Council Directive 2001/114/EC of 20 December 2001 relating to certain partly or wholly dehydrated preserved milk for human consumption
Date: 2001-12-20
Institutions: Council of the European Union
Subjects: common market, consumer information, food preserving, human nutrition, labelling, packaging, powdered milk

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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,

hygiene and the health rules laid down in Council
Directive 92/46/EEC (5).

Having regard to the Treaty establishing the European
Community, and in particular Article 37 thereof,

(5)

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)

(2)

(3)

(4)

Certain vertical Directives relating to foodstuffs should
be simplified to take account only of
the essential
requirements to be 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 11 and 12
December 1992, as confirmed by those of the European
Council

in Brussels on 10 and 11 December 1993.

Council Directive 76/118/EEC of 18 December 1975 on
the approximation of the laws of the Member States
relating to certain partly or wholly dehydrated preserved
milk for human consumption (4) was justified by the fact
that differences between national
concerning
preserved milk could result
in conditions of unfair
competition likely to mislead consumers, and thereby
have a direct effect on the establishment and functioning
of the common market.

laws

Directive 76/118/EEC was consequently designed to lay
down definitions and common rules governing the
composition, manufacturing specifications and labelling
of certain preserved milk, so as to ensure its free move-
ment within the Community.

Directive 76/118/EEC should be brought into line with
general Community legislation on foodstuffs, particu-
authorised additives,
larly legislation on labelling,

(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.

(6)

(7)

(8)

(9)

For the sake of clarity, Directive 76/118/EEC should be
recast in order to make the rules on the conditions for
the production and marketing of certain partly or
wholly dehydrated preserved milk for human consump-
tion more accessible.

The general food-labelling rules laid down in Directive
2000/13/EC of
the
Council (6) should apply subject to certain conditions.

the European Parliament and of

is

Subject
to Council Directive 90/496/EEC of 24
September 1990 on nutrition labelling for foodstuffs (7),
the addition of vitamins to the products defined in this
Directive
authorised in certain Member States.
However, no decision can be taken to extend such
authorisation to the Community as a whole. Member
States are therefore free to authorise or prohibit the
addition of vitamins to their national products although
the free movement of goods within the Community is,
in any case, to be guaranteed in accordance with the
rules and principles deriving from the Treaty.

For products intended for infants, Commission Directive
91/321/EEC of 14 May 1991 on infant formulae and
follow-on formulae (8) applies.

In accordance with the principles of subsidiarity and
proportionality established by Article 5 of the Treaty,
the objective of laying down common definitions and
rules for the products concerned and bringing the provi-
sions into line with general Community legislation on
sufficiently achieved by the
foodstuffs
Member States and can therefore, by reason of
the
nature of
this Directive, be better achieved by the
Community. This Directive does not go beyond what is
necessary in order to achieve the said objective.

cannot be

(10)

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (9).

(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.
(8) 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).

(9) OJ L 184, 17.7.1999, p. 23.

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(11)

To avoid creating new barriers to free movement,
Member States should refrain from adopting, for the
products in question, national provisions not provided
for by this Directive,

Article 4

For the products defined in Annexes I and II, Member States
shall not adopt national provisions not provided for by this
Directive.

HAS ADOPTED THIS DIRECTIVE:

Article 5

Article 1

This Directive shall apply to partly or wholly dehydrated
preserved milk defined in Annex I.

The measures necessary for
this
Directive relating to the matters referred to below shall be
adopted in accordance with the regulatory procedure referred
to in Article 6(2):

the implementation of

— bringing this Directive into line with general Community

legislation on foodstuffs,

— adaptations to technical progress.

Article 2

Article 6

Member States may, subject to Directive 90/496/EEC, authorise
the addition of vitamins to the products defined in Annex I
hereto.

The Commission shall be assisted by the Standing
1.
Committee on Foodstuffs
‘the
(hereinafter
Committee’) set up by Article 1 of Decision 69/414/EEC (1).

referred to as

Article 3

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply.

Directive 2000/13/EC shall apply to the products defined in
Annex I, subject to the following conditions.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

1.

(a) The product names listed in Annex I shall apply only to
the products referred to therein and shall, without preju-
dice to subparagraph (b), be used in trade to designate
them;

(b) as an alternative to the product names referred to in
subparagraph (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), and the percentage of fat-free
dried milk extract in the case of the products defined in
Annex I(1). These particulars shall appear near the 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 dilu-
tion or reconstitution, including details of the fat content of
the product thus diluted or reconstituted.

4. Where products weighing less than 20 g per unit are
packed in an outer packaging, the particulars required by
this Article need appear on 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’.

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 refer-
ences to this Directive.

Article 8

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive before 17 July 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.

(1) OJ L 291, 19.11.1969, p. 9.

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However, the marketing of products which fail to conform to
this Directive but which were labelled before 17 July 2004 in
accordance with Directive 76/118/EEC shall be permitted until
stocks run out.

When Member States adopt these measures these shall contain
a reference to this Directive or shall be accompanied by such
reference at the time of their official publication. The procedure
for such reference shall be adopted by Member States.

Article 9

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Communities.

Article 10

This Directive is addressed to the Member States.

Done at Brussels, 20 December 2001.

For the Council

The President

C. PICQUÉ

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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 dehydrated 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.

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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 raw 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.

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 ‘kondensierte 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 ‘roompoeder’, 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 %.