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
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 |
|---|---|---|---|---|---|---|---|---|---|
| No | EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | mg/kg of complete feedingstuff | mg/kg of complete feedingstuff | Other provisions | Duration of authorisation |
| 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 | |
| E 16lg | Canthaxanthin | C40H52O2 | 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 | |
| E 16lg | Canthaxanthin | C40H52O2 | Dogs, cats and ornamental fish | — | — | — | — | Without a time limit | |
| E 16lg | Canthaxanthin | C40H52O2 | 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 | |
| E 161j | Astaxanthin | C40H52O4 | 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 | ||
| E4 | Copper-Cu | Basic cupric carbonate, monohydrate | CuCO3 . Cu(OH)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 | ||
| E4 | Copper-Cu | Cupric chloride, dihydrate | CuCl2 . 2H2O | 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 | ||
| E4 | Copper-Cu | ————— | ————— | ————— | ————— | ————— | ————— | ————— |
| E4 | Copper-Cu | |||||||
| E4 | Copper-Cu | Cupric oxide | CuO | 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 | ||
| E4 | Copper-Cu | Cupric sulphate, pentahydrate | CuSO4 . 5H2O | 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 | ||
| E4 | Copper-Cu | 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) Calves: — milk replacers: 30 (total) — other complete feedingstuffs: 50 (total) Ovines: 15 (total) Other species or categories of animals: 35 (total) | 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 | |
| E4 | Copper-Cu | Cupric sulphate, pentahydrate | CuSO4 . 5H2O | 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) | 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 | |
| E4 | Copper-Cu | 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 | — | — | — | — | — | ||
| E5 | Manganese-Mn | Manganous chloride, tetrahydrate | MnCl2 . 4H2O | 250 (total) | — | Without a time limit | ||
| E5 | Manganese-Mn | ————— | ————— | ————— | ————— | ————— | ————— | ————— |
| E5 | Manganese-Mn | |||||||
| E5 | Manganese-Mn | Manganous oxide | MnO | 250 (total) | — | Without a time limit | ||
| E5 | Manganese-Mn | ————— | ————— | ————— | ————— | ————— | ————— | ————— |
| E5 | Manganese-Mn | |||||||
| E5 | Manganese-Mn | Manganous sulphate, monohydrate | MnSO4 . H2O | 250 (total) | — | Without a time limit | ||
| E5 | Manganese-Mn | 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 | — | — | — | — | — | ||
| E6 | Zinc-Zn | Zinc acetate, dihydrate | Zn(CH3COO)2 . 2H2O | 250 (total) | — | Without a time limit | ||
| E6 | Zinc-Zn | ————— | ————— | ————— | ————— | ————— | ————— | ————— |
| E6 | Zinc-Zn | |||||||
| E6 | Zinc-Zn | Zinc oxide | ZnO | 250 (total) | Maximum content of lead: 600 mg/kg | Without a time limit | ||
| E6 | Zinc-Zn | Zinc sulphate, heptahydrate | ZnSO4 . 7H2O | 250 (total) | — | Without a time limit | ||
| E6 | Zinc-Zn | Zinc sulphate, monohydrate | ZnSO4 . H2O | 250 (total) | — | Without a time limit | ||
| E6 | Zinc-Zn | 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 |
|---|---|---|---|---|---|---|---|---|
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | mg/kg of complete feedingstuff | Maximum content | Other provisions | Duration of authorisation |
| E 320 | Butylated hydroxyanisole (BHA) | C11H16O2 | Image omitted; see official source All species or categories of animals except dogs | — | — | Image omitted; see official source 150: alone or together | Image omitted; see official source All feedingstuffs | Image omitted; see official source Without a time limit |
| E 321 | Butylated hydroxytoluene (BHT) | C15H24O | Image omitted; see official source All species or categories of animals except dogs | — | — | Image omitted; see official source 150: alone or together | Image omitted; see official source All feedingstuffs | Image omitted; see official source Without a time limit |
| E 324 | Ethoxyquin | C14H19ON | Image omitted; see official source All species or categories of animals except dogs | — | — | Image omitted; see official source 150: alone or together | Image omitted; see official source All feedingstuffs | Image omitted; see official source Without a time limit |
| E 320 | Butylated hydroxyanisole (BHA) | C11H16O2 | Image omitted; see official source Dogs | — | — | Image omitted; see official source 150: alone or together | Image omitted; see official source 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 | Image omitted; see official source Without a time limit |
| E 321 | Butylated hydroxytoluene (BHT) | C15H24O | Image omitted; see official source Dogs | — | — | Image omitted; see official source 150: alone or together | Image omitted; see official source 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 | Image omitted; see official source Without a time limit |
| E 324 | Ethoxyquin | C14H19ON | Dogs | — | — | 100 | Image omitted; see official source 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 | Image omitted; see official source Without a time limit |
ANNEX IV
| No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum activity | Maximum activity | Other provisions | Duration of authorisation |
|---|---|---|---|---|---|---|---|---|
| No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Unit of activity per kg of complete feedingstuff | Maximum activity | Other provisions | Duration of authorisation |
| 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 [^E0001]/g for solid and liquid preparations | Pigs (all categories of animals) | — | — | — | — | 21.4.1999 |
| 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 [^E0001]/g for solid and liquid preparations | Chickens (all categories of animals) | — | — | — | — | 21.4.1999 |
| 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 [^E0001]/g for solid and liquid preparations | 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 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.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.