Undesirable Substances in Animal Feeds (Amendment) (No. 2) Rules, 2007 (L.N. 119 of 2007)

B 1884 Title :ind Scnpe. L.N 8 I of 1005 A mends Scbedu.le T t o fhe principal rules. L.N. 119 of 2007 VETERINARY SERVICES ACT (CAP 437) Undesirable Substances in Animal Feeds (Amendment) (No. 2) Rules, 2007 IN exercise of the powers conferred. by article 22(c) of the Veterina1y Services Act, 2001 , the Minister for Rural Affairs and. the Environment has made the following rules: 1. (]) The title of these rules is the Undesirable Substances in Animal Feeds (Amendment No.2)Rules'' 2007 and. they shall be read. and. construed as one with as Undesirable Substances in Animal Feeds Rules, 2005, herinaftes referred to as "the principal mies. (2) The scope of these rules is to implement the provisions found under Commission Directive 2006/13/EC of 3rd. February 2006 amendingAlmexes I and II to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards dioxins and dioxin-like PCBs' 2. For point 27 in Schedule I to the principal rules shall be subsituted as follows: there Undesirable substances Products intended for animal feed (1) (2) 27a. Dioxins (sum of (a) Feed.materials of plant origin poly chlorinated dibenzqpara- with the exception of vegetable dioxins (PCDDs) and oils and their byproducts polychlorinateddibenwfurans (PCDFs) expressed in World Health Oi;ganisation (WHO) toxic equivalents, using the WHO TEFs (toxicequivalency factors, 1997 (*) (b) Vegetable oils and their by-products (c) Feedmaterials ofmineralorigin ( d) Animal fat, including milk fat and egg fat. ( e) Other land animal products including milk and milk products and eggs and egg products (1) Fish oil (g) Fish, other aquatic animals, their products and by-products with the exception.offish.oil and fish protein hydrolysates containing more than"20 ¾fat (h) Fish protein hydrolysates containing mare than 20 % fat (i) The additives kaolinitic clay, calcirun sulphate ·dihydrate, venniculile, riatrolitephonolite, Synthetic calcium aluminates and clinoptilolite of sedimentary origin belongi.J:ig to the functional groups of binders and anti. caking agents G) Additives belonging to Ille functidnal group of compounds of trace elements (k) Premixtures (1) Compouudfeedingstuffs, with.the exception of feed far fur animals, pet foods and feed for fish B 1885 Maximum contentrelative to a feedingstnff with a moisture c.oritent of 12 % (3) 0,75 ng WHO-PCDDIF-TEQ/kg (**) (**>I<) 0,75 ng WHO-PCDDIF-TEQ/kg (**) (***) l ,0ng WHO-PCDD/F-TEQ/kg (**) (**"') 2,0 ng WHO-PCDD/F-TEQ/kg (*"') (**"') 0,75 ng WHO-PCDD/F-TEQ/kg (*"') (**"') 6,0 ng WFIO-PCDD/F-TEQ/kg (*"') (***) . l,25ng WHO-PCDD/F-TEQJkg ("'*) (**"') 2,25 ng WHO-PCDD/F-TEQ/kg (*"') (***) 0,75 ng WHO-PCDD/F-TEQJkg ("'*) (**"') 1,0 ng WFIO-PCDD/F-TEQ/kg (*"') (***) . 1,0 ng WHO-PCDD/F-TEQ/kg (**) (**"') 0,75ng WHO-PCDD/F-TEQ/kg (*"') (***) B 1886 (m) Feed for fish. 2,'?.5 ng WHO-PCDDIF-TEQlkg (**) Pet foods (***) 27b. Sum of dioxins and dioxin- like PCBs (a) Feed materials ofplant origin with 1,25ng WHO-PCDD/F-PCB-TEQ/kg (sum of polythlprinated dibenzp-para- the exception of vegeiable oils and their (**) dioxins (PCDD,), poly chlorinated byproducts dibeozofurans (PCDFs) and poly chlorinated biphenyls (PCBs) expressed in World Healtl1 Organisation (WHO) toxic e·quivalents. using WHO-TEFs (toxic equivalency factors, the 1997 (*) (b) Vegetable oils and their by-products l,$ng WHO-PCDD/F-PCB-TEQ/kg (**) ( c) Feed materials of mineral origin 1,5 ng WHO-PCDD/F-PCB-IEQ/kg (**) ( d) Animal fal, including milk fat and 3,0 ng WHO-PCDD/F-PCB-IEQ/kg egg fal (**) ( e) Other land animal products 1,25 ng WHO-PCDDIF-PCB-TEQ/kg including milk and milk products and (**) eggs and egg produc~'> (t) Fish oil 24,0 ng WHO-PCDD/F-PCB-TEQ!kg (**) (g) Fish, other aqualic animals, their 4,5 ng WHO-PCDD/F-PCB-IEQ/kg products (**) and by-products with the excepti.onof fish oil and fish protein hydrolysates containing more than 20 % fat (h) Fishprotein hydrolysates containing 11,0ng WHO-PCDD/F-PCB-TEQ/kg more (**) than20%fat (i) Additives belonging to the 1,5 ng WHO-PCDD/F-PCB-TEQ/kg functional (**) groups ofbinders and anti-caking agents (j) Additives belonging to the 1,5 ng WHO-PCDDIF-PCB functional group of compoll)lds of trace TEQ/kg(**) elements (k) Premixtures 1,5 ng WH O-PCDD/F-PCB-IBQ/kg (**) (1) Cbmpound .feediugstuffi, with the 1,5 ng WHO-PCDDIF-PCB-IEQ/kg ex.c epti on of feed for fur animals, pet (**) foods and feed for fish (m) Feed for fish. 7,0 ng WHO-PCDD/F-PCB-TEQ/kg Pet foods (**) (*) WHO-TEFs for human risk assessment based on the conch1sions of the World Health Organisation meeting in Stockholm, Sweden, U-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs)for PCBs, PCDDs, and PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775). B 1887 Congener TEFvalue Congener TEFvalue Dibenzo-p-dioxms "Dioxin-Like PCBs'' (PCDSS) 2-3-7-8 TCDD 1 Non-ortho 0.0001 PCBs+Mono-ortho 0.0001 1,2,3 7 8 PeCDD 1 Non-m1ho PCBs 0. 1 0.01 1,2,3,4,7, HxCDD 0,1 PCB77 1,2,3, 7 ,8 HxCDD 0,1 PCB81 1,2,3,4,7,8 Hx.CDD 0.01 PCB 126 OCDD 0.0001 PCB 169 Dibenzofw·ans Mono-ortho PCB.~ (PCDFs) 2,3,7,8-TCDF 0,1 PCB 105 0,0001 1,2,3, 7 ,8-PeCDF 0,05 PCB 114 0,0005 2,3,4, 7 ,8-PeCDF 0,5 PCB 118 0,0001 1,2,3,4,7,8-HxCDF 0,1 PCB 123 0,0001 1,2,3,6,7 ,8-H,'<CDF 0,1 PCB 156 0,0005 1,2,3,,7,8,9-HxCDF 0,1 PCB 157 0,0005 2,3,4,6,7 ,8aHxCDF 0,1 PCB 167 0,00001 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,4,7,8,9-HpCDF 0,01 PCB 189 OCDF 0,0001 0,0001 (**) Upper-bound concentrations; U!)per·bouod,concentrations are,calculated on the assumption that all values of the different congeners below the limit or quantification are equal to the limit of quantificaiion. (***) The separate maximum level for dioxins (PCDD/F) remains applicable for a temporacy period. The products intended for animal feed menti9J1ed in point 27a have lo comply both with the maximum levels for dioxins and with th.e maximum levels for the sum of dioxins and dioxin-Like PCBs ,hiring ihat I emporary p·eriod. (••• •)Fresh fah directly delivered and used without .intennediale proc·essing for the production of feed for fur animals is not subj'ect to the mmtimum levels, whilemaximum levels of4,0 ng WHO-PCDDIF·TEQ/kg product and 8,0 n.g WHO-PCDDIF·PCB·1EQ/kg product we applicable to fresh fish used for the direct feeding ofpet animals, zoo and circus.animals. The products, processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and can.not be fed to fanned auimals wi1ich we kept. fattened or bred for the product ion of food.' B 1888 Amendment to Schedule II to tbe principal rules. 3. For Schedule II to tlie principal rules, shall be subsituted by the following: ' SCHEDULE II 'Undesirable substances Products intended for animal Action threshold relative to a Cortunents and·additionaJ feed feedingstuffwith a nio~sture information cont em of 12 % (e.g. nature of investigations to be performed) (1)) (2) (3 (4) 1. Dioxins (sum of a)Feed materials ofplantO 0,5 ng WHO-PCDD/F-TEQ/ Identification of source of polychlorinated (origin with the exception of kg contamination. Once source di benzo-para-dioxins vegetable oils and their is identified, (PCDDs). byproducts take appropriate measures. polychlorinated PCDFs) where expresseclin World possible, to reduce or Health Organisation (WHO eliminate source of dibenzofurans toxic contamination equivalents, using the WH 0 TEFs (toxic equivalency factors, 1997 (*) (b) Vegetable oils and their 0,5ng WHO-PCDDIF-TEQ Identification of soUI"ce of byproducts contamination. Once source is identified, t.ai,.e appropriate measures, where possible, to reduce or eliminate soUI"ce of contamination ( c) Feed materials of mineral 0,5 ng WHO-PCDDIF-TEQ! Identification of source of origin kg contaminati.on. Once s ource is identified, take appropriate measures. where possible, to reduce or eliminate som-ce of contamination ( d) Animal fat , including l ,Ong WHO-PCDD/F-TEQ/ Identification of source of milk fat kg contamination. and egg fat Once source is identified; take appropriate measures. where possible, to reduce or eliminate source of contamination ( e) Other land animal 0,5 ng WHO-PCDD/F-TEQ/ Identification ohource of products kg contamination. including milk and milk Once source is identified; products and eggs and egg take appropriate measures. products where possible, to reduce or eliminate source of cortiamination (t) Fish oil/ 5,0 ng WHO-PCDD/F-TEQ In many cruses it might not l)e necessary to perfonn an investigation into the source of contamination as the backgrnund level in some areas is close to or above the action level However, in cases where the action level is exceeded all infortnatil'Il , such as sampling (g) Fish, other aquatic animals, their products and byproducts with the exce ption of fish oil and fish protein 'hydrolysates contairring more than 20 % fat h) Fish protein hych:olysates containing more than 20 % fat . i) Additives belonging to the functional groups of binders and anli-caking agents 0,5 ng WHO-PCD.1)/F-TEQ/ kg 1,75 ng WHO-PCDD/F TEQ/ kg 0,5 ng WHO-PCDD/F-TEQ/ kg B 1889 period, geographical origin, fish species etc., should be Tecorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. 1n many C!J!,es it might not be necessary to perform an investigatidn into the s01uce of contamination as the bac'l;groUJl(l 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., r,hould be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compc,unds in these materials for animal nutrition. lnmany cases it might not be necessary to perfoll1l an investigatidn 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, fi.sh species etc., should be Tecorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. Identification of source of contaminatiOIL Once source is identified, take appropriate :measures, where possible, to reduce or eliminate source of contamination B 1890 j) Mditives belonging to the functional group of compounds of trace elements (k) Ptemixtures (1) Compound feedingstuffu, with the exception of feedingstuffs for fur animals, pet foods and feedingstuffs for fish (m) Feedingstufts for .fish. Pet foods ('"**) Q,Sng WHO-PCDD/F-TEQ/ kg 0,5 ng WHO-PCDD/F-TEQ/ kg O,Sng WHO-PCDD/F-TEQ/ kg l ,75ng WHO-PCDD/F TEQ/.kg Identificat.ion of source of contamination. Once source is identified take appropriate measures, where possible, to reduce or el:imi.nate source of contamination Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination Identification of source of confaminatioJL Once source is identified, take appropriate measu,es; where possible. to reduce or eliminate source of contamination 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. (. B 1891 2. Dioxin like PCBs (smn of (a) Feed materials of plaru 0,35 ng WRO-PCB-TEQ/, Identification of source of polychlorinated drigin with the exception of kg confa:minatiorL biphenyls (PCBs) vegetable oils and their Once source is identi1ied, expressed in World Health byproducts take appropriate measures, Organisation (WHO) toxic whei:e possible, to reduce or equivalents, using the eliminate WHO'IEFs source of contamination (toxic equivalency factors; 1997 (*) b) Vegetable oils and their 0,5ng WHO-PCB-TEQ/ Identification of source of byproducts source of kg contanriil.ation. conta:minati on. Once source is identified, take appropriate measures; where possib1e, to reduce or eliminate ( c) Feed materials of mineral 0,35 ng WHO-PCB-TEQ/ Identification. of source of origin kg contamination. Once source is ideliti1ied, take ap propriate measures, where possible , to reduce or eli:miil.ate source of contamination ( d) Alli:mal fat, including 0,75 ng WHO-PCB-TEQ/ Identification. of source of milk fat kg (**) (***) contamination. ande~ fat Once source is ideliti1ied, take appropriate measures, where possible, to reduce or eliminate source of contamination e) Other land ani::mal 0,35 ng WHO-PCB-TEQI ldentification of source of products kg (**) ("'"'*) contamination. including :milk and milk Once sonrce is identified, products and eggs and egg take appropriate measures, prodncts where possible, to re duce or eli:niinate sourte of contamination fJFish oil 14,Q ng WHO-PCB-TEQI 1n many cases it might not kg ("'*) (***) be necessary to perform aii. investigation into tlie source of contanrination. as the backgroundlevelin some areas is close to or above tlie action level. However, in cases where the action level is exceeded, all information, such as sampling period, geogmphical origin, fish species etc., must be recorded with a view to future measures lo manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. B 1892 (g) Fish, other aquatic animals, their products and byproducts with the exception of :fish oil and fish protein h ydrblysates containing more than 20 % fat (h) Fish protein hydrolysates containing more than20 % fat (i) Addilives belonging to the functional groups cifbinders and anti-caking agents (j) Addilives belonging to the functional group of compounds of trace elements (k) Pre mixtures 2,5 ng WHO-PGB-TEQ/ kg 7,0 ng WHO-PCB-TEQ/ kg (**) ("'**) 0,5 ng WHO-PCB-TEQ/ kg 0,35 ng WHO-PCB-TEQ/ kg 0,35 ng WHO-PCB-TEQ/ kg In many cases it might. nol be necessary lo perform an investigatioo 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 infonnation. 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. 1n 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 perio.d geographical ongm, fish species etc., ml.19t be recorded with. a view to future measures to manage the presence of dioxins and dioxin-like compounds· in these materials for animal nutrition. Identification of source of contaminatiorL Once source is identified,Lake appropriate meas.ures, where possible, to reduce or eliminate source of contamination ldentification of source of contamination. Once source is identified, take appropriate measures. where possible, to reduce or eliminate source of contaminatiOIL Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination (1) Compound feedingstuffs, with the exception of feedingstuffs for fur animals, pet foods and feedingstu.ffii for fish (m) Feeclingstuffs for fuh. Pet foods 0,5 ng WHO-PCB-TEQ/ kg 3,5 ng WHO-PCB-TEQ/ kg B 1893 Identification of source of contamination. .Once source is identified, take appropriate measures, where possible., to reduce or eliminatesource of contamination In. many cases it might not be necessary lo perform an irtvestigatidn into the somce of contamination as the background level .in some a)'eas 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 dio~like compounds.in these materials for animal nutrition. (*) WH0-1EFs fur human risk assessment based on 1he conclusions of the World Health Orgarusatwn meetmg m Stockholm, Sweden, u,13, June 1997 (Van den Berg et al, , (1998) Toxio Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for I:Inmans and for Wildlife. Environmental Health Perspectives, 106(12), 775). · B 1894 Congener TEF value Congener TEF value Dibenzo-p-dioxins "Dioxin-Like PCB~" (PCDSS) 2-3-7-8 TCDD 1 Non-ortho PCBs+MonoOortho 1,2,3 7 8 PeCDD 1 Non-ortho PCBs 0.0001 1,2,3,4,7, HxCDD 0,1 PCB 77 0.1 1,2,3,7,8 HxCDD 0,1 PCB 81 0.01 1,2,3,4,7,8 HxCDD 0.01 PCB 126 0.0001 OCDD 0.0001 PCB 169 Dibenzofurans Mono-or1ho PCBs (PCDFs) 2,3, 7 ,8-TCDF 0,1 PCB 105 0,0001 1,2,3, 7,8-PeCDF 0,05 PCB 114 0,0005 2,3,4,7,8-PeCDF 0,5 PCB 118 0,0001 1,2,3,4, 7,8-HxCDF 0) PCB 123 0,0001 1,2,3,6, 7 ,8-HxCDF 0,1 PCB 156 0,0005 1,2,3,,7,8,9-HxCDF 0,1 PCB 157 0,0005 2,3,4,·6,7 ,8-Hx.CDF 0,1 PCB 167 0,00001 1,2,3,4,6,7 ,8-HpCDF 0,01 1,2,3,4,7,8,9-HpCDF 0,01 PCB 189 OCDF 0,0001 0,()001 (**) U'pf>er-bound concentrations; u pper-bou11d concentrations are calculated on the as,;umption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. (**") 11ie Commission will revie.wthese actio11 levels by 31 December 2008 at the latest at the srune tini.e as it reviews the maximuri1 levels the sum ofdio.xins and dioxin-like PCBs.' Ippubbllkat 1nid--bipartimem ta' 1-fnfonn:azzjrnri (doi.gov.mc) - ·v atlecrn - f',d,/l.\-he,l by 1he Ve1x,rmienrof lnformarum tclm. :;m•.nn) - Vn/lma Mllbugh fl-Tstamperija tal-Gvern - Primed ca rhe Gt1 l'emm~nt Prmrin.¢ Press PmzzlP.rice Li1i0.44c (£ 1.02)