Fruit Trees Propagation Material Regulations, 2010

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,578, 13 ta’ April, 2010

L.N. 223 of 2010

PLANT QUARANTINE ACT

(CAP. 433)

Fruit Trees Propagation Material Regulations, 2010

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

Quarantine Act, 2001, the Minister for Resources and Rural Affairs

has made the following regulations:-

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

Propagation Material Regulations, 2010;

(2) These regulations shall come into force on the 30th

September 2012.

(1) The scope of these regulations is to make provisions

to assure that any propagation material of fruit trees and fruit trees

for fruit production produced in Malta or placed on the market in

Malta or intended to be marketed in another Member State meet

specified standards of quality.

(2) These regulations shall apply to the marketing

of propagation material of fruit trees and fruit trees intended for

fruit production within the European Union, of the genera and

species and their hybrids listed in Schedule I to these regulations

and shall apply without prejudice to the plant health rules laid

down by Council Directive 2000/29/EC as transposed in the Plant

Quarantine (Harmful Organisms) Regulations, 2004 and their

amendments.

(3) Rootstocks and other parts of plants of other

genera or species than those listed in Schedule I or their hybrids

shall also be subject to these regulations if material of genera or

species listed in Schedule I or their hybrids, is grafted or is to be

grafted onto them.

(4) These regulations shall not apply to propagation

material or fruit trees intended to be exported to third countries

provided that they are identified as such and kept sufficiently

isolated.

(5)

These regulations transpose Council Directive

2008/90/EC.

For the purpose of these regulations, the following

definitions shall apply

“the Act” means the Plant Quarantine Act;

“basic material” refers to propagation material which

(a) has been produced either directly or in a

known number of stages in a vegetative way from pre-

basic material, according to generally accepted methods,

for the maintenance of the identity of the variety

including the relevant pomological characteristics and

for the prevention of diseases;

(b) is intended for the production of certified

material;

(c) satisfies the specific requirements for basic

material, established pursuant to regulation 5; and

(d) has been found by official inspection to

satisfy the above mentioned conditions;

“certified material” refers to

(a)

propagation material which

(i) which has been produced directly in

a vegetative way from basic material or pre-

basic material or, if intended to be used for the

production of rootstocks, by certified seeds from

basic or certified material of rootstocks;

(ii)

is intended for the production of fruit

trees;

(iii) satisfies the specific requirements for

certified material, established pursuant to regulation

5; and

(iv) has been found by official inspection to

satisfy the above mentioned conditions;

(b) fruit trees which

(i) have been produced directly from

certified, basic or pre-basic propagation material;

(ii) are intended for the production of fruit;

(iii) satisfy the specific requirements for

certified material, established pursuant to regulation

5; and

(iv) have been found by official inspection

to satisfy the above mentioned conditions;

“clone” refers to the vegetative genetically uniform

progeny of a single plant;

“Conformitas Agraria Communitatis material” or “CAC

material” refers to propagation material and fruit trees which

(a)

have varietial identity and adequate varietal

purity;

(b) are intended for

-

the production of propagation material;

-

the production of fruit trees, and/or

-

the production of fruit;

(c) satisfy the specific requirements for CAC

material established pursuant to regulation 5;

“the Department” means the Department responsible for

plant health;

“the Director” means the Director responsible for the

Department and includes to the extent of the authority given,

any officer authorised by him, in writing, to act in that behalf

for any of the purposes of the Act;

“fruit trees” are plants intended to be planted or

replanted, after marketing;

“lot” is a number of units of a single commodity,

identifiable by its homogeneity in composition and origin;

“marketing” refers to the sale, holding with a view to

sale, offer for sale and any disposal, supply or transfer aimed

at commercial exploitation of propagation material or fruit

trees to third parties, whether or not for consideration;

“official inspection” is an inspection carried out by the

responsible official body or under the responsibility of the

responsible official body;

“pre-basic material” refers to propagation material

which

(a) has been produced according to generally

accepted methods for the maintenance of the identity

of the variety including the relevant pomological

characteristics and for the prevention of diseases;

(b) is intended for the production of basic

material or certified material other than fruit plants;

(c) satisfies the specific requirements for pre-

basic material established pursuant to regulation 5; and

(d) has been found by official inspection to

satisfy the above mentioned conditions;

“propagation material” refers to seeds, parts of plants

and all plant material, including rootstocks, intended for the

propagation and production of fruit plants;

“variety” refers to a plant grouping within a single

botanical taxon of the lowest known rank, which can be

(a) defined by the expression of the characteristics

resulting from a given genotype or combination of

genotypes;

(b) distinguished from any other plant

grouping by the expression of at least one of the said

characteristics; and

(c) considered as an entity in view of its ability to

be propagated unchanged;

“responsible official body” means the Department;

“supplier” means any natural or legal person carrying

out professionally at least one of the following activities with

regards to propagation material or fruit trees: reproducing,

producing, preserving or treating, importing and marketing.

Any person or entity introducing or importing in Malta Notification.

propagation material or fruit trees from a foreign country shall

notify the Department in accordance with the Trading Regulations, L.N. 315 of 2004.

2004.

(1) Specific requirements for each genus or species

listed in Schedule I to these regulations shall be established in

accordance with the procedure referred to in Article 19(3) of

Council Directive 2008/90/EC, specifying

(a) the conditions with which CAC material must

comply, in particular those relating to the propagation system

applied, to the purity of the growing crop, plant health, and,

except in the case of rootstocks, where the material does not

belong to a variety, to varietal aspects;

(b) the conditions with which pre-basic, basic and

certified material must comply, relating to quality (including,

for pre-basic and basic material, methods for the maintenance

of the identity of the variety and, where applicable, of the

clone, including the relevant pomological characteristics),

plant health, the testing methods and procedures applied,

the propagation system(s) applied and, except in the case of

rootstocks where the material does not belong to a variety, to

varietal aspects;

(c) the conditions with which rootstocks and other

parts of plants of genera or species other than those listed

in Schedule I, or their hybrids, must comply if propagation

material of the genus or species listed in Schedule I or their

hybrids is grafted onto them.

(1) Propagation material and fruit trees shall be Specific requirements

marketed with a reference to the variety to which they belong. for varieties.

Where, in the case of rootstocks, the material does not belong to

a variety, reference shall be made to the species or interspecific

hybrid concerned.

(2) The varieties to which reference shall be made

pursuant to subregulation (1) shall be

(a) legally protected by a plant variety right in

accordance with provisions on the protection of new varieties;

(b) officially registered pursuant to subregulation (4)

of this regulation; or

(c) commonly known; a variety is considered to be

commonly known if

(i) it has been officially registered in another

Member State;

(ii) it is the subject of an application for official

registration in any Member State, or of an application

for a plant variety right referred to in paragraph (a); or

(iii) it has already been marketed before 30th

September 2012 in Malta or in another Member State,

provided that it has an officially recognised description

Provided that reference pursuant to subregulation

(1) may also be made to a variety of no intrinsic

value for commercial crop production in so far as the

variety has an officially recognised description and the

propagation material and fruit trees are marketed as CAC

material in the territory of Malta and are identified by a

reference to this regulation on the label or document.

(3) As far as possible, each variety shall bear the

same denomination in all Member States, in accordance with the

implementing measures which may be adopted in accordance

with the procedure of Article 19(2) of Council Directive 2008/90/

EC or, in their absence, in accordance with accepted international

guidelines.

(4) (a) Varieties may be officially registered if they

have been found to satisfy certain officially approved conditions

and have an official description. They may also be officially

registered if their material has been already marketed before the

30th September 2012 in the territory of Malta, provided that they

have an officially recognised description.

(b) A genetically modified variety may be

officially registered only if the genetically modified organism of

which it consists has been authorised pursuant to Council Directive

2001/18/EC as transposed in L. N. 170 of 2002 – The Deliberate

Release into the Environment of Genetically Modified Organisms

Regulations, 2002 (hereinafter the 2002 Regulations) or pursuant

to Regulation (EC) No 1829/2003. Where products derived from

fruit trees or propagation material are intended to be used as, or

in, food falling within the scope of Article 3 or as in a feed falling

within the scope of Article 15 of Regulation (EC) No 1829/2003,

the variety concerned shall be officially registered only if the food

or feed derived from this material has been authorised pursuant to

that Regulation.

(5) Requirements for the official registration referred

to in subregulation (4) shall be established in accordance with

the procedure of Article 19(2) of Council Directive 2008/90/EC,

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; and

(d) the maximum period of validity of the official

registration of a variety.

(6) It may be decided in accordance with the procedure

of Article 19(2) of Council Directive 2008/90/EC that

(a) a system for the notification of varieties or species

or interspecific hybrids to the responsible official bodies of

the Member States may be set up; and

(b) a common list of varieties may be established and

published.

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

suppliers are officially registered in relation to the activities which

they carry out under these regulations.

(b) Malta may decide not to apply paragraph

(a) hereof to suppliers marketing only to non-professional final

consumers.

(2) It shall be ensured that pre-basic, basic,

certified material as well as CAC material is produced under the

responsibility of suppliers that are engaged in the production or

reproduction of propagation material and fruit trees. To this effect,

those suppliers shall

(a) identify and monitor critical points in their

production process which influence the quality of the

material;

(b) keep information on the monitoring referred to

in paragraph (a) hereof available for examination when

requested by the responsible official body;

(c) take samples where necessary for analysis in a

laboratory; and

(d) ensure that, during production, lots of propagating

material remain separately identifiable.

(3) It shall be ensured that in the case of the appearance,

on the premises of a supplier, of a harmful organism listed in the

Annexes to Council Directive 2000/29/EC as transposed in the

Plant Quarantine (Harmful Organisms) Regulations, 2004 and their

amendments or referred to in the specific requirements established

pursuant to regulation 5 of these regulations at a level higher

than the level allowed in these specific requirements, the supplier

shall report such presence to the responsible official body without

delays, notwithstanding any reporting obligations under Council

Directive 2000/29/EC as transposed in the Plant Quarantine

(Harmful Organisms) Regulations, 2004 and their amendments

and carry out any measures imposed by that body.

(4) (a) Suppliers shall keep records of their sales or

purchases for at least three years when propagation material or fruit

trees are marketed.

(b) Paragraph (a) shall not apply to suppliers who

are exempted from registration in accordance with subregulation

(1) (b) hereof.

(5) Detailed rules for the application of subregulations

(1) and (2) hereof may be established in accordance with the

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

(1) Propagation material and fruit plants shall be

marketed only in sufficiently homogeneous lots and if they have

(a) qualified as CAC material and accompanied by

a document issued by the supplier in accordance with the

specific requirements established pursuant to regulation 5. If

an official declaration appears on this document, it shall be

clearly separate from all other information in the document;

or

(b) qualified as pre-basic, basic or certified material

and certified as such by the responsible official body, in

accordance with the specific requirements established

pursuant to regulation 5.

Provided that requirements in respect of propagation

material or fruit trees with regard to labelling and/or sealing

and packaging may be indicated in implementing measures to

be adopted in accordance with the procedure of Article 19(3)

of Council Directive 2008/90/EC.

(2) In the case of retail supply of propagation material

or fruit trees to a non-professional final consumer, requirements

regarding labelling referred to in subregulation (1) may be confined

to appropriate product information.

(3) In the case of propagation material or fruit trees

of a variety which has been genetically modified, any label and

document, official or otherwise, which is affixed to or accompanies

the material under these regulations shall clearly indicate that

the variety has been genetically modified and shall identify the

genetically modified organisms.

(1) While growing and during lifting or removal from Lot composition and

the parent material, propagation material and fruit trees shall be

kept in separate lots.

(2) If propagation material and fruit trees of different

origins are put together or mixed during packaging, storage,

transport or at delivery, the supplier shall keep records including

the data relating to the composition of the lot and origin of its

individual components.

(1)

Propagation material and fruit trees may only be

marketed if

(a) the propagation material has been officially

certified as “pre-basic material”, “basic material” or “certified

material” or if it meets the conditions to be qualified as CAC

material;

(b) the fruit trees have been officially certified as

certified material or they meet the conditions to be qualified

as CAC material.

(2) Propagation material and fruit trees which consist

of a genetically modified organism within the meaning of points 1

and 2 of Article 2 of Council Directive 2001/18/EC as transposed

in the 2002 Regulations shall be placed on the market only if

the genetically modified organism has been authorised pursuant

to that Directive or pursuant to Regulation (EC) No 1829/2003.

Where products derived from fruit trees or propagation material

are intended to be used as or in food falling within the scope of

Article 3 or as or in a feed falling within the scope of Article 15 of

Regulation (EC) No 1829/2003, the propagation material and fruit

trees concerned shall be placed on the market only if the food or

the feed derived from this material has been authorised pursuant to

that Regulation.

(3) Notwithstanding subregulation (1), suppliers may

be authorised to place on the market in Malta appropriate quantities

of propagation material or fruit trees intended for

(a)

trials or scientific purposes;

(b)

selection work; or

(c)

conservation of genetic diversity.

Provided that the conditions under which Member States

may grant such authorisation may be adopted in accordance

with the procedure referred to in Article 19(2) of Council

Directive 2008/90/EC.

(1) The responsible official body may exempt

(a) from the application of regulation 8 (1), small

producers all of whose production and sales of propagation

material and fruit trees is intended for final use by persons on

the local market who are not professionally involved in plant

production (local circulation);

(b) from the checks and official inspections provided

for in regulation 12, the local circulation of propagation

material and fruit trees produced by such exempt persons.

(2) Implementing measures relating to other

requirements concerning the exemptions referred to in

subregulation (1), in particular as regards the concepts of “small

producers” and “local market”, and to related procedures, may

be adopted in accordance with the procedure of Article 19(2) of

Council Directive 2008/90/EC.

(1) The responsible official body shall ensure that Official inspections.

propagation material and fruit trees are officially inspected

during production and marketing to verify compliance with the

requirements and conditions set out in these regulations. To this

effect, the responsible official body shall have free access to all

parts of premises of suppliers at all reasonable times. Detailed

rules for the application of subregulation (1) shall be adopted

in accordance with the procedure of Article 19(2) of Council

Directive 2008/90/EC. These rules shall be proportionate to the

category of the material concerned.

(2) The responsible official body may, as stipulated

in notices issued by the Director, delegate the tasks provided for

in these regulations to be accomplished under its authority and

supervision to any legal person, whether governed by public or

private law, which, under its officially approved statute, is charged

exclusively with specific public functions, provided that such

person, and its members, has no personal interest in the outcome of

the measures it takes.

(3) Any other legal person established on behalf of

the responsible official body and acting under the authority and

supervision of such body may be approved in accordance with

the procedure of Article 19(2) of Council Directive 2008/90/EC,

provided that such person has no personal interest in the outcome

of the measures it takes.

(1) It shall be ensured that propagation material and

fruit trees intended for marketing, comply with the requirements of

these regulations.

(2) If, during the official inspection referred to

in regulation 12 or the trials referred to in regulation 17, it is

found that propagation material or fruit trees do not meet the

requirements of these regulations, the responsible official body

shall take appropriate action to ensure that they do comply with

the provisions of these regulations or, if that is not possible, to ban

the marketing of that propagation material or those fruit trees in the

Community.

(3) If it is found that propagation material or fruit

trees marketed by a particular supplier do not comply with the

requirements and conditions of these regulations, the responsible

official body shall ensure that appropriate measures are taken

against that supplier in line with the Act and regulations made

hereunder.

(4) Any measures taken under subregulation (3) shall

be withdrawn as soon as it has been established with sufficient

certainty that the propagation material or fruit trees intended for

marketing by the supplier will, in the future, comply with the

requirements and conditions of these regulations.

In the event of temporary difficulties in the supply of

propagation material and fruit trees satisfying the requirements

of these regulations due to natural disasters or unforeseen

circumstances, measures may be adopted in accordance with

the procedure of Article 19(2) of Council Directive 2008/90/EC,

concerning the marketing of propagation material and fruit trees

meeting less stringent requirements.

Propagation material and fruit trees which comply

with the requirements and conditions of these regulations shall

be subject to no marketing restrictions as regards suppliers, plant

health, growing medium and inspection arrangements, other than

those laid down in these regulations.

(1) In accordance with the procedure of Article 19(2) Equivalence.

of Council Directive 2008/90/EC, it shall be decided whether

propagation material and fruit trees produced in a third country

and affording the same guarantees as regards obligations on the

supplier, identity, characteristics, plant health, growing medium,

packaging, inspection arrangements, marking and sealing are

equivalent in all these respects to propagation material and

fruit trees produced in the Community and complying with the

requirements and conditions of these regulations.

Pending the decision referred to in subregulation (1),

Malta may until the 31st December 2010 and without prejudice

to the provisions of Council Directive 2000/29/EC as transposed

in the Plant Quarantine (Harmful Organisms) Regulations, 2004

and their amendments apply to the import of propagation material

and fruit trees from third countries conditions at least equivalent to

those indicated, on a temporary or permanent basis, in the specific

requirements adopted pursuant to regulation 5. If such conditions

are not laid down in the specific requirements, the conditions

for importation must at least be equivalent to those applicable to

production in Malta.

(2) Propagation material and fruit trees imported by

Malta in accordance with a decision taken by the same country

pursuant to subregulation (2) shall be subject to no marketing

restrictions in the other Member States as regards the matters

referred to in subregulation (1).

(1) Trials, or, where appropriate, tests shall be carried Community

out at European Union level on samples to check that propagation monitoring.

material or fruit trees comply with the requirements and conditions

laid down in these regulations, including those relating to plant

health.

(2) Community comparative trials and trials may be

carried out within the Community for the post-control of samples

of propagation material or fruit trees placed on the market under the

provisions of these regulations whether mandatory or discretionary,

including those relating to plant health.

Malta may, until 31st December 2018, allow the

marketing in its territory of propagation material and fruit trees

taken from parent plants that existed before 30th September

2012 and have been officially certified or meet the conditions

to be qualified as CAC material before 31st December 2018.

When marketed, such propagation material and fruit trees shall

be identified by a reference to this regulation on the label and/or

document. Beyond 31st December 2018, propagation material and

fruit trees may be marketed if the requirements of this subsidiary

legislation are fulfilled.

The Fruit Trees Propagation Material Regulations, 2004

2004. are hereby revoked.

B

Schedule I

List of genera and species

The following table lists the genera and species to which these regulations apply

Table 1.1

Latin Name

Common Name

Castanea sativa Mill.

European chestnut

Citrus L.

Orange, lemon, grapefruit, mandarin, lime, etc.

Corylus avellana L.

Hazel

Cydonia oblonga Mill.

Quince

Ficus carica L.

Fig

Fortunella Swingle

Kumquat

Fragaria L.

Strawberry

Juglans regia L.

Walnut

Malus Mill.

Apple

Olea europaea L.

Olive

Pistacia vera L.

Pistachio

Poncirus Raf.

Hardy/Bitter Orange

Prunus amygdalus Batsch.

Almond

Prunus armeniaca L.

Apricot

Prunus avium (L.) L.

Sweet cherry

Prunus cerasus L.

Sour cherry

Prunus domestica L.

Plum

Prunus persica (L.) Batsch.

Peach

Prunus salicina Lindley

Japanese plum

Pyrus L.

Pear

Ribes L.

Redcurrant

Rubus L.

Blackberry

Vaccinium L.

Blueberry/Bilberry/Cranberry

!

!

!

B

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