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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)

Modified by

Commission Implementing Regulation (EU) 2017/1145of 8 June 2017on 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), 32017R1145, June 29, 2017

Commission Regulation (EC) No 2316/98of 26 October 1998concerning authorisation of new additives and amending the conditions for authorisation of a number of additives already authorised in feedingstuffs(Text with EEA relevance)

Article 11.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 21.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 3This 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		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
				Salmon, trout	—	—	80	Use permitted from the age of six months onwardsThe 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 onwardsThe 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 astaxanthinUse only permitted from the age of six months onwardsThe 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 2000 mg/kg	Salmon, trout	—	—	100	The maximum content is expressed as astaxanthinUse permitted only from the age of six months onwardsThe 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 feedingstuffEthoxyquin 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 methionate	Cu(C5H10NO2S)2		—	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 powdersubject to the relevant provisions of Commission Regulations (EEC) No 368/77 and (EEC) No 443/77declaration 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			Without a time limit
		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 1500	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	MnCO3	250 (total)	—	Without a time limit
		Manganous chloride, tetrahydrate	MnCl2 . 4H2O	250 (total)	—	Without a time limit
		Manganous hydrogen phosphate, trihydrate	MnHPO4 . 3H2O	250 (total)	—	Without a time limit
		Manganous oxide	MnO	250 (total)	—	Without a time limit
		Manganic oxide	Mn2O3	250 (total)	—	Without a time limit
		Manganous sulphate, tetrahydrate	MnSO4 . 4H2O	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 1500	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(C3H5O3)2. 3H2O	250 (total)	—	Without a time limit
		Zinc acetate, dihydrate	Zn(CH3COO)2 . 2H2O	250 (total)	—	Without a time limit
		Zinc carbonate	ZnCO3	250 (total)	—	Without a time limit
		Zinc chloride, monohydrate	ZnCl2 . H2O	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 1500	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	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	Dogs	—	—	150:alone or together
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
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 5000 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 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