Commission Recommendation

of 2 March 2005

on the coordinated inspection programme in the field of animal nutrition for the year 2005 in accordance with Council Directive 95/53/EC

(Text with EEA relevance)

(2005/187/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition [1], and in particular Article 22(3) thereof,

Whereas:

(1) In 2004 Member States identified certain issues as worthy of a coordinated inspection programme to be carried out in the year 2005.

(2) Although Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [2] establishes maximum contents of aflatoxin B1 in feedingstuffs, there are no Community rules 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 and oil seeds are particularly exposed to mycotoxin contamination because of harvesting, storage and transport conditions. As mycotoxin concentration varies from year to year, it is appropriate to collect data from consecutive years for all mycotoxins mentioned.

(3) 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 antibiotics and coccidiostats in certain feedingstuffs 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 justify the continuation of checks.

(4) 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 Community legislation, are effectively enforced.

(5) 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 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 [3].

(6) The measures provided for in this Recommendation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HEREBY RECOMMENDS:

1. It is recommended that Member States carry out during the year 2005 a coordinated inspection programme aimed to check:

(a) the concentration of mycotoxins (aflatoxin B1, ochratoxin A, zearalenone, deoxynivalenol and fumonisins) 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;

(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 use of feed materials of animal origin, as set out in Annex III;

(d) the levels of copper and zinc in compound feedingstuffs for pigs, as set out in Annex IV.

2. It is recommended that Member 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 by 1 April 2006 in accordance with Article 22(2) of Directive 95/53/EC and the latest version of the harmonised reporting model.

Done at Brussels, 2 March 2005.

For the Commission

Markos Kyprianou

Member of the Commission

[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).

[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).

[3] OJ L 187, 26.7.2003, p. 11. Regulation as amended by Regulation (EC) No 2112/2003 (OJ L 317, 2.12.2003, p. 22).

--------------------------------------------------

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 | Sampling (random or targeted) | Type and concentration of mycotoxins (渭g/kg relative to a feedingstuff with a moisture content of 12 %) |

Type | Country of origin | Aflatoxin B1 | Ochratoxin A | Zearalenone | Deoxynivalenol | Fumonisins [1] |

| | | | | | | |

| | | | | | | |

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.

[1] The concentration of fumonisins comprises the total of fumonisins B1, B2 and B3.

--------------------------------------------------

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 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

meticlorpindol/methylbenzoquate

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 infringement [2] | Action taken |

| | | | |

| | | | |

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.

[2] Reason leading to the presence of the unauthorised substance in the feedingstuff, as concluded after an investigation carried out by the competent authority.

--------------------------------------------------

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, Member States should during 2005 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 to 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, Member 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. Member 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 the effective separation of lines, control of ingredients, internal laboratory, sampling procedures) | |

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 content High volume of bulk feedingstuffs traded Dealers in compound feedingstuffs produced abroad | |

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 | |

Means of transportation | Vehicles used for the transportation of processed animal proteins and feedingstuffs Vehicles with previous history, or suspicion, of non-compliance | |

As an alternative to these indicative premises and criteria, Member States may forward their own risk assessment to the Commission 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, Member States should focus on the analysis of sugar beet pulp and imported feed materials.

The minimum number of inspections per year in a Member State should be 10 per 100000 tonnes of compound feed produced. The minimum number of official samples per year in a Member State should be 20 per 100000 tonnes of compound feed produced. Pending the approval of alternative methods, microscopic identification and estimation as described in Commission Directive 2003/126/EC of 23 December 2003 on the analytical method for the determination of constituents of animal origin for the official control of feedingstuffs [2] 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 Commission 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: ‘︹�‘︹�‘︹�‘︹�. | | |

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

Premises | 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 | Feed materials | Compound feedingstuffs | Feed materials | Compound feedingstuffs |

for ruminants | for non-ruminants | for ruminants | for non-ruminants | for ruminants | for non-ruminants |

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 | | | |

‘�| | | |

| | | |

[1] OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 214/2005 (OJ L 37, 10.2.2005, p. 9).

[2] OJ L 339, 24.12.2003, p. 78.

--------------------------------------------------

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 [1] | Action taken |

| | | | |

| | | | |

[1] As concluded after an investigation carried out by the competent authority.

--------------------------------------------------