Recommendation of the EFTA Surveillance Authority No 150/06/COL of 17 May 2006 concerning a coordinated inspection programme in the field of animal nutrition for the year 2006
Date: 2006-05-17
Institutions: EFTA Surveillance Authority
Subjects: EFTA countries, animal nutrition, food additive, food inspection, foodstuffs legislation

L 366/96

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Official Journal of the European Union

21.12.2006

RECOMMENDATION OF THE EFTA SURVEILLANCE AUTHORITY

No 150/06/COL

of 17 May 2006

concerning a coordinated inspection programme in the field of animal nutrition for the year 2006

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,

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)

In 2005 the EFTA States identified certain issues as worthy
of a coordinated inspection programme to be carried out in
2006.

(2) Although the Act referred to at point 33 of Chapter II of
Annex I to the EEA Agreement (Council Directive 2002/32/
EC of the European Parliament and of the Council of 7 May
2002 on undesirable substances in animal feed (2)), as amended,
establishes maximum contents of aflatoxin B1 in feeding-
stuffs, there are no EEA rules for other mycotoxins, such as
ochratoxin A, zearalenone, deoxynivalenol, fumonisins., T-
2 and HT-2 toxins. 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 and oil seeds are
particularly exposed to mycotoxin contamination because
of harvesting,
conditions. As
storage and transport
it is
mycotoxin concentration varies from year to year,
appropriate to collect data from consecutive years for all
mycotoxins mentioned.

(3)

Previous results of checks for the presence of antibiotics
and coccidiostats in certain feedingstuffs intended for
animal
active
substances are not authorized indicate that this type of
infringement still occurs. Furthermore, in accordance with

category for which those

species or

the provisions of Article 11(2) 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 (3)),
the
phasing out of antibiotic feed additives is effectively
enforced.

to ensure that

is important

it

(4)

(5)

(6)

(7)

The participation of Norway and Iceland in the pro-
grammes within the scope of Annex II of this Recommen-
dation 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
Agreement and, in particular, from the Act referred to at
Point 1a of Chapter II of Annex I to the EEA Agreement,
Regulation (EC) No 1831/2003.

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

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

I of Annex I

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 for authorisation of a
number of additives in feedingstuffs belonging to the group of
trace elements (4)), as amended. The participation of Norway
in 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.

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 Author-
ity,

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

(3) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission

Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

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

last amended by

(4) OJ L 187, 26.7.2003, p. 11. Regulation as amended by Regulation

Commission Directive 2006/77/EC (OJ L 271, 30.9.2006, p. 53).

(EC) No 1980/2005 (OJ L 318, 6.12.2005, p. 3).

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Official Journal of the European Union

L 366/97

HEREBY RECOMMENDS:

1.

It is recommended that the EFTA States carry out during
2006 a coordinated inspection programme aimed to check:

(a)

(b)

concentration of mycotoxins

the
(aflatoxin B1,
ochratoxin A, zearalenone, deoxynivalenol, fumoni-
sins, T-2 and HT-2 toxins) in feedingstuffs, indicating
the methods of 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 dairy cattle; the results of the checks should
be reported using the model set out in Annex I;

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 substances are not authorised; the checks should
target those substances in pre-mixtures and com-
pound feedingstuffs
competent authority
considers that there is a greater probability of finding
the checks should be
irregularities;
reported using the model set out in Annex II;

the results of

the

if

(c)

(d)

the implementation of the phasing out of antibiotics
as feed additives as set out in Annex II;

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

(e)

the levels of copper and zinc in compound feeding-
stuffs for pigs, as set out in Annex IV.

2.

It is recommended that EFTA States include the results of
the coordinated inspection programme provided for in
paragraph 1 in a separate Chapter in the annual report on
inspection activities
to be transmitted to the EFTA
Surveillance Authority by 1 April 2007 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) and the latest version of the harmonised
reporting model.

Done at Brussels, of 17 May 2006.

For the EFTA Surveillance
Authority
Kristján Andri STEFÁNSSON
College Member

Niels FENGER
Director

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Official Journal of the European Union

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Concentration of certain mycotoxins (aflatoxin B1, ochratoxin A, zearalenone, deoxynivalenol, fumonisins, T-2
and HT-2-toxins) in feedingstuffs

ANNEX I

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

Feedingstuffs

Sampling
(random
or tar-
geted)

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

Class (a)

Type (b)

Country of
origin

Aflatoxin
B1

Ochra-
toxin A

Zearale-
none

Deoxyni-
valenol

Fumoni-
sins (c)

T-2 and HT-
2-toxins (d)

(a)
(b)

Select one of the following classes: feed material, feed additive, premixture, complementary feed, complete feed, compound feed.
Select one of the following types: (a) for feed materials, the name of the feed material as laid down in part B of the Annex to the Act
referred to at point 14a of Chapter II of Annex I to the EEA Agreement (Council Directive 96/25/EC of 29 April 1996 on the circulation of
feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC); (b) for other
feedingstuffs, the target species.
The concentration of fumonisins B1 and B2 can be reported as the sum of both.

(c)
(d) The concentration of the T-2 and HT-2 toxins can be reported as the sum of both.

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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Official Journal of the European Union

L 366/99

Presence of certain medicinal substances not authorised as feed additives

ANNEX II

Certain 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).

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:

decoquinate (Deccox)

diclazuril (Clinacox 0,2 %)

halofuginone hydrobromide (Stenorol)

lasalocid A sodium (Avatec 15 %)

maduramicin ammonium alpha(Cygro 1 %)

monensin sodium (Elancoban G100, 100, G200, 200)

narasin

narasin — nicarbazin (Maxiban G160)

robenidine hydrochloride (Cycostat 66G)

salinomycin sodium (Sacox 120G, 120)

semduramicin sodium (Aviaz 5 %)

2.

Medicinal substances no longer authorised as feed additives:

amprolium

amprolium/ethopabate

arprinocid

avilamycin

avoparcin

carbadox

dimetridazole

dinitolmid

flavophospholipol

ipronidazol

meticlorpindol

meticlorpindol/methylbenzoquate

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nicarbazin

nifursol

olaquindox

ronidazol

spiramycin

tetracyclines

tylosin phosphate

virginiamycin

zinc bacitracin

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 infrin-
gement (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.

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Official Journal of the European Union

L 366/101

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 2006 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
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

Criteria

Weighting

Feed mills

— 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
lines, control of
laboratory, sampling proce-
ingredients,
dures).

the effective separation of
internal

Border Inspection Posts and other
points of entry into the Commu-
nity

— 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 feeding-

stuffs with high protein content.

— High volume of bulk feedingstuffs traded.
— Dealers
abroad.

in compound feedingstuffs produced

(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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Premises

Criteria

Weighting

Mobile mixers

— 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.

— Vehicles used for the transportation of processed

animal proteins and feedingstuffs.

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

compliance.

Means of transportation

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 May 2006.

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).

Controls could also be extended to the analyses of dust in vehicles, manufacturing equipment and storage areas.

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 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.

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

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

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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

Intermediaries of feedingstuffs

Means of transport

Farms keeping non-ruminants

Farms keeping ruminants

Others:

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 pro-
tein from fish

Premises

Feed
mater-
ials

Compound
feedingstuffs

for
rumi-
nants

for non-
rumi-
nants

Feed
mater-
ials

Compound
feedingstuffs

for
rumi-
nants

for non-
rumi-
nants

Feed
mater-
ials

Compound
feedingstuffs

for
rumi-
nants

for non-
ruminants

At import

Feed mills

Intermediaries/sto-
rage

Means of transport

Home mixers/mobile
mixers

On farm

Others:

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C.

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

ruminants

Month of sampling

Type degree and origin of con-
tamination

Sanctions (or other measures)
applied

1

2

3

4

5

…

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Official Journal of the European Union

L 366/105

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

ANNEX IV

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.