S.L. 433.30 Art. 6Conditions for listing of varieties of agricultural plants and vegetable species.

(1) A variety of seeds of agricultural plants and vegetables cannot be certified and marketed unless it is officially accepted according to the following provisions of this regulation. One or more catalogues of all varieties that are officially accepted for certification, verification as standard seed (in the case of vegetable seeds) and marketing in Malta, must be established. In the case of vegetables, the catalogues shall be subdivided according to the varieties:

(a) the seeds of which may be certified as either basic seed or certified seed, or may be verified as standard seed; or

(b) the seeds of which 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, is clearly distinguishable in one or more important characteristics from any other variety known in the European Union. The characteristics must lead to a precise recognition and precise definition. A variety known in the European Union 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 EU Common Catalogue of varieties of agricultural plant species or the EU 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 or in another EU Member State, 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 EU 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 sub-regulation (2)(a) 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 the seeds of which are to be marketed in another EU 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 sub-regulation (2)(a);

Provided 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 EU 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 European Union within the meaning of sub-regulation (2)(a).

(b) For the purpose of applying sub-regulation (6), 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) 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 EU 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 EU 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 those of other EU Member States and the European Commission who are able to show a legitimate interest. Information that is treated as confidential such as results of examination studies of the genealogical components of hybrids and synthetic varieties shall not be exchanged apart from exceptional cases.

(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 this sub-regulation 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 EU 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 sub-regulation (2) 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 European Union within the meaning of sub-regulation (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 EU Member States and the European Commission.