Additive Application

Application for a new additive in the EU

16 December 2008 a legislative package of four Regulations was adopted by the European Parliament and Council. The package is consisting of Regulation (EC) No 1333/2008 on food additives, Regulation (EC) No 1332/2008 on food enzymes, Regulation (EC) No 1334/2008 on flavorings and a separate Regulation (EC) No 1331/2008 on a common procedure for evaluation and authorization of these substances.

Reasons for using this type of application

  • Expand the category of an already approved additive
  • Introducing a new additive in the EU

The formal requirements are listed in headlines below. The application must follow this structure and any conclusion in the application must be derived there from.

Preparing the application is text-wise extremely important as only a few wrong terms or sentences may compromise an application which in all other aspects is perfect.

The dossier must contain the following information:

INTRODUCTION

SUMMARY DOCUMENT

PART I ADMINISTRATIVE DATA

PART II TECHNICAL DATA

1. Identity of substance

2. Microbiological characteristics

3. Proposed chemical and microbiological specifications

4. Manufacturing process

5. Methods of analysis in food

6. Reaction and fate in food

7. Case of need and proposed uses

8. Exposure

9. Additives produced by microbiological processes

10. Additives produced from genetically modified organisms

11. Information on national authorizations

PART III TOXICOLOGICAL DATA

1. General framework for the toxicological evaluation of food additives

2. Study protocols

3. Toxicological section of the dossier

3.1 Core studies

3.2 Other studies

4. Data reporting

5. Review of results and conclusions

PART IV REFERENCES AND REPORTS

1. List of references

2. Appended papers and study reports

APPENDIX I Flowchart of the process of evaluation by the SCF of a dossier on a food additive

APPENDIX 1I General criteria for the use of food additives

ANNEX