Recommendation of the EFTA Surveillance Authority No 59/05/COL of  5 April 2005  on the co-ordinated inspection programme in the field of animal nutrition for 2005
Date: 2005-04-05
Institutions: EFTA Surveillance Authority
Subjects: EFTA, action programme, animal feedingstuffs, animal nutrition, food inspection, food standard, veterinary inspection

25.5.2006

EN

Official Journal of the European Union

L 137/19

II

(Acts whose publication is not obligatory)

EUROPEAN ECONOMIC AREA

EFTA SURVEILLANCE AUTHORITY

RECOMMENDATION OF THE EFTA SURVEILLANCE AUTHORITY

No 59/05/COL

of 5 April 2005

on the co-ordinated inspection programme in the field of animal nutrition for 2005

THE EFTA SURVEILLANCE AUTHORITY,

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)

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 organization of
inspections in the field of animal nutrition (1)), as amended, and as
adapted to the EEA Agreement by Protocol 1 thereto, and in
particular Article 22(3) thereof,

Whereas:

(1)

(2)

In 2004 the EFTA States identified certain issues as
worthy of a co-ordinated inspection programme to be
carried out in 2005.

(4)

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
feed (2)), as amended,
on undesirable substances in animal
establishes maximum contents of aflatoxin B1 in feeding-
stuffs, there are no EEA rules for other mycotoxins, such
as ochratoxin A, zearalenone, deoxynivalenol and fumo-
nisins. Gathering information on the presence of those

(5)

(1) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive
the Council

the European Parliament and of

2001/46/EC of
(OJ L 234, 1.9.2001, p. 55).

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

last amended by
Commission Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33).

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 and oil seeds are
particularly exposed to mycotoxin contamination because
storage and transport conditions. As
of harvesting,
mycotoxin concentration varies from year to year, it is
appropriate to collect data from consecutive years for all
mycotoxins mentioned.

Antibiotics, other than coccidiostats and histomonostats,
may be marketed and used as feed additives only until 31
December 2005. Previous checks for the presence of
in certain feedingstuffs
antibiotics and coccidiostats
where some of
those substances are not authorised
indicate that this type of infringement still occurs. The
frequency of such findings and the sensitivity of this
matter
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.

continuation of

checks.

justify

the

It

The participation of Norway
and Iceland in the
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
exemptions from Chapter II of Annex I
to the EEA
in particular, from the Act referred to
Agreement and,
to the EEA
at Point 1a of Chapter
Agreement, Regulation (EC) No 1831/2003 of
the
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition.

II of Annex I

scope of Annex III of

The participation of Iceland in the programmes within
the
this Recommendation
concerning restrictions on the production and use of
feed materials of
to be
evaluated with respect to its exemptions from Chapter I
of Annex I to the EEA Agreement.

animal origin will have

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Official Journal of the European Union

25.5.2006

(6)

It is appropriate to ensure that the levels of the trace
elements copper and zinc in compound feedingstuffs
for pigs do not exceed the maximum content
laid
down by the Act referred to at Point 1zq of Chapter II
of Annex I to the EEA Agreement (Commission Regulation
(EC) No 1334/2003 of 25 July 2003 amending the
conditions
in
feedingstuffs belonging to the group of trace elements (1)), as
amended.
the
programmes within the scope of Annex IV will have
to be evaluated with respect
to its exemptions from
Chapter II of Annex I to the EEA Agreement.

for authorisation of a number of additives

of Norway

participation

The

in

(7)

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:

1. It is recommended that the EFTA States carry out during
2005 a co-ordinated inspection programme aimed to
check:

(a) the

(aflatoxin

concentration

of mycotoxins

in feedingstuffs,

B1,
ochratoxin A, zearalenone, deoxynivalenol and fumo-
indicating the methods of
nisins)
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; in the case of
aflatoxin B1, particular attention should also be paid to
compound feedingstuffs for dairy animals other than
should be
dairy cattle;
reported using the model set out in Annex I;

results of

checks

the

the

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

(c) the implementation of restrictions on the production and
feed materials of animal origin, as set out in

use of
Annex III;

(d) the levels of copper and zinc in compound feedingstuffs

for pigs, as set out in Annex IV.

for

provided

inspection

programme

2. It is recommended that EFTA States include the results of the
co-ordinated
in
paragraph 1 in a separate Chapter in the annual report on
inspection activities
transmitted to the EFTA
Surveillance Authority by 1 April 2006 in accordance with
Article 22(2) of 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 organization
inspections in the field of animal nutrition) and the latest
of
version of the harmonised reporting model.

to be

Done at Brussels, 5 April 2005.

For the EFTA Surveillance Authority

Niels FENGER
Director

Bernd HAMMERMANN
College Member

(1) OJ L 187, 26.7.2003, p. 11.

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Official Journal of the European Union

L 137/21

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

Deoxynivalenol

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 medicinal substances not authorised as feed additives

Certain antibiotics, coccidiostats and other medicinal substances may be legally present as additives in pre-mixtures and
compound feedingstuffs for certain species and categories of animals, when fulfilling the requirements of Article 10 of the
Act referred to at Point 1a of Chapter II of Annex I to the EEA Agreement, (Regulation (EC) No 1831/2003 of the European
Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1)).

The presence of unauthorised medicinal substances in feedingstuffs constitutes an infringement.

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

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

avilamycin

decoquinate

diclazuril
flavophospholipol

halofuginone hydrobromide

lasalocid A sodium
maduramicin ammonium alpha

monensin sodium

narasin
narasin — nicarbazin
robenidine hydrochloride

salinomycin sodium

semduramicin sodium

2. Medicinal substances no longer authorised as feed additives:

amprolium
amprolium/ethopabate

arprinocid

avoparcin
carbadox

dimetridazole

dinitolmid
ipronidazol

meticlorpindol

nicarbazin
nifursol

olaquindox

ronidazol
spiramycin

tetracyclines

tylosin phosphate
virginiamycin

zinc bacitracin

meticlorpindol/methylbenzoquate

other antimicrobial substances

3. Medicinal 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.

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.

(1) OJ L 268, 18.10.2003, p. 29.

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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, EFTA States should during 2005 undertake a co-
ordinated 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
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. The 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

cross-contamination resulting

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

from internal

of

Border Inspection Posts
and other points of entry
into the Community

— 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. Regulation as last amended by Commission Regulation (EC) No 1993/2004 (OJ L 344, 20.11.2004, p. 12).

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As an alternative to these indicative premises and criteria, the EFTA States may forward their own risk assessment to the
EFTA Surveillance Authority before 31 March 2005.

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

In 2005, the EFTA States should focus on the analysis of sugar beet pulp and imported feed materials.

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 the Act referred to at Point 31i of Chapter II of Annex I to the EEA Agreement (Commission Directive
2003/126/EC on the analytical method for the determination of constituents of animal origin for the official control of feeding-
stuffs (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. Documented inspections

Stage

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

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

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:

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

(1) OJ L 339, 24.12.2003, p. 78.

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B. Sampling and testing of feed materials and compound feedingstuffs for processed animal proteins

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
feedingstuffs

for
ruminants

for non-
ruminants

Feed
materials

Compound
feedingstuffs

for
ruminants

for non-
ruminants

Feed
materials

Compound
feedingstuffs

for
ruminants

for non-
ruminants

Premises

At import

Feed mills

Intermediaries/storage

Means of transport

Home mixers/mobile
mixers

On farm

Others:

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

C. Summary of prohibited processed animal proteins found in samples of feedingstuffs intended for ruminants

Month of sampling

Type degree and origin of contamination

Sanctions (or other measures) applied

1

2

3

4

5

…

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ANNEX IV

Individual results of all samples (both compliant and non-compliant) concerning the content of copper and zinc
in compound feedingstuffs for pigs

Type of compound
feedingstuff (animal
category)

Trace element
(copper or zinc)

Level found (mg/kg of
complete feedingstuff)

Reason for exceeding the
maximum content (a)

Action taken

(a) As concluded after an investigation carried out by the competent authority.