DIRECTIVES 
COMMI SSION DIRECTIVE (EU) 2018/350 
of 8 March 2018 
amending Directiv e 2001/18/EC of the European Parliament and of the Council as regards the 
environmenta l risk assessment of genetically modif ied organisms 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 
deliberate release into the envi ronment of genetically modifi ed organisms and repealing Council Directive 
90/220/EEC (1), and in particular Article 27 thereof, 
Whereas: 
(1)  Directive 2001/18/EC sets out requirements for the environmental risk assessment of genetically modified 
organisms (‘GMOs ’). 
(2)  On 4 December 2008, the Council adop ted Conclusions on GMOs stressing the need to updat e and strengthen 
the environmental risk assessment of GMOs, in particular concer ning the assessment of long-ter m environmental 
effects. 
(3)  Followin g a request from the Commission, the European Food Safety Author ity (EFSA ) adopt ed in October 2010 
a Scientifi c opinion establishing guidance on the environmental risk assessment of genetically modified plants (2) 
(‘the Guidance ’), which is a revision of the previous guidance. Other guidance documents issued by EFSA and by 
the European Medicines Age ncy are relevant to the environmental risk assessment of GMOs other than plants. 
(4)  Article 3 of Directive (EU) 2015/412 of the European Parliament and of the Council (3) provides that by 3 Apr il 
2017 the Commission has to update the Annex es to Directive 2001/18/EC as regar ds the environmental risk 
assessment with a view to incor porating and building upon the Guidance, which is not legally binding. 
(5)  In order to adap t to technical progress and taking into account the exper ience gained in the environmental risk 
assessment of genetically modified plants, the essential elements of the Guidance should be incor porat ed in 
Directive 2001/18/EC. In doing so, the principle that the environmental risk assessment should be carried out on 
a case-by-case basis should be respected. 
(6)  The Guidance was essentially designed for notifi cations for the purpose of placing on the mark et (‘Par t C 
notifications ’) of genetically modifi ed plants, while Annex II to Directive 2001/18/EC applies to both Part C 
notifications and notifications for other purposes than placing on the mark et (‘Par t B notifi cations’). Theref ore, 
certain requirements resulting from the incor poration of the Guidance in Annex II should only apply to Part C 
notifications, as they would be irrelevant or dispropor tionate in the context of Part B notific ations, whic h 
essentially concer n exper imental releases. 
(7)  Part C of Annex II to Directive 2001/18/EC concer ns the methodology of the envi ronmental risk assessment. It 
should be update d in order to incor porate, in particular , the terminology used to descr ibe the six steps of the 
assessment approach as descr ibed in the Guidance. 9.3.2018 L 67/30 Official Jour nal of the European Union EN     
(1)OJ L 106, 17.4.2001, p. 1. 
(2)EFSA Journal 2010;8(11):1879. 
(3)Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards 
the possibility for the Member States to restr ict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory 
(OJ L 68, 13.3.2015, p. 1). (8)  Part D of Annex II to Directive 2001/18/EC applies to the conclusions of the environmental risk assessment and 
contains two distinct sections, concer ning GMOs other than higher plants (Section D.1) and genetically modified 
higher plants (Section D.2) respectively . The Guidance considers seven specific areas of risk to be addressed in the 
environmental risk assessment of genetically modif ied plants in order to draw conclusions. The structure and 
cont ent of Section D.2 of Annex II should theref ore be update d to reflect those areas of risk. 
(9)  Where the environmental risk assessment concer ns a genetically modified plant made tolerant to a herbicide, its 
scope should be consistent with Directive 2001/18/EC. The environmental risk assessment of the use of a plant 
prot ection product, including its use on a genetically modifi ed plant, falls under the scope of Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council (1) and will be carried out at Member State level 
to take into account the specifi c agricultural conditions. 
(10)  Annex III B to Directive 2001/18/EC lists the information required in notifi cations concer ning releases of 
genetically modified higher plants and applies to both Part C notifi cations and Part B notificati ons. Its structure, 
cont ent and level of detail should be amended to ensure consistency with the Guidance. As most of the chang es 
induced by the Guidance concer n the environmental risk assessment of Part C notifi cations, and in the inter est of 
clarity and simplification for the notifiers and the compet ent author ities, it is appropr iate to modify the structure 
of Annex III B by separating the requirements concer ning Part C notifications from the requirements concer ning 
Part B notific ations. 
(11)  The majority of the requests for author isation of the placing on the mark et of genetically modified plants are 
submitte d in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council (2). 
In the inter est of simplification, it is theref ore appropr iate to align, to the extent possible, the order of the pieces 
of information required for Part C notifi cations in Annex III B to Directive 2001/18/EC with the order followed 
in Commission Implementing Regulation (EU) No 503/2013 (3). 
(12)  Annex IV to Directive 2001/18/EC sets out additional information requirements only for Part C notifi cations. The 
requirements set out in that Annex concer ning detection methods should be updat ed in the light of technical 
progress, in particular as regards the submission by notifier s of the referen ce mater ial. 
(13)  The measures provi ded for in this Directive are in accordance with the opinion of the Committ ee set up under 
Article 30 of Directive 2001/18/EC, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex es II, III, III B and IV to Directive 2001/18/EC are amended in accordance with the Annex to this Directive. 
Article 2 
1. Member State s shall bring into force the laws, regulations and administrative provis ions necessar y to comply with 
this Directive by 29 September 2019 at the latest. They shall forthwith communicate to the Commission the text of 
those provis ions. 
When Member States adop t those provi sions, they shall contain a reference to this Directive or be accompan ied by such 
a reference on the occasion of their official publication. Member States shall determine how such reference is to be 
made. 9.3.2018 L 67/31 Official Jour nal of the European Union EN     
(1)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 Octo ber 2009 concer ning the placing of plant 
prot ection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
(2)Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on genetically modified food and 
feed (OJ L 268, 18.10.2003, p. 1). 
(3)Commission Implementing Regulation (EU) No 503/2013 of 3 Apr il 2013 on applications for author isation of genetically modified 
food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending 
Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1). 2. Member States shall communicate to the Commission the text of the main provisions of national law whic h they 
adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the twentieth day follo wing that of its publication in the Official Journal of the 
European Union. 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 8 March 2018. 
For the Commission 
The President 
Jean-Claude JUNCKER  9.3.2018 L 67/32 Official Jour nal of the European Union EN     ANNEX 
Directive 2001/18/EC is amended as follo ws:  
(1) Annex II is amended as follows: 
(a)  Section C is replaced by the follo wing: 
‘C.  Methodology 
Guidance issued by the European Food Safety Author ity is available for the implementation of this section 
for Part C notificati ons. 
C.1.  General and specific considerations for the e.r.a.  
1. Intended and unintended changes 
As part of the identification and evaluation of the pote ntial adverse effects refer red to in Section A, 
the e.r.a shall identify the intended and unintend ed change s resulting from the genetic modification and 
shall evaluate their poten tial to cause adverse effects on human health and on the environment. 
Intended chang es resulting from the genetic modifi cation are changes that are designed to occur and 
whic h fulfil the original objectives of the genetic modif ication. 
Unintended chang es resulting from the genetic modification are consistent changes which go beyond 
the intende d change(s) resulting from the genetic modifi cation. 
Intended and unint ended changes can have either direct or indirect, and either immediate or dela yed 
effects on human health and on the environment.  
2. Long-ter m adverse effects and cumulative long-ter m adverse effects in the e.r.a. of Part C notifications 
Long-t erm effects of a GMO are effects resulting either from a dela yed response by organisms or their 
prog eny to long-t erm or chronic exposure to a GMO or from an extensi ve use of a GMO in time and 
space. 
The identif ication and evaluation of the poten tial long-t erm adverse effects of a GMO on human health 
and on the environment shall take into account the follo wing: 
(a)  the long-t erm inter actions of the GMO and the receiving environment ; 
(b)  the character istics of the GMO which become impor tant on a long-t erm basis; 
(c)  data obtained from repeated deliberate releases or placings on the market of the GMO over a long 
period. 
The identif ication and evaluation of the potential cumulative long-t erm adverse effects refer red to in the 
introduct ory part of Annex II shall also take into account the GMOs deliberately released or placed on 
the mark et in the past.  
3. Quality of the data 
In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifi er shall collat e 
already available data from scientifi c literature or from other sources, including monitori ng repor ts, and 
shall generat e the necessar y data by perf orming, where possible, appropr iate studies. Where applicable, 
the notifier shall justify in the e.r.a. why generating data by studies is not possible. 
The e.r.a. for notificati ons under Part B of the Directive shall be based at least on already available data 
from scientific literature or from other sources and may be supplemented by additional data generat ed 
by the notifier . 9.3.2018 L 67/33 Official Jour nal of the European Union EN     Where data generat ed outside Europe is provided in the e.r.a., its relevance to receiving envi ronment(s) 
in the Union shall be justif ied. 
Data provided in the e.r.a for notifi cations under part C of this Directive shall compl y with the 
following requirements: 
(a)  where toxicological studies carried out to assess risk to human or animal health are provid ed in 
the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities 
whic h compl y with: 
(i)  the requirements of Directive 2004/10/EC; or 
(ii)  the “OECD Principles on Good Laboratory Practice” (GLP), if carried out outside the Union; 
(b)  where studies other than toxicological studies are provided in the e.r.a., they shall: 
(i)  compl y with the principles of Good Laboratory Practice (GLP) laid down in Directive 
2004/10/EC, where relevant ; or 
(ii)  be conduct ed by organisations accredit ed under the relevant ISO standard; or 
(iii)  in the absence of a relevant ISO standard, be conducted in accordance with internati onally 
recognised standards; 
(c)  information on the results obtained from the studies referred to in points (a) and (b) and on the 
study prot ocols used shall be reliable and comprehensive and shall include the raw data in an 
electronic format suitable for carrying out statistical or other analysis; 
(d)  the notifier shall specify , where possible, the size of effect that each study performe d intends to 
detect and justify it; 
(e)  the selection of sites for field studies shall be based on relevant receiving environments in view of 
the pote ntial exposure and impact that would be obser ved where the GMO may be released. The 
selection shall be justif ied in the e.r.a.; 
(f)  the non-geneticall y modified compar ator shall be appropr iate for the relevant receiving 
environment(s) and shall have a genetic backg round comparable to the GMO. The choice of the 
compara tor shall be justified in the e.r.a.  
4. Stacked transformation events in Part C notifications 
The followi ng shall apply to the e.r.a. of a GMO containing stack ed transf ormation events in Part C 
notifications: 
(a)  the notifier shall provi de an e.r.a. for each sing le transf ormation event in the GMO or refer to 
already submitted notificati ons for those sing le transf ormation events; 
(b)  the notifier shall provid e an assessment of the following aspects: 
(i)  the stability of the transf ormation events; 
(ii)  the expression of the transf ormation events; 
(iii)  the poten tial additive, synergistic or antagonistic effects resulting from the combination of the 
transf ormation events; 
(c)  where the prog eny of the GMO can contain various subcombinations of the stack ed transf ormation 
events, the notifier shall provide a scientific rationale justifying that there is no need to provi de 
exper imental data for the concer ned subcombinations, independently of their origin, or, in the 
absence of such scientifi c rationale, shall provide the relevant exper imental data. 9.3.2018 L 67/34 Official Jour nal of the European Union EN     C.2.  Characteristics of the GMO and of the releases 
The e.r.a. shall take into account the relevant technical and scientifi c details regarding charact eristics of: 
—  the recipient or parental organism(s), 
—  the genetic modifi cation(s), be it inser tion or deletion of genetic mater ial, and relevant information on 
the vect or and the donor , 
—  the GMO, 
—  the intended release or use including its scale, 
—  the potential receiving environment(s) into which the GMO will be released and into which the 
transg ene may spread, and 
—  the interaction(s) between these charact eristics. 
Relevant information from previous releases of the same or similar GMOs and organisms with similar 
traits and their biotic and abiotic inter action with similar receiving environments, including information 
resulting from the monitori ng of such organisms, shall be considered in the e.r.a., subject to Article 6(3) or 
Article 13(4). 
C.3.  Steps in the e.r.a. 
The e.r.a. refer red to in Articles 4, 6, 7 and 13 shall be conducted for each relevant area of risk refer red to 
in Section D1 or in Section D2 in accordance with the following six steps:  
1. Problem formulat ion including hazar d identification 
The problem formulation shall: 
(a)  identify any changes in the character istics of the organism, linked to the genetic modification, by 
compari ng the charact eristics of the GMO with those of the chosen non-geneticall y modifi ed 
compara tor under corresponding conditions of release or use; 
(b)  identify poten tial adverse effects on human health or the environment which are linked to the 
changes that have been identified under point (a) above; 
Potential adverse effects shall not be discounted on the basis that they are unlikely to occur . 
Potential adverse effects will vary from case to case, and may include: 
—  effects on the dynamics of populations of species in the receiving environment and the genetic 
diversity of each of these populations leading to a poten tial decline in biodiversity , 
—  altered susceptibi lity to pathogen s facilitating the dissemination of infec tious diseases or creating 
new reser voirs or vect ors, 
—  compr omising prophylactic or therapeutic medical, veterinar y, or plant prot ection treatments, 
for exam ple by transfer of genes conferr ing resistance to antibiotics used in human or veterinar y 
medicine, 
—  effects on biogeoc hemistr y (biog eochemical cycles), including carbon and nitroge n recy cling 
through changes in soil decomposition of organic mat erial, 
—  disease affecting humans, including allergenic or toxic reactions, 
—  disease affecting animals and plants, including toxic, and, in the case of animals, allergen ic 
reactions, where appropr iate. 9.3.2018 L 67/35 Official Jour nal of the European Union EN     Where poten tial long-t erm adverse effects of a GMO are identified, they shall be assessed in the 
form of desk based studies using, where possible, one or more of the follo wing: 
(i)  evidence from previous exper iences; 
(ii)  available data sets or literature; 
(iii)  mathematical modelling; 
(c)  identify relevant assessment endpoints. 
Those poten tial adverse effects that could impact the identif ied assessment endpoints shall be 
considered in the next steps of the risk assessment ; 
(d)  identify and descr ibe the exposure pathwa ys or other mechanisms through whic h adverse effects 
may occur . 
Adverse effects may occur directly or indirectly through exposure pathwa ys or other mecha nisms 
whic h may include: 
—  the spread of the GMO(s) in the environment, 
—  the transfer of the inser ted genetic mat erial to the same orga nism or other organisms, whether 
genetically modified or not, 
—  phenotypic and genetic instability , 
—  interactions with other organisms, 
—  change s in manag ement, including, where applicable, in agricultural practices; 
(e)  formulate testab le hypotheses, and define relevant measurement endpoints, to allow, where possible, 
a quantitative evaluation of the poten tial adverse effect(s); 
(f)  consider possible uncer tainties, including knowle dge gaps and methodological limitations.  
2. Hazar d character isation 
The magnitude of each potential adverse effect shall be evaluated. This evaluation shall assume that such 
an adverse effect will occur . The e.r.a shall consider that the magnitude is likely to be influenced by the 
receiving envi ronment(s) into whic h the GMO is intended to be released and by the scale and conditions 
of the release. 
Where possible, the evaluation shall be expressed in quantitative terms. 
Where the evaluation is expressed in qualitative term s, a categor ical descr iption (“high”, “moderate”, 
“low” or “neg ligible”) shall be used and an explanation of the scale of effect represente d by each 
cate gory shall be provided.  
3. Exposure character isation 
The likelihood or probability of each identif ied poten tial adverse effect occur ring shall be evaluated 
to provide, where possible, a quantitative assessment of the exposure as a relative measure of 
probability , or other wise a qualitative assessment of the exposure. The charact eristics of the receiving 
environment(s) and the scope of the notific ation shall be taken into consideration. 
Where the evaluation is expressed in qualitative term s, a categor ical descr iption (“high”, “moderate”, 
“low” or “neg ligible”) of the exposure shall be used and an explanation of the scale of effect represente d 
by each cate gory shall be provided.  
4. Risk character isation 
The risk shall be characteri sed by combining, for each poten tial adverse effect, the magnitude with the 
likelihood of that adverse effect occur ring to provide a quantitative or semi quantitative estimation of 
the risk. 9.3.2018 L 67/36 Official Jour nal of the European Union EN     Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk 
shall be provided. In that case, a catego rical descr iption (“high”, “moderate”, “low” or “neg ligible”) of the 
risk shall be used and an explanation of the scale of effect represente d by each catego ry shall be 
provi ded. 
Where relevant, the uncer tainty for each identif ied risk shall be descr ibed and, where possible, 
expressed in quantitative term s.  
5. Risk managemen t strategies 
Where risks are identified that require, on the basis of their charact erisation, measures to manage them, 
a risk management strategy shall be proposed. 
The risk management strategies shall be descr ibed in term s of reducing the hazard or the exposure, or 
both, and shall be propor tionate to the intended reduction of the risk, the scale and conditions of the 
release and the levels of uncer tainty identified in the e.r.a. 
The consequent reduction in overall risk shall be quantifi ed where possible.  
6. Over all risk evaluation and conclusions 
A qualitative and, where possible, quantitative evaluation of the overall risk of the GMO shall be made 
taking into account the results of the risk charact erisation, the proposed risk management strateg ies and 
the associated levels of uncer tainty . 
The overall risk evaluation shall include, where applicable, the risk manag ement strateg ies proposed for 
each identif ied risk. 
The overall risk evaluation and conclusions shall also propose specifi c requirements for the monitor ing 
plan of the GMO and, where appropr iate, the monitor ing of the efficacy of the proposed risk 
manag ement measures. 
For notifi cations under Part C of the Directive, the overall risk evaluation shall also include an 
explanation of the assum ptions made during the e.r.a. and of the nature and magnitude of uncer tainties 
associated with the risks, and a justif ication of the risk management measures proposed.’ 
(b)  The title and the introduct ory paragraph of Section D are replaced by the follo wing:  
‘D. Conclusions on the specif ic areas of risk of the e.r.a. 
Conclusions on the potential environmental impact in relevant receiving envi ronments from the release or 
the placing on the market of GMOs shall be drawn for each relevant area of risk listed in Section D1 for 
GMOs other than higher plants or Section D2 for genetically modified higher plants, on the basis of an e.r.a. 
carried out in accordance with the principles outlined in Section B and followi ng the methodology descr ibed 
in Section C, and on the basis of the information required pursuant to Annex III.’ 
(c)  Section D.2 is replaced by the followi ng:  
‘D.2. In the case of genetically modif ied higher plants (GMHP) 
“Higher plants” shall mean plants whic h belong to the taxonomic group Sper matoph ytae (Gymnosper mae 
and Angiosper mae).  
1. Persiste nce and invasiven ess of the GMHP , including plant to plant gene transfer  
2. Plant to micro-orga nisms gene transfer  
3. Inter actions of the GMHP with target organisms  
4. Inter actions of the GMHP with non-target organisms 9.3.2018 L 67/37 Official Jour nal of the European Union EN     5. Impacts of the specif ic cultivation, manage ment and harvesting techniques  
6. Effects on biogeoc hemical processes  
7. Effects on human and animal health.’  
(2) Annex III is replaced by the followi ng: 
‘ANNEX III 
INFORMA TION REQUIRED IN THE NOTIFIC ATION 
Notif ications refer red to in Parts B and C of this Directive shall, as a rule, include the information set out in 
Annex III A, for GMOs other than higher plants, or in Annex III B, for genetically modified higher plants. 
The provision of a given subset of information listed in Annex III A or in Annex III B shall not be required where it 
is not relevant or necessar y for the purposes of risk assessment in the context of a specifi c notificati on, in view 
especially of the charact eristics of the GMO, of the scale and conditions of the release or of its intended conditions 
of use. 
The appropr iate level of detail for each subset of information may also vary according to the nature and the scale of 
the proposed release. 
For each required subset of information, the following shall be provided: 
(i)  the summar ies and results of the studies refer red to in the notification, including an explanation about their 
relevance to e.r.a., where applicable; 
(ii)  for notificati ons refer red to in Part C of this Directive, Annex es with detailed information on those studies, 
including a descr iption of the methods and mater ials used or the reference to standardised or intern ationally 
recognised methods and the name of the body or bodies responsible for carrying out the studies. 
Future developments in genetic modification may necessitate adap ting this Annex to technical progress or 
developing guidance notes on this Annex. Further differentiation of information requirements for different types of 
GMOs, for example perennial plants and trees, sing le celled organisms, fish or insects, or for particular use of GMOs 
like the development of vaccines, may be possible once sufficient exper ience with notifications for the release of 
particular GMOs has been gain ed in the Union.’  
(3) Annex III B is replaced by the followi ng: 
‘ANNEX III B 
INFORMA TION REQUIRED IN NOTIFIC ATIONS CONCERNING RELEASES OF GENETIC ALL Y 
MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)  
I. INFORMA TION REQUIRED IN NOTIFICA TIONS SUBMITTED PURSU ANT TO ARTICLES 6 AND 7  
A. General informa tion 
1.  Name and address of the notifi er (com pany or institute) 
2.  Name, qualifi cations and exper ience of the responsible scientist(s) 
3.  Title of the project 
4.  Information relating to the release 
(a)  Purpose of the release 
(b)  Foreseen date(s) and duration of the release 
(c)  Method by whic h the GMHP will be released 9.3.2018 L 67/38 Official Jour nal of the European Union EN     (d)  Method for prepar ing and managing the release site, prior to, during and post release, including 
cultivation practices and harvesting methods 
(e)  Appro ximat e number of plants (or plants per m2). 
5.  Information relating to the site of release 
(a)  Location and size of the release site(s). 
(b)  Descr iption of the release site ecosystem, including climate, flora and fauna. 
(c)  Presence of sexually compatible wild relatives or cultivated plant species. 
(d)  Proximity to officially recognised biotopes or protect ed areas whic h may be affected.  
B. Scientif ic information 
1.  Information relating to the recipient plant or, where appropr iate, to the parental plants 
(a)  Complet e name: 
(i)  family name 
(ii)  genus 
(iii)  species 
(iv)  subspecies 
(v)  cultivar or breeding line 
(vi)  common name. 
(b)  Geographical distr ibution and cultivation of the plant within the Union. 
(c)  Information concer ning reproduction: 
(i)  mode(s) of reproduction 
(ii)  specifi c factors affecting reproduction, if any 
(iii)  generation time. 
(d)  Sexual compati bility with other cultivated or wild plant species, including the distr ibution in Europe of 
the compati ble species. 
(e)  Survivability: 
(i)  ability to form structures for survival or dormancy 
(ii)  specific factors affecting survivability , if any. 
(f)  Dissemination: 
(i)  ways and extent of dissemination 
(ii)  specific factors affecting dissemination, if any. 
(g)  Where a plant species is not normally grown in the Union, a descr iption of the natural habitat of the 
plant, including information on natural predators, parasites, competit ors and symbionts. 
(h)  Poten tial interactions of the plant, that are relevant to the GMHP , with organisms in the ecosystem 
where it is usually grown, or elsewhere, including information on toxic effects on humans, animals 
and other organisms. 
2.  Molecular characteri sation 
(a)  Information relating to the genetic modifi cation 
(i)  Descr iption of the methods used for the genetic modification. 9.3.2018 L 67/39 Official Jour nal of the European Union EN     (ii)  Nature and source of the vect or used. 
(iii)  Source of the nucleic acid(s) used for transf ormation, size, and intended function of each 
constituent fragment of the region intended for inser tion. 
(b)  Information relating to the GMHP 
(i)  General descr iption of the trait(s) and charact eristics which have been introduced or modified. 
(ii)  Information on the sequences actually inser ted/delet ed: 
—  size and copy number of all inser t(s) and methods used for its/their charact erisation, 
—  in case of deletion, size and function of the delet ed region(s), 
—  subcellular location(s) of the inser t(s) in the plant cells (integrat ed in the 
nucleus, chloroplasts, mitoc hondr ia, or maintained in a non-integ rated form), and methods for 
its/their deter mination. 
(iii)  Parts of the plant where the inser t is expressed. 
(iv)  Genetic stability of the inser t and phenotypic stability of the GMHP . 
(c)  Conclusions of the molecular charact erisation 
3.  Information on specific areas of risk 
(a)  Any chang e to the persist ence or invasiveness of the GMHP , and its ability to transfer genetic mater ial 
to sexually compati ble relatives and the adverse environmental effects thereof. 
(b)  Any change to the ability of the GMHP to transfer genetic mat erial to microorganisms and the adverse 
environmental effects thereof. 
(c)  Mechanism of intera ction between the GMHP and target organisms (if applicable) and the adverse 
environmental effects thereof. 
(d)  Poten tial changes in the inter actions of the GMHP with non-targe t organisms resulting from the 
genetic modifi cation and the adverse environmental effects thereof. 
(e)  Poten tial chang es in agricultural practices and management of the GMHP resulting from the genetic 
modif ication and the adverse envi ronmental effects thereof. 
(f)  Poten tial interactions with the abiotic environment and the adverse environmental effects thereof. 
(g)  Information on any toxic, allergen ic or other harmful effects on human and animal health arising from 
the genetic modifi cation. 
(h)  Conclusions on the specific areas of risk. 
4.  Information on control, monitoring, post-release and waste treatment plans 
(a)  Any measures taken, including: 
(i)  spatial and temporal isolation from sexually compati ble plant species, both wild and weedy 
relatives and crops; 
(ii)  any measures to minimise or prevent the dispersal of any reproductive part of the GMHP . 
(b)  Descr iption of methods for post-release treatment of the site. 
(c)  Descr iption of post-release treatment methods for the genetically modifi ed plant mate rial including 
wast es. 
(d)  Descr iption of monitori ng plans and techniques. 
(e)  Descr iption of any emergency plans. 9.3.2018 L 67/40 Official Jour nal of the European Union EN     (f)  Descr iption of the methods and procedures to: 
(i)  avoid or minimise the spread of the GMHPs beyond the site of release; 
(ii)  protect the site from intrusion by unauthor ised individuals; 
(iii)  prevent other organisms from entering the site or minimise such entr ies. 
5.  Descr iption of detec tion and identification techniques for the GMHP . 
6.  Information about previous releases of the GMHP , if applicable.  
II. INFORMA TION REQUIRED IN NOTIFICA TIONS SUBMITTED PURSU ANT TO ARTICLE 13  
A. General informa tion 
1.  Name and address of the notifi er (com pany or institute). 
2.  Name, qualifi cations and exper ience of the responsible scientist(s). 
3.  Designation and specifi cation of the GMHP . 
4.  Scope of the notification. 
(a)  Cultivation 
(b)  Other uses (to be specified in the notifi cation).  
B. Scientif ic information 
1.  Information relating to the recipient plant or, where appropr iate, to the parental plants 
(a)  Complet e name: 
(i)  family name 
(ii)  genus 
(iii)  species 
(iv)  subspecies 
(v)  cultivar/breeding line 
(vi)  common name. 
(b)  Geographical distr ibution and cultivation of the plant within the Union. 
(c)  Information concer ning reproduction: 
(i)  mode(s) of reproduction 
(ii)  specifi c factors affecting reproduction, if any 
(iii)  generation time. 
(d)  Sexual compat ibility with other cultivated or wild plant species, including the distr ibution in the 
Union of the compati ble species. 
(e)  Survivability: 
(i)  ability to form structures for survival or dormancy 
(ii)  specific factors affecting survivability , if any. 
(f)  Dissemination: 
(i)  ways and extent of dissemination; 
(ii)  specific factors affecting dissemination, if any. 9.3.2018 L 67/41 Official Jour nal of the European Union EN     (g)  Where a plant species is not normally grown in the Union, a descr iption of the natural habitat of the 
plant, including information on natural predators, parasites, competit ors and symbionts. 
(h)  Poten tial interactions of the plant, that are relevant to the GMHP , with organisms in the ecosystem 
where it is usually grown, or elsewhere, including information on toxic effects on humans, animals 
and other organisms. 
2.  Molecular characteri sation 
(a)  Information relating to the genetic modifi cation 
(i)  Descr iption of the methods used for the genetic modification. 
(ii)  Nature and source of the vect or used. 
(iii)  Source of the nucleic acid(s) used for transf ormation, size, and intended function of each 
constituent fragment of the region intended for inser tion. 
(b)  Information relating to the genetically modified plant 
(i)  Descr iption of the trait(s) and character istics which have been introduced or modified. 
(ii)  Information on the sequences actually inser ted or delet ed: 
—  size and copy number of all detectable inser ts, both partial and complet e, and methods used 
for its charact erisation, 
—  the organisation and sequence of the inser ted genetic mate rial at each inser tion site in 
a standardised electronic format, 
—  in case of deletion, size and function of the delet ed region(s), 
—  subcellular location(s) of the inser t(s) (integ rated in the nucleus, chloroplasts, mitochondr ia, or 
maintained in a non-integ rated form), and methods for its/their deter mination, 
—  in the case of modifi cations other than inser tion or deletion, function of the modifi ed genetic 
mater ial before and after the modific ation, as well as direct changes in expression of genes as 
a result of the modification, 
—  sequence information in a standardised electronic format for both 5′ and 3′ flanking regions 
at each inser tion site, 
—  bioinf ormatic analysis using up-to -date databases, to investigat e possible interr uptions of 
known genes, 
—  all Open Reading Frames, (hereaf ter refer red to as “ORFs”) within the inser t (either due to 
rear rangement or not) and those creat ed as a result of the genetic modification at the junction 
sites with genomic DNA . ORF is defined as a nucleotide sequence that contains a string of 
codons that is uninter rupted by the presence of a stop codon in the same reading frame, 
—  bioinf ormatic analysis using up-to-dat e databases, to investiga te possible similar ities between 
the ORFs and known genes which may have adverse effects, 
—  primar y structure (amino acid sequence) and, if necessar y, other structures, of the newly 
expressed prote in, 
—  bioinf ormatic analysis using up-to -date databases, to investigat e possible sequence homologies 
and, if necessar y, structural similar ities between the newly expressed prote in and known 
protein s or peptides which may have adverse effects. 
(iii)  Information on the expression of the inser t: 
—  method(s) used for expression analysis together with their perf ormance charact eristics, 
—  information on the developmental expression of the inser t during the life cycle of the plant, 9.3.2018 L 67/42 Official Jour nal of the European Union EN     —  parts of the plant where the inser t/modif ied sequence is expressed, 
—  poten tial unint ended expression of new ORFs identif ied under the seventh indent of point (ii), 
which raise a safety concer n, 
—  protein expression data, including the raw data, obtained from field studies and related to the 
conditions in which the crop is grown. 
(iv)  Genetic stability of the inser t and phenotypic stability of the GMHP . 
(c)  Conclusions of molecular charact erisation 
3.  Comparative analysis of agronomic and phenotypic charact eristics and of compo sition 
(a)  Choice of conven tional counter part and additional comparat ors. 
(b)  Choice of sites for field studies. 
(c)  Exper imental design and statistical analysis of data from field trials for comparative analysis: 
(i)  Descr iption of field studies design 
(ii)  Descr iption of relevant aspect of the receiving envi ronments 
(iii)  Statistical analysis. 
(d)  Selection of plant mate rial for analysis, if relevant. 
(e)  Com parative analysis of agronomic and phenotypic charact eristics. 
(f)  Com parative analysis of composition, if relevant. 
(g)  Conclusions of comparative analysis. 
4.  Specifi c information for each area of risk 
For each of the seven areas of risk referred to in Section D.2 of Annex II the notifier shall first descr ibe the 
pathwa y to harm explaining in a chain of cause and effect how the release of the GMHP could lead to 
harm, taking into account both hazard and exposure. 
The notifier shall submit the followi ng information, excep t where it is not relevant in view of the intended 
uses of the GMO: 
(a)  Persist ence and invasiveness including plant to plant gene transfe r 
(i)  Assessment of the potential for the GMHP to become more persist ent or invasive and the adverse 
environmental effects thereof; 
(ii)  Assessment of the poten tial for the GMHP to transmit transgene(s) to sexually compati ble relatives 
and the adverse environmental effects thereof; 
(iii)  Conclusions on the adverse environmental effect(s) of persist ence and invasiveness of the GMHP 
including the adverse environmental effect(s) of plant-to-plant gene transfer . 
(b)  Plant to micro-org anism gene transfer 
(i)  Assessment of the poten tial for transfer of newly inser ted DNA from the GMHP to microorg anisms 
and the adverse effects thereof; 
(ii)  Conclusions on the adverse effect(s) of the transfer of newly inser ted DNA from the GMHP to 
microorg anisms for human and animal health and the envi ronment ; 
(c)  Interactions of the GMHP with target organisms, if relevant 
(i)  Assessment of the poten tial for change s in the direct and indirect inter actions between the GMHP 
and target organisms and the adverse environmental effect(s); 9.3.2018 L 67/43 Official Jour nal of the European Union EN     (ii)  Assessment of the poten tial for evolution of resistance of the target organism to the expressed 
protein (based on the histo ry of evolution of resistance to conven tional pesticides or transg enic 
plants expressing similar traits) and any adverse environmental effect(s) thereof; 
(iii)  Conclusions on adverse environmental effect(s) of inter actions of the GMHP with target 
organisms. 
(d)  Interactions of the GMHP with non-target organisms. 
(i)  Assessment of the poten tial for direct and indirect intera ctions of the GMHP with non-target 
organisms, including prote cted species, and the adverse effect(s) thereof. 
The assessment shall also take into account the pote ntial adverse effect(s) on relevant ecosyste m 
services and on the species provid ing those services. 
(ii)  Conclusions on adverse environmental effect(s) of interactions of the GMHP with non-target 
organisms. 
(e)  Impacts of the specifi c cultivation, manag ement and harvesting techniques 
(i)  For GMHPs for cultivation, assessment of the changes in the specific cultivation, manag ement and 
harvesting techniques used for the GMHP and the adverse envi ronmental effect(s) thereof; 
(ii)  Conclusions on adverse environmental effect(s) of the specifi c cultivation, management and 
harvesting techniques. 
(f)  Effects on biogeoc hemical processes 
(i)  Assessment of the changes in the bioge ochemical processes within the area in which the GMHP is 
to be grown and in the wider environment, and the adverse effects thereof; 
(ii)  Conclusions on adverse effects on biogeoc hemical processes. 
(g)  Effects on human and animal health 
(i)  Assessment of poten tial direct and indirect intera ctions between the GMHP and persons working 
with or coming into contact with the GMHPs, including through pollen or dust from a processed 
GMHP , and assessment of the adverse effects of those inter actions on human health; 
(ii)  For GMHPs not destined for human consump tion, but where the recipient or parental organism(s) 
may be considered for human consum ption, assessment of the likelihood of and possible adverse 
effects on human health due to accidental intake; 
(iii)  Assessment of the poten tial adverse effects on animal health due to accidental consump tion of the 
GMHP or of mater ial from that plant by animals; 
(iv)  Conclusions on the effects on human and animal health. 
(h)  Overall risk evaluation and conclusions. 
A summar y of all the conclusions under each area of risk shall be provided. 
The summar y shall take into account the risk charact erisation in accordance with steps 1 to 4 of the 
methodology descr ibed in Section C.3 of Annex II and the risk manage ment strategies proposed in 
accordance with point 5 of Section C.3 of Annex II. 
5.  Descr iption of detec tion and identification techniques for the GMHP . 
6.  Information about previous releases of the GMHP , if applicable.’ 9.3.2018 L 67/44 Official Jour nal of the European Union EN     (4) Section A of Annex IV is amended as follo ws: 
(a)  point 1 is replaced by the followi ng: 
‘1.  proposed commercial names of the products and names of GMOs contained therein, and a proposal for 
a unique identif ier for the GMO, developed in accordance with Commission Regulation (EC) No 65/2004 (*). 
After the consent any new commercial names should be provided to the compet ent author ity,  
(*)Commission Regulation (EC) No 65/2004 of 14 Januar y 2004 establishing a system for the development 
and assignment of unique identifiers for genetically modifi ed organisms (OJ L 10, 16.1.2004, p. 5).’ 
(b)  point 7 is replaced by the followi ng: 
‘7.  methods for detection, identification and, where appropr iate, quantifi cation of the transf ormation event ; 
sample s of the GMO(s) and their control samples, and information as to the place where the reference 
mate rial can be accessed. Information that cannot be placed, for conf identiality reasons, in the publicly 
accessible part of the register (s) refer red to in Article 31(2) should be identif ied,’.  9.3.2018 L 67/45 Official Jour nal of the European Union EN