ANNEXU.K.
‘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)’
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.