1983L0417 — EN — 05.06.2003 — 002.001 — 1
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►B COUNCILDIRECTIVE
of25July1983
on the approximation of the laws of the Member States relating to certain lactoproteins (caseins
andcaseinates)intendedforhumanconsumption
(83/417/EEC)
(OJ L 237, 26.8.1983, p. 25)
Amended by:
Official Journal
No page date
►M1 Council Regulation (EC) No 807/2003 of 14 April 2003 L 122 36 16.5.2003
Amended by:
►A1 Actof Accession of Spain and Port ugal L 302 23 15.11.1985
▼B
COUNCILDIRECTIVE
of25July1983
on the approximationof the lawsofthe Member States relating to
certain lactoproteins (caseins and caseinates) intended for human
consumption
(83/417/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 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 the laws, regulations and administrative provisions in force in
some Member States define the composition and manufacturing charac-teristics of caseins and caseinates intended for human consumption,together with the conditions with which these products must comply
in order that certain designations may be used in their regard or that
their use in the preparation of other foodstuffs may be authorized;whereas such provisions do not exist at present in other Member States;
Whereas this situation is such as to hinder the free movement of
caseins and caseinates intended for human consumption and to createconditions of unfair competition between users; whereas it thereforehas a direct effect on the establishment and functioning of the common
market;
Whereas it is therefore necessary to determine, at Community level, the
rules which must be observed as regards the composition and labellingof these products;
Whereas atpresentedible caseins and caseinat es are notgenerally sold
to the ultimate consumer; whereas, however, should such a sale occur,Council Directive 79/112/EEC of 18 December 1978 on the approxi-
mation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs for sale to the ultimatecustomer (
4) will also apply;
Whereas, on the other hand, with a view to facilitating trade it is advi-
sable to adopt, at Community level, rules for labelling applicable toedible caseins and caseinates intended for use within the trade;
Whereas the preliminary programme of the European Economic
Community for a consumer protection and information policy (
5)
provides for Community action in fields which are of special impor-tance for the protection of the consumer's health and safety, notably inthat of foodstuffs;
Whereas the process of defining the sampling procedures and methods
of analysis necessary for testing the composition and other properties
of the products in question constitutes a technical implementing
measure the adoption of which should be entrusted to the Commissionin order to simplify and speed up the procedure;
Whereas, in all the cases for which the Commission is empowered by
the Council to implement the rules applicable to foodstuffs for humanconsumption, a procedure should be provided for instituting closecooperation between the Member States and the Commission within1983L0417 — EN — 05.06.2003 — 002.001 — 2
(1) OJ No C 50, 24. 2. 1979, s. 5.
(2) OJ No C 140, 5. 6. 1979, s. 174.
(3) OJ No C 247, 1. 10. 1979, s. 54.
(4) OJ No L 33, 8. 2. 1979, p. 1.
(5) OJ No C 92, 25. 4. 1975, p. 1.
▼B
the Standing Committee for Foodstuffs set up pursuant to Decision 69/
414/EEC (1),
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive concerns lactoproteins, as defined in the Annexes,
which are intended for human consumption and mixtures thereof.
2. For the purposes of this Directive:
— ‘caseins’ means the principal protein constituent of milk, washed
and dried, insoluble in water and obtained from skimmed milk by
precipitation:
— by the addition of acid, or
— by microbial acidification, or— by using rennet, or
— by using other milk-coagulating enzymes,
without prejudice to the possibility of prior use of ion exchange
processes and concentration processes,
— ‘caseinates’ means products obtained by drying caseins treated with
neutralizing agents,
— ‘skimmed milk’ means the milk of one or more cows to which
nothing has been added and of which only the fat content has beenreduced.
Article 2
The Member States shall take all the necessary steps to ensure that:
— the products defined in the Annexes may be marketed only if they
conform to the definitions and rules laid down in this Directive and
the Annexes thereto, and
— products which do not satisfy the criteria laid down in the Annexes
are named and labelled in such a way that the buyer is not misledas to their nature, quality or use.
Article 3
The names referred to in the Annexes shall be reserved for the products
defined and must be used commercially to designate those products.
Article 4
1. Without prejudice to Directive 79/112/EEC and without prejudice
to the provisions to be adopted by the Community concerning the
labelling of foodstuffs not intended for the ultimate consumer, the
only mandatory particulars to be marked on the packages, containersor labels of the products defined in the Annexes, particulars whichmustbe clearly visible, easily legible and in indelible charact ers, shallbe as follows:
(a) the name reserved for these products in accordance with Article 3
with, in the case of caseinates, an indication of the cation orcations;
(b) in the case of products marketed as mixtures,
— the words ‘mixture of …’ followed by the names of the
different products which make up the mixture, in decreasingorder of weight,
— an indication of the cation or cations in the case of caseinate or
caseinates,
— the protein content in the case of mixtures containing casei-
nates;1983L0417 — EN — 05.06.2003 — 002.001 — 3
(1) OJ No L 291, 29. 11. 1969, p. 9.
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(c) the net quantity expressed in the following units of mass: kilograms
or grams. Until the end of the transitional period during which useof the imperial units of measurement contained in Chapter D of the
Annex to Council Directive 71/354/EEC of 18 October 1971 on the
approximation of the laws of the Member States relating to units ofmeasurement(
1), as lastamended by Direct ive 76/770/EEC (2), is
authorized in the Community, Ireland and the United Kingdommay permit the quantity to be expressed only in imperial units of
measurement calculated on the basis of the following conversion
rates:
— 1 ml = 0,0352 fluid ounces,
— 1 l = 1,760 pints 0,220 gallons,— 1 g = 0,0353 ounces (avoirdupois),— 1 kg = 2,205 pounds;
(d) the name or business name and the address of the manufacturer or
packager or of a seller established within the Community;
however, in the case of their national production, Member States
may maintain in force national provisions requiring details of themanufacturing or packaging establishment to be mentioned;
(e) in the case of products imported from third countries, the name of
the country of origin;
(f) the date of manufacture or some marking by which the batch can
be identified.
2. Member States shall prohibit the marketing of edible caseins and
caseinates in their territory if the particulars referred to in paragraphs 1
(a), (b), (e) and (f) do notappear in a language easily underst ood by
the purchaser, unless the latter is given such information by othermeans; this provision shall not preclude the appearance of the saidparticulars in several languages.
The particulars specified in paragraph 1 (b), third indent, (c), (d) and
(e), need appear only in an accompanying document. For transport inbulk, this derogation may be extended to (b), second indent, and (f).
Article 5
Without prejudice to Community provisions to be adopted in the field
of health and hygiene in connection with the basic materials referred to
in Annexes I and II, such products must be subjected to heat treatment
which will render the phosphatase negative.
Article 6
1. Member States shall take all the necessary steps to ensure that
trade in products referred to in Article 1 which comply with the defini-tions and rules laid down in this Directive and the Annexes theretocannot be impeded by the application of non-harmonized national
provisions governing the composition, manufacturing specifications,
packaging or labelling of these products or of foodstuffs in general.
2. Paragraph 1 shall notapply t o non-harmonized provisions which
are justified on the grounds of:
— protection of public health,
— prevention of fraud unless such provisions are liable to impede the
application of the definitions and rules laid down by this Directive,
— protection of industrial and commercial property, indications of
source, registered designation of origin and prevention of unfaircompetition.1983L0417 — EN — 05.06.2003 — 002.001 — 4
(1) OJ No L 243, 29. 10. 1971, p. 29.
(2) OJ No L 262, 27. 9. 1976, p. 204.
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Article 7
1. Where, as a resultof new informat ion or of a reassessmentof
existing information made since the Directive was adopted, a MemberState finds there is detailed evidence that the use in the productsdefined in Annexes I and II hereto of one of the substances referredto therein or the maximum quantity of such substance that may beused constitutes a danger to human health, even though it complies
with the provisions of this Directive, that Member State may tempora-
rily suspend or restrict application of the provisions in question in itsterritory. It shall immediately inform the other Member States and theCommission thereof and give 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 within the Standing Committee for Foodstuffs; it shall thendeliver its opinion forthwith and take the appropriate measures.
3. If the Commission considers that amendments to the Directive are
necessary in order to remedy the difficulties referred to in paragraph 1and to protect human health, it shall initiate the procedure provided forin Article 10 for the purpose of adopting such amendments. In thatcase, the Member State which has adopted safeguard measures may
maintain them until the amendments enter into force.
Article 8
The Council, acting on a proposal from the Commission, shall adopt
where necessary purity criteria for the technological adjuvants referred
to in the Annexes.
Article 9
The following shall be determined in accordance with the procedure
laid down in Article 10:
(a) the methods of analysis necessary for checking the purity criteria
referred to in Article 8;
(b) the sampling procedures and methods of analysis necessary for
checking the composition and manufacturing specifications at thetime of manufacture of the products defined in the Annexes.
Article 10
1. 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 178/2002 (
1).
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (2) shall apply.
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 11
This Directive shall not apply to products referred to in Article 1
intended for export to third countries.
Article 12
Member States shall make such amendments to their laws as may be
necessary to comply with this Directive and shall forthwith inform the1983L0417 — EN — 05.06.2003 — 002.001 — 5
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼M1
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Commission thereof; the laws thus amended shall be applied in such a
way as to:
— permit trade in products complying with this Directive not later
than two years after its notification (1),
— prohibit trade in products not complying with this Directive three
years after its notification.
Article 13
This Directive is addressed to the Member States.1983L0417 — EN — 05.06.2003 — 002.001 — 6
(1) This Directive was notified to the Member States on 2 August 1983.
▼B
ANNEX I
EDIBLECASEINS
I. NAMES AND DEFINITIONS
(a)‘edible acid casein’ means edible casein obtained by precipitation using
the technological adjuvants and bacterial cultures listed in Section II (d)
which comply with the standards laid down in Section II.
(b)‘edible rennet casein’ means edible casein obtained by precipitation
using the technological adjuvants listed in Section III (d) which comply
with the standards laid down in Section III.
II. STANDARDS APPLICABLE TO ‘EDIBLE ACID CASEIN’
(a)Essentialfactorsofcomposition
1. Maximum moisture content 10,0 % by weight
2. Minimum milk protein content calculated
on the dried extract 90 % by weight
of which minimum casein content 95 % by weight
3. Maximum milk fat content calculated on
the dried extract 2,25 % by weight
4. Maximum titratable acidity, expressed in
ml of decinormal sodium hydroxide solu-
tion per g 0,27
5. Maximum ash content (P2O5included) 2,5 % by weight
6. Maximum anhydrous lactose content 1 % by weight
7. Maximum sediment content (burnt parti-
cles) 22,5 mg in 25 g
(b)Contaminants
Maximum lead content 1 mg/kg
(c)Impurities
Extraneous matter (such as wood or metal parti-
cles, hairs or insectfragment s) nil in 25 g
(d)Harmlesstechnologicaladjuvantsandbacterialculturessuitablefor
humanconsumption
(i) — lactic acid (E 270)
— hydrochloric acid
— sulphuric acid— citric acid (E 330)
— acetic acid (E 260)
— orthophosphoric acid
(ii) — whey
— bacterial cultures producing lactic acid
(e)Organolepticcharacteristics
1.Odour: No foreign odours
2.Appearance: Colour ranging from white to creamy white; the
product must not contain any lumps that would
notbreak up under slightpressure.1983L0417 — EN — 05.06.2003 — 002.001 — 7
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III. STANDARDS APPLICABLE TO ‘EDIBLE RENNET CASEIN’
(a)Essentialfactorsofcomposition
1. Maximum moisture content 10 % m/m
2. Minimum milk protein content calculated
on the dried extract 84 % by weight
of which minimum casein content 95 % by weight
3. Maximum milk fat content calculated on
the dried extract 2 % by weight
4. Minimum ash content (P2O5included) 7,50 % by weight
5. Maximum anhydrous lactose content 1 % by weight
6. Maximum sediment content (burnt parti-
cles) 22,5 mg in 25 g
(b)Contaminants
Maximum lead content 1 mg/kg
(c)Impurities
Extraneous matter (such as wood or metal parti-
cles, hairs or insectfragment s) nil in 25 g
(d)Harmlesstechnologicaladjuvantssuitableforhumanconsumption
— rennet
— other milk-coagulating enzymes
(e)Organolepticcharacteristics
1.Odour: No foreign odours
2.Appearance: Colour ranging from white to creamy white; the
product must not contain any lumps that would
notbreak up under slightpressure.1983L0417 — EN — 05.06.2003 — 002.001 — 8
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ANNEX II
EDIBLECASEINATES
I. DENOMINATIONS AND DEFINITIONS
‘edible caseinates’ means caseinates obtained from edible caseins using
neutralizing agents of edible quality listed under Section II (d) and
complying with the standards set out in Section II.
II. STANDARDS APPLICABLE TO EDIBLE CASEINATES
(a)Essentialfactorsofcomposition
1. Maximum moisture content 8 % by weight
2. Minimum content of milk protein casein,
calculated on the dried extract 88 % by weight
3. Maximum content of milk fat, calculated
on the dried extract 2,0 % by weight
4. Maximum anhydrous lactose content 1,0 % by weight5. pH value 6,0 to 8,0
6. Maximum sediment content (burnt parti-
cles) 22,5 mg in 25 g
(b)Contaminants
Maximum lead content 1 mg/kg
(c)Impurities
Extraneous matter (such as wood or metal parti-
cles, hairs or insectfragment s) nil in 25 g
(d)Technological adjuvantsofediblequality
(optlonal neutralizing and buffering agents)
hydroxides
of/C148/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C150sodium
potassium
calcium
ammonium
magnesiumcarbonates
phosphates
citrates
(e)Characteristics
1.Odour: Very slightforeign flavours and odours.
2.Appearance: Colour ranging from white to creamy white; the
productmustnotcont ain any lumps t hatdo not
break under slightpressure.
3.Solubility: Almost entirely soluble in distilled water, except
for the calcium caseinate.1983L0417 — EN — 05.06.2003 — 002.001 — 9