S.I. No. 306/2001 - European Communities (Vegetable Seeds) Regulations, 2001

I, Joe Walsh, Minister for Agriculture, Food and Rural Development in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), for the purpose of giving effect to Council Directive No. 70/458/EEC of 29 September, 1970⁽¹⁾ , as amended by Council Directive No. 71/162/EEC of 30 March, 1971⁽²⁾ , Council Directive No. 72/274/EEC of 20 July, 1972⁽³⁾ , Council Directive No. 72/418/EEC of 6 December, 1972⁽⁴⁾ , Act of Accession⁽⁵⁾ , Council Decision of 1 January, 1973⁽⁶⁾ , Council Directive No. 73/438/EEC of 11 December, 1973⁽⁷⁾ , Council Directive No. 76/307/EEC of 15 March, 1976⁽⁸⁾ , Council Directive No. 78/55/EEC of 19 December, 1977⁽⁹⁾ , Council Directive No. 78/692/EEC of 25 July, 1978⁽¹⁰⁾ , Commission Directive No. 79/641/EEC of 27 June, 1979⁽¹¹⁾ , Council Directive No. 79/692/EEC of 24 July, 1979⁽¹²⁾ , Council Directive No. 79/967/EEC of 12 November, 1979⁽¹³⁾ , Council Directive No. 80/1141/EEC of 8 December, 1980⁽¹⁴⁾ , Commission Directive No. 87/120/EEC of 14 January, 1987⁽¹⁵⁾ , Commission Directive No. 87/481/EEC of 9 September, 1987⁽¹⁶⁾ , Council Directive No. 88/380/EEC of 13 June, 1988⁽¹⁷⁾ , Commission Directive No. 89/14/EEC of 15 December, 1988⁽¹⁸⁾ , Commission Directive 96/18/EC of 19 March 1996⁽¹⁹⁾ , Council Directive 96/72/EC of 18 November 1996⁽²⁰⁾ , Council Directive 98/95/EC of 14 December 1998⁽²¹⁾ , insofar as they relate to vegetable seeds, hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Vegetable Seeds) Regulations, 2001 and shall come into operation on the _____ day of June 2001.

2. (1) In these Regulations -

“Annex I” means Annex I to Council Directive No. 70/458/EEC, as amended by Commission Directive 87/120/EEC, by Commission Directive 87/481/EEC, by Council Directive 88/380/EEC, by Commission Directive 89/14/EEC, which Annex is contained in the Schedule hereto;

“Annex II” means Annex II to Council Directive No. 70/458/EEC, as amended by Commission Directive 87/120/EEC, by Council Directive 88/380/EEC, which Annex is contained in the Schedule hereto;

“Annex III” means Annex III to Council Directive No. 70/458/EEC, as amended by Commission Directive 87/120/EEC, by Council Directive 88/380/EEC, by Commission Directive 96/18/EEC, which Annex is contained in the Schedule hereto;

“Annex IV” means Annex IV to Council Directive No. 70/458/EEC, as amended by Council Directive 88/380/EEC, by Council Directive 96/72/EC, which Annex is contained in the Schedule hereto;

“Annex V” means Annex V to Council Directive No. 70/458/EEC, as inserted by Council Directive 88/380/EEC, which Annex is contained in the Schedule hereto;

“authorised officer” means an officer of the Minister authorised in writing by the Minister for the purposes of these Regulations;

“Commission” means the Commission of the European Communities;

“basic seed” means seed of varieties of vegetables 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 Regulation 7 of these Regulations, satisfies the conditions laid down in Annex I and Annex II for basic seed and

(d)  has been found on official examination to have been so produced, to be so intended and to have satisfied the said conditions;

“certified seed” means seed of vegetables which

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

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

(c)  subject to Regulation 7 of these Regulations, satisfies the conditions laid down in Annex I and Annex II for certified seed,

(d)  has been found on official examination to have been so produced, to be so intended and to have satisfied the said conditions, and

(e)  is subject to official post control by check inspection to verify the varietal identity and varietal purity;

“Common Catalogue” means the Common Catalogue of Varieties of Vegetable species published from time to time by the Commission of the European Communities in the Official Journal of the European Communities;

“the directive” means Council Directive No. 70/458/EEC of 29 September 1970⁽¹⁾ , as amended by Council Directive No. 71/162/EEC of 30 March, 1971⁽²⁾ , Council Directive No. 72/274/EEC of 20 July, 1972⁽³⁾ , Council Directive No. 72/418/EEC of 6 December, 1972⁽⁴⁾ , Act of Accession⁽⁵⁾ , Council Decision of 1 January, 1973⁽⁶⁾ , Council Directive No. 73/438/EEC of 11 December, 1973⁽⁷⁾ , Council Directive No. 76/307/EEC of 15 March, 1976⁽⁸⁾ , Council Directive No. 78/55/EEC of 19 December, 1977⁽⁹⁾ , Council Directive No. 78/692/EEC of 25 July, 1978⁽¹⁰⁾ , Commission Directive No. 79/641/EEC of 27 June, 1979⁽¹¹⁾ Council Directive No. 79/692/EEC of 24 July, 1979⁽¹²⁾ , Council Directive No. 79/967/EEC of 12 November, 1979⁽¹³⁾ ,

Council Directive No. 80/1141/EEC of 8 December, 1980⁽¹⁾ Commission Directive No. 87/120/EEC of 14 January, 1987⁽²⁾ Commission Directive No. 87/481/EEC of 9 September, 1987⁽³⁾ Council Directive No. 88/380/EEC of 13 June, 1988⁽⁴⁾ , Commission Directive No. 89/14/EEC of 15 December, 1988⁽⁵⁾ , Commission Directive 96/18/EC of 19 March 1996⁽⁶⁾ , Council Directive 96/72/EC of 18 November 1996⁽⁷⁾ ;

“Member State” means a Member State of the European Communities:

“the Minister” means the Minister for Agriculture, Food and Rural Development;

“national catalogue” means the National Catalogue of Vegetable Varieties;

“official” other than in the expression “official authority” or “official language”, refers to any work or measure carried out or taken by an official authority in connection with such work:

“official authority” means the authority officially designated by a Member State to carry out the work in connection with the certification, examination, sampling or closing of vegetable seed, or any other work or measure relevant to the provisions of the directive or these Regulations, or any similar authority in a third country;

“pre-basic seed” means vegetable seed of generations prior to basic 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 pre-basic seed, basic seed or certified seed.

(c)  subject to Regulation 7 of these Regulations, satisfies the conditions laid down in Annex I and Annex II for basic seed, and

(d)  has been found on official examination to have been so produced, to be so intended and to have satisfied the said conditions;

“small packages” means packages containing seed up to a maximum net weight of:

(a)  5 kg. in case the package contains seed of legumes,

(b)  500g. in case the package contains seed of any one of the following, namely, onions, red beet or beetroot, turnips, marrows, carrots, radish or spinach,

(c)  100g. in case the package contains the seed of any other species of vegetable;

“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 Annex II and

(d)  is subject to official post-control by check inspection to verify its varietal identity and varietal purity;

“statute” has the same meaning as in section 3 of the Interpretation Act, 1937 (No. 38 of 1937);

“third country” means a country or territory which is not a Member State;

“vegetable” means plants of the following species intended for agricultural or horticultural production but not for ornamental uses:

(2)  A word or expression that is used in these Regulations and is also used in the directive has, unless the contrary intention appears, the meaning in these Regulations that it has in the directive.

(3)  In these Regulations, unless otherwise indicated -

(a)  a reference to a Regulation is to a Regulation of these Regulations,

(b)  a reference to a Schedule is to a Schedule to these Regulations,

(c)  a reference to a paragraph is to the paragraph of the Regulation in which the reference occurs.

3. These Regulations shall apply to the production with a view to marketing, and to the marketing, of vegetable seed within the Community.

For the purposes of these Regulations, “marketing” shall mean 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.

Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:

-     the supply of seed to official testing and inspection bodies,

-     the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.

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 the provider of services does not acquire title to either the seed thus supplied or the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.

The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 40 of Council Directive 70/458/EEC of 29 September 1970,⁽¹⁾

4. The Minister, or any person or body authorised by the Minister for the purpose, shall be the official authority for the State for the purposes of these Regulations and of the directive.

5.  (1) Notwithstanding Regulation 23 of these Regulations, the catalogue which immediately before the commencement of that Regulation was being maintained by the Minister under Regulation 3 of the European Communities (Vegetable Seeds) Regulations, 1973 ( S.I. No. 173 of 1973 ), shall continue in being and shall continue to be maintained by the Minister but shall henceforth be known as the National Catalogue of Vegetable Varieties (which catalogue is in these Regulations referred to as “National Catalogue”).

(2)(a)  A variety may be accepted in the National Catalogue only if it is distinct, stable and sufficiently uniform. In the case of industrial chicory, the variety must be of satisfactory value for cultivation and use.

(b)  In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Council Directive 90/220EEC of 23 April 1990⁽¹⁾ , on the deliberate release into the environment of genetically modified organisms, the variety shall be accepted in the National Catalogue only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.

An environmental risk assessment equivalent to that laid down in Directive 90/220/EEC shall be carried out.

The procedures ensuring that the environmental risk assessment and other relevant elements shall be equivalent to those laid down in Directive 90/220/EEC shall be introduced on an proposal from the Commission, in a Council Regulation based on the appropriate legal basis in the Treaty. The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedures laid down in Article 40 of Directive 70/458/EEC of 29 September, 1970⁽²⁾ . Until this Regulation enters into force genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for marketing in accordance with Directive 90/220/EEC.

Genetically modified varieties which have been accepted will be clearly indicated as such in the National Catalogue of varieties.

(c)  However, 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 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients⁽¹⁾ : these foods or food ingredients must not:

-     present a danger for the consumer,

-     mislead the consumer,

-    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.

A variety intended to be used for the purpose laid down in this paragraph may be accepted only if:

-     the food or the food ingredient has already been authorised pursuant to Regulation (EC) No 258/97, or

-     the authorisation decisions referred to in Regulation(EC) No 258/97 are taken in accordance With the procedure provided for in Article 40 of Directive 70/458/EEC of 29 September 1970⁽²⁾ .

The technical and scientific details of the implementation shall be adopted in accordance with the procedure laid down in Article 40 of Directive 70/458/EEC of 29 September 1970⁽²⁾ . The criteria set out in Article 4(5) of Directive 70/458/EEC of 29 September 1970 and the assessment principles laid down in Regulation(EC) No 258/97 shall be taken into account.

(d)  In the interest of conserving plant genetic resources as specified in Article 39(a)(2)(a) and (2)(b) of Council Directive 70/458/EEC of 29 September 1970, the Member States may depart from the acceptance criteria set out in Paragraph (a) in so far as specific conditions are established in accordance with the procedure laid down in Article 40 of Council Directive 70/458/EEC of 29 September 1970⁽²⁾ considering the requirements of Article 39(a)(3)(i) and 3(ii) of that Directive.

(3)(a)  There shall be registered in the National Catalogue such particulars with respect to the varieties therein registered as the Minister considers proper (including, in relation to each variety, particulars with respect to a person accepting responsibility for maintenance of the variety),

(b)  the National Catalogue shall be subdivided in accordance with the requirements of Article 3(2) of the directive.

(4) Registration of a variety in the Common Catalogue or in the Catalogue of a Member State corresponding to the National Catalogue shall be regarded as being equivalent to registration of the variety in the National Catalogue if, but only if, the Minister gives a direction under this paragraph as regards the variety.

(5) Where a variety is registered in the National Catalogue, the person registered as responsible for the maintenance for conservation of that variety shall -

(a)  allow an authorised officer to examine the production of the variety for conservation and all records relating to such production including examination with respect to generations preceding basic seed,

(b)  supply to an authorised officer, or allow an authorised officer to take, samples of the variety.

(6) Acceptance of a variety for inclusion in the National Catalogue and revocation of such an acceptance and deletion of such variety from that Catalogue shall be effected by the Minister in accordance with the directive.

(7) The Minister shall from time to time publish the National Catalogue.

(8) Acceptance of a variety may be renewed at given intervals if it is 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, or the criteria determined under Article 39(a)(3) and (4), of Council Directive 70/458/EEC of 29 September 1970⁽¹⁾ are still satisfied. Except in the case of plant genetic resources within the meaning of Article 39(a), of Council Directive 70/458/EEC of 29 September 1970 of applications for renewal shall be submitted not later than two years before expiry of acceptance.

6.  (1) Subject to Regulation 7 of these Regulations and to paragraph (2) of this Regulation, vegetable seed shall not be placed on the market unless -

(a)  the seed is a variety which is

(i)  a variety registered in the National Catalogue, or

(ii)  a variety registered in the Common Catalogue and as regards which there is not in that catalogue an entry indicating that a prohibition on the marketing of the variety in the State has been authorised and is in force.

(b)  it has been officially certified as pre-basic seed, basic seed or certified seed or is standard seed,

(bb)  in case the seed is harvested in a third country, its characteristics and the arrangements for its examination, for ensuring identity, for marking and for control is equivalent to those of and for basic seed, certified seed or standard seed harvested within the community and complying with Council Directive No. 70/458/EEC of 29 September 1970⁽¹⁾

(c)  it satisfies the conditions laid down in Annex II,

(d)  the seed is in sufficiently homogeneous lots and in packages

complying with the requirements of these Regulations, and

(e)  any person marketing GMO varieties must indicate in his/her sales catalogue that the variety is genetically modified

(2)  The requirements of paragraph (1) of this Regulation shall not apply to the following vegetable seed, namely:

(a)  small quantities of seed intended for tests or scientific purposes.

(b)  small quantities of seed intended for selection work,

(c)  seed which has not been processed and which is marketed for processing and as regards which the official authority is satisfied that appropriate measures have been taken to ensure the identity of the seed.

(d)  bred seed of generations prior to basic seed

(i)  provided it has been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;

(ii)  packed in accordance with this Directive; and

(iii)  labelled in accordance with Paragraph 10(4).

(e)  The Minister may subject to conditions set down by the Commission authorise breeders and their Representatives established in their territory to market, for a limited period, seed belonging to a variety for which an application for inclusion in a national catalogue has been submitted in at least one Member State and for which specific technical information has been submitted.

(f)  The Minister may authorise their own producers to place on the market, small packages of mixtures of standard 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 by the EU Commission.

6A (1) Vegetable seed -

(a) which has been produced directly from basic seed or certified seed officially certified either in one or more Member States or in a third country which has been granted equivalence in accordance with Article 32(1)(d) of Council Directive No. 70/458/EEC of 29 September 1970⁽¹⁾ , or which has been produced directly from the crossing of basic seed officially certified in a Member State with basic seed officially certified in such a third country, and

(b) which has been harvested in another Member State,

shall, on request, be officially certified as certified seed if it has undergone field inspection satisfying the conditions laid down in Annex I for the relevant category and official examination has shown that the conditions laid down in Annex II of the same category are satisfied, and where in such cases vegetable seed has been produced directly from officially certified seed of pre-basic seed, it shall be officially certified as basic seed if the conditions laid down for the species concerned are satisfied.

(2)      Vegetable seed which has been harvested in another Member State and which is intended for certification in Accordance with the provisions laid down in paragraph 1 shall -

(a)  be packed and labelled with an official label satisfying the conditions laid down in paragraphs (A) and (B) of Annex V, in accordance with the provisions laid down in Regulation 10, and

(b)  be accompanied by an official document satisfying the conditions laid down in paragraph (C) of Annex V.

(3)  Vegetable seed -

(a) which has been produced directly from basic seed officially certified either in one or more Member States or in a third country to which Article 32(1)(d) of Council Directive No. 70/458/EEC of 29 September 1970⁽¹⁾ , applies or which has been produced directly from the crossing of basic seed officially certified in such a third country, and

(b) which has been harvested in a third country

shall, on request, be officially certified as certified seed if the seed has undergone field inspection satisfying the conditions laid down in an equivalence decision made under Article 32(1)(a) of Council Directive No. 70/458/EEC of 29 September 1970⁽¹⁾ , for the relevant category, and if official examination has shown that the conditions laid down in Annex II for the same category are satisfied.

7 (1). The Minister may where the Commission makes a decision in that regard, set down specific conditions to take account of developments:

(a) under which chemically treated seed may be marketed;

(b) under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;

(c) under which seed suitable for organic production may be marketed.

(2). The specific conditions referred to in paragraph 1 shall include in particular the following points:

(i)    in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;

(ii)    in the case of (b), appropriate quantitative restrictions.

8 (1). Subject to Regulation 15 of these Regulations the Minister may authorise the certification and marketing of pre-basic seed and basic seed which does not satisfy the conditions laid down in Annex II in respect of germination; provided that the supplier of the seed guarantees a specific germination for the seed which guaranteed germination shall be shown on a special label giving the name and address of the supplier and the reference number of the relevant lot of seed.

(2)(a) Subject to Regulation 15 of these Regulations and to sub paragraph (b) of this paragraph, the Minister may, where the official examination in respect of germination pursuant to Annex II has not concluded, authorise the official certification of basic seed or certified seed, and the marketing of those categories of seed by way of trade as far as the first buyer.

(b) The powers conferred on the Minister by subparagraph (a) of this paragraph shall be exercised by the Minister subject to the following conditions:

(i)      a provisional analytical report on the seed, which should include the germination of the seed, shall be sent to the official authority by the supplier of the seed,

(ii)      the name and address of the first buyer shall be given to the official authority by such supplier,

(iii)     the supplier of the seed shall guarantee the germination ascertained at the provisional analysis,

(iv)     the germination so guaranteed shall be stated on a special label bearing the name and address of such supplier and the reference number of the relevant lot of seed.

(3) The Minister may for such period as he shall specify authorise the marketing of seed of a variety which is not registered in the National Catalogue but which is registered in a catalogue of a Member State which corresponds to the National Catalogue.

(4) The Minister may, where the Commission makes a decision in that regard, authorise the marketing, for a period specified in the decision, of seed of a category specified in the decision subject to less stringent requirements than those of these Regulations for pre-basic seed, basic seed, certified seed or standard seed, or of seed of varieties included neither in the Common Catalogue nor in the National Catalogues of the Member States.

(5) The foregoing provisions of this Regulation, other than paragraph (4), shall not apply to seed imported from a third country unless such seed has been produced directly from basic seed certified as such in the State.

(6) The Minister may, upon application which shall be dealt with as provided for in Article 40 or in Article 40(a) of Directive 70/458/EEC of 29 September 1970 in the case of genetically modified varieties, be authorised to prohibit the use of the variety in all or in part of its territory or to lay down appropriate conditions for cultivating the variety in accordance, in cases provided for in paragraph (b), with the conditions for using the products resulting from such cultivation:

(a)  where it is established that the cultivation of the variety could be harmful from the point of view of plant health to the cultivation of other varieties or species; or

(b)  where it has valid reasons other than those already mentioned or which may have been mentioned during the procedure referred to in Article 11(2) of Commission Directive 70/458/EEC of 29 September 1970⁽¹⁾ for Considering that the variety presents a risk for human health or the environment';

(7) If it is established that the cultivation of a variety included in the common catalogue of varieties could in any Member State be harmful from the point of view of plant health to the cultivation of other varieties or species, or present a risk for the environment or for human health, that Member State may upon application, be authorised in accordance with the procedure laid down in Article 40 or in Article 40(a) of Commission Directive 70/458/EEC of 29 September 1970, in the case of a genetically modified variety to prohibit the marketing of the seed or propagating material of that variety in all or part of its territory. Where there is imminent danger of the spread of harmful organisms or imminent danger for human health or for the environment, that prohibition may be imposed by the Member State concerned as soon as its application has been lodged until such time as a final decision has been taken. That decision shall be taken within a period of three months in accordance with the procedure laid down in Article 40 or in Article 40(a) in the case of genetically modified variety.

9. (1) Packages of basic seed, and packages of certified seed, which, in either case, are not made up in the form of small packages, shall be closed, either officially or under official supervision, in such a manner that they cannot be opened without either damaging the closing system or leaving evidence of tampering either on the official label provided in pursuance of Regulation 10 of these Regulations or on the package.

(2) Except where a non-reusable closing system is used, the closing system used to comply with this Regulation shall, except in the case of small packages, be at least comprised of a lead or equivalent closing device which shall be attached to the package by the person responsible for attaching labels.

(3) Packages of basic seed or certified seed shall not be reclosed on one or more occasions unless this is done officially or under official supervision. If any such packages are reclosed the fact of reclosing, the date of reclosing and the authority by whom or under whose supervision the reclosing was carried out shall be stated on the label required under Regulation 10(1) of these Regulations.

(4) Packages of standard seed shall be closed in such a manner that they cannot be opened without damaging the closing system or leaving evidence of tampering on the label or package. In addition to complying with the requirements of Regulation 10 of these Regulations such packages shall bear a lead or equivalent closing device and such closing device shall be attached by the person responsible for labelling the packages to comply with the said requirements.

(5) Small packages of certified seed shall be closed in such a manner that they cannot be opened without either damaging the closing system or leaving evidence of tampering either on the official label provided in pursuance of Regulation 10 of these Regulations or on the package. Such packages shall not be closed or reclosed except under official supervision.

10. (1) The following provisions shall apply as regards packages of basic seed and certified seed, other than small packages of basic seed and certified seed:

(a)  they shall be labelled with an official label (adhesive or otherwise) which has not previously been used and which gives the information and satisfies the condition as to dimensions specified in Annex IV(A) and on which such information is given in one of the official languages of the European Communities,

(b)  the colour of the said label shall be white for basic seed and blue or certified seed.

(c)  the label shall be placed on the outside of the package, but if a transparent package is used the label may be placed inside the package provided it can be read,

(d)  when a label with a stringhole is used, an official seal shall be used in relation to its attachment to the package,

(e)  where Regulation 7 of these Regulations relates, the fact that the seed does not satisfy the conditions laid down in Annex II in respect of germination and the fact that it is seed to which such an authorisation relates shall both be stated on the label.

(f)  they shall contain an official document, of the same colour as the said label, giving at least the information required under subparagraph 4, 5, 6 and 7 of paragraphs A(a) of Annex IV, and

(g)  the aforesaid document shall be drawn up in such a manner that it cannot be confused with the official label referred to in paragraph (1) (a) of this Regulation.

(2) The requirements of subparagraphs (f) and (g) of paragraph (1) of this Regulation shall not apply to a package to which that paragraph applies if,

(a)  the information mentioned therein is indelibly printed on the package, or

(b)  an adhesive label is used on the package, or

(c)  a tear-resistant label is attached to the package, or

(d)  the package is transparent and the label is placed inside the package in a manner enabling it easily to be read.

(3)(a)Packages of standard seed and small packages of certified seed shall, in accordance with paragraph B of Annex IV, bear a suppliers label or a printed or a stamped notice in one of the official languages of the European Community,

(b)  In the case of small packages of standard seed up to a maximum net weight of 100 grams, the information prescribed or authorised under this provision shall be kept clearly separate from any other information given on the label or the package.

(c)  The colour of the label provided pursuant to this paragraph shall be blue for certified seed and dark yellow for standard seed.

(4) Paragraph (1) of this Regulation shall apply to packages of pre-basic seed subject to the following modifications:

(a)    the colour of the label shall be white with a violet diagonal line.

(b) the label shall give the following information:

(i)   the certification authority and the Member State by which the authority is designated or their distinguishing abbreviation.

(ii)  the lot reference number.

(iii) the month and year of closing or the month and year of the last official sampling for the purposes of certification,

(iv)  the species, indicated at least in roman characters, under its botanical name, which may be given in abridged form and without the authorities names, or under its common name, or both.

(v)   the variety, indicated at least in roman characters,

(vi)  the description “pre-basic seed”, and

(vii) the number of generations preceding seed of the category certified seed of the first generation.

(5) In the case of varieties which were widely known on the 1st day of January, 1973, reference may be made on the label to any particular method for maintenance of the variety; provided that reference to any special properties which might be connected with such method shall not be so made.

This reference shall follow the varietal name, from which it shall be clearly separated, and shall not be given greater prominence than the varietal name.

(5) (A) For seed of varieties not included in the above mentioned catalogues the colour of the label shall be brown. The label shall always state that the seed in question is of a category satisfying less stringent requirements.

(6) Where the Commission makes a decision in that regard, it may be provided that in cases other than those already provided for in these Regulations, packages of basic seed, certified seed of any kind or standard seed shall bear a supplier's label (which may either be a label separate from the official label or take the form of supplier's information printed on the package itself). The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article

40 of Directive 70/458/EEC of 29 September 1970⁽¹⁾ .

(7) In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, shall clearly indicate that the variety has been genetically modified.;

11. Notwithstanding anything contained in the Regulations mixtures of standard seed of different varieties of Lactuca sativa L (Lettuce) and mixtures of standard seed of different varieties of Raphanus sativus L (Radish) may be marketed in small packages not exceeding 50g provided that the words “mixture of varieties” and the names of the varieties making up the mixture are shown on the package.

12. Any chemical treatment of pre-basic seed, basic seed, certified seed or standard seed shall be indicated either on the official label or on the supplier's label or on the package or inside it. In relation to small packages, this information may be printed directly on the container or inside it.

13. The Minister may prohibit the marketing in all or part of the State of a variety of seed of vegetables registered in the Common Catalogue if, in his opinion, the cultivation of that variety may be harmful, from the point of view of plant health, to the cultivation of other varieties or species of plants.

14. (1) In the official examination of vegetable seed for certification or for post-control testing, samples shall be officially drawn both from sufficiently homogeneous lots and in accordance with the International Rules for Seed Testing published by the International Seed Testing Association and the maximum weight of a lot of seed and the minimum weight of a sample shall be as laid down in Annex III.

(2) Where an authorised officer takes a sample of seed pursuant to these Regulations, the provisions of paragraph (1) of this Regulation shall apply as regards the minimum weight of the sample and the sample shall be drawn in accordance with the Rules mentioned in that paragraph.

15. Notwithstanding the non-compliance with a requirement of these Regulations as to packaging, closing or marketing, vegetable seed may be marketed at the retail stage to the final consumer in quantities not exceeding 5 kg if, but only if, the seed is taken, in the presence of the purchaser, from the package in which it was packed under official supervision and such package is, when the seed is taken from it, marked in accordance with these Regulations.

16. (1) The Minister shall, in accordance with the provisions of these Regulations, set up and maintain a register to be known as the Register of Vegetable Seed Processors, Importers and Packers (in these Regulations referred to as “the register”).

(2) On and from the 1st day of April, 1981 a person shall not carry on the business of a seed processor, a seed importer, or a seed packer, unless he is registered in the register as such.

(3) There shall be entered in the register the following particulars, namely:

(a) the full name, address and description of the person registered therein.

(b) in case a person is registered therein as a deed processor, or a seed packer, a description of the premises in which such person carries on the business of seed processing or seed packing which description shall be sufficient to identify those premises and the limits and extent thereof and also the place where the relevant vegetable seed is stored and

(4) Any change in the name or address or a person registered in the register shall be notified by him to the Minister.

(5) On the application, in such form and containing such particulars as the Minister may direct, by or on behalf of a person who proposes to carry on the business of a seed processor, seed importer or a seed packer, the Minister may register the person in the register as such.

(6) Before the Minister registers any person under paragraph(5) of this Regulation the Minister shall be satisfied that there are available to the person such premises and facilities as are adequate to enable the person to carry on the business to which the application relates.

(7) Whenever the Minister proposes to refuse an application for registration in the register he shall, before doing so, notify in writing the applicant for registration of his intention and of the reasons therefore, and, if any representations are made to the Minister by the applicant within seven days after the giving of the notification, the Minister shall consider them.

(8) In this Regulation -

“seed importer” means a person who imports vegetable seed in any quantity exceeding 2 kg. and “importer” shall be construed accordingly;

“seed packer” means a person who packs seed into small packages;

“seed processor” means a person who assembles, dries, cleans, treats, mixes or otherwise processes (apart from measuring) vegetable seed which is intended for sale and “seed processing” and “seed process” shall be construed accordingly.

17. (1) Any person who carries on the business of processing, packing or marketing vegetable seed (including the importation and storage of such seed) shall

(a)  keep records of his transactions in such seed,

(b)  produce at the request of an authorised officer any such records or any books, documents or other records relating to the said business which are in the possession or under the control of such person,

(c)  permit any such officer to inspect and take extracts from such books, documents or records and give to the officer any information which he may reasonably require in relation to any entries therein,

(d)  afford to any such officer reasonable facilities for inspecting the stock of any such seed on any premises on which such person carries on such a business,

(e)  give to an authorised officer any information he or she may reasonably require in relation to such transactions including in particular information which he or she may reasonably require regarding any vegetable seed specified by him or her, whether imported from other Member States or from third countries.

(2)      A person who imports (whether from another Member State or from a third country) a quantity of vegetable seed exceeding 2 kg. shall, at the time of importation, furnish to the Minister in writing the following particulars regarding the seed, namely, the species, variety, category, country of production, name of the relevant official authority, country of dispatch, importer and quantity of the seed.

(3)  A person responsible for affixing the labels for standard seed intended for marketing shall,

(a)  inform the Minister of the dates when his said responsibility begins and ends,

(b)  keep records of all lots of standard seed and make them available for examination by or on behalf of the Minister for a period of not less than three years,

(c)  draw samples from each lot of such seed which is intended for marketing and make them available for examination by or on behalf of the Minister for a period of not less than two years,

and in case the person is the producer of standard seed, he shall, in addition to complying with the foregoing provisions of this Regulation, make available to the Minister for a period of not less than two years control samples described in Article 37(1) of the directive.

18. (1) In addition to the powers conferred by Regulation 17 of these Regulations an authorised officer may at any reasonable time enter and inspect any premises in which he has reasonable grounds for believing that the business of processing, packing, mixing or marketing or of importing or exporting vegetable seed is carried on or any other premises in which he so believes such seed to be kept, being seed which he so believes to have been landed or otherwise brought into the State, or any railway wagon, vehicle, ship, vessel or aircraft in which he so believes such seed to be kept, and any such officer may examine the stock and take samples of any vegetable seed which he finds in the course of his inspection.

(2) Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall:-

(a)  notify forthwith the appropriate person that the sample is so taken, and

(b)  if so required by the appropriate person at the time of the giving of the notification, take a second sample, which shall be like the sample already so taken, and mark and leave it with the appropriate person.

and in case a second sample is left pursuant to a requirement under this Regulation, the person making the requirement may cause the sample to be tested, examined or analysed.

(3) Any person who obstructs or interferes with an authorised officer in the course of exercising a power conferred on him under this Regulation shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £200.

(4) The Minister shall furnish an authorised officer with a certificate of his appointment and, when exercising any powers conferred by these Regulations, the officer shall, if requested by any person affected, produce the certificate to that person.

(5) In this Regulation -

“the appropriate person” means,

(a)  in relation to premises, any person who appears to an authorised officer to be, for the time being, in charge of the premises,

(b)  in relation to a railway wagon, vehicle, ship, vessel or aircraft the owner thereof or person who is, for the time being, in charge thereof or the agent of such owner.

19. (1) Where a sample of seed is taken pursuant to these Regulations by an authorised officer and is found on official examination not to comply with a requirement of these Regulations, the Minister may require that the seed shall be destroyed or otherwise disposed of in such manner as the Minister shall determine.

(2) In case the Minister makes a requirement under this Regulation the following provisions shall apply.

(a)  he shall inform in writing of the requirement the person who is in possession or control of the seed to which the requirement relates.

(b)  where such person is so informed, pending the disposal of such seed in accordance with the requirement, the seed shall be moved only with the consent of an authorised officer, and

(c)  such person shall dispose of the seed, or cause or permit it to be disposed of, only in accordance with the requirement.

20. An Offence under these Regulations may be prosecuted by the Minister.

21. A person who contravenes these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £400 or, at the discretion of the Court, to imprisonment for a term not exceeding six months.

22. Nothing in these Regulations shall be construed as affecting a provision of any statute, whether passed before or after the making of these Regulations, which is a provision for the protection of human life or health, animal life or health, plant life or health, or industrial or commercial property.

23. The following Regulations are hereby revoked:-

(i)   The European Communities (Vegetable Seeds) Regulations 1981 ( S.I. No. 73 of 1981 )

(ii)  European Communities (Vegetable Seeds) (Amendment) Regulations, 1985 ( S.I. No. 349 of 1985 )

(iii) European Communities (Vegetable Seeds) (Amendment) Regulations, 1991 ( S.I. No. 107 of 1991 )

(iv) European Communities (Vegetable Seeds) (Amendment) Regulations, 1997 ( S.I. No. 56 of 1997 ).

SCHEDULE

ANNEX I

CONDITIONS FOR CROP CERTIFICATION

1.  The crop shall have sufficient varietal identity and varietal purity.

2.  In the case of basic seed, at least one official field inspection shall be carried out. In the case of certified seed, at least one field inspection shall be carried out, officially controlled by means of check inspection of at least 20% of the crop of each species.

3.  The cultural condition of the field and the stage of development of the crop shall be such as to permit varietal identity and varietal purity and health status to be adequately checked.

4.  The minimum distances from neighbouring plants which might result in undesirable foreign pollination shall be:

A.  Beta vulgaris

The groups of varieties referred to in 2 and 3 shall be classified in five groups, according to their characteristics, as follows:

I. Beta vulgaris L. var. vulgaris, Spinach beet, chard, and beta vulgaris L. var. conditiva Alef., red beet or beetroot. Where the crop is of a genetically monogerm variety, multigerm varieties shall be regarded as belonging to a different group.

II.     Beta vulgaris L. var. vulgaris, Spinach beet, chard. Subject to point I, varieties shall be classified in five groups, according to their characteristics, as follows:

III.   Beta vulgaris L. var. conditiva Alef., red beet or beetroot. Subject to point I, varieties shall be classified in six groups. According to their characteristics, as follows:

A.  (a) Brassica species

(1)       From sources of foreign pollen liable to cause serious deterioration of varieties of Brassica species:

(2)       From pollen sources of varieties of the same subspecies belonging to a different group of varieties:

B.  Other species

(1)      From sources of foreign pollen liable to cause serious deterioration of varieties of other species as a result of cross-fertilisation:

(2)      From other sources of foreign pollen liable to cross with varieties of other species as a result of cross-fertilisation:

These distances can be disregarded if there is sufficient protection from any undesirable foreign pollination.

5.  Diseases and harmful organisms which reduce the usefulness of the seed shall be at the lowest possible level.

ANNEX II

CONDITIONS TO BE SATISFIED BY THE SEED

1.   The seeds shall have sufficient varietal identity and varietal purity.

2.   Diseases and harmful organisms which reduce the usefulness of the seed shall be at the lowest possible level.

3.   The seeds shall also satisfy the following conditions:

(a)  Standards:

(b) Additional requirements:

(i)     legume seed shall not be contaminated by the following live insects:

Acanthoscelides obtectus sag.

Bruchus affinis Froel.

Bruchus atomarius L.

Bruchus pisorum L.

Bruchus rufimanus Boh.

(ii)     seed shall not be contaminated by live Acarina.

ANNEX III

1.  Maximum weight of a seed lot:

The maximum lot weight shall not be exceeded by more than 5%.

2.  Minimum weight of a sample

In the case of F 1 hybrid varieties of the above species, the minimum weight of the sample may be decreased to a quarter of the specified weight. However, the sample must have a weight of at least 5 grammes and consist of at least 400 seeds.

ANNEX IV

LABEL

A.  Official label (basic seed and certified seed, excluding small packages)

(a) Required information:

1.   “EC rules and standards”.

2.   Certification authority and Member State or their initials.

3.   Month and year of sealing expressed thus: “sealed...” (month and year),

or

month and year of the last official sampling for the purposes of certification expressed thus: “sampled...” (month and year).

4.   Reference number of lot.

5.   Species, indicated at least in roman characters, under its botanical name, which may be given in abridged form and without the authorities' names, or its common name, or both.

6.   Variety, indicated at least in roman characters.

7.   Category.

8.   Country of production.

9.   Declared net or gross weight or declared number of seeds.

10.    Where weight is indicated and granulated pesticides, pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of clusters or pure seeds and total weight.

11. In the case of varieties which are hybrids or inbred lines:

(i)   for basic seed where the hybrid or inbred line to which the seed belongs has been officially accepted under this Directive:

the name of the component under which it has been officially accepted, with or without reference to the final variety, accompanied, in the case of hybrids or inbred lines which are intended solely as components for final varieties, by the word component.

(ii)  for basic seed in other cases:

the name of the component to which the basic seed belongs, which may be given in code form, accompanied by a reference to the final variety, with or without reference to its function (male or female), and accompanied by the word component.

(iii) for certified seed:

the name of the variety to which the seed belongs, accompanied by the word hybrid.

12.  Where at least germination has been retested, the words “retested...” (month and year) may be indicated

(b) minimum dimensions: 110 × 67 mm.

B.       Supplier's label or inscription on the package (standard seed and small packages of the category ‘certified seed’):

(a) Required information:

1.   “EC rules and standards”.

2.   Name and address of the person responsible for affixing the labels or his identification mark.

3.   Marketing year of the sealing or of the last examination of germination. The end of the marketing year may be indicated.

4.   Species, indicated at least in roman characters.

5.   Variety, indicated at least in roman characters.

6.   Category: in the case of small packages, certified seed may be marked with the letter “C” or “Z” and standard seed with the letters “ST”.

7.   Reference number given by the person responsible for affixing the labels - in the case of standard seed.

8.   Reference number enabling the certified lot to be identified - in the case of certified seed.

9.   Declared net or gross weight or declared number of seeds, except for small packages of up to 500 rams.

10. Where weight is indicated and granulated pesticides, pelleting substances or other solid additives are used, the nature of the additive and also the approximate ratio between the weight of cluster or pure seeds and the total weight.

(b) Minimum dimensions of the label (excluding small packages): 110 × 67 cm.

ANNEX V

Label and document provided in the case of seed not finally certified, harvested in another Member State.

A. Information required for the label

1.     the authority responsible for field inspection and the Member State by which the authority was designated or their initials,

2.     the species, indicated at least in roman characters, under its botanical name, which may be given in abridged form and without the authorities' names, or under its common name, or both,

3.     the variety, indicated at least in roman characters,

4.     the category,

5.     the field or lot reference number,

6.     the declared net or gross weight,

7.     the words “seed not finally certified”.

B.        Colour of the label

the label shall be grey

C.        Information required for the document

1.     the authority issuing the document,

2.     the species, indicated least in roman characters, under its botanical name, which may be given in abridged form and without the authorities' names, or under its common name, or both,

3.     the variety, indicated at least in roman characters,

4.     the category,

5.     the reference number of the seed used to sow the field and the name of the country or countries which certified that seed,

6.     the field or lot reference number,

7.     the area cultivated for the production of the lot covered by the document,

8.     the quantity of seed harvested and the number of packages,

9.     the attestation that the conditions to be satisfied by the crop from which the seed comes have been fulfilled,

10.   where appropriate, the results of a preliminary seed analysis.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

The Regulations -

(1)      consolidate existing Regulations made under the European Communities Act, 1972 , relating to such seeds

(2)      provide a framework to introduce detailed rules in respect of genetically modified plant varieties and plant genetic resources.

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽²⁾ OJ No. L87/24, 17 April, 1971

⁽³⁾ OJ No. L171/37, 29 July, 1972

⁽⁴⁾ OJ No. L287/22, 26 December, 1972

⁽⁵⁾ OJ No. Special Edition p. 14, 27 March, 1972

⁽⁶⁾ OJ No. L2/1, 1 January, 1973

⁽⁷⁾ OJ No. L356/79, 27 December, 1973

⁽⁸⁾ OJ No. L72/16, 18 March, 1976

⁽⁹⁾ OJ No. L16/23, 20 January, 1978

⁽¹⁰⁾ OJ No. L236/13, 26 August, 1978

⁽¹¹⁾ OJ No. L183/13, 19 July, 1979

⁽¹²⁾ OJ No. L205/1, 13 August, 1979

⁽¹³⁾ OJ No. L293/16, 20 November, 1979

⁽¹⁴⁾ OJ No. L341/27, 16 December, 1980

⁽¹⁵⁾ OJ No. L49/39, 18 February, 1987

⁽¹⁶⁾ OJ No. L273/47, 26 September, 1987

⁽¹⁷⁾ OJ No. L187/31, 16 July, 1988

⁽¹⁸⁾ OJ No. L8/9, 11 January, 1989

⁽¹⁹⁾ OJ No. L76/21, 26 March, 1996

⁽²⁰⁾ OJ No. L304/10, 27 November, 1996

⁽²¹⁾ OJ No. L25/1, 1 February, 1999

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽²⁾ OJ No. L87/24, 17 April, 1971

⁽³⁾ OJ No. L171/37, 29 July, 1972

⁽⁴⁾ OJ No. L287/22, 26 December, 1972

⁽⁵⁾ OJ No. Special Edition p. 14, 27 March, 1972

⁽⁶⁾ OJ No. L2/1, 1 January, 1973

⁽⁷⁾ OJ No. L356/79, 27 December, 1973

⁽⁸⁾ OJ No. L72/16, 18 March, 1976

⁽⁹⁾ OJ No. L16/23, 20 January, 1978

⁽¹⁰⁾ OJ No. L236/13, 26 August, 1978

⁽¹¹⁾ OJ No. L183/13, 19 July, 1979

⁽¹²⁾ OJ No. L205/1, 13 August, 1979

⁽¹³⁾ OJ No. L293/16, 20 November, 1979

⁽¹⁾ OJ No. L341/27, 16 December, 1980

⁽²⁾ OJ No. L49/39, 18 February, 1987

⁽³⁾ OJ No. L273/45, 26 September, 1987

⁽⁴⁾ OJ No. L187/31, 16 July, 1988

⁽⁵⁾ OJ No. L8/9, 11 January, 1989

⁽⁶⁾ OJ No. L76/21, 26 March, 1996

⁽⁷⁾ OJ No. L304/10, 27 November, 1996

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L117/15, 8 May, 1990

⁽²⁾ OJ No. L225/7, 12 October 1990

⁽¹⁾ OJ No. L43/1, 14 February, 1997

⁽²⁾ OJ No. L225/7, 12 October, 1990

⁽²⁾ OJ No. L225/7, 12 October, 1990

⁽²⁾ OJ No. L225/7, 12 October, 1990

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970

⁽¹⁾ OJ No. L225/7, 12 October, 1970