Commission 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
1
Beta-carotene, belonging to Part 1 ‘Carotenoids and xanthophylls’ of the group ‘Colouring matters including pigments’, may be authorised in accordance with Directive 70/524/EEC as additive E 160a in feedingstuffs under the conditions laid down in Annex I to this Regulation.
2
Astaxanthin-rich Phaffia rhodozyma (ATCC 74219), belonging to Part 1 ‘Carotenoids and xanthophylls’ of the group ‘Colouring matters including pigments’, may be authorised in accordance with Directive 70/524/EEC as additive 12 in feedingstuffs under the conditions laid down in Annex I to this Regulation.
3
The substance ‘cupric chelate of amino acids hydrate’, belonging to the group ‘Trace elements’, element E4 ‘Copper-Cu’, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
4
The substance ‘manganese chelate of amino hydrate’, belonging to the group ‘Trace elements’, element E5 ‘Manganese-Mn’, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
5
The substance ‘zinc chelate of amino acids hydrate’, belonging to the group ‘Trace elements’, element E6 ‘Zinc-Zn’, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
Article 2
1
The conditions for authorisation of the additive E 324 Ethoxyquin, belonging to the group ‘Antioxidants’, shall be replaced in accordance with Directive 70/524/EEC by the conditions laid down in Annex III to this Regulation.
2
Additive E161g Canthaxanthin, belonging to Part 1 ‘Carotenoids and xanthophylls’ of the group ‘Colouring matters including pigments’ for the category of ‘Pet and ornamental birds’, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex I to this Regulation.
3
Additive 3-phytase (EC 3.1.3.8), belonging to the group ‘Enzymes’, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex IV to this Regulation.
4
Additive 11, Astaxanthin-rich Phaffia rhodozyma, belonging to Part 1 ‘Carotenoids and xanthophylls’ of the group ‘Colouring matters including pigments’ for the category of animal ‘Salmon, trout’, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex I to this Regulation.
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 pigments 1. Carotenoids and xanthophylls | | | | | | |
| E 160a | Beta-carotene | C40H 56 | 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 carbonate | MnCO 3 | 250 (total) | — | Without a time limit
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 lactate, trihydrate | Zn(C 3 H 5 O 3 ) 2 . 3H 2 O | 250 (total) | — | Without a time limit
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
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
E 321 | Butylated hydroxytoluene (BHT) | C15H24O | — | —
E 324 | Ethoxyquin | C14H19ON | Dogs | — | — | 100
ANNEX IV
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.
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 /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 pelleting 2. Recommended dose per kg of complete feedingstuff: 200-800 FTU 3. For use in compound feedingstuffs with a minimum content of 0,3 % phytate, e.g. 20 % wheat | 30.9.1999
Deleted by Commission Implementing Regulation (EU) 2017/1145 of 8 June 2017 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives (Text with EEA relevance).