182 tal-2019

L.N. 182 of 2019

ENVIRONMENT PROTECTION ACT

(CAP. 549)

Deliberate Release into the Environment of Genetically Modified

Organisms (Amendment) Regulations, 2019

BY VIRTUE of the powers conferred by articles 54 and 55 of the

Environment Protection Act, the Minister for the Environment,

Sustainable Development and Climate Change, after consultation with

the Environment and Resources Authority, has made the following

regulations:-

The title of these regulations is the Deliberate Release into

the Environment of Genetically Modified Organisms (Amendment)

Regulations, 2019 and they shall be read and construed as one with the

Deliberate Release into the Environment of Genetically Modified

Organisms Regulations, hereinafter referred to as "the principal

regulations".

In regulation 2 of the principal regulations, in the definition

"competent authority", the words "of these regulations;" shall be

substituted by the words "of these regulations:" and immediately

thereafter there shall be added the following new proviso

"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.".

Regulation 6 of the principal regulations shall be amended

as follows

(a) paragraph (c) of sub-regulation (2) thereof, shall be

substituted by the following

"(c) the notification shall be accompanied by the

relevant documents and any other requisite information as

specified and required by the competent authority. The

notifier shall clearly indicate whether the notification

would prejudice any enforcement case, court case or other

causes currently sub-judice.";

(b) in the Maltese version, in paragraph (b) of sub-

regulation (2) thereof, the words "tal-metodi użati." shall be

substituted by the words "tal-metodi użati;" and immediately

thereafter, there shall be added the following new paragraph

"(ċ) in-notifika għandha tkun akkumpanjata mid-

dokumenti relevanti u kwalunkwe informazzjoni oħra

meħtieġa kif speċifikat u meħtieġ mill-awtorità kompetenti.

In-notifikant għandu jindika b’mod ċar jekk in-notifika

tkunx ser tippreġudika xi każ ta’ infurzar, xi każ pendenti

quddiem il-qorti jew xi kawżi oħra li jkunu għandhom sub-

judice."; and

(c) in sub-regulation (7) thereof, the words "sub-

regulation (5)" shall be substituted by the words "sub-regulation

(6)", wherever they occur.

Sub-regulation (3) of regulation 7 of the principal Amends

regulation 7 of

regulations, shall be substituted by the following

the principal

regulations.

"(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.".

Regulation 12 of the principal regulations shall be amended Amends

regulation 12 of

as follows

the principal

regulations.

(a) in paragraph (e) of sub-regulation (2) thereof, the

words "regulation 14(4)" shall be substituted by the words

"regulation 14(5)";

(b) paragraph (j) of sub-regulation (2) thereof, shall be

substituted by the following

"(j) the notifier shall clearly indicate whether the

notification would prejudice any enforcement case, court

case or other causes currently sub-judice:";

(c) in sub-regulation (5) thereof, for the words "the

requirements laid down" there shall be substituted the words "the

relevant requirements laid down";

(d) in paragraph (b) of sub-regulation (5) thereof, the

words "to an application" shall be substituted by the words "to a

notification"; and

(e) in paragraph (c) of sub-regulation (5) thereof, the

words "regulation 13(b)" shall be substituted by the words

"regulation 13(1)(b)".

Regulation 13 of the principal regulations shall be amended

(a) in paragraph (b) of sub-regulation (1) thereof, the

words "regulation 12(2)(h)" shall be substituted by the words

"regulation 12(2)(i)"; and

(b) immediately after sub-regulation (4) thereof, there

shall be added the following new sub-regulation (5)

"(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.".

Regulation 14 of the principal regulations shall be amended

(a)

in paragraph (b) of sub-regulation (1) thereof, the

words "ninety days" shall be substituted by the words "sixty (60)

days"; and

(b) sub-regulation (3) thereof, shall be substituted by the

following

"(3) If the competent authority decides that the

product may be placed on the 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.".

Regulation 15 of the principal regulations shall be amended Amends

regulation 15 of

as follows

the principal

regulations.

(a) in sub-regulation (1) thereof, the words "the

procedure set out in sub-regulations (2) to (5)" shall be

substituted by the words "the procedure set out in sub-

regulations (2) to (6)";

(b) in paragraph (d) of sub-regulation (4) thereof, the

words "Schedule V" shall be substituted by the words "Schedule

VI";

(c) sub-regulations (5) to (9) thereof, shall

be

renumbered as sub-regulations (6) to (10) respectively;

(d)

immediately after sub-regulation (4) thereof there

shall be added the following new sub-regulation

"(5) The provisions under regulation 13(5)

concerning a demand or demands for the adjustment to the

geographical scope of a written consent shall also apply for

the renewal of consents.";

(e) in sub-regulation (7) thereof, as renumbered, the

words "sub-regulation (4)(d)" shall be substituted by the words

"sub-regulation (6)(b)" wherever they occur; and

(f) sub-regulation (8) thereof, as re-numbered, shall be

substituted by the following

"(8) When the competent authority renews a consent

in accordance to sub-regulation (7), it shall transmit to the

notifier the final decision in writing and shall inform the

other Member States and the Commission thereof 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.".

Immediately after sub-regulation (3) of regulation 16 of the

principal regulations, there shall be added the following new sub-

regulation

"(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.".

Immediately after regulation 16 of the principal regulations,

there shall be added the following new regulations

Without prejudice to Regulation (EC) No

1829/2003 on genetically modified food and feed

prohibiting the

cultivation in all or

part of the Maltese

(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.".

11. Regulation 17 of the principal regulations, shall be

amended as follows

(a) sub-regulation (2) thereof, shall be substituted by the

following

"(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.";

(b) in sub-regulation (3) thereof, immediately after the

words "the provisions in regulation 14" there shall be added the

words "and 15";

(c) in paragraph (b) of sub-regulation (4) thereof, the

words "Schedule V" shall be substituted by the words "Schedule

VI"; and

(d) in sub-regulation (5) thereof, the words "sub-

regulation (4)(b)(i)" shall be substituted by the words "sub-

regulation (4)(b)" wherever they occur.

12. In sub-regulation (1) of regulation 18 of the principal Amends

regulations immediately after the words "regulations 14(2)," there regulation

the principal

shall be added the words "15(7)".

regulations.

13. In sub-regulation (1) of regulation 19 of the principal Amends

regulations the words "Without prejudice to this regulation, the regulation

the principal

competent authority may not prohibit, restrict or impede placing on regulations.

market of any GMO, as or in products, which comply with these

regulations except where," shall be substituted by the word "Where,".

14. In regulation 21 of the principal regulations the words Amends

regulation 21 of

"regulation 2(1)" shall be substituted by the words "regulation 2".

the principal

regulations.

15. Regulation 23 of the principal regulations shall be amended Amends

regulation 23 of

as follows

the principal

regulations.

(a) sub-regulations (3) to (7) thereof, shall be re-

numbered as sub-regulations (5) to (9) respectively;

(b) sub-regulation (2) thereof, shall be substituted by the

following new sub-regulation

"(2) Any person who commits an offence against the

provisions concerning the deliberate release of GMOs, for

any other purpose than for placing on the market shall, on

conviction, be liable

(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."; and

(c) immediately after sub-regulation (2) thereof, there

shall be added the following new sub-regulations (3) and (4)

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

provisions concerning the placing on the market of 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.".

16. Immediately after regulation 26 of the principal

regulations, there shall be added the following new regulation

The provisions of regulations 13(5), 15(5)

and 16A shall not affect the free circulation of

authorized GMOs as, or in, products"."

17. Schedule II to the principal regulations, shall be amended

(a) Section C thereof, shall be substituted by the

following

"C. Methodology

Guidance issued by the European Food Safety

Authority is available for the implementation of this

section for Part C notifications.

C.1. General and specific 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.

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 12(4).

C.3. Steps in the e.r.a.

The e.r.a. referred to in regulations 4, 6, 7 and 12

shall be conducted for each relevant area of risk

referred to in Section D1 or in Section D2 of Part D 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.

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 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

propose 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

measures proposed.";

(b) The title and the introductory paragraph of Section D

thereof, shall be substituted by the following

"D. Conclusions on the specific areas of risk of the

e.r.a.

Conclusions on the potential environmental impact in

relevant receiving environments from the release or

the placing on the market of GMOs shall be drawn for

each relevant area of risk listed in Section D1 for

GMOs other than higher 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."; and

(c) Section D.2 thereof, shall be substituted by the

following

"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.

6. Effects on biogeochemical processes.

7. Effects on human and animal health.".

18. Schedule III to the principal regulations, shall be

substituted by the following

"SCHEDULE III

(Regulations 4, 5, 6, 7, 11 and 12)

INFORMATION REQUIRED IN THE NOTIFICATION

Notifications referred to in Parts B and C shall, as a rule,

include the information set out in Schedule III A, for

GMOs other than higher plants, or in Schedule III B, for

genetically modified higher plants.

The provision of a given subset of information listed in

Schedule III A or in Schedule III B shall not be required

where it is not relevant or necessary for the purposes of risk

assessment in the context of a specific notification, in view

especially of the characteristics of the GMO, of the scale

and conditions of the release or of its intended conditions of

use.

The appropriate level of detail for each subset of

information may also vary according to the nature and the

scale of the proposed release.

For each required subset of 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.".

19. Schedule III B to the principal regulations, shall be Substitutes

Schedule III B

substituted by the following

to the principal

regulations.

"SCHEDULE III B

INFORMATION REQUIRED IN NOTIFICATIONS

CONCERNING RELEASES OF GENETICALLY MODIFIED

HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND

ANGIOSPERMAE)

I. INFORMATION REQUIRED IN NOTIFICATIONS

SUBMITTED PURSUANT TO REGULATIONS 6 AND 7

A.

General information

1. Name and address of the notifier (company or

institute).

2. Name, qualifications and experience of the

responsible scientist(s).

3. Title of the project.

4. Information 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

(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

A.

General information.

1. Name and address of the notifier (company or

institute).

2. Name, qualifications and experience of the

responsible scientist(s).

3. Designation and specification of the GMHP.

4. Scope of the notification

(a)

cultivation;

(b) other uses (to be specified in the

notification).

B.

Scientific Information.

1. Information relating to the recipient plant or,

where appropriate, to the parental plants.

(a)

Complete name

(i)

family name;

(ii)

genus;

(iii) species;

(iv) subspecies;

(v)

cultivar/breeding line;

(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.

(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 Schedule II.

5. Description of detection and identification

techniques for the GMHP.

6. Information about previous releases of the

GMHP, if applicable.".

20. Schedule IV to the regulations shall be amended as follows

(a)

item 1 shall be substituted by the following

"1. proposed commercial names of the products

and names of GMOs contained therein, and a proposal for a

unique identifier for the GMO, developed in accordance

with Commission Regulation (EC) No 65/2004 * . After the

consent any new commercial names should be provided to

the competent authority,"; and

(b)

Point 7 shall be substituted by the following

"7. methods for detection, 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,".

* Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a

system for the development and assignment of unique identifiers for genetically

modified organisms (OJ L 10, 16.1.2004, p. 5).

€2.97