2001L0018 — EN — 07.11.2003 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE2001/18/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of12March2001
on the deliberate release into the environment of genetically modified organisms and repealing
CouncilDirective 90/220/EEC
(OJ L 106, 17.4.2001, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Decision 2002/623/EC of 24 July 2002 L 200 22 30.7.2002
►M2Regulation (EC) No 1829/2003 of the European Parliament and of the
Council of 22 September 2003L 268 1 18.10.2003
►M3Regulation (EC) No 1830/2003 of the European Parliament and of the
Council of 22 September 2003L 268 24 18.10.2003
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DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of12March2001
on the deliberate release into the environment of genetically modi-
fiedorganismsandrepealingCouncilDirective 90/220/EEC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Acting in accordance with the procedure laid down in Article 251 of
the Treaty, in the light of the joint text approved by the Conciliation
Committee on 20 December 2000 (3),
Whereas:
(1)The Report of the Commission on the Review of Council Direc-
tive 90/220/EEC of 23 April 1990 on the deliberate release intothe environment of genetically modified organisms (
4), adopted
on 10 December 1996, identified a number of areas where
improvement is needed.
(2)There is a need for clarification of the scope of Directive 90/220/EEC and of the definitions therein.
(3)Directive 90/220/EEC has been amended. Now that new amend-ments are being made to the Directive, it is desirable, for reasons
of clarity and rationalisation, that the provisions in questionshould be recast.
(4)Living organisms, whether released into the environment in largeor small amounts for experimental purposes or as commercialproducts, may reproduce in the environment and cross nationalfrontiers thereby affecting other Member States. The effects ofsuch releases on the environment may be irreversible.
(5)The protection of human health and the environment requiresthat due attention be given to controlling risks from the delib-
erate release into the environment of genetically modified
organisms (GMOs).
(6)Under the Treaty, action by the Community relating to the envir-onment should be based on the principle that preventive actionshould be taken.
(7)It is necessary to approximate the laws of the Member Statesconcerning the deliberate release into the environment of GMOsand to ensure the safe development of industrial productsutilising GMOs.
(8)The precautionary principle has been taken into account in thedrafting of this Directive and must be taken into account when
implementing it.
(9)Respect for ethical principles recognised in a Member State is
particularly important. Member States may take into considera-2001L0018 — EN — 07.11.2003 — 002.001 — 2
(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 C64, 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 Direc-
tive 97/35/EC (OJ L 169, 27.6.1997, p. 72).
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tion ethical aspects when GMOs are deliberately released or
placed on the market as or in products.
(10)For a comprehensive and transparent legislative framework, it is
necessary to ensure that the public is consulted by either the
Commission or the Member States during the preparation ofmeasures and that they are informed of the measures takenduring the implementation of this Directive.
(11)Placing on the market also covers import. Products containingand/or consisting of GMOs covered by this Directive cannot be
imported into the Community if they do not comply with its
provisions.
(12)Making GMOs available to be imported or handled in bulkquantities, such as agricultural commodities, should be regardedas placing on the market for the purpose of this Directive.
(13)The content of this Directive duly takes into account interna-
tional experience in this field and international trade
commitments and should respect the requirements of the Carta-gena Protocol on Biosafety to the Convention on BiologicalDiversity. As soon as possible, and in any case before July2001, the Commission should, in the context of the ratification
of the Protocol, submit the appropriate proposals for its imple-
mentation.
(14)Guidance on the implementation of provisions related to thedefinition of the placing on the market in this Directive shouldbe provided by the Regulatory Committee.
(15)When defining ‘genetically modified organism’ for the purposeof this Directive, human beings should not be considered as
organisms.
(16)The provisions of this Directive should be without prejudice to
national legislation in the field of environmental liability, whileCommunity legislation in this field needs to be complementedby rules covering liability for different types of environmental
damage in all areas of the European Union. To this end the
Commission has undertaken to bring forward a legislativeproposal on environmental liability before the end of 2001,which will also cover damage from GMOs.
(17)This Directive should not apply to organisms obtained throughcertain techniques of genetic modification which have conven-
tionally been used in a number of applications and have a long
safety record.
(18)It is necessary to establish harmonised procedures and criteriafor the case-by-case evaluation of the potential risks arisingfrom the deliberate release of GMOs into the environment.
(19)A case-by-case environmental risk assessment should always be
carried out prior to a release. It should also take due account of
potential cumulative long-term effects associated with the inter-action with other GMOs and the environment.
(20)It is necessary to establish a common methodology to carry outthe environmental risk assessment based on independent scien-tific advice. It is also necessary to establish common objectives
for the monitoring of GMOs after their deliberate release or
placing on the market as or in products. Monitoring of potentialcumulative long-term effects should be considered as a compul-sory part of the monitoring plan.
(21)Member States and the Commission should ensure thatsystematic and independent research on the potential risks
involved in the deliberate release or the placing on the market
of GMOs is conducted. The necessary resources should besecured for such research by Member States and the Communityin accordance with their budgetary procedures and independentresearchers should be given access to all relevant material, whilerespecting intellectual property rights.2001L0018 — EN — 07.11.2003 — 002.001 — 3
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(22)The issue of antibiotic-resistance genes should be taken into
particular consideration when conducting the risk assessment of
GMOs containing such genes.
(23)The deliberate release of GMOs at the research stage is in mostcases a necessary step in the development of new productsderived from, or containing GMOs.
(24)The introduction of GMOs into the environment should becarried out according to the ‘step by step’ principle. This meansthat the containment of GMOs is reduced and the scale ofrelease increased gradually, stepby step , but only if evaluationof the earlier steps in terms of protection of human health andthe environment indicates that the next stepcan be taken.
(25)No GMOs, as or in products, intended for deliberate release areto be considered for placing on the market without first havingbeen subjected to satisfactory field testing at the research anddevelopment stage in ecosystems which could be affected bytheir use.
(26)The implementation of this Directive should be carried out inclose liaison with the implementation of other relevant instru-ments such as Council Directive 91/414/EEC of 15 July 1991concerning the placing of plant protection products on themarket (
1). In this context the competent authorities concerned
with the implementation of this Directive and of those instru-
ments, within the Commission and at national level, shouldcoordinate their action as far as possible.
(27)Concerning the environmental risk assessment for part C, riskmanagement, labelling, monitoring, information to the public
and safeguard clause, this Directive should be a point of refer-
ence for GMOs as or in products authorised by otherCommunity legislation which should therefore provide for aspecific environmental risk assessment, to be carried out inaccordance with the principles set out in Annex II and on thebasis of information specified in Annex III without prejudice to
additional requirements laid down by the Community legislation
mentioned above, and for requirements as regards risk manage-ment, labelling, monitoring as appropriate, information to thepublic and safeguard clause at least equivalent to that laid downin this Directive. To this end it is necessary to provide for coop-eration with the Community and Member State bodies
mentioned in this Directive for the purpose of its implementa-
tion.
(28)It is necessary to establish a Community authorisation procedurefor the placing on the market of GMOs, as or in products, wherethe intended use of the product involves the deliberate release of
the organism(s) into the environment.
(29)The Commission is invited to conduct a study which should
contain an assessment of various options to improve further theconsistency and efficiency of this framework, particularlyfocusing on a centralised authorisation procedure for the placing
on the market of GMOs within the Community.
(30)For sectoral legislation, monitoring requirements may have to be
adapted to the product concerned.
(31)Part C of this Directive does not apply to products covered byCouncil Regulation (EEC) No 2309/93 of 22 July 1993 laying
down Community procedures for the authorisation and supervi-
sion of medicinal products for human and veterinary use andestablishing a European Agency for the Evaluation of Medicinal2001L0018 — EN — 07.11.2003 — 002.001 — 4
(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Direc-
tive 1999/80/EC (OJ L 210, 10.8.1999, p. 13).
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Products(1), provided that it includes an environmental risk
assessment equivalent to that provided for by this Directive.
(32)Any person, before undertaking a deliberate release into theenvironment of a GMO, or the placing on the market of GMOs,as or in products, where the intended use of the product involves
its deliberate release into the environment, is to submit a notifi-
cation to the national competent authority.
(33)That notification should contain a technical dossier of informa-
tion including a full environmental risk assessment, appropriate
safety and emergency response, and, in the case of products,precise instructions and conditions for use, and proposed label-ling and packaging.
(34)After notification, no deliberate release of GMOs should becarried out unless the consent of the competent authority hasbeen obtained.
(35)A notifier should be able to withdraw his dossier at any stage ofthe administrative procedures laid down in this Directive. Theadministrative procedure should come to an end when a dossieris withdrawn.
(36)Rejection of a notification for the placing on the market of aGMO as or in products by a competent authority should bewithout prejudice to the submission of a notification of the
same GMO to another competent authority.
(37)An agreement should be reached at the end of the mediation
period when no objections remain.
(38)Rejection of a notification following a confirmed negativeassessment report should be without prejudice to future decisionsbased on the notification of the same GMO to another competent
authority.
(39)In the interests of the smooth functioning of this Directive,
Member States should be able to avail themselves of the various
provisions for the exchange of information and experience
before having recourse to the safeguard clause in this Directive.
(40)In order to ensure that the presence of GMOs in products
containing, or consisting of, genetically modified organisms is
appropriately identified, the words ‘This product contains geneti-cally modified organisms’ should appear clearly either on a labelor in an accompanying document.
(41)A system should be designed using the appropriate committeeprocedure, for the assignment of a unique identifier to GMOs,taking into account relevant developments in international fora.
(42)It is necessary to ensure traceability at all stages of the placingon the market of GMOs as or in products authorised under partC of this Directive.
(43)It is necessary to introduce into this Directive an obligation toimplement a monitoring plan in order to trace and identify anydirect or indirect, immediate, delayed or unforeseen effects onhuman health or the environment of GMOs as or in products
after they have been placed on the market.
(44)Member States should be able, in accordance with the Treaty, totake further measures for monitoring and inspection, for example
by official services, of the GMOs as or in products placed on themarket.
(45)Means should be sought for providing possibilities for facili-tating the control of GMOs or their retrieval in the event ofsevere risk.2001L0018 — EN — 07.11.2003 — 002.001 — 5
(1) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission Regula-
tion (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).
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(46)Comments by the public should be taken into consideration in
the drafts of measures submitted to the Regulatory Committee.
(47)The competent authority should give its consent only after it hasbeen satisfied that the release will be safe for human health and
the environment.
(48)The administrative procedure for granting consents for theplacing on the market of GMOs as or in products should bemade more efficient and more transparent and first-time consentshould be granted for a fixed period.
(49)For products for which consent has been granted for a fixedperiod a streamlined procedure should apply as regards therenewal of consent.
(50)The existing consents granted under Directive 90/220/EEC haveto be renewed in order to avoid disparities between consents
granted under that Directive and those pursuant to this Directive
and in order to take full account of the conditions of consentunder this Directive.
(51)Such renewal requires a transitional period during which existingconsents granted under Directive 90/220/EEC remain unaffected.
(52)When a consent is renewed, it should be possible to revise allthe conditions of the original consent, including those related tomonitoring and the time limitation of the consent.
(53)Provision should be made for consultation of the relevant Scien-tific Committee(s) established by Commission Decision 97/579/
EC (
1) on matters which are likely to have an impact on human
health and/or the environment.
(54)The system of exchange of information contained in notifica-tions, established under Directive 90/220/EEC, has been usefuland should be continued.
(55)It is important to follow closely the development and use ofGMOs.
(56)When a product containing a GMO, as or in products, is placedon the market, and where such a product has been properlyauthorised under this Directive, a Member State may notprohibit, restrict or impede the placing on the market of GMOs,
as or in products, which comply with the requirements of this
Directive. A safeguard procedure should be provided in case ofrisk to human health or the environment.
(57)The Commission's European Group on Ethics in Science andNew Technologies should be consulted with a view to obtainingadvice on ethical issues of a general nature regarding the delib-erate release or placing on the market of GMOs. Such
consultations should be without prejudice to the competence of
Member States as regards ethical issues.
(58)Member States should be able to consult any committee theyhave established with a view to obtaining advice on the ethicalimplications of biotechnology.
(59)The measures necessary for the implementation of this Directiveare to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on the Commis-
sion(
2).
(60)The information exchange set upunder this Directive should also
cover experience gained with the consideration of ethicalaspects.
(61)In order to increase the effective implementation of the provi-sions adopted under this Directive it is appropriate to provide2001L0018 — EN — 07.11.2003 — 002.001 — 6
(1) OJ L 237, 28.8.1997, p. 18.
(2) OJ L 184, 17.7.1999, p. 23.
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for penalties to be applied by Member States, including in the
event of release or placing on the market contrary to the provi-sions of this Directive, particularly as a result of negligence.
(62)A report to be issued every three years by the Commission,
taking into account the information provided by Member States,
should contain a separate chapter regarding the socioeconomicadvantages and disadvantages of each category of GMOsauthorised for placing on the market, which will take dueaccount of the interest of farmers and consumers.
(63)The regulatory framework for biotechnology should be reviewedso as to identify the feasibility of improving further the consis-
tency and efficiency of that framework. Procedures may need to
be adapted so as to optimise efficiency, and all options whichmight achieve that should be considered,
HAVE ADOPTED THIS DIRECTIVE:
PART A
GENERALPROVISIONS
Article 1
Objective
In accordance with the precautionary principle, the objective of this
Directive is to approximate the laws, regulations and administrativeprovisions of the Member States and to protect human health and the
environment when:
— carrying out the deliberate release into the environment of geneti-
cally modified organisms for any other purposes than placing on
the market within the Community,
— placing on the market genetically modified organisms as or in
products within the Community.
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 hasbeen 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 nospecific containment measures are used to limit their contact withand to provide a high level of safety for the general populationand the environment;2001L0018 — EN — 07.11.2003 — 002.001 — 7
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(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 23April 1990 on the contained use of genetically modifiedmicroorganisms (
1) 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 limittheir contact with and to provide a high level of safety forthe general population and the environment, the measuresshould be based on the same principles of containment as laiddown in Directive 90/219/EEC,
— making available GMOs to be used exclusively for deliberate
releases complying with the requirements laid down in part Bof 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 placingon 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 modi-
fied organisms by rail, road, inland waterway, sea or air.
Article 4
General obligations
1. Member States shall, in accordance with the precautionary prin-
ciple, ensure that all appropriate measures are taken to avoid adverseeffects on human health and the environment which might arise fromthe deliberate release or the placing on the market of GMOs. GMOsmay only be deliberately released or placed on the market in confor-
mity 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 informationwhich may be necessary to carry out the environmental risk assessmentis laid down in Annex III. Member States and the Commission shallensure that GMOs which contain genes expressing resistance to anti-
biotics in use for medical or veterinary treatment are taken into
particular consideration when carrying out an environmental riskassessment, with a view to identifying and phasing out antibiotic resis-tance markers in GMOs which may have adverse effects on humanhealth 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 GMOsauthorised under part B.2001L0018 — EN — 07.11.2003 — 002.001 — 8
(1) OJ L 117, 8.5.1990, p. 1. Directive as amended by Directive 98/81/EC (OJ
L 330 5.12.1998, p. 13).
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3. Member States and where appropriate the Commission shall
ensure that potential adverse effects on human health and the environ-ment, 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 withAnnex II taking into account the environmental impact according tothe nature of the organism introduced and the receiving environment.
4. Member States shall designate the competent authority or authori-
ties responsible for complying with the requirements of this Directive.The competent authority shall examine notifications under part B andpart 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 ensurecompliance 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 necessarymeasures are taken to terminate the release or placing on the market,to initiate remedial action if necessary, and to inform its public, theCommission and other Member States.
PART B
DELIBERATERELASEOFGMOsFORANYOTHERPURPOSETHAN
FORPLACINGONTHEMARKET
Article 5
1. Articles 6 to 11 shall not apply to medicinal substances and
compunds for human use consisting of, or containing, a GMO orcombination of GMOs provided that their deliberate release for anypurpose other than that of being placed on the market is authorised byCommunity legislation which provides:
(a) for a specific environmental risk assessment in accordance with
Annex II and on the basis of the type of information specified inAnnex III without prejudice to additional requirements providedfor by the said legislation;
(b) for explicit consent prior to release;
(c) for a monitoring plan in accordance with the relevant parts of
Annex III, with a view to detecting the effects of the GMO or
GMOs on human health or the environment;
(d) in an appropriate manner for requirements relating to treatment of
new items of information, information to the public, information onthe results of releases, and exchanges of information at leastequivalent to those contained in this Directive and in the measurestaken in accordance therewith.
2. Assessment of the risks to the environment presented by such
substances and compounds shall be carried out in coordination withthe 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 mustbe provided for by the said legislation, which must refer to this Direc-tive.
Article 6
Standardauthorisationprocedure
1. Without prejudice to Article 5, any person must, before under-
taking a deliberate release of a GMO or of a combination of GMOs,submit a notification to the competent authority of the Member Statewithin whose territory the release is to take place.2001L0018 — EN — 07.11.2003 — 002.001 — 9
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2. The notification referred to in paragraph 1 shall include:
(a) a technical dossier supplying the information specified in Annex III
necessary for carrying out the environmental risk assessment of thedeliberate release of a GMO or combination of GMOs, in parti-
cular:
(i) general information including information on personnel and
training,
(ii) information relating to the GMO(s),(iii) information relating to the conditions of release and the
potential receiving environment,
(iv) information on the interactions between the GMO(s) and the
environment,
(v) a plan for monitoring in accordance with the relevant parts of
Annex III in order to identify effects of the GMO(s) onhuman health or the environment,
(vi) information on control, remediation methods, waste treatment
and emergency response plans,
(vii) a summary of the dossier;
(b) the environmental risk assessment and the conclusions required in
Annex II, section D, together with any bibliographic reference and
indications of the methods used.
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 theiragreement in writing, or may submit additional information heconsiders 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 obser-vations 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:
(a) indicating that it is satisfied that the notification is in compliance
with this Directive and that the release may proceed; or
(b) indicating that the release does not fulfil the conditions of this
Directive and that notification is therefore rejected.
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:
(a) is awaiting further information which it may have requested from
the notifier, or
(b) is carrying out a public inquiry or consultation in accordance with
Article 9; this public inquiry or consultation shall not prolong the
90 day period referred to in paragraph 5 by more than 30 days.
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 confor-mity 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 onthe market, unless in accordance with part C.2001L0018 — EN — 07.11.2003 — 002.001 — 10
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Article 7
Differentiatedprocedures
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 theCommission a reasoned proposal for the application of differentiatedprocedures 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,
(a) forward the proposal to the competent authorities, which may,
within 60 days, present observations and at the same time;
(b) make available the proposal to the public which may, within 60
days, make comments; and
(c) consult the relevant Scientific Committee(s) which may, within 60
days give an opinion.
3. A decision shall be taken on each proposal in accordance with the
procedure laid down in Article 30(2). This decision shall establish theminimum amount of technical information from Annex III necessaryfor evaluating any foreseeable risks from the release, in particular:
(a) information relating to the GMO(s);
(b) information relating to the conditions of release and the potential
receiving environment;
(c) information on the interactions between the GMO(s) and the envir-
onment;
(d) the environmental risk assessment.
4. This decision shall be taken within 90 days of the date of the
Commission's proposal or of receipt of the competent authority'sproposal. 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 ofScientific 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 receivedthe written consent of the competent authority. The notifier shallproceed with the release in conformity with any conditions required inthis 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 ondifferent 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 (
1) 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 4for releases of GMOs within its territory, it shall inform the Commis-sion thereof.
Article 8
Handlingofmodificationsandnewinformation
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 couldhave consequences with regard to risks for human health and the envir-onment after the competent authority has given its written consent, or if2001L0018 — EN — 07.11.2003 — 002.001 — 11
(1) OJ L 292, 12.11.1994, p. 31.
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new information has become available on such risks, either while the
notification is being examined by the competent authority of a MemberState or after that authority has given its written consent, the notifier
shall immediately:
(a) take the measures necessary to protect human health and the envir-
onment;
(b) inform the competent authority in advance of any modification or
as soon as the unintended change is known or the new informationis available;
(c) revise the measures specified in the notification.
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 underthe circumstances described in paragraph 1, the competent authorityshall evaluate such information and make it available to the public. Itmay require the notifier to modify the conditions of, suspend or termi-
nate the deliberate release and shall inform the public thereof.
Article 9
Consultationofandinformationtothepublic
1. Member States shall, without prejudice to the provisions of Arti-
cles 7 and 25, consult the public and, where appropriate, groups on theproposed deliberate release. In doing so, Member States shall lay downarrangements for this consultation, including a reasonable time-period,in order to give the public or groups the opportunity to express anopinion.
2. Without prejudice to the provisions of Article 25:
— Member States shall make available to the public information on all
part B releases of GMOs in their territory;
— the Commission shall make available to the public the information
contained in the system of exchange of information pursuant toArticle 11.
Article 10
Reportingbynotifiersonreleases
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 environ-ment, with, where appropriate, particular reference to any kind ofproduct that the notifier intends to notify at a later stage. The formatfor the presentation of this result shall be established in accordancewith the procedure laid down in Article 30(2).
Article 11
Exchange of information between competent authorities and the
Commission
1. The Commission shall set upa system of exchange of the infor-
mation contained in the notifications. The competent authorities shallsend to the Commission, within 30 days of its receipt, a summary ofeach notification received under Article 6. The format of this summaryshall be established and modified if appropriate in accordance with theprocedure laid down in Article 30(2).2001L0018 — EN — 07.11.2003 — 002.001 — 12
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2. The Commission shall, at the latest 30 days following their
receipt, forward these summaries to the other Member States, whichmay, 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 rele-vant 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 thereleases 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 theCommission, which shall forward them to the competent authorities ofthe other Member States.
PART C
PLACINGONTHEMARKETOFGMOsASORINPRODUCTS
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 fora specific environmental risk assessment carried out in accordance withthe principles set out in Annex II and on the basis of information speci-fied in Annex III without prejudice to additional requirements provided
for by the Community legislation mentioned above, and for require-
ments as regards risk management, labelling, monitoring asappropriate, information to the public and safeguard clause at leastequivalent 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 orin products as far as they are authorised by that Regulation providedthat a specific environmental risk assessment is carried out in accor-dance with the principles set out in Annex II to this Directive and onthe 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 Communitylegislation concerning medicinal products for human and veterinaryuse.
3. Procedures ensuring that the risk assessment, requirements
regarding risk management, labelling, monitoring as appropriate, infor-mation to the public and safeguard clause are equivalent to those laiddown 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 tothis Directive. Until the Regulation enters into force, any GMO as orin products as far as they are authorised by other Community legisla-tion shall only be placed on the market after having been accepted forplacing 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 theCommunity under this Directive and by Member States for the purposeof implementing this Directive shall be consulted.2001L0018 — EN — 07.11.2003 — 002.001 — 13
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Article 12a
Transitional measures for adventitious or technically unavoidable
presence of genetically modified organisms having benefited from
afavourableriskevaluation
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 proces-
sing 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 September2003 on genetically modified food and feed (
1).
2. This Article shall be applicable for a period of three years after
the date of application of Regulation (EC) No 1829/2003.
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 onthe market for the first time. The competent authority shall acknowl-edge the date of receipt of the notification and immediately forwardthe summary of the dossier referred to in paragraph 2(h) to the compe-tent authorities of the other Member States and the Commission.
The competent authority shall without delay examine whether the noti-
fication is in accordance with paragraph 2 and shall, if necessary, askthe 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 Article14(2), the competent authority shall forward a copy of the notificationto the Commission which shall, within 30 days of its receipt, forward itto the competent authorities of the other Member States.
2. The notification shall contain:
(a) the information required in Annexes III and IV. This information
shall take into account the diversity of sites of use of the GMO asor in a product and shall include information on data and results
obtained from research and developmental releases concerning the
impact of the release on human health and the environment;
(b) the environmental risk assessment and the conclusions required in
Annex II, section D;
(c) the conditions for the placing on the market of the product,
including specific conditions of use and handling;
(d) with reference to Article 15(4), a proposed period for the consent
which should not exceed ten years;
(e) a plan for monitoring in accordance with Annex VII, including a
proposal for the time-period of the monitoring plan; this time-
period may be different from the proposed period for the consent;
(f) a proposal for labelling which shall comply with the requirements
laid down in Annex IV. The labelling shall clearly state that aGMO is present. The words ‘this product contains geneticallymodified organisms’ shall appear either on a label or in an accom-panying document;
(g) a proposal for packaging which shall comprise the requirements
laid down in Annex IV;
(h) a summary of the dossier. The format of the summary shall be
established in accordance with the procedure laid down in Article30(2).2001L0018 — EN — 07.11.2003 — 002.001 — 14
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If on the basis of the results of any release notified under part B, or on
other substantive, reasoned scientific grounds, a notifier considers thatthe 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 informationrequired 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 ofGMOs previously or currently notified and/or carried out by the noti-
fier 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 informationhe considers relevant, provided that the information, data and resultsare non-confidential or these notifiers have given their agreement inwriting.
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 sepa-
rate 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 writtenconsent is granted, the notifier shall immediately take the measuresnecessary 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
Assessmentreport
1. On receipt and after acknowledgement of the notification in
accordance with Article 13(2), the competent authority shall examineit for compliance with this Directive.
2. Within 90 days after receipt of the notification the competent
authority shall:
— prepare an assessment report and send it to the notifier. A subse-
quent withdrawal by the notifier shall be without prejudice to anyfurther submission of the notification to another competentauthority;
— in the case referred to in paragraph 3(a), send its report, together
with the information referred to in paragraph 4 and any other infor-mation on which it has based its report, to the Commission which
shall, within 30 days of its receipt, forward it to the competent
authorities of the other Member States.
In the case referred to paragraph 3(b), the competent authority shall
send its report, together with the information referred to in paragraph4 and any other information on which it has based its report, to theCommission no earlier than 15 days after sending the assessment reportto the notifier and no later than 105 days after receipt of the notifica-
tion. 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:
(a) the GMO(s) in question should be placed on the market and under
which conditions; or
(b) the GMO(s) in question should not be placed on the market.
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 authorityis awaiting further information which it may have requested from thenotifier shall not be taken into account. The competent authority shallstate the reasons in any request for further information.2001L0018 — EN — 07.11.2003 — 002.001 — 15
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Article 15
Standardprocedure
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 circu-lation of the assessment report.
Comments or reasoned objections and replies shall be forwarded to the
Commission which shall immediately circulate them to all competentauthorities.
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 calculatingthe final 45 day period for arriving at an agreement. Reasons shall bestated 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. Thisdecision 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 anyreasoned objection from a Member State or the Commission within 60days 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 authoritywhich prepared the report shall give consent in writing for placing onthe market, shall transmit it to the notifier and shall inform the otherMember 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 relevantCommunity provisions, the period of the first consent shall end at thelatest ten years after the date of the first inclusion of the first plantvariety containing the GMO on an official national catalogue of plant
varieties in accordance with Council Directives 70/457/EEC (
1) and 70/
458/EEC (2).
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 inclu-sion of basic material containing the GMO on an official nationalregister of basic material in accordance with Council Directive 1999/105/EC (
3).
Article 16
Criteria andinformationforspecifiedGMOs
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 theplacing on the market of certain types of GMOs as or in products.2001L0018 — EN — 07.11.2003 — 002.001 — 16
(1) Council Directive 70/457/EEC of 29 September 1970 on the common cata-
logue 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).
(2) 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.
(3) Council Directive 1999/105/EC of 22 December 1999 on the marketing of
forest reproductive material (OJ L 11, 15.1.2000, p. 17).
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2. These criteria and information requirements as well as any appro-
priate requirements for a summary shall be adopted, after consultationof the relevant Scientific Committee(s), in accordance with the proce-
dure laid down in Article 30(2). The criteria and the information
requirements shall be such as to ensure a high level of safety to humanhealth and the environment and be based on the scientific evidenceavailable on such safety and on the experience gained from the releaseof comparable GMOs.
The requirements set out in Article 13(2) shall be replaced by those
adopted above, and the procedure set out in Article 13(3), (4), (5) and(6) and Articles 14 and 15 shall apply.
3. Before the procedure laid down in Article 30(2) for a decision on
criteria and information requirements referred to in paragraph 1 isinitiated, 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 withan analysis, to the Committee set upp ursuant to Article 30.
Article 17
Renewalofconsent
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:
(a) consents granted under part C; and
(b) before 17 October 2006 of consents granted under Directive 90/
220/EEC for placing on the market of GMOs as or in products
before 17 October 2002,
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, forthe consents referred to in paragraph 1(b), the notifier under thisArticle shall submit a notification to the competent authority whichreceived the original notification, which shall contain:
(a) a copy of the consent to the placing on the market of the GMOs;
(b) a report on the results of the monitoring which was carried out
according to Article 20. In the case of consents referred to in para-graph 1(b), this report shall be submitted when the monitoring was
carried out;
(c) any other new information which has become available with regard
to the risks of the product to human health and/or the environment;
and
(d) as appropriate, a proposal for amending or complementing the
conditions of the original consent, inter alia the conditions
concerning future monitoring and the time limitation of the
consent.
The competent authority shall acknowledge the date of receipt of the
notification and when the notification is in accordance with this para-graph it shall without delay forward a copy of the notification and itsassessment report to the Commission, which shall, within 30 days oftheir 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:
(a) the GMO(s) should remain on the market and under which condi-
tions; or
(b) the GMO(s) should not remain on the market.
4. The other competent authorities or the Commission may ask for
further information, make comments, or present reasoned objectionswithin a period of 60 days from the date of circulation of the assess-ment report.2001L0018 — EN — 07.11.2003 — 002.001 — 17
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5. All comments, reasoned objections and replies shall be forwarded
to the Commission which shall immediately circulate them to allcompetent 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 fromthe date of circulation of the assessment report, the competent authoritywhich prepared the report shall transmit to the notifier the final deci-
sion in writing and shall inform the other Member States and the
Commission thereof within 30 days. The validity of the consent shouldnot, as a general rule, exceed ten years and may be limited or extendedas 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 thereport 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 accor-
dance 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
Communityprocedure incaseofobjections
1. In cases where an objection is raised and maintained by a compe-
tent authority or the Commission in accordance with Articles 15, 17and 20, a decision shall be adopted and published within 120 days inaccordance with the procedure laid down in Article 30(2). This deci-sion 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 itmay have requested from the notifier or is seeking the opinion of theScientific Committee which has been consulted in accordance withArticle 28 shall not be taken into account. The Commission shall state
reasons in any request for further information and inform the compe-
tent authorities of its requests to the notifier. The period of timeduring which the Commission is awaiting the opinion of the ScientificCommittee 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 tothe placing on the market or to the renewal of the consent, shalltransmit 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 legis-
lation, only if a written consent has been given for the placing on themarket of a GMO as or in a product may that product be used withoutfurther notification throughout the Community in so far as the specificconditions of use and the environments and/or geographical areas stipu-
lated 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 authorityin accordance with Articles 15, 17 and 18, and in conformity with anyconditions required in that consent.2001L0018 — EN — 07.11.2003 — 002.001 — 18
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3. The written consent referred to in Articles 15, 17 and 18 shall, in
all cases, explicitly specify:
(a) the scope of the consent, including the identity of the GMO(s) to
be placed on the market as or in products, and their unique identi-fier;
(b) the period of validity of the consent;
(c) the conditions for the placing on the market of the product,
including any specific condition of use, handling and packaging ofthe GMO(s) as or in products, and conditions for the protection of
particular ecosystems/environments and/or geographical areas;
(d) that, without prejudice to Article 25, the notifier shall make control
samples available to the competent authority on request;
(e) the labelling requirements, in compliance with the requirements
laid down in Annex IV. The labelling shall clearly state that aGMO is present. The words ‘This product contains geneticallymodified organisms’ shall appear either on a label or in a documentaccompanying the product or other products containing the
GMO(s);
(f) monitoring requirements in accordance with Annex VII, including
obligations to report to the Commission and competent authorities,
the time period of the monitoring plan and, where appropriate, anyobligations on any person selling the product or any user of it, inter
alia, in the case of GMOs grown, concerning a level of information
deemed appropriate on their location.
4. Member States shall take all necessary measures to ensure that
the written consent and the decision referred to in Article 18, whereapplicable, are made accessible to the public and that the conditionsspecified in the written consent and the decision, where applicable,
are complied with.
Article 20
Monitoringandhandlingofnewinformation
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 carriedout according to the conditions specified in the consent. The reports of
this monitoring shall be submitted to the Commission and the compe-
tent authorities of the Member States. On the basis of these reports, inaccordance with the consent and within the framework for the moni-toring plan specified in the consent, the competent authority whichreceived the original notification may adapt the monitoring plan afterthe 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 theenvironment 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 humanhealth or the environment, or under the circumstances described inparagraph 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) whereappropriate, when the information has become available before thewritten consent.
When the information has become available after the consent has been
given, the competent authority shall within 60 days after receipt of thenew information, forward its assessment report indicating whether andhow the conditions of the consent should be amended or the consentshould be terminated to the Commission which shall, within 30 days2001L0018 — EN — 07.11.2003 — 002.001 — 19
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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 forwardthem 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 thenew information or if outstanding issues are resolved within 75 days,the competent authority which prepared the report shall amend theconsent 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 avail-able.
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 relevantrequirements specified in the written consent referred to in Articles15(3), 17(5) and (8), 18(2) and 19(3).
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
according to the provision in paragraph 1. The threshold levels shallbe established according to the product concerned, under the procedurelaid down in Article 30(2).
3. For products intended for direct processing, paragraph 1 shall not
apply to traces of authorised GMOs in a proportion no higher than
0,9 % or lower thresholds established under the provisions of Article30(2), provided that these traces are adventitious or technicallyunavoidable.
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 inproducts, which comply with the requirements of this Directive.
Article 23
Safeguardclause
1. Where a Member State, as a result of new or additional informa-
tion made available since the date of the consent and affecting theenvironmental 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 hasbeen properly notified and has received written consent under thisDirective constitutes a risk to human health or the environment, thatMember State may provisionally restrict or prohibit the use and/orsale of that GMO as or in a product on its territory.2001L0018 — EN — 07.11.2003 — 002.001 — 20
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The Member State shall ensure that in the event of a severe risk, emer-
gency measures, such as suspension or termination of the placing onthe 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 givereasons for its decision, supplying its review of the environmental riskassessment, 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 isbased.
2. A decision shall be taken on the matter within 60 days in accor-
dance with the procedure laid down in Article 30(2). For the purpose of
calculating the 60 day period, any period of time during which theCommission is awaiting further information which it may haverequested from the notifier or is seeking the opinion of the ScientificCommittee(s) which has/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(s) consulted shall not exceed60 days.
Likewise, the period of time the Council takes to act in accordance
with the procedure laid down in Article 30(2) shall not be taken into
account.
Article 24
Informationtothepublic
1. Without prejudice to Article 25, upon receipt of a notification in
accordance with Article 13(1), the Commission shall immediately makeavailable 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 makecomments to the Commission within 30 days. The Commission shallimmediately 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 placingon the market was rejected as or in products under this Directive, theassessment reports carried out for these GMOs and the opinion(s) ofthe Scientific Committees consulted shall be made available to thepublic. For each product, the GMO or GMOs contained therein and
the use or uses shall be clearly specified.
PART D
FINALPROVISIONS
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 confiden-
tial. 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:
— general description of the GMO or GMOs, name and address of the
notifier, purpose of the release, location of release and intendeduses;2001L0018 — EN — 07.11.2003 — 002.001 — 21
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— methods and plans for monitoring of the GMO or GMOs and for
emergency response;
— environmental risk assessment.
5. If, for whatever reasons, the notifier withdraws the notification,
the competent authorities and the Commission must respect the confi-dentiality of the information supplied.
Article 26
Labelling of GMOs referred to in Article 2(4), second subpara-
graph
1. The GMOs to be made available for operations referred to under
Article 2(4), second subparagraph, shall be subject to adequate label-
ling requirements in accordance with the relevant sections of AnnexIV in order to provide for clear information, on a label or in an accom-panying document, on the presence of GMOs. To that effect the words‘This product contains genetically modified organisms’ shall appeareither on a label or in an accompanying document.
2. The conditions for the implementation of paragraph 1 shall,
without duplicating or creating inconsistencies with existing labellingprovisions laid down in existing Community legislation, be determinedin accordance with the procedure laid down in Article 30(2). In doing
so, account should be taken, as appropriate, of labelling provisions
established by Member States in accordance with Community legisla-tion.
Article 26a
MeasurestoavoidtheunintendedpresenceofGMOs
1. Member States may take appropriate measures to avoid the unin-
tended presence of GMOs in other products.
2. The Commission shall gather and coordinate information based
on studies at Community and national level, observe the developmentsregarding coexistence in the Member States and, on the basis of the
information and observations, developguidelines on the coexistence
of genetically modified, conventional and organic crops.
Article 27
AdaptationofAnnexestotechnical progress
Sections C and D of Annex II, Annexes III to VI, and section C of
Annex VII shall be adapted to technical progress in accordance with
the procedure laid down in Article 30(2).
Article 28
ConsultationofScientific 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 authorityor the Commission and maintained in accordance with Article 15(1),17(4), 20(3) or 23, or where the assessment report referred to in Article14 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 objec-tion.
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 2.2001L0018 — EN — 07.11.2003 — 002.001 — 22
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Article 29
ConsultationofCommittee(s)onEthics
1. Without prejudice to the competence of Member States as regards
ethical issues, the Commission shall, on its own initiative or at therequest of the European Parliament or the Council, consult anycommittee it has created with a view to obtaining its advice on theethical 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
Committeeprocedure
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 ofArticle 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The committee shall adopt its own rules of procedure.
Article 31
Exchangeofinformationandreporting
1. Member States and the Commission shall meet regularly and
exchange information on the experience acquired with regard to theprevention of risks related to the release and the placing on the marketof 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 consultationand information of the public.
Where necessary, guidance on the implementation of Article 2(4),
second subparagraph, may be provided by the committee establishedunder Article 30(1).
2. The Commission shall establish one or several register(s) for the
purpose of recording the information on genetic modifications inGMOs mentioned in point A No 7 of Annex IV. Without prejudice toArticle 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 Article30(2).
3. Without prejudice to paragraph 2 and point A No 7 of Annex IV,
(a) Member States shall establish public registers in which the location
of the release of the GMOs under part B is recorded.
(b) Member States shall also establish registers for recording the loca-
tion of GMOs grown under part C, inter alia so that the possible
effects of such GMOs on the environment may be monitored inaccordance with the provisions of Articles 19(3)(f) and 20(1).
Without prejudice to such provisions in Articles 19 and 20, the
said locations shall:
— be notified to the competent authorities, and
— be made known to the public2001L0018 — EN — 07.11.2003 — 002.001 — 23
▼B
in the manner deemed appropriate by the competent authorities and
in accordance with national provisions.
4. Every three years, Member States shall send the Commission a
report on the measures taken to implement the provisions of this Direc-tive. This report shall include a brief factual report on their experiencewith GMOs placed on the market in or as products under this Direc-tive.
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 partC including an assessment of:
(a) all its implications, particularly to take account of the diversity of
European ecosystems and the need to complement the regulatoryframework in this field;
(b) the feasibility of various options to improve further the consistency
and efficiency of this framework, including a centralised Commu-nity authorisation procedure and the arrangements for the finaldecision making by the Commission;
(c) whether sufficient experience has accumulated on the implementa-
tion of part B differentiated procedures to justify a provision onimplicit consent in these procedures and on part C to justify the
application of differentiated procedures; and
(d) the socioeconomic implications of deliberate releases and placing
on the market of GMOs.
8. The Commission shall send to the European Parliament and the
Council every year, a report on the ethical issues referred to in Article29(1); this report may be accompanied, if appropriate, by a proposalwith a view to amending this Directive.
Article 32
ImplementationoftheCartagenaProtocol onbiosafety
1. The Commission is invited to bring forward as soon as possible
and in any case before July 2001 a legislative proposal for imple-
menting in detail the Cartagena Protocol on biosafety. The proposal
shall complement and, if necessary, amend the provisions of this Direc-tive.
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 penal-ties 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 by17 October 2002. They shall forthwith inform the Commission thereof.2001L0018 — EN — 07.11.2003 — 002.001 — 24
▼B
When Member States adopt these measures they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on theoccasion 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 fieldcovered by this Directive.
Article 35
Pendingnotifications
1. Notifications concerning placing on the market of GMOs as or in
products received pursuant to Directive 90/220/EEC, and in respect ofwhich the procedures of that Directive have not been completed by 17October 2002 shall be subject to the provisions of this Directive.
2. By 17 January 2003 notifiers shall have complemented their noti-
fication 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 withthe 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.2001L0018 — EN — 07.11.2003 — 002.001 — 25
▼B
ANNEX I A
TECHNIQUESREFERREDTOINARTICLE2(2)
PART 1
Techniques of genetic modification referred to in Article 2(2)(a) are inter alia:
(1) recombinant nucleic acid techniques involving the formation of new combi-
nations 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 two or more cells by means of methods that do not
occur naturally.
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 recombi-
nant nucleic acid molecules or genetically modified organisms made by
techniques/methods other than those excluded by Annex I B:
(1) in vitro fertilisation,
(2) natural processes such as: conjugation, transduction, transformation,
(3) polyploidy induction.2001L0018 — EN — 07.11.2003 — 002.001 — 26
▼B
ANNEX I B
TECHNIQUESREFERREDTOINARTICLE3
Techniques/methods of genetic modification yielding organisms to be excluded
from the Directive, on the condition that they do not involve the use of recom-
binant nucleic acid molecules or genetically modified organisms other than
those produced by one or more of the techniques/methods listed below are:
(1) mutagenesis,
(2) cell fusion (including protoplast fusion) of plant cells of organisms which
can exchange genetic material through traditional breeding methods.2001L0018 — EN — 07.11.2003 — 002.001 — 27
▼B
ANNEX II
PRINCIPLESFORTHEENVIRONMENTALRISKASSESSMENT
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. It will be supplemented by guidance notes to be developed
in accordance with the procedure laid down in Article 30(2). These guidance
notes shall be completed by 17 October 2002.
With a view to contributing to a common understanding of the terms ‘direct,
indirect, immediate and delayed’ when implementing this Annex, without preju-
dice 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 GMO itself and which do not occur through a
causal chain of events;
— ‘indirect effects’ refers to effects on human health or the environment occur-
ring 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 accumu-
lated effects of consents on human health and the environment, including inter
aliaflora and fauna, soil fertility, soil degradation of organic material, the feed/
food chain, biological diversity, animal health and resistance problems in rela-
tion to antibiotics.
A.Objective
The objective of an e.r.a. is, on a case by case basis, to identify and eval-
uate 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.GeneralPrinciples
In accordance with the precautionary principle, the following general prin-
ciples should be followed when performing the e.r.a.:
— identified characteristics of the GMO and its use which have the poten-
tial 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 e.r.a. should be carried out in a scientifically sound and transparent
manner based on available scientific and technical data;
— the e.r.a. should be carried out on a case by case basis, meaning that
the required information may vary depending on the type of the
GMOs concerned, their intended use and the potential receiving envir-
onment, taking into account, i.a., GMOs already in the environment;
— if new information on the GMO and its effects on human health or the
environment becomes available, the e.r.a. may need to be readdressed
in order to:
— determine whether the risk has changed;
— determine whether there is a need for amending the risk manage-
ment accordingly.2001L0018 — EN — 07.11.2003 — 002.001 — 28
▼B
C.Methodology
C.1. Characteristics of GMOs and releases
Depending on the case the e.r.a. has to take into account the relevant tech-
nical and scientific details regarding characteristics of:
— the recipient or parental organism(s);
— the genetic modification(s), be it inclusion or deletion of genetic mate-
rial, 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 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 unli-
kely to occur.
Potential adverse effects of GMOs will vary from case to case, and may
include:
— disease to humans including allergenic or toxic effects (see for
example items II.A.11. and II.C.2(i) in Annex III A, and B 7 in
Annex III B);
— disease to animals and plants including toxic, and where appro-
priate, allergenic effects (see for example items II.A.11. and
II.C.2(i) in Annex III A, and B 7 and D 8 in Annex III B);
— 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 Annex III A);
— altered susceptibility to pathogens facilitating the dissemination of
infectious diseases and/or creating new reservoirs or vectors;
— compromising prophylactic or therapeutic medical, veterinary, or
plant protection treatments, for example by transfer of genes confer-
ring resistance to antibiotics used in human or veterinary medicine
(see for example items II.A.11(e) and II.C.2(i)(iv) in Annex III A);
— effects on biogeochemistry( biogeochemical cycles), particularly
carbon and nitrogen recycling through changes in soil decomposi-
tion of organic material (see for example items II.A.11(f) and
IV.B.15 in Annex III A, and D 11 in Annex III B).
Adverse effects may occur directly or indirectly through mechanisms
which may include:
— the spread of the GMO(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 GMO(s) is (are) intended to be released
and the manner of the release.2001L0018 — EN — 07.11.2003 — 002.001 — 29
▼B
3.Evaluation of the likelihood of the occurrence of each identified poten-
tial 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.Conclusionsonthepotentialenvironmentalimpactfromthereleaseor
theplacingonthemarketofGMOs
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 environ-
mental impact from the release or the placing on the market of GMOs:
D.1. In the case of GMOs other than higher plants
1. Likelihood of the GMO 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 GMO 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 GMO and any selective advantage or disadvan-
tage conferred to those species.
4. Potential immediate and/or delayed environmental impact of the direct
and indirect interactions between the GMO and target organisms (if
applicable).
5. Potential immediate and/or delayed environmental impact of the direct
and indirect interactions between the GMO with non-target organisms,
including impact on population levels of competitors, prey, hosts,
symbionts, predators, parasites and pathogens.
6. Possible immediate and/or delayed effects on human health resulting
from potential direct and indirect interactions of the GMO and persons
working with, coming into contact with or in the vicinity of the GMO
release(s).
7. Possible immediate and/or delayed effects on animal health and conse-
quences for the feed/food chain resulting from consumption of the
GMO 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 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 techniques used for the management of the
GMO where these are different from those used for non-GMOs.
D.2. In the case of genetically modified higher plants (GMHP)
1. Likelihood of the GMHP becoming more persistent than the recipient or
parental plants in agricultural habitats or more invasive in natural habi-
tats.
2. Any selective advantage or disadvantage conferred to the GMHP.2001L0018 — EN — 07.11.2003 — 002.001 — 30
▼B
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 organ-
isms), 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 conse-
quences 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 techni-
ques used for the GMHP where these are different from those used for
non-GMHPs.2001L0018 — EN — 07.11.2003 — 002.001 — 31
▼M1
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 obliga-
tions 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 environ-
mental 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(1).
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 applic-
able).
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 organ-
isms, 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 para-
graph, 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.2001L0018 — EN — 07.11.2003 — 002.001 — 32
(1) The text in italics is taken directly from Annex II to Directive 2001/18/EC.
▼M1
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:
—‘direct effects’ refers to primary effects on human health or the environment
which are a result of the GMO itself and which do not occur through a
causal chain of events (for example, the direct effect of the Bt toxin on
target organisms, or the pathogenic effect of a GM microorganism on human
health),
—‘indirect effects’ refers to effects on human health or the environment occur-
ring 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(for example, where reducing the target population of insects affects
the population of other insects, or where the development of multiple resis-
tance or systemic effects will require assessment of long-term interaction;
however, some indirect effects such as reductions in usage of pesticides
could be immediate),
—‘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 (for example, death of insects foraging on
transgenic plants that have pest-resistant traits, or the induction of allergies
in susceptible humans due to exposure to a particular GMO),
—‘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 (for example, establishment or invasive behaviour
of a GMO after several generations following deliberate release, which is
very important if the GMO lives for a long time, for example, genetically
modified tree species; or hybrids of close relatives of a transgenic crop
becoming invasive in natural ecosystems).
The delayed effects in particular may be difficult to determine, especially if they
become apparent only in the long term. Appropriate measures such as moni-
toring (see below) can helpin detecting these effects.
3.GENERALPRINCIPLES
In accordance with the precautionary principle, the ERA should be based on the
following general principles:
—Identified characteristics of the GMO and its use which have the potential to
cause adverse effects should be compared to those presented by the non-
modified organism from which it is derived and its use under corresponding
situations.
A baseline of the receiving environment, including its organisms and their
interactions and their known variations, should be determined before any
(harmful) characteristics of the GMO can be identified. The baseline serves
as a point of reference against which future changes can be compared. For
example, in the case of vegetatively propagated crops, comparative analysis
should include the parental species used to generate the transgenic lines. In
the case of crops that reproduce sexually, comparators would include appro-
priate isogenic lines. If crops are developed using back-crossing, it is
important that in such cases substantial equivalence testing uses the most
appropriate controls and does not simply rely on comparisons with original
parental material.
If the existing data are not sufficient, a baseline has to be defined on other
references to allow a comparison. The baseline will depend to a considerable
extent on the receiving environment, including biotic and abiotic factors (for
example, natural preserved habitats, agricultural farmland or contaminated
land) or a combination of different environments.
—The ERA should be carried out in a scientifically sound and transparent
manner based on available scientific and technical data.
Evaluation of potential adverse effects should be based on scientific and
technical data and on common methodology for the identification, gathering
and interpretation of the relevant data. Data, measurements and tests should
be clearly described. In addition, the use of scientifically sound modelling
procedures could provide missing data useful for ERA.
ERA has to take into account uncertainty at various levels. Scientific uncer-
tainty results usually from five characteristics of the scientific method: the
variable chosen, the measurements made, the samples taken, the models
used and the causal relationships employed. Scientific uncertainty may also
arise from a controversy on existing data or lack of some relevant data.
Uncertainty may relate to qualitative or quantitative elements of the analysis.
The level of knowledge or data for a baseline is reflected by the level of
uncertainty, which has to be provided by the notifier (assessment of uncer-2001L0018 — EN — 07.11.2003 — 002.001 — 33
▼M1
tainty, including lack of data, knowledge gaps, standard deviation,
complexity, etc.) in comparison with the scientific uncertainties in current
practice.
The ERA may not always result in definitive answers to all the questions
considered because of lack of data. For potential long-term effects, in parti-
cular, the availability of data may be very low. In these cases in particular
appropriate risk management (safeguards) has to be considered in accor-
dance with the precautionary principle in order to prevent adverse effects
on human health and the environment.
As a general principle, the ERA should include the results of adequate
research into the potential risks involved in the deliberate release or placing
on the market of GMOs, along with any clearly documented comparable
experience.
Use of the step-by-step approach (i.e. all the steps beginning with experi-
ments in the contained use system through deliberate release upto p lacing
on the market) can be useful. Data from each stepshould be collected as
early as possible during the procedure. Simulated environmental conditions
in a contained system could give results of relevance to deliberate release
(for example, the behaviour of microorganisms can be simulated in micro-
cosms, or the behaviour of plants can be simulated in greenhouses to a
certain extent).
For GMOs to be placed on the market, relevant and available data from
deliberate releases should be provided from the types of environment where
the GMO will be used.
—The ERA should be carried out on a case by case basis, meaning that the
required information may vary depending on the type of the GMOs
concerned, their intended use and the potential receiving environment,
taking into account, inter alia , GMOs already in the environment.
The ERA should use the case-by-case principle because of the broad range
of individual characteristics of different organisms (GMO by GMO) and
different environments (site by site and region by region).
There may be a huge variety in the environmental effects of genetically
modified microorganisms (because of their small size and their often
unknown interactions), plants (for example, higher plants used for food and
feed, or trees because of their potential longevity), and animals (for example,
insects because of their small size and their high potential for overcoming
barriers; or saltwater fish because of their high distribution potential).
Moreover, there may be a broad range of environmental characteristics (site-
specific or regional-specific) to be taken into account. To support a case-by-
case assessment, it may be useful to classify regional data by habitat area,
reflecting aspects of the receiving environment relevant to GMOs (for
example, botanical data on the occurrence of wild relatives of GMO plants
in different agricultural or natural habitats of Europe).
The notifier must also take into account potentially harmful interactions of
the GMO with any relevant GMOs that may have been deliberately released
or placed on the market in the past, including repeated releases of the same
GMO, such as the use of plant protection products. Repeated releases, as
compared to occasional releases, might in time cause a high background
level of the GMO to become permanent in the environment.
If new information on the GMO and its effects on human health or the
environment becomes available, the ERA may need to be re-addressed in
order to:
— determine whether the risk has changed,
— determine whether there it is necessary to amend the risk management
accordingly.
In the case of new information, irrespective of whether immediate measures
need to be taken, there may have to be a new ERA to assess the need to
change the terms of authorisation for the GMO's release or placing on the
market, or to adjust risk management measures (see also Chapter 6). New
information can arise from research or from monitoring plans, or from rele-
vant experience elsewhere.
ERA and monitoring are closely linked. The ERA provides the basis for the
monitoring plans, which focus on adverse effects on human health and the
environment. The requirements for the monitoring plans for the deliberate
release of GMOs (Part B in accordance with the relevant parts of Annex
III) and the placing on the market of GMOs (Part C in accordance with
Annex VII) are different. The Part C monitoring, including general surveil-
lance, may also play an important role in providing data for long-term,
potentially adverse effects of GMOs. Monitoring results may confirm the
ERA or may lead to re-evaluation of the ERA.
—A general principle for ERA 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 flora and2001L0018 — EN — 07.11.2003 — 002.001 — 34
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fauna, soil fertility, soil degradation of organic material, the feed/food
chain, biological diversity, animal health and resistance problems in relation
to antibiotics.
In considering the potential cumulative long-term effects, the ERA should
take into account issues such as:
— the long-term interactions of the GMO and the receiving environment,
— the characteristics of a GMO which become important on a long-term
basis,
— repeated deliberate releases or placings on the market over a long period,— the GMOs deliberately released or placed on the market in the past.Further information may be required on long-term effects in particular (for
instance, multiple herbicide resistances) and there must be adequate
research, partly within the framework of the monitoring plans, which can
provide important data for assessing cumulative long-term effects. Further
guidance on this item may be recommended.
4.METHODOLOGY
4.1.CharacteristicsofGMOs andreleases
The ERA has to take into account the relevant technical and scientific details
regarding characteristics of:
— the recipient or parental organism(s),
— the genetic modification(s), be it inclusion or deletion of genetic material,
and relevant information on the vector and the donor,
— 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 and organisms withsimilar
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 identi-
fying 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 parti-
cular 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.StepsintheanalysisofERA
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.2001L0018 — EN — 07.11.2003 — 002.001 — 35
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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-modi-
fied 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:
— disease to humans including allergenic or toxic effects,
— disease to animals and plants including toxic, and where appropriate, aller-
genic effects,
— effects on the dynamics of populations of species in the receiving environ-
ment and the genetic diversity of each of these populations,
— altered susceptibility to pathogens facilitating the dissemination of infectious
diseases and/or creating new reservoirs or vectors,
— compromising prophylactic or therapeutic medical, veterinary, or plant
protection treatments, for example by transfer of genes conferring resistance
to antibiotics used in human or veterinary medicine,
— effects on biogeochemistry (biogeochemical cycles), particularly carbon and
nitrogen recycling through changes in soil decomposition of organic mate-
rial.
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 intro-
duced 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 interac-
tion 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)2001L0018 — EN — 07.11.2003 — 002.001 — 36
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— to negative consequences and these consequences in turn can have different
orders of magnitude (step2). 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:
— The spread of the GMO(s) in the environment
Distribution pathways show the potential pathways of distribution of the
GMO or of the potential hazard into and within the environment (for
example, human toxicity: inhalation of toxic microorganisms or toxic
proteins).
The potential of a GMO to spread into the environment will depend, for
example, on:
— its biological fitness (GMOs designed for better performance in the
environment of interest by the expression of traits leading to increased
competitiveness in natural environments, or qualitative and quantitative
change in composition of ingredients, or GMOs with resistance to natural
selection pressure like disease, or abiotic stress like heat, cold, salt, or
production of anti-microbial substances in microorganisms),
— the conditions of the deliberate release or placing on the market (particu-
larly the area of release and the scale, that is to say, the number of
GMOs released),
— the likelihood of a deliberate release or placing on the market, or unin-
tentional releases into the environment (for example, GMOs for
processing),
— pathways of dispersal of viable material (for example, seeds, spores and
so on) by wind, water, animals, etc.,
— particular environmental considerations (site-specific or regional-
specific): to allow a site-by-site or a region-by-region assessment it may
be useful to classify data by habitat area, reflecting aspects of the
receiving environment relevant to the GMO (for example, botanical
data on the occurrence of crossable wild relatives of GMO plants in
different agricultural or natural habitats of Europe).
It is also important to assess the length of time an individual GMO or a
specific number of GMOs of a certain species is generally likely to survive,
and the readiness with which it can be disseminated and become established
in a variety of habitats. Consideration will need to be given to reproductive,
survival and dormant forms, including, for example:
— for plants: the viability of pollen, seeds and vegetative structures,
— for microorganisms: the viability of spores as survival forms, or the
potential of the microorganisms to enter the viable but not cultivable
state.
The overall spread potential may vary considerably, depending on the
species, the genetic modification and the receiving environment, for example
plant cultivation in the desert or fish cultivation in the sea.
— The transfer of the inserted genetic material to other organisms, or the same
organism whether genetically modified or not
A hazard could result in adverse effects through gene transfer within the
same species or to other species (vertical and horizontal gene transfer). The
speed and extent of gene transfer to other species (usually sexually compa-
tible in the case of higher organisms) will depend, for example, on:
— the reproductive properties of the GMO itself, including the modified
sequences,
— the conditions of release, and particular environmental considerations
such as climate (for example, wind),
— differences in reproduction biology,
— agricultural practices,— the availability of potential crossing partners,— transport and pollinating vectors (for example, insects or birds, animals
in general),
— the availability of hosts for parasites.
The occurrence of specific adverse effects through gene transfer may be
linked to the number of GMOs released. Large fields of transgenic plants
may have a completely different potential for gene transfer from small2001L0018 — EN — 07.11.2003 — 002.001 — 37
▼M1
fields, even on a proportional basis. Moreover, qualitative and quantitative
information about the existence of potential crossing partners or recipients
(for plants within relevant distances) is very important.
For higher plants and animals, further distinctions should be made regarding
possible gene transfer to the same, closely related, distantly related and unre-
lated species.
In the case of microorganisms, horizontal gene transfer plays a more impor-
tant role. Certain genetic material can be easy transferred between more
closely related organisms, for example, via plasmids or phages. The potential
rapid growth rate of microorganisms can enable gene transfer at relatively
high levels compared to higher organisms.
Transfer of transgenes may lead to a mixed population of GMOs or to
different gene-plant combinations after a time, which can then give rise to
complex patterns of especially long-term adverse effects. These will become
more complex as more transgenic material is transferred into a population
(for example, gene stacking).
In some cases, the method of genetic modification may change the potential
for gene transfer, such as in the case of non-integrating plasmids or viral
vectors. The method of genetic modification may also decrease the potential
for gene transfer, for example, chloroplast transformation.
Gene transfer may result in persistence of the introduced genetic material in
natural populations. If a GMO has the potential for gene transfer, this does
not necessarily mean intrinsic risk, or a change in the capacity to survive, to
become established or cause adverse effects. This will depend on the genetic
material inserted, the species and the receiving environment, including the
potential recipients.
— Phenotypic and genetic instability
The extent to which genetic (in)stability might lead to phenotypic
(in)stability and result in a hazard should be considered. Instability of the
genetic modification may in certain cases result in reversion into the wild
type phenotype. Other cases should be considered, for example:
— if in a transgenic plant line that contains more than one transgene, the
subsequent segregation process results in these transgenes being divided
up in the progeny, there could be plants with less transgenes but new
phenotypes,
— if attenuated mutants may, due to instability (because of the construction
of the particular mutation) revert to virulence,
— if duplication of transgenes leads to gene silencing,
— if copy numbers are very high,
— if re-insertion of transposable elements results in new phenotypes, due to
inactivation of the transgene by the insertion of mobile genetic elements,
— if the level of transgene expression is important (for example, a very low
expression of a toxic substance), the genetic instability of the regulatory
element(s) may result in a higher transgene expression.
Phenotypic instability could result from interaction with the environment
during cultivation, so the effects of environmental and agronomic factors
on expression of transgenes should be considered in the ERA.
If transgene expression is limited to a certain compartment in the GMO
(such as a certain plant tissue), instability of regulation could result in
expression of the transgene in the entire organism. In this context regulatory
signals (such as promoters) play an important role and should be considered.
Also the expression of the transgene at a certain time in the life cycle of the
organism or under specific environmental conditions should be considered.
Specific infertility transgenes may have been introduced into the GMO to
make it infertile (for example, to prevent transfer and spread of certain trans-
genes). Instability of the infertility transgenes could result in reactivation of
the fertility of the plant allowing the spread of the transgenes, which could
have adverse affects.
The stability of the different transgene(s) not only in the primary GMO but
also in its progeny is of importance for long-term effects in particular.
— Interactions with other organisms (other than exchange of genetic material/
pollen)
Possible interactions with other organisms, including other GMOs, have to
be carefully assessed, taking into account the complexity of multitrophic
interactions. Directly hazardous interactions which could cause adverse
effects might include:
— exposure to humans (such as farmers, consumers),2001L0018 — EN — 07.11.2003 — 002.001 — 38
▼M1
— exposure to animals,
— competition for natural resources like soil, area, water, light,— displacement of natural populations of other organisms,— delivery of toxic substances,— different growth patterns.
In general, if biological fitness is enhanced by the genetic modification, the
GMO may invade new environments and replace existing species. Often the
occurrence of specific adverse effects is proportionally linked to scale of
release.
— Changes in management, including, where applicable, in agricultural prac-
tices
The relevance of changes in management procedures as an unavoidable
consequence of the deliberate release of the GMO has to be assessed on
the basis of existing procedures. Changes in farm management could, for
example, relate to:
— sowing, planting, growing, harvesting or transporting crops (for example,
planting in small or large fields), timing,
— crop rotation (for example, cultivating the same plant species every year
or every fourth year),
— disease and pest control (for example, type and dose of insecticide for
plants, or antibiotics for animals, or alternative measures),
— resistance management (for example, type and dose of herbicide for
herbicide-tolerant plants, or change in use of biological control via Bt
proteins, or impact of viruses),
— isolation in land agricultural and aquatic agricultural systems (for
example, isolation distances in plant cultivation or quality of isolation
in fish farms),
— agricultural practices (farming GMOs and non transgenic farming,
including organic farming),
— management in non-agricultural systems (for example, isolation distances
of natural habitats from GMO planting areas).
4.2.2.Step 2: Evaluation of the potential consequences of each adverse effect, if
it occurs
The 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 influ-
enced by:
— genetic construction,
— each adverse effect identified,
— the number of GMOs released (scale),
— the environment into which the GMO(s) is (are) to be released,— the conditions of the release, including control measures,— combinations of the above.
For each adverse effect identified, the consequences for other organisms, popu-
lations, 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 insignif-
icant.
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
upthe consequences:
— ‘high level consequences’ might be significant changes in the numbers of
one or more species of other organisms, including endangered and beneficial2001L0018 — EN — 07.11.2003 — 002.001 — 39
▼M1
species in the short or long term. Such changes might include a reduction in
or complete eradication of a species leading to a negative effect on the func-
tioning of the ecosystem and/or other connected ecosystems. Such changes
would probably not be readily reversible and any recovery of the ecosystem
that did take place would probably be slow,
— ‘moderate consequences’ might be significant changes in population densi-
ties of other organisms, but not a change which could result in the total
eradication of a species or any significant effect on endangered or beneficial
species. Transient and substantial changes in populations might be included
if likely to be reversible. There could be long-term effects, provided there
are no serious negative effects on the functioning of the ecosystem,
— ‘low level consequences’ might be non-significant changes in population
densities of other organisms, which do not result in the total eradication of
any population or species of other organisms and have no negative effects on
functioning of the ecosystem. The only organisms that might be affected
would be non-endangered, non-beneficial species in the short or long term,
— ‘negligible consequences’ would mean that no significant changes had been
caused in any of the populations in the environment or in any ecosystems.
The above examples reflect the potential adverse effects of GMOs on popula-
tions, 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 uncer-
tainty.
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,
step2) evaluating the likelihood of adverse effects occurring is another imp or-
tant 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 step2 (evaluate the p otential 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 popula-
tions, 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 enti-
ties which could be affected (such as species, populations, trophic levels,
ecosystems) including measures about the potential effect as well as the level
of uncertainty.2001L0018 — EN — 07.11.2003 — 002.001 — 40
▼M1
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 step1. Again
quantitative evaluation is unlikely to be possible. The evaluation for each hazard
should consider:
— the magnitude of the consequences (‘high’, ‘moderate’, ‘low’ or ‘negli-
gible’),
— the likelihood of the adverse effect (‘high’, ‘moderate’, ‘low’ or ‘negli-
gible’),
— if a hazard has more than one adverse effect, the magnitude and likelihood
of each individual adverse effect.
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:
— assumptions and extrapolations made at various levels in the ERA,
— different scientific assessments and viewpoints,— uncertainties,— the known limits of mitigation measures,— conclusions that can be derived from the data.
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 delib-
erate 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 rele-
vant 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:
— the use of the GMO (type and scale of deliberate release or placing on the
market),2001L0018 — EN — 07.11.2003 — 002.001 — 41
▼M1
— the type of GMO (for example, genetically modified microorganisms, higher
annual plant, higher long-life plant or animal, GMO with single or multiple
modification, one or different kinds of GMOs),
— the general type of habitat (for example, biogeochemical status, climate,
availability of inter- and interspecific crossing partners, centres of origin,
connection of different habitats),
— the type of agricultural habitat (for example, agriculture, forestry, aquatic
culture, rural areas, size of sites, number of different GMOs),
— the type of natural habitat (for example, status of preserved areas).
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 uncertain-
ties.
5.CONCLUSIONSON THE POTENTIALENVIRONMENTALIMPACT
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 witha 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.REVIEWANDADAPTATION
6.1.ReviewandadaptationofanERA
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.ReviewandadaptationoftheERAguidance
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 organ-
isms, 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 para-
graph).
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
developfurther guidance based on exp erience — 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 environ-
ment in connection with the placing on the market of certain GMOs (Article
16(2)).2001L0018 — EN — 07.11.2003 — 002.001 — 42
▼B
ANNEX III
INFORMATIONREQUIREDINTHENOTIFICATION
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 interna-
tionally 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).2001L0018 — EN — 07.11.2003 — 002.001 — 43
▼B
ANNEX III A
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING
RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER
THANHIGHERPLANTS
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 GMO
A.Characteristics of (a) the donor, (b) the recipient or (c) (where
appropriate)parentalorganism(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:
(a) classification of hazard according to existing Community rules
concerning the protection of human health and/or the environ-
ment;
(b) generation time in natural ecosystems, sexual and asexual repro-
ductive cycle;
(c) information on survival, including seasonability and the ability
to form survival structures;
(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;
(e) antibiotic resistance, and potential use of these antibiotics in
humans and domestic organisms for prophylaxis and therapy;
(f) involvement in environmental processes: primary production,
nutrient turnover, decomposition of organic matter, respiration,
etc.
12. Nature of indigenous vectors:
(a) sequence;
(b) frequency of mobilisation;
(c) specificity;
(d) presence of genes which confer resistance.
13. History of previous genetic modifications.
B.Characteristics ofthevector
1. nature and source of the vector,
2. sequence of transposons, vectors and other non-coding genetic
segments used to construct the GMO and to make the introduced
vector and insert function in the GMO,2001L0018 — EN — 07.11.2003 — 002.001 — 44
▼B
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 ofthemodifiedorganism
1. Information relating to the genetic modification:
(a) methods used for the modification;
(b) methods used to construct and introduce the insert(s) into the
recipient or to delete a sequence;
(c) description of the insert and/or vector construction;
(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;
(e) methods and criteria used for selection;
(f) sequence, functional identity and location of the altered/inserted/
deleted nucleic acid segment(s) in question with particular refer-
ence to any known harmful sequence.
2. Information on the final GMO:
(a) description of genetic trait(s) or phenotypic characteristics and in
particular any new traits and characteristics which may be
expressed or no longer expressed;
(b) structure and amount of any vector and/or donor nucleic acid
remaining in the final construction of the modified organism;
(c) stability of the organism in terms of genetic traits;
(d) rate and level of expression of the new genetic material. Method
and sensitivity of measurement;
(e) activity of the expressed protein(s);
(f) description of identification and detection techniques including
techniques for the identification and detection of the inserted
sequence and vector;
(g) sensitivity, reliability (in quantitative terms) and specificity of
detection and identification techniques;
(h) history of previous releases or uses of the GMO;
(i) considerations for human health and animal health, as well as
plant health:
(i) toxic or allergenic effects of the GMOs and/or their meta-
bolic products;
(ii) comparison of the modified organism to the donor, recipient
or (where appropriate) parental organism regarding patho-
genicity;
(iii) capacity for colonisation;(iv) if the organism is pathogenic to humans who are immuno-
competent:
— 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.Informationontherelease
1. description of the proposed deliberate release, including the
purpose(s) and foreseen products,2001L0018 — EN — 07.11.2003 — 002.001 — 45
▼B
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(s) to be used for the release,
6. quantities of GMOs to be released,7. disturbance on the site (type and method of cultivation, mining, irri-
gation, or other activities),
8. worker protection measures taken during the release,
9. post-release treatment of the site,
10. techniques foreseen for elimination or inactivation of the GMOs at
the end of the experiment,
11. information on, and results of, previous releases of the GMOs, espe-
cially 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(s) (in case of
notifications under part C the site(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(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(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
GMOs AND THE ENVIRONMENT
A.Characteristics affectingsurvival,multiplicationanddissemination
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.Interactionswiththeenvironment
1. predicted habitat of the GMOs,
2. studies of the behaviour and characteristics of the GMOs and their
ecological impact carried out in simulated natural environments,
such as microcosms, growth rooms, greenhouses,
3. genetic transfer capability
(a) postrelease transfer of genetic material from GMOs into organ-
isms in affected ecosystems;
(b) postrelease transfer of genetic material from indigenous organ-
isms to the GMOs;
4. likelihood of postrelease 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.
Description 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 interac-
tion with the disseminating agent, including inhalation, ingestion,
surface contact, burrowing, etc.,2001L0018 — EN — 07.11.2003 — 002.001 — 46
▼B
7. description of ecosystems to which the GMOs could be dissemi-
nated,
8. potential for excessive population increase in the environment,
9. competitive advantage of the GMOs 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 GMOs and the target organism(s) if applicable,
12. identification and description of non-target organisms which may be
adversely affected by the release of the GMO, and the anticipated
mechanisms of any identified adverse interaction,
13. likelihood of postrelease 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, preda-
tors, 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.Monitoringtechniques
1. methods for tracing the GMOs, and for monitoring their effects,
2. specificity (to identify the GMOs, and to distinguish them from the
donor, recipient or, where appropriate, the parental organisms), sensi-
tivity 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.Controloftherelease
1. methods and procedures to avoid and/or minimise the spread of the
GMOs 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.Wastetreatment
1. type of waste generated,
2. expected amount of waste,
3. description of treatment envisaged.
D.Emergencyresponseplans
1. methods and procedures for controlling the GMOs in case of unex-
pected spread,
2. methods for decontamination of the areas affected, for example
eradication of the GMOs,
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.2001L0018 — EN — 07.11.2003 — 002.001 — 47
▼B
ANNEX III B
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING
RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS
(GMHPs)(GYMNOSPERMAEANDANGIOSPERMAE)
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:
(a) family name
(b) genus
(c) species
(d) subspecies
(e) cultivar/breeding line
(f) common name.
2. (a) Information concerning reproduction:
(i) mode(s) of reproduction
(ii) specific factors affecting reproduction, if any(iii) generation time.
(b) Sexual compatibility with other cultivated or wild plant species,
including the distribution in Europe of the compatible species.
3. Survivability:
(a) ability to form structures for survival or dormancy
(b) specific factors affecting survivability, if any.
4. Dissemination:
(a) ways and extent (for example an estimation of how viable pollen and/
or seeds declines with distance) of dissemination
(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(s),
description of the natural habitat of the plant, including information on
natural predators, parasites, competitors and symbionts.
7. Other potential interactions, relevant to the GMO, 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(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(s) and characteristics which have been intro-
duced or modified.
2. Information on the sequences actually inserted/deleted:
(a) size and structure of the insert and methods used for its characterisa-
tion, including information on any parts of the vector introduced in
the GMHP or any carrier or foreign DNA remaining in the GMHP;
(b) in case of deletion, size and function of the deleted region(s);
(c) copy number of the insert;2001L0018 — EN — 07.11.2003 — 002.001 — 48
▼B
(d) location(s) of the insert(s) in the plant cells (integrated in the chro-
mosome, chloroplasts, mitochondria, or maintained in a non-
integrated form), and methods for its determination.
3. Information on the expression of the insert:
(a) information on the developmental expression of the insert during the
lifecycle of the plant and methods used for its characterisation;
(b) parts of the plant where the insert is expressed (for example roots,
stem, pollen, etc.).
4. Information on how the genetically modified plant differs from the reci-
pient plant in:
(a) mode(s) and/or rate of reproduction;
(b) dissemination;
(c) survivability.
5. Genetic stability of the insert and phenotypic stability of the GMHP.
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 GMHP to animal health, particularly
regarding any toxic, allergenic or other harmful effects arising from the
genetic modification, where the GMHP is intended to be used in animal
feedstuffs.
9. Mechanism of interaction between the genetically modified plant and
target organisms (if applicable).
10. Potential changes in the interactions of the GMHP with non-target
organisms resulting from the genetic modification.
11. Potential interactions with the abiotic environment.12. Description 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 PURSUANT TO ARTICLES 6 AND 7)
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 NOTIFI-
CATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7)
1. Purpose of the release.
2. Foreseen date(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
postrelease, including cultivation practices and harvesting methods.
5. Approximate number of plants (or plants per m
2).
G. INFORMATION ON CONTROL, MONITORING, POSTRELEASE AND
WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS
SUBMITTED PURSUANT TO ARTICLES 6 AND 7)
1. Any precautions taken:
(a) distance(s) from sexually compatible plant species, both wild rela-
tives and crops
(b) any measures to minimise/prevent dispersal of any reproductive organ
of the GMHP (for example pollen, seeds, tuber).
2. Description of methods for postrelease treatment of the site.3. Description of postrelease treatment methods for the genetically modified
plant material including wastes.2001L0018 — EN — 07.11.2003 — 002.001 — 49
▼B
4. Description of monitoring plans and techniques.
5. Description of any emergency plans.6. Methods and procedures to protect the site.2001L0018 — EN — 07.11.2003 — 002.001 — 50
▼B
ANNEX IV
ADDITIONALINFORMATION
This Annex describes in general terms the additional information to be provided
in the case of notification for placing on the market and information for label-
ling requirements regarding GMOs as or in product to be placed on the market,
and GMO exempted under Article 2(4), second subparagraph. It will be supple-
mented by guidance notes, as regards i.a. the description of how the product is
intended to be used, to be developed in accordance with the procedure laiddown in Article 30(2). The labelling of exempted organisms as required by
Article 26 shall be met by providing appropriate recommendations for, and
restrictions on, use:
A. The following information shall be provided in the notification for placing
on the market of GMOs as or in product in addition to that of Annex III:
1. proposed commercial names of the products and names of GMOs
contained therein, and any specific identification, name or code used by
the notifier to identify the GMO. After the consent any new commercial
names should be provided to the competent authority,
2. name and full address of the person established in the 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(s) of control samples,
4. description of how the product and the GMO as or in product are
intended to be used. Differences in use or management of the GMO
compared to similar non-genetically modified products should be high-
lighted,
5. description of the geographical area(s) and types of environment where
the product is intended to be used within the 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 purposes of placing on
one or several registers modifications in organisms, which can be used
for the detection and identification of particular GMO products to facili-
tate post-marketing control and inspection. This information should
include where appropriate the lodging of samples of the GMO or its
genetic material, with the competent authority and 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 demon-
strating the specificity of the methodology. Information that cannot be
placed, for confidentiality reasons, in the publicly accessible part of the
register should be identified,
8. proposed labelling on a label or in an accompanying document. This must
include, at least in summarised form, a commercial name of the product,
a statement that ‘This product contains genetically modified organisms’,
the name of the GMO and the information referred to in point 2, the
labelling should indicate how to access the information in the publicly
accessible part of the register.
B. The following information shall be provided in the notification, when rele-
vant, in addition to that of point A, in accordance with Article 13 of this
Directive:
1. measures to take in case of unintended release or misuse,
2. specific instructions or recommendations for storage and handling,3. specific instructions for carrying out monitoring and reporting to the noti-
fier and, if required, the competent authority, so that the competent
authorities can be effectively informed of any adverse effect. These
instructions should be consistent with Annex VII part C,
4. proposed restrictions in the approved use of the GMO, for example where
the product may be used and for what purposes,
5. proposed packaging,6. estimated production in and/or imports to the Community,
7. proposed additional labelling. This may include, at least in summarised
form, the information referred to in points A 4, A 5, B 1, B 2, B 3 and
B4 .2001L0018 — EN — 07.11.2003 — 002.001 — 51
▼B
ANNEX V
CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCE-
DURES(ARTICLE7)
The criteria referred to in Article 7(1) are set out below.
1. The taxonomic status and the biology (for example mode of reproduction and
pollination, ability to cross with related species, pathogenecity) of the non-
modified (recipient) organism shall be well-known.
2. There shall be sufficient knowledge about the safety for human health and
the environment of the parental, where appropriate, and recipient organisms
in the environment of the release.
3. Information shall be available on any interaction of particular relevance for
the risk assessment, involving the parental, where appropriate, and recipient
organism and other organisms in the experimental release ecosystem.
4. Information shall be available to demonstrate that any inserted genetic mate-
rial is well characterised. Information on the construction of any vector
systems or sequences of genetic material used with the carrier DNA shall
be available. Where a genetic modification involves the deletion of genetic
material, the extent of the deletion shall be known. Sufficient information
on the genetic modification shall also be available to enable identification
of the GMO and its progeny during a release.
5. The GMO shall not present additional or increased risks to human health or
the environment under the conditions of the experimental release that are not
presented by releases of the corresponding parental, where appropriate, and
recipient organisms. Any capacity to spread in the environment and invade
other unrelated ecosystems and capacity to transfer genetic material to other
organisms in the environment shall not result in adverse effects.2001L0018 — EN — 07.11.2003 — 002.001 — 52
▼B
ANNEX VI
GUIDELINESFORTHEASSESSMENTREPORTS
The assessment report provided for by Articles 13, 17, 19 and 20 should include
in particular the following:
1. Identification of the characteristics of the recipient organism which are rele-
vant to the assessment of the GMO(s) in question. Identification of any
known risks to human health and the environment resulting from the release
into the environment of the recipient non-modified organism.
2. Description of the result of the genetic modification in the modified
organism.
3. Assessment of whether the genetic modification has been characterised suffi-
ciently for the purpose of evaluating any risks to human health and the
environment.
4. Identification of any new risks to human health and the environment that
may arise from the release of the GMO(s) in question as compared to the
release of the corresponding non-modified organism(s), based on the environ-
mental risk assessment carried out in accordance with Annex II.
5. A conclusion on whether the GMO(s) in question should be placed on the
market or as (a) product(s) and under which conditions, whether the GMOs
in question shall not be placed on the market or whether the views of other
competent authorities and the Commission are sought for on specific issues
of the e.r.a.. These aspects should be specified. The conclusion should clearly
address the use proposed, risk management and the monitoring plan
proposed. In the case that it has been concluded that the GMOs should not
be placed on the market, the competent authority shall give reasons for its
conclusion.2001L0018 — EN — 07.11.2003 — 002.001 — 53
▼B
ANNEX VII
MONITORINGPLAN
This Annex describes in general terms the objective to be achieved and the
general principles to be followed to design the monitoring plan referred to in
Articles 13(2), 19(3) and 20. It will be supplemented by guidance notes to be
developed in accordance with the procedure laid down in Article 30(2).
These guidance notes shall be completed by 17 October 2002.
A.Objective
The objective of a monitoring plan is to:
— confirm that any assumption regarding the occurrence and impact of poten-
tial adverse effects of the GMO or its use in the e.r.a. are correct, and
— identify the occurrence of adverse effects of the GMO or its use on human
health or the environment which were not anticipated in the e.r.a.
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 consid-
ered 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.Designofthemonitoringplan
The design of the monitoring plan should:
1. be detailed on a case by case basis taking into account the e.r.a.,
2. take into account the characteristics of the GMO, the characteristics and scale
of its intended use and the range of relevant environmental conditions where
the GMO is expected to be released,
3. incorporate general surveillance for unanticipated adverse effects and, if
necessary, (case-) specific monitoring focusing on adverse effects identified
in the e.r.a.:
3.1. whereas case-specific monitoring should be carried out for a sufficient
time period to detect immediate and direct as well as, where appropriate,
delayed or indirect effects which have been identified in the e.r.a.,
3.2. whereas surveillance could, if appropriate, make use of already estab-
lished routine surveillance practices such as the monitoring of
agricultural cultivars, plant protection, or veterinary and medical
products. An explanation as to how relevant information collected
through established routine surveillance practices will be made available
to the consent-holder should be provided.
4. facilitate the observation, in a systematic manner, of the release of a GMO in
the receiving environment and the interpretation of these observations with
respect to safety to human health or the environment.
5. identify who (notifier, users) will carry out the various tasks the monitoring
plan requires and who is responsible for ensuring that the monitoring plan is
set into place and carried out appropriately, and ensure that there is a route
by which the consent holder and the competent authority will be informed on
any observed adverse effects on human health and the environment. (Time
points and intervals for reports on the results of the monitoring shall be indi-
cated).
6. give consideration to the mechanisms for identifying and confirming any
observed adverse effects on human health and environment and enable the
consent holder or the competent authority, where appropriate, to take the
measures necessary to protect human health and the environment.2001L0018 — EN — 07.11.2003 — 002.001 — 54
▼B
ANNEX VIII
CORRELATIONTABLE
Directive 90/220/EEC This Directive
Article 1 (1) Article 1
Article 1 (2) Article 3 (2)Article 2 Article 2Article 3 Article 3 (1)Article 4 Article 4— Article 5Article 5
Article 6Article 6 (1) to 4
Article 6 (5) Article 7
Article 6 (6) Article 8Article 7 Article 9Article 8 Article 10Article 9 Article 11Article 10 (2) Article 12Article 11 Article 13Article 12 (1) to (3) and (5) Article 14Article 13 (2) Article 15 (3)
— Article 15 (1), (2) and (4)
— Article 16— Article 17Article 13 (3) and (4) Article 18Article 13 (5) and (6) Article 19 (1) and (4)Article 12 (4) Article 20 (3)Article 14 Article 21Article 15 Article 22Article 16 Article 23— Article 24 (1)
Article 17 Article 24 (2)
Article 19 Article 25— Article 26Article 20 Article 27— Article 28— Article 29Article 21 Article 30Article 22 Article 31 (1), (4) and (5)Article 18 (2) Article 31 (6)
Article 18 (3) Article 31 (7)
— Article 32— Article 33Article 23 Article 34— Article 35— Article 36— Article 37Article 24 Article 38Annex I A Annex I AAnnex I B Annex I B
— Annex II
Annex II Annex IIIAnnex II A Annex III AAnnex II B Annex III BAnnex III Annex IV— Annex V— Annex VI— Annex VII2001L0018 — EN — 07.11.2003 — 002.001 — 55