DELIBERATE RELEASE INTO THE ENVIRONMENT OF GENETICALLY MODIFIED ORGANISMS REGULATIONS (scheduleia)

SUBSIDIARY LEGISLATION 549.60

DELIBERATE RELEASE INTO THE

ENVIRONMENT OF GENETICALLY MODIFIED

ORGANISMS REGULATIONS

16th November, 2010

LEGAL NOTICE 485 of 2010, as amended by Legal Notice 182 of 2019.

(1) The title of these regulations is the Deliberate Release

i n t o t h e E n v i r o n m e n t o f G e n e t i c a l l y M o d i f i e d O rg a n i s m s

Regulations.

(2) In accordance with the precautionary principle, the

objective of these regulations is to provide for the protection of

human health and the environment when

(a) carrying out the deliberate release into the

environment of genetically modified organisms for any

other purposes than placing on the market within

Malta,

(b) placing on the market genetically modified organisms

as or in products within Malta.

(3) These regulations provide the provisions required for the

implementation in Malta of the European Council Directive 2001/

18/EC of the 12th of March 2001 on the deliberate release into the

environment of genetically modified organisms and repealing

Council Directive 90/220/EEC and shall be read and construed as

one with such legal instrument.

PART A: GENERAL PROVISIONS

Techniques referred to in the definition of GMO in regulation 2

Techniques of genetic modification referred to in paragraph (a) in the definition of

GMO in regulation 2 are inter alia

(1) recombinant nucleic acid techniques involving the formation of new

combinations of genetic material by the insertion of nucleic acid

molecules produced by whatever means outside an organism, into any

virus, bacterial plasmid or other vector system and their incorporation

into a host organism in which they do not naturally occur but in which

they are capable of continued propagation;

(2) techniques involving the direct introduction into an organism of

heritable material prepared outside the organism including

microinjection, macro-injection and microencapsulation;

(3) cell fusion (including protoplast fusion) or hybridisation techniques

where live cells with new combinations of heritable genetic material are

formed through the fusion of two or more cells by means of methods

that do not occur naturally.

PART 2

Techniques referred to in sub-paragraph (b) in the definition of GMO which are

not considered to result in genetic modification, on condition that they do not

involve the use of recombinant nucleic acid molecules or genetically modified

organisms made by techniques/methods other than those excluded by Schedule I B

(1) in vitro fertilisation,

(2) natural processes such as: conjugation, transduction, transformation,

(3) polyploidy induction.

In these regulations, unless the context otherwise requires

"the Commission" means the European Commission;

"the competent authority" means the Environment and Resources

Authority as prescribed by the Nomination of the Competent

Authority Order, and such other body or person as the Minister

responsible for the environment may by order in the Gazette

prescribe and different bodies or persons may be designated as the

competent authority for different provisions and different purposes

of these regulations

Provided that the competent authorities for issues relating to

genetically modified organisms for food and feed and their placing on

the market shall be the same as the entities responsible for the

implementation of Regulation (EC) No 1829/2003 of the European

Parliament and of the Council of 22 September 2003 on genetically

modified food and feed in Malta, as provided in the Enforcement of

Various European Union Regulations on Food Safety Regulations.

"deliberate release" means any intentional introduction into the

environment of a GMO or a combination of GMOs for which no

specific containment measures are used to limit their contact with

and to provide a high level of safety for the general population and

the environment;

"the Directive" means Directive 2001/18/EC of the European

Parliament and of the Council of 12 March 2001 on the deliberate

release into the environment of genetically modified organisms and

repealing Council Directive 90/220/EEC;

"environment risk assessment” means the evaluation of risks to

human health and the environment, whether direct or indirect,

immediate or delayed, which the deliberate release or the placing

on the market of GMOs may pose and carried out in accordance

with Schedule II;

"genetically modified organism" (GMO) means an organism,

with the exception of human beings, in which the genetic material

has been altered in a way that does not occur naturally by mating or

natural recombination, and within the terms of this definition

(a) genetic modification occurs at least through the use of

the techniques listed in Schedule I A, part 1;

(b) the techniques listed in Schedule I A, part 2, are not

considered to result in genetic modification;

"Member State" means Member State of the European

Community;

"notification" means the submission, in writing and digital

format, of the information required under these regulations to the

competent authority;

"notifier" means any legal or physical person submitting a

notification or, where the context so requires, any legal or physical

person responsible for a deliberate release or for a placing on the

market, or for meeting any other requirement of these regulations

in relation to a deliberate release or a placing on the market;

"organism" means any biological entity capable of replication or

of transferring genetic material;

"placing on the market" means making available to third parties,

whether in return for payment or free of charge; the following

operations shall not be regarded as placing on the market

(a) making available genetically modified micro-

organisms for activities regulated under the Contained

Use of Genetically Modified Micro-organisms

Regulations, including culture collections;

(b) making available GMOs other than micro-organisms

referred to in paragraph (a), to be used exclusively for

activities where appropriate stringent containment

measures are used to limit their contact with, and to

provide a high level of safety for the general

population and the environment, the measures should

be based on the same principles of containment as laid

down in the Contained Use of Genetically Modified

Micro-organisms Regulations;

(c) making available GMOs to be used exclusively for

deliberate releases complying with the requirements

laid down in Part B of these regulations;

"product" means a preparation consisting of, or containing, a

GMO or a combination of GMOs, which is placed on the market.

Techniques referred to in regulation 3

Techniques or methods of genetic modification yielding organisms to be excluded

from this regulation, on the condition that they do not involve the use of recombinant

nucleic acid molecules or genetically modified organisms other than those produced

by one or more of the techniques or methods listed below are

(1) mutagenesis,

(2) cell fusion (including protoplast fusion) of plant cells of organisms

which can exchange genetic material through traditional breeding

methods.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(1) These regulations shall not apply to organisms

obtained through the techniques of genetic modification listed in

Schedule I B.

(2) These regulations shall not apply to the carriage of

genetically modified organisms by road, sea or air.

Amended by

L.N. 182 of 2019.

Principles for the Environment risk assessment

This Schedule describes in general terms the objective to be achieved, the

elements to be considered and the general principles and methodology to be

followed to perform the environment risk assessment referred to in regulations 4 and

12. Technical guidance notes may be developed in accordance with the regulatory

procedure referred to in Article 30(2) of the Directive, in order to facilitate the

implementation and explanation of this Annex.

Without prejudice to further guidance in this respect and in particular as regards

the extent to which indirect effects can and should be taken into account, the

following terms are described as follows

-

"direct effects" refers to primary effects on human health or the

environment which are a result of the GMO itself and which do not

occur through a causal chain of events;

-

"indirect effects" refers to effects on human health or the environment

occurring through a causal chain of events, through mechanisms such as

interactions with other organisms, transfer of genetic material, or

changes in use or management.

Observations of indirect effects are likely to be delayed;

-

"immediate effects" refers to effects on human health or the

environment which are observed during the period of the release of the

GMO. Immediate effects may be direct or indirect;

-

"delayed effects" refers to effects on human health or the environment

which may not be observed during the period of the release of the GMO,

but become apparent as a direct or indirect effect either at a later stage

or after termination of the release.

A general principle for environment risk assessment is also that an analysis of the

"cumulative long-term effects" relevant to the release and the placing on the market

is to be carried out. "Cumulative long-term effects" refers to the accumulated effects

of consents on human health and the environment, including inter alia flora and

fauna, soil fertility, soil degradation of organic material, the feed/food chain,

biological diversity, animal health and resistance problems in relation to antibiotics.

A.

Objective

The objective of an environment risk assessment is, on a case-by-case basis, to

identify and evaluate potential adverse effects of the GMO, either direct and

indirect, immediate or delayed, on human health and the environment which the

deliberate release or the placing on the market of GMOs may have. The environment

risk assessment should be conducted with a view to identifying if there is a need for

risk management and if so, the most appropriate methods to be used.

B.

General Principles

In accordance with the precautionary principle, the following general principles

should be followed when performing the environment risk assessment

-

identified characteristics of the GMO and its use which have the

potential to cause adverse effects should be compared to those presented

by the non-modified organism from which it is derived and its use under

corresponding situations;

the environment risk assessment should be carried out in a scientifically

sound and transparent manner based on available scientific and

technical data;

the environment risk assessment should be carried out on a case-by-case

basis, meaning that the required information may vary depending on the

type of the GMOs concerned, their intended use and the potential

receiving environment, taking into account, inter alia, GMOs already in

the environment;

if new information on the GMO and its effects on human health or the

environment becomes available, the environment risk assessment may

need to be re-addressed in order to

•

determine whether the risk has changed;

•

determine whether there is a need for amending the risk

management accordingly.

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 considerations for the e.r.a.

1. Intended and unintended changes

As part of the identification and evaluation of the potential adverse effects

referred to in Section A, the e.r.a shall identify the intended and unintended changes

resulting from the genetic modification and shall evaluate their potential 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 beyond the intended change(s) resulting from the genetic

modification.

Intended and unintended changes can have either direct or indirect, and either

immediate or delayed effects on human health and on the environment.

2. Long-term adverse effects and cumulative long-term adverse effects in the

e.r.a. of Part C notifications

Long-term effects of a GMO are effects resulting either from a delayed response by

organisms or their progeny to long-term or chronic exposure to a GMO or 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 health and on the environment shall take into account the following

(a) the long-term interactions of the GMO and the receiving environment;

(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.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

The identification and evaluation 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 collate

already available data from scientific literature or from other sources, including

monitoring reports, and shall generate the necessary data by performing, where

possible, appropriate 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 notifications under Part B shall be based at least on already available

data from scientific literature or from other sources and may be supplemented by

additional data generated by the notifier.

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 in the e.ra., the notifier shall provide

evidence to demonstrate 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 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 with internationally recognised standards;

(c) information on the results obtained from the studies referred to in items

(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 each

study performed 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 potential exposure and impact

that would be observed where the GMO may be released. The selection

shall be justified 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 provide an e.r.a. for each single transformation event

in the GMO or refer to already submitted notifications 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, the notifier shall provide a scientific

rationale justifying that there is no need to provide experimental data

for the concerned sub-combinations, independently of their origin, or, in

the absence of such scientific rationale, shall provide the relevant

experimental data.

C.2. Characteristics 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 relevant information 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.

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 to regulation 6(3) or regulation

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 in

accordance 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 characteristics of the GMO with

those of the chosen non-genetically modified comparator under

corresponding conditions of release or use;

(b) identify potential adverse effects on human health or the environment

which are linked to the changes that have been identified under item (a)

above.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

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

(i)

effects on the dynamics of populations of species 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 dissemination

of infectious diseases or creating new reservoirs or vectors;

(iii) compromising prophylactic or therapeutic medical, veterinary, or

plant protection treatments, for example by transfer of genes

conferring resistance to antibiotics used in human or veterinary

medicine;

(iv) effects on biogeochemistry (biogeochemical cycles), including

carbon and nitrogen 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 of desk based studies using, where possible, one or more of 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 which adverse effects may occur.

Adverse effects may occur directly or indirectly through exposure pathways or

other mechanisms which may include

(i)

the spread of the GMO(s) in the environment;

(ii)

the transfer of the inserted genetic material to the same organism

or other organisms, whether genetically 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

endpoints, to allow, where possible, a quantitative evaluation of the

potential adverse effect(s);

(f)

consider possible uncertainties, including

knowledge

gaps

and

methodological limitations.

2. Hazard characterisation

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

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

magnitude is likely to be influenced by the receiving environment(s) into which 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 terms, a categorical description

("high", "moderate", "low" or "negligible") shall be used and an explanation of the

scale of effect represented by each category shall be provided.

3. Exposure characterisation

The likelihood or probability 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.

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 risk shall be provided. In that case, a categorical description

("high", "moderate", "low" or "negligible") of the risk shall be used and an

explanation of the scale of effect represented by each category shall be provided.

Where relevant, the uncertainty for each identified risk shall be described and, where

possible, expressed in quantitative terms.

5. Risk management strategies

Where risks are identified that require, on the basis of their characterisation,

measures to manage them, a risk management strategy shall be proposed.

The risk management strategies shall be described in terms of reducing the hazard or

the exposure, or both, and shall be proportionate to the intended reduction of the

risk, the scale and conditions 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 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 characterisation, the

proposed risk management strategies and the associated levels of uncertainty.

The overall risk evaluation shall include, where applicable, the risk management

strategies proposed for each identified risk.

The overall risk evaluation and conclusions shall also p ropose specific

requirements for the monitoring plan of the GMO and, where appropriate, the

monitoring of the efficacy of the proposed risk management measures.

For notifications under Part C, the overall risk evaluation shall also include an

explanation of the assumptions made during the e.r.a. and of the nature and magnitude of

uncertainties associated with the risks, and a justification of the risk management

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

measures proposed.

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 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 Part B and following the methodology described in Part C, and

on the basis of the information required pursuant to Schedule III.

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

1. Likelihood of the GMO to become persistent and invasive in natural habitats

under the conditions of any proposed release.

2. Any selective advantage or disadvantage conferred to the GMO and the

likelihood of this becoming realised under the conditions of any proposed release.

3. Potential for gene transfer to other species under conditions of the proposed

release of the GMO and any selective advantage or disadvantage conferred to those

species.

4. Potential immediate or delayed environmental risk of the direct and indirect

interactions between the GMO and target organisms (if applicable).

5. Potential immediate or delayed environmental risk of the direct and indirect

interactions between the GMO with non-target organisms, including risk on

population levels of competitors, prey, hosts, symbionts, predators, parasites and

pathogens.

6. Possible immediate or delayed effects on human health resulting from

potential direct and indirect interactions of the GMO and persons working with,

coming into contact with or in the vicinity of the GMO release.

7. Possible immediate or delayed effects on animal health and consequences

for the feed or food chain resulting from consumption of the GMO and any product

derived from it, if it is intended to be used as animal feed.

8. Possible immediate or delayed effects on biogeochemical processes

resulting from potential direct and indirect interactions of the GMO and target and

non-target organisms in the vicinity of any GMO release.

9. Possible immediate or delayed, direct and indirect environmental impacts of

the specific techniques used for the management of the GMO where these are

different from those used for non-GMOs.

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

"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.

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.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

6. Effects on biogeochemical processes.

7. Effects on human and animal health.

(1) GMOs may only be deliberately released or placed on

the market in conformity with Part B or Part C of these regulations

respectively.

(2) Any person shall, before submitting a notification under

Part B or Part C, carry out an environment risk assessment. The

information which may be necessary to carry out the environment

risk assessment is laid down in Schedule III.

GMOs which contain genes expressing resistance to antibiotics

in use for medical or veterinary treatment shall be taken into

particular consideration when carrying out an environment risk

assessment, with a view to identifying and phasing out antibiotic

resistance markers in GMOs which may have adverse effects on

human health and the environment. This phasing out shall have

taken place by the 31st December 2004 in the case of GMOs placed

on the market according to Part C and by 31st December 2008 in

the case of GMOs authorised under Part B.

(3) Potential adverse effects on human health and the

environment, which may occur directly or indirectly through gene

transfer from GMOs to other organisms, shall be accurately

assessed on a case-by-case basis. T his assessment shall be

conducted in accordance with Schedule II taking into account the

environmental impact according to the nature of the organism

introduced and the receiving environment.

(4) The competent authority shall be responsible for ensuring

compliance with the requirements of these regulations, and it shall

examine notifications under Part B and Part C for compliance with

the requirements of these regulations and whether the assessment

provided for in sub-regulation (2) is appropriate.

(5) The competent authority shall organise inspections and

other control measures as appropriate, to ensure compliance with

these regulations. In the event of a release of any GMO or placing

on the market as or in products for which no authorisation was

given, the competent authority shall ensure that necessary measures

are taken to terminate the release or placing on the market, to

initiate remedial action if necessary, and to inform the public, the

Commission and other Member States.

PART B

DELIBERATE RELEASE OF GMOs FOR ANY OTHER

PURPOSE THAN FOR PLACING ON THE MARKET

Substituted by

L.N. 182 of 2019.

(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 information, the following shall be provided

(a) the summaries and results 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 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 necessitate adapting this Schedule

to technical progress or developing guidance notes on this Schedule. Further

differentiation of information requirements for different types of GMOs, for example

perennial plants and trees, single celled organisms, fish or insects, or for particular use of

GMOs like the development of vaccines, may be possible once sufficient experience

with notifications for the release of particular GMOs has been gained in the Union.

(1) Regulations 6 to 10 shall not apply to medicinal

substances and compounds for human use consisting of, or

containing, a GMO or combination of GMOs provided that their

deliberate release for any purpose other than that of being placed

on the market is authorised through the Medicines (Marketing

Authorisation) Regulations, and Directive 2001/83/EC of the

European Parliament and the Council of 6 November 2001 on the

Community Code relating to medicinal products for human use,

which provide

(a) for a specific environment risk assessment in

accordance with Schedule II and on the basis of the

type of information specified in Schedule III without

prejudice to additional requirements provided for by

the said legislation;

(b) for explicit consent prior to release;

(c) for a monitoring plan in accordance with the relevant

parts of Schedule III, with a view to detecting the

effects of the GMO or GMOs on human health or the

environment;

(d) in an appropriate manner for requirements relating to

treatment of new items of information, information to

the public, information on the results of releases, and

exchanges of information at least equivalent to those

contained in these regulations and in the measures

taken in accordance therewith.

(2) Assessment of the risks to the environment presented by

such substances and compounds shall be carried out, in accordance

with the provisions of Article 5 of the Directive.

Information Required in Notifications concerning Releases of Genetically

Modified Organisms other than Higher Plants

I.

GENERAL INFORMATION

A.

Name and address of the notifier (company or institute)

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

Name, qualifications and experience of any responsible scientist

Title of the project

INFORMATION RELATING TO THE GMO

Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate)

parental organism(s)

1. scientific name,

2. taxonomy,

3. other names (usual name, strain name, etc.),

4. phenotypic and genetic markers,

5. degree of relatedness between donor and recipient or between parental

organisms,

6. description of identification and detection techniques,

7. sensitivity, reliability (in quantitative terms) and specificity of detection

and identification techniques,

8. description of the geographic distribution and of the natural habitat of

the organism including information on natural predators, preys,

parasites and competitors, symbionts and hosts,

9. organisms with which transfer of genetic material is known to occur

under natural conditions,

10. verification of the genetic stability of the organisms and factors

affecting it,

11. pathological, ecological and physiological traits

(a) classification of hazard according to existing Community rules

concerning the protection of human health or the environment;

(b) generation time in natural ecosystems, sexual and asexual

reproductive cycle;

(c) information on survival, including seasonability and the ability to

form survival structures;

(d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity,

carrier (vector) of pathogen, possible vectors, host range

including non-target organism. Possible activation of latent

viruses (proviruses). Ability to colonise other organisms;

(e) antibiotic resistance, and potential use of these antibiotics in

humans and domestic organisms for prophylaxis and therapy;

(f) involvement in environmental processes: primary production,

nutrient turnover, decomposition of organic matter, respiration,

etc.

12. Nature of indigenous vectors

(a)

sequence;

(b)

frequency of mobilisation;

(c)

specificity;

(d)

presence of genes which confer resistance.

13. History of previous genetic modifications.

Characteristics of the vector

1. nature and source of the vector,

2. sequence of transposons, vectors and other non-coding genetic

segments used to construct the GMO and to make the introduced vector

and insert function in the GMO,

3. frequency of mobilisation of inserted vector or genetic transfer

capabilities and methods of determination,

4. information on the degree to which the vector is limited to the DNA

required to perform the intended function.

Characteristics of the modified organism

1. Information relating to the genetic modification

(a) methods used for the modification;

(b) methods used to construct and introduce any insert into the recipient or

to delete a sequence;

(c) description of the insert or vector construction;

(d) purity of the insert from any unknown sequence and information on the

degree to which the inserted sequence is limited to the DNA required to

perform the intended function;

(e) methods and criteria used for selection;

(f)

sequence, functional identity and location of the altered or inserted or

deleted nucleic acid segment(s) in question with particular reference to

any known harmful sequence.

2. Information on the final GMO

(a) description of any genetic trait or phenotypic characteristics and in

particular any new traits and characteristics which may be expressed or

no longer expressed;

(b) structure and amount of any vector or donor nucleic acid remaining in

the final construction of the modified organism;

(c) stability of the organism in terms of genetic traits;

(d) rate and level of expression of the new genetic material. Method and

sensitivity of measurement;

(e) activity of any expressed protein;

(f)

description of identification and detection techniques including

techniques for the identification and detection of the inserted sequence

and vector;

(g) sensitivity, reliability (in quantitative terms) and specificity of detection

and identification techniques;

(h) history of previous releases or uses of the GMO;

(i)

considerations for human health and animal health, as well as plant

health

(i)

toxic or allergenic effects of the GMOs or their metabolic

products;

(ii) comparison of the modified organism to the donor, recipient or

(where appropriate) parental organism regarding pathogenicity;

(iii) capacity for colonisation;

(iv) if the organism is pathogenic to humans who are

immunocompetent

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

-

diseases caused and mechanism of pathogenicity including

invasiveness and virulence,

- communicability,

- infective dose,

- host range, possibility of alteration,

- possibility of survival outside of human host,

- presence of vectors or means of dissemination,

- biological stability,

- antibiotic resistance patterns,

- allergenicity,

- availability of appropriate therapies.

(v)

other product hazards.

III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND

THE RECEIVING ENVIRONMENT

Information on the release

1. description of the proposed deliberate release, including any purpose

and foreseen products,

2. foreseen dates of the release and time planning of the experiment

including frequency and duration of releases,

3. preparation of the site previous to the release,

4. size of the site,

5. any method to be used for the release,

6. quantities of GMOs to be released,

7. disturbance on the site (type and method of cultivation, mining,

irrigation, or other activities),

8. worker protection measures taken during the release,

9. post-release treatment of the site,

10. techniques foreseen for elimination or inactivation of the GMOs at the

end of the experiment,

11. information on, and results of, previous releases of the GMOs,

especially at different scales and in different ecosystems.

Information on the environment (both on the site and in the wider

environment)

1. geographical location and grid reference of any site (in case of

notifications under Part C of any site of release will be the foreseen

areas of use of the product),

2. physical or biological proximity to humans and other significant biota,

3. proximity to significant biotopes, protected areas, or drinking water

supplies,

4. climatic characteristics of any region likely to be affected,

5. geographical, geological and pedological characteristics,

6. flora and fauna, including crops, livestock and migratory species,

7. description of target and non-target ecosystems likely to be affected,

8. a comparison of the natural habitat of the recipient organism with any

proposed site of release,

9. any known planned developments or changes in land use in the region

which could influence the environmental impact of the release.

IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE

GMOs AND THE ENVIRONMENT

Characteristics affecting survival, multiplication and dissemination

1. biological features which affect survival, multiplication and dispersal,

2. known or predicted environmental conditions which may affect

survival, multiplication and dissemination (wind, water, soil,

temperature, pH, etc.),

3. sensitivity to specific agents.

Interactions with the environment

1. predicted habitat of the GMOs,

2. studies of the behaviour and characteristics of the GMOs and their

ecological impact carried out in simulated natural environments, such as

microcosms, growth rooms, greenhouses,

3. genetic transfer capability

(a) post-release transfer of genetic material from GMOs into

organisms in affected ecosystems;

(b) post-release transfer of genetic material from indigenous

organisms to the GMOs;

4. likelihood of postrelease selection leading to the expression of

unexpected or undesirable traits in the modified organism,

5. measures employed to ensure and to verify genetic stability. Description

of genetic traits which may prevent or minimise dispersal of genetic

material. Methods to verify genetic stability,

6. routes of biological dispersal, known or potential modes of interaction

with the disseminating agent, including inhalation, ingestion, surface

contact, burrowing, etc.,

7. description of ecosystems to which the GMOs could be disseminated,

8. potential for excessive population increase in the environment,

9. competitive advantage of the GMOs in relation to the unmodified

recipient or any parental organism,

10. identification and description of the target organisms if applicable,

11. anticipated mechanism and result of interaction between the released

GMOs and any target organism if applicable,

12. identification and description of non -target organisms which may be

adversely affected by the release of the GMO, and the anticipated

mechanisms of any identified adverse interaction,

13. likelihood of postrelease shifts in biological interactions or in host

range,

14. known or predicted interactions with non-target organisms in the

environment, including competitors, preys, hosts, symbionts, predators,

parasites and pathogens,

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

15. known or predicted involvement in biogeochemical processes,

16. other potential interactions with the environment.

INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT

AND EMERGENCY RESPONSE PLANS

Monitoring techniques

1. methods for tracing the GMOs, and for monitoring their effects,

2. specificity (to identify the GMOs, and to distinguish them from the

donor, recipient or, where appropriate, the parental organisms),

sensitivity and reliability of the monitoring techniques,

3. techniques for detecting transfer of the donated genetic material to other

organisms,

4. duration and frequency of the monitoring.

Control of the release

1. methods and procedures to avoid or minimise the spread of the GMOs

beyond the site of release or the designated area for use,

2. methods and procedures to protect the site from intrusion by

unauthorised individuals,

3. methods and procedures to prevent other organisms from entering the

site.

Waste treatment

1. type of waste generated,

2. expected amount of waste,

3. description of treatment envisaged.

Emergency response plans

1. methods and procedures for controlling the GMOs in case of

unexpected spread,

2. methods for decontamination of the areas affected, for example

eradication of the GMOs,

3. methods for disposal or sanitation of plants, animals, soils, etc., that

were exposed during or after the spread,

4. methods for the isolation of the area affected by the spread,

5. plans for protecting human health and the environment in case of the

occurrence of an undesirable effect.

(1) Without prejudice to regulation 5, any person shall,

before undertaking a deliberate release of a GMO or of a

combination of GMOs, submit a notification to the competent

authority.

(2) The notification referred to in sub-regulation (1) shall

include

(a) a technical dossier supplying the information specified

in Schedule III necessary for carrying out the

environment risk assessment of the deliberate release

of a GMO or combination of GMOs, in particular

(i)

general information including information on

personnel and training,

(ii) information relating to any GMO,

(iii) information relating to the conditions of release

and the potential receiving environment,

(iv) information on the interactions between any

GMO and the environment,

(v)

a plan for monitoring in accordance with the

relevant parts of Schedule III in order to identify

effects of any GMO on human health or the

environment,

(vi)

information on control, remediation methods,

waste treatment and emergency response plans,

(vii)

a summary of the dossier in the format

established in accordance with the procedure

laid down in Article 30(2) of the Directive;

(b) the environment risk assessment and the conclusions

required in Schedule II, section D, together with any

bibliographic reference and indications of the methods

used;

(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 indicate whether the notification

would prejudice any enforcement case, court case or

other causes currently sub-judice.

(3) The notifier may refer to data or results from notifications

previously submitted by other notifiers, provided that the

information, data and results are non confidential or these notifiers

have given their agreement in writing, or may submit additional

information he considers relevant.

(4) The competent authority may accept that releases of the

same GMO or of a combination of GMOs on the same site or on

different sites for the same purpose and within a defined period

may be notified in a single notification.

(5) On receipt of the notification under sub-regulation (1) the

competent authority shall

(a) acknowledge to the notifier the date of such receipt in

writing;

(b) forward to the Commission, within 30 days of receipt

of the notification, a copy of the summary of the

notification received in accordance with sub-

regulation (2)(a)(vii);

(c) examine it for compliance with these regulations;

(d) consider any observations received from a competent

authority of another Member State in accordance with

Article 11(2) of the Directive;

(e) if requested by a competent authority of another

Member State for the purposes of the Directive,

forward a copy of the full notification to the said

authority;

(f)

evaluate the risks posed by the proposed deliberate

release for human health and the environment; and

(g) record its conclusions in writing.

(6)

The competent authority shall respond in writing to the

notifier within ninety days of receipt of the notification by

indicating that consent to the deliberate release is either -

(a) granted, with or without, conditions, or

(b) refused and the reasons for the refusal.

(7) For the purpose of calculating the ninety day period

referred to in sub-regulation (6), no account shall be taken of any

periods of time during which the competent authority

(a) is awaiting further information which it may have

requested from the notifier, or

(b) is carrying out a public inquiry or consultation in

accordance with regulation 9; this public inquiry or

consultation shall not prolong the ninety day period

referred to in sub-regulation (6) by more than thirty

days.

(8) If the competent authority requests new information it shall

simultaneously give its reasons for so doing.

(9) The notifier may proceed with the release only when he has

received the written consent of the competent authority, and in

conformity with any conditions required in this consent.

(10) No material derived from GMOs which are deliberately

released in accordance with Part B shall be placed on the market,

unless in accordance with Part C.

Substituted by

L.N. 182 of 2019.

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

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 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 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.

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 distribution and cultivation of the plant within the Union;

(c) information concerning reproduction

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(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

(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, including information on natural

predators, parasites, competitors and symbionts;

(h) 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

(aa) size and copy number of all insert(s) and methods used for its/their

characterisation;

(bb) in case of deletion, size and function of the deleted region(s);

(cc) sub-cellular location(s) of the insert(s) in the plant cells (integrated in

the 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 and

the adverse environmental effects thereof.

(b) Any change to the ability 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 the adverse environmental effects thereof.

(d) Potential changes in the interactions of the GMHP with non-target

organisms resulting from the genetic modification and the adverse

environmental effects thereof.

(e) Potential changes in agricultural practices and management of the

GMHP resulting from the genetic modification and the 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 health arising 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 of the 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;

(ii) protect the site from intrusion by unauthorised individuals;

(iii) prevent other organisms from entering the site 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

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.

4. Scope of the notification

(a) cultivation;

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(b) other uses (to be specified in the notification).

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;

(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 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, including information on natural

predators, parasites, competitors and symbionts.

(h) 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 genetically modified plant.

(i)

Description of the trait(s) and characteristics which have been

introduced or modified.

(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 each

insertion 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) (integrated in the nucleus,

chloroplasts, mitochondria, or maintained in a non-integrated form),

and methods for its/their determination;

(ee) 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;

(ff) sequence information in a standardised electronic format for both 5′ and

3′ flanking regions at each insertion site;

(gg) bioinformatic analysis using up-to-date databases, to investigate

possible interruptions of known genes;

(hh) all Open Reading Frames, (hereafter referred to as "ORFs") within the

insert (either due to rearrangement or not) and those created 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 uninterrupted by the presence of a stop codon in the same reading

frame;

(ii) bioinformatic analysis using up-to-date databases, to investigate

possible similarities between the ORFs and known genes which may

have adverse effects;

(jj) primary structure (amino acid sequence) and, if necessary, other

structures, of the newly expressed protein;

(kk) bioinformatic analysis using up-to-date databases, to investigate

possible sequence homologies and, if necessary, structural similarities

between the newly expressed protein and known proteins or peptides

which may have adverse effects.

(iii) Information on the expression 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;

(cc) parts of the plant where the insert/modified sequence 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 from field

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 characteristics and of

composition.

(a) Choice of conventional counterpart and additional comparators.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(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.

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 and exposure.

The notifier shall submit the following information, except where it is not relevant 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 invasive and the adverse environmental effects

thereof;

(ii) assessment of the potential for the GMHP to transmit transgene(s)

to sexually compatible relatives and the adverse environmental

effects thereof;

(iii) conclusions on the adverse environmental effect(s) of persistence

and invasiveness 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 the GMHP to microorganisms for human and

animal 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 between the GMHP and target organisms and the

adverse environmental 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 conventional pesticides or transgenic

plants expressing similar traits) and any adverse environmental

effect(s) thereof;

(iii) conclusions on adverse environmental effect(s) of interactions of

the GMHP with target organisms.

(d) Interactions of the GMHP with non-target organisms

(i)

assessment of the potential for direct and indirect interactions of

the GMHP with non-target organisms, including protected

species, and the adverse effect(s) thereof.

The assessment shall also take into account the potential adverse

effect(s) on relevant ecosystem services and on the species

providing those services;

(ii) conclusions on adverse environmental effect(s) of 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 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 specific

cultivation, management and harvesting techniques.

(f)

Effects on biogeochemical processes

(i)

assessment of the changes in the biogeochemical 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 biogeochemical processes.

(g) Effects on human and animal health

(i)

assessment of potential direct and indirect interactions 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 interactions

on human health;

(ii) for GMHPs not destined for human consumption, but where the

recipient or parental organism(s) may be considered for human

consumption, assessment of the likelihood of and possible

adverse effects on human health due to accidental intake;

(iii) assessment of the potential adverse effects on animal health due

to accidental consumption of the GMHP or of material from that

plant by animals;

(iv) conclusions on the 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 Section C.3 of

5. Description of detection and identification techniques for the GMHP.

6. Information about previous releases of the GMHP, if applicable.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(1) If sufficient experience has been obtained of releases

of certain GMOs in certain ecosystems, and the GMOs concerned

meet the criteria set out in Schedule V, the competent authority, in

accordance with the procedure set through Article 7 of the

Directive, may apply differentiated procedures to such types of

GMOs.

(2) The notifier may proceed with the release only when he has

received the written consent of the competent authority, and in

accordance with the minimum amount of Schedule III technical

information necessary for evaluating any foreseeable risks from

release, in particular

(a) information relating to GMOs;

(b) information relating to conditions of release and

potential receiving environment;

(c) information on interactions between GMOs and

environment;

(d) environment risk assessment.

(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 genetically modified plants included in

item 1 of Schedule IX.

Amended by

L.N. 182 of 2019.

Additional Information

This Schedule describes in general terms the additional information to be provided

in the case of notification for placing on the market and information for labelling

requirements regarding GMOs as or in product to be placed on the market, and GMO

exempted under regulation 2 definition of "placing on the market". Technical

guidance notes, as regards, inter alia, the description of how the product is intended

to be used, may be developed in accordance with the regulatory procedure referred

to Article 30(2) of the Directive, in order to facilitate the implementation and

explanation of this Schedule. The labelling of exempted organisms as required by

regulation 21 shall be met by providing appropriate recommendations for, and

restrictions on, use

The following information shall be provided in the notification for placing

on the market of GMOs as or in product in addition to that of Schedule III

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,

2. name and full address of the person established in the Community who

is responsible for the placing on the market, whether it be the

manufacturer, the importer or the distributor,

3. name and full address of any supplier of control samples,

4. description of how the product and the GMO as or in product are

intended to be used. Differences in use or management of the GMO

compared to similar non-genetically modified products should be

highlighted,

5. description of any geographical area and types of environment where

the product is intended to be used within the Community, including,

where possible, estimated scale of use in each area,

6. intended categories of users of the product e.g. industry, agriculture and

skilled trades, consumer use by public at large,

7. 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)

of the Directive should be identified,

8. proposed labelling on a label or in an accompanying document. This

must include, at least in summarised form, a commercial name of the

product, a statement that "This product contains genetically modified

organisms", the name of the GMO and the information referred to in

Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the develop-

ment and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004,

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

point 2, the labelling should indicate how to access the information in

the publicly accessible part of the register.

B.

The following information shall be provided in the notification, when

relevant, in addition to that of point A, in accordance with regulation 12 of these

regulations

1. measures to take in case of unintended release or misuse,

2. specific instructions or recommendations for storage and handling,

3. specific instructions for carrying out monitoring and reporting to the

notifier. These instructions should be consistent with Schedule VII Part

C,

4. proposed restrictions in the approved use of the GMO, for example

where the product may be used and for what purposes,

5. proposed packaging,

6. estimated production in or imports to the Community,

7. proposed additional labelling. This may include, at least in summarised

form, the information referred to in points A 4, A 5, B 1, B 2, B 3 and B

4. SCHEDULE V

Criteria for the Application of Differentiated Procedures (Regulation 7)

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

1. The taxonomic status and the biology (for example mode of reproduction

and pollination, ability to cross with related species, pathogenecity) of the non-

modified (recipient) organism shall be well-known.

2. There shall be sufficient knowledge about the safety for human health and

the environment of the parental, where appropriate, and recipient organisms in the

environment of the release.

3. Information shall be available on any interaction of particular relevance for

the risk assessment, involving the parental, where appropriate, and recipient

organism and other organisms in the experimental release ecosystem.

4. Information shall be available to demonstrate that any inserted genetic

material is well characterised. Information on the construction of any vector systems

or sequences of genetic material used with the carrier DNA shall be available. Where

a genetic modification involves the deletion of genetic material, the extent of the

deletion shall be known. Sufficient information on the genetic modification shall

also be available to enable identification of the GMO and its progeny during a

release.

5. The GMO shall not present additional or increased risks to human health or

the environment under the conditions of the experimental release that are not

presented by releases of the corresponding parental, where appropriate, and recipient

organisms. Any capacity to spread in the environment and invade other unrelated

ecosystems and capacity to transfer genetic material to other organisms in the

environment shall not result in adverse effects.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(1) In the event of any modification of, or unintended

change to, the deliberate release of a GMO or of a combination of

GMOs which could have consequences with regard to risks for

human health and the environment after the competent authority

has given its written consent, or if new information has become

available on such risks, either while the notification is being

examined by the competent authority or after the competent

authority has given its written consent, the notifier shall

immediately

(a) take the measures necessary to protect human health

and the environment;

(b) inform the competent authority in advance of any

modification or as soon as the unintended change is

known or the new information is available;

(c) revise the measures specified in the notification.

(2) If information becomes available to the competent authority

referred to in sub-regulation (1) which could have significant

consequences with regard to risks for human health and the

environment or under the circumstances described in sub-

regulation (1), the competent authority

(a) shall evaluate such information and make it available

to the public;

(b) may require the notifier to modify the conditions of,

suspend or terminate the deliberate release and shall

inform the public thereof;

(c) may require the notifier to defray or contribute

towards any or all of the costs incurred by it in order to

protect human health and the environment.

(3) With respect to both sub-regulations (1) and (2) above, the

notifier shall amend the notification on which consent was granted

and submit the amended notification to the competent authority.

(4) Where the competent authority receives an amended

notification in accordance with sub-regulations (1) and (2), it shall

deal with the amended notification as if it were a new notification

under regulation 6 in relation to the proposed modified deliberate

release.

(5) The notifier shall not proceed with the proposed modified

deliberate release unless he has received written consent from the

competent authority.

Guidelines for the Assessment Reports

The assessment report provided for by regulations 13, 14, 15 and 17 should

include in particular the following

1. Identification of the characteristics of the recipient organism which are

relevant to the assessment of any GMO in question. Identification of any known

risks to human health and the environment resulting from the release into the

environment of the recipient non-modified organism.

2. Description of the result of the genetic modification in the modified

organism.

3. Assessment of whether the genetic modification has been characterised

sufficiently for the purpose of evaluating any risks to human health and the

environment.

4. Identification of any new risks to human health and the environment that

may arise from any release of the GMO in question as compared to any release of the

corresponding non-modified organism, based on the environment risk assessment

carried out in accordance with Schedule II.

5. A conclusion on whether any GMO in question should be placed on the

market or as any product and under which conditions, whether the GMOs in question

shall not be placed on the market or whether the views of other competent authorities

and the Commission are sought for on specific issues of the environment risk

assessment. These aspects should be specified. The conclusion should clearly

address the use proposed, risk management and the monitoring plan proposed. In the

case that it has been concluded that the GMOs should not be placed on the market,

the competent authority shall give reasons for its conclusion.

(1) The competent authority shall, without prejudice to the

provisions of regulations 7 and 20, consult the public and, where

appropriate, groups on the proposed deliberate release.

(2) Subject to sub-regulation (3), the notifier of a proposed

deliberate release for the purposes other than placing on the market

shall, not more than fourteen days after the date of receipt by the

competent authority of the notification, cause to be published in a

prominent local newspaper a notice with heading "PROPOSED

DELIBERATE RELEASE OF A GENETICALLY MODIFIED

ORGANISM" and containing the following information -

(a) the name and address of the notifier,

(b) the description of the genetically modified organism

proposed to be released,

(c) the fact that a notification has been submitted to the

competent authority, and the location and purpose of

the proposed deliberate release,

(d) the period of time in which the proposed deliberate

release is to be carried out,

(e) the fact that further information on the proposed

deliberate release may be obtained from the competent

authority,

(f)

the full title of the competent authority and the full

postal address of its headquarters,

(g) the fact that, in accordance with sub-regulation (5),

any person or body may, within the period of twenty-

eight days beginning on the day of publication of the

notice, make representations in writing to the

competent authority regarding the notification,

and shall send a copy of the notice to the competent authority

within the said fourteen days.

(3) The information on the location of the proposed deliberate

release published pursuant to sub-regulation (2) shall be the same

as the information on its location which is placed on the register

m a in t a i n e d by t he c o m pe t e n t a ut h o ri t y i n a c c o rd a nc e w it h

regulation 22, and, for that purpose, the notifier shall ascertain

from the competent authority the information on the location which

is to be or has been placed on the said register.

(4) The notifier shall, not more than fourteen days after the

date of receipt by the competent authority of the notification, send

a copy of the notice published pursuant to sub-regulation (2) to -

(a) the owner of the site of the proposed deliberate

release, if the said owner is a person other than the

notifier, and

(b) the competent authority.

(5) Any person or body may, within the period of twenty-eight

days beginning on the day of publication of a notice pursuant to

sub-regulation (2), make representations to the competent authority

in relation to the notification. The representations shall be -

(a) made in writing,

(b) addressed to

the

competent

authority

at

its

headquarters,

(c) forwarded so as to reach the competent authority

within the period of twenty-eight days beginning on

the day of publication of the notice pursuant to sub-

regulation (2).

(6) Representations which do not comply with sub-regulation

(5) shall be invalid. Where the competent authority receives

representations in accordance with sub-regulation (5), it shall -

(a) acknowledge receipt of the representations, and

(b) consider the representations in determining the

notification.

Monitoring Plan

This Schedule describes in general terms the objective to be achieved and the

general principles to be followed in the design of the monitoring plan referred to in

regulations 12(2), 15(3), 16 (3) and 17. Technical guidance notes may be developed

in accordance with the regulatory procedure referred to in Article 30(2) of the

Directive, in order to facilitate the implementation and explanation of this Schedule.

A.

Objective

The objective of a monitoring plan is to

-

confirm that any assumption regarding the occurrence and impact of

potential adverse effects of the GMO or its use in the environment risk

assessment are correct, and

-

identify the occurrence of adverse effects of the GMO or its use on

human health or the environment which were not anticipated in the

environment risk assessment

B.

General principles

Monitoring, as referred to in regulations 12, 15, 16 and 17, takes place after the

consent to the placing of a GMO on the market.

The interpretation of the data collected by monitoring should be considered in the

light of other existing environmental conditions and activities. Where changes in the

environment are observed, further assessment should be considered to establish

whether they are a consequence of the GMO or its use, as such changes may be the

result of environmental factors other than the placing of the GMO on the market.

Experience and data gained through the monitoring of experimental releases of

GMOs may assist in designing the post marketing monitoring regime required for

the placing on the market of GMOs as or in products.

Design of the monitoring plan

The design of the monitoring plan should

1. be detailed on a case by case basis taking into account the environment

risk assessment,

2. take into account the characteristics of the GMO, the characteristics and

scale of its intended use and the range of relevant environmental

conditions where the GMO is expected to be released,

3. incorporate general surveillance for unanticipated adverse effects and, if

necessary, (case-) specific monitoring focusing on adverse effects

identified in the environment risk assessment

3.1. whereas case-specific monitoring should be carried out for a

sufficient time period to detect immediate and direct as well as,

where appropriate, delayed or indirect effects which have been

identified in the environment risk assessment,

3.2. whereas surveillance could, if appropriate, make use of already

established routine surveillance practices such as the monitoring

of agricultural cultivars, plant protection, or veterinary and

medical products. An explanation as to how relevant information

collected through established routine surveillance practices will

be made available to the consent-holder should be provided.

4. facilitate the observation, in a systematic manner, of the release of a

GMO in the receiving environment and the interpretation of these

observations with respect to safety to human health or the environment.

5. identify who (notifier, users) will carry out the various tasks the

monitoring plan requires and who is responsible for ensuring that the

monitoring plan is set into place and carried out appropriately, and

ensure that there is a route by which the consent holder and the

competent authority will be informed on any observed adverse effects

on human health and the environment. (Time points and intervals for

reports on the results of the monitoring shall be indicated).

6. give consideration to the mechanisms for identifying and confirming

any observed adverse effects on human health and environment and

enable the consent holder or the competent authority, where appropriate,

to take the measures necessary to protect human health and the

environment.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

(1) The notifier shall -

(a) on completion of the deliberate release, and

(b) at any subsequent intervals specified in the consent,

submit a report to the competent authority on the results of the

deliberate release.

(2) The report referred to in sub-regulation (1) shall be

provided in such a format or formats as may be determined in

accordance with the procedure laid down in Article 30(2) of the

Directive, or in the absence of such a determination appropriate to

the relevant consent, in such format as may be specified in the

consent, and shall include

(a) a post-release evaluation of the risks to human health

or the environment, and

(b) where appropriate, a statement on the results of the

deliberate release in relation to any product, or type of

product, in respect of which consent to placing on the

market may be sought.

(3) A copy of any report received by the competent authority

pursuant to sub-regulation (1) shall, after its receipt, be sent by the

competent authority to the Commission in accordance with Article

11(3) of the Directive.

PART C

PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS

1. In the case of more than one release of genetically modified plants which

have resulted from the same recipient crop plant species but which may differ in any

of the inserted or deleted sequences or have the same inserted or deleted sequence

but differ in phenotypes, a single notification dossier shall be submitted.

2. A notifier can submit in a single notification information on several releases

of genetically modified crop plants, to be released on several different site on the

following conditions

the taxononic status and biology of the recipient plants species is well

known,

information is available on the interactions of the recipient plant species

in the ecosystems in which the experimental or agricultural releases are

scheduled,

scientific data is available on the safety to human health and the

environment of experimental releases involving genetically modified

plants of the same recipient plant species,

the inserted sequences and their expression products should be safe for

human health and the environment under the conditions of the

experimental release,

the inserted sequences have been well characterized,

all the inserted sequences are integrated into the plant nuclear genome,

all the releases are for an a priori specified programme of work,

all the releases take place within an a priori specified time period.

4. Only one single consent is required for all the releases described in the

single notification submitted to the competent authority. The procedure to be used in

granting that consent is the following

(1) any person, wishing to undertake a deliberate release of a GMO or a

combination of GMOs in Malta for the purpose of research and

development, or for any other purpose than for placing on the market,

must submit a notification to the competent authority;

(2) the notification shall include

(a) a technical dossier supplying the information specified in

Schedule II necessary for evaluating the foreseeable risks,

whether immediate or delayed, which the GMO or combination of

GMOs may pose to human health or the environment, together

with the methods used and the bibliographic reference to them

and covering, in particular

(i) general information including information on personnel and

training,

(ii) information relating to any GMO,

(iii) information relating to the conditions of release and the

receiving environment,

(iv) information on the interactions between any GMO and the

environment,

(v) information on monitoring, control, waste treatment and

emergency response plans;

(b) a statement evaluating the impacts and risks posed by any GMO

to human health or the environment from the uses envisaged;

(3) the competent authority may accept that releases of a combination of

GMOs on the same site or of the same GMO on different sites for the

same purpose and within a limited period may be notified in a single

notification;

(4) the notifier shall include in the notification information on data or

results from releases of the same GMOs or the same combination of

GMOs previously or currently notified or carried out by him either in

Malta or abroad. The notifier may also refer to data or results from

notifications previously submitted by other notifiers, provided that the

latter have given their agreement in writing;

(5) in the case of a subsequent release of the same GMO or combination of

GMOs previously notified as part of the same research programme, the

notifier shall be required to submit a new notification. In this case, the

notifier may refer to data from previous notifications or results from

previous releases;

(6) in the event of any modification of the deliberate release of GMOs or a

combination of GMOs which could have consequences with regard to

the risks for human health or the environment or if new information has

become available on such risks, either while the notification is being

examined by the competent authority or after the competent authority

has given its written consent, the notifier shall immediately

(a) revise the measures specified in the notification,

(b) inform the competent authority in advance of any modification or

as soon as the new information is available,

(c) take the measures necessary to protect human health and the

environment.

(7)

(i) On receipt and after acknowledgment of the notification the

competent authority shall

-

examine it for compliance with these regulations,

-

evaluate the risks posed by the release,

-

record its conclusions in writing, and, if necessary,

-

carry out tests or inspections as may be necessary for control

purposes.

(7)

(ii) The competent authority, shall respond in writing to the notifier

within ninety days of receipt of the notification by either

(a) indicating that it is satisfied that the notification is in

compliance with these regulations and that the release may

proceed, or

(b) indicating that the release does not fulfil the conditions of

these regulations and the notification is therefore rejected.

(7)

(iii) For the purpose of calculating the ninety-day period referred to in

the preceding paragraph, any periods of time during which the

competent authority

-

is awaiting further information which it may have requested

from the notifier, or

-

is carrying out a public inquiry or consultation in accordance

with paragraph (8) shall not be taken into account.

(7)

(iv) The notifier may proceed with the release only when he has

received the written consent of the competent authority, and in

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

conformity with any conditions required in this consent.

(7)

(v) If information becomes available subsequently to the competent

authority which could have significant consequences for the risks

posed by the release, the competent authority may require the

notifier to modify the conditions of, suspend or terminate the

deliberate release.

(8) Where the competent authority considers it appropriate, it may consult

groups or the public on any aspect of the proposed deliberate release.

(9) After completion of a release, the notifier shall send to the competent

authority the result of the release in respect of any risk to human health

or the environment, with particular reference to any kind of product that

the notifier intends to notify at a later stage.

5. In order to obtain one single consent covering several releases, all the

necessary information for each release should be indicated in the single notification,

including sufficient information on the different sites of the releases and on the

experimental design, as well as indication of any conditions for risk management for

each different release. Clear reference to each release to be covered should be made

in the notification, and the appropriate information should be included to allow

completion of the summary notification information format.

6. A notifier can also submit a single notification covering a whole, a priori

specified, programme of development work with a single specific recipient plant

species and a specified range of inserts or deletions over several years and on several

different sites, and receive a single consent for the whole programme of work.

6(1). In such cases, detailed indications or descriptions of the different sites of the

releases, subsequent intra-specific sexual crosses or the conditions of release need

not be given in the notification, as would be required under the conditions indicated

in paragraph 5. However, the notification must contain sufficient information to

enable overall an evaluation of risk, and a detailed risk assessment to be made for at

least the first release in the programme of work. The information that need not be

given may only relate to the sites of the releases, the description of the sites and their

surface area, the number of plants released, and the subsequent sexual crosses of the

initially notified plants (including progenies) with themselves or with plant lines of

the initially notified recipient plant species (including the progenies of these

crossings).

7. In the cases referred to in paragraph 6(1) the notifier will submit to the

competent authority the additional information together with a statement indicating

whether the original risk assessment remains valid and if not, provide further

evaluation. This information should be sent before the specific release to which it

refers is carried out, in the form of a simple additional notice for information only.

7(1). The notifier can proceed with the release in question after fifteen days from

the date of receipt by the competent authority of this additional information, unless

he receives written indication from the competent authority.

7(2). If any new information submitted is such that the original consent under

simplified procedures is no longer applicable, then it is for the competent authority

to indicate to the notifier within 15 days of receipt of the notification that he may

only proceed with the intended release if a consent is granted under the standard

procedure laid down in these regulations.

8. When the single consent under simplified procedures is granted, conditions

can be attached to each of the releases to which it refers. These conditions can

subsequently be altered by the competent authority, as indicated in paragraph

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

4(7)(v).

9. On completion of one or more of the releases approved within the simplified

procedure, the notifier shall submit to the competent authority a report with the

results of any release at the time specified in the consent. Such reports may be

submitted separately, or as a clearly identifiable section in support of a notification

for subsequent releases.

10. The competent authority may alter the conditions of the original consent or

intervene to alter the conditions of specific subsequent releases on the basis of the

results indicated in the reports or on the basis of information obtained during

inspections.

(1) Regulations 12 to 19 shall not apply to any GMO as or

in products, as far as they are authorised by any relevant legislation

which provides for a specific environment risk assessment, to be

carried out in accordance with the principles set out in Schedule II

and on the basis of information specified in Schedule III, without

prejudice to additional requirements provided for by the relevant

legislation, and for requirements as regards risk management,

labelling, monitoring as appropriate, information to the public and

safeguard clause at least equivalent to that laid down in these

regulations, or in any other relevant regulations concerning

medicinal products for human and veterinary use.

(2) Without prejudice to Schedule I B and subject to the

exclusions in sub-regulation (1), a person shall not place on the

market any product containing or consisting of a genetically

modified organism unless

(a) consent in writing has been received from the

competent authority under Part C, or

(b) consent in writing has been received from the

competent authority of another Member State in

accordance with Part C of the Directive,

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

and the conditions attached to the consent have been complied

12.(1)(a) Before a GMO or a combination of GMOs as or in

products is placed on the market for the first time, a

notification shall be submitted to the competent

authority.

(b) The competent authority shall acknowledge the date of

receipt of the notification.

(c) The competent authority shall without delay examine

whether the notification is in accordance with sub-

regulation (2) and shall, if necessary, ask the notifier

for additional information.

(2)

The notification shall contain

(a) the information required in Schedules III and IV. This

information shall take into account the diversity of

sites of use of the GMO as or in a product and shall

include information on data and results obtained from

research and developmental conclusions concerning

the impact of the release on human health and the

environment;

(b) the environment risk assessment and the conclusions

required in Schedule II;

(c) the conclusions arrived at by the notifier in accordance

with Schedule II, together with any bibliographic

references and details of the methods used;

(d) the conditions for the placing on the market of the

product, including specific conditions of use and

handling;

(e) with reference to regulation 14(5), a proposed period

for the consent which should not exceed ten years;

(f)

a plan for monitoring in accordance with Schedule

VII, including a proposal for the time-period of the

monitoring plan; this time period may be different

from the proposed period for the consent;

(g) a proposal for labelling which shall comply with the

requirements laid down in Schedule IV and, the

labelling shall clearly state that a GMO is present and,

the words "this product contains genetically modified

organisms" shall appear either on a label or in an

accompanying document;

(h) a proposal for packaging which shall comprise the

requirements laid down in Schedule IV;

(i)

a summary of the notification as may be established by

the competent authority from time to time in the

format established in accordance with the procedure

laid down in Article 30(2) of the Directive; this shall

also apply in a case to which Article 16 of the

Directive applies;

(j)

the notifier shall clearly indicate whether the notification

would prejudice any enforcement case, court case or

other causes currently sub-judice

Provided that if on the basis of the results of any release notified

under Part B, or on other substantive, reasoned scientific grounds, a

notifier considers that the placing on the market and use of a GMO

as or in a product do not pose a risk to human health and the

environment, he may propose to the competent authority not to

provide part or all of the information required in Schedule IV,

section B.

(3) The notifier shall include in this notification information on

data or results from releases of the same GMOs or the same

combination of GMOs previously or currently notified or carried

out by the notifier either in Malta or abroad.

(4) The notifier may also refer to data or results from

notifications previously submitted by other notifiers or submit

additional information he considers relevant, provided that the

information, data and results are non-confidential or these notifiers

have given their agreement in writing.

(5) The notifier proposing to place a product containing or

consisting of a genetically modified organism on the market for the

first time shall publish a notice according to regulation 9 with the

wording "PROPOSED PLAC ING ON TH E MARKET O F A

PRODUCT CONTAINING/CONSISTING OF A GENETICALLY

MODIFIED ORGANISM". In addition to the relevant requirements

laid down in regulation 9(2) the notice shall also include -

(a) the full postal address of the Commission,

(b) with respect to a notification submitted in accordance

with sub-regulation (1), regulation 9(2)(g) shall not

apply and shall be replaced by paragraph (c),

(c) the fact that any person or body may make

representations in writing to the said Commission

regarding the notification within the period of thirty

days beginning on the day that the Commission makes

the summary of the notification received by it in

accordance with regulation 13(1)(b) available to the

public.

(6) In order for a GMO or combination of GMOs to be used for

a purpose different from that already specified in a notification, a

separate notification shall be submitted.

(7) If new information has become available with regard to the

risks of the GMO to human health or the environment, before the

written consent is granted, the notifier shall immediately take the

measures necessary to protect human health and the environment,

and inform the competent authority thereof. In addition, the notifier

shall revise the information and conditions specified in the

notification and submit an amended notification to the competent

authority, and the first notification under sub-regulation (1) shall

not be further considered by the competent authority.

(1) On receipt of a notification under regulation 12(2) the

competent authority shall

(a) acknowledge to the notifier the date of such receipt in

writing,

(b) immediately forward a copy of the summary

notification received in accordance with regulation

12(2)(i) to the competent authorities of the other

Member States for the purposes of the Directive and to

the Commission,

(c) examine it for compliance with these regulations and

in particular regulation 12,

(d) ask the notifier in writing for any further information

which the competent authority considers necessary,

stating its reasons for so doing. Any periods of time

during which the competent authority is awaiting

further information shall not be taken into account

when calculating the ninety-day period referred to in

sub-regulation (2),

(e) send a copy of the notification to the Commission once

it is satisfied that the requirements of regulation 12

have been complied with, and no later than the time at

which it sends to the Commission a copy of the

assessment report mentioned in accordance with sub-

regulation (3) or (4).

(2) Within ninety days of the receipt of a notification under

regulation 12, the competent authority shall

(a) prepare, in accordance with Schedule VI, an

assessment report which shall also indicate whether

(i)

the genetically modified organism concerned

should be placed on the market and under which

conditions (referred to as a "favourable

assessment"); or

(ii) the genetically modified organism concerned

should not be placed on the market (referred to

as an "unfavourable assessment"), and

(b) send a copy of the assessment report to the notifier.

(3) In the case of a favourable assessment, the competent

authority shall send a copy of the assessment report to the notifier

and to the Commission, any further information obtained from the

notifier in accordance with sub-regulation (l)(d), and any other

information on which the competent authority has based its report.

(4) In the case of an unfavourable assessment, the competent

authority shall, no sooner than fifteen days after it sends a copy of

the assessment report to the notifier and no later than one hundred

and five days after it received the notification, send to the

Commission a copy of the said report, any further information

obtained from the notifier in accordance with sub-regulation (l)(d),

and any other information on which the competent authority has

based its report.

(5) Without prejudice to Regulation (EC) No 1829/2003 on

genetically modified 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 the territory 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 with Article 26b (1) of the

Directive;

(b) within thirty (30) days from the presentation of the

demand to the notifier by the Commission, 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 be implemented in the

written consent issued under these regulations;

(d) where applicable, the written consent issued under

these regulations by the competent authority shall then

be issued on the basis of the adjusted geographical

scope of the notification.

(1) In the case of a favourable assessment, the competent

authority shall

(a) provide any further information to the Commission,

where such information is requested by the said

Commission or by a competent authority of a Member

State for the purposes of the Directive,

(b) consider any comments, or reasoned objections

concerning the placing of the product on the market

made by the Commission or by a competent authority

of another Member State for the purposes of the

Directive where such comments or objections are

made within a period of sixty (60) days beginning on

the day on which the documents referred to in

regulation 13(3) were forwarded to each such

competent authority by the Commission, and

(c) participate in any discussions in relation to the

assessment report initiated by the Commission on

grounds of reasoned objections made in accordance

with paragraph (b) with a view to reaching an

agreement within a period of one hundred and five

days, beginning on the day on which the documents

referred to in regulation 13(3) were forwarded to each

such competent authority by the Commission

Provided that any periods of time during which further

information from the notifier is awaited shall not be taken into

account for the purpose of calculating the final forty-five day

period for arriving at an agreement.

(2)

The competent authority shall grant consent to the notifier,

in writing, to place the product on the market where it has

concluded a favourable assessment of the proposal, and

(a) no reasoned objection to the favourable assessment

has been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (1)(b), or

(b) a reasoned objection to the favourable assessment has

been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (1)(b) but the matters concerned have been

resolved in accordance with the provisions of Article

15(1) of the Directive, or

(c) a reasoned objection to the favourable assessment has

been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (1)(b) and the said Commission has adopted

a favourable decision in accordance with the

provisions of Article 18(1) of the Directive.

(3) If the competent authority decides that the product may be

placed on the market, it shall give consent in writing, transmit it to

the notifier and inform other Member States and the Commission

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 the assessment report required under

regulation 13(2) the timelines to issue the written consent shall be

extended by a single period of fifteen (15) days, regardless of the

number of the demands presented. Such further provision shall be

without prejudice to Regulation (EC) No 1829/2003 on genetically

modified food and feed.

(4) The competent authority shall, where it has concluded an

unfavourable assessment, or where the Commission has adopted an

unfavourable decision in accordance with the provisions of Article

18(1) of the Directive, inform the notifier in writing, that consent is

refused and stating the reasons for the refusal.

(5) Subject to the provisions of sub-regulation (6), the

competent authority shall not grant a consent under Part C for a

period which exceeds 10 years beginning on the date on which the

consent is issued.

(6) In cases relating to a genetically modified organism or a

progeny of that organism intended only for the marketing of its

seeds under legislation of the European Union for the time being in

force, or to genetically modified forest reproductive material, the

period of first consent shall be limited in accordance with the

provisions of Article 15(4) of the Directive.

(1) By way of derogation from regulations 12, 13 and 14,

the procedure set out in sub-regulations (2) to (6) shall be applied

to the renewal of consents granted under Part C.

(2)

A person seeking to renew a consent granted by the

competent authority under regulation 14 or a consent previously

renewed under this regulation shall

(a) submit a notification to the competent authority no

later than nine months before the expiry of the consent

that it is proposed to have renewed,

(b) a person who has submitted a notification under this

regulation may continue to market the product

concerned in accordance with the terms and conditions

of the relevant consent until a final decision has been

made on the notification.

(3) A notification in accordance with sub-regulation (2)(a)

shall include

(a) a copy of the consent granted by the competent

authority to the product being placed on the market

and of any renewed consent,

(b) a report on the monitoring carried out in accordance

with regulation 17,

(c) any new information that has become available with

regard to the risks of the product to human health or to

the environment, and

(d) any proposals the notifier considers appropriate for the

amendment of, or measures additional to, the

conditions contained in the original consent granted by

the competent authority, including conditions relating

to future monitoring and time limitation of the

consent.

(4) On receipt of a notification under sub-regulation (2), the

competent authority shall

(a) acknowledge to the notifier the date of such receipt in

writing,

(b) examine it for compliance with sub-regulation (3),

(c) ask the notifier in writing for any further information

which the competent authority considers necessary,

stating its reasons for so doing,

(d) prepare, in accordance with Schedule

VI,

an

assessment report which shall indicate

(i)

whether the genetically modified organism

concerned should remain on the market and

under which conditions (referred to as a

"favourable assessment");

(ii) or the genetically modified organism concerned

should not remain on the market (referred to as a

"unfavourable assessment"),

(e) send a copy of the notification and of the assessment

report to the Commission, and

(f)

send a copy of the assessment report to the notifier.

(5) The provisions under regulation 13(5) concerning a demand

or demands for the adjustment to the geographical scope of a

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

written consent shall also apply for the renewal of consents.

(6) In the case of a favourable assessment, the competent

authority shall

(a) provide any further information to the Commission

where such information is requested by the said

Commission or by a competent authority of a Member

State for the purposes of the Directive,

(b) consider any comments, concerns or reasoned

objections to the product remaining on the market

made by the Commission or by a competent authority

of another Member State for the purposes of the

Directive where such comments or objections are

made within a period of sixty days beginning on the

day on which the documents referred to in sub-

regulation (4)(d) were forwarded to each such

competent authority by the Commission, and

(c) participate in any discussions in relation to the

assessment report initiated by the Commission on the

grounds of reasoned objections made in accordance

with paragraph (b) with a view to reaching an

agreement within a period of seventy-five days,

beginning on the day on which the documents referred

to in sub-regulation (4)(d) were forwarded to each

such competent authority by the Commission.

(7) The competent authority shall renew consent to market a

product where it has concluded a favourable assessment of the

proposal, and -

(a) no reasoned objection to the favourable assessment

has been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (6)(b), or

(b) a reasoned objection to the favourable assessment has

been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (6)(b) but the matters concerned have been

resolved in accordance with the provisions of Article

17(7) and (8) of the Directive, or

(c) a reasoned objection to the favourable assessment has

been made raised by the Commission or by a

competent authority of a Member State in accordance

with sub-regulation (6)(b) and the said Commission

has adopted a favourable decision in accordance with

the provisions of Article 18(1) of the Directive.

(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 within thirty (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 the assessment report, the timelines to issue

the written renewal consent shall be extended 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.

(9) The competent authority shall, where it has concluded an

unfavourable assessment, or where the Commission has adopted an

unfavourable decision in accordance with the provisions of Article

18(1) of the Directive, inform the notifier that renewal of the

consent is refused and stating the reasons for the refusal.

(10) A renewal or a refusal of consent under this regulation shall

be conveyed by the competent authority to the notifier in writing.

In the case of a renewal of consent, its validity shall not exceed ten

years and may be limited or extended as appropriate for specific

reasons.

(1) Only if a written consent has been given for the

placing on the market of a GMO as or in a product by a competent

authority of a Member State may that product be used without

further notification to the competent authority in so far as the

specific conditions of use and the environment or geographical

areas stipulated in these conditions are strictly adhered to.

(2)

(a) The notifier may proceed with the placing on the

market only when he has received the written consent

of the competent authority in accordance with

regulations 14 and 15 and in conformity with any

conditions required in that consent.

(b) The competent authority shall take all necessary

measures to ensure that any written consent is made

accessible to the public and that conditions specified

in the written consent are complied with.

(3) The written consent referred to in regulations 14 and 15

shall, in all cases, explicitly specify

(a) the scope of the consent, including the identity of any

GMO to be placed on the market as or in products, and

their unique identifier;

(b) the period of validity of the consent;

(c) the conditions for the placing on the market of the

product, including any specific condition of use,

handling and packaging of any GMO as or in products,

and conditions for the protection of particular

ecosystems, environments or geographical areas;

(d) that, without prejudice to regulation 20, the notifier

shall make control samples available to the competent

authority on request;

(e) the labelling requirements, in compliance with the

requirements laid down in Schedule IV. The labelling

shall clearly state that a GMO is present. The words

"This product

contains genetically modified

organisms" shall appear either on a label or in a

document accompanying the product or other products

containing any GMO;

(f)

monitoring requirements in accordance with Schedule

VII, including obligations to report to the

Commission, the time period of the monitoring plan

and, where appropriate, any obligations on any person

selling the product or any user of it, inter alia, in the

case of any GMO grown, concerning a level of

information deemed appropriate on their location.

(4) (a) Another Member State may request the competent

authority to reintegrate 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 consent

accordingly.

(b) The competent authority may, if necessary, reintegrate

all or part of the Maltese Islands into the geographical

scope of the consent 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.

Without prejudice to Regulation (EC) No 1829/2003 on

genetically modified food and feed

(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, the competent authority

may adopt measures restricting or prohibiting the cultivation in all or

part of the Maltese territory of a GMO, or group 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 based on 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 the exception of sub-paragraph

(vii) of sub-regulation (2)(a), which cannot be invoked

individually. Grounds would depend on the particular

circumstances of Malta, the region or area in which the

measures would apply and shall, in no case, conflict

with the environmental risk assessment carried out

pursuant to the Directive or these regulations.

(3)

A draft of the measures the competent authority intends

to adopt and the corresponding grounds invoked shall be duly

communicated to the Commission. Such communication may take

place before the GMO authorisation procedure under Part C of the

Directive or these regulations has been completed.

(4)

The competent authority shall issue a notice in the

Gazette which shall prohibit 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, adopt measures

restricting or prohibiting the cultivation of the GMO or the group of

GMOs referred to in sub-regulation (4). Such measures shall either be

those originally 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.

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

GMOs is prohibited, as appropriate. Such measures shall be

communicated to the Commission.

(1) Following the placing on the market of a GMO as or in

a product, the notifier shall ensure that monitoring and reporting on

it are carried out according to the conditions specified in the

consent. On the basis of these reports, in accordance with the

consent and within the framework for the monitoring plan specified

in the consent, the competent authority may adapt the monitoring

plan after the first or subsequent monitoring period.

(2) If new information has become available, from the users or

other sources, with regard to the risks of any GMO to human health

or the environment after the written consent has been given, the

notifier shall

(a) revise the notification, as required; and

(b) immediately take the measures necessary to protect

human health and the environment, and inform the

competent authority thereof.

(3) If information becomes available to the competent authority

which could have consequences for the risks of any GMO to human

health or the environment, or under the circumstances described in

sub-regulation (2), it may avail itself of the provisions in regulation

14 and 15where appropriate, when the information has become

available before the written consent.

(4) If, after granting consent under regulation 14 or renewing a

consent under regulation 15, the competent authority is informed or

becomes aware, of information which could have consequences for

the risks of any GMO to human health or the environment, or under

the circumstances described in sub-regulation (2), it shall

(a) immediately forward the information to the

Commission and to the competent authorities of the

Member States for the purposes of the Directive,

(b) prepare an assessment report in accordance with

Schedule VI which shall indicate

(i)

whether the genetically modified organism

concerned should remain on the market and

under which conditions (referred to as

"favourable assessment");

(ii) or the genetically modified organism concerned

should not remain on the market (referred to as

"unfavourable assessment"),

(c) within sixty days of the receipt of the information,

forward a copy of the assessment report to the

Commission, and

(d) send a copy of the assessment report to the notifier. If

the competent authority deems through the assessment

report, that the new information provides considerable

changes to the notification, the competent authority

may ask the notifier to cease marketing under this

regulation and submit an amended notification

Provided that in case of impacts to human health and the

environment, the notifier may be asked to defray or contribute

towards any or all of the costs incurred by it in order to protect

human health and the environment.

(5) In the case of a favourable assessment, the competent

authority shall

(a) provide any further information to the Commission

where such information is requested by the said

Commission or by a competent authority of a Member

State for the purposes of the Directive;

(b) consider any comments, concerns or reasoned

objections to the assessment report referred to in sub-

regulation (4)(b) made by the Commission or by a

competent authority of another Member State for the

purposes of the Directive where such comments or

objections are made within a period of sixty days

beginning on the day on which a copy of the said

assessment report was forwarded to each such

competent authority by the Commission, and

(c) participate in any discussions in relation to the

assessment report initiated by the Commission on the

grounds of reasoned objections made in accordance

with paragraph (b) with a view to reaching an

agreement within a period of seventy-five days,

beginning on the day on which the documents referred

to in sub-regulation (4)(b) were forwarded to each

such competent authority by the Commission.

(6) The competent authority shall consent to the continued

marketing of a product where it has concluded a favourable

assessment of the information, and -

(a) no reasoned objection to the favourable assessment

has been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (5)(b), or

(b) a reasoned objection to the favourable assessment has

been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (5)(b) but the matters concerned have been

resolved in accordance with the provisions of Article

20(3) of the Directive, or

(c) a reasoned objection to the favourable assessment has

been made by the Commission or by a competent

authority of a Member State in accordance with sub-

regulation (5)(b) and the said Commission has adopted

a favourable decision in accordance with the

provisions of Article 18(1) of the Directive.

(7) The competent authority shall, within a period of thirty

days beginning on the day that consent to the continued marketing

is granted, inform the competent authority of each Member State

and the Commission that it has done so.

(8) The competent authority shall, where it has concluded an

unfavourable assessment, or where the Commission has adopted an

unfavourable decision in accordance with the provisions of Article

18(1) of the Directive, direct the notifier to cease marketing the

product and stating the reasons for the direction.

(9) The notifier shall comply with any direction given by the

competent authority under sub-regulation (8).

(10) A consent to continue, or a direction to cease, marketing

under this regulation shall be conveyed by the competent authority

to the notifier in writing.

(11) The competent authority shall make the results of the

monitoring carried out under Part C publicly available.

(1) At all stages of the placing on the market, the labelling

and packaging of any GMO placed on the market as or in products

shall comply with the relevant requirements specified in the written

consent referred to in regulations 14(2), 15(7) and 16(3).

(2) For products where adventitious or technically unavoidable

traces of any authorised GMO cannot be excluded, the competent

authority may establish a minimum threshold below which these

products shall not have to be labelled in accordance with sub-

regulation (1).

(3) For products intended for direct processing, sub-regulation

(1) shall not apply to traces of any authorised GMO in proportions

no higher than 0.9% or lower thresholds, provided that these traces

are adventitious or technically unavoidable.

(1) Where, as a result of new or additional information

made available since the date of the consent and affecting the

environmental risk assessment or r eassessment of existing

information on the basis of new or additional scientific knowledge,

the competent authority has detailed grounds for considering that a

GMO as or in a product which has been properly notified and has

received written consent under these regulations constitutes a risk

to human health or the environment, the competent authority may

provisionally restrict or prohibit the use or sale of that GMO as or

in a product.

(2) The competent authority shall ensure that in the event of a

severe risk, emergency measures, such as suspension or

term inatio n of the placing on the m arket, shall be applied,

including giving information to the public.

(3) For the purposes of sub-regulation (1), the procedures

mentioned in regulation 17 shall be adopted.

PART D

CONFIDENTIALITY AND PUBLIC REGISTER

(1) The competent authority shall not divulge to third

parties any confidential information notified or exchanged under

these regulations and shall protect intellectual property rights

relating to the data received.

(2) The notifier may indicate the information in the notification

submitted under these regulations, the disclosure of which might

harm his competitive position and which should therefore be

treated as confidential, and verifiable justification must be given in

such cases.

(3) The competent authority shall, after consultation with the

notifier, decide which information will be kept confidential and

shall inform the notifier of its decisions.

(4) In no case may the following information when submitted

according to regulations 6, 7, 8, 12, 15, 17 or 19 be kept

confidential

(a) general description of any GMO, name and address of

the notifier, purpose of the release, location of release

and intended uses;

(b) methods and plans for monitoring of any GMO and for

emergency response;

(c) environment risk assessment.

(5) If, for whatever reasons, the notifier withdraws the

notification, the competent authority must respect the

confidentiality of the information supplied.

Any GMO to be made available for operations referred to

in the definition of "placing on the market" in regulation 2, shall be

subject to adequate labelling requirements in accordance with the

relevant sections of Schedule IV in order to provide for clear

information, on a label or in an accompanying document, on the

presence of GMOs. To that effect the words "This product contains

genetically modified organisms" shall appear either on a label or in

an accompanying document.

(1) Without prejudice to sub-regulation (2) and point A

No 7 of Schedule IV, the competent authority shall

(a) establish public registers in which the location of the

release of any GMO under Part B is recorded;

(b) also establish registers for recording the location of

GMOs grown under Part C, inter alia so that the

possible effects of such GMOs on the environment

may be monitored in accordance with the provisions of

regulation 16(3)(f) and 17(1).

(2) Without prejudice to such provisions in regulation 16 and

17, the said locations shall

-

be notified to the competent authority, and

-

be made known to the public in the manner deemed

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS

appropriate by the competent authority.

PART E

OFFENCES

(1) Any person who -

(a) fails to observe any provision of these regulations or

any other lawful order given by virtue of any provision

of these regulations; or

(b) infringes any restriction, prohibition or requirement

imposed by or under these regulations; or

(c) fails to observe any condition of a permit or consent

granted under the provisions of these regulations; or

(d) acts in contravention of any of the provisions of these

regulations; or

(e) makes a statement or presents information or

documentation, which such person knows to be false

for the purpose of obtaining the approval or

continuation of a consent under these regulations; or

(d) conspires or attempts, or aids, or abets, any other

person by whatever means, including advertising,

counselling or procurement to contravene the

provisions of these regulations or to fail to comply

with any such provisions, including any order lawfully

given in terms of any of the provisions of these

regulations, or to contravene any restriction,

prohibition or requirement imposed by or under the

said regulations,

shall be guilty of an offence under these regulations.

(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

(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 thousand euro (€100,000) or to

imprisonment for a term not exceeding two (2) years, or

to both such fine and imprisonment.

(3) Any person who commits an offence against the provisions

concerning the placing on the market of GMOs shall, on

conviction, be liable

(a) on a first conviction to a fine (multa) of not less than

sixty thousand euro (€60,000) but not exceeding

ninety thousand 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 and twenty

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 these regulations to pay the

expenses incurred by the competent authority as a result of the said

offence, the revocation of the notification issued by the competent

authority and the confiscation of the corpus delicti.

(5) The Court shall order the offender to remove the causes of

the offence and to undo anything which was done without a permit

within a time sufficient for the purpose to be fixed by the Court;

and, if the offender fails to comply with any such order within the

time so fixed, he shall be liable to a fine (multa) of not less than

sixty euro (€60) and not more than five hundred euro (€500), as the

Court may fix, for every day that the default continues after the

expiration of the said time.

(6) Any person who has been found guilty of committing an

offence against these regulations shall also pay for the expenses

incurred for the keeping, transport and remedying the damage

caused by the said infringement, and for any other expense incurred

or mitigation measures required to remedy such doings, damage

and infringement.

(7) The provisions of articles 23 and 30 of the Criminal Code

shall apply, mutatis mutandis, to proceedings in respect of offences

against these regulations, so however that the disqualification from

holding or obtaining a licence or permit from the competent

authority shall in no case be for less than one year.

(8) Notwithstanding the provisions of article 370 of the

C r i m i n a l C o d e , p r o c e e d i n g s f o r a n o ff e n c e a g a i n s t t h e s e

regulations shall be held before the Court of Magistrates (Malta) or

the Court of Magistrates (Gozo), as the case may be, and shall be in

accordance with the provisions of the Criminal Code regulating the

procedure before the said courts as courts of criminal judicature.

(9) Notwithstanding the provisions of the Criminal Code, the

Attorney General shall always have a right of appeal to the Court of

Criminal Appeal from any judgement given by the Court of

Magistrates (Malta) or the Court of Magistrates (Gozo) in respect

of proceedings for any offence against these regulations.

PART E

FEES

(1) A fee shall be paid to the competent authority in

respect of a notification under regulation 6 of a proposed deliberate

release for purposes other than placing on the market.

(2) The fee payable under sub-regulation (1) shall be thirty-

seven thousand euro (€37,000).

(3) A fee shall be paid to the competent authority in respect of

a notification under regulation 12 of a proposed placing on the

market of a product and a notification under regulation 15 of a

proposal for renewal of a consent.

(4) The fee payable under sub-regulation (3) shall in each case

be forty-thousand euro (€47,000).

(5) A fee shall be paid to the competent authority in respect of

an amended notification under regulation 8(3) in relation to a

deliberate release for purposes other than placing on the market.

(6) The fee payable under sub-regulation (5) shall be five

thousand euro (€5,000).

(7) A fee shall be paid to the competent authority in respect of

an amended notification under regulation 12(6) and 17(4)(d) in

connection with the proposed placing of a product on the market.

(8) The fee payable under sub-regulation (7) shall in each case

be fourteen thousand euro (€14,000).

The competent authority may require a notifier to make

periodic payments, not exceeding the costs incurred by the

competent authority, for the purpose of defraying or contributing

towards the costs incurred by the competent authority in

monitoring, carrying out inspections, or otherwise ensuring

compliance with the requirements of these regulations and any

other expenses related to the consent, conditions or other

requirements pursuant to these regulations.

The competent authority may carry out, or arrange to have

carried out, such investigations as it considers necessary, as part of

its examination or monitoring of a notification of a deliberate

release, placing on the market or other matter related to these

regulations, to enable it properly to assess the notification and may

require the notifier to defray or contribute towards the cost of any

such investigations.

The provisions of regulations 13(5), 15(5) and 16A shall not

affect the free circulation of authorized GMOs as, or in, products

PART F

OTHER PROVISIONS

The Schedules I to IX to these regulations are being

published in the English language with the English text of these

regulations.

DELIBERATE RELEASE INTO THE ENVIRONMENT OF

GENETICALLY MODIFIED MICRO-ORGANISMS