2004/842/EC: Commission Decision of 1 December 2004 concerning implementing rules whereby Member States may authorise the placing on the market of seed belonging to varieties for which an application for entry in the national catalogue of varieties of agricultural plant species or vegetable species has been submitted (notified under document number C(2004) 4493)Text with EEA relevance
Date: 2004-12-01
Institutions: European Commission
Subjects: crop production, marketing standard, seed

9.12.2004

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Official Journal of the European Union

L 362/21

COMMISSION DECISION

of 1 December 2004

concerning implementing rules whereby Member States may authorise the placing on the market of
seed belonging to varieties for which an application for entry in the national catalogue of varieties
of agricultural plant species or vegetable species has been submitted

(notified under document number C(2004) 4493)

(Text with EEA relevance)

(2004/842/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Whereas:

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 66/401/EEC of 14 June
seed (1), and in
1966 on the marketing of
particular Article 4a(2) thereof,

fodder plant

Having regard to Council Directive 66/402/EEC of 14 June
1966 on the marketing of cereal seed (2), and in particular
Article 4a(2) thereof,

Having regard to Council Directive 2002/54/EC of 13 June
2002 on the marketing of beet seed (3), and in particular
Article 6(2) thereof,

Having regard to Council Directive 2002/55/EC of 13 June
2002 on the marketing of vegetable seed (4), and in particular
Article 23(2) thereof,

Having regard to Council Directive 2002/56/EC of 13 June
2002 on the marketing of seed potatoes (5), and in particular
Article 6(2) thereof,

Having regard to Council Directive 2002/57/EC of 13 June
2002 on the marketing of seed of oil and fibre plants (6), and
in particular Article 6(2) thereof,

(1) OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by
Commission Directive 2004/55/EC (OJ L 114, 21.4.2004, p. 18).
(2) OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by

Directive 2003/61/EC (OJ L 165, 3.7.2003, p. 23).

(3) OJ L 193, 20.7.2002, p. 12. Directive as amended by Directive

2003/61/EC.

(4) OJ L 193, 20.7.2002, p. 33. Directive as last amended by Regulation
(EC) No 1829/2003 of the European Parliament and of the Council
(OJ L 268, 18.10.2003, p. 1).

(5) OJ L 193, 20.7.2002, p. 60. Directive as last amended by Directive

2003/61/EC.

(6) OJ L 193, 20.7.2002, p. 74. Directive as last amended by Directive

2003/61/EC.

(1)

(2)

(3)

(4)

66/401/EEC,

to Directives

Pursuant
66/402/EEC,
2002/54/EC, 2002/56/EC and 2002/57/EC, Member
States may authorise producers of agricultural seed to
place on the market seed belonging to a variety for
which an application for entry in the catalogue of the
Member State in question, as provided for in Council
Directive 2002/53/EC of 13 June 2002 on the
common catalogue of varieties of agricultural plant
species (7), has been lodged.

In addition, pursuant to Directive 2002/55/EC, Member
States may authorise breeders or their representatives of
vegetable seed to place on the market seed belonging to
a variety for which an application for entry in a national
catalogue of at least one Member State, as provided for in
that Directive has been lodged.

To enable Member States to grant such authorisations it
is necessary to lay down implementing rules for those
Directives, covering in particular the purposes for and the
conditions under which those authorisations may be
granted, the labelling of the seed packages and in the
case of agricultural seed, the quantities. It is also appro-
priate that
in the case of a variety derived from a
genetically modified organism, this genetically modified
organism must be authorised for the placing on the
market according to the Community legislation.

in this Decision are in
The measures provided for
accordance with
Standing
the
Committee on Seeds and Propagating Material for Agri-
culture, Horticulture and Forestry,

opinion

the

of

HAS ADOPTED THIS DECISION:

CHAPTER I

General provision

Article 1

Subject matter

The purpose of this Decision is to lay down the rules whereby a
Member State may grant an authorisation to place on the
market:

(7) OJ L 193, 20.7.2002, p. 1. Directive as last amended by Regulation
(EC) No 1829/2003 of the European Parliament and of the Council.

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(a) seed of varieties of agricultural plant species for which an
application for entry in the national catalogue, provided for
in Article 1(2) of Directive 2002/53/EC, has been submitted
to the Member State in question, subject to compliance with
Chapter II of this Decision; or

(d) the maintenance of the variety.

Article 4

Purpose

(b) seed of varieties of vegetable species for which an appli-
cation for entry in a national catalogue, provided for in
Article 3(3) of Directive 2002/55/EC, has been submitted
least one Member State and for which specific
in at
technical
to
information has been submitted,
compliance with Chapter III of this Decision.

subject

CHAPTER II

Agricultural plant species

Article 2

Authorisation

For

species

agricultural plant

covered by Directives
1.
66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/56/EC and
2002/57/EC, Member States may authorise producers estab-
lished in their own territory to place on the market seed
belonging to a variety for which an application for entry in
the national catalogue of varieties of agricultural plant species
(the national catalogue) has been submitted to the Member State
in question, subject to compliance with Articles 3 to 18 of this
Decision.

2. Member States shall ensure that when an authorisation
has been granted in accordance with this Decision, the author-
isation holder shall comply with any condition or restriction
attached to such authorisation.

Article 3

Application

1.
The authorisation may be requested by the person who
has duly submitted an application for entry of the varieties
concerned in the catalogue of the Member State in question
(hereafter called the applicant, which includes the representative
of such a person, provided the representative has been officially
delegated).

2.

The applicant shall submit the following information:

(a)

the envisaged tests and trials;

Authorisations shall only be granted for tests or trials carried
out at agricultural enterprises to gather information on the
cultivation or use of the variety.

Article 5

Technical conditions

Fodder plant seed shall comply with the conditions laid

1.
down in Annexes I and II to Directive 66/401/EEC for:

(a) certified seed (all species other than Pisum sativum and Vicia

faba); or

(b) ‘certified seed, second generation’ (Pisum sativum, Vicia faba).

Cereal seed shall comply with the conditions laid down in

2.
Annexes I and II to Directive 66/402/EEC for:

(a) certified seed (Phalaris canariensis, other than hybrids, Secale
cereale, Sorghum bicolor, Sorghum sudanense, Zea mays and
hybrids of Avena sativa, Hordeum vulgare, Oryza sativa,
Triticum aestivum, Triticum durum, Triticum spelta and x Triti-
cosecale other than self-pollinating varieties); or

(b) ‘certified seed, second generation’

(Avena sativa, Hordeum
vulgare, Oryza sativa, Triticum aestivum, Triticum durum,
Triticum spelta and self-pollinating varieties of x Triticosecale,
other than hybrids in each case).

Beet seed shall comply with the conditions laid down in

3.
Annex I to Directive 2002/54/EC for certified seed.

4.
Seed potatoes shall comply with the conditions laid down
in Annexes I and II to Directive 2002/56/EC for certified seed
potatoes.

Seed of oil and fibre plants
laid down in Annexes

5.
conditions
2002/57/EC for:

shall comply with the
to Directive
I and II

(b) the name(s) of the Member State(s) in which those tests and

trials are to be carried out;

(a) certified seed (all species other than Linum usitatissimum);

(c) a description of the variety;

tissimum).

(b) ‘certified seed, second and third generation’

(Linum usita-

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Article 6

Examination

However, if such quantities are not sufficient to sow 10 ha per
Member State for which the seed is intended,
the quantity
needed for such an area may be authorised.

Compliance with the conditions referred to in Article 5

1.
shall be assessed:

(a)

in the case of seed potatoes, by an official examination;

(b) in the other case, by an official examination or an exam-

ination under official supervision.

For the assessment of compliance with the conditions
2.
concerning varietal identity and varietal purity, the description
of the variety as supplied by the applicant, or where applicable
the provisional description of the variety based on the results of
the official examination of distinctness, stability and uniformity
of
in Article 7 of Directive
2002/53/EC, shall be used.

the variety, as provided for

Examination shall be carried out

in accordance with
3.
current international methods, in so far as such methods exist.

Article 8

Packages and sealing

Seed may be marketed only in closed packages or containers
bearing a sealing device. Seed packages and containers shall be
sealed officially or under official supervision in such a manner
that
they cannot be opened without damaging the sealing
system or leaving evidence of tampering on either the official
label provided for in Article 9 or on the package. In order to
ensure sealing, the sealing system shall comprise at least either
the official label or the affixing of an official seal.

In the case of seed potatoes, the packages shall be new and the
container shall be clean.

Article 9

Labelling

4.
For the examination, samples shall be drawn officially or
under official supervision or, in the case of seed potatoes, offi-
cially in accordance with appropriate methods.

The seed packages shall bear an official label in one of the

1.
official languages of the Community.

5.

Samples shall be drawn from homogeneous lots.

The label provided for in paragraph 1 shall

2.
following information:

include the

The maximum weight of a lot and the minimum weight

6.
of a sample are given in:

(a)

the certification authority and Member State or their distin-
guishing abbreviation;

(a)

fodder plants: Annex III to Directive 66/401/EEC;

(b) cereals: Annex III to Directive 66/402/EEC;

(c) beet: Annex II to Directive 2002/54/EC;

(d) oil and fibre plants: Annex III to Directive 2002/57/EC.

(b) the lot reference number;

(c)

the month and year of sealing;

(d) the species;

Article 7

Quantities

(e)

the denomination of the variety under which the seed is to
be marketed (the breeder’s reference, the proposed denomi-
nation or the approved denomination) and the official appli-
cation number for listing the variety, if any;

The quantities authorised for each variety shall not exceed the
following percentages of seed of the same species utilised yearly
in the Member State(s) for which the seed is intended:

(f)

the indication ‘variety not yet officially listed’;

(a)

in the case of durum wheat: 0,05 %;

(g) the indication ‘for tests and trials only’;

(b) in the case of field pea, field bean, oats, barley and wheat:

0,3 %;

(h) where applicable, the words ‘genetically modified variety’;

(c)

in all other cases: 0,1 %.

(i)

size (only for seed potatoes);

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(j) declared net or gross weight or declared number of pure

seeds or, where applicable, clusters;

Article 14

Safeguard

(k) 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 pure seeds or, where applicable,
clusters and the total weight.

3.

The label provided for in paragraph 1 shall be orange.

Article 10

Chemical treatment

Any chemical treatment shall be noted either on the official
label provided for in Article 9, or on a supplier’s label and
on the package, or inside it, or on the container.

Article 11

Time period

Without prejudice to Articles 13 and 14, authorisations granted
in accordance with the provisions of this Decision shall be valid
for a period not exceeding one year and shall be renewable in
accordance with Article 12.

Article 12

Renewal of authorisations

1. Without prejudice to Articles 13 and 14, authorisations
referred to in Article 2 shall be renewable for periods not
exceeding one year each.

The application shall be accompanied by the following

2.
documents:

(a) a reference to the original authorisation;

(b) any available information which supplements the infor-
mation already provided on the description,
the main-
tenance and/or the cultivation or use of the variety subject
to the original authorisation;

Notwithstanding an authorisation granted under Article 2, a
Member State may prohibit the use of the variety in all or in
part of its territory or lays down appropriate conditions for
cultivating the variety in accordance, in cases provided for in
subparagraph (c), 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 official growing trials carried out in the applicant
Member State show that the variety does not, in any part
of
its territory, produce results corresponding to those
obtained from a comparable variety accepted in the
territory of that Member State or, where it is well known
that the variety is not suitable for cultivation in any part of
its territory because of its type of maturity class; or

(c) where it has valid reasons for considering that the variety
presents a risk for human health or the environment.

Article 15

Reporting obligations

Following the grant of the authorisation, the authorising

1.
Member State may require the authorised person to report:

(a)

the results of the tests or trials carried out at agricultural
enterprises to gather information on the cultivation or use
of the variety;

(b) the quantities of seed placed on the market during the
authorised period and the Member State for which the
seed was intended.

The information provided for in point (b) of paragraph 1

2.
shall be treated as confidential.

(c) evidence that evaluation for the entry into the catalogue of
if not otherwise

the variety concerned is still ongoing,
available to the Member State.

Article 16

Maintenance checks

Article 13

Cessation of validity

The authorising Member State may check maintenance of the
variety.

Authorisations shall cease to be valid if the application for entry
in the national catalogue is withdrawn or rejected, or the variety
is entered in the catalogue.

Where maintenance takes place in a Member State other than
the authorising Member State, the Member States shall assist
each other administratively as regards the necessary checks.

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A Member State may accept maintenance in a third country,
provided that it has been decided under Article 22(1)(b) of
Directive 2002/53/EC that the checks on practices for the main-
tenance afford the same assurances as those carried out by the
Member States.

2. Member States shall ensure that when an authorisation
has been granted in accordance with this Decision, the author-
isation holder shall comply with any condition or restrictions
attached to such authorisation.

Article 17

Notification

Member States shall notify each other and the Commission of
the following:

Article 21

Application

1.
The authorisation may be requested by the person who
has duly submitted an application for entry of the varieties
concerned in the catalogue of at
least one Member State
(hereafter called ‘the applicant’ which includes the representative
of such a person, provided that the representative has been
officially delegated).

(a) an application, as soon as this is received, or the rejection of

an application for authorisation; and

2.

The applicant shall submit the following information:

(b) the grant, renewal, revocation or withdrawal of an author-

isation.

(a) a description of the variety;

Article 18

Exchange of information

Member States shall use the existing computerised information
exchange systems to facilitate the exchange of information as
regards the connection with the application for acceptance of
varieties into the national catalogues and the authorisation for
seed of varieties not yet listed.

Article 19

Publication of a list of varieties

The Commission may, on the basis of the information supplied
by the Member States, publish a list of varieties that have been
authorised.

CHAPTER III

Vegetable species

Article 20

Authorisation

1.
For vegetable species covered by Directive 2002/55/EC,
Member States may authorise breeders established on their
own territory to place on the market seed belonging to a
variety for which an application for inclusion in a national
catalogue of varieties of vegetable
(the national
catalogue) has been submitted in at least one Member State
information has been
and for which specific
technical
submitted in the Member State(s)
to
in question,
compliance with Articles 21 to 37 of this Decision.

subject

species

(b) the maintenance of the variety.

Article 22

Purpose

The authorisation shall only be granted for the purpose of
gaining knowledge from practical experience during cultivation.

Article 23

Technical conditions

Vegetable seed shall comply with the conditions laid down in
Annex II to Directive 2002/55/EC.

Article 24

Examination

Vegetable seed shall be subject to official post-control by
1.
check inspection to verify its varietal identity and varietal purity
on the basis of the description of the variety as supplied by the
applicant, or where available the provisional description of the
variety based on the results of
the official examination of
distinctness, stability and uniformity of the variety as provided
for in Article 7 of Directive 2002/55/EC.

2.

Samples shall be drawn from homogeneous lots.

3.
The maximum weight of a lot and the minimum weight
of a sample are given in Annex III to Directive 2002/55/EC.

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Article 25

Genetically modified varieties

In the case of a genetically modified variety, the authorisation
may be granted only if all appropriate measures have been
taken to avoid adverse effects on human health and the envir-
onment. The genetically modified material must either be
authorised under Directive 2001/18/EC of
the European
Parliament and of the Council (1), or be authorised under Regu-
lation (EC) No 1829/2003.

(d) the denomination of the variety under which the seed is to
be marketed (the breeder’s reference, the proposed denomi-
nation or the approved denomination) and the official appli-
cation number for listing the variety, if any;

(e)

the indication ‘variety not yet officially listed’;

(f) where applicable, the words ‘genetically modified variety’;

Article 26

Supplier

(g) declared net or gross weight or declared number of pure

seeds or, where applicable, clusters;

The persons responsible for affixing the label or printing or
stamping notice on the packages shall:

(a)

inform the Member State of the dates when their activities
begin and end;

(h) 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 pure seeds or, where applicable,
clusters and the total weight.

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

the Member States for not less than three years;

3.

The label provided for in paragraph 1 shall be orange.

(c) draw samples from each lot intended for marketing and
make them available to Member States for not less than
two years.

Article 29

Chemical treatment

The operations referred to in points (b) and (c) shall be subject
to official checks carried out on a random basis.

Any chemical
provided for in Article 28 and on the package or inside it.

treatment shall be noted either on the label

Article 27

Packages and sealing

Article 30

Time period

Seed may be marketed only in closed packages bearing a sealing
device. Seed packages shall be sealed in such a manner that they
cannot be opened without damaging the sealing device or
leaving evidence of tampering either on the label provided for
in Article 28 or on the package.

Without prejudice to Articles 32 and 33, authorisations granted
in accordance with the provisions of this Decision shall be valid
for a period not exceeding one year and shall be renewable in
accordance with Article 31.

Article 28

Labelling

Article 31

Renewal of authorisations

The seed packages shall bear a supplier’s label or a printed
the

1.
or stamped notice in one of
Community.

languages of

the official

1. Without prejudice to Articles 32 and 33, authorisations
referred to in Article 20 shall be renewable, maximum twice for
a period not exceeding one year each.

The label provided for in paragraph 1 shall

2.
following information:

include the

The application shall be accompanied by the following

2.
documents:

(a)

the lot reference number;

(b) the month and year of sealing;

(c)

the species;

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(a) a reference to the original authorisation;

(b) any available information which supplements the infor-
mation already provided on the description,
the main-
tenance and/or the knowledge from practical experience
during the cultivation of the variety subject to the original
authorisation;

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(c) evidence that the evaluation for the entry into the catalogue
if not otherwise

of the variety concerned is still ongoing,
available to the Member State.

Where maintenance takes place in a Member State other than
the authorising Member State, the Member States shall assist
each other administratively as regards the necessary checks.

Article 32

Cessation of validity

Authorisations shall cease to be valid,
if the application for
entry in the national catalogue is withdrawn or rejected, or
the variety is entered in the catalogue.

Article 33

Safeguard

Notwithstanding an authorisation granted under Article 20 a
Member State may be authorised to prohibit the use of the
variety in all or in part of its territory or to lay down appro-
priate 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 Member State may accept maintenance in a third country,
provided that it has been decided under Article 37(1)(b) of
Directive 2002/55/EC that the checks on practices for the main-
tenance afford the same assurances as those carried out by the
Member States.

Article 36

Notification

Member States shall notify each other and the Commission of
the following:

(a) an application, as soon as this is received, or the rejection of

an application for authorisation; and

(b) the grant, renewal, revocation or withdrawal of an author-

isation.

(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

Article 37

Exchange of information

(b) where it has valid reasons for considering that the variety
presents a risk for human health or the environment.

Article 34

Reporting obligations

Following the grant of the authorisation, the authorising

1.
Member State may require the authorised person to report:

(a)

the knowledge gained from practical experience during
cultivation;

(b) the quantities of seed placed on the market during the
authorised period and the Member State for which the
seed was intended.

Member States shall use the existing computerised information
exchange systems to facilitate the exchange of information as
regards the connection with the application for acceptance of
varieties into the national catalogues and the authorisation for
seed of varieties not yet listed.

Article 38

Publication of a list of varieties

The Commission may, on the basis of the information supplied
by the Member States, publish a list of varieties that have been
authorised.

CHAPTER IV

Article 39

Addressees

The information provided for in point (b) of paragraph 1

2.
shall be treated as confidential.

This Decision is addressed to the Member States.

Article 35

Maintenance checks

The authorising Member State may check maintenance of the
variety.

Done at Brussels, 1 December 2004.

For the Commission

Markos KYPRIANOU
Member of the Commission