LegalizeCommission Regulation (EC) No 2316/98 of 26 October 1998 concerning authorisation of new additives and amending the conditions for authorisation of a number of additives already authorised in feedingstuffs (Text with EEA relevance)
Article 1
Article 2
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
It shall apply from 15 December 1998.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| No | EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | Duration of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feedingstuff | |||||||||
| Colouring matters including pigments1.Carotenoids and xanthophylls | |||||||||
| E 160a | Beta-carotene | C40H56 | Canaries | — | — | — | — | 30.9.1999 | |
| E 160c | Capsanthin | C40H56O3 | Poultry | — | — | 80 (alone or with the other carotenoids and xanthophylls) | — | Without a time limit | |
| E 160e | Beta-apo-8′-carotenal | C30H40O | Poultry | — | — | 80 (alone or with the other carotenoids and xanthophylls) | — | Without a time limit | |
| E 160f | Ethyl ester of beta-apo-8′-carotenoic acid | C32H44O2 | Poultry | — | — | 80 (alone or with the other carotenoids and xanthophylls) | — | Without a time limit | |
| E 161b | Lutein | C40H56O2 | Poultry | — | — | 80 (alone or with the other carotenoids and xantho-phylls) | — | Without a time limit | |
| E 161c | Cryptoxanthin | C40H56O | Poultry | — | — | 80 (alone or with the other carotenoids and xantho-phylls) | — | Without a time limit | |
| E 16lg | Canthaxanthin | C40H52O2 | Poultry | — | — | 80 (alone or with the other carotenoids and xantho-phylls) | — | Without a time limit | |
| Salmon, trout | — | — | 80 | Use permitted from the age of six months onwards The mixture of canthaxanthin with astaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff | Without a time limit | ||||
| Dogs, cats and ornamental fish | — | — | — | — | Without a time limit | ||||
| Pet and ornamental birds | — | — | — | — | 30.9.1999 | ||||
| E 161h | Zeaxanthin | C40H56O2 | Poultry | — | — | 80 (alone or with the other carotenoids and xanthophylls) | — | Without a time limit | |
| E 16li | Citranaxanthin | C33H44O | Laying hens | — | — | 80 (alone or with the other carotenoids and xanthophylls) | — | Without a time limit | |
| E 161j | Astaxanthin | C40H52O4 | Salmon, trout | — | — | 100 | Use only permitted from the age of six months onwards The mixture of astaxanthin with canthaxanthin is allowed provided that the total concentration of the mixture does not exceed 100 mg/kg in the complete feedingstuff | Without a time limit | |
| Ornamental fish | — | — | — | — | Without a time limit | ||||
| 11 | Astaxanthin-rich Phaffia rhodozyma (CBS 116.94) | Concentrated biomass of the yeast Phaffia rhodozyma (CBS 116.94), killed, containing at least 2,5 g astaxanthin per kilogram additive | Salmon, trout | — | — | 100 | The maximum content is expressed as astaxanthin Use only permitted from the age of six months onwards The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff | 21.4.1999 | |
| 12 | Astaxanthin-rich Phaffia rhodozyma (ATCC 74219) | Concentrated biomass of the yeast Phaffia rhodozyma (ATCC 74219), killed, containing at least 4,0 g astaxanthin per kilogram of additive and having a maximum ethoxyquin content of 2 000 mg/kg | Salmon, trout | — | — | 100 | The maximum content is expressed as astaxanthin Use permitted only from the age of six months onwards The mixture of the additive with canthaxanthin is allowed provided that the total concentration of astaxanthin and canthaxanthin does not exceed 100 mg/kg in the complete feedingstuff Ethoxyquin content to be declared | 30.9.1999 |
ANNEX II
| EC No | Element | Additive | Chemical formula | Maximum content of the element in mg/kg of the complete feedingstuff | Other provisions | Duration of authorisation |
|---|---|---|---|---|---|---|
| E4 | Copper-Cu | Cupric acetate, monohydrate | Cu(CH3COO)2 . H2O | Pigs for fattening: in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to slaughter: 35 (total) in Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to 6 months: 100 (total) — over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: — milk replacers: 30 (total) — other complete feedingstuffs: 50 (total) Ovines: 15 (total) Other species or categories of animals: 35 (total) | — | Without a time limit |
| Basic cupric carbonate, monohydrate | CuCO3 . Cu(OH)2 . H2O | — | Without a time limit | |||
| Cupric chloride, dihydrate | CuCl2 . 2H2O | — | Without a time limit | |||
| ————— | ||||||
| Cupric oxide | CuO | — | Without a time limit | |||
| Cupric sulphate, pentahydrate | CuSO4 . 5H2O | — | Without a time limit | |||
| Cupric sulphate, monohydrate | CuSO4 . H2O | Pigs for fattening: in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to slaughter: 35 (total) in Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to 6 months: 100 (total) — over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Ovines: 15 (total) Other species or categories of animals with the exception of calves: 35 (total) | Denatured skimmed milk powder and compound feedingstuffs manufactured from denatured skimmed milk powder — subject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77 — declaration of the amount of copper added, expressed as the element, on the label or package or container of denatured skimmed milk powder | Without a time limit | ||
| Cupric sulphate, pentahydrate | CuSO4 . 5H2O | |||||
| Cupric chelate of amino acids hydrate | Cu (x)1-3 . nH2O (x = anion of any amino acid derived from hydrolysed soya protein) Molecular weight not exceeding 1 500 | Pigs for fattening: in Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to slaughter: 35 (total) in Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilisable agricultural land: — up to 16 weeks: 175 (total) — from 17th week up to six months: 100 (total) — over six months up to slaughter: 35 (total) Breeding pigs: 35 (total) Other species or categories of animals, with the exception of calves prior to the start of rumination and sheep: 35 (total) | Not more than 20 mg/kg of copper in the complete feedingstuff may come from cupric chelate of amino acids hydrate | Without a time limit | ||
| E5 | Manganese-Mn | — | — | — | — | — |
| Manganous chloride, tetrahydrate | MnCl2 . 4H2O | 250 (total) | — | Without a time limit | ||
| ————— | ||||||
| Manganous oxide | MnO | 250 (total) | — | Without a time limit | ||
| ————— | ||||||
| Manganous sulphate, monohydrate | MnSO4 . H2O | 250 (total) | — | Without a time limit | ||
| Manganese chelate of amino acids hydrate | Mn (x)1-3 . nH2O (x = anion of any amino acid derived from hydrolysed soya protein) Molecular weight not exceeding 1 500 | 250 (total) | Not more than 40 mg/kg of manganese in the complete feedingstuff may come from manganese chelate of amino acids hydrate | Without a time limit | ||
| E6 | Zinc-Zn | — | — | — | — | — |
| Zinc acetate, dihydrate | Zn(CH3COO)2 . 2H2O | 250 (total) | — | Without a time limit | ||
| ————— | ||||||
| Zinc oxide | ZnO | 250 (total) | Maximum content of lead: 600 mg/kg | Without a time limit | ||
| Zinc sulphate, heptahydrate | ZnSO4 . 7H2O | 250 (total) | — | Without a time limit | ||
| Zinc sulphate, monohydrate | ZnSO4 . H2O | 250 (total) | — | Without a time limit | ||
| Zinc chelate of amino acids hydrate | Zn (x)1-3 . nH2O (x = anion of any amino acid derived from hydrolysed soya protein) Molecular weight not exceeding 1 500 | 250 (total) | Not more than 80 mg/kg of zinc in the complete feedingstuff may come from zinc chelate of amino acids hydrate | Without a time limit |
ANNEX III
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | Duration of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feedingstuff | ||||||||
| E 320 | Butylated hydroxyanisole (BHA) | C11H16O2 | All species or categories of animals except dogs | — | — | 150: alone or together | All feedingstuffs | Without a time limit |
| All species or categories of animals except dogs | ||||||||
| 150: alone or together | ||||||||
| All feedingstuffs | ||||||||
| Without a time limit | ||||||||
| E 321 | Butylated hydroxytoluene (BHT) | C15H24O | — | — | ||||
| E 324 | Ethoxyquin | C14H19ON | — | — | ||||
| E 320 | Butylated hydroxyanisole (BHA) | C11H16O2 | Dogs | — | — | 150: alone or together | The mixture of ethoxyquin with BHA and/or BHT is allowed provided the total concentration of the mixture does not exceed 150 mg/kg of complete feedingstuff | Without a time limit |
| Dogs | ||||||||
| 150: alone or together | ||||||||
| The mixture of ethoxyquin with BHA and/or BHT is allowed provided the total concentration of the mixture does not exceed 150 mg/kg of complete feedingstuff | ||||||||
| Without a time limit | ||||||||
| E 321 | Butylated hydroxytoluene (BHT) | C15H24O | — | — | ||||
| E 324 | Ethoxyquin | C14H19ON | Dogs | — | — | 100 |
ANNEX IV
| No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum activity | Maximum activity | Other provisions | Duration of authorisation |
|---|---|---|---|---|---|---|---|---|
| Unit of activity per kg of complete feedingstuff | ||||||||
| 1 | 3-phytase (EC 3.1.3.8) | Preparation of 3-phytase produced by Aspergillus niger (CBS 114.94) having a minimum phytase activity of 5 000 FTU (1)/g for solid and liquid preparations | Pigs (all categories of animals) | — | — | — | — | 21.4.1999 |
| Chickens (all categories of animals) | — | — | — | — | 21.4.1999 | |||
| Turkeys | — | 125 FTU | — | 1.Indicate in the directions for use for the additive and the premixture the storage temperature, storage duration and stability on pelleting2.Recommended dose per kg of complete feedingstuff: 200-800 FTU3.For use in compound feedingstuffs with a minimum content of 0,3 % phytate, e.g. 20 % wheat | 30.9.1999 | |||
| (1) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C. |
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