# 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) EU Regulation No 2316/1998 · adopted 26 October 1998 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) PDFs: Printed copy https://openlegislation.uk/eu-regulation-1998-2316/pdf/eur_19982316_adopted_en.pdf; Revised version (19 July 2017) https://openlegislation.uk/eu-regulation-1998-2316/pdf/eur_19982316_2017-07-19_en.pdf ## Introductory text 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) ## 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. ## 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. ## 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. ## Signature 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 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 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 --- Source: https://www.legislation.gov.uk/eur/1998/2316 (the official version) Page: https://openlegislation.uk/eu-regulation-1998-2316 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.