1999R2439 — EN — 29.02.2000 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION REGULATION (EC) No 2439/1999
of 17 November 1999
on the conditions for the authorisation of additives belonging to the group ‘binders, anti-caking
agents and coagulants' in feedingstuffs
(OJ L 297, 18.11.1999, p. 8)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EC) No 739/2000 of 7 April 2000 L 87 14 8.4.2000
1999R2439 — EN — 29.02.2000 — 001.001 — 2
▼B
COMMISSION REGULATION (EC) No 2439/1999
of 17 November 1999
ontheconditionsfortheauthorisationofadditivesbelongingtothe
group ‘binders, anti-caking agents and coagulants'in feedingstuffs
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs (1), as lastamended by Commis-
sion Regulation (EC) No 1636/1999 (2), and in particular Article 11
thereof,
Whereas:
(1) kaolinitic clays originating from certain mines situated in the
Federal Republic of Germany have been found to containextremely high levels of dioxins. According to available informa-tion, this could be a contamination of geological origin;
(2) under Article 11 of Directive 70/524/EEC, a Member Statewhich, as a resultof new informat ion or of a reassessmentofexisting information made since the provisions in question wereadopted, finds that the use of one of the additives listed in theDirective constitutes a danger to animal or human health or theenvironment may temporarily suspend the authorisation to usethat additive;
(3) several Member States have prohibited the use of contaminatedkaolinitic clays in pre-mixtures and feedingstuffs;
(4) under Article 3a(b) of Directive 70/524/EEC, authorisation of anadditive is to be given only if, taking account of the conditions ofuse, itdoes notadversely affecthuman or animal healt h or t heenvironment;
(5) the use of feedingstuffs contaminated with dioxins may contami-nate foodstuffs of animal origin. Dioxins are classified as ahuman carcinogen by recognised international organisations.These organisations recommend that measures are taken toreduce the ingestion of dioxins through food as much as possible;
(6) contaminated additives should be avoided as much as possible;
(7) a complet e risk assessmentcannotbe carried outfor lack ofadequate scientific data. In view of the need for urgent measuresto prevent an unacceptable degree of contamination of feeding-stuffs and pending the results of the monitoring programme onclays and the risk assessment, the acceptable level of dioxins inkaolinitic clays should be restricted by way of precaution to theanalytical limit of determination. This limit may be reviewed inthe light of the results of any investigations carried out and of themonitoring programme;
(8) the contamination of kaolin found in Germany could in fact alsoconcern other additives authorised for use as binders, anti-cakingagents and coagulants under Directive 70/524/EEC, as indicatedby the fact that ball clay, sedimentary clays containing otherminerals besides kaolin, originating from a mine in the UnitedStates has also been shown to be heavily naturally contaminatedby dioxins of geological origin. It is appropriate to examine in theframe of the monitoring programme the possible presence ofdioxins in all these authorised additives. It is foreseen for thetime being to apply a provisional maximum limit only for thekaolinitic clays, the analytical limit of determination will apply as
(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 194, 27.7.1999, p. 17.
1999R2439 — EN — 29.02.2000 — 001.001 — 3
▼B
the maximum limit after a well-defined period of time for theadditives other than the kaolinitic clays in the absence of theestablishment, if required, of a specific maximum limit based onsufficient data concerning the presence of dioxins;
(9) the measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee for Feedingstuffs,
HAS ADOPTED THIS REGULATION:
Article 1
The conditions for the authorisation of additives belonging to the group
‘binders, anti-caking agents and coagulants' referred to in the Annex tothis Regulation are hereby replaced by those set out in the Annex heretoin accordance with Directive 70/524/EEC.
The Commission shall re-examine the provisions of this Regulation
before►
M115 October 2000 ◄in the light of any investigations
carried out and of the results of the monitoring programme.
Article 2
This Regulation shall enter into force on the day of its publication in the
Official Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
1999R2439 — EN — 29.02.2000 — 001.001 — 4▼M1
Minimum
contentMaximum
content
EC No Additive Chemical formula, description Species or category of animalMaximum
agemg/kg of complete
feedingstuffOther provisions Period of authorisationANNEX
Binders, anti-caking agents and coagulants
E 330 Citric acid C6H8O7All species or categories
of animals— — — All feedingstuffs. Compliance
with the provisions of Article16(1)(g)Without a time limit
E 470 Sodium, potassium and
calcium stearatesC18H35O2Na
C18H35O2K
C36H70O4Ca
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 516 Calcium sulphate, dihy-
drateCaSO4.2H2O
Maximum dioxin content: (1)All species or categories
of animals— — 30 000 All feedingstuffs Without a time limit
E 551a Silicic acid, precipitated
and dried—
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 551b Colloidal silica —
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 551c Kieselgur (diatomaceous
earth, purified)—
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 552 Calcium silicate, synthetic —
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 554 Sodium aluminosilicate,
synthetic—
Maximum dioxin content: (1)All species or categories
of animals— — — All feedingstuffs Without a time limit
E 558 Bentonite-montmorillonite —
Maximum dioxin content: (1)All species or categories
of animals— — 20 000 All feedingstuffs
Mixing with additives from theantibiotics, growth promoters,coccidiostats and other medicalsubstances groups is prohibited,Without a time limit
1999R2439 — EN — 29.02.2000 — 001.001 — 5▼M1
Minimum
contentMaximum
content
EC No Additive Chemical formula, description Species or category of animalMaximum
agemg/kg of complete
feedingstuffOther provisions Period of authorisation
exceptin t he case of:
monensin-sodium, narasin,lasalocid-sodium, flavophos-pholipol, salinomycin sodium,nicarbazin and robenidineIndication on the label of thespecific name of the additive
E 559 Kaolinitic clays, free ofasbestos Naturally occurring mixtures ofminerals containing at least 65 %complex hydrated aluminium sili-cates whose main constitutent iskaolinite.Maximum dioxin content: 500 pgWHO-PCCD/F-TEQ/kg (
2)All species or categoriesof animals — — — All feedingstuffs Without a time limit
E 560 Natural mixtures of stea-tites and chlorite Natural mixtures of steatite andchlorite, free of asbestos: minimumpurity of the mixtures 85 %. All species or categoriesof animals — — — All feedingstuffs Without a time limit
E 561 Vermiculite Natural silicate of magnesium,aluminium and iron, expanded byheating, free of asbestos.Maximum fluorine content: 0,3 %Maximum dioxin content: (
1)All species or categoriesof animals — — — All feedingstuffs Without a time limit
E 562 Sepiolite Hydrated magnesium silicate ofsedimentary origin, containing atleast60 % sepiolit e and maximum30 % montmorillonite, free ofasbestos All species or categoriesof animals — — 20 000 All feedingstuffs Without a time limit
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Minimum
contentMaximum
content
EC No Additive Chemical formula, description Species or category of animalMaximum
agemg/kg of complete
feedingstuffOther provisions Period of authorisation
E 563 Sepiolitic clay Hydrated magnesium silicate of
sedimentary origin, containing atleast 40 % sepiolite and 25 % illite,free of asbestos.All species or categoriesof animals — — 20 000 All feedingstuffs Without a time limit
E 565 Lignosulphonates —Maximum dioxin content: (
1)All species or categoriesof animals — — — All feedingstuffs Without a time limit
E 566 Natrolite-phonolite Natural mixture of aluminium sili-cates, alkalines and alkaline-earthand aluminium hydrosilicates, natro-lite (43 to 46,5 %) and feldspar.Maximum dioxin content: (
1)All species or categoriesof animals — — 25 000 All feedingstuffs Without a time limit
E 598 Synthetic calcium alumi- Mixture of calcium aluminates Poultry — — 20 000 All feedingstuffs Without a time limit
nates containing between 35 and 51 % of
AI2O3.
Maximum molybdenum content:Rabbits — — 20 000 All feedingstuffs Without a time limit
20 mg/kgMaximum dioxin content: (
1)Pigs — — 20 000 All feedingstuffs Without a time limit
Dairy cows — — 8 000 All feedingstuffs Without a time limit
Cattle for fattening — — 8 000 All feedingstuffs Without a time limit
Calves — — 8 000 All feedingstuffs Without a time limit
Lambs — — 8 000 All feedingstuffs Without a time limit
Kids — — 8 000 All feedingstuffs Without a time limit
E 599 Perlite Natural silicate of sodium andaluminium, expanded by heating,free of asbestos.Maximum dioxin content: (
1)All species or categoriesof animals — — — All feedingstuffs Without a time limit
1999R2439 — EN — 29.02.2000 — 001.001 — 7▼M1
Minimum
contentMaximum
content
No (or EC
No)Additive Chemical formula, description Species or category of animalMaximum
agemg/kg of complete
feedingstuffOther provisions Period of authorisation
Binders, anti-caking agents and coagulants
3 Clinoptilolite of volcanic
originCalcium hydrated aluminosilicate of
volcanic origin containing aPigs — — 20 000 All feedingstuffs 30.9.2000 (3)
minimum of 85 % of clinoptilolite
and a maximum of 15 % of feldspar,micas and clays free of fibres and Rabbits — — 20 000 All feedingstuffs 30.9.2000 (3)
quartz
Maximum lead content: 80 mg/kgMaximum dioxin content: (
1)Poultry — — 20 000 All feedingstuffs 30.9.2000 (3)
(1) In the absence of the establishment, if required, of a specific maximum limit based on sufficient data on the presence of dioxins, the maximum limit of 500 pg WHO-PCCD/F-TEQ/kg will apply from 15 October 2000.
(2) The dioxin content is the sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, applying WHO TEFs (toxic
equivalence factors, 1997).
The content must be expressed as upperbound, i.e. it is calculated assuming that all the values of the different congener elments below the limit of detection are equal to the limit of detection.
(3) First authorisation Commission Regulation (EC) No 1245/1999 (OJ L 150, 17.6.1999, p. 15).