INHALT

Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)

COMMISSION REGULATION (EC)
No 429/2008
of 25 April 2008
on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives
(Text with EEA relevance)
Article 1
Definitions
Article 2
Application
Article 3
Dossier
Article 4
Transitional measures
Article 5
Entry into force
ANNEX I
APPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA
1. APPLICATION FORM
EUROPEAN COMMISSION
HEALTH AND CONSUMER PROTECTION
DIRECTORATE-GENERAL
1.1. Identification and characterisation of additive
1.2. Conditions of use
1.2.1. Use in complete feedingstuffs
1.2.2. Use in water
1.2.3. Special conditions of use (if appropriate)
1.3. Reference samples
1.4. Modification requested (where appropriate)
1.5. Enclosures:
2. ADMINISTRATIVE DATA OF APPLICANT(S)
ANNEX II
GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3
GENERAL ASPECTS
Safety assessment
Efficacy assessment
1. SECTION I: SUMMARY OF THE DOSSIER
1.1. Public summary according to Article 7(3)(h) of Regulation (EC) No 1831/2003
1.1.1. Contents
1.1.2. Description
1.2. Scientific summary of the dossier
1.3. List of documents and other particulars
1.4. List of parts of the dossier requested to be treated as confidential, where necessary
2. SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS
2.1. Identity of the additive
2.1.1. Name of the additive
2.1.2. Proposal for classification
2.1.3. Qualitative and quantitative composition (active substance/agent, other components, impurities, batch to batch variation)
2.1.4. Purity
2.1.4.1. Additives whose authorisation is linked to a holder of authorisation
2.1.4.2. Additives whose authorisation is not linked to a holder of authorisation
2.1.5. Physical state of each form of the product
2.2. Characterisation of the active substance(s)/agent(s)
2.2.1. Description
2.2.1.1. Chemical substances
2.2.1.2. Micro-organisms
2.2.2. Relevant properties
2.2.2.1. Chemical substances
2.2.2.2. Micro-organisms
2.3. Manufacturing process, including any specific processing procedures
2.3.1. Active substance(s)/agent(s)
2.3.2.
Additive
2.4. Physico-chemical and technological properties of the additive
2.4.1. Stability
2.4.2. Homogeneity
2.4.3. Other characteristics
2.4.4. Physico-chemical incompatibilities or interactions
2.5. Conditions of use of the additive
2.5.1. Proposed mode of use in animal nutrition
2.5.2. Information related to users/workers safety
2.5.2.1. Chemical substances
2.5.2.2. Micro-organisms
2.5.2.3. Labelling requirements
2.6. Methods of analysis and reference samples
2.6.1. Methods of analysis for the active substance
2.6.2. Methods of analysis for the determination of the residues of the additive or of its metabolites in food
2.6.3. Methods of the analysis relating to the identity and characterisation of the additive
3. SECTION III: STUDIES CONCERNING SAFETY OF THE ADDITIVE
3.1. Studies concerning the safety of use of the additive for the target animals
3.1.1. Tolerance studies for the target species
3.1.1.1. The design of a tolerance test includes a minimum of three groups:
3.1.1.2. Duration of tolerance trials
3.1.1.3. Experimental conditions
3.1.2. Microbial studies
3.2. Studies concerning the safety of use of the additive for consumers
3.2.1. Metabolic and residue studies
3.2.1.1. Metabolic studies
3.2.1.2. Residue studies
3.2.1.3. Metabolic and disposition studies
3.2.1.4. Bioavailability of residues
3.2.2. Toxicological studies
3.2.2.1. Acute toxicity
3.2.2.2. Genotoxicity studies including mutagenicity
3.2.2.3. Sub-chronic repeated dose oral toxicity studies
3.2.2.4. Chronic oral toxicity studies (including carcinogenicity studies)
3.2.2.5. Reproduction toxicity studies (including prenatal developmental toxicity)
3.2.2.5.1. Two generation reproduction toxicity study
3.2.2.5.2. Prenatal developmental toxicity study (teratogenicity study)
3.2.2.6. Other specific toxicological and pharmacological studies
3.2.2.7. Determination of No Observed Adverse Effect Levels (NOAEL)
3.2.3. Assessment of consumer safety
3.2.3.1. Proposal of the acceptable daily intake (ADI) for the active substance(s)
3.2.3.2. Tolerable upper intake level (UL)
3.2.3.3. Consumer exposure
3.2.3.4. Proposal for maximum residue limits (MRLs)
3.2.3.5. Proposal for a withdrawal period
3.3. Studies concerning the safety of use of the additive for users/workers
3.3.1. Toxicological risk assessment for user/worker safety
3.3.1.1. Effects on the respiratory system
3.3.1.2. Effects on the eyes and skin
3.3.1.3. Systemic toxicity
3.3.1.4. Exposure assessment
3.3.2. Measures to control exposure
3.4. Studies concerning the safety of use of the additive for the environment
3.4.1. Phase I assessment
3.4.1.1. Additives for terrestrial animals
3.4.1.2. Additives for aquatic animals
Phase I — Decision tree
3.4.2. Phase II assessment
3.4.2.1. Phase II A
3.4.2.2. Phase IIB (more detailed ecotoxicological studies)
4. SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE
4.1.
In vitro
studies
4.2. Short term efficacy studies with animals
4.3. Long term efficacy studies with animals
4.4. Duration of long term efficacy studies with target animals
4.5. Efficacy requirements for additive categories and functional groups
4.6. Studies on the quality of animal products where this is not the effect claimed
5. SECTION V: POST-MARKET MONITORING PLAN
ANNEX III
SPECIFIC REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3 WITH RESPECT TO CERTAIN CATEGORIES OF ADDITIVES OR CERTAIN PART ICULAR SITUATIONS, AS PROVIDED FOR IN ARTICLE 7(5) OF REGULATION (EC) No 1831/2003
List of the specific requirements for establishing dossiers for:
General conditions
1. TECHNOLOGICAL ADDITIVES
1.1. Section I: summary of the dossier
1.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
1.3. Section III: studies concerning the safety of the additive
1.3.1. Studies concerning the safety of use of the additive to the target animals
1.3.1.1. Tolerance studies for the target species
1.3.1.2. Microbial studies
1.3.2. Studies concerning the safety of use of the additive for consumers
1.3.3. Studies concerning the safety of use of the additive for users/workers
1.3.4. Studies concerning the safety of use of the additive for the environment
1.4. Section IV: studies concerning the efficacy of the additive
1.5. Section V: post-market monitoring plan
2. SENSORY ADDITIVES
2.1. Colourants
2.1.1. Section I: summary of the dossier
2.1.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
2.1.3. Section III: studies concerning the safety of the use of the additive
2.1.4. Section IV: studies concerning the efficacy of the additive
2.1.5. Section V: post-market monitoring plan
2.2. Flavouring compounds
2.2.1. Section I: summary of the dossier
2.2.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
2.2.3. Section III: studies concerning the safety of the additive
2.2.4. Section IV: studies concerning the efficacy of the additive
2.2.5. Section V: post-market monitoring plan
3. NUTRITIONAL ADDITIVES
3.1. Section I: summary of the dossier
3.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
3.3. Section III: studies concerning the safety of the additives
3.3.1. Studies concerning the safety of use of the additive for the target species
3.3.2. Studies concerning the safety of use of the additive for consumers
3.3.3. Studies concerning the safety of use of the additive for users/workers
3.3.4. Studies concerning the safety of use of the additive for the environment
3.4. Section IV: studies concerning the efficacy of the additive
3.5. Section V: post-market monitoring plan
4. ZOOTECHNICAL ADDITIVES
4.1. Zootechnical additives other than enzymes and micro-organisms
4.1.1. Section I: summary of the dossier.
4.1.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
4.1.3. Section III: studies concerning the safety of the additives
4.1.4. Section IV: studies concerning the efficacy of the additive
4.1.5. Section V: post-market monitoring plan
4.2. Zootechnical additives: enzymes and micro-organisms
4.2.1. Section I: summary of the dossier
4.2.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
4.2.3. Section III: studies concerning the safety of the additives
4.2.4. Section IV: studies concerning the efficacy of the additives
4.2.5. Section V: post-market monitoring plan
5. COCCIDIOSTATS AND HISTOMONOSTATS
5.1. Section I: summary of the dossier
5.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
5.3. Section III: studies concerning the safety of the additives
5.3.1. Studies concerning the safety of use of the additive for target animals
5.3.2. Studies concerning the safety of use of the additive for consumer
5.3.3. Studies concerning the safety of use of the additive for users/workers
5.3.4. Studies concerning the safety of use of the additive for environment
5.4. Section IV: studies concerning the efficacy of the additive
5.5. Section V: post-market monitoring plan
6. EXTRAPOLATION FROM MAJOR TO MINOR SPECIES
6.1. Section I: summary of the dossier
6.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
6.3. Section III: studies concerning the safety of the use of the additive
6.3.1. Studies concerning the safety of use of the additive for the target animals
6.3.2. Studies concerning the safety of use of the additive for the human consumers
6.3.3. Studies concerning the safety of use of the additive for users/workers
6.3.4. Studies concerning the safety of use of the additive for the environment
6.4. Section IV: studies concerning the efficacy of the additive
6.5. Section V: post-market monitoring plan
7. PETS AND OTHER NON FOOD-PRODUCING ANIMALS
7.1. Section I: summary of the dossier
7.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
7.3. Section III: studies concerning the safety of the additive
7.3.1. Studies concerning the safety of use of the additive for the target animals
7.3.2. Studies concerning the safety of use of the additive for consumers
7.3.3. Studies concerning the safety of use of the additive for users/workers
7.3.4. Studies concerning the safety of use of the additive for the environment
7.4. Section IV: studies concerning the efficacy of the additive
7.5. Section V: post-market monitoring plan
8. ADDITIVES ALREADY AUTHORISED FOR USE IN FOOD
8.1. Section I: summary of the dossier
8.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
8.3. Section III: studies concerning the safety of the additives
8.3.1. Studies concerning the safety of use of the additive for the target animals
8.3.2. Studies concerning the safety of use of the additive for consumers
8.3.3. Studies concerning the safety of use of the additive for users/workers
8.3.4. Studies concerning the safety of use of the additive for the environment
8.4. Section IV: studies concerning the efficacy of the additive
8.5. Section V: post-market monitoring plan
9. MODIFICATION OF THE AUTHORISATIONS
10. RENEWAL OF AUTHORISATIONS
10.1. Section I: summary of the dossier
10.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
10.3. Section III: studies concerning the safety of the additives
11. RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC
11.1. Section I: summary of the dossier
11.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
11.3. Section III: studies concerning the safety of the additives
11.4. Section IV: studies concerning the efficacy of the additive
11.5. Section V: post-market monitoring plan
ANNEX IV
Categories and definitions of target animals and indication of the minimum duration of efficacy studies
1. Table. Animal categories: Pigs
2. Table. Animal categories: Poultry
3. Table. Animal categories: Bovines (domestic bovine animals including bubalus and bison species)
4. Table. Animal categories: Sheep
5. Table. Animal categories: Goats
6. Table. Animal categories: Fish
7. Table. Animal categories: Rabbits
8. Table. Animal Categories: horses