1982L0471 — EN — 03.05.2000 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of30June1982
concerningcertain productsusedinanimalnutrition
(82/471/EEC)
(OJ L 213, 21.7.1982, p. 8)
Amended by:
Official Journal
No page date
►M1CommissionDirective 84/443/EEC of 26 July 1984 L 245 21 14.9.1984
►M2CommissionDirective 85/509/EEC of 6 November 1985 L 314 25 23.11.1985
►M3Council Regulation (EEC) No 3768/85 of 20 December 1985 L 362 8 31.12.1985
►M4CommissionDirective 86/530/EEC of 28 October 1986 L 312 39 7.11.1986
►M5CommissionDirective 88/485/EEC of 26 July 1988 L 239 36 30.8.1988
►M6CommissionDirective 89/520/EEC of 6 September 1989 L 270 13 19.9.1989
►M7CommissionDirective 90/439/EEC of 24 July 1990 L 227 33 21.8.1990
►M8Council Directive 90/654/EEC of 4 December 1990 L 353 48 17.12.1990
►M9CommissionDirective 93/26/EEC of 4 Jun e 1993 L 179 2 22.7.1993
►M10CommissionDirective 93/56/EEC of 29 Jun e 1993 L 206 13 18.8.1993
►M11Council Directive 93/74/EEC of 13 September 1993 L 237 23 22.9.1993
►M12CommissionDirective 95/33/EC of 10 July 1995 L 167 17 18.7.1995
►M13Council Directive 95/69/EC of 22 December 1995 L 332 15 30.12.1995
►M14►M15Council Directive 96/25/EC of 29 April 1996 ◄ L 125 35 23.5.1996
►M15amended by Directive 2000/16/EC of the European Parliament and the
Council of 10 April 2000L 105 36 3.5.2000
►M16Council Directive 1999/20/EC of 22 March 1999 L 80 20 25.3.1999
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼B
COUNCILDIRECTIVE
of30June1982
concerningcertain productsusedinanimalnutrition
(82/471/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 43 and 100 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas livestock productionoccupies a very importan t place inthe
agriculture of the Community and satisfactory results depend to a largeextent on the use of appropriate and good quality feedingstuffs;
Whereas the existence of rules concerning feedingstuffs isessential to an
increase in agricultural productivity;
Whereas consumption of feed proteins is continually rising in the
Community due to the ever increasing needs of livestock production;
Whereas this increasing demand has been accompanied in recent years
by anappreciable declin e inthe supply onthe world market of certain
proteinfeedin gstuffs;
Whereas this shortage has caused the feedingstuffs industry to carry out
research into substitution products to assure the availability of supplies;
Whereas the provisions laid down in the Member States by law,
regulation or administrative action concerning these products, in so faras they exist, differ as regards their basic principles; whereas it followsthat they directly affect the establishment and functioning of the
common market and should therefore be harmonized;
Whereas these substitution products are produced by new technical
processes and it is therefore desirable to regulate their marketing asfeedingstuffs or constituents of feedingstuffs by prescribing, for each
group concerned, which individual products shall be authorized and
under what conditions of use;
Whereas it is necessary, before including a new product in one of the
groups concerned, to ascertain that it has the required nutritional value;
whereas it must be established that these products, whenused sen sibly,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;
Whereas, in order to ensure compliance with the fundamental principles
laid downfor the authorization , a dossier should be submitted officiallyby a Member State for products belonging to certain groups; whereas, inorder to facilitate the examination of the substances concerned, thesedossiers should be prepared in accordance with the common guidelines
to be set by the Council not later than the date of application of the
Directive;
Whereas it is desirable, pending a Community decision, to allow
Member States temporarily to maintain the national authorizations they
have 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-alkanes a Community decisionshould be takenwithintwo years of the n otificationof this Directive;1982L0471 — EN — 03.05.2000 — 002.001 — 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 indirect
provision of protein, must be subject to the provisions of this Directive;whereas it is consequently desirable to amend with regard to its Annexes
Council Directive 70/524/EEC of 23 November 1970 concerning
additives infeedin gstuffs(
1), which temporarily regulates the use of
products of this group;
Whereas the nutritional value and safety of the products in question
depend 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 user
against fraud and to facilitate the optimal use of the products available to
him;
Whereas it is not appropriate to apply Community provisions to the
products concerned, or to feedingstuffs containing these products,intended for export to third countries because in general these countrieshave their ownregulation s;
Whereas, in order to ensure that the requirements of this Directive are
satisfied when these products, or feedingstuffs containing theseproducts, are placed onthe market, Member States must make provision
for appropriate control arrangements;
Whereas products, or feedingstuffs containing such products, satisfying
these requirements must be subject only to the marketing restrictions
provided for inthis Directive;
Whereas an appropriate Community procedure is essential to adapt the
provisions 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 inthe light of the developmen t of
scientific and technical knowledge;
Whereas, with a view to providing all necessary guarantees, the
Community procedure adopted should make provision in certain cases of
amendment 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 retainthe power, if humanor an imal
health is endangered, temporarily to suspend authorization of the use ofa product or to amend any provisions relating thereto;
Whereas, inorder that a Member State should n ot abuse that power,
possible amendments to the Annex based on supporting documents
should be decided by emergency Community procedure;
Whereas, inorder to facilitate implemen tationof this Directive, a
procedure 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 DIRECTIVE:
Article 1
1. 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 infeedingstuffs.
2. This Directive shall be without prejudice to Community provisions
concerning:
(a) additives infeedin gstuffs;1982L0471 — EN — 03.05.2000 — 002.001 — 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 and
products infeedin gstuffs;
(c) the fixing of maximum levels for pesticide residues on and in
products 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 circulationof feed materials.
Article 2
The definitions contained in Article 2 of Council Directive 70/524/EEC
shall apply to this Directive.
Article 3
1. 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 inquestionappears inthe An n ex;
(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 anadequate official in spectionis carried out.
3. Member States shall require that products referred to inChapter 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(
1)
may be put into circulation only by establishments or intermediarieswhich 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 4
1. 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 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 of
this 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.
2. Member States shall send to the other Member States and the
Commissionthe list of products allowed ontheir territories inaccordance with paragraph 1.1982L0471 — EN — 03.05.2000 — 002.001 — 4
(1) OJ No L 332, 30.12.1995, p. 15.▼M11
▼M14
▼B
▼M13
▼M16
▼B
▼M8
3. Inthe territory of the former GermanDemocratic Republic, the use
in feedingstuffs of protein products obtained from yeast of the Candidagenus 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 5
1. Without prejudice to the labelling provisions applicable to straight
and compound feedingstuffs, Member States shall prescribe that theproducts 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 inbulk
the particulars referred to inparagraph 1 shall appear onanaccompanying document.
Article 6
1. Amendments to be made to the Annex as a result of developments
in scientific or technical knowledge shall be adopted in accordance withthe procedure laid downinArticle 13. Inthe 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 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), adecisionshall be adopted, inaccordan ce with the procedure set out in
Article 13, withintwo years of n otificationof this Directive, after
consulting 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 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 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 conditions
listed inA is n ot 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 procedurelaid downinArticle 13.
Article 7
1. 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), theMember States shall ensure that a dossier, prepared in accordance withthe 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 inparagraph 1 so that these guidelines can be applied on the date ofapplicationof this Directive at the latest.1982L0471 — EN — 03.05.2000 — 002.001 — 5
▼B
▼B
The amendments to be made to the guidelines subsequently as a result of
developments 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 of
the dossier referred to inparagraph 1 shall en sure, if requested ongoodgrounds 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 information
concerning 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 new
evaluation of existing data that have become evident since the adoptionof 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 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 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 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 are
necessary to alleviate the difficulties referred to in paragraph 1 and to
ensure 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 particulars
referred to inArticle 5 shall be giveninat least on e of the officiallanguages of the country of destination.
Article 10
The 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 11
The Member States shall ensure that animal products are not subject to
any marketing restriction as a result of the application of this Directive.
Article 12
The Member States shall take all measures necessary to ensure that the
compliance of feedingstuffs with the requirements of this Directive isofficially monitored, at least by sampling, during marketing.
Article 13
1. Where the procedure described inthis Article is to be followed,
matters shall be referred to the Standing Committee for Feedingstuffs1982L0471 — EN — 03.05.2000 — 002.001 — 6
▼B
(hereinafter called ‘the Committee’), by its chairman, either on his own
initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shall
deliver its opinion on the draft within a time limit which the Chairmanmay lay down according to the urgency of the matter. The opinion shallbe delivered by the majority laid downinArticle 148 (2) of the Treaty inthe case of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the representatives of the
Member States within the Committee shall be weighted in the mannerset out inthat Article. The Chairmanshall n ot vote.
3. (a) The Commissionshall adopt the measures en visaged where they
are in accordance with the Committee's opinion.
(b) Where the measures envisaged are not in accordance with the
Committee's opinion, or if no opinion is delivered, the
Commissionshall without delay submit to the Coun cil a proposal
regarding the measures to be adopted. The Council shall act by aqualified majority.
(c) If the Council has not acted within three months of the date when
the matter is referred to it, the proposed measures shall beadopted by the Commission, except where the Council hasdecided against them by a simple majority.
Article 14
1. Where the procedure described inthis Article is to be followed,
matters shall be referred to the Committee by its chairman, either on his
own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver its opinion within two days. The opinion shall be delivered bythe majority laid downinArticle 148 (2) of the Treaty inthe case ofdecisions which the Council is required to adopt on a proposal from the
Commission. The votes of the representatives of the Member States
within the Committee shall be weighted in the manner set out in thatArticle. The Chairmanshall n ot vote.
3. (a) The Commissionshall adopt the measures en visaged where they
are in accordance with the Committee's opinion.
(b) Where the measures envisaged are not in accordance with the
Committee's opinion, or if no opinion is delivered, the
Commissionshall without delay submit to the Coun cil a proposal
regarding the measures to be adopted. The Council shall act by aqualified majority.
(c) If the Council has not acted within 15 days of the date when the
matter is referred to it, the proposed measures shall be adopted bythe Commission, except where the Council has decided againstthem by a simple majority.
Article 15
All 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 16
This Directive shall not apply to feedingstuffs which, as proved at least
by the relevant information, are intended for export to third countries.
Article 17
The Member States shall bring into force, two years after notification of
this Directive, the laws, regulations and administrative provisions1982L0471 — EN — 03.05.2000 — 002.001 — 7
▼A1
▼B
▼A1
▼B
▼B
necessary to comply with this Directive. They shall immediately inform
the Commissionthereof.
However, the Federal Republic of Germany may until 31 December
1991 derogate from the labelling provisions in Article 5 for feedingstuffsproduced inthe territory of the former GermanDemocratic Republic.
Article 18
This Directive is addressed to the Member States.1982L0471 — EN — 03.05.2000 — 002.001 — 8
▼M8
▼B
ANNEX
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
1. Proteinsobtainedfromthe
followinggroupsofmicro-
organisms
1.1.Bacteria
▼M4
1.1.1.Bacteria cultivated
onmethan ol1.1.1.1. Proteinproduct of
fermentation obtained
by culture ofMethy-
lophilusmethylotro-
phusonmethan olMethylophilusmethylo-
trophusNCIB strain
10.515Methanol — Crude protein: min.
68 %
— Reflectance index
at least 50— Pigs
— Calves— Poultry— FishDeclarations 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,— Declarationof the words
‘Avoid inhalation’.
►
M16— as from 1 April
2001: approval number ◄
Declarations to be made on the
label or packaging of
compound feedingstuffs:
— amount of the product
contained in the feeding-
stuff.▼B1982L0471 — EN — 03.05.2000 — 002.001 — 9
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M12
1.1.2.Bacteria cultivated
onn atural gas1.1.2.1. proteinproduct of
fermentation from
natural gas obtained
by culture of:Methy-
lococcuscapsulatus
(Bath),Alcaligenes
acidovorans,Bacillus
brevisetBacillus
firmus,andthecells
ofwhichhavebeen
killedMethylococcuscapsu-
latus(Bath) NCIMB
strain11132
Alcaligenesacido-
vorans
NCIMB strain
12387BacillusbrevisstrainNCIMB strain
13288
BacillusfirmusstrainNCIMB strain
13280Natural gas: (approx.
91 % methane,5 % ethane,2 % propane,
0,5 % isobutane,
0,5 % n-butane,1 % other components),
ammonia, mineral saltsCrude protein: min.
65 %— Pigs for fattening
from 25 to 60 kg
— Calves from 80 kg
on
— SalmonDeclarations to be made on the
label or the packaging of the
product:
— the name: ‘Protein product
of fermentation from
natural gas obtained by
culture ofMethylococcus
capsulatus(Bath),Alcali-
genesacidovorans,Bacillus
brevisandBacillusfirmus, ’
— crude protein— crude ash— crude fat
— moisture content
— instructions for use— maximum incorporation
rate inthe feed:
— 8 % pigs for fattening
— 8 % calves— 19 % salmon(fresh-
water)
— 33 % salmon(seawater)— declarationof the
words: ‘avoid inhala-
tion’▼B1982L0471 — EN — 03.05.2000 — 002.001 — 10
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M12
►M16— as from 1 April
2001: approval number ◄
Declarations 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 feeding-
stuffs
▼B
1.2.Yeasts
1.2.1.Yeasts cultivated on
substrates of animal
or vegetable origin/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150All yeasts
— obtained from the
micro-organisms and
subtrates listed in
columns 3 and 4
respectively/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Saccharomyces
cerevisiae, Sacchar-
omyces carlsber-
giensis
Kluyveromyces
lactis, Kluyvero-
myces fragilis/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Molasses, distillery
residues, cereals and
products containing
strarch, fruit juice,
whey, lactic acid,
hydrolyzed vege-
table fibres—/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150All animal species
— the cells of which have
beenkilled
1.2.2.Yeasts cultivated on
substrates other than
those givenin1.2.1.▼B1982L0471 — EN — 03.05.2000 — 002.001 — 11
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
1.3.Algae ——
1.4.Lowerfungi
▼M7
1.4.1.Products from
productionof an ti-
biotics by fermenta-
tion1.4.1.1. Mycelium, wet by-
product from the
productionof pen i-
cillin, ensiled by
means oflactoba-
cillusbrevis, plan-
tarun, sake, collenoid
andstreptococcus
lactisto inactive the
penicillin and heat
treatedNitrogenous compound
Penicillium chryso-
genum ATCC 48271Different sources of
carbohydrates and their
hydrolysatesNitrogenexpressed as
crude protein: min. 7 %Ruminants
PigsDeclarationbe be made onthe
label or packaging of the
product:
— the name: ‘Mycelium silage
from the productionof
penicillin’
— Nitrogenexpressed as crude
protein
— crude ash
— moisture
— animal species or category
►M16— as from 1 April
2001: approval number ◄
Declarationto be made onthe
label or packaging of the
compound feedingstuff:
— the name: ‘Mycelium silage
from the productionof
penicillin’.▼B1982L0471 — EN — 03.05.2000 — 002.001 — 12
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M1
2.Non-proteinnitrogenous
compounds
2.1.Ureaanditsderivatives 2.1.1. Urea, technically pure CO(NH2)2— Urea: minimum 97 %/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Ruminants from the
beginning of rumi-
nationDeclarations to be made on the
label or packaging of the
product:
2.1.2. Biuret, technically pure (CONH
2)2-NH — Biuret: minimum 97 % — the name ‘Urea’, ‘Biuret’,
‘Urea-phosphate’ or ‘Diur-
eidoisobutane’, as the case
may be,
2.1.3. Urea-phosphate, techni-
cally pureCO(NH2)2·H3PO4— Nitrogen: minimum
16,5 %
Phosphorus: minimum
18 %— nitrogen level; and in addi-
tionfor 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 ‘Diur-
eidoisobutane’ as the case
may be,
— amount of the product
contained in the feeding-
stuff,
— percentage of the total
crude proteinprovided bynon-protein nitrogen,▼B1982L0471 — EN — 03.05.2000 — 002.001 — 13
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M1
— indication, in the instruc-
tions 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.Ammoniumsalts 2.2.1. Ammonium lactate,
produced by fermenta-
tionwith Lactobacillus
bulgaricusCH3CHOHCOONH4Whey Nitrogenexpressed as
crude protein:
minimum 44 %Ruminants from the
beginning of rumina-
tionDeclarations 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 feeding-
stuff,
— percentage of the total
crude proteinprovided by
non-protein nitrogen,▼B1982L0471 — EN — 03.05.2000 — 002.001 — 14
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M1
— indication, in the instruc-
tions for use, of the level of
total non-protein nitrogen
which should not be
exceeded inthe daily ration
of each animal species or
category.
▼M4
2.2.2. Ammonium acetate in
aqueuous solutionCH3COONH4— Ammonium acetate:
min. 55 %Ruminants, from the
start of ruminationDeclarations 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 feeding-
stuff,
— percentage of the total
crude proteinprovided by
non protein nitrogen,
— indication in the instruc-
tions for use of the level of
total non-protein nitrogen
which should not be
exceeded inthe daily ration
of each animal species or
category.▼B1982L0471 — EN — 03.05.2000 — 002.001 — 15
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M10
2.2.3 Ammonium sulfate in
aqueous solution(NH4)2SO4— Ammonium sulfate:
35 %Ruminants, from the
start of ruminationDeclarations to be made on the
label or packaging of the
product:
— the words: ‘Ammonium
sulfate’,
— nitrogen and moisture
contents,
— animal species,— inthe case of youn g rumi-
nants, the incorporation rate
inthe daily rationmay n ot
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 feeding-
stuff,
— percentage of the total
crude proteinprovided 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 rationof each
animal species,
— inthe case of youn g rumi-
nants, the incorporation rate
inthe daily rationmay n ot
exceed 0,5 %▼B1982L0471 — EN — 03.05.2000 — 002.001 — 16
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M1
2.3.By-productsfromthe
productionofaminoacids
byfermentation2.3.1. Concentrated liquid by-
products from the
productionof L-
glutamic acid by
fermentation with
Corynebacterium
melassecolaAmmonium salts and
other nitrogenous
compoundsSucrose, molasses,
starch products and
their hydrolysatesNitrogenexpressed as
crude protein:
minimum 48 %
Moisture: maximum
28 %Ruminants from the
beginning of rumina-
tionDeclarations to be made on the
label or packaging of the
product:
— the name ‘by-products from
the productionof L-
glutamic acid’ inthe case of
product 2.3.1; ‘by-products
from the productionof L-
lysine’ in the case of
product 2.3.2,
— nitrogen, expressed as crude
protein,
— crude ash,— moisture,— animal species or category.►
M16— as from 1 April
2001: approval number ◄
Declarations to be made on the
label or packaging of
compound feedingstuffs:
►M2 ◄
— percentage of the total
crude proteinprovided by
non-protein nitrogen,
— indication, in the instruc-
tions for use, of the level of
total non-protein nitrogen
which should not be
exceeded inthe daily ration
of each animal species or
category.2.3.2. Concentrated liquid by-
products from the
productionof L-lysin e
monohydrochloride by
fermentation with
Brevibacterium lacto-
fermentumAmmonium salts and
other nitrogenous
compoundsSucrose, molasses,
starch products and
their hydrolysatesNitrogenexpressed as
crude protein:
minimum 45 %Ruminants from the
beginning of rumina-
tion▼B1982L0471 — EN — 03.05.2000 — 002.001 — 17
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M5
3.Aminoacidsandtheirsalts
3.1. Methionine 3.1.1. DL-Methionine, techni-
cally pureCH3S(CH2)2-CH(NH2)-
COOH— DL-Methionine:
minimum 98 %All animal species/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Declarations to be made on
the label or packaking of the
product:
3.1.2. Dihydrated calcium salt
of N-hydroxy-methyl-
DL-methionine, techni-
cally pure[CH
3S(CH2)2-CH(NH-
CH2-OH)-COO]2Ca-
2H2O— DL-Methionine:
minimum 67 %
Formaldehyde:
maximum 14 %
Calcium:
minimum 9 %/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Ruminants from the
beginning of rumi-
nation— the name ‘DL-methio-
nine’, in the case of
products 3.1.1, ‘Dihy-
drated 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,
3.1.3. Methionine-zinc, tech-
nically pure[CH
3S(CH2)2-CH(NH2)-
COO]2Zn— DL-Methionine:
minimum 80 %
Zn: maximum 18,5 %— animal species or cate-
gory inthe case of
products 3.1.2. and 3.1.3,
►M16— as from 1 April
2001: approval
number◄
▼M6
3.1.4. Concentrated liquid
sodium DL-methionine
technically pure[CH3S (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-methio-
nine’
— DL-Methionine content
— moisture content
►M16— as from 1 April
2001: approval number ◄▼B1982L0471 — EN — 03.05.2000 — 002.001 — 18
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M9
3.1.5. DL-methionine, techni-
cally pure protected
with copolymer vinyl-
pyridine/styreneCH3S(CH2)2-CH(NH2)-
COOH— DL-Methionine:
minimum 65 %
copolymer vinylpyri-
dine/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 contents
— animal species
►M16— as from 1 April
2001: approval number ◄
▼M5
3.2. Lysine 3.2.1. L-Lysine, technically
pureNH2-(CH2)4-CH(NH2)-
COOH— L-Lysine:
minimum 98 %/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150All animal species/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Declarations 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-monohy-
drochloride’ inthe case
of product 3.2.3,
‘Concentrated liquid L-
lysine monohy-
drochloride’ inthe case
of product 3.2.4, ‘L-
lysine sulphate and its
by-products from
fermentation’ in the case
of product 3.2.5,3.2.2. Concentrated liquid L-
lysine (base)NH
2-(CH2)4-CH(NH2)-
COOHSaccharose, molasses,
starch products and
their hydrolysates►M12L-Lysine:
min. 50 % ◄
3.2.3. L-Lysine-monohy-
drochloride, technically
pureNH2-(CH2)4-CH(NH2)-
COOH-HCl— L-Lysine:
min. 78 %
3.2.4. Concentrated liquid L-
lysine-monohy-
drochlorideNH2-(CH2)4-CH(NH2)-
COOH-HClSaccharose, molasses,
starch products and
their hydrolysatesL-Lysine:
min. 22.4 %
3.2.5. L-Lysine-sulphate
produced by fermenta-
tionwithCorynebac-
teriumglutamicum[NH2-(CH2)4-CH(NH2)-
COOH]2·H2SO4Sugar syrup, molasses,cereals, starch products
and their hydrolysatesL-Lysine:
min. 40 %▼B1982L0471 — EN — 03.05.2000 — 002.001 — 19
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M5
— L-lysine and moisture
contents
►M16— as from 1 April
2001: approval
number◄
▼M7
3.2.6. L-lysine phosphate and
its by-products
produced by fermenta-
tionwithBrevibac-
teriumlactofermentum
NRRL B-11470[NH2-(CH2)4-CH(NH2)-
COOH].H3PO4Sucrose ammonia andfish solublesL-lysine: min. 35 %
Phosphorus:min: 4,3 %Poultry
PigsDeclarationto be made onthe
label or packaging of the
product:
— the name ‘L-lysine phos-
phate and its by-products
from fermentation’.
— L-lysine and moisture
content.
►
M16— as from 1 April
2001: approval number ◄
▼M9
3.2.7. Mixtures of:
(a) L-lysine-monohy-
drochloride, techni-
cally pure and,
(b) DL-methionine,
technically pure
protected with copo-
lymer vinyl-pyridine/
styreneNH2-(CH2)4-CH(NH2)-
COOH-HCl
CH3S(CH2)2-CH(NH2)-
COOH— L-lysine: + DL-
methionine: minimum
50 % (including DL-
methionine: minimum
15 %)
Copolymer vinyl-pyri-
dine/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 contents
— animal species
►M16— as from 1 April
2001: approval number ◄▼B1982L0471 — EN — 03.05.2000 — 002.001 — 20
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M5
3.3. Threonine 3.3.1. L-Threonine, techni-
cally pureCH3-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
contents
►M16— as from 1 April
2001: approval number ◄
3.4 Tryptophan 3.4.1. L-Tryptophan, techni-
cally 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-tryptophanan d moisture
contents
►M16— as from 1 April
2001: approval number ◄
3.4.2. DL-Tryptophan, techni-
cally 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-tryptophanan d
moisture contents
►M16— as from 1 April
2001: approval number ◄▼B1982L0471 — EN — 03.05.2000 — 002.001 — 21
1 2 3456 7
Name of product group Name of product►M1Designation of
nutritive principle or
identity of micro-
organism ◄►M1Culture substrate
(specifications, if any) ◄Compositioncharacteris-
tics of productAnimal species Special provisions
▼M9
4.Analoguesofaminoacids
4.1. Analogues of methionine 4.1.1. Hydroxy analogue of
methionineCH3S(CH2)2-CH(OH)-
COOH— Total of acids:
minimum 85 %
Monomer acid:
minimum 65 %/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150All animal species
►
M10 ◄/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Declarations to be made on
the label or packaging of the
product:
— if appropriate, the name
(column2),
4.1.2. Calcium salt of hydroxy
analogue of methionine[CH
3-S-(CH2)2-
CH(OH)-COO]2Ca— Monomer acid:
minimum: 83 %
Calcium: minimum
12 %— 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.
►M16— as from 1 April
2001: approval
number◄
Declarations to be made on
the label or packaging of
compound feedingstuffs:
— if appropriate, the name
(column2),
— 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.
▼M1
(*) The contents laid down or to be declared in accordance with columns 5 and 7 refer to the product as such.▼B1982L0471 — EN — 03.05.2000 — 002.001 — 22