Annex

‘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

1. ☐

   Application for the authorisation of a new food additive

2. ☐

   Application for the modification of the conditions of use of an already authorised food additive

3. ☐

   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^f1:

(list)

….

Food categories and required levels:

Food category	Normal use level	Maximum proposed use level

Yours sincerely,

Signature: …………………

Enclosures:

1. ☐

   Complete dossier

2. ☐

   Public summary of the dossier (non-confidential)

3. ☐

   Detailed summary of the dossier

4. ☐

   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

5. ☐

   List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

6. ☐

   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

1. ☐

   Application for the authorisation of a new food enzyme

2. ☐

   Application for the modification of the conditions of use of an already authorised food enzyme

3. ☐

   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:

1. ☐

   Complete dossier

2. ☐

   Public summary of the dossier (non-confidential)

3. ☐

   Detailed summary of the dossier

4. ☐

   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

5. ☐

   List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

6. ☐

   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

1. ☐

   Application for the authorisation of a new flavouring substance

2. ☐

   Application for the authorisation of a new flavouring preparation

3. ☐

   Application for the authorisation of a new flavour precursor

4. ☐

   Application for the authorisation of a new thermal process flavouring

5. ☐

   Application for the authorisation of a new other flavouring

6. ☐

   Application for the authorisation of a new source material

7. ☐

   Application for the modification of the conditions of use of an already authorised food flavouring

8. ☐

   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:

1. ☐

   Complete dossier

2. ☐

   Public summary of the dossier (non-confidential)

3. ☐

   Detailed summary of the dossier

4. ☐

   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

5. ☐

   List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

6. ☐

   Copy of administrative data of applicant(s)’