Article 1Definitions
Article 2Application
Article 3Dossier
Article 4Transitional measures
Article 5Entry into force
ANNEX IAPPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA
1.APPLICATION FORM 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) (1)Applicant company or person (2)Contact person (for all correspondence with Commission, Authority and CRL)...
ANNEX IIGENERAL 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...2.SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE...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...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...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 2.6.1.1.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...3.1.1.Tolerance studies for the target species 3.1.1.1.The design of a tolerance test includes a minimum of...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...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...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...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...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...5.SECTION V: POST-MARKET MONITORING PLAN
ANNEX IIISPECIFIC 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
Regulation (EC) No 1831/2003 foresees additional assistance for the preparation of...
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...1.3.Section III: studies concerning the safety of the additive 1.3.1.Studies concerning the safety of use of the additive to...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...1.3.2.1.Metabolic and residue studies 1.3.2.2.Toxicological studies 1.3.2.3.Assessment of consumer safety 1.3.3.Studies concerning the safety of use of the additive for...1.3.4.Studies concerning the safety of use of the additive for...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...2.1.3.Section III: studies concerning the safety of the use of...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...2.2.2.1.Characterisation of active substance(s)/agent(s) 2.2.2.2.Method of production and manufacture 2.2.2.3.Methods of analysis 2.2.3.Section III: studies concerning the safety of the additive 2.2.3.1.Studies concerning the safety of use of the additive for...2.2.3.2.Studies concerning the safety of use of the additive for...2.2.3.3.Studies concerning the safety of use of the additive for...2.2.3.4.Studies concerning the safety of use of the additive for...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...3.3.Section III: studies concerning the safety of the additives 3.3.1.Studies concerning the safety of use of the additive for...3.3.1.1.Tolerance of the target species 3.3.1.2.Microbial studies 3.3.2.Studies concerning the safety of use of the additive for...3.3.2.1.Metabolic and residue studies 3.3.2.2.Toxicological studies 3.3.2.3.Assessment of consumer safety 3.3.3.Studies concerning the safety of use of the additive for...3.3.4.Studies concerning the safety of use of the additive for...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...4.1.3.Section III: studies concerning the safety of the additives 4.1.3.1.Studies concerning the safety of use of the additive for...4.1.3.2.Studies concerning the safety of use of the additive for...4.1.3.3.Studies concerning the safety of the additive for users/workers 4.1.3.4.Studies concerning the safety of the additive for the environment...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...4.2.3.Section III: studies concerning the safety of the additives 4.2.3.1.Studies concerning the safety of use of the additive for...4.2.3.2.Studies concerning the safety of the additive use for consumer...4.2.3.3.Studies concerning the safety of the additive for users/workers 4.2.3.4.Studies concerning the safety of the additive for the environment...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...5.3.Section III: studies concerning the safety of the additives 5.3.1.Studies concerning the safety of use of the additive for...5.3.2.Studies concerning the safety of use of the additive for...5.3.3.Studies concerning the safety of use of the additive for...5.3.4.Studies concerning the safety of use of the additive for...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...6.3.Section III: studies concerning the safety of the use of...6.3.1.Studies concerning the safety of use of the additive for...6.3.1.1.Tolerance of the target species 6.3.2.Studies concerning the safety of use of the additive for...6.3.2.1.Metabolic studies 6.3.2.2.Residue studies 6.3.2.3.Assessment of consumer safety 6.3.3.Studies concerning the safety of use of the additive for...6.3.4.Studies concerning the safety of use of the additive for...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...7.3.Section III: studies concerning the safety of the additive 7.3.1.Studies concerning the safety of use of the additive for...7.3.2.Studies concerning the safety of use of the additive for...7.3.3.Studies concerning the safety of use of the additive for...7.3.4.Studies concerning the safety of use of the additive for...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...8.3.Section III: studies concerning the safety of the additives 8.3.1.Studies concerning the safety of use of the additive for...8.3.2.Studies concerning the safety of use of the additive for...8.3.2.1.Food additives for which an ADI is not specified 8.3.2.2.Food additives with an established ADI or UL 8.3.2.3.Food additives for which no ADI is allocated 8.3.3.Studies concerning the safety of use of the additive for...8.3.4.Studies concerning the safety of use of the additive for...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...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...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 IVCategories 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...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

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition1, and in particular Article 7(4) and (5) thereof,

After consulting the European Food Safety Authority in accordance with Article 7(4) and (5) of Regulation (EC) No 1831/2003,

Whereas:

(1)

It is necessary to establish implementing rules concerning the procedure for the authorisation of feed additives under Regulation (EC) No 1831/2003, including rules for the preparation and the presentation of the applications and for the assessment and the authorisation of such additives. These rules are intended to replace the provisions laid down in the Annex to Council Directive 87/153/EEC2 fixing guidelines for the assessment of additives in animal nutrition.

(2)

Those rules should provide for the requirements to be satisfied by the dossier accompanying the application. They should, in particular, set out the scientific data to be submitted for the identification and the characterisation of the additive concerned and the studies to be submitted to demonstrate its efficacy and its safety for humans, animals and the environment in view of the verification and assessment of the applications for authorisation by the European Food Safety Authority (the Authority).

(3)

Depending on the nature of the additive or its requested conditions of use, the extent of the studies necessary to evaluate its properties or its effects may vary. Operators should, therefore, be granted some flexibility with respect to the kind of studies and material to be submitted to demonstrate the safety and the efficacy of the additive concerned. Operators making use of that flexibility should have to justify their choice in the dossier.

(4)

The Authority should have the possibility to request supplementary information, where appropriate, in order to determine whether the additive complies with the conditions for authorisation referred to in Article 5 of Regulation (EC) No 1831/2003.

(5)

It is indispensable to apply appropriate quality standards when developing dossiers for additives intended for use in feed or water to ensure that the results of laboratory tests are not disputed.

(6)

Where necessary, specific requirements should be established for each category of additives referred to in Article 6(1) of Regulation (EC) No 1831/2003.

(7)

To stimulate efforts to obtain authorisations for minor species while keeping the necessary level of safety, specific conditions should be provided for taking into account the possibility of extrapolating the results of the studies carried out on major species to minor species.

(8)

Implementing rules concerning applications for authorisation should take into account different requirements for food-producing animals and other animals, for which aspects regarding the safety evaluation for the human consumer are not relevant.

(9)

Recourse to procedures involving the use of laboratory animals for experimental or other scientific purposes and animal testing according to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of the animals used for experimental and other scientific purposes3 should be kept to a minimum.

(10)

To avoid repeating studies unnecessarily, simplified procedures should be provided for the authorisation of additives already authorised for use in food.

(11)

As regards additives already authorised without a time limit under Council Directive 70/524/EEC4, where appropriate, the possibility should be provided for the applicant to demonstrate efficacy, where studies are not available, by any other material which is available to demonstrate efficacy, in particular material concerning the long history of use of the additive concerned.

(12)

Rules should be provided for applications for modifications of authorisations in accordance with Article 13(3) of Regulation (EC) No 1831/2003.

(13)

Rules should also be provided for applications for the renewal of authorisation under Article 14 of Regulation (EC) No 1831/2003.

(14)

With respect to the provisions concerning the safety and efficacy studies to be carried out in support of the application, it is necessary to provide for a transitional period during which the present rules continue to apply. Applications submitted before the entry into force of this Regulation should continue to be treated in accordance with the Annex to Directive 87/153/EEC. With respect to applications submitted during a certain period after entry into force, taking into account the long period of time required for some studies, applicants should have a choice between the rules provided for in this Regulation and the Annex to Directive 87/153/EEC. The implementing rules have been drawn up on the basis of present scientific and technical knowledge and they should be adapted if necessary to any new developments.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION: