Common Position (EC) No 8/2008 of 10 March 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council 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 (Text with EEA relevance)
Date: 2008-03-10
Institutions: Council of the European Union
Subjects: approximation of laws, consumer protection, enzyme, food safety, foodstuff, foodstuffs legislation, public health

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COMMON POSITION (EC) No 8/2008

adopted by the Council on 10 March 2008

with a view to adopting Regulation (EC) No …/2008 of the European Parliament and of the Council
of … 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

(Text with EEA relevance)

(2008/C 111 E/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

(1)

(2)

(3)

(4)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes
significantly to the health and well-being of citizens, and
to their social and economic interests.

A high level of protection of human life and health
should be assured in the pursuit of Community policies.

Food enzymes other than those used as food additives
are not currently regulated or are regulated as processing
aids under the legislation of the Member States. Differ-
ences between national laws, regulations and administra-
tive provisions concerning the assessment and authorisa-
tion of food enzymes may hinder their free movement,
creating conditions for unequal and unfair competition. It
is therefore necessary to adopt Community rules harmo-
nising national provisions relating to the use of enzymes
in foods.

This Regulation should only cover enzymes that are
added to food to perform a technological function in the
manufacture, processing, preparation, treatment, packa-
including
ging,

transport or

such food,

storage of

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (not yet published
in the Official Journal), Council Common Position of 10 March 2008,
Position of the European Parliament of … (not yet published in the
Official Journal) and Council Decision of …

enzymes used as processing aids (hereinafter referred to
as ‘food enzymes’). The scope of this Regulation should
therefore not extend to enzymes that are not added to
food to perform a technological
function but are
intended for human consumption, such as enzymes for
nutritional purposes. Microbial cultures traditionally used
in the production of food, such as cheese and wine, and
which may incidentally produce enzymes but are not
specifically used to produce
them should not be
considered food enzymes.

the European Parliament and of

Food enzymes used exclusively in the production of food
additives falling within the scope of Regulation (EC)
No …/2008 of
the
Council of … on food additives (3) should be excluded
from the scope of this Regulation, since the safety of
these foods is already assessed and regulated. However,
when these food enzymes are used as such in food, they
are covered by this Regulation.

Food enzymes should be approved and used only if they
the criteria laid down in this Regulation. Food
fulfil
enzymes must be safe when used, there must be a tech-
nological need for their use and their use must not
mislead the consumer. Misleading the consumer includes,
but is not limited to, issues related to the nature, fresh-
ingredients used, the naturalness of a
ness, quality of
product or of the production process, or the nutritional
quality of the product. The approval of food enzymes
should also take into account other factors relevant to
societal,
the matter under
economic, traditional, ethical and environmental factors
and the feasibility of controls.

consideration including

Some food enzymes are permitted for specific uses, such
as in fruit juices and certain similar products and certain
lactoproteins intended for human consumption, and for
certain authorised oenological practices and processes.
The use of such food enzymes should comply with this
Regulation and with the specific provisions laid down in
the
relevant Community legislation. Council Direc-
tive 2001/112/EC of 20 December 2001 relating to fruit
juices and certain similar products intended for human

(5)

(6)

(7)

(3) See page 10 of this Official Journal.

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consumption (1), 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 (2) and
Council Regulation (EC) No 1493/1999 of 17 May 1999
on the common organisation of the market in wine (3)
should therefore be amended accordingly. Since all food
enzymes should be covered by this Regulation, Regu-
lation (EC) No 258/97 of the European Parliament and of
the Council of 27 January 1997 concerning novel foods
and novel food ingredients (4) should be amended accord-
ingly.

Food enzymes the use of which is permitted within the
that
Community should appear in a Community list
should clearly describe the enzymes and specify any
conditions governing their use, including where necessary
information on their function in the final food. This list
in particular
should be supplemented by specifications,
on their origin,
information
including where relevant
about allergenic properties, and purity criteria.

In order to ensure harmonisation, the risk assessment of
food enzymes and their inclusion in the Community list
should be carried out in accordance with the procedure
the
laid down in Regulation (EC) No …/2008 of
European Parliament and of the Council of … estab-
lishing a common authorisation procedure for food addi-
tives, food enzymes and food flavourings (5).

(8)

(9)

(10) Under 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 (6), the
European Food Safety Authority (hereinafter referred to
as the ‘Authority’) is to be consulted on matters likely to
affect public health.

(11) A food enzyme which falls within the scope of Regu-
lation (EC) No 1829/2003 of the European Parliament
and of the Council of 22 September 2003 on genetically
modified food and feed (7) should be subject
to the
that Regulation with
authorisation procedure under

(1) OJ L 10, 12.1.2002, p. 58. Directive as amended by Regulation (EC)

No 1182/2007 (OJ L 273, 17.10.2007, p. 1).

(2) OJ L 237, 26.8.1983, p. 25. Directive as last amended by Regulation

(EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

(3) OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Regulation

(EC) No 1234/2007 (OJ L 299, 16.11.2007, p. 1).

(4) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(5) See page 1 of this Official Journal.
(6) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC)

No 575/2006 (OJ L 100, 8.4.2006, p. 34).

(7) OJ L 268, 18.10.2003, p. 1.

regard to the safety assessment of the genetic modifica-
tion, while the final authorisation of the food enzyme
should be granted under this Regulation.

(12) A food enzyme already included in the Community list
under this Regulation which is prepared by production
methods or using starting materials significantly different
from those included in the risk assessment of
the
Authority, or different from those covered by the authori-
sation and the specifications under
this Regulation,
should be submitted for evaluation by the Authority.
‘Significantly different’ could mean inter alia a change of
the production method from extraction from a plant to
production by fermentation using a micro-organism or a
genetic modification of the original micro-organism, a
change in starting materials, or a change in particle size.

(13)

Since many food enzymes are already on the Community
market, provision should be made to ensure that the
switchover to a Community list of food enzymes takes
place smoothly and does not disturb the existing food
enzyme market. Sufficient time should be allowed for
applicants to make available the information necessary
these products. An initial
for the risk assessment of
two-year period should therefore be allowed following
the date of application of the implementing measures to
be laid down in accordance with Regulation (EC)
in order to give applicants sufficient
No …/2008 (*),
time to submit
the information on existing enzymes
which may be included in the Community list to be
drawn up under
It should also be
this Regulation.
possible to submit applications for the authorisation of
two-year period. The
new enzymes during the initial
Authority should evaluate without delay all applications
for food enzymes for which sufficient information has
been submitted during that period.

(14)

In order to ensure fair and equal conditions for all appli-
cants, the Community list should be drawn up in a single
step. That list should be established after completion of
the risk assessment of all food enzymes for which suffi-
cient information has been submitted during the initial
two-year period.

(15) A significant number of applications is expected to be
submitted during the initial two-year period. A lengthy
period may therefore be needed before the risk assess-
ment of these has been completed and the Community
list is drawn up. In order to ensure equal access to the

(*) See page 1 of this Official Journal.

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market for new food enzymes after the initial two-year
period, a transitional period should be provided for
during which food enzymes and food using food
in
enzymes may be placed on the market and used,
accordance with the existing national
in the
Member States, until the Community list has been drawn
up.

rules

labelling in cases where the enzyme performs no techno-
logical function in the final product but is present in the
foodstuff only as a result of carry-over from one or more
of the ingredients of the foodstuff or where it is used as a
processing aid. Directive 2000/13/EC should be amended
accordingly.

(16)

(17)

The food enzymes E 1103 Invertase and E 1105
Lysozyme, that have been authorised as food additives
under Directive 95/2/EC of the European Parliament and
of the Council of 20 February 1995 on food additives
other than colours and sweeteners (1), and the conditions
governing their use should be carried over from Direc-
tive 95/2/EC to the Community list when it is drawn up
by this Regulation. In addition, Council Regulation (EC)
No 1493/1999 authorises the use of urease, beta-gluca-
nase and lysozyme in wine subject to the conditions laid
down in Commission Regulation (EC) No 1622/2000 of
24 July 2000 laying down certain detailed rules for
implementing Regulation (EC) No 1493/1999 on the
common organisation of the market in wine and estab-
lishing a Community code of oenological practices and
processes (2). Those substances are food enzymes and
they should fall within the scope of this Regulation. They
should therefore also be added to the Community list
when it is drawn up for their use in wine in accordance
with Regulation (EC) No 1493/1999 and Regulation (EC)
No 1622/2000.

Food enzymes remain subject to the general
labelling
obligations provided for in 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 adver-
tising of foodstuffs (3) and, as the case may be, in Regu-
lation (EC) No 1829/2003 and in Regulation (EC)
No 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the trace-
ability and labelling of genetically modified organisms
and the traceability of food and feed products produced
from genetically modified organisms (4).
In addition,
specific provisions on the labelling of food enzymes sold
as such to the manufacturer or to the consumer should
be contained in this Regulation.

(18)

Food enzymes are covered by the definition of food in
Regulation (EC) No 178/2002 and are therefore, when
used in food, required to be indicated as ingredients in
the labelling of
the food in compliance with Direc-
tive 2000/13/EC. Food enzymes should be designated by
their technological
followed by the
function in food,
specific name of the food enzyme. However, provision
should be made for a derogation from the provisions on

(1) OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive

2006/52/EC (OJ L 204, 26.7.2006, p. 10).

(2) OJ L 194, 31.7.2000, p. 1. Regulation as last amended by Regulation

(EC) No 1300/2007 (OJ L 289, 7.11.2007, p. 8).

(3) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

2007/68/EC (OJ L 310, 28.11.2007, p. 11).

(4) OJ L 268, 18.10.2003, p. 24.

(19)

(20)

(21)

(22)

Food enzymes should be kept under continuous observa-
tion and should be re-evaluated whenever necessary in
the light of changing conditions governing their use and
new scientific information.

The measures necessary for the implementation of this
adopted in accordance with
Regulation should be
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (5).

In particular the Commission should be empowered to
adopt appropriate transitional measures. Since those
measures are of general scope and are designed to amend
inter alia by
non-essential elements of this Regulation,
supplementing it with new non-essential elements, they
must be adopted in accordance with the regulatory
procedure with scrutiny provided for in Article 5a of
Decision 1999/468/EC.

In order to develop and update Community law on food
enzymes in a proportionate and effective way, it is neces-
sary to collect data, share information and coordinate
work between Member States. For that purpose, it may
be useful to undertake studies to address specific issues
with a view to facilitating the decision-making process. It
is appropriate that the Community finance such studies
as part of its budgetary procedure. The financing of such
measures is covered by Regulation (EC) No 882/2004 of
the European Parliament
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 (6).

and of

(23) Member States are to carry out official controls in order
to enforce compliance with this Regulation in accordance
with Regulation (EC) No 882/2004.

(24)

Since the objective of
this Regulation, namely to lay
down Community rules on food enzymes, cannot be
sufficiently achieved by the Member States and can there-
fore, in the interests of market unity and a high level of
consumer protection, be better achieved at Community
level, the Community may adopt measures, in accordance

(5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Council Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(6) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,
amended by Council Regulation (EC)

p. 1. Regulation as
No 1791/2006.

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with the principle of subsidiarity as set out in Article 5
of the Treaty. In accordance with the principle of propor-
tionality, as set out in that Article, this Regulation does
not go beyond what is necessary in order to achieve that
objective,

incidentally produce enzymes, but which are not specifically
used to produce them.

Article 3

Definitions

HAVE ADOPTED THIS REGULATION:

CHAPTER I

1.
For the purposes of this Regulation, the definitions laid
down in Regulation (EC) No 178/2002, Regulation (EC)
No 1829/2003 and Regulation (EC) No …/2008 (*) shall apply.

SUBJECT MATTER, SCOPE AND DEFINITIONS

2.

The following definitions shall also apply:

Article 1

Subject matter

(a)

‘food enzyme’ means a product obtained from plants,
animals or micro-organisms or products thereof including a
product obtained by a fermentation process using micro-or-
ganisms:

This Regulation lays down rules on food enzymes used in foods,
including such enzymes used as processing aids, to ensure the
effective functioning of the internal market and a high level of
protection of human health and protection of consumers' inter-
ests,
including fair practices in food trade, taking account of,
where appropriate, the protection of the environment.

(i) containing one or more enzymes capable of catalyzing a

specific biochemical reaction; and

(ii) added to food for a technological purpose at any stage
treat-
the manufacturing, processing, preparation,

of
ment, packaging, transport or storage of foods;

For those purposes, this Regulation provides for:

(a) a Community list of approved food enzymes;

(b) conditions of use of food enzymes in foods;

(c) rules on the labelling of food enzymes sold as such.

(b) ‘food enzyme preparation’ means a formulation consisting
of one or more food enzymes in which substances such as
food additives and/or other food ingredients are incorpo-
rated to facilitate their storage, sale, standardisation, dilution
or dissolution.

Article 2

Scope

This Regulation shall apply to food enzymes as defined in

1.
Article 3.

CHAPTER II

COMMUNITY LIST OF APPROVED FOOD ENZYMES

Article 4

Community list of food enzymes

This Regulation shall not apply to food enzymes when

2.
and insofar as they are used in the production of:

(a)

food additives falling within the scope of Regulation (EC)
No …/2008 (*);

Only food enzymes included in the Community list may be
placed on the market as such and used in foods, in accordance
with the specifications and conditions of use provided for in
Article 7(2).

(b) processing aids.

This Regulation shall apply without prejudice to any

3.
specific Community rules concerning the use of food enzymes:

Article 5

(a)

in specific foods;

(b) for purposes other than those covered by this Regulation.

This Regulation shall not apply to microbial cultures that
4.
are traditionally used in the production of food and which may

(*) See page 10 of this Official Journal.

Prohibition of non-compliant

food enzymes

and/or

non-compliant food

No person shall place on the market a food enzyme or any food
in which such a food enzyme has been used if the use of the
food enzyme does not comply with this Regulation and its
implementing measures.

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Article 6

Article 8

General conditions for inclusion of food enzymes in the
Community list

Food enzyme falling within the scope of Regulation (EC)
No 1829/2003

A food enzyme may be included in the Community list only if
it meets the following conditions and, where relevant, other
legitimate factors:

(a)

it does not, on the basis of the scientific evidence available,
pose a safety concern to the health of the consumer at the
level of use proposed and

(b) there is a reasonable technological need and

(c)

its use does not mislead the consumer.

Article 7

The content of the Community list of food enzymes

1.
A food enzyme which complies with the conditions set
out in Article 6 may, in accordance with the procedure referred
to in Regulation (EC) No …/2008 (*), be included in the Com-
munity list.

The entry of a food enzyme in the Community list shall

2.
specify:

(a)

the name of the food enzyme;

(b) the specifications of the food enzyme, including its origin,

purity criteria and any other necessary information;

(c)

if necessary, the foods to which the food enzyme may be
added;

(d)

if necessary, the conditions under which the food enzyme
may be used; where appropriate, no maximum level shall be
fixed for a food enzyme. In that case, the food enzyme shall
be used in accordance with the principle of quantum satis;

(e)

if appropriate, whether there are any restrictions on the sale
of the food enzyme directly to the final consumer;

(f) where necessary, specific requirements in respect of

the
labelling of food in which the food enzymes have been used
in order to ensure that the final consumer is informed of
the physical condition of the food or the specific treatment
it has undergone.

The Community list shall be amended in accordance with

3.
the procedure referred to in Regulation (EC) No …/2008 (*).

(*) See page 1 of this Official Journal.

A food enzyme falling within the scope of Regulation (EC)
No 1829/2003 may be included in the Community list
in accordance with this Regulation only when it is covered by
an
(EC)
No 1829/2003.

accordance with Regulation

authorisation

in

Article 9

Interpretation decisions

Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 15(2) whether or not:

(a) a given substance meets the definition of food enzyme in

Article 3;

(b) a particular food belongs to a category of food in the Com-

munity list of food enzymes.

CHAPTER III

LABELLING

Article 10

Labelling of food enzymes and food enzyme preparations
not intended for sale to the final consumer

1.
Food enzymes and food enzyme preparations not intended
for sale to the final consumer, whether sold singly or mixed
with each other and/or other food ingredients, as defined in
Article 6(4) of Directive 2000/13/EC, may only be marketed
with the labelling provided for in Article 11 of this Regulation,
which must be easily visible, clearly legible and indelible. The
information provided for in Article 11 shall be in a language
easily understandable to purchasers.

2. Within its own territory, the Member State in which the
product is marketed may, in accordance with the Treaty, stipu-
late that the information provided for in Article 11 shall be
languages of the Com-
given in one or more of the official
munity, to be determined by that Member State. This shall not
preclude such information from being indicated in several
languages.

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Article 11

ents, their packaging or containers shall bear a list of all ingredi-
ents in descending order of their percentage by weight of the
total.

General labelling requirements for food enzymes and food
enzyme preparations not intended for sale to the final
consumer

1. Where food enzymes and food enzyme preparations not
intended for sale to the final consumer are sold singly or mixed
with each other and/or other food ingredients, their packaging
or containers shall bear the following information:

(a)

the name laid down under this Regulation in respect of each
food enzyme or a sales description which includes the name
of each food enzyme or in the absence of a name, a descrip-
tion of the food enzyme that is sufficiently precise to distin-
guish it from products with which it could be confused;

(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use;

(c)

if necessary, the special conditions of storage and/or use;

(d) a mark identifying the batch or lot;

3.
The packaging or containers of food enzyme preparations
shall bear a list of all components in descending order of their
percentage by weight of the total.

By way of derogation from paragraphs 1, 2 and 3, the
4.
information required in paragraph 1 points (e) to (g) and in
paragraphs 2 and 3 may appear merely on the documents
relating to the consignment which are to be supplied with or
prior to the delivery, provided that the indication ‘not for retail
the packaging or
sale’ appears on an easily visible part of
container of the product in question.

By way of derogation from paragraphs 1, 2 and 3, where
5.
food enzymes and food enzyme preparations are supplied in
tankers all of the information may appear merely on the accom-
panying documents relating to the consignment which are to be
supplied with the delivery.

(e)

instructions for use, if the omission thereof would preclude
appropriate use of the food enzyme;

Article 12

(f)

the name or business name and address of the manufac-
turer, packager or seller;

Labelling of food enzymes and food enzyme preparations
intended for sale to the final consumer

(g) an indication of the maximum quantity of each component
or group of components subject to quantitative limitation in
food and/or appropriate information in clear and easily
understandable terms enabling the purchaser to comply
with this Regulation or other relevant Community law;
where the same limit on quantity applies to a group of
components used singly or in combination, the combined
percentage may be given as a single figure; the limit on
quantity shall be expressed either numerically or by the
quantum satis principle;

(h) the net quantity;

(i)

the activity of the food enzyme(s);

1. Without prejudice to Directive 2000/13/EC, Council
Directive 89/396/EEC of 14 June 1989 on indications or marks
identifying the lot to which a foodstuff belongs (1) and Regu-
lation (EC) No 1829/2003, food enzymes and food enzyme
preparations sold singly or mixed with each other and/or other
food ingredients intended for sale to the final consumer may be
marketed only if their packaging contains the following infor-
mation:

(a)

the name laid down under this Regulation in respect of each
food enzyme or a sales description which includes the name
of each food enzyme or in the absence of a name, a descrip-
tion of the food enzyme that is sufficiently precise to distin-
guish it from products with which it could be confused;

(j)

the date of minimum durability or use-by-date;

(b) the statement ‘for food’ or the statement ‘restricted use in
food’ or a more specific reference to its intended food use.

(k) where relevant,

information on a food enzyme or other
substances as referred to in this Article and listed in
Annex IIIa to Directive 2000/13/EC.

2.
For the information provided for in paragraph 1 of this
Article, Article 13(2) of Directive 2000/13/EC shall apply
accordingly.

2. Where food enzymes and/or food enzyme preparations
are sold mixed with each other and/or with other food ingredi-

(1) OJ L 186, 30.6.1989, p. 21. Directive as last amended by Directive

92/11/EEC (OJ L 65, 11.3.1992, p. 32).

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Article 13

Other labelling requirements

3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

Articles 10 to 12 shall be without prejudice to more detailed or
more extensive laws, regulations or administrative provisions
regarding weights and measures or applying to the presentation,
classification, packaging and labelling of dangerous substances
and preparations or applying to the transport of such substances
and preparations.

CHAPTER IV

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 14

Information obligation

A producer or user of a food enzyme shall

1.
inform the
Commission immediately of any new scientific or technical
information which might affect the assessment of the safety of
the food enzyme.

2.
For a food enzyme already approved under this Regulation
which is prepared by production methods or using starting
materials significantly different from those included in the risk
assessment of the European Food Safety Authority (hereinafter
referred to as the ‘Authority’), a producer or user shall, before
marketing the food enzyme, submit to the Commission the
necessary data to allow an evaluation of the food enzyme with
regard to the modified production method or characteristics to
be undertaken by the Authority.

A producer or user of a food enzyme shall, at the request
inform it of the actual use of the food
to

3.
of the Commission,
enzyme.
Member States by the Commission.

Such information shall be made

available

Article 15

Committee

Article 16

Community financing of harmonised policies

The legal basis for the financing of measures resulting from this
Regulation shall be Article 66(1)(c) of Regulation (EC)
No 882/2004.

CHAPTER V

TRANSITIONAL AND FINAL PROVISIONS

Article 17

Establishment of the Community list of food enzymes

The Community list of food enzymes shall be drawn up

1.
on the basis of applications made pursuant to paragraph 2.

Interested parties may submit applications for the inclu-

2.
sion of a food enzyme in the Community list.

for

submitting such applications

The deadline
shall be
24 months after the date of application of the implementing
measures to be laid down in accordance with Article 9(1) of
Regulation (EC) No …/2008 (*).

food
The Commission shall establish a Register of all
3.
enzymes to be considered for inclusion in the Community list
in respect of which an application complying with the validity
criteria to be laid down in accordance with Article 9(1) of Regu-
lation (EC) No …/2008 (*) has been submitted in accordance
with paragraph 2 of this Article (hereinafter referred to as ‘the
Register’). The Register shall be made available to the public.

The Commission shall submit the applications to the Authority
for its opinion.

4.
The Community list shall be adopted by the Commission
in accordance with the procedure laid down in Regulation (EC)
No …/2008 (*), once the Authority has issued an opinion on
each food enzyme included in the Register.

The Commission shall be assisted by the Standing

1.
Committee on the Food Chain and Animal Health.

However, by way of derogation from that procedure:

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard to
the provisions of Article 8 thereof.

(a) Article 5(1) of Regulation (EC) No …/2008 (*) shall not

apply to the Authority's adoption of its opinion;

(b) the Commission shall adopt the Community list for the first
time after the Authority has delivered its opinion on all the
food enzymes listed in the Register.

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

(*) See page 1 of this Official Journal.

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5.
If necessary, any appropriate transitional measures for the
purposes of this Article which are designed to amend non-es-
sential elements of this Regulation, inter alia by supplementing
it, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 15(3).

‘3.
Enzymes and enzymatic preparations used in the
authorised oenological practices and processes listed in
Annex IV shall meet the requirements of Regulation (EC)
No …/2008 of the European Parliament and of the Council
of … 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 (*).

Article 18

(*) OJ L …’.

Transitional measures

Notwithstanding Articles 7 and 17 of this Regulation, the
include the following

1.
Community list shall, when drawn up,
food enzymes:

(a) E 1103 Invertase and E 1105 Lysozyme, stating the condi-
tions governing their use as specified in Annex I and Part C
of Annex III to Directive 95/2/EC;

(b) Urease, beta-glucanase and lysozyme for use in wine in
accordance with Regulation (EC) No 1493/1999 and the
implementing rules for that Regulation.

Food enzymes,

food enzyme preparations and food
2.
containing food enzymes placed on the market or labelled
before … (*) which do not comply with the provisions of Arti-
cles 10 to 12 may be marketed until their date of minimum
durability or use-by-date.

Article 21

Amendments to Directive 2000/13/EC

Directive 2000/13/EC is hereby amended as follows:

1. Article 6(4) shall be amended as follows:

(a) point (a) shall be replaced by the following:

‘(a) “Ingredient”

including
shall mean any substance,
additives and enzymes, used in the manufacture or
preparation of a foodstuff and still present in the
finished product, even if in altered form.’;

Article 19

(b) in point (c)(ii), the introductory word ‘additives’ shall be

replaced by ‘additives and enzymes’;

Amendments to Directive 83/417/EEC

(c)

in point (c)(iii), the words ‘additives or flavouring’ shall
be replaced by ‘additives or enzymes or flavourings’;

In Directive 83/417/EEC, in Annex I, Section III(d), the indents
shall be replaced by the following:

2. the following indent shall be added to Article 6(6):

‘— rennet meeting the requirements of Regulation (EC)
No …/2008 of the European Parliament and of the
Council of … on food enzymes and amending Council
Directive
(EC)
No 1493/1999, Directive 2000/13/EC, Council Direc-
tive 2001/112/EC and Regulation (EC) No 258/97 (*),

83/417/EEC,

Regulation

Council

‘— enzymes other than as referred to in paragraph 4(c)(ii)
shall be designated by the name of one of the categories
of
followed by their
specific name.’.

ingredients listed in Annex II,

— other milk-coagulating enzymes meeting the require-

ments of Regulation (EC) No …/2008.

Article 22

(*) OJ L …’.

Amendments to Directive 2001/112/EC

Article 20

In Directive 2001/112/EC, in Annex I, Section II(2), the fourth,
fifth and sixth indents shall be replaced by the following:

Amendment to Regulation (EC) No 1493/1999

In Regulation (EC) No 1493/1999,
shall be added to Article 43:

the following paragraph

(*) 12 months after the date of entry into force of this Regulation.

‘— Pectolytic enzymes meeting the requirements of Regu-
lation (EC) No …/2008 of the European Parliament and
of the Council of … on food enzymes and amending
Council Directive 83/417/EEC, Council Regulation (EC)
No 1493/1999, Directive 2000/13/EC, Council Direc-
tive 2001/112/EC and Regulation (EC) No 258/97 (1).

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— Proteolytic enzymes meeting the requirements of Regu-

lation (EC) No …/2008.

No 1493/1999, Directive 2000/13/EC, Council Direc-
tive 2001/112/EC and Regulation (EC) No 258/97 (1).

— Amylolytic enzymes meeting the requirements of Regu-

lation (EC) No …/2008.

(1) OJ L …’.

(1) OJ L …’.

Article 24

Entry into force

Article 23

Amendment to Regulation (EC) No 258/97

In Regulation (EC) No 258/97, the following point shall be
added to Article 2(1):

‘(d) food enzymes falling within the scope of Regulation
(EC) No …/2008 of the European Parliament and of
the Council of … on food enzymes and amending
Council Directive 83/417/EEC, Council Regulation (EC)

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

Article 4 shall apply from the date of application of the Com-
munity list. Until
in force
concerning the placing on the market and use of food enzymes
and food produced with food enzymes shall continue to apply
in the Member States.

that date, national provisions

Articles 10 to 13 shall apply from … (*).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, …

For the European Parliament

The President

For the Council

The President

(*) 12 months after the date of entry into force of this Regulation.

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

On 28 July 2006, the Commission adopted a proposal for a Regulation of the European Parliament and
of the Council on food enzymes (1). The proposal is based on Article 95 of the Treaty establishing the
European Community.

The European Parliament adopted its Opinion at first reading on 10 July 2007 (2).

Following the European Parliament's first reading opinion, the Commission submitted an amended
proposal on 24 October 2007 (3).

On 10 March 2008, the Council adopted its Common Position in accordance with Article 251(2) of the
Treaty.

In carrying out its work, the Council also took account of the opinion of the European Economic and
Social Committee adopted on 25 April 2007 (4).

II. OBJECTIVE

The proposed Regulation, as part of four proposals designed to overhaul the Community's rules on food
improvement agents, introduces for the first time harmonized rules on food enzymes used in food,
establishes a Community list of food enzymes and rules on labelling of food enzymes and food enzymes
preparations.

The harmonised rules aim to ensure proper functioning of the internal market, including fair practices
in food trade, and a high level of protection of human health, of consumer interests and of the environ-
ment.

III. ANALYSIS OF THE COMMON POSITION

1. Introductory remarks

The Common Position reflects the result of the examination of the Commission's proposal by the
Council. The Council introduced a number of modifications in the text, some of them inspired by
the amendments proposed by the European Parliament. On its own initiative, the Council introduced
some of the European Parliament amendments in each of the three sectoral proposals, with a view to
harmonising their provisions. The modifications introduced by the Council may be summed up as
follows:

— Preference for a single legal basis: Article 95 of the Treaty (in line with amendment 35)

According to established case-law (5), the legal basis for an act must be determined having regard
to its own aim and content. If the examination of a Community measure reveals that it serves a
two-fold purpose or that it has a two-fold component and if one of those is identifiable as the
main or predominant purpose or component, whereas the other is merely incidental, the act
must be based on a single legal basis, namely that required by the main or predominant purpose
or component (6). In this case, the Council considered that the agricultural aspects of the proposal
are merely incidental while the internal market objective is the main or predominant purpose or
component and as such, in line with the case law of the ECJ, it decided to retain Article 95 as the
sole legal basis.

(1) COM(2006) 425 final.
(2) Doc. 11641/07 CODEC 777.
(3) COM(2007) 670 final.
(4) OJ C 168, 20.7.2007, p. 29.
(5) See Case 45/86, Commission v Council [1987] ECR 1493, paragraph 11; Case C-300/89, Commission v Council (Titanium
Dioxide) [1991] ECR I-2867, paragraph 10; Case C-268/94, Portugal v Council [1996] ECR I-6177, paragraph 22; and Case
C-176/03, Commission v Council [2005] ECR I-0000, paragraph 45.

(6) See Case C-36/98, Spain v Council [2001] ECR I-779, paragraph 59; Case C-211/01, Commission v Council [2003]

ECR I-8913, paragraph 39; and Case C-338/01, Commission v Council [2004] ECR I-4829, paragraph 55.

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— Misleading the consumer (in line with amendment 4)

The Council included, in recital 6, elements integrating the notion of misleading the consumer.

— Protection of the environment

The Council considered that, apart
the food
enzymes should also take into account other relevant factors, such as the protection of the
environment. The Council also included a reference to the protection of the environment among
the objectives of the Regulation;

from scientific evidence,

the authorisation of

— Regulatory comitology procedure with scrutiny (in line with amendments 28 and 30)

The Council adapted the proposal to the new comitology procedure rules, requiring the regula-
tory procedure with scrutiny to be applied for the adoption of measures supplementing the Regu-
lation.

— Submission of the interpretation decisions to the regulatory comitology procedure

The Council regrouped all the provisions on interpretation decisions into a new single Article,
and, as they would not supplement the proposed Regulation, made them subject to the regulatory
comitology procedure without scrutiny.

— Transitional measures for products already on the market (in line with amendment 36)

The Council provided for a 1 year transition period from the date of entry into force of the
proposed Regulation. Foods lawfully placed on the market or labelled during this year may be
marketed until their date of minimum durability or use-by-date.

— Provision prohibiting the placing on the market of non-compliant food enzymes (in line with amend-

ment 15)

For reasons of clarity, legal certainty and proper functioning of the market, the Council inserted
an Article on the prohibition of placing non-compliant food enzymes on the market. This is
consistent with the proposals on flavourings and on food additives.

— Authorisation of enzymes falling within the scope of Regulation (EC) No 1829/2003 of the European
Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1)
(in line with Amendments 7 and 34 (second part))

The Council agrees that the two authorisation procedures for any substance can be carried out
simultaneously. The Council subjected that principle to some drafting changes in order to make
the provision more compatible with Regulation (EC) No 1829/2003.

— Labelling

The Council streamlined and reinforced the labelling provisions, respecting the distinction
between ‘business to business’ labelling and labelling requirements for products intended for the
sale to the final consumer. Although the Council organised the labelling chapter in a way different
from that proposed by the European Parliament, the principles underlying its content are in line
with amendments 21 (first and second parts), 22, 23, 24, 25, 27.

The Commission has accepted the Common Position agreed by the Council.

(1) OJ L 268, 18.10.2003, p. 1.

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2. The amendments of the European Parliament

In its Plenary vote on 10 July 2007, the European Parliament adopted 33 amendments to the
proposal.

In its Common Position, the Council incorporated, in full or in principle, 21 amendments.

(a) Amendments incorporated in the Common Position

In addition to amendments mentioned in part 1 above, the Common Position incorporates, in
full or in principle, other European Parliament's first reading amendments, aimed at improving or
clarifying the text of the proposal, in particular, amendments 10, 12 (first part), 14 (third and
fifth parts), 16 (second part), 20, 31, 34 (first part).

(b) Amendments not introduced (1)

The Council was not able to incorporate all the amendments, for following reasons:

— Enzymes added to food for nutritional purposes and digestive aids (amendment 3, 11, and 12 —

recital 4, Articles 2(2)(c new), 2(4))

The Council considers that there is no need to mention explicitly that the enzymes intended
for direct human consumption (such as enzymes used for nutritional purposes or as digestive
aids) are excluded from the scope of the proposed Regulation. In fact, the scope of the
proposed Regulation only includes enzymes added to food to perform a technological func-
tion.

With regard to amendment 12 (first part), the Council emphasises the exclusion of cultures
that are ‘traditionally’ used in the production of food (e.g. cheese, wine, etc.) and which may
incidentally produce enzymes. In reality, the deletion of the word ‘traditionally’ would enlarge
the scope of the exclusion and could result in cultures, which are added to food for the tech-
nological function of the enzyme that they produce, (e.g. preservation) not being regulated.

— Enzymes having a benefit

for

the consumer

(amendments 4, 16 (third part) — recital 6,

Article 6(c))

The proposed Regulation covers enzymes that are added to food for a technological function
and hence the use of enzymes in most cases improves the environmental performance of the
production process which brings an indirect rather than direct benefit for the consumer.

— Genetically modified organisms (GMO's)

(a) Labelling

of GMO (amendment 14 (fourth part), 32, 37 (point ba), 38 —

Articles 3(3 new), 13, 21(2) and recital 11)

As mentioned in recital 17, the food enzymes remain subject to the labelling provisions
defined in Directive 2000/13 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) and in Regulation (EC) No 1829/2003 of
the European Parliament and of the Council of 22 September 2003 on genetically modi-
fied food and feed (3). The Council adopted a prudent approach, not accepting amend-
ments that could interfere with the scope of the horizontal Regulations in force.

(1) Numbering of Articles in this part refers to the text of the Common Position.
(2) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2007/68/EC (OJ L 310, 28.11.2007, p. 11).
(3) OJ L 268, 18.10.2003, p. 1.

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(b) Unique

identifier as defined in Regulation (EC) No 1830/2003 (amendment 18 —

Article 7(2)(b))

On account of proportionality and simplification,
the Council deleted the reference
requiring that the enzyme specification in the Community list of food enzymes, would
indicate the unique identifier of GMOs as defined in Regulation (EC) No 1830/2003 of
the European Parliament and of the Council of 22 September 2003 concerning the trace-
ability of food and feed products produced from genetically modified organisms (1).
Where relevant, the provisions in Article 6(2)(b) would be sufficient to cover this informa-
tion. Thus amendment 18 is superfluous.

— Requirements already addressed in the Regulation (EC) No 178/2002 on general provisions and

requirements of food law (amendments 6, 8, 16)

(a) Precautionary principle (amendments 6, 16 (first part) — recital 9 and Article 6)

The precautionary principle is one of the general principles underlying the general food
law (2). Consequently, it applies to the proposed Regulation with no need for a specific
reference to it. Moreover, in the risk analyses framework, the precautionary principle can
only be taken into account the context of risk management, never in the risk assessment
phase, as suggested by the European Parliament.

(b) Publication of the opinions of the European Food Safety Authority (EFSA) (amendment 8 —

recital 14)

Publication of the opinions of EFSA is already provided for by Article 38(1)(b) of Regu-
lation (EC) No 178/2002.

— Re-evaluation every 10 years (amendment 9 — recital 19)

For the Council, a system of continuous observation and of re-evaluation whenever necessary
in the light of changing conditions and of new scientific information, will guarantee food
safety. An additional review every 10 years would represent an unnecessary administrative
burden for producers, users, EFSA, the Commission and the Member States.

— Decisions submitted to the comitology procedure without scrutiny (amendment 13 — Article 9(a)

Decisions on whether or not a given substance falls within the scope of the proposed Regu-
lation are of interpretative nature and will not supplement the Regulation. Therefore, they
would not fall within the scope of the regulatory comitology procedure with scrutiny.

— Definition of enzymes (amendment 14, 17 — Article 3(2), 7(2)(a))

The subject of this Regulation is ‘food enzymes’, which is defined. An additional definition of
‘enzymes’ did not seem to be essential.

— Specifications of the entries of food enzymes in the list (amendment 19 — Article (7)(2) (c) to (f))

In Article 7(2)(c) to (e) the Council preferred to provide for certain specifications only if
necessary and not more often than needed.

(1) OJ L 268, 18.10.2003, p. 24.
(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 (OJ L 31, 1.2.2002, p. 1). Regulation as last amended by Regulation (EC) No 575/2006 (OJ L 100,
8.4.2006, p. 34).

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In Article 7(2)(f), the Council considers that the words ‘where necessary’ should be kept. The
need for such a labelling concerns only a restricted number of cases, where the physical
condition of the food has been changed due to the use of food enzyme. Only in this cases,
the consumer has to be informed of the fact.

— Labelling

Although the Council organised the labelling chapter in a way different from that proposed
by the European Parliament, the principles underlying its content are in line with some of the
amendments related to Articles 10 to 13. However, the Council could not accept some
amendments proposed by the European Parliament, as the Council considers that the provi-
sions are either already incorporated or form part of other specific Community legislation.

information on the
Amendment 21 (third part) requires the inclusion in the label of
side-effects of the use of enzymes in excessive quantities. However, EFSA already took such
information into account during the evaluation procedure and, if applicable, the authorisation
for the food enzyme would be subject to appropriate conditions of use.

Amendments 32 and 37 (last part) are incompatible with Directive 2000/13/EC, which
excludes from labelling substances used as processing aids which are present in the final
product only as technically unavoidable residue and which do not have any technological
effect on the food.

Information on the technological
(second part), would not be useful to non-specialists.

function of

the enzyme, required by amendment 37

— ‘Fast

track’
Article 17(4)(c new))

procedure

for

enzymes

currently

on

the market

(amendment

29 —

The Council considers that all food enzymes should undergo the same safety evaluation
procedure, by EFSA, the Community risk assessment body.

Amendment 2 is of editorial nature and has not been introduced.

IV. Conclusions

The Council believes that the Common Position represents a balance of concerns and interests that
would respect the objectives of the Regulation. It looks forward to constructive discussions with the
European Parliament with a view to the early adoption of the Regulation, ensuring a high level of
human health and consumer protection.