1983L0417 — EN — 01.01.1986 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 25July 1983
on the approximation of the laws of the Member States relating to certain lactoproteins (caseins
and caseinates) intended for human consumption
(83/417/EEC)
(OJ L 237, 26.8.1983, p. 25)
Amended by:
Official Journal
No page date
►A1Act of Accession of Spain and Portugal L 302 23 15.11.1985
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COUNCIL DIRECTIVE
of 25July 1983
on the approximation of the laws of the 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 inorder that certain designations may be used in their regard or that theiruse in the preparation of other foodstuffs may be authorized; whereassuch 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 create conditionsof unfair competition between users; whereas it therefore has a directeffect 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 at present edible caseins and caseinates are not generally sold
to the ultimate consumer; whereas, however, should such a sale occur,Council Directive 79/112/EEC of 18 December 1978 on the approx-imation 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
advisable 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 ofthe products in question constitutes a technical implementing measurethe adoption of which should be entrusted to the Commission in orderto 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, aprocedure should be provided for instituting closecooperation between the Member States and the Commission within the
(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.
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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 byprecipitation:
— 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 andthe 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 misled asto 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 thelabelling of foodstuffs not intended for the ultimate consumer, the onlymandatory particulars to be marked on the packages, containers orlabels of the products defined in the Annexes, particulars which must beclearly visible, easily legible and in indelible characters, shall be asfollows:
(a) the name reserved for these products in accordance with Article 3
with, in the case of caseinates, an indication of the cation or cations;
(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 decreasing order ofweight,
— an indication of the cation or cations in the case of caseinate or
caseinates,
— the protein content in the case of mixtures containing caseinates;
(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
(1) OJ No L 291, 29. 11. 1969, p. 9.
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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 last amended by Directive 76/770/EEC (2), is
authorized in the Community, Ireland and the United Kingdom maypermit the quantity to be expressed only in imperial units of meas-urement 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 not appear in a language easily understood by thepurchaser, unless the latter is given such information by other means;this provision shall not preclude the appearance of the said particulars inseveral 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 toin Annexes I and II, such products must be subjected to heat treatmentwhich 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 provi-sions governing the composition, manufacturing specifications, pack-aging or labelling of these products or of foodstuffs in general.
2. Paragraph 1 shall not apply to 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.
Article 7
1. Where, as a result of new information or of a reassessment of
existing information made since the Directive was adopted, a MemberState finds there is detailed evidence that the use in the products defined
(1) OJ No L 243, 29. 10. 1971, p. 29.
(2) OJ No L 262, 27. 9. 1976, p. 204.
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in Annexes I and II hereto of one of the substances referred to therein orthe maximum quantity of such substance that may be used constitutes adanger to human health, even though it complies with the provisions ofthis Directive, that Member State may temporarily suspend or restrictapplication of the provisions in question in its territory. It shall imme-diately inform the other Member States and the Commission thereof andgive 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 that case,the Member State which has adopted safeguard measures may maintainthem 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 referredto 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. Where the procedure laid down in this Article is invoked, the
matter shall be referred to the Standing Committee for Foodstuffs set upby Decision 69/414/EEC, hereinafter referred to as ‘the Committee',byits chairman, either on his own initiative or at the request of a repres-entative of a Member State.
2. The Commission shall submit to the Committee a draft of the
measures to be adopted. The Committee shall give its opinion on thesaid draft within such time as the chairman of the Committee maydetermine in the light of the urgency of the matter in question. TheCommittee shall decide by a majority of at least ►
A1fifty-four ◄
votes, the votes of the Member States being weighted in accordancewith Article 148 (2) of the Treaty. The chairman shall not take part inthe vote.
3. (a) The Commission shall adopt the measures contemplated where
they are in accordance with the opinion of the Committee.
(b) Where the measures contemplated are not in accordance with the
opinion of the Committee, or where no such opinion has beenissued, the Commission shall forthwith submit to the Council aproposal on the measures to be taken. The Council shall act by aqualified majority.
(c) If, on expiry of aperiod of three months from the da te on which
the matter was referred to the Council, the latter has not acted,the proposed measures shall be adopted by the Commission.
Article 11
This Directive shall not apply to products referred to in Article 1
intended for export to third countries.
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Article 12
Member States shall make such amendments to their laws as may be
necessary to comply with this Directive and shall forthwith inform theCommission thereof; the laws thus amended shall be applied in such away 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.
(1) This Directive was notified to the Member States on 2 August 1983.
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ANNEX I
EDIBLE CASEINS
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 complywith the standards laid down in Section III.
II. STANDARDS APPLICABLE TO ‘EDIBLE ACID CASEIN'
(a)Essential factors of composition
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 solution perg 0,27
5. Maximum ash content (P
2O5included) 2,5 % by weight
6. Maximum anhydrous lactose content 1 % by weight7. Maximum sediment content (burnt particles) 22,5 mg in 25 g
(b)Contaminants
Maximum lead content 1 mg/kg
(c)Impurities
Extraneous matter (such as wood or metal
particles, hairs or insect fragments) nil in 25 g
(d)Harmless technological adjuvants and bacterial cultures suitable for
human consumption
(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)Organoleptic characteristics
1.Odour: No foreign odours
2.Appear-
ance:Colour ranging from white to creamy white; the product
must not contain any lumps that would not break upunder slight pressure.
III. STANDARDS APPLICABLE TO ‘EDIBLE RENNET CASEIN'
(a)Essential factors of composition
1. Maximum moisture content 10 % m/m
2. Minimum milk protein content calculated on
the dried extract 84 % by weight
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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 weight6. Maximum sediment content (burnt particles) 22,5 mg in 25 g
(b)Contaminants
Maximum lead content 1 mg/kg
(c)Impurities
Extraneous matter (such as wood or metal
particles, hairs or insect fragments) nil in 25 g
(d)Harmless technological adjuvants suitable for human consumption
— rennet
— other milk-coagulating enzymes
(e)Organoleptic characteristics
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 slight pressure.
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ANNEX II
EDIBLE CASEINATES
I. DENOMINATIONS AND DEFINITIONS
‘edible caseinates' means caseinates obtained from edible caseins using
neutralizing agents of edible quality listed under Section II (d) andcomplying with the standards set out in Section II.
II. STANDARDS APPLICABLE TO EDIBLE CASEINATES
(a)Essential factors of composition1. Maximum moisture content 8 % by weight2. 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 8,06. Maximum sediment content (burnt particles) 22,5 mg in 25 g
(b)ContaminantsMaximum lead content 1 mg/kg
(c)ImpuritiesExtraneous matter (such as wood or metalparticles, hairs or insect fragments) nil in 25 g
(d)Technological adjuvants of edible quality(optlonal neutralizing and buffering agents)hydroxidessodium
carbonatespotassium
phosphatesof calcium
citratesammoniummagnesium
(e)Characteristics1.Odour: Very slight foreign flavours and odours.
2.Appearance: Colour ranging from white to creamy white; theproduct must not contain any lumps that do not breakunder slight pressure.
3.Solubility: Almost entirely soluble in distilled water, except forthe calcium caseinate.