(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

(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

(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

(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— (

1. a)a copy of the consent granted by the Agency to the product being placed on the market and of any renewed consent, (
2. b)a report on the monitoring carried out on foot of the consent or renewed consent in accordance with article 27

(1)(f), (

1. c)any new information that has become available with regard to the risks of the product to human health or to the environment, and (
2. 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— (

1. a)acknowledge to the notifier the date of such receipt in writing, (
2. b)examine it for compliance with article 37, and (
3. 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— (

1. a)prepare, in accordance with the Fifth Schedule, an assessment report which shall indicate whether: (
2. 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 (
3. ii)the genetically modified organism concerned should not remain on the market (in this Chapter referred to as an “unfavourable assessment”). (
4. b)send a copy of the notification and of the assessment report to the Commission of the European Communities, and (
5. c)send a copy of the assessment report to the notifier.

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

1. 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, (
2. 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)(

1. b)were forwarded to each such competent authority by the Commission, and (
2. 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 (
3. 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

(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

(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

(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

1. 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
2. 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- (

1. 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. (
2. b)prepare, in accordance with the Fifth Schedule, an assessment report which shall indicate whether; (
3. 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 (
4. ii)the genetically modified organism concerned should not remain on the market (in this Chapter referred to as an “unfavourable assessment”), (
5. 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 (
6. d)send a copy of the assessment report to the notifier.

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

1. 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, (
2. b)consider any comments concerning, or reasoned objections to, the assessment report referred to in sub-article

(1)(b)(

1. 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 (
2. 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 (
3. 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

(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

(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

(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- (

1. 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. (
2. b)a fee has been paid in respect in respect of the earlier notification. (
3. 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. (
4. 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

1. Claim for refund to be in writing
2. 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

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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- (

1. a)specify the measures which appear to the Agency to be necessary in order to protect human health or the environment, (
2. b)direct the notifier on whom the notice is served to take such measures as may be specified in the notice, and (
3. c)specify a date by which such measures are to be taken.

(3)A notice under this article - (

1. 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 (
2. 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: (

1. a)the Agency, (
2. b)the Minister, (
3. c)the Minister for Agriculture and Food, (
4. d)the Minister for Health and Children, (
5. e)the Minister for Enterprise, Trade and Employment, (
6. f)the National Authority for Occupational Safety and Health, (
7. g)the Director of Consumer Affairs, (
8. 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, (
9. i)organisations which, in the opinion of the Agency are concerned with environmental protection, (
10. 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

1. 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
2. The Genetically Modified Organisms Advisory Committee may regulate, by standing orders or otherwise, its procedure or business. PART VII MISCELLANEOUS Testing, monitoring etc.
3. 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
4. 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- (

1. a)the insertion of the word “or” after “article 10,” in paragraph (
2. ii)and (
3. b)the insertion, after paragraph (
4. 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 extant1 . 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(

1. 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(
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.(
3. 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.(
4. 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.(
5. 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(
6. 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(
7. 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(
8. 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. 6. Determination of the overall risk of the genetically modified organism(s): An evaluation of the overall risk of the GMO(
9. s)should be made taking into account any risk management strategies which are proposed. D. Conclusions on the potential environmental impact from the release or the placing on the market of genetically modified organisms On the basis of an environmental risk assessment carried out in accordance with the principles and methodology outlined in parts B and C of this schedule, information on the points listed in parts D1 or D2 of this schedule should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of genetically modified organisms. D.1. In the case of genetically modified organisms other than higher plants: 1. Likelihood of the genetically modified organism to become persistent and invasive in natural habitats under the conditions of the proposed release(s). 2. Any selective advantage or disadvantage conferred to the genetically modified organism and the likelihood of this becoming realised under the conditions of the proposed release(s). 3. Potential for gene transfer to other species under conditions of the proposed release of the genetically modified organism and any selective advantage or disadvantage conferred to those species. 4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and target organisms (if applicable). 5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism with non-target organisms including impact on population levels of competitors, prey, hosts, symbionts predators, parasites and pathogens. 6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the genetically modified organism and persons working with, coming into contact with or in the vicinity of the genetically modified organism release(s). 7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any product derived from it, if it is intended to be used as animal feed. 8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s). 9. Possible immediate and/or delayed, direct, and indirect environmental impacts of the specified techniques used for the management of the genetically modified organism where these are different from those used for non-genetically modified organisms. D.2. In the case of genetically modified higher plants (hereinafter referred to as “GMHP”): 1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats. 2. Any selective advantage or disadvantage conferred to the GMHP. 3. Potential for gene transfer to the same or other sexually compatible plant species under conditions of planting the GMHP and any selective advantage or disadvantage conferred to those plant species. 4. Potential immediate and/or delayed environmental impact resulting from direct and indirect interactions between the GMHP and target organisms, such as predators parasitoids and pathogens (if applicable). 5. Possible immediate and/or delayed environmental impact resulting from direct and indirect interactions of the GMHP with 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. 6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s). 7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any products derived from it, if it is intended to be used as animal feed. 8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO release(s). 9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for the GMHP where these are different from those used for non-GMHPs. THIRD SCHEDULE INFORMATION REQUIRED IN NOTIFICATIONS Articles 14 and 30 The notifications referred to in article 14 or 30 shall include, as appropriate, the information set out in Parts I and II of this Schedule. Not all the points included will apply to every case. It is to be expected that individual notifications will address only the particular subset of considerations which is appropriate to individual situations. The level of detail required in response to each subset of considerations is also likely to vary according to the nature and the scale of the proposed release. The description of the methods used or the reference to standardised or internationally recognised methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible for carrying out the studies. Part I applies to releases of all types of genetically modified organisms other than higher plants. Part II applies to releases of genetically modified higher plants. The term ‘higher plants’ means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae). PART I INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS I. GENERAL INFORMATION A. Name and address of the notifier (company or institute); B. Name, qualifications and experience of the responsible scientist(s); C. Title of the project. II. INFORMATION RELATING TO THE GENETICALLY MODIFIED ORGANISM A. Characteristics of (
10. a)the donor, (
11. b)the recipient or (
12. c)(where appropriate parental organism(s): 1. scientific name, 2. taxonomy, 3. other names (usual name, strain name, etc.), 4. phenotypic and genetic markers, 5. degree of relatedness between donor and recipient or between parental organisms, 6. description of identification and detection techniques, 7. sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques, 8. description of the geographic distribution and of the natural habitat of the organism, including information on natural predators, preys, parasites and competitors, symbionts and hosts, 9. organisms with which transfer of genetic material is known to occur under natural conditions, 10. verification of the genetic stability of the organisms and factors affecting it,’ 11. pathological, ecological and physiological traits: (
13. a)classification of hazard according to existing Community rules concerning the protection of human health and/or the environment; (
14. b)generation time in natural ecosystems, sexual and asexual reproductive cycle; (
15. c)information on survival, including seasonability and the ability to form survival structures; (
16. d)pathogenicity; infectivity, toxigenicity, virulence, allergenicity carrier (vector) of pathogen, possible vectors, host range (including non-target organism). Possible activation of latent viruses (proviruses). Ability to colonise other organisms; (
17. e)antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy; (
18. f)involvement in environmental processes; primary production nutrient turnover, decomposition of organic matter, respiration etc., 12. nature of indigenous vectors: (
19. a)sequence; (
20. b)frequency of mobilisation; (
21. c)specificity; (
22. d)presence of genes which confer resistance. 13. history of previous genetic modifications. B. Characteristics of the vector: 1. nature and source of the vector, 2. sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organism and to make the introduced vector and insert function in the genetically modified organism. 3. frequency of mobilisation of inserted vector and/or genetic transfer capabilities and methods of determination, 4. information on the degree to which the vector is limited to the DNA required to perform the intended function. C. Characteristics of the modified organism: I. information relating to the genetic modification: (
23. a)methods used for the modification; (
24. b)methods used to construct and introduce the insert(
25. s)into the recipient or to delete a sequence; (
26. c)description of the insert and/or vector construction; (
27. d)purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function; (
28. e)methods and criteria used for selection; (
29. f)sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(
30. s)in question with particular reference to any known harmful sequence. 2. information on the final genetically modified organism: (
31. a)description of genetic trait(
32. s)or phenotypic characteristic(
33. s)and in particular any new traits and characteristics which may be expressed or no longer expressed; (
34. b)structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism; (
35. c)stability of the organism in terms of genetic traits; (
36. d)rate and level of expression of the new genetic material. Method and sensitivity of measurement; (
37. e)activity of the expressed protein(s); (
38. f)description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector; (
39. g)sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques; (
40. h)history of previous releases or uses of the genetically modified organism; (
41. i)considerations for human health and animal health, as well as plant health: (I) toxic or allergenic effects of the genetically modified organisms and/or their metabolic products; (II)comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity; (III)capacity for colonisation; (IV)if the organism is pathogenic to humans who are immunocompetent: - diseases caused and mechanism of pathogenicity including invasiveness and virulence, - communicability, - 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, - availability of appropriate therapies. (V)other product hazards III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT A. Information on the release: 1. description of the proposed deliberate release, including the purpose(
42. s)and foreseen products, 2. foreseen dates of the release and time planning of the experiment including frequency and duration of releases, 3. preparation of the site previous to the release, 4. size of the site, 5. method(
43. s)to be used for the release, 6. quantities of genetically modified organisms to be released, 7. disturbance on the site (type and method of cultivation, mining, irrigation or other activities), 8. worker protection measures to be taken during release, 9. post-release treatment of the site, 10. techniques foreseen for elimination or inactivation of the genetically modified organisms at the end of the experiment, 11. information on, and results of, previous releases of the genetically modified organisms, especially at different scales and in different ecosystems. B. Information on the environment (both on the site and in the wider environment): 1. geographical location and grid reference of the site(
44. s)(in the case of a notification referred to in article 30, the site(
45. s)of release will be the foreseen areas of use of the product), 2. physical or biological proximity to humans and other significant biota, 3. proximity to significant biotopes, protected areas or drinking water supplies, 4. climatic characteristics of the region(
46. s)likely to be affected, 5. geographical, geological and pedological characteristics, 6. flora and fauna, including crops, livestock and migratory species, 7. description of target and non-target ecosystems likely to be affected, 8. a comparison of the natural habitat of the recipient organism with the proposed site(
47. s)of release, 9. any known planned developments or changes in land use in the region which could influence the environmental impact of the release. IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GENETICALLY MODIFIED ORGANISMS AND THE ENVIRONMENT A. Characteristics affecting survival, multiplication and dissemination: 1. biological features which affect survival, multiplication and dispersal, 2. known or predicted environmental conditions which may affect survival multiplication and dissemination (wind, water, soil, temperature, pH, etc.). 3. sensitivity to specific agents. B. Interactions with the environment: 1. predicted habitat of the genetically modified organisms, 2. studies of the behaviour and characteristics of the genetically modified organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses, 3. genetic transfer capability: (
48. a)post-release transfer of genetic material from genetically modified organisms into organisms in affected ecosystems; (
49. b)post-release transfer of genetic material from indigenous organisms to the genetically modified organisms, 4. likelihood of post-release selection leading to the expression of unexpected and or undesirable traits in the modified organism, 5. measures employed to ensure and to verify genetic stability. Descriptions of genetic traits which may prevent or minimise dispersal of genetic material. Methods to verify genetic stability, 6. routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc., 7. description of ecosystems to which the genetically modified organisms could be disseminated, 8. potential for excessive population increase in the environment, 9. competitive advantage of the genetically modified organisms in relation to the unmodified recipient or parental organism(s), 10. identification and description of the target organisms if applicable, 11. anticipated mechanism and result of interaction between the released genetically modified organisms and the target organism(
50. s)if applicable, 12. identification and description of non-target organisms which may be adversely affected by the release of the genetically modified organism, and the anticipated mechanisms of any identified adverse interaction, 13. likelihood of post-release shifts in biological interactions or in host range, 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: 1. methods for tracing the genetically modified organisms, and for monitoring their effects, 2. specificity (to identify the genetically modified organisms and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques, 3. techniques for detecting transfer of the donated genetic material to other organisms, 4. duration and frequency of the monitoring. B. Control of the release: 1. methods and procedures to avoid and or minimise the spread of the genetically modified organisms beyond the site of release or the designated area for use. 2. methods and procedures to protect the site from intrusion by unauthorised individuals, 3. methods and procedures to prevent other organisms from entering the site. C. Waste treatment: 1. type of waste generated, 2. expected amount of waste, 3. description of treatment envisaged. D. Emergency response plans: 1. methods and procedures for controlling the genetically modified organisms in case of unexpected spread, 2. methods for decontamination of the areas affected, for example eradication of the genetically modified organisms, 3. methods for disposal or sanitation of plants, animals, soils, etc. that were exposed during or after the spread, 4. methods for the isolation of the area affected by the spread. 5. plans for protecting human health and the environment in case of the occurrence of an undesirable effect. PART II INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE) A. GENERAL INFORMATION 1. Name and address of the notifier (company or institute); 2. Name, qualifications and experience of the responsible scientist(s); 3. Title of the project. B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE PARENTAL PLANTS 1. Complete name: (
51. a)family name; (
52. b)genus; (
53. c)species; (
54. d)subspecies; (
55. e)cultivar/breeding line; (
56. f)common name. 2. (
57. a)Information concerning reproduction; (
58. i)mode(
59. s)of reproduction; (
60. ii)specific factors affecting reproduction, if any; (iii) generation time. (
61. b)Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species. 3. Survivability: (
62. a)ability to form structures for survival or dormancy; (
63. b)specific factors affecting survivability, if any. 4. Dissemination: (
64. a)ways and extent (for example, an estimation of how viable pollen and/or seeds declines with distance) of dissemination; (
65. b)specific factors affecting dissemination, if any. 5. Geographical distribution of the plant. 6. In the case of plant species not normally grown in the Member State(
66. s)of the European Communities, description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts. 7. Other potential interactions, relevant to the genetically modified organism, of the plant with 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 1. Description of the methods used for the genetic modification. 2. Nature and source of the vector used. 3. Size, source (name) of donor organism(
67. s)and intended function of each constituent fragment of the region intended for insertion. D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT 1. Description of the trait(
68. s)and characteristics which have been introduced or modified. 2. Information on the sequences actually inserted/deleted: (
69. a)size and structure of the insert and methods used for its characterisation including information on any parts of the vector introduced in the genetically modified higher plant or any carrier or foreign DNA remaining in the genetically modified higher plant; (
70. b)in case of deletion, size and function of the deleted region(s); (
71. c)copy number of the insert; (
72. d)location(
73. s)of the insert(
74. s)in the plant cells (integrated in the chromosome chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination; 3. Information on the expression of the insert: (
75. a)information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation; (
76. b)parts of the plant where the insert is expressed (for example, roots, stems pollen, etc.); 4. Information on how the genetically modified plant differs from the recipient plant in: (
77. a)mode(
78. s)and/or rate of reproduction; (
79. b)dissemination; (
80. c)survivability. 5. Genetic stability of the insert and phenotypic stability of the genetically modified higher plant; 6. Any change to the ability of the GMHP to transfer genetic material to other organisms; 7. Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification; 8. Information on the safety of the genetically modified higher plant to animal health particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the genetically modified higher plant is intended to be used in animal feedstuffs. 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) 1. Location and size of the release site(s). 2. Description of the release site ecosystem, including climate, flora and fauna. 3. Presence of sexually compatible wild relatives or cultivated plant species. 4. Proximity to officially recognised biotopes or protected areas which may be affected. F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED IN ACCORDANCE WITH ARTICLE 14) 1. Purpose of the release. 2. Foreseen date(
81. s)and duration of the release. 3. Method by which the genetically modified plants will be released. 4. Method for preparing and managing the release site prior to, during and post-release including cultivation practices and harvesting methods. 5. Approximate number of plants (or plants per m2). G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED IN ACCORDANCE WITH ARTICLE 14) 1. Any precautions taken: (
82. a)distance(
83. s)from sexually compatible plant species, both wild relatives and crops; (
84. b)any measures to minimise/prevent dispersal of any reproductive organ of the genetically modified higher plant (for example, pollen, seeds, tuber). 2. Description of methods for post-release treatment of the site. 3. Description of post-release treatment methods for the genetically modified plant material, including wastes. 4. Description of monitoring plans and techniques. 5. Description of any emergency plans. 6. Methods and procedures to protect the site. FOURTH SCHEDULE ADDITIONAL INFORMATION REQUIRED IN THE CASE OF NOTIFICATION FOR PLACING ON THE MARKET OF PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS Articles 27 and 30 PART I The following information shall be provided in the notification for placing on the market of a product containing or consisting of a genetically modified organism, in addition to that required pursuant to the Third Schedule: 1. proposed commercial name(
85. s)of the product and name(
86. s)of genetically modified organisms contained therein, and any specific identification, name or code used by the notifier to identify the genetically modified organism. After any consent, any new commercial name(
87. s)should be provided to the Agency by the notifier, 2. name and full address of the person established in the European Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor, 3. name and full address of the supplier(
88. s)of control samples, 4. description of how the product and the genetically modified organism as or in product are intended to be used. Differences in use or management of the genetically modified organism compared to similar non-genetically modified products should be highlighted. 5. description of the geographical area(
89. s)and types of environment where the product is intended to be used within the European Community, including where possible, estimated scale of use in each area, 6. intended categories of users of the product (e.g. industry, agriculture and skilled trades, consumer use by public at large). 7. information on the genetic modification for the purpose of placing on one or several registers, established by the Commission of the European Communities pursuant to Article 31

(2)of the Directive, modifications in organisms which can be used for the 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 Agency and details of nucleotide sequences or other type of information which is necessary to identify the GMO product and its progeny, for example, the methodology for detecting and identifying the GMO product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the said register or registers should be identified. 8. proposed labelling on a label or in an accompanying