2001L0114 — EN — 01.05.2004 — 001.001 — 1
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►B COUNCIL DIRECTIVE 2001/114/EC
of 20 December 2001
relating to certain partly or wholly dehydrated preserved milk for human consumption
(OJ L 15, 17.1.2002, p. 19)
Amended by:
Official Journal
No page date
►A1 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic of
Malta, the Republic of Poland, the Republic of Slovenia and the Slovak
Republic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
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COUNCIL DIRECTIVE 2001/114/EC
of 20 December 2001
relating to certain partly or wholly dehydrated preserved milk for
human consumption
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 37 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:
(1) Certain vertical Directives relating to foodstuffs should be
simplified to take account only of the essential requirements tobe met by the products they cover so as to allow those products
to move freely within the internal market, in accordance with the
conclusions of the European Council held in Edinburgh on 11and 12 December 1992, as confirmed by those of the EuropeanCouncil in Brussels on 10 and 11 December 1993.
(2) Council Directive 76/118/EEC of 18 December 1975 on theapproximation of the laws of the Member States relating tocertain partly or wholly dehydrated preserved milk for human
consumption (
4) was justified by the fact that differences
between national laws concerning preserved milk could result inconditions of unfair competition likely to mislead consumers,and thereby have a direct effect on the establishment and func-tioning of the common market.
(3) Directive 76/118/EEC was consequently designed to lay downdefinitions and common rules governing the composition, manu-facturing specifications and labelling of certain preserved milk,
so as to ensure its free movement within the Community.
(4) Directive 76/118/EEC should be brought into line with generalCommunity legislation on foodstuffs, particularly legislation on
labelling, authorised additives, hygiene and the health rules laiddown in Council Directive 92/46/EEC (
5).
(5) For the sake of clarity, Directive 76/118/EEC should be recast inorder to make the rules on the conditions for the production andmarketing of certain partly or wholly dehydrated preserved milkfor human consumption more accessible.
(6) The general food-labelling rules laid down in Directive 2000/13/EC of the European Parliament and of the Council (
6) should
apply subject to certain conditions.
(7) Subject to Council Directive 90/496/EEC of 24 September 1990on nutrition labelling for foodstuffs (
7), the addition of vitamins
to the products defined in this Directive is authorised in certainMember States. However, no decision can be taken to extendsuch authorisation to the Community as a whole. Member Statesare therefore free to authorise or prohibit the addition of vita-mins to their national products although the free movement of2001L0114 — EN — 01.05.2004 — 001.001 — 2
(1) OJ C 231, 9.8.1996, p. 20.
(2) OJ C 279, 1.10.1999, p. 95.
(3) OJ C 56, 24.2.1997, p. 20.
(4) OJ L 24, 30.1.1976, p. 49. Directive as last amended by the 1994 Act of
Accession.
(5) OJ L 268, 14.9.1992, p. 1. Directive as last amended by Directive 94/71/EC
(OJ L 368, 31.12.1994, p. 33).
(6) OJ L 109, 6.5.2000, p. 29.
(7) OJ L 276, 6.10.1990, p. 40.
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goods within the Community is, in any case, to be guaranteed in
accordance with the rules and principles deriving from theTreaty.
(8) For products intended for infants, Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on
formulae (
1) applies.
(9) In accordance with the principles of subsidiarity and proportion-ality established by Article 5 of the Treaty, the objective of
laying down common definitions and rules for the productsconcerned and bringing the provisions into line with generalCommunity legislation on foodstuffs cannot be sufficientlyachieved by the Member States and can therefore, by reason of
the nature of this Directive, be better achieved by the Commu-
nity. This Directive does not go beyond what is necessary inorder to achieve the said objective.
(10) The measures necessary for the implementation of this Directiveshould be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on the Commis-sion (
2).
(11) To avoid creating new barriers to free movement, Member Statesshould refrain from adopting, for the products in question,
national provisions not provided for by this Directive,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive shall apply to partly or wholly dehydrated preserved
milk defined in Annex I.
Article 2
Member States may, subject to Directive 90/496/EEC, authorise the
addition of vitamins to the products defined in Annex I hereto.
Article 3
Directive 2000/13/EC shall apply to the products defined in Annex I,
subject to the following conditions.
1. (a) The product names listed in Annex I shall apply only to the
products referred to therein and shall, without prejudice tosubparagraph (b), be used in trade to designate them;
(b) as an alternative to the product names referred to in subpara-
graph (a), Annex II provides a list of particular designations.These designations may be used in the language and under the
conditions laid down in Annex II.
2. The labelling must state the percentage of milk fat, expressed by
weight in relation to the finished product, except in the case of the
products defined in Annex I(1)(d) and (g) and Annex I(2)(d), andthe percentage of fat-free dried milk extract in the case of theproducts defined in Annex I(1). These particulars shall appear nearthe trade name.
3. In the case of the products defined in Annex I(2), the label must
state the recommendations as to the method of dilution or reconsti-tution, including details of the fat content of the product thus dilutedor reconstituted.2001L0114 — EN — 01.05.2004 — 001.001 — 3
(1) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 1999/50/
EC (OJ L 139, 2.6.1999, p. 29).
(2) OJ L 184, 17.7.1999, p. 23.
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4. Where products weighing less than 20 g per unit are packed in an
outer packaging, the particulars required by this Article need appearon the outer packaging only, except for the designation required by
point 1(a).
5. The labelling of the products defined in Annex I(2) shall state that
the product is ‘not intended as a food for infants under 12 months’.
Article 4
For the products defined in Annexes I and II, Member States shall not
adopt national provisions not provided for by this Directive.
Article 5
The measures necessary for the implementation of this Directive
relating to the matters referred to below shall be adopted in accordancewith the regulatory procedure referred to in Article 6(2):
— bringing this Directive into line with general Community legislation
on foodstuffs,
— adaptations to technical progress.
Article 6
1. The Commission shall be assisted by the Standing Committee on
Foodstuffs (hereinafter referred to as ‘the Committee’) set up byArticle 1 of Decision 69/414/EEC (
1).
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC 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 7
Directive 76/118/EEC is hereby repealed with effect from 17 July
2003.
References to the repealed Directive shall be construed as references to
this Directive.
Article 8
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive before 17July 2003. They shall forthwith inform the Commission thereof.
The measures shall be applied so as to:
— authorise the marketing of the products defined in Annex I if they
conform to the definitions and rules laid down in this Directive,with effect from 17 July 2003,
— prohibit the marketing of products which fail to conform to this
Directive, with effect from 17 July 2004.
However, the marketing of products which fail to conform to this
Directive but which were labelled before 17 July 2004 in accordancewith Directive 76/118/EEC shall be permitted until stocks run out.
When Member States adopt these measures these shall contain a refer-
ence to this Directive or shall be accompanied by such reference at thetime of their official publication. The procedure for such referenceshall be adopted by Member States.2001L0114 — EN — 01.05.2004 — 001.001 — 4
(1) OJ L 291, 19.11.1969, p. 9.
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Article 9
This Directive shall enter into force on the day of its publication in the
Official Journal of the European Communities .
Article 10
This Directive is addressed to the Member States.2001L0114 — EN — 01.05.2004 — 001.001 — 5
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ANNEX I
DEFINITIONS OF PRODUCTS AND PRODUCT NAMES
1. Partly dehydrated milk
This means the liquid product, whether or not sweetened, obtained directly
by the partial removal of water from milk, from wholly or partly skimmed
milk or from a mixture of these products, which may have an admixture of
cream or of wholly dehydrated milk or both, the addition of wholly dehy-
drated milk not to exceed, in the finished products, 25 % of total milk solids.
— Types of unsweetened condensed milk
(a) Condensed high-fat milk
Partly dehydrated milk containing, by weight, not less than 15 % fat,
and not less than 26,5 % total milk solids.
(b) Condensed milk
Partly dehydrated milk containing, by weight, not less than 7,5 % fat
and not less than 25 % total milk solids.
(c) Condensed, partly skimmed milk
Partly dehydrated milk containing, by weight, not less than 1 % and
less than 7,5 % fat, and not less than 20 % total milk solids.
(d) Condensed skimmed milk
Partly dehydrated milk containing, by weight, not more than 1 % fat
and not less than 20 % total milk solids.
— Types of sweetened condensed milk
(e) Sweetened condensed milk
Partly dehydrated milk with an admixture of sucrose (semi-white
sugar, white sugar or extra-white sugar) and containing, by weight,not less than 8 % fat and not less than 28 % total milk solids.
(f) Sweetened condensed, partly skimmed milk
Partly dehydrated milk with an admixture of sucrose (semi-white
sugar, white sugar or extra-white sugar) and containing, by weight,
not less than 1 % and less than 8 % fat, and not less than 24 % total
milk solids.
(g) Sweetened condensed skimmed milk
Partly dehydrated milk with an admixture of sucrose (semi-white
sugar, white sugar or extra-white sugar) and containing, by weight,
not more than 1 % fat and not less than 24 % total milk solids.
2. Totally dehydrated milk
This means the solid product, where the water content does not exceed 5 %
by weight of the finished product, obtained directly by the removal of water
from milk, from wholly or partly skimmed milk, from cream or from a
mixture of these products.
(a) Dried high-fat milk or high-fat milk powder
Dehydrated milk containing, by weight, not less than 42 % fat.
(b) Dried whole milk or whole milk powder
Dehydrated milk containing, by weight, not less than 26 % and less than
42 % fat.
(c) Dried partly skimmed milk or partly skimmed-milk powder
Dehydrated milk with a fat content of more than 1,5 % and less than
26 % by weight.
(d) Dried skimmed milk or skimmed-milk powder
Dehydrated milk containing, by weight, not more than 1,5 % fat.
3. Treatments
(a) An additional quantity of lactose not greater than 0,03 % by weight of
the finished product is authorised for the manufacture of the products
defined in 1(e) to (g).
(b) Without prejudice to Directive 92/46/EEC of 16 June 1992 laying down
the health rules for the production and placing on the market of raw2001L0114 — EN — 01.05.2004 — 001.001 — 6
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milk, heat-treated milk and milk-based products, the preservation of the
products referred to in 1 and 2 shall be achieved:
— by heat-treatment (sterilisation, UHT, etc.), for the products referred
to in 1(a) to (d),
— by the addition of sucrose, for the products referred to in 1(e) to (g),— by dehydration, for the products referred to in 2.
4. Authorised additions
Pursuant to Article 2, the addition of vitamins is authorised in the case of the
products referred to in this Annex, subject to Directive 90/496/EEC.2001L0114 — EN — 01.05.2004 — 001.001 — 7
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ANNEX II
PARTICULAR DESIGNATIONS FOR CERTAIN PRODUCTS LISTED
IN ANNEX I
(a) The English term ‘evaporated milk’ means the product defined in Annex
I(1)(b) containing, by weight, at least 9 % fat and 31 % total milk solids.
(b) The French terms ‘lait demi-écrémé concentré’ and ‘lait demi-écrémé
concentré non sucré’, the Spanish term ‘leche evaporada semidesnatada’,
the Dutch terms ‘geëvaporeerde halfvolle melk’ or ‘halfvolle koffiemelk’and the English term ‘evaporated semi-skimmed milk’ mean the product
defined in Annex I(1)(c) containing, by weight, between 4 % and 4,5 %
fat and not less than 24 % total solids.
(c) The Danish term ‘kondenseret kaffefløde’ and the German term ‘konden-
sierte Kaffeesahne’ mean the product defined in Annex I(1)(a).
(d) The Danish term ‘flødepulver’, the German terms ‘Rahmpulver’ and
‘Sahnepulver’, the French term ‘crème en poudre’, the Dutch term ‘room-
poeder’, the Swedish term ‘gräddpulver’ and the Finnish term ‘kermajauhe’
mean the product defined in Annex I(2)(a).
(e) The French term ‘lait demi-écrémé concentré sucré’, the Spanish term
‘leche condensada semidesnatada’ and the Dutch term ‘gecondenseerde
halfvolle melk met suiker’ mean the product defined in Annex I(1)(f)
containing, by weight, between 4 % and 4,5 % fat and not less than 28 %
total milk solids.
(f) The French term ‘lait demi-écrémé en poudre’, the Dutch term ‘halfvolle
melkpoeder’ and the English terms ‘semi-skimmed milk powder’ or ‘dried
semi-skimmed milk’ mean the product defined in Annex I(2)(c) with a fat
content of between 14 % and 16 %.
(g) The Portuguese term ‘leite em pó meio gordo’ means the product defined
in Annex I(2)(c) with a fat content of between 13 % and 26 %.
(h) The Dutch term ‘koffiemelk’ means the product defined in Annex I(1)(b).
(i) The Finnish term ‘rasvaton maitojauhe’ means the product defined in
Annex 1(2)(d).
(j) The Spanish term ‘leche en polvo semidesnatada’ means the product
defined in Annex I(2)(c) with a fat content of between 10 % and 16 %.
(k) The Maltese term ‘ ħalib evaporat’ means the product defined in Annex
I(1)(b).
(l) The Maltese term ‘ ħalib evaporat b'kontenut baxx ta' xa ħam’ means the
product defined in Annex I(1)(c).
(m) The Estonian term ‘koorepulber’ means the product defined in Annex
I(2)(a).
(n) The Estonian term ‘piimapulber’ means the product defined in Annex
I(2)(b).
(o) The Estonian term ‘väherasvane kondenspiim’ means the product defined in
Annex I(1)(c).
(p) The Estonian term ‘magustatud väherasvane kondenspiim’ means the
product defined in Annex I(1)(f).
(q) The Estonian term ‘väherasvane piimapulber’ means the product defined in
Annex I(2)(c).
(r) The Czech term ‘zahušt ěná neslazená smetana’ means the product defined
in Annex I (1)(a).
(s) The Czech term ‘zahušt ěné neslazené plnotu čné mléko’ means the product
defined in Annex I (1)(b).
(t) The Czech term ‘zahušt ěné neslazené polotu čné mléko’ means the product
defined in Annex I (1)(c) containing, by weight, between 4 % and 4,5 %
fat.
(u) The Czech term ‘zahušt ěné slazené plnotu čné mléko’ means the product
defined in Annex I (1)(e).
(v) The Czech term ‘zahušt ěné slazené polotu čné mléko’ means the product
defined in Annex I (1)(f) containing, by weight, between 4 % and 4,5 %
fat.2001L0114 — EN — 01.05.2004 — 001.001 — 8
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(w) The Czech term ‘sušená smetana’ means the product defined in Annex I
(2)(a).
(x) The Czech term ‘sušené polotu čné mléko’ means the product defined in
Annex I (2)(c) containing, by weight, between 14 % and 16 % fat.2001L0114 — EN — 01.05.2004 — 001.001 — 9