) The question of genes expressing resistance to antibiotics, should especially be taken into consideration when conducting the risk assessment of GMOs containing such genes.
(23) The deliberate release of GMOs at the research stage is in most cases a necessary step in the development of new products derived from, or containing GMOs.
(24) The introduction of GMOs into the environment should be carried out in stages. This means that the containment of GMOs is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps in terms of protection of human health and the environment indicates that the next step can be taken.
(25) No GMOs, as or in products, and intended for release may be marketed without prior satisfactory field testing at the research and development stage in ecosystems which could be affected by their use.

(26) This Directive should be implemented in close liaison with the implementation of other relevant instruments such as Council Directive 91/414 / EEC of 15 July 1991 concerning the placing of plant protection products. The competent authorities within the Commission and in the Member States concerned with the implementation of this Directive and those instruments must in this regard coordinate their action as far as possible.
(27) This Directive should as far as environmental risk assessment for Part C, risk management, labeling, monitoring, information to the public and safeguard clause be reference for GMOs as or in products authorized under other Community legislation which should therefore provide for a specific environmental risk assessment to be carried out in accordance with the principles in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements above Community law, and for requirements as regards risk management, labeling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to the requirements of this Directive. To this end, it should be ensured that for cooperation with bodies in the Community and the Member States listed in this Directive in the implementation thereof.
(28) It is necessary to establish a Community authorization procedure for placing GMOs as or in products, where the intended use of the product involves the deliberate release of the organism.
(29) The Commission requested to conduct an investigation, which should include an assessment of the various options to further improve the coherence and efficiency of this framework, with particular emphasis on a centralized authorization procedure for placing GMOs in Community.
(30) For sectoral legislation, monitoring requirements may have to be adapted to the product.
(31) Part C of this Directive shall not apply to products covered by Council Regulation (EEC) no. 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary medicines and establishing a European Medicines agency, provided that it includes an environmental risk assessment equivalent to that prescribed in this Directive.
(32) Any person intending deliberate release of a GMO or the marketing of GMOs as or in products, where the intended use of the product implies that it released into the environment, is to submit a notification to the competent national authority.
(33) That notification should contain a technical dossier of information including a full environmental risk assessment, appropriate safety and emergency response, and, in the case of products, precise instructions and conditions for use, and proposed labeling and packaging.
(34) After notification should deliberate release of GMOs not take place where the competent authority has been obtained.
(35) A notifier may withdraw its notification at any stage of the administrative procedures provided for in this Directive; the administrative procedure should stop when a dossier is withdrawn.
(36) rejects a competent authority a notification concerning the marketing of a GMO as or in a product, this should not affect the possibility of submitting a notification of the same GMO to another competent authority.
(37) have been agreed by the end of the mediation period when no objections remain.
(38) Rejection of a notification following a confirmed negative assessment report should be without prejudice to future decisions based on the notification of the same GMO to another competent authority.
(39) In order to ensure that the Directive functions properly, Member States should apply the various provisions for the exchange of information and experience before having recourse to the safeguard clause in this Directive.
(40) To ensure that the presence of GMOs in products containing or consisting of genetically modified organisms is appropriately identified, the words This product contains genetically modified organisms appear clearly either on a label or in an accompanying document.
(41) When the appropriate committee procedure establishes a system whereby GMOs given a unique identifier, taking into account relevant developments in international fora.

(42) It is necessary to ensure traceability of GMOs authorized under part C of this Directive, at all stages of their market as or in a product.
(43) It is necessary to introduce into this Directive an obligation to implement a monitoring plan in order to trace the direct or indirect, immediate, delayed or unforeseen effects on human health or the environment according to their market as or in a product can be traced and identified.
(44) Member States should, in accordance with the Treaty could apply further measures such. public authorities, monitoring and control of GMOs on the market as or in a product.
(45) Provision should be made for facilitating the control of GMOs or their retrieval in the event of serious risk.
(46) should be taken into account comments from the public on the draft measures submitted to the Regulatory Committee.
(47) The competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment.
(48) The administrative procedure for granting marketing authorization for GMOs as or in products should be made more efficient and more transparent and first-time consent should be granted for a fixed period.
(49) For products for which consent has been granted for a fixed period should be a simplified procedure for renewal of the authorization.
(50) Existing authorizations issued under Directive 90/220 / EEC have to be renewed in order to avoid disparities between permits issued pursuant thereto and permits issued pursuant to this Directive and to fully take the conditions for authorization under this Directive.
(51) Such renewal requires a transitional period during which existing consents granted under Directive 90/220 / EEC, is not affected.
(52) When a consent is renewed, it should be possible to revise all the conditions of the original consent, including those related to monitoring and the time limitation of the consent.
(53) Provision should be made for consultation of one or more of the scientific committees set up by Commission Decision 97/579 / EC regarding the issues which could have implications for human health and / or the environment.
(54) The system of exchange of information contained in notifications, established under Directive 90/220 / EEC, has been useful and should be maintained.
(55) It is important that the development and use of GMOs followed closely.
(56) When a product containing a GMO, as or in products placed on the market and when that product has been properly authorized under this Directive, a Member State may not prohibit, restrict or prevent the marketing of GMO 'is, as or in products that meet the requirements of this Directive. There should be a safeguard procedure in case of risk to human health or the environment.
(57) The European Group on Ethics in Science and New Technologies should be consulted for advice on ethical issues of general nature regarding the deliberate release or marketing of GMOs. Such consultations should be without prejudice to Member States as regards ethical issues.
(58) Member States should be able to consult any committee they have established for advice on the ethical aspects of biotechnology.
(59) The measures necessary for implementing this Directive should be adopted in accordance with Council Decision 1999/468 / EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.
(60) The exchange of information under this Directive should also cover experience gained with the consideration of ethical aspects.
(61) In order to make the implementation of the provisions adopted pursuant to this Directive, more efficient, to lay down rules on penalties, Member States must apply, including in the event of release or placing on the market, contrary to this Directive provisions, in particular as a result of negligence.
(62) The Commission, in the report to be issued every three years and in which it takes into account information from Member States, in a separate chapter regarding the socioeconomic advantages and disadvantages of each category of GMOs with marketing , taking due account of farmers and consumers.

(63) The regulatory framework for biotechnology should be reviewed in order to identify opportunities to further improve the coherence and efficiency of this framework. Procedures may need to be adjusted to optimize efficiency, and all options which can lead to this outcome should be taken into account -
ADOPTED THIS DIRECTIVE: PART A


GENERAL PROVISIONS Article 1 || | purpose
the purpose of this Directive are in accordance with the precautionary principle to make an approximation of the laws and regulations and to protect human health and the environment associated with:



- Deliberate release into the environment of genetically modified organisms for any other purposes than placing on the Community

- Marketing of genetically modified organisms as or in products within the Community.

Article 2

Definitions The following definitions shall apply:



1) organism means any biological entity capable of replication or of transferring genetic material

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

In the context of this definition:



a) genetic modification occurs at least through the use of the techniques listed in Annex IA, Part 1

b) the techniques listed in Annex IA, Part 2, not to lead to genetic modification

3) release means any intentional introduction into the environment of a GMO or a combination of GMOs for which or which no specific containment measures to limit their contact with and to provide a high level of public and environmental || |
4) marketing means making available to third parties against payment or free of charge.

The following actions are not regarded as marketing:



- Making available genetically modified microorganisms for activities covered by Council Directive 90/219 / EEC of 23 April 1990 on the contained use of genetically modified microorganisms, including culture collections

- Making available GMOs other than the first indent, microorganisms to be used exclusively for activities where appropriate stringent containment measures to limit their contact with and to provide a high level of public and environment; measures should be based on the same principles of containment as in Directive 90/219 / EEC

- Making available GMOs exclusive use of hauls, which meets the requirements of Part B

5) Review: submission of the information required under this Directive to the competent authority of a Member

6) reviewing: the person submitting the notification

7) product means a preparation consisting of or containing a GMO or a combination of GMOs, which is marketed

8) environmental risk assessment carried out in accordance with Annex II of the risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or marketing of GMOs may have.

Article 3 Exceptions

first This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex IB
second This Directive shall not apply to the transport of genetically modified organisms by rail, road, inland waterway, sea or air.

Article 4 General obligations
first Member States, in accordance with the precautionary principle that all measures be taken to avoid adverse effects on human health and the environment resulting from the release or marketing of GMOs. GMOs may only be released or marketed in conformity with Part B or Part C.

Second Any person intending to submit a notification under Part B or Part C, carry out an environmental risk assessment. The information may be necessary to perform the environmental risk assessment are set out in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment, made specially considering the environmental risk assessment with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by 31 December 2004 for GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorized under part B. | || third Member States and where appropriate the Commission must ensure that in each case made a careful assessment of potential adverse effects on human health or the environment that directly or indirectly may be caused by gene transfer from GMOs to other organisms. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.
Fourth Member States shall designate the competent authorities responsible for ensuring that the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and in paragraphs. 2 above assessment is satisfactory.
Fifth Member States shall ensure that the competent authority organizes inspections and other control measures to ensure compliance with this Directive. In the event of release or marketing of one or more GMOs as or in products for which no authorization was given, ensuring the Member State concerned to take the necessary measures to bring the release or placing an end to if necessary, corrective action and to inform the public, the Commission and other Member States.
PART B
RELEASE OF GMOs FOR ANY OTHER PURPOSE THAN MARKETING
Article 5
first Article 6-11 shall not apply to medical products and preparations for human use consisting of or containing a GMO or combination of GMOs provided that their deliberate release for any purpose other than marketing is permitted under Community legislation



a) requires a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements under such legislation

b) requires that there must be an explicit consent prior to release

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

d) contain appropriate requirements for the treatment of new information, public information, information on the results of releases, and exchanges of information at least equivalent to the requirements of this Directive and of the measures taken thereunder.

Second The assessment of the environmental risks presented by such substances and preparations means to be made in cooperation with the authorities in the Member States and the Community, as mentioned in this Directive.
Third The procedures that ensure the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for in the said legislation, which must refer to this Directive.

Article 6 Standard authorization procedure
first Subject to Article 5, any person who intends to carry out a deliberate release of a GMO or a combination of GMOs, submit a notification to the competent authority of the Member State where the release is to take place.
Second The paragraph. 1 shall must include:



a) a technical dossier in Annex III information necessary to conduct the environmental risk assessment of the deliberate release of a GMO or a combination of GMOs, in particular:

i) general information including information on personnel and training

ii) information on the GMO

iii) information relating to the conditions of release and the potential receiving

iv) information on the interactions between the GMO and the environment


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

vi) information on control, remediation methods, waste treatment and emergency response plans

vii) a summary of the dossier.

b) environmental risk assessment and the conclusions required in Annex II, section D, together with any bibliographic reference and indications of the methods used.

Third The notifier may refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non confidential or these notifiers have given written consent; .
Fourth The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be covered by a single notification.
Fifth The competent authority shall acknowledge the date of receipt of the notification and, where appropriate, taking into account comments from other Member States made in accordance with Article 11, the notifier a written response within 90 days of receipt of the notification which the competent authority declares:



a) that it is satisfied that the notification is in accordance with this Directive and that the release may or

b) that the release does not fulfill the conditions of this Directive and that notification is therefore rejected.

6th When calculating the 90 day period referred to in paragraph. 5, shall not include the time during which the competent authority:



a) awaiting further information it has requested from the notifier, or

b) carrying out a public consultation in accordance with Article 9; this public consultation shall not prolong the 90 day period referred to in paragraph. 5 by more than 30 days.

7th If the competent authority requests new information it must simultaneously justify this.
8 thereof. Notifier may proceed with the release only when he has received the competent authority's written permission, and subject to the conditions attached thereto.
9th Member States shall ensure that no material derived from GMOs, which is exposed in accordance with Part B, marketed, unless in accordance with Part C.
Article 7 Differentiated procedures

first If there is sufficient experience with releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal for the application of differentiated procedures to such types of GMO ' is.
Second 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 observations within 60 days, while

b) make available the proposal to the public, which may make observations within 60 days, and

c) consult the relevant Scientific Committee may issue an opinion within 60 days.

Third There must in accordance with Article 30. 2, a decision on each proposal. Decision shall establish the amount of technical information from Annex III as the minimum necessary for evaluating any foreseeable risks from the release, in particular:



a) information on the GMO

b) information relating to the conditions of release and the potential receiving

c) information on the interactions between the GMO and the environment

d) the environmental risk assessment.

Fourth This decision must be taken within 90 days of the date of the Commission's proposal or of receipt of the competent authority's proposal. In this 90-day period shall not include the period during which the Commission is awaiting the observations of competent authorities, the comments of the public or the opinion of Scientific Committees, see. Paragraph. 2.
fifth The decision taken in accordance with paragraph. 3 and 4 shall provide that the notifier may proceed with the release only when he has received the competent authority's written permission. The notifier shall proceed with the release in accordance with the conditions specified in the permit.

The decision taken in accordance with paragraph. 3 and 4 may provide that releases of a GMO or a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be covered by a single notification.
6th Commission Decision 94/730 / EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6. 5 of Council Directive 90/220 / EEC continues to apply, see. However paragraph. 1-5 of this Article.
7th If a Member State in respect of releases of GMOs on its territory decide to use or not to use a procedure established in a decision taken in accordance with paragraph. 3 and 4 shall inform the Commission thereof.

Article 8 Handling of modifications and new information
first If there is a change or unintended change of the release of a GMO or a combination of GMOs which could have consequences with regard to risks for human health and the environment after the competent authority has given its written consent, or if new information on such risks, either while the notification is being examined by the competent authority of a Member State or by its written consent, the notifier shall immediately:



a) take the necessary measures to protect human health and the environment

b) inform the competent authority in advance of any modification or as soon as the unintended change is known or the new information is available

c) revise the notification, the measures.

Second If the paragraph. 1 being the competent authority comes into possession of information that could have significant consequences with regard to risks for human health and the environment, or in paragraph. 1 circumstances described, is the competent authority shall evaluate such information and make it publicly available. It may require the notifier to modify the conditions of, put suspend or terminate, and inform the public accordingly.

Article 9 Consultation of and information to the public
first Subject to Articles 7 and 25, they shall consult the public and, where appropriate, groups on the proposed deliberate release. In this context, Member States shall lay down arrangements for this consultation, including a reasonable time in order to give the public or groups the opportunity to express their opinion.
Second Without prejudice to Article 25:



- Member States information on all Part B releases on their territory of GMOs publicly available

- Does the Commission information contained in the system for the exchange of information under Article 11 publicly available.


Article 10 Reporting by notifiers on releases
When a release is complete and then at the intervals specified in the permit on the basis of the results of the environmental risk assessment, the notifier shall send the competent authority the result of the release in respect of any risk to human health or the environment, where appropriate, with particular reference to any kind of product that the notifier intends to notify at a later date. It establishes a model for the presentation of this result in accordance with Article 30. 2.

Article 11 Exchange of information between the competent authorities and the Commission
first The Commission shall establish a system of exchange of the information contained in the notifications. The competent authorities shall send the Commission a summary of each notification received under Article 6 within 30 days of receipt. The model for this summary shall be prepared and revised as necessary in accordance with Article 30. 2.
second The Commission shall, within 30 days of receipt of these summaries to the other Member States within a period of 30 days, present observations through the Commission or directly. A Member State shall upon request be entitled to a copy of the full notification from the competent authority of the Member State concerned.
Third The competent authorities shall inform the Commission of the final decisions taken in accordance with Article 6. 5, including where relevant the reasons for rejecting a notification, and of the results of the releases received in accordance with Article 10.

Fourth With regard to the release of GMOs referred to in Article 7 Member States shall submit annually a list of GMOs which have been released on their territory and a list of notifications that were rejected to the Commission, which will forward them to the competent authorities of the other Member States.
PART C
MARKET OF GMOs AS OR IN PRODUCTS
Article 12
Vertical legislation
first Article 13-24 does not apply to GMOs as or in products as far as they are permitted under Community legislation, which partly requires a specific environmental risk assessment in accordance with the principles in Annex II and on the basis of information listed in Annex III without prejudice to additional requirements under the Community legislation mentioned above, and for requirements as regards risk management, labeling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to the requirements of this Directive.
Second With regard to Council Regulation (EEC) no. 2309/93, Article 13-24 of this Directive shall not apply to GMOs as or in products, to the extent they are authorized under that Regulation, provided that implemented a specific environmental risk assessment in accordance with the principles in Annex II and on the basis of the type of information specified in Annex III without prejudice to other applicable requirements in terms of risk assessment, risk management, labeling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use.
Third The procedures ensuring that the risk assessment, requirements regarding risk management, labeling, monitoring as appropriate, information to the public and safeguard clause are equivalent to what is provided for in this Directive shall be determined by a regulation of the European Parliament and the Council. Future sectoral legislation based on the provisions of the said Regulation shall contain a reference to this Directive. Until the Regulation enters into force, any GMO as or in products as far as they are authorized by other Community legislation may be marketed only after having been accepted for marketing in accordance with this Directive.
Fourth During the assessment of applications for marketing in paragraph. 1 GMOs referred to the bodies set up by the Community under this Directive and by Member States for the implementation shall be consulted.

Article 12a Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms for which there is a favorable risk evaluation
first The marketing of GMOs or combinations of GMOs, occurring as traces in products intended for direct use as food or feed or for processing shall be exempted from Article 13-21, if they fulfill the conditions of Article 47 of the European Parliament and Council Regulation (EC) no. 1829/2003 on genetically modified food and feed.
Second This article is valid for three years after the date from which Regulation (EC) no. 1829/2003.

Article 13 Notification procedure
first Before a GMO or a combination of GMOs as or in products placed on the market must submit a notification to the competent authority of the Member State where the GMO will be marketed first time. The competent authority shall acknowledge the date of receipt of the notification and immediately forward the summary of the dossier referred to in paragraph. 2, point h) to the competent authorities of the other Member States and the Commission.
The competent authority shall without delay examine whether the notification is in accordance with paragraph. 2, and if necessary, request the notifier for additional information.
When the notification is in accordance with paragraph. 2, the competent authority at the latest when it pursuant to Article 14. 2 sends its assessment report, a copy of the notification to the Commission, within 30 days of its receipt, forward it to the competent authorities of the other Member States.
Second The notification must include:



a) the information required in Annexes III and IV. This information must take into account that the sites of use of the GMO as or in a product that is diverse, and include information on data and results from releases in research and development purposes relating to expose the effects on human health and the environment || |
b) environmental risk assessment and the conclusions required in Annex II, section D

c) conditions for the marketing of the product, including specific conditions of use and handling


d) a proposed period for the consent which should not exceed ten years, cf. Article 15. 4

e) a plan for monitoring in accordance with Annex VII, including a proposal for the duration of the monitoring plan; this period may be different from the proposed period for the consent

f) a proposal for labeling which shall comply with Annex IV. It must be clear on the label that the product contains a GMO. The words This product contains genetically modified organisms shall appear either on a label or in an accompanying document

g) a proposal for packaging which shall meet the requirements of Annex IV

h) a summary of the dossier. The model of the summary shall be established in accordance with Article 30. 2.

If on the basis of the results of any release notified under Part B, or on other substantive, reasoned scientific grounds, to the marketing and use of a GMO as or in a product, no risk to human health and the environment, may propose to the competent authority that it fails to deliver some or all of the information required in Annex IV, section B.
third Notifier shall include in the notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and / or carried out or are in the process of notifying and / or conduct in or outside the Community .
Fourth The notifier may also refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non confidential or these notifiers have given their written consent.
Fifth Should a GMO or combination of GMOs to be used for purposes other than those already specified in a notification, must submit a separate notification shall.
6th If there is any new information about the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the necessary measures to protect human health and the environment, and inform the competent authority accordingly. In addition, the notifier shall revise the information and conditions specified in the notification.
Article 14
Assessment Report
first After receipt and acknowledgment of the notification in accordance with Article 13. 2, the competent authority shall, if the notification is in accordance with this Directive.
Second Within 90 days of receipt of the notification the competent authority:



- Prepare an assessment report and send it to the notifier. A subsequent withdrawal of his notification, does not preclude the review later submitted to another competent authority

- In the paragraph. 3, point a) above, send its report, together with the paragraph. 4 referred information and any other information which based its report, to the Commission, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

In the case referred. 3, point b) above, the competent authority of its report, together with the paragraph. 4 referred information and any other information which based its report to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of receiving the report to the competent authorities of the other Member States.
Third The assessment report shall indicate



a) whether the GMO should be marketed and under what conditions, or

b) whether the GMO should not be marketed.

Assessment reports prepared in accordance with guidelines specified in Annex VI.
Fourth When calculating the amount in paragraph. 2 stated period of 90 days is not included time during which the competent authority is awaiting further information it has requested from the notifier. The competent authority must justify any request for further information.
Article 15
Standard Procedure
first In Article 14, paragraph. 3 case referred to a competent authority or request further information, make comments or reasoned objections to the marketing of the GMO within 60 days of the date of circulation of the assessment report.
Comments or reasoned objections and replies sent to the Commission which shall promptly forward them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues to reach agreement within 105 days from the date of circulation of the assessment report.
In calculating the final 45 days to reach agreement shall not be taken for periods when there is more information from the notifier. Any request for additional information should be justified.

2. In Article 14, paragraph. 3, point b), the notification shall be refused if the competent authority which prepared the report decides that the GMO should not be marketed. This decision must be substantiated.
Third If the competent authority which prepared the report decides that the product may be marketed in the absence of any reasoned objection from a Member State or the Commission within 60 days of the date of circulation of the in Article 14. 3, point a), the assessment report or if outstanding issues are resolved before the end of the paragraph. 1 shall be extended to 105 days, the competent authority which prepared the report, written authorization for marketing, shall transmit it to the notifier and inform the other Member States and the Commission thereof within 30 days.
Fourth The authorization is granted for a period not exceeding ten years from the date of its issue.
In connection with the approval of a GMO or its offspring alone for marketing of their seeds under the relevant Community provisions, the term of validity of the initial authorization, within ten years after the date of the first plant variety containing the GMO recorded on an official national catalog of plant varieties in accordance with Council Directive 70/457 / EEC and 70/458 / EEC.
In the case of forest reproductive material, the period of the first authorization within ten years from the date on which the basic material containing GMOs was first recorded in an official national register of basic material in accordance with Council Directive 1999/105 / EC.

Article 16 Criteria and information for specified GMOs
first Notwithstanding Article 13, a competent authority or on its own initiative, make a proposal on criteria and information requirements to be met for the notification for marketing of certain types of GMOs as or in products.
Second The prices referred to in paragraph. 1 mentioned criteria and information requirements as well as the appropriate requirements for a summary of the dossier. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted after consultation of the relevant scientific committees under the regulatory procedure with scrutiny referred to in Article 30. 3. The criteria and information requirements shall be such as to ensure a high degree of safety to human health and the environment and shall be based on the scientific evidence available on such safety and on experience gained from the release of comparable GMOs .
The requirements of Article 13. 2, replaced by those adopted in accordance with the first paragraph and the procedure in Article 13. 3, 4, 5 and 6, 14 and 15 shall apply.
Third Within the regulatory procedure with scrutiny in Article 30. 3, begins with a view to a decision on criteria and information requirements referred to in paragraph. 1, the Commission shall publish the proposal. The public has a period of 60 days to submit comments to the Commission. The Commission shall send such comments, together with an analysis, to the Committee established pursuant to Article 30. Article 17

Renewal of consent
first Notwithstanding Articles 13, 14 and 15, the procedure in paragraph. 2-9



a) of consents granted under Part C, and

b) before 17 October 2006 for renewal of permits by 17 October 2002, granted pursuant to Directive 90/220 / EEC on the marketing of GMOs as or in products.

Second Within nine months before the end of the consent, for the consents referred to in paragraph. 1, point a), and by 17 October 2006 for the consents referred to in paragraph. 1, point b), the notifier under this Article shall submit to the competent authority that received the original notification, a notification must include:



a) a copy of the marketing authorization for GMOs

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

As regards the authorizations referred to in paragraph. 1, point b), this report shall be submitted when made monitoring




c) any other new information on risks of the product to human health and / or the environment, and

d) where appropriate, a proposal for amending or complementing the conditions of the original consent, inter alia the conditions concerning future monitoring and the time limitation of the consent.

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph, the competent authority forthwith a copy of the notification and the assessment report to the Commission, within 30 days of its receipt, forward them to the competent authorities of the other Member States. The competent authority shall also send its assessment report to the notifier.
Third The assessment report must specify:



a) whether the GMO should remain on the market and under which conditions, or

b) whether the GMO should not remain on the market.

Fourth The other competent authorities or the Commission may request further information, make comments or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.
Fifth All comments, reasoned objections and replies sent to the Commission, which shall promptly forward them to all competent authorities.
6th For the purposes of paragraph. 3, point a), the competent authority which prepared the report in the absence of any reasoned objection from a Member State or the Commission within 60 days of the date of circulation of the assessment report shall transmit to the notifier the final decision in writing and inform the other Member States and Commission within 30 days. The validity of the permit should generally not exceed ten years and may be limited or extended for specific reasons.
7th The competent authorities and the Commission may discuss any outstanding issues with a view to reaching an agreement within 75 days from the date of circulation of the assessment report.
8 thereof. If outstanding issues are resolved before the end of the paragraph. 7 relevant period of 75 days, the competent authority which prepared the report, sending its final decision in writing to the notifier and inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.
9th After a notification for the renewal of a consent in accordance with paragraph. 2 notifier may continue to GMOs on the market in the authorization, pending a final decision on the notification.

Article 18 Community procedure in case of objections
first If a competent authority or the Commission in accordance with Articles 15, 17 and 20 shall make and maintain objections, must be in accordance with Article 30. 2, within 120 days of adopted and published the decision. This decision shall contain the same information as listed in Article 19. 3.
When calculating the period of 120 days shall not be counted period during which the Commission is awaiting further information it has requested from the notifier or is seeking the opinion of a Scientific Committee which has been consulted in accordance with Article 28 Commission justify any request for further information and inform the competent authorities of its requests to the notifier. The period during which the Commission is awaiting the opinion of the scientific committee shall not exceed 90 days.
The period where the Council decides in accordance with Article 30. 2 are not included.
Second If there is a positive decision, the competent authority which prepared the report shall give consent in writing for marketing or for the renewal of the permit, submit it to the notifier and inform the other Member States and the Commission within 30 days of the publication or notification of decision.
Article 19

permission first Only if granted written permission to market a GMO as or in products, this product is subject to the requirements of other Community legislation used without further notification throughout the Community in so far as the specific conditions of use and their requirements with respect to the environment and / or geographical areas should be strictly observed.
Second The notifier may start marketing when he received the competent authority's written authorization in accordance with Articles 15, 17 and 18, and subject to the conditions required in that consent.
Third The Articles 15, 17 and 18 of the written consent shall, in all cases, explicitly specify:




a) scope of the consent, including the identity of the GMO, as or in products, and to be marketed, and their unique identifier

b) the license validity period

c) conditions for the marketing of the product, including any specific condition of use, handling and packaging of the GMO as or in products, and conditions for the protection of particular ecosystems / environments and / or geographical areas

d) that, without prejudice to Article 25, upon request shall make control samples available to the competent authority

e) labeling requirements in accordance with the requirements of Annex IV. Labeling shall clearly state that a GMO. The words This product contains genetically modified organisms must appear either on a label or in a document accompanying the product or other products containing GMO

f) monitoring requirements in accordance with Annex VII, including obligations to report to the Commission and the competent authorities, the time period of the monitoring plan and, where appropriate, any obligations on any person selling the product or any user, in particular, as regards cultivated GMOs, concerning a level of information deemed appropriate on their location where they are.

Fourth Member States shall take all measures necessary to ensure that the written consent and, where appropriate, the decision referred to in Article 18 are made publicly available, and that the conditions in the written consent and, where appropriate, in the decision complied with.

Article 20 Monitoring and handling of new information
first Following the marketing of a GMO as or in a product, the notifier shall ensure that there is the monitoring and reporting on the monitoring in accordance with the authorization. The reports of this monitoring must be submitted to the Commission and the competent authorities. On the basis of these reports, in accordance with the consent and within the framework of the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.
Second Is there, after the written consent is granted, new information from users or other sources about the risks of the GMO to human health or the environment, the notifier shall immediately take the necessary measures to protect human health and the environment and inform the competent authority accordingly.
In addition, the notifier shall revise the notification information and conditions specified.
Third Should the competent authority in possession of information which could have consequences with regard to the risks of the GMO to human health or the environment or in paragraph. 2-described circumstances, the competent authority information immediately to the Commission and the competent authorities of the other Member States and may avail itself of the provisions of Article 15. 1, and Article 17. 7, if the information has become available before the written consent.
The information has become available after the consent was given, the competent authority within 60 days of receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent terminated to the Commission that within 30 days of its receipt, forward it to the competent authorities of the other Member States.
Comments or reasoned objections to further commercialization of the GMO or on the proposal for amending the conditions for authorization within 60 days after circulation of the assessment report is sent to the Commission which shall immediately transmit it to all competent authorities.
The competent authorities and the Commission may discuss any outstanding issues in order to reach an agreement within 75 days from the date of circulation of the assessment report.
In the absence of any reasoned objection from a Member State or the Commission within 60 days after the submission of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and inform the other Member States and the Commission thereof within 30 days.
Fourth In order to ensure transparency, the results of monitoring carried out under part C made publicly available.
Article 21
Label

First Member States shall take all measures necessary to ensure that the labeling and packaging of marketed GMOs as or in products at all stages of marketing is in accordance with the requirements in Article 15. 3, Article 17. 5 and 8, Article 18. 2, and Article 19. 3, issue written permission.
Second For products where adventitious or technically unavoidable traces of authorized GMOs can not be excluded that there may fix a minimum threshold below which such products do not have to be labeled in accordance with paragraph. 1.
threshold values ​​determined taking into account the particular product. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30. 3.
third For products intended for direct processing, paragraph. 1 does not apply to traces of authorized GMOs in proportions no higher than 0,9% or lower thresholds, provided that these traces are adventitious or technically unavoidable.
May be set thresholds referred to in the first paragraph. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30. 3. Article 22


Free circulation Member States shall not prohibit, restrict or prevent the marketing of GMOs as or in products, which fulfill the requirements of this Directive laid. However, Article 23.
Article 23
Safeguards
first If, as a result of new or additional information since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge has reason to believe that a GMO as or in products, and which has been duly notified, and which has received written consent under this Directive constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and / or sale of that GMO as or in a product on its territory.
Member State shall ensure that in the event of a severe risk, emergency measures, for example. suspension or termination of the marketing information to the public.
Member State shall immediately inform the Commission and other Member States of the measures taken under this Article and give reasons for it, instead supplying its review of the environmental risk assessment, indicating whether the conditions of the consent should be amended or withdrawal, and how this should be done, and where appropriate, the new or additional information on which the decision is based.
Second Within 60 days after the date of receipt of the Member State information submitted shall be taken on the measure taken by the Member State concerned by the regulatory procedure in Article 30. 2. In calculating the 60 day period shall not include time during which the Commission is awaiting further information it has requested from the notifier or is seeking the opinion of the Scientific Committee which has been consulted. The period during which the Commission is awaiting the opinion of the Scientific Committee shall not exceed 60 days.
Similarly excluded the time used by the Council to act under the regulatory procedure in Article 30. 2. Article 24

public information
first After receiving a notification in accordance with Article 13. 1, the Commission shall immediately make it in Article 13. 2, point h) of paragraph summary available to the public pursuant. To Article 25. The Commission must immediately make available to the public in the cases provided for in Article 14. 3, point a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.
Second For all GMOs as or in a product, and which has received written consent for marketing, or marketing has been rejected in accordance with this Directive, the assessment reports carried out for these GMOs and the opinions of the scientific committee, who consulted shall be made available to the public pursuant. to Article 25. for each product clearly indicated the GMO or GMOs contained therein and the use thereof.

PART D FINAL PROVISIONS Article 25

Privacy

First The Commission and the competent authorities shall not divulge to third parties confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
Second The notifier may indicate the information in the notification pursuant to this Directive that should be treated as confidential because disclosure of which might harm his competitive position. There must then provide verifiable justification.
Third The competent authority shall, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.
Fourth The following information must under no circumstances be treated as confidential when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23:



- A general description of the GMO or GMOs, name and address, purpose of the release, location of release and intended uses

- Methods and plans for monitoring of the GMO or GMOs and for emergency response

- Environmental risk assessment.

Fifth Pulling the notifier its notification, for whatever reasons, the competent authorities and the Commission must respect the confidentiality of data.

Article 26 Labelling of GMOs referred to in Article 2, no. 4, second paragraph
first GMOs to be made available for the actions referred to in Article 2, no. 4, second paragraph, adequate labeling requirements in accordance with the relevant sections of Annex IV, so that it is clear from a label or an accompanying document to the use of GMOs. The words This product contains genetically modified organisms shall appear either on a label or in an accompanying document.
Second Conditions for the implementation of paragraph. 1 down, without duplicating or creating inconsistencies with existing labeling provisions in existing legislation must be avoided. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30. 3. In this context appropriate consideration to labeling provisions established by Member States in accordance with Community law.

Article 26a Measures to avoid the unintended presence of GMOs
first Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.
Second The Commission shall gather and coordinate information based on studies at Community and national level, monitors the development of co-existence of genetically modified, conventional and organic crops in the Member States and develop guidelines based on the information and observations.

Article 27 Adaptation of the Annexes to technical progress
adaptation of Sections C and D of Annex II, Annex III to VI, and Section C of Annex VII, designed to amend non-essential elements of this Directive takes accordance with the regulatory procedure with scrutiny referred to in Article 30. 3.

Article 28 Consultation of one or more scientific committees
first In cases where an objection as regards the risks of GMOs to human health or the environment is raised by a competent authority or the Commission and maintained in accordance with Article 15. 1, Article 17. 4, Article 20. 3, or 23, or where in the Article 14 report stated that the GMO should not be placed on the market, the Commission on its own initiative or at the request of a Member State to hear the relevant Scientific Committee on the objection.
Second The Commission may also on its own initiative or at the request of a Member State to hear the relevant scientific committees on all matters referred to in this Directive and which could have adverse effects on human health and the environment.
Third The administrative procedures laid down in this Directive are not affected by paragraph. 2.

Article 29 Consultation of one or more committees on ethical issues
first Without prejudice to Member States' competence in ethical questions on its own initiative or at the request of the European Parliament or the Council, consult any committee it has set up to advise on the ethical aspects of biotechnology, for example. 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.
Second This consultation is conducted under clear rules of openness, transparency and public accessibility. The result should be available to the public.

Third The administrative procedures laid down in this Directive are not affected by paragraph. 1.

Article 30 Committee procedure
first The Commission shall be assisted by a committee.
Second Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468 / EC pursuant to Article 8 thereof.
Deadline in Article 5. 6 of Decision 1999/468 / EC shall be three months.
Third Where reference is made to this paragraph, Article 5a. 1-4, and Article 7 of Decision 1999/468 / EC pursuant to Article 8 thereof.
Article 31
Exchange of information and reporting
first The Member States and the Commission shall meet regularly and exchange information on the experience acquired with the prevention of risks related to the release and marketing of GMOs. This information exchange shall also cover experience gained in the implementation of Article 2, no. 4, second subparagraph, environmental risk assessment, monitoring and the issue of consultation and information of the public.
The guidelines for implementation of Article 2, no. 4, second paragraph, may, if necessary, be determined by the committee set up under Article 30. 1.
second The Commission shall establish one or more registers to store the information on genetic modifications in GMOs, provided for in Annex IV, Section A, no. 7. Without prejudice to Article 25, the register / registers include a portion available to the public. The modalities of how the register / registers should function, determined in accordance with Article 30. 2.
third Subject to paragraph. 2 and Part A, paragraph. 7 of Annex IV



a) Member States shall establish public registers in which the release of GMOs under Part B is recorded

b) the Member States shall also maintain records containing information about GMOs grown under Part C, is, in particular to the possible effects of such GMOs on the environment may be monitored in accordance with Article 19. 3, point f) and Article 20. 1. Without prejudice to such provisions in Articles 19 and 20, the said locations

- Notified to the competent authorities, and

- Made publicly available

In the way the competent authorities consider appropriate and in accordance with national regulations.
Fourth Member States shall every three years, a report on the measures taken to implement this Directive. This report shall include a brief factual report on their experience with GMOs as or in products, and marketed in accordance with this Directive.
Fifth The Commission shall publish every three years a summary based on the paragraph. 4 reports referred.
6th The Commission shall forward in 2003 and every three years to the European Parliament and the Council a report on Member States' experience with GMOs placed on the market under this Directive.
7th When submitting this report in 2003, it presented the same time a special report on how Part B and Part C including an assessment of



a) all its implications, particularly to take the diversity of European ecosystems into account, as well as the need to complement the regulatory framework in this area

b) the feasibility of various options to further improve the coherence and efficiency of this framework, including a centralized Community authorization procedure and the arrangements for the final decision

c) whether sufficient experience has accumulated with the implementation of part B differentiated procedures to justify a provision on implicit consent in these procedures and on part C to that it can justify the application of differentiated procedures;

d) the socioeconomic implications of deliberate releases and marketing of GMOs.

8 thereof. Commission sends annually to the European Parliament and the Council a report on the ethical issues referred to in Article 29. 1; This report may, where appropriate, be accompanied by proposals for amending the Directive.

Article 32 Implementation of the Cartagena Protocol on Biosafety
first The Commission requested as soon as possible and in any case before July 2001, to submit a legislative proposal in order to detail the Cartagena Protocol on Biosafety. The proposal shall complement and, if necessary, amend the provisions of this Directive.

Second This proposal shall include in particular appropriate measures to implement the procedures laid down in the Cartagena Protocol and, in accordance with the Protocol, require Community exporters to ensure that all requirements of the Advance Informed Agreement (Advance Informed Agreement- procedure), cf.. Article 7-10, 12 and 14 of the Cartagena Protocol, are fulfilled.
Article 33

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

Article 34 Transposition
first Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 October 2002. They shall forthwith inform the Commission thereof.
Those provisions, they shall contain a reference to this Directive or be accompanied by such a reference. The sates determined by Member States.
Second 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 Pending notifications
first Reviews on the market of GMOs as or in products received pursuant to Directive 90/220 / EEC and for which the procedures of that Directive have not been completed by 17 October 2002, subject to the provisions in this Directive.
Second By 17 January 2003 notifiers shall have complemented their notification in accordance with this Directive.
Article 36 Repeal

first Directive 90/220 / EEC is repealed on 17 October 2002.
second References to the repealed Directive shall be construed as references to this Directive and should be read in conjunction with the correlation table in Annex VIII.

Article 37 This Directive shall enter into force on the day of its publication in the Official Journal.

Article 38 This Directive is addressed to the Member States.

ANNEX IA

TECHNIQUES REFERRED TO IN ARTICLE 2. 2

PART 1 Techniques of genetic modification referred. Article 2 no. 2, point a) are inter alia .:



1) recombinant nucleic acid techniques, thereby creating novel combinations of genetic material by the insertion of nucleic acid molecules produced by any means outside an organism, a virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not occur naturally, but wherein they are capable of replication

2) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation

3) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the merger of two or more cells by means of methods that do not occur naturally.

PART 2
techniques that are not considered to result in genetic modification referred. Article 2, no. 2, point b), provided that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques / methods other than those excluded by Annex IB:



1) in vitro fertilization

2) natural processes such. conjugation, transduction and transformation

3) inducing polyploidy

ANNEX IB

TECHNIQUES REFERRED TO IN ARTICLE 3
Techniques / methods of genetic modification yielding organisms to be excluded from this Directive, provided that these techniques / methods do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the following techniques / methods:



1) mutagenesis

2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.

ANNEX II

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT
This appendix 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 to perform the environmental risk assessment referred to in Articles 4 and 13. Technical guidance notes may be developed in accordance with the regulatory procedure in Article 30. 2, to facilitate the implementation and explanation of this Annex.

In order to contribute to a common understanding of the terms direct, indirect, immediate and delayed the implementation of this Annex, without prejudice to further guidance in this regard, particularly with regard to the question of whether there can and must be taken into account indirect effects, these terms are described as follows:



- Direct effects refer to primary effects on human health or the environment as a result of the GMO itself and which do not occur through a causal chain of events

- Indirect effects refer to effects on human health or the environment as a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management.

Indirect effects are likely to be delayed



- Immediate effects refer to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect

- Delayed effects refers to effects on human health or the environment that can not be observed during the period of the release of the GMO but become apparent as a direct or indirect effect either at a later stage or after the release will be ceased.

A general principle for ERA is also that there should be an analysis of the cumulative long-term effects associated with the release and marketing. Cumulative long-term effects refer to the accumulated effects on human health and the environment, including flora and fauna, soil fertility, soil degradation of organic material, the feed and food chain, biological diversity, animal health and resistance problems in relation to antibiotics.
A. Goals
The objective of an era is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the market of GMOs may pose. The era should be conducted with a view to identifying if there is a need for risk management and if so, what methods are most appropriate to use.
B. General principles
In accordance with the precautionary principle, the following general principles followed when performing the era:



- Identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations

- The environmental risk assessment carried out in a scientifically sound and transparent manner based on available scientific and technical data

- The era should be made on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking particular taken of GMOs already in the environment

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

- Determine whether the risk has changed

- To determine whether there is a need for amending the risk management accordingly.

C. Methods
C.1. Characteristics of GMOs and releases
Depending on the case the era has to take into account the relevant technical and scientific details regarding characteristics of:



- The recipient or parental organism (s)

- The genetic modifications, be it inclusion or deletion of genetic material, and relevant information on the vector and the donor

- GMO

- The intended release or use including its scale

- The potential receiving environment, and

- The interaction between these.

Assist the ERA using information from releases of similar organisms and organisms with similar traits and their interaction with similar environments.
C.2. Steps in the era
In drawing conclusions for in Articles 4, 6, 7 and 13 of the environmental risk assessment should take into account the following points:
first Identification of characteristics which may cause adverse effects

Characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment must be identified. A comparison of GMOs characteristics with the non-modified organism under corresponding conditions of the release or use will assist in identifying the particular potential adverse effects of the genetic modification. It is important not to discount any potential adverse effect, even though it is considered unlikely.
Potential adverse effects of GMOs will vary from case to case and may include:



- Disease to humans including allergenic or toxic effects (see eg. Section II, paragraph A, no. 11, and Title II, section C, no. 2, point i) of Annex III A and point B . 7 of Annex III B)

- Disease to animals and plants including toxic, and where appropriate, allergenic effects (see eg. Section II, paragraph A, no. 11, and Title II, section C, no. 2, point i) of Annex III A and point B, no. 7, and point D, no. 8, in Annex III B)

- Effects on population dynamics of species in the receiving environment and the genetic diversity of each of these populations (see eg. Title IV, Section B, no. 8, 9 and 12 in Annex III A)

- Altered susceptibility to pathogens facilitating the dissemination of infectious diseases and / or creating new reservoirs or vectors

- Compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example. by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine (see eg. Title II, Part A, paragraph. 11, point e), and Section II, paragraph C, no. 2, point i ), no. iv) of Annex III A)

- Effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see eg. Section II, paragraph A, no. 11, point f), and Title IV, point B . 15, in Annex III A and point D, no. 11, in Annex III B).

Adverse effects may occur directly or indirectly through mechanisms which may include:



- The spread of GMO into the environment

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

- Phenotypic and genetic instability

- Interactions with other organisms

- Changes in management, including, where applicable, in agricultural practices.

Second Evaluation of the potential consequences of each adverse effect, if it occurs
The magnitude of the consequences of each potential adverse effect should be evaluated. This evaluation should assume that such an adverse effect will occur. The extent of the consequences is likely influenced by the environment in which the GMO to be released, and the manner of the release.
Third Evaluation of the probability that each identified potential adverse effect
An important factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment in which the GMO intended to be released , and the manner of the release.
Fourth Evaluation of the risk posed by each identified characteristic of the GMO implies
should be based on the current scientific level as far as possible, permit an estimation of the risk posed by each identified characteristic of the GMO that may cause adverse effects to human health or the environment, by combining the likelihood that the adverse effect occurring and the magnitude of the consequences, if it occurs.
Fifth Use of strategies for risks from the deliberate release or marketing of GMO
The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.
6th Determination of the overall risk of the GMO
There should be an assessment of the overall risk of the GMO, taking into account the proposed risk management strategies.
D. Conclusions on the potential environmental impact from the release or marketing of GMO
On the basis of an environmental risk assessment carried out in accordance with the principles and methodology outlined in sections B and C should be in the reviews included, as appropriate information on the points listed in sections D.1 or D.2 in order to draw conclusions on the potential environmental impact from the release or marketing of GMOs:
D.1. In the case of GMOs other than higher plants

First Likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the proposed release.
Second Any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realized under the conditions of the proposed release.
Third Possibility of gene transfer to other species under conditions of the proposed release of the GMO and any selective advantage or disadvantage for these species.
Fourth Possible immediate and / or delayed environmental impact resulting from direct and indirect interactions between the GMO and target organisms (if applicable).
Fifth Possible immediate and / or delayed environmental impact resulting from direct and indirect interactions between the GMO with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.
6th Possible immediate and / or delayed effects on human health resulting from potential direct and indirect interactions of the GMO and persons working with, coming into contact with or in the vicinity of the GMO releases.
7th Possible immediate and / or delayed effects on animal health and consequences for the food chain after consuming GMOs and products derived from it if it is intended for animal feed.
8 thereof. Possible immediate and / or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions between the GMO and target and non-target organisms in the vicinity of the GMO releases.
9th Possible immediate and / or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the GMO where these are different from those used for non-GMOs.
D.2. In the case of genetically modified higher plants (GMHP)
first Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural or more invasive in natural habitats.
Second Any selective advantage or disadvantage of the GMO.
Third Possibility of gene transfer to the same or other sexually compatible plant species under conditions of planting the GMHP and any selective advantage or disadvantage to those plant species.
Fourth Potential immediate and / or delayed environmental impact resulting from direct and indirect interactions between the GMO and target organisms, such as predators, parasitoids and pathogens (if applicable).
Fifth Possible immediate and / or delayed environmental impact resulting from direct and indirect interactions between the GMO and non-target organisms, (also taking into account organisms which interact with target organisms), including impact on population levels of competitors, herbivores, symbionts (where applicable), parasites and pathogens.
6th Possible immediate and / or delayed effects on human health resulting from potential direct and indirect interactions between the GMO and persons working with, coming into contact with or near it or the GMHP release.
7th Possible immediate and / or delayed effects on animal health and consequences for the food chain after consumption of the GMO and products derived from it if it is intended for animal feed.
8 thereof. Possible immediate and / or delayed direct and indirect effects of the specific cultivation, harvest and handling techniques used for the GMO, if they are different from those used for non-GMHP.
9th Possible immediate and / or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions between the GMO and target and non-target organisms in the vicinity of the the GMHP release.
GUIDANCE NOTES ON THE OBJECTIVE, ELEMENTS, GENERAL PRINCIPLES AND METHODOLOGY OF THE ENVIRONMENTAL RISK ASSESSMENT REFERRED TO IN ANNEX II TO DIRECTIVE 2001/18 / EC
first INTRODUCTION

Environmental risk is in Article 2. 8 of Directive 2001/18 / EC defined as the assessment of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or marketing of GMOs may have. As one of the general obligations of the Directive states in Article 4. 3 Member States and where appropriate the Commission must ensure that potential adverse effects on human health or the environment that may be caused, directly or indirectly, in each case carefully assessed taking into account the environmental impact according to the characteristics of the organism introduced and the receiving environment. ERA is carried out in accordance with Annex II and is also referred to in Parts B and C of Annex II contains a general description of the objectives to be achieved, the factors to be taken into account, and the general principles and methods must be followed to perform the ERA, taking into account the effects on human health and the environment according to the characteristics of the organism introduced and the receiving environment.
The reviewers must submit a notification including an ERA for deliberate release under Article 6. 2, or an environmental risk assessment for marketing purposes under Article 13, paragraph. 2.
This manual supplements Annex II to Directive 2001/18 / EC and describes the environmental risk assessment objectives, principles and methods. The purpose is to assist the reviewers and the competent authorities to make it easier to carry out a comprehensive and appropriate ERA under Directive 2001/18 / EC and make the environmental risk assessment process transparent to the public.
The six steps in the ERA are set out in Section 4.2.
Second OBJECTIVES
According to Annex II of Directive 2001/18 / EC is the purpose of an environmental risk assessment on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or marketing of GMOs may have. The era should be conducted with a view to identifying if there is a need for risk management and, if so, what methods are most appropriate to use.
ERA therefore covers deliberate release (Part B) and marketing (Part C) as specified in Directive 2001/18 / EC. Placing on the market very often, but not necessarily, release into the environment, but there is in any case an intentional introduction on the market (eg. Agricultural products containing or consisting of GMOs, only for use as food, feed and processing). Also in this case, the notification must include an environmental risk assessment. Environmental risk assessments for the release can generally be distinguished from environmental impact assessments for marketing, for example. as a result of differences in existing data, time and area extent.
In addition, these guidance notes cover all GMOs, including microorganisms, plants and animals. So far, most of the vulnerable or marketed GMOs are higher plants, but it may change in the future.
The ERA will serve as the basis for identifying the need for risk management and if so, the most appropriate methods to be used, and for focused monitoring (see. Chapter 3).
The overall case-by-case assessment covers the GMO (assessment of each GMO) and or the environments in which the GMO is to be released (eg. The assessment of each locality or region if applicable).
As a result of further developments in genetic modification may make it necessary to adapt Annex II and these guidance notes to technical progress. Further differentiation of information requirements for different types of GMOs, for example. celled organisms, fish or insects, or for particular use of GMOs like. development of vaccines, may be possible once there is sufficient experience with notifications for the release of particular GMOs in the Community (Annex III, section 4 and section 6).
Risk assessment of the use of antibiotic resistance marker genes is a very specific issue and further guidance in this area may be needed.
In Annex II to Directive 2001/18 / EC outlines the different impact categories of GMOs on human health and the environment. In order to ensure a common interpretation, the definitions set out in the directive, illustrated as follows:




- Direct effects refer to primary effects on human health or the environment as a result of the GMO itself and which do not occur through a causal chain of events (eg. The direct effect of the Bt toxin on target organisms or GM microorganism pathogenic effects on human health).

- Indirect effects refer to effects on human health or the environment as a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management. Indirect effects are likely to be delayed (eg. Where reducing the target insects affects the population of other insects, or where the development of multiple resistance or systemic effects will require assessment of long-term interaction; however, some indirect effects eg. a decrease in the use of pesticides could be immediate).

- Immediate effects refer to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect (eg., Death of insects foraging on transgenic plants that have pest-resistant traits, or the induction of allergies in humans due to exposure to a particular GMO).

- Delayed effects refer to effects on human health or the environment, may not be observed during the period of the release of the GMO but become apparent as a direct or indirect effect either at a later stage or after the release will be ceased (eg. a GMO establishment or invasive several generations after the release, which is very important if the GMO lives long like. GM tree species or hybrids of close relatives of transgenic crop becoming invasive in natural ecosystems ).

It may be particularly difficult to identify the delayed effects, especially if they are only in the long term. Appropriate measures such. monitoring (see below) can help in detecting these effects.
Third GENERAL PRINCIPLES
In accordance with the precautionary principle, the ERA should be based on the following general principles:



- Identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations.

A baseline of the receiving environment, including its organisms and their interactions and their known variations, should be determined before any GMO (harmful) characteristics can be detected. The baseline serves as a point of reference against which future changes can be compared. In the case of crops that reproduce vegetatively, comparative analysis should include the parental used to generate the transgenic plant varieties. In the case of crops that reproduce sexually reproducing, the appropriate isogenic lines in the comparison.
Crops are developed using back-crossing, it is important that in such cases substantial equivalence testing uses the most appropriate controls and does not simply be based on comparisons with original parental material.
If the existing data are not sufficient, there must define an initial state of the other reference points so that can be compared. The baseline will depend largely on the receiving environment, including biotic and abiotic factors (eg., Natural preserved habitats, agricultural farmland or contaminated land) or a combination of different environments.



- The ERA should be carried out in a scientifically sound and transparent manner based on available scientific and technical data.

Evaluation of potential adverse effects should be based on scientific and technical data and on common methodology for the identification, collection and interpretation of the relevant data. Data, measurements and tests should be clearly described. Furthermore, the use of scientifically sound modeling procedures could provide missing data that could be useful for ERA.

ERA has to take into account various uncertainties. Scientific uncertainty results usually from five characteristics of the scientific method: the variable chosen, the measurements, the samples taken, the models used and the causal relationships. Scientific uncertainty may also be due to a controversy on existing data or lack of relevant data. Uncertainty may relate to qualitative or quantitative elements of the analysis. The level of knowledge or data for a baseline is reflected by the degree of uncertainty, the notifier must disclose (assessment of uncertainty, including lack of data, knowledge gaps, standard deviation, complexity, etc.), With respect to scientific uncertainties in current practice.
The ERA may not always result in definitive answers to all the questions due to lack of data. For potential long-term effects to the available data, very limited. In these specific cases, it is important to consider the appropriate risk management (safeguards) in accordance with the precautionary principle in order to prevent adverse effects on human health and the environment.
As a general principle, the ERA should include adequate research into the potential risks associated with the release or marketing of GMOs, along with any clearly documented comparable experience.
It may be helpful to use a step by step approach (ie all the steps beginning with experiments contained use system through deliberate release up to marketing). Data from each step should be collected as early in the procedure as possible. Simulated environmental conditions in a contained system could give results of relevance to deliberate release (eg. Behavior of microorganisms can be simulated in microcosms, or the behavior of plants can to some extent be simulated in greenhouses).
When it comes to GMOs to be marketed, it should obtain relevant and available data from releases in the types of environment where the GMO will be marketed.



- The ERA is made on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking particular be taken of GMOs which are already in the environment.

ERA should be based on a case-by-case principle because of the different organisms individual characteristics (GMO by GMO) and different environments (from place to place and from region to region).
There may be a huge variety in the environmental effects of genetically modified microorganisms (because of their small size and their often unknown interactions), plants (eg. Higher plants used for food and feed, or trees because of their potential longevity), and animals (eg. insects, because they are small and greatly abilities to overcome obstacles, or fish in coastal waters because of their high distribution potential).
Moreover, there may be a broad range of environmental characteristics (site-specific or region-specific) to be taken into account. To support a case-by-case assessment, it may be useful to classify regional data by habitat area, aspects of the receiving environment relevant to GMOs reflected (eg. Botanical data on the occurrence of wild relatives of GMO plants in different agricultural or natural habitats of Europe).
The notifier must also take into account the GMO potentially harmful interactions with other relevant GMOs that have been previously released or marketed, including repeated releases of the same GMO as such. use of plant protection products. Repeated releases, as distinct from individual hauls in time lead to a significant permanent background level of the GMO to become permanent in the environment.
If new information on the GMO and its effects on human health or the environment, it may be necessary to repeat the environmental risk assessment for



- Determine whether the risk has changed

- To determine whether there is a need for amending the risk management accordingly.

If new information becomes available, regardless of whether there is a need to take immediate action or not, must be made a new ERA to assess the need to modify the conditions of approval of the release or marketing of GMO or to adjust risk management measures (see also Chapter 6). New information can arise from research or monitoring plans or relevant experience elsewhere.

ERA and monitoring are closely linked. ERA provides the basis for the monitoring plans, which focus on the (negative) effects on human health and the environment. The monitoring requirements in the deliberate release of GMOs (Part B in accordance with the relevant parts of Annex III) and the market of GMOs (Part C in accordance with Annex VII) are different. Part C monitoring (including general surveillance) can also play an important role as a source of information on the (potentially negative) effects of GMOs. Monitoring results may confirm or lead to a reassessment of the environmental risk assessment.



- A general principle for ERA is also that there should be an analysis of long-term dekumulative virkningeri connection with the release and marketing. Cumulative long-term effects refer to the accumulated effects on human health and the environment, including flora and fauna, soil fertility, soil degradation of organic material, the food and feed chain, biological diversity, animal health and resistance problems in relation to antibiotics.

When assessing the potential cumulative long-term effects should include the following subjects for the ERA:



- The interaction between the GMO and the receiving long-term

- Characteristics of a GMO which become important on a long-term

- Repeated deliberate releases or placings on the market over a long time

- GMOs released or marketed.

There may be a need for more information, especially about long-term effects (eg., Multiple herbicide resistances) and there must be adequate research - partly within the framework of the monitoring plans - which can provide important data for assessing cumulative long-term effects. Further guidance on this item may be necessary.
Fourth METHODOLOGY
4.1. Characteristics of GMOs and releases into the environment
The ERA has to take into account the relevant technical and scientific details regarding characteristics of:



- The recipient or parental organism (s)

- The genetic modification (s), be it inclusion or deletion of genetic material, and relevant information on the vector and the donor

- GMO

- The intended release or use including its scale

- The potential receiving environment, and

- The interaction between these.

Assist the ERA using information from releases of similar organisms and organisms with similar traits and their interaction with similar environments.
Prior to deliberate release of a GMO or a combination of GMOs under Part B or marketing under Part C notifier to the competent authority of the Member State where the release or marketing to take place for the first time, a notification containing the information set out in Annex III A / B (information on the GMO, the donor, recipient, vector, release conditions and environment, interactions between the GMOs and the environment and of monitoring GMOs).
Those notifications should contain a technical dossier of information including a full ERA in accordance with Article 6. 2 and 13, paragraph. 2. The level of detail of the information that is needed to substantiate any point depending on its importance in the ERA. Notifiers shall provide bibliographic references and indicate the methods used.
The information required under Annex III A / B to be given on recipient, donor, vector, genetic modification and the GMO, does not depend on the environment the GMO experimental purposes must be released or marketed in, and conditions for . This information serves to identify any potential harmful characteristics (potential hazards) of the GMO. Knowledge and experience acquired in connection with releases of the same or similar GMOs may provide important information on the potential hazards of the release.
The information required under Annex III A / B shall be given of the intended release, receiving environment and interaction between these relate to the particular environment of the release and the release conditions, including the scale. This information will determine the extent of any potentially harmful characteristics of the GMO.
4.2. Steps in the analysis of ERA

In drawing conclusions for the ERA referred to in Articles 4, 6, 7 and 13 of Directive 2001/18 / EC, the focus should be on the following basic steps in the ERA.


One danger (harmful characteristics) is defined as an organism's potential to cause harm to or adverse effects on human health and / or the environment.
Risk is the combination of the magnitude of a hazard consequences, if it occurs, and the likelihood that the consequences occur.
4.2.1. Step 1: Identification of characteristics which may cause adverse effects
characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment must be identified. A comparison of GMOs characteristics with the non-modified organism under corresponding conditions of the release or use will assist in identifying the particular potential adverse effects of the genetic modification. It is important not to discount any potential adverse effect, even though it is considered unlikely.
Potential adverse effects of GMOs will vary from case to case and may include:



- Disease to humans including allergenic or toxic effects

- Disease to animals and plants including toxic, and where appropriate, allergenic effects

- Effects on population dynamics of species in the receiving environment and the genetic diversity of each of these populations

- Altered susceptibility to pathogens facilitating the dissemination of infectious diseases and / or creating new reservoirs or vectors

- Compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example. by the transfer of genes conferring resistance to antibiotics used in human or veterinary medicine

- Effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material.

It gives examples of the potential adverse impact of Annex III A and III B of Directive 2001/18 / EC.
Most of the identifiable hazards (harmful characteristics) which may cause adverse effects caused by it or the gene (s) inserted in the GMO, and the expression of their protein product (s). Additional adverse effects, for example. pleiotropic effects that could be generated as a result of the method used to create the transgenes, as well as the location in the genome of the GMO, wherein the transgenes are inserted. When transferring more than one transgene into a recipient or where a transgene is transferred into a GMO, must take into account the potential interaction of the different transgenes, epigenetic or regulatory effects.
It is important to define the hazard as accurately as possible, it will, in many cases, be useful to consider for the following items and then to specify the risk identified for the purpose of the environmental risk assessment (eg whether . potential for adverse effects on human health, allergenicity and toxigenicity, these should be considered separately in the ERA).
If the GMO is fraught with danger, this will always be present and can be considered an intrinsic property. Hazards can - with a given likelihood (step 3) - lead (negative) consequences and these consequences in turn can have different degrees (step 2). Finally, the individual hazards of the GMO to be summarized.
At this stage of the ERA, however, it is only necessary to consider the hazards introduced as a result of genetic modification that could cause adverse effects. Step 1 provides the scientific basis for the following steps in the ERA. Even at this stage it is crucial that, for each potential hazard identifies the specific level of scientific uncertainty so that it can be considered at a later stage.
Adverse effects may occur directly or indirectly through mechanisms which may include:



- The spread of the GMO (s) in the environment

Distribution pathways show the potential pathways of the GMO or of the potential hazard to the spread or the environment (eg., Human toxicity: inhalation of toxic microorganisms or toxic proteins).
Potential of a GMO to spread into the environment will include depend on:




- Its biological fitness (GMOs designed for better performance in the environment through the expression of the characteristics that give them a competitive advantage in the natural environment, or qualitative and quantitative change in composition of ingredients, or GMOs with resistance to natural selection pressures, or abiotic stress like. heat, cold, salt, or production of anti-microbial substances in microorganisms)

- The terms of the release or marketing (especially the area of ​​release and the scale, the number of GMOs)

- The likelihood of release or marketing, or unintentional releases of GMOs into the environment (eg., GMOs for processing)

- Dispersal of viable material (eg. Seeds, spores etc.) By wind, water, animals, etc.

- Particular environmental considerations (site-specific or regional-specific): To support a site-specific or region-specific assessment may be useful to classify data by habitat area, reflecting aspects of the receiving environment relevant to the GMO (eg. Botanical data on the presence of sexually compatible wild relatives of GMO plants in different agricultural or natural habitats of Europe).

It is also important to assess the length of time an individual GMO or a specific number of GMOs of a certain species is generally likely to survive, and how easy it / they can be disseminated and become established in different habitats. Consideration must be given to reproductive, survival and dormant forms, including:



- For plants: the viability of pollen, seeds and vegetative structures

- For microorganisms: the survival, or survival, but not dyrkbarhed.

The overall spread potential may vary considerably (depending on the species, the genetic modification and the receiving environment, for example. Plant cultivation in the desert or fish in the sea)



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

A hazard could result in adverse effects through gene transfer within the same species or to other species (vertical and horizontal gene transfer). The speed and extent of gene transfer to other species (usually sexually compatible species, the case of higher organisms) will depend example. of:



- The GMO propagation characteristics, including the modified sequences

- The conditions of release, and particular environmental considerations such as climate (eg. Wind)

- Differences in reproduction biology

- Agricultural practices

- The availability of potential crossing partners

- Transport and pollinating vectors (eg., Insects or birds, animals in general)

- The availability of hosts for parasites.

The occurrence of specific adverse effects through gene transfer may be linked to number of GMOs. Large fields of transgenic plants may have a completely different potential for gene transfer from small fields than proportional basis. Moreover, qualitative and quantitative information about the existence of potential crossing partners or recipients (for plants within relevant distances) is very important.
For higher plants and animals distinction should be made regarding possible gene transfer to the same, closely related species, distantly related species and unrelated species.
In the case of microorganisms, horizontal gene transfer plays a more important role. Certain genetic material can be easy transferred between more closely related organisms (eg. Via plasmids or phages). As a result of microbial rapid growth can enable gene transfer at relatively high levels compared to higher organisms.
Transfer of transgenes may eventually result in a mixed population of GMOs or to different gene / plant combinations, this can give rise to complex patterns of particular (unwanted) long-term effects. The complexity grows, the more transgenic material is transferred into a population (eg. Genakkumulation gene stacking).
In some cases of genetic modification may change the potential for gene transfer, for example. by non-integrating plasmids or viral vectors. The method by which the genetic modification may also decrease the potential for gene transfer (eg. Chloroplast transformation).

Gene transfer can the insert be persistent in natural populations. A GMO has the potential for gene transfer does not necessarily mean intrinsic risk, or a change in its survivability or dissemination or ability to cause adverse effects. This will depend on the genetic material inserted, the species and the receiving environment, including the potential recipients



- Phenotypic and genetic instability

There should be taken of the extent to which genetic (in) stability might lead to phenotypic (in) stability and result in a hazard. Is the genetic modification genetically unstable, it may in some cases result in reversion into the wild type phenotype. Other cases should be considered, for example .:



- If in a transgenic plant line that contains more than one transgene, the subsequent segregation process is divided in the progeny, there could be plants with less transgenes but new phenotypes.

- If attenuated mutants may, due to instability (because of the construction of the particular mutation) revert to virulence.

- Transgenes leads to gene inactivation (gene silencing).

- If copy numbers are very high.

- Reinstatement of transposable elements results in new phenotypes, due to inactivation of the transgene by the insertion of mobile genetic elements.

- If the level of transgene expression is important (eg. A very low expression of a toxic substance), it can be the regulatory element genetic instability lead to stronger expression of the transgene.

Phenotypic instability could result from interaction with the environment during cultivation, so that should be the era has to consider the effects of environmental and agronomic factors on expression of transgenes.
If transgene expression is limited to a specific part of the GMO (eg. A certain plant tissue), instability of regulation could result in expression of the transgene in the entire organism. In this context regulatory signals (eg. Promoters) play an important role and should be considered.
Expression of the transgene at a given time in the organism's life cycle or under specific environmental conditions should also be considered.
There may be inserted Specific infertility transgenes into the GMO to make it infertile (eg. To prevent certain transgenes transfer and dissemination). The infertility transgenes unstable, it can lead to reactivation of the fertility of the plant allowing the spread of the transgenes, which could have adverse effects.
The different transgene stability not only in the primary GMO but also in its progeny is of great importance, especially for long-term effects



- Interactions with other organisms (other than exchange of genetic material / pollen)

Possible interactions with other organisms, including other GMOs, have to be carefully assessed, taking into account the complexity of multitrophic interactions. There may be mentioned Directly hazardous interactions which could cause adverse effects:



- Exposure of humans (eg. Farmers, consumers)

- Exposure to animals

- Competition for natural resources like soil, area, water, light

- Displacement of natural populations of other organisms

- Delivery of toxic substances

- Different growth patterns.

If the genetic modification increases the biological fitness, the GMO may invade new environments and replace existing species. The occurrence of specific adverse effects is often proportional to the scale of release



- Changes in management, including, where applicable, in agricultural practices

The relevance of changes in management procedures as an unavoidable consequence of the deliberate release of GMO has to be assessed on the basis of existing procedures. Changes in farm management could, for example. include:



- Sowing, planting, growing, harvesting or transporting crops (eg., Planting in small or large fields), timing

- Crop rotation (eg. The cultivation of the same plant species every year or every fourth year)

- Disease and pest control (eg. The type and dose of insecticide for plants, or antibiotics for animals, or alternative measures)

- Resistance management (eg. The type and dose of herbicide for herbicide-tolerant plants, or change in use of biological control via Bt proteins or virus)


- Isolation in terrestrial and aquatic cultivation and breeding systems (eg. Isolation distances in plant cultivation or improvement of isolation quality in fish farms)

- Agricultural practices (farming GMOs and agriculture without the use of GMOs, including organic farming)

- Handling outside agriculture (eg. Isolation distances of natural habitats from GMO planting areas).

4.2.2. Step 2: Evaluation of the potential consequences of each adverse effect, if it occurs
The scale of the potential consequences of each adverse effect should be evaluated.
In addition to the likelihood that the potential harmful characteristics will occur (see. Section 4.2.3, step 3), the magnitude of the consequences is an important element in the risk assessment. The magnitude is the extent to which the consequences of the potential hazards of the GMOs released or placed on the market will become a reality.
Magnitude is to be compared to the baseline and likely to be influenced by the following factors:



- Genetic construction

- Each adverse effect identified

- The number of GMOs released (scale)

- The environment into which the GMO is to be released

- The conditions of release, including control

- Combinations of these factors.

For each adverse effect identified, the consequences for other organisms, populations, species or ecosystems exposed to the GMO. This requires detailed knowledge of the environment in which the GMO is to be released (eg. Site, region) and the method of release. Consequences will range from negligible or insignificant and self-limiting to substantial or significant, either having an immediate and serious effects or the long term can lead to permanent adverse effects.
Magnitude should, if possible, be expressed quantitatively significant, moderate, poor or negligible. It is in some cases not possible to detect the undesirable effects in a given environment. In such cases, the risk associated with that particular adverse effect could be assessed as negligible or insignificant.
The following qualitative examples may serve to illustrate. They are neither definitive nor exhaustive, but to give an indication of the considerations that might be taken into account when weighing up the consequences.



- Significant impacts could be significant changes in the number of one or more species of other organisms, including endangered and beneficial species in the short or long term. There may be a reduction in or complete eradication of a species leading to negative consequences for the ecosystem and / or other connected ecosystems. Such changes can be readily reversible and any recovery of the ecosystem is likely to be slow.

- Moderate consequences could be significant changes in other organisms population density, but not a change that can lead to the complete eradication of a species or any significant effect on endangered or beneficial species. Transient and substantial changes in populations might be included in this category if likely to be reversible. Also long-term effects, provided there are no serious negative effects on the functioning of the ecosystem.

- Rings consequences could be non-significant changes in population densities of other organisms, which do not lead to total eradication of any population or species of other organisms and have no negative effects on functioning of the ecosystem. Only non-endangered, non-beneficial species could be affected in the short or long term.

- Negligible consequences mean that no significant changes in populations in the environment or in any ecosystems.

The above examples reflect GMOs potential adverse effects on populations, although in some cases it may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one (unwanted) effect, and there may also be differences in the level of the individual adverse effects. The adverse effects of one single hazard of various kinds to human health, agricultural and natural habitats.
The potential consequences could be summarized in such a way that they include all the ecological entities which could be affected (eg. Species, populations, trophic levels, ecosystems) including the potential effect and the level of uncertainty.

4.2.3. Step 3: Evaluation of the likelihood that each identified potential adverse effect
An important factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment in which the GMO (s ) intended to be released, and the conditions of the release.
Besides the magnitude of the consequences of the hazards (see. Section 4.2.2, step 2) evaluating the likelihood of the occurrence of adverse effects, an important element in the risk assessment. At this stage it is estimated the probability that there will be an undesirable effect. In some cases both the likelihood and frequency are taken into account. As in step 2 (evaluate the potential consequences of each adverse effect) are important factors in assessing the probability, besides the hazard itself, the number of GMOs, the receiving environment and the conditions of release. There must therefore take into account the climatic, geographical, soil and demographic conditions and the species of flora and fauna in the potential receiving environment.
What assessment capability of survival, it is therefore appropriate to assess the proportion of GMOs that are likely to survive, outside the intended risk management measures proposed for the deliberate release or marketing. When is likely to occur gene transfer, should take into account the probable number or scope thereof. If the GMO has pathogenic or toxic characteristics, should assess the proportion of target organisms in the environment likely to be affected.
The likelihood that an effect occurs will also depend on the risk management measures that may prevent that the effect will occur (eg. Pollen dispersal is impossible due to the destruction of the inflorescences).
For each adverse effect will probably not be possible to make a qualitative assessment of the relative likelihood of it occurring, but the probability can be expressed as significant, moderate, poor or negligible.
The above examples reflect GMOs potential adverse effects on populations, although in some cases it may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one (unwanted) effect, so there may also be differences in the likelihood that the individual adverse effects. The adverse effects of one single hazard of various kinds to human health, agricultural and natural habitats.
Likelihood could be summarized in such a way that it covers all the ecological entities which could be affected (eg. Species, populations, trophic levels, ecosystems) including measures as well as the level of uncertainty.
4.2.4. Step 4: Evaluation of the risk posed by each identified characteristic of the GMO implies
should be based on the current scientific level as far as possible, permit an estimation of the risk posed by each identified characteristic of the GMO that can cause adverse effects to human health or the environment, by combining the likelihood that the adverse effect occurring and the magnitude of the consequences, if it occurs.
Based on the conclusions of steps 2 and 3 should be an assessment of the risk of adverse effects for each of the hazards identified in step 1. Again, it may be difficult to make a quantitative assessment. The evaluation for each hazard should be considered:



- Magnitude of the consequences (significant, moderate, poor or insignificant)

- The likelihood that the adverse effect (significant, moderate, poor or negligible)

- If a hazard has more than one adverse effect, the magnitude and likelihood of each individual adverse effect.

Each GMOs should be treated on a case-by-case basis. Any attempt to quantify the above guidelines must be made very carefully. If, for example. the extent of the consequences of an adverse effect in a particular case considered significant, while the probability of it occurring is assessed as negligible, the risk could account for the whole range from high to negligible. The result will depend on the circumstances and of the weighting of certain factors, which should be described and justified in the recorded ERA.
For each identified risk, the overall uncertainty is described, possibly including documentation, for example. in:



- Assumptions and extrapolations made at various levels in the ERA


- Different scientific assessments and viewpoints

- Uncertainties

- The known limits of mitigation measures

- Conclusions that can be drawn from the data.

Although the ERA should be based on quantifiable results, many of the results of the ERA will have to be qualitative. But even if the final results of the environmental risk assessment is qualitative, they should necessarily have substantially relative (eg. Compared to a non-GM reference).
4.2.5. Step 5: Application of management strategies for risks from the deliberate release or marketing of GMO (s)
The risk assessment may identify risks that require measures, should be defined a management strategy.
Before applying risk management, apart from prevention into consideration to modifying the release - as far as possible in such a way that the risk is negligible. Eg. in the gene construction one should avoid the use of genetic elements that can cause adverse effects or are undefined. If this is not possible, these genetic elements should preferably be removed from the GMO at a later stage, prior to release or marketing.
This should be taken into account in steps 1-4. Risk management should control an identified risk and cover the uncertainties. The measures should be proportionate to the risk level and the level of uncertainty. When at a later stage appears relevant data, risk management must be adapted to the new data.
Risk management measures should clearly be directed at reducing the risk. Where, for instance. the risk of a gene toxic to insects inserted into a crop plant being transferred to related plant species, suitable control measures might include spatial or temporal isolation from those related species or perhaps changing the release site to an area, where the risk (eg. plant species) are present.
Management Strategy, for example. include isolation measures at every relevant stage of the handling and use of GMOs. It may also include a variety of measures, for example. different methods to isolate reproduction, physical or biological barriers, and cleaning machines or containers that have been in contact with GMOs, and so on.
The Detailed risk management procedures will depend on:



- Use of the GMO (release or marketing's type and extent)

- Type of GMO (eg. Genetically modified microorganisms, higher annual plant, higher plants and animals with long life, GMO with single or multiple modification, one or different kinds of GMOs)

- General type of habitat (eg. Biogeochemical status, climate, availability of crossing partners within the same and other species, centers of origin, connection of different habitats)

- Type of agricultural habitat (eg. Agriculture, forestry, aquaculture, rural areas, size of sites, number of different GMOs)

- The type of natural habitat (eg. Of preserved areas).

It should clearly indicate what risk management involves in terms of the necessary adjustments to experiments, conditions for placing etc., And the consequent reduction in risk likely to be achieved.
4.2.6. Step 6: Determination of the overall risk of the GMO (s)
There should be an assessment of the overall risk of the GMO (s) taking into account the proposed risk management strategies.
On the basis of step 4 and, if appropriate, step 5, there should be a final evaluation of the overall risk, including the magnitude and likelihood of adverse effects of the GMO, based on the combination of the risks from each individual adverse effect, including cumulative effects from other GMOs. This final evaluation should be designed as a summary of the overall risks from deliberate release or marketing and should also include the overall uncertainties.
Fifth CONCLUSIONS ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OR MARKET OF GMOs
On the basis of an environmental risk assessment carried out in accordance with the principles and methodology outlined in sections 3 and 4 should be in the reviews included, as appropriate information on the points listed in sections D.1 or D.2 in Annex II to Directive 2001/18 / EC, so that on this basis can easily draw conclusions on the potential environmental impact from the release or the marketing of GMOs.

As a result of future developments, in particular for non-plant area, may be a need for additional guidance on what information should be given in the notifications.
6th REVIEW AND ADAPTATION
6.1. Review and adaptation of an ERA
An ERA should not be regarded as final. It should be regularly reviewed and updated or perhaps changed to take account of relevant new data (in accordance with Article 8 or 20 of Directive 2001/18 / EC). Any reviews should consider the effectiveness and accuracy of environmental risk assessment and risk management, taking account of data from research, other deliberate releases and monitoring. This will also depend on the level of uncertainty determined by the ERA.
Following any such reviews, the ERA and risk management should be adapted or improved.
6.2. Review and adaptation of the ERA guidance
As a result of further developments in genetic modification may make it necessary to adapt Annex II and these guidance notes to technical progress. Further differentiation of information requirements for different types of GMOs, for example. celled organisms, fish or insects, or for particular use of GMOs like. development of vaccines, may be possible once there is sufficient experience with notifications for the release of particular GMOs in the Community (Annex III, fourth paragraph).
The review and adaptation of the ERA guidance should, where appropriate, taken into account the need for adaptation to technical progress and to develop further guidance based on experience - where sufficient - with releases of certain GMOs in certain ecosystems, in accordance with the criteria set out in Annex V (Article 7. 1), as well as on the basis of the experience gained and the scientific evidence of safety for human health and the environment in the marketing of certain GMOs (Article 16, paragraph. 2).

ANNEX III

INFORMATION REQUIRED IN THE NOTIFICATION
A notification referred to in Parts B or C shall include in the annexes the information to the extent they are relevant.
Not all the points included will apply in each case. A specific review is expected to cover only the points that are relevant to the situation.
The need for a detailed response to each item can also vary according to the proposed release nature and extent.
Further developments in genetic modification may make it necessary to adapt that Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example. celled organisms, fish or insects, or for particular use of GMOs like. development of vaccines, may be possible only after gathering sufficient experience with notifications for the release of particular GMOs in the Community.
The dossier shall also include a description of the methods used or the reference to standardized or internationally recognized methods and the name of the body or bodies responsible for the conduct of investigations.
Annex III A applies to releases of all types of genetically modified organisms other than higher plants. Annex III B applies to release of genetically modified higher plants.
In higher plants mean gymnosperms and angiosperms (GYMNOSPERMAE and ANGIOSPERMAE).

ANNEX III A

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS
I. GENERAL INFORMATION
A. Name and address (business or institution).
B. The responsible scientist Name, qualifications and experience.
C. Project title.
II. INFORMATION ABOUT THE GMO
A. Characteristics of a) the donor, b) the recipient or c) (where appropriate) parental organism (s)
first Scientific name.
Second Taxonomy.
Third Other names (usual name, strain name, etc.).
Fourth Phenotypic and genetic markers.
Fifth The degree of relatedness between donor and recipient or between parental organisms.
6th Description of identification and detection.
7th Detection and identification sensitivity, reliability (in quantitative terms) and specificity.
8 thereof. Description of the geographic distribution and natural habitat, including information on natural predators, preys, parasites and competitors, symbionts and hosts.

9th Organisms with which it is known that under natural conditions transfer of genetic material.
10th Verification of the organisms' genetic stability and factors affecting it.
11th Pathological, ecological and physiological traits:



a) classification of hazard according to existing Community rules on the protection of human health and / or environment

b) generation time in natural ecosystems, sexual and asexual reproductive cycle

c) information on survival, including seasonality and the ability to form survival structures

d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier, possible vectors, host range including non-target organisms. Possible activation of latent viruses (proviruses). Ability to colonize other organisms

e) antibiotic resistance, and potential use of these antibiotics for prophylaxis and therapy in humans and domestic

f) involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.

12th Nature of indigenous vectors:



a) sequence

b) frequency of mobilization

c) specificity

d) the presence of genes which confer resistance.

13th History of previous genetic modifications.
B. Characteristics of the vector
first Nature and source.
Second Sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO and to make the introduced vector and insert function in the GMO.
Third Frequency of mobilization of inserted vector and / or the ability to transfer genetic material and methods of determination.
Fourth Information on the extent to which the vector is limited to the DNA required to perform the intended function.
C. Characteristics of the modified organism
first Information on the genetic modification:



a) methods used for the modification

b) methods used to construct and introduce the insert into the recipient or to delete a sequence

c) description of the insert and / or vector

d) the purity of the insert from any unknown sequence and information on the extent to which the inserted sequence is limited to the DNA required to perform the intended function

e) methods and criteria used for selection

f) sequence, functional identity and location of the altered / inserted / deleted nucleic acid segment with particular reference to any known harmful sequence.

Second Information on the final GMO:



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

b) structure and amount of any vector and / or donor nucleic acid remaining in the modified organism final construction

c) stability of the organism in terms of genetic traits

d) the new genetic material expression rate and level. Metering mode and sensitivity

e) the expressed protein activity

f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector

g) detection and identification sensitivity, reliability (in quantitative terms) and specificity

h) history of previous releases or uses of the GMO

i) considerations for human and animal health and plant health:

i) toxic or allergenic effects of the GMOs and / or their metabolic products;

ii) the modified organism pathogenicity compared to the donor, recipient or (where appropriate) parental organism

iii) colonization

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

- Diseases caused and the pathogenic mechanism including invasiveness and virulence

- Infectivity

- Infective dose

- Host range, possibility of alteration

- Possibility of survival outside of human host

- Presence of vectors or means of dissemination

- Biological stability

- Antibiotic resistance patterns

- Allergenicity

- Inequality of appropriate therapies

v) other product hazards.


III. INFORMATION ON THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT
A. Information on the release
first Description of the proposed release, including the purpose (s) and foreseen products.
Second Foreseen dates of the release and time planning of the experiment including frequency and duration of releases.
Third Preparation of the site previous to the release.
Fourth Size of the site.
Fifth Method (s) to be used for the release.
6th Quantities of GMOs to be released.
7th Disturbance on the site (cultivation type and method, mining, irrigation, or other activities).
8 thereof. Worker protection measures taken during the release.
9th Treatment of site after release.
10th Techniques foreseen for elimination or inactivation of the GMOs at the end.
11th Details and results of, previous releases of the GMOs, especially at different scales and in different ecosystems.
B. Information on the environment (both on the site and in the surrounding environment)
first The on-site or geographical location and grid reference (in case of notifications under Part C the site (s) of the intended use of the product).
Second Physical or biological proximity to humans and other significant biota.
Third Proximity to significant biotopes, protected areas or drinking water supplies.
Fourth Climatic characteristics of the area or areas that are likely to be affected.
Fifth Geographical, geological and pedological characteristics.
6th Flora and fauna including crops, livestock and migratory species.
7th Description of target and non-target ecosystems likely to be affected.
8 thereof. A comparison of the recipient natural habitat with it or the proposed site.
9th Any known planned developments or changes in land use in the region which could influence the environmental impact of.
IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOS AND THE ENVIRONMENT
A. Characteristics affecting survival, multiplication and dissemination
first Biological features which affect survival, multiplication and dissemination.
Second Known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.).
Third Sensitivity to specific agents.
B. Interactions with the environment
first Predicted habitat of the GMOs.
Second Surveys of GMOs behavior and characteristics and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses.
Third Transfer capability:



a) postrelease transfer of genetic material from GMOs into organisms in affected ecosystems

b) postrelease transfer of genetic material from indigenous organisms to the GMOs.

Fourth The probability that after the release selection leading to the expression of unexpected or undesirable traits in the modified organism.
Fifth Measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimize the spread of genetic material. Methods to verify genetic stability.
6th Routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.
7th Description of ecosystems to which the GMOs could be disseminated.
8 thereof. Potential for excessive population increase in the environment.
9th GMOs competitive advantage in relation to the unmodified recipient or parental organisms.
10th Identification and description of the target, if applicable.
11th Anticipated mechanism and result of interaction between the released GMOs and the target organism, if appropriate.
12th Identification and description of non-target organisms which may be adversely affected by the release of the GMO, and the anticipated mechanisms of any identified adverse interaction.
13th Probability of changes in biological interactions or in host range after the release.
14th Known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens.
15th Known or predicted involvement in biogeochemical processes.
16th Other potential interactions with the environment.
V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS
A. Monitoring techniques
first Methods for tracing the GMOs, and for monitoring their effects.

Second Specificity (to identify the GMOs, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability.
Third Techniques for detecting transfer of the donated genetic material to other organisms.
Fourth Duration and frequency of the monitoring.
B. Control of the release
first Methods and procedures to avoid and / or minimize the spread of the GMOs beyond the site of release or the designated area for use.
Second Methods and procedures to protect the site from intrusion by unauthorized individuals.
Third Methods and procedures to prevent other organisms from entering the site.
C. Waste Treatment
first Waste generated art.
Second Expected amount of waste.
Third Description of treatment envisaged.
D. Contingency plans
first Methods and procedures for controlling the GMOs in case of unexpected spread.
Second Methods for decontamination of the affected areas, for example. eradication of the GMOs.
Third Methods for disposal or sanitation of plants, animals, soils, etc., That were exposed during or after the spread.
Fourth Methods for the isolation of the area affected by the spread.
5 plans for protecting human health and the environment in the event of adverse effects.

ANNEX III B

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHP) (GYMNOSPERMAE AND ANGIOSPERMAE)
A. GENERAL INFORMATION
first Name and address (business or institution).
Second The responsible scientist Name, qualifications and experience.
Third Project title.
B. INFORMATION A) THE RECIPIENT OR B) (WHERE APPROPRIATE) PARENTAL PLANTS (R)
first Full Name:



a) family

b) the genus

c) species

d) subspecies

e) cultivar / breeding

f) common name.

Second



a) Information concerning reproduction:

i) the reproduction mode (s)

ii) specific factors affecting reproduction

iii) generation

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

Third Survivability:



a) ability to form structures for survival or dormancy

b) specific factors affecting survivability.

Fourth Spreading:



a) ways and extent (eg. an estimate of how the amount of viable pollen and / or seeds declines with distance)

b) specific factors affecting dissemination.

Fifth The plant's geographical spread.
6th For plant species not normally grown in the Member State (s) described the plant's natural habitat, including information on natural predators, parasites, competitors and symbionts.
7th Other potential interactions, relevant to the GMO, of the plant with other organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.
C. INFORMATION RELATING TO THE GENETIC MODIFICATION
first Description of the methods used for the genetic modification.
Second The vector used nature and origin.
Third Size, source (name) of donor organism / -organismerne and intended function of each component of the region to be inserted.
D. INFORMATION ON THE GENETICALLY MODIFIED PLANT
first Description of the traits and characteristics which have been introduced or modified.
Second Information actually inserted / deleted sequences:



a) insert size and structure and the methods used for its characterization, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP | ||
b) in case of deletion, or deleted region size and function

c) copy number of the insert

d) location of the insert in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination.

Third Information about the expression of the insert:



a) information on the insert developmental expression throughout the plant's life cycle and the methods used to characterize the

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

Fourth Information on how the genetically modified plant differs from the recipient plant in:




a) reproduction manner and / or rate

b) spread

c) survivability.

Fifth The insert genetic stability and GMHP phenotypic stability.
6th Changes in the ability of the GMHP to transfer genetic material to other organisms.
7th Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.
8 thereof. Information about the safety of the GMHP to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the GMHP is intended to be used in feed.
9th Of interaction between the genetically modified plant and target organisms.
10th Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification.
11th Potential interactions with the abiotic environment.
12th Description of techniques for the detection and identification of the genetically modified plant.
13th Information about previous releases of the genetically modified plant.
E. INFORMATION ON THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS PURSUANT TO ARTICLES 6 AND 7)
first Release site location and size.
Second Description of the release site ecosystem, including climate, flora and fauna.
Third Presence of sexually compatible wild relatives or cultivated plant species.
Fourth Proximity to officially recognized biotopes or protected areas which may be affected.
F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS PURSUANT TO ARTICLES 6 AND 7)
first Purpose of the release.
Second Foreseen date and duration.
Third Launching Method by which the genetically modified plants.
Fourth Method for preparing and managing the release site, prior to, during and postrelease, including cultivation practices and harvesting methods.
Fifth Approximate number of plants (or plants per. M2).
G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS PURSUANT TO ARTICLES 6 AND 7)
first Any precautions taken:



a) distance from sexually compatible plant species, both wild relatives and crops

b) any measures to minimize / prevent dispersal of GMHP reproductive organs (eg. pollen, seeds, tuber).

Second Description of methods for finishing spot after the release.
Third Description of postrelease treatment methods for the genetically modified plant material including wastes.
Fourth Description of monitoring plans and techniques.
Fifth Description of contingency plans.
6th Methods and procedures to protect the site.

ANNEX IV

FURTHER INFORMATION
This appendix contains a general description of the additional information to be provided in notifications of marketing and information for labeling requirements regarding GMOs as or in products to be marketed and GMO 'is exempted under Article 2, no. 4), second subparagraph. Technical guidance notes concerning, inter alia description of expected use, prepared in accordance with the regulatory procedure in Article 30. 2, to facilitate the implementation and explanation of this Annex. The labeling requirements for exempted organisms set out in Article 26 are met by providing appropriate recommendations for, and restrictions on, use
A. In addition to those listed in Annex III information should be a review of the market of GMOs as or in products, contain the following information:
first Proposed commercial names of the products and names of GMOs contained therein, and any specific identification, name or code used by the notifier to identify the GMO. After permission has been granted, any new commercial names the competent authority.
Second Name and full address of the person established in the Community who is responsible for marketing, whether it be the manufacturer, importer or distributor.
Third Name and full address of the supplier / s of control samples.
Fourth Description of how the product and the GMO as or in a product to be used. It must be emphasized, use or management of the GMO compared to similar non-genetically modified products.
Fifth Description of the geographical areas and types of environment where the product is expected to be used in the Community, including where possible, estimated scale of use in each area.
6th Intended categories of users of the product eg. industry, agriculture and skilled trades, general consumption.

7th Information on the genetic modification in order in one or several registers modifications in organisms, which can be used for detection and identification of particular GMO products to facilitate post-marketing control and inspection. This information should include, where appropriate the lodging of samples of the GMO or its genetic material with the competent authority and detailed nucleotide sequences or other information necessary to identify the GMO product and its progeny, for example. method for detecting and identifying the GMO product, including experimental data demonstrating the specificity of the methodology. Information for confidentiality reasons not stated in the publicly accessible part of the register should be identified.
8 thereof. Proposed labeling on a label or in an accompanying document. This must be - at least in summary form - include commercial name, this product contains genetically modified organisms, the name of the GMO and the information in paragraph 2. The labeling should indicate how to access the information in the publicly accessible part register.
B. In addition to those mentioned in section A. information, the following information is provided in the notification, when relevant, see. Article 13:
first Measures to be taken in case of accidental release or misuse.
Second Specific instructions or recommendations for storage and handling.
Third Specific instructions for monitoring and reporting to the notifier and, if required, to the competent authority so that the competent authorities can be effectively informed of any adverse effects. These instructions should be in accordance with Annex VII, section C.
fourth Proposed restrictions in the approved use of the GMO, for instance. the product may be used and for what purposes it should be used.
Fifth Proposed packaging.
6th Estimated production and / or imports to the Community.
7th A proposed additional labeling. This will, at least in summary form, could include the information referred to in Section A, Nos. 4 and 5, and point B, no. 1, 2, 3 and 4.

ANNEX V

CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7)
The criteria set out in Article 7 paragraph. 1, follows below.
First The non-modified (recipient) taxonomic status and the biology (eg. The reproduction and pollination, ability to cross with related species, pathogenicity) should be familiar.
Second There shall be sufficient knowledge about the parental, where appropriate, and recipient organisms in the release environment to human health and the environment.
Third There must be information on the interaction of particular relevance for the risk assessment, involving the parental, where appropriate, and recipient organism and other organisms in the experimental release ecosystem.
Fourth There must be information indicating that any inserted genetic material is well characterized. There must be information on the construction of any vector systems or sequences of genetic material used with the carrier DNA. Where a genetic modification involves the deletion of genetic material, there must be information on the extent of the deletion. Furthermore, there must be so much information on the genetic modification, the GMO and its progeny can be identified during a release.
Fifth The GMO shall not in the experimental release involve additional or increased risks to human health or the environment by releases of the corresponding parental (where applicable) and recipient. The ability to spread in the environment and invade other unrelated ecosystems and capacity to transfer genetic material to other organisms in the environment shall not result in adverse effects.

ANNEX VI

GUIDELINES FOR THE ASSESSMENT REPORTS
to in Articles 13, 17, 19 and 20 to assess reports shall include the following:
first Identification of the characteristics of the recipient organism which are relevant to the assessment of the GMO. Identification of any known risks to human health and the environment resulting from the release into the environment of the non-modified recipient.
Second Description of the result of the genetic modification in the modified organism.
Third Assessment of whether the genetic modification has been characterized sufficiently to allow for an assessment of possible risks to human health and the environment.

Fourth Identification of any new risks to human health and the environment, as the release of the GMO may result compared to the release of the corresponding non-modified organisms, based on the environmental risk assessment carried out in accordance with Annex II.
Fifth A conclusion on whether the GMO should be marketed as a product or as a component of a product, and under which conditions, whether the GMOs should not be placed on the market or are sought opinions from other competent authorities and the Commission on certain specific issues of the era. These aspects should be specified. The use proposed, risk management and monitoring plan must clearly state the conclusion. If it has been concluded that the GMOs should not be marketed, the competent authority must justify its conclusion.

ANNEX VII


MONITORING PLAN This Annex describes in general terms the objective to be achieved and the general principles to be followed to design it in Article 13. 2, Article 19. 3 and 20. monitoring plan. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30 paragraph. 2, to facilitate the implementation and explanation of this Annex.
A. Goals
The purpose of the monitoring plan is



- To confirm that the assumptions of the environmental risk assessment regarding the occurrence and impact of potential adverse effects of the GMO or its use is accurate and

- Identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the ERA.

B. General principles
Monitoring, as referred to in Articles 13, 19 and 20, takes place after granted marketing authorization for a GMO.
The data collected by monitoring should be interpreted in light of other existing environmental conditions and activities. If you notice any changes in the environment, should be considered to make a further assessment to determine whether they are a consequence of the GMO or its use, as such changes may be the result of environmental factors other than the market of the GMO.
Experience and data from monitoring of experimental releases of GMOs may assist in designing the monitoring system to be used for marketing, which is required for the marketing of GMOs as or in products.
C. Design of the monitoring plan
The monitoring plan should:
first On a case by case basis taking into account the environmental risk assessment.
Second Take into account the characteristics of the GMO, the characteristics and scale of its intended use and scope of the relevant environmental conditions where the GMO is expected to be postponed.
Third Incorporate general surveillance for unanticipated adverse effects and, if necessary, specific monitoring (in each case), which focus on adverse effects identified in the era:
3.1. specific monitoring should be carried out in a period that is long enough to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the era
3.2. whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as monitoring of agricultural cultivars, plant protection, or veterinary and medical products. There should thereby be an explanation as to how relevant information collected through established routine surveillance practices will be made available for the holder.
Fourth Systematically facilitate the release of a GMO in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment.
Fifth Identify who (notifier, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set and carried out appropriately, and ensure that there is a route by which the holder of the permit and the competent authority will be informed on any observed adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring shall be indicated.)
6th Take into account mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or, where appropriate, the competent authority to take the measures necessary to protect human health and the environment.


ANNEX VIII

ASSEMBLY TABLE







Directive 90/220 / EEC


This Directive



Article 1, paragraph. 1


Article 1



Article 1, paragraph. 2


Article 3. 2



Article 2


Article 2



Article 3


Article 3. 1



Article 4


Article 4



-


Article 5



Article 5


Article 6



Article 6, paragraph. 1-4


-



Article 6, paragraph. 5


Article 7



Article 6, paragraph. 6


Article 8



Article 7


Article 9



Article 8


Article 10



Article 9


Article 11



Article 10, paragraph. 2


Article 12



Article 11


Article 13



Article 12, paragraph. 1-3 and 5


Article 14



Article 13, paragraph. 2


Article 15, paragraph. 3



-


Article 15, paragraph. 1-2 and 4



-


Article 16



-


Article 17



Article 13, paragraph. 3 and 4


Article 18



Article 13, paragraph. 5 and 6


Article 19. 1 and 4



Article 12, paragraph. 4


Article 20, paragraph. 3



Article 14


Article 21



Article 15


Article 22




Article 16


Article 23



-


Article 24, paragraph. 1



Article 17


Article 24, paragraph. 2



Article 19


Article 25



-


Article 26



Article 20


Article 27



-


Article 28



-


Article 29



Article 21


Article 30



Article 22


Article 31, paragraph. 1, 4 and 5



Article 18, paragraph. 2


Article 31, paragraph. 6



Article 18, paragraph. 3


Article 31, paragraph. 7



-


Article 32



-


Article 33



Article 23


Article 34



-


Article 35



-


Article 36



-


Article 37



Article 24


Article 38



Annex IA


Annex IA



Annex IB


Annex IB



-


Annex II



Annex II


Annex III



Annex II A


Annex III A



Annex II B


Annex III B



Annex III


Annex IV



-


Annex V




-


Annex VI



-


Annex VII





Official notes

1) The Order contains provisions that implement European Parliament and Council Directive 2001/18 / EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220 / EEC, Official Journal 2001, No . L 106, page 1.

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