Commission Implementing Regulation (EU) 2020/1823Show full title

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)

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 categoryNormal use levelMaximum 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:

NameSpecificationsFoodsConditions of useRestrictions on the sale of the food enzyme to the final consumerSpecific 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 categoryNormal use levelMaximum 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)

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.