Commission Directive 98/51/EC of 9 July 1998 laying down certain measures for implementing Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (Text with EEA relevance)
Date: 1998-07-09
Institutions: European Commission
Subjects: animal nutrition, food industry, third country

24. 7. 98

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Official Journal of the European Communities

L 208/43

COMMISSION DIRECTIVE 98/51/EC

of 9 July 1998

laying down certain measures for implementing Council Directive 95/69/EC
laying down the conditions and arrangements for approving and registering
certain establishments and intermediaries operating in the animal feed sector

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 95/69/EC of 22
December 1995 laying down the conditions and arrange-
ments for approving and registering certain establish-
ments and intermediaries operating in the animal feed
sector and amending Directives 70/524/EEC, 74/63/EEC,
79/373/EEC and 82/471/EEC (1) hereinafter
‘Directive
95/69/EC’, and in particular Article 15 thereof,

Whereas this Directive has laid down rules in respect of
conditions for approving and registering these establish-
ments located in the Community; whereas equivalent
provisions for approving and registering establishments
located in third countries must be adopted;

Whereas the choice of these countries must be based on
criteria of a general nature such as the rules in force in
the field of production of feedingstuffs and the organisa-
tion and powers of the competent authority responsible
for the controls in this field;

Whereas it must be ensured that these establishments
located in third countries meet at least equivalent condi-
tions to those laid down for the establishments located in
the Member States, in order to ensure that the products
deriving from them do not pose risks for human or
animal health or the environment;

send the Commission and the other Member States the
information concerning the establishments located in
third countries authorised to put products into circulation
within the Community which have a representative
located on their territory;

Whereas uniform arrangements should be adopted to
define a model both for the register of approved establish-
ments and intermediaries and for the list of registered
establishments and intermediaries;

Whereas uniform arrangements should be adopted to
define the structure both for the approval number and for
the registration number of the establishments and inter-
mediaries;

Whereas the measures provided for in this Directive are
the Standing
in accordance with the opinion of
Committee for Feedingstuffs,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

Definitions

Article 1

Whereas the possibility that experts from the Commis-
sion and the Member States verify in third countries the
respect of the rules laid down by the present Directive
must be foreseen;

For the purposes of this Directive ‘competent authority’
means the Member State’s or the third country’s authority
responsible for carrying out official checks in the field of
animal nutrition.

Whereas the list of third countries and of their establish-
ments will be made the subject of further implementing
Decisions;

Whereas it is necessary, in order not to interrupt the trade
with third countries, to have transitional arrangements for
the changeover from the old to the new import authorisa-
tion system, pending the full
the new
regime;

functioning of

Whereas, pending the adoption of the lists of establish-
ments located in third countries, Member States should

(1) OJ L 332, 30. 12. 1995, p. 15.

CHAPTER II

List of third countries

Article 2

1.
The Commission deciding in accordance with the
procedure laid down in Article 16 of Directive 95/69/EC
shall lay down the list referred to in Article 15(a), first
indent, of the said Directive. The list may be modified or
integrated in accordance with the same procedure.

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2.
In deciding whether a country may appear on the
list referred to in paragraph 1 particular account shall be
taken of:

(a) that country’s legislation in the sector of feedingstuffs
and in particular the rules relating to manufacturing
and putting
and
substances intended to be used in animal nutrition
and the control rules;

circulation of products

into

(b) the structure and organisation of the competent au-
thority, as well as the powers available to that compe-
tent authority and the guarantees that it can provide in
regard to the implementation of Community rules;

(c) the organisation and implementation of adequate

controls in the sector of feedingstuffs;

(d) the guarantees which that third country can give on
the compliance with standards at least equivalent to
those laid down in the Annex to Directive 95/69/EC.

3.
The decisions referred to in paragraph 1 shall be
published; every five years, a consolidated list shall be
published.

CHAPTER III

Approval of establishments located in third coun-
tries

Article 3

Lists of approved establishments

The Commission, deciding in accordance with the
1.
procedure laid down in Article 16 of Directive 95/69/EC,
and on the basis of a communication from the competent
authorities of the third countries referred to in Article
2(1), shall lay down the lists of establishments located in
third countries from where Member States shall authorise
the import of the products referred to in Article 2(a), (b),
(c) and (d) of the said Directive. The list may be modified
according to the same procedure:

— in line with the result of the inspections provided for

in Article 5, or

CHAPTER IV

Registration of establishments located in third
countries

Article 4

Lists of registered establishments

1.
The Commission, deciding in accordance with the
procedure laid down in Article 16 of Directive 95/69/EC,
and on the basis of a communication from the competent
authorities of the third countries referred to in Article
2(1), shall lay down the lists of establishments located in
third countries from where Member States shall authorise
the import of the products referred to in Article 7(2)(a), (b)
and (c) of the said Directive. The list may be modified
according to the same procedure:

— in line with the result of the inspections provided for

in Article 5, or

— on the basis of unfavourable results of the checks

carried out on products imported, or

— to take account of new information received from the

competent authority of the third country.

2.

An establishment may appear on the list only:

— if it is situated in one of the countries on the list

referred to in Article 2(1),

— if it is complying with requirements at least equi-
valent to those laid down in Directive 95/69/EC.

3.
The decisions referred to in paragraph 1 shall be
published; every five years, a consolidated list shall be
published.

CHAPTER V

General provisions

Article 5

— on the basis of unfavourable results of the checks

On-the-spot checks

carried out on products imported, or

— to take account of new information received from the

competent authority of the third country.

2.

An establishment may appear on the list only:

— if it is situated in one of the countries on the list

referred to in Article 2(1),

— if it is complying with requirements at least equi-
valent to those laid down in Directive 95/69/EC.

1. Inspections on-the-spot may be carried out by experts
the Commission and the Member States, where
of
necessary,
this
Directive, and in particular those of Articles 2(2), 3(2)
second indent and Article 4(2) second indent are actu-
ally being applied.

to verify whether the provisions of

experts

from the Member States

The
shall be
appointed by the Commission, acting on a proposal
from the Member States.

3.
The decisions referred to in paragraph 1 shall be
published; every five years, a consolidated list shall be
published.

2. The Commission shall

inform the Member States
about the results of the inspections referred to in para-
graph 1.

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CHAPTER VI

Transitional arrangements

Article 6

Pending the decisions referred to in Article 2(1),
1.
Article 3(1) and Article 4(1), Member States may only
authorise the import from third countries of products
referred to in Articles 3 and 4 from establishments which
have a representative established within the Community.

They shall require that the name and the address of the
representative established within the Community appears
opposite the name and the address of the manufacturer
on the register and on the list referred to in Article 8.

Representatives

2.
referred to in paragraph 1 who
intend to exercise for the first time their activity shall, as
from 1 January 1999 submit a declaration to the com-
the Member State where they are
petent authority of
located in which they undertake:

— to ensure that the establishment fulfils the conditions
laid down in Article 3(2) second indent or Article 4(2)
second indent, as applicable,

— to keep a register of products referred to in Articles 3
and 4, as applicable, that the establishments which
they represent have put into circulation within the
Community, according to the relevant provisions laid
down in the Annex to Directive 95/69/EC.

3.
Representatives referred to in paragraph 1 who, on
31 December 1998, were in activity, may continue their
activities on condition that they submit the declaration
referred to in paragraph 2 before 1 May 1999.

4. Member States shall prohibit
the release for free
circulation within the Community of products coming
from an establishment:

(a) if its representative in the Community does not fulfil

the conditions of paragraphs 2 or 3; or

(b) if, in the first place, the establishment or its repres-
entative no longer fulfils an essential condition appli-
cable to their activities on the basis of the results:

— of the controls on the imported products, or

— of an on-the-spot inspection referred to in Article

5,

and if, in the second place, the establishment or the
representative do not comply with that condition
within a reasonable time.

Article 7

1.
Pending the decisions referred to in Article 2(1),
Article 3(1) and Article 4(1), Member States shall send the

Commission and the other Member States for the first
time before 30 June 1999 a copy of the register and of
the list referred to in Article 8 of the establishments
referred to in Article 6(1).

2.
Any amendments made to the register and to the list
referred to in paragraph 1 after 30 June 1999 shall be
forwarded separately to the other Member States and to
the Commission.

CHAPTER VII

Register and list of establishments and intermedi-
aries; approval and registration number

Article 8

The register referred to in Article 5(1) and the list referred
to in Article 10(1) of Directive 95/69/EC must be drawn
up in accordance with the model laid down respectively
in Chapters I.1 or I.2 of the Annex to this Directive.

Article 9

The approval number referred to in Article 5(1) and the
registration number referred to in Article 10(1) of Dir-
ective 95/69/EC shall be in the form laid down in
Chapter II of the Annex to this Directive.

CHAPTER VIII

Final provisions

Article 10

1. Member States shall adopt and publish no later than
31 December 1998, immediately informing the Commis-
sion thereof,
regulations and administrative
provisions needed to comply with this Directive.

the laws,

They shall apply these provisions from 1 January 1999.

These provisions shall contain a reference to this Dir-
ective or be accompanied by such a reference on official
publication. Details of the reference shall be set by the
Member States.

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2. Member States shall send the Commission the text
of primary provisions of national
law adopted on the
matters regulated by this Directive.

Article 12

This Directive is addressed to the Member States.

Article 11

Done at Brussels, 9 July 1998.

This Directive shall enter into force on the third day
following its publication in the Official Journal of the
European Communities.

For the Commission

Franz FISCHLER

Member of the Commission

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ANNEX

CHAPTER I

I.1. REGISTER OF APPROVED ESTABLISHMENTS/INTERMEDIARIES

(Article 5(1) of Directive 95/69/EC)

1

2

3

4

5

6

Approval
number

Activity
code (1)

Name
or business
name (2)

Address (3)

Notes
related to
Article 13
of Directive
70/524/EEC (4)

Remarks

(1) A = establishments referred to in Article 2(2)(a) of Directive 95/69/EC.

B = establishments referred to in Article 2(2)(b) of Directive 95/69/EC.

C = establishments referred to in Article 2(2)(c) of Directive 95/69/EC.

D = establishments referred to in Article 2(2)(d) of Directive 95/69/EC.

E = establishments referred to in Article 2(2)(e) of Directive 95/69/EC.

F = establishments referred to in Article 2(2)(f) of Directive 95/69/EC.

I = intermediaries referred to in Article 3(1) of Directive 95/69/EC.

(2) Name or business name of the establishment/intermediary and of the representative, where applicable.

(3) Address of the establishment/intermediary and of the representative, where applicable.

(4)

(1) = ‘Manufacturers of compound feedingstuffs authorised to use a minimum proportion of 0,05 % by weight of

premixtures’ referred to in Article 13(3) of Directive 70/524/EEC.

(2) = ‘Manufacturers of compound feedingstuffs authorised to add antibiotics, coccidiostats and other medicinal
substances, and growth promoters directly to compound feedingstuffs’ referred to in Article 13(4)(b) of Dir-
ective 70/524/EEC.

(3) = ‘Manufacturers of compound feedingstuffs authorised to add copper, selenium and vitamins A and D directly

to compound feedingstuffs’ referred to in Article 13(4)(b) of Directive 70/524/EEC.

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I.2. LIST OF REGISTERED ESTABLISHMENTS/INTERMEDIARIES

(Article 10(1) of Directive 95/69/EC)

1

2

3

4

5

6

Registration
number

Activity
code (1)

Name
or business
name (2)

Address (3)

Notes
related to
Article 13
of Directive
70/524/EEC (4)

Remarks

(1) A = establishments referred to in Article 7(2)(a) of Directive 95/69/EC.
B = establishments referred to in Article 7(2)(b) of Directive 95/69/EC.
C = establishments referred to in Article 7(2)(c) of Directive 95/69/EC.
D = establishments referred to in Article 7(2)(d) of Directive 95/69/EC.
I = intermediaries referred to in Article 8(1) of Directive 95/69/EC.

(2) Name or business name of the establishment/intermediary and of the representative, where applicable.

(3) Address of the establishment/intermediary and of the representative, where applicable.

(4)

(1) = ‘Manufacturers of compound feedingstuffs authorised to use a minimum proportion of 0,05 % by weight of

premixtures’ referred to in Article 13(3) of Directive 70/524/EEC.

(2) = ‘Manufacturers of compound feedingstuffs authorised to add copper, selenium and vitamins A and D directly

to compound feedingstuffs’ referred to in Article 13(4)(b) of Directive 70/524/EEC.

CHAPTER II

The approval number referred to in Article 5(1) and the registration number referred to in Article 10(1) of
Directive 95/69/EC must have the following structure:
1. The character ‘a’ if the establishment or the intermediary is approved.

2. The ISO code of the Member State or of the third country where the establishment or the intermediary is

located,

3. The national reference number with a maximum of eight alphanumerical characters.