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 feed (1), 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 (2) should also apply to this Regulation.
(4)
Commission Regulation (EC) No 641/2004 (3) 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 (4), 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 (5).
(10)
In accordance with the applicable guidance of the EFSA (6), 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 (7), 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 (8). 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 (9) 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 (10).
(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 (11).
(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 (12) 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)
1. The application submitted under Articles 5(1) and 17(1) of Regulation (EC) No 1829/2003 shall:
(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.
2. The application shall include, for each of the specific requirements laid down in 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.
3. The application shall contain a checklist demonstrating that the information required under Articles 4, 5 and 6 is complete.
4. Where an application is limited to either food or feed use, it shall contain a verifiable justification explaining why the authorisation shall not cover both uses in accordance with Article 27 of Regulation (EC) No 1829/2003.
5. The application shall, at the time of submission, clearly state which parts of the application are claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.
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.
6. When studies have been already submitted to the European Food Safety Authority (EFSA) for the purposes of an application and, where relevant, to the extent that they may be used by the applicant in accordance with Article 31 of Regulation (EC) No 1829/2003, a reference to such studies and the results of the EFSA’s assessment may, with the agreement of EFSA, be made in the framework of another application.
CHAPTER III
SPECIFIC REQUIREMENTS
Article 4
Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)
1. Toxicological studies shall be conducted in facilities which comply with the:
(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.
2. Studies, other than toxicological studies, shall:
(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.
3. Information on the study protocols and the results obtained from the studies referred to in paragraphs 1 and 2 shall be comprehensive and include the raw data in an electronic format, suitable for carrying out statistical or other analysis.
Article 5
Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)
1. Information, including studies, required to accompany the application as referred to in Article 5(3)(a) to (f) and (h) and in Article 17(3)(a) to (f) and (h) of Regulation (EC) No 1829/2003 shall be provided in accordance with the scientific requirements for the risk assessment of genetically modified food and feed set out in Annex II to this Regulation.
2. By way of derogation from paragraph 1, an application may be submitted that does not satisfy all the requirements of that paragraph provided that:
(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.
3. Paragraphs 1 and 2 shall not prevent the EFSA to request, where appropriate, the applicant to supplement the particulars accompanying the application as provided for in Articles 6(2) and 18(2) of Regulation (EC) No 1829/2003.
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)
1. In addition to the information required in accordance with Article 5 and Annex II, the application shall include 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.
2. During the authorisation procedure, the applicant shall submit, without delay, to the EFSA additional information which might influence the risk assessment of the genetically modified food or feed generated following the submission of the application. In particular, the applicant shall submit to the EFSA information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a risk assessment of the genetically modified food and feed.
Article 7
Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
1. The applicant shall submit a proposal for post-market monitoring regarding the use of the food and feed as referred to in Articles 5(3)(k) and 17(3)(k) of Regulation (EC) No 1829/2003 when the information provided in accordance with Articles 4, 5 and 6 demonstrates that the genetically modified food and feed comply with Articles 4(1) and 16(1) of Regulation (EC) No 1829/2003 and when, in accordance with the outcome of the risk assessment, it is appropriate to confirm:
(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.
2. The applicant shall ensure that the post-market monitoring is:
(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)
1. Applications submitted under Articles 5(1) and 17(1) of Regulation (EC) No 1829/2003 shall comply with the following requirements, as referred to in Article 5(3)(i) and (j) and Article 17(3)(i) and (j) of that Regulation, and set out in Annex III to this Regulation, for:
(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.
2. For applications submitted under Articles 11(1) and 23(1) of Regulation (EC) No 1829/2003, the requirements set out in Annex III to this Regulation for:
(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
1. Until 8 December 2013, applicants may choose to submit applications falling under the scope of this Regulation under Regulation (EC) No 641/2004 in the version of that Regulation in force on 8 June 2013.
2. By way of derogation from Article 4(2), in the case of studies launched prior to the date of entry into force of this Regulation and conducted under quality assurance systems other than GLP and ISO, the applicant shall provide:
(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 (13).
(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 (14),
-
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.
(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
1. The Commission shall monitor the application of this Regulation, the developments in scientific knowledge on replacement, reduction and refinement of animal use in scientific procedures and the publication of new guidance from EFSA. The Commission shall in particular monitor the outcome of the research project called GRACE (GMO Risk Assessment and Communication of Evidence) under the 2012 work programme of the seventh Framework Programme for Research (FP7).
2. The Commission shall review the requirement to perform 90-day feeding studies in rodents with whole genetically modified food/feed (point 1.4.4.1 of Annex II) on the basis of new scientific information. The results of this review shall be published by 30 June 2016 at the latest.
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.