EN Official Journal of the European Union L 337/51

COMMISSION RECOMMENDATION

of 14 December 2005

on the coordinated inspection programme in the field of animal nutrition for the year 2006 in accordance with Council Directive 95/53/EC

(2005/925/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 2005 Member States identified certain issues as worthy of a coordinated inspection programme to be carried out in the year 2006.

(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, 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, 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) Previous results of checks for the presence of antibiotics and coccidiostats in certain feedingstuffs intended for animal species or category for which those active substances are not authorised indicate that this type of infringement still occurs. Furthermore, in accordance with the provisions of Article 11(2) 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 (3), it is important to ensure that the phasing out of antibiotic feed additives is effectively enforced.

(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 (4).

(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 THAT MEMBER STATES:

1. carry out during the year 2006 a coordinated inspection programme aimed to check: (a) the concentration of mycotoxins (aflatoxin B1, ochratoxin A, zearalenone, deoxynivalenol, fumonisins, 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; (b) 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 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 the phasing out of antibiotics as feed additives as set out in Annex II; (d) 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 feedingstuffs for pigs, as set out in Annex IV.

2. include the results of the co-ordinated inspection programme provided for in paragraph 1 in a separate Chapter in the annual report on inspection activities to be transmitted by 1 April 2007 and the latest version of the harmonised reporting model.

Done at Brussels, 14 December 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 2005/8/EC (OJ L 27, 29.1.2005, p. 44).

(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).

(4) 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, T-2 and HT-2-toxins) 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 (μg/kg relative to a feedingstuff with a moisture content of 12 %) Class (1) Type (2) Country of origin Aflatoxin B1 Ochratoxin A Zearalenone Deoxynivalenol Fumonisins (3) T-2- and HT-2-toxins (4)

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) Select one of the following classes: feed material, feed additive, premixture, complementary feed, complete feed, compound feed.

(2) 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 Council Directive 96/25/EC (OJ L 125, 23.5.1996, p. 35); (b) for other feedingstuffs, the target species.

(3) The concentration of fumonisins B1 and B2 can be reported as the sum of both.

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

ANNEX II

Presence of certain medicinal substances not authorised as feed additives

Certain medicinal substances may be legally present as additives in pre-mixtures and compound feedingstuffs for certain animal species and categories, when fulfilling the requirements of Article 10 of Regulation (EC) No 1831/2003.

The presence of unauthorised medicinal substances in feedingstuffs for certain animal species and categories 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 (Monteban) narasin — nicarbazin (Maxiban G160) robenidine hydrochloride (Cycostat 66 G) salinomycin sodium (Sacox 120G, 120) semduramicin sodium (Aviax 5 %)

2. Medicinal substances no longer authorised as feed additives: amprolium amprolium/ethopabate arprinocid avilamycin avoparcin carbadox dimetridazole dinitolmid flavophospholipol 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 (1) 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) 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 Article 3 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (1), Member 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 to Regulation (EC) No 999/2001 of the European Parliament and of the Council (2), are effectively applied, Member States should implement a specific control programme based on targeted controls. In accordance with Article 3 of Regulation (EC) No 882/2004, 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 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 analysis of dust in vehicles, manufacturing equipment and storage areas.

The minimum number of inspections per year in a Member State should be 10 per 100 000 tonnes of compound feed produced. The minimum number of official samples per year in a Member 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 2003/126/EC (3) should be used for analysing samples. The detection of animal proteins shall be interpreted in line with the provisions in Regulation (EC) No 999/2001.

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 165, 30.4.2004, p. 1.

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

(3) 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.