2001L0018 — EN — 21.03.2008 — 003.001

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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B	DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p.1)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION DECISION of 24 July 2002	L 200	22	30.7.2002
►M2	REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003	L 268	1	18.10.2003
►M3	REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003	L 268	24	18.10.2003
►M4	DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008	L 81	45	20.3.2008

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▼B

DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 March 2001

on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

PART A

GENERAL PROVISIONS

Article 1

Objective

In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:

Article 2

Definitions

For the purposes of this Directive:

(1)	‘organism’means any biological entity capable of replication or of transferring genetic material;

(2)

‘genetically modified organism (GMO)’ means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; Within the terms of this definition: (a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1; (b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification;

(3)	‘deliberate release’means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment;

(4)

‘placing on the market’ means making available to third parties, whether in return for payment or free of charge; The following operations shall not be regarded as placing on the market: — making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms ( 9 ) including culture collections, — making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC, — making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive;

(5)	‘notification’means the submission of the information required under this Directive to the competent authority of a Member State;

(6)	‘notifier’means the person submitting the notification;

(7)	‘product’means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market;

(8)	‘environmental risk assessment’means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II.

Article 3

Exemptions

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

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

Article 4

General obligations

1.  Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.

2.  Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorised under part B.

3.  Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.

4.  Member States shall designate the competent authority or authorities responsible for complying with the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate.

5.  Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

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▼B

PART B

DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Article 5

1.  Articles 6 to 11 shall not apply to medicinal substances and compunds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised by Community legislation which provides:

2.  Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive.

3.  Procedures ensuring conformity of the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for by the said legislation, which must refer to this Directive.

Article 6

Standard authorisation procedure

1.  Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place.

2.  The notification referred to in paragraph 1 shall include:

3.  The notifier may refer to data or results from notifications previously submitted by other notifiers, provided that the information, data and results are non confidential or these notifiers have given their agreement in writing, or may submit additional information he considers relevant.

4.  The competent authority may accept that releases of the same GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

5.  The competent authority shall acknowledge the date of receipt of the notification and, having considered, where appropriate, any observations by other Member States made in accordance with Article 11, shall respond in writing to the notifier within 90 days of receipt of the notification by either:

6.  For the purpose of calculating the 90 day period referred to in paragraph 5, no account shall be taken of any periods of time during which the competent authority:

7.  If the competent authority requests new information it must simultaneously give its reasons for so doing.

8.  The notifier may proceed with the release only when he has received the written consent of the competent authority, and in conformity with any conditions required in this consent.

9.  Member States shall ensure that no material derived from GMOs which are deliberately released in accordance with part B is placed on the market, unless in accordance with part C.

Article 7

Differentiated procedures

1.  If sufficient experience has been obtained of releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V, a competent authority may submit to the Commission a reasoned proposal for the application of differentiated procedures to such types of GMOs.

2.  Following its own initiative or at the latest 30 days following the receipt of a competent authority's proposal, the Commission shall,

3.  A decision shall be taken on each proposal in accordance with the procedure laid down in Article 30(2). This decision shall establish the minimum amount of technical information from Annex III necessary for evaluating any foreseeable risks from the release, in particular:

4.  This decision shall be taken within 90 days of the date of the Commission's proposal or of receipt of the competent authority's proposal. This 90 day period shall not take into account the period of time during which the Commission is awaiting the observations of competent authorities, the comments of the public or the opinion of Scientific Committees, as provided for in paragraph 2.

5.  The decision taken under paragraphs 3 and 4 shall provide that the notifier may proceed with the release only when he has received the written consent of the competent authority. The notifier shall proceed with the release in conformity with any conditions required in this consent.

The decision taken under paragraphs 3 and 4 may provide that releases of a GMO or of a combination of GMOs on the same site or on different sites for the same purpose and within a defined period may be notified in a single notification.

6.  Without prejudice to paragraphs 1 to 5, Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC ( 10 ) shall continue to apply.

7.  Where a Member State decides to make use or not of a procedure established in a decision taken in accordance with paragraphs 3 and 4 for releases of GMOs within its territory, it shall inform the Commission thereof.

Article 8

Handling of modifications and new information

1.  In the event of any modification of, or unintended change to, the deliberate release of a GMO or of a combination of GMOs which could have consequences with regard to risks for human health and the environment after the competent authority has given its written consent, or if new information has become available on such risks, either while the notification is being examined by the competent authority of a Member State or after that authority has given its written consent, the notifier shall immediately:

2.  If information becomes available to the competent authority referred to in paragraph 1 which could have significant consequences with regard to risks for human health and the environment or under the circumstances described in paragraph 1, the competent authority shall evaluate such information and make it available to the public. It may require the notifier to modify the conditions of, suspend or terminate the deliberate release and shall inform the public thereof.

Article 9

Consultation of and information to the public

1.  Member States shall, without prejudice to the provisions of Articles 7 and 25, consult the public and, where appropriate, groups on the proposed deliberate release. In doing so, Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion.

2.  Without prejudice to the provisions of Article 25:

Article 10

Reporting by notifiers on releases

After completion of a release, and thereafter, at any intervals laid down in the consent on the basis of the results of the environmental risk assessment, the notifier shall send to the competent authority the result of the release in respect of any risk to human health or the environment, with, where appropriate, particular reference to any kind of product that the notifier intends to notify at a later stage. The format for the presentation of this result shall be established in accordance with the procedure laid down in Article 30(2).

Article 11

Exchange of information between competent authorities and the Commission

1.  The Commission shall set up a system of exchange of the information contained in the notifications. The competent authorities shall send to the Commission, within 30 days of its receipt, a summary of each notification received under Article 6. The format of this summary shall be established and modified if appropriate in accordance with the procedure laid down in Article 30(2).

2.  The Commission shall, at the latest 30 days following their receipt, forward these summaries to the other Member States, which may, within 30 days, present observations through the Commission or directly. At its request, a Member State shall be permitted to receive a copy of the full notification from the competent authority of the relevant Member State.

3.  The competent authorities shall inform the Commission of the final decisions taken in compliance with Article 6(5), including where relevant the reasons for rejecting a notification, and of the results of the releases received in accordance with Article 10.

4.  For the releases of GMOs referred to in Article 7, once a year Member States shall send a list of GMOs which have been released on their territory and a list of notifications that were rejected to the Commission, which shall forward them to the competent authorities of the other Member States.

PART C

PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS

Article 12

Sectoral legislation

1.  Articles 13 to 24 shall not apply to any GMO as or in products as far as they are authorised by Community legislation which provides for a specific environmental risk assessment carried out in accordance with the principles set out in Annex II and on the basis of information specified in Annex III without prejudice to additional requirements provided for by the Community legislation mentioned above, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in this Directive.

2.  As far as Council Regulation (EEC) No 2309/93 is concerned, Articles 13 to 24 of this Directive shall not apply to any GMO as or in products as far as they are authorised by that Regulation provided that a specific environmental risk assessment is carried out in accordance with the principles set out in Annex II to this Directive and on the basis of the type of information specified in Annex III to this Directive without prejudice to other relevant requirements as regards risk assessment, risk management, labelling, monitoring as appropriate, information to the public and safeguard clause provided by Community legislation concerning medicinal products for human and veterinary use.

3.  Procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in this Directive shall be introduced, in a Regulation of the European Parliament and of the Council. Future sectoral legislation based on the provisions of that Regulation shall make a reference to this Directive. Until the Regulation enters into force, any GMO as or in products as far as they are authorised by other Community legislation shall only be placed on the market after having been accepted for placing on the market in accordance with this Directive.

4.  During evaluation of the requests for the placing on the market of the GMOs referred to in paragraph 1, the bodies established by the Community under this Directive and by Member States for the purpose of implementing this Directive shall be consulted.

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Article 12a

Transitional measures for adventitious or technically unavoidable presence of genetically modified organisms having benefited from a favourable risk evaluation

1.  Placing on the market of traces of a GMO or combination of GMOs in products intended for direct use as food or feed or for processing shall be exempted from Articles 13 to 21 provided that they meet the conditions referred to in Article 47 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed ( 11 ).

2.  This Article shall be applicable for a period of three years after the date of application of Regulation (EC) No 1829/2003.

▼B

Article 13

Notification procedure

1.  Before a GMO or a combination of GMOs as or in products is placed on the market, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. The competent authority shall acknowledge the date of receipt of the notification and immediately forward the summary of the dossier referred to in paragraph 2(h) to the competent authorities of the other Member States and the Commission.

The competent authority shall without delay examine whether the notification is in accordance with paragraph 2 and shall, if necessary, ask the notifier for additional information.

When the notification is in accordance with paragraph 2, and at the latest when it sends its assessment report in accordance with Article 14(2), the competent authority shall forward a copy of the notification to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

2.  The notification shall contain:

If on the basis of the results of any release notified under part B, or on other substantive, reasoned scientific grounds, a notifier considers that the placing on the market and use of a GMO as or in a product do not pose a risk to human health and the environment, he may propose to the competent authority not to provide part or all of the information required in Annex IV, section B.

3.  The notifier shall include in this notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community.

4.  The notifier may also refer to data or results from notifications previously submitted by other notifiers or submit additional information he considers relevant, provided that the information, data and results are non-confidential or these notifiers have given their agreement in writing.

5.  In order for a GMO or combination of GMOs to be used for a purpose different from that already specified in a notification, a separate notification shall be submitted.

6.  If new information has become available with regard to the risks of the GMO to human health or the environment, before the written consent is granted, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof. In addition, the notifier shall revise the information and conditions specified in the notification.

Article 14

Assessment report

1.  On receipt and after acknowledgement of the notification in accordance with Article 13(2), the competent authority shall examine it for compliance with this Directive.

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

In the case referred to paragraph 3(b), the competent authority shall send its report, together with the information referred to in paragraph 4 and any other information on which it has based its report, to the Commission no earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification. The Commission shall, within 30 days of its receipt, forward the report to the competent authorities of the other Member States.

3.  The assessment report shall indicate whether:

The assessment reports shall be established in accordance with the guidelines laid down in Annex VI.

4.  For the purpose of calculating the 90 day period referred to in paragraph 2, any periods of time during which the competent authority is awaiting further information which it may have requested from the notifier shall not be taken into account. The competent authority shall state the reasons in any request for further information.

Article 15

Standard procedure

1.  In the cases referred to in Article 14(3), a competent authority or the Commission may ask for further information, make comments or present reasoned objections to the placing on the market of the GMO(s) in question within a period of 60 days from the date of circulation of the assessment report.

Comments or reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 105 days from the date of circulation of the assessment report.

Any periods of time during which further information from the notifier is awaited shall not be taken into account for the purpose of calculating the final 45 day period for arriving at an agreement. Reasons shall be stated in any request for further information.

2.  In the case referred to in Article 14(3)(b), if the competent authority which prepared the report decides that the GMO(s) should not be placed on the market, the notification shall be rejected. This decision shall state the reasons.

3.  If the competent authority which prepared the report decides that the product may be placed on the market, in the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the assessment report referred to in Article 14(3)(a) or if outstanding issues are resolved within the 105 day period referred to in paragraph 1, the competent authority which prepared the report shall give consent in writing for placing on the market, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

4.  The consent shall be given for a maximum period of ten years starting from the date on which the consent is issued.

For the purpose of approval of a GMO or a progeny of that GMO intended only for the marketing of their seeds under the relevant Community provisions, the period of the first consent shall end at the latest ten years after the date of the first inclusion of the first plant variety containing the GMO on an official national catalogue of plant varieties in accordance with Council Directives 70/457/EEC ( 12 ) and 70/458/EEC ( 13 ).

In the case of forest reproductive material, the period of the first consent shall end at the latest ten years after the date of the first inclusion of basic material containing the GMO on an official national register of basic material in accordance with Council Directive 1999/105/EC ( 14 ).

Article 16

Criteria and information for specified GMOs

1.  A competent authority, or the Commission on its own initiative, may make a proposal on criteria and information requirements to be met for the notification, by way of derogation from Article 13, for the placing on the market of certain types of GMOs as or in products.

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2.  The criteria and information requirements referred to in paragraph 1, as well as any appropriate requirements for a summary of the dossier, shall be established. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted, after consultation of the relevant Scientific Committee, in accordance with the regulatory procedure with scrutiny referred to in Article 30(3). The criteria and information requirements shall be such as to ensure a high level of safety of human health and the environment and shall be based on the available scientific evidence concerning such safety and on experience gained from the release of comparable GMOs.

The requirements set out in Article 13(2) shall be replaced by those adopted in accordance with the first subparagraph, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply.

3.  Before the regulatory procedure with scrutiny referred to in Article 30(3) is initiated with a view to a decision on criteria and information requirements referred to in paragraph 1, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the Committee established pursuant to Article 30.

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Article 17

Renewal of consent

1.  By way of derogation from Articles 13, 14 and 15, the procedure set out in paragraphs 2 to 9 shall be applied to the renewal of:

2.  At the latest nine months before the expiry of the consent, for the consents referred to in paragraph 1(a), and before 17 October 2006, for the consents referred to in paragraph 1(b), the notifier under this Article shall submit a notification to the competent authority which received the original notification, which shall contain:

The competent authority shall acknowledge the date of receipt of the notification and when the notification is in accordance with this paragraph it shall without delay forward a copy of the notification and its assessment report to the Commission, which shall, within 30 days of their receipt, forward them to the competent authorities of the other Member States. It shall also send its assessment report to the notifier.

3.  The assessment report shall indicate whether:

4.  The other competent authorities or the Commission may ask for further information, make comments, or present reasoned objections within a period of 60 days from the date of circulation of the assessment report.

5.  All comments, reasoned objections and replies shall be forwarded to the Commission which shall immediately circulate them to all competent authorities.

6.  In the case of paragraph 3(a) and in the absence of any reasoned objection from a Member State or the Commission within 60 days from the date of circulation of the assessment report, the competent authority which prepared the report shall transmit to the notifier the final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent should not, as a general rule, exceed ten years and may be limited or extended as appropriate for specific reasons.

7.  The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

8.  If outstanding issues are resolved within the 75 day period referred to in paragraph 7, the competent authority which prepared the report shall transmit to the notifier its final decision in writing and shall inform the other Member States and the Commission thereof within 30 days. The validity of the consent may be limited as appropriate.

9.  Following a notification for the renewal of a consent in accordance with paragraph 2, the notifier may continue to place the GMOs on the market under the conditions specified in that consent until a final decision has been taken on the notification.

Article 18

Community procedure in case of objections

1.  In cases where an objection is raised and maintained by a competent authority or the Commission in accordance with Articles 15, 17 and 20, a decision shall be adopted and published within 120 days in accordance with the procedure laid down in Article 30(2). This decision shall contain the same information as in Article 19(3).

For the purpose of calculating the 120 day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee which has been consulted in accordance with Article 28 shall not be taken into account. The Commission shall state reasons in any request for further information and inform the competent authorities of its requests to the notifier. The period of time during which the Commission is awaiting the opinion of the Scientific Committee shall not exceed 90 days.

The period of time that the Council takes to act in accordance with the procedure laid down in Article 30(2) shall not be taken into account.

2.  Where a favourable decision has been taken, the competent authority which prepared the report shall give consent in writing to the placing on the market or to the renewal of the consent, shall transmit it to the notifier and shall inform the other Member States and the Commission thereof within 30 days following the publication or notification of the decision.

Article 19

Consent

1.  Without prejudice to requirements under other Community legislation, only if a written consent has been given for the placing on the market of a GMO as or in a product may that product be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to.

2.  The notifier may proceed with the placing on the market only when he has received the written consent of the competent authority in accordance with Articles 15, 17 and 18, and in conformity with any conditions required in that consent.

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

4.  Member States shall take all necessary measures to ensure that the written consent and the decision referred to in Article 18, where applicable, are made accessible to the public and that the conditions specified in the written consent and the decision, where applicable, are complied with.

Article 20

Monitoring and handling of new information

1.  Following the placing on the market of a GMO as or in a product, the notifier shall ensure that monitoring and reporting on it are carried out according to the conditions specified in the consent. The reports of this monitoring shall be submitted to the Commission and the competent authorities of the Member States. On the basis of these reports, in accordance with the consent and within the framework for the monitoring plan specified in the consent, the competent authority which received the original notification may adapt the monitoring plan after the first monitoring period.

2.  If new information has become available, from the users or other sources, with regard to the risks of the GMO(s) to human health or the environment after the written consent has been given, the notifier shall immediately take the measures necessary to protect human health and the environment, and inform the competent authority thereof.

In addition, the notifier shall revise the information and conditions specified in the notification.

3.  If information becomes available to the competent authority which could have consequences for the risks of the GMO(s) to human health or the environment, or under the circumstances described in paragraph 2, it shall immediately forward the information to the Commission and the competent authorities of the other Member States and may avail itself of the provisions in Articles 15(1) and 17(7) where appropriate, when the information has become available before the written consent.

When the information has become available after the consent has been given, the competent authority shall within 60 days after receipt of the new information, forward its assessment report indicating whether and how the conditions of the consent should be amended or the consent should be terminated to the Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Comments or reasoned objections to further placing on the market of the GMO or on the proposal for amending the conditions of the consent shall, within 60 days following the circulation of the assessment report, be forwarded to the Commission which shall immediately forward them to all competent authorities.

The competent authorities and the Commission may discuss any outstanding issues with the aim of arriving at an agreement within 75 days from the date of circulation of the assessment report.

In the absence of any reasoned objection from a Member State or the Commission within 60 days following the date of circulation of the new information or if outstanding issues are resolved within 75 days, the competent authority which prepared the report shall amend the consent as proposed, shall transmit the amended consent to the notifier and shall inform the other Member States and the Commission thereof within 30 days.

4.  So as to ensure its transparency, the results of the monitoring carried out under part C of the Directive shall be made publicly available.

Article 21

Labelling

1.  Member States shall take all necessary measures to ensure that at all stages of the placing on the market, the labelling and packaging of GMOs placed on the market as or in products comply with the relevant requirements specified in the written consent referred to in Articles 15(3), 17(5) and (8), 18(2) and 19(3).

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2.  For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded, a minimum threshold may be established below which these products shall not have to be labelled in accordance with paragraph 1.

Threshold levels shall be established according to the product concerned. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3).

3.  For products intended for direct processing, paragraph 1 shall not apply to traces of authorised GMOs in proportions no higher than 0,9 % or lower thresholds, provided that these traces are adventitious or technically unavoidable.

The threshold levels referred to in the first subparagraph may be established. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3).

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Article 22

Free circulation

Without prejudice to Article 23, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.

Article 23

Safeguard clause

1.  Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.

The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based.

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2.  Within 60 days of the date of receipt of the information transmitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days.

Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.

▼B

Article 24

Information to the public

1.  Without prejudice to Article 25, upon receipt of a notification in accordance with Article 13(1), the Commission shall immediately make available to the public the summary referred to in Article 13(2)(h). The Commission shall also make available to the public assessment reports in the case referred to in Article 14(3)(a). The public may make comments to the Commission within 30 days. The Commission shall immediately forward the comments to the competent authorities.

2.  Without prejudice to Article 25, for all GMOs which have received written consent for placing on the market or whose placing on the market was rejected as or in products under this Directive, the assessment reports carried out for these GMOs and the opinion(s) of the Scientific Committees consulted shall be made available to the public. For each product, the GMO or GMOs contained therein and the use or uses shall be clearly specified.

PART D

FINAL PROVISIONS

Article 25

Confidentiality

1.  The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.

2.  The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive positionand which should therefore be treated as confidential. Verifiable justification must be given in such cases.

3.  The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions.

4.  In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential:

5.  If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied.

Article 26

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

1.  The GMOs to be made available for operations referred to under Article 2(4), second subparagraph, shall be subject to adequate labelling requirements in accordance with the relevant sections of Annex IV in order to provide for clear information, on a label or in an accompanying document, on the presence of GMOs. To that effect the words ‘This product contains genetically modified organisms’ shall appear either on a label or in an accompanying document.

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2.  Conditions for the implementation of paragraph 1 shall be established, without duplicating or creating inconsistencies with labelling provisions laid down in existing Community legislation. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3). In so doing, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Community legislation.

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Article 26a

Measures to avoid the unintended presence of GMOs

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

2.  The Commission shall gather and coordinate information based on studies at Community and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified, conventional and organic crops.

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Article 27

Adaptation of annexes to technical progress

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

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Article 28

Consultation of Scientific Committee(s)

1.  In cases where an objection as regards the risks of GMOs to human health or to the environment is raised by a competent authority or the Commission and maintained in accordance with Article 15(1), 17(4), 20(3) or 23, or where the assessment report referred to in Article 14 indicates that the GMO should not be placed on the market, the relevant Scientific Committee(s) shall be consulted by the Commission, on its own initiative or at the request of a Member State, on the objection.

2.  The relevant Scientific Committee(s) may also be consulted by the Commission, on its own initiative or at the request of a Member State, on any matter under this Directive that may have an adverse effect on human health and the environment.

3.  The administrative procedures laid down in this Directive shall not be affected by paragraph 2.

Article 29

Consultation of Committee(s) on Ethics

1.  Without prejudice to the competence of Member States as regards ethical issues, the Commission shall, on its own initiative or at the request of the European Parliament or the Council, consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies, on ethical issues of a general nature.

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

2.  This consultation is conducted under clear rules of openness, transparency and public accessibility. Its outcome shall be accessible to the public.

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

Article 30

Committee procedure

1.  The Commission shall be assisted by a committee.

2.  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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

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3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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Article 31

Exchange of information and reporting

1.  Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release and the placing on the market of GMOs. This information exchange shall also cover experience gained from the implementation of Article 2(4), second subparagraph, environmental risk assessment, monitoring and the issue of consultation and information of the public.

Where necessary, guidance on the implementation of Article 2(4), second subparagraph, may be provided by the committee established under Article 30(1).

2.  The Commission shall establish one or several register(s) for the purpose of recording the information on genetic modifications in GMOs mentioned in point A No 7 of Annex IV. Without prejudice to Article 25, the register(s) shall include a part which is accessible to the public. The detailed arrangements for the operation of the register(s) shall be decided in accordance with the procedure laid down in Article 30(2).

3.  Without prejudice to paragraph 2 and point A No 7 of Annex IV,

4.  Every three years, Member States shall send the Commission a report on the measures taken to implement the provisions of this Directive. This report shall include a brief factual report on their experience with GMOs placed on the market in or as products under this Directive.

5.  Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 4.

6.  The Commission shall send to the European Parliament and the Council, in 2003 and thereafter every three years, a report on the experience of Member States with GMOs placed on the market under this Directive.

7.  When submitting this report in 2003, the Commission shall at the same time submit a specific report on the operation of part B and part C including an assessment of:

8.  The Commission shall send to the European Parliament and the Council every year, a report on the ethical issues referred to in Article 29(1); this report may be accompanied, if appropriate, by a proposal with a view to amending this Directive.

Article 32

Implementation of the Cartagena Protocol on biosafety

1.  The Commission is invited to bring forward as soon as possible and in any case before July 2001 a legislative proposal for implementing in detail the Cartagena Protocol on biosafety. The proposal shall complement and, if necessary, amend the provisions of this Directive.

2.  This proposal shall, in particular, include appropriate measures to implement the procedures laid down in the Cartagena Protocol and, in accordance with the Protocol, require Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Cartagena Protocol, are fulfilled.

Article 33

Penalties

Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.

Article 34

Transposition

1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 October 2002. They shall forthwith inform the Commission thereof.

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

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

Article 35

Pending notifications

1.  Notifications concerning placing on the market of GMOs as or in products received pursuant to Directive 90/220/EEC, and in respect of which the procedures of that Directive have not been completed by 17 October 2002 shall be subject to the provisions of this Directive.

2.  By 17 January 2003 notifiers shall have complemented their notification in accordance with this Directive.

Article 36

Repeal

1.  Directive 90/220/EEC shall be repealed on 17 October 2002.

2.  References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex VIII.

Article 37

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

Article 38

This Directive is addressed to the Member States.

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ANNEX I A

TECHNIQUES REFERRED TO IN ARTICLE 2(2)

PART 1

Techniques of genetic modification referred to in Article 2(2)(a) are inter alia:

PART 2

Techniques referred to in Article 2(2)(b) which are not considered to result in genetic modification, 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 Annex I B:

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ANNEX I B

TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

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ANNEX II

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

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This Annex 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 the environmental risk assessment (e.r.a.) referred to in Articles 4 and 13. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex.

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With a view to contributing to a common understanding of the terms ‘direct, indirect, immediate and delayed’ when implementing this Annex, 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:

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 e.r.a. is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The e.r.a. 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 e.r.a.:

C.   Methodology

C.1.   Characteristics of GMOs and releases

Depending on the case the e.r.a. has to take into account the relevant technical and scientific details regarding characteristics of:

Information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can assist the e.r.a.

C.2.   Steps in the e.r.a.

In drawing conclusions for the e.r.a. referred to in Articles 4, 6, 7 and 13 the following points should be addressed:

1.   Identification of characteristics which may cause adverse effects:

Any characteristics of the GMOs 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 it is unlikely to occur.

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

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

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 GMO(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 GMO(s) is intended to be released, and the manner of the release.

4.   Estimation of the risk posed by each identified characteristic of the GMO(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the GMO 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 GMO(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 GMO(s)

An evaluation of the overall risk of the GMO(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 GMOs

On the basis of an e.r.a. carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D1 or D2 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 GMOs:

D.1.   In the case of GMOs other than higher plants

D.2.   In the case of genetically modified higher plants (GMHP)

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GUIDANCE NOTES ON THE OBJECTIVE, ELEMENTS, GENERAL PRINCIPLES AND METHODOLOGY OF THE ENVIRONMENTAL RISK ASSESSMENT REFERRED TO IN ANNEX II TO DIRECTIVE 2001/18/EC

1.   INTRODUCTION

Environmental risk assessment (ERA) is defined in Article 2(8) of Directive 2001/18/EC as ‘the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose’. As one of the general obligations under the Directive, Article 4(3) requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment, which may occur in particular directly or indirectly, are accurately assessed on a case-by-case basis taking into account the environmental impact according to the nature of the organism introduced and the receiving environment. ERA is carried out in accordance with Annex II to the Directive, and is also referred to in Parts B and C thereof. Annex II 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 the ERA, taking into account the impact on human health and the environment according to the nature of the organism introduced and the receiving environment.

Notifiers must submit a notification including an ERA for deliberate release under Article 6(2) or for placing on the market under Article 13(2).

This guidance note supplements Annex II to Directive 2001/18/EC and outlines the objectives and principles as well as the methodology for the ERA, in order to assist notifiers, to facilitate the performance by the competent authorities of a comprehensive and appropriate ERA under Directive 2001/18/EC and to make the process of ERA transparent to the general public.

The six steps in the ERA are set out in Chapter 4.2.

2.   OBJECTIVE

In accordance with Annex II to Directive 2001/18/EC, the objective of an ERA is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or placing on the market of GMOs may have. The ERA should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used ( 15 ).

The ERA therefore covers deliberate release (Part B) and placing on the market (Part C) as referred to in Directive 2001/18/EC. Placing on the market very often, but not necessarily, includes deliberate release into the environment, but is always an intentional introduction on the market (for example, agricultural products containing or consisting of GMOs, only for the use of food, feed and processing). In these cases too an ERA has to be included in the notification process. In general there may be a difference between the ERA for deliberate release and that for placing on the market, due, for example, to the differences in existing data, time-scale and area.

In addition, these guidance notes cover all GMOs, including microorganisms, plants and animals. Although so far most GMOs deliberately released or placed on the market are higher plants, this may change in future.

The ERA will serve as the basis for identifying the need for risk management and, if so, the most appropriate methods to be used, and for focused monitoring (see Chapter 3).

The overall case-by-case assessment covers the GMO(s) concerned (GMO-by-GMO assessment) and the environment(s) in which the GMO is to be released (for example, site-by-site assessment and region-by-region assessment, if applicable).

Future developments in genetic modification may make it necessary to adapt Annex II and these guidance notes to technical progress. Further differentiation of information requirements for different types of GMOs, like single cell organisms, fish or insects, or for particular uses of GMOs, like the development of vaccines, may be possible once there is sufficient experience with notifications for the release of particular GMOs in the Community (Annex III, fourth paragraph, and Chapter 6).

Risk assessment of the use of antibiotic resistance marker genes is a very specific issue and further guidance on this item may be recommended.

Different ‘effect categories’ of GMOs on human health or the environment are described in Annex II to Directive 2001/18/EC. In the interests of a common interpretation, the definitions given in the Directive of the following terms are illustrated as follows:

The delayed effects in particular may be difficult to determine, especially if they become apparent only in the long term. Appropriate measures such as monitoring (see below) can help in detecting these effects.

3.   GENERAL PRINCIPLES

In accordance with the precautionary principle, the ERA should be based on the following general principles:

4.   METHODOLOGY

4.1.   Characteristics of GMOs and releases

The ERA has to take into account the relevant technical and scientific details regarding characteristics of:

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

Prior to deliberate release of a GMO or a combination of GMOs under Part B or to the placing on the market under Part C of the Directive, a notification including the information set out in Annexes IIIA and IIIB to the Directive (information on the GMO, the donor, the recipient, the vector, the conditions of the release and the environment, the interactions between the GMOs and the environment and of monitoring GMOs) should be submitted to the competent authority of the Member State where the release or the placing on the market is to take place for the first time.

Those notifications should contain a technical dossier of information including a full ERA in accordance with Article 6(2) and Article 13(2) of the Directive, the amount of detail needed to substantiate any point depending on its importance in the ERA. Notifiers shall provide bibliographic references and indicate the methods used.

The information on recipient, donor, vector, genetic modification and the GMO, on the basis of information requested in Annexes IIIA and IIIB to the Directive, is independent of the environment in which the GMO is to be experimentally released or placed on the market, and the conditions under which it will be experimentally released or marketed. This information is the basis for identifying any potential harmful characteristics (potential hazards) of the GMO. Knowledge and experience gained in releases of the same or similar GMOs may provide important information on the potential hazards of the release in question.

Information on intended release, receiving environment and interaction between these, as requested in Annexes IIIA and IIIB to the Directive relates to the particular environment into which the GMO will be released, and the conditions, including the scale of the release. This information will determine the extent of any potentially harmful characteristics of the GMO.

4.2.   Steps in the analysis of ERA

In drawing conclusions for the ERA referred to in Articles 4, 6, 7 and 13 of Directive 2001/18/EC, the following points should be addressed as main steps in the ERA.

A ‘hazard’ (harmful characteristics) is defined as the potential of an organism to cause harm to or adverse effects on human health and/or the environment.

A ‘risk’ is the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that the consequences occur.

4.2.1.   Step 1: Identification of characteristics which may cause adverse effects

Any characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment must be identified. A comparison of 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 in the GMO. It is important not to discount any potential adverse effect on the basis that it is unlikely to occur.

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

Examples of the above potential adverse effects are given in Annexes IIIA and IIIB to Directive 2001/18/EC.

Most of the identifiable hazards (harmful characteristics) which may cause adverse effects will be related to the gene or genes of interest, deliberately introduced into the GMO and the corresponding protein(s) being expressed from these genes. Additional adverse effects, for example, pleiotropic effects, might have been generated as a result of the method used to create the transgenes, and of the location of the construction in the genome of the GMO where the transgenes were inserted. Where more than one transgene is transferred into a recipient or where a transgene is transferred into a GMO, the potential interaction of the different transgenes has to be taken into account considering potentially epigenetic or regulatory effects.

While it is important to define the hazard as accurately as possible, it will, in many cases, be useful to consider hazards under the headings set out below, and then to specify the particular hazard identified for the purposes of ERA (for example, if in a specific case a potential for adverse effects on human health — allergenicity and toxigenicity — were identified, these should be considered separately in the ERA).

If a hazard is present in the GMO, it is always present and it can be regarded as an inherent property. Hazards can give rise — with a given likelihood (step 3) — to negative consequences and these consequences in turn can have different orders of magnitude (step 2). Finally, the individual hazards have to be summarised for the GMO.

At this stage of the ERA, however, it is only necessary to consider the hazards introduced as a result of genetic modification that could cause adverse effects. Step 1 provides the scientific basis for the following steps in the ERA. Even at this stage, it is critical to identify, for each potential hazard, the specific level of scientific uncertainty so that it can be taken into account at a later stage.

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

4.2.2.   Step 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.

Apart from the likelihood that the potential harmful characteristics will occur (see Chapter 4.2.3, step 3), evaluating the magnitude of the consequences is an important part of risk assessment. The magnitude is the extent to which the consequences of any potential hazards of the GMOs to be deliberately released or placed on the market will be realised.

The magnitude is to be seen in relation to the baseline and likely to be influenced by:

For each adverse effect identified, the consequences for other organisms, populations, species or ecosystems exposed to the GMO have to be evaluated. This requires detailed knowledge of the environment into which the GMO is to be released (site, region) and the method of release. Consequences will range from ‘negligible’ or insignificant and self-limiting to ‘high’ or significant, either having an immediate and serious adverse effect or possibly leading to long-term, permanent adverse effects.

In quantitative terms the magnitude should, if possible, be expressed as ‘high’, ‘moderate’, ‘low’ or ‘negligible’. In some cases, it is not possible to identify an adverse effect in a particular environment. In such cases, the risk associated with that particular adverse effect could be assessed as ‘negligible’ or insignificant.

The following are suggested as illustrative and qualitative examples in a very broad sense. They are not intended to be definitive or exclusive, but to give an indication of the considerations that might be taken into account when weighing up the consequences:

The above examples reflect the potential adverse effects of GMOs on populations, although in some cases, it may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one adverse effect, and in fact the magnitudes of the individual adverse effects could be different. The adverse effects of one single hazard on human health, and agricultural and natural habitats could vary.

The potential consequences could be summarised in such a way as to cover all the ecological entities which could be affected (such as species, populations, trophic levels, ecosystems) including the potential effect and the level of uncertainty.

4.2.3.   Step 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 GMO(s) is intended to be released, and the manner of the release.

Besides the magnitude of the consequences of the hazards (see Chapter 4.2.2, step 2) evaluating the likelihood of adverse effects occurring is another important part in assessing risks. This step is to estimate how likely it is that adverse effects will actually occur. In some cases both the likelihood and the frequency should be addressed. As in step 2 (evaluate the potential consequences of each adverse effect if it occurs), besides the hazard itself, the number of GMOs, the receiving environment and the conditions of the release are important for defining the likelihood. Climatic, geographical, soil and demographic conditions, and the types of flora and fauna in the potential receiving environment are some of the important considerations.

For capability of survival, therefore, it is appropriate to assess the proportion of GMOs that are likely to survive, outside the intended risk management measures proposed for the deliberate release or placing on the market. Where gene transfer is likely, the probable number of such events or the extent to which transfer will occur should be considered. If the GMO has pathogenic or toxic characteristics, the proportion of target organisms in the environment likely to be affected should be assessed.

Moreover, the likelihood of the occurrence of an effect will depend on the specific risk management measures that may prevent that risk from occurring (for example, if pollen dispersal is impossible due to the destruction of the inflorescences).

For each adverse effect identified, the relative likelihood of the consequence can probably not be assessed quantitatively, but it can be expressed in terms of ‘high’, ‘moderate’, ‘low’ or ‘negligible’.

The above examples reflect the potential adverse effect of the GMO on populations, although in some cases, it may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one adverse effect, so the likelihood of individual adverse effects could also be different. The adverse effects of one single hazard on human health, agricultural and natural habitats could vary.

Likelihood could be summarised in a way which covers all the ecological entities which could be affected (such as species, populations, trophic levels, ecosystems) including measures about the potential effect as well as the level of uncertainty.

4.2.4.   Step 4: Estimation of the risk posed by each identified characteristic of the GMO(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the GMO 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.

On the basis of the conclusions reached in steps 2 and 3, an estimate of the risk of adverse effects should be made for each hazard identified in step 1. Again quantitative evaluation is unlikely to be possible. The evaluation for each hazard should consider:

Each GMO has to be considered on a case-by-case basis. Any general attempt to quantify what has been described before has to be made very carefully. For example, in one case the high magnitude of the consequences of an adverse effect may be combined with a negligible likelihood of it occurring, resulting in the whole range from high risk down to negligible risk. The result will depend on the circumstances of the case and the weighting of certain factors by the notifier, all of which should be set out clearly and justified in the recorded ERA.

The overall uncertainty for each identified risk has to be described, possibly including documentation relating to:

Although the ERA should be based on quantifiable outcomes, it is likely that many of the results of the ERA will have to be qualitative. But it is necessary, wherever possible, to have ERA results which are relative (compared with a non-GM reference, for instance), even if they are qualitative.

4.2.5.   Step 5: Application of management strategies for risks from the deliberate release or marketing of GMO(s)

The ERA may identify risks that require measures to manage them, and a risk management strategy should be defined.

Before applying risk management, consideration should be given, with a view to prevention, to modifying the release, preferably until the risk is negligible. For example, genetic elements, which may cause adverse effects or are undefined, should be avoided in the gene construction process. If this is not possible, these genetic elements should preferably be removed from the GMO at a later stage, prior to its deliberate release or placing on the market.

This should be taken into account in steps 1 to 4. Risk management should control an identified risk and cover the uncertainties. Safeguard measures should be proportionate to the level of risk and to the level of uncertainty. When relevant data becomes available at a later stage, risk management should be adapted in line with that new data.

To reduce the risk by management, the measures should clearly achieve that end. For example, if there is a risk of a gene toxic to insects inserted into a crop plant being transferred to related plant species, suitable control measures might include spatial or temporal isolation from those related species or perhaps changing the release site to an area where there is no exposure to a specific risk (such as plant species).

Management strategies can include isolation measures at every relevant stage of the handling and use of GMOs. They can also include a wide range of measures, including various means to isolate reproduction, physical or biological barriers, and cleaning machines or containers in contact with GMOs, and so on.

Detailed risk management procedures will depend on:

There should be a clear statement of the implications of risk management in terms of the necessary adjustments to experiments, conditions for placing on the market, and so on, and the consequent reduction in risk likely to be achieved.

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

An evaluation of the overall risk of the GMO(s) should be made taking into account any risk management strategies which are proposed.

On the basis of step 4 and, if appropriate, step 5, a final evaluation should be made of the overall risk, including the magnitude and likelihood of the adverse effects of the GMO, based on the combination of the risks from each individual adverse effect, including cumulative effects from other GMOs. This final evaluation should be expressed in the form of a summary of the overall risks from deliberate release or placing on the market, including the overall uncertainties.

5.   CONCLUSIONS ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OR THE PLACING ON THE MARKET OF GMOs

On the basis of an ERA, carried out in accordance with the general principles and methodology outlined in sections 3 and 4, information on the points listed in sections D1 or D2 of Annex II to Directive 2001/18/EC 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 GMOs.

Future developments, especially in the non-plant area, may give further guidance on the information to be included in the notifications.

6.   REVIEW AND ADAPTATION

6.1.   Review and adaptation of an ERA

An ERA should not be viewed as static. It should be regularly reviewed and updated or perhaps changed to take account of relevant new data (in accordance with Articles 8 or 20 of Directive 2001/18/EC). Any reviews should consider the effectiveness, efficiency and accuracy of the ERA and risk management, taking account of data from research, other deliberate releases and monitoring data. This will also depend on the level of uncertainty determined by the ERA.

Following any such reviews, the ERA and risk management should be adapted or upgraded as appropriate.

6.2.   Review and adaptation of the ERA guidance

Future developments in genetic modification may make it necessary to adapt to technical progress Annex II and these guidance notes. Further differentiation of information requirements for different types of GMOs, like single cell organisms, fish or insects, or for particular use of GMOs, like the development of vaccines, may be possible once there is sufficient experience with notifications for the release of particular GMOs in the Community (Annex III, fourth paragraph).

The review and adaptation of the ERA guidance should also take into account, where appropriate, the need to adapt to technical progress and the need to develop further guidance based on experience — where sufficient — with releases of certain GMOs into certain ecosystems, in accordance with the criteria set out in Annex V (Article 7(1)) of the Directive, as well as experience and scientific evidence relating to the safety of human health and the environment in connection with the placing on the market of certain GMOs (Article 16(2)).

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ANNEX III

INFORMATION REQUIRED IN THE NOTIFICATION

A notification referred to in part B or part C of the Directive is to include, as appropriate, the information set out below in the sub-Annexes.

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.

Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Community.

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.

Annex III A applies to releases of all types of genetically modified organisms other than higher plants. Annex III B applies to release of genetically modified higher plants.

The term ‘higher plants’ means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

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ANNEX III A

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

I.   GENERAL INFORMATION

II.   INFORMATION RELATING TO THE GMO

A.   Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate) parental organism(s):

B.   Characteristics of the vector

C.   Characteristics of the modified organism

III.   INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

A.   Information on the release

B.   Information on the environment (both on the site and in the wider environment):

IV.   INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOs AND THE ENVIRONMENT

A.   Characteristics affecting survival, multiplication and dissemination

B.   Interactions with the environment

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

A.   Monitoring techniques

B.   Control of the release

C.   Waste treatment

D.   Emergency response plans

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ANNEX III B

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

A.   GENERAL INFORMATION

B.   INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS

C.   INFORMATION RELATING TO THE GENETIC MODIFICATION

D.   INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

E.   INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

F.   INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

G.   INFORMATION ON CONTROL, MONITORING, POSTRELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)

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ANNEX IV

ADDITIONAL INFORMATION

▼M4

This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and the information for labelling requirements regarding GMOs as or in products to be placed on the market and GMOs exempted under the second subparagraph of Article 2(4). Technical guidance notes, as regards, inter alia, the description of how the product is intended to be used, may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex. The labelling requirements for exempted organisms set out in Article 26 shall be met by providing appropriate recommendations for, and restrictions on, use.

▼B

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ANNEX V

CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7)

The criteria referred to in Article 7(1) are set out below.

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ANNEX VI

GUIDELINES FOR THE ASSESSMENT REPORTS

The assessment report provided for by Articles 13, 17, 19 and 20 should include in particular the following:

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ANNEX VII

MONITORING PLAN

▼M4

This Annex describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in Article 13(2), Article 19(3) and Article 20. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex.

▼B

A.   Objective

The objective of a monitoring plan is to:

B.   General principles

Monitoring, as referred to in Articles 13, 19 and 20, takes place after the consent to the placing of a GMO on the market.

The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the GMO or its use, as such changes may be the result of environmental factors other than the placing of the GMO on the market.

Experience and data gained through the monitoring of experimental releases of GMOs may assist in designing the post marketing monitoring regime required for the placing on the market of GMOs as or in products.

C.   Design of the monitoring plan

The design of the monitoring plan should:

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ANNEX VIII

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( 1 ) OJ C 139, 4.5.1998, p. 1.

( 2 ) OJ C 407, 28.12.1998, p. 1.

( 3 ) Opinion of the European Parliament of 11 February 1999 (OJ C 150, 28.5.1999, p. 363), Council Common Position of 9 December 1999 (OJ C 64, 6.3.2000, p. 1) and Decision of the European Parliament of 12 April 2000 (OJ C 40, 7.2.2001, p. 123). Decision of the European Parliament of 14 February 2001 and Decision of the Council of 15 February 2001.

( 4 ) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

( 5 ) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 1999/80/EC (OJ L 210, 10.8.1999, p. 13).

( 6 ) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

( 7 ) OJ L 237, 28.8.1997, p. 18.

( 8 ) OJ L 184, 17.7.1999, p. 23.

( 9 ) OJ L 117, 8.5.1990, p. 1. Directive as amended by Directive 98/81/EC (OJ L 330 5.12.1998, p. 13).

( 10 ) OJ L 292, 12.11.1994, p. 31.

( 11 ) OJ L 268, 18.10.2003, p. 1.

( 12 ) Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (OJ L 225, 12.10.1970, p. 1). Directive as last amended by Directive 98/96/EC (OJ L 25, 1.2.1999, p. 27).

( 13 ) Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (OJ L 225, 12.10.1970, p. 7). Directive as last amended by Directive 98/96/EC.

( 14 ) Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material (OJ L 11, 15.1.2000, p. 17).

( 15 ) The text in italics is taken directly from Annex II to Directive 2001/18/EC.