APPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA
GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3
2. SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE...
2.3. Manufacturing process, including any specific processing procedures
2.4. Physico-chemical and technological properties of the additive
2.6. Methods of analysis and reference samples
2.6.1. Methods of analysis for the active substance
2.6.1.1. These methods shall meet the same requirements as those for...
2.6.1.2. The detailed characterisation of the method(s) shall include the appropriate...
2.6.1.3. Performance characteristics of in-house validated methods shall be verified by...
2.6.1.4. The CRL may select appropriate characteristics as mentioned under Annex III...
2.6.1.5. Performance criteria for methods for specific groups of substances (e.g....
2.6.2. Methods of analysis for the determination of the residues of...
2.6.2.1. These methods shall meet the same requirements as those for...
2.6.2.2. The detailed characterisation of the method(s) shall include the appropriate...
2.6.2.3. Performance characteristics of in-house validated methods shall be verified by...
2.6.2.4. The CRL may select appropriate characteristics from the ones mentioned...
2.6.2.5. Performance criteria for methods for specific groups of substances (e.g....
2.6.3. Methods of the analysis relating to the identity and characterisation...
3. SECTION III: STUDIES CONCERNING SAFETY OF THE ADDITIVE
3.1. Studies concerning the safety of use of the additive for...
3.2. Studies concerning the safety of use of the additive for...
3.3. Studies concerning the safety of use of the additive for...
3.4. Studies concerning the safety of use of the additive for...
4. SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE
Regulation (EC) No 1831/2003 foresees additional assistance for the preparation of...
List of the specific requirements for establishing dossiers for:
1.2. Section II: identity, characterisation and conditions of use of the...
1.3. Section III: studies concerning the safety of the additive
1.4. Section IV: studies concerning the efficacy of the additive
3.2. Section II: identity, characterisation and conditions of use of the...
3.3. Section III: studies concerning the safety of the additives
3.4. Section IV: studies concerning the efficacy of the additive
4.1. Zootechnical additives other than enzymes and micro-organisms
6. EXTRAPOLATION FROM MAJOR TO MINOR SPECIES
6.2. Section II: identity, characterisation and conditions of use of the...
6.3. Section III: studies concerning the safety of the use of...
6.4. Section IV: studies concerning the efficacy of the additive
8. ADDITIVES ALREADY AUTHORISED FOR USE IN FOOD
8.2. Section II: identity, characterisation and conditions of use of the...
8.3. Section III: studies concerning the safety of the additives
8.4. Section IV: studies concerning the efficacy of the additive
11. RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC