Commission Regulation (EU) No 574/2011 of 16 June 2011 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for nitrite, melamine, Ambrosia spp. and carry-over of certain coccidiostats and histomonostats and consolidating Annexes I and II thereto  Text with EEA relevance
Date: 2011-06-16
Institutions: European Commission
Subjects: animal feedingstuffs, market approval, toxic substance




L_2011159EN.01000701.xml










17.6.2011   


EN


Official Journal of the European Union


L 159/7








            COMMISSION REGULATION (EU) No 574/2011
of 16 June 2011
         
amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for nitrite, melamine, Ambrosia spp. and carry-over of certain coccidiostats and histomonostats and consolidating Annexes I and II thereto
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) and the first indent of Article 8(2) thereof,

Whereas:







(1)


Directive 2002/32/EC provides that the use of products intended for animal feed that contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited. For certain undesirable substances, Member States are to carry out investigations identifying the sources of those substances if the thresholds set out in Annex II of that Directive are exceeded.












(2)


As regards nitrite, it was found that the products and by-products from sugar beet and sugarcane and from the starch production contain under certain conditions levels of nitrite exceeding the maximum levels recently established in Annex I to Directive 2002/32/EC. Furthermore, it appears that the method of analysis for the determination of nitrite in feed does not always provide reliable analytical results with regard to the products and by-products from sugar beet and sugarcane and from the starch production. Given that the European Food Safety Authority (EFSA) concluded in its opinion of 25 March 2009 (2) that the presence of nitrite in animal products does not raise any concern for human health, the products concerned should be exempted for the time being from the maximum level for nitrite in feed materials, while nitrite levels in those products and appropriate methods of analysis are further examined.












(3)


As regards melamine, the EFSA adopted on 18 March 2010 a scientific opinion on melamine in food and feed (3). EFSA findings show that exposure to melamine can result in the formation of crystals in the urinary tract. These crystals cause proximal tubular damage and have been observed in animals and children as a result of incidents involving adulteration of feed and infant formula with melamine, leading to fatalities in some instances. The Codex Alimentarius Commission has established maximum levels for melamine in feed and food (4). It is appropriate to include these maximum levels in Annex I to Directive 2002/32/EC to protect animal and public health as these levels are in accordance with the conclusions of the EFSA opinion. It is appropriate to exempt some feed additives from the maximum levels as they contain unavoidably a level of melamine above the maximum level as a result of the normal production process.












(4)


As regards Ambrosia spp., EFSA concluded in its opinion of 4 June 2010 (5) that bird feed may be an important means of Ambrosia spp. dispersal, especially in previously uninfested areas, as it often contains significant quantities of unprocessed seeds of Ambrosia spp. Therefore, the prevention of the use of bird feed contaminated with unprocessed seeds of Ambrosia spp. is likely to attenuate the further dispersal of Ambrosia spp. in the Union. Ambrosia spp. are of public health concern due to the allergenic properties of their pollen. Inhalation of the plant pollen may, amongst other conditions, cause rhino-conjunctivitis and asthma. There is also some evidence for allergenicity of Ambrosia spp. pollen in animals. It is therefore appropriate to limit the presence of Ambrosia spp. seeds in feed materials and compound feed containing unground grains and seeds and to establish a maximum level of Ambrosia spp. seeds in unground grains and seeds as low as reasonably achievable (ALARA) by good agricultural practices and cleaning techniques.












(5)


As regards coccidiostats and histomonostats, transfer from one production lot to another may occur when such substances are used as authorised feed additives. Such transfer may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of such substances, referred to as unavoidable carry-over or cross-contamination, in feed for which coccidiostats and histomonostats are not authorised, referred to as non-target feed. Taking into account the application of good manufacturing practices, maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA (As Low As Reasonably Achievable) principle. For the purpose of enabling the feed manufacturer to manage unavoidable carry-over, a carry-over rate of approximately 3 % of the authorised maximum content should be considered acceptable as regards feed for less sensitive non-target animal species while a carry-over rate of approximately 1 % of the authorised maximum content should be considered acceptable for feed intended to sensitive non-target animal species and feed used for the period before slaughter. The carry-over rate of 1 % should also be considered acceptable for cross-contamination of other feed for target species to which no coccidiostats or histomonostats are added, and as regards non-target feed for ‘continuous food-producing animals’, such as dairy cows or laying hens, where there is evidence of transfer from feed to food of animal origin. Where feed materials are fed directly to the animals or where complementary feedingstuffs are used, this should not lead to an exposure of the animals to a higher level of coccidiostats or histomonostats than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.












(6)


As regards the coccidiostats narasin, nicarbazin and lasalocid-sodium, Annex I to Directive 2002/32/EC should be amended to take into account recent modifications of the authorisations of those substances and Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (6) should consequently be amended.












(7)


Annexes I and II to Directive 2002/32/EC had already been adapted substantially and many times in the past. It is therefore appropriate to consolidate those Annexes. To improve the clarity and readability of those Annexes, it is appropriate to restructure them and to harmonise terminology. Given that the provisions contained in the Annexes have a direct application and are binding in their entirety, it is appropriate to establish these Annexes by a Regulation.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,





HAS ADOPTED THIS REGULATION



Article 1
Annexes I and II to Directive 2002/32/EC are replaced by the text in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 July 2011.
The provisions as regards Ambrosia spp. shall apply from 1 January 2012.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 June 2011.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 140, 30.5.2002, p. 10.

(2)  EFSA Panel on Contaminants in the Food Chain, Scientific Opinion on Nitrite as undesirable substances in animal feed, The EFSA Journal (2009) 1017, 1-47. Available online: http://www.efsa.europa.eu/en/scdocs/doc/1017.pdf

(3)  EFSA Panel on Contaminants in the Food Chain (CONTAM) and EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Melamine in Food and Feed. EFSA Journal 2010; 8(4):1573. [145 pp.]. doi:10.2903/j.efsa.2010.1573. Available online: http://www.efsa.europa.eu/en/scdocs/doc/1573.pdf

(4)  Report on the Thirty-Third Session of the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Geneva, Switzerland, 5-9 July 2010 (ALINORM 10/33/REP).

(5)  EFSA Panel on Contaminants in the Food Chain (CONTAM), EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) and EFSA Panel on Plant Health (PLH); Scientific Opinion on the effect on public or animal health or on the environment on the presence of seeds of Ambrosia spp. in animal feed. EFSA Journal 2010; 8(6):1566 [37 pp.]. doi:10.2903/j.efsa.2010.1566. Available online: http://www.efsa.europa.eu/en/scdocs/doc/1566.pdf

(6)  
            OJ L 140, 11.2.2009, p. 7.




ANNEX
Annexes I and II to Directive 2002/32/EC are replaced by the following:



‘ANNEX I

MAXIMUM LEVELS OF UNDESIRABLE SUBSTANCES, AS REFERRED TO IN ARTICLE 3(2)

SECTION I:   INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS







Undesirable substance


Products intended for animal feed


Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %












1.


Arsenic (1)







Feed materials


2 




with the exception of:


 










—


meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp,






4 










—


palm kernel expeller,






4  (2)











—


phosphates and calcareous marine algae,






10 










—


calcium carbonate,






15 










—


magnesium oxide and magnesium carbonate,






20 










—


fish, other aquatic animals and products derived thereof,






25  (2)











—


seaweed meal and feed materials derived from seaweed.






40  (2)





Iron particles used as tracer.


50 




Feed additives belonging to the functional groups of compounds of trace elements


30 




with the exception of:


 










—


cupric sulphate pentahydrate and cupric carbonate,






50 










—


zinc oxide, manganous oxide and cupric oxide.






100 




Complementary feed


4 




with the exception of:


 










—


mineral feed.






12 




Complete feed


2 




with the exception of:


 










—


complete feed for fish and fur animals.






10  (2)













2.


Cadmium






Feed materials of vegetable origin.


1 




Feed materials of animal origin.


2 




Feed materials of mineral origin


2 




with the exception of:


 










—


phosphates.






10 




Feed additives belonging to the functional group of compounds of trace elements


10 




with the exception of:


 










—


cupric oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate.






30 




Feed additives belonging to the functional groups of binders and anti-caking agents.


2 




Premixtures (6)



15 




Complementary feed


0,5 




with the exception of:


 










—


mineral feed






 










- -


containing < 7 % phosphorus (8),






5 










- -


containing ≥ 7 % phosphorus (8),






0,75 per 1 % phosphorus (8), with a maximum of 7,5










—


complementary feed for pet animals.






2 




Complete feed


0,5 




with the exception of:


 










—


complete feed for cattle (except calves), sheep (except lambs), goats (except kids) and fish,






1 










—


complete feed for pet animals.






2 












3.


Fluorine (7)







Feed materials


150 




with the exception of:


 










—


feed materials of animal origin except marine crustaceans such as marine krill,






500 










—


marine crustaceans such as marine krill,






3 000 










—


phosphates,






2 000 










—


calcium carbonate,






350 










—


magnesium oxide,






600 










—


calcareous marine algae.






1 000 




Vermiculite (E 561).


3 000 




Complementary feed:


 










—


containing ≤ 4 % phosphorus (8),






500 










—


containing > 4 % phosphorus (8).






125 per 1 % phosphorus (8)





Complete feed


150 




with the exception of:


 










—


complete feed for pigs,






100 










—


complete feed for poultry (except chicks) and fish,






350 










—


complete feed for chicks,






250 










—


complete feed for cattle, sheep and goats






 










- -


in lactation,






30 










- -


other.






50 












4.


Lead






Feed materials


10 




with the exception of:


 










—


forage (3),






30 










—


phosphates and calcareous marine algae,






15 










—


calcium carbonate,






20 










—


yeasts.






5 




Feed additives belonging to the functional group of compounds of trace elements


100 




with the exception of:


 










—


zinc oxide,






400 










—


manganous oxide, ferrous carbonate, cupric carbonate.






200 




Feed additives belonging to the functional group of binders and anti-caking agents


30 




with the exception of:


 










—


clinoptilolite of volcanic origin.






60 




Premixtures (6).


200 




Complementary feed


10 




with the exception of:


 










—


mineral feed.






15 




Complete feed.


5 












5.


Mercury (4)







Feed materials


0,1 




with the exception of:


 










—


fish, other aquatic animals and products derived thereof,






0,5 










—


calcium carbonate.






0,3 




Compound feed


0,1 




with the exception of:


 










—


mineral feed,






0,2 










—


compound feed for fish,






0,2 










—


compound feed for dogs, cats and fur animals.






0,3 












6.


Nitrite (5)







Feed materials


15 




with the exception of:


 










—


fishmeal,






30 










—


silage,






—










—


products and by-products from sugar beet and sugarcane and from starch production.






—




Complete feed


15 




with the exception of:


 










—


complete feed for dogs and cats with a moisture content exceeding 20 %.






—












7.


Melamine (9)







Feed


2,5 




with the exception of the feed additives:


 










—


guanidino acetic acid (GAA),






—










—


urea,






—










—


biuret.






—







SECTION II:   MYCOTOXINS







Undesirable substance


Products intended for animal feed


Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %












1.


Aflatoxin B1







Feed materials


0,02 




Complementary and complete feed


0,01 




with the exception of:


 










—


compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals,






0,005 










—


compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals).






0,02 










2.


Rye ergot (Claviceps purpurea)







Feed materials and compound feed containing unground cereals.


1 000 







SECTION III:   INHERENT PLANT TOXINS







Undesirable substance


Products intended for animal feed


Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %












1.


Free gossypol






Feed materials


20 




with the exception of:


 










—


cottonseed,






5 000 










—


cottonseed cakes and cottonseed meal.






1 200 




Complete feed


20 




with the exception of:


 










—


complete feed for cattle (except calves),






500 










—


complete feed for sheep (except lambs) and goats (except kids),






300 










—


complete feed for poultry (except laying hens) and calves,






100 










—


complete feed for rabbits, lambs, kids and pigs (except piglets).






60 












2.


Hydrocyanic acid






Feed materials


50 




with the exception of:


 










—


linseed,






250 










—


linseed cakes,






350 










—


manioc products and almond cakes.






100 




Complete feed


50 




with the exception of:


 










—


complete feed for young chickens (< 6 weeks).






10 












3.


Theobromine






Complete feed


300 




with the exception of:


 










—


complete feed for pigs,






200 










—


complete feed for dogs, rabbits, horses and fur animals.






50 












4.


vinyl thiooxazolidone (5-vinyloxazolidine-2-thione)






Complete feed for poultry


1 000 




with the exception of:


 










—


complete feed for laying hens.






500 












5.


Volatile mustard oil (10)







Feed materials


100 




with the exception of:


 










—


rapeseed cakes.






4 000 




Complete feed


150 




with the exception of:


 










—


complete feed for cattle (except calves), sheep (except lambs) and goats (except kids),






1 000 










—


complete feed for pigs (except piglets) and poultry.






500 







SECTION IV:   ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)







Undesirable substance


Products intended for animal feed


Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %










1.


Aldrin (11)







Feed materials and compound feed


0,01  (12)













2.


Dieldrin (11)







with the exception of:


 










—


fats and oils,






0,1  (12)











—


compound feed for fish.






0,02  (12)













3.


Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 62 (13)







Fish, other aquatic animals and products derived thereof


0,02 




with the exception of


 










—


fish oil.






0,2 




Complete feed for fish.


0,05 












4.


Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane)






Feed materials and compound feed


0,02 




with the exception of:


 










—


fats and oils.






0,05 












5.


DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT)






Feed materials and compound feed


0,05 




with the exception of:


 










—


fats and oils.






0,5 












6.


Endosulfan (sum of alpha- and beta- isomers and of endosulfansulphate expressed as endosulfan)






Feed materials and compound feed


0,1 




with the exception of:


 










—


maize and maize products derived from the processing thereof,






0,2 










—


oilseeds and products derived from the processing thereof, except crude vegetable oil,






0,5 










—


crude vegetable oil,






1,0 










—


complete feed for fish.






0,005 












7.


Endrin (sum of endrin and of delta-ketoi-endrin, expressed as endrin)






Feed materials and compound feed


0,01 




with the exception of:


 










—


fats and oils.






0,05 












8.


Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor)






Feed materials and compound feed


0,01 




with the exception of:


 










—


fats and oils.






0,2 












9.


Hexachlorobenzene (HCB)






Feed materials and compound feed


0,01 




with the exception of:


 










—


fats and oils.






0,2 



10.   Hexachlorocyclohexane (HCH)











—


alpha-isomers






Feed materials and compound feed


0,02 




with the exception of:


 










—


fats and oils.






0,2 










—


beta-isomers






Feed materials


0,01 




with the exception of:


 










—


fats and oils.






0,1 




Compound feed


0,01 




with the exception of:


 










—


compound feed for dairy cattle.






0,005 










—


gamma-isomers






Feed materials and compound feed


0,2 




with the exception of:


 










—


fats and oils.






2,0 







SECTION V:   DIOXINS AND PCBs







Undesirable substance


Products intended for animal feed


Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt) ( (14), (15)) relative to a feed with a moisture content of 12 %












1.


Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO –TEFs (toxic equivalency factors, 1997 (17))






Feed materials of plant origin


0,75 




with the exception of:


 










—


vegetable oils and their by-products






0,75 




Feed materials of mineral origin


1,0 




Feed materials of animal origin:


 










—


Animal fat, including milk fat and egg fat






2,0 










—


Other land animal products including milk and milk products and eggs and egg products.






0,75 










—


Fish oil






6,0 










—


Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (16)







1,25 










—


Fish protein hydrolysates containing more than 20 % fat.






2,25 




The feed additives kaolinitic clay, calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents.


0,75 




Feed additives belonging to the functional group of compounds of trace elements.


1,0 




Premixtures


1,0 




Compound feed


0,75 




with the exception of:


 










—


compound feed for pet animals and fish,






2,25 










—


compound feed for fur animals.






—












2.


Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs)) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (17))






Feed materials of plant origin


1,25 




with the exception of:


 










—


vegetable oils and their by-products.






1,5 




Feed materials of mineral origin


1,5 




Feed materials of animal origin:


 










—


Animal fat, including milk fat and egg fat,






3,0 










—


Other land animal products including milk and milk products and eggs and egg products.






1,25 










—


Fish oil






24,0 










—


Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (16)







4,5 










—


Fish protein hydrolysates containing more than 20 % fat.






11,0 




The feed additives kaolinitic clay, calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents.


1,5 




Feed additives belonging to the functional group of compounds of trace elements.


1,5 




Premixtures


1,5 




Compound feed


1,5 




with the exception of:


 










—


compound feed for pet animals and fish,






7,0 










—


compound feed for fur animals.






—







SECTION VI:   HARMFUL BOTANICAL IMPURITIES







Undesirable substance


Products intended for animal feed


Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %












1.


Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including






Feed materials and compound feed


3 000 










—



Datura sp.






 


1 000 










2.



Crotalaria spp.






Feed materials and compound feed


100 










3.


Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives (18), separately or in combination






Feed materials and compound feed


10  (19)











4.


Unhusked beech mast – Fagus silvatica L.










5.


Purghera – Jatropha curcas L.










6.


Indian mustard – Brassica juncea (L.) Czern. And Coss. ssp. integrifolia (West.) Thell.










7.


Sareptian mustard – Brassica juncea (L.) Czern. And Coss. ssp.juncea











8.


Chinese mustard – Brassica juncea (L.) Czern. And Coss. ssp. juncea var. lutea Batalin










9.


Black mustard – Brassica nigra (L.) Koch










10.


Ethiopian mustard – Brassica carinata A. Braun






Feed materials and compound feed


Seeds and fruit of the plant species listed opposite as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable












11.


Seeds from Ambrosia spp.






Feed materials


50 




with the exception of:


 










—


Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals.






200 




Compound feed containing unground grains and seeds


50 







SECTION VII:   AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER







Coccidiostat


Products intended for animal feed (20)



Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 %












1.


Decoquinate






Feed materials


0,4 




Compound feed for


 










—


laying birds and chickens reared for laying (> 16 weeks),






0,4 










—


chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed),






0,4 










—


other animal species.






1,2 




Premixtures for use in feed in which the use of decoquinate is not authorised.



 (21)













2.


Diclazuril






Feed materials


0,01 




Compound feed for


 










—


laying birds, chickens reared for laying (> 16 weeks) and turkeys for fattening (> 12 weeks),






0,01 










—


rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed),






0,01 










—


other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening (< 12 weeks).






0,03 




Premixtures for use in feed in which the use of diclazuril is not authorised.



 (21)













3.


Halofuginone hydrobromide






Feed materials


0,03 




Compound feed for


 










—


laying birds, chickens reared for laying and turkeys (> 12 weeks),






0,03 










—


chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed),






0,03 










—


other animal species.






0,09 




Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised.



 (21)













4.


Lasalocid sodium






Feed materials


1,25 




Compound feed for


 










—


dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks),






1,25 










—


chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of lasalocid sodium is prohibited (withdrawal feed),






1,25 










—


other animal species.






3,75 




Premixtures for use in feed in which the use of lasalocid sodium is not authorised



 (21)













5.


Maduramicin ammonium alpha






Feed materials


0,05 




Compound feed for


 










—


equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks),






0,05 










—


chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed),






0,05 










—


other animal species.






0,15 




Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.



 (21)













6.


Monensin sodium






Feed materials


1,25 




Compound feed for


 










—


equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks),






1,25 










—


chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed),






1,25 










—


other animal species.






3,75 




Premixtures for use in feed in which the use of monensin sodium is not authorised.



 (21)













7.


Narasin






Feed materials


0,7 




Compound feed for


 










—


turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks),






0,7 










—


other animal species.






2,1 




Premixtures for use in feed in which the use of narasin is not authorised.



 (21)













8.


Nicarbazin






Feed materials


1,25 




Compound feed for


 










—


equine species, laying birds and chickens reared for laying (> 16 weeks),






1,25 










—


other animal species.






3,75 




Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised.



 (21)













9.


Robenidine hydrochloride






Feed materials


0,7 




Compound feed for


 










—


laying birds and chickens reared for laying (> 16 weeks),






0,7 










—


chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed),






0,7 










—


other animal species.






2,1 




Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.



 (21)













10.


Salinomycin sodium






Feed materials


0,7 




Compound feed for


 










—


equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks),






0,7 










—


chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed),






0,7 










—


other animal species.






2,1 




Premixtures for use in feed in which the use of salinomycin sodium is not authorised



 (21)













11.


Semduramicin sodium






Feed materials


0,25 




Compound feed for


 










—


laying birds and chickens reared for laying (> 16 weeks),






0,25 










—


chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed),






0,25 










—


other animal species.






0,75 




Premixtures for use in feed in which the use of semduramicin sodium is not authorised.



 (21)









‘ANNEX II

ACTION THRESHOLDS TRIGGERING INVESTIGATIONS BY MEMBER STATES, AS REFERRED TO IN ARTICLE 4(2)







SECTION:

DIOXINS AND PCBs











Undesirable substances


Products intended for animal feed


Action threshold in ng WHO-PCDD/F-TEQ/kg (ppt) (23), (24) relative to a feed with a moisture content of 12 %


Comments and additional information (e.g. nature of investigations to be performed)












1.


Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs)) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (22))






Feed materials of plant origin


0,5 



 (25)





with the exception of:


 


 










—


vegetable oils and their by-products,






0,5 



 (25)





Feed materials of mineral origin


0,5 



 (25)





Feed materials of animal origin:


 


 










—


Animal fat, including milk fat and egg fat,






1,0 



 (25)











—


Other land animal products including milk and milk products and eggs and egg products.






0,5 



 (25)











—


Fish oil






5,0 



 (26)











—


Fish, other aquatic animals, and products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (24).






1,0 



 (26)











—


Fish protein hydrolysates containing more than 20 % fat.






1,75 



 (26)





Feed additives belonging to the functional groups of binders and anti-caking agents.


0,5 



 (26)





Feed additives belonging to the functional group of compounds of trace elements


0,5 



 (25)





Premixtures


0,5 



 (25)





Compound feed


0,5 



 (25)





with the exception of:


 


 










—


compound feed for pet animals and fish,






1,75 



 (26)











—


compound feed for fur animals.






—


 












2.


Dioxin-like PCBs (sum of polychlorinated biphenyls (PCBs)) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (22))






Feed materials of plant origin


0,35 



 (25)





with the exception of:


 


 










—


vegetable oils and their by-products,






0,5 



 (25)





Feed materials of mineral origin


0,35 



 (25)





Feed materials of animal origin:


 


 










—


Animal fat, including milk fat and egg fat,






0,75 



 (25)











—


Other land animal products including milk and milk products and eggs and egg products.






0,35 



 (25)











—


Fish oil






14,0 



 (26)











—


Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (24),






2,5 



 (26)











—


Fish protein hydrolysates containing more than 20 % fat.






7,0 



 (26)





Feed additives belonging to the functional groups of binders and anti-caking agents.


0,5 



 (25)





Feed additives belonging to the functional group of compounds of trace elements.


0,35 



 (25)





Premixtures


0,35 



 (25)





Compound feed


0,5 



 (25)





with the exception of:


 


 










—


compound feed for pet animals and fish,






3,5 



 (26)











—


compound feed for fur animals.






—


 





’


(1)  The maximum levels refer to total arsenic.

(2)  Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of inorganic arsenic is lower than 2 ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme.

(3)  Forage includes products intended for animal feed such as hay, silage, fresh grass, etc.

(4)  The maximum levels refer to total mercury.

(5)  The maximum levels are expressed as sodium nitrite.

(6)  The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 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 (OJ L 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed.

(7)  Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

(8)  The % of phosphorus is relative to a feed with a moisture content of 12 %.

(9)  The maximum level refers to melamine only. The inclusion of the structurally related compounds cyanuric acid, ammeline and ammelide in the maximum level will be considered at a later stage.

(10)  The maximum levels are expressed as allyl isothiocyanate.

(11)  Singly or combined expressed as dieldrin.

(12)  Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.

(13)  Numbering system according to Parlar, prefixed by either CHB or “Parlar”:






 


CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane,










 


CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane,










 


CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane.





(14)  Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

(15)  The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed mentioned in point 1 have to comply both with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs during that temporary period.

(16)  Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 4,0 ng WHO-PCDD/F-TEQ/kg product and 8,0 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 25,0 ng WHO-PCDD/F-PCB-TEQ/kg product to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

(17)  WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).






Congener


TEF value





Dibenzo-p-dioxins (“PCDDs”) and dibenzofurans (PCDFs)






2,3,7,8-TCDD


1 




1,2,3,7,8-PeCDD


1 




1,2,3,4,7,8-HxCDD


0,1 




1,2,3,6,7,8-HxCDD


0,1 




1,2,3,7,8,9-HxCDD


0,1 




1,2,3,4,6,7,8-HpCDD


0,01 




OCDD


0,0001 




2,3,7,8-TCDF


0,1 




1,2,3,7,8-PeCDF


0,05 




2,3,4,7,8-PeCDF


0,5 




1,2,3,4,7,8-HxCDF


0,1 




1,2,3,6,7,8-HxCDF


0,1 




1,2,3,7,8,9-HxCDF


0,1 




2,3,4,6,7,8-HxCDF


0,1 




1,2,3,4,6,7,8-HpCDF


0,01 




1,2,3,4,7,8,9-HpCDF


0,01 




OCDF


0,0001 





“Dioxin-like” PCBs Non-ortho PCBs + Mono-ortho PCBs






 


 





Non-ortho PCBs






PCB 77


0,0001 




PCB 81


0,0001 




PCB 126


0,1 




PCB 169


0,01 





Mono-ortho PCBs






PCB 105


0,0001 




PCB 114


0,0005 




PCB 118


0,0001 




PCB 123


0,0001 




PCB 156


0,0005 




PCB 157


0,0005 




PCB 167


0,00001 




PCB 189


0,0001 




 


 




 


 




Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.





(18)  In so far determinable by analytical microscopy.

(19)  Includes also seed husk fragments.

(20)  Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 29).

(21)  The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed.

(22)  WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).

(23)  Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

(24)  The Commission will review these action levels at the same time as it reviews the maximum levels for the sum of dioxins and dioxin-like PCBs.

(25)  Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

(26)  In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc …, must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.






Congener


TEF value





Dibenzo-p-dioxins (“PCDDs”) and diobenzofurans (“PCDFs”)






2,3,7,8-TCDD


1 




1,2,3,7,8-PeCDD


1 




1,2,3,4,7,8-HxCDD


0,1 




1,2,3,6,7,8-HxCDD


0,1 




1,2,3,7,8,9-HxCDD


0,1 




1,2,3,4,6,7,8-HpCDD


0,01 




OCDD


0,0001 




2,3,7,8-TCDF


0,1 




1,2,3,7,8-PeCDF


0,05 




2,3,4,7,8-PeCDF


0,5 




1,2,3,4,7,8-HxCDF


0,1 




1,2,3,6,7,8-HxCDF


0,1 




1,2,3,7,8,9-HxCDF


0,1 




2,3,4,6,7,8-HxCDF


0,1 




1,2,3,4,6,7,8-HpCDF


0,01 




1,2,3,4,7,8,9-HpCDF


0,01 




OCDF


0,0001 





“Dioxin-like” PCBs Non-ortho PCBs + Mono-ortho PCBs






 


 





Non-ortho PCBs






PCB 77


0,0001 




PCB 81


0,0001 




PCB 126


0,1 




PCB 169


0,01 





Mono-ortho PCBs






PCB 105


0,0001 




PCB 114


0,0005 




PCB 118


0,0001 




PCB 123


0,0001 




PCB 156


0,0005 




PCB 157


0,0005 




PCB 167


0,00001 




PCB 189


0,0001 




 


 




 


 




Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.