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11.3.2011 Official
Journal
of
the
European
Union L
64/15
COMMISSION REGULATION (EU) No 234/2011
of 10 March 2011
implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council
establishing a common authorisation procedure for food additives, food enzymes and food
flavourings
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
Authority
adopted
a
scientific
opinion
on
9
July
2009 on data requirements for the evaluation of food
additive applications ( 5 ). This data should be provided
Having regard to the Treaty on the Functioning of the European
when an application for the use of a new food additive
Union,
is submitted. In case of an application for a modification
of the conditions of use of an already authorised food
additive or for a modification of the specifications of an
Having regard to Regulation (EC) No 1331/2008 of the
already authorised food additive, the data required for
European Parliament and of the Council of 16 December
risk assessment may not be required, as long as this is
2008 establishing a common authorisation procedure for
justified by the applicant.
food additives, food enzymes and food flavourings ( 1 ), and in
particular Article 9(1) thereof,
(5) The
Authority
adopted
a
scientific
opinion
on
23
July
2009 on data requirements for the evaluation of food
After consulting the European Food Safety Authority pursuant
enzyme applications (
to Article 9(2) of Regulation (EC) No 1331/2008,

6 ). This data should be provided
when an application for the use of a new food enzyme
is submitted. In case of an application for a modification
of the conditions of use of an already authorised food
Whereas:
enzyme or for a modification of the specifications of an
already authorised food enzyme, the data required for
risk assessment may not be required, as long as this is
(1) Regulation
(EC)
No
1331/2008
lays
down
procedural
justified by the applicant.
arrangements for updating the lists of substances the
marketing of which is authorised in the Union
pursuant to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council of
(6) The
Authority
adopted
a
scientific
opinion
on
19
May
16 December 2008 on food additives ( 2 ), Regulation
2010 on data requirements for the risk assessment of
(EC) No 1332/2008 of the European Parliament and of
flavourings to be used in or on foods ( 7 ). This data
the Council of 16 December 2008 on food enzymes ( 3 )
should be provided when an application for the use of
and Regulation (EC) No 1334/2008 of the European
a new flavouring is submitted. In case of an application
Parliament and of the Council of 16 December 2008
for a modification of the conditions of use of an already
on flavourings and certain food ingredients with
authorised flavouring or for a modification of the spec
flavouring properties for use in and on foods ( 4 ) (here
ifications of an already authorised flavouring, the data
inafter referred to as ‘the sectoral food laws’).
required for risk assessment may not be required, as
long as this is justified by the applicant.
(2) Pursuant
to
Article
9
of
Regulation
(EC)
No
1331/2008
it is for the Commission to adopt the implementing
measure as regards the content, drafting and presentation
(7) It
is
important
that
toxicological
tests
are
performed
to
a
of applications to update the Union lists under each
certain standard. Therefore Directive 2004/10/EC of the
sectoral food law, arrangements for checking the
European Parliament and of the Council of 11 February
validity of applications and the type of information
2004 on the harmonisation of laws, regulations and
that should be included in the opinion of the European
administrative provisions relating to the application of
Food Safety Authority (hereinafter referred to as ‘the
the principles of good laboratory practice and the verifi
Authority’).
cation of their applications for tests on chemical
substances ( 8 ) should be followed. Where such tests are
carried out outside the territory of the Union, they
should follow ‘the OECD Principles of Good Laboratory
(3)
In order to update the lists it is necessary to verify that
Practice’ (GLP) (OECD, 1998) (
the use of the substance complies with the general and

9 ).
specific conditions of use as provided for in the
respective sectoral food laws.
( 5 ) http://www.efsa.europa.eu/en/scdocs/doc/1188.pdf
( 6 ) http://www.efsa.europa.eu/en/scdocs/doc/1305.pdf
( 7 ) http://www.efsa.europa.eu/en/scdocs/doc/1623.pdf
( 1 ) OJ L 354, 31.12.2008, p. 1.
( 8 ) OJ L 50, 20.2.2004, p. 44.
( 2 ) OJ L 354, 31.12.2008, p. 16.
( 9 ) OECD Series on Principles of Good Laboratory Practice and
( 3 ) OJ L 354, 31.12.2008, p. 7.
Compliance Monitoring. Number 1. OECD Principles on Good
( 4 ) OJ L 354, 31.12.2008, p. 34.
Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.

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L 64/16
EN
Official Journal of the European Union
11.3.2011
(8)
The use of food additives and food enzymes should
HAS ADOPTED THIS REGULATION:
always be technologically justified. Applicants should
also explain in case of a food additive why the tech
nological effect cannot be achieved by any other econ
CHAPTER I
omically and technologically practicable means.
GENERAL PROVISIONS
Article 1
(9) The
use
of
a
substance
should
be
authorised
if
it
does
not
mislead the consumer. Applicants should explain that the
Scope
requested uses do not mislead the consumer. The
This Regulation shall apply to applications as referred to in
advantages and benefits for the consumer should also
Article 3(1) of Regulation (EC) No 1331/2008 establishing a
be explained in case of a food additive.
common authorisation procedure for food additives, food
enzymes and food flavourings.
(10) Without prejudice to Article 9 of Regulation (EC)
No 1332/2008, Article 19 of Regulation (EC)
CHAPTER II
No 1333/2008 and Article 13 of Regulation (EC)
No 1334/2008, the Commission should verify the
CONTENT, DRAFTING AND PRESENTATION OF AN APPLI
validity of the application and whether it falls within
CATION
the scope of the respective sectoral food law. An
Article 2
advice from the Authority should be taken into
account, where appropriate, on the suitability of the
Content of an application
submitted data for risk assessment. Such verification
1. The
application
referred
to
in
Article
1
shall
consist
of
the
should not delay the assessment of an application.
following:
(11) The information provided in the opinion of the
(a) a letter;
Authority should be sufficient to ascertain whether the
authorisation of the proposed use of the substance is safe
for consumers. This includes conclusions on the toxicity
(b) a technical dossier;
of the substance, where appropriate, and possible estab
lishment of an acceptable daily intake (ADI) expressed in
a numerical form with details of a dietary exposure
(c) a summary of the dossier.
assessment for all food categories, including exposure
of vulnerable consumer groups.
2. The
letter
referred
to
in
paragraph
1(a)
shall
be
drafted
in
accordance with the model provided in the Annex.
(12) The
applicant
should
also
take
into
account
detailed
guidance concerning the data required for risk assessment
3. The
technical
dossier
referred
to
in
paragraph
1(b)
shall
established by the Authority (The EFSA Journal ( 1 )).
contain:
(13) This
Regulation
takes
into
account
current
scientific
and
(a) the administrative data as provided for in Article 4;
technical knowledge. The Commission may revise this
Regulation in the light of any developments in this
field and the publication of any revised or additional
(b) the data required for risk assessment as provided for in
scientific guidance by the Authority.
Articles 5, 6, 8 and 10; and
(14) Practical
arrangements
related
to
an
application
for
the
(c) the data required for risk management as provided for in
authorisation of food additives, food enzymes and
Articles 7, 9 and 11.
flavourings, such as addresses, persons to contact, trans
mission of documents, etc., should be made available in a
separate communication of the Commission and/or the
4. In
case
of
an
application
for
a
modification
of
the
Authority.
conditions of use of an already authorised food additive, food

enzyme or flavouring all the data mentioned in Articles 5 to 11
may not be required. The applicant shall submit a verifiable
(15) It
is
necessary
to
provide
for
a
time
period
in
order
to
justification why the proposed changes do not affect the
allow the applicants to comply with the provisions of
results of the existing risk assessment.
this Regulation.
5. In case of an application for a modification of the spec
ifications of an already authorised food additive, food enzyme
(16) The
measures
provided
for
in
this
Regulation
are
in
or flavouring:
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(a) the data may be limited to the justification of the request
( 1 ) http://www.efsa.europa.eu/en/efsajournal.htm
and the changes in the specification;

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(b) the applicant shall submit a verifiable justification why the
European Parliament and of the Council of 22 September
proposed changes do not affect the results of the existing
2003 on genetically modified food and feed ( 2 );
risk assessment.
6. The
summary
of
the
dossier
referred
to
in
paragraph
1(c)
(k) table of content of the dossier;
shall include a reasoned statement that the use of the product
complies with the conditions laid down in:
(l) list
of
documents
and
other
particulars;
the
applicant
shall
identify the number and titles of volumes of documen
(a) Article 6 of Regulation (EC) No 1332/2008; or
tation submitted in support of the application; a detailed
index with a reference to volumes and pages shall be
(b) Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or
included;
(c) Article 4 of Regulation (EC) No 1334/2008.
(m) list of the parts of the dossier to be treated as confidential;
applicants shall indicate what they wish to be treated as
Article 3
confidential and give verifiable justification in accordance
Drafting and presentation
with Article 12 of Regulation (EC) No 1331/2008.
1. Applications
shall
be
sent
to
the
Commission.
The
applicant shall take into account the practical guidance on the
Article 5
submission of applications made available by the Commission
General provisions on data required for risk assessment
(Directorate General for Health and Consumers’ ( 1 ) website).
1. The
dossier
submitted
in
support
of
an
application
for
the
2. For the establishment of the Union list of food enzymes
safety evaluation of a substance shall enable a comprehensive
as referred to in Article 17 of Regulation (EC) No 1332/2008,
risk assessment of the substance and shall permit verification
the deadline for submitting applications shall be 24 months
that the substance does not pose a safety concern to consumers
after the date of application of the implementing measures
within the meaning of Article 6(a) of Regulation (EC) No
established by this Regulation.
1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008
and Article 4(a) of Regulation (EC) No 1334/2008.
Article 4
Administrative data
2. The
application
dossier
shall
include
all
the
available
data
relevant for the purpose of the risk assessment (i.e. full
The administrative data as referred to in Article 2(3)(a) shall
published papers of all references cited or full copies of the
include:
original unpublished studies).
(a) name of the applicant (company, organisation, etc.), address
and contact details;
3. The
applicant
shall
take
into
account
the
latest
guidance
documents adopted or endorsed by the Authority available at
the time of the submission of the application (The EFSA
(b) name of the manufacturer(s) of the substance, if different
Journal).
than the applicant’s, address and contact details;
(c) name of the person responsible for the dossier, address and
4. The
documentation
on
the
procedure
followed
when
contact details;
gathering the data shall be provided, including the literature
search strategies (assumptions made, key words used,
(d) date of submission of the dossier;
databases used, time period covered, limitation criteria, etc.)
and a comprehensive outcome of such search.
(e) type of the application, i.e. concerning a food additive, a
food enzyme, or a flavouring;
5. The
safety
evaluation
strategy
and
the
corresponding
testing strategy shall be described and justified with rationales
(f) where applicable, chemical name according to IUPAC
for inclusion and exclusion of specific studies and/or
nomenclature;
information.
(g) where applicable, E-number of the additive as defined in
the Union legislation on food additives;
6. The
individual
raw
data
of
the
unpublished
studies
and,
where possible, of the published studies as well as the individual
(h) where applicable, a reference to similar authorised food
results of examinations shall be made available on request from
enzymes;
the Authority.
(i) where
applicable,
the
FL-number
of
a
flavouring
substance
7. For
each
biological
or
toxicological
study,
it
shall
be
as defined in the Union legislation on flavourings;
clarified whether the test material conforms to the proposed
or existing specification. Where the test material differs from
(j) where
applicable,
the
information
on
authorisations
falling
that specification, the applicant shall demonstrate the relevance
within the scope of Regulation (EC) No 1829/2003 of the
of those data to the substance under consideration.
( 1 ) http://ec.europa.eu/dgs/health_consumer/index_en.htm
( 2 ) OJ L 268, 18.10.2003, p. 1.

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L 64/18
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Official Journal of the European Union
11.3.2011
Toxicological studies shall be conducted in facilities which
Article 7
comply with the requirements of Directive 2004/10/EC of the
European Parliament and of the Council or, if they are carried
Data required for risk management of food additives
out outside the territory of the Union, they shall follow ‘the
1. The
dossier
submitted
in
support
of
an
application
shall
OECD Principles of Good Laboratory Practice’ (GLP). The
include the information necessary to verify whether there is a
applicant shall provide evidence to demonstrate that those
reasonable technological need that cannot be achieved by other
requirements are complied with. For studies not conducted
economically and technologically practicable means and
according to standard protocols, data interpretation, as well as
whether the proposed use does not mislead the consumer
a justification on their appropriateness for the risk assessment,
within the meaning of points (b) and (c) of Article 6(1) of
shall be provided.
Regulation (EC) No 1333/2008.
8. The
applicant
shall
propose
an
overall
conclusion
on
the 2. In
order
to
ensure
the
verification
referred
to
in
paragraph
safety of the proposed uses of the substance. The overall
1, appropriate and sufficient information shall be provided on:
evaluation of potential risk to human health shall be made in
the context of known or likely human exposure.
(a) the identity of the food additive, including reference to the
existing specifications;
Article 6
(b) the function and technological need for the level proposed
Specific data required for risk assessment of food additives
in each of the food categories or products for which auth
1. In addition to data to be provided pursuant to Article 5,
orisation is requested and an explanation that this can not
information shall be provided on:
be reasonably achieved by other economically and tech
nologically practical means;
(a) the identity and characterisation of the additive, including
(c) the investigations on the efficacy of the food additive for the
the proposed specifications and analytical data;
intended effect at the use level proposed;
(b) where applicable, the particle size, particle size distribution
(d) advantages and benefit for the consumer. The applicant
and other physicochemical characteristics;
shall take into account the requirements laid down in
Article 6(2) of Regulation (EC) No 1333/2008;
(c) the manufacturing process;
(e) why the use would not mislead the consumer;
(d) presence of impurities;
(f) proposed normal and maximum use levels in the food
categories mentioned in the Union list, or in a newly
(e) the stability, reaction and fate in foods to which the additive
proposed food category, or in a more specific foodstuff
is added;
belonging to one of these categories;
(f) where applicable, the existing authorisations and risk
(g) the exposure assessment, based on normal and maximum
assessments;
intended use for each of the categories or products
concerned;
(g) proposed normal and maximum use levels in the food
categories mentioned in the Union list, or in a newly
(h) the amount of the food additive present in the final food as
proposed food category, or in a more specific foodstuff
consumed by the consumer;
belonging to one of these categories;
(i) analytical methods allowing the identification and quantifi
(h) a dietary exposure assessment;
cation of the additive or its residues in food;
(j) where applicable, the compliance with the specific
(i) the biological and toxicological data.
conditions for sweeteners and for colours as laid down in
Articles 7 and 8 of Regulation (EC) No 1333/2008.
2. As
regards
to
the
biological
and
toxicological
data,
referred to in point (i) of paragraph 1, the following core
Article 8
areas shall be covered:
Specific data required for risk assessment of food enzymes
(a) toxicokinetics;
1. In addition to data to be provided pursuant to Article 5,
information shall be provided on:
(b) subchronic toxicity;
(a) name(s), synonyms, abbreviations and classification(s);
(c) genotoxicity;
(b) Enzyme Commission Number;
(d) chronic toxicity/carcinogenicity;
(c) the proposed specifications, including the origin;
(e) reproductive and developmental toxicity.
(d) the properties;

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(e) the reference to any similar food enzyme;
(c) where applicable, information on particle size, particle size
distribution and other physicochemical characteristics;
(f) the source material;
(g) the manufacturing process;
(d) where applicable the existing authorisations and evaluations;
(h) the stability, reaction and fate in foods in which the food
(e) the proposed uses in food and proposed normal and
enzyme is used;
maximum use levels in the categories according to the
Union list or in a more specified type of product within
(i) where applicable the existing authorisations and evaluations;
the categories;
(j) the proposed uses in food and, where applicable, the
(f) the data on dietary sources;
proposed normal and maximum use levels;
(k) the dietary exposure assessment;
(g) the dietary exposure assessment;
(l) the biological and toxicological data.
(h) the biological and toxicological data.
2. As
regards
to
the
biological
and
toxicological
data, 2. As regards to the biological and toxicological data,
referred to in point (1) of paragraph 1, the following core
referred to in point (h) of paragraph 1, the following core
areas shall be covered:
areas shall be covered:
(a) subchronic toxicity;
(a) examination for structural/metabolic similarity to flavouring
(b) genotoxicity.
substances in an existing flavouring group evaluation (FGE);
Article 9
(b) genotoxicity;
Data required for risk management of food enzymes
(c) subchronic toxicity, where applicable;
1. The
dossier
submitted
in
support
of
an
application
shall
include the information necessary to verify whether there is a
reasonable technological need and whether the proposed use
(d) developmental toxicity, where applicable;
does not mislead the consumer within the meaning of points
(b) and (c) of Article 6 of Regulation (EC) No 1332/2008.
(e) chronic toxicity and carcinogenicity data, where applicable.
2. In order to ensure the verification referred to in paragraph
Article 11
1, appropriate and sufficient information shall be provided on:
Data required for risk management of flavourings
(a) the identity of the food enzyme, including reference to the
The dossier submitted in support of an application shall include
specifications;
the following information:
(b) the function and technological need, including a description
of the typical process(es) in which the food enzyme may be
(a) the identity of the flavouring, including reference to the
applied;
existing specifications;
(c) the effect of the food enzyme on the final food;
(b) organoleptic properties of the substance;
(d) why the use would not mislead the consumer;
(c) the proposed normal and maximum use levels in the food
(e) the proposed normal and maximum use levels where
categories or in a more specific food belonging to one of
applicable;
these categories;
(f) the dietary exposure assessment, as described in the
(d) the exposure assessment, based on normal and maximum
Authority’s guidance document on food enzymes ( 1 ).
intended use for each of the categories or products
concerned.
Article 10
Specific data required for risk assessment of flavourings
CHAPTER III
1. In addition to data to be provided pursuant to Article 5,
ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN
information shall be provided on:
APPLICATION
Article 12
(a) the manufacturing process;
Procedures
(b) specifications;
1. On
receipt
of
an
application
the
Commission
shall
without delay verify whether the food additive, food enzyme
( 1 ) Guidance of EFSA prepared by the Scientific Panel of Food Contact
or flavouring falls within the scope of the appropriate sectoral
Material, Enzymes, Flavourings and Processing Aids on the
Submission of a Dossier on Food Enzymes. The EFSA Journal
food law and whether the application contains all the elements
(2009) 1305, p. 1.
required under Chapter II.

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Official Journal of the European Union
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2. Where
the
application
contains
all
the
elements
required
CHAPTER IV
under Chapter II, the Commission shall, where necessary,
request the Authority to verify the suitability of the data for
OPINION OF THE AUTHORITY
risk assessment in accordance with the scientific opinions on
Article 13
data requirements for the evaluation of substance applications
and to prepare, if appropriate, an opinion.
Information to be included in the opinion of the Authority
1. The opinion of the Authority shall include the following
3. Within
30
working
days
following
the
receipt
of
the information:
Commission’s request, the Authority shall inform the
Commission by letter about the suitability of the data for risk
(a) the identity and characterisation of the food additive, food
assessment. If the data is considered suitable for risk assessment,
enzyme or flavouring;
the evaluation period referred to in Article 5(1) of Regulation
(EC) No 1331/2008 shall begin from the date when the
(b) the assessment of the biological and toxicological data;
Authority’s letter is received by the Commission.
(c) a dietary exposure assessment for the European population
However, in accordance with point (a) of the second
taking into account other possible sources of dietary
subparagraph of Article 17(4) of Regulation (EC) No
exposure;
1332/2008, in the case of establishment of the Union list of
food enzymes, Article 5(1) of Regulation (EC) No 1331/2008
(d) an overall risk assessment establishing if possible and
shall not apply.
relevant a health-based guidance value, and highlighting
uncertainties and limitations where relevant;
4. In case of an application to update the Union list of food
additives, food enzymes or flavourings, the Commission may
(e) when the dietary exposure exceeds the health-based
request additional information from the applicant on matters
guidance value identified in the overall risk assessment,
regarding the validity of the application and inform the
the dietary exposure assessment of the substance shall be
applicant of the period within which that information shall be
detailed, providing where possible the contribution to the
provided. In the case of applications submitted in compliance
total exposure of each food category or foodstuff for which
with Article 17(2) of Regulation (EC) No 1332/2008, the
the use is authorised or has been requested;
Commission shall determine that period together with the
applicant.
(f) conclusions.
5. When the application does not fall within the appropriate
2. The
Commission
may
ask
for
more
specific
additional
sectoral food law or when it does not contain all the elements
information in its request for an opinion of the Authority.
required under Chapter II or when the Authority considers that
the data for risk assessment are not suitable, the application
CHAPTER V
shall be considered as not valid. In such a case the Commission
shall inform the applicant, the Member States and the Authority
FINAL PROVISIONS
indicating the reasons why the application is considered not
Article 14
valid.
Entry into force and application
6. By
way
of
derogation
from
paragraph
5,
an
application This Regulation shall enter into force on the 20th day following
may be considered as valid even if it does not contain all the
its publication in the Official Journal of the European Union.
elements required under Chapter II, provided that the applicant
has submitted verifiable justification for each missing element.
It shall apply from 11 September 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 March 2011.
For the Commission
The President
José Manuel BARROSO

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ANNEX
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ADDITIVES
EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: ...........................................................................................
................................................................................................
...............................
Subject: Application for authorisation of food additive in accordance with Regulation (EC) No 1331/2008.
Application for an authorisation of a new food additive
Application for a modification of the conditions of use of an already authorised food additive
Application for a modification of the specifications of an already authorised food additive
(Please indicate clearly by ticking one of the boxes).
The Applicant(s) and/or his/their Representative(s) in the European Union.
(name, address, …)
................................................................................................
.....................................................................................................................................
................................................................................................
.....................................................................................................................................
................................................................................................
.....................................................................................................................................
submit(s) the present application in order to update the EU list on food additives.
Food additive name:
................................................................................................
.....................................................................................................................................
ELINCS or EINECS number (if attributed)
CAS No (if applicable)
Functional class(es) of food additives ( 1 ):
(list)
................................................................................................
.....................................................................................................................................
Food categories and required levels:
Food category Normal
use
level Maximum
proposed
use
level
( 1 ) The functional classes of food additives in foods and of food additives in food additives and food enzymes are listed in Annex I to
Regulation (EC) No 1333/2008. If the additive does not belong to one of the mentioned classes, a new functional class name and
definition can be proposed.

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Yours sincerely,
Signature: ..................................................................................................................................................................................
...............................
Enclosures:
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ENZYMES
EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: ...........................................................................................
................................................................................................
...............................
Subject: Application for authorisation of food enzyme in accordance with Regulation (EC) No 1331/2008.
Application for an authorisation of a new food enzyme
Application for a modification of the conditions of use of an already authorised food enzyme
Application for a modification of the specifications of an already authorised food enzyme
(Please indicate clearly by ticking one of the boxes)
The Applicant(s) and/or his/their Representative(s) in the European Union
(name, address, …)
................................................................................................
.....................................................................................................................................
................................................................................................
.....................................................................................................................................
submit(s) the present application in order to update the EU list on food enzymes.
Food enzyme name:
................................................................................................
.....................................................................................................................................
Enzyme Classification Number of Enzyme Commission of the IUBMB
Source material
................................................................................................
.....................................................................................................................................
................................................................................................
.....................................................................................................................................

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Restrictions on the Specific requirement
Name Specifications Foods Conditions
of
use
sale of the food
enzyme to the final in respect of labelling
consumer
of food
Yours sincerely,
Signature: ..................................................................................................................................................................................
...............................
Enclosures:
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FLAVOURINGS
EUROPEAN COMMISSION
Directorate General
Directorate
Unit
Date: ...........................................................................................
................................................................................................
...............................
Subject: Application for authorisation of food flavouring in accordance with Regulation (EC) No 1331/2008.
Application for an authorisation of a new flavouring substance
Application for an authorisation of a new flavouring preparation
Application for an authorisation of a new flavour precursor
Application for an authorisation of a new thermal process flavouring
Application for an authorisation of a new other flavouring
Application for an authorisation of a new source material
Application for a modification of the conditions of use of an already authorised food flavouring
Application for a modification of the specifications of an already authorised food flavouring
(Please indicate clearly by ticking one of the boxes)
The Applicant(s) and/or his/their Representative(s) in the European Union
(name, address, …)
................................................................................................
.....................................................................................................................................
................................................................................................
.....................................................................................................................................

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L 64/24
EN
Official Journal of the European Union
11.3.2011
submit(s) the present application in order to update the EU list on food flavourings.
Name of the flavouring or source material:
................................................................................................
.....................................................................................................................................
FL-, CAS-, JECFA-, CoE-number (if attributed)
Organoleptic properties of the flavouring
................................................................................................
.....................................................................................................................................
Food categories and required levels:
Food category Normal
use
level Maximum
proposed
use
level
Yours sincerely,
Signature: ..................................................................................................................................................................................
...............................
Enclosures:
Complete dossier
Public summary of the dossier
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential
Copy of administrative data of applicant(s)

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