22
1982L0471 — EN — 18.04.2004 — 004.001 — 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B C O U N C IL D IR E C TIV E of 3 0 J une 1 9 8 2 concerning certain products used in animal nutrition (82/471/EEC ) (O J L 213 , 21.7.1982, p . 8) A m ended by: O fficial Journal No page d a te M 1 C o m m is s io n D ire c tiv e 84/443 /EEC o f 26 J u ly 1984 L 245 21 14.9.1984 M 2 C o m m is s io n D ire c tiv e 85 /5 09/EEC o f 6 No v e m b e r 1985 L 3 14 25 23 .11.1985 M 3 C o u n c il R e g u la tio n (EEC ) No 3 76 8/85 o f 20 D e c e m b e r 1985 L362 8 3 1.12.1985 M 4 C o m m is s io n D ire c tiv e 86 /5 3 0/EEC o f 28 O c to b e r 1986 L 3 12 39 7.11.1986 M 5 C o m m is s io n D ire c tiv e 88/485 /EEC o f 26 J u ly 1988 L 23 9 36 3 0.8.1988 M 6 C o m m is s io n D ire c tiv e 89/5 20/EEC o f 6 S e p te m b e r 1989 L 270 13 19.9.1989 M 7 C o m m is s io n D ire c tiv e 90/43 9/EEC o f 24 J u ly 1990 L 227 33 21.8.1990 M 8 C o u n c il D ire c tiv e 90/6 5 4/EEC of 4 D ecem ber 1990 L353 48 17.12.1990 M 9 C o m m is s io n D ire c tiv e 93 /26 /EEC o f 4 J u n e 1993 L 179 2 22.7.1993 M 10 C o m m is s io n D ire c tiv e 93 /5 6 /EEC o f 29 J u n e 1993 L 206 13 18.8.1993 M 11 C o u n c il D ire c tiv e 93 /74/EEC o f 13 S e p te m b e r 1993 L 23 7 23 22.9.1993 M 12 C o m m is s io n D ire c tiv e 95 /3 3 /EC o f 10 J u ly 1995 L 16 7 17 18.7.1995 M 13 C o u n c il D ire c tiv e 95 /6 9/EC of 22 D ecem ber 1995 L332 15 3 0.12.1995 M 14 M 15 C o u n c il D ire c tiv e 96 /25 /EC o f 29 A p ril 1996 L 125 35 23 .5 .1996 M 15 am ended by D ire c tiv e 2000/16 /EC of the European Parliam ent and the C o u n c il o f 10 A p ril 2000 L 105 36 3 .5 .2000 M 16 C o u n c il D ire c tiv e 1999/20/EC of 22 M arch 1999 L 80 20 25 .3 .1999 M 17 R e g u la tio n (EC ) No 1829/2003 of the European Parliam ent and o f th e C o u n c il o f 22 S e p te m b e r 2003 L 26 8 1 18.10.2003 M 18 R e g u la tio n (EC ) No 1882/2003 of the European Parliam ent and o f th e C o u n c il o f 29 S e p te m b e r 2003 L 284 1 3 1.10.2003 M 19 C o m m is s io n D ire c tiv e 2003 /104/EC o f 12 No v e m b e r 2003 L 295 83 13 .11.2003 A m ended by: A1 A ct of A ccession of A ustria, Sw eden and Finland C 241 21 29.8.1994 (a d a p te d b y C o u n c il D e c is io n 95 /1/EC , Eu ra to m , EC S C ) L1 1 1.1.1995

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  • 1982L0471 — EN — 18.04.2004 — 004.001 — 1

    This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

    ►B C O U N C I L D I R E C TI V E

    of 3 0 J une 1 9 8 2

    concerning certain products used in animal nutrition

    (82/471/EEC )

    (O J L 213 , 21.7.1982, p . 8)

    A m e n d e d b y :

    O ffic ia l J o u rn a l

    No p a g e d a te

    ►M 1 C o m m is s io n D ire c tiv e 84/443 /EEC o f 26 J u ly 1984 L 245 21 14.9.1984

    ►M 2 C o m m is s io n D ire c tiv e 85 /5 09/EEC o f 6 No v e m b e r 1985 L 3 14 25 23 .11.1985

    ►M 3 C o u n c il R e g u la tio n (EEC ) No 3 76 8/85 o f 20 D e c e m b e r 1985 L 3 6 2 8 3 1.12.1985

    ►M 4 C o m m is s io n D ire c tiv e 86 /5 3 0/EEC o f 28 O c to b e r 1986 L 3 12 3 9 7.11.1986

    ►M 5 C o m m is s io n D ire c tiv e 88/485 /EEC o f 26 J u ly 1988 L 23 9 3 6 3 0.8.1988

    ►M 6 C o m m is s io n D ire c tiv e 89/5 20/EEC o f 6 S e p te m b e r 1989 L 270 13 19.9.1989

    ►M 7 C o m m is s io n D ire c tiv e 90/43 9/EEC o f 24 J u ly 1990 L 227 3 3 21.8.1990

    ►M 8 C o u n c il D ire c tiv e 90/6 5 4/EEC o f 4 D e c e m b e r 1990 L 3 5 3 48 17.12.1990

    ►M 9 C o m m is s io n D ire c tiv e 93 /26 /EEC o f 4 J u n e 1993 L 179 2 22.7.1993

    ►M 1 0 C o m m is s io n D ire c tiv e 93 /5 6 /EEC o f 29 J u n e 1993 L 206 13 18.8.1993

    ►M 1 1 C o u n c il D ire c tiv e 93 /74/EEC o f 13 S e p te m b e r 1993 L 23 7 23 22.9.1993

    ►M 1 2 C o m m is s io n D ire c tiv e 95 /3 3 /EC o f 10 J u ly 1995 L 16 7 17 18.7.1995

    ►M 1 3 C o u n c il D ire c tiv e 95 /6 9/EC o f 22 D e c e m b e r 1995 L 3 3 2 15 3 0.12.1995

    ►M 1 4 ►M 1 5 C o u n c il D ire c tiv e 96 /25 /EC o f 29 A p ril 1996 ◄ L 125 3 5 23 .5 .1996

    ►M 1 5 a m e n d e d b y D ire c tiv e 2000/16 /EC o f th e Eu ro p e a n P a rlia m e n t a n d th eC o u n c il o f 10 A p ril 2000

    L 105 3 6 3 .5 .2000

    ►M 1 6 C o u n c il D ire c tiv e 1999/20/EC o f 22 M a rc h 1999 L 80 20 25 .3 .1999

    ►M 1 7 R e g u la tio n (EC ) No 1829/2003 o f th e Eu ro p e a n P a rlia m e n t a n d o f th eC o u n c il o f 22 S e p te m b e r 2003

    L 26 8 1 18.10.2003

    ►M 1 8 R e g u la tio n (EC ) No 1882/2003 o f th e Eu ro p e a n P a rlia m e n t a n d o f th eC o u n c il o f 29 S e p te m b e r 2003

    L 284 1 3 1.10.2003

    ►M 1 9 C o m m is s io n D ire c tiv e 2003 /104/EC o f 12 No v e m b e r 2003 L 295 83 13 .11.2003

    A m e n d e d b y :

    ►A 1 A c t o f A c c e s s io n o f A u s tria , S w e d e n a n d F in la n d C 241 21 29.8.1994

    (a d a p te d b y C o u n c il D e c is io n 95 /1/EC , Eu ra to m , EC S C ) L 1 1 1.1.1995

  • ▼B

    COUNCIL DIRECTIVE

    of 30 June 1982

    concerning certain products used in animal nutrition

    (82/471/EEC)

    T H E COU NCIL OF T H E EU ROPEAN COMMU NIT IES,

    H aving regard to the T reaty establishing the European EconomicCommunity, and in particular Articles 43 and 100 thereof,

    H aving regard to the proposal from the Commission (1),

    H aving regard to the opinion of the European Parliament (2),

    H aving regard to the opinion of the Economic and Social Committee (3),

    W hereas livestock production occupies a very important place in theagriculture of the Community and satisfactory results depend to a largeex tent on the use of appropriate and good q uality feedingstuffs;

    W hereas the ex istence of rules concerning feedingstuffs is essential to anincrease in agricultural productivity;

    W hereas consumption of feed proteins is continually rising in theCommunity due to the ever increasing needs of livestock production;

    W hereas this increasing demand has been accompanied in recent yearsby an appreciable decline in the supply on the world mark et of certainprotein feedingstuffs;

    W hereas this shortage has caused the feedingstuffs industry to carry outresearch into substitution products to assure the availability of supplies;

    W hereas the provisions laid down in the Member States by law,regulation or administrative action concerning these products, in so faras they ex ist, differ as regards their basic principles; whereas it followsthat they directly affect the establishment and functioning of thecommon mark et and should therefore be harmoniz ed;

    W hereas these substitution products are produced by new technicalprocesses and it is therefore desirable to regulate their mark eting asfeedingstuffs or constituents of feedingstuffs by prescribing, for eachgroup concerned, which individual products shall be authoriz ed andunder what conditions of use;

    W hereas it is necessary, before including a new product in one of thegroups concerned, to ascertain that it has the req uired nutritional value;whereas it must be established that these products, when used sensibly,have no detrimental effect on human or animal health or on theenvironment and do not harm the consumer by impairing the distinctivefeatures of animal products;

    W hereas, in order to ensure compliance with the fundamental principleslaid down for the authoriz ation, a dossier should be submitted officiallyby a Member State for products belonging to certain groups; whereas, inorder to facilitate the ex amination of the substances concerned, thesedossiers should be prepared in accordance with the common guidelinesto be set by the Council not later than the date of application of theDirective;

    W hereas it is desirable, pending a Community decision, to allowMember States temporarily to maintain the national authoriz ations theyhave granted for products which do not at present appear in the Annex tothe Directive or for specific products meeting in certain cases otherconditions; whereas, however, for products obtained from yeasts of the‘Candida’ variety and cultivated on n-alk anes a Community decisionshould be tak en within two years of the notification of this Directive;

    1982L0471 — EN — 18.04.2004 — 004.001 — 2

    (1) OJ No C 197, 18. 8. 1977, p. 3.(2) OJ No C 63, 13. 3. 1978, p. 53.(3) OJ No C 84, 8. 4. 1978, p. 4.

  • ▼B

    Whereas non-protein nitrogenous compounds, by reason of their indirectprovision of protein, must be subject to the provisions of this Directive;whereas it is consequently desirable to amend with regard to its AnnexesCouncil Directive 70/524/EEC of 23 November 1970 concerningadditives in feedingstuffs (1), which temporarily regulates the use ofproducts of this group;

    Whereas the nutritional value and safety of the products in questiondepend to a large extent on their compositional characteristics,conditions of use and processes of manufacture; whereas it is thereforeessential to provide in certain cases for labelling to protect the useragainst fraud and to facilitate the optimal use of the products available tohim;

    Whereas it is not appropriate to apply Community provisions to theproducts concerned, or to feedingstuffs containing these products,intended for export to third countries because in general these countrieshave their own regulations;

    Whereas, in order to ensure that the requirements of this Directive aresatisfied when these products, or feedingstuffs containing theseproducts, are placed on the market, Member States must make provisionfor appropriate control arrangements;

    Whereas products, or feedingstuffs containing such products, satisfyingthese requirements must be subject only to the marketing restrictionsprovided for in this Directive;

    Whereas an appropriate Community procedure is essential to adapt theprovisions of the Annex and the guidelines laid down for the submissionof dossiers relating to certain products and, where necessary, to fixcriteria of composition and purity as well as the physico-chemical andbiological properties of these products in the light of the development ofscientific and technical knowledge;

    Whereas, with a view to providing all necessary guarantees, theCommunity procedure adopted should make provision in certain cases ofamendment of the Annex for the compulsory consultation of theScientific Committee for Animal Nutrition and the Scientific Committeefor Food, set up by the Commission;

    Whereas Member States should retain the power, if human or animalhealth is endangered, temporarily to suspend authorization of the use ofa product or to amend any provisions relating thereto;

    Whereas, in order that a Member State should not abuse that power,possible amendments to the Annex based on supporting documentsshould be decided by emergency Community procedure;

    Whereas, in order to facilitate implementation of this Directive, aprocedure should be applied which establishes close cooperationbetween Member States and the Commission within the StandingCommittee for Feedingstuffs set up by Decision 70/372/EEC (2),

    HAS ADOPTED THIS DIRECTIV E:

    Article 1

    1. This Directive concerns products which act as direct or indirectprotein sources, are manufactured by certain technical processes and areput into circulation within the Community as feedingstuffs or infeedingstuffs.

    2. This Directive shall be without prejudice to Community provisionsconcerning:

    (a) additives in feedingstuffs;

    1982L0471 — EN — 18.04.2004 — 004.001 — 3

    (1) OJ No L 270, 14. 12. 1970, p. 1.(2) OJ No L 170, 3. 8. 1970, p. 1.

  • ▼B

    (b) the fixing of maximum levels for undesirable substances andproducts in feedingstuffs;

    (c) the fixing of maximum levels for pesticide residues on and inproducts intended for human or animal nutrition;

    (d) the marketing ►M14 ◄ 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 orindirect protein sources that fall within the scope of Regulation (EC) No1829/2003 of the European Parliament and of the Council of 22September 2003 on genetically modified food and feed (1).

    Article 2

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

    Article 3

    1. Member States shall prescribe that feedingstuffs belonging to oneof the product groups listed in the Annex or containing such productsmay 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, providedthat 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 downthe conditions and arrangements for approving and registering certainestablishments and intermediaries operating in the animal feed sector (2)may be put into circulation only by establishments or intermediarieswhich meet the conditions laid down in Article 2 or Article 3 of thatDirective, as appropriate.

    4. Paragraph 3 shall apply without prejudice to Article 4(2) ofDirective 95/69/EC.

    Article 4

    1. Notwithstanding Article 3 (1), the Member States may, until suchtime as a decision has been taken in accordance with Article 6, maintain:

    (a) authorizations granted within their territories before the date ofapplication of this Directive concerning products not listed under theproduct groups indicated in the Annex with the exception ofproducts obtained from yeasts of the ‘Candida’ variety andcultivated on n-alkanes;

    (b) authorizations granted within their territories before notification ofthis Directive concerning on the one hand products obtained fromyeasts of the ‘Candida’ variety and cultivated on n-alkanes and onthe other hand products listed in the Annex, Section 1.2.1, meetingrequirements different from those laid down therein.

    1982L0471 — EN — 18.04.2004 — 004.001 — 4

    (1) OJ L 268, 18.10.2003, p. 1.(2) OJ No L 332, 30.12.1995, p. 15.

    ▼M11

    ▼M14

    ▼M17

    ▼B

    ▼M13

    ▼M16

    ▼B

  • ▼B

    2. Member States shall send to the other Member States and theCommission the list of products allowed on their territories inaccordance with paragraph 1.

    3. In the territory of the former G erman Democratic Republic, the usein feedingstuffs of protein products obtained from yeast of the Candidagenus cultured on n-alkanes shall not be prohibited until 31 December1991. The Federal Republic of G ermany shall ensure that the products inquestion are not dispatched to other parts of the Community.

    Article 5

    1. Without prejudice to the labelling provisions applicable to straightand compound feedingstuffs, Member States shall prescribe that theproducts listed in the Annex may not be marketed as feedingstuffs orincorporated in feedingstuffs unless any particulars laid down in theAnnex appear in the package or container or on a label attached thereto.

    2. Member States shall prescribe that for material marketed in bulkthe particulars referred to in paragraph 1 shall appear on anaccompanying document.

    Article 6

    1. Amendments to be made to the Annex as a result of developmentsin scientific or technical knowledge shall be adopted in accordance withthe procedure laid down in Article 13. In the case of the productsreferred to in Sections 1.1 and 1.2 of the Annex the Commission shallconsult the Scientific Committee for Animal Nutrition and the ScientificCommittee 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), adecision shall be adopted, in accordance with the procedure set out inArticle 13, within two years of notification of this Directive, afterconsulting the Scientific Committee for Animal Nutrition and theScientific 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 nitrogenor protein;

    (b) when used sensibly it has no detrimental effect on human oranimal health or on the environment and does not harm theconsumer by impairing the distinctive features of animalproducts;

    (c) it can be monitored in feedingstuffs.

    B . A product shall be deleted from the Annex if one of the conditionslisted in A is not satisfied.

    3. Criteria making it possible to define the products included in thisDirective, particularly the criteria of composition and purity and thephysico-chemical and biological properties, may be set in the light ofscientific and technical knowledge and in accordance with the procedurelaid down in Article 13.

    Article 7

    1. In order to ensure that the products referred to in Sections 1.1 and1.2 of the Annex comply with the principles set out in Article 6 (2), theMember States shall ensure that a dossier, prepared in accordance withthe provisions of paragraph 2 below, is sent officially to the MemberStates, 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 theguidelines to be observed in preparing the dossier referred to in

    1982L0471 — EN — 18.04.2004 — 004.001 — 5

    ▼M8

    ▼B

  • ▼B

    paragraph 1 so that these guidelines can be applied on the date ofapplication of this Directive at the latest.

    The amendments to be made to the guidelines subsequently as a result ofdevelopments in scientific or technical knowledge shall be adopted inaccordance with the procedure laid down in Article 13.

    3. The Member States, the Commission and the other recipients ofthe dossier referred to in paragraph 1 shall ensure, if requested on goodgrounds by an applicant, that information whose disclosure couldadversely affect industrial or commercial property rights is keptconfidential.

    Industrial and commercial secrecy shall not apply to:

    — the names and composition of the product, and any informationconcerning the substrate and the micro-organism,

    — the physico-chemical and biological properties of the product,

    — the interpretation of the pharmacological, toxicological and ecotox-icological data,

    — the analytical methods for monitoring the product in the feeding-stuffs.

    Article 8

    1. If, on the basis of detailed grounds due to new data or a newevaluation of existing data that have become evident since the adoptionof the provisions in question, a Member State finds that one of theproducts listed in the Annex or its use under any conditions that havebeen set represents a danger to human or animal health even though itcomplies with the provisions of this Directive, the Member States maytemporarily suspend or restrict the application of those provisions in itsterritory. It shall immediately inform the other Member States and theCommission thereof, giving the reasons for its decision.

    2. The Commission shall examine as soon as possible the reasonsgiven by the Member State concerned and shall consult the MemberStates in the Standing Committee for Feedingstuffs and shall then giveits opinion without delay and take appropriate action.

    3. If the Commission considers that amendments to the Directive arenecessary to alleviate the difficulties referred to in paragraph 1 and toensure the protection of human or animal health, it shall initiate theprocedure laid down in Article 14 so as to adopt such amendments; inthat case, the Member State which has adopted safeguard measures mayretain them until the amendments come into force.

    Article 9

    With regard to marketing between Member States, the particularsreferred to in Article 5 shall be given in at least one of the officiallanguages of the country of destination.

    Article 10

    The Member States shall ensure that as far as the presence and labellingof the products listed in the Annex is concerned, feedingstuffs thatcomply with the provisions of this Directive are subject only to themarketing restrictions contained in this Directive.

    Article 11

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

    Article 12

    The Member States shall take all measures necessary to ensure that thecompliance of feedingstuffs with the requirements of this Directive isofficially monitored, at least by sampling, during marketing.

    1982L0471 — EN — 18.04.2004 — 004.001 — 6

  • ▼M18

    Article 13

    1. The Commission shall be assisted by the Standing Committee onthe Food Chain and Animal Health, set up by Article 58 of Regulation(EC) No 178/2002 (1), hereinafter referred to as ‘the Committee’.

    2. Where reference is made to this Article, Articles 5 and 7 ofDecision 1999/468/EC (2) shall apply, having regard to the provisions ofArticle 8 thereof.

    The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at three months.

    3. The Committee shall adopt its rules of procedure.

    Article 14

    Where reference is made to this Article, Articles 5 and 7 of Decision1999/468/EC shall apply, having regard to the provisions of Article 8thereof.

    The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at 15 days.

    Article 15

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

    Article 16

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

    Article 17

    The Member States shall bring into force, two years after notification ofthis Directive, the laws, regulations and administrative provisionsnecessary to comply with this Directive. They shall immediately informthe Commission thereof.

    However, the Federal Republic of Germany may until 31 December1991 derogate from the labelling provisions in Article 5 for feedingstuffsproduced in the territory of the former German Democratic Republic.

    Article 18

    This Directive is addressed to the Member States.

    1982L0471 — EN — 18.04.2004 — 004.001 — 7

    (1) OJ L 31, 1.2.2002, p. 1.(2) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures

    for the exercise of implementing powers conferred on the Commission (OJ L184, 17.7.1999, p. 23).

    ▼B

    ▼M8

    ▼B

  • ANNEX

    1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    1. P roteins obtained from thefollow ing groups of micro-organisms

    1.1. B a cteria

    ▼M41.1.1. Bacteria cultivated

    on methanol1.1.1.1. Protein product of

    fermentation obtainedby culture of M eth y -lo p h ilu s m eth y lo tro -p h u s on methanol

    M eth y lo p h ilu s m eth y lo -tro p h u s NCIB strain10.515

    Methanol — Crude protein: min.68 %

    — Reflectance indexat least 50

    — Pigs

    — Calves

    — Poultry

    — Fish

    Declarations to be made on thelabel or packaging of theproduct:

    — name of the product,

    — crude protein,

    — crude ash,

    — crude fat,

    — moisture content,

    — instructions for use,

    — Declaration of the words‘Avoid inhalation’.

    ►M16 — as from 1 April2001: approval number ◄

    Declarations to be made on thelabel or packaging ofcompound feedingstuffs:

    — amount of the productcontained in the feeding-stuff.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —8

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M121.1.2. Bacteria cultivated

    on natural gas1.1.2.1. protein product of

    fermentation fromnatural gas obtainedby culture of: Methy-lococcus capsulatus(Bath), Alcalig en esacid ov oran s, Bacillusb rev is et Bacillusfirmus, an d the cellsof w hich hav e b eenk illed

    Methylococcus capsu-latus (Bath) NCIMBstrain 11132

    Alcalig en es acid o-v oran s

    NCIMB strain

    12387

    Bacillus b rev is strain

    NCIMB strain

    13288

    Bacillus firmus strain

    NCIMB strain

    13280

    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 fatteningfrom 25 to 60 kg

    — Calves from 80 kgon

    — Salmon

    Declarations to be made on thelabel or the packaging of theproduct:

    — the name: ‘Protein productof fermentation fromnatural gas obtained byculture of Methylococcuscapsulatus (Bath), Alcali-g en es acid ov oran s, Bacillusb rev is and Bacillus firmus,’

    — crude protein

    — crude ash

    — crude fat

    — moisture content

    — instructions for use

    — maximum incorporationrate in the feed:

    — 8 % pigs for fattening

    — 8 % calves

    — 19 % salmon (fresh-water)

    — 33 % salmon (seawater)

    — declaration of thewords: ‘avoid inhala-tion’

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —9

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M12►M16 — as from 1 April

    2001: approval number ◄

    Declarations to be made on thelabel or packaging of thecompound feedingstuffs:

    — The name: ‘Protein productobtained by bacterialfermentation of natural gas’

    — amount of the productcontained in the feeding-stuffs

    ▼B1.2. Yeasts

    1.2.1. Y easts cultivated onsubstrates of animalor vegetable origin

    All yeasts

    — obtained from themicro-organisms andsubtrates listed incolumns 3 and 4respectively

    Saccharomycescerevisiae, Sacchar-omyces carlsber-giensis

    Kluyveromyceslactis, Kluyvero-myces fragilis

    Molasses, distilleryresidues, cereals andproducts containingstrarch, fruit juice,whey, lactic acid,hydrolyzed vege-table fibres

    All animal species

    — the cells of which havebeen killed

    1.2.2. Y easts cultivated onsubstrates other thanthose given in 1.2.1.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —10

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    1.3. Algae — —

    1.4. L ower fungi

    ▼M71.4.1. Products from

    production of anti-biotics by fermenta-tion

    1.4.1.1. Mycelium, wet by-product from theproduction of peni-cillin, ensiled bymeans of lactoba-cillus brevis, plan-tarun, sake, collenoidand streptococcuslactis to inactive thepenicillin and heattreated

    Nitrogenous compoundPenicillium chryso-genum ATCC 48271

    Different sources ofcarbohydrates and theirhydrolysates

    Nitrogen expressed ascrude protein: min. 7 %

    Ruminants

    Pigs

    Declaration be be made on thelabel or packaging of theproduct:

    — the name: ‘Mycelium silagefrom the production ofpenicillin’

    — Nitrogen expressed as crudeprotein

    — crude ash

    — moisture

    — animal species or category

    ►M16 — as from 1 April2001: approval number ◄

    Declaration to be made on thelabel or packaging of thecompound feedingstuff:

    — the name: ‘Mycelium silagefrom the production ofpenicillin’.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —11

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M12. Non-protein nitrogenous

    compounds

    2.1. Urea and its derivatives 2.1.1. Urea, technically pure CO(NH2)

    2— Urea: minimum 97 %

    ��

    ��

    Ruminants from thebeginning of rumi-nation

    Declarations to be made on thelabel or packaging of theproduct:

    2.1.2. Biuret, technically pure (CONH2)

    2-NH — Biuret: minimum 97 % — the name ‘Urea’, ‘Biuret’,

    ‘Urea-phosphate’ or ‘Diur-eidoisobutane’, as the casemay be,

    2.1.3. Urea-phosphate, techni-cally pure

    CO(NH2)

    2· H

    3PO

    4— Nitrogen: minimum

    16,5 %

    Phosphorus: minimum18 %

    — nitrogen level; and in addi-tion for product 2.1.3,phosphorus level,

    2.1.4. Diureidoisobutane,technically pure

    (CH3)

    2-(CH)

    2-

    (NHCONH2)

    2

    — Nitrogen: minimum30%

    Isobutyraldehyde:minimum 35 %

    — animal species or category.

    Declarations to be made on thelabel or packaging ofcompound feedingstuffs:

    — the name ‘Urea’, ‘Biuret’,‘Urea-phosphate’ or ‘Diur-eidoisobutane’ as the casemay be,

    — amount of the productcontained in the feeding-stuff,

    — percentage of the totalcrude protein provided bynon-protein nitrogen,

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —12

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M1

    — indication, in the instruc-tions for use, of the level oftotal non-protein nitrogenwhich should not beextended in the daily rationof each animal species orcategory.

    2.2. Ammonium salts 2.2.1. Ammonium lactate,produced by fermenta-tion with Lactobacillusbulgaricus

    CH3CHOHCOONH

    4Whey Nitrogen expressed as

    crude protein:minimum 44 %

    Ruminants from thebeginning of rumina-tion

    Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘Ammoniumlactate from fermentation’,

    — nitrogen expressed as crudeprotein,

    — crude ash,

    — moisture,

    — animal species or category.

    Declarations to be made on thelabel or packaging ofcompound feedingstuffs:

    — the name ‘Ammonium-lactate from fermentation’,

    — amount of productcontained in the feeding-stuff,

    — percentage of the totalcrude protein provided bynon-protein nitrogen,

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —13

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M1

    — indication, in the instruc-tions for use, of the level oftotal non-protein nitrogenwhich should not beexceeded in the daily rationof each animal species orcategory.

    ▼M42.2.2. Ammonium acetate in

    aqueuous solutionCH

    3COONH

    4— Ammonium acetate:

    min. 55 %Ruminants, from thestart of rumination

    Declarations to be made on thelabel or packaging of theproduct:

    — the words: Ammoniumacetate,

    — nitrogen and moisturecontents,

    — animal species or category.

    Declarations to be made on thelabel or packaging ofcompound feedingstuffs:

    — the words: Ammoniumacetate

    — the amount of the productcontained in the feeding-stuff,

    — percentage of the totalcrude protein provided bynon protein nitrogen,

    — indication in the instruc-tions for use of the level oftotal non-protein nitrogenwhich should not beexceeded in the daily rationof each animal species orcategory.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —14

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M102.2.3 Ammonium sulfate in

    aqueous solution(NH

    4)

    2SO

    4— Ammonium sulfate:

    35 %Ruminants, from thestart of rumination

    Declarations to be made on thelabel or packaging of theproduct:

    — the words: ‘Ammoniumsulfate’,

    — nitrogen and moisturecontents,

    — animal species,

    — in the case of young rumi-nants, the incorporation ratein the daily ration may notexceed 0,5 %

    Declarations to be made on thelabel or packaging of thecompound feedingstuffs:

    — the words: ‘Ammoniumsulfate’,

    — the amount of the productcontained in the feeding-stuff,

    — percentage of the totalcrude protein provided bynon-protein nitrogen,

    — indication in the instructionfor use of the level of totalnon-protein nitrogen whichshould not be exceeded inthe daily ration of eachanimal species,

    — in the case of young rumi-nants, the incorporation ratein the daily ration may notexceed 0,5 %

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —15

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M12.3. By-products from the

    production of amino acidsby fermentation

    2.3.1. Concentrated liquid by-products from theproduction of L-glutamic acid byfermentation withCorynebacteriummelassecola

    Ammonium salts andother nitrogenouscompounds

    Sucrose, molasses,starch products andtheir hydrolysates

    Nitrogen expressed ascrude protein:minimum 48 %

    Moisture: maximum28 %

    Ruminants from thebeginning of rumina-tion

    Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘by-products fromthe production of L-glutamic acid’ in the case ofproduct 2.3.1; ‘by-productsfrom the production of L-lysine’ in the case ofproduct 2.3.2,

    — nitrogen, expressed as crudeprotein,

    — crude ash,

    — moisture,

    — animal species or category.

    ►M16 — as from 1 April2001: approval number ◄

    Declarations to be made on thelabel or packaging ofcompound feedingstuffs:

    ►M2 ◄

    — percentage of the totalcrude protein provided bynon-protein nitrogen,

    — indication, in the instruc-tions for use, of the level oftotal non-protein nitrogenwhich should not beexceeded in the daily rationof each animal species orcategory.

    2.3.2. Concentrated liquid by-products from theproduction of L-lysinemonohydrochloride byfermentation withBrevibacterium lacto-fermentum

    Ammonium salts andother nitrogenouscompounds

    Sucrose, molasses,starch products andtheir hydrolysates

    Nitrogen expressed ascrude protein:minimum 45 %

    Ruminants from thebeginning of rumina-tion

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —16

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M53. Amino acids and their salts

    3.1. Methionine 3.1.1. DL-Methionine, techni-cally pure

    CH3S(CH

    2)

    2-CH(NH

    2)-

    COOH— DL-Methionine:

    minimum 98 %All animal species

    Declarations to be made onthe label or packaking of theproduct:

    3.1.2. Dihydrated calcium saltof N-hydroxy-methyl-DL-methionine, techni-cally pure

    [CH3S(CH

    2)

    2-CH(NH-

    CH2-OH)-COO]

    2Ca-

    2H2O

    — DL-Methionine:minimum 67 %

    Formaldehyde:maximum 14 %

    Calcium:minimum 9 %

    Ruminants from thebeginning of rumi-nation

    — the name ‘DL-methio-nine’, in the case ofproducts 3.1.1, ‘Dihy-drated calcium salt of N-hydroxy-menthyl-DL-mentionine’ in the caseof product 3.1.2, ‘Z inc-methionine’ in the caseof products 3.1.3,

    — DL-methionine andmoisture contents,

    3.1.3. Methionine-zinc, tech-nically pure

    [CH3S(CH

    2)

    2-CH(NH

    2)-

    COO]2Z n

    — DL-Methionine:minimum 80 %

    Z n: maximum 18,5 %

    — animal species or cate-gory in the case ofproducts 3.1.2. and 3.1.3,

    ►M16 — as from 1 April2001: approvalnumber ◄

    ▼M63.1.4. Concentrated liquid

    sodium DL-methioninetechnically pure

    [CH3

    S (CH2)

    2-

    CH(NH2)-COO]Na

    — DL-Methionine:minimum 40,0 %

    Sodium: minimum6,2 %

    All animal species Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘concentratedliquid sodium-DL-methio-nine’

    — DL-Methionine content

    — moisture content

    ►M16 — as from 1 April2001: approval number ◄

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —17

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M93.1.5. DL-methionine, techni-

    cally pure protectedwith copolymer vinyl-pyridine/styrene

    CH3S(CH

    2)

    2-CH(NH

    2)-

    COOH— DL-Methionine:

    minimum 65 %

    copolymer vinylpyri-dine/styrene: maximum3 %

    Dairy cows Declarations to be made on thelabel or packaging of theproduct:

    — ‘Protected methionine withcopolymer vinyl-pyridine/styrene’

    — DL-methionine andmoisture contents

    — animal species

    ►M16 — as from 1 April2001: approval number ◄

    ▼M53.2. Lysine 3.2.1. L-Lysine, technically

    pureNH

    2-(CH

    2)

    4-CH(NH

    2)-

    COOH— L-Lysine:

    minimum 98 %

    All animal species

    Declarations to be made onthe label or packaging of theproduct:

    — the name ‘L-lysine’ inthe case of product 3.2.1,‘Concentrated liquid L-lysine base’ in the caseof product 3.2.2, ‘L-lysine-monohy-drochloride’ in the caseof product 3.2.3,‘Concentrated liquid L-lysine monohy-drochloride’ in the caseof product 3.2.4, ‘L-lysine sulphate and itsby-products fromfermentation’ in the caseof product 3.2.5,

    3.2.2. Concentrated liquid L-lysine (base)

    NH2-(CH

    2)

    4-CH(NH

    2)-

    COOHSaccharose, molasses,starch products andtheir hydrolysates

    ►M12 L-Lysine:

    min. 50 % ◄

    3.2.3. L-Lysine-monohy-drochloride, technicallypure

    NH2-(CH

    2)

    4-CH(NH

    2)-

    COOH-HCl— L-Lysine:

    min. 78 %

    3.2.4. Concentrated liquid L-lysine-monohy-drochloride

    NH2-(CH

    2)

    4-CH(NH

    2)-

    COOH-HClSaccharose, molasses,starch products andtheir hydrolysates

    L-Lysine:

    min. 22.4 %

    3.2.5. L-Lysine-sulphateproduced by fermenta-tion with Corynebac-terium glutamicum

    [NH2-(CH

    2)

    4-CH(NH

    2)-

    COOH]2·H

    2SO

    4

    Sugar syrup, molasses,cereals, starch productsand their hydrolysates

    L-Lysine:

    min. 40 %

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —18

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M5— L-lysine and moisture

    contents

    ►M16 — as from 1 April2001: approvalnumber ◄

    ▼M73.2.6. L-lysine phosphate and

    its by-productsproduced by fermenta-tion with Brevibac-terium lactofermentumNRRL B-11470

    [NH2-(CH

    2)

    4-CH(NH

    2)-

    COOH].H3PO

    4

    Sucrose ammonia andfish solubles

    L-lysine: min. 35 %

    Phosphorus: min: 4,3 %

    Poultry

    Pigs

    Declaration to be made on thelabel or packaging of theproduct:

    — the name ‘L-lysine phos-phate and its by-productsfrom fermentation’.

    — L-lysine and moisturecontent.

    ►M16 — as from 1 April2001: approval number ◄

    ▼M93.2.7. Mixtures of:

    (a) L-lysine-monohy-drochloride, techni-cally pure and,

    (b) DL-methionine,technically pure

    protected with copo-lymer vinyl-pyridine/styrene

    NH2-(CH

    2)

    4-CH(NH

    2)-

    COOH-HCl

    CH3S(CH

    2)

    2-CH(NH

    2)-

    COOH

    — L-lysine: + DL-methionine: minimum50 % (including DL-methionine: minimum15 %)

    Copolymer vinyl-pyri-dine/styrene: maximum3 %

    Dairy cows Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘mixture of L-lysine monohydrochlorideand DL-methionineprotected with copolymervinyl-pyridine/styrene’

    — L-lysine, DL-methionineand moisture contents

    — animal species

    ►M16 — as from 1 April2001: approval number ◄

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —19

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M53.3. Threonine 3.3.1. L-Threonine, techni-

    cally pureCH

    3-CH(OH)-

    CH(NH2)-COOH

    — L-Threonine: minimum98 %

    All animal species Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘L-threonine’,

    — L-threonine and moisturecontents

    ►M16 — as from 1 April2001: approval number ◄

    3.4 Tryptophan 3.4.1. L-Tryptophan, techni-cally pure

    (C8H

    5NH)-CH

    2-

    CH(NH2)-COOH

    — L-Tryptophan:minimum 98 %

    All animal species Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘L-tryptophan’,

    — L-tryptophan and moisturecontents

    ►M16 — as from 1 April2001: approval number ◄

    3.4.2. DL-Tryptophan, techni-cally pure

    (C8H

    5NH)-CH

    2-

    CH(NH2)-COOH

    — DL-Tryptophan:minimum 98 %

    All animal species Declarations to be made on thelabel or packaging of theproduct:

    — the name ‘DL-tryptophan’,

    — DL-tryptophan andmoisture contents

    ►M16 — as from 1 April2001: approval number ◄

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —20

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M94. Analogues of amino acids

    4.1. Analogues of methionine 4.1.1. Hydroxy analogue ofmethionine

    CH3S(CH

    2)

    2-CH(OH)-

    COOH— Total of acids:

    minimum 85 %

    Monomer acid:minimum 65 %

    All animal species►M10 ◄

    Declarations to be made onthe label or packaging of theproduct:

    — if appropriate, the name(column 2),

    4.1.2. Calcium salt of hydroxyanalogue of methionine

    [CH3-S-(CH

    2)

    2-

    CH(OH)-COO]2Ca

    — Monomer acid:minimum: 83 %

    Calcium: minimum12 %

    — monomer acid and totalacids contents in the caseof product 4.1.1. andmonomer acid content inthe case of product 4.1.2,

    — moisture content,

    — animal species.

    ►M16 — as from 1 April2001: approvalnumber ◄

    Declarations to be made onthe label or packaging ofcompound feedingstuffs:

    — if appropriate, the name(column 2),

    — monomer acid and totalacids contents in the caseof product 4.1.1. andmonomer acid content inthe case of product 4.1.2,

    — amount of the productcontained in thefeedingstuff.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —21

  • 1 2 3 4 5 6 7

    Name of product group Name of product

    ►M1 Designation ofnutritive principle or

    identity of micro-organism ◄

    ►M1 Culture substrate(specifications, if any) ◄

    Composition characteris-tics of product

    Animal species Special provisions

    ▼M194.1.3 Isopropyl ester of the

    hydroxylated analogueof methionine

    CH3-S-(CH

    2)

    2-CH(OH)

    -COO-CH-(CH3)

    2

    — — Monomer esters:90 % minimum

    — Humidity:maximum 1 %

    Dairy cows Statement to be included on thelabel or the packaging of theproduct:

    — Isopropyl ester of 2-hydroxy-4-methylthiobuta-noic acid

    Statements to be included onthe labelling or the packagingof the compounded feed:

    — Analogue of methionine:Isopropyl ester of 2-hydroxy-4-methylthiobuta-noic acid

    — Percentage of incorporationof analogue of methioninein the feed.

    ▼M1(* ) The contents laid down or to be declared in accordance with columns 5 and 7 refer to the product as such.

    ▼B

    1982L

    0471

    —E

    N—

    18.0

    4.2

    004

    —004.0

    01

    —22