Article 11.This Directive concerns products which act as direct or indirect protein sources, are manufactured by certain technical processes and are put into circulation within the Community as feedingstuffs or in feedingstuffs.2.This Directive shall be without prejudice to Community provisions concerning:(a)additives in feedingstuffs;(b)the fixing of maximum levels for undesirable substances and products in feedingstuffs;(c)the fixing of maximum levels for pesticide residues on and in products intended for human or animal nutrition;(d)the marketing compound;(e)pathogenic micro-organisms in feedingstuffs.(f)feedingstuffs for particular nutritional purposes;(g)the circulation of feed materials.3.This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feedOJ L 268, 18.10.2003, p. 1..

Article 2The definitions contained in Article 2 of Council Directive 70/524/EEC shall apply to this Directive.

Article 31.Member States shall prescribe that feedingstuffs belonging to one of the product groups listed in the Annex or containing such products may be marketed only if:(a)the product in question appears in the Annex;(b)any conditions laid down therein are fulfilled.2.Member States may, for experimental or scientific purposes, provide for derogations from the provisions of paragraph 1, provided that an adequate official inspection is carried out.3.Member States shall require that products referred to in Chapter I.1 (a) of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sectorOJ No L 332, 30.12.1995, p. 15. may be put into circulation only by establishments or intermediaries which meet the conditions laid down in Article 2 or Article 3 of that Directive, as appropriate.4.Paragraph 3 shall apply without prejudice to Article 4(2) of Directive 95/69/EC.

Article 41.Notwithstanding Article 3 (1), the Member States may, until such time as a decision has been taken in accordance with Article 6, maintain:(a)authorizations granted within their territories before the date of application of this Directive concerning products not listed under the product groups indicated in the Annex with the exception of products obtained from yeasts of the "Candida" variety and cultivated on n-alkanes;(b)authorizations granted within their territories before notification of this Directive concerning on the one hand products obtained from yeasts of the "Candida" variety and cultivated on n-alkanes and on the other hand products listed in the Annex, Section 1.2.1, meeting requirements different from those laid down therein.2.Member States shall send to the other Member States and the Commission the list of products allowed on their territories in accordance with paragraph 1.3.In the territory of the former German Democratic Republic, the use in feedingstuffs of protein products obtained from yeast of the Candida genus cultured on n-alkanes shall not be prohibited until 31 December 1991. The Federal Republic of Germany shall ensure that the products in question are not dispatched to other parts of the Community.

Article 51.Without prejudice to the labelling provisions applicable to straight and compound feedingstuffs, Member States shall prescribe that the products listed in the Annex may not be marketed as feedingstuffs or incorporated in feedingstuffs unless any particulars laid down in the Annex appear in the package or container or on a label attached thereto.2.Member States shall prescribe that for material marketed in bulk the particulars referred to in paragraph 1 shall appear on an accompanying document.

Article 61.Amendments to be made to the Annex as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 13. In the case of the products referred to in Sections 1.1 and 1.2 of the Annex the Commission shall consult the Scientific Committee for Animal Nutrition and the Scientific Committee for Food.However, in the case of products obtained from yeasts of the "Candida" variety and cultivated on n-alkanes, referred to in Article 4 (1), a decision shall be adopted, in accordance with the procedure set out in Article 13, within two years of notification of this Directive, after consulting the Scientific Committee for Animal Nutrition and the Scientific Committee for Food.2.In amending the Annex, the following principles shall be observed:A.A product shall not be included in the Annex unless:(a)it has nutritional value for animals because it provides nitrogen or protein;(b)when used sensibly it has no detrimental effect on human or animal health or on the environment and does not harm the consumer by impairing the distinctive features of animal products;(c)it can be monitored in feedingstuffs.B.A product shall be deleted from the Annex if one of the conditions listed in A is not satisfied.3.Criteria making it possible to define the products included in this Directive, particularly the criteria of composition and purity and the physico-chemical and biological properties, may be set in the light of scientific and technical knowledge and in accordance with the procedure laid down in Article 13.

Article 71.In order to ensure that the products referred to in Sections 1.1 and 1.2 of the Annex comply with the principles set out in Article 6 (2), the Member States shall ensure that a dossier, prepared in accordance with the provisions of paragraph 2 below, is sent officially to the Member States, to the Commission and, if it is requested that they be consulted, to the members of the Scientific Committees set up by the Commission.2.On a proposal from the Commission, the Council shall adopt the guidelines to be observed in preparing the dossier referred to in paragraph 1 so that these guidelines can be applied on the date of application of this Directive at the latest.The amendments to be made to the guidelines subsequently as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 13.3.The Member States, the Commission and the other recipients of the dossier referred to in paragraph 1 shall ensure, if requested on good grounds by an applicant, that information whose disclosure could adversely affect industrial or commercial property rights is kept confidential.Industrial and commercial secrecy shall not apply to:the names and composition of the product, and any information concerning the substrate and the micro-organism,the physico-chemical and biological properties of the product,the interpretation of the pharmacological, toxicological and ecotoxicological data,the analytical methods for monitoring the product in the feedingstuffs.

Article 81.If, on the basis of detailed grounds due to new data or a new evaluation of existing data that have become evident since the adoption of the provisions in question, a Member State finds that one of the products listed in the Annex or its use under any conditions that have been set represents a danger to human or animal health even though it complies with the provisions of this Directive, the Member States may temporarily suspend or restrict the application of those provisions in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the reasons for its decision.2.The Commission shall examine as soon as possible the reasons given by the Member State concerned and shall consult the Member States in the Standing Committee for Feedingstuffs and shall then give its opinion without delay and take appropriate action.3.If the Commission considers that amendments to the Directive are necessary to alleviate the difficulties referred to in paragraph 1 and to ensure the protection of human or animal health, it shall initiate the procedure laid down in Article 14 so as to adopt such amendments; in that case, the Member State which has adopted safeguard measures may retain them until the amendments come into force.

Article 9With regard to marketing between Member States, the particulars referred to in Article 5 shall be given in at least one of the official languages of the country of destination.

Article 10The Member States shall ensure that as far as the presence and labelling of the products listed in the Annex is concerned, feedingstuffs that comply with the provisions of this Directive are subject only to the marketing restrictions contained in this Directive.

Article 11The Member States shall ensure that animal products are not subject to any marketing restriction as a result of the application of this Directive.

Article 12The Member States shall take all measures necessary to ensure that the compliance of feedingstuffs with the requirements of this Directive is officially monitored, at least by sampling, during marketing.

Article 131.The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002OJ L 31, 1.2.2002, p. 1., hereinafter referred to as "the Committee".2.Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/ECCouncil Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23). shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3.The Committee shall adopt its rules of procedure.

Article 14Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

Article 15All references to non-protein nitrogenous compounds in Annex I, part K and Annex II, part Db to Directive 70/524/EEC shall be deleted.

Article 16This Directive shall not apply to feedingstuffs which, as proved at least by the relevant information, are intended for export to third countries.

Article 17The Member States shall bring into force, two years after notification of this Directive, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.However, the Federal Republic of Germany may until 31 December 1991 derogate from the labelling provisions in Article 5 for feedingstuffs produced in the territory of the former German Democratic Republic.

Article 18This Directive is addressed to the Member States.

nullANNEX

The contents laid down or to be declared in accordance with columns 5 and 7 refer to the product as such.1.Proteins obtained from the following groups of micro-organisms2.Non-protein nitrogenous compounds3.Amino acids and their salts4.Analogues of amino acids

Name of product group	Name of product	Designation of nutritive principle or identity of micro-organism	Culture substrate (specifications, if any)	Composition characteristics of product	Animal species	Special provisions
1	2	3	4	5	6	7
1.1.Bacteria
1.1.1.Bacteria cultivated on methanol	1.1.1.1.Protein product of fermentation obtained by culture of Methylophilus methylotrophus on methanol	Methylophilus methylotrophus NCIB strain 10.515	Methanol	Crude protein: min. 68 %Reflectance index at least 50	PigsCalvesPoultryFish	Declarations to be made on the label or packaging of the product:name of the product,crude protein,crude ash,crude fat,moisture content,instructions for use,Declaration of the words "Avoid inhalation".as from 1 April 2001: approval numberDeclarations to be made on the label or packaging of compound feedingstuffs:amount of the product contained in the feedingstuff.
1.1.2.Bacteria cultivated on natural gas	1.1.2.1.protein product of fermentation from natural gas obtained by culture of: Methylococcus capsulatus (Bath), Alcaligenes acidovorans, Bacillus brevis et Bacillus firmus, and the cells of which have been killed	Methylococcus capsulatus (Bath) NCIMB strain 11132Alcaligenes acidovoransNCIMB strain12387Bacillus brevis strainNCIMB strain13288Bacillus firmus strainNCIMB strain13280	Natural gas: (approx.91 % methane,5 % ethane,2 % propane,0,5 % isobutane,0,5 % n-butane,1 % other components), ammonia, mineral salts	Crude protein: min. 65 %	Pigs for fattening from 25 to 60 kgCalves from 80 kg onSalmon	Declarations to be made on the label or the packaging of the product:the name: "Protein product of fermentation from natural gas obtained by culture of Methylococcus capsulatus (Bath), Alcaligenes acidovorans, Bacillus brevis and Bacillus firmus,"crude proteincrude ashcrude fatmoisture contentinstructions for usemaximum incorporation rate in the feed:8 % pigs for fattening8 % calves19 % salmon (freshwater)33 % salmon (seawater)declaration of the words: "avoid inhalation"as from 1 April 2001: approval numberDeclarations to be made on the label or packaging of the compound feedingstuffs:The name: "Protein product obtained by bacterial fermentation of natural gas"amount of the product contained in the feedingstuffs
1.2.Yeasts1.2.1.Yeasts cultivated on substrates of animal or vegetable origin	All yeastsobtained from the micro-organisms and subtrates listed in columns 3 and 4 respectively	Saccharomyces cerevisiae, Saccharomyces carlsbergiensisKluyveromyces lactis, Kluyveromyces fragilis	Molasses, distillery residues, cereals and products containing strarch, fruit juice, whey, lactic acid, hydrolyzed vegetable fibres	—	All animal species
	the cells of which have been killed
1.2.2.Yeasts cultivated on substrates other than those given in 1.2.1.
1.3.Algae	—	—
1.4.Lower fungi
1.4.1.Products from production of antibiotics by fermentation	1.4.1.1.Mycelium, wet by-product from the production of penicillin, ensiled by means of lactobacillus brevis, plantarun, sake, collenoid and streptococcus lactis to inactive the penicillin and heat treated	Nitrogenous compound Penicillium chrysogenum ATCC 48271	Different sources of carbohydrates and their hydrolysates	Nitrogen expressed as crude protein: min. 7 %	RuminantsPigs	Declaration be be made on the label or packaging of the product:
						—the name: "Mycelium silage from the production of penicillin"
						—Nitrogen expressed as crude protein
						—crude ash
						—moisture
						—animal species or category
						—as from 1 April 2001: approval number
						Declaration to be made on the label or packaging of the compound feedingstuff:
						—the name: "Mycelium silage from the production of penicillin".
2.1.Urea and its derivatives	2.1.1.Urea, technically pure	CO(NH2)2	—	Urea: minimum 97 %	Ruminants from the beginning of rumination	Declarations to be made on the label or packaging of the product:
	2.1.2.Biuret, technically pure	(CONH2)2-NH	—	Biuret: minimum 97 %		—the name "Urea", "Biuret", "Urea-phosphate" or "Diureidoisobutane", as the case may be,
	2.1.3.Urea-phosphate, technically pure	CO(NH2)2 · H3PO4	—	Nitrogen: minimum 16,5 %Phosphorus: minimum 18 %		—nitrogen level; and in addition for product 2.1.3, phosphorus level,
	2.1.4.Diureidoisobutane, technically pure	(CH3)2-(CH)2-(NHCONH2)2	—	Nitrogen: minimum 30%Isobutyraldehyde: minimum 35 %		—animal species or category.
						Declarations to be made on the label or packaging of compound feedingstuffs:
						—the name "Urea", "Biuret", "Urea-phosphate" or "Diureidoisobutane" as the case may be,
						—amount of the product contained in the feedingstuff,
						—percentage of the total crude protein provided by non-protein nitrogen,
						—indication, in the instructions for use, of the level of total non-protein nitrogen which should not be extended in the daily ration of each animal species or category.
2.2.Ammonium salts	2.2.1.Ammonium lactate, produced by fermentation with Lactobacillus bulgaricus	CH3CHOHCOONH4	Whey	Nitrogen expressed as crude protein: minimum 44 %	Ruminants from the beginning of rumination	Declarations to be made on the label or packaging of the product:
						—the name "Ammonium lactate from fermentation",
						—nitrogen expressed as crude protein,
						—crude ash,
						—moisture,
						—animal species or category.
						Declarations to be made on the label or packaging of compound feedingstuffs:
						—the name "Ammonium-lactate from fermentation",
						—amount of product contained in the feedingstuff,
						—percentage of the total crude protein provided by non-protein nitrogen,
						—indication, in the instructions for use, of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species or category.
	2.2.2.Ammonium acetate in aqueuous solution	CH3COONH4	—	Ammonium acetate: min. 55 %	Ruminants, from the start of rumination	Declarations to be made on the label or packaging of the product:
						—the words: Ammonium acetate,
						—nitrogen and moisture contents,
						—animal species or category.
						Declarations to be made on the label or packaging of compound feedingstuffs:
						—the words: Ammonium acetate
						—the amount of the product contained in the feedingstuff,
						—percentage of the total crude protein provided by non protein nitrogen,
						—indication in the instructions for use of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species or category.
	2.2.3Ammonium sulfate in aqueous solution	(NH4)2SO4	—	Ammonium sulfate: 35 %	Ruminants, from the start of rumination	Declarations to be made on the label or packaging of the product:
						—the words: "Ammonium sulfate",
						—nitrogen and moisture contents,
						—animal species,
						—in the case of young ruminants, the incorporation rate in the daily ration may not exceed 0,5 %
						Declarations to be made on the label or packaging of the compound feedingstuffs:
						—the words: "Ammonium sulfate",
						—the amount of the product contained in the feedingstuff,
						—percentage of the total crude protein provided by non-protein nitrogen,
						—indication in the instruction for use of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species,
						—in the case of young ruminants, the incorporation rate in the daily ration may not exceed 0,5 %
2.3.By-products from the production of amino acids by fermentation	2.3.1.Concentrated liquid by-products from the production of L-glutamic acid by fermentation with Corynebacterium melassecola	Ammonium salts and other nitrogenous compounds	Sucrose, molasses, starch products and their hydrolysates	Nitrogen expressed as crude protein: minimum 48 %Moisture: maximum 28 %	Ruminants from the beginning of rumination	Declarations to be made on the label or packaging of the product:the name "by-products from the production of L-glutamic acid" in the case of product 2.3.1; "by-products from the production of L-lysine" in the case of product 2.3.2,nitrogen, expressed as crude protein,crude ash,moisture,animal species or category.as from 1 April 2001: approval numberDeclarations to be made on the label or packaging of compound feedingstuffs:percentage of the total crude protein provided by non-protein nitrogen,indication, in the instructions for use, of the level of total non-protein nitrogen which should not be exceeded in the daily ration of each animal species or category.
	2.3.2.Concentrated liquid by-products from the production of L-lysine monohydrochloride by fermentation with Brevibacterium lactofermentum	Ammonium salts and other nitrogenous compounds	Sucrose, molasses, starch products and their hydrolysates	Nitrogen expressed as crude protein: minimum 45 %	Ruminants from the beginning of rumination
3.1.Methionine	3.1.1.DL-Methionine, technically pure	CH3S(CH2)2-CH(NH2)-COOH	—	DL-Methionine:minimum 98 %	All animal species	Declarations to be made on the label or packaking of the product:the name "DL-methionine", in the case of products 3.1.1, "Dihydrated calcium salt of N-hydroxy-menthyl-DL-mentionine" in the case of product 3.1.2, "Zinc-methionine" in the case of products 3.1.3,DL-methionine and moisture contents,animal species or category in the case of products 3.1.2. and 3.1.3,as from 1 April 2001: approval number
	3.1.2.Dihydrated calcium salt of N-hydroxy-methyl-DL-methionine, technically pure	[CH3S(CH2)2-CH(NH-CH2-OH)-COO]2Ca-2H2O	—	DL-Methionine:minimum 67 %Formaldehyde:maximum 14 %Calcium:minimum 9 %	Ruminants from the beginning of rumination
	3.1.3.Methionine-zinc, technically pure	[CH3S(CH2)2-CH(NH2)-COO]2Zn	—	DL-Methionine: minimum 80 %Zn: maximum 18,5 %	Ruminants from the beginning of rumination
	3.1.4.Concentrated liquid sodium DL-methionine technically pure	[CH3 S (CH2)2-CH(NH2)-COO]Na	—	DL-Methionine: minimum 40,0 %Sodium: minimum 6,2 %	All animal species	Declarations to be made on the label or packaging of the product:the name "concentrated liquid sodium-DL-methionine"DL-Methionine contentmoisture contentas from 1 April 2001: approval number
	3.1.5.DL-methionine, technically pure protected with copolymer vinylpyridine/styrene	CH3S(CH2)2-CH(NH2)-COOH	—	DL-Methionine: minimum 65 %copolymer vinylpyridine/styrene: maximum 3 %	Dairy cows	Declarations to be made on the label or packaging of the product:"Protected methionine with copolymer vinyl-pyridine/styrene"DL-methionine and moisture contentsanimal speciesas from 1 April 2001: approval number
3.2.Lysine	3.2.1.L-Lysine, technically pure	NH2-(CH2)4-CH(NH2)-COOH	—	L-Lysine:minimum 98 %	All animal species	Declarations to be made on the label or packaging of the product:the name "L-lysine" in the case of product 3.2.1, "Concentrated liquid L-lysine base" in the case of product 3.2.2, "L-lysine-monohydrochloride" in the case of product 3.2.3, "Concentrated liquid L-lysine monohydrochloride" in the case of product 3.2.4, "L-lysine sulphate and its by-products from fermentation" in the case of product 3.2.5,L-lysine and moisture contentsas from 1 April 2001: approval number
	3.2.2.Concentrated liquid L-lysine (base)	NH2-(CH2)4-CH(NH2)-COOH	Saccharose, molasses, starch products and their hydrolysates	L-Lysine:min. 50 %
	3.2.3.L-Lysine-monohydrochloride, technically pure	NH2-(CH2)4-CH(NH2)-COOH-HCl	—	L-Lysine:min. 78 %
	3.2.4.Concentrated liquid L-lysine-monohydrochloride	NH2-(CH2)4-CH(NH2)-COOH-HCl	Saccharose, molasses, starch products and their hydrolysates	L-Lysine:min. 22.4 %
	3.2.5.L-Lysine-sulphate produced by fermentation with Corynebacterium glutamicum	[NH2-(CH2)4-CH(NH2)-COOH]2·H2SO4	Sugar syrup, molasses, cereals, starch products and their hydrolysates	L-Lysine:min. 40 %
	3.2.6.L-lysine phosphate and its by-products produced by fermentation with Brevibacterium lactofermentum NRRL B-11470	[NH2-(CH2)4-CH(NH2)-COOH].H3PO4	Sucrose ammonia and fish solubles	L-lysine: min. 35 %Phosphorus: min: 4,3 %	PoultryPigs	Declaration to be made on the label or packaging of the product:the name "L-lysine phosphate and its by-products from fermentation".L-lysine and moisture content.as from 1 April 2001: approval number
	3.2.7.Mixtures of:(a)L-lysine-monohydrochloride, technically pure and,(b)DL-methionine, technically pureprotected with copolymer vinyl-pyridine/styrene	NH2-(CH2)4-CH(NH2)-COOH-HClCH3S(CH2)2-CH(NH2)-COOH		L-lysine: + DL-methionine: minimum 50 % (including DL-methionine: minimum 15 %)Copolymer vinyl-pyridine/styrene: maximum 3 %	Dairy cows	Declarations to be made on the label or packaging of the product:the name "mixture of L-lysine monohydrochloride and DL-methionine protected with copolymer vinyl-pyridine/styrene"L-lysine, DL-methionine and moisture contentsanimal speciesas from 1 April 2001: approval number
3.3.Threonine	3.3.1.L-Threonine, technically pure	CH3-CH(OH)-CH(NH2)-COOH	—	L-Threonine: minimum 98 %	All animal species	Declarations to be made on the label or packaging of the product:the name "L-threonine",L-threonine and moisture contentsas from 1 April 2001: approval number
3.4Tryptophan	3.4.1.L-Tryptophan, technically pure	(C8H5NH)-CH2-CH(NH2)-COOH	—	L-Tryptophan: minimum 98 %	All animal species	Declarations to be made on the label or packaging of the product:the name "L-tryptophan",L-tryptophan and moisture contentsas from 1 April 2001: approval number
3.4Tryptophan	3.4.2.DL-Tryptophan, technically pure	(C8H5NH)-CH2-CH(NH2)-COOH	—	DL-Tryptophan: minimum 98 %	All animal species	Declarations to be made on the label or packaging of the product:the name "DL-tryptophan",DL-tryptophan and moisture contentsas from 1 April 2001: approval number
4.1.Analogues of methionine	4.1.1.Hydroxy analogue of methionine	CH3S(CH2)2-CH(OH)-COOH	—	Total of acids: minimum 85 %Monomer acid: minimum 65 %	All animal species	Declarations to be made on the label or packaging of the product:if appropriate, the name (column 2),monomer acid and total acids contents in the case of product 4.1.1. and monomer acid content in the case of product 4.1.2,moisture content,animal species.as from 1 April 2001: approval numberDeclarations to be made on the label or packaging of compound feedingstuffs:if appropriate, the name (column 2),monomer acid and total acids contents in the case of product 4.1.1. and monomer acid content in the case of product 4.1.2,amount of the product contained in the feedingstuff.
	4.1.2.Calcium salt of hydroxy analogue of methionine	[CH3-S-(CH2)2-CH(OH)-COO]2Ca	—	Monomer acid: minimum: 83 %Calcium: minimum 12 %	All animal species
	4.1.3Isopropyl ester of the hydroxylated analogue of methionine	CH3-S-(CH2)2-CH(OH) -COO-CH-(CH3)2	—	—Monomer esters: 90 % minimum—Humidity: maximum 1 %	Dairy cows	Statement to be included on the label or the packaging of the product:Isopropyl ester of 2- hydroxy-4-methylthiobutanoic acidStatements to be included on the labelling or the packaging of the compounded feed:Analogue of methionine: Isopropyl ester of 2- hydroxy-4-methylthiobutanoic acidPercentage of incorporation of analogue of methionine in the feed.

January 1, 1986	article 13.2	Amendment
January 1, 1986	article 14.2	Amendment

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition

Modified by

Council Regulation (EEC) No 3768/85 of 20 December 1985 adapting, on account of the accession of Spain and Portugal, certain agricultural acts as regards the voting procedure of the Committees