S.I. No. 500/2003 - Genetically Modified Organisms (Deliberate Release) Regulations 2003

1. be detailed on a case by case basis taking into account the environmental risk assessment.

2. take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released.

3. incorporate general surveillance for unanticipated adverse effects and, if necessary, (case- specific monitoring focusing on adverse effects identified in the environmental risk assessment

3.1 whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the environmental risk assessment.

3.2 whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation should be provided as to how relevant information collected through established routine surveillance practices will be made available to the notifier.

4. facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or in the environment.

5. 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 into place and carried out appropriately, and ensure that there is a route by which the notifier and the Agency 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).

6. give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and the environment and enable the notifier or the Agency, where appropriate, to take the measures necessary to protect human health and the environment.

GIVEN under the Official Seal of the Minister for the Environment, Heritage and Local Government

this 22

nd

day of October 2003.

Martin Cullen

Minister for the Environment, Heritage and Local Government.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation)

These Regulations give effect to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. They replace the Genetically Modified Organisms Regulations 1994 (other than Part II, and certain other provisions, of those Regulations in relation to the contained use of genetically modified organisms which were already replaced by the Genetically Modified Organisms (Contained Use) Regulations 2001).

The Environmental Protection Agency (EPA) is the competent authority for the purposes of the new Regulations and it may consult the Genetically Modified Organisms Advisory Committee on any aspect of its functions. This Committee (established under Part VI of the Regulations) replaces the Advisory Committee on Genetically Modified Organisms established under the 1994 Regulations.

The fundamental objective of the Regulations is to protect people and the environment from any adverse effects arising from the deliberate release into the environment or marketing of genetically modified organisms (GMOs). In this regard, they provide for the application of various safety, public notice and procedural matters to deliberate releases and marketing.

Subject to limited exclusions, all deliberate releases of GMOs to the environment (whether for marketing or not) must comply with the Regulations. Proposed releases must be subjected to an environmental risk assessment (e.r.a.) which must be submitted to the EPA. Information on all proposals submitted to the EPA must be included in a publicly available register maintained by the Agency and information on all proposals made to the Agency, including the Agency's assessment of the proposal, must be circulated to the competent authorities of the other Member States of the European Communities to enable such bodies to comment on, or object to, the Agency's analysis of the proposal. Public comment on proposals is also provided for by the Regulations.

Part II regulates the deliberate release of GMOs to the environment for purposes other than marketing (for example, field trials). Among the requirements of the Regulations are- notification (accompanied by a comprehensive e.r.a.) to the EPA of proposals; public advertisement by the notifier; consideration of comments by the public and from other Member States in relation to the proposal by the EPA; and entry in a public register of proposals and decisions thereon.

Part III regulates the first time placing on the market of products containing or consisting of GMOs. The Regulations include requirements in relation to - notification; the carrying out of an e.r.a. by the notifier; public advertisement of the proposal including information on how to make objections known to the European Commission; inclusion of the other Member States of the European Communities in the decision-making process; a limitation on any period of consent; monitoring procedures; and labelling of approved products to facilitate consumer choice. Procedures for the renewal of consent are also provided as is power for the EPA, where it is concerned as to possible risks to human health or the environment, to restrict or prohibit use or placing on the market.

Part IV enables the EPA to impose fees and charges in respect of its duties under the Regulations including in respect of applications and monitoring. Part V provides for enforcement by the EPA including powers to prosecute offences, to obtain a High Court order to prohibit or restrict any activity involving a GMO, or to serve notice on a notifier to take specific measures for the protection of people or the environment.

The Regulations come into effect on 1 November 2003.

1

OJ No. L106, 17.04.2001, p.1.

2

OJ No. L117, 08.05.1990, p.15, as last amended by Commission Directive 97 35 EC. OJ No. L169, 27.06.1997, p.72.

1

OJ No. L280. 18.10.2002. p.62.

1

OJ No. L 254, 08.10.2003. p. 21

1

OJ No. L280, 18.10.2002. p.37.

1

OJ No. L200. 30.07. 2002. p.

1

OJ No. L280 18.10.2002, p.27.

7. proposed additional labelling to include, at least in summarised form, the information referred to in points 4 and 5 of Part I of this schedule and points 1, 2, 3 and 4 of this Part.

FIFTH SCHEDULE

GUIDELINES FOR THE ASSESSMENT REPORTS

Articles 32

,

38

and

44

An assessment report prepared in accordance with articles 32, 38 and 44 should include, in particular the following

8. proposed labelling on a label or in an accompanying document. This shall include, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the information referred to at 2 above. The labelling should indicate how to access the information in the publicly accessible part of the register or registers referred to at 7 above.

PART II

The following information shall be provided in the notification, in accordance with article 30, when relevant, in addition to that required by Part I of this schedule

9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).

10. Potential changes in the interactions of the genetically modified higher plant with non-target organisms resulting from the genetic modification.

11. Potential interactions with the abiotic environment.

12. Descriptions of detection and identification techniques for the genetically modified plant.

13. Information about previous releases of the genetically modified plant, if applicable.

E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED IN ACCORDANCE WITH ARTICLE 14)

14. known or predicted interactions with non-target organisms in the environment including competitors, preys, hosts, symbionts, predators, parasites and pathogens,

15. known or predicted involvement in biogeochemical processes,

16. other potential interactions with the environment.

V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

A.

Monitoring techniques

17. (1) If, after the receipt by the Agency of a notification under article 14 but before the making of a decision by it on a proposed deliberate release under this Part, —

(a) there is a modification of the proposed deliberate release, or

(b) new information relevant to the proposed deliberate release becomes available.

which could have consequences for the risks to human health or the environment the notifier shall inform the Agency immediately in writing and submit an amended notification to the Agency, and the first notification under article 14 shall not be further considered by the Agency.

(2) An amended notification under sub-article (1) shall be accompanied by the fee payable in accordance with article 49.

(3) Where the Agency receives an amended notification in accordance with sub-article (1), it shall deal with the amended notification as if it were a new notification under article 14 in relation to the proposed deliberate release.

(4) The provisions of this Part shall apply to an amended notification under sub-article (1) as if it were a new notification under article 14, and the proposed deliberate release shall not be carried out unless and until a consent is granted under this Part.

Duty of the Agency on foot of notification

18. (1) On receipt of a notification under article 14, the Agency shall—

(a) acknowledge to the notifier the date of such receipt in writing.

(b) forward to the Commission of the European Communities, within 30 days of the receipt of the notification, a copy of the summary of the notification received in accordance with article 14(2)(b).

(c) examine it for compliance with these Regulations.

(d) having regard to the Second Schedule, decide whether the environmental risk assessment carried out by the notifier pursuant to article 5(2) is appropriate.

(e) consider any observations received from a competent authority of another Member State of the European Communities for the purposes of the Directive where such observations are received by the Agency within a period of 30 days beginning with the day on which the summary of the notification was forwarded by the Commission of the European Communities to the competent authorities of the Member States of the European Communities for the purposes of the Directive.

(f) if requested by a competent authority of a Member State of the European Communities for the purposes of the Directive, forward a copy of the notification to the said authority,

(g) evaluate the risks posed by the proposed deliberate release for human health or the environment, and

(h) record its conclusions in writing.

(2) (a) The evaluation in accordance with sub-article (1)(g) shall include an assessment conducted in accordance with the Second Schedule of the potential adverse effects that the proposed deliberate release may pose, whether direct or indirect for human health or the environment, or both, arising from the transfer of 1 or more genes from a genetically modified organism to another organism.

(b) The evaluation in accordance with sub-article (1)(g) shall take into account the nature of the organism to be released and the receiving environment.

(3) In carrying out the evaluation in accordance with sub-article (1)(g), the Agency shall give particular attention to the risks to human health or the environment posed by the proposed deliberate release of a genetically modified organism which contains 1 or more genes expressing resistance to antibiotics which are used in human or veterinary medicine and shall aim to phase out the use of such genes where such use may have an adverse effect on human health or the environment.

(4) The Agency shall not grant consent under this Part after 31 December 2008 where the genetically modified organism contains 1 or more genes expressing resistance to antibiotics which are used in human or veterinary medicine and the Agency considers that the deliberate release of the said organism may have an adverse effect on human health or the environment.

(5) The Agency shall respond in writing to the notifier within 90 days of receipt of the notification by indicating that consent to the deliberate release is either—

(a) granted, with or without, conditions, or

(b) refused and the reasons for the refusal,

Power of the Agency to request further information.

19. (1) (a) The Agency may, in the case of a notification under article 14, request the notifier to provide further information on the proposed deliberate release.

(b) Where, in accordance with paragraph (a), the Agency requests further information, it shall give its reasons in writing for so doing.

(2) Notwithstanding any other provision of this Part, where the Agency makes a request under sub-article (1)(a), the deliberate release shall not be carried out unless following a response to the request from the notifier, the Agency has granted consent in accordance with article 18(5)(a) and any conditions attached to the consent have been complied with.

Modification of deliberate release following grant of consent by the Agency

20. (1) A notifier who, after the Agency has granted consent in writing for a deliberate release under this Part, proposes to modify the said deliberate release in a way which could have consequences for the risks to human health or the environment shall amend the notification on foot of which consent was granted and submit the amended notification to the Agency.

(2) An amended notification under sub-article (1) shall be accompanied by the fee payable in accordance with article 49.

(3) Where the Agency receives an amended notification in accordance with sub-article (1), it shall deal with the amended notification as if it were a new notification under article 14 in relation to the proposed modified deliberate release.

(4) The provisions of this Part shall apply to an amended notification under sub-article (1) as if it were a new notification under article 14, and the proposed modified deliberate release shall not be carried out unless and until a consent is granted under this Part.

Duty to inform the Agency of new information, etc.

21. If, after the Agency has granted consent in writing to a deliberate release under this Part,—

(a) there is any unintended change to the deliberate release, or

(b) new information relevant to the deliberate release becomes available,

which could have consequences for the risks to human health or the environment, the notifier shall—

(i) immediately take the measures necessary to protect human health and the environment;

(ii) inform the Agency as soon as the unintended change is known or the new information becomes available; and

(iii) inform the Agency as soon as possible of such further measures he or she has taken or proposes to take in relation to the matters concerned.

Power of the Agency to modify, suspend or terminate consent

22. (1) If, after granting consent in writing to a deliberate release under this Part, the Agency—

(a) becomes aware of information which, in its view, could have significant consequences for the risks to human health or the environment, or

(b) is notified of a proposed modification in accordance with article 20, or

(c) is informed of an unintended change or new information in accordance with article 21.

it may, following an evaluation of the matters concerned, require the notifier, in writing, to modify the conditions of, suspend or terminate the deliberate release.

(2) A deliberate release suspended in accordance with sub-article (1) shall not be resumed unless the written consent of the Agency for the resumption has been received by the notifier and any modifications to the original consent which the Agency may require have been complied with in respect of the deliberate release.

Notification of decisions

23. (1) The Agency shall, within 14 days of indicating its decision to the notifier in accordance with article 18(5), inform in writing—

(a) any person or body to whom a copy of a notice in respect of the notification was sent in accordance with article 15(3),

(b) the Commission of the European Communities, and

(c) any person or body who made representations in respect of the notification to the Agency in accordance with article 16(1).

of its decision in relation to a notification.

(2) The Agency shall, within 14 days of requiring the notifier to modify the conditions of, suspend or terminate the deliberate release in accordance with article 22(1) or of granting consent for the resumption of the deliberate release in accordance with article 22(2), inform in writing—

(a) any person or body to whom a copy of a notice in respect of the notification was sent in accordance with article 15(3),

(b) the Commission of the European Communities, and

(c) any person or body who made representations in respect of the notification to the Agency in accordance with article 16(1).

Post-release procedures

24. (1) Without prejudice to the generality of article 18(5)(a), the notifier shall—

(a) on completion of the deliberate release, and

(b) at any subsequent intervals specified in the consent,

submit a report to the Agency on the results of the deliberate release.

(2) The report referred to in sub-article (1) shall be provided in such format or formats as may be determined in accordance with the procedure laid down in Article 30(2) of the Directive and for the time being extant

1

, or, in the absence of such a determination appropriate to the relevant consent, in such format as may be specified in the consent, and shall include—

(a) a post-release evaluation of the risks to human health or the environment, and

(b) where appropriate, a statement on the results of the deliberate release in relation to any product, or type of product, in respect of which consent to placing on the market may be sought.

(3) A copy of any report received by the Agency pursuant to sub-article (1) shall, as soon as may be after its receipt, be sent by the Agency to the Commission of the European Communities.

PART III

PLACING ON THE MARKET OF PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS

CHAPTER 1

GENERAL PROVISIONS RELATING TO THIS PART

Exclusions from this Part

25. This Part shall not apply to any genetically modified organism to which Article 12(1) or 12(2) of the Directive applies.

Duty to comply with this Part

26. Without prejudice to article 7 and subject to the exclusions in article 25, a person shall not place on the market any product containing or consisting of a genetically modified organism unless-

(a) consent in writing has been received from the Agency under this Part, or

(b) consent in writing has been received from the competent authority of another Member State of the European Communities in accordance with Part C of the Directive,

and the conditions attached to the consent have been complied with.

Mandatory requirements in consents under this Part

27. (1) Notwithstanding any other provision of this Part, a consent or renewed consent granted by the Agency under this Part shall specify at least-

(a) the scope of the consent, including the identity of any genetically modified organism to which the consent refers and the unique identifier of the genetically modified organism concerned,

(b) the period of validity of the consent,

(c) conditions under which the product may be placed on the market, including any specific condition of use, handling and packaging and conditions for the protection of ecosystems, environments or geographical areas,

(d) a requirement, without prejudice to article 10, on the notifier to make control samples available to the Agency on request,

(e) labelling requirements, in accordance with the Fourth Schedule, clearly stating the presence of a genetically modified organism and including, either on a label or in a document accompanying the product, the words, “This product contains genetically modified organisms” and the name and address of the person established in the European Community who is responsible for the placing on the market,

(f) monitoring requirements in accordance with the Sixth Schedule, including the time period of the monitoring plan, an obligation to report on the monitoring to the Commission of the European Communities and to the competent authorities of the Member States of the European Communities for the purposes of the Directive and, where appropriate, obligations on a person selling the product or any user of it, which may include an obligation to provide information at an appropriate level on the location at which the genetically modified organism concerned is grown.

(2) The Agency shall not grant consent under this Part after 31 December 2004 where the genetically modified organism contains 1 or more genes expressing resistance to antibiotics which are used in human or veterinary medicine and the Agency considers that the placing on the market of the said organism may have an adverse effect on human health or the environment.

Power of the Agency to restrict or prohibit use or placing on market

28. (1) Where, as a result of either-

(a) new or additional information made available since the date of a consent granted under this Part or under Part C of the Directive and affecting the environmental risk assessment in respect of the product concerned, or

(b) a reassessment of existing information in respect of that product on the basis of new or additional scientific information,

the Agency has detailed grounds for considering that the product constitutes a risk to human health or the environment, it may, notwithstanding article 26, 33 or 39 by notice in writing to the notifier or other person concerned provisionally restrict or prohibit the use, or placing on the market, in the State of the product.

(2) Where, in the circumstances described in sub-article (1), the Agency considers that a product constitutes a severe risk to human health or the environment, it shall notwithstanding article 26, 33 or 39, by notice in writing to the notifier or other person concerned require such measures to be taken as it considers appropriate (including suspension or termination of the placing on the market).

(3) Where the Agency avails of the provisions of sub-article (1) or (2), it shall immediately inform-

(a) the Commission of the European Communities,

(b) the competent authorities of the other Member States of the European Communities for the purposes of the Directive, and

(c) the public, by means of, at least, publication of a notice in a newspaper circulating in the State,

of its decision and the reasons therefor.

(4) In informing the Commission of the European Communities and the competent authorities of the other Member States of the European Communities in accordance with sub-article (3), the Agency shall provide-

(a) a review of the environmental risk assessment,

(b) information as to whether or not it considers that the conditions of the consent should be amended and, if so, how, or whether the consent should be revoked and

(c) any additional information on which it has based its action under sub-article (1 or (2).

(5) The notifier shall comply with any notice in writing given by the Agency under sub-article (1) or (2), within any period specified in the notice.

(6) A decision taken under Article 23(2) of the Directive shall be accepted by the Agency in respect of any notice in writing given by it under sub-article (1) or (2 and the Agency shall send a copy of the said decision to the person who had been granted consent under article 33 or 39.

CHAPTER 2

PLACING ON THE MARKET FOR THE FIRST TIME

Duty to give notification and to advertise

29. (1) A person proposing to place a product containing or consisting of a genetically modified organism on the market for the first time shall, in the absence of an appropriate consent granted by the competent authority of another Member State of the European Communities under Part C of the Directive, give a notification to the Agency.

(2) A notification under this article shall be accompanied by the fee specified in article 47.

(3) The notifier shall, not more than 14 days after the date of receipt by the Agency of the notification, cause to be published in a newspaper circulating in the State a notice of its proposal to place on the market a product containing or consisting of a genetically modified organism and shall send a copy of the notice to the Agency within the said 14 days.

(4) A notice under sub-article (3) shall have the heading, “PROPOSED PLACING ON THE MARKET OF A PRODUCT CONTAINING/CONSISTING OF A GENETICALLY MODIFIED ORGANISM” and shall contain the following information—

(a) the name and address of the notifier,

(b) the description of the genetically modified organism concerned,

(c) the fact that a notification has been submitted to the Agency,

(d) the fact that further information on the proposed placing on the market may be obtained from the Agency,

(e) the full title of the Agency and the full postal address of its headquarters,

(f) the full postal address of the Commission of the European Communities and said title in respect of the Commission,

(g) the fact that any person or body may make representations in writing to the said Commission regarding the notification within the period of 30 days beginning on the day that the Commission makes the summary of the notification received by it in accordance with article 32(1)(b) available to the public.

(5) In this article, an “appropriate consent” means a consent granted by the competent authority of another Member State of the European Communities under Part C of the Directive and the conditions specified in that consent relating to use, handling and packaging, and ecosystems, environments or geographical areas, enable it to be placed on the market in accordance with Article 19 of the Directive.

Information to be contained in a notification

30. (1) A notification under article 29 shall include either the following—

(a) the information specified in the Third Schedule, insofar as that Schedule is appropriate to the particular placing on the market,

(b) subject to sub-article (3), the information specified in the Fourth Schedule,

(c) information on data and results obtained from any previous release of the organism or of organisms of the same description, which has been carried out by the notifier, whether inside or outside the European Community, and such information from any previous notification in connection with a release of the organism or of organisms of the same description, which the notifier has made to the Agency in accordance with these Regulations, or to the competent authority of another Member State of the European Communities for the purposes of the Directive, which satisfies the provisions of Part C of the Directive,

(d) an environmental risk assessment pursuant to article 5(2) and in accordance with the Second Schedule,

(e) the conclusions arrived at by the notifier in accordance with Part D of the Second Schedule, together with any bibliographic references and details of the methods used.

(f) conditions for the placing on the market of the product, including specific conditions of use and handling,

(g) a proposed period of validity of the consent not exceeding 10 years,

(h) a plan for monitoring in accordance with the Sixth Schedule, including a proposal for a time-period for the monitoring plan (which may vary from the proposed period of validity of the consent),

(i) a proposal for labelling in accordance article 27(1)(e),

(j) a proposal for packaging in accordance with the Fourth Schedule, and

(k) a summary of the notification in the format established in accordance with the procedure laid down in Article 30(2) of the Directive and for the time being extant

1

,

or, in a case to which Article 16 of the Directive applies, information specified for the purposes of that Article in accordance with the procedures set out in Article 30(2) of the Directive.

(2) The notifier shall give the Agency a separate notification under article 29 in respect of a genetically modified organism for which a consent has been sought or granted under this Part or under Part C of the Directive, where the product concerned is intended for a use that is different to the use for which consent has been sought or granted.

(3) Where the notifier considers, on the basis of the results of any release on foot of a consent granted under Part II, or a consent granted by the competent authority of another Member State of the European Communities on foot of Part B of the Directive, or on substantive, reasoned scientific grounds, that the placing on the market and use of the product would not pose a risk to human health or the environment, the notifier may propose to the Agency not to supply part or all of the information specified in Part II of the Fourth Schedule.

(4) The notifier may, in making a notification under sub-article (I).-

(a) refer to data or results from a notification previously given by another notifier provided that the data or results are not confidential information in accordance with article 10 or that the said other notifier has agreed in writing to such reference and a copy of this agreement is included in the notification,

(b) provide relevant information, additional to that required under sub-article (I).

(5) The information provided by the notifier pursuant to sub-articles (I)(a) and (b) shall take into account the diversity of sites of use of the genetically modified organism concerned and shall include information obtained from research and development releases concerning the impact of the release on human health and the environment.

Modification of notification prior to the Agency's decision

31. (1) If, after the receipt by the Agency of a notification under article 29 but before the making of a decision by it on a proposed placing on the market. -

(a) there is a modification of the proposed placing on the market, or

(b) new information relevant to the proposed placing on the market becomes available,

which could have consequences for the risks to human health or the environment the notifier shall inform the Agency immediately in writing and submit an amended notification to the Agency, and the first notification under article 29 shall not be further considered by the Agency.

(2) An amended notification under sub-article (I) shall be accompanied by the fee payable in accordance with article 50,

(3) Where the Agency receives an amended notification in accordance with sub-article (1), it shall deal with the amended notification as if it were a new notification under article 29 in relation to the proposed placing on the market.

(4) The provisions of this Part shall apply to an amended notification under sub-article (1) as if it were a new notification under article 29, and the proposed placing on the market shall not be carried out unless and until a consent is granted under this Part.

Duty of the Agency on foot of notification

32. (1) On receipt of a notification under article 29, the Agency shall—

(a) acknowledge to the notifier the date of such receipt in writing.

(b) immediately forward a copy of the summary of the notification received in accordance with article 30(l)(k) to the competent authorities of the other Member States of the European Communities for the purposes of the Directive and to the Commission of the European Communities.

(c) without delay examine it for compliance with articles 30(1), (2) and (5) and the other relevant provisions of these Regulations.

(d) having regard to the Second Schedule, decide whether the environmental risk assessment carried out by the notifier pursuant to article 5(2) is appropriate.

(e) ask the notifier in writing for any further information which the Agency considers necessary, stating its reasons for so doing, and

(f) once it is satisfied that the requirements of articles 30(1), (2) and (5) have been complied with, and, in any event, no later than the time at which it sends to the Commission of the European Communities a copy of the assessment report in accordance with sub-article (3) or (4), send a copy of the notification to the said Commission.

(2) Within 90 days of the receipt of a notification under article 29, the Agency shall—

(a) prepare, in accordance with the Fifth Schedule, an assessment report which shall indicate whether

(i) the genetically modified organism concerned should be placed on the market and under which conditions (in this Chapter referred to as a “favourable assessment”); or

(ii) the genetically modified organism concerned should not be placed on the market (in this Chapter referred to as an “unfavourable assessment”), and

(b) send a copy of the assessment report to the notifier.

(3) In the case of a favourable assessment, the Agency shall, at the same time as it sends a copy of the assessment report to the notifier, send to the Commission of the European Communities a copy of the said report, any further information obtained from the notifier in accordance with sub-article (l)(e), and any other information on which the Agency has based its report.

(4) In the case of an unfavourable assessment, the Agency shall, no sooner than 15 days after it sends a copy of the assessment report to the notifier and no later than 105 days after it received the notification, send to the Commission of the European Communities a copy of the said report, any further information obtained from the notifier in accordance with sub-article (l)(e), and any other information on which the Agency has based its report.

(5) In the case of a favourable assessment, the Agency shall—

(a) provide any further information to the Commission of the European Communities, where such information is requested by the said Commission or by a competent authority of a Member State of the European Communities for the purposes of the Directive.

(b) consider any comments concerning, or reasoned objections to the placing of the product on the market made by the Commission of the European Communities or by a competent authority of another Member State of the European Communities for the purposes of the Directive where such comments or objections are made within a period of 60 days beginning on the day on which the documents referred to in sub-article (3) were forwarded to each such competent authority by the Commission, and

(c) participate in any discussions in relation to the assessment report initiated by the Commission of the European Communities on foot of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of 105 days, beginning on the day on which the documents referred to in sub-article (3) were forwarded to each such competent authority by the Commission.

Decision on the notification

33. (1) The Agency shall grant consent to the notifier to place the product on the market where it has concluded a favourable assessment of the proposal, and

(i) no reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 32(5)(b), or

(ii) a reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 32(5)(b) but the matters concerned have been resolved in accordance with the provisions of Article 15(1) of the Directive, or

(iii) a reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 32(5)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.

(2) The Agency shall, within a period of 30 days beginning on the day that a consent is granted, inform the competent authority of each Member State of the European Communities and the Commission of the European Communities that it has done so.

(3) The Agency shall, where it has concluded an unfavourable assessment, or where the Commission of the European Communities has adopted an unfavourable decision in accordance with the provisions of Article 18(1) of the Directive, inform the notifier that consent is refused and stating the reasons for the refusal.

(4) A grant or a refusal of consent under this article shall be conveyed by the Agency to the notifier in writing.

Limitation on consent

34. (1) Subject to the provisions of sub-article (2), the Agency shall not grant a consent under this Chapter for a period which exceeds 10 years beginning on the date on which the consent is issued.

(2) In cases relating to a genetically modified organism or a progeny of that organism intended only for the marketing of its seeds under legislation of the European Communities for the time being in force, or to genetically modified forest reproductive material, the period of first consent shall be limited in accordance with the provisions of Article 15(4) of the Directive.

CHAPTER 3

RENEWAL OF CONSENT

Duty to comply with renewal requirements

35. A person seeking to maintain on the market a product containing or consisting of a genetically modified organism beyond the date of the expiry of a consent granted under article 33, or of a consent previously renewed under article 39, shall comply with the requirements of this Chapter.

Submission of renewal notification

36. (1) A person seeking to renew a consent granted by the Agency under article 33 or a consent previously renewed under article 39 shall submit a notification to the Agency no later than 9 months before the expiry of the consent that it is proposed to have renewed.

(2) A notification under this article shall be accompanied by the fee specified in article 47.

(3) A person who has submitted a notification under this article may continue to market the product concerned in accordance with the terms and conditions of the relevant consent until a final decision has been made on the notification.

Information to be contained in a renewal notification

37. A notification under article 36 shall include—

(a) a copy of the consent granted by the Agency to the product being placed on the market and of any renewed consent,

(b) a report on the monitoring carried out on foot of the consent or renewed consent in accordance with article 27(1)(f),

(c) any new information that has become available with regard to the risks of the product to human health or to the environment, and

(d) any proposals the notifier considers appropriate for the amendment of, or measures additional to, the conditions contained in the consent granted by the Agency, including conditions relating to future monitoring and time limitation of the consent.

Duty of the Agency on foot of renewal notification

38. (1) On receipt of a notification under article 36, the Agency shall—

(a) acknowledge to the notifier the date of such receipt in writing,

(b) examine it for compliance with article 37, and

(c) ask the notifier in writing for any further information which the Agency considers necessary, stating its reasons for so doing.

(2) As soon as may be after the Agency is satisfied that the notification is in compliance with article 37, the Agency shall—

(a) prepare, in accordance with the Fifth Schedule, an assessment report which shall indicate whether

(i) the genetically modified organism concerned should remain on the market and under which conditions (in this Chapter referred to as a “favourable assessment”); or

(ii) the genetically modified organism concerned should not remain on the market (in this Chapter referred to as an “unfavourable assessment”).

(b) send a copy of the notification and of the assessment report to the Commission of the European Communities, and

(c) send a copy of the assessment report to the notifier.

(3) In the case of a favourable assessment, the Agency shall—

(a) provide any further information to the Commission of the European Communities, where such information is requested by the said Commission or by a competent authority of a Member State of the European Communities for the purposes of the Directive,

(b) consider any comments concerning, or reasoned objections to, the product remaining on the market made by the Commission of the European Communities or by a competent authority of another Member State of the European Communities for the purposes of the Directive where such comments or objections are made within a period of 60 days beginning on the day on which the documents referred to in sub-article (2)(b) were forwarded to each such competent authority by the Commission, and

(c) participate in any discussions in relation to the assessment report initiated by the Commission of the European Communities on foot of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of 75 days, beginning on the day on which the documents referred to in sub-article (2)(b) were forwarded to each such competent authority by the Commission.

Decision on the renewal notification

39. (1) The Agency shall renew consent to market a product where it has concluded a favourable assessment of the proposal, and

(i) no reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 38(3)(b), or

(ii) a reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 38 (3)(b) but the matters concerned have been resolved in accordance with the provisions of Article 17(7) and (8) of the Directive, or

(iii) a reasoned objection to the favourable assessment has been made raised by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 38(3)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.

(2) The Agency shall, within a period of 30 days beginning on the day that consent is renewed, inform the competent authority of each Member State of the European Communities and the Commission of the European Communities that it has done so.

(3) The Agency shall, where it has concluded an unfavourable assessment, or where the Commission of the European Communities has adopted an unfavourable decision in accordance with the provisions of Article 18(1) of the Directive, inform the notifier that renewal of the consent is refused and stating the reasons for the refusal.

(4) A renewal or a refusal of consent under this article shall be conveyed by the Agency to the notifier in writing.

Limitation on renewal of consent

40. (1) Subject to the provisions of sub-article (2), the Agency shall not renew a consent under this Chapter for a period which exceeds 10 years beginning on the date on which the renewal of the consent is issued.

(2) Where the Agency has specific grounds for considering that it would not be appropriate to renew a consent for a period of 10 years, it may, subject to compliance with article 39 and the other provisions of this Chapter, renew the consent for such longer or shorter period as it considers justified, in which case it shall give its reasons in writing.

CHAPTER 4

POST APPROVAL

General

41. (1) The notifier shall comply with all conditions attached to a grant of consent under article 33 or a renewal of consent under article 39.

(2) The notifier shall submit reports as specified in the monitoring plan under the consent, as soon as may be after they are completed, to the Agency, the Commission of the European Communities and the competent authorities of the Member States of the European Communities for the purposes of the Directive.

Power of the Agency to adapt monitoring plan

42. The Agency may adapt a monitoring plan under any consent it has granted or renewed on foot of consideration of the first or a subsequent report submitted by the notifier in accordance with the monitoring plan.

Duty to inform the Agency of new information

43. If, after the Agency has granted consent under article 33 or a renewal of consent under article 39, new information relevant to the placing on the market becomes available which could have consequences for the risks to human health or the environment, the notifier shall—

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

(b) inform the Agency as soon as the new information becomes available; and

(c) inform the Agency as soon as possible of such further measures he or she has taken or proposes to take in relation to the matters concerned.

Duty of the Agency on receipt of new information

44. (1) If, after granting consent under article 33 or renewing a consent under article 39, the Agency is informed under article 43, or otherwise becomes aware, of information which, in its view, could have consequences for the risks to human health or the environment, it shall-

(a) immediately forward the information to the Commission of the European Communities and to the competent authorities of the Member States of the European Communities for the purposes of the Directive.

(b) prepare, in accordance with the Fifth Schedule, an assessment report which shall indicate whether;

(i) the genetically modified organism concerned should remain on the market and under which conditions (in this Chapter referred to as a “favourable assessment”); or

(ii) the genetically modified organism concerned should not remain on the market (in this Chapter referred to as an “unfavourable assessment”),

(c) within 60 days of the receipt of the information, forward a copy of the assessment report to the Commission of the European Communities, and

(d) send a copy of the assessment report to the notifier.

(2) In the case of a favourable assessment, the Agency shall-

(a) provide any further information to the Commission of the European Communities, where such information is requested by the said Commission or by a competent authority of a Member State of the European Communities for the purposes of the Directive,

(b) consider any comments concerning, or reasoned objections to, the assessment report referred to in sub-article (1)(b)(i) made by the Commission of the European Communities or by a competent authority of another Member State of the European Communities for the purposes of the Directive where such comments or objections are made within a period of 60 days beginning on the day on which a copy of the said assessment report was forwarded to each such competent authority by the Commission, and

(c) participate in any discussions in relation to the assessment report initiated by the Commission of the European Communities on foot of reasoned objections made in accordance with paragraph (b) with a view to reaching an agreement within a period of 75 days, beginning on the day on which a copy of the assessment report referred to in sub-article (1)(b)(i) was forwarded to each such competent authority by the Commission.

Decision on foot of new information

45. (1) The Agency shall consent to the continued marketing of the product where it has concluded a favourable assessment of the information and

(i) no reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 44(2)(b), or

(ii) a reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 44(2)(b) but the matters concerned have been resolved in accordance with the provisions of Article 20(3) of the Directive, or

(iii) a reasoned objection to the favourable assessment has been made by the Commission of the European Communities or by a competent authority of a Member State of the European Communities in accordance with article 44(2)(b) and the said Commission has adopted a favourable decision in accordance with the provisions of Article 18(1) of the Directive.

(2) The Agency shall, within a period of 30 days beginning on the day that consent to the continued marketing is granted, inform the competent authority of each Member State of the European Communities and the Commission of the European Communities that it has done so.

(3) The Agency shall, where it has concluded an unfavourable assessment, or where the Commission of the European Communities has adopted an unfavourable decision in accordance with the provisions of Article 18(1) of the Directive, direct the notifier to cease marketing the product and stating the reasons for the direction.

(4) The notifier shall comply with any direction given by the Agency under sub-article (3).

(5) A consent to continue, or a direction to cease, marketing under this article shall be conveyed by the Agency to the notifier in writing.

PART IV

FEES AND CHARGES

Fee for notification of a proposed deliberate release

46. (1) A fee shall be paid to the Agency in respect of a notification under article 14 of a proposed deliberate release for purposes other than placing on the market.

(2) The fee payable under sub-article (1) shall be €3,000.

Fee for notification of a proposed placing of a product on the market and renewal of consent

47. (1) A fee shall be paid to the Agency in respect of a notification under article 29 of a proposed placing on the market of a product and a notification under article 36 of a proposal for renewal of a consent.

(2) The fee payable under sub-article (1) shall in each case be €30,000.

Fee for representations

48. (1) A fee shall be paid to the Agency in respect of representations made to it under article 16.

(2) The fee payable under sub-article (1) shall be €10.

Fee for amended notification in relation to a deliberate release

49. (1) A fee shall be paid to the Agency in respect of an amended notification under articles 17 and 20 in relation to a deliberate release for purposes other than placing on the market.

(2) The fee payable under sub-article (1) shall in each case be €1,125.

Fee for amended notification of a proposed placing of a product on the market

50. (1) A fee shall be paid to the Agency in respect of an amended notification under article 31 in connection with the proposed placing of a product on the market.

(2) The fee payable under sub-article (1) shall be €11,250.

Refund of fee in case of certain repeat notifications

51. (1) Where a notification under article 14, 29 or 36 is withdrawn before a decision is made by the Agency and a subsequent such notification is made by or on behalf of the same notifier, the Agency shall, subject to article 52, refund three quarters of the fee paid to it in respect of the subsequent notification if each of the conditions mentioned in sub-article (2) is complied with.

(2) The conditions referred to in sub-article (1) are that-

(a) the Agency is satisfied that the subsequent notification relates to a deliberate release or placing on the market, as the case may be, of the same nature and scale as the earlier notification related.

(b) a fee has been paid in respect in respect of the earlier notification.

(c) the period between the withdrawal of the first notification and the date of receipt of the subsequent notification which complies with the requirements of these Regulations does not exceed 12 months.

(d) no previous refund under sub-article (1) has at any time been made to the same notifier in respect of a notification which related substantially to the same deliberate release or placing on the market, as the case may be, as that to which the subsequent notification relates, and

(e) the case is not a case where a reduced fee has been paid under article 53.

Claim for refund to be in writing

52. A refund under article 51 shall be made on a claim in that behalf made in writing to the headquarters of the Agency and received by it within the period of 2 months beginning on the day of the giving of the decision by the Agency on the subsequent notification.

Discretionary power to refund or waive fee in certain limited circumstances

53. (1) Notwithstanding any other provision of these Regulations, the Agency shall have an absolute discretion to refund or waive up to half of the fee payable in respect of a particular notification where it is satisfied that the payment in full of the fee would not be just and reasonable having regard to the limited scale of the proposal.

(2) A decision under sub-article (1) shall contain a statement specifying the reasons for the decision.

Periodic charges for monitoring

54. The Agency may require a notifier to make periodic payments, not exceeding the costs incurred by the Agency, for the purpose of defraying or contributing towards the costs incurred by it in monitoring, carrying out inspections, or otherwise ensuring compliance with the requirements of these Regulations and any consent, conditions or other requirements pursuant to these Regulations.

Agency investigations

55. The Agency may carry out, or arrange to have carried out, such investigations as it considers necessary, as part of its examination of a notification, amended notification or other matter related to these Regulations, to enable it properly to assess the notification amended notification or other matter concerned, and may require the notifier to defray or contribute towards the cost of any such investigations.

Recovery of costs or charges

56. The Agency may recover the amount of any payment due to it arising from a requirement under article 54 or 55 as a simple contract debt in any court of competent jurisdiction.

PART V

ENFORCEMENT AND REGULATION

Authorised persons

57. The Agency may appoint such of its officers to be authorised persons as it considers necessary for the purpose of these Regulations.

Prosecution of offences

58. An offence under these Regulations, or an offence arising from the exercise of powers under the Act by authorised persons appointed pursuant to article 57, may be prosecuted by the Agency.

High Court injunction

59. The High Court may, on the application of the Agency, by order, prohibit or restrict any activity involving a deliberate release or placing on the market where the Court is satisfied that the commencement or continuation of the activity would-

(a) constitute a contravention of these Regulations, or

(b) pose a real and substantial danger to human health or the environment.

Notice to take measures

60. (1) Where it appears to the Agency that it is necessary to do so in order to protect human health or the environment, it may serve a notice in writing under this article on any notifier.

(2) A notice pursuant to this article shall-

(a) specify the measures which appear to the Agency to be necessary in order to protect human health or the environment,

(b) direct the notifier on whom the notice is served to take such measures as may be specified in the notice, and

(c) specify a date by which such measures are to be taken.

(3) A notice under this article -

(a) may be served whether or not there has been a prosecution for an offence under these Regulations in relation to the particular activity the subject of the notice. and

(b) shall not prejudice the initiation of a prosecution for an offence under these Regulations or under the Act.

(4) A notifier on whom a notice under this article has been served, may, within such period as may be specified in the notice, make representations in writing to the Agency concerning the terms of the notice and the Agency, having considered any such representations, may amend or revoke the notice.

(5) A person on whom notice under this article has been served shall, within the period specified, comply with the notice.

PART VI

GENETICALLY MODIFIED ORGANISMS ADVISORY COMMITTEE

Genetically Modified Organisms Advisory Committee

61. The Agency shall appoint a committee to be known as the “Genetically Modified Organisms Advisory Committee” for the purposes of consultation on any aspect of its functions in relation to genetically modified organisms which the Agency considers appropriate.

Membership of Advisory Committee

62. (1) Subject to sub-article (3), the membership of the Genetically Modified Organisms Advisory Committee shall include persons nominated by the following

(a) the Agency,

(b) the Minister,

(c) the Minister for Agriculture and Food,

(d) the Minister for Health and Children,

(e) the Minister for Enterprise, Trade and Employment,

(f) the National Authority for Occupational Safety and Health,

(g) the Director of Consumer Affairs,

(h) organisations which in the opinion of the Agency are representative of persons whose professions or occupations relate to biotechnology research or the biotechnology industry,

(i) organisations which, in the opinion of the Agency are concerned with environmental protection,

(j) organisations, other than the Office of the Director of Consumer Affairs, which in the opinion of the Agency are concerned with consumer affairs.

(2) The number of members of the Genetically Modified Organisms Advisory Committee, including the person appointed under article 64 to chair the meetings shall not exceed 14.

(3) Pending the expiry, following the coming into operation of these Regulations, of the term of office of the Advisory Committee on Genetically Modified Organisms established under Part VI of the Genetically Modified Organisms Regulations 1994 the membership of the said Committee on the day immediately before the said coming into operation shall serve as the membership of the Genetically Modified Organisms Advisory Committee.

Term of appointment of members of Advisory Committee

63. Subject to article 62(3), a member shall be appointed to the Genetically Modified Organisms Advisory Committee for such term (not exceeding 3 years) as shall be specified by the Agency and a member whose term of office expires by the effluxion of time shall be eligible for reappointment.

Appointment of person to chair meetings

64. The Agency shall appoint a person to chair the meetings of the Genetically Modified Organisms Advisory Committee and a person to act in the absence of the person appointed.

Regulation of procedure or business

65. The Genetically Modified Organisms Advisory Committee may regulate, by standing orders or otherwise, its procedure or business.

PART VII

MISCELLANEOUS

Testing, monitoring etc.

66. The Agency shall carry out, cause to be carried out, or arrange for such testing monitoring, inspections, or other measures as it considers necessary for the purposes of the performance of any of its functions under these Regulations.

Reporting on functions under these Regulations

67. The Agency shall provide to the Minister such information in relation to the performance of its functions under these Regulations as the Minister may specify from time to time.

Amendment of Genetically Modified Organisms (Contained Use) Regulations 2001

68. (1) Article 26(1) of the Genetically Modified Organisms (Contained Use) Regulations 2001 is amended by-

(a) the insertion of the word “or” after “article 10,” in paragraph (ii) and

(b) the insertion, after paragraph (ii) of the following

“(iii) a notification has been given to the Agency in relation to a class two contained use in accordance with article 18(3) and the Agency has required the user to give notice of the notification in a newspaper under article 20 (1),”.

(2) Articles 59 and 60 of the Genetically Modified Organisms (Contained Use Regulations 2001 are revoked.

Revocation and application of Genetically Modified Organisms Regulations 1994

69. The Genetically Modified Organisms Regulations 1994 are revoked and, subject to articles 10 and 41 of the Genetically Modified Organisms (Contained Use) Regulations 2001 and article 11 of these Regulations, shall cease to apply.

FIRST SCHEDULE

TECHNIQUES OF GENETIC MODIFICATION

Article 3

PART I

Techniques of genetic modification are inter alia

(1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(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 fusion of 2 or more cells by means of methods that do not occur naturally.

PART II

Techniques which are not considered to result in genetic modifications, on condition 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 article 7(a)

(1) in vitro fertilisation.

(2) natural processes such as conjugation, transduction, transformation.

(3) polyploidy induction.

SECOND SCHEDULE

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

Articles 3

.

5

.

14

.

18

.

30

and

32

This schedule describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform an environmental risk assessment required by these Regulations. It is supplemented by guidance notes developed in accordance with the procedure laid down in Article 30(2) of the Directive and for the time being extant

1

.

With a view to contributing to a common understanding of the terms “direct, indirect, immediate and delayed” when implementing this schedule, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows

- ‘direct effects’ refers to primary effects on human health or the environment which are a result of the genetically modified organism (hereinafter referred to as “GMO” itself and which do not occur through a causal chain of events

- ‘indirect effects’ refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management. Observations of indirect effects are likely to be delayed

- ‘immediate effects’ refers 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 which 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 termination of the release.

A general principle for environmental risk assessment is also that an analysis of the ‘cumulative long-term effects’ relevant to the release and the placing on the market is to be carried out. ‘Cumulative long-term effects’ refers to the accumulated effects of consents on human health and the environment including

inter alia

, flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics.

A.

Objective

The objective of an environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the genetically modified organisms, either direct and indirect, immediate or delayed, on human health or the environment which the deliberate release or the placing on the market of genetically modified organisms may have. The environmental risk assessment should be conducted with a view to identifying if there is a need for risk management and, if so, the most appropriate methods to be used.

B.

General Principles

In accordance with the precautionary principle, the following general principles should be followed when performing the environmental risk assessment;

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

- the environmental risk assessment should be carried out on a case by case basis meaning that the required information may vary depending on the type of the genetically modified organisms concerned, their intended use and the potential receiving environment, taking into account

inter alia

, genetically modified organisms already in the environment;

- if new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be re-addressed in order to

• determine whether the risk has changed;

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

C.

Methodology

C.1. Characteristics of genetically modified organisms and releases

Depending on the case, the environmental risk assessment 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;

- the GMO;

- the intended release or use including its scale;

- the potential receiving environment; and

- the interaction between these.

Information from releases of similar organisms with similar traits and their interaction with similar environments can assist the environmental risk assessment.

C.2. Steps in the environmental risk assessment

In drawing conclusions for the environmental risk assessment, the following points should be addressed

1.

Identification of characteristics which may cause adverse effects

Any characteristics of the genetically modified organisms linked to the genetic modification that may result in adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the GMO(s) with those of the non-modified organism under corresponding conditions of the release or use will assist in identifying the particular potential adverse effects arising from the genetic modification.

It is important not to discount any potential adverse effect on the basis that is unlikely to occur.

Potential adverse effects of genetically modified organisms will vary from case to case and may include

- disease to humans including allergenic or toxic effects (see for example items II.A.11. and II.C.2(i) in Part I of the Third Schedule, and B.7. in Part II of that Schedule);

- disease to animals and plants including toxic, and where appropriate, allergenic effects (see for example items II.A.11. and II.C.2.(i) in Part I of the Third Schedule, and B.7. and D.8. in Part II of that Schedule);

- effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations (see for example items IV.B.8. 9 and 12 in Part I of the Third Schedule);

- 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 for example items II.A. 11.(e) and II.C.2.(i)(IV) in Part I of the Third Schedule);

- effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see for example items II.A.11.(f) and IV.B.I 5 in Part I of the Third Schedule and D.11 in Part II of that Schedule).

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

- the spread of the genetically modified organism(s) in the environment;

- the 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.

2.

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 magnitude of the consequences is likely to be influenced by the environment into which the genetically modified organism(s) is (are) intended to be released and the manner of the release.

3.

Evaluation of the likelihood of the occurrence of each identified potential adverse effect

A major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the genetically modified organism(s) is (are intended to be released, and the manner of the release.

4.

Estimation of the risk posed by each identified characteristic of the genetically modified organism(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the genetically modified organism which has the potential to cause adverse effects should be made as far as possible, given the state of the art, by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, if it occurs.

5.

Application of management strategies for risks from the deliberate release or marketing of genetically modified organism(s)

The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.