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 {SEC(2006) 1044} {SEC(2006) 1045}
Date: 2006-07-28
Institutions: European Commission
Subjects: approximation of laws, consumer protection, enzyme, foodstuff, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.7.2006 
COM(2006) 425 final 

2006/0144 (COD) 

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 

(presented by the Commission) 

{SEC(2006) 1044} 
{SEC(2006) 1045} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

• 

Grounds for and objectives of the proposal 

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. 

Currently  the  scope  of  Directive  89/107/EEC  only  covers  enzymes  used  as 
food additives and only two enzymes are authorised under this Directive. The 
remaining enzymes are not regulated at all or are regulated as processing aids 
under the legislation of the Member States, which is diverse. Thus, there is a 
need for harmonised rules at Community level, in order to promote fair trading 
and  effective  functioning  of  the  internal  market  in  food  enzymes  and  ensure 
protection  of  human  health  and  consumers'  interest.  A  proposal  for  a  new 
Regulation  on  food  enzymes,  as  part  of  the  package  on  food  improvement 
agents,  is  included  in  the  Commission  Legislative  Working  Programme  of 
2005. 

• 

General context 

The legislation controlling the use of  enzymes in food processing is not  fully 
harmonised  in  the  EU.  The  national  regulatory  context  for  enzymes  used  as 
processing aids in food production differs significantly among Member States. 
Only  a  few  Member  States  have  a  mandatory  or  voluntary  authorisation 
procedure, the majority have none at all. Moreover, there are divided opinions 
among  Member  States  in  relation  to  the  categorisation  of  enzymes  into  food 
additives or processing aids according to their function in the food process or 
in  the  final  food.  This  lack  of  harmonised  rules  in  the  Community  created 
barriers to the trade of food enzymes and has hindered growth in this field. 

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.  Historically,  food  enzymes  were  considered  to  be  non-toxic. 
However, the food enzyme industry is continually striving to develop improved 
technology  resulting  in  the  development  of  food  enzymes  which  became 
through  the  years  more  complex  and  sophisticated.  There  could  be  some 
potential  hazards  arising  from  their  chemical  nature  and  source  such  as 
allergenicity,  activity-related  toxicity,  residual  microbiological  activity,  and 
chemical  toxicity.  Therefore  safety  evaluation  of  all  food  enzymes,  including 
those produced by genetically modified micro-organisms (GMOs), is essential 
in order to ensure consumer safety. 

• 

Existing provisions in the area of the proposal 

Directive 95/2/EC on food additives other than colours and sweeteners allows 
for  the  use  of  two  enzymes  as  food  additives:  E  1103  Invertase  and  E1105 
Lysozyme. 

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In addition, Council Directive 2001/112/EC relating to fruit juices and certain 
similar  products 
intended  for  human  consumption,  Council  Directive 
83/417/EEC relating to certain lactoproteins (caseins and caseinates) intended 
for  human  consumption  and  Council  Regulation  (EC)  No  1493/1999  on  the 
common  organisation  of  the  market  in  wine,  regulate  the  use  of  certain  food 
enzymes in these specific foods. 

• 

Consistency with other policies and objectives of the Union 

The policy objectives to be met are: 

– 

the  promotion  of  fair  trading  in  food  enzymes  in  order  to  ensure  an 
efficient and internationally competitive food industry; 

– 

the protection of human health and consumers' interest. 

These objectives will contribute to the strategic objectives of the Commission 
as  set  out  in  the  Lisbon  Strategy,  the  Commission  five  year  plan  and  the 
Commission's White paper of Food Safety published in 2000. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

• 

Consultation of interested parties 

Consultation  methods,  main  sectors 
respondents 

targeted  and  general  profile  of 

The  opinion  of  Member  States  and  stakeholders  has  been  sought  through 
consultations  at  several  working  groups  and  during  bilateral  contacts  with 
stakeholders since 2000. Some of the stakeholders consulted were: 

BEUC (The European Consumers' Organisation) 

CIAA (Confederation of the food and drink industries of the EU) 

CEFIC (European Chemical Industry Council) 

AMFEP (Association of Manufacturers and Formulators of Enzyme products) 

ELC (Federation of European Food Additives and Food Enzymes Industries) 

ISA (International Sweeteners Association) 

FEDIMA  (Federation  of  the  Intermediate  products  Industries  for  the  Bakery 
and Confectionery trades in the EEA) 

CAOBISCO  (Association  of  the  Chocolate,  Biscuit  and  Confectionery 
Industries of the EU) 

Moreover, a questionnaire on the impacts of the proposal was circulated to the 
different  stakeholders  on  22.2.2005  to  which  70  replies  were  received  by  the 
end of the consultation. 

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Summary of responses and how they have been taken into account 

After each consultation, comments have been  considered and  texts have been 
adapted. General consensus exists on the proposal. The following points were 
specifically raised and comments considered as follows: 

1.  Harmonisation and scope of legislation: 

The  introduction  of  specific  harmonising  legislation  on  food  enzymes 
was generally welcomed.  

2.  Harmonisation of safety evaluation and authorisation:  

All  stakeholders  were  generally  positive  to  the  introduction  of  a 
European wide safety evaluation and authorisation of food enzymes. 

3. 

Labelling of enzymes on food: 

Initially  proposed  labelling  of  enzymes  which  have  no  function  in  food 
raised  concerns  among  the  food  industry.  On  the  other  hand  some 
Member  States  and  consumer's  association  supported  more  specific 
labelling  for  enzymes  present  in  food.  Revised  labelling  rules  require 
specific  and 
for  enzymes  which  have  a 
technological  function  in  the  final  food,  but  exclude  from  labelling 
enzymes which are used as processing aids. 

informative 

labelling 

4. 

Time limited authorisation: 

There  was  a  strong  indication  from  industry  that  a  time  limited 
authorisation could be a barrier to innovation. On the other hand Member 
States  and  consumer  organisations  considered  that  enzyme  approvals 
should  be  kept  under  review  to  ensure  that  they  remain  current.  An 
intermediate  solution  is  proposed  where  producers  or  users  of  enzymes 
should  provide  to  the  Commission  on  its  request  information  on  actual 
uses. 

5. 

Transitional periods: 

The  proposal  sets  out  a  procedure  for  a  smooth  transition  to  a 
Community  positive  list.  The  consultation  pointed  out  that  during  this 
transition  period,  industry  should  continue  to  be  able  to  develop  and 
market  new  enzymes.  In  order  to  avoid  hindering  innovation  in  this 
sector, the proposal now provides for additional transitional measures. 

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• 

Collection and use of expertise 

Scientific/expertise domains concerned 

A  "study  of  the  enzymes  used  in  foodstuffs  and  collation  of  data  on  their 
safety",  was  generated  under  the  scientific  co-operation  procedure  within  the 
legal  frame  of  Council  Directive  93/5/EEC 
'on  the  assistance  to  the 
Commission  and  co-operation  by  the  Member  States  in  the  scientific 
examination of questions relating to food (SCOOP)'. 

Methodology used 

Data  was  collected  from  9  Member  States  on  the  approval  systems,  safety 
evaluation procedures and uses of enzymes in the EU. 

Main organisations/experts consulted 

Experts from 9 Member States and AMFEP. 

Summary of advice received and used 

The  existence  of  potentially  serious  risks  with  irreversible  consequences  has 
not been mentioned. 

The  SCOOP  Task  Force  concluded  that  "A  consensus  was  obtained  to  assert 
that,  in  all  cases,  whatever  the  status  or  the  categorisation  of  the  enzyme,  a 
rationale for safety evaluation is necessary". 

Means used to make the expert advice publicly available 

The report was published on: 
http://europa.eu.int/comm/food/fs/scoop/7.4.1_en.pdf 

• 

Impact assessment 

The  impacts  expected  on  the  different  options  concern  economic  and  social 
aspects.  Environmental  impacts  are  not  expected  from  the  different  options 
considered,  since  the  industry  concerned  -  the  food  industry  -  is  involved  in 
secondary or tertiary processing of food products. Enzymes are already widely 
used.  

1.  No action 

1.1  Economic impact 

The  current  legal  uncertainty  due  to  the  differing  regulatory 
approaches  among  Member  States  would  remain,  along  with  the 
current  market  distortions  in  the  trade  of  food  enzymes.  Enzyme 
producers  would  continue  to  seek  authorisation  for  the  same 
enzyme in more than one Member States which is an administrative 
and financial burden for industry.  

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1.2  Social impact  

Differences in risk perception, safety assessment and regulation of 
food enzymes among Member States would lead to different levels 
of  consumer  protection.  GMO  produced  enzymes  not  covered  by 
Regulation  1829/2003,  such  as  microbial  enzymes,  would  not  be 
assessed for their safety. 

2.  Non-Regulatory instrument 

2.1  Economic impact  

Self-regulation  would  provide  flexibility;  on  the  other  hand,  food 
enzymes  are  already  regulated  when  used  as  food  additives  by 
Community law and as processing aids by national legislation. This 
could lead to contradictory and confusing situation for the industry 
and negative economic impact. 

2.2  Social impact 

A  safety  assessment,  which  is  not  carried  out  by  an  independent 
body, would not get the same level of acceptance from the public. 
The transparency of the procedures built in a self-regulatory system 
would be limited. An unclear legal situation would result in loss of 
consumer  confidence,  especially  with  regard  to  enzymes  obtained 
from GMOs. 

3. 

Regulatory approach 

3.1  Economic impacts 

The  harmonisation  of  the  safety  evaluation  and  authorisation  of 
food  enzymes,  may  result  in  higher  upfront  investments  before 
market introduction of food enzymes due to the authorisation cost, 
estimated to be in the range of 150-250k € per enzyme. However, 
some  Member  States  already  have  authorisation  procedures  in 
place  entailing  similar  costs  for  companies  that  market  their 
products in those Member States. With this proposal industry will 
benefit  from  a  harmonised  Community  procedure  with  defined 
deadlines, instead of multiple national ones. 

The  proposal  exempts  from  labelling  those  food  enzymes  used  as 
processing  aids.  Food  enzymes  used  in  the  same  way  as  food 
additives, to exert a technological function in the final food should 
be  labelled  with  their  function  (e.g.  stabiliser  etc)  and  specific 
name.  This  provision  is  unlikely  to  have  an  economic  impact  on 
businesses as only a limited number of enzymes (currently only 2 
and in the future not more than a dozen) would need to be labelled. 
This implies no major change to the current situation.  

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This  proposal  will  have  a  very  limited  impact  on  households. 
Although the costs of evaluation seem high it is unlikely that these 
costs  will  result  in  any  significant  increases  in  the  cost  which 
consumers pay for food. 

3.2  Social impact 

It  can  be  expected  that  the  proposed  comprehensive  system  of 
safety  evaluation  of  food  enzymes  will  have  positive  impacts  on 
public health and consumer confidence. 

The  Commission  carried  out  an  impact  assessment  listed  in  the 
on 
Work 
http://ec.europa.eu/food/food/chemicalsafety/additives/index_en.htm. 

Programme,  whose 

accessible 

report 

is 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

• 

Summary of the proposed action 

The proposed Regulation sets the conditions of use of food enzymes, provides 
for the establishment of a Community list of approved food enzymes and lays 
down  labelling  rules  for  those  enzymes.  The  proposal  will  complete  the 
framework of GM food and feed legislation. 

• 

Legal basis 

Article 95 of the EC Treaty 

• 

Subsidiarity principle 

The subsidiarity principle applies insofar as the proposal does not fall under the 
exclusive competence of the Community. 

The objectives of the proposal cannot be sufficiently achieved by the Member 
States for the following reason(s). 

In the absence of harmonisation and to the extent that there is still uncertainty 
in the current state of scientific research, which is particularly the case in new 
technology sectors such as food enzymes, it is for the Member States to decide 
on the level of protection of human health they wish to ensure and whether to 
require prior authorisation for the marketing of foodstuffs, taking into account 
the  requirements  of  the  free  movement  of  goods  within  the  Community.  In 
terms  of  risk  assessment,  Member  States  often  start  with  different  scientific 
assumptions  and  may  require  different  scientific  data.  Therefore,  if  Member 
States were to introduce their own legislation, that would risk creating barriers 
to  trade  and  possible  burdens  to  industry  from  different  requirements  which 
might arise, as well as different levels of consumer protection among Member 
States. 

Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the 
following reason(s). 

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As food enzymes and food containing those enzymes are traded across borders, 
Member  States  cannot  by  themselves  achieve  the  objectives  of  the  proposal 
sufficiently.  300  food  enzymes  need  to  be  managed.  This  requires  a 
harmonised and centralised approach. 

Efficiency  of  the  authorisation  procedure  and  effective  functioning  of  the 
internal  market  with  a  level  playing  field  for  all  economic  operators  will 
indicate that the objectives are best met by the Community action. 

The proposal achieves its objectives by limiting its scope to general conditions 
for  the  safe  use  of  food  enzymes,  provisions  for  the  establishment  of  a 
Community list of food enzymes and common labelling provisions. 

The proposal therefore complies with the subsidiarity principle. 

• 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason(s). 

The proposal is a framework Regulation that sets the general rules for the safe 
use  and  authorisation  of  food  enzymes  via  a  Community  list.  In  terms  of 
consumer  information,  the  proposal  provides  for  a  proportionate  labelling  of 
food  enzymes  with  a  limited  cost  for  industry  while  at  the  same  time  offers, 
where necessary, sufficient information to the consumer. 

The  Community  procedure  for  the  safety  assessment  of  food  enzymes  will 
have  a  financial  and  administrative  impact  upon  the  European  Food  Safety 
Authority. However, it will move the burden of safety assessment from those 
Member States that have currently legislation on food enzymes, and will allow 
them to direct their resources more towards the implementation of legislation 
and control activities. The financial and in particular administrative impact on 
economic  operators  will  be  decreased  as  they  will  have  to  apply  for  a  single 
Community authorisation instead of multiple national ones. 

• 

Choice of instruments 

Proposed instruments: regulation. 

Other means would not be adequate for the following reason(s). 

The provisions of this proposal are of technical nature. The use of regulation as 
the legal instrument for the proposal will ensure uniform and direct application 
of the rules for the benefit both of the consumers and of the competitiveness of 
the industry. 

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4. 

BUDGETARY IMPLICATION 

The Community may finance the establishment of a harmonised policy and system in 
the field of food enzymes including: 

development  of  an  appropriate  database  for  gathering  and  storing  all  information 
relating to Community legislation on enzymes, undertaking of studies necessary for 
the  preparation  of  legislation,  for  the  harmonisation  of  procedures,  for  decision-
making  criteria  and  data  requirements  to  facilitate  work  sharing  between  Member 
States and to develop guidance in these areas.  

5. 

ADDITIONAL INFORMATION 

• 

Simulation, pilot phase and transitory period 

There was or there will be a transitory period for the proposal. 

• 

Simplification 

The  proposal  provides  for  simplification  of  administrative  procedures  for 
public authorities (EU or national), simplification of administrative procedures 
for private parties. 

The evaluation and authorisation of food enzymes by national authorities will 
be replaced by a Community procedure. 

Administrative burden will be decreased for private parties as they will have to 
apply for a single Community authorisation instead of multiple national ones. 

The  proposal  is  included  in  the  Commission's  rolling  programme  for  up-date 
and  simplification of the  acquis communautaire and its Work  and Legislative 
Programme under the reference 2005/SANCO/034. 

• 

European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 

• 

Detailed explanation of the proposal 

Chapter I - Subject matter, scope and definitions. 

The  proposed  Regulation  will  apply  to  enzymes  used  for  a  technological 
purpose  in  the  manufacture,  processing,  preparation,  treatment,  packaging, 
transport  or  storage  of  food,  including  those  used  as  processing  aids  ('food 
enzymes'). Food enzymes shall be subject to safety evaluation and approval via 
a community list. 

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Chapter II - Community list of approved food enzymes 

All  food  enzymes  and  their  use  in  food  will  be  evaluated  for  safety, 
technological need, benefit to the consumer and that the consumer is not being 
misled  by  the  use.  In  line  with  the  decision  to  separate  risk  management  and 
risk assessment, the European Food Safety Authority (EFSA) will carry out the 
safety evaluations. The inclusion of a food enzyme in the Community list will 
be  considered  by  the  Commission  on  the  basis  of  the  opinion  from  EFSA, 
taking  into  account  the  other  general  criteria  (technological  need,  consumer 
aspects).  For  every  food  enzyme  included  in  the  positive  list  specifications, 
including the criteria on purity and the origin of the food enzyme shall be laid 
down.  

Chapter III - Labelling 

The  proposed  Regulation  will  introduce  labelling  requirements  for  food 
enzymes sold to the manufacturer or directly to the consumer. For the purpose 
of  labelling,  enzymes  used  in  food  should  be  considered  as  ingredients 
similarly  to  additives  according  to  Directive  2000/13/EC  relating  to  the 
labelling,  presentation  and  advertising  of  foodstuffs.  In  most  cases  food 
enzymes will be used as processing aids i.e. will be present in food in the form 
of  a  residue,  if  at  all  and  will  have  no  technological  effect  on  the  finished 
product.  Taking  into  account  that  all  food  enzymes  will  be  assessed  for  their 
safety, it is proposed that food enzymes which are used as processing aids are 
exempted from labelling. Food enzymes used to exert a technological function 
in  the  final  food,  will  be  labelled  with  their  function  (e.g.  stabiliser  etc)  and 
specific name.  

Chapter IV - Procedural provisions and implementation 

Wherever  necessary,  producers  or  users  of  food  enzymes  will  be  obliged  to 
inform  the  Commission  of  any  new  information  which  may  affect  the  safety 
assessment of the food enzyme.  

Implementation of the measures proposed in the Regulation will be adopted by 
the  Commission  in  accordance  with  the  regulatory  procedure  laid  down  in 
Council Decision 1999/468/EC.  

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Chapter V -Transitional and final provisions 

Since  many  food  enzymes  are  already  on  the  market  in  the  Community,  the 
transition to a Community positive list should be smooth and should not lead to 
unfair  conditions  for  enzyme  producers.  Therefore,  the  proposal  provides  for 
an initial period of 24 months, after the date of application of the implementing 
measures  foreseen  in  the  common  procedure  Regulation,  during  which 
applications  can  be  submitted.  The  establishment  of  the  Community  list  will 
take place in a single step procedure after the Authority has expressed opinions 
on all products for which sufficient information has been submitted during the 
24-month period. Until the establishment of the Community list, food enzymes 
and food produced with food enzymes may be placed on the market and used, 
according  to  the  existing  national  rules.  A  transitional  period  is  also  foreseen 
for the proposed labelling requirements. 

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2006/0144 (COD) 

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 

(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 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) 

(4) 

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

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

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. 

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 

1 
2 

OJ C […],[…], p. […]. 
OJ C […],[…], p. […]. 

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(5) 

(6) 

(7) 

(8) 

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. 

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. 

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  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/EC7,  the  unique  identifier  assigned  to  the  GMO  under  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 

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 268, 18.10.2003, p. 24. 

EN 

13 

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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 flavourings8. 

(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 safety9, 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  feed10  should  be  authorised  in  accordance  with  that  Regulation, 
prior to its approval 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. 

(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  been  submitted 
during that period. 

(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.  

(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 

8 
9 

10 

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. 

EN 

14 

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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  sweeteners11, 
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  processes12.  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.  

(17)  Food  enzymes  remain  subject  to  the  general  labelling  obligations  provided  for  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 
foodstuffs13.  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.  

(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. 

11 
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). 
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). 

EN 

15 

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(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 Commission14. 

(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 rules15 and consequently the legal basis for the 
financing of the above measures will be Regulation (EC) No 882/2004. 

(22)  Member  States  are  to  carry  out  official  controls  in  order  to  enforce  compliance  with 

this Regulation in accordance with 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 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) 

14 
15 

a Community list of approved food enzymes; 

conditions of use of food enzymes in foods; 

rules on labelling of food enzymes sold as such. 

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

EN 

16 

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1. 

2. 

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. 

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. 

5. 

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

Where necessary, it may be decided in accordance with the procedure referred to in 
Article  16(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 definition shall also apply: 

‘food  enzyme’  means  a  product  obtained  by  extraction  from  plants  or  animals  or  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 

17 

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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(2).  

Article 5 
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  
The content of the Community list of food enzymes 

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;  

(b) 

the  specifications  of  the  food  enzyme,  including  its  origin,  purity  criteria  and 
any other necessary information; where the food enzyme falls 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;  

(e) 

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

EN 

18 

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(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 7 
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 only 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 
Labelling of food enzymes not intended for sale to the final consumer  

Food enzymes not intended for sale to the final consumer, whether sold singly or mixed with 
each other and/or with other ingredients as defined in Article 6(4) of Directive 2000/13/EC, 
may be marketed only where the packaging or containers bear the information provided for in 
Articles 9 to 12 of this Regulation, which must be easily visible, clearly legible and indelible. 

Article 9 
Information requirements concerning the identification of food enzymes 

1. 

Where  food  enzymes  not  intended  for  sale  to  the  final  consumer  are  sold  singly  or 
mixed  with  each  other,  their  packaging  or  containers  shall  bear  the  following 
information in respect of each food enzyme: 

(a) 

the name laid down in this Regulation; or 

(b) 

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. 

EN 

19 

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2. 

Where food enzymes are sold mixed with each other, the information provided for in 
paragraph 1 shall be given in respect of each food enzyme in descending order of its 
percentage by weight of the total. 

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, 
standardisation,  dilution  or  dissolution, 
the  packaging,  containers  or  accompanying 
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; 

(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; 

EN 

20 

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(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 
Labelling of food enzymes intended for sale to the final consumer 

Without  prejudice  to  Directive  2000/13/EC,  food  enzymes  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) 

(b) 

1. 

2. 

the name 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; 

the information required in accordance with Articles 9, 10, and 11 and points (a) to 
(e) and (g) and (h) of Article 12(1). 

SECTION 3 
OTHER LABELLING REQUIREMENTS 

Article 14 
Other labelling requirements 

Articles 8 to 13 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.  

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. 

EN 

21 

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Chapter IV 
Procedural provisions and implementation 

1. 

2. 

1. 

2. 

Article 15 
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 
Committee 

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

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. 

The Committee shall adopt its Rules of Procedure. 

Article 17 
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 
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.  

EN 

22 

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2. 

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

3. 

4. 

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.  

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. 

laid  down 

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

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

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

(a) 

(b) 

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;  

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

EN 

23 

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Article 20 
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”. 

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,”; 

EN 

24 

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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 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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25 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  food 
enzymes. 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned: Health and Consumer Protection 

Activity/Activities: Food Safety, Animal Health, Animal Welfare and Plant Health 

3. 

BUDGET LINES 

3.1.  Budget  lines  (operational  lines  and  related  technical  and  administrative 

assistance lines (ex- B..A lines)) including headings: 

17.01.04.05:  Feed  and  food  safety  and  related  activities  —  Expenditure  on 
administrative management. 

3.2.  Duration of the action and of the financial impact: 

Open ended 

3.3.  Budgetary characteristics : 

Budget line 

Type of 
expenditure 

New 

EFTA 
contributio
n 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

17.01.04.05 

Comp/ 

Diff16 

NO 

NO 

NO 

No 1a  

In  order  to  develop  and  update  Community  legislation  on  food  enzymes  in  a 
proportionate and effective way, it may be useful to undertake studies to collect 
data,  share  information  and  coordinate  work  between  Member  States.  This 
kind  of  support  expenditure,  indicated  under  points  4.1  and  8.1,  is  covered  by 
Regulation  (EC)  no  882/2004  on  official  feed  and  food  controls  within  the 
amounts foreseen for its implementation during 2007/2013. 

16 

Differentiated appropriations. 

EN 

26 

   EN 

 
 
 
 
                                                 
4. 

SUMMARY OF RESOURCES 

4.1.  Financial Resources 

4.1.1. Summary  of 

commitment  appropriations 

(CA)  and  payment 

appropriations (PA) 

EUR million (to 3 decimal places) 

Expenditure type 

Section 
no. 

Year 
n 

n + 1  n + 2  n + 3  n + 4 

n + 5 
and 
later 

Total 

Operational 
expenditure17 
Commitment 
Appropriations 
(CA) 

8.1. 

a 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

Payment 
Appropriations 
(PA) 
Administrative expenditure within reference amount18 

0.05 

0.05 

0.1 

b 

0.05 

0.05 

0.05 

0.35 

Technical & 
administrative 
assistance (NDA) 

8.2.4. 

c 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

0.0 

TOTAL REFERENCE AMOUNT 

Commitment 
Appropriations 

a+c 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

Payment 
Appropriations 
Administrative expenditure not included in reference amount19 

b+c

0.05 

0.05 

0.05 

0.1 

0.05 

0.05 

0.35 

Human resources 
and associated 
expenditure (NDA) 

Administrative 
costs, other than 
human resources 
and associated 
costs, not included 
in reference 
amount (NDA) 

8.2.5. 

d 

8.2.6. 

e 

17 
18 
19 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Total indicative financial cost of intervention 

TOTAL CA 
including cost of 
Human Resources 

TOTAL PA 
including cost of 
Human Resources 

Co-financing details 

a+c
+d
+e 

b+c
+d
+e 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

0.1 

0.05 

0.05 

0.05 

0.05 

0.05 

0.35 

If  the  proposal  involves  co-financing  by  Member  States,  or  other  bodies  (please 
specify  which),  an  estimate  of  the  level  of  this  co-financing  should  be  indicated  in 
the table below (additional lines may be added if different bodies are foreseen for the 
provision of the co-financing): 

EUR million (to 3 decimal places) 

Year 
n 

n + 1 n + 2 n + 3 n + 4 

n + 5 
and 
later 

Total 

Co-financing body 

…………………… 

TOTAL CA including co-
financing 

f 

a+c
+d
+e
+f 

4.1.2. Compatibility with Financial Programming 

(cid:50) 

(cid:133) 

(cid:133) 

Proposal is compatible with existing financial programming. 

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the 
financial perspective. 

Proposal  may  require  application  of  the  provisions  of  the 
Interinstitutional Agreement20 (i.e. flexibility instrument or revision 
of the financial perspective). 

4.1.3. Financial impact on Revenue 

(cid:50) 

Proposal has no financial implications on revenue 

(cid:133) 

Proposal has financial impact – the effect on revenue is as follows: 

EUR million (to one decimal place) 

20 

See points 19 and 24 of the Interinstitutional agreement. 

EN 

28 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Budget line 

Revenue 

Prior to
action 
[Year 
n-1] 

Situation following action 

[Yea
r n] 

[n+1] [n+2]  [n+3

] 

[n+4] [n+5]

21 

(a) Revenue in absolute terms  

(b) Change in revenue 

 ∆ 

4.2.  Human Resources FTE (including officials, temporary and external staff) 

– see detail under point 8.2.1. 

Annual requirements 

Year n 

n + 1 

n + 2 

n + 3 

n + 4 

n + 5 
and 
later 

Total number of human 
resources 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1.  Need to be met in the short or long term 

The  proposed  Regulation  on  Food  enzymes  aims  at  harmonising  the  use  of 
food  enzymes  within  the  EU.  The  Regulation  provides,  among  other,  for  the 
establishment  of  a  Community  list  of  authorised  food  enzymes  after  the 
European  Food  Safety  Authority  (EFSA)  has  evaluated  them  for  their  safety. 
About 200 food enzymes are already on the market in the Community subject 
to national laws of the Member States. Their safety assessment and transfer to 
the  Community  list  should  be  smooth  and  fair  for  all  producers.  Therefore 
transition  periods  are  provided  for,  until  the  initial  establishment  of  the 
Community list. During this period the Commission should maintain and make 
available  to  the  public  a  database  of  food  enzymes  for  which  a  valid 
application  has  been  submitted  with  information  about  the  status  of  their 
assessment.  

Moreover in the future, data on usage of food enzymes may be needed in some 
cases for risk management decisions. 

In  order  to  assure  proportionality  of  the  implementing  measures  that  will  be 
taken in the framework of the proposed regulation and to meet the objectives of 
Regulation  (EC)  882/2004  on  official  feed  and  food  control,  the  following 
instruments are therefore needed:  

• 

An appropriate database for gathering and storing all information relating 
to Community legislation on food enzymes, 

21 

Additional columns should be added if necessary i.e. if the duration of the action exceeds 6 years. 

EN 

29 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
• 

• 

undertaking of studies necessary for the preparation and development of 
legislation on food enzymes, 

undertaking  of  studies  necessary  to  harmonise  procedures,  decision-
making criteria and data requirements, to facilitate work sharing between 
Member States and to develop guidance in these areas. 

5.2.  Value-added  of  Community  involvement  and  coherence  of  the  proposal 

with other financial instruments and possible synergy 

The data and information obtained will help in assuring the best protection of 
the health of the consumer while allowing industry to continue to develop and 
use food enzymes.  

In the harmonised market this can only be achieved via a coordinated approach 
allowing exchange of comparable information between Member States. 

5.3.  Objectives,  expected  results  and  related  indicators  of  the  proposal  in  the 

context of the ABM framework 

Objective 1:  Create and maintain a database and undertake related studies in  
collaboration with external organisations to be selected via the  
appropriate procedures. 

Objective 2:  Assure  that  the  use  of  food  enzymes  does  not  lead  to  
unacceptable risks for the consumer and at the same time does  
not impose unnecessary burden to the industry. 

Objective 3:  Effective  and  transparent  handling  of  the  food  enzymes  
applications  before 
the  Community  
positive  list,  via  a  centralised  database  containing  updated  
information  about  the  status  of  the  applications  and  safety  
assessments. 

the  establishment  of 

5.4.  Method of Implementation (indicative) 

X 

Centralised Management 

X 

directly by the Commission 

(cid:133) 

indirectly by delegation to: 

(cid:133) 

executive Agencies 

(cid:133) 

(cid:133) 

bodies set up by the Communities as referred to in art. 185 of 
the Financial Regulation 

national  public-sector  bodies/bodies  with  public-service 
mission 

EN 

30 

   EN 

 
 
 
 
 
 
 
 
 
 
 
(cid:133) 

Shared or decentralised management 

(cid:133)  with Member states 

(cid:133)  with Third countries 

(cid:133) 

Joint management with international organisations (please specify) 

Relevant comments: 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The content of the database and the conclusions of the results of the studies can 
be monitored via their usability for proposing good implementing measures. A 
basic  tool  will  be  the  Standing  Committee  for  the  Food  Chain  and  Animal 
Health. 

6.2.  Evaluation 

6.2.1. Ex-ante evaluation 

The anticipated expenditure is not significant and therefore data for an ex 
ante evaluation are not currently available. 

6.2.2. Measures  taken  following  an  intermediate/ex-post  evaluation  (lessons 

learned from similar experiences in the past) 

6.2.3. Terms and frequency of future evaluation 

Ongoing in relation to the need to propose implementing measures. 

7. 

ANTI-FRAUD MEASURES  

EN 

31 

   EN 

 
 
 
 
8. 

DETAILS OF RESOURCES 

8.1.  Objectives of the proposal in terms of their financial cost 

Type of output 

Av. 
cost 

Year n 

Year n+1 

Year n+2 

Year n+3 

Year n+4 

Year n+5 and 
later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

Commitment appropriations in EUR million (to 3 decimal places) 

1 

1 

0.123 

0.1 

1 

1 

0.0524 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

1 

1 

0.05 

0.05 

6 

6 

0.35 

0.35 

(Headings of 
Objectives, 
actions and 
outputs should be 
provided) 

OPERATIONAL 
OBJECTIVE  No.1 
22……… 

TOTAL COST 

22 
23 
24 

As described under Section 5.3. 
Creation of the database. 
Updating and maintaining database, and organising related studies. 

EN 

32 

EN 

 
  
 
 
 
 
                                                 
8.2.  Administrative Expenditure 

8.2.1. Number and type of human resources 

Types of post 

Staff to be assigned to management of the action using existing and/or 
additional resources (number of posts/FTEs) 

Year 
n+1 

0.2 

0.2 

Year 
n+2 

0.2 

0.2 

Year 
n+3 

0.2 

0.2 

Year 
n+4 

0.2 

0.2 

Year 
n+5 

0.2 

0.2 

Year n 

Officials or 
temporary 
staff25  
(17 01 01) 

A*/AD 

0.2 

B*, 
C*/AST 

0.2 

Staff  financed26  by  art. 
XX 01 02 

Other  staff27  financed  by 
art. XX 01 04/05 

TOTAL 

0.4 

0.4 

0.4 

0.4 

0.4 

0.4 

8.2.2. Description of tasks deriving from the action 

Examination  of 
commitments and pass to payment 

technical  and  financial  reports,  preparations  of 

8.2.3. Sources of human resources (statutory) 

X 

(cid:133) 

(cid:133) 

(cid:133) 

(cid:133) 

Posts  currently  allocated  to  the  management  of  the  programme  to 
be replaced or extended 

Posts pre-allocated within the APS/PDB exercise for year n 

Posts to be requested in the next APS/PDB procedure 

Posts  to  be  redeployed  using  existing  resources  within  the 
managing service (internal redeployment) 

Posts  required  for  year  n  although  not  foreseen  in  the  APS/PDB 
exercise of the year in question 

25 
26 
27 

Cost of which is NOT covered by the reference amount. 
Cost of which is NOT covered by the reference amount. 
Cost of which is included within the reference amount. 

EN 

33 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4. Other  Administrative  expenditure  included  in  reference  amount  (XX  01 

04/05 – Expenditure on administrative management) 

EUR million (to 3 decimal places) 

Budget line 
(number and heading) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and 
later 

TOTAL 

1. 

Technical and 
administrative 
assistance (including 
related staff costs) 

Executive agencies28 

Other 
and 
technical 
administrative assistance 

intra muros  

extra muros 

Total Technical and 
administrative assistance 

8.2.5. Financial cost of human resources and associated costs not included in 

the reference amount 

Type of human resources 

Year n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and later 

EUR million (to 3 decimal places) 

Officials 
and 
staff (XX 01 01) 

temporary 

Staff financed by Art XX 01 
02 (auxiliary, END, contract 
staff, etc.) 

(specify budget line) 

Total cost of Human 
Resources and associated 
costs (NOT in reference 
amount) 

Calculation – Officials and Temporary agents 

28 

Reference should be made to the specific legislative financial statement for the Executive Agency(ies) 
concerned. 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Calculation – Staff financed under art. XX 01 02 

8.2.6.  Other  administrative  expenditure  not  included  in  reference 

amount 

EUR million (to 3 decimal places) 

Year 
n 

Year 
n+1 

Year 
n+2 

Year 
n+3 

Year 
n+4 

Year 
n+5 
and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX  01  02  11  02  –  Meetings 
& Conferences 

XX  01  02  11  03  – 
Committees29  

XX 01 02 11 04 – Studies & 
consultations 

XX  01  02  11  05 
Information systems 

- 

Total Other 
Management 
Expenditure 
(XX 01 02 11) 

Other  expenditure  of  an 
administrative 
nature 
(specify  including  reference 
to budget line) 

2. 

3. 

Total Administrative expenditure, 
other than human resources and 
associated costs (NOT included in 
reference amount) 

Calculation – Other administrative expenditure not included in reference amount 

29 

Specify the type of committee and the group to which it belongs. 

EN 

35 

   EN