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Plant Quarantine Act (Cap. 433) Seeds Of Vegetable Landraces And Varieties Regulations, 2011 (L.N. 22 Of 2011 )

PLANT QUARANTINE ACT (CAP. 433)Seeds of Vegetable Landraces and Varieties Regulations, 2011

IN exercise of the powers conferred by article 32 of the Plant Quarantine Act, the Minister for Resources and Rural Affairs after consulting the Plant Health Directorate has made the following regulations:-

Vegetable Landraces and Varieties Regulations, 2011.
(2) The scope of these regulations is to transpose C o m m i s s i o n D i r e c t i v e 2 0 0 9 / 1 4 5 / E C p r o v i d i n g f o r c e r t a i n derogations for the acceptance for inclusion of vegetable landraces and varieties in national catalogues of varieties of vegetable species as provided for in the Seeds of Agricultural Plants and Vegetables Regulations, 2010 to ensure the sustainable use of such plant genetic resources through growing. Such derogation shall apply to the following:
(a) vegetable landraces and varieties which have been traditionally grown in particular localities and regions hereinafter referred to as “conservation in situ” and are threatened by genetic erosion hereinafter referred to as “conservation varieties”; and
(b) vegetable varieties with no intrinsic value for commercial crop production but solely developed for growing under particular pedological or agro-technical conditions hereinafter referred to as “varieties developed for growing under particular conditions”,
a n d c o n s e q u e n t l y f o r m a r k e t i n g o f s e e d s o f s u c h vegetable landraces and varieties.
(3) These regulations shall be deemed to have come into force on the 31st December, 2010.

Title, scope and commencement.

L.N. 331 of 2010

.

B 382

Interpretation. Cap. 433.

(2) For the purpose of these regulations and unless the
context otherwise requires, the following definitions shall apply:
“the Act” means the Plant Quarantine Act;
“the applicant” means any person, farmer or breeder who submits an application to the Directorate whereby he may be granted an authorisation in accordance with these regulations;
“authorisation” means any permit, licence, decision or concession granted by the Directorate to the applicant in terms of these regulations;
“certified seed” shall have the same meaning as that provided for under the Seeds of Agricultural Plants and Vegetables Regulations, 2010;
“co n s er v atio n in s itu ” means th e co n s er vatio n o f genetic material in its natural surroundings and, in the case of cultivated plant species, in the farmed environment where they have developed their distinctive properties;
“conservation varieties” means vegetable landraces and varieties which have been traditionally grown in particular localities and regions and are threatened by genetic erosion;
“the Commission” means the European Commission; “the Community” means the European Community as
established by the Treaty of the European Union;
“the Directorate” means the directorate responsible for plant health;
“genetic erosion” means the loss of genetic diversity between and within populations or varieties of the same species over time, or reduction of the genetic basis of a species due to human intervention or environmental change;

“landrace” means a set of populations or clones of a plant species which are naturally adapted to the environmental conditions of their region;
“Member State” means a state which is a member of the
European Union;
“person” means any natural or legal person;
“ s t a n d a r d s e e d ” s h a l l h a v e t h e s a m e m e a n i n g a s that provided under the Seeds of Agricultural Plants and Vegetables Regulations, 2010.
“varieties developed for growing under particular conditions” means varieties with no intrinsic value for commercial crop production but solely developed for growing under particular pedological or agro-technical conditions.

(2) Such varieties shall be accepted:
(a) as a variety the seeds of which may either be certified as “certified seed of a conservation variety” or verified as “standard seed of a conservation variety”. Such a variety shall enter the Common Catalogue of varieties of vegetable species as a “conservation variety the seeds of which shall be certified in accordance with regulation 11 of these regulations or verified in accordance with regulation 12 of these regulations”;
(b) as a variety the seeds of which may only be verified as “standard seed of a conservation variety”. Such a variety shall enter the Common Catalogue of varieties of vegetable species as a “conservation variety the seeds of which shall be verified in accordance with regulation 12 of these regulations”.
B 383

Applicability.

Acceptance

for inclusion of conservation varieties in national catalogues.

B 384

Substantive requirements for acceptance of a landrace or variety as a

conservation variety.

LN 87 of 2007.

Procedural requirements for the acceptance

of conservation varieties.

(2) The Directorate may adopt its own provisions as regards distinctness, stability and uniformity of conservation varieties by way of derogation from paragraphs (a) and (b) of sub-regulation (1) of regulation 3 of the Examination of Varieties of Vegetable Species Regulations, 2007. In such cases, the Directorate shall ensure that for the purpose of distinctness and stability, at least the characteristics referred to in the following shall apply:
(a) the technical questionnaires associated with the test protocols of the Community Plant Variety Office (CPVO) listed in Schedule I to the Examination of Varieties of Vegetable Species Regulations, 2007, which apply to those species; or
(b) the technical questionnaires of the guidelines of the International Union for the Protection of New Varieties of Plants (UPOV) listed in Schedule II to the Examination of Varieties of Vegetable Species Regulations, 2007, which apply to those species.
(3) The provisions contained under the Examination of Varieties of Vegetable Species Regulations, 2007 shall apply with regard to the assessment of uniformity. However, if the uniformity level is established on the basis of off-types, a population standard of 10% and an acceptance probability of at least 90 % shall apply.

(a) the description of the conservation variety and its denomination;
(b) the results of unofficial tests;

(c) knowledge gained from practical experience during cultivation, reproduction and use, as notified by the applicant to the Directorate;
(d) other information in particular that obtained from the plant genetic resources authorities or from other organisations or entities recognised as such by the Directorate.

(a) it is already listed in the Common Catalogue of varieties of vegetable species as a variety other than a conservation variety; or
(b) it was deleted from such catalogue during the years
2008 to 2010 or within the two years immediately following the expiry period of the acceptance granted under sub- regulation (11) of regulation 6 of the Seeds of Agricultural Plants and Vegetables Regulations, 2010; or
(c) it is protected by a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 on Community plant variety rights or by a national plant variety right, or where an application for such a right is pending.

(2) Notwithstanding sub-regulation (6) of regulation
6 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010 providing that a variety shall be known by the same name in all Member States at the time of acceptance, the Directorate may accept more than one name for a variety if the names concerned are historically known.

B 385

Exception to the acceptance of a conservation variety.

Denominations of conservation varieties.

Region of origin of conservation varieties.

B 386

Maintenance of conservation varieties.

Certification of seeds.

Verification of seeds of a conservation variety.

identified, and hereinafter these shall be referred to as the “region of origin”. Information available from plant genetic resources authorities or from other organisations or entities recognised as such shall be taken into account. If the region of origin is located in Malta and in other Member States, it shall be identified by all Member States concerned by means of a common accord.
(2) The Directorate or the other competent authorities of other Member States, as the case may be, identifying the region of origin shall notify such identification to the Commission.

provided for in sub-regulations (1) of regulation 7 and regulation
9 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010, the Directorate may provide that the seed of a conservation variety may be certified as certified seed of a conservation variety if it meets the following requirements:
(a) the seed originates from seeds produced according t o w e l l d e fi n e d p r a c t i c e s f o r t h e m a i n t e n a n c e o f t h e conservation variety;
(b) the seed shall comply with the requirements for certification of certified seed provided for in sub-regulation (5) of regulation 3 of the Seeds of Agricultural Plants and Vegetables Regulations, 2010 except with the requirements in respect of minimum varietal purity and the requirements concerning official examination or examination under official supervision; and
(c) the seed shall have sufficient varietal purity.

provided for in sub-regulation (1) of regulation 7and regulation
9 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010, the Directorate may provide that seeds of a conservation variety be verified as standard seeds of a conservation variety if it meets the following requirements:
(a) the seed shall comply with the requirements for the marketing of “standard seed” provided for in the Seeds of Agricultural Plants and Vegetables Regulations, 2010

other than those requirements set out in respect of minimum varietal purity; and
(b) the seed shall have sufficient varietal purity.

(2) The tests referred to in sub-regulation (1) hereof shall be carried out in accordance with current international methods, or in the absence of such, in accordance with any appropriate methods.
(3) Samples taken for the tests referred to in sub- regulation (1) hereof shall be drawn from homogeneous lots. The rules on lot weight and sample weight provided for in Schedule IV to the Seeds of Agricultural Plants and Vegetables Regulations,
2010 shall be applied.

(2) The Directorate shall notify the Commission and the other Member States on the additional regions which it intends to approve for seed production pursuant to sub-regulation (1) hereof.

marketed if the following conditions are satisfied:
(a) they shall have been produced in their region of origin or in a region referred to in regulation 14 of these regulations; and
(b) marketing shall take place in their region of origin.
B 387

Seed testing

of a conservation variety.

Region of seed production of a conservation variety.

Marketing of seeds.

B 388

Quantitative restrictions for conservation varieties.

Application

of quantitative restrictions.

Sealing of packages of conservation varieties.

(2) By way of derogation from sub-regulation (1)(b) hereof, additional regions may be approved by the Directorate in Malta for the marketing of seeds of a conservation variety provided that those regions are comparable to the region of origin as regards the natural and semi-natural habitats of such variety. If the Directorate approves such additional regions, it shall ensure that the amount of seed necessary for the production of at least the quantity of seed referred to in regulation 16 hereof is reserved to conserve the variety in its region of origin. The Directorate shall inform the Commission and the other Member States of the approval of such additional regions.
(3) If the Directorate approves additional regions for seed production in accordance with regulation 14 hereof, it shall not use the derogation provided for in sub-regulation (2) of this regulation.

(2) If, based on the notifications referred to in sub- regulation (1) hereof, the quantities referred to in regulation 16 of these regulations are likely to be exceeded, the Directorate shall allocate to each producer concerned the quantity which may be marketed in the respective production season.

(2) Seed packages shall be sealed by the supplier in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering with the supplier’s label, or with the package.
(3) In order to ensure sealing in accordance with sub- regulation (2) hereof, the sealing system shall at least include the label or the affixing of a seal.

(a) the words “EC rules and standards”;
(b) the name and address of the person responsible for
affixing the labels or the identification mark of such person;
(c) the year of sealing expressed as: “sealed in (year)”, or the year of the last sampling taken for the purposes of the last testing of germination expressed as: “sampled in (year)”;
(d) the species;
(e) the denomination of the conservation variety;
(f) the words “certified seed of a conservation variety”
or “standard seed of a conservation variety”; (g) the region of origin;
(h) where the region of seed production is different from the region of origin, the indication of the region of seed production;
(i) the reference number of the lot given by the
person responsible for affixing the labels;
(j) the declared net or gross weight, or declared number of seeds; and
(k) where the weight is indicated, and granulated pesticides, pelleting substances or other solid additives are used, the nature of the chemical treatment or additive and the approximate ratio between the weight of clusters or pure seeds and the total weight.

(2) T he offic i a l post c ont rol re fe rre d t o i n sub-
regulation (1) hereof shall be carried out in accordance with current
B 389

Labelling of packages of conservation varieties.

Official post control for conservation varieties.

B 390

Monitoring of conservation varieties.

Acceptance of varieties developed for growing under particular conditions.

Substantive requirements for the acceptance of a variety developed for growing under

particular conditions.

international methods, or, in the absence of such, in accordance with any appropriate methods.

(2) A variety developed for growing under particular conditions shall be accepted as a variety the seeds of which may only be verified as “standard seed of a variety developed for growing under particular conditions”. Such a variety shall be entered into the Common Catalogue of varieties of vegetable species as a “variety developed for growing under particular conditions the seeds of which shall be verified in accordance with regulation 27 of these regulations”.

(2) A variety shall be considered as having been developed for growing under particular conditions if it has been developed for growing under particular agro-technical, climatic or pedological conditions.
(3) The Directorate may adopt its own provisions as regards distinctness, stability and uniformity of varieties developed for growing under particular conditions by way of derogation from sub-regulation (1) (a) and (b) of regulation 3 of the Examination of Varieties of Vegetable Species Regulations, 2007. In such cases, the Directorate shall ensure that for the determination of distinctness and stability, at least the characteristics referred to in the following shall apply:
(a) the technical questionnaires associated with the
test protocols of the Community Plant Variety Office (CPVO)

listed in Schedule I to the Examination of Varieties of Vegetable Species Regulations, 2007, which apply to those species, or
(b) the technical questionnaires of the guidelines of the International Union for the Protection of New Varieties of Plants (UPOV) listed in Schedule II to the Examination of Varieties of Vegetable Species Regulations, 2007, which apply to those species.
(4) For the assessment of uniformity, the provisions of the Examination of Varieties of Vegetable Species Regulations,
2007 shall apply. However, if the uniformity level is established on the basis of off-types, a population standard of 10% and an acceptance probability of at least 90 % shall be applied.

6 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010, no official examination shall be required if a decision is taken by the Directorate regarding the acceptance of varieties developed for growing under particular conditions based on the following information:
(a) the description of the variety developed for growing under particular conditions and its denomination;
(b) the results of unofficial tests;
(c) knowledge gained from practical experience during cultivation, reproduction and use, as notified by the applicant to the Directorate concerned;
(d) other information in particular that obtained from the plant genetic resources authorities or from other organisations or entities recognised as such by the Directorate.

(a) it is already listed in the Common Catalogue of varieties of vegetable species as a variety other than a variety developed for growing under particular conditions; or
B 391

Procedural requirements of varieties developed for growing under particular conditions.

Exception to the acceptance

of varieties developed for growing under particular conditions.

B 392

Denominations

of varieties developed for growing under particular conditions.

Verification

of seeds of varieties developed for growing under particular conditions.

(b) it was deleted from such catalogue during the years
2008 to 2010 or within the two years immediately following the expiry period of the acceptance granted under sub- regulation (11) of regulation 6 of the Seeds of Agricultural Plants and Vegetables Regulations, 2010; or
(c) it is protected by a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 on Community plant variety rights or by a national plant variety right, or an application for such a right is pending.

(2) Notwithstanding sub-regulation (6) of regulation
6 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010 providing that a variety shall be known by the same name in all Member States at the time of acceptance, the Directorate may accept more than one name for a variety if the names concerned are historically known.

provided for in sub-regulation (1) of regulation 7 and regulation
9 of the Seeds of Agricultural Plants and Vegetables Regulations,
2010, the Directorate may provide that seed of a variety developed for growing under particular conditions be verified as standard seed of a variety developed for growing under particular conditions if it meets the following requirements:
(a) the seed shall comply with the requirements for the marketing of “standard seed” provided for in the Seeds of Agricultural Plants and Vegetables Regulations, 2010 other than those requirements set out in respect of minimum varietal purity; and
(b) the seed shall have sufficient varietal purity.

(2) The tests referred to in sub-regulation (1) hereof shall be carried out in accordance with current international methods, or in the absence of such, in accordance with any appropriate methods.

(2) Seed packages shall be sealed by the supplier in such a manner that they cannot be opened without damaging the sealing system or leaving evidence of tampering with the supplier’s label, or with the package.
(3) In order to ensure sealing in accordance with sub- regulation (2) hereof, the sealing system shall at least include the label or the affixing of a seal.

(a) the words “EC rules and standards”;
(b) the name and address of the person responsible for
affixing the labels or the identification mark of such person;
(c) the year of sealing expressed as: “sealed in (year)”, or the year of the last sampling taken for the purposes of the last testing of germination expressed as: “sampled in (year)”;
(d) the species;
(e) the denomination of the variety;
B 393

Seed testing

of varieties developed for growing under particular conditions.

Quantitative restrictions

for varieties developed for growing under particular conditions.

Sealing of packages

of varieties developed for growing under particular conditions.

Labeling of packages of varieties developed for growing under particular conditions.

B 394

Official post control of varieties developed for growing under particular conditions.

Monitoring of varieties developed for growing under particular conditions.

(f) the words “variety developed for growing under particular conditions”;
(g) the reference number of the lot given by the person
responsible for affixing the labels;
(h) the declared net or gross weight, or declared number of seeds; and
(i) where the weight is indicated, and granulated pesticides, pelleting substances or other solid additives are used, the nature of the chemical treatment or additive and the approximate ratio between the weight of clusters or pure seeds and the total weight.

(2) The official post control referred to in sub-regulation (1) hereof shall be carried out in accordance with current international methods, or in the absence of such, in accordance with any appropriate methods.

B 395

Schedule I

Regulation 16

Quantitative restrictions for the marketing of seed of conservation varieties

B 396

B 397

Schedule II

Regulation 29

Maximum net weight per package

B 398