CELEX: E2006C0150
Language: en
Date: 2006-05-17 00:00:00
Title: 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

21.12.2006   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 366/96
            
         
      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 feedingstuffs, 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, 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 authorized indicate that this type of infringement still occurs. Furthermore, in accordance with 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)), it is important to ensure that the phasing out of antibiotic feed additives is 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.
               
            
         
               (5)
            
            
               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.
            
         
               (6)
            
            
               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.
            
         
               (7)
            
            
               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 Authority,
   HEREBY RECOMMENDS:
   
               1.
            
            
               It is recommended that the EFTA States carry out during 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.
            
            
               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
         
      
   
   
      (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 2006/77/EC (OJ L 271, 30.9.2006, p. 53).
   
      (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 1980/2005 (OJ L 318, 6.12.2005, p. 3).
   
      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 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.
      
         (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 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
                           
                        
                               
                           
                           
                              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 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 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 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
          (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.
   
   
      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.