# Commission Implementing Regulation (EU) 2020/1823 of 2 December 2020 amending Regulation (EU) No 234/2011 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), Annex

Extent: E+W+S+N.I.

‘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:
(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)’

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Source: https://www.legislation.gov.uk/eur/2020/1823/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-1823/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.