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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)

EU Regulation No 429/2008 · Adopted 25 April 2008 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 nutritionf1, 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/EECf2 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 purposesf3 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/EECf4, 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:

Annotations to the whole text

Footnotes

f1

OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 68).

f2

OJ L 64, 7.3.1987, p. 19. Repealed by Regulation (EC) No 1831/2003.

f3

OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of European Parliament and the Council (OJ L 230, 16.9.2003, p. 32).

f4

OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).

Contents

  1. 1Definitions
  2. 2Application
  3. 3Dossier
  4. 4Transitional measures
  5. 5Entry into force
  6. Signature
  7. Annex I: APPLICATION FORM REFERRED TO IN ARTICLE 2(1) AND ADMINISTRATIVE DATA
  8. 1APPLICATION FORM
  9. 1.1Identification and characterisation of additive
  10. Conditions of use
  11. 1.2.1Use in complete feedingstuffs
  12. 1.2.2Use in water
  13. 1.2.3Special conditions of use (if appropriate)
  14. 1.3Reference samples
  15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  16. 1.5Enclosures:
  17. 2ADMINISTRATIVE DATA OF APPLICANT(S)
  18. (1)Applicant company or person
  19. (2)Contact person (for all correspondence with appropriate authority, Food Safety Authority and reference laboratory)
  20. Annex II: GENERAL REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3
  21. GENERAL ASPECTS
  22. Safety assessment
  23. Efficacy assessment
  24. SECTION I: SUMMARY OF THE DOSSIER
  25. 1.1Public summary according to Article 7(3)(h) of Regulation (EC) No 1831/2003
  26. 1.1.1Contents
  27. 1.1.2Description
  28. 1.2Scientific summary of the dossier
  29. 1.3List of documents and other particulars
  30. 1.4List of parts of the dossier requested to be treated as confidential, where necessary
  31. 2SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS
  32. Identity of the additive
  33. 2.1.1Name of the additive
  34. 2.1.2Proposal for classification
  35. 2.1.3Qualitative and quantitative composition (active substance/agent, other components, impurities, batch to batch variation)
  36. 2.1.4Purity
  37. 2.1.4.1Additives whose authorisation is linked to a holder of authorisation
  38. 2.1.4.2Additives whose authorisation is not linked to a holder of authorisation
  39. 2.1.5Physical state of each form of the product
  40. Characterisation of the active substance(s)/agent(s)
  41. 2.2.1Description
  42. 2.2.1.1Chemical substances
  43. 2.2.1.2Micro-organisms
  44. Relevant properties
  45. 2.2.2.1Chemical substances
  46. 2.2.2.2Micro-organisms
  47. 2.3Manufacturing process, including any specific processing procedures
  48. 2.3.1Active substance(s)/agent(s)
  49. 2.3.2Additive
  50. Physico-chemical and technological properties of the additive
  51. 2.4.1Stability
  52. 2.4.2Homogeneity
  53. 2.4.3Other characteristics
  54. 2.4.4Physico-chemical incompatibilities or interactions
  55. Conditions of use of the additive
  56. 2.5.1Proposed mode of use in animal nutrition
  57. Information related to users/workers safety
  58. 2.5.2.1Chemical substances
  59. 2.5.2.2Micro-organisms
  60. 2.5.2.3Labelling requirements
  61. 2.6Methods of analysis and reference samples
  62. 2.6.1Methods of analysis for the active substance
  63. 2.6.1.1These methods shall meet the same requirements as those for methods of analysis used for official control purpose laid down in Regulation (EU) 2017/625. In particular they shall meet at least one of the following requirements:
  64. 2.6.1.2Division 2.6.1.2
  65. 2.6.1.3Division 2.6.1.3
  66. 2.6.1.4Division 2.6.1.4
  67. 2.6.1.5Division 2.6.1.5
  68. 2.6.2Methods of analysis for the determination of the residues of the additive or of its metabolites in food
  69. 2.6.2.1Division 2.6.2.1
  70. 2.6.2.2The detailed characterisation of the method(s) shall include the appropriate characteristics as set out in Annex III of Regulation (EU) 2017/625 and shall take into account the requirements set out in Commission Decision 2002/657/EC. The same performance criteria laid down in Commission Decisions laying down analytical methods to be used for detecting certain substances and residues thereof in live animal products according to Council Directive 96/23/EC shall be considered where appropriate.
  71. 2.6.2.3Division 2.6.2.3
  72. 2.6.2.4Division 2.6.2.4
  73. 2.6.2.5Division 2.6.2.5
  74. 2.6.3Methods of the analysis relating to the identity and characterisation of the additive
  75. 3SECTION III: STUDIES CONCERNING SAFETY OF THE ADDITIVE
  76. 3.1Studies concerning the safety of use of the additive for the target animals
  77. 3.1.1Tolerance studies for the target species
  78. 3.1.1.1The design of a tolerance test includes a minimum of three groups:
  79. 3.1.1.2Duration of tolerance trials
  80. 3.1.1.3Experimental conditions
  81. 3.1.2Microbial studies
  82. 3.2Studies concerning the safety of use of the additive for consumers
  83. 3.2.1Metabolic and residue studies
  84. 3.2.1.1Metabolic studies
  85. 3.2.1.2Residue studies
  86. 3.2.1.3Metabolic and disposition studies
  87. 3.2.1.4Bioavailability of residues
  88. 3.2.2Toxicological studies
  89. 3.2.2.1Acute toxicity
  90. 3.2.2.2Genotoxicity studies including mutagenicity
  91. 3.2.2.3Sub-chronic repeated dose oral toxicity studies
  92. 3.2.2.4Chronic oral toxicity studies (including carcinogenicity studies)
  93. 3.2.2.5Reproduction toxicity studies (including prenatal developmental toxicity)
  94. 3.2.2.5.1Two generation reproduction toxicity study
  95. 3.2.2.5.2Prenatal developmental toxicity study (teratogenicity study)
  96. 3.2.2.6Other specific toxicological and pharmacological studies
  97. 3.2.2.7Determination of No Observed Adverse Effect Levels (NOAEL)
  98. 3.2.3Assessment of consumer safety
  99. 3.2.3.1Proposal of the acceptable daily intake (ADI) for the active substance(s)
  100. 3.2.3.2Tolerable upper intake level (UL)
  101. 3.2.3.3Consumer exposure
  102. 3.2.3.4Proposal for maximum residue limits (MRLs)
  103. 3.2.3.5Proposal for a withdrawal period
  104. 3.3Studies concerning the safety of use of the additive for users/workers
  105. 3.3.1Toxicological risk assessment for user/worker safety
  106. 3.3.1.1Effects on the respiratory system
  107. 3.3.1.2Effects on the eyes and skin
  108. 3.3.1.3Systemic toxicity
  109. 3.3.1.4Exposure assessment
  110. 3.3.2Measures to control exposure
  111. 3.4Studies concerning the safety of use of the additive for the environment
  112. 3.4.1Phase I assessment
  113. 3.4.1.1Additives for terrestrial animals
  114. 3.4.1.2Additives for aquatic animals
  115. Phase I — Decision tree
  116. 3.4.2Phase II assessment
  117. 3.4.2.1Phase II A
  118. 3.4.2.2Phase IIB (more detailed ecotoxicological studies)
  119. 4SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE
  120. 4.1In vitro studies
  121. 4.2Short term efficacy studies with animals
  122. 4.3Long term efficacy studies with animals
  123. 4.4Duration of long term efficacy studies with target animals
  124. 4.5Efficacy requirements for additive categories and functional groups
  125. 4.6Studies on the quality of animal products where this is not the effect claimed
  126. 5SECTION V: POST-MARKET MONITORING PLAN
  127. 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
  128. List of the specific requirements for establishing dossiers for:
  129. General conditions
  130. TECHNOLOGICAL ADDITIVES
  131. 1.1Section I: summary of the dossier
  132. 1.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  133. 1.3Section III: studies concerning the safety of the additive
  134. 1.3.1Studies concerning the safety of use of the additive to the target animals
  135. 1.3.1.1Tolerance studies for the target species
  136. 1.3.1.2Microbial studies
  137. Studies concerning the safety of use of the additive for consumers
  138. 1.3.2.1Metabolic and residue studies
  139. 1.3.2.2Toxicological studies
  140. 1.3.2.3Assessment of consumer safety
  141. 1.3.3Studies concerning the safety of use of the additive for users/workers
  142. 1.3.4Studies concerning the safety of use of the additive for the environment
  143. 1.4Section IV: studies concerning the efficacy of the additive
  144. 1.5Section V: post-market monitoring plan
  145. SENSORY ADDITIVES
  146. Colourants
  147. 2.1.1Section I: summary of the dossier
  148. 2.1.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  149. 2.1.3Section III: studies concerning the safety of the use of the additive
  150. 2.1.4Section IV: studies concerning the efficacy of the additive
  151. 2.1.5Section V: post-market monitoring plan
  152. Flavouring compounds
  153. 2.2.1Section I: summary of the dossier
  154. 2.2.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  155. 2.2.2.1Characterisation of active substance(s)/agent(s)
  156. 2.2.2.2Method of production and manufacture
  157. 2.2.2.3Methods of analysis
  158. 2.2.3Section III: studies concerning the safety of the additive
  159. 2.2.3.1Studies concerning the safety of use of the additive for target animals
  160. 2.2.3.2Studies concerning the safety of use of the additive for consumers
  161. 2.2.3.3Studies concerning the safety of use of the additive for users/workers
  162. 2.2.3.4Studies concerning the safety of use of the additive for the environment
  163. 2.2.4Section IV: studies concerning the efficacy of the additive
  164. 2.2.5Section V: post-market monitoring plan
  165. NUTRITIONAL ADDITIVES
  166. 3.1Section I: summary of the dossier
  167. 3.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  168. Section III: studies concerning the safety of the additives
  169. Studies concerning the safety of use of the additive for the target species
  170. 3.3.1.1Tolerance of the target species
  171. 3.3.1.2Microbial studies
  172. Studies concerning the safety of use of the additive for consumers
  173. 3.3.2.1Metabolic and residue studies
  174. 3.3.2.2Toxicological studies
  175. 3.3.2.3Assessment of consumer safety
  176. 3.3.3Studies concerning the safety of use of the additive for users/workers
  177. 3.3.4Studies concerning the safety of use of the additive for the environment
  178. 3.4Section IV: studies concerning the efficacy of the additive
  179. 3.5Section V: post-market monitoring plan
  180. ZOOTECHNICAL ADDITIVES
  181. Zootechnical additives other than enzymes and micro-organisms
  182. 4.1.1Section I: summary of the dossier.
  183. 4.1.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  184. Section III: studies concerning the safety of the additives
  185. 4.1.3.1Studies concerning the safety of use of the additive for target animals
  186. 4.1.3.2Studies concerning the safety of use of the additive for consumer
  187. 4.1.3.3Studies concerning the safety of the additive for users/workers
  188. 4.1.3.4Studies concerning the safety of the additive for the environment
  189. 4.1.4Section IV: studies concerning the efficacy of the additive
  190. 4.1.5Section V: post-market monitoring plan
  191. Zootechnical additives: enzymes and micro-organisms
  192. 4.2.1Section I: summary of the dossier
  193. 4.2.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  194. Section III: studies concerning the safety of the additives
  195. 4.2.3.1Studies concerning the safety of use of the additive for the target animals
  196. 4.2.3.2Studies concerning the safety of the additive use for consumer
  197. 4.2.3.3Studies concerning the safety of the additive for users/workers
  198. 4.2.3.4Studies concerning the safety of the additive for the environment
  199. 4.2.4Section IV: studies concerning the efficacy of the additives
  200. 4.2.5Section V: post-market monitoring plan
  201. COCCIDIOSTATS AND HISTOMONOSTATS
  202. 5.1Section I: summary of the dossier
  203. 5.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  204. Section III: studies concerning the safety of the additives
  205. 5.3.1Studies concerning the safety of use of the additive for target animals
  206. 5.3.2Studies concerning the safety of use of the additive for consumer
  207. 5.3.3Studies concerning the safety of use of the additive for users/workers
  208. 5.3.4Studies concerning the safety of use of the additive for environment
  209. 5.4Section IV: studies concerning the efficacy of the additive
  210. 5.5Section V: post-market monitoring plan
  211. 6EXTRAPOLATION FROM MAJOR TO MINOR SPECIES
  212. 6.1Section I: summary of the dossier
  213. 6.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  214. Section III: studies concerning the safety of the use of the additive
  215. Studies concerning the safety of use of the additive for the target animals
  216. 6.3.1.1Tolerance of the target species
  217. Studies concerning the safety of use of the additive for the human consumers
  218. 6.3.2.1Metabolic studies
  219. 6.3.2.2Residue studies
  220. 6.3.2.3Assessment of consumer safety
  221. 6.3.3Studies concerning the safety of use of the additive for users/workers
  222. 6.3.4Studies concerning the safety of use of the additive for the environment
  223. 6.4Section IV: studies concerning the efficacy of the additive
  224. 6.5Section V: post-market monitoring plan
  225. 7PETS AND OTHER NON FOOD-PRODUCING ANIMALS
  226. 7.1Section I: summary of the dossier
  227. 7.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  228. Section III: studies concerning the safety of the additive
  229. 7.3.1Studies concerning the safety of use of the additive for the target animals
  230. 7.3.2Studies concerning the safety of use of the additive for consumers
  231. 7.3.3Studies concerning the safety of use of the additive for users/workers
  232. 7.3.4Studies concerning the safety of use of the additive for the environment
  233. 7.4Section IV: studies concerning the efficacy of the additive
  234. 7.5Section V: post-market monitoring plan
  235. ADDITIVES ALREADY AUTHORISED FOR USE IN FOOD
  236. 8.1Section I: summary of the dossier
  237. 8.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  238. 8.3Section III: studies concerning the safety of the additives
  239. 8.3.1Studies concerning the safety of use of the additive for the target animals
  240. 8.3.2Studies concerning the safety of use of the additive for consumers
  241. 8.3.2.1Food additives for which an ADI is not specified
  242. 8.3.2.2Food additives with an established ADI or UL
  243. 8.3.2.3Food additives for which no ADI is allocated
  244. 8.3.3Studies concerning the safety of use of the additive for users/workers
  245. 8.3.4Studies concerning the safety of use of the additive for the environment
  246. 8.4Section IV: studies concerning the efficacy of the additive
  247. 8.5Section V: post-market monitoring plan
  248. 9MODIFICATION OF THE AUTHORISATIONS
  250. 10Division 10
  251. 11RE-EVALUATION OF CERTAIN ADDITIVES ALREADY AUTHORISED UNDER DIRECTIVE 70/524/EEC
  252. 11.1Section I: summary of the dossier
  253. 11.2Section II: identity, characterisation and conditions of use of the additive; methods of analysis
  254. 11.3Section III: studies concerning the safety of the additives
  255. 11.4Section IV: studies concerning the efficacy of the additive
  256. 11.5Section V: post-market monitoring plan
  257. Annex IV: Categories and definitions of target animals and indication of the minimum duration of efficacy studies
  258. 1Table. Animal categories: Pigs
  259. 2Table. Animal categories: Poultry
  260. 3Table. Animal categories: Bovines (domestic bovine animals including bubalus and bison species)
  261. 4Table. Animal categories: Sheep
  262. 5Table. Animal categories: Goats
  263. 6Table. Animal categories: Fish
  264. 7Table. Animal categories: Rabbits
  265. 8Table. Animal Categories: horses