1976L0118 — EN — 01.01.1995 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 18December 1975
on the approximation of the laws of the Member States relating to certain partly or wholly
dehydrated preserved milk for human consumption
(76/118/EEC)
(OJ L 24, 30.1.1976, p. 49)
Amended by:
Official Journal
No page date
►M1Council Directive 78/630/EEC of 19 June 1978 L 206 12 29.7.1978
►M2Council Directive 83/635/EEC of 13 December 1983 L 357 37 21.12.1983
Amended by:
►A1Act of Accession of Greece L 291 17 19.11.1979
►A2Act of Accession of Spain and Portugal L 302 23 15.11.1985
►A3Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
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▼B
COUNCIL DIRECTIVE
of 18December 1975
on the approximation of the laws of the Member States relating to
certain partly or wholly dehydrated preserved milk for human
consumption
(76/118/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,Having regard to the opinion of the European Parliament (
1),
Having regard to the opinion of the Economic and Social Committee (2),
Whereas in order to contribute towards the establishment of a single
market for preserved milk, to lay down conditions of production whichtake account of consumer requirements and to facilitate trade relationson the basis of fair competition, common rules must be adoptedgoverning composition, use of reserved descriptions, manufacturingspecification and labelling of the products concerned;
Whereas existing differences between national provisions governing
these products constitute barriers to free movement and create unfairconditions of competition;
Whereas the determination of methods of analysis for checking the
purity criteria of the additives and processing aids used in the manufac-ture of preserved milk, and the determination of the sampling procedureand the methods of analysis required for checking the composition andthe manufacturing specifications of this milk, are implementing meas-ures of a technical nature, the adoption of which should be left to theCommission so as to simplify and expedite the procedure;
Whereas, it is desirable that for all cases where the Council empowers
the Commission to implement rules relating to foodstuffs, provisionshould be made for a procedure establishing close cooperation betweenthe Member States and the Commission within the Standing Committeeon Foodstuffs set up by the Council Decision of 13 November 1969 (
3);
Whereas certain labelling rules laid down in this Directive cannot be
implemented at present on account of the problems of understandingwhich this would create for the buyer;
Whereas in some cases it is sufficient to provide for a supplementary
period after which the Directive would be applicable in its entirety;
Whereas in other cases national provisions must be maintained and a
review clause applied;
Whereas pending the adoption of Community rules on indication of
quality applicable to preserved milk, national provisions on this subjectshall not be affected, but this situation must be reviewed if aCommunity system cannot be established within three years,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive concerns partly or wholly dehydrated preserved
milk as defined in the Annex.
(1) OJ No C 65, 5. 6. 1970, p. 47.
(2) OJ No C 146, 11. 12. 1970, p. 26.
(3) OJ No L 291, 29. 11. 1969, p. 9.
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2. For the purposes of this Directive:
(a) ‘partly dehydrated milk'means the liquid product obtained directly
by the partial removal of water from milk, from wholly or partlyskimmed milk, or from amixture of these products, which ma yhave an admixture of cream or of wholly dehydrated milk or ofboth, the addition of wholly dehydrated milk not to exceed, in thefinished product, 25 % of total milk solids; however, MemberStates may maintain in their territory any ban on the use of whollydehydrated milk in the production and marketing of partly dehy-drated milk, if the ban existed prior to 1 October 1974.
When adopting the quality criteria referred to in Article 11 (1) (d)
and in any case not later than two years after notification of thisDirective, the Council shall decide whether or not to continue topermit these prohibitions;
(b) ‘wholly dehydrated milk' means the solid product whose moisture
content is not more than 5 % by weight in the finished productobtained directly by the removal of water from milk, wholly orpartly skimmed milk, cream or from a mixture of these products.
3. The preservation of the products defined in the Annex shall be
achieved as follows:
(i) products in point 1 (a) to (d) by sterilization through heat treat-
ment;
(ii) products in point 1 (e) to (g) by the addition of sucrose (semi-white
sugar, sugar or white sugar or extra white sugar);
(iii) products in point 2 by dehydration.
Article 2
Member States shall take all measures necessary to ensure that the
products defined in the Annex may be marketed only if they conform tothe definitions and rules laid down in this Directive and the Annexthereto.
Article 3
1. The designations referred to in the Annex shall apply only to the
products defined therein and must be used in trade to denote suchproducts.
2. The use of the following designations may also be reserved, in
their territory, by the Member States concerned:
(a) ‘evaporated milk' in Ireland and the United Kingdom to denote
unsweetened condensed milk containing, by weight, at least 9 % fatand 31 % total milk solids;
(b)‘kondenseret kaffefløde' in Denmark, ‘kondensierte Kaffeesahne' in
Germany and ‘panna da caffè' in Italy to denote the product defined
in point 1 (d) of the Annex;
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(c)‘flødepulver' in Denmark, ‘Rahmpulver' and ‘Sahnepulver' in
Germany and Austria, ‘gräddpulver' in Sweden and ‘kermajauhe /
gräddpulver' in Finland to denote the product defined in point 2 (d)
of the Annex ;
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(d)‘Geëvaporeerde halfvolle melk' in Belgium and the Netherlands and
‘lait demi-écrémé concentré' and‘lait demi-écrémé concentré non
sucré'in Belgium, France and Luxembourg, to denote, in the case
of sale by retail, the product defined in point 1 (c) of the Annex ;
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(e)‘lait demi-écrémé concentré sucré' in Belgium, France and Luxem-
bourg and ‘gecondenseerde halfvolle melk met suiker' in Belgium
and the Netherlands, to denote, in the case of retail sale, the productdefined in point 1 (g) of the Annex;
(f)‘lait demi-écrémé en poudre' in Belgium, France and Luxembourg
and ‘halfvollemelkpoeder' in Belgium and the Netherlands, to
denote, in the case of retail sale, the product defined in point 2 (c)
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of the Annex and containing, by weight, between 14 and 16 grams
of fat per 100 grams ;
▼A2
(g)‘leite em pó meio gordo' in Portugal to describe dehydrated milk
with a fat content superior to 13 % and inferior to 26 %.
▼M2
▼B
Article 4
Without prejudice to provisions concerning health and hygiene to be
adopted by the Community in relation to the basic materials referred toin Article 1 (2), such materials must be subjected to heat treatment atleast equivalent to pasteurization where the process of manufacture ofthe products defined in Article 1 (1) does not include such treatment.
Article 5
1. In the manufacture of the products defined in point 1 (a) to (d) of
the Annex, only the use of the following shall be authorized:
sodium and potassium bicarbonates,
E 331 sodium citrates (sodium salts of citric acid),E 332 potassium citrates (potassium salts of citric acid),E 339 sodium orthophosphates (sodium salts of orthophosphoric
acid),
E 340 potassium orthophosphates (potassium salts of orthophos-
phoric acid),
calcium chloride,
E 450 sodium and potassium polyphosphates:
(a) diphosphates,(b) triphosphates in the case of ultra heat treated (UHT)
unsweetened partly dehydrated milk,
(c) linear polyphosphates (containing not more than 8 %
cyclic compounds) in the case of ultra heat treated(UHT) unsweetened partly dehydrated milk;
— provided that the total quantity by weight of these added substances
in the finished product is not greater than:
— 0,2 % for products with a total dry matter content not
exceeding 28 %,
— 0,3 % for products with a total dry matter content exceeding
28 %;
— provided that the total triphosphate and linear polyphosphate content
by weight expressed as P2O5, in ultra heat treated (UHT) unsweet-ened partly dehydrated milk, is not greater than 0,1 %;
— provided that the total added phosphate content expressed as P2O5
is not greater than 0,1 % for products whose total dry mattercontent does not exceed 28 %, and is not greater than 0,15 % forproducts whose total dry matter content exceeds 28 %.
2. In the manufacture of the products defined in point 1 (e) to (g) of
the Annex, only the use of the following shall be authorized:
(a) the substances listed in paragraph 1, provided that their total
quantity by weight in the finished product is not greater than 0,2 %and that the total added phosphate content expressed as P2O5 doesnot exceed 0,1 %;
(b) a quantity of lactose that is not greater than 0,02 % by weight of
the finished product with the addition, where appropriate, of trical-
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cium phosphate, the quantity of which must not exceed 10 % of the
lactose added.
3. In the manufacture of the products defined in point 2 of the
Annex, only the use of the following shall be authorized:
(a) the substances listed in paragraph 1:
— provided that their total quantity, by weight, in the finished
product is not greater than 0,5 % of which the maximumcontent of sodium and potassium bicarbonate is 0,2 %. Thelatter quantity may be a maximum of 0,3 % in the case ofwholly dehydrated milk of the ‘Hatmaker'or‘Roller'types otherthan that intended for retail sale and for the manufacture ofwhich none of the other substances listed in paragraph 1 is used;however, the United Kingdom may authorize the retail sale ofthis milk in its territory;
— provided that the total added phosphate content expressed as
P2O5 does not exceed 0,25 %;
(b) L-ascorbic acid (E 300), sodium L-ascorbate (E 301) and ascorbyl
palmitate (E 304), singly or mixed at a maximum level, by weight,of the finished product, of 0,05 % expressed as ascorbic acid.
4. Where the designation of the products defined in point 2 (a), (c)
and (d) of the Annex refers to instant solubility, the use of lecithins (E322) shall also be authorized for their manufacture at a maximum level,by weight, of 0,5 %.
5. Where this Article refers to the percentage of an additive, the
anhydrous substance is meant.
6. Member States may authorize in their territory the use of addi-
tional additives for wholly dehydrated milk used in vending machinesand clearly labelled as such.
7. Notwithstanding paragraphs 1 to 3, Member States may authorize
in their territory the addition of vitamins to the products defined in theAnnex.
Article 6
Without prejudice to the provisions adopted under Article 11 (1), the
lactate content of the products defined in the Annex shall not be greaterthan 300 mg per 100 g of milk solids not fat.
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M2
Article 7
1. Directive 79/112/EEC shall apply under the following conditions
to the products defined in the Annex which are intended to be suppliedin the unaltered state to the ultimate consumer.
2. (a) The designation under which the products defined in the Annex
are sold is one of the designations reserved for the said productspursuant to Article 3.
(b) In the case referred to in Article 5 (4), the word ‘instant'shall be
added to the name under which the product is sold.
3. The net quantity of the products defined in the Annex shall be
expressed in units of mass and, in the case of the products defined inpoint 1 (a), (b), (c) and (d) of the Annex, if they are packed in anythingother than tubes or metal tins, in units of mass and volume.
4. The following particulars shall furthermore appear on the pack-
aging, containers or labels of the said products:
(a) the percentage of milk fat, expressed by weight in relation to the
finished product, except in the case of the products defined in points1 (b) and (f) and 2 (b) of the Annex and the percentage of fat-freedried milk extract in the case of the products defined in point 1 ofthe Annex;
(b) in the case of the products defined in point 1 of the Annex, the
recommendations on the method of dilution or reconstitution; theseparticulars may be replaced by relevant information on the use of
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the products when the latter are intended for use in the unaltered
state;
(c) in the case of the products defined in point 2 of the Annex, the
recommendations on the method of dilution or reconstitution,including details of the fat content of the product thus diluted orreconstituted, except in the case of the products defined in point 2(b) of that Annex;
(d) the expressions ‘UHT'or ‘ultra heat treated'for the products defined
in point 1 (a), (b), (c) and (d) of the Annex, where these productsare obtained as a result of such treatment and aseptically packed.
5. Paragraphs 1 to 4 shall apply under the following conditions:
— the particulars set out under paragraphs 2 and 4 (a) shall appear in
the same field of vision as those listed in Article 11 (3) (a) ofDirective 79/112/EEC,
— where products weighing less than 20 grams per unit are packed in
an outer packaging, the particulars required by this paragraph needappear on the outer packaging only, except for the designation underwhich the product is sold, required by paragraph 2 (a),
— in the case referred to in Article 5 (7), Member States shall be
empowered to insist on the inclusion of details of the nature andquantity of added vitamins,
— the Member States may retain national provisions requiring the
inclusion of a special warning concerning the use of whollyskimmed products as baby food.
Article 7a
1. Without prejudice to the provisions to be adopted by the
Community concerning the labelling of foodstuffs not intended for theultimate consumer, the only mandatory particulars to be marked on thepackages, containers or labels of the products defined in the Annex,which particulars must be clearly visible, easily legible and in indeliblecharacters, shall be as follows:
(a) the name reserved for these products pursuant to Article 3;
(b) the net quantity expressed in kilograms or grams. Until the end of
the transitional period during which use of the imperial units ofmeasurement contained in Chapter D of the Annex to CouncilDirective 71/354/EEC of 18 October 1971 on the approximation ofthe laws of the Member States relating to units of measurement (
1),
as last amended by Directive 76/770/EEC (2), is authorized in the
Community, Ireland and the United Kingdom may permit thequantity to be expressed only in imperial units of measurementcalculated on the basis of the following conversion rates:
— one millilitre = 0,0352 fluid ounces,— one litre = 1,760 pints or 0,220 gallons,— one gram = 0,0353 ounces (avoirdupois),— one kilogram = 2,205 pounds;
(c) the name or business name and the address of the manufacturer or
packer 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 packing establishment to be mentioned;
(d) in the case of products imported from third countries, the name of
the country of origin;
(e) the date of manufacture or some marking by which the batch can be
identified.
(1) OJ No L 243, 29. 10. 1971, p. 29.
(2) OJ No L 262, 27. 9. 1976, p. 204.
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2. Member States shall prohibit the marketing in their territory of theproducts defined in the Annex if the particulars referred to in paragraph1 (a), (d) and (e) 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) and (d)need appear only on an accompanying document.
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B
Article 8
The products referred to in Article 1 and destined for retail sale shall be
packaged by the manufacturer or packer in sealed containers whichprotect the product from harmful influence and which must be deliveredintact to the consumer.
Article 9
1. Member States shall adopt all the measures necessary to ensure
that trade in products referred to in Article 1 which comply with thedefinitions and rules laid down in this Directive and the Annex cannotbe impeded by the application of non-harmonized national provisionsgoverning the composition, manufacturing specifications, packaging orlabelling of these products or foodstuffs in general.
2. Paragraph 1 shall not be applicable to non-harmonized provisions
justified on grounds of:
— protection of public health,— prevention of frauds 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 and prevention of unfair competition.
Article 10
1. Where a Member State, as a result of new information or of a
re-assessment of existing information made since the Directive wasadopted, has detailed grounds for establishing that the use, in theproducts referred to in the Annex, of one of the substances listed inArticle 5, or where the maximum level which may be employed endan-gers human health although it complies with the provisions of thisDirective, 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 grounds
given by the Member State concerned and consult the Member Stateswithin the Standing Committee for Foodstuffs, and shall then deliver itsopinion forthwith and take the appropriate measures.
3. If the Commission considers that amendments to the Directive are
necessary in order to resolve the difficulties mentioned in paragraph 1and to ensure the protection of human health, it shall initiate theprocedure laid down in Article 12, with a view to adopting theseamendments; the Member State which has adopted safeguard measuresmay in that event retain them until the amendments enter into force.
Article 11
1. The Council, acting on a proposal from the Commission, shall lay
down:
(a) as far as is necessary, the purity criteria for the additives or products
used as additives referred to in Article 5;
(b) the hygienic, chemical and physical criteria for the products defined
in the Annex;
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(c) the microbiological criteria for the products defined in the Annex;
(d) the quality criteria for wholly dehydrated milk which may be used
in the production of partly dehydrated milk in accordance withArticle 1 (2) (a).
2. The following shall be determined in accordance with the proce-
dure laid down in Article 12:
(a) the methods of analysis necessary for checking the above purity
criteria;
(b) the sampling procedures and methods of analysis necessary for
checking the composition and manufacturing specifications of theproducts defined in the Annex.
Article 12
1. Where the procedure laid down in this Article is to be followed,
the matter shall be referred to the Standing Committee on Foodstuffs setup by the Council Decision of 13 November 1969 (hereinafter called‘the committee') by its chairman, either on his own initiative or at therequest of arepresenta tive of aMember Sta te.
2. The Commission representative shall submit to the committee a
draft of the measures to be taken. The committee shall give its opinionon this draft within a time limit set by the chairman having regard to theurgency of the matter. Opinions shall be delivered by a majority of►
A2fifty-four ◄votes, the votes of the Member States being
weighted in accordance with Article 148 (2) of the Treaty. Thechairman shall not vote.
3. (a) Where the measures envisaged are in accordance with the
opinion of the committee, the Commission shall adopt them.
(b) Where the measures envisaged are not in accordance with the
opinion of the committee, or if no opinion is delivered, theCommission shall without delay submit to the Council a proposalon the measures to be taken. The Council shall act by a qualifiedmajority.
(c) If, within three months of the proposals having been submitted to
it, the Council has not acted, the proposed measures shall beadopted by the Commission.
Article 13
The provisions of Article 12 shall apply for a period of 18 months from
the date on which the matter was first referred to the committee underArticle 12 (1).
Article 14
This Directive shall not affect the laws of the Member States
concerning indications of quality applicable to products referred to inthe Annex and manufactured in their territory.
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In the absence of relevant Community provisions as at 1 April 1986, theCouncil shall re-examine the provisions of this Article on the basis of areport from the Commission, accompanied by any appropriateproposals.
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Article 15
This Directive shall not apply:
— without prejudice to any provisions to be adopted by the
Community, to dietetic products or products specifically preparedfor babies and young children;
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— to products intended for export outside the Community.
Article 16
Within a period of one year from notification of this Directive, the
Member States shall, where necessary, amend their laws to comply withthe provisions of this Directive. They shall immediately inform theCommission of these amendments and of those exceptions laid down bythis Directive of which they avail themselves. Not later than two yearsafter notification of this Directive the laws thus amended shall apply tothe products put on the market for the first time in the Member States.
Article 17
This Directive is addressed to the Member States.
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ANNEX
DESIGNATIONS AND DEFINITIONS OF PRODUCTS
1.Partly dehydrated milk to which this Directive is applicable
(a)Unsweetened condensed milk
Partly dehydrated milk containing, by weight, not less than 7,5 % fat and
25 % total milk solids.
(b)Unsweetened condensed skimmed milk
Partly dehydrated milk containing, by weight, not more than 1 % fat and
not less than 20 % total milk solids.
(c)Unsweetened condensed partly skimmed milk
Partly dehydrated milk containing, by weight, not less than 1 % and not
more than 7,5 % fat, and not less than 20 % total milk solids. Partlydehydrated milk containing, by weight, between 4 and 4,5 % fat and notless than 24 % total milk solids is the only milk which may be sold retailwith this designation.
(d)Unsweetened condensed high-fat milk
Partly dehydrated milk containing, by weight, not less than 15 % fat and
not less than 26,5 % total milk solids.
(e)Sweetened condensed milk
Partly dehydrated milk with an admixture of sucrose (semi-white sugar,
sugar or white sugar or extra white sugar) and containing, by weight, notless than 8 % fat and 28 % total milk solids. Partly dehydrated milk withan admixture of sucrose (semi-white sugar, sugar or white sugar or extrawhite sugar) and containing, by weight, not less than 9 % fat and 31 %total milk solids is the only milk which may be sold retail with thisdesignation.
(f)Sweetened condensed skimmed milk
Partly dehydrated milk with an admixture of sucrose (semi-white sugar,
sugar or white sugar or extra white sugar) and containing, by weight, notmore tha n1%f atan dn o t less than 24 % total milk solids.
(g)Sweetened condensed partly skimmed milk
Partly dehydrated milk with an admixture of sucrose (semi-white sugar,
sugar or white sugar or extra white sugar) and containing by weight notless than 1 % and not more than 8 % fat and not less than 24 % totalmilk solids. Partly dehydrated milk with an admixture of sucrose (semi-white sugar, sugar or white sugar or extra white sugar) and containing, byweight, between 4 and 4,5 % fat and not less than 28 % total milk solidsis the only milk which may be sold retail with this designation.
2.Wholly dehydrated milk to which this Directive is applicable
(a)Dried whole milk or whole milk powder
Dehydrated milk containing, by weight, not less than 26 % fat.
(b)Dried skimmed milk or skimmed-milk powder
Dehydrated milk containing, by weight, not more than 1,5 % fat.
(c)Dried partly skimmed milk or partly skimmed-milk powder
Dehydrated milk with a fat content not less than 1,5 % and not more than
26 % by weight.
(d)Dried high-fat milk or high-fat milk powder
Dehydrated milk containing, by weight, not less than 42 % fat.