http://www.legislation.gov.uk/id/eur/1998/2316

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
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 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
	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
		Basic cupric carbonate, monohydrate	CuCO₃ . Cu(OH)₂ . H₂O		—	Without a time limit
		Cupric chloride, dihydrate	CuCl₂ . 2H₂O		—	Without a time limit
		F1
		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			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 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	~~F1Manganous carbonate~~	~~F1MnCO~~₃	~~F1250 (total)~~	~~F1—~~	~~F1Without a time limit~~
		Manganous chloride, tetrahydrate	MnCl₂ . 4H₂O	250 (total)	—	Without a time limit
		F1
		Manganous oxide	MnO	250 (total)	—	Without a time limit
		F1
		F1
		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	~~F1Zinc lactate, trihydrate~~	~~F1Zn(C~~₃H₅O₃)₂~~. 3H~~₂O	~~F1250 (total)~~	~~F1—~~	~~F1Without a time limit~~
		Zinc acetate, dihydrate	Zn(CH₃COO)₂ . 2H₂O	250 (total)	—	Without a time limit
		F1
		F1
		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
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

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 FTU1/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

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.