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Document 02011R0234-20210327
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02011R0234 — EN — 27.03.2021 — 002.001
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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 (OJ L 064 11.3.2011, p. 15) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) No 562/2012 of 27 June 2012 |
L 168 |
21 |
28.6.2012 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1823 of 2 December 2020 |
L 406 |
43 |
3.12.2020 |
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)
CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
This Regulation shall apply to applications as referred to in Article 3(1) of Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
Article 1a
Definitions
For the purposes of this Regulation the following definitions shall apply:
‘Status of Qualified Presumption of Safety’ means the safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns.
‘SCF guidelines of 1992’ means the guidelines for the presentation of data on food enzymes set out in the opinion expressed by the Scientific Committee for Food on 11 April 1991 ( 1 ).
CHAPTER II
CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION
Article 2
Content of an application
The application referred to in Article 1 shall consist of the following:
a letter;
a technical dossier;
a detailed summary and a public summary of the dossier.
The technical dossier referred to in paragraph 1(b) shall contain:
the administrative data as provided for in Article 4;
the data required for risk assessment as provided for in Articles 5, 6, 8 and 10 and information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002; and
the data required for risk management as provided for in Articles 7, 9 and 11 and information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002.
In case of an application for a modification of the specifications of an already authorised food additive, food enzyme or flavouring:
the data may be limited to the justification of the request and the changes in the specification;
the applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in:
Article 6 of Regulation (EC) No 1332/2008; or
Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or
Article 4 of Regulation (EC) No 1334/2008.
The public summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 12 of Regulation (EC) No 1331/2008 and 39a of Regulation (EC) No 178/2002.
Article 3
Drafting and presentation
Article 4
Administrative data
The administrative data as referred to in Article 2(3)(a) shall include:
name of the applicant (company, organisation, etc.), address and contact details;
name of the manufacturer(s) of the substance, if different than the applicant’s, address and contact details;
name of the person responsible for the dossier, address and contact details;
date of submission of the dossier;
type of the application, i.e. concerning a food additive, a food enzyme, or a flavouring;
where applicable, chemical name according to IUPAC nomenclature;
where applicable, E-number of the additive as defined in the Union legislation on food additives;
where applicable, a reference to similar authorised food enzymes;
where applicable, the FL-number of a flavouring substance as defined in the Union legislation on flavourings;
where applicable, the information on authorisations falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed ( 3 );
table of content of the dossier;
list of documents and other particulars; the applicant shall identify the number and titles of volumes of documentation submitted in support of the application; a detailed index with a reference to volumes and pages shall be included;
where the applicant submits, in accordance with Article 12 of Regulation (EC) No 1331/2008, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree;
a list of the studies submitted to support the application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.
Article 5
General provisions on data required for risk assessment
Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC of the European Parliament and of the Council or, if they are carried out outside the territory of the Union, they shall follow ‘the OECD Principles of Good Laboratory Practice’ (GLP). The applicant shall provide evidence to demonstrate that those requirements are complied with. For studies not conducted according to standard protocols, data interpretation, as well as a justification on their appropriateness for the risk assessment, shall be provided.
Article 6
Specific data required for risk assessment of food additives
In addition to data to be provided pursuant to Article 5, information shall be provided on:
the identity and characterisation of the additive, including the proposed specifications and analytical data;
where applicable, the particle size, particle size distribution and other physicochemical characteristics;
the manufacturing process;
presence of impurities;
the stability, reaction and fate in foods to which the additive is added;
where applicable, the existing authorisations and risk assessments;
proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;
a dietary exposure assessment;
the biological and toxicological data.
As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered:
toxicokinetics;
subchronic toxicity;
genotoxicity;
chronic toxicity/carcinogenicity;
reproductive and developmental toxicity.
Article 7
Data required for risk management of food additives
In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:
the identity of the food additive, including reference to the existing specifications;
the function and technological need for the level proposed in each of the food categories or products for which authorisation is requested and an explanation that this can not be reasonably achieved by other economically and technologically practical means;
the investigations on the efficacy of the food additive for the intended effect at the use level proposed;
advantages and benefit for the consumer. The applicant shall take into account the requirements laid down in Article 6(2) of Regulation (EC) No 1333/2008;
why the use would not mislead the consumer;
proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;
the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned;
the amount of the food additive present in the final food as consumed by the consumer;
analytical methods allowing the identification and quantification of the additive or its residues in food;
where applicable, the compliance with the specific conditions for sweeteners and for colours as laid down in Articles 7 and 8 of Regulation (EC) No 1333/2008.
Article 8
Specific data required for risk assessment of food enzymes
In addition to data to be provided pursuant to Article 5, information shall be provided on:
name(s), synonyms, abbreviations and classification(s);
Enzyme Commission Number;
the proposed specifications, including the origin;
the properties;
the reference to any similar food enzyme;
the source material;
the manufacturing process;
the stability, reaction and fate in foods in which the food enzyme is used;
where applicable the existing authorisations and evaluations;
the proposed uses in food and, where applicable, the proposed normal and maximum use levels;
the dietary exposure assessment;
the biological and toxicological data.
As regards to the biological and toxicological data, referred to in point (1) of paragraph 1, the following core areas shall be covered:
subchronic toxicity;
genotoxicity.
By way of derogation from point (l) of paragraph 1 the dossier submitted in support of an application for the safety evaluation of a food enzyme does not need to include toxicological data if the food enzyme in question is obtained from:
edible parts of plants or animals intended to be or reasonably expected to be ingested by humans; or
micro-organisms having the status of Qualified Presumption of Safety.
Food enzymes may be grouped under one application provided that they have the same catalytic activity, are processed from the same source material (e.g. at species level) and with a substantially same production process, and have been obtained from:
edible parts of plants or animals intended to be or reasonably expected to be ingested by humans; or
micro-organisms having the status of Qualified Presumption of Safety; or
micro-organisms which have been used in the production of food enzymes that have been evaluated and authorised by the competent authorities in either France or Denmark in accordance with the SCF guidelines of 1992.
Article 9
Data required for risk management of food enzymes
In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:
the identity of the food enzyme, including reference to the specifications;
the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied;
the effect of the food enzyme on the final food;
why the use would not mislead the consumer;
the proposed normal and maximum use levels where applicable;
the dietary exposure assessment, as described in the Authority’s guidance document on food enzymes ( 5 ).
Article 10
Specific data required for risk assessment of flavourings
In addition to data to be provided pursuant to Article 5, information shall be provided on:
the manufacturing process;
specifications;
where applicable, information on particle size, particle size distribution and other physicochemical characteristics;
where applicable the existing authorisations and evaluations;
the proposed uses in food and proposed normal and maximum use levels in the categories according to the Union list or in a more specified type of product within the categories;
the data on dietary sources;
the dietary exposure assessment;
the biological and toxicological data.
As regards to the biological and toxicological data, referred to in point (h) of paragraph 1, the following core areas shall be covered:
examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE);
genotoxicity;
subchronic toxicity, where applicable;
developmental toxicity, where applicable;
chronic toxicity and carcinogenicity data, where applicable.
Article 11
Data required for risk management of flavourings
The dossier submitted in support of an application shall include the following information:
the identity of the flavouring, including reference to the existing specifications;
organoleptic properties of the substance;
the proposed normal and maximum use levels in the food categories or in a more specific food belonging to one of these categories;
the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned.
CHAPTER III
ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN APPLICATION
Article 12
Procedures
However, in accordance with point (a) of the second subparagraph of Article 17(4) of Regulation (EC) No 1332/2008, in the case of establishment of the Union list of food enzymes, Article 5(1) of Regulation (EC) No 1331/2008 shall not apply.
The application shall be considered not valid if:
it does not fall within the appropriate sectoral food law,
it does not contain all the elements required under Chapter II,
it does not comply with Article 32b of Regulation (EC) No 178/2002 or,
the Authority considers that the data for risk assessment are not suitable.
In such a case, the Commission shall inform the applicant, the Member States and the Authority indicating the reasons why the application is considered not valid.
CHAPTER IV
OPINION OF THE AUTHORITY
Article 13
Information to be included in the opinion of the Authority
The opinion of the Authority shall include the following information:
the identity and characterisation of the food additive, food enzyme or flavouring;
the assessment of the biological and toxicological data;
a dietary exposure assessment for the European population taking into account other possible sources of dietary exposure;
an overall risk assessment establishing if possible and relevant a health-based guidance value, and highlighting uncertainties and limitations where relevant;
when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the substance shall be detailed, providing where possible the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;
conclusions;
the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.
CHAPTER V
FINAL PROVISIONS
Article 14
Entry into force and application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 11 September 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD ADDITIVES
EUROPEAN COMMISSION
Directorate-General
Directorate
Unit
Date: ………………
Subject: |
Application for the authorisation of a food additive in accordance with Regulation (EC) No 1331/2008 |
Application for the authorisation of a new food additive
Application for the modification of the conditions of use of an already authorised food additive
Application for the 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 for the authorisation of (a) food additive(s).
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 |
|
|
|
|
|
|
Yours sincerely,
Signature: …………………
Enclosures:
Complete dossier
Public summary of the dossier (non-confidential)
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD ENZYMES
EUROPEAN COMMISSION
Directorate-General
Directorate
Unit
Date: ……………………
Subject: |
Application for the authorisation of a food enzyme in accordance with Regulation (EC) No 1331/2008 |
Application for the authorisation of a new food enzyme
Application for the modification of the conditions of use of an already authorised food enzyme
Application for the 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 for the authorisation of (a) food enzyme(s).
Food enzyme name:
…
Enzyme Classification Number of Enzyme Commission of the IUBMB:
Source material:
…
…
Name |
Specifications |
Foods |
Conditions of use |
Restrictions on the sale of the food enzyme to the final consumer |
Specific requirement in respect of labelling of food |
|
|
|
|
|
|
Yours sincerely,
Signature: ……………………
Enclosures:
Complete dossier
Public summary of the dossier (non-confidential)
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002
Copy of administrative data of applicant(s)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD FLAVOURINGS
EUROPEAN COMMISSION
Directorate-General
Directorate
Unit
Date: ……………………
Subject: |
Application for the authorisation of a food flavouring in accordance with Regulation (EC) No 1331/2008 |
Application for the authorisation of a new flavouring substance
Application for the authorisation of a new flavouring preparation
Application for the authorisation of a new flavour precursor
Application for the authorisation of a new thermal process flavouring
Application for the authorisation of a new other flavouring
Application for the authorisation of a new source material
Application for the modification of the conditions of use of an already authorised food flavouring
Application for the 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, …)
…
…
submit(s) the present application for the authorisation of (a) food flavouring(s).
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 (non-confidential)
Detailed summary of the dossier
List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree
List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002
Copy of administrative data of applicant(s)
( 1 ) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_27.pdf.
( 2 ) https://ec.europa.eu/food/safety_en
( 3 ) OJ L 268, 18.10.2003, p. 1.
( 4 ) OJ L 125, 21.5.2009, p. 75.
( 5 ) Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, p. 1.
( *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.