Seeds of Agricultural Plants and Vegetables Regulations, 2004

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,584, 14 ta’ Mejju, 2004

L.N. 276 of 2004

PLANT QUARANTINE ACT, 2001

(ACT NO. XVIII OF 2001)

Seeds of Agricultural Plants and Vegetables Regulations, 2004

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

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

Environment has made the following regulations>-

(1) The title of these regulations is the Seeds of Agricultural Title and

commencement.

Plants and Vegetables Regulations, 2004.

(2) These regulations shall come in force on the 15th May,

2004.

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

assuring that any seeds produced, placed on the market in Malta or

being transhipped through Malta prior to its transport to another Member

State meets specified standards of quality.

(2)

These regulations also control the production, with a

view to marketing and to the marketing, of seeds of agricultural plants

and vegetables of the genera, species and their hybrids listed in Schedule

I of these regulations within the Community.

(3)

These regulations shall apply to seeds intended to be

used only for the production of crops and shall not apply to seeds>

(a)

marketed for delivery to third countries<

(b)

used or to be used in the course of a process of selection<

or

(c) marketed with a view to processing, treatment or

cleaning, where their identity is stated by the person by whom

they are marketed.

(4) These regulations shall not apply to propagation or

planting material intended to be exported to third countries, if properly

identified as such and kept sufficiently isolated, without prejudice to

the health rules laid down in the Act.

(1) For the purpose of these regulations, the following

general definitions shall apply>

“agricultural plants” are plants that are subdivided into>

(a) cereals that are plants of the genera and species

listed in Table 1.1 of Schedule I of these regulations, intended

for agricultural or horticultural production other than the

production for ornamental purposes<

(b) fodder plants that are plants of genera and species

listed in Tables 1.2 and 1.3 of Schedule I<

(c) seed potatoes that are tubers or propagation material

for planting other than true potato seed, of the genus and

species stated in Table 1.4 of Schedule I<

“the Act” means the Plant Quarantine Act, 2001<

“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<

“genetically-modified seed” refers to seed that has its genetic

material altered in a way that does not exist naturally within the

meaning of Directive 2001#18#EC of the European Parliament and

of the Council of the 12th March, 2001.

“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 seed to third parties, whether or not

for consideration, and “market” and “marketed” shall be construed

accordingly>

Provided that trade in seed that is not aimed at commercial

exploitation of the variety, such as the following operations, shall

not be regarded as marketing>

(a)

the supply of seed to official testing and inspection

bodies<

(b) the supply of seed to providers of services for

processing or packaging, provided that the provider of services

does not acquire title to seed thus supplied.

Provided further that the supply of seed, under certain conditions

to providers of services for the production of certain agricultural raw

materials, intended for industrial purposes, or seed propagation for that

purpose, shall not be regarded as marketing, provided that the provider

of services does not acquire title to either the seed thus supplied or the

product of the harvest. The supplier of seed shall provide the Seed

Certification Authority with a copy of the relevant parts of the contracts

made with the provider of services and this shall include the standards

and conditions currently met by the seed provided<

“official examination” means>

(a) an examination carried out by or on behalf of the

Director, subject to an application for such examination having

been done to the Director in such form and manner and at

such time as the Director may, at his discretion, require and

to the payment of any fees<

(b) an examination carried out by or on behalf of the

said Department< or

(c) in relation to seed produced elsewhere other than

in Malta, an examination approved by the Director<

“official label” means a label issued or authorised by the

Department<

“official measures” are measures taken by>

(a)

the Department<

(b) any legal person acting under the responsibility of

the Department< or

(c) any natural person duly designated for that purpose,

in the case of ancillary activities, which are also subject to

the Department’s control>

Provided that the persons mentioned under (b) and (c) above derive

no private gain from such measures<

“seed lot” means an identifiable consignment of seed of a

weight not exceeding that specified in Schedule IV, bearing a

unique reference number, in which the seed shall have been mixed

or blended so that, as far as is practicable, the seed lot shows no

evidence of heterogeneity<

“seed as grown” means seed as harvested, marketed for

processing, provided that the identity of the seed is ensured<

“small packages of fodder plants” refers to packages of seed

containing a net weight of not more than 10 kilograms of pre-

basic seed<

“small EC A packages of fodder plants” are packages

containing a mixture of seeds not intended for the production of

fodder plants with a net weight of not more than 2 kilograms,

excluding, where appropriate, granulated pesticides, pelleting

substances or other solid additives<

“small EC B packages of fodder plants” are packages which

may contain basic seed, certified seed, commercial seed or, if the

packages concerned are not small EC A packages, a mixture of

seed with a net weight not exceeding 10 kilograms excluding, where

appropriate, granulated pesticides, pelleting substances or other

solid additives<

“small EC packages of vegetables” refers to packages with

certified seed or standard seed up to a maximum net weight as

specified hereunder>

(a)

5 kilograms for legumes<

(b) 500 grams for asparagus, red beet or beetroot,

carrots, gourd, marrows, onions, radish, spinach, spinach beet

or chard, turnips and watermelons< and

(c)

100 grams for all other species of vegetables<

“vegetables” are plants of the genera and species listed in

Table 1.5 of Schedule I and intended for agricultural or horticultural

production but not for ornamental uses.

(2) The following definitions shall apply in respect of cereals>

“basic seed of hybrids of oats, barley, rye, wheat, durum wheat,

spelt wheat and self-pollinating triticale” means seed which -

(a)

is intended for the production of hybrids<

(b) subject to the provisions of regulation 16 hereof,

satisfies the conditions laid down in Schedules II and III for

basic seed< and

(c) has been found by official examination, to satisfy

the conditions mentioned above<

“basic seed of maize and sorghum species” refers to seed that -

1. basic seed of open-pollinated varieties refers to seed

which -

(a) has been produced under the responsibility of

the breeder according to accepted practices for the

maintenance of the variety<

(b) is intended for the production of certified seed

of the same varieties, top cross hybrids or of inter-varietal

hybrids<

(c) subject to the provisions of regulation 16,

satisfies the conditions laid down in Schedules II and III

for basic seed< and

(d) has been found by official examination, to

satisfy the above mentioned conditions<

2. basic seed of inbred lines refers to seed which -

(a) subject to the provisions of regulation 16,

satisfies the conditions laid down in Schedules II and III

for basic seed< and

(b) has been found to satisfy the above mentioned

conditions, by official examination.

3. basic seed of simple hybrids means seed that -

(a) is intended for the production of double

hybrids, triple cross or top cross hybrids<

(b) subject to the provisions of regulation 16,

satisfies the conditions laid down in Schedules II and

III< and

(c) has been found to satisfy the above mentioned

conditions, by official examination<

“basic seed of oats, barley, canary grass, rye, wheat, durum

wheat, spelt wheat and self-pollinating triticale, other than hybrids

in each case” refers to seed that -

(a) has been produced by or under the responsibility

of the breeder, according to accepted practices for the

maintenance of the variety<

(b) is intended for the production of certified seed,

certified seed of the first generation or certified seed of the

second generation<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for basic

seed, and

(d) has been found by official examination, to satisfy

the above mentioned conditions<

“certified seed of canary grass, other than hybrids, rye,

sorghum, sudan grass, maize and hybrids of oats, barley, wheat,

durum wheat, spelt wheat and self-pollinating triticale” refers to

seed which -

(a) has originated directly from basic seed or, if the

breeder so requests, from pre-basic seed which can satisfy

and has been found, by official examination, to satisfy the

conditions laid down in Schedules II and III for basic seed<

(b) is intended for purposes other than the production

of cereal seed<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for certified

seed< and

(d) has been found by official examination, to satisfy

the above mentioned conditions, or to satisfy the requirements

laid down in Schedule II, either by official examination or by

examination carried out under official supervision<

“certified seed of the first generation of oats, barley, wheat,

durum wheat, spelt wheat and self-pollinating triticale, other than

hybrids in each case” refers to seed which -

(a) has been produced directly from basic seed or, if

the breeder so requests, from pre-basic seed, which has been

found by official examination, to satisfy the conditions laid

in Schedules II and III, for basic seed<

(b) is intended either for the production of certified

seed of the second generation or for purposes other than the

production of cereal seed<

(c) satisfies the conditions laid down in Schedules II

and III, for certified seed of the first generation< and

(d) has been found by official examination, to satisfy

the above mentioned conditions, or to satisfy the requirements

laid down in Schedule II, either by official examination or by

examination carried out under official supervision<

“certified seed of the second generation of oats, barley, wheat,

durum wheat, spelt wheat and self-pollinating triticale, other than

hybrids in each case” means seed that -

(a) has been produced directly from basic seed, from

certified seed of the first generation, or if the breeder so

requests, from seed of a generation prior to basic seed which

has been found by official examination to satisfy conditions

laid down in Schedules II and III for basic seed<

(b) is intended for purposes other than the production

of cereal seed<

(c) satisfies the conditions laid down in Schedules II

and III for certified seed of the second generation< and

(d) has been found by official examination, to satisfy

the above mentioned conditions, or to satisfy the requirements

laid down in Schedule II, either by official examination or by

examination carried out under official supervision<

“pre-basic seed” means seed -

(a) of a generation earlier than that of basic seed and

has been produced by or under the responsibility of the

breeder< and

(b) which is intended for the production of basic seed

or, if the breeder so requests, certified seed, certified seed of

the first generation or certified seed of the second generation<

and

(c)

which satisfies the requirements for basic seed<

“varieties, hybrids and inbred lines of maize and sorghum

species” refer to -

(a) the open-pollinated variety which is a sufficiently

uniform and stable variety<

(b) the inbred line which is a sufficiently uniform and

stable line, obtained either by artificial self-fertilization

accompanied with selection over several successive

generations or by equivalent operations<

(c) the simple hybrid which refers to the first generation

of a cross, defined by the breeder, between two inbred lines<

(d) the double hybrid which is the first generation of a

cross, defined by the breeder, between two simple hybrids<

(e) the triple cross hybrid meaning the first generation

of a cross, defined by the breeder, between an inbred line and

a simple hybrid<

(f) the top cross hybrid being the first generation of a

cross, defined by the breeder, between either an inbred line

or a simple hybrid and an open-pollinated variety<

(g) the intervarietal hybrid which refers to the first

generation of a cross, defined by the breeder, between plants

grown from basic seed of two open-pollinated varieties,

defined by the breeder.

(3) The following definitions shall apply in respect of fodder

“basic seed of bred varieties” refers to seed which -

(a) has been produced under the responsibility of the

breeder according to accepted practices for the maintenance

of the variety<

(b) is intended for the production of certified seed<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for basic

seed< and

(d) has been found to satisfy the above mentioned

conditions by official examination<

“basic seed of local varieties” refers to seed that -

(a) has been produced under official control from

material officially accepted as being of the local variety on

one or more holdings situated within a clearly demarcated

region of origin<

(b) is intended for the production of certified seed<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for basic

seed< and

(d) has been found by official examination, to satisfy

the above mentioned conditions<

“certified seed of the first generation of Medicago sativa,

Pisum sativum, Vicia faba and Vicia sativa” means seed which -

(a) has been produced directly from basic seed, or if

the breeder so requests, from seed of a generation prior to

basic seed which has been found by official examination to

satisfy conditions laid in Schedules II and III for basic seed<

(b) is intended either for the production of certified

seed of the second generation or for purposes other than the

production of fodder plant seeds<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for certified

seed< and

(d) has been found to satisfy the above mentioned

conditions, by official examination<

“certified seed of the second generation of Medicago sativa,

Pisum sativum, Vicia faba and Vicia sativa” refers to seed which -

(a) has been produced directly from basic seed, from

certified seed of the first generation or, if the breeder so

requests, from seed of a generation prior to basic seed which

can satisfy and has been found by official examination to

satisfy conditions laid in Schedules II and III for basic seed<

(b) is intended for purposes other than the production

of seeds of fodder plants<

(c) subject to the provisions of regulation 16 regarding

seed as grown, satisfies the conditions laid down in Schedules

II and III for certified seed< and

(d) has been found by official examination, to satisfy

the above mentioned conditions<

“certified seed of all the species listed in Tables 1.2 and 1.3

of Schedule I other than Medicago sativa, Pisum sativum and Vicia

spp.”, refers to seed which -

(a) has been produced directly from basic seed, or if

the breeder so requests, from seed of a generation prior to

basic seed which has been found, by official examination, to

satisfy the conditions laid in Schedules II and III for basic

seed<

(b) is intended for purposes other than the production

of seed<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for certified

seed< and

(d) has been found by official examination, either to

satisfy the above mentioned conditions, or to satisfy the

requirements laid down in Schedule II, either by official

examination or by examination carried out under official

supervision<

“commercial seed” refers to seed which

(a)

is identifiable as belonging to a species<

(b) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedule III for commercial seed<

and

(c) has been found by official examination, to satisfy

the above mentioned conditions.

(4)

The following definitions shall apply in respect of

“basic seed potatoes” refers to potato tubers which -

(a) have been produced according to accepted practices

for the maintenance of the variety and of health<

(b) are intended mainly for the production of certified

seed potatoes<

(c) satisfy the minimum conditions laid down in

Schedules II and III for basic seed potatoes< and

(d) have been found by official examination, to satisfy

the minimum conditions mentioned above<

“certified seed potatoes” means potato tubers that -

(a) are of direct descent from basic seed, certified seed

or from seed of a generation prior to basic seed which have

been found by official examination, to satisfy the conditions

laid down in Schedules II and III for basic seed<

(b) are intended mainly for the production of potatoes

other than seed potatoes<

(c) satisfy the minimum conditions laid down in

Schedules II and III for certified seed potatoes< and

(d) have been found by official examination, to satisfy

the above minimum conditions<

“pre-basic seed potatoes” refers to potato tubers which

(a) have been produced in accordance with accepted

practices for the maintenance of the variety and of health<

(b)

are intended mainly for the production of basic

seed<

(c)

satisfy the minimum conditions for pre-basic seed<

and

(d) have been found by official examination, to satisfy

the minimum conditions referred to in point (c) of this

definition.

(5)

The following definitions shall apply in respect of

“basic seed” refers to seed which -

(a) has been produced under the responsibility of the

breeder according to accepted practices for the maintenance

of the variety<

(b) is intended for the production of certified seed<

(c) subject to the provisions of regulation 16, satisfies

the conditions laid down in Schedules II and III for basic

seed< and

(d) has been found by official examination, to satisfy

the above mentioned conditions<

“certified seed” means seed that -

(a) is produced directly from basic seed or, if the

breeder so requests, from pre-basic seed, which can satisfy

and has been found by official examination, to satisfy the

conditions laid down in Schedules II and III for basic seed<

(b) is intended mainly for the production of vegetables<

(c) subject to the provisions of regulation 16, satisfies

the conditions in Schedules II and III for certified seed<

(d) satisfies the afore mentioned conditions by official

examination< and

(e) is subject to official post-control examination by

check inspection to verify its varietal identity and varietal

purity<

“standard seed” means seed of vegetables which -

(a)

has sufficient varietal identity and varietal purity<

(b) is intended mainly for the production of vegetables<

(c)

satisfies the conditions laid down in Schedule III<

and

(d) is subject to official post-control examination by

check inspection to verify its varietal identity and varietal

purity.

No person shall produce, place on the market in Malta or Certification.

tranship through Malta prior to its transport to another Member State

any propagation material unless this has been certified by the Director

for any such purpose.

(1) Any person producing, placing on the market in Malta Notification.

or transhipping through Malta prior to its transport to another Member

State any propagation material shall notify the Director.

(2) A notice submitted in accordance with subregulation

(1) of this regulation shall be submitted on such form and in such manner

and within such time as the Director may form time to time by notice in

the Gazette, establish.

(1) Upon receipt of a notice in accordance with the General certification

procedure.

provisions of regulation 5 hereof, the Director shall ascertain that the

conditions for certification have been met and the Director shall issue

such a certificate only if the propagation material meets such conditions

or standards.

(2) Prior to certifying any propagation material in

accordance with subregulation (1) of this regulation, the Director or his

authorised representative shall inspect, collect and test such sample or

samples as may be required in order to establish that any provisions of

these regulations are satisfied.

(3) Any certificate issued in accordance with this regulation

shall only be valid for the propagation material for which the inspection,

sample and testing were carried out in accordance with subregulation

(2) hereof.

For cereals, fodder plants, potatoes and vegetables, only Listing of varieties.

varieties officially accepted by the Department may be marketed.

National catalogues of such varieties shall be established and such

catalogues may be consulted by any person.

(1) A variety may not verified as standard seed (in the case Conditions for

listing of varieties

of vegetable species), certified and marketed unless it is officially of agricultural

accepted. One or more catalogues of the varieties that are officially plants and vegetable

species.

accepted for certification, verification as standard seed and marketing

in Malta, must be established. In the case of vegetables, the catalogues

shall be subdivided according to the varieties>

(a) whose seed may be certified as either basic seed or

certified seed, or may be verified as standard seed, or

(b)

whose seed may not be verified except as standard seed.

(2) (a) A variety is accepted only if it is distinct, stable

and sufficiently uniform. In the case of a genetically-modified

variety, the deliberate release into the environment of the variety

shall be accepted only if all appropriate measures have been taken

to avoid adverse effects on human health and the environment. In

the case of agricultural plants and industrial chicory (vegetable),

the variety must be of satisfactory value for cultivation and use.

(b) A variety shall be regarded as distinct if, whatever the

origin (artificial or natural) of the initial variation from which it

has resulted, it is clearly distinguishable in one or more important

characteristics from any other variety known in the Community.

The characteristics must lead to a precise recognition and precise

definition. A variety known in the Community shall be any one

which, at the time when the application for its acceptance to be

assessed is duly made, is either listed in the Common Catalogue

of varieties of agricultural plants species or the Common Catalogue

of varieties of vegetable species, or if not listed in these Common

Catalogues, has been accepted or has been submitted for acceptance

in Malta, either for certification and marketing, or for certification

for other countries, or for verification as standard seed in the case

of vegetables, unless the afore mentioned conditions are no longer

fulfilled in all the Member States concerned before the decision

on the application for acceptance of the variety to be assessed, is

taken.

(c) A variety shall be regarded as stable if, after successive

propagation or multiplications or at the end of each cycle (where

the breeder has defined a particular cycle of propagation or

multiplications), it remains true to the description of its essential

characteristics.

(d) A variety shall be regarded as sufficiently uniform if,

apart from a very few aberrations, the plants of which it is composed

are, taking into account the distinctive features of the reproductive

systems of the plants, similar or genetically identical as regards

the characteristics taken as a whole, which are considered for this

purpose.

(3) (a) Examination of the value for cultivation and use

referred to in paragraph (2) (a) of this regulation shall not be

required for the acceptance of>

(i) varieties of grasses if the breeder declares that

the seeds of his variety are not intended for the production

of fodder plants. It may be decided to the extent that this

is justified in the interest of free circulation of seed, that

varieties have to be shown by appropriate examination

to be suitable for the purpose for which they are declared

to be intended to be used. In such cases, the conditions

for the examination shall be determined<

(ii) varieties whose seeds are to be marketed in

another Member State which has already accepted the

varieties, taking into consideration their value for

cultivation and use<

(iii) for the acceptance of varieties (inbred lines

and hybrids) which are intended solely as components

for hybrid varieties satisfying the requirements laid down

in paragraph (2)(a)>

Provided further that where material derived from a plant variety

is intended to be used as a food or food ingredient falling within the

scope of Regulation (EC) No. 258#97, these must not present a danger

for the consumer, mislead the consumer and differ from foods or food

ingredients which they are intended to replace to such an extent that

their normal consumption would be nutritionally disadvantageous for

the consumer.

(b) The value of a variety of agricultural plants for

cultivation or use shall be regarded as satisfactory if, compared to

other varieties accepted in the national catalogue, its qualities, taken

as a whole, offer, at least as far as production in any given region

is concerned, a clear improvement either for cultivation or as

regards the uses which can be made of the crops or the products

derived therefrom. Where other superior characteristics are present,

individual inferior characteristics may be disregarded.

(4) The acceptance of varieties shall be based on the results

of official examinations, particularly growing trials, covering a sufficient

number of characteristics for the variety to be described. The methods

used for determining characteristics must be accurate and reliable. It

shall be ensured that varieties coming from other Member States are

subject to the same requirements, in particular as regards the acceptance

procedure, as those that apply to local varieties.

(5) (a) In order to establish distinctness, the growing trials

shall include at least the available comparable varieties which are

known in the Community within the meaning of paragraph (2)(a)

hereof.

(b) For the purpose of applying subregulation (6) of this

regulation, other available comparable varieties shall be included.

In the case of vegetable varieties whose seed may not be verified

except as standard seed, the results of unofficial examinations and

knowledge gained from practical experience during cultivation may

be taken into consideration in relation to the results of an official

examination.

(c) It may be prescribed that, as from dates established

according to rules of the European Union, varieties of certain

vegetable species will no longer be accepted except on the basis of

official tests. Current scientific and technical knowledge on the

following matters shall be taken into account>

(i) the characteristics to be covered as a minimum by

the examinations of the various species<

(ii) the minimum requirements for carrying out the

examinations<

(iii) the necessary arrangements for the growing trials

to be carried out with a view to assessing the value for

cultivation or use in the case of agricultural plants.

(6) (a) Official publication of the national catalogues of

varieties accepted in Malta, shall be arranged and, where

maintenance breeding of the variety is required, the name of the

person or persons responsible for this in Malta, should be noted.

When several persons are responsible for the maintenance of a

variety, the names need not be published. Instead, the catalogue

shall indicate the authority holding the list of names of persons

responsible for the maintenance of the variety. At the time of

acceptance, the variety shall be known by the same name in all the

Member States. If it is known that seed or propagation material of

a variety is marketed in another country under a different name,

that name shall also be indicated in the catalogue. For each new

variety accepted in Malta, the other Member States and the

European Commission have to receive a brief description of the

most important character for use.

(7) (a) A special file on each accepted variety, containing a

description of the variety and a clear summary of all the facts on

which acceptance was based, shall be compiled. The varietal

descriptions shall apply for plants produced directly from>

(i) seeds and young plants of the category certified seed

and propagation material, in the case of agricultural plants<

and

(ii) certified seed or from standard seed, in the case of

vegetables.

(b) Acceptance files shall be made available for the personal

and exclusive use of any person including the other Member States

and the European Commission able to show a legitimate interest,

except information that is treated as confidential such as, results

of examination studies of the genealogical components of hybrids

and synthetic varieties.

(c) If and when genetically-modified varieties are accepted,

they should be clearly indicated as such in the catalogue of varieties.

It shall be ensured that any person marketing such a variety, clearly

indicates in his sales catalogue that the variety is genetically-

modified.

(d) In the case of varieties (inbred lines, hybrids) of

agricultural plants that are intended solely as components for final

varieties, the provisions of paragraph 7 apply only to the extent

that the seeds that belong to them are to be marketed under their

names. In the meantime, in the case of cereals other than maize,

these provisions may be applied to other component varieties in

respect of seed intended for certification in Malta. Component

varieties shall be indicated as such.

(8) (a) Acceptance of a variety shall be valid until the end

of the tenth calendar year following acceptance. It may be renewed at

given intervals if it still cultivated on such a scale as to justify this, or

should be retained in the interest of conserving plant genetic resources,

and providing that the requirements as to distinctness, uniformity and

stability, are still satisfied.

(b) For both agricultural plants and vegetables, applications

for renewal shall be submitted not later than two years before the

expiry of acceptance except for plant genetic resources. The period

of validity of acceptance shall be extended provisionally until a

decision is taken on the application for renewal.

(c) Accepted varieties must be maintained according to

accepted practices for the maintenance of the variety. It must at all

times be possible to check maintenance from the records kept by

the person or persons responsible for the variety. These records

shall also cover the production of all generations prior to basic

seed (of agricultural plants and vegetables) or propagation material

(of agricultural plants). Samples may be requested from the person

responsible for the variety. Such samples may if necessary be taken

officially.

(d) Where maintenance takes place in another Member

State, Malta and the other country shall assist each other

administratively as regards verification.

(9) (a) Any doubts which arise after the acceptance of a

variety concerning the appraisal of its distinctness or of its name at the

time of acceptance are clarified.

(b) Where, after acceptance of a variety, it is established

that the condition concerning distinctness within the meaning of

subregulation (2) of this regulation was not fulfilled at the time of

acceptance, acceptance shall be replaced by another decision or,

where appropriate, a revocation, which conforms with these

regulations. By this other decision, the variety shall, with effect

from the date of its initial acceptance, no longer be regarded as a

variety known in the Community within the meaning of paragraph

(2) (b). Where, after acceptance of a variety, it is established that

its name was not acceptable when the variety was accepted, the

name shall be adapted in such a way that it conforms with these

regulations. It may be permitted that the previous name may be

used temporarily as an additional name. The detailed arrangements

in accordance with which the previous name may be used as an

additional name shall be established according to the rules of the

European Union.

(10) (a) Acceptance of a variety is surely revoked if it is

proved, on examination, that the variety is no longer distinct, stable

or sufficiently uniform or, if the person or persons responsible for

the variety so request, unless maintenance of the variety is assured.

(b) Acceptance of a variety may be revoked if the laws,

regulations and administrative provisions adopted in this regulation

are not complied with and, if, at the time of the application for

acceptance or during examination, false or fraudulent particulars

were supplied concerning the facts on the basis of which acceptance

was granted.

(c) Where acceptance is refused or revoked, the results of

the examinations shall be made available to persons affected by

such a decision. It shall be ensured that a variety is deleted from

the catalogues if its acceptance has been revoked or if the period

of validity of acceptance has expired.

(11) A period of certification, verification as standard seed

(of vegetables) and marketing of seed (of agricultural plants and

vegetables) and propagation material (of agricultural plants), may be

allowed up to the 30th June of the third year at most after expiry of the

acceptance.

(12) Any application or withdrawal of an application for

acceptance of a variety, any entry in the catalogues of varieties as well

as any amendments thereto shall be notified forthwith to the other

Member States and the European Commission.

(1) Seed of the categories indicated below, may not be placed Seed certification.

on the market unless it has been officially certified as such>

(a)

In the case of agricultural plants -

(i) Cereals - basic or certified seed,

(ii) Fodder plants - as referred to in subregulation (2),

(iii) Potatoes - basic or certified seed,

and

(b) In the case of vegetables -

(i) Other than in the case of industrial chicory - basic,

certified or standard seed,

(ii) Industrial chicory - basic or certified seed.

(2) Seed of fodder kale, meadow fescue, red fescue, Italian

ryegrass, perennial ryegrass, lucerne, field pea and red clover may not

be placed on the market unless it has been officially certified as basic or

certified seed. Fodder plant seed of the genera and species other than

those mentioned above may not be placed on the market unless the

seed has been officially certified as basic or certified seed or is

commercial seed.

(1) When examination of cereal and fodder plant seeds is

carried out under official supervision, the following requirements shall

be complied with>

(a)

The inspectors of the seed company shall>

(i) have the necessary technical qualifications<

(ii) derive no private gain in connection with the

carrying out of the inspections<

(iii) have been officially licensed by the Seed

Certification Authority and this licensing shall include either

the oath of inspectors or the signature by inspectors of a written

statement of commitment to the rules governing official

examinations<

(iv) carry out inspections under official supervision in

accordance with the rules applicable to official inspections<

(b) The seed crop that is going to be inspected, shall be

grown from seed which has undergone official post-control, the

results of which have been satisfactory<

(c) A proportion of seed shall be checked by official

inspectors. That proportion shall be 10% for self-pollinated crops

and 20% for cross-pollinated crops or, for those species which the

Department provides for official laboratory seed testing using

morphological, physiological or, where appropriate, biochemical

procedures to identify the variety and establish purity, 5 and 15%

respectively<

(d) A proportion of samples from the seed lots harvested

from the seed crops shall be drawn for official post-control tests

and where, appropriate, for official laboratory seed testing in respect

of varietal identity and purity<

(e) Infringements of the rules governing examination under

official supervision will be regulated under regulations 29 and 30

of the Act. The penalties must be effective, proportionate and

dissuasive. The recognition of officially licensed inspectors as

referred to in sub-paragraph (a)(iii) hereof who are found guilty of

deliberately or negligently contravening the rules governing official

examinations, shall be withdrawn. Any certification of seed that

has been examined shall be annulled in the event of such

contravention unless it has been shown that such seed still meets

all relevant requirements.

(2)

The Director can establish further implementing

measures for the examination under official supervision.

Official seed examinations should be carried out in Seed examination.

accordance with current international methods, in so far as such methods

exist.

(1) Sampling carried out must be carried out officially in Sampling of seeds.

accordance with appropriate methods. This applies to the following>

(a) checking of varieties (cereals and fodder plants) and

inbred lines of maize (cereals)<

(b) examination of commercial seed (fodder plants)<

(c) examination of seed for certification (cereals, fodder

plants, potatoes and vegetables)< and

(d) post-control tests of standard seed (vegetables).

(2)

For the examination of seed for certification,

examination of commercial seed and post-control tests, samples shall

be drawn from homogeneous lots. The maximum weight of a lot and

the minimum weight of a sample are given in Schedule IV to these

regulations.

(1) If it is repeatedly found, during post-control tests carried Post-control tests.

out in the field, that vegetable seed of any one variety does not adequately

satisfy the conditions laid down in respect of varietal identity and purity,

the Department shall ensure that the person marketing it, is wholly or

partially forbidden to market such seed (where appropriate, for a

specified period). Any measures taken shall be withdrawn as soon as it

has been established with adequate certainty, that the seed intended for

marketing will in the future satisfy the conditions as to varietal identity

and varietal purity.

(2) Seed of the categories certified seed and standard seed

is subject to official post-control in the field by inspection to compare

their varietal identity and purity against standard controls.

(1) Packages or containers containing basic and certified Packaging of seeds.

seed of cereals, fodder plants, potatoes and vegetables, and commercial

seed of fodder plants, except small packages of basic and certified

vegetable seeds and, in the case of fodder plants small EC B packages

of certified and commercial seed, be sealed officially or under official

supervision in such a manner that they cannot be opened without

damaging the sealing system or leaving evidence of tampering on either

the official label or on the package. In order to ensure closure, the sealing

system shall comprise at least either the official label or the affixing of

an official seal. This measure will not be necessary if a non-reusable

sealing system is used. The Department may establish exceptions to

this subregulation as it may deem fit in the case of small packages sealed

in Malta of cereal and potato seeds, EC B packages of fodder plant

seeds. In the case of vegetable seeds, there may be determined exceptions

to this subregulation and subregulation (2) for small packages of basic

vegetable seed.

(2) Packages containing seeds of agricultural plants and

vegetables, except small EC B packages of fodder plant seeds, shall not

be resealed on one or more occasions unless this is carried out officially

or under official supervision. If packages are re-sealed, the fact of

resealing and the most recent date of re-sealing and the authority

responsible for resealing, shall be stated on the label required under

regulation 15.

(3) Packages of standard vegetable seed, small packages of

certified vegetable seed, and small EC B packages of fodder plant seeds,

shall be sealed (not necessarily officially or under official supervision)

in such a manner that they cannot be opened without damaging the

sealing system or without leaving evidence of tampering on the label or

the package. Packages of standard vegetable seed shall also bear a lead

or an equivalent sealing device attached by the person responsible for

attaching labels.

(4) In the case of small packages of certified seed of fodder

plants and vegetables, packages shall not be sealed on one or more

occasions under official supervision. All necessary measures shall be

taken to ensure that in the case of small packages of certified vegetable

seed and small packages of fodder plant seeds, the identity of the seed

can be verified in particular at the time when seed lots are divided. At

this stage, it may be required that small packages divided or produced

in Malta, be sealed officially or under official supervision.

(1) The packages of all seed categories referred to in

regulation 9 hereof, excluding standard vegetable seed, small packages

of basic and certified vegetable seed and small EC B packages of certified

and commercial seed of fodder plants, shall have affixed on the outside,

an official label that has not been previously used, and as appropriate to

the seed, with the particulars as specified in Schedule V hereof, in

Maltese or in English. The information should be printed indelibly on

the label. Delible printing is not authorised. The dimensions and colour

of the label are specified in the same Schedule. The labels on packages

containing vegetable seeds may be placed inside transparent packages

provided it can be read. The labels must be adhesive and made from

tear-resistant material. When a label with a string-hole is used, its

attachment to the package shall be ensured in all cases with an official

seal. The use of official adhesive labels shall be authorised. The indelible

printing of the prescribed particulars on the package in accordance with

the label models may be authorised under official supervision. If in

cases under regulation 16, the seed of the categories listed below does

not satisfy the conditions laid down in Schedule III in respect of

germination, this fact shall be stated on the label>

(a)

for agricultural plants -

cereals - basic or maize seed<

fodder plants - basic and certified seed< and

(b) for vegetables - basic seed.

The Department may establish exceptions to the provisions

of subregulation (1) hereof in the case of small packages of vegetables

sealed in Malta.

(2) When a non-adhesive label is used, the package shall

contain an official document in the same colour as the official label

giving at least the information mentioned below>

(a)

for agricultural plants -

(i) cereals (basic and certified seed) -

- reference number of lot,

- species and variety.

(ii) fodder plants (basic, certified and commercial seed

except small EC B packages of certified and commercial seed) -

- reference number of lot,

- species and variety,

In the case of commercial seed, reference number of lot,

species and the words “Commercial seed” should be written down.

(iii) potatoes (basic and certified seed)

- producer’s identity number or reference number

of lot,

- month and year of sealing,

- country of production.

(b) Vegetables (basic and certified seed except small

packages)

- reference number of lot,

- species and variety,

- category.

This document shall be drawn up in such a manner that it

cannot be confused with the official label referred to under subregulation

(1). This document is not necessary if the information is printed indelibly

on the package or if, in accordance with the provisions under

subregulation (1), an adhesive label, a label of tear-resistant material or

a label inside a transparent package, is used. Packages should also include

the producer’s identification particulars.

(3) (a) In cases other than those provided for in these

regulations, packages or containers of basic and certified seed of

agricultural plants and vegetables, commercial seed of fodder plants

and standard vegetable seed shall bear a supplier’s label which may be

either a label separate from the official label or take the form of the

supplier’s information as stated in Schedule V printed on the package

or container itself. In the case of cereals, seed lots have to comply with

the provisions referred to in regulation 29 concerning the presence of

Avena fatua and an official certificate attesting compliance with these

conditions has to be issued.

(b) Small EC B packages of fodder plant seeds, packages

of standard vegetable seed and small packets of certified vegetable

seed shall bear on the outside a supplier’s label or a printed or

stamped notice in Maltese or English, except for small packages

of standard seed in which case the information stated under this

provision shall be clearly separate from any information given on

the label or the package. In the case of transparent packages, this

label may be placed inside, provided it can be read through the

package.

(c) In the case of small EC B packages of fodder plant seeds,

the packages can also bear an officially assigned serial number on

the outside or on the supplier’s label. Should an official, adhesive

label be used, the particulars to be written on the label are indicated

in Schedule V. This serial number shall not be required for small

EC A packages of fodder plant seeds.

(4) It shall be ensured that persons responsible for affixing

the labels on packages containing standard vegetable seed intended for

marketing>

(a) inform the authorities of the dates when their activities

begin and end<

(b) keep records of all lots of standard seed and make them

available to the country for not less than three years<

(c) make available for not less than two years, a control

sample of seed of varieties for which maintenance is required< and

(d) draw samples from each lot intended for marketing and

make them available for not less than two years.

The operations referred to in subregulations (2) and (4) shall

be subject to official checks carried out on a random basis. The obligation

stated in subregulation (3), shall apply only to producers.

(1) For the purpose of making seed of cereals, fodder plants Provisional

certification.

and vegetables rapidly available, not withstanding the fact that the

official examination to check compliance with the conditions laid down

in Schedule III in respect of germination has not been concluded, the

official certification or approval (the latter applying for fodder plants

only) and marketing as far as the first purchaser by way of trade of the

categories basic seed or certified seed of cereals, fodder plants and

vegetables, or commercial seed in the case of fodder plants, may be

authorised.

(2) Certification or approval shall be granted only on

prescription of a provisional analytical report on the seeds and provided

that the name and address of the first recipient are given. All necessary

measures shall be taken to ensure that the supplier guarantees the

germination ascertained at the provisional analysis, this germination

shall be stated for marketing purposes on a special label bearing the

name and address of the supplier and reference number of the lot. The

above provisions shall not apply to seeds imported from third countries.

(1) Seeds of the categories indicated in regulation 9 shall Marketing of seeds.

be marketed in sufficiently homogeneous lots and in sealed packages

or containers with appropriate labelling as described in regulation 15.

The packages must be new and the containers must be clean.

(2) Seed as grown of cereals, fodder plants and vegetables

may be marketed for processing, provided that the identity of the seed

is ensured.

(3) Bred seed of generations prior to basic seed of

agricultural plants and vegetables, may also be placed on the market.

The conditions under which bred seed of generations prior to basic seed

may be placed on the market, shall be as follows>

(a) it shall have been officially inspected by the competent

certification authority in accordance with the provisions applicable

to the certification of basic seed<

(b) it shall be packed in packages or containers as described

in these regulations< and

(c) the packages shall bear an official label giving the

particulars as shown in Schedule V for pre-basic seed.

(1) Mixtures of seeds of various species of cereals can be

marketed, provided that the components of which complied, before

mixing, with the marketing rules applicable to them. Specific cereal

mixtures of seeds of various varieties but belonging to the same species

can be marketed, provided that scientific or technical knowledge

indicates that these mixtures are such as to be particularly effective

against the propagation of certain harmful organisms and provided also

that the components of the mixtures comply, before mixing, with the

marketing rules applicable to them.

(2) Producers may be authorised to place on the market small

packages of mixtures of standard vegetable seed of different varieties

of the same species. The species, where this provision applies, the rules

for the maximum size of the small packages and the requirements for

labelling shall be established.

(3) Mixtures of various genera, species or varieties of fodder

plants may be placed on the market if they are intended for use>

(a) not as fodder plants, in which case the mixtures may

contain seeds of fodder plants listed in Tables 1.2 and 1.3 of

Schedule I and so covered by these regulations<

(b) as fodder plants, in which case the mixture may contain

seeds of plant species listed in Tables 1.1, 1.3 or 1.5 of Schedule I,

with the exception of varieties of grasses listed in Table 1.2 of the

same Schedule which are not intended for the production as fodder

plants< or

(c) in the preservation of the natural environment in the

context of the conservation of genetic resources in which case the

mixtures may contain seeds of fodder plant species and seeds of

other plant species within the meaning of these regulations.

Regulations 14, 15, 17 (1) and (4) and 20 shall apply for the

above seed mixtures. For this purpose, small EC A packages of fodder

plant seeds shall be considered as small EC B packages.

In the case of seeds of a variety that have been genetically- Genetically-

modified, any label or document, official or otherwise, which is affixed modified seeds.

to or accompanies the seed lot, shall clearly indicate that the variety has

been genetically-modified.

(1) If any seeds of the categories mentioned in regulation Chemically-treated

seeds.

9, have been subjected to any chemical treatment, this fact and the nature

of the treatment or the proprietary name of the chemical substance used

in the treatment, shall be stated either on the official or supplier’s label,

or on the package or container, or in a statement enclosed in the package

or container.

(2) In the case of small packages of vegetables, this

information may be printed directly on the package or inside it.

The Director may authorise local producers or breeders to Seed

purposes.

place on the market small but appropriate quantities of seeds for scientific

purposes or selection work and, for other test or trial purposes, provided

that the seeds belong to varieties for which an application for entry in

the national catalogues has been submitted and, in the case of vegetable

seeds, specific technical information has been submitted. In case of

genetically-modified seeds, such authorisation should be granted only

if all appropriate measures have been taken to avoid adverse effects on

human health and the environment in accordance with Directive

2001#18#EC of the European Parliament and of the Council of the 12th

March, 2001.

(1) In order to remove any temporary difficulties, which Less

requirements.

cannot be overcome, in the general supply of seed of the categories

mentioned in regulation 9, the Department may be authorised to permit

for a specified period, the marketing in quantities necessary to resolve

the supply difficulties of seed of a category subject to less stringent

requirements, or of seed of a variety not included in the Common

Catalogues of varieties of agricultural plant and vegetable species or in

the national catalogues of varieties. For a category of seed of any given

variety, the official or supplier’s label shall be that provided for the

corresponding category. For seeds of varieties not included in the above

mentioned catalogues, the colour of the official label shall be brown.

The label shall always state that the seed in question, is of a category

satisfying less stringent requirements.

(2) The Department may authorise the official certification

and marketing of basic seed of cereals, fodder plants and vegetables

except seed potatoes, which does not satisfy the conditions laid down

in Schedule III in respect of germination. A similar authorisation may

be granted in respect of certified seed of Trifolium pratense where such

seed is intended for the further production of other certified seed. In

such cases, all necessary measures shall be taken to ensure that the

supplier guarantees a specific germination that he shall state for

marketing purposes on a special label bearing his name and address

and the reference number of seed lot.

The Department may as regards the conditions laid down in

Schedules II and III, impose additional or more stringent requirements

for the certification of seeds of agricultural plants and vegetables

produced in Malta and also for the examination of commercial seed of

fodder plants produced in Malta.

Seeds placed on the market under the provisions of the

European Union directives, whether mandatory or discretionary, shall

not be subject to any marketing restrictions as regards their

characteristics, examination requirements, marking and sealing, other

than those laid down in the directives.

Seeds harvested in another country may upon request be

certified in Malta on the condition that the crop has been inspected by

the competent authorities in that country and have been found to comply

with the provisions of these regulations.

Seeds coming from authorised third countries must afford

the same assurances as seeds originating from the Community with

respect to their characteristics and the arrangements for their inspection,

for ensuring identity, for marketing and for control. In such case, the

seeds shall be equivalent in these respects to seeds harvested within the

Community and complying with the provisions of these regulations.

For purposes of certification, the maximum moisture content

for basic and certified seed of cereals (except maize) shall be 13% by

weight. That for maize shall be 14%. The Director may alter the

maximum moisture content as the need be.

Unless otherwise specified, seed of the hybrids listed in Table

1.1 of Schedule I shall be subject to the standards or other conditions

applicable to seed of each of the species from which they are derived.

The official certificate referred to in paragraph 15 (3)(a) of

these regulations shall be issued in the following case>

the crop shall be free from Avena fatua at the time of field

inspection officially carried out in conformity with the provisions

of Schedule II and if a sample of at least 1 kilogram is drawn in

accordance with established procedures, no seeds of Avena fatua

should be found at the time of official examination.

For seed potatoes produced by micropropagation techniques Seed potatoes

produced by

and which do not meet the size requirements of these regulations, the micropropagation.

Director may determine the following according to the rules of the

European Union>

(a) derogation from specific provisions of these regulations<

and

(b) the conditions and designations applicable to such seed

potatoes.

For plant health reasons, seed potatoes produced in Malta Separation

potatoes from other

may be separated during production from other potatoes. This potatoes.

requirement may include measures for the separation of the production

of seed potatoes and other potatoes, and the separation of the grading,

storage, transportation and handling of seed potatoes and other potatoes.

Seed potatoes may not be marketed unless they have a Size

of seed potatoes and

minimum size such that they do not pass through a square mesh of tubers.

25mm x 25mm. In the case of potato tubers which are too large to pass

through a square mesh of 35mm x 35mm, the upper and lower size

limits shall be expressed in multiples of 5. The maximum variation in

size between tubers in a lot shall be such that the difference between

the dimensions of the two square meshes used does not exceed 25mm.

These sizing standards may be modified in accordance with the rules of

the European Union. A lot shall not contain more than 3% by weight of

tubers smaller than the minimum size indicated or, more than 3% by

weight of tubers larger than the maximum size indicated.

Seed potatoes may not be placed on the market if they have Treatment of seed

potatoes with sprout

been treated with sprout inhibitors.

inhibitors.

(1) Seed potatoes that do not, during marketing, satisfy the Grading of seed

minimum conditions laid down in Schedule III may be sorted. The tubers potatoes.

that are not rejected shall then undergo a further official examination.

(2) Basic seeds are subdivided into Community grades (EC

1, EC 2 and EC 3) satisfying different requirements as specified in

Schedules II and III. Certified seed may also be subdivided into grades.

The conditions and designations applicable to such grades are determined

according to the rules of the European Union.

The Department shall ensure that official inspections and Official inspections

testing of seeds are carried out. These shall be performed in relation to and testing.

the marketing of seeds of cereals, fodder plants, potatoes and vegetables,

at least by random checks to verify compliance with the requirements

and conditions of these regulations.

In the interest of conserving plant genetic resources, the

Department may depart from the criteria laid down in paragraph (2) (a)

of regulation 8. Therefore, specific conditions may be established that

take into account developments in relation to the conservation in situ

and the sustainable use of plant genetic resources through growing and

marketing of seed of landraces and varieties which are naturally adapted

to the local and regional conditions and threatened by genetic erosion.

These conditions shall include in particular the following points>

(a) landraces and varieties shall be accepted in accordance

with the provisions of these regulations. In the case of agricultural

plants, the procedure of official acceptance shall take into account

specific quality characteristics and requirements. In particular, the

results of unofficial tests and knowledge gained from practical

experience during cultivation, reproduction and use and the detailed

descriptions of the varieties and their relevant denominations shall

be taken into account and, if sufficient, shall result in exemption

from the requirement of official examination. Upon acceptance of

a landrace or variety, it shall be indicated as a conservation variety

in the Common Catalogues.

(b) appropriate quantitative restrictions.

For the purpose of seeking improved alternatives to certain

provisions set out in these regulations, temporary experiments other

than those related to plant health, may be organised under specified

conditions at Community level, the duration of which shall not exceed

seven years. In the context of such experiments, the Department may

be released from certain obligations laid down in these regulations. The

extent of that release shall be defined with reference to the provisions

to which it applies.