# EUR-Lex - 52014PC0174 - EN

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# 52014PC0174

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approximation of the laws of the Member States relating to caseins and caseinates intended for human consumption and repealing Council Directive 83/417/EEC /* COM/2014/0174 final - 2014/0096 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

Grounds for and objectives of the proposal

Council
Directive 83/417/EEC provides for the approximation of the laws of the Member
States relating to certain lactoproteins (caseins and caseinates) intended for
human consumption. It is proposed to repeal this Directive and replace it with
a new text for the following reasons: (1) align the powers conferred on the
Commission with the new distinction introduced by the Treaty on the Functioning
of the European Union (TFEU) (2) take account of other legislation adopted in
the meantime, notably with regard to food law (3) align the compositional
requirements of the products concerned to the relevant international standard
issued by the Codex Alimentarius.

(1)     The Treaty on the Functioning of the
European Union (TFEU) distinguishes between, on the one hand, the power
delegated to the Commission to adopt non legislative acts of general
application to supplement or amend certain non-essential elements of a
legislative act, as set out in Article 290 (delegated acts), and, on the other
hand, the power conferred on the Commission to adopt implementing acts where
uniform conditions are needed, as referred to in Article 291 (implementing
acts). The scrutiny exercise of the provisions of Directive 83/417/EEC in
relation to the new distinction between delegated and implementing acts has
shown the need for the Commission to be empowered to adopt delegated acts to
amend, where appropriate, the technical definitions and standards established
in the annexes for edible caseins and caseinates to take account of
developments in relevant international standards and of technical progress. A
corresponding empowerment is included in the present proposal.

(2)     The present proposal takes account of the further development of parallel
legislation, notably with regard to food law. This notably concerns updates to
Directive 2000/13/EC[1], Regulation (EC) No 178/2002[2],
Regulation (EC) No 882/2004[3], Regulation (EC) No 1332/2008[4]
and Regulation (EC) No 1333/2008[5].

(3)     An international standard has been adopted by the Codex Alimentarius for edible
casein products[6]. That standard defines, among others, the essential composition and
quality factors of casein products. To allow food business operators to benefit
from a level-playing field on the world market, the present proposal adjusts
the compositional requirements laid down in the annexes for edible casein and
caseinates to those applicable in the above mentioned Codex standard. This
adjustment results in two changes: the maximum moisture content of edible
casein is increased from 10 to 12% and the maximum milk fat content of edible
acid casein is decreased from 2.25 to 2%. With this change, the compositional
requirements laid down in the proposal are fully in line with the international
standard.

The proposal has
no financial implications for the EU budget.

General context

Articles 290
and 291 of the Treaty on the Functioning of the European Union (TFEU)
distinguish two different types of Commission acts:

Article 290 of the TFEU allows the legislator
to "delegate to the Commission the power to adopt non-legislative acts of
general application to supplement or amend certain non-essential elements of a
legislative act". Legal acts adopted by the Commission in this way are
referred to in the terminology used by the Treaty as "delegated acts"
(Article 290(3)).

Article 291 of the TFEU allows Member States to "adopt all measures of
national law necessary to implement legally binding Union acts". Those
acts shall confer implementing powers on the Commission where uniform
conditions for implementing them are needed. Legal acts adopted by the
Commission in this way are referred to in the terminology used by the Treaty as
"implementing acts" (Article 291(4)).

Since the
adoption of the original Directive in 1983, a number of legal acts have been
adopted in the field of food law. They must be taken account of.

The production
of casein and caseinates from milk was subject to an internal subsidy scheme
operated by the Union until 2006. This subsidy scheme has ceased to be applied
since then and has been definitively repealed by the political agreement
reached on the reformed single Common Market Organisation for Agricutural
Products in 2013. Specific provisions, differing from international standards,
are therefore no longer justified. As a consequence, the proposal adjusts the
compositional requirements of casein products to the relevant Codex standard.

Existing provisions in the area of the proposal

Articles 290 and
291 of the Treaty on the Functioning of the European Union (TFEU).

Directive
2000/13/EC, Regulation (EC) No 178/2002, Regulation (EC) No 882/2004,
Regulation (EC) No 1332/2008 and Regulation (EC) No 1333/2008.

Codex Stan
290-1995.

Consistency with the other policies and objectives
of the Union

The proposal is
consistent with the new classification of powers conferred to the Commission by
the TFEU, with the relevant legal acts in the field of food law and with the
international standard issued for casein products by the Codex Alimentarius.

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

Consultation of interested parties

There is no
need for consultation of interested parties since the proposal deals mainly
with inter-institutional issues and does not alter the substance of Directive
83/417/EEC which has worked well for decades. The proposal also allows for a
better integration of the rules on caseins and caseinates into the wider legal
framework related to food law which brings advantages in terms of clarity and
simplification. Also the rules on the provision of information from business to
business have been streamlined.

The further
alignment to the international standard has been discussed with the industry
and they warmly welcome the proposed change.

Collection and use of expertise

There is equally
no need for external expertise for the same reasons.

Impact assessment

There is equally
no need for an impact assessment for the same reasons.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

Summary of the proposed action

The proposal (1) identifies the need for
delegated power to be conferred on the Commission for the purpose of adopting
amendments to Annexes I and II and establishes the corresponding procedure for
adoption of these acts in the new legal context determined by the entry into
force of Articles 290 and 291 of the TFEU (2) adapts existing provisions to the
further development of legislation notably in the field of food law (3) adjust,
where appropriate, the composition requirements of edible caseins to the
corresponding Codex standard.

Legal basis

Article 114 of
the Treaty on the Functioning of the European Union.

Subsidiarity principle

The proposal
falls under shared competence between the EU and the Member States and complies with the subsidiarity principle.

Proportionality principle

The proposal
complies with the proportionality principle.

Choice of instruments

The form of the
original act (a Directive) is not changed. The proposal is aimed at designing
the Commission's empowerment in the new legal context created by the Lisbon
Treaty. It also takes account of the further development of legislation in the
past years and of existing, updated international standards.

Moreover the
proposal takes into consideration the need for the Member States to have some
margin to adapt the implementation to the national legal and administrative
environment, in particular with reference to the possible adoption of national
measures in matters not specifically harmonised by the proposal.

2014/0096 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the approximation of the laws of the
Member States relating to caseins and caseinates intended for human consumption
and repealing Council Directive 83/417/EEC

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[7],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Council Directive
83/417/EEC[8]
provides for the approximation of the laws of the Member States relating to
certain lactoproteins (caseins and caseinates) intended for human consumption. Since
the entry into force of that Directive several changes have taken place,
notably the development of a comprehensive legal framework in the area of food
law and the adoption of an international standard by the Codex Alimentarius[9] for edible casein
products, which need to be taken into account.

(2)       Directive 83/417/EEC
confers powers on the Commission in order to implement some of its provisions. As
a consequence of the entry into force of the Lisbon Treaty, those powers need
to be aligned to Article 290 of the Treaty on the Functioning of the European
Union (the Treaty).

(3)       For the sake of clarity, Directive
83/417/EEC should therefore be repealed and replaced with a new Directive.

(4)       Taking into account that
Regulation (EC) No 882/2004 of the European Parliament and of the Council[10], contains general,
horizontal and uniform Union rules concerning the methods of sampling and
analysis of foodstuffs, the related provisions of Directive 83/417/EEC are
therefore no longer necessary.

(5)       Taking into account that
Regulation (EC) No 178/2002 of the European Parliament and of the Council[11] contains general,
horizontal and uniform Union rules concerning the adoption of emergency
measures for food and feed, the related provisions of Directive 83/417/EEC are therefore
no longer necessary.

(6)       Directive 2000/13/EC of
the European Parliament and of the Council[12]
does not apply to business to business relations. Since the products covered by
this Directive are not meant to be sold to the final consumer but only from
business to business for the preparation of food products, it is appropriate to
maintain, adapt to the current legal framework and simplify the specific rules
already included in Directive 83/417/EEC. Those rules provide for the
information to be provided for those products in order to allow the food
business operators, on the one hand, to avail of the information they need for
the labelling of the final products, for example when it comes to allergens,
and on the other hand to avoid that those products can be confused with similar
products not meant for human consumption.

(7)       Regulation (EC) No
1333/2008 of the European Parliament and of the Council[13] provides for the
definition of processing aids referred to as technological adjuvants in
Directive 83/417/EEC. Consequently, this Directive should use the term
‘processing aids’ instead of ‘technological adjuvants’.

(8)       Other terms and references
used in the Annexes to Directive 83/417/EEC should be adapted to take into
account those used in Regulation (EC) No 1333/2008 and Regulation (EC) No
1332/2008 of the European Parliament and of the Council[14].

(9)       Annex I to Directive
83/417/EEC fixes the maximum moisture content for edible caseins at 10% and the
maximum milk fat content for edible acid casein at 2.25%. Taking into
consideration that international standard 290–1995 set by the Codex
Alimentarius fixes those parameters at respectively 12% and 2%, the corresponding
parameters should be set in line with the international standard so as to avoid
trade distortions.

(10)     In order to promptly adapt
or update the technical elements contained in the Annexes to take account of
developments in relevant international standards or technical progress, the
power to adopt acts in accordance with Article 290 of the Treaty should be
delegated to the Commission in respect of the standards applicable to edible
caseins and edible caseinates laid down in Annexes I and II.

(11)     It is of particular
importance that the Commission carries out appropriate consultations during its
preparatory work, including at expert level. The Commission, when preparing and
drawing-up delegated acts, should ensure a simultaneous, timely and appropriate
transmission of relevant documents to the European Parliament and to the
Council.

(12)     Member States should have
some margin to adopt national measures in matters not specifically harmonised
by this Directive to adapt to the national legal and administrative environment.
In such cases, Member States should notify their national measures to the
Commission in accordance with the procedure laid down in Directive 98/34/EC of
the European Parliament and of the Council[15],

HAVE ADOPTED THIS DIRECTIVE:

Article 1

This Directive applies to caseins and
caseinates, which are intended for human consumption and mixtures thereof.

Article 2

For the purposes of this Directive, the
following definitions shall apply:

(a) 
‘caseins’ means the principal protein
constituent of milk, washed and dried, insoluble in water and obtained from
skimmed milk by precipitation:

(i)      by the addition of acid, or

(ii)     by microbial acidification, or

(iii)    by using rennet, or

(iv)    by using other milk-coagulating
enzymes,

and subjected to heat treatment rendering the
phosphatase negative, without prejudice to the possibility of prior use of ion
exchange processes and concentration processes;

(b) 
‘caseinates’ means products obtained by drying
caseins treated with neutralizing agents and subjected to heat treatment
rendering the phosphatase negative;

(c) 
‘skimmed milk’ means milk to which nothing has
been added and of which only the fat content has been reduced.

(d) 
‘edible acid casein’ means casein intended for
human consumption obtained by precipitation using the processing aids and
bacterial cultures listed in Section I(d) of Annex I which comply with the
standards laid down in Section I of that Annex;

(e) 
‘edible rennet casein’ means casein intended for
human consumption  obtained by precipitation using the processing aids listed
in Section II(d) of Annex I which comply with the standards laid down in
Section II of that Annex;

(f) 
‘edible caseinates’ means caseinates obtained
from edible caseins using neutralizing agents of edible quality listed under point
(d) of Annex II and complying with the standards set out in that Annex.

Article 3

Member States shall take all the necessary
steps to ensure that:

(a) 
the products defined in Article 2 are marketed
only if they conform to the rules and standards laid down in this Directive and
Annexes I and II thereto, and

(b) 
products which do not satisfy the standards laid
down in Annexes I and II are not used for the preparation of foodstuffs and are
named and labelled in such a way that the buyer is not misled as to their
nature, quality or use.

Article 4

The names laid down in Article 2(d), (e)
and (f) shall be reserved for the products defined and shall be used
commercially to designate those products.

Article 5

1.           The mandatory particulars
to be marked on the packages, containers or labels of the products defined in Article
2 shall be easily visible, clearly legible and in indelible characters, and
shall be the following:

(a) 
the name reserved for those products in
accordance with Article 4 with, in the case of caseinates, an indication of the
cation or cations;

(b) 
in the case of products marketed as mixtures:

(i)      the words ‘mixture of ...’ followed by
the names of the different products which make up the mixture, in decreasing
order of weight,

(ii)     an indication of the cation or
cations in the case of caseinate or caseinates,

(iii)    the protein content in the case of
mixtures containing caseinates;

(c) 
the net quantity expressed in kilograms or
grams;

(d) 
the name or business name and the address of the
operator under whose name or business name the food is marketed or, if that
operator is not established in the Union, the importer into the Union market;

(e) 
in the case of products imported from third
countries, the name of the country of origin;

(f) 
the lot identification or the date of
production.

2.           Member States shall
prohibit the marketing of products defined in Article 2(d), (e) and (f) in
their territory if the particulars referred to in paragraph 1 do not appear in
a language easily understood by the purchasers of the Member States where those
products are marketed, unless such information is given by other means; this
shall not preclude the appearance of those particulars in several languages.

3.           The particulars referred
to in paragraph 1(b)(iii) and in paragraph 1(c), (d) and (e), need appear only
in an accompanying document.

Article 6

1.           Member States may adopt
national measures concerning matters not specifically harmonised by this
Directive provided that they do not prohibit, impede or restrict the free
movement of goods that are in conformity with this Directive.

2.           Member States shall
immediately communicate to the Commission any such national measure in
accordance with the procedure laid down in Directive 98/34/EC.

Article 7

The Commission shall be empowered to adopt
delegated acts in accordance with Article 8, concerning amendments to Annexes I
and II to take account of the developments in relevant international standards
and of technical progress.

Article 8

1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.           The power to adopt
delegated acts referred to in Article 7 shall be conferred on the Commission
for an indeterminate period of time from (...). (Publications Office is to
fill in the date of entry into force of this Act).

3.           The delegation of power
referred to in Article 7 may be revoked at any time by the European Parliament
or by the Council. A decision to revoke shall put an end to the delegation of
the power specified in that decision. It shall take effect the day following
the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the
validity of the delegated acts already in force.

4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.           A delegated act adopted
pursuant to Article 7 shall enter into force only if no objection has been
expressed either by the European Parliament or the Council within a period of
two months from the date of notification of that act to the European Parliament
and the Council or if, before the expiry of that period, the European
Parliament and the Council have both informed the Commission that they will not
object. That period shall be extended by two months at the initiative of the
European Parliament or of the Council.

Article 9

1.           Member States shall bring
into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 31 March 2015 at the latest. They shall forthwith
communicate to the Commission the text of those provisions.

When Member States adopt those
provisions, they shall contain a reference to this Directive or be accompanied
by such a reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2.           Member States shall
communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.

Article 10

Directive 83/417/EEC is repealed.

References to the repealed Directive shall
be construed as references to this Directive and read
in accordance with the correlation table in Annex III.

Article 11

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 12

This Directive is addressed to the
Member States.

Done at Brussels,

For the European Parliament                        For
the Council

The President                                                 The
President

[1]               Directive 2000/13/EC of the European Parliament and
of the Council of 20 March 2000 on the approximation of the laws of the Member
States relating to the labelling, presentation and advertising of foodstuffs

[2]               Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety

[3]               Regulation (EC) No 882/2004 of the European
Parliament and of the Council of 29 April 2004 on official controls performed
to ensure the verification of compliance with feed and food law, animal health
and animal welfare rules

[4]               Regulation (EC) No 1332/2008 of the European
Parliament and of the Council of 16 December 2008 on food enzymes and amending
Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive
2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97

[5]               Regulation (EC) No 1333/2008 of the European
Parliament and of the Council of 16 December 2008 on food additives

[6]               Codex Stan 290-1995

[7]               OJ C , , p. .

[8]               Council Directive 83/417/EEC of 25 July 1983 on the
approximation of the laws of the Member States relating to certain
lactoproteins (caseins and caseinates) intended for human consumption (OJ L
237, 26.8.1983, p. 25).

[9]               Standard 290-1995 http://www.codexalimentarius.org/standards/en/

[10]               Regulation (EC) No 882/2004 of the European
Parliament and of the Council of 29 April 2004 on official controls performed
to ensure the verification of compliance with feed and food law, animal health
and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

[11]               Regulation
(EC) No 178/2002 of the European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements of food law, establishing
the European Food Safety Authority and laying down procedures in matters of
food safety (OJ L 31, 1.2.2002, p. 1).

[12]               Directive
2000/13/EC of the European Parliament and of the Council of 20 March 2000 on
the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29).

[13]               Regulation (EC) No 1333/2008 of the European
Parliament and of the Council of 16 December 2008 on food additives (OJ L 354,
31.12.2008, p. 16).

[14]               Regulation (EC) No 1332/2008 of
the European Parliament and of the Council of 16 December 2008 on food enzymes and
amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999,
Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No
258/97 (OJ L 354, 31.12.2008, p. 7).

[15]               Directive 98/34/EC of the European Parliament and of
the Council of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations (OJ L 204,
21.7.1998, p. 37)

ANNEX I

EDIBLE CASEINS

I.            STANDARDS APPLICABLE TO EDIBLE
ACID CASEIN'

(a) 
Essential factors of composition

1.         Maximum
moisture content                                                                         12,0
% 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                   2,0 % by weight

4.         Maximum
titratable acidity, expressed in ml of                                       
decinormal
sodium
hydroxide solution per g                                             0,27

5.         Maximum
ash content (P2O5  included)                                                      2,5 % by weight

6.         Maximum
anhydrous lactose content                                                        1 % by weight

7.         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) 
Processing aids and bacterial cultures

(i)         —lactic
acid

—hydrochloric
acid

—sulphuric
acid

—citric
acid

—acetic
acid

—orthophosphoric
acid

(ii)        —
whey

—bacterial
cultures producing lactic acid

(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 not break up
under slight pressure.

II.          STANDARDS APPLICABLE TO EDIBLE RENNET CASEIN

(a) 
Essential factors of composition

1.         Maximum
moisture content                                                                         12
% m/m

2.         Minimum
milk protein content calculated                                                 84
% by weight
on the dried extract

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 (P2O5
included)                                                        7,50 % by weight

5.         Maximum
anhydrous lactose content                                                        1
% by weight

6.         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) 
Processing aids

—Rennet
meeting the requirements of Regulation (EC) No 1332/2008;

—other
milk-coagulating enzymes meeting the requirements of Regulation (EC) No 1332/2008.

(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 not break up
under slight pressure.

ANNEX II

EDIBLE CASEINATES

STANDARDS APPLICABLE
TO EDIBLE CASEINATES

(a) 
Essential factors of composition

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 weight

5.         pH value                                                                                                                   6,0
to 8,0

6.         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) 
Processing aids

(optional neutralizing
and buffering agents)

hydroxydes                         sodium

carbonates                          potassium

of            calcium

phosphates                         ammonium

citrates                                 magnesium

(e) 
Characteristics

1          Odour:                      Very
slight foreign flavours and odours.

2.         Appearance:             Colour
ranging from white to creamy white; the product must not
                                    contain any lumps that do not break under
slight pressure.

3.         Solubility:                 Almost
entirely soluble in distilled water, except for the calcium caseinate.

ANNEX III

Correlation table

Council Directive No 83/417/EEC || This Directive

Article 1 || Articles 1 and 2

Article 2 || Article 3

Article 3 || Article 4

Article 4(1) || Article 5(1)

Article 4(2), first subparagraph || Article 5(2)

-Article 4(2), second subparagraph || Article 5(3)

Article 5 || Article 2(a) and (b)

- || Article 6(1)

Article 6(1) || Article 6(2)

Article 6(2) || Article 6(3)

Article 7 || -

Article 8 || -

Article 9 || -

Article 10 || -

Article 11 || -

- || Article 7

- || Article 8

Article 12 ||  Article 9

- || Article 10

- || Article 11

Article 13 || Article 12

Annex I, section I || Article 2, points (d) and (e)

Annex I, section II || Annex I, section I

Annex I, section III || Annex I, section II

Annex II, section I || Article 2, point (f)

Annex II, section II || Annex II

- || Annex III