Regulations, 2017

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 19,735, 3 ta’ Marzu, 2017

L.N. 74 of 2017

PLANT QUARANTINE ACT

(CAP. 433)

Fruit Trees Propagating Material (Amendment No. 2)

Regulations, 2017

IN exercise of the powers conferred by article 32 of the Plant

Quarantine Act, the Minister for Sustainable Development, the

Environment and Climate Change has made the following

regulations:-

(1) The title of these regulations is the Fruit Trees Citation and

Propagating Material (Amendment No. 2) Regulations, 2017, and scope.

these regulations shall be read and construed as one with the Fruit S.L. 433.08

Trees Propagating Material Regulations, hereinafter referred to as

"the principal regulations".

(2) The scope of these regulations is to transpose Commission

Implementing Directive 2014/97/EU as regards the registration of

suppliers and of varieties and the common list of varieties.

Sub-regulations (5) and (6) of regulation 6 of the principal Amends

regulation 6 of

regulations shall be substituted by the following

the principal

regulations.

"(5) The requirements for the official registration

referred to in sub-regulation (4) are provided in Schedule III,

taking into account current scientific and technical knowledge

and covering

(a) the conditions of official registration, which

may include in particular, distinctness, stability and

sufficient uniformity;

(b) the characteristics which, as a minimum, the

examinations of the various species must cover;

(c) the minimum requirements for carrying out

the examinations;

(d) the maximum period of validity of the official

registration of a variety.

(6) Rules on the system for the notification of varieties

or species or interspecific hybrids to the responsible official

bodies of the Member States and on a common list of varieties

are provided in Schedule III.".

Sub-regulation (5) of regulation 7 of the principal

regulations shall be substituted by the following

"(5) Detailed rules for the application of sub-regulation

(1) are provided in Schedule III and the rules for the application

of sub-regulation (2) may be established in accordance with the

procedure of Article 19(2) of Council Directive 2008/90/EC.".

Immediately after Schedule II to the principal regulations,

there shall be added the following new schedule

"SCHEDULE III

Registration of Suppliers

I.

Register of suppliers

(1) The responsible official body shall keep and update a

register of suppliers, as provided for in regulation 7(1) of these

regulations. That register shall be referred to hereinafter as "the

register of suppliers". In addition to suppliers registered in

accordance with these regulations, that register shall include suppliers

accredited in accordance with the provisions of regulation 10(1) of

the Fruit Trees Propagation Material Regulations, 2010 * . Where

appropriate, the responsible official body shall make available the

register of suppliers.

(2) The register of suppliers shall include the following

information

(a)

the name, address and contact details of the supplier;

(b) the activities, within the meaning of the term

"supplier" in regulation 3 of these regulations that are exercised

by the supplier in Malta, the address of the premises involved

and the main genera or species concerned; and

(c)

the registration number or code.

(3) The responsible official body shall ensure that it removes a

natural or legal person from the register of suppliers, if it is

established that that person no longer exercises any activity within the

meaning of term "supplier" in regulation 3 of these regulations.

II.

Notification obligation of suppliers

* promulgated by Legal Notice 271 of 2004 and revoked by Legal Notice 223 of

2010. (1) The responsible official body shall ensure that suppliers

notify the information referred to in Section I point (2)(a) and (b). No

notification shall, however, be required from suppliers accredited in

accordance with regulation 10(1) of the Fruit Trees Propagation

Material Regulations, 2010 * .

(2) The responsible official body shall ensure that suppliers

notify any change in their situation concerning the information

referred to in Section I point (2)(a) and (b).

(3) The responsible official body shall ensure that suppliers

are informed of their registration and of any modifications thereto

within a time period to be laid down by national legislation.

Registration of Varieties

III. Variety register

(1) The responsible official body shall keep, update and

publish a register of varieties (hereinafter "variety register"). In

addition to varieties registered in accordance with these regulations,

the variety register shall include varieties registered before 30

September 2012 in accordance with regulation 8(3) of the Fruit Trees

Propagation Material Regulations, 2010 ** and varieties registered in

accordance with the second sentence of regulation 6(4)(a) of these

regulations.

(2) The

variety

register

shall

include

the

following

information

(a)

the denomination of the variety and synonyms;

(b)

the species the variety belongs to;

(c)

the indication "official description" or "officially

recognised description", as appropriate;

(d) the date of registration, or, where applicable, of

renewal of registration;

(e)

the end of validity of registration.

(3) The responsible official body shall keep a file for each

* promulgated by Legal Notice 271 of 2004 and revoked by Legal Notice 223 of

2010. ** promulgated by Legal Notice 271 of 2004 and revoked by Legal Notice 223 of

2010. variety it registers. That file shall contain a description of the variety

and a summary of all the facts relevant to the registration of the

variety.

IV. Conditions for registration of varieties

(1) The responsible official body shall ensure that a variety is

registered as a variety with an official description if it fulfils the

following requirements

(a)

it is distinct, uniform and stable within the meaning

of point (2) of this Section;

(b)

a sample of the variety is available; and

(c)

as regards genetically modified varieties, the

genetically modified organism of which the variety consists is

authorised for cultivation pursuant to Directive 2001/18/EC or

Regulation (EC) No 1829/2003.

(2) A variety shall be considered as

(a)

"distinct" where it is clearly distinguishable, by

reference to the expression of the characteristics that result from

a particular genotype or combination of genotypes, from any

other variety commonly known at the date of the application

referred to in Section V;

(b) "uniform" where, subject to the variation that may

be expected from the particular features of its propagation, it is

sufficiently uniform in the expression of those characteristics

which are included in the examination for distinctness, as well

as any other characteristics used for the variety description;

(c)

"stable" where the expression of the characteristics

which are included in the examination for distinctness, as well

as any other characteristics used for the variety description,

remains unchanged after repeated propagation or, in the case of

micro propagation at the end of each cycle.

V.

Application for registration of a variety

(1) For registration of a variety as a variety with an official

description, the responsible official body shall require to receive a

written application.

(2) The application shall be accompanied by the following

(a)

the information required by the

technical

questionnaires set out at the time of application

(i) in Annex II to the "Protocols for distinctness,

uniformity and stability tests" of the Administrative

Council of the Community Plant Variety Office (CPVO)

for the relevant species for which such a protocol has been

published; or, where no such protocols have been

published,

(ii) in Section X of the "Test guidelines for the

conduct of tests for distinctness, uniformity and stability"

of the International Union for the Protection of new

Varieties of Plants (UPOV) and the Annex to the Test

guideline concerned for the relevant species for which

such guidelines have been published; or, where no such

guidelines have been published,

(iii) in national provisions;

(b) information on whether the variety is officially

registered in another Member State, or is the subject of an

application for such a registration in another Member State;

(c)

a proposed denomination;

(d) in the case of a genetically modified variety,

evidence that the genetically modified organism of which the

variety consists is authorised for cultivation pursuant to

Directive 2001/18/EC or Regulation (EC) No 1829/2003.

(3) The applicant may submit any of the following with its

application

(a)

an official description established, in accordance

with point (5) of Section VI, by a responsible official body of

another Member State;

(b)

any other relevant information.

VI. Examination of applications

(1) It shall be ensured that, where the responsible official body

receives an application for registration of a variety as a variety with

an official description, an examination of that variety is performed in

accordance with points (2), (3) and (4) of this Section.

(2) Growing trials shall be carried out to establish an official

description of the variety. Where the applicant submits information in

accordance with point (3)(a) of Section V and the responsible official

body considers that this information shows that the conditions for

registration provided for in Section IV are fulfilled, no growing trials

shall, however, be carried out. Where growing trials are to be carried

out, the responsible official body shall request a sample of the

material of the variety.

(3) The growing trials referred to in point (2) of this Section

shall be performed by

(a)

the

responsible

official

body

receiving

the

application; or

(b) the responsible official body of another Member

State having agreed to perform those trials; or

(c)

any legal person, in accordance with regulation

12(2) of these regulations.

Where point (c) applies and trials are carried out on the

premises of private enterprises, the responsible official body shall

ensure that no measures are applied that might interfere with the

official examination.

(4) The growing trials shall be performed in accordance with

the following provisions as regards trial design, growing conditions

and characteristics of the variety to be covered as a minimum

(a)

the "Protocols for distinctness, uniformity and

stability tests" of the Administrative Council of the Community

Plant Variety Office (CPVO) applicable at the beginning of the

technical examination; or, where no protocols have been

published for the relevant species,

(b) the "Test guidelines for the conduct of tests for

distinctness, uniformity and stability" of the International Union

for the Protection of New Varieties of Plants (UPOV) applicable

at the beginning of the technical examination; or, where no

guidelines have been published for the relevant species,

(c)

national provisions.

(5) If, based on the examination referred to in point (1) of this

Section, the responsible official body concludes that the variety

concerned fulfils the conditions of Section V it shall establish an

official description and include that variety in the variety register.

VII. Period of validity of variety registration

(1) The maximum period of validity of the registration of a

variety shall be 30 years.

In the case of genetically modified varieties, the validity of

the registration shall be limited to the period for which the genetically

modified organism of which the variety consists is authorised for

cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No

1829/2003.

VIII. Renewal of variety registration

(1) The responsible official body shall ensure that the

registration of a variety may be renewed for further maximum periods

of 30 years, provided that material of that variety is still available.

In the case of a genetically modified variety, renewal shall,

in addition, be subject to the condition that the respective genetically

modified organism continues to be authorised for cultivation pursuant

to Directive 2001/18/EC or Regulation (EC) No 1829/2003. The

renewal period shall be limited to the period of authorisation of the

genetically modified organism concerned.

(2) For renewal of the registration, the responsible official

body shall require to receive a written application. The application

shall be accompanied by evidence showing that the conditions set out

in point (1) of this Section are fulfilled. The responsible official body

may, however, renew the registration of a variety for which no written

application has been submitted, where it considers that renewal serves

to preserve genetic diversity and sustainable production or serves

another general interest.

IX. Removal of a variety from the variety register

(1) The responsible official body shall ensure that a variety is

removed from the variety register if

(a)

the conditions for registration, as set out in Section

IV, are no longer fulfilled;

(b) at the time of the application for registration or

during examination, false or fraudulent particulars had been

supplied concerning the facts on the basis of which the variety

was registered.

X.

Notifications

(1) The responsible official body shall notify to the

responsible official bodies of the other Member States and the

European Commission the information required to access the variety

register of the Member State concerned.

(2) The responsible official body shall notify the European

Commission as soon as possible of the inclusion of a variety in its

variety register, and any other amendment to its variety register.

(3) The responsible official body shall, on request, make

available to another Member State or the European Commission

(a)

the official or officially recognised description of

varieties registered in the variety register of Malta;

(b) the results of examinations of applications for

registration of varieties performed by Malta pursuant to Section

VI;

(c)

any other information available in respect of

varieties included in the variety register of Malta or removed

from that register;

(d) the list of varieties for which applications for

registration are pending in Malta.

Common List of Varieties

XI. Common list

The European Commission shall, on the basis of the information

received pursuant to point (2) of Section X, establish, regularly

update and publish in an electronic format a common list of the

varieties included in the variety registers of the Member States.

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