Commission Regulation (EU) No 277/2012 of 28 March 2012 amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels and action thresholds for dioxins and polychlorinated biphenyls  Text with EEA relevance

ANNEX
ANNEX
(1)
In Annex I to Directive 2002/32/EC, Section V: Dioxins and PCBs is replaced by the following:
‘SECTION V:   DIOXINS AND PCBs
Undesirable substance
Products intended for animal feed
Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt)  ( 1 ) 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), 2005  ( 2 ) )
Feed materials of plant origin with the exception of:
0,75
—
vegetable oils and their by-products
0,75
Feed materials of mineral origin
0,75
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat
1,50
—
Other land animal products including milk and milk products and eggs and egg products
0,75
—
Fish oil
5,0
—
Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat  ( 3 )
1,25
—
Fish protein, hydrolysed, containing more than 20 % fat
1,75
The feed additives kaolinitic clay, 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 with the exception of:
0,75
—
compound feed for pet animals and fish
1,75
—
compound feed for fur animals
—
Undesirable substance
Products intended for animal feed
Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt)  ( 1 ) relative to a feed with a moisture content of 12 %
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), 2005  ( 2 ) )
Feed materials of plant origin with the exception of:
1,25
—
vegetable oils and their by-products
1,5
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
1,25
—
Fish oil
20,0
—
Fish, other aquatic animals, and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat  ( 3 )
4,0
—
Fish protein, hydrolysed, containing more than 20 % fat
9,0
The feed additives kaolinitic clay, 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 with the exception of:
1,5
—
compound feed for pet animals and fish
5,5
—
compound feed for fur animals
—
Undesirable substance
Products intended for animal feed
Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12 %  ( 1 )
3.
Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6)  ( 1 ) )
Feed materials of plant origin
10
Feed materials of mineral origin
10
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat
10
—
Other land animal products including milk and milk products and eggs and egg products
10
—
Fish oil
175
—
Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat  ( 4 )
30
—
Fish protein, hydrolysed, containing more than 20 % fat
50
The feed additives kaolinitic clay, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents
10
Feed additives belonging to the functional group of compounds of trace elements
10
Premixtures
10
Compound feed with the exception of:
10
—
compound feed for pet animals and fish
40
—
compound feed for fur animals
—
(2)
Annex II to Directive 2002/32/EC is replaced by the following:
‘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)  ( 6 ) relative to a feedingstuff 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), 2005  ( 5 ) )
Feed materials of plant origin with the exception of:
0,5
( 7 )
—
vegetable oils and their by-products
0,5
( 7 )
Feed materials of mineral origin
0,5
( 7 )
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat
0,75
( 7 )
—
Other land animal products including milk and milk products and eggs and egg products
0,5
( 7 )
—
Fish oil
4,0
( 8 )
—
Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat  ( 7 )
0,75
( 8 )
—
Fish protein, hydrolysed, containing more than 20 % fat
1,25
( 8 )
Feed additives belonging to the functional groups of binders and anti-caking agents
0,5
( 7 )
Feed additives belonging to the functional group of compounds of trace elements
0,5
( 7 )
Premixtures
0,5
( 7 )
Compound feed with the exception of:
—
compound feed for pet animals and fish
1,25
( 8 )
—
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, 2005)  ( 5 ) )
Feed materials of plant origin with the exception of:
0,35
( 7 )
—
vegetable oils and their by-products
0,5
( 7 )
Feed materials of mineral origin
0,35
( 7 )
Feed materials of animal origin:
—
Animal fat, including milk fat and egg fat
0,75
( 7 )
—
Other land animal products including milk and milk products and eggs and egg products
0,35
( 7 )
—
Fish oil
11,0
( 8 )
—
Fish, other aquatic animals and products derived thereof with the exception of fish oil and fish protein, hydrolysed, containing more than 20 % fat  ( 7 )
2,0
( 8 )
—
Fish protein, hydrolysed, containing more than 20 % fat
5,0
( 8 )
Feed additives belonging to the functional groups of binders and anti-caking agents
0,5
( 7 )
Feed additives belonging to the functional group of compounds of trace elements
0,35
( 7 )
Premixtures
0,35
( 7 )
Compound feed with the exception of:
0,5
( 7 )
—
compound feed for pet animals and fish
2,5
( 8 )
—
compound feed for fur animals
—
( 1 )   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.
( 2 )   Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:
WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
Congener
TEF value
Dibenzo-para-dioxins (“PCDDs”) and Dibenzo-para-furans (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
0,0003
2,3,7,8-TCDF
0,1
1,2,3,7,8-PeCDF
0,03
2,3,4,7,8-PeCDF
0,3
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
0,0003
“Dioxin-like” PCBs: Non-ortho PCBs + Mono-ortho PCBs
Non-ortho PCBs
PCB 77
0,0001
PCB 81
0,0003
PCB 126
0,1
PCB 169
0,03
Mono-ortho PCBs
PCB 105
0,00003
PCB 114
0,00003
PCB 118
0,00003
PCB 123
0,00003
PCB 156
0,00003
PCB 157
0,00003
PCB 167
0,00003
PCB 189
0,00003
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.
( 3 )   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 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable 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.
( 4 )   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 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable 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.’
( 5 )   Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs:
WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
Congener
TEF value
Dibenzo-para-dioxins (“PCDDs”) and Dibenzo-para-furans (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
0,0003
2,3,7,8-TCDF
0,1
1,2,3,7,8-PeCDF
0,03
2,3,4,7,8-PeCDF
0,3
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
0,0003
“Dioxin-like” PCBs: Non-ortho PCBs + Mono-ortho PCBs
Non-ortho PCBs
PCB 77
0,0001
PCB 81
0,0003
PCB 126
0,1
PCB 169
0,03
Mono-ortho PCBs
PCB 105
0,00003
PCB 114
0,00003
PCB 118
0,00003
PCB 123
0,00003
PCB 156
0,00003
PCB 157
0,00003
PCB 167
0,00003
PCB 189
0,00003
Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzodioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.
( 6 )   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.
( 7 )   Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.
( 8 )   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., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.’
Commission Regulation (EU) No 277/2012 of 28 March 2012 amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels and action thresholds for dioxins and polychlorinated biphenyls Text with EEA relevance

Schedules & Appendices

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