B 1392
L.N. 182 of 2019
ENVIRONMENT PROTECTION ACT
(CAP. 549)
Deliberate Release into the Envir onment of Genetic ally Modified  
Organisms (Amendment) Regulations, 2019
BY VIRTUE of the powers confer red by articles 54 and 55 of the
Environment Protection Act, the  Minister for the Environment,
Sustainable Development and Clim ate Change, after consultation with
the Environment and Resources Authority, has made the following
regulations:-
Citation. 
S.L. 549.60.1. The title of these regulations is the Deliberate Release into
the Environment of Genetically Modified Organisms (Amendment)
Regulations, 2019 and they shall b e read and construed as one w ith the
Deliberate Release into the Envi ronment of Genetically Modified
Organisms Regulations, hereinafte r referred to as "the principa l
regulations".
Amends 
regulation 2 of the principal 
regulations.2. In regulation 2 of the principal regulations, in  the definition
"competent authority", the words "of these regulations;" shall be
substituted by the words "of these regulations:" and immediatel y
thereafter there shall be added the following new proviso:
S.L. 449.56."Provided that the competent authorities for issues relating
to genetically modified organis ms for food and feed and their
placing on the market shall b e  t h e  s a m e  a s  t h e  e n t i t i e s
responsible for the implementation of Regulation (EC) No 1829/
2003 of the European Parliament and of the Council of 22September 2003 on genetically modi fied food and feed in Malta,
as provided in the Enforcement of Various European UnionRegulations on Food Safety Regulations.".
Amends 
regulation 6 of 
the principal regulations.3. Regulation 6 of the principal regulations shall be amended
as follows:
(a) paragraph (c) of sub-regulation (2) thereof, shall be
substituted by the following:
"(c) the notification shall be accompanied by the
relevant documents and any other requisite information as
specified and required by the competent authority. The
notifier shall clearly indica te whether the notification
would prejudice any enforcement case, court case or other
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causes currently sub-judice .";
(b) in the Maltese version, in paragraph (b) of sub-
regulation (2) thereof, the words "tal-metodi użati." shall be
substituted by the words "tal-metodi użati;" a nd immediately
thereafter, there shall be adde d the following new paragraph:
"(ċ) in-notifika għandha  tkun akkumpanjata mid-
dokumenti relevanti u kwal unkwe informazzjoni oħra
meħtieġa kif speċifikat u meħt ieġ mill-awtorità kompetenti.
In-notifikant għandu jindika  b’mod ċar jekk in-notifika
tkunx ser tippreġudika xi każ ta ’ infurzar, xi każ pendenti
quddiem il-qorti jew xi kawżi oħra li jkunu għandhom sub-
judice ."; and
(c) in sub-regulation (7) thereof, the words "sub-
regulation (5)" shall be substituted by the words "sub-regulati on
(6)", wherever they occur.
Amends 
regulation 7 of 
the principal regulations.4. Sub-regulation (3) of regul ation 7 of the principal
regulations, shall be substituted by the following:
"(3) Without prejudice to sub-regulations (1) and (2), the
simplified procedures laid down in Schedule IX shall be
applicable to the deliberate release into the environment of
genetically modified plants fitting the definition of genetical ly
modified plants included i n item 1 of Schedule IX.".
Amends 
regulation 12 of the principal 
regulations.5. Regulation 12 of the principal regulations shall be amended
as follows:
(a) in paragraph (e) of sub-regulation (2) thereof, the
words "regulation 14(4)" shall be substituted by the words
"regulation 14(5)";
(b) paragraph (j) of sub-regulation (2) thereof, shall be
substituted by the following:
"(j) the notifier shall cl early indicate whether the
notification would prejudice  any enforcement case, court
case or other causes currently sub-judice:" ;
(c) in sub-regulation (5) thereof, for the words "the
requirements laid down" there sha ll be substituted the words "the
relevant requirements laid down";
(d) in paragraph (b) of sub-regulation (5) thereof, the
words "to an application" shall be substituted by the words "to  a
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notification"; and
(e) in paragraph (c) of sub-regulation (5) thereof, the
words "regulation 13(b)" shall be substituted by the words
"regulation 13(1)(b)".
Amends 
regulation 13 of 
the principal 
regulations.6. Regulation 13 of the principal regulations shall be amended
as follows:
(a) in paragraph (b) of sub-regulation (1) thereof, the
words "regulation 12(2)(h)" sha ll be substituted by the words
"regulation 12(2)(i)"; and
(b) immediately after sub-re gulation (4) thereof, there
shall be added the following new sub-regulation (5):
"(5) Without prejudice to Regulation (EC) No 1829/
2003 on genetically modifi ed food and feed:
(a) during the authorisation procedure the
competent authority or other Member States may
demand that the geographical scope of the written
consent be adjusted to the effect that all or part of theterritory of Malta or the concerned Member State, as
the case may be, is to be excluded from cultivation.
Such a demand shall be made in accordance withArticle 26b (1) of the Directive;
(b) within thirty (30) days from the
presentation of the demand to the notifier by theCommission, the notifier may adjust or confirm the
geographical scope of the  initial notification;
(c) in the absence of the confirmation of the
initial geographical scope by the notifier, the
adjustment of the geographical scope shall beimplemented in the written consent issued under
these regulations;
(d) where applicable, the written consent
issued under these regulations by the competentauthority shall then be issued on the basis of the
adjusted geographical scope of the notification.".
Amends 
regulation 14 of the principal 
regulations.7. Regulation 14 of the principal regulations shall be amended
as follows:
(a) in paragraph (b) of sub-regulation (1) thereof, the
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words "ninety days" shall be substituted by the words "sixty (6 0)
days"; and
(b) sub-regulation (3) thereof,  shall be substituted by the
following:
"(3) If the competent authority decides that the
product may be placed on the ma rket, it shall give consent
in writing, transmit it to the notifier and inform other
Member States and the Commi ssion thereof within a period
of thirty (30) days:
Provided that where a demand, or demands, in
accordance with regulation 13( 5) are communicated to the
Commission after the date of the circulation of theassessment report required under regulation 13(2) the
timelines to issue the written consent shall be extended by a
single period of fifteen (15) day s, regardless of the number
of the demands presented. Su ch further provision shall be
without prejudice to Regulation (EC) No 1829/2003 ongenetically modified food and feed.".
Amends 
regulation 15 of 
the principal regulations.8. Regulation 15 of the principal r egulations shall be amended
as follows:
(a) in sub-regulation (1) thereof, the words "the
procedure set out in sub-regul ations (2) to (5)" shall be
substituted by the words "the procedure set out in sub-
regulations (2) to (6)";
(b) in paragraph (d) of sub-regulation (4) thereof, the
words "Schedule V" shall be substituted by the words "ScheduleVI"; 
(c) sub-regulations (5) to (9) thereof, shall be
renumbered as sub-regulations  (6) to (10) respectively;
(d)  immediately after sub-re gulation (4) thereof there
shall be added the fol lowing new sub-regulation:
"(5) The provisions under regulation 13(5)
concerning a demand or demands for the adjustment to thegeographical scope of a  written consent shall also apply for
the renewal of consents.";
(e) in sub-regulation (7) thereof, as renumbered, the
words "sub-regulation (4)(d)" shall be substituted by the words"sub-regulation (6)(b)" wherever they occur; and
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(f) sub-regulation (8) thereo f, as re-numbered, shall be
substituted by the following:
"(8) When the competent authority renews a consent
in accordance to sub-regulation (7), it shall transmit to the
notifier the final decision in writing and shall inform the
other Member States and the Commission thereof withinthirty (30) days beginning on the day that the consent was
renewed:
Provided that where a demand, or demands, in
accordance with sub-regulation (5) are communicated to
the Commission after the date of the circulation of theassessment report, the timelines to issue the written
renewal consent shall be ext ended by a single period of
fifteen (15) days, regardless of the number of the demands
presented. This provision shall be without prejudice to
Regulation (EC) No 1829/2003 on genetically modified
food and feed.".
Amends 
regulation 16 of the principal 
regulations.9. Immediately after sub-regulat ion (3) of regulation 16 of the
principal regulations, there shall be added the following new s ub-
regulation:
"(4) (a) Another Member State may request the
competent authority to reintegrat e all or part of its territory  into
the geographical scope of a consent from which it was excluded
pursuant to sub-regulations 13(5) and 15(5). The competent
authority shall then amend the geographical scope of the consen t
accordingly.
(b) The competent authority may, if necessary,
reintegrate all or part of the Maltese Islands into the
geographical scope of the c onsent from which it had been
excluded pursuant to sub-regulations 13(5) and 15(5).
(c) Once the adjustment pursuant to paragraph (a)
or (b) is completed the competent authority shall duly
inform the Commission, the Member States and the consent
holder.".
Adds new 
regulations 16A and 16B to the 
principal 
regulations.10. Immediately after regulation 16 of the principal regulations,
there shall be added the following new regulations:
"Measures restricting or 
prohibiting the 
cultivation in all or part of the Maltese territory.16A. Without prejudice to Regulation (EC) No
1829/2003 on genetically modified food and feed:
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(1) Where no demand for the adjustment of the
geographical scope of a written consent was made
pursuant to the Directive or  these regulations, as the
case may be, or where the notifier has confirmed the
geographical scope of its initial notification, thecompetent authority may a dopt measures restricting or
prohibiting the cultivation in all or part of the Malteseterritory of a GMO, or gro up of GMOs defined by crop
or trait, once the placing on the market is authorised in
accordance with the Directive or through these
regulations.
(2) (a) Measures adopted pursuant to sub-
regulation (1) shall be in conformity with Union law,
reasoned, proportional, non-discriminatory and basedon compelling grounds, such as those related to:
(i) environmental policy objectives;
(ii) town and country planning;
(iii) land use;(iv) socioeconomic impacts;
(v) avoidance of GMO presence in
other products without prejudice to
regulation 16B;
(vi) agricultural policy objectives;
and
(vii) public policy.
(b) The compelling grounds may be
invoked individually or in combination, with theexception of sub-paragra ph (vii) of sub-regulation
(2)(a), which cannot be invoked individually.
Grounds would depend on the particular
circumstances of Malta, the region or area inwhich the measures would apply and shall, in no
case, conflict with the environmental risk
assessment carried out pursuant to the Directiveor these regulations.
( 3 ) A  d r a f t  o f  t h e  m e a s u r e s  t h e  c o m p e t e n t
authority intends to adopt and the corresponding
grounds invoked shall be duly communicated to the
Commission. Such communication may take placebefore the GMO authorisation procedure under Part C
of the Directive or these regulations has been
completed.
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Amends 
regulation 17 of 
the principal 
regulations.11. Regulation 17 of the princip al regulations, shall be
amended as follows:
(a) sub-regulation (2) thereof, shall be substituted by the
following:
"(2) If new information ha s become available, from
the users or other sources, with regard to the risks of any(4) The competent authority shall issue a notice
in the Gazette which shall p rohibit the planting of the
GMO or GMOs for which measures have been drafted,
pursuant to sub-regulation (3).  Such notice shall cover a
period of seventy-five (75) days, starting from the day
that the draft measures are communicated to the
Commission.
(5) On the expiry of the seventy-five (75) day
period referred to in sub-regulation (4) the competent
authority may, for the whole duration of the consent for
the placing on the market and as from the date of entry
into force of the concerned authorisation, adoptmeasures restricting or prohibiting the cultivation of the
GMO or the group of GMOs referred to in sub-
regulation (4). Such measures shall either be thoseoriginally proposed by the competent authority, or as
amended following the comments received from the
Commission.
(6) (a) Once the competent authority adopts
measures in accordance with  this regulation it shall
immediately communicate such measures to the
Commission, the other Member States and the consent
holder without delay.
(b) The competent authority shall also
publish any measures adopted pursuant to sub-regulation (5) in the Gazette.
(7) The competent authority may revoke the
measures taken pursuant to this regulation at any time.
Such revocation shall be immediately communicated to
the Commission and other Member States.
Measures to avoid 
cross-border 
contamination.16B. The competent authority in collaboration
with other relevant authorities, may take appropriate
measures in border areas which aim at avoiding
possible cross-border contamination into neighbouring
Member States in which the cultivation of those GMOsis prohibited, as appropriate. Such measures shall be
communicated to the Commission.".
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GMO to human health or the environment after the written
consent has been give n, the notifier shall:
(a) revise the notification, as required; and
(b) immediately take t he measures necessary
to protect human health and the environment, and
inform the competent authority thereof.";
(b) in sub-regulation (3) thereof, immediately after the
words "the provisions in regulation 14" there shall be added th e
words "and 15";
(c) in paragraph (b) of sub-regulation (4) thereof, the
words "Schedule V" shall be substituted by the words "ScheduleVI"; and
(d) in sub-regulation (5) thereof, the words "sub-
regulation (4)(b)(i)" shall be substituted by the words "sub-
regulation (4)(b)" wherever they occur.
Amends 
regulation 18 of 
the principal regulations.12. In sub-regulation (1) of regulation 18 of the principal
regulations immediately after the  words "regulations 14(2)," there
shall be added the words "15(7)".
Amends regulation 19 of 
the principal 
regulations.13. In sub-regulation (1) of regulation 19 of the principal
regulations the words "Without p rejudice to this regulation, th e
competent authority may not prohibit, restrict or impede placin g on
market of any GMO, as or in products, which comply with these
regulations except where," sha ll be substituted by the word "Wh ere,". 
Amends 
regulation 21 of 
the principal regulations. 14. In regulation 21 of the principal regulations the words
"regulation 2(1)" shall be substituted by the words "regulation  2".
Amends 
regulation 23 of 
the principal regulations.15. Regulation 23 of the principal regulations shall be amended
as follows:
(a) sub-regulations (3) to (7) thereof, shall be re-
numbered as sub-regulations (5) to (9) respectively;
(b) sub-regulation (2) thereof, shall be substituted by the
following new sub-regulation:
"(2) Any person who commits an offence against the
provisions concerning the deliberate release of GMOs, for
any other purpose than for placing on the market shall, on
conviction, be liable:
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(a) on a first conviction to a fine (multa) of
not less than fifty thousand euro (€50,000) but not
exceeding seventy-five thousand euro (€75,000);
(b) on a second or subsequent conviction, to a
fine ( multa) of not less than sixty-five thousand euro
(€65,000), but not exceeding one hundred thousandeuro (€100,000) or to imprisonment for a term not
exceeding two (2) years, or to both such fine and
imprisonment."; and
(c) immediately after sub-re gulation (2) thereof, there
shall be added the following new sub-regulations (3) and (4):
"(3) Any person who commits an offence against the
provisions concerning the placing on the market of GMOsshall, on conviction, be liable: 
 (a) on a first conviction to a fine ( multa ) of
not less than sixty thousand euro (€60,000) but notexceeding ninety th ousand euro (€90,000);
(b) on a second or subsequent convictions, to
a fine (multa ) of not less than seventy-five thousand
euro (€75,000), but not exceeding one hundred andtwenty thousand euro (€120,000) or to imprisonment
for a term not exceeding two (2) years, or to both
such fine and imprisonment.
(4) The court shall order any person who has been
found guilty of committing an offence against theseregulations to pay the expenses incurred by the competentauthority as a result of the s aid offence, the revocation of
the notification issued by the competent authority and theconfiscation of the corpus delicti .".
Adds new 
regulation 26A 
to the principal regulations.16. Immediately after regulation 26 of the principal
regulations, there shall be added the following new regulation:
Amends Schedule II to 
the principal 
regulations.17. Schedule II to the principal regulations, shall be amended
as follows:
(a) Section C thereof, shall be substituted by the
following:"Free circulation of authorized GMOs. 26A. The provisions of regulations 13(5), 15(5)
and 16A shall not affect t he free circulation of
authorized GMOs as, or in, products"."
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"C. Methodology
Guidance issued by the European Food Safety
Authority is available for the implementation of this
section for Part C notifications. 
C.1. General and specific cons iderations for the e.r.a. 
1. Intended and unintended changes  
As part of the identification and evaluation of the
potential adverse effects re ferred to in Section A, the
e.r.a shall identify the intended and unintended
changes resulting from the genetic modification and
shall evaluate their potenti al to cause adverse effects
on human health and on the environment. 
Intended changes resulting from the genetic
modification are changes that are designed to occur
and which fulfil the original objectives of the genetic
modification. 
Unintended changes resulting from the genetic
modification are consistent changes which go beyondthe intended change(s) resulting from the genetic
modification. 
Intended and unintended changes can have either
direct or indirect, and either immediate or delayedeffects on human health and on the environment. 
2. Long-term adverse effe cts and cumulative long-
term adverse effects in the e.r.a. of Part Cnotifications  
Long-term effects of a GMO are effects resulting
either from a delayed response by organisms or theirprogeny to long-term or chronic exposure to a GMOor from an extensive use of a GMO in time and space.
The identification and evaluation of the potential
long-term adverse effects of a GMO on human healthand on the environment shall take into account the
following: 
(a) the long-term interactions of the GMO
and the receiving environment; 
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(b) the characteristics of the GMO which
become important on a long-term basis; 
(c) data obtained from repeated deliberate
releases or placings on the market of the GMO over a
long period. 
The identification and ev aluation of the potential
cumulative long-term adverse effects referred to in
the introductory part of Schedule II shall also take
into account the GMOs deliberately released or
placed on the market in the past. 
3. Quality of the data  
In order to carry out an e.r.a. for a notification under
Part C, the notifier shall coll ate already available data
f r o m  s c i e n t i f i c  l i t e r a t u r e  o r  f r o m  o t h e r  s o u r c e s ,
including monitoring reports, and shall generate the
necessary data by performing, where possible,
appropriate studies. Where applicable, the notifiershall justify in the e.r.a. why generating data by
studies is not possible. 
The e.r.a. for notifications under Part B shall be based
at least on already available data from scientificliterature or from other sources and may be
supplemented by additional data generated by thenotifier. 
Where data generated outside Europe is provided in
the e.r.a., its relevance to  receiving environment(s) in
the Union shall be justified. 
Data provided in the e.r.a for notifications under Part
C shall comply with the following requirements: 
(a) where toxicological studies carried out to
assess risk to human or animal health are provided inthe e.ra., the notifier shall provide evidence todemonstrate that they were conducted in facilities
which comply with: 
(i) the requirements of Directive 2004/
10/EC; or 
(ii) the "OECD Principles on Good
Laboratory Practice" (GLP), if carried out
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outside the Union; 
(b) where studies other than toxicological
studies are provided in the e.r.a., they shall: 
(i) comply with the principles of Good
Laboratory Practice (GLP) laid down in
Directive 2004/10/EC, where relevant; or 
(ii) be conducted by organisations
accredited under the relevant ISO standard; or 
(iii) in the absence of a relevant ISO
standard, be conducted in accordance withinternationally recognised standards; 
(c) information on the results obtained from
the studies referred to in i tems (a) and (b) and on the
study protocols 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 eac h study performed intends to
detect and justify it; 
(e) the selection of sites for fie ld studies shall
be based on relevant recei ving environments in view
of the potential exposure and impact that would be
observed where the GMO may be released. The
selection shall be justi fied in the e.r.a.; 
(f) the non-genetically modified comparator
shall be appropriate for  the relevant receiving
environment(s) and shall have a genetic background
comparable to the GMO. The choice of the
comparator shall be justified in the e.r.a. 
4. Stacked transformation events in Part C
notifications  
The following shall apply to the e.r.a. of a GMO
containing stacked transformation events in Part C
notifications: 
(a) the notifier shall pr ovide an e.r.a. for each
single transformation even t  i n  t h e  G M O  o r  r e f e r  t o
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already submitted notifi cations for those single
transformation events; 
(b) the notifier shall provide an assessment of
the following aspects: 
(i) the stability of the transformation
events; 
(ii) the expression of  the transformation
events; 
(iii) the potential additive, synergistic or
antagonistic effects  resulting from the
combination of the transformation events; 
(c) where the progeny of the GMO can
contain various sub-combinations of the stacked
transformation events, th e notifier shall provide a
scientific rationale justify ing that there is no need to
provide experimental data for the concerned sub-combinations, independently o f their origin, or, in the
absence of such scientific rationale, shall provide the
relevant experimental data. 
C.2. Characteristic s of the GMO and of the releases 
The e.r.a. shall take into account the relevant
technical and scientific details regarding
characteristics of: 
(a) the recipient or parental organism(s); 
(b) the genetic modification(s), be it insertion
or deletion of genetic material, and relevantinformation on the vector and the donor;
(c) the GMO; 
(d) the intended release or use including its
scale;
(e) the potential receiving environment(s)
into which the GMO will be released and into which
the transgene may spread; and 
(f) the interaction(s) between these
characteristics. 
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Relevant information from previous releases of the
same or similar GMOs and organisms with similar
traits and their biotic and abiotic interaction with
similar receiving environments, including
information resulting from the monitoring of such
organisms, shall be considered in the e.r.a., subject toregulation 6(3) or regulation 12(4). 
C.3. Steps in the e.r.a. 
The e.r.a. referred to in regulations 4, 6, 7 and 12
shall be conducted for each relevant area of risk
referred to in Section D1 or in Section D2 of Part D inaccordance with the following six steps: 
1. Problem formulation including hazard
identification  
The problem formulation shall: 
(a) identify any changes in the characteristics
of the organism, linked to the genetic modification,by comparing the character istics of the GMO with
those of the chosen non-genetically modifiedcomparator under correspondi ng conditions of release
or use; 
(b) identify potential adverse effects on
human health or the environment which are linked tothe changes that have been identified under item (a)
above. 
Potential adverse effects shall not be discounted on
the basis that they are unlikely to occur. 
Potential adverse effects wi ll vary from case to case,
and may include: 
(i) effects on the dynamics of
populations of specie s in the receiving
environment and the genetic diversity of each
of these populations leading to a potential
decline in biodiversity; 
(ii) altered susceptibility to pathogens
facilitating the dissem ination of infectious
diseases or creating new reservoirs or vectors;
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(iii) compromising prophylactic or
therapeutic medical, veterinary, or plant
protection treatments, for example by transferof genes conferring resistance to antibiotics
used in human or veterinary medicine; 
(iv) effects on biogeochemistry
(biogeochemical cycles), including carbon andnitrogen recycling through changes in soil
decomposition of organic material;
(v) disease affecting humans, including
allergenic or toxic reactions;
(vi) disease affecting animals and plants,
including toxic, and, in the case of animals,allergenic reactions, where appropriate. 
Where potential long-term adverse effects of a GMO
are identified, they shall be assessed in the form ofdesk based studies using, where possible, one or moreof the following: 
(aa) evidence from previous
experiences; 
(bb) available data sets or literature; 
(cc) mathematical modelling; 
(c) identify relevant assessment endpoints. 
Those potential adverse effects that could impact the
identified assessment endpoints shall be considered in
the next steps of the risk assessment; 
 (d) identify and describe the exposure
pathways or other mechanisms through whichadverse effects may occur. 
Adverse effects may occu r directly or indirectly
through exposure pathways or other mechanismswhich may include: 
(i) the spread of the GMO(s) in the
environment;
(ii) the transfer of the inserted genetic
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material to the same organism or other
organisms, whether genet ically modified or not;
(iii) phenotypic and genetic instability;
(iv) interactions with other organisms;
(v) changes in management, including,
where applicable, in agricultural practices;
(e) formulate testable hypotheses, and define
relevant measurement endp oints, to allow, where
possible, a quantitative evaluation of the potential
adverse effect(s); 
(f) consider possible uncertainties, including
knowledge gaps and methodol ogical limitations.
2. Hazard characterisation  
The magnitude of each potential adverse effect shall
be evaluated. This evaluation shall assume that suchan adverse effect will occu r. The e.r.a shall consider
that the magnitude is likely to be influenced by the
receiving environment(s)  into which the GMO is
intended to be released and by the scale andconditions of the release. 
Where possible, the evaluat ion shall be expressed in
quantitative terms. 
Where the evaluation is expressed in qualitative
terms, a categorical descr iption ("high", "moderate",
"low" or "negligible") shall be used and anexplanation of the scale of effect represented by each
category shall be provided. 
3. Exposure characterisation  
The likelihood or probabili ty of each identified
potential adverse effect occurring shall be evaluated
to provide, where possible, a quantitative assessment
of the exposure as a relative measure of probability,or otherwise a qualitative assessment of the exposure.
The characteristics of the receiving environment(s)and the scope of the notification shall be taken into
consideration. 
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Where the evaluation is expressed in qualitative
terms, a categorical description ("high", "moderate",
"low" or "negligible") of the exposure shall be used
and an explanation of the scale of effect represented
by each category shall be provided. 
4. Risk characterisation  
The risk shall be characterised by combining, for
each potential adverse effect, the magnitude with the
likelihood of that adverse effect occurring to provide
a quantitative or semi-quantitative estimation of the
risk. 
Where a quantitative or semi-quantitative estimation
is not possible, a qualitative estimation of the riskshall be provided. In that case, a categoricaldescription ("high", "moderate", "low" or
"negligible") of the risk shall be used and anexplanation of the scale of effect represented by eachcategory shall be provided. 
Where relevant, the uncertainty for each identified
risk shall be described a nd, where possible, expressed
in quantitative terms. 
5. Risk management strategies 
Where risks are identified th at require, on the basis of
their characterisation, me asures to manage them, a
risk management strategy shall be proposed.
The risk management strategies shall be described in
terms of reducing the haza rd or the exposure, or both,
and shall be proportionate to the intended reductionof the risk, the scale and c onditions of the release and
the levels of uncertainty identified in the e.r.a. 
The consequent reduction in overall risk shall be
quantified where possible.
 6. Overall risk eval uation and conclusions  
A qualitative and, where possible, quantitative
evaluation of the overall risk of the GMO shall bemade taking into account the results of the risk
characterisation, the proposed risk management
strategies and the associated levels of uncertainty. 
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The overall risk evaluati on shall include, where
applicable, the risk management strategies proposed
for each identified risk. 
The overall risk evaluation and conclusions shall also
propose specific requirements for the monitoring planof the GMO and, where appropriate, the monitoringof the efficacy of the proposed risk management
measures. 
For notifications under P art C, the overall risk
evaluation shall also include an explanation of the
assumptions made during the e.r.a. and of the natureand magnitude of uncertainties associated with the
risks, and a justificati on of the risk management
measures proposed.";
(b) The title and the introductory paragraph of Section D
thereof, shall be substituted 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
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 pl ants 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 Part B and following the methodologydescribed in Part C, and on the basis of the
information required pursuant to Schedule III."; and
 (c) Section D.2 thereof, shall be substituted by the
following: 
"D.2. In the case of gene tically modified higher
plants (GMHP) 
"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 transfer.
2. Plant to micro-organisms gene transfer.
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3. Interactions of the GMHP with target
organisms.
4. Interactions of the GMHP with non-target
organisms.
5. Impacts of the specific cultivation,
management and harvesting techniques.
6. Effects on biogeochemical processes.
7. Effects on human and animal health.".
Substitutes 
Schedule III to the principal 
regulations.18. Schedule III to the princ ipal regulations, shall be
substituted by the following:
"SCHEDULE III
(Regulations 4, 5, 6, 7, 11 and 12)
INFORMATION REQUIRED IN THE NOTIFICATION
Notifications referred to in Parts B and C shall, as a rule,
include the information set out in Schedule III A, for
GMOs other than higher plants , or in Schedule III B, for
genetically modified higher plants. 
The provision of a given subset of information listed in
Schedule III A or in Schedule III B shall not be required
where it is not relevant or necessary for the purposes of risk
assessment in the context of a specific notification, in view
especially of the characteristics of the GMO, of the scale
and conditions of the release or  of its intended conditions of
use. 
The appropriate 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 in formation, the following shall
be provided: 
(a) the summaries and re sults of the studies
referred to in the notification, including an explanation
about their relevance to e.r.a., where applicable; 
(b) for notifications referred to in Part C, Annexes
with detailed information on those studies, including a
description of the methods and materials used or the
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reference to standardised or internationally recognised
methods and the name of the body or bodies responsible for
carrying out the studies. 
Future developments in ge netic modification may
necessitate adapting this Sch edule to technical progress or
developing guidance notes on this Schedule. Furtherdifferentiation of information requirements for different
t y p e s  o f  G M O s ,  f o r  e x a m p l e  p erennial plants and trees,
single celled organisms, fish or insects, or for particular useof GMOs like the development of vaccines, may be
possible once sufficient experi ence with notifications for
the release of particular GMOs has been gained in the
Union.".
Substitutes 
Schedule III B 
to the principal 
regulations.19. Schedule III B to the princ ipal regulations, shall be
substituted by the following:
"SCHEDULE III B
INFORMATION REQUIRED IN NOTIFICATIONS 
CONCERNING RELEASES OF GENETICALLY MODIFIED 
HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND 
ANGIOSPERMAE)
I. INFORMATION REQUIRED IN NOTIFICATIONS 
SUBMITTED PURSUANT TO REGULATIONS 6 AND 7 
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.
4. Information rela ting 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;
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(d) method for preparing and managing the
release site, prior to, during and post release,
including cultivation practices and harvestingmethods;
(e) approximate number of plants (or plants
per m
2). 
5. Information relating to the site of release;
(a) location and size of the release site(s); 
(b) description 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 protected areas  which may be affected. 
B. Scientific Information
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) sub-species;
(v) cultivar or breeding line; (vi) common name;
(b) geographical distri bution and cultivation
of the plant within the Union;
(c) information concer ning reproduction: 
(i) mode(s) of reproduction;(ii) specific factors affecting
reproduction, if any;
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(iii) generation time; 
(d) sexual compatibility with other cultivated
or wild plant species, incl uding the distribution in
Europe of the compatible 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 description of the natural
habitat of the plant, incl uding information on natural
predators, parasites, competitors and symbionts;
(h) potential interactions of the plant, that are
relevant to the GMHP, with organisms in the
e c o s y s t e m  w h e r e  i t  i s  u s u a l l y  g r o w n ,  o r  e l s e w h e r e ,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.
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(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: 
(aa) size and copy number of all
insert(s) and methods used for its/theircharacterisation;
(bb) in case of deletion, size and
function of the deleted region(s);
(cc) sub-cellular location(s) of the
i n s e r t ( s )  i n  t h e  p l a n t  c e l l s  ( i n t e g r a t e d  i nthe nucleus, chloroplasts, mitochondria,or maintained in a non-integrated form),
and methods for its/their determination;
(iii) parts of the plant where the insert is
expressed;
(iv) genetic stability of the insert and
phenotypic stability of the GMHP. 
(c) Conclusions of the molecular
characterisation.
3. Information on specific areas of risk.
(a) Any change to the persistence or
invasiveness of the GMHP, and its ability to transfer
genetic material to sexually compatible relatives andthe adverse environmental effects thereof. 
(b) Any change to the ab ility of the GMHP to
transfer genetic material to microorganisms and the
adverse environmental effects thereof. 
(c) Mechanism of interaction between the
GMHP and target organisms (if applicable) and theadverse environmental effects thereof. 
(d) Potential changes in the interactions of
the GMHP with non-target organisms resulting from
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the genetic modification and the adverse
environmental effects thereof. 
(e) Potential changes in agricultural practices
and management of the GMHP resulting from thegenetic modification and th e adverse environmental
effects thereof. 
(f) Potential interactions with the abiotic
environment and the adverse environmental effects
thereof. 
(g) Information on any toxic, allergenic or
other harmful effects on human and animal healtharising from the genetic modification. 
(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 compatible plant species, both wild
and weedy relatives and crops; 
(ii) any measures to minimise or
prevent the dispersal of any reproductive part ofthe GMHP. 
(b) Description of methods for post-release
treatment of the site. 
(c) Description of post-release treatment
methods for the genetically modified plant material
including wastes. 
(d) Description of monitoring plans and
techniques. 
(e) Description of any emergency plans. 
(f) Description of the methods and
procedures to:
(i) avoid or minimise the spread of the
GMHPs beyond the site of release; 
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(ii) protect the site from intrusion by
unauthorised individuals; 
( i i i )p r e v e n t  o t h e r  o r g a n i s m s  f r o m
entering the s ite or minimise such entries. 
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 REGULATION 12
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 specifi cation of the GMHP. 
4. Scope of the notification:
(a) cultivation;
(b) other uses (to be specified in the
notification). 
B. Scientific Information.
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/breeding line;
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(vi) common name.
(b) Geographical distri bution 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 the
Union of the compatible 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 description of the natural
habitat of the plant, incl uding information on natural
predators, parasites, competitors and symbionts. 
(h) Potential interactions of the plant, that are
relevant to the GMHP, with organisms in thee c o s y s t e m  w h e r e  i t  i s  u s u a l l y  g r o w n ,  o r  e l s e w h e r e ,
including information on toxic effects on humans,
animals and other organisms. 
2. Molecular characterisation.
(a) Information relating to the genetic
modification.
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(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 genetically
modified plant.
(i) Description of the trait(s) and
characteristics which have been introduced ormodified. 
(ii) Information on the sequences
actually inserted or deleted: 
(aa) size and copy number of all
detectable inserts, both partial and
complete, and methods used for its
characterisation;
(bb) the organisation and sequence
of the inserted genetic material at eachinsertion site in a standardised electronic
format;
(cc) in case of deletion, size and
function of the deleted region(s);
(dd) sub-cellular location(s) of the
insert(s) (integrate d in the nucleus,
chloroplasts, mitochondria, or maintainedin a non-integrated form), and methodsfor its/their determination;
(ee) in the case of modifications
other than insertion or deletion, functionof the modified genetic material before
and after the modification, as well as
direct changes in expression of genes as aresult of the modification;
(ff) sequence information in a
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standardised electronic format for both 5′
and 3′ flanking regions at each insertion
site;
(gg) bioinformatic analysis using
up-to-date databases, to investigatepossible interruptions of known genes;
(hh) all Open Reading Frames,
(hereafter referred to as "ORFs") withinthe insert (either due to rearrangement or
not) and those created as a result of the
genetic modification at the junction siteswith genomic DNA. ORF is defined as a
nucleotide sequence that contains a string
of codons that is uninterrupted by thepresence of a stop codon in the same
reading frame;
(ii) bioinformati c analysis using
up-to-date databases, to investigatepossible similarities between the ORFs
and known genes which may have adverseeffects;
(jj) primary structure (amino acid
sequence) and, if necessary, otherstructures, of the newly expressed protein;
(kk) bioinformatic analysis using
up-to-date databases, to investigatepossible sequence homologies and, if
necessary, structural  similarities between
the newly expressed protein and known
proteins or peptides which may have
adverse effects.
(iii) Informatio n on the expr ession of the
insert: 
(aa) method(s) used for expression
analysis together with their performance
characteristics;
(bb) information on the
developmental expression of the insert
during the life cycle of the plant;
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(cc) parts of the plant where the
insert/modified se quence is expressed;
(dd) potential unintended
expression of new ORFs identified under
sub-sub-paragraph (gg) of sub-paragraph
(ii), which raise  a safety concern;
(ee) protein expression data,
including the raw data, obtained fromfield studies and related to the conditions
in which the crop is grown. 
(iv) Genetic stability of the insert and
phenotypic stability of the GMHP. 
(c) Conclusions of molecular
characterisation.
3. Comparative analysis of agronomic and
phenotypic characteris tics and of composition.
(a) Choice of conventional counterpart and
additional comparators. 
(b) Choice of sites for field studies. (c) Experimental design and statistical
analysis of data from field trials for comparative
analysis: 
(i) description of field studies design;
(ii) description of relevant aspect of the
receiving environments;
(iii) statistical analysis. 
(d) Selection of plant material for analysis, if
relevant. 
(e) Comparative analysis of agronomic and
phenotypic characteristics. 
(f) Comparative analysis of composition, if
relevant. 
(g) Conclusions of comparative analysis.
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4. Specific information for each area of risk.
For each of the seven areas of risk referred to in
Section D.2 of Schedule II the notifier shall first
describe the pathway 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 andexposure. 
The notifier shall submit the following information,
except where it is not relev ant in view of the intended
uses of the GMO: 
(a) Persistence and invasiveness including
plant to plant gene transfer:
(i) assessment of the potential for the
GMHP to become more persistent or invasiveand the adverse environmental effects thereof;
(ii) assessment of the potential for the
GMHP to transmit transgene(s) to sexuallycompatible relatives and the adverse
environmental effects thereof;
(iii) conclusions on the adverse
environmental effect(s) of persistence andinvasiveness of the GMHP including the
adverse environmental effect(s) of plant-to-
plant gene transfer.
(b) Plant to micro-organism gene transfer:
(i) assessment of the potential for
transfer of newly inserted DNA from the
GMHP to microorganisms and the adverse
effects thereof; 
(ii) conclusions on the adverse effect(s)
of the transfer of newly inserted DNA from theGMHP to microorganisms for human andanimal health and the environment.
(c) Interactions of the GMHP with target
organisms, if relevant:
(i) assessment of the potential for
changes in the direct and indirect interactions
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between the GMHP and target organisms and
the adverse environm ental effect(s); 
 (ii) assessment of the potential for
evolution of resistance of  the target organism to
the expressed protein (based on the history of
evolution of resistance to conventionalpesticides or transgenic plants expressing
similar traits) and any adverse environmental
effect(s) thereof; 
(iii) conclusions on adverse
environmental effect(s) of interactions of theGMHP with target organisms.
(d) Interactions of the GMHP with non-target
organisms:
(i) assessment of the potential for
direct and indirect interactions of the GMHPwith non-target organisms, including protectedspecies, and the adverse effect(s) thereof. 
The assessment shall also take into
account the potential adverse effect(s) onrelevant ecosystem services and on the species
providing those services;
(ii) conclusions on adverse
environmental effect(s) of interactions of theGMHP with non-target organisms.
(e) Impacts of the specific cultivation,
management and harvesting techniques:
(i) for GMHPs for cultivation,
assessment of the changes in the specific
cultivation, management and harvesting
techniques used for the GMHP and the adverse
environmental effect(s) thereof; 
(ii) conclusions on adverse
environmental effect(s) of the specificcultivation, management and harvestingtechniques. 
(f) Effects on biogeochemical processes:
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(i) assessment of the changes in the
biogeochemical processes within the area in
which the GMHP is to be grown and in thewider environment, and the adverse effects
thereof; 
(ii) conclusions on adverse effects on
biogeochemical processes. 
(g) Effects on human and animal health:
(i) assessment of potential direct and
indirect interactions b etween 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 interactions onhuman health; 
(ii) for GMHPs not destined for human
consumption, but where the recipient orparental organism(s) may be considered for
human consumption, assessment of the
likelihood of and possible adverse effects onhuman health due to acci dental intake; 
(iii) assessment of the potential adverse
effects on animal health due to accidentalconsumption of the GMHP or of material from
that plant by animals; 
(iv) conclusions on t he effects on human
and animal health. 
(h) Overall risk evaluation and conclusions.
A summary of all the conclusions under each area of
risk shall be provided.
The summary shall take into account the risk
characterisation in accordance with steps 1 to 4 of the
methodology described in Section C.3 of Schedule II
and the risk management strategies proposed in
accordance with item 5 of S ection C.3 of Schedule II.
5. Description of detection and identification
techniques for the GMHP. 
6. Information about previous releases of the
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_________________________________________________________________________________________________________________________
Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta
Mitbugħ fl-Istamperija tal-Gvern fuq karta FSC — Printed at the Government Printing Press on FSC certified paper
Prezz/Price
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GMHP, if applicable.".
Amends 
Schedule IV to 
the principal 
regulations.20. Schedule IV to the regulations shall be amended as follows:
(a) item 1 shall be substituted 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 65/2004*. After the
consent any new commercial names should be provided to
the competent authority,"; and
(b) Point 7 shall be substituted by the following:
"7. methods for detection, identificati on and, where
appropriate, quantification of the transformation event;
samples of the GMO(s) and their control samples, and
information as to the place wh ere the reference material can
be accessed. Information th at cannot be placed, for
confidentiality reasons, in the publicly accessible part ofthe register(s) referred to in Article 31(2) of the Directiveshould be identified,".
* Commission Regulation (EC) No 65/2004 of 14 January 2004 estab lishing a 
system for the development and assignment of unique identifiers  for genetically 
modified organisms (OJ L 10, 16.1.2004, p. 5).
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