EN Official Journal of the European Union L 137/19

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,

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

(2) 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)), as amended, establishes maximum contents of aflatoxin B1 in feedingstuffs, there are no EEA 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. 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.

(4) The participation of Norway and Iceland in the programmes within the scope of Annex II of this Recommendation 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 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition.

(5) 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 I of Annex I to the EEA Agreement.

(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 for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements (3)), 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.

(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 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 EFTA States 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 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 of inspections in the field of animal nutrition) and the latest version of the harmonised reporting model.

Done at Brussels, 5 April 2005. For the EFTA Surveillance Authority Niels FENGER Director Bernd HAMMERMANN College Member

(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.

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 (μg/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 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 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, 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 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, 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 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 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: ...

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 1993/2004 (OJ L 344, 20.11.2004, p. 12). (2) OJ L 339, 24.12.2003, p. 78.