L.S. 433.34 Regolamenti dwar Plant Quarantine (National Certification Scheme) Regulations

(1)The scope of these regulations is to make provision with regards to certification in order to: Scope. (

1. a)regulate the production, marketing and control of propagation material of vegetables (excluding seeds), vines and ornamental plants; and (
2. b)improve the sanitary and the pomological qualities of propagation material of vegetables (excluding seeds), vines and ornamental plants and other reproductive vegetative species.

(2)In the implementation of these regulations, the provisions of the following regulations shall also be taken into account: (

1. a)Plant Regulations; Organisms) S.L. 433.03. (
2. b)Vegetable Propagation and Planting Material Regulations; S.L. 433.13. (
3. c)Quarantine (Harmful Propagation Material of Vines Regulations; and (
4. d)Propagation Regulations. Material of Ornamental S.L. 433.15. Plants S.L. 433.31. 3. For the purpose of these regulations, the following definitions shall apply: Definitions. "the Act" means the Plant Quarantine Act; Cap. 433. "the Directorate" means the Directorate or Department responsible for plant health. 4.

(1)There shall be a national certification authority which shall be responsible for regulating the certification process at national level. The Directorate is hereby being established as the national certification authority.

(2)The tasks of the authority shall be: (

1. a)to establish guidelines for the certification of the Establishment of the National Certification Authority. 1 2 PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 various vegetatively-propagated species which are then made publicly available; (
2. b)to formulate the technical protocols for each species or group of species which are then made publicly available; (
3. c)to define the necessary schedules for the certification processes; (
4. d)to receive a n d a p p r o v e the requests received from establishments to be recognised as centres for conservation, pre-multiplication and multiplication; (
5. e)to monitor the whole process of certification at national level; (
6. f)to verify that the propagated variety admitted for certification has already been included in the National Catalogue of Certified Varieties; and (
7. g)to make the necessary arrangements for propagation material from the repositories, foundation blocks, mother blocks or in vitro laboratories located abroad to be brought to Malta; (
8. h)to consult with the Plant Protection Board referred to in article 4 of the Act on paragraphs (a), (
9. b)and (
10. c)above. Inspections and controls. 5.

(1)The inspections and the controls during the certification phases shall be carried out by the Directorate.

(2)The Directorate shall be responsible for the verification of: (

1. a)the suitability of the facilities and the plots employed for growing mother plants and for the production of certified material, according to the technical protocols established for each species or group of species; (
2. b)the sanitary status of the mother plants and propagation material during each certification phase according to the technical protocols established for each species or group of species; and (
3. c)true-to-type controls of the mother plants during each certification phase according to the technical protocols set up by the Directorate as established for each species or group of species.

(3)The activities referred to in sub-regulation

(2)may be carried out in collaboration with other scientific institutions. PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 6. Certification shall be organised in accordance with the following phases: (

1. a)conservation for pre-multiplication; (
2. b)pre-multiplication; and (
3. c)multiplication. 7. Propagation material (seeds, buds, bulbs, cuttings, rhizomes, root-stocks, in vitro cultures, etc.) at different stages of development, grafted trees and self-rooted plants shall be classified into the following categories: 3 Certification phases. Classification of propagation material. (
4. a)primary source, that is, the material of origin produced by the breeder and kept by the breeder or by the successor of such breeder; (
5. b)pre-basic material produced from the first multiplication of the primary source and grown in the repository. At least two mother plants must be maintained for each variety; (
6. c)basic, that is, material produced from the first multiplication of pre-basic material. The material is grown in the foundation block and used for the establishment of mother blocks. At least two specimens shall be kept for each variety; and (
7. d)certified, that is, material produced from the first multiplication of the basic material from mother blocks to be utilised for the commercial production of certified material. At least two specimens shall be maintained for each variety. 8.

(1)The acquisition of the primary source involves the pomological and sanitary selection and, if necessary, the sanitation of ecotypes of Maltese cultivars or those grown in the country for a long period of time. These activities are carried out by the national scientific institutions. Foreign scientific institutions may also collaborate, if necessary, upon approval of the Directorate.

(2)For the registration procedure, the breeder must: (

1. a)keep the primary source under appropriate conditions so that the material remains healthy; (
2. b)submit to application form with: the Directorate the appropriate (
3. i)an authentic copy of the plant variety right in the case of protected varieties; (
4. ii)a data sheet of the varietal characteristics; Primary source and registration. 4 PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 (iii) documents regarding the health status with respect to the diseases indicated in the technical protocols for the relevant species or group of species; (
5. iv)in the case of unprotected varieties, a declaration stating that the variety can be multiplied freely; and (
6. v)in case the registration is accepted, the breeder shall provide two specimens of the primary source to the centre of conservation for pre-multiplication (repository).

(3)The primary sources submitted for certification shall be reported in the National Catalogue of Certified Varieties.

(4)In the case of new cultivars and, or selections, the breeder must declare, under his responsibility, the origin of the material, for such breeder to be authorised to introduce such material in the various phases of certification. Conservation for pre-multiplication: functions, material and location. 9.

(1)The phase of conservation for pre-multiplication shall be carried out in the repository. It can be either governmental, or if privately owned, it shall be recognised by the Directorate.

(2)The phase of conservation for pre-multiplication consists of: (

1. a)the conservation of at least two specimens of the primary source under healthy conditions; and (
2. b)the production in vivo and, or in vitro of prebasic material under healthy conditions.

(3)In order to be recognised by the Directorate, the repository must: (

1. a)submit to the Directorate application for the recognition of the centre; an appropriate (
2. b)have adequate facilities for the conservation of the pre-basic material according to the technical protocols established for every species or group of species; and (
3. c)have a responsible person qualifications and the necessary skills.

(4)with appropriate The pre-basic propagation material must undergo: (

1. a)sanitary controls by the Directorate according to the technical protocols issued for every species or group of species; and PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 5 (
2. b)true-to-type controls by the Directorate according to the technical protocols established for every species or group of species.

(5)Grafted or self-rooted plants will be certified as prebasic plants after they have taken root and have been inspected.

(6)The pre-basic material may originate from repositories located abroad upon the approval of the Directorate. 10.

(1)The pre-multiplication phase is carried out in a foundation block. This can be either governmental or, if privately owned, it has to be recognised by the Directorate.

(2)The pre-multiplication phase consists of: (

1. a)the conservation of plants of the basic category according to the technical protocols concerning each species or group of species; and (
2. b)the production in vivo and, or in vitro of plants of the basic category by grafting or self-rooting according to the technical protocols established for each species or group of species.

(3)To be recognised by the Directorate, the pre-multiplication centre must: (

1. a)submit to the Directorate application for the recognition of the centre; an appropriate (
2. b)have adequate facilities for the conservation of prebasic material according to the technical protocols established for every species or group of species; and (
3. c)have a responsible person with appropriate qualifications and having the necessary skills.

(4)The pre-basic plants will be certified after verifying that grafted plants or self-rooted plants have taken root.

(5)The basic material may originate from foundation blocks located abroad upon the approval of the Directorate.

(6)In particular cases, upon the approval of the Directorate, plants produced directly from the primary source can be used to establish the foundation block. In this case, the breeder must submit a document regarding the origin of the plants to the Directorate.

(7)To satisfy certain particular necessities, in vitro propagation or other rapid propagation techniques may be applied to speed up the propagation of the basic material, upon the approval of the Pre-multiplication: functions, material and location. 6 PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 Directorate and according to the technical protocols established for every species or group of species. Multiplication: functions, material and location. 11.

(1)The multiplication phase is carried out in the multiplication centres which include mother blocks or in vitro laboratories and nurseries. These can be either governmental, or if privately owned, these have to be recognised by the Directorate.

(2)The multiplication phase consists of: (

1. a)growing of certified mother plants in compliance with the technical protocols established for each species or group of species; (
2. b)in vitro multiplication of certified material in compliance with the technical rules for each species or group of species; and (
3. c)the production of propagation material which has been certified.

(3)The mother blocks and the in vitro laboratories must meet the requirements included in the technical protocols established for each species or group of species.

(4)To be approved by the Directorate, the multiplication centre shall: (

1. a)submit to the Directorate application for the recognition of the centre; an appropriate (
2. b)have plots and facilities in compliance with the protocols for each plant species or group of species; and (
3. c)have a responsible person qualifications and the necessary skills. with appropriate

(5)To satisfy certain particular necessities, in vitro propagation or other rapid propagation techniques may be applied to speed up the propagation of the basic material, upon the approval of the Directorate and according to the technical protocols established for every species or group of species.

(6)In particular cases, upon the approval of the Directorate, plants produced directly from the primary source or from pre-basic plants can be used to establish the foundation block. In the first case, the breeder must submit a document regarding the origin of the plants to the Directorate. Nursery activity. 12.

(1)The phase concerning nursery activity is carried out under the responsibility of the nurserymen. PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 7

(2)It consists of the production of plant material (root-stocks, grafted plants, self-rooted plants, etc.) which has been certified and is in compliance with the protocols for each plant species or group of species.

(3)The plants (grafted or self-rooted) that are present at the nurseries will be certified after they have taken root and after fulfilling the conditions of certification during inspections. The Directorate will then release the official certificates in terms of regulation 15. 13. For the categories referred in regulation 7, two sanitary statuses are envisaged: Sanitary status of the propagation material. (

1. a)virus-free (v.f.) shall refer to material free from all viruses, viroids, phytoplasmas and systemic pathogens known at the moment of the official publication of the protocols concerning the certification of virus-free material; and (
2. b)virus-tested (v.t.) shall refer to material free from certain serious viruses, viroids, phytoplasmas and systemic pathogens specifically mentioned in the certification protocols and stated in the official certificates in terms of regulation 15: Provided that in the case of plants grafted with plant material of a different health status, the final product shall be certified as the lowest state, that is, virus-tested. 14.

(1)Propagation material shall be certified for the persons or their representatives authorised to operate a nursery, in compliance with the laws in force, where they declare that they utilise the multiplied plant material offered by the Directorate, in accordance with the requirements specified in the technical protocols for each species or group of species.

(2)The certified plants that are free from harmful organisms indicated in the Plant Quarantine (Harmful Organisms) Regulations and that are in conformity with the regulations referred to in regulation 2

(2), shall be accompanied by official certificates in terms of regulation 15. Certification of propagation material in the nursery. S.L. 433.03.

(3)The institutions and facilities referred to in these regulations shall undergo inspections by the Directorate and shall be requested to supply to the latter all the necessary information and documentation for the verification of the proper conduct of their activities. 15. With respect to the rules concerning certification, official certificates in the form of labels as approved by the Directorate have to accompany the certified propagation material. Official certificates. 16.

(1)In derogation to these regulations, plant material from any Member State may be submitted to the national certification Transitory rules. 8 PLANT QUARANTINE (NATIONAL CERTIFICATION SCHEME) [ S.L. 433.34 scheme.

(2)The propagation material should be introduced in the following circumstances: (

1. a)the rapid activation of the certification system in Malta; (
2. b)the inclusion of new cultivars in the Maltese certification system; and (
3. c)the counteraction to particular necessities that might arise within the context of the certification system.

(3)The introduction of propagation material shall be permitted from time to time upon the advice of the Directorate.

(4)Alternatively, propagation material produced from mother plants derived from propagation material obtained from a certification system of another Member State may be certified accordingly.

(5)The establishments, to be recognised, must undergo checks according to the protocols of certification of the respective Member State on the advice of the Directorate.