PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) REGULATIONS

(NATIONAL CERTIFICATION SCHEME)

SUBSIDIARY LEGISLATION 433.34

PLANT QUARANTINE (NATIONAL CERTIFICATION

SCHEME) REGULATIONS

21st April, 2020

LEGAL NOTICE 154 of 2020.

The title of these regulations is the Plant Quarantine

(National Certification Scheme) Regulations.

(1)

The scope of these regulations is to make provision

with regards to certification in order to

(a)

regulate the production, marketing and control

of propagation material of vegetables (excluding seeds), vines

and ornamental plants; and

(b)

improve the sanitary and the pomological

qualities of propagation material of vegetables (excluding

seeds), vines and ornamental plants and other reproductive

vegetative species.

(2)

In the implementation of these regulations, the provisions of

the following regulations shall also be taken into account

(a)

Plant

Quarantine

(Harmful

Organisms)

Regulations;

(b)

Vegetable Propagation and Planting Material

Regulations;

(c)

Propagation Material of Vines Regulations; and

(d)

Propagation

Material

of

Ornamental

Plants

Regulations.

For the purpose of these regulations, the following

definitions shall apply

"the Act" means the Plant Quarantine Act;

"the Directorate" means the Directorate or Department

responsible for plant health.

(1)

There shall be a national certification authority

which shall be responsible for regulating the certification process at

national level. The Directorate is hereby being established as the national

certification authority.

(2)

The tasks of the authority shall be

(a)

to establish guidelines for the certification of the

(NATIONAL CERTIFICATION SCHEME)

various vegetatively-propagated species which are then made

publicly available;

(b)

to formulate the technical protocols for each

species or group of species which are then made publicly

available;

(c)

to define the necessary schedules for the

certification processes;

(d)

to receive a n d a p p r o v e the requests received

from establishments to be recognised as centres for

conservation, pre-multiplication and multiplication;

(e)

to monitor the whole process of certification at

national level;

(f)

to verify that the propagated variety admitted

for certification has already been included in the National

Catalogue of Certified Varieties; and

(g)

to make the necessary arrangements for propagation

material from the repositories, foundation blocks, mother blocks

or in vitro laboratories located abroad to be brought to Malta;

(h)

to consult with the Plant Protection Board referred to

in article 4 of the Act on paragraphs (a), (b) and (c) above.

(1)

The inspections and the controls during the

certification phases shall be carried out by the Directorate.

(2)

The Directorate shall be responsible for the verification of

(a)

the suitability of the facilities and the plots

employed for growing mother plants and for the production of

certified material, according to the technical protocols

established for each species or group of species;

(b)

the sanitary status of the mother plants and

propagation material during each certification phase according to

the technical protocols established for each species or group of

species; and

(c)

true-to-type controls of the mother plants during

each certification phase according to the technical protocols set

up by the Directorate as established for each species or group of

species.

(3)

The activities referred to in sub-regulation (2) may be

carried out in collaboration with other scientific institutions.

(NATIONAL CERTIFICATION SCHEME)

Certification shall be organised in accordance with the

following phases

(a)

conservation for pre-multiplication;

(b)

pre-multiplication; and

(c)

multiplication.

Propagation material (seeds, buds, bulbs, cuttings,

rhizomes, root-stocks, in vitro cultures, etc.) at different stages of

development, grafted trees and self-rooted plants shall be classified

into the following categories

(a)

primary source, that is, the material of origin

produced by the breeder and kept by the breeder or by the

successor of such breeder;

(b)

pre-basic material produced from the first

multiplication of the primary source and grown in the repository.

At least two mother plants must be maintained for each variety;

(c)

basic, that is, material produced from the first

multiplication of pre-basic material. The material is grown in

the foundation block and used for the establishment of mother

blocks. At least two specimens shall be kept for each variety;

and

(d)

certified, that is, material produced from the first

multiplication of the basic material from mother blocks to be

utilised for the commercial production of certified material. At

least two specimens shall be maintained for each variety.

(1)

The acquisition of the primary source involves

the pomological and sanitary selection and, if necessary, the sanitation

of ecotypes of Maltese cultivars or those grown in the country for a

long period of time. These activities are carried out by the national

scientific institutions. Foreign scientific institutions may also

collaborate, if necessary, upon approval of the Directorate.

(2)

For the registration procedure, the breeder must

(a)

keep the primary source under appropriate

conditions so that the material remains healthy;

(b)

submit to

the Directorate

the appropriate

application form with

(i)

an authentic copy of the plant variety right

in the case of protected varieties;

(ii)

a data sheet of the varietal characteristics;

(NATIONAL CERTIFICATION SCHEME)

(iii) documents regarding the health status with

respect to the diseases indicated in the technical protocols

for the relevant species or group of species;

(iv) in the case of unprotected varieties, a

declaration stating that the variety can be multiplied

freely; and

(v)

in case the registration is accepted, the breeder

shall provide two specimens of the primary source to the

centre of conservation for pre-multiplication (repository).

(3)

The primary sources submitted for certification shall be

reported in the National Catalogue of Certified Varieties.

(4)

In the case of new cultivars and, or selections, the breeder

must declare, under his responsibility, the origin of the material, for

such breeder to be authorised to introduce such material in the various

phases of certification.

(1)

The phase of conservation for pre-multiplication

shall be carried out in the repository. It can be either governmental, or if

privately owned, it shall be recognised by the Directorate.

(2)

The phase of conservation for pre-multiplication

consists of

(a)

the conservation of at least two specimens of the

primary source under healthy conditions; and

(b)

the production in vivo and, or in vitro of pre-

basic material under healthy conditions.

(3)

In order to be recognised by the Directorate, the repository

must

(a)

submit to the Directorate

an appropriate

application for the recognition of the centre;

(b)

have adequate facilities for the conservation of the

pre-basic material according to the technical protocols

established for every species or group of species; and

(c)

have a responsible person

with

appropriate

qualifications and the necessary skills.

(4)

The pre-basic propagation material must undergo

(a)

sanitary controls by the Directorate according to

the technical protocols issued for every species or group of

species; and

(NATIONAL CERTIFICATION SCHEME)

(b)

true-to-type controls by the Directorate according

to the technical protocols established for every species or group

of species.

(5)

Grafted or self-rooted plants will be certified as pre-

basic plants after they have taken root and have been inspected.

(6)

The pre-basic material may originate from repositories

located abroad upon the approval of the Directorate.

(1)

The pre-multiplication phase is carried out in

a foundation block. This can be either governmental or, if privately owned,

it has to be recognised by the Directorate.

(2)

The pre-multiplication phase consists of

(a)

the conservation of plants of the basic category

according to the technical protocols concerning each species or

group of species; and

(b)

the production in vivo and, or in vitro of plants of

the basic category by grafting or self-rooting according to the

technical protocols established for each species or group of

species.

(3)

To be recognised by the Directorate, the pre-multiplication

centre must

(a)

submit to the Directorate

an appropriate

application for the recognition of the centre;

(b)

have adequate facilities for the conservation of pre-

basic material according to the technical protocols established

for every species or group of species; and

(c)

have a responsible person with appropriate

qualifications and having the necessary skills.

(4)

The pre-basic plants will be certified after verifying that

grafted plants or self-rooted plants have taken root.

(5)

The basic material may originate from foundation blocks

located abroad upon the approval of the Directorate.

(6)

In particular cases, upon the approval of the Directorate,

plants produced directly from the primary source can be used to establish

the foundation block. In this case, the breeder must submit a document

regarding the origin of the plants to the Directorate.

(7)

To satisfy certain particular necessities, in vitro

propagation or other rapid propagation techniques may be applied to

speed up the propagation of the basic material, upon the approval of the

(NATIONAL CERTIFICATION SCHEME)

Directorate and according to the technical protocols established for every

species or group of species.

(1)

The multiplication phase is carried out in

the multiplication centres which include mother blocks or in vitro

laboratories and nurseries. These can be either governmental, or if

privately owned, these have to be recognised by the Directorate.

(2)

The multiplication phase consists of

(a)

growing of certified mother plants in compliance

with the technical protocols established for each species or

group of species;

(b)

in vitro multiplication of certified material in

compliance with the technical rules for each species or group of

species; and

(c)

the production of propagation material which

has been certified.

(3)

The mother blocks and the in vitro laboratories must

meet the requirements included in the technical protocols established

for each species or group of species.

(4)

To be approved by the Directorate, the multiplication

centre shall

(a)

submit to the Directorate

an appropriate

application for the recognition of the centre;

(b)

have plots and facilities in compliance with the

protocols for each plant species or group of species; and

(c)

have a responsible person

with

appropriate

qualifications and the necessary skills.

(5)

To satisfy certain particular necessities, in vitro

propagation or other rapid propagation techniques may be applied to

speed up the propagation of the basic material, upon the approval of the

Directorate and according to the technical protocols established for

every species or group of species.

(6)

In particular cases, upon the approval of the

Directorate, plants produced directly from the primary source or from

pre-basic plants can be used to establish the foundation block. In the

first case, the breeder must submit a document regarding the origin of

the plants to the Directorate.

(1)

The phase concerning nursery activity is carried

out under the responsibility of the nurserymen.

(NATIONAL CERTIFICATION SCHEME)

(2)

It consists of the production of plant material (root-stocks,

grafted plants, self-rooted plants, etc.) which has been certified and is in

compliance with the protocols for each plant species or group of species.

(3)

The plants (grafted or self-rooted) that are present at

the nurseries will be certified after they have taken root and after fulfilling

the conditions of certification during inspections. The Directorate

will then release the official certificates in terms of regulation 15.

For the categories referred in regulation 7, two sanitary

statuses are envisaged

(a)

virus-free (v.f.) shall refer to material free from all

viruses, viroids, phytoplasmas and systemic pathogens known

at the moment of the official publication of the protocols

concerning the certification of virus-free material; and

(b)

virus-tested (v.t.) shall refer to material free from

certain serious viruses, viroids, phytoplasmas and systemic

pathogens specifically mentioned in the certification protocols

and stated in the official certificates in terms of regulation 15

Provided that in the case of plants grafted with

plant material of a different health status, the final product shall

be certified as the lowest state, that is, virus-tested.

(1)

Propagation material shall be certified for the

persons or their representatives authorised to operate a nursery, in

compliance with the laws in force, where they declare that they utilise the

multiplied plant material offered by the Directorate, in accordance

with the requirements specified in the technical protocols for each

species or group of species.

(2)

The certified plants that are free from harmful organisms

indicated in the Plant Quarantine (Harmful Organisms) Regulations

and that are in conformity with the regulations referred to in regulation

2(2), shall be accompanied by official certificates in terms of

regulation 15.

(3)

The institutions and facilities referred to in these

regulations shall undergo inspections by the Directorate and shall be

requested to supply to the latter all the necessary information and

documentation for the verification of the proper conduct of their

activities.

With respect to the rules concerning certification,

official certificates in the form of labels as approved by the Directorate

have to accompany the certified propagation material.

(1)

In derogation to these regulations, plant material

from any Member State may be submitted to the national certification

(NATIONAL CERTIFICATION SCHEME)

scheme.

(2)

The propagation material should be introduced in the

following circumstances

(a)

the rapid activation of the certification system in

Malta;

(b)

the inclusion of new cultivars in the Maltese

certification system; and

(c)

the counteraction to particular necessities that

might arise within the context of the certification system.

(3)

The introduction of propagation material shall be

permitted from time to time upon the advice of the Directorate.

(4)

Alternatively, propagation material produced from

mother plants derived from propagation material obtained from a

certification system of another Member State may be certified

accordingly.

(5)

The establishments, to be recognised, must undergo

checks according to the protocols of certification of the respective

Member State on the advice of the Directorate.