Proposal for a Council Directive amending Council Directive 1999/29/EC on the undesirable
substances and products in animal nutrition
(2001/C 332 E/06)
COM(2001) 493 final
(Submitted by the Commission on 28 August 2001)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European
Community,
Having regard to Council Directive 1999/29/EC of 22 April
1999 on the undesirable substances and products in animalnutrition (
1), and in particular Article 10 point (a) thereof,
Having regard to the proposal from the Commission,Whereas:
(1) Directive 1999/29/EC provides that that feed materials
may only be put into circulation in the Community ifthey are sound, genuine and of merchantable quality.
(2) The term dioxins covers a group of 75 polychlorinated
dibenzo-p-dioxin (PCDD) and 135 polychlorinated diben-zofuran (PCDF) congeners, of which 17 are of toxico-logical concern. The most toxic congener is2,3,7 ,8-tetrachlordibenzo-p-dioxin (TCDD) classified bythe International Agency for Research on Cancer andother reputable international organisations as a knownhuman carcinogen. The Scientific Committee for Food(SCF), in line with the World Health Organisation(WHO), concluded that the carcinogenic effect ofdioxins does not occur at levels below a certain threshold.Other adverse effects, such as endometriosis, neurobehav-ioural and immunosuppressive effects occur at muchlower levels and are therefore considered relevant forthe determination of a tolerable intake.
(3) Polychlorinated biphenyls, (PCBs), are a group of 209
different congeners which can be divided into twogroups according to their toxicological properties: 12congeners exhibit toxicological properties similar todioxins and are therefore often termed dioxin-like PCBs.The other PCBs do not exhibit dioxin-like toxicity buthave a different toxicological profile.
(4) Each congener of dioxins or dioxin-like PCBs presents a
different level of toxicity. In order to be able to sum upthe toxicity of these different congeners, the concept of
toxic equivalency factors (TEFs) has been introduced to
facilitate risk assessment and regulatory control. This
means that the analytical results relating to all 17 indi-vidual dioxin congeners and to the 12 dioxin-like PCBcongeners are expressed in terms of a single quantifiableunit: TCDD toxic equivalent concentration (TEQ).
(5) Dioxins and PCBs are extremely resistant to chemical and
biological degradation and therefore persist in theenvironment and accumulate in the feed and food chain.
(6) The distribution of dioxins, PCBs and dioxin-like PCBs
throughout the environment causes background contami-nation affecting all terrestrial plants directly grazed orused as feed materials for animal feed as well as theaquatic feed chain. The same applies to the soil thatmight contaminate feed materials or be directly ingested
by animals. In addition to background contamination,
direct accidental pollution of feed materials may occurdue to localised discharge of dioxins from industrialactivities, contamination of feed materials during theirproduction, processing and transportation, and illegalpractices or management failures during feed production.
(7) More than 90 % of human dioxin exposure derives from
foodstuffs. Foodstuffs of animal origin normally contributeto approximately 80 % of overall exposure. The dioxinburden in animals derives mainly from feedingstuffs.Therefore feedingstuffs, and in some cases soil, are ofconcern as potential sources of dioxins.
(8) The SCF adopted an opinion on the Risk Assessment of
Dioxins and Dioxin-like PCBs in Food on 30 May 2001;
this is an update based on new scientific informationavailable since the adoption of the SCF opinion on thismatter on 22 November 2000. The SCF fixed a tolerableweekly intake (TWI) for dioxins and dioxin-like PCBs of14 pg WHO-TEQ/kg body weight. Exposure estimatesindicate that a considerable proportion of theCommunity population has a dietary intake in excess ofthe tolerable intake.EN C 332 E/242 Official Journal of the European Communities 27.11.2001
(1) OJ L 115, 4.5.1999, p. 32.
(9) The reduction of human exposure to dioxins through food
consumption is therefore important and necessary toensure consumer protection. As food contamination isdirectly related to feed contamination, an integratedapproach must be adopted to reduce dioxin incidencethroughout the food chain, i.e. from feed materialsthrough food-producing animals to humans. The intro-duction of measures relating to feed materials and feed-
ingstuffs is therefore a crucial step towards reducing
dioxin intake by humans.
(10) The Scientific Committee for Animal Nutrition (SCAN)
has been asked to advise on the sources of contaminationof feedingstuffs with dioxins and PCBs, includingdioxin-like PCBs, the exposure of food-producinganimals to dioxins and PCBs, the carry-over of thesecompounds to food products of animal origin, and anyimpact on animal health of dioxins and PCBs present infeedingstuffs. The SCAN adopted an opinion on 6November 2000. It identified fish meal and fish oil asthe most heavily contaminated feed materials, withproducts of European origin more heavily contaminated.
Animal fat was identified as the next most seriously
contaminated material. All other feed materials ofanimal and plant origin had relatively low levels ofdioxin contamination. Roughages presented a wide rangeof dioxin contamination depending on location, degree ofcontamination with soil and exposure to sources of aerialpollution.
(11) Measures should be implemented with the aim of
reducing the presence and release of dioxin contaminationof the environment in order to reduce the impact ofenvironmental pollution on the contamination of feedmaterials. The SCAN recommended, inter alia , that
emphasis should be placed on reducing the impact of
the most contaminated feed materials on overall dietcontamination.
(12) Maximum levels for dioxins and dioxin like PCBs should
be an appropriate tool to prevent unacceptably highexposure of animals and to prevent the distribution offeedingstuffs with an unacceptably high level of contami-nation, e.g. in cases of accidental pollution and exposure.Furthermore the setting of maximum levels is indis-pensable for the implementation of a regulatory controlsystem and to ensure uniform application.
(13) Measures based solely on establishing maximum levels for
dioxins and dioxin-like PCBs in feedingstuffs would not besufficiently effective in reducing human exposure todioxins unless the levels were set so low that a largepart of the feed supply would have to be declared unfitfor animal consumption. It is generally recognised that, inorder to actively reduce the presence of dioxins in feed-ingstuffs, maximum levels should be accompanied by
measures stimulating an active approach, includingaction levels and target levels for feedingstuffs in combi-nation with measures to limit emissions. Target levelsindicate the levels to be achieved in order to ultimatelybring human exposure for the majority of the populationdown to the TWI set by the SCF. Action levels are a toolfor competent authorities and operators to identify those
cases where it is appropriate to identify a source of
contamination and to take measures for its reduction orelimination, not only in the event of non-compliance withthe provisions of this Directive but also where significantlevels of dioxins above normal background levels arefound. This will result in a gradual reduction of dioxinlevels in feedingstuffs, and the target levels will ultimatelybe achieved. A Recommendation from the Commissionon this issue is therefore being addressed to the MemberStates.
(14) Although, from a toxicological point of view, any level
should apply to dioxins, furans and dioxin-like PCBs, forthe time being the maximum levels are set only for
dioxins and furans and not for dioxin-like PCBs, given
the very limited data available on the prevalence of thelatter. However, monitoring will continue, in particular onthe presence of dioxin-like PCBs with a view to includingthese substances in the maximum levels.
(15) The unacceptability of the dioxin content of feedingstuffs
should be assessed in the light of the current backgroundlevels of contamination, which differ from feed material tofeed material. The maximum level should be fixed, takingaccount of background contamination, at a strict butfeasible level.
(16) In order to ensure that all operators in the food and feed
chain continue to make all possible efforts and do all thatis necessary to limit the presence of dioxins in feed andfood, the maximum levels applicable should be reviewedwithin a defined period with a view to setting lowermaximum levels. An overall reduction of at least 25 %in human exposure to dioxins should be achieved by2006.
(17) Compound feedingstuffs and feed materials of plant origin
do not normally contain high levels of dioxins. Since feed
materials of plant origin are by far the largest component
in the diet of many species of animals, it is appropriate toset a maximum level also for these feed materials. Themore sensitive the method of analysis, the more expensiveand time-consuming the analysis to check for dioxin. As itis important that as many samples as possible be analysed,the maximum levels proposed are somewhat higher thannormal background levels given that they constituteupperbound levels.EN 27.11.2001 Official Journal of the European Communities C 332 E/243
(18) Certain clays authorised for use as binders, anti-caking
agents and coagulants have been found to becontaminated by dioxins or, in some cases, it cannot beruled out that they may be contaminated. Trace elementssuch as zinc oxide and copper oxide have also been foundto be contaminated with dioxins. It is appropriate forthese additives to be subject to a maximum level in linewith that applying to maximum level established for
minerals. However, since maximum levels of undesirable
substances in additives do not fall within the scope ofCouncil Directive 1999/29/EC, a maximum level shouldbe set within the framework of Directive 70/524/EEC of23 November 1970 concerning additives in feed-ingstuffs (
1).
(19) It is of utmost importance to reduce that overall levels of
dioxin contamination in feedingstuffs be reduced. It is
therefore absolutely necessary to prohibit the mixing of
feed materials and feedingstuffs complying with themaximum levels with feed materials/feedingstuffsexceeding these maximum levels.
(20) Directive 1999/29/EC should therefore be amended
accordingly.
(21) The Standing Committee for Feedingstuffs did not deliver
a favourable opinion. The Commission has been thereforeunable to adopt the provisions it envisaged according tothe procedure laid down in Article 13 of Council Directive1999/29/EC of 22 April 1999,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes I and II, to Directive 1999/29/EC are amended in
accordance with the Annex to this Directive.These provisions shall be reviewed for the first time by 31
December 2004 at the latest in the light of new data on thepresence of dioxins and dioxin-like PCBs, in particular with aview to the inclusion of dioxin-like PCBs in the levels to be set.
These provisions shall be further reviewed by 31 December
2006 at the latest with the aim of significantly reducing themaximum levels.
Article 2
1. Member States shall adopt and publish, before 1 January
2002 the laws, regulations and administrative provisionsnecessary to comply with this Directive. They shall forthwithinform the Commission thereof. They shall apply theseprovisions from 1 January 2002.
2. When the Member States adopt those provisions, they
shall contain a reference to this Directive or be accompaniedby such a reference on the occasion of their official publication.Member States shall determine how such reference is to bemade.
3. Member States shall communicate to the Commission the
texts of the provisions of national law, which they adopt in thefield covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities .
Article 4
This Directive is addressed to the Member States.EN C 332 E/244 Official Journal of the European Communities 27.11.2001
(1) OJ L 270, 14.12.1970, p. 1.
ANNEX
Annexes I and II to Directive 1999/29/EC are amended as follows:
1. In Annex I, under point B. Products, point 21 is replaced by the following:
Substances products FeedingstuffsMaximum content relative to a
feedingstuff with a moisture content
of 12 %
21. Dioxin (sum of polychlorinated
dibenzo- para -dioxins (PCDDs)
and polychlorinated diben-
zofurans (PCDFs) expressed inWorld Health Organisation(WHO) toxic equivalents, usingthe WHO TEFs (toxic equiv-alency factors, 1997)) PCDD/FAll feed materials of plant origin
including vegetable oils and
by-products0,75 ng WHO-PCDD/F-TEQ/
kg (
5)(6)
Minerals 1,0 ng WHO-PCDD/F-TEQ/
kg (5)(6)
Animal fat, including milk fat and
egg fat2,0 ng WHO-PCDD/F-TEQ/
kg (5)(6)
Other land animal products
including milk and milk productsand eggs and egg products.0,75 ng WHO-PCDD/F-TEQ/
kg (
5)(6)
Fish oil 6 ng WHO-PCDD/F-TEQ/
kg (5)(6)
Fish, other aquatic animals, their
products and by-products with theexception of fish oil1,25 ng WHO-PCDD/F-TEQ/
kg (
5)(6)
Compound feedingstuffs, with the
exception of feedingstuffs for furanimals and feedingstuff for fish0,75 ng WHO-PCDD/F-TEQ/
kg (
5)(6)
Feedingstuffs for fish 2,25 ng WHO-PCDD/F-TEQ/
kg (5)(6)
(5) Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less
than the limit of determination are equal to the limit of determination.
(6) These maximum limits shall be reviewed for the first time before 31 December 2004 in the light of new data on the presence of
dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and will befurther reviewed before 31 December 2006 with the aim of significantly reducing of the maximum levels.
(
7) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for fur animals is
exempted from the maximum limit. The products, processed animal proteins produced from these fur animals cannot enter thefood chain and the feeding thereof is prohibited to farmed animals which are kept, fattened or bred for the production of food.EN 27.11.2001 Official Journal of the European Communities C 332 E/245
2. In Annex II, point 4 of Part A is replaced by the following:
Substances products FeedingstuffsMaximum content relative to a
feedingstuff with a moisture content
of 12 %
4. Dioxin (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)) PCDD/FAll feed materials of plant origin
including vegetable oils andby-products0,75 ng WHO-PCDD/F-TEQ/
kg (
2)(3)
Minerals 1,0 ng WHO-PCDD/F-TEQ/
kg (2)(3)
Animal fat, including milk fat and
egg fat.2,0 ng WHO-PCDD/F-TEQ/
kg (2)(3)
Other land animal products
including milk and milk productsand eggs and egg products0,75 ng WHO-PCDD/F-TEQ/
kg (
2)(3)
Fish oil 6 ng WHO-PCDD/F-TEQ/
kg (2)(3)
Fish, other aquatic animals, their
products and by-products with theexception of fish oil1,25 ng WHO-PCDD/F-TEQ/
kg (
2)(3)
Compound feedingstuffs, with the
exception of feedingstuffs for furanimals and feedingstuffs for fish0,75 ng WHO-PCDD/F-TEQ/
kg (
2)(3)
Feedingstuffs for fish 2,25 ng WHO-PCDD/F-TEQ/
kg (2)(3)
(2) Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less
than the limit of determination are equal to the limit of determination.
(3) These maximum levels shall be reviewed for the first time by 31 December 2004 at the latest in the light of new data on the
presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and
will be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels.
(4) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for fur animals is
exempted from the maximum limit. The products, processed animal proteins produced from these fur animals cannot enter thefood chain and the feeding thereof is prohibited to farmed animals which are kept, fattened or bred for the production of food.EN C 332 E/246 Official Journal of the European Communities 27.11.2001