Recommendation of the EFTA Surveillance Authority No 65/04/COL of 31 March 2004 concerning a coordinated programme for the official control of feedingstuffs for 2004
Date: 2004-03-31
Institutions: EFTA Surveillance Authority
Subjects: EFTA, animal nutrition, food inspection, veterinary legislation

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Official Journal of the European Union

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EUROPEAN ECONOMIC AREA

EFTA SURVEILLANCE AUTHORITY

RECOMMENDATION OF THE EFTA SURVEILLANCE AUTHORITY

No 65/04/COL

of 31 March 2004

concerning a coordinated programme for the official control of feedingstuffs for 2004

THE EFTA SURVEILLANCE AUTHORITY,

Agreement, and the protection of public and animal
health.

Having regard to the Agreement on the European Economic
Area, and in particular Article 109 and Protocol 1 thereof,

Having regard to the Agreement between the EFTA States on
the establishment of a Surveillance Authority and a Court of
Justice, and in particular Article 5(2)(b) and Protocol 1 thereof,

(3)

(4)

Having regard to the Act referred to at point 31a of Chapter II
of Annex I to the EEA Agreement (Council Directive 95/53/EC
of 25 October 1995 fixing the principles governing the orga-
nisation of official
animal
nutrition (1)),
adapted to the EEA
Agreement by Protocol 1 thereto, and in particular Article
22(3) thereof,

inspections

amended,

field of

and as

in the

as

Whereas:

(1)

It is necessary, with a view to the sound operation of the
European Economic Area,
to arrange for coordinated
feed inspection programmes within the EEA designed
to improve the harmonised implementation of
the
official controls by the EEA States.

results

from simultaneous

The
implementation of
national programmes and coordinated programmes may
provide information and experience on which to base
future control activities and legislation.

Although the Act referred to at point 33 of Chapter II of
Annex I to the EEA Agreement (Directive 2002/32/EC of
the European Parliament and of the Council of 7 May
2002 on undesirable substances in animal feed (2)) estab-
lishes maximum contents of aflatoxin B1 in feedingstuffs,
there is no legislation in force under the EEA Agreement
for other mycotoxins, such as ochratoxin A, zearalenone,
deoxynivalenol and fumonisins. Gathering information
on the presence of those mycotoxins through random
sampling could provide useful data for an assessment
of the situation with a view to the development of the
legislation. Furthermore, certain feed materials such as
cereals
exposed to
mycotoxin contamination because of harvesting, storage
and transport conditions. As mycotoxin concentration
is appropriate to collect
it
varies from year to year,
all mycotoxins
years
data
mentioned.

from consecutive

are particularly

and oil

seeds

for

(2)

Such programmes should place emphasis on complicance
legislation in force under the EEA
with the relevant

(5)

Previous checks for the presence of antibiotics and cocci-
diostats in certain feedingstuffs where those substances
are not authorised indicate that this type of infringement
still occurs. The frequency of such findings and the sensi-
tivity of this matter justify the continuation of checks.

(1) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive
2001/46/EC of the European Parlament and of the Council
(OJ
L 234, 1.9.2001, p. 55).

(2) OJ L 140, 30.5.2002, p. 10. Directive as

last amended by

Commission Directive 2005/8/EC (OJ L 27, 29.1.2005, p. 44).

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(6)

(7)

(8)

and Iceland in the
The participation of Norway
programmes within the scope of Annex II of this Recom-
mendation concerning substances not authorised as feed
additives will have to be evaluated with respect to their
to the EEA
exemptions from Chapter II of Annex I
Agreement.

It is important to ensure that the restrictions on the use
of feed materials of animal origin in feedingstuffs, as laid
down in the relevant EEA legislation, are effectively
enforced.

The case of contamination of the feed and food chain
with medroxyprogesterone acetate (MPA) highlighted the
value of the selection of supplies in the safety of feeding-
stuffs. Some ingredients in feedingstuffs are by-products
of agri-food industries, or of other industries, or of
mineral extraction. The source of
feed materials of
industrial origin and the processing methods applied to
them may be of particular significance in the safety of
the products. Therefore the competent authorities should
consider this aspect when carrying out their checks.

(9)

The measures provided for in this Recommendation are
in accordance with the opinion of the EFTA Plants and
Animal Feedingstuffs Committee assisting the EFTA
Surveillance Authority,

HEREBY RECOMMENDS TO THE EFTA STATES:

1. During 2004,

to carry out

a

coordinated inspection

programme aimed to check:

(a)

concentration

the
B1,
ochratoxin A, zearalenone, deoxynivalenol and fumo-
indicating the methods of
nisins)

in feedingstuffs,

of mycotoxins

(aflatoxin

analysis; the method of sampling should comprise both
random and targeted sampling; in the case of targeted
sampling, the samples should be feed materials suspected
of containing higher concentrations of mycotoxins, such
as cereal grains, oil seeds, oil fruits, their products and
by-products, and feed materials stored for a long time or
transported by sea over a long distance; the results of the
checks should be reported using the model set out in
Annex I;

(b) certain medicinal substances, whether or not authorised
as feed additives for certain animal species and cate-
gories,
in non-medicated pre-mixtures and compound
feedingstuffs in which these medicinal substances are
not
those
checks
medicinal substances in pre-mixtures and compound
feedingstuffs if the competent authority considers that
finding irregularities;
there is a greater probability of
the results should be reported using the model set out
in Annex II;

authorised;

should

target

the

(c)

the implementation of restrictions on the production and
use of
feed materials of animal origin, as set out in
Annex III;

(d) the procedures applied by manufacturers of compound
feedingstuffs in order to select and assess their supplies
of feed materials of industrial origin and to ensure the
quality and safety of such ingredients, as set out
in
Annex IV.

2. To include

the

the

results of

coordinated inspection
in paragraph 1 in a separate
programme provided for
Chapter in the annual report on inspection activities to be
transmitted to the EFTA Surveillance Authority by 1 April
2005 in accordance with Article 22(2) of Directive 95/53/EC
and the latest version of the harmonised reporting model.

Done at Brussels, 31 March 2004.

For the EFTA Surveillance Authority

Bernd HAMMERMAN
College Member

Niels FENGER
Director

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ANNEX I

Concentration of certain mycotoxins (aflatoxin B1, ochratoxin A, zearalenone, deoxynivalenol, fumonisins) in
feedingstuffs

Individual results of all tested samples; model for reports as referred to in paragraph 1(a)

Feedingstuffs

Type

Country of
origin

Sampling
(random or
targeted)

Type and concentration of mycotoxins (μg/kg relative to a feedingstuff with a
moisture content of 12 %)

Aflatoxin B1

Ochratoxin A

Zearalenone

Deoxyni-
valenol

Fumonisins (a)

(a) The concentration of fumonisins comprises the total of fumonisins B1, B2 and B3.

The competent authority should also indicate:
— the action taken when maximum levels for aflatoxin B1 are exceeded,
— the methods of analysis used,
— the limits of detection.

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ANNEX II

Presence of certain substances not authorised as feed additives

Certain antibiotics, coccidiostats and other substances may be legally present as additives in pre-mixtures and compound
feedingstuffs for certain species and categories of animals, when authorised under the Act referred to at point 1 of
Chapter II of Annex I to the EEA Agreement (Council Directive 70/524/EEC of 23 November 1970 concerning additives
in feedingstuffs (1)).

The presence of unauthorised substances in feedingstuffs constitutes an infringement.

The substances to be controlled should be chosen from the following:

1. Substances authorised as feed additives for certain animal species or categories only:

avilamycin

decoquinate

diclazuril

flavophospholipol

halofuginone hydrobromide

lasalocid A sodium

maduramicin ammonium alpha

2. Substances no longer authorised as feed additives:

amprolium

amprolium/ethopabate

arprinocid

avoparcin

carbadox

dimetridazole

dinitolmid

ipronidazol

meticlorpindol

monensin sodium

narasin

narasin — nicarbazin

robenidine hydrochloride

salinomycin sodium

semduramicin sodium

nicarbazin

nifursol

olaquindox

ronidazol

spiramycin

tetracyclines

tylosin phosphate

virginiamycin

zinc bacitracin

meticlorpindol/methylbenzoquate

other antimicrobial substances

3. Substances never authorised as feed additives:

other substances

Individual results of all non-compliant samples; model for reports as referred to in paragraph 1(b)

Type of feedingstuff
(animal species and
category)

Substance detected

Level found

Reason for the
infringement (a)

Action taken

(a) Reason leading to the presence of the unauthorised substance in the feedingstuff, as concluded after an investigation carried out by the

competent authority.

(1) OJ L 270, 14.12.1970, p. 1.

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The competent authority should also indicate:

— the total number of samples tested,

— the names of the substances which have been investigated,

— the methods of analysis used,

— the limits of detection.

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ANNEX III

Restrictions on the production and use of feed materials of animal origin

Without prejudice to Articles 3 to 13 and 15 of Directive 95/53/EC, the EFTA States should during 2004 undertake a
coordinated inspection programme to determine whether restrictions on the production and use of feed materials of
animal origin have been complied with.

In particular, in order to ensure that the ban on feeding processed animal protein to certain animals, as laid down in the
Annex IV of the Act referred to at point 7, 1, 12 of Chapter I of Annex I to the EEA Agreement (Regulation (EC)
No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention,
control and eradication of certain transmissible spongiform encephalopathies (1)), are effectively applied, EFTA States
should implement a specific control programme based on targeted controls. In accordance with Article 4 of Directive
95/53/EC, that control programme should be based on a risk-based strategy where all stages of production and all types
of premises where feed is produced, handled and administered are included. EFTA States should pay special attention to
the definition of criteria that can be related to a risk. The weighting given to each criterion should be proportional to the
risk. The inspection frequency and the number of samples analysed in the premises should be in correlation to the sum of
weightings allocated to those premises.

The following indicative premises and criteria should be considered when drawing up a control programme:

Premises

Feed mills

Criteria

Weighting

— Double-stream feed mills producing ruminant compound feed and non-
ruminant compound feed containing derogated processed animal proteins

— Feed mills with previous history, or suspicion, of non-compliance
— Feed mills with a large amount of

imported feedingstuffs with high
protein content such as fishmeal, soybean meal, corn gluten meal and
protein concentrates

— Feed mills with a high production of compound feed
— Risk of

cross-contamination resulting

from internal operational
procedures (dedication of silos, control of the effective separation of
laboratory, sampling procedures,
lines, control of ingredients,
etc.)

internal

Inspection Posts
of
points

Border
and
other
entry into the EEA

— Large/small amount of imports of feedingstuffs
— Feedingstuffs with high protein content

Farms

— Home mixers using derogated processed animal proteins
— Farms keeping ruminants and other species (risk of cross feeding)
— Farms purchasing feedingstuffs in bulk

Dealers

— Warehouses and intermediate storage of feedingstuffs with high protein

Mobile mixers

content

— High volume of bulk feedingstuffs traded
— Dealers in compound feedingstuffs produced abroad

— Mixers producing for both ruminants and non-ruminants
— Mixers with previous history, or suspicion, of non-compliance
— Mixers incorporating feedingstuffs with high protein content
— Mixers with high production of feedingstuffs
— Large number of farms served including farms which keep ruminants

Means of transportation — Vehicles used for the transportation of processed animal proteins and

feedingstuffs

— Vehicles with previous history, or suspicion, of non-compliance

(1) OJ L 147, 31.5.2001, p. 1.

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As an alternative to these indicative premises and criteria, EFTA States may forward their own risk assessment to the
EFTA Surveillance Authority before 30 April 2004.

Sampling should be targeted on batches or events where cross-contamination with prohibited processed proteins is most
feedingstuffs containing animal protein prohibited in this batch, technical
likely (first batch after the transport of
problems or changes in production lines, changes in storage bunkers or silos for bulk material).

The minimum number of inspections per year in an EFTA State should be 10 per 100 000 tonnes of compound feed
produced. The minimum number of official samples per year in an EFTA State should be 20 per 100 000 tonnes of
compound feed produced. Pending the approval of alternative methods, microscopic identification and estimation as
described in Commission Directive 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identi-
fication and estimation of constituents of animal origin for the official control of feedingstuffs (1) should be used for
analysing samples. Any presence of prohibited constituents of animal origin in feedingstuffs should be considered as a
breach of the feed ban.

The results of the inspection programmes should be communicated to the EFTA Surveillance Authority using the
following formats:

Summary of checks concerning feeding restrictions for feed of animal origin (feeding of prohibited processed animal proteins)

A. D o c u m e n t e d i n s p e c t i o n s

Number of inspections
comprising checks on the
presence of processed animal
proteins

Number of breaches based on
documentary checks etc. rather
than laboratory testing

Stage

Import of feed materials

Storage of feed materials

Feed mills

Home mixers/mobile mixers

Intermediaries of feedingstuffs

Means of transport

Farms keeping non-ruminants

Farms keeping ruminants

Others:

................................................................................................

B. S a m p l i n g a n d t e s t i n g o f

f e e d m a t e r i a l s a n d c o m p o u n d f e e d i n g s t u f f s f o r p r o c e s s e d

a n i m a l p r o t e i n s

Number of official samples tested
for processed animal proteins

Number of non-compliant samples

Presence of processed animal
protein from terrestrial animals

Presence of processed animal
protein from fish

Feed
materials

Compound feeding-
stuffs

for
ruminants

for non-
ruminants

Feed
materials

Compound feeding-
stuffs

for
ruminants

for non-
ruminants

Feed
materials

Compound feeding-
stuffs

for
ruminants

for non-
ruminants

Premises

At import

Feed mills

Intermediaries/
storage

Means of transport

Home mixers/
mobile mixers

On farm

Others:

......................

(1) OJ L 318, 27.11.1998, p. 45.

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C. S u m m a r y o f p r o h i b i t e d p r o c e s s e d a n i m a l p r o t e i n s f o u n d i n s a m p l e s o f
f e e d i n g s t u f f s i n t e n d e d f o r r u m i n a n t s

Month of sampling

Type, degree and origin of contami-
nation

Sanctions (or other measures) applied

1

2

3

4

5

…

In addition, EFTA States should analyse fats and vegetable oils intended for feedingstuffs for the presence of traces of
bones and include the results of such analyses in the report referred to in paragraph 2 of this Recommendation.

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ANNEX IV

Procedures for selection and assessment of supplies of feed materials of industrial origin

The competent authorities should identify and shortly describe the procedures followed by manufacturers of compound
feedingstuffs in order to select and assess supplies of feed materials of industrial origin. Some procedures may be related
to the prior establishment of characteristics or requirements for the products to be supplied, or for the suppliers. Other
procedures may be related to own-checks for the verification of compliance with certain parameters, carried out by
manufacturers of compound feedingstuffs at the reception of supplies.

For each identified procedure (procedure for selection and assessment of supplies), the competent authorities should
indicate the advantages and disadvantages of the application of the procedure in terms of feed safety. Finally they should
assess whether, taking into account the potential risks, each procedure is acceptable,
insufficient or unacceptable for
ensuring the safety of feedingstuffs, stating the reasons leading to that conclusion.

Evaluation of procedures

Procedure (short description,
including criteria for acceptance/
rejection of feed materials)

Advantages

Disadvantages

Assessment of acceptability of
procedures