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

8.6.2013	EN	Official Journal of the European Union	L 157/1

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 feed [^ntr1-L_2013157EN.01000101-E0001], 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 safety [^ntr2-L_2013157EN.01000101-E0002] should also apply to this Regulation.

• (4) Commission Regulation (EC) No 641/2004 [^ntr3-L_2013157EN.01000101-E0003] 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/EEC [^ntr4-L_2013157EN.01000101-E0004], 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 plant [^ntr5-L_2013157EN.01000101-E0005].

• (10) In accordance with the applicable guidance of the EFSA [^ntr6-L_2013157EN.01000101-E0006], 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 purposes [^ntr7-L_2013157EN.01000101-E0007], 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 substances [^ntr8-L_2013157EN.01000101-E0008]. 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 Biosafety [^ntr9-L_2013157EN.01000101-E0009] 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 organisms [^ntr10-L_2013157EN.01000101-E0010].

• (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 organisms [^ntr11-L_2013157EN.01000101-E0011].

• (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 organisms [^ntr12-L_2013157EN.01000101-E0012] 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:

CHAPTER I GENERAL PROVISIONS

Article 1

Scope

This Regulation shall apply to applications submitted under Articles 5, 11, 17 and 23 of Regulation (EC) No 1829/2003 for the authorisation of:

• (a) genetically modified plants for food or feed uses;

• (b) food or feed containing or consisting of genetically modified plants;

• (c) food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants.

Article 2

Definitions

For the purposes of this Regulation, the definitions in Regulation (EC) No 1829/2003 apply.

The definitions of ‘risk’, ‘risk assessment’ and ‘hazard’ applicable for the purposes of this Regulation are those provided in Article 3 of Regulation (EC) No 178/2002.

CHAPTER II GENERAL REQUIREMENTS

Article 3

Preparation and presentation of applications submitted under Articles 5(1) and 17(1)

• (a) be submitted in accordance with the requirements for the preparation and presentation of applications set out in Annex I;

• (b) contain all the information required by Annex I, in accordance with the specific requirements of Articles 4, 5 and 6.

• (a) the summaries and results of the studies referred to in the application;

• (b) annexes where detailed information on those studies is provided.

Additional information submitted during the authorisation procedure shall, at the time of submission, clearly state which parts of this additional information is claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.

CHAPTER III SPECIFIC REQUIREMENTS

Article 4

Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)

• (a) requirements of Directive 2004/10/EC; or

• (b) ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside the Union.

The applicant shall provide evidence to demonstrate such compliance.

• (a) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or

• (b) be conducted by organisations accredited under the relevant ISO standard.

Article 5

Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)

• (a) particular information is not necessary owing to the nature of the genetic modification or of the product; or

• (b) it is not scientifically necessary, or technically possible to supply such information.

The applicant shall submit reasoned justification for the derogation.

Article 6

Additional information related to the risk assessment of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)

Article 7

Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)

• (a) that specific recommendations of uses are followed by the consumer/animal owner;

• (b) the predicted consumption of the genetically modified food or feed; or

• (c) the relevance and intensity of effects and unintended effects detected during the pre-market risk assessment which can only be further characterised by post-market monitoring.

• (a) developed to collect reliable information with respect to one or several of the aspects set out in paragraph 1. This information shall allow the detection of indications on whether any (adverse) effect on health may be related to genetically modified food or feed consumption;

• (b) based on strategies aiming at collecting relevant information from specific stakeholders including consumers and on a reliable and validated flow of information between the different stakeholders. More specific strategies shall be included when data on individual intakes of a specific food item or intakes of particular age groups have to be collected;

• (c) accompanied by adequate justification and a thorough description of the selected methodologies for the proposed post-market monitoring including aspects related to the analysis of the collected information.

Article 8

Requirements 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), 11(2), 17(3) and 23(2)

• (a) the methods for detection and identification of the transformation event;

• (b) samples of food or feed and their control samples, and information as to the place where the reference material can be accessed.

• (a) the methods for detection and identification of the transformation event;

• (b) samples of food or feed and their control samples, and information as to the place where the reference material can be accessed,

shall apply only for the purposes of application of Articles 11(2)(d) and 23(2)(d).

CHAPTER IV TRANSITIONAL AND FINAL PROVISIONS

Article 9

Transitional provisions

• (a) a thorough description of the quality assurance system under which such studies were performed; and

• (b) comprehensive information on the protocols and the results obtained from the studies including the raw data.

Article 10

Amendments to Regulation (EC) No 641/2004

Regulation (EC) No 641/2004 is amended as follows:

• (1) Article 1 is replaced by the following:

‘Article 1

This chapter provides detailed rules concerning applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 except for those applications covered by Commission Implementing Regulation (EU) No 503/2013[^ntr*1-L_2013157EN.01000101-E0013].

[^ntr*1-L_2013157EN.01000101-E0013]: OJ L 157, 8.6.2013, p. 1.’;"

• (2) Articles 5 to 19 are deleted.

Article 11

Amendments to Regulation (EC) No 1981/2006

Regulation (EC) No 1981/2006 is amended as follows:

• (1) in Article 2, point (a) is replaced by the following:

• ‘(a) “full validation procedure” means:

• (i) the assessment through a ring trial involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled “Definition of minimum performance requirements for analytical methods of GMO testing” referred to:

• — in the case of genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food produced from or containing ingredients produced from genetically modified plants or feed produced from genetically modified plants, in point 3.1.C.4 of Annex III to Commission Implementing Regulation (EU) No 503/2013[^ntr*2-L_2013157EN.01000101-E0014],

• — in all other cases, in point 1(B) of Annex I to Regulation (EC) No 641/2004;

and

• (ii) the assessment of the precision and trueness of the method provided by the applicant.

[^ntr*2-L_2013157EN.01000101-E0014]: OJ L 157, 8.6.2013, p. 1.’;"

• (2) in Article 3(2), the first and second subparagraphs are replaced by the following:

‘2.   The CRL shall request the applicant to pay an additional contribution of EUR 60 000 where a full validation procedure of a method of detection and identification for a single GMO event according to the requirements laid down in the following provisions is required:

• (a) Annex III to Implementing Regulation (EU) No 503/2013, when the application is related to:

• (i) genetically modified plants for food or feed uses;

• (ii) food or feed containing or consisting of genetically modified plants;

• (iii) food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants; or

• (b) point 1(B) of Annex I to Regulation (EC) No 641/2004, in all other cases.

That amount shall be multiplied by the number of GMO events to be fully validated.’.

Article 12

Review

Article 13

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 April 2013.

For the Commission

The President

José Manuel BARROSO

[^ntr1-L_2013157EN.01000101-E0001]: OJ L 268, 18.10.2003, p. 1.

[^ntr2-L_2013157EN.01000101-E0002]: OJ L 31, 1.2.2002, p. 1.

[^ntr3-L_2013157EN.01000101-E0003]: OJ L 102, 7.4.2004, p. 14.

[^ntr4-L_2013157EN.01000101-E0004]: OJ L 106, 17.4.2001, p. 1.

[^ntr5-L_2013157EN.01000101-E0005]: Codex Alimentarius Commission, GL 45-2003.

[^ntr6-L_2013157EN.01000101-E0006]: EFSA Journal 2011; 9(5):2150.

[^ntr7-L_2013157EN.01000101-E0007]: OJ L 276, 20.10.2010, p. 33.

[^ntr8-L_2013157EN.01000101-E0008]: OJ L 50, 20.2.2004, p. 44.

[^ntr9-L_2013157EN.01000101-E0009]: OJ L 201, 31.7.2002, p. 48.

[^ntr10-L_2013157EN.01000101-E0010]: OJ L 287, 5.11.2003, p. 1.

[^ntr11-L_2013157EN.01000101-E0011]: OJ L 10, 14.1.2004, p. 5.

[^ntr12-L_2013157EN.01000101-E0012]: OJ L 368, 23.12.2006, p. 99.

ANNEX I

PREPARATION AND PRESENTATION OF APPLICATIONS

The application shall contain the following information:

PART I

GENERAL INFORMATION

	1.	Name and address of the applicant (company or institute).
---	---	---
	2.	Name, qualification and experience of the responsible scientist(s) and contact details of the responsible person for all dealings with the European Food Safety Authority (EFSA).
---	---	---
	3.	Designation and specification of the genetically modified plant and its products.
---	---	---
	4.	Scope of the application: (a) Genetically modified food  Food containing or consisting of genetically modified plants  Food produced from genetically modified plants or containing ingredients produced from genetically modified plants (b) Genetically modified feed  Feed containing or consisting of genetically modified plants  Feed produced from genetically modified plants (c) Genetically modified plants for food or feed uses  Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation  Seeds and other plant propagating material for cultivation in the Union.
---	---	---
	5.	Unique identifier. A proposal for a unique identifier for the genetically modified plant developed in accordance with Regulation (EC) No 65/2004.
---	---	---
	6.	Where applicable, a detailed description of the method of production and manufacturing. This description would include, for example, a detailed description of specific methods of production of food or feed which would be due to the nature of the genetic modification or which would lead to food or feed with specific characteristics.
---	---	---
	7.	Where appropriate, the conditions for the placing on the market of the genetically modified food(s) or feed(s), including specific conditions for use and handling.
---	---	---
	8.	Where applicable, the status of the food or feed or of related substances under other provisions of Union law. Additional authorisation requirements provided for in Union law, related to the placing on the market of the food or feed or applicable ‘maximum residue level’ (MRL) where the food or feed is likely to contain residues of plant protection products.

PART II

SCIENTIFIC INFORMATION

All the requirements of Part II shall be provided in the application except where such requirements are not justified by the scope of the application (for example, where the application is limited to food or feed produced from GMOs).

1. HAZARD IDENTIFICATION AND CHARACTERISATION

1.1.   Information relating to the recipient or (where appropriate) parental plants

	(a)	Complete name: (i) family name; (ii) genus; (iii) species; (iv) subspecies; (v) cultivar, breeding line; (vi) common name;
---	---	---
	(b)	Geographical distribution and cultivation of the plant within the Union;
---	---	---
	(c)	Information on the recipient or parental plants relevant to their safety, including any known toxicity or allergenicity;
---	---	---
	(d)	Data on the past and present use of the recipient plant, such as history of safe use for consumption as food or feed, including information on how the plant is typically cultivated, transported and stored, whether special processing is required to make the plant safe to eat, and the plant normal role in the diet (for example, which part of the plant is used as a food source, whether its consumption is important in particular subgroups of the population, what important macro- or micro-nutrients it contributes to the diet);
---	---	---
	(e)	Additional information relating to the recipient or parental plants required for the environmental safety aspects: (i) information concerning reproduction: — mode(s) of reproduction; — specific factors affecting reproduction (if any); — generation time; (ii) sexual compatibility with other cultivated or wild plant species; (iii) survivability: — ability to form structures for survival or dormancy; — specific factors, if any, affecting survivability; (iv) dissemination: — ways and extent of dissemination (to include, for example, an estimation of how viable pollen and/or seed declines with distance); — special factors affecting dissemination, if any; (v) geographical distribution within the Union of the sexually compatible species; (vi) where a plant species is not grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts; (vii) other potential interactions of the genetically modified 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.

1.2.   Molecular Characterisation

1.2.1.   Information relating to the genetic modification

	1.2.1.1.	Description of the methods used for the genetic modification
---	---	---
	1.2.1.2.	Nature and source of vector used
---	---	---
	1.2.1.3.	Source of donor nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

1.2.2.   Information relating to the genetically modified plant

	1.2.2.1.	General description of the trait(s) and characteristics which have been introduced or modified
---	---	---
	1.2.2.2.	Information on the sequences actually inserted/deleted
---	---	---
	1.2.2.3.	Information on the expression of the insert(s)
---	---	---
	1.2.2.4.	Genetic stability of the insert and phenotypic stability of the genetically modified plant
---	---	---
	1.2.2.5.	Potential risk associated with horizontal gene transfer

1.2.3.   Additional information relating to the genetically modified plant required for the environmental safety aspects

	1.2.3.1.	Information on how the genetically modified plant differs from the recipient plant in reproduction, dissemination, survivability or other properties.
---	---	---
	1.2.3.2.	Any change to the ability of the genetically modified plant to transfer genetic material to other organisms, namely: (a) Plant to bacteria gene transfer; (b) Plant to plant gene transfer.

1.2.4.   Conclusions of the molecular characterisation

1.3.   Comparative analysis

1.3.1.   Choice of the conventional counterpart and additional comparators

1.3.2.   Experimental design and statistical analysis of data from field trials for comparative analysis

	1.3.2.1.	Description of the protocols for the experimental design
---	---	---
	1.3.2.2.	Statistical analysis

1.3.3.   Selection of material and compounds for analysis

1.3.4.   Comparative analysis of composition

1.3.5.   Comparative analysis of agronomic and phenotypic characteristics

1.3.6.   Effects of processing

1.3.7.   Conclusion

1.4.   Toxicology

1.4.1.   Testing of newly expressed proteins

1.4.2.   Testing of new constituents other than proteins

1.4.3.   Information on natural food and feed constituents

1.4.4.   Testing of the whole genetically modified food or feed

	1.4.4.1.	90-day feeding study in rodents
---	---	---
	1.4.4.2.	Animal studies with respect to reproductive, developmental or chronic toxicity
---	---	---
	1.4.4.3.	Other animal studies to examine the safety and the characteristics of genetically modified food and feed

1.4.5.   Conclusion of the toxicological assessment

1.5.   Allergenicity

1.5.1.   Assessment of allergenicity of the newly expressed protein

1.5.2.   Assessment of allergenicity of the whole genetically modified plant

1.5.3.   Conclusion of the allergenicity assessment

1.6.   Nutritional assessment

1.6.1.   Nutritional assessment of the genetically modified food

1.6.2.   Nutritional assessment of the genetically modified feed

1.6.3.   Conclusion of the nutritional assessment

2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE

3. RISK CHARACTERISATION

4. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED

5. ENVIRONMENTAL ASSESSMENT

6. ENVIRONMENTAL MONITORING PLAN

7. ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED FOOD OR FEED

A systematic review of studies published in the scientific literature and studies performed by the applicant within the period of 10 years prior to the date of submission of the dossier on the potential effects on human and animal health of the genetically modified food and feed covered by the application shall be included in the application. This systematic review shall be carried out by taking into account the guidance of EFSA on application of systematic review methodology to food and feed safety assessments to support decision making [^ntr1-L_2013157EN.01000801-E0001].

Where the information obtained from those studies is not coherent with the information obtained from the studies performed in accordance with the requirements set out in Annex II, the applicant shall provide a thorough analysis of the respective studies and provide plausible explanations for the observed discrepancies.

Additional information which might influence the evaluation of the safety of the genetically modified food or feed generated following the submission of the application, as well as any information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a safety assessment shall be provided by the applicant.

PART III

CARTAGENA PROTOCOL

The application shall provide the information required under Articles 5(3)(c) and 17(3)(c) of Regulation (EC) No 1829/2003 for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

The provided information shall contain as a minimum the information specified in Annex II to Regulation (EC) No 1946/2003 of the European Parliament and of the Council [^ntr2-L_2013157EN.01000801-E0002]:

• (a) The name and contact details of the applicant for a decision for domestic use;

• (b) The name and contact details of the authority responsible for the decision;

• (c) Name and identity of the GMO;

• (d) Description of the gene modification, the technique used, and the resulting characteristics of the GMO;

• (e) Any unique identification of the GMO;

• (f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety;

• (g) Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate;

• (h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety;

• (i) Approved uses of the GMO;

• (j) A risk assessment report consistent with Annex II to Directive 2001/18/EC;

• (k) Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.

PART IV

LABELLING

The application shall include:

• (a) a proposal for labelling in all official languages of the Union, where a proposal for specific labelling is required in accordance with Articles 5(3)(f) and 17(3)(f) of Regulation (EC) No 1829/2003;

• (b) either a reasoned statement that the food or feed does not give rise to ethical or religious concerns or a proposal for labelling in all official languages of the Union as required by Articles 5(3)(g) and 17(3)(g) of Regulation (EC) No 1829/2003;

• (c) when appropriate a proposal for labelling complying with the requirements of point A(8) of Annex IV to Directive 2001/18/EC.

PART V

METHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL

The applicant shall provide methods for detection, sampling and identification, as well as samples of the food or feed and their controls samples to the European Union Reference Laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003.

The application shall include a copy of the completed form for the submission of those samples to the EURL and proof of sending to the EURL.

The application shall include information as to the place where the reference material can be accessed.

The applicant shall follow the instructions for the preparation and the sending of the samples provided by the EU Reference laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003. These instructions are published on the following webpage: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm

PART VI

ADDITIONAL INFORMATION TO BE PROVIDED FOR GENETICALLY MODIFIED PLANTS AND/OR FOOD OR FEED CONTAINING OR CONSISTING OF GENETICALLY MODIFIED PLANTS

The information required in the notification as set out in Annex III to Directive 2001/18/EC shall be provided where it is not covered by the requirements of other parts of the application.

PART VII

SUMMARY OF APPLICATIONS

This Part specifies the standardised form, which the summary of the application dossier must follow.

Depending on the scope of the application, some of the requested information may not be applicable.

The summary shall not contain parts considered to be confidential in accordance with Article 30 of Regulation (EC) No 1829/2003.

1. GENERAL INFORMATION

1.1.   Details of application

	(a)	Member State of application
---	---	---
	(b)	Application number
---	---	---
	(c)	Name of the product (commercial and any other names)
---	---	---
	(d)	Date of acknowledgement of valid application

1.2.   Applicant

	(a)	Name of applicant
---	---	---
	(b)	Address of applicant
---	---	---
	(c)	Name and address of the representative of the applicant established in the Union (if the applicant is not established in the Union)

1.3.   Scope of the application

	(a)	Genetically modified food  Food containing or consisting of genetically modified plants  Food produced from genetically modified plants or containing ingredients produced from genetically modified plants
---	---	---
	(b)	Genetically modified feed  Feed containing or consisting of genetically modified plants  Feed produced from genetically modified plants
---	---	---
	(c)	Genetically modified plants for food and feed use  Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation  Seeds and plant propagating material for cultivation in the Union

1.4. Is the product or the uses of the associated plant protection product(s) already authorised or subject to another authorisation procedure within the Union?

No	
Yes		(in that case, specify)

1.5. Has the genetically modified plant been notified under Part B of Directive 2001/18/EC?

Yes	
No		(in that case, provide risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC)

1.6. Has the genetically modified plant or derived products been previously notified for marketing in the Union under Part C of Directive 2001/18/EC?

No	
Yes		(in that case, specify)

1.7. Has the product been subject to an application and/or authorised in a third country either previously or simultaneously to this application?

No	
Yes		In that case, specify the third country, the date of application and, where available, a copy of the risk assessment conclusions, the date of the authorisation and the scope of the application

1.8.   General description of the product

	(a)	Name of the recipient or parental plant and the intended function of the genetic modification
---	---	---
	(b)	Types of products planned to be placed on the market according to the authorisation applied for and any specific form in which the product must not be placed on the market (such as seeds, cut-flowers, vegetative parts) as a proposed condition of the authorisation applied for
---	---	---
	(c)	Intended use of the product and types of users
---	---	---
	(d)	Any specific instructions and recommendations for use, storage and handling, including mandatory restrictions proposed as a condition of the authorisation applied for
---	---	---
	(e)	If applicable, geographical areas within the Union to which the product is intended to be confined under the terms of the authorisation applied for
---	---	---
	(f)	Any type of environment to which the product is unsuited
---	---	---
	(g)	Any proposed packaging requirements
---	---	---
	(h)	Any proposed labelling requirements in addition to those required by other applicable EU legislation 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 In the case of products other than food and feed containing or consisting of genetically modified plants, a proposal for labelling which complies with the requirements of point A(8) of Annex IV to Directive 2001/18/EC must be included.
---	---	---
	(i)	Estimated potential demand (i) In the EU (ii) In EU export markets
---	---	---
	(j)	Unique identifier in accordance with Regulation (EC) No 65/2004.

1.9.   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

2. INFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS

2.1.   Complete name

	(a)	Family name
---	---	---
	(b)	Genus
---	---	---
	(c)	Species
---	---	---
	(d)	Subspecies
---	---	---
	(e)	Cultivar/breeding line
---	---	---
	(f)	Common name

2.2.   Geographical distribution and cultivation of the plant, including the distribution within the Union

2.3.   Information concerning reproduction (for environmental safety aspects)

	(a)	Mode(s) of reproduction
---	---	---
	(b)	Specific factors affecting reproduction
---	---	---
	(c)	Generation time

2.4.   Sexual compatibility with other cultivated or wild plant species (for environmental safety aspects)

2.5.   Survivability (for environmental safety aspects)

	(a)	Ability to form structures for survival or dormancy
---	---	---
	(b)	Specific factors affecting survivability

2.6.   Dissemination (for environmental safety aspects)

	(a)	Ways and extent of dissemination
---	---	---
	(b)	Specific factors affecting dissemination

2.7.   Geographical distribution within the Union of the sexually compatible species (for environmental safety aspects)

2.8.   In the case of plant species not normally grown in the Union description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts (for environmental safety aspects)

2.9.   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)

3. MOLECULAR CHARACTERISATION

3.1.   Information relating to the genetic modification

	(a)	Description of the methods used for the genetic modification
---	---	---
	(b)	Nature and source of the vector used
---	---	---
	(c)	Source of donor nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

3.2.   Information relating to the genetically modified plant

3.2.1.   Description of the trait(s) and characteristics which have been introduced or modified

3.2.2.   Information on the nucleic acid(s) sequences actually inserted or deleted

	(a)	The copy number of all detectable inserts, both complete and partial
---	---	---
	(b)	In the case of deletion(s), size and function of the deleted region(s)
---	---	---
	(c)	Subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form) and methods for its/their determination
---	---	---
	(d)	The organisation of the inserted genetic material at the insertion site
---	---	---
	(e)	In the case of modifications other than insertion or deletion, describe function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification

3.2.3.   Information on the expression of the insert

	(a)	Information on developmental expression of the insert during the life cycle of the plant
---	---	---
	(b)	Parts of the plant where the insert is expressed

3.2.4.   Genetic stability of the insert and phenotypic stability of the genetically modified plant

3.2.5. Information (for environmental safety aspects) on how the genetically modified plant differs from the recipient plant in:

	(a)	Mode(s) and/or rate of reproduction
---	---	---
	(b)	Dissemination
---	---	---
	(c)	Survivability
---	---	---
	(d)	Other differences

3.2.6.   Any change to the ability of the genetically modified plant to transfer genetic material to other organisms (for environmental safety aspects)

	(a)	Plant to bacteria gene transfer
---	---	---
	(b)	Plant to plant gene transfer

4. COMPARATIVE ANALYSIS

4.1.   Choice of the conventional counterpart and additional comparators

4.2.   Experimental design and statistical analysis of data from field trials for comparative analysis

Description of the experimental design (number of locations, growing seasons, geographical spread, replicates and number of commercial varieties in each location) and of the statistical analysis.

4.3.   Selection of material and compounds for analysis

4.4.   Comparative analysis of agronomic and phenotypic characteristics

4.5.   Effect of processing

5. TOXICOLOGY

	(a)	Toxicological testing of newly expressed proteins
---	---	---
	(b)	Testing of new constituents other than proteins
---	---	---
	(c)	Information on natural food or feed constituents
---	---	---
	(d)	Testing of the whole genetically modified food and feed

6. ALLERGENICITY

	(a)	Assessment of allergenicity of the newly expressed protein
---	---	---
	(b)	Assessment of allergenicity of the whole genetically modified plant

7. NUTRITIONAL ASSESSMENT

	(a)	Nutritional assessment of the genetically modified food
---	---	---
	(b)	Nutritional assessment of the genetically modified feed

8. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE

9. RISK CHARACTERISATION

10. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED

11. ENVIRONMENTAL ASSESSMENT

11.1.   Mechanism of interaction between the genetically modified plant and target organisms

11.2.   Potential changes in the interactions of the genetically modified plant with the biotic environment resulting from the genetic modification

	(a)	Persistence and invasiveness
---	---	---
	(b)	Selective advantage or disadvantage
---	---	---
	(c)	Potential for gene transfer
---	---	---
	(d)	Interactions between the genetically modified plant and target organisms
---	---	---
	(e)	Interactions of the genetically modified plant with non-target organisms
---	---	---
	(f)	Effects on human health
---	---	---
	(g)	Effects on animal health
---	---	---
	(h)	Effects on biogeochemical processes
---	---	---
	(i)	Impacts of the specific cultivation, management and harvesting techniques

11.3.   Potential interactions with the abiotic environment

11.4.   Risk characterisation

12. ENVIRONMENTAL MONITORING PLAN

	(a)	General (risk assessment, background information)
---	---	---
	(b)	Interplay between environmental risk assessment and monitoring
---	---	---
	(c)	Case-specific genetically modified plant monitoring (approach, strategy, method and analysis)
---	---	---
	(d)	General surveillance of the impact of the genetically modified plant (approach, strategy, method and analysis)
---	---	---
	(e)	Reporting the results of monitoring

13. DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT

14. INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT (FOR ENVIRONMENTAL RISK ASSESSMENT ASPECTS)

14.1.   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 [^ntr3-L_2013157EN.01000801-E0003] by the same notifier

	(a)	Notification number
---	---	---
	(b)	Conclusions of post-release monitoring
---	---	---
	(c)	Results of the release with respect to any risk to human health and the environment, submitted to the competent authority in accordance with Article 10 of Directive 2001/18/EC

14.2.   History of previous releases of the genetically modified plant carried out outside the Union by the same notifier

	(a)	Release country
---	---	---
	(b)	Authority overseeing the release
---	---	---
	(c)	Release site
---	---	---
	(d)	Aim of the release
---	---	---
	(e)	Duration of the release
---	---	---
	(f)	Aim of post-releases monitoring
---	---	---
	(g)	Duration of post-releases monitoring
---	---	---
	(h)	Conclusions of post-release monitoring
---	---	---
	(i)	Results of the release with respect to any risk to human health and the environment

[^ntr1-L_2013157EN.01000801-E0001]: EFSA Journal 2010; 8(6):1637.

[^ntr2-L_2013157EN.01000801-E0002]: OJ L 287, 5.11.2003, p. 1.

[^ntr3-L_2013157EN.01000801-E0003]: OJ L 117, 8.5.1990, p. 15.

ANNEX II

SCIENTIFIC REQUIREMENTS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED FOOD AND FEED

I. INTRODUCTION

1. DEFINITIONS

For the purpose of this Annex, the following definitions shall apply:

• 1. ‘hazard identification’ means the identification of biological, chemical and physical agents capable of causing adverse health effects and which may be present in a particular food and feed or group of foods and feeds;

• 1. ‘hazard characterisation’ means the qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food and feed;

• 1. ‘risk characterisation’ means the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterisation and exposure assessment.

2. SPECIFIC CONSIDERATIONS

2.1.   Insertion of marker genes and other nucleic acid(s) sequences not essential to achieve the desired trait

In order to facilitate the risk assessment, the applicant shall endeavour to minimise the presence of inserted nucleic acid(s) sequences not essential to achieve the desired trait.

During the process of 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. The applicant shall carefully select such marker genes and Article 4(2) of Directive 2001/18/EC shall be respected. Against that background, the applicant shall therefore aim to develop GMOs without the use of antibiotic resistance marker genes.

2.2.   Risk assessment of genetically modified food and feed containing stacked transformation events

For the risk assessment of genetically modified food and feed containing stacked transformation events obtained by conventional crossing of genetically modified plants containing one or several transformation event(s), the applicant shall provide a risk assessment of each single transformation event or, in accordance with Article 3(6) of this Regulation, refer to already submitted application(s). The risk assessment of genetically modified food and feed containing stacked transformation events shall also include an assessment of the following aspects:

• (a) stability of the transformation events;

• (b) expression of the transformation events;

• (c) potential synergistic or antagonistic effects resulting from the combination of the transformation events shall be subject to an assessment in accordance with Sections 1.4 (Toxicology), 1.5 (Allergenicity) and 1.6 (Nutritional assessment).

For genetically modified food and feed containing, consisting of or produced from genetically modified plants, whose cultivation is associated with the production of genetically modified material containing various subcombinations of transformation events (segregating crops), the application shall include all subcombinations independently of their origin which have not yet been authorised. In such a case, the applicant shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations or, in the absence of such scientific rationale, provide the experimental data.

For genetically modified food and feed containing, consisting of or produced from genetically modified plants, the cultivation of which does not lead to the production of genetically modified material containing various combinations of transformation events (non-segregating crops), the application shall only cover the combination which is to be placed on the market.

The rules set out in this Section apply mutatis mutandis to transformation events which are combined by other means such as co- and retransformation.

II.   SCIENTIFIC REQUIREMENTS

1. HAZARD IDENTIFICATION AND CHARACTERISATION

1.1.   Information relating to the recipient or (where appropriate) parental plants

	1.1.1.	The applicant shall provide comprehensive information relating to the recipient or (where appropriate) the parental plants in order to: (a) evaluate all issues of potential concern, such as the presence of natural toxins or allergens; (b) identify the need for specific analyses.
---	---	---
	1.1.2.	For the purposes referred to in point 1.1.1, the applicant shall provide the following information: (a) Complete name: (i) family name; (ii) genus; (iii) species; (iv) subspecies; (v) cultivar/breeding line or strain; (vi) common name. (b) Geographical distribution and cultivation of the plant, including its distribution within the Union. (c) Information on the recipient or parental plants relevant to their safety, including any known toxicity or allergenicity. (d) Data on the past and present use of the recipient plant. This information shall include the history of safe use for consumption as food or feed, information on how the plant is typically cultivated, transported and stored, whether special processing is required to make the plant safe to eat, and describe the normal role of the plant in the diet (such as which part of the plant is used as a food or feed source, whether its consumption is important in particular subgroups of the population, what important macro- or micro-nutrients it contributes to the diet).

1.2.   Molecular Characterisation

1.2.1.   Information relating to the genetic modification

The applicant shall provide sufficient information on the genetic modification:

• (a) to identify the nucleic acid(s) intended for transformation and related vector sequences potentially delivered to the recipient plant;

• (b) to characterise the nucleic acid(s) actually inserted in the plant.

1.2.1.1.   Description of the methods used for the genetic modification

The applicant shall provide information on the following elements:

• (a) the method of genetic transformation including relevant references;

• (b) the recipient plant material;

• (c) the species and the strain of Agrobacterium and other microbes, if used during the genetic transformation process;

• (d) the helper plasmids, if used during the genetic transformation process;

• (e) the source of carrier nucleic acid(s), if used during the genetic transformation process.

1.2.1.2.   Nature and source of vector used

The applicant shall provide the following information:

• (a) a physical map of the functional elements and other plasmid/vector components together with the relevant information needed for the interpretation of the molecular analyses (such as restriction sites, the position of primers used in polymerase chain reaction (PCR), the location of probes used in Southern analysis). The region intended for insertion shall be clearly indicated;

• (b) a table identifying each component of the plasmid/vector (including the region intended for insertion), its size, its origin and its intended function.

1.2.1.3.   Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

The applicant shall provide information on the donor organism(s) and on the nucleic acid(s) sequence(s) intended to be inserted in order to determine whether the nature of the donor organism(s) or the nucleic acid sequence(s) may trigger any safety issue.

Information regarding the function of the nucleic acid region(s) intended for insertion shall comprise the following elements:

• (a) the complete sequence of the nucleic acid(s) intended to be inserted, including information on any deliberate alteration(s) to the corresponding sequence(s) in the donor organism(s);

• (b) the history of safe use of the gene product(s) arising from the regions intended for insertion;

• (c) data on the possible relationship of the gene products with known toxins, anti-nutrients and allergens.

Information regarding each donor organism shall comprise:

• — taxonomic classification;

• — history of use regarding food and feed safety.

1.2.2.   Information relating to the genetically modified plant

1.2.2.1.   General description of the trait(s) and characteristics which have been introduced or modified

Information provided under this point may be limited to a general description of the introduced trait(s) and the resulting changes to the phenotype and metabolism of the plant.

For example, when the introduced trait is herbicide tolerance, the applicant shall provide information on the mode of action of the active substance and its metabolism in the plant.

1.2.2.2.   Information on the sequences actually inserted/deleted

The applicant shall provide the following information:

• (a) the size and copy number of all detectable inserts, both complete and partial; this is typically determined by Southern analysis.

Probe/restriction enzyme combinations used for this purpose shall provide complete coverage of sequences that could be inserted into the genetically modified plant, such as any parts of the plasmid/vector or any carrier or foreign nucleic acid(s) remaining in the genetically modified plant.

The Southern analysis shall span the entire transgenic locus(i) as well as flanking sequences and include all appropriate controls.

For the determination of copy number of the insert, complementary methods may also be used (such as real-time PCR);

• (b) the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format, with the aim of identifying changes in the inserted sequences compared to the sequence intended for insertion;

• (c) in the case of deletion(s), size and function of the deleted region(s), whenever possible;