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Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)

EU Regulation No 503/2013 · Adopted 3 April 2013 · 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 Implementing Regulation (EU) No 503/2013

of 3 April 2013

on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feedf1, and in particular Articles 5(7), 11(5), 17(7) and 23(5) thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)

Regulation (EC) No 1829/2003 lays down Union procedures for the authorisation and supervision of genetically modified food and feed, including rules for the labelling of such food and feed. That Regulation provides for a scientific evaluation to be carried out on the risks that the genetically modified food or feed may present for human and animal health and, as the case may be, for the environment. It also provides that a genetically modified food or feed must not mislead the consumer or the user and must not differ from the food or feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals.

(2)

Regulation (EC) No 1829/2003 provides, in particular, that applications for authorisation are to adequately and sufficiently demonstrate that the genetically modified food and feed satisfy the requirements laid down in that Regulation, in respect of their proposed uses.

(3)

In the interest of consistency of Union legislation, certain definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyf2 should also apply to this Regulation.

(4)

Commission Regulation (EC) No 641/2004f3 on detailed rules for the implementation of Regulation (EC) No 1829/2003 provides for certain detailed rules concerning applications for authorisation submitted in accordance with Regulation (EC) No 1829/2003. To facilitate the preparation of applications and ensure that they contain all the information needed for their assessment, it is necessary to provide for more comprehensive and systematic rules concerning applications for authorisation, which should also be specific to each type of genetically modified organisms (GMO), namely plants, animals and micro-organisms.

(5)

The rules laid down in this Regulation should only cover applications concerning genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food or feed produced from such plants. Genetically modified plants, for which sufficient experience is available to date, constitute the vast majority of current applications.

(6)

The rules laid down in this Regulation should specify the general requirements for the presentation and preparation of applications, namely requirements to provide general and scientific information, including methods for detection, and identification, as well as reference material so as to ensure that applications comply with the conditions laid down in Articles 5, 17 and 30 of Regulation (EC) No 1829/2003.

(7)

The applicant should also take into consideration the scientific information to be provided in the application as regards the environmental risk assessment of GMOs or food and feed containing or consisting of GMOs, as set out in the principles for the environmental risk assessment in Annex II to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EECf4, as well as the applicable guidance published by the European Food Safety Authority (EFSA) in this regard.

(8)

In addition to the general requirements for the presentation and preparation of applications, it is appropriate to provide for specific rules to ensure that the scientific information required in the application adequately and sufficiently demonstrates that the genetically modified food or feed satisfy the requirements laid down in Regulation (EC) No 1829/2003, in respect of their proposed uses.

(9)

These rules should therefore provide for a set of studies that should be included in all applications, as well as the test methods to be followed to perform such studies, whilst taking into account relevant international standards, such as the guideline of the Codex Alimentarius for the conduct of safety assessment of foods derived from the recombinant-DNA plantf5.

(10)

In accordance with the applicable guidance of the EFSAf6, the safety assessment of the genetically modified food or feed should include studies related to new components resulting from the genetic modification, the molecular characterisation of the genetically modified plant, the comparative analysis of the composition and the phenotype of the genetically modified plant compared to its conventional counterpart. Depending on the characteristics of the genetically modified plant and on the outcome of that first set of studies, the EFSA guidance indicates that it may be necessary to perform additional studies. In that respect, the EFSA considers that notwithstanding its limitations, a 90-day feeding study in rodents with whole food or feed is, when justified, the primary additional study to address uncertainties identified in the course of the safety assessment.

(11)

It has, however, not been proved possible to define with the necessary precision the level of uncertainties which would require the submission of 90-day feeding studies. In addition, some food and feed assessment bodies of Member States are of the opinion that such study should be performed in all applications for genetically modified plants containing single transformation events. Considering these diverging views, as well as to improve consumer confidence, such studies should be, for the time being, requested in all applications related to genetically modified plants with single transformation events and, where appropriate, on genetically modified plants containing stacked transformation events.

(12)

Studies to demonstrate that a genetically modified food or feed fulfils the requirements of Regulation (EC) No 1829/2003 involving the use of laboratory animals should be carried out in accordance with Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 regarding the protection of the animals used for scientific purposesf7, and should be kept to a minimum while ensuring an adequate demonstration of the safety of the genetically modified food or feed. The current uncertainties in relation to the need and design of 90-day feeding trials will be addressed by a large research project under the 2012 work programme of Theme 2 ‘Food, Agriculture and Fisheries, and Biotechnologies’ of the seventh Framework Programme for Research (FP7). The requirements regarding animal feeding trials in the context of GMO risk assessments should be reviewed in the light of the outcome of this project expected to be available by the end of 2015 at the latest. Other credible scientific knowledge which might be available at that time should also be taken into account.

(13)

While the rules laid down in this Regulation should be valid for all applications for genetically modified plants, the type and necessity of the studies to evaluate the characteristics and safety of genetically modified food or feed subject to an application may vary, depending on the nature of the genetic modification or of the product. For example, genetic modifications which have negligible impact on the composition of a genetically modified food or feed or highly refined products that may be proven to be identical to products produced from the conventional counterpart require different studies than a product resulting from complex genetic modification aiming to modify its nutritional characteristics.

(14)

The requirements laid down in this Regulation regarding the studies which have to be included in an application for authorisation under Regulation (EC) No 1829/2003 should not prevent the EFSA to request, where appropriate, the applicant to supplement the particulars accompanying the application in accordance with Articles 6(2) and 18(2) of Regulation (EC) No 1829/2003.

(15)

In order to ensure that studies are of high quality and documented in a transparent way, it is essential that they are performed under appropriate quality assurance systems and raw data should be provided in all cases and be in a suitable electronic format. Toxicological studies should be performed in accordance with the quality assurance principles laid down by Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substancesf8. If such studies are carried out outside the Union, they should follow the state-of-the-art OECD Principles on Good Laboratory Practice (GLP). With regard to studies other than toxicological studies, they should be conducted under ISO or GLP standards.

(16)

It is also necessary to define the requirements regarding the submission of additional information related to the safety of the GMO and scientific peer-reviewed literature related to the potential effects on health and on the environment of the products covered by the application.

(17)

During the process of the genetic modification of plants and other organisms, marker genes are often used to facilitate the selection and identification of genetically modified cells, containing the gene of interest inserted into the genome of the host organism, among the vast majority of untransformed cells. Such marker genes should be carefully selected. In addition, it is now possible to develop GMOs without the use of antibiotic resistance marker genes. Against this background and in accordance with Article 4(2) of Directive 2001/18/EC, the applicant should therefore aim to develop GMOs without the use of antibiotic resistance marker genes.

(18)

The harvest of segregating genetically modified plants (segregating crops) containing stacked transformation events contains various subcombinations of transformation events. In addition, current control procedures do not allow identifying the origin of combinations of transformation events. Therefore, in order to ensure that authorisations are coherent with the products of which the placing on the market is unavoidable and for the feasibility of controls, the applications for genetically modified food and feed from segregating crops should include all subcombinations independently of their origin and not yet authorised.

(19)

Regulation (EC) No 1829/2003 provides that a proposal for post-market monitoring of the use of the genetically modified food or feed shall only be submitted by the applicant where it is appropriate. It is therefore necessary to set out the conditions under which such a proposal should, according to the outcome of the risk assessment, accompany the application. Post-market monitoring should only be considered in cases where, notwithstanding the fact that the safety of genetically modified food and feed has been demonstrated, it is appropriate to confirm the expected consumption, the application of conditions of uses or identified effects. This is for example the case when the genetically modified food or feed has altered nutritional composition or when that its nutritional value differs from the conventional food or feed that it would replace or when there is a likelihood of increased allergenicity due to the genetic modification.

(20)

This Regulation should take account of the international trade commitments of the Union and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol), approved by Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafetyf9 as well as the provisions of Regulation (EC) No 1946/2003 of 15 July 2003 of the European Parliament and of the Council on transboundary movements of genetically modified organismsf10.

(21)

In order to ensure that test methods included in the application are adequate to demonstrate that the food or feed complies with the requirements for authorisation set out in Regulation (EC) No 1829/2003, they should be carried out in accordance with the present Regulation, or internationally agreed guidelines such as those described by the OECD, when available. To ensure that applications for renewal meet the same standards as regards tests methods, it is appropriate that these requirements also apply to application for renewal of authorisation of GM food and feed.

(22)

In order to provide an accurate designation of the GM food or feed subject to an application under Regulation (EC) No 1829/2003, applications should include proposals for a unique identifier for each GMO concerned in accordance with Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organismsf11.

(23)

This Regulation replaces certain provisions of Regulation (EC) No 641/2004 as regards genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food or feed produced from genetically modified plants. However, Regulation (EC) No 641/2004 should continue to apply as regards other types of genetically modified products, namely genetically modified animals and genetically modified micro-organisms. Moreover, certain provisions of that Regulation are obsolete. Regulation (EC) No 641/2004 should therefore be amended accordingly.

(24)

Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organismsf12 should be amended to include references to this Regulation.

(25)

Regulation (EC) No 1829/2003 provides that the Commission is to consult the EFSA before establishing implementing rules with regard to the applications for authorisation under that Regulation. The EFSA has been consulted on those rules accordingly.

(26)

This Regulation has been drawn up on the basis of current scientific and technical knowledge. Therefore, the Commission should monitor any developments in this field and the publication of new or additional guidance by the EFSA.

(27)

This Regulation applies to applications submitted after its entry into force. It is necessary to provide for transitional measures in order to enable the applicants to comply with those rules and for the current applications or the applications close to being submitted to proceed without unnecessary delays.

(28)

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. 1.

f2

OJ L 31, 1.2.2002, p. 1.

f3

OJ L 102, 7.4.2004, p. 14.

f4

OJ L 106, 17.4.2001, p. 1.

f5

Codex Alimentarius Commission, GL 45-2003.

f6

EFSA Journal 2011; 9(5):2150.

f7

OJ L 276, 20.10.2010, p. 33.

f8

OJ L 50, 20.2.2004, p. 44.

f9

OJ L 201, 31.7.2002, p. 48.

f10

OJ L 287, 5.11.2003, p. 1.

f11

OJ L 10, 14.1.2004, p. 5.

f12

OJ L 368, 23.12.2006, p. 99.

Contents

  1. Chapter I: GENERAL PROVISIONS
  2. 1Scope
  3. 2Definitions
  4. Chapter II: GENERAL REQUIREMENTS
  5. 3Preparation and presentation of applications submitted under Articles 5(1) and 17(1)
  6. Chapter III: SPECIFIC REQUIREMENTS
  7. 4Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)
  8. 5Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)
  9. 6Additional information related to the risk assessment of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
  10. 7Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
  11. 8Requirements concerning the methods of detection, identification and quantification and for control samples and reference material of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
  12. Chapter IV: TRANSITIONAL AND FINAL PROVISIONS
  13. 9Transitional provisions
  14. 10Amendments to Regulation (EC) No 641/2004
  15. 11Amendments to Regulation (EC) No 1981/2006
  16. 12Review
  17. 13Entry into force
  18. Signature
  19. Annex IPREPARATION AND PRESENTATION OF APPLICATIONS
  20. Part I: GENERAL INFORMATION
  21. 1Division 1
  22. 2Division 2
  23. 3Division 3
  24. 4Scope of the application:
  25. 5Unique identifier.
  26. 6Where applicable, a detailed description of the method of production and manufacturing.
  27. 7Division 7
  28. 8Where applicable, the status of the food or feed or of related substances under other provisions of legislation in force in the relevant constituent territory of Great Britain.
  29. IISCIENTIFIC INFORMATION
  30. HAZARD IDENTIFICATION AND CHARACTERISATION
  31. Information relating to the recipient or (where appropriate) parental plants
  32. (a)Complete name:
  33. (b)Division (b)
  34. (c)Division (c)
  35. (d)Division (d)
  36. (e)Additional information relating to the recipient or parental plants required for the environmental safety aspects:
  37. Molecular Characterisation
  38. Information relating to the genetic modification
  39. 1.2.1.1Division 1.2.1.1
  40. 1.2.1.2Division 1.2.1.2
  41. 1.2.1.3Division 1.2.1.3
  42. Information relating to the genetically modified plant
  43. 1.2.2.1Division 1.2.2.1
  44. 1.2.2.2Division 1.2.2.2
  45. 1.2.2.3Division 1.2.2.3
  46. 1.2.2.4Division 1.2.2.4
  47. 1.2.2.5Division 1.2.2.5
  48. Additional information relating to the genetically modified plant required for the environmental safety aspects
  49. 1.2.3.1Division 1.2.3.1
  50. 1.2.3.2Any change to the ability of the genetically modified plant to transfer genetic material to other organisms, namely:
  51. Conclusions of the molecular characterisation
  52. Comparative analysis
  53. Choice of the conventional counterpart and additional comparators
  54. Experimental design and statistical analysis of data from field trials for comparative analysis
  55. 1.3.2.1Division 1.3.2.1
  56. 1.3.2.2Division 1.3.2.2
  57. Selection of material and compounds for analysis
  58. Comparative analysis of composition
  59. Comparative analysis of agronomic and phenotypic characteristics
  60. Effects of processing
  61. Conclusion
  62. Toxicology
  63. Testing of newly expressed proteins
  64. Testing of new constituents other than proteins
  65. Information on natural food and feed constituents
  66. Testing of the whole genetically modified food or feed
  67. 1.4.4.1Division 1.4.4.1
  68. 1.4.4.2Division 1.4.4.2
  69. 1.4.4.3Division 1.4.4.3
  70. Conclusion of the toxicological assessment
  71. Allergenicity
  72. Assessment of allergenicity of the newly expressed protein
  73. Assessment of allergenicity of the whole genetically modified plant
  74. Conclusion of the allergenicity assessment
  75. Nutritional assessment
  76. Nutritional assessment of the genetically modified food
  77. Nutritional assessment of the genetically modified feed
  78. Conclusion of the nutritional assessment
  79. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE
  80. RISK CHARACTERISATION
  81. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
  82. ENVIRONMENTAL ASSESSMENT
  83. ENVIRONMENTAL MONITORING PLAN
  84. 7ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED FOOD OR FEED
  85. IIICARTAGENA PROTOCOL
  86. IVLABELLING
  87. VMETHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL
  88. VIADDITIONAL INFORMATION TO BE PROVIDED FOR GENETICALLY MODIFIED PLANTS AND/OR FOOD OR FEED CONTAINING OR CONSISTING OF GENETICALLY MODIFIED PLANTS
  89. VIISUMMARY OF APPLICATIONS
  90. GENERAL INFORMATION
  91. Details of application
  92. (a)Division (a)
  93. (b)Division (b)
  94. (c)Division (c)
  95. (d)Division (d)
  96. Applicant
  97. (a)Division (a)
  98. (b)Division (b)
  99. (c)Division (c)
  100. Scope of the application
  101. (a)Genetically modified food
  102. (b)Genetically modified feed
  103. (c)Genetically modified plants for food and feed use
  104. 1.4Division 1.4
  105. 1.5Division 1.5
  106. 1.6Division 1.6
  107. 1.7Division 1.7
  108. General description of the product
  109. (a)Division (a)
  110. (b)Division (b)
  111. (c)Division (c)
  112. (d)Division (d)
  113. (e)Division (e)
  114. (f)Division (f)
  115. (g)Division (g)
  116. (h)Any proposed labelling requirements in addition to those required by other applicable legislation in force in the relevant constituent territory of Great Britain than Regulation (EC) No 1829/2003 and when necessary a proposal for specific labelling in accordance with Article 13(2) and (3), Article 25(2)(c) and (d) and Article 25(3) of Regulation (EC) No 1829/2003
  117. (i)Estimated potential demand—
  118. (j)Division (j)
  119. Measures suggested by the applicant to take in the case of unintended release or misuse of the product as well as measures for its disposal and treatment
  120. INFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS
  121. Complete name
  122. (a)Division (a)
  123. (b)Division (b)
  124. (c)Division (c)
  125. (d)Division (d)
  126. (e)Division (e)
  127. (f)Division (f)
  128. Geographical distribution and cultivation of the plant, including the distribution within Great Britain
  129. Information concerning reproduction (for environmental safety aspects)
  130. (a)Division (a)
  131. (b)Division (b)
  132. (c)Division (c)
  133. Sexual compatibility with other cultivated or wild plant species (for environmental safety aspects)
  134. Survivability (for environmental safety aspects)
  135. (a)Division (a)
  136. (b)Division (b)
  137. Dissemination (for environmental safety aspects)
  138. (a)Division (a)
  139. (b)Division (b)
  140. Geographical distribution within Great Britain of the sexually compatible species (for environmental safety aspects)
  141. In the case of plant species not normally grown in Great Britain description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts (for environmental safety aspects)
  142. Other potential interactions, relevant to the genetically modified plant, of the plant with organisms in the ecosystem where it is usually grown, or used elsewhere, including information on toxic effects on humans, animals and other organisms (for environmental safety aspects)
  143. MOLECULAR CHARACTERISATION
  144. Information relating to the genetic modification
  145. (a)Division (a)
  146. (b)Division (b)
  147. (c)Division (c)
  148. Information relating to the genetically modified plant
  149. Description of the trait(s) and characteristics which have been introduced or modified
  150. Information on the nucleic acid(s) sequences actually inserted or deleted
  151. (a)Division (a)
  152. (b)Division (b)
  153. (c)Division (c)
  154. (d)Division (d)
  155. (e)Division (e)
  156. Information on the expression of the insert
  157. (a)Division (a)
  158. (b)Division (b)
  159. Genetic stability of the insert and phenotypic stability of the genetically modified plant
  160. 3.2.5Division 3.2.5
  161. (a)Division (a)
  162. (b)Division (b)
  163. (c)Division (c)
  164. (d)Division (d)
  165. Any change to the ability of the genetically modified plant to transfer genetic material to other organisms (for environmental safety aspects)
  166. (a)Division (a)
  167. (b)Division (b)
  168. COMPARATIVE ANALYSIS
  169. Choice of the conventional counterpart and additional comparators
  170. 4.2Experimental design and statistical analysis of data from field trials for comparative analysis
  171. Selection of material and compounds for analysis
  172. Comparative analysis of agronomic and phenotypic characteristics
  173. Effect of processing
  174. TOXICOLOGY
  175. (a)Division (a)
  176. (b)Division (b)
  177. (c)Division (c)
  178. (d)Division (d)
  179. ALLERGENICITY
  180. (a)Division (a)
  181. (b)Division (b)
  182. NUTRITIONAL ASSESSMENT
  183. (a)Division (a)
  184. (b)Division (b)
  185. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE
  186. RISK CHARACTERISATION
  187. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
  188. ENVIRONMENTAL ASSESSMENT
  189. Mechanism of interaction between the genetically modified plant and target organisms
  190. Potential changes in the interactions of the genetically modified plant with the biotic environment resulting from the genetic modification
  191. (a)Division (a)
  192. (b)Division (b)
  193. (c)Division (c)
  194. (d)Division (d)
  195. (e)Division (e)
  196. (f)Division (f)
  197. (g)Division (g)
  198. (h)Division (h)
  199. (i)Division (i)
  200. Potential interactions with the abiotic environment
  201. Risk characterisation
  202. ENVIRONMENTAL MONITORING PLAN
  203. (a)Division (a)
  204. (b)Division (b)
  205. (c)Division (c)
  206. (d)Division (d)
  207. (e)Division (e)
  208. DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT
  209. INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT (FOR ENVIRONMENTAL RISK ASSESSMENT ASPECTS)
  210. History of previous releases of the genetically modified plant notified under Part B of Directive 2001/18/EC or under Part B of Council Directive 90/220/EEC by the same notifier
  211. (a)Division (a)
  212. (b)Division (b)
  213. (c)Division (c)
  214. History of previous releases of the genetically modified plant carried out outside Great Britain by the same notifier
  215. (a)Division (a)
  216. (b)Division (b)
  217. (c)Division (c)
  218. (d)Division (d)
  219. (e)Division (e)
  220. (f)Division (f)
  221. (g)Division (g)
  222. (h)Division (h)
  223. (i)Division (i)
  224. Annex II: SCIENTIFIC REQUIREMENTS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED FOOD AND FEED
  225. INTRODUCTION
  226. 1DEFINITIONS
  227. SPECIFIC CONSIDERATIONS
  228. 2.1Insertion of marker genes and other nucleic acid(s) sequences not essential to achieve the desired trait
  229. 2.2Risk assessment of genetically modified food and feed containing stacked transformation events
  230. SCIENTIFIC REQUIREMENTS
  231. HAZARD IDENTIFICATION AND CHARACTERISATION
  232. Information relating to the recipient or (where appropriate) parental plants
  233. 1.1.1The applicant shall provide comprehensive information relating to the recipient or (where appropriate) the parental plants in order to:
  234. 1.1.2For the purposes referred to in point 1.1.1, the applicant shall provide the following information:
  235. Molecular Characterisation
  236. 1.2.1Information relating to the genetic modification
  237. 1.2.1.1Description of the methods used for the genetic modification
  238. 1.2.1.2Nature and source of vector used
  239. 1.2.1.3Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion
  240. Information relating to the genetically modified plant
  241. 1.2.2.1General description of the trait(s) and characteristics which have been introduced or modified
  242. 1.2.2.2Information on the sequences actually inserted/deleted
  243. 1.2.2.3Information on the expression of the insert(s)
  244. 1.2.2.4Genetic stability of the insert and phenotypic stability of the genetically modified plant
  245. 1.2.2.5Potential risk associated with horizontal gene transfer
  246. 1.2.3Conclusions of the molecular characterisation
  247. 1.3Comparative analysis
  248. 1.3.1Choice of the conventional counterpart and additional comparators
  249. Experimental design and statistical analysis of data from field trials for comparative analysis
  250. Description of the protocols for the experimental design
  251. (a)Principles of experimental design
  252. (b)Specific protocols for experimental design
  253. 1.3.2.2Statistical analysis
  254. 1.3.3Selection of material and compounds for analysis
  255. 1.3.4Comparative analysis of composition
  256. 1.3.5Comparative analysis of agronomic and phenotypic characteristics
  257. 1.3.6Effects of processing
  258. 1.3.7Conclusion
  259. 1.4Toxicology
  260. 1.4.1Testing of newly expressed proteins
  261. 1.4.2Testing of new constituents other than proteins
  262. 1.4.3Information on altered levels of food and feed constituents
  263. 1.4.4Testing of the whole genetically modified food and feed
  264. 1.4.4.190-day feeding study in rodents with whole genetically modified food/feed
  265. 1.4.4.2Animal studies with respect to reproductive and developmental toxicity testing
  266. 1.4.4.3Other animal studies to examine the safety and the characteristics of genetically modified food and feed (see also Sections 1.6.1 and 1.6.2)
  267. 1.4.4.4Interpretation of relevance of animal studies
  268. 1.4.5Conclusion of the toxicological assessment
  269. 1.5Allergenicity
  270. 1.5.1Assessment of allergenicity of the newly expressed protein
  271. 1.5.2Assessment of allergenicity of the genetically modified food or feed
  272. 1.5.3Adjuvanticity
  273. 1.5.4Conclusion of the allergenicity assessment
  274. Nutritional assessment
  275. 1.6.1Objectives of the nutritional assessment
  276. 1.6.2Points to consider for the nutritional assessment of genetically modified food and feed
  277. 1.6.3Nutritional studies of genetically modified food
  278. 1.6.4Nutritional studies of genetically modified feed
  279. 1.6.5Conclusion of the nutritional assessment
  280. 1.7Standardised guidelines for toxicity tests
  281. 2EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE
  282. RISK CHARACTERISATION
  283. 3.1Introduction
  284. 3.2Issues to be considered for risk characterisation
  285. 3.2.1Molecular characterisation
  286. 3.2.2Comparative analysis
  287. 3.2.3Food and feed safety in relation to intake
  288. 3.3The result of risk characterisation
  289. Annex III: VALIDATION OF METHODS FOR THE DETECTION, IDENTIFICATION AND QUANTIFICATION OF THE TRANSFORMATION EVENT, AND REQUIREMENTS FOR CONTROL SAMPLES AND THE CERTIFIED REFERENCE MATERIAL
  290. INTRODUCTION
  291. 1For the purposes of implementing Article 5(3)(i) and (j) and Article 17(3)(i) and (j) of Regulation (EC) No 1829/2003, this Annex sets out requirements on:
  292. 2Division 2
  293. 3Division 3
  294. 2DEFINITIONS
  295. METHOD VALIDATION
  296. Information about the method
  297. AThe method(s) shall refer to all the methodological steps needed to analyse the relevant food and feed material in accordance with Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003.
  298. BThe applicant shall be allowed to refer to validated protocols, if available and appropriate, for method modules used in the analytical procedure such as a DNA extraction protocol from a certain matrix.
  299. CThe applicant shall demonstrate that the method(s) fulfils the following requirements:
  300. DDivision D
  301. EThe applicant shall provide a complete and detailed description of the method.
  302. Information about the method testing carried out by the applicant
  303. ADivision A
  304. BDivision B
  305. CThe applicant shall provide the following information about the method development and the method optimisation:
  306. DThe applicant shall, in addition to the information required under Sections A, B and C provide the following information regarding the testing:
  307. 3.3Samples of the food and feed and their control samples
  308. 4CERTIFIED REFERENCE MATERIAL