EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11248/2016 ANNEX 
(POOL/E3/2016/11248/11248 -EN 
ANNEX.doc)  
[…](2016) XXX  draft 
ANNEX 1  
  
ANNEX  
to Commission Directive (EU) ../.. of XXX amending Directive 2001/18/EC of the 
European Parliament and of the Council as regards the environmental risk assessment 
of genetically modified organisms    
EN 2   EN ANNEX  
Directive 2001/18/EC is amended as follows : 
1. Annex II is amended as follows:  
(a) Section  C is replaced by the following:  
"C. Methodology  
C.1. General and specific considerations for the e.r.a.  
1. Intended and Unintended Effects  
The e.r.a shall identify and characterise the intended and 
unintended effects of the genetic modification with respect to 
possible adverse impacts on human and animal health and the 
environment.  
"Intended effects " are those that are designed to occur and which 
fulfil the original objectives of the genetic modification.  
"Unintended effects " are consistent (non -trans ient) differences 
between the GMO and its chosen comparator, which go beyond the 
intended effect(s) of introducing the genetic modification.  
2. Delayed effects  
For notifications under Part C of this Directive the e.r.a shall be 
relevant to the receiving environment(s) and intended use(s) of the 
GMO(s) and shall include an assessment of the potential delayed 
environmental effects in the form of a desk based study using  one 
or more of the following;  
– evidence from previous experienc es; 
– available data sets/literature;  
– mathematical models predictions . 
3. Data  
To carry out an e.r.a. the notifier shall generate the necessary data. 
Where applicable, data already available from scientific literature 
may be used.  
Information from any previo us releases of the same or similar 
GMOs  and organisms with similar traits and their biotic and abiotic 
interaction with similar receiving environments shall be considered 
in the e.r.a, subject to Article 6(3) or Article 13(4 ). Data provided 
in the e.r.a sh all comply with the following requirements:  
(a) The use of data generated outside Europe shall be justified 
with regard to relevance to European receiving 
environment(s).  
(b) Toxicological studies carried out to assess risk(s) to human or 
animal health sha ll be conducted in facilities which comply 
with the:  
 (i) requirements of Directive 2004/10/EC; or   
EN 3   EN  (ii) ‘OECD Principles on Good Laboratory Practice’ 
(GLP), if carried out outside the Union . 
  The applicant shall provide evidence to demonstrate 
such compl iance.  
(c) Studies other than toxicological studies  shall:   
 (i) comply with the principles of Good Laboratory Practice 
(GLP) laid down in Directive 2004/10/EC; or  
 (ii) be conducted by organisations accredited under the 
relevant ISO standard.  
(d) Information on the study protocols and the results obtained 
from the studies referred to points ( b) and ( c) shall  be 
comprehensive and include the raw data in an electronic 
format, suitable for carrying out statistical or other analysis.  
(e) Selection of s ites for field studies shall be representative of 
the receiving environments where the GMO(s) may be 
released and shall be justified explicitly.  
(f) The non -genetically modified comparator shall be 
appropriate f or the relevant receiving environment(s)  have a 
genetic background comparable to the GMO and its choice 
shall be justified in the e.r.a .  
4. Stacked transformation events  
For the e.r.a. of GMOs containing stacked transformation events 
obtained by conventional crossing of organisms containing one or 
several transformation event(s) the notifier shall provide an e.r.a. 
for each single transformation event or refer to already submitted 
notifications in accordance with  Article 6(3) or Article 13(4).  
The notifier shall consider the potential for progeny of  the GMO 
containing various sub combinations of the transformation events 
to occur and assess the need to consider sub combinations of the 
higher stack in the risk assessment.  
The e.r.a. of GMOs containing stacked transformation events shall 
include an ass essment of the following aspects : 
(a) stability of the transformation events;  
(b) expression of the transformation events;  
(c) potential additive, synergistic or antagonistic effects resulting 
from the combination of the transformation events . 
C.2. Charact eristics of the GMO  
The notifier shall take into account the relevant technical and scientific 
details regarding characteristics of:  
– the rec ipient 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;   
EN 4   EN – 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 transgene may spread; and  
– the interaction(s) between t hese.  
Information on the recipient, donor, vector, genetic modification and the 
GMO shall be independent of the environment and the conditions of the 
release.  
C.3. Steps in the e.r.a.  
The e.r.a. referred to in Articles 4, 6, 7 and 13 shall be conducted 
following the six steps below:  
1. Problem formulation including hazard identification:  
The problem formulation shall:  
– define assessment endpoints that are representative of the 
protection goals;  
– identify the hazards;  
– describe the pathway to harm;  
– formulate t estable hypotheses that are clearly phrased and 
easily transferable to data to be generated or evaluated;  
– define measurement endpoints as measurement units for both 
hazard and exposure;  
– define the magnitude of tolerable effect;  
– consider possible uncertainties , including  knowledge gaps  
and methodological limitations.  
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. Potential adverse effect s shall not 
be discounted  on the basis that they are  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, allergenic effects ; 
– effects on the dynamics of populations of species in the 
receiving environment and the genetic diversity of each of 
these populations ; 
– altered susceptibility to pathogens facilitating the 
dissemination of infec tious diseases  or creating new 
reservoirs or vectors;   
EN 5   EN – compromising prophylactic or therapeutic  medical, 
veterinary, or plant protection treatments, f or example by 
transfer of genes;  
– conferring resistance to antibiotics used in human or 
veterinary medicine ; 
– effects on biogeochemistry  (biogeochemical cycles), 
including carbon and nitrogen recycling through changes in 
soil decomposition of organic material.   
Adverse effects may occur directly or indirectly through exposure 
pathways which may include:  
– the sprea d 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, in cluding, where applicable, in 
agricultural practices.  
2. Hazard characterisation  
The magnitude of the consequences of each potential adverse effect 
shall be evaluated. This evaluation shall assume that such an 
adverse effect will occur. The e.r.a shall con sider that the 
magnitude of the consequences is likely to be influenced by the 
receiving environment(s) into which the GMO(s) is (are) intended 
to be released and the scale and conditions of the release.  
The evaluation shall be expressed where possible in quantitative 
terms.  
If expressed in qualitative terms , a categorical description ( "high", 
"moderate ", "low" or "negligible ") shall be used and an explanation 
of the scale of effect represented by each description provided.  
3. Exposure characterisation  
The likelihood or probability of each identified potential adverse 
effect occurring shall be evaluated to provide a qualitative or 
quantitative assessment of the exposure. A qualitative assessment 
shall be further defined using an appropriate scale , which may  
notably consist in a numerical scale from 0 to1. The characteristics 
of the receiving environment(s), and the scope of the application 
shall be taken  into consideration.  
4. Risk characterisation  
The risk shall be characterised by combining the magnitude o f the 
consequences of a hazard and the likelihood of the adverse effects 
occurring to provide a quantitative or semi quantitative estimation 
of the risk.   
EN 6   EN Where relevant the uncertainty for each identified risk shall be 
described and expressed in quantitati ve terms.  
5. Risk management strategies  
A risk management strategy to manage the identified risks and 
reduce them to a level of no concern shall be defined.  
The risk management strategies shall be described in terms of 
reducing the hazard or the exposure , or both,  and the consequent 
reduction in overall risk shall be quantified (when possible) and 
shall be proportionate to the protection goals in the identified 
receiving environments, the scale and conditions of the release and 
the levels of uncertainty ide ntified in the e.r.a.  
6. Overall risk evaluation and conclusions  
An evaluation of the overall risk of the GMO(s) shall be made 
taking into account the results of the risk characterisation (step 4), 
the proposed risk management strategies (step 5) and the a ssociated 
levels of uncertainty.  
The overall risk evaluation and conclusions shall determine the 
requirements for the Post Market Environmental Monitoring 
(PMEM) plan of the GMO(s) and the monitoring of the efficacy of 
the proposed risk management measures ." 
(b) The title and the first subparagraph of section D are replaced by the following:  
"D. Conclusions on the specific areas of risk of the e.r.a.   
Conclusions on the potential environmental impact in relevant receiving 
environments from the release or th e placing on the market of GMOs shall be 
drawn on each of the points listed in sections D1 or D2, on the basis of an e.r.a. 
carried out in accordance with the principles outlined in section B  and 
following the methodology  described in section C, and on the  basis of the 
information required pursuant to Annex III."  
(c) Section D.2 . is replaced by the following:  
"D.2. In the case of genetically modified higher plants (GMHP)  
 The term ‘higher plants’ means plants which belong to the taxonomic group 
Spermatophytae (Gymnospermae and Angiospermae).   
1. Persistence and invasiveness  of the GMHP , including plant to plant gene 
flow 
2. Plant to micro -organisms gene transfer  
3. Interactions of the GMHP  with target organisms  
4. Interactions of the GMHP  with no n-target organisms  
5. Impacts of the specific cultivation, management and harvesting 
techniques .   
6. Effects on biogeochemical processes  
7. Effects on human and animal health ." 
2. Annex III is replaced by the following:   
EN 7   EN "ANNEX III  
INFORMATION REQUIRED IN  THE NOTIFICATION  
The notification s referred to in Parts B and C of the Directive shall include the  
information set out in the applicable sub-Annex , including an e.r.a. carried out in 
accordance with Annex II.  Annex III A applies to releases of all types of genetically 
modified organisms other than higher plants. Annex III B applies to release of 
GMHP.  
A given subset of information shall not be required where it is not relevant or 
necessary in the context of the notification concerned. The notifier shall p rovide a 
justification for any subset of information it does not provide . 
The level of detail required 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 summaries and results of the studies referred to in the notification, 
including an explanation about their relev ance to e.r.a. where applicable ; 
(ii) annexes where detailed information on those studies is provided including a 
description of the methods and materials used or the reference to standardised 
or internationally recognised methods and the name of the body or bodies 
responsible for carrying out the studies.  
Future developments in genetic modification may ne cessitate 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 
perennial plants and trees, single celled organisms, fish or insect s, 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 Union .  
In addition to the information set out in the sub -Annexes:  
(i) The notification shall contain a checklist demonstrating that the information 
required under the applicable sub -Annex is complete;  
(ii) In accordance with Article 25(2), the notification may indicate the information 
in the notification that should be tre ated as confidential and shall, in such cases, 
provide verifiable justification. " 
3. Annex III B is replaced by the following:  
"ANNEX III B  
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES 
OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) 
(GYMNOSPERMA E AND ANGIOSPERMAE)  
I. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED 
PURSUANT TO ARTICLES 6 AND 7  
A. GENERAL INFORMATION  
1. Name and address of the notifier (company or insti tute) 
2. Name, qualifications and experience of the responsible scientist(s)   
EN 8   EN 3. Title of the project  
4. Designation and specification of the GMHP   
5. Information relating to the release  
(a) Purpose of the release  
(b) Foreseen date(s) and duration of the release  
(c) Method by which the GMHP  will be released  
(d) Method for preparing and  managing the release site, prior to, 
during and post release, including cultivation practices and 
harvesting methods  
(e) Approximate number of plants (or plants per m2).  
6. Information relating to the site of release  
(a) Location and size of the release s ite(s).  
(b) Description of the release site ecosystem, including climate, 
flora and fauna.  
(c) Proximity to officially recognised biotopes or protected areas 
which may be affected.  
B. SCIENTIFIC INFORMATION  
All the subsets of information listed below shall  be provided in the notification, 
except where the notifier can justify that a specific subset is not relevant or 
necessary in the context of the notification concerned.  
1. Information relating to the recipient plant or, where appropriate , to the 
parental plants   
(a) Complete name:  
(i) family name  
(ii) genus  
(iii) species  
(iv) subspecies  
(v) cultivar  or breeding line  
(vi) common name.  
(b) Geographical distribution and cultivation of the plant within the 
Union.  
(c) Information concerning reproduction:  
(i) mode(s) of reproduction  
(ii) specific factors affecting reproduction, if any  
(iii) generation time.  
(d) Sexual compatibility with other cultivated or wild plant species, 
including the distribution in Europe of the compatible species.  
(e) Survivability:   
EN 9   EN (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 grown in the Union, a description of 
the natural habitat of the plant, including information on natural 
predators, parasites, competitors and symbionts.  
(h) Other potential 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 characterisation  
(a) Information relating to the genetic modification  
(i) Description of the methods used for the genetic modification.  
(ii) Nature and source of the vector used.  
(iii) Source of the nucleic acid(s) used for transformation, size, 
and intended function of each constituent fragment of the 
region intended for insertion.  
(b) Information relating to the GMHP  
(i) General description of the trait(s) and characteristics which 
have been introduced or modified.  
(ii) Information on the sequences actually inserted/deleted:  
 ‒ size and copy number of all detectable insert(s), both 
partial and complete and methods used for i ts/their 
characterisation;  
 ‒ the organisation and sequence of the inserted genetic 
material at each insertion site in a standardised 
electronic format;  
 ‒ in case of deletion, size and function of the deleted 
region(s) whenever possible;  
 ‒ subcellular lo cation(s) of the insert(s) in the plant cells 
(integrated in the nucleus, chloroplasts, mitochondria, 
or maintained in a non -integrated form), and meth ods 
for its/their determination.  
(iii) Information on the expression of the insert:  
 ‒ the method(s) used  for expression analysis together 
with their performance characteristics;  
 ‒ information on the developmental expression of the 
insert during the lifecycle of the plant;  
 ‒ parts of the plant where the insert  is expressed.   
EN 10   EN (iv) Genetic stability of the ins ert and phenotypic stability of the 
GMHP.  
(c) Conclusions of the molecular characterisation  
3. Information on specific areas of risk  
(a) Any change to the ability of the GMHP to become more persistent 
or invasive, including the ability to transfer genetic material to 
other plants.  
(b) Any change to the ability of the GMHP to transfer genetic material 
to microorganisms.  
(c) Mechanism of interaction between the GMHP  and target organisms 
(if applicable).  
(d) Potential changes in the interactions of the GMHP wi th non -target 
organisms resulting from the genetic modification.  
(e) Potential interactions with the abiotic environment.  
(f) Information on any toxic, allergenic or other harmful effects on 
human health arising from the genetic modification.  
(g) Conclusio ns on the specific areas of risk . 
4. Information on control, monitoring, post -release and waste treatment 
plans  
(a) Any precautions taken:  
(i) distance(s) from sexually compatible plant species, both wild 
relatives and crops  
(ii) any measures to minimise  or prevent the dispersal of any 
reproductive organ of the GMHP (for example pollen, seeds, 
tuber).  
(b) Description of methods for post -release treatment of the site.  
(c) Description of post -release treatment methods for the genetically 
modified plant mate rial including wastes.  
(d) Description of monitoring plans and techniques.  
(e) Description of any emergency plans.  
(f) Methods and procedures to protect the site.  
5. Description of detection and identification techniques for the GMHP.  
6. Information about previous releases of the GMHP , if applicable.  
II. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED 
PURSUANT TO ARTICLE 13  
A. GENERAL INFORMATION  
1. Name and address of the notifier (company or institute).  
2. Name, qualifications and experience of the responsible scientist(s).  
3. Designation and specification of the GMHP.   
EN 11   EN 4. Scope of the notification.  
(a) Cultivation  or growing  
(b) Other uses . 
B. SCIENTIFIC INFORMATION  
All the subsets of information listed below shall be provided in the notification, 
except where the notifier can justify that a specific subset is not relevant or 
necessary in the context of the notification concerned.  
1. Information relating to the recipient plant or, where appropriate , to the 
parental plants   
(a) Complete name:  
(i) famil y name  
(ii) genus  
(iii) species  
(iv) subspecies  
(v) cultivar/breeding line  
(vi) common name.  
(b) Geographical distribution and cultivation area of the plant within 
the Union.  
(c) Information concerning reproduction:  
(i) mode(s) of reproduction  
(ii) specific factors affecting reproduction, if any  
(iii) generation time.  
(d) Sexual compatibility with other cultivated or wild plant species, 
including the distribution in the Union of the compatible species.  
(e) Survivability:  
(i) ability to form structure s for survival or dormancy  
(ii) specific factors affecting survivability, if any.  
(f) Dissemination:  
(i) ways and extent of dissemination (for example an estimation 
of how viable pollen and/or  seeds declines with distance)  
(ii) specific factors affecting dissemination, if any.  
(g) Where a plant species is not grown in the Union, a description of 
the natural habitat of the plant, including information on natural 
predators, parasites, competitors and symbionts.  
(h) Other potential 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 characterisation   
EN 12   EN (a) Information relating to the genetic mod ification  
(i) Description of the methods used for the genetic modification.  
(ii) Nature and source of the vector used.  
(iii) Source of the nucleic acids(s) used for transformation, size, 
and intended function of each constituent fragment of the 
region inte nded for insertion.  
(b) Information relating to the genetically modified plant  
(i) Description of the trait(s) and characteristics which have been 
introduced or modified.  
(ii) Information on the sequences actually inserted/deleted:  
 ‒ size and copy number of all detectable inserts, both 
partial and complete, and methods used for its 
characterisation;  
 ‒ the organisation and sequence of the inserted genetic 
material at each insertion site in a standardised 
electronic format;  
 ‒ in case of deletion, size and function of the deleted 
region(s) whenever possible;  
 ‒ subcellular location(s) of the insert(s) (integrated in the 
nucleus, chloroplasts, mitochondria, or maintained in a 
non-integrated form), and methods for its/their 
determination;  
 ‒ In the case of modifications other than insertion or 
deletion, function of the modified genetic material 
before and after the modification, as well as direct 
changes in expression of genes as a result of the 
modification;  
 ‒ sequence information in a stand ardised electronic 
format for both 5’ and 3’ flanking regions at each 
insertion site;  
 ‒ nucleotide sequence that contains a string of codons 
that is uninterrupted by the presence of a stop codon in 
the same reading frame ( Open Reading Frames , 
hereafter re ferred to as ‘ORFs’) created as a result of 
the genetic modification either at the junction sites with 
genomic DNA or due to internal rearrangements of the 
insert(s).  
(iii) Information on the expression of the insert:  
 ‒ the method(s) used for expression a nalysis together 
with their performance characteristics;  
 ‒ information on the developmental expression of the 
insert during the lifecycle of the plant;   
EN 13   EN  ‒ parts of the plant where the insert/modified sequence 
are expressed;  
 ‒ potential unintended express ion of new ORFs identified 
under the sixth indent of point (ii), which raise a safety 
concern;  
 ‒ protein expression data, including the raw data, 
obtained from field trials and related to the conditions 
in which the crop is grown;  
 ‒ expression data with regard to the stacking of 
transformation events by conventional crossing  and, 
where concerns arise, additional information.   
(iv) Genetic stability of the insert and phenotypic stability of the 
GMHP.  
(c) Conclusions of molecular characterisation  
3. Compara tive analysis  
(a) Choice of conventional counterpart and additional comparators . 
(b) Choice of representative site locations . 
(c) Experimental design and statistical analysis of data from field trials 
for comparative analysis  
(i) Description of field trial design  
(ii) Description of relevant aspect of the receiving environments  
(iii) Statistical analysis  
(d) Selection of plant material and compounds for analysis, if 
applicable.  
(e) Comparative analysis of agronomic and phenotypic characteristics, 
if applicable.  
(f) Comparative analysis of composition, if applicable.  
(g) Conclusions of comparative analysis . 
4. Specific 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 des cribe the pathway to harm explaining in a chain 
of cause and effect how the deployment of the GMHP could lead to 
harm, taking into account both hazard and exposure.  
(a) Persistence and invasiveness including plant to plant gene flow  
(i) Assessment of the potential for the GMHP to become 
persistent or invasive  or to transmit transgene(s) to relatives 
and the environmental consequences thereof .  
(ii) Conclusions on impacts of persistence and invasiveness 
including plant -to-plant gene flow . 
(b) Plant to micro -organism gene transfer   
EN 14   EN (i) Assessment of the potential impact of transfer or  long-term 
establishment of newly inserted DNA from the GM HP to 
microorganisms ; (ii) Assessment of the potential 
impact of the transfer of newly inserted DNA for human and 
animal health and the environment ; 
(iii) Conclusions on impacts of plant to microorganism gene 
transfer.  
(c) Interactions of the GMHP with target organisms  
(i) Assessment of the potential immediate and delayed 
environmental impact(s) resulting from undesired changes in 
the direct and indirect interactions between the GMHP and 
target organisms ; 
(ii) Assessment of the potential immediate and delayed 
environmental impact(s) resulting from the development of 
resistance of the target organism to the expressed prote in 
based on the history of development of resistance to 
conventional pesticides or transgenic plants expressing 
similar traits ; 
(iii) Conclusions on interactions of the GMHP with target 
organisms.  
(d) Interactions of the GMHP with non -target organisms .  
(i) Assessment of the possible immediate and delayed 
environmental impact(s) resulting from direct and indirect 
interactions of the GMHP with non -target organisms, (also 
taking into account organisms which interact with target 
organisms), including impact on  population levels of a 
representative subset of species of herbivores, predators, 
parasitoids, parasites and pathogens, entomopathogenic 
organisms, pollinators, decomposers and plant symbionts 
(where applicable), and taking into account the potential 
impa ct(s) on relevant ecosystem services ; 
(ii) Conclusions on interactions of the GMHP with non -target 
organisms.  
(e) Impacts of the specific cultivation, management and harvesting 
techniques  
(i) For GMHPs for cultivation, assessment of the possible 
immediate and delayed, direct and indirect environmental 
impacts of the specific cultivation, management and 
harvesting techniques used for the GMHP ; 
(ii) Conclusions on impacts of the specific cultivation, 
management and harvesting techniques . 
(f) Effects on biogeo chemical processes  
(i) Assessment of the possible immediate and delayed effects on 
biogeochemical processes in the production site, which  
EN 15   EN comprises the soil, plants, animals and microorganisms 
within the area in which the GM HP is to be grown ; 
(ii) Assessme nt of the possible immediate and delayed effects on 
biogeochemical processes in the wider environment, which 
comprises land, water and air outside the production site, 
with which the GM HP and its management might interact ; 
(iii) Conclusions on effects on b iogeochemical processes . 
(g) Effects on human and animal health  
(i) Assessment of possible immediate and delayed effects on 
human health resulting from potential direct and indirect 
interactions of the GMHP and persons working with, coming 
into contact wit h the GMHP release(s) (products such as 
pollen or dust from processed plants) ;  
(ii) For GMHPs not destined for human consumption but where 
the recipient or parental organism(s) may be considered for 
human consumption the likelihood of accidental intake ; 
(iii) Possible immediate and delayed effects on animal health and 
consequences for the feed/food chain resulting from the 
unintended or accidental exposure to the GM HP and products 
derived from it ; 
(iv) Conclusions on the effects on human and  animal health . 
(h) Overall risk evaluation and conclusions . 
5. Description of detection and identification techniques for the GMHP.  
6. Information about previous relea ses of the GMHP, if applicable.  
4. Section A of Annex IV is amended as follows : 
(a) Point 1 is replaced  by the following:  
"1. proposed commercial names of the products and names of GMOs 
contained therein, and a proposal for a unique identifier for the GMO, 
developed in accordance with Commission Regulation (EC) No 
65/20041. After the consent any new commerc ial names should be 
provided to the competent authority,  
(b) Point 7  is replaced by the following:  
"7. methods for detection, identification and , where appropriate, 
quantification  of the transformation event ; samples of the GMO(s) and 
their control samples , and information as to the place where the reference 
material can be accessed. Information that cannot be placed, for 
confidentiality reasons, in the publicly accessible part of the register(s) 
referred to in Article 31(2) should be identified, ". 
                                                 
1 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the 
development and assignment of unique identifiers for genetically modified organis ms (OJ L 10, 
16.1.2004, p. 5)."