2.2What happens after an application has been submitted? 2.2.1Acknowledgement of receipt
The Commission shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it.
2.2.2Validity check
The Commission shall without delay verify whether the application falls within the scope of the appropriate sectoral food law and whether the application contains all the elements required.
Where necessary, the Commission shall request EFSA to verify the suitability of the data for risk assessment within 30 working days following the receipt of the Commission's request.
Where necessary, the Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information shall be provided. In the context of food enzyme applications the Commission shall determine that period together with the applicant.
When the application does not fall within the appropriate sectoral food law or when it does not contain all the elements required or when the Authority considers that the data for risk assessment are not suitable, the application shall be considered as not valid. In such a case the Commission shall inform the applicant indicating the reasons why the application is considered not valid.
2.2.3Risk assessment
When the Commission requests EFSA to carry out risk assessment, EFSA shall give its opinion within 9 months from the date when the EFSA's letter on suitability of the data is received by the Commission. However, this deadline does not apply to food enzymes until the first Union list has been established.
According to Article 6 of Regulation (EC) No 1331/2008 this period may be extended in duly justified cases such as when the Authority requests additional information from applicants.
2.2.4Risk management and updating the Union list
Either within 9 months of EFSA giving its opinion or within 9 months of the date the Commission receives a valid application (in those cases where an EFSA opinion has not been requested) the Commission shall submit to the Standing Committee on Plants, Animals Food and Feed a draft regulation updating the Union list, taking account of the EFSA opinion, any relevant provisions of Union law and any legitimate factors relevant to the matter under consideration.
This period may be extended where the Commission requests additional information from applicants on matters concerning risk management.
In exceptional circumstances the time limits for both risk assessment and risk management may be extended if the nature of the matter in question so justifies.
The Commission may end the authorisation procedure and decide not to proceed with a planned update, at any stage of the procedure, if it judges that such an update is not justified.
In such cases the Commission shall inform the applicant indicating in its letter the reasons for not considering the update justified.
3Annexes 3.1Checklists
There are 4 possible options in the drop-down lists (grey rectangles in the column "Information / document provided?") which are explained below. The applicant shall select one of the opinions provided (where relevant, only one or two options are available in a drop down list) by double clicking on a grey rectangle and choosing the appropriate option.
Options in the drop down lists are:
YES Information or document is included in the dossier.
IN PART Information or document is partly included in the dossier. A verifiable justification for each missing element has to be provided in a separate document (point 3 of the checklists).
NO Information or document is not included in the dossier. A verifiable justification has to be provided in a separate document (point 3 of the checklist).
NOT RELEVANT Information or document is not relevant / requested for the application in question.
3.1.1Checklist for food additive applications
No
|
Type of information / document
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Information / document provided?
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Do NOT fill the boxes below
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1
|
Accompanying letter - see Annex to Regulation EU (No) 234/2011
|
|
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2
|
Technical dossier
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2.1
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Administrative data
|
|
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2.1.1
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Name, address and contact details of the applicant
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2.1.2
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Name, address and contact details of the manufacturer
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|
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2.1.3
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Name, address and contact details of the person responsible for the dossier
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2.1.4
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Date of submission
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2.1.5
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Type of application indicated: i.e. new food additive; modification of the conditions of use of an already authorised food additive; modification of the specifications of an already authorised food additive
|
|
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2.1.6
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Identification of the substance (e.g. chemical name, E-number, INS-number, CAS registry number)
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|
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2.1.7
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Information on authorisation falling under Regulation (EC) No 1829/2003 on genetically modified food and feed
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|
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2.1.8
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Table of content of the dossier
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2.1.9
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References - list of documents – the number and titles of volumes of documents submitted in support of the application; a detailed index with a reference to volumes and pages
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|
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2.1.10
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List of parts of the dossier to be treated as confidential with a verifiable justification for each part for which a confidential treatment is required
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2.2
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Risk assessment data
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2.2.1
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Identity and characterisation of the additive, including the proposed specifications and analytical data
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2.2.2
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Information on particle size, particle size distribution and other physicochemical characteristics
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2.2.3
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Manufacturing process - 2 versions to be submitted:
A. Detailed description of man. process
B. Concise description of man. process
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2.2.4
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Presence of impurities
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2.2.5
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Stability, reaction and fate in foods to which the additive is added
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2.2.6
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Existing authorisations and risk assessments
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2.2.7
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Proposed normal and maximum use levels in the food categories mentioned in Annex II to Regulation (EC) No 1333/2008, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories
|
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2.2.8
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Dietary exposure assessment and data on dietary sources
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2.2.9
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Biological and toxicological data
|
|
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2.2.9.1
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Toxicokinetics
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2.2.9.2
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Subchronic toxicity
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2.2.9.3
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Genotoxicity
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2.2.9.4
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Chronic toxicity and carcinogenicity
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2.2.9.5
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Reproductive and developmental toxicity
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2.2.10
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Overall conclusion on the safety of the proposed uses
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2.2.11
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Documentation on the procedure followed when gathering the data
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2.2.12
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Safety evaluation strategy and corresponding testing strategy
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2.2.13
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Relevant published paper and unpublished studies including the individual raw data
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|
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2.3
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Risk management data
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2.3.1
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Identity of the food additive, including reference to the existing specifications
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2.3.2
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Function and technological need for the level proposed in each food category for which authorisation is requested and an explanation why this can not be reasonably achieved by other economically and technologically practical means
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2.3.3
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Investigations on the efficacy of the food additive for the intended effect at the use level proposed
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2.3.4
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Advantages and benefits for the consumer according to the requirements laid down in Article 6 (2) of Regulation (EC) No 1333/2008
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2.3.5
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Information why the use would not mislead the consumer
|
|
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2.3.6
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Proposed normal and maximum use levels in the food categories mentioned in Annex II to Regulation (EC) No 1333/2008, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories
|
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2.3.7
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Exposure assessment based on normal and maximum use levels for each of the categories or products concerned
|
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2.3.8
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Amount of the food additive present in the final food as consumed by the consumer
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2.3.9
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Analytical methods allowing the identification and quantification of the additive or its residues in food
|
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2.3.10
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Compliance with specific conditions for sweeteners as laid down in Article 7 of Regulation (EC) No 1333/2008
|
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2.3.11
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Compliance with specific conditions for colours as laid down in Article 8 of Regulation (EC) No 1333/2008
|
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3
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Verifiable justification for each missing element of data required
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|
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4
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Summary of the dossier
|
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5
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Public summary of the dossier
|
|
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6
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Separate copy of administrative data
|
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7
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Letter declaring that the electronic and the paper versions of the dossier are identical
|
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8
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2x CD/DVD containing copies of all documents mentioned above in el. format
|
|
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9
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If confidential treatment is required then in addition to document under 2.1.10 also the following has to be included:
|
9.1
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Complete dossier without confidential parts in el. format (2x CD/DVD)
|
|
|
3.1.2Checklist for food enzyme applications
No
|
Type of information / document
|
Information / document provided?
|
Do NOT fill the boxes below
|
1 Letters
|
1.1
|
Accompanying letter- Annex to Regulation EU (No) 234/2011
|
|
|
2 Summaries of the Dossier
|
2.1
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Summary of the dossier
|
|
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2.2
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Public summary of the dossier
|
|
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3 Technical dossier
|
3.1 Administrative data
|
3.1.1
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Name, address and contact details of the applicant
|
|
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3.1.2
|
Name, address and contact details of the manufacturer if different than the above applicant
|
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3.1.3
|
Name, address and contact details of the person responsible for the dossier
|
|
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3.1.4
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Date of submission
|
|
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3.1.5
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Scope of the application
|
|
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3.1.6
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Where relevant, a reference to similar authorised food enzymes
|
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3.1.7
|
Table of contents of the dossier
|
|
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3.1.8
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References - list of documents – the number and titles of volumes of documents submitted in support of the application; a detailed index with a reference to volumes and pages
|
|
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3.2 Risk assessment data (as described by EFSA guidance)
|
3.2.1
|
Technical data
|
3.2.1.1
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Identity of the Food Enzyme
|
3.2.1.1.1
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Name(s), synonyms, abbreviations and classification(s) (EC Number) of the enzyme protein
|
|
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3.2.1.1.2
|
Chemical composition, properties and specifications
|
|
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3.2.1.1.2.1
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Chemical composition
|
|
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3.2.1.1.2.2
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Proposed chemical and microbiological specifications
|
|
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3.2.1.1.2.3
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Properties of the food enzyme
|
|
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3.2.1.2
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Source material and manufacturing process
|
3.2.1.2.1
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Source materials
|
|
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3.2.1.2.2
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Production from animal sources
|
|
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3.2.1.2.3
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Production from plant and basidiomycete sources
|
|
|
3.2.1.2.3.1
|
If a genetically modified plant or fungus is used, information should be provided on the organism in accordance with the Guidance for risk assessment of food and feed from genetically modified plants (EFSA 2011).
|
|
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3.2.1.2.4
|
Production from microbial sources
|
|
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3.2.1.2.4.1
|
If a genetically modified micro-organism is used, information should be provided in accordance with the guidance on the risk assessment of genetically modified micro-organisms and their products intended for food and feed use (EFSA, 2011)
|
|
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3.2.1.2.5
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Manufacturing process
|
|
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3.2.1.3
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Reaction and fate in food
|
|
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3.2.1.4
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Proposed conditions of use in food manufacturing and, where applicable, the proposed normal and maximum use levels
|
|
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3.2.1.5
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Dietary exposure
|
|
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3.2.1.6
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Information on existing authorisations and evaluations
|
|
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3.2.2
|
Toxicological data
|
3.2.2.1
|
Toxicological Testing
|
3.2.2.1.1
|
The toxicological Data Set
|
|
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3.2.2.1.1.1
|
Assessment of genotoxicity
|
|
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3.2.2.1.1.2
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Assessment of systemic toxicity
|
|
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3.2.2.1.1.3
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When toxicological testing may not be needed
|
|
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3.2.2.1.1.4
|
Data reporting
|
|
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3.2.2.1.1.5
|
Review of toxicological and exposure data and conclusions
|
|
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3.2.2.2
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Allergenicity
|
|
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3.2.3
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Conclusion (on safety data and toxicological tests)
|
|
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3.2.4
|
Dossier bibliography (risk assessment part)
|
|
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3.3 Risk management data
|
3.3.1
|
The identity of the food enzyme, including reference to the specifications, including the source material
|
|
|
3.3.2
|
The function and technological need, including a description of the typical process(es) in which the food enzyme may be applied
|
|
|
3.3.3
|
The effect of the food enzyme on the final food
|
|
|
3.3.4
|
Why the use would not mislead the consumer
|
|
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3.3.5
|
The proposed normal and maximum use levels where applicable
|
|
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3.3.6
|
The dietary exposure assessment
|
|
|
4
|
In addition to the simplified paper copy (Commission's copy- accompanying letter, summary of the dossier and confidential information) of the dossier, 2x CD/DVD’s containing copies of all documents mentioned above in electronic format
|
|
|
5
|
If confidential treatment is required also the following has to be included:
|
5.1
|
List of parts of the dossier to be treated as confidential with a verifiable justification for each part for which a confidential treatment is required
|
|
|
5.2
|
Complete dossier without confidential parts in electronic format (2x CD/DVD)
|
|
| 3.1.3Checklist for food flavouring applications
No
|
Type of information / document
|
Information / document provided?
|
Do NOT fill the boxes below
|
1
|
Accompanying letter - see Annex to Regulation EU (No) 234/2011
|
|
|
2
|
Technical dossier
|
2.1
|
Administrative data
|
|
|
2.1.1
|
Name, address and contact details of the applicant
|
|
|
2.1.2
|
Name, address and contact details of the manufacturer
|
|
|
2.1.3
|
Name, address and contact details of the person responsible for the dossier
|
|
|
2.1.4
|
Date of submission
|
|
|
2.1.5
|
Type of application - flavouring substance, flavouring preparation, flavouring precursor, thermal process flavouring, other flavouring
|
|
|
2.1.6
|
Identification of the substance (e.g. chemical name, FL-No, JECFA No, CoE No)
|
|
|
2.1.7
|
Information on authorisation falling under Regulation (EC) No 1829/2003 on genetically modified food and feed
|
|
|
2.1.8
|
Table of content of the dossier
|
|
|
2.1.9
|
References - list of documents – the number and titles of volumes of documents submitted in support of the application; a detailed index with a reference to volumes and pages
|
|
|
2.1.10
|
List of parts of the dossier to be treated as confidential with a verifiable justification for each part for which a confidential treatment is required
|
|
|
2.2
|
Risk assessment data
|
|
|
2.2.1
|
Manufacturing process
|
|
|
2.2.2
|
Specifications
|
|
|
2.2.3
|
Where applicable information on particle size, particle size distribution and other physicochemical characteristics
|
|
|
2.2.4
|
Where applicable existing authorisations and evaluations
|
|
|
2.2.5
|
Proposed uses in food and proposed normal and maximum use levels in food categories or in a more specific food
See Data requirements for evaluation of new food flavourings applications (Appendix 2, Table 1)
|
|
|
2.2.6
|
Data on dietary and non dietary sources
|
|
|
2.2.7
|
Dietary exposure assessment
|
|
|
2.2.8
|
Biological and toxicological data
|
|
|
2.2.8.1
|
Examination of structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation, relevant published papers and unpublished studies including the individual reports.
|
|
|
2.2.8.2
|
Genotoxicity, relevant published papers and unpublished studies including the individual reports
|
|
|
2.2.8.3
|
Subchronic toxicity, relevant published papers and unpublished studies including the individual reports
|
|
|
2.2.8.4
|
Developmental toxicity, relevant published papers and unpublished studies including the individual reports
|
|
|
2.2.8.5
|
Chronic toxicity and carcinogenicity, relevant published papers and unpublished studies including the individual reports
|
|
|
2.2.9
|
Documentation on the procedure followed when gathering the data
|
|
|
2.2.10
|
Safety evaluation strategy and corresponding testing strategy
|
|
|
2.3
|
Risk management data
|
2.3.1
|
Identity of the flavouring, including reference to the existing specifications
|
|
|
2.3.2
|
Organoleptic properties of the substance
|
|
|
2.3.3
|
Proposed normal and maximum use levels in the food categories or in a more specific food
|
|
|
2.3.4
|
Exposure assessment based on normal and maximum use levels
|
|
|
3
|
Classification and sensory profiles (see Guidance notes on the classification of a flavouring substance with modifying properties and a flavour enhancer)
|
|
|
4
|
Verifiable justification for each missing element of data required
|
|
|
5
|
Summary of the dossier
|
|
|
6
|
Public summary of the dossier
|
|
|
7
|
Separate copy of administrative data
|
|
|
8
|
Simplified paper copy (Commission's copy) consisting of an accompanying letter, summary of the dossier and confidential information of the dossier
|
|
|
9
|
3x CD/DVD containing copies of all documents mentioned above in electronic. format
|
|
|
10
|
If confidential treatment is required then in addition to document under 2.1.10 also the following has to be included:
|
10.1
|
Complete dossier without confidential parts in el. format (3x CD/DVD)
|
|
|
3.2References
All applicants shall familiarise themselves with documents under "general references" and according to the application with one of the sectoral references.
3.2.1General references
Regulation (EC) No 1331/2008 establishing a common authorisation procedure
Regulation (EU) No 234/2011 implementing Regulation 1331/2008
Regulation (EU) No 562/2012 amending Commission Regulation (EU) No 234/2011
In case of a substance produced with genetically modified microorganisms also:
EFSA: Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use
EFSA: Evaluation of trial descriptions of strains of Bacillus licheniformis and Aspergillus niger genetically modified with alpha-amylase gene(s)
In case of a substance produced with genetically modified plants or fungus also:
EFSA: Guidance for risk assessment of food and feed from genetically modified plants
In case of use of nanotechnologies also:
EFSA: Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain
3.2.2Food additives
Regulation (EC) No 1333/2008 on food additives
EFSA: Data requirements for evaluation of new food additive applications
EFSA: Guidance for submission for food additive evaluations
Food additives intake model (FAIM)
3.2.3Food enzymes
Regulation (EC) No 1332/2008 on food enzymes
Regulation (EU) No 1056/2012 amending Regulation (EC) No 1332/2008 on food enzymes
Guidance document on categorisation of food enzymes
EFSA: Data requirements for evaluation of new food enzymes applications
Updated Explanatory Note for Guidance
3.2.4Food flavourings
Regulation EC (No) 1334/2008 on flavourings and certain food ingredients with flavouring properties
EFSA: Data requirements for evaluation of new food flavourings applications
EFSA: Proposed template to be used in drafting scientific opinion on flavouring substances (explanatory notes for guidance included)
European Commission: Guidance notes on the classification of a flavouring substance with modifying properties and a flavour enhancer
3.3The most common drawbacks of the applications received
If the application is incomplete or the data provided are not of a sufficient quality (i.e. not suitable for risk assessment/risk management) the application might be considered as not valid. In order to avoid such situation please find below the most common drawbacks of the food additive applications that have been received since the common authorisation procedure applies.
Please take note that some items listed below are not relevant for the extension of use of already authorised substance but only for a request for new substance authorisation.
-
Full copies of the references (i.e. published papers and unpublished studies) are missing in the technical dossier
-
The electronic and the paper versions of the application are not identical
-
Verifiable justification for each piece of information marked as confidential is missing; claim for confidentiality does not respect Regulation No. 1331/2008, Art 12; Technical dossier without confidential parts’ is not provided
-
Verifiable justification for each missing part of the application is not included
-
Identity and characterisation of the proposed food additive is not sufficient - full set of specifications and analytical methods for substance’s characterisation and detection in food are missing
-
Insufficient information on toxicological data not following the ‘EFSA guidance for submission for food additive evaluations’
-
Missing description of the test material used in the toxicological studies
-
Proposed use levels of the substance are not specified
3.4Changes introduced in the updated versions
Version 10: administrative changes (name of the DG, Unit, contact person, contact details etc.); request that all electronic files should allow content copying and printing (see chapter 2.1.6)
Version 11: administrative changes (name of contact person, name of the unit and contact details)
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