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 (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, enzyme, food safety, foodstuff, free movement of goods, public health

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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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(4)

Having regard to the Treaty establishing the European Commu-
nity, 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 laid down in Article 251
of the Treaty (2),

Whereas:

(1)

(2)

(3)

The free movement of safe and wholesome food is an
essential aspect of the internal market and contributes sig-
nificantly 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. Differences
between national laws, regulations and administrative pro-
visions concerning the assessment and authorisation of
food enzymes may hinder their free movement, creating
conditions for unequal and unfair competition. It is there-
fore necessary to adopt Community rules harmonising
national provisions relating to the use of enzymes in foods.

(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E,
10.7.2008, p. 162), Council Common Position of 10 March 2008
(OJ C 111 E, 6.5.2008, p. 32), Position of the European Parliament of
8 July 2008 (not yet published in the Official Journal) and Council
Decision of 18 November 2008.

This Regulation should only cover enzymes that are added
to food to perform a technological function in the manu-
facture, processing, preparation, treatment, packaging,
transport or storage of such food, including 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 tech-
nological function but are intended for human consump-
tion, such as enzymes for nutritional or digestive 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.

Food enzymes used exclusively in the production of food
additives falling within the scope of Regulation (EC)
No 1333/2008 of the European Parliament and of the
Council of 16 December 2008 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
fulfil the criteria laid down in this Regulation. Food
enzymes must be safe when used, there must be a techno-
logical 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, freshness, qual-
ity of ingredients used, the naturalness of a 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 the matter under
consideration including societal, economic, traditional,
ethical and environmental factors, the precautionary prin-
ciple and the feasibility of controls.

(5)

(6)

(7)

Some food enzymes are permitted for specific uses, such as
in fruit juices and certain similar products and certain lac-
toproteins intended for human consumption, and for cer-
tain authorised oenological practices and processes. The
use of such food enzymes should comply with this

(3) See page 16 of this Official Journal.

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Regulation and with the specific provisions laid down in
the relevant Community legislation. Council Directive
2001/112/EC of 20 December 2001 relating to fruit juices
and certain similar products intended for human con-
sumption (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 casein-
ates) 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, Regulation (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 accordingly.

Food enzymes the use of which is permitted within the
Community should appear in a Community list that should
clearly describe the enzymes and specify any conditions
governing their use, including where necessary informa-
tion on their function in the final food. This list should be
supplemented by specifications, in particular on their ori-
gin, including where relevant information 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
laid down in Regulation (EC) No 1331/2008 of the Euro-
pean Parliament and of the Council of 16 December 2008
establishing a common authorisation procedure for food
additives, food enzymes and food flavourings (5).

(8)

(9)

(10) Under Regulation (EC) No 178/2002 of the European Par-
liament 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 lay-
ing 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 Regulation
(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 authorised in accordance with
that Regulation as well as under this Regulation.

(1) OJ L 10, 12.1.2002, p. 58.
(2) OJ L 237, 26.8.1983, p. 25.
(3) OJ L 179, 14.7.1999, p. 1.
(4) OJ L 43, 14.2.1997, p. 1.
(5) See page 1 of this Official Journal.
(6) OJ L 31, 1.2.2002, p. 1.
(7) OJ L 268, 18.10.2003, p. 1.

(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 Author-
ity, or different from those covered by the authorisation
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 fer-
mentation using a micro-organism or a genetic modifica-
tion 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 for
the risk assessment of these products. An initial 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) No 1331/2008 [estab-
lishing a common authorisation procedure for food addi-
tives, food enzymes and food flavourings], in order to give
applicants sufficient time to submit the information on
existing enzymes which may be included in the Commu-
nity list to be drawn up under this Regulation. It should
also be possible to submit applications for the authorisa-
tion of new enzymes during the initial two-year period.
The Authority should evaluate without delay all applica-
tions 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 sufficient
information has been submitted during the initial two-year
period. However, the risk assessments of the Authority for
individual enzymes should be published as soon as they
are completed.

(15) A significant number of applications is expected to be sub-
mitted during the initial two-year period. A lengthy period
may therefore be needed before the risk assessment of
these has been completed and the Community list is drawn
up. In order to ensure equal access to the market for new
food enzymes after the initial two-year period, a transi-
tional period should be provided for during which food
enzymes and food using food enzymes may be placed on
the market and used,
in accordance with the existing
national rules in the Member States, until the Community
list has been drawn up.

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(16)

(17)

(18)

The food enzymes E 1103 Invertase and E 1105 Lysozyme,
that have been authorised as food additives under Direc-
tive 95/2/EC of the European Parliament and of the Coun-
cil of 20 February 1995 on food additives other than
colours and sweeteners (1), and the conditions governing
their use should be carried over from Directive 95/2/EC to
the Community list when it is drawn up by this Regulation.
In addition, Council Regulation (EC) No 1493/1999 autho-
rises the use of urease, beta-glucanase and lysozyme in
wine subject to the conditions laid down in Commission
Regulation (EC) No 423/2008 of 8 May 2008 on laying
down certain detailed rules for implementing Council
Regulation (EC) No 1493/1999 and establishing a Com-
munity 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 423/2008.

Food enzymes remain subject to the general labelling obli-
gations provided for in Directive 2000/13/EC of the Euro-
pean Parliament and of the Council of 20 March 2000 on
the approximation of the laws of the Member States relat-
ing to the labelling, presentation and advertising of food-
stuffs (3) and, as the case may be,
in Regulation (EC)
No 1829/2003 and in Regulation (EC) No 1830/2003 of
the European Parliament and of the Council of 22 Septem-
ber 2003 concerning the traceability 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 label-
ling of food enzymes sold as such to the manufacturer or
to the consumer should be contained in this Regulation.

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 Directive
2000/13/EC. Food enzymes should be designated by their
technological function in food, followed by the specific
name of the food enzyme. However, provision should be
made for a derogation from the provisions on labelling in
cases where the enzyme performs no technological func-
tion in the final product but is present in the foodstuff only
as a result of carry-over from one or more of the ingredi-
ents of the foodstuff or where it is used as a processing aid.
Directive 2000/13/EC should be amended accordingly.

(1) OJ L 61, 18.3.1995, p. 1.
(2) OJ L 127, 15.5.2008, p. 13.
(3) OJ L 109, 6.5.2000, p. 29.
(4) OJ L 268, 18.10.2003, p. 24.

(19)

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.

(20)

(21)

(22)

The measures necessary for the implementation of this
Regulation 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 con-
ferred on the Commission (5).

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

this Regulation,

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 appropri-
ate 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 and of the Council of 29 April 2004 on official
controls performed to ensure the verification of compli-
ance with feed and food law, animal health and animal
welfare rules (6).

(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 therefore, in the
interests of market unity and a high level of consumer pro-
tection, be better achieved at Community level, the Com-
munity may adopt measures,
in accordance with the
principle of subsidiarity as set out in Article 5 of the Treaty.
In accordance with the principle of proportionality, as set
out in that Article, this Regulation does not go beyond
what is necessary in order to achieve that objective,

(5) OJ L 184, 17.7.1999, p. 23.
(6) OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 28.5.2004,

p. 1.

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HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on food enzymes used in foods,
including such enzymes used as processing aids, with a view to
ensuring the effective functioning of the internal market whilst
ensuring a high level of protection of human health and a high
level of consumer protection, including the protection of con-
sumer interests and fair practices in food trade, taking into
account, where appropriate, the protection of the environment.

Article 3

Definitions

For the purposes of this Regulation, the definitions laid
1.
down in Regulation (EC) No 178/2002, Regulation (EC)
No 1829/2003 and Regulation (EC) No 1333/2008 [on food
additives] shall apply.

2.

The following definitions shall also apply:

(a)

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

For those purposes, this Regulation provides for:

(i)

containing one or more enzymes capable of catalyzing
a specific biochemical reaction; and

(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.

Article 2

Scope

(ii) added to food for a technological purpose at any stage
of the manufacturing, processing, preparation, treat-
ment, packaging, transport or storage of foods;

(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 incorporated to
facilitate their storage, sale, standardisation, dilution or
dissolution.

This Regulation shall apply to food enzymes as defined in

1.
Article 3.

CHAPTER II

This Regulation shall not apply to food enzymes when and

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

(a)

food additives falling within the scope of Regulation (EC)
No 1333/2008 [on food additives];

(b) processing aids.

This Regulation shall apply without prejudice to any spe-

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

COMMUNITY LIST OF APPROVED FOOD ENZYMES

Article 4

Community list of food enzymes

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).

(a)

in specific foods;

(b)

for purposes other than those covered by this Regulation.

Article 5

Prohibition of non-compliant food enzymes and/or
non-compliant food

4.
This Regulation shall not apply to microbial cultures that
are traditionally used in the production of food and which may
incidentally produce enzymes, but which are not specifically used
to produce them.

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 implement-
ing measures.

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Article 6

General conditions for inclusion of food enzymes in the
Community list

The Community list shall be amended in accordance with
3.
the procedure referred to in Regulation (EC) No 1331/2008
[establishing a common authorisation procedure for food addi-
tives, food enzymes and food flavourings].

A food enzyme may be included in the Community list only if it
meets the following conditions and, where relevant, other legiti-
mate 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;

(b)

there is a reasonable technological need, and

(c)

its use does not mislead the consumer. Misleading the con-
sumer includes, but is not limited to, issues related to the
nature, freshness and quality of the ingredients used, the
naturalness of a product or of the production process, or the
nutritional quality of the product.

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 1331/2008 [establishing a common authori-
sation procedure for food additives, food enzymes and food fla-
vourings], be included in the Community list.

Article 8

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

1.
A food enzyme falling within the scope of Regulation (EC)
No 1829/2003 may be included in the Community list in accor-
dance with this Regulation only when it is covered by an autho-
risation in accordance with Regulation (EC) No 1829/2003.

2. When a food enzyme already included in the Community
list is produced from a different source falling within the scope of
Regulation (EC) No 1829/2003, it will not require a new autho-
risation under this Regulation, as long as the new source is cov-
ered by an authorisation in accordance with Regulation (EC)
No 1829/2003 and the food enzyme complies with the specifi-
cations established under this Regulation.

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:

The entry of a food enzyme in the Community list shall

2.
specify:

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

Article 3;

(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)

the foods to which the food enzyme may be added;

(d)

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 quantum satis principle;

(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 label-
ling 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.

(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 label-
ling provided for in Article 11 of this Regulation, which must be
easily visible, clearly legible and indelible. The information pro-
vided for in Article 11 shall be in a language easily understand-
able to purchasers.

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

(h)

the net quantity;

(i)

the activity of the food enzyme(s);

(j)

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

Article 11

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

(k) where relevant, information on a food enzyme or other sub-
stances as referred to in this Article and listed in Annex IIIa
to Directive 2000/13/EC.

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 such a name, the
accepted name laid down in the nomenclature of the Inter-
national Union of Biochemistry and Molecular Biology
(IUBMB);

(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;

(e)

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

(f)

the name or business name and address of the manufacturer,
packager or seller;

(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;

2. Where food enzymes and/or food enzyme preparations are
sold mixed with each other and/or with other food ingredients,
their packaging or containers shall bear a list of all ingredients in
descending order of their percentage by weight of the total.

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 infor-
4.
mation required in paragraph 1 points (e) to (g) and in para-
graphs 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 sale’ appears
on an easily visible part of the packaging or container of the prod-
uct 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.

Article 12

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

1. Without prejudice to Directive 2000/13/EC, Council Direc-
tive 89/396/EEC of 14 June 1989 on indications or marks iden-
tifying the lot to which a foodstuff belongs (1) and Regulation (EC)
No 1829/2003, food enzymes and food enzyme preparations
sold singly or mixed with each other and/or other food ingredi-
ents intended for sale to the final consumer may be marketed only
if their packaging contains 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 such a name, the
accepted name laid down in the nomenclature of the IUBMB;

(1) OJ L 186, 30.6.1989, p. 21.

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(b)

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

Article 16

Community financing of harmonised policies

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

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

Article 13

Other labelling requirements

CHAPTER V

TRANSITIONAL AND FINAL PROVISIONS

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.

Article 17

Establishment of the Community list of food enzymes

The Community list of food enzymes shall be drawn up on

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

CHAPTER IV

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Interested parties may submit applications for the inclusion

2.
of a food enzyme in the Community list.

Article 14

Information obligation

A producer or user of a food enzyme shall inform the Com-
1.
mission immediately of any new scientific or technical informa-
tion 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 mate-
rials significantly different from those included in the risk assess-
ment 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.

3.
A producer or user of a food enzyme shall, at the request of
the Commission, inform it of the actual use of the food enzyme.
Such information shall be made available to Member States by the
Commission.

Article 15

Committee

The Commission shall be assisted by the Standing Commit-

1.
tee on the Food Chain and Animal Health.

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

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

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.

The deadline for submitting such applications 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 1331/2008 [establishing a common authorisation procedure
for food additives, food enzymes and food flavourings].

3.
The Commission shall establish a Register of all food
enzymes to be considered for inclusion in the Community list in
respect of which an application complying with the validity cri-
teria to be laid down in accordance with Article 9(1) of Regula-
tion (EC) No 1331/2008 [establishing a common authorisation
procedure for food additives, food enzymes and food flavourings]
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 1331/2008 [establishing a common authorisation procedure
for food additives, food enzymes and food flavourings], once the
Authority has issued an opinion on each food enzyme included
in the Register.

However, by way of derogation from that procedure:

(a) Article 5(1) of Regulation (EC) No 1331/2008 [establishing
a common authorisation procedure for food additives, food
enzymes and food flavourings] shall not apply to the Authori-
ty’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.

5.
If necessary, any appropriate transitional measures for the
purposes of this Article which are designed to amend non-
essential 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).

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Article 18

Transitional measures

Article 21

Amendments to Directive 2000/13/EC

Notwithstanding Articles 7 and 17 of this Regulation, the
1.
Community list shall, when drawn up, include the following food
enzymes:

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

(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;

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

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

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

2.
Food enzymes, food enzyme preparations and food con-
taining food enzymes placed on the market or labelled before
20 January 2010 which do not comply with the provisions of
Articles 10 to 12 may be marketed until their date of minimum
durability or use-by-date.

Article 19

Amendments to Directive 83/417/EEC

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

‘— rennet meeting the requirements of Regulation (EC)
No 1332/2008 of the European Parliament and of the Coun-
cil of 16 December 2008 on food enzymes (*);

‘(a)

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

(b)

in point (c)(ii), the introductory word ‘additives’ shall be
replaced by ‘additives and enzymes’;

(c)

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

2.

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

‘— enzymes other than as referred to in paragraph 4(c)(ii)
shall be designated by the name of one of the categories
of ingredients listed in Annex II, followed by their spe-
cific name,’.

— other milk-coagulating enzymes meeting the requirements of

Regulation (EC) No 1332/2008.

Article 22

Amendments to Directive 2001/112/EC

(*) OJ L 354, 31.12.2008, p. 7.’

Article 20

Amendment to Regulation (EC) No 1493/1999

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

‘3.
Enzymes and enzymatic preparations used in the autho-
rised oenological practices and processes listed in Annex IV shall
meet the requirements of Regulation (EC) No 1332/2008 of the
European Parliament and of the Council of 16 December 2008 on
food enzymes (*).

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

‘— Pectolytic enzymes meeting the requirements of Regulation
(EC) No 1332/2008 of the European Parliament and of the
Council of 16 December 2008 on food enzymes (*);

— Proteolytic enzymes meeting the requirements of Regulation

(EC) No 1332/2008;

— Amylolytic enzymes meeting the requirements of Regulation

(EC) No 1332/2008.

(*) OJ L 354, 31.12.2008, p. 7.’

(*) OJ L 354, 31.12.2008, p. 7.’

31.12.2008

EN

Official Journal of the European Union

L 354/15

Article 23

Amendment to Regulation (EC) No 258/97

Article 24

Entry into force

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 1332/2008 of the European Parliament and of the Coun-
cil of 16 December 2008 on food enzymes (*).

This Regulation shall enter into force on the 20th 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 Commu-
nity list. Until that date, national provisions in force concerning
the placing on the market and use of food enzymes and food pro-
duced with food enzymes shall continue to apply in the Member
States.

(*) OJ L 354, 31.12.2008, p. 7.’

Articles 10 to 13 shall apply from 20 January 2010.

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

Done at Strasbourg, 16 December 2008.

For the European Parliament
The President
H.-G. PÖTTERING

For the Council
The President
B. LE MAIRE