Preparation for the Council meeting (AGRICULTURE AND FISHERIES) on 17 - 18 December 2007 Proposal for 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 of the European Parliament and of the Council - Political Agreement - Hoofdinhoud
COUNCIL OFBrussels, 29 November 2007
THE EUROPEAN UNION
DENLEG 125 CODEC 1369
to: Permanent Representatives Committee (Part I)
No. Cion prop.: 12179/06 DENLEG 40 CODEC 827
No. previous doc.: 15441/07 DENLEG 114 CODEC 1303
Preparation for the Council meeting (AGRICULTURE AND FISHERIES) on
17 - 18 December 2007 Proposal for a Regulation of the European Parliament and of the Council on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No
258/97 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95
Having regard to the proposal from the Commission1,
Having regard to the opinion of the European Economic and Social Committee2,
Acting in accordance with the procedure laid down in Article 251 of the Treaty,
(3) 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 provisions concerning the assessment and authorisation
of food enzymes may hinder their free movement, creating conditions for unequal and unfair
competition. It is therefore necessary to adopt Community rules harmonising national
provisions relating to the use of enzymes in foods.
(4) This Regulation should only cover enzymes that are added to food to perform a technological
function in the manufacture, processing, preparation, treatment, packaging, transport or
storage of such food, including enzymes used as processing aids (`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.
(5) Food enzymes used exclusively in the production of food additives falling within the scope of
the Regulation [...] on food additives should be excluded from the scope of this Regulation,
since the safety of these foods is already assessed and regulated. However, when these food
(6) Food enzymes should be approved and used only if they fulfil the criteria laid down in this
Regulation. Food enzymes should be safe when used, there should be a technological need for
their use and their use should not mislead the consumer. Misleading the consumer includes,
but is not limited to, issues related to the nature, freshness, quality 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 and the feasibility of controls.
(7) 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. Those food enzymes should be used in accordance with
this 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 consumption1, 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 consumption2 and Council
Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in
wine3 should therefore be amended accordingly. Since all food enzymes should be covered by
this Regulation, Regulation (EC) No 258/1997 of the European Parliament and of the
Council of 27 January 1997 concerning novel foods and novel food ingredients4 should be
(8) Food enzymes the use of which is permitted within the Community should appear in a
Community list that should clearly describe the enzymes, specify any conditions governing
their use, including where necessary information on their function in the final food. This list
should be supplemented by specifications, in particular on their origin, including where
relevant information about allergenic properties, and purity criteria.
(9) With a view to 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 [...] of the European Parliament and of the Council of [...] establishing a
common authorisation procedure for the food additives, food enzymes and food flavourings1.
(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 safety2,
the European Food Safety Authority (`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 feed3 should be subject to the authorisation procedure under that Regulation with regard
to the safety assessment of the genetic modification, while the final authorisation of the food
(12) A food enzyme already included in the Community list under this Regulation which is
prepared by production methods or starting materials significantly different from those
included in the risk assessment of the Authority, or different than 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 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 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 Article 9(1) of
Regulation (EC) No [...] [establishing a common authorisation procedure for the food
additives, 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 Community list to
be drawn up under this Regulation. It should also be possible to submit applications for the
authorisation of new enzymes during the initial two-year period. The Authority should
evaluate without delay all applications for food enzymes for which sufficient information has
(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 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 transitional 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.
(16) 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 sweeteners1, 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
authorises the use of urease, beta-glucanase 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 establishing a Community code of oenological
practices and processes2. Those substances are food enzymes and they should fall within the
scope of this Regulation. They should therefore be also added to the Community list when it
is drawn up for their use in wine in accordance with Regulation (EC) No 1493/1999 and
(17) 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
advertising of foodstuffs1 and, as the case may be, in Regulations (EC) No 1829/2003 and
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22
September 2003 concerning the traceability and labelling of genetically modified organisms
and the traceability of food and feed products produced from genetically modified organisms
and amending Directive 2001/18/EC2. In addition, specific labelling provisions for food
enzymes sold as such to the manufacturer or to the consumer should be laid down in this
(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 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 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.
(20) The measures necessary for the implementation of this Regulation should be in accordance
with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the
exercise of implementing powers conferred on the Commission1.
(20a) In particular power should be conferred on the Commission to adopt appropriate transitional
measures. Since those measures are of general scope and are designed to amend non-essential
elements of this Regulation, and/or to supplement it by the addition of 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.
(21) In order to develop and update Community legislation on food enzymes in a proportionate
and effective way, it is necessary 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 may 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
compliance with feed and food law, animal health and animal welfare rules2 and consequently
the legal basis for the financing of the above measures will be Regulation (EC) No 882/2004.
(23) Since the objective of the action to be taken, namely to lay down Community rules on food
enzymes cannot be sufficiently achieved by the Member States and can therefore, by reason
of market unity and high level of consumer protection be better achieved at Community level,
the Community 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 those
HAVE ADOPTED THIS REGULATION
SUBJECT MATTER, SCOPE AND DEFINITIONS
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' interests, including fair practices in food
1.This Regulation shall apply to food enzymes as defined in Article 3.
2.This Regulation shall not apply to food enzymes when and insofar as they are used in the
(a) food additives falling within the scope of Regulation (EC) No ...[on food additives];
(b) processing aids.
3.This Regulation shall apply without prejudice to any specific Community rules concerning the
use of food enzymes:
(a) in specific foods ;
(b) for purposes other than those covered by this Regulation.
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.
1."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-
(a) containing one or more enzymes capable of catalyzing a specific biochemical reaction;
(b) added to food for a technological purpose at any stage of the manufacturing, processing,
preparation, treatment, packaging, transport or storage of foods.
2."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.
COMMUNITY LIST OF APPROVED FOOD ENZYMES
Community list of food enzymes
Only food enzymes included in the Community list may be placed on the market as such and used
General conditions for inclusion and use of food enzymes in the Community list
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.
The content of the Community list of food enzymes
1.A food enzyme which complies with the conditions set out in Article 5 may, in accordance
with the procedure laid down in Regulation (EC) No [...][establishing a common
authorisation procedure for food additives, food enzymes and food flavourings], be included
in the Community list.
2.The entry of a food enzyme in the Community list shall specify:
(a) the name of the food enzyme;
(e) if appropriate, whether there are any restrictions on the sale of the food enzyme directly
to the final consumers;
(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.
3.The Community list shall be amended in accordance with the procedure referred to in
Regulation (EC) No [...] establishing a common authorisation procedure for food additives,
food enzymes and food flavourings.
Food enzyme falling within the scope of Regulation (EC) No 1829/2003
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
authorisation in accordance with Regulation (EC) No 1829/2003.
Article 7a (new)
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 if they comply with the labelling
provided for in Article 10 of this Regulation, which must be easily visible, clearly legible and
indelible. The information provided for in Article 10 shall be in a language easily
understandable to purchasers.
2.Within its own territory, the Member States in which the product is marketed may, in
accordance with the rules of the Treaty, stipulate that this information shall be given in one or
more official languages of the Community, to be determined by that Member State. This shall
not preclude such information from being indicated in several languages.
General labelling requirements for food enzymes and food enzyme preparations not intended for
(xx) 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
description of the food enzyme that is sufficiently precise to distinguish it from products
with which it could be confused.
(a) the statement either `for food ' or the statement `restricted use in food' or a more
specific reference to its intended food use;
(b) if necessary, the special conditions of storage and/or use;
(c) a mark identifying the batch or lot;
(d) instructions for use, if the omission thereof would preclude appropriate use of the food
(e) the name or business name and address of the manufacturer, packager or seller;
(f) 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 legislation;
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;
(g) the net quantity;
(h) the activity of the food enzyme(s);
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.
4.By way of derogation from paragraphs 1, 2 and 3, the information required in paragraph 1
points (d) to (f) 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 sale" appears on an easily visible part of the packaging or container
of the product in question.
5.By way of derogation from paragraphs 1, 2 and 3 of this article, where enzymes are supplied
in tankers all of the information may appear merely on the accompanying documents relating
to the consignment which are to be supplied with the delivery.
Labelling of food enzymes and food enzyme preparations intended for sale to the final consumer
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 information:
(b) the statement either `for food' or the statement `restricted use in food' or a more specific
reference to its intended food use.
2.For the information provided for in paragraph (1), Article 13(2) of the Directive 2000/13/EC
shall apply accordingly.
Other labelling requirements
Articles 8 to 11 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.
PROCEDURAL PROVISIONS AND IMPLEMENTATION
1a. For a food enzyme already approved under this Regulation which is prepared by production
methods or starting materials significantly different from those included in the risk assessment
of the European Food Safety Authority (hereinafter referred to as the `Authority'), before
marketing the food enzyme a producer or user shall 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.
2.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
1.The Commission shall be assisted by the Standing Committee on the Food Chain and Animal
Health (hereinafter referred to as "the Committee").
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.
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
Community financing of harmonised policies
The legal basis for the financing of measures resulting from this Regulation is Article 66(1)(c) of
TRANSITIONAL AND FINAL PROVISIONS
Establishment of the Community list of food enzymes
1.The Community list of food enzymes shall be drawn up on the basis of applications made
pursuant to paragraph 2.
2.Interested parties may submit applications for the inclusion of a food enzyme in the
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
4.The Community list shall be adopted by the Commission in accordance with the procedure
laid down in Regulation (EC) No [...][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 [...] [establishing a common authorisation
procedure] 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.
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
Notwithstanding Articles 6 and 18 of the present Regulation, the Community list shall, when drawn
up, include the following food enzymes:
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 [the proposal for a] Regulation [.../..] on food enzymes
-other milk-coagulating enzymes meeting the requirements of [the proposal for a] Regulation
[.../..] on food enzymes".
Amendment to Regulation (EC) No 1493/1999
In Article 43 of Regulation (EC) No 1493/1999, the following paragraph 3 shall be added:
"3. Enzymes and enzymatic preparations used in the authorised oenological practices and
processes listed in Annex IV shall meet the requirements of [the proposal for a] Regulation
[.../..] on food enzymes.".
Amendments to Directive 2000/13/EC
Directive 2000/13/EC is hereby amended as follows:
2.In Article 6(6), the following indent shall be added:
"- enzymes other than as referred to in paragraph 4(c)(ii) must be designated by the name
of one of the categories of ingredients listed in Annex II, followed by their specific
Amendments to Directive 2001/112/EC
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 [the proposal for a] Regulation [.../..] on
-Proteolytic enzymes meeting the requirements of [the proposal for a] Regulation [.../..] on
-Amylolytic enzymes meeting the requirements of [the proposal for a] Regulation [.../..] on
food enzymes. "
Amendment to Regulation (EC) No 258/1997
Entry into force
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 Community list. Until that date, national
provisions 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.
Articles 8 to 12 shall apply from [12 months after the date of publication of this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament For the Council
The President The President