Amended 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 of the European Parliament and of the Council, and Council Directive 2001/112/EC and Regulation (EC) No 258/97 of the European Parliament and of the Council (presented by the Commission pursuant to article 250 (2) of the EC Treaty)
Date: 2007-10-24
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, foodstuff, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 24.10.2007 
COM(2007) 670 final 

2006/0144 (COD) 

Amended 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 of the European Parliament and of the Council, and 
Council Directive 2001/112/EC and Regulation (EC) No 258/97 of the European 
Parliament and of the Council 

(presented by the Commission pursuant to article 250 (2) of the EC Treaty) 

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EXPLANATORY MEMORANDUM 

I. 

PROCEDURE 

1.  On  28th  July  2006,  the  Commission  adopted  the  proposal  for  a  European 
Parliament  and  Council  Regulation  on  food  enzymes  and  amending  Council 
Directive  83/417/EEC,  Council  Regulation  (EC)  No  1493/1999,  Directive 
2000/13/EC,  and  Council  Directive  2001/112/EC 
(COM 
(2006)0425 final)] as part of a package of four proposals on food improvement 
agents.  The  proposal  was  submitted  to  the  Council  and  the  European 
Parliament on 28th July 2006. 

[Document 

2. 

3. 

4. 

5. 

The Economic and Social Committee adopted its opinion on 25th April 2007 

The  Council  has  agreed  a  ‘general  approach’  on  the  proposal  at  the  EPSCO 
meeting on 31st May 2007. 

The European Parliament has given in first reading a favourable opinion on the 
proposal on 9 July 2007. 

The  present  proposal  amends  the  original  proposal  [COM  (2006)0425  – 
2006/0144(COD)] so as to take into account the amendments of the European 
Parliament that were accepted by the Commission. 

With  regard  to  the  original  proposal,  the  European  Parliament  adopted  33 
amendments.  Commissioner  Kyprianou  had  indicated  to  the  plenary  meeting 
on  9  July  2007  that  the  Commission  could  accept  most  of  the  amendments, 
wholly or in part, and subject to rewording. From the adopted amendments the 
following cannot be accepted by the Commission: 6, 9, 13, 16, 32, 37, 38. 

The  amendments  in  the  revised  proposal  are  in  bold  and  underlined.  A 
number of amendments have been reformulated so as to ensure consistency of 
the  terminology  used  throughout  the  proposal  and  the  other  proposals  of  the 
package,  or  to  bring  the  text  in  line  with  the  approach  of  the  Council  with 
regard to similar amendments.  

The numbering of the Articles has been adapted to take into account a number 
of  amendments.  Within  certain  Articles, the  numbering of  the paragraphs  has 
been adapted in order to take into account the addition or deletion of elements 
in the Commission proposal. 

II. 

OBJECTIVES OF THE PROPOSAL 

6. 

The  Commission  announced  in  the  White  Paper  on  Food  Safety  a  proposal 
amending the framework Directive 89/107/EEC on food additives to lay down 
specific  provisions  in  respect  of  food  enzymes.  In-depth  assessment  of  the 
situation has led to the development of a specific proposal for food enzymes. 

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7. 

Currently  the  scope  of  Directive  89/107/EEC  only  covers  enzymes  used  as 
food additives. The remaining enzymes are not regulated at all or are regulated 
as processing aids under the legislation of the Member States, which is diverse. 
With  respect  to  safety,  there  is  neither  safety  evaluation  nor  authorisation  of 
food enzymes  at  European level, except for those that are considered as food 
additives. The proposal aims to establish harmonised rules for food enzymes at 
Community level, in order to promote fair trading and effective functioning of 
the  internal  market  and  to  ensure  protection  of  human  health  and  consumers' 
interest. 

III. 

OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT 

8. 

Technical/editorial amendments 

Amendments 2, 8, 10 and 17 aim to improve the proposal from a technical and 
editorial point of view and have been taken over by the Commission, in some 
cases subject to some editorial changes. Amendment 19 was partially accepted. 

Amendment 31 amends Regulation (EC) No 258/97 on novel foods in order to 
clarify  that  food  enzymes  which  are  covered  by  the  proposed  Regulation  on 
food enzymes will be excluded from the scope of the novel food Regulation. 

9. 

Legal basis 

Amendment  35  deletes  Article  37  of  the  Treaty  from  the  legal  basis  of  the 
proposed  Regulation.  Since 
the  proposal 
(amendments to vertical agricultural texts) are only secondary objectives of the 
proposed  Regulation,  the  deletion  of  Article  37  has  been  endorsed  in  the 
amended proposal. 

the  agricultural  aspects  of 

10.  Scope (Article 2) 

Amendments  3,  11  and  12  aim  to  clarify  that  the  proposal  does  not  apply  to 
food  enzymes  intended  for  direct  human  consumption,  such  as  enzymes  for 
nutritional purposes or enzymes used as digestive aids. The principle of these 
amendments  is  in  line  with  the  Commission  proposal.  As  these  enzymes  are 
not added to food to perform a technological function, they are not covered by 
the definition of food enzymes. However, the text proposed under amendment 
11 is not well placed under Article 2 (2) and the proposed exclusion is better 
covered  by  amendment  12.  Therefore,  amendment  11  is  redundant  and  not 
taken on board in the amended proposal.  

With  regard  to  amendment  12,  the  Commission  retains  the  exclusion  of 
cultures that are ‘traditionally’ used in the production of foods such as cheese, 
wine  etc.  and  which  may  incidentally  produce  enzymes.  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 technological function of the enzyme 
that they produce (e.g. preservation), not being regulated. 

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11.  Definitions (Article 3) 

Amendment  14  introduces  some  new  definitions.  The  definitions  of  ‘enzyme’ 
and ‘food enzyme preparation’ are incorporated with some editorial changes in 
the amended proposal.  

However the definition of 'produced by GMOs' is not necessary for the scope 
of the proposed Regulation which covers all food enzymes regardless of falling 
or  not  within  the  scope  of  Regulation  (EC)  No  1829/2003.  Such  definition 
relates  to  genetically  modified  (GM)  food  in  general  and  it  is  therefore  not 
appropriate to add this definition in the proposed sector specific Regulation on 
food enzymes. 

The definition of ‘quantum satis’ is laid down in the definitions of the proposal 
on  food  additives.  Since  all  definitions  of  food  additives  apply  also  for  food 
enzymes, its repetition in the proposal on food enzymes is not necessary. 

12.  Prohibition of non-compliant food enzymes (Article 5) 

Amendment  15  aims  to  clarify  that  a  food  enzyme  or  a  food  in  which  an 
enzyme is used should not be placed on the market, if the enzyme or its use do 
not comply with the proposed regulation. This clarification is endorsed in the 
amended proposal.  

13.  General criteria for inclusion and use of food enzymes in the Community 

list (Article 6)  

The Commission proposal  sets criteria for the authorisation of food enzymes. 
Enzymes  must  be  safe;  there  must  be  a  technological  need  for  their  use;  and 
their use must not mislead the consumer.  

Amendment  4,  second  part  introduces  clarification  of  what  is  meant  by 
misleading the consumer. This part of amendment 4 is included in the amended 
proposal. 

Amendments 6 and 16 require the authorisation of food enzymes to be based 
on the precautionary principle. The precautionary principle and the conditions 
for its application are already laid down in the General Food Law (Regulation 
(EC) No 178/2002) and it should not be repeated here.  

Amendments 4 and 16 also require food enzymes to bring a clear benefit to the 
consumer in order to be authorised. Most enzymes are used as processing aids. 
Such  uses  can  improve  the  environmental  performance  of  production 
processes, through lower energy consumption, less raw materials, fewer waste 
and  better  biodegradability.  This  cannot  always  be  translated  into  a  direct 
benefit  to  the  consumer,  although  there  is  an  indirect  benefit  from  the 
environmental  advantage.  These  provisions  have  not  been  taken  over  by  the 
Commission. 

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14.  Relation with Regulation (EC) No 1829/2003 on GM food and feed (Article 

9) and Regulation (EC) No 1830/2003 (Article 7) 

The  Commission  proposal  aimed  to  cover  all  food  enzymes  including  those 
produced  from  genetically  modified  organisms  (GMOs)  or  by  fermentation 
using  genetically  modified  micro-organisms  (GMMs).  Food  enzymes  which 
fall within the scope of Regulation (EC) No 1829/2003, i.e. enzymes produced 
from  GMOs,  will  be  also  subject  to  that  Regulation  with  regard  to  the  safety 
assessment  of  the  genetic  modification,  while  the  other  aspects  of  safety  and 
the  final  authorisation  will  be  dealt  with  under  the  enzymes  Regulation.  The 
two evaluations and authorisations can run in parallel. 

Amendments 7 and 34 clarify that the two procedures can run simultaneously 
in accordance with good administrative practice. The proposed clarification is 
endorsed  by  the  Commission,  subject  to  some  drafting  changes  in  order  to 
make the provision more compatible with Regulation (EC) No1829/2003. 

The  Commission  proposal  also  aimed  to  ensure  that  the  unique  identifier 
attributed to a GMO in accordance with Regulation (EC) No 1830/2003 should 
be included in the specifications of the enzyme produced from the GMO.  

Amendments  18  and  38  aim  to  clarify  this  provision,  however  the  proposed 
wording  is  not  compatible  with  Regulation  (EC)  No  1830/2003.  The 
Commission  accepted  in  principle  the  proposed  clarification,  however  the 
wording was changed in order to make it consistent with that Regulation.  

15.  Comitology (Article 2§5, Article 15 and Article 17) 

Since  the  proposal  was  adopted  around  the  time  that  Decision  2006/512/EC 
amending Decision 1999/468/EC laying down the procedures for the exercise 
of  implementing  powers  conferred  on  the  Commission  was  adopted,  the 
Commission  proposal  referred  to  the  normal  regulatory  procedure.  Therefore 
the alignment of the amended proposal with Decision 2006/512/EC is generally 
endorsed by the Commission. Amendments 10, 28 and 30 are acceptable. 

However amendment 13 introduces the regulatory procedure with scrutiny for 
deciding  whether  or  not  a  given  substance  falls  within  the  scope  of  the 
Regulation. The application of this provision is an implementation of the rules 
contained in the basic act ('food enzyme' definition) and therefore does not fall 
within the regulatory procedure with scrutiny. The normal regulatory procedure 
should therefore apply. 

16.  10-year review  

Amendment 9 introduces a regular review of the evaluation and authorisation 
of  all  food  enzymes  every  10  years.  Such  requirement  would  impose  a 
significant administrative burden. For reasons of proportionality and since the 
proposal already provides that substances will be under continuous observation 
and  be  evaluated  whenever  necessary  in  the  light  of  new  scientific  or 
technological  information,  this  amendment  was  not  taken  up  in  the  amended 
proposal. 

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17.  Fast track authorisation (Article 17) 

Amendment 29 provides for enzymes which are currently on the market to be 
transferred  directly  to  the  Community  list,  if  the  European  Food  Safety 
Authority (EFSA) is satisfied with the previous safety assessment carried out at 
Community or national level. 

EFSA is the risk assessment body in the Community. An automatic transfer of 
food enzymes into the Community list, without a previous evaluation by EFSA 
is not appropriate. As part of usual practice, when EFSA evaluates substances 
they  consider  any  relevant  scientific  assessments  undertaken  by  other  bodies. 
The  Commission  has  introduced  in  the  amended  proposal  wording  to  clarify 
that EFSA could consider existing opinions as part of their evaluation. 

18.  Labelling (Articles 10 to 13 and Article 22) 

Labelling  of  food  enzymes  sold  from  business  to  business  or  to  the  final 
consumer 

Amendments 21-27 aim to ensure a new presentation and simplification of the 
labelling provisions for food enzymes sold from business to business or to the 
final  consumer.  The  Commission  has  taken  over  the  main  ideas  of  these 
amendments  but  re-drafted  the  text  so  as  to  take  into  account  similar 
amendments of the Council and to ensure coherence with the other proposals of 
the Food Improvement Agents package. 

However, the provision of amendment 21 requiring information on  the “side-
effects  of  their  use  in  excessive  quantities”  is  not  relevant,  as  food  enzymes 
will be evaluated for their safety by EFSA and any side effects would be taken 
into account when authorising the food enzyme, if necessary, with appropriate 
conditions  of  use  that  should  be  respected  by  all  operators.  This  provision  is 
therefore not accepted. 

In  addition,  amendment  21  requires  that  food  enzymes  should  be  added  to 
foods only in a dose which is strictly necessary in order to achieve the purpose 
for  which  they  are  used.  This  is  the  quantum  satis  principle  which  is  in  line 
with  the  Commission  proposal.  It  was  therefore  introduced  in  the  amended 
proposal, subject to redrafting and under Article 7 relating to the content of the 
Community list of food enzymes. 

With  regard  to  the  labelling  of  food  enzymes  intended  for  sale  to  the  final 
consumer,  these  are  considered  food  and  must  comply  with  the  relevant 
labelling  provisions  of  Directive  2000/13/EC  relating  to  the  labelling, 
presentation  and  advertising  of  foodstuffs.  Therefore,  Article  12  was  further 
simplified so as not to repeat the provisions of Directive 2000/13/EC.  

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Amendment  37  requires  labelling  of  the  technological  function  of  food 
enzymes  sold  directly  to  the  final  consumer.  Directive  2000/13/EC  already 
provides that on the label of a food, including a food enzyme, instructions for 
use should be included. This information will be more useful for the consumer 
than a technical description of the function of the enzyme which could lead to 
confusion and misunderstanding. Therefore, this amendment is not accepted.  

Labelling of food enzymes in food  

Most food enzymes are used as processing aids in the production of food and 
they  are  present  in  food  in  the  form  of  a  residue,  if  at  all,  and  have  no 
technological  function  on  the  finished  product.  Taking  into  account  that  all 
food  enzymes  will  be  assessed  for  their  safety,  the  Commission  proposal 
provided  for  an  exception  from  labelling  of  food  enzymes  which  are  used  as 
processing  aids.  Food  enzymes  used  to  exert  a  technological  function  in  the 
final  food  would  be  labelled  with  their  function  (e.g.  stabiliser  etc.)  and 
specific name. 

Amendment  32  introduces  labelling  of  all  food  enzymes  present  in  the  final 
food, irrespective of the level of residues and whether they continue to function 
or not. The labelling should also indicate whether the enzymes are still active 
or not in the final product. 

Amendment  37  requires  information  about  all  food  enzymes  used  in  the 
production  process  to  be  made  available  to  consumers,  if  not  on  the  label  at 
least through other information channels. Both amendments are not compatible 
with Directive 2000/13/EC which excludes from labelling processing aids, i.e. 
substances  which  are  present  in  the  final  product  only  as  technically 
unavoidable residues and do not have any technological effect on the finished 
product. Labelling of food enzymes used as processing aids would be therefore 
disproportionate.  In  addition  labelling  of  food  enzymes  on  food  as  'active'  or 
'inactive', may give misleading information to the consumer as to what is meant 
by 'active' or 'inactive', e.g. it could be associated with a nutritional effect. 

With regard to labelling of GMOs, Article 12 of Regulation 1829/2003 already 
provides for labelling of food, including food enzymes, produced from GMOs. 
Therefore the inclusion here is redundant.  

Therefore, amendments 32 and 37 are not accepted by the Commission. 

19.  Transitional measures (Article 18) 

Amendment  36  introduces  transitional  measures  for  food  enzymes,  food 
enzyme preparations and food containing food enzymes which were put on the 
market  or  labelled  before  the  date  of  application  of  the  proposed  Regulation. 
Such  provision  is  appropriate  and  the  amendment  has  been  endorsed  in  the 
Commission amended proposal. 

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20.  Changes  in  production  process  or  starting  materials  of  a  food  enzyme 

(Article 8)  

The  amended  Commission  proposal  includes  a  new  Article  8  introducing 
requirements for food enzymes already included in the Community list which 
are prepared by production methods or starting materials significantly different 
from  those  included  in  the  risk  assessment  of  the  Authority.  This  Article 
reflects  the  principle  in  recital  (12)  of  the  Commission  proposal  and  keeps 
consistency with the proposal on food additives, where the same text has been 
introduced in order to address an amendment concerning 'nano' substances.  

21.  Pursuant  to  Article  250(2)  of  the  EC-Treaty,  the  Commission  amends  it 

proposal in accordance with the lines set out above. 

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2006/0144 (COD) 

Amended 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, and Council Directive 2001/112/EC and 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 
Articles 37 and Article 95 thereof, 

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, 

Whereas: 

(1) 

(2) 

(3) 

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. 

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. 

1 
2 

OJ C […],[…], p. […]. 
OJ C 168, 20.7.2007. p 34. 

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(4) 

(5) 

(6) 

(7) 

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  or  digestive 
purposes.  Microbial  cultures  traditionally  used  in  the  production  of  food,  such  as 
cheese  and,  wine  and  which  may  contain  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 the Regulation […] on food additives, flavourings falling within the scope of 
the  Regulation  […]  on  flavourings  […]  and  novel  foods  falling  within  the  scope  of 
Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  of  27 
January 1997 concerning novel foods and novel food ingredients3 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  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. 

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 
consumption4, 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 consumption5 and Council Regulation (EC) No 1493/1999 of 17 
May  1999  on  the  common  organisation  of  the  market  in  wine6  should  therefore  be 
amended  accordingly.  Since  all  food  enzymes  should  be  covered  by  this 
Regulation,  Regulation  (EC)  258/1997  of  the  European  Parliament  and  of  the 
Council  of  27  January  1997  concerning  novel  foods  and  novel  food 
ingredients7should be amended accordingly. 

3 

4 
5 

6 

7 

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). 
OJ L 10, 12.1.2002, p. 58. 
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). 
OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Regulation (EC) No 2165/2005 (OJ L 345, 
28.12.2005, p. 1). 
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). 

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(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 and be supplemented by specifications, in particular on their origin 
and purity criteria. Where the food enzyme contains or consists of is produced from a 
genetically  modified  organism  (“GMO”)  within  the  meaning  of  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/EC8,  the  unique  identifier  assigned  to  the  GMO 
under  in  accordance  with  that  Regulation  should  also  be  included  in  the 
specifications.  

(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 flavourings9. 

(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 safety10, 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  feed11  should  be  authorised  in  accordance  with  that  Regulation, 
prior  to  its  approval  under  this  Regulation  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 enzyme should be granted 
under this Regulation. 

(12)  A  food  enzyme  already  included  in  the  Community  list  under  this  Regulation  and 
prepared by production methods or from starting materials significantly different from 
those covered by the Authority’s risk assessment, or different from those covered by 
the authorisation and the specifications under this Regulation should be submitted to 
the  Authority  for  an  evaluation  with  emphasis  on  the  specifications.  Significantly 
different  production  methods  or  starting  materials  could  mean  a  change  in  the 
production method from extraction from plants to production by fermentation using a 
micro-organism or genetic modification of the original micro-organism. 

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9 
10 

11 

OJ L 268, 18.10.2003, p. 24. 
OJ L […], […], p. […]. 
OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245, 
29.9.2003, p. 4). 
OJ L 268, 18.10.2003, p. 1. 

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(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  food 
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  food enzymes during the initial two-year period. The Authority should evaluate 
without delay  all  applications for food enzymes for which  sufficient  information has 
been  submitted  during  that  period.  For  food  enzymes  which  are  already  on  the 
Community  market  and  have  undergone  an  adequate  safety  assessment  by  a 
competent  Community  or  national  body,  the  Authority  may  decide  to  take  into 
account this safety assessment. 

(14) 

In  order  to  ensure  fair  and  equal  conditions  for  all  applicants,  the  Community  list 
should  be  drawn  up  in  a  single  step.  That  list  should  be  established  after  the  risk 
assessment  of  all  food  enzymes  for  which  sufficient  information  has  been  submitted 
during the initial two-year period has been completed. However, the opinions of the 
Authority should be published as soon as the scientific assessment is completed. 

(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  sweeteners12, 
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  processes13.  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  Regulation 
(EC) No 1622/2000.  

12 
13 

OJ L 61, 18.3.1995 p. 1. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ L 194, 31.7.2000, p. 1. Regulation as last amended by Regulation (EC) No 1163/2005 (OJ L 188, 
20.7.2005, p. 3). 

EN 

12 

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(17)  Food  enzymes  remain  subject  to  the  general  labelling  obligations  provided  for  in 
Directive  2000/13/EC  and,  as  the  case  may  be,  in  Regulation  (EC)  No  1829/2003 
and  Regulation  (EC)  No  1830/2003  as  applicable.  In  addition,  specific  labelling 
provisions  for  food  enzymes  sold  as  such  to  the  manufacturer  or  to  the  consumer 
should be laid down 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  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 
foodstuffs14.  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  food 
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.  

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

(20)  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 conferred on the Commission15. 

(21) 

(22) 

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. 

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 rules16 and consequently the legal basis for the 
financing of the above measures will be Regulation (EC) No 882/2004. 

14 

15 

16 

OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, 
p. 15). 
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L  200, 22.7.2006, 
p. 1) 
OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). 

EN 

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(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 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 objectives. 

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, to ensure the effective functioning of the internal market and a high level 
of human health protection and consumer protection.  

For those purposes, this Regulation provides for: 

(a) 

(b) 

(c) 

1. 

2. 

a Community list of approved food enzymes; 

conditions of use of food enzymes in foods; 

rules on labelling of food enzymes sold as such. 

Article 2 
Scope 

This Regulation shall apply to food enzymes. 

This Regulation shall not apply to food enzymes used exclusively in the production 
of: 

(a) 

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

(b) 

flavourings falling within the scope of Regulation (EC) No …[on flavourings]; 

(c) 

novel foods falling within the scope of Regulation (EC) No 258/97. 

EN 

14 

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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: 

(a)  microbial  cultures  that  are  traditionally  used  in  the  production  of  food  and 
which  may  incidentally  produce  contain  enzymes  but  which  are  not 
specifically used to produce them;  

(b) 

enzymes  intended  for  direct  human  consumption,  such  as  enzymes  for 
nutritional purposes or enzymes used as digestive aids. 

5. 

Where necessary, it may be decided in accordance with the procedure referred to in 
Article  1516(2)  whether  or  not  a  given  substance  falls  within  the  scope  of  this 
Regulation. 

Article 3 
Definitions 

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 […] [Regulation on food 
additives] shall apply.  

The following definitions shall also apply: 

1. 

2. 

‘enzyme’ means any protein of vegetable, animal or microbial origin, capable of 
catalysing a specific biochemical reaction, without changing its own structure in 
the  process,  including  "pro-enzymes",  i.e.  compounds  that  are  inactive  or 
nearly inactive precursors of enzymes and can be converted to active enzymes if 
subjected to a specific catalytic change. 

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

(a) 

(b) 

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

added  to  food  to  perform  a  technological  function  in  the  manufacture, 
processing, preparation, treatment, packaging, transport or storage of foods. 

EN 

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3. 

‘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. 

Chapter II 
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  compliance  with  the  specifications  and  conditions  of  use  provided  for  in 
Article 6 7(2).  

Article 5 
Prohibition of non-compliant food enzymes and/or non-compliant foodstuffs  

No  food  enzyme  and/or  any  food  in  which  such  a  food  enzyme  has  been  used  may  be 
placed on the market, if the food enzyme or its use does not comply with this Regulation 
and its implementing measures.  

Article 5 6 
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: 

(a) 

(b) 

(c) 

1. 

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; 

there is a reasonable technological need; 

its use does not mislead the consumer. 

Article 6 7 
The content of the Community list of food enzymes 

A  food  enzyme  which  complies  with  the  conditions  set  out  in  Article  5  6  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. 

EN 

16 

   EN 

 
2. 

The entry of a food enzyme in the Community list shall specify: 

(a) 

(b) 

the  name  description  of  the  food  enzyme,  including  its  common  or 
recommended name, systematic name and synonyms, if possible according 
to  the  nomenclature  of  the  International  Union  of  Biochemistry  and 
Molecular  Biology  and,  in  the  case  of  complex  food  enzymes,  selected  on 
the basis of the enzyme activity that determines the enzyme's function;  

the  specifications  of  the  food  enzyme,  including  its  origin,  purity  criteria  and 
any  other  necessary  information;  where  the  food  enzyme  falls  is  produced 
from a genetically modified organism (“GMO”) within the meaning within 
the  scope  of  Regulation  (EC)  No  1830/2003,  a  reference  to  the  unique 
identifier  attributed  to  the  genetically  modified  organism  pursuant  to  that 
Regulation shall be included in the specifications; 

(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 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. 

Article 8  
Changes in production process or starting materials of a food enzyme already included in a 
Community list 

When,  as  regard  a  food  enzyme  already  included  in  a  Community  list,  there  is  a 
significant change in the production methods or the starting materials, the food enzyme 
prepared by these new methods or materials shall be considered as a different enzyme 
and a new entry in the Community lists or change in the specifications shall be required 
before it can be placed on the market. 

EN 

17 

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Article 7 9 
Food enzymes falling within the scope of Regulation (EC) No 1829/2003 Inclusion of 
genetically modified enzymes on the Community list 

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.  after  it  has  been 
authorised in accordance with the procedure referred to in Article 7 of that Regulation.  

Chapter III 
Labelling 

SECTION 1 
LABELLING OF FOOD ENZYMES NOT INTENDED FOR SALE TO THE FINAL 
CONSUMER 

Article 8 10 
Labelling of food enzymes and food enzyme preparations not intended for sale to the final 
consumer  

1. 

2. 

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  with  other  food 
ingredients  as  defined  in  Article  6(4)  of  Directive  2000/13/EC,  may  be  marketed 
only where the packaging or containers bear if they comply with the labelling the 
information  provided  for  in  Articles  11  9  to  12  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. 

Within  its  own  territory,  the  Member  State  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. 

Article 911 
General labelling requirements for food enzymes and food enzyme preparations not 
intended for sale to the final consumer  
Information requirements concerning the identification of food enzymes 

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  in 
respect of each food enzyme: 

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18 

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(a) 

the name laid down in under this Regulation in respect of each food enzyme, 
and  the  description  according  to  the  nomenclature  of  the  International 
Union of Biochemistry and Molecular Biology; or in the absence of a name, 
as referred to in point (a), a description of the food enzyme that is sufficiently 
precise to distinguish it from products with which it could be confused. 

(b) 

the statement either ‘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) 

(f) 

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

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

(g)  where  applicable,  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;  

(h) 

the net quantity; 

(i) 

the activity of the food enzyme(s);  

(j) 

the date of minimum durability; 

(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 
to enable the purchaser to ensure compliance with that Directive. 

Where  food enzymes and/or food enzyme preparations are sold mixed with  each 
other  and/or  with  other  food  ingredients,  the  packaging  or  containers  of  the 
resulting product shall bear a list  of  all ingredients all the information  provided 
for in paragraph 1 shall be given in respect of each food enzyme in descending order 
of its their percentage by weight of the total. 

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. 

2. 

3. 

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19 

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4. 

5. 

By way of derogation from paragraphs 1, 2 and 3, the information required in 
paragraph  1  points  (e)  to  (g),  (i),  (k)  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  “intended  for  the 
manufacture of food and not for retail sale” is easily visible on the packaging or 
container of the product in question. 

By  way  of  derogation  from  paragraphs  1,  2  and  3,  where  food  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. 

Article 10 
Information requirements where other substances, materials or food ingredients are 
incorporated in food enzymes 

Where substances, materials or food ingredients other than food enzymes are incorporated in 
food  enzymes  not  intended  for  sale  to  the  final  consumer  to  facilitate  their  storage,  sale, 
the  packaging,  containers  or  accompanying 
standardisation,  dilution  or  dissolution, 
documents  of  the  food  enzyme  shall  bear  the  information  provided  for  in  Article  9  and  an 
indication of each component in descending order of its percentage by weight of the total.  

Article 11 
Information requirement where food enzymes are mixed with other food ingredients  

Where food enzymes not intended for  sale to  the  final consumer  are mixed with other food 
ingredients,  the  packaging  or  containers  of  the  food  enzymes  shall  bear  a  list  of  all 
components in descending order of their percentage by weight of the total. 

Article 12 
General information requirements for food enzymes 

1. 

The  packaging  or  containers  of  food  enzymes  not  intended  for  sale  to  the  final 
consumer shall bear the following information: 

(a) 

the statement either ‘for use in 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 use; 

(c) 

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

(d) 

a mark identifying the batch or lot; 

(e) 

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

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20 

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(f)  where a component of the food enzyme is subject to a limit on quantity in food, 
an indication of that component’s percentage of the food enzyme or sufficient 
information on the composition of the food enzyme to enable the purchaser to 
ensure compliance with the limit on quantity in food; 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)  where relevant, information on a food enzyme or other substances as referred 
to in Articles 9, 10 and 11 of the present Regulation and listed in Annex IIIa to 
Directive 2000/13/EC.  

2. 

By way of derogation from paragraph 1, the information required in points (c) to (f) 
and  (h)  of  that  paragraph  may  appear  merely  on  the  documents  relating  to  the 
consignment  which  are  to  be  supplied  with  or  prior  to  delivery,  provided  that  the 
indication “intended for the manufacture of food and not for retail sale” appears on a 
easily visible part of the packaging or container of the product in question.  

SECTION 2 
LABELLING OF FOOD ENZYMES INTENDED FOR SALE TO THE FINAL CONSUMER 

Article 13 12  
Labelling of food enzymes and food enzyme preparations intended for sale to the final 
consumer 

1. 

Without  prejudice  to  Directive  2000/13/EC,  Directive  89/396/EEC  and  to 
Regulation  (EC)  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 which must be easily visible, clearly legible and indelible: 

(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 description of the food enzyme that is sufficiently 
precise  to  distinguish  it  from  products  with  which  it  could  be  confused 
under  which  the  food  enzyme  is  sold;  that  name  shall  be  constituted  by  the 
name laid down by any Community provisions applying to the food enzyme in 
question; 

(b) 

the statement either ‘for food ' or the statement ‘restricted use in food’ or 
a more specific reference to its intended food use the information required in 
accordance with Articles 9, 10, and 11 and points (a) to (e) and (g) and (h) of 
Article 12(1).  

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21 

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2. 

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

SECTION 3 
OTHER LABELLING REQUIREMENTS 

Article 14 13 
Other labelling requirements 

Articles  8  10  to  1213  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.  

2. 

The  information  provided  for  in  Articles  8  to  13  shall  be  in  a  language  easily 
understandable to purchasers. 

Within its own territory, the Member State 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 of the official languages of the Community, to be determined by that 
Member State.  

The  first  and  second  subparagraph  of  this  paragraph  shall  not  preclude  such 
information from being indicated in several languages. 

Chapter IV 
Procedural provisions and implementation 

Article 15 14 
Information obligation 

A producer or user of a food enzyme  shall inform the Commission immediately of 
any new scientific or technical information which might affect the assessment of the 
safety of the food enzyme. 

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. 

Article 16 15  
Committee 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health (hereinafter referred to as “the Committee”). 

1. 

2. 

1. 

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22 

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2. 

3. 

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. 

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 Committee shall adopt its Rules of Procedure. 

Article 17 16 
Community financing of harmonised policies 

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

CHAPTER V 
Transitional and final provisions 

Article 18 17  
Establishment of the Community list of food enzymes 

1. 

2. 

3. 

The Community list of food enzymes shall be drawn up on the basis of applications 
made pursuant to paragraph 2.  

Interested parties may submit applications for the inclusion of a food enzyme in the 
Community list.  

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 […] [establishing a common authorisation procedure for 
food additives, food enzymes and food flavourings]. 

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  criteria  to  be  laid  down  in  accordance  with  Article  9(1)  of  Regulation 
(EC) No […] [establishing a common authorisation procedure] has been submitted in 
accordance with paragraph 2 (‘the Register’). The Register shall be made available to 
the public.  

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

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4. 

laid  down 

The  Community  list  shall  be  adopted  by  the  Commission  in  accordance  with  the 
procedure 
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. 
For  those  food  enzymes,  the  Authority  in  preparing  its  opinion  may  consider, 
where  relevant,  scientific  assessments  undertaken  by  the  national  competent 
organisations in the Member States. 

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 may be adopted in accordance with the regulatory 
procedure with scrutiny referred to in Article 15 (3)16 (2). 

Article 19 18 
Transitional measures for certain food enzymes already covered by Community legislation  

1. 

Notwithstanding  Articles  6  7  and  18  17  of  the  present  Regulation,  the  Community 
list shall, when drawn up, include the following food enzymes: 

(a)  E 1103 Invertase and E 1105 Lysozyme, stating the conditions governing their 
use as specified in Annexes 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.  

2. 

Food  enzymes,  food  enzyme  preparations  and  food  containing  food  enzymes 
which  do  not  comply  with  the  provisions  of  Articles  10  to  13  and  were  legally 
placed  on  the  market  or  labelled  prior  to  [12  months  after  the  date  of 
publication of this Regulation] may continue to be marketed until their date of 
minimum durability. 

Article 20 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  [the  proposal  for  a]  Regulation  […/..]  on  food 
enzymes 

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– 

other  milk-coagulating  enzymes  meeting  the  requirements  of  [the  proposal  for  a] 
Regulation […/..] on food enzymes”. 

Article 20  
Amendment to Regulation (EC) No 258/1997 

In Article 2(1) of Regulation (EC) No 258/1997, the following point (d) shall be added: 

– 

"(d)  food  enzymes  falling  within  the  scope  of  Regulation  (EC)  No  …….  [on 
food enzymes] ". 

Article 21 
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.” 

Article 22 
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’ 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’; 

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 name,”; 

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Article 23 
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 food enzymes 

Proteolytic  enzymes  meeting  the  requirements  of  [the  proposal  for  a]  Regulation 
[…/..] on food enzymes 

Amylolytic  enzymes  meeting  the  requirements  of  [the  proposal  for  a]  Regulation 
[…/..] on food enzymes”. 

Article 24 
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  10  to  13  8  to  14  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 
The President 

For the Council 
The President 

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