Search Legislation

Advanced Search

Commission Implementing Regulation (EU) No 503/2013Show full title

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)

Help about what version

What Version

Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Changes to legislation:

There are outstanding changes not yet made to Commission Implementing Regulation (EU) No 503/2013. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made to the legislation appear in the content and are referenced with annotations. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the affected provisions when you open the content using the Table of Contents below.

View outstanding changes

Changes and effects yet to be applied to :

Changes and effects yet to be applied to the whole legislation item and associated provisions

  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

  3. CHAPTER II GENERAL REQUIREMENTS

    1. Article 3.Preparation and presentation of applications submitted under Articles 5(1) and 17(1)

  4. CHAPTER III SPECIFIC REQUIREMENTS

    1. Article 4.Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)

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

    3. 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)

    4. Article 7.Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)

    5. 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)

  5. CHAPTER IV TRANSITIONAL AND FINAL PROVISIONS

    1. Article 9.Transitional provisions

    2. Article 10.Amendments to Regulation (EC) No 641/2004

    3. Article 11.Amendments to Regulation (EC) No 1981/2006

    4. Article 12.Review

    5. Article 13.Entry into force

  6. Signature

    1. ANNEX I

      PREPARATION AND PRESENTATION OF APPLICATIONS

      1. The application shall contain the following information:

      2. PART I GENERAL INFORMATION

        1. 1. Name and address of the applicant (company or institute).

        2. 2. Name, qualification and experience of the responsible scientist(s) and contact...

        3. 3. Designation and specification of the genetically modified plant and its...

        4. 4. Scope of the application:

        5. 5. Unique identifier.

        6. 6. Where applicable, a detailed description of the method of production...

        7. 7. Where appropriate, the conditions for the placing on the market...

        8. 8. Where applicable, the status of the food or feed or...

      3. PART II SCIENTIFIC INFORMATION

        1. 1. HAZARD IDENTIFICATION AND CHARACTERISATION

          1. 1.1. Information relating to the recipient or (where appropriate) parental plants...

            1. (a) Complete name:

            2. (b) Geographical distribution and cultivation of the plant within the Union;...

            3. (c) Information on the recipient or parental plants relevant to their...

            4. (d) Data on the past and present use of the recipient...

            5. (e) Additional information relating to the recipient or parental plants required...

          2. 1.2. Molecular Characterisation

            1. 1.2.1. Information relating to the genetic modification

              1. 1.2.1.1. Description of the methods used for the genetic modification

              2. 1.2.1.2. Nature and source of vector used

              3. 1.2.1.3. Source of donor nucleic acid(s) used for transformation, size and...

            2. 1.2.2. Information relating to the genetically modified plant

              1. 1.2.2.1. General description of the trait(s) and characteristics which have been...

              2. 1.2.2.2. Information on the sequences actually inserted/deleted

              3. 1.2.2.3. Information on the expression of the insert(s)

              4. 1.2.2.4. Genetic stability of the insert and phenotypic stability of the...

              5. 1.2.2.5. Potential risk associated with horizontal gene transfer

            3. 1.2.3. Additional information relating to the genetically modified plant required for...

              1. 1.2.3.1. Information on how the genetically modified plant differs from the...

              2. 1.2.3.2. Any change to the ability of the genetically modified plant...

            4. 1.2.4. Conclusions of the molecular characterisation

          3. 1.3. Comparative analysis

            1. 1.3.1. Choice of the conventional counterpart and additional comparators

            2. 1.3.2. Experimental design and statistical analysis of data from field trials...

              1. 1.3.2.1. Description of the protocols for the experimental design

              2. 1.3.2.2. Statistical analysis

            3. 1.3.3. Selection of material and compounds for analysis

            4. 1.3.4. Comparative analysis of composition

            5. 1.3.5. Comparative analysis of agronomic and phenotypic characteristics

            6. 1.3.6. Effects of processing

            7. 1.3.7. Conclusion

          4. 1.4. Toxicology

            1. 1.4.1. Testing of newly expressed proteins

            2. 1.4.2. Testing of new constituents other than proteins

            3. 1.4.3. Information on natural food and feed constituents

            4. 1.4.4. Testing of the whole genetically modified food or feed

              1. 1.4.4.1. 90-day feeding study in rodents

              2. 1.4.4.2. Animal studies with respect to reproductive, developmental or chronic toxicity...

              3. 1.4.4.3. Other animal studies to examine the safety and the characteristics...

            5. 1.4.5. Conclusion of the toxicological assessment

          5. 1.5. Allergenicity

            1. 1.5.1. Assessment of allergenicity of the newly expressed protein

            2. 1.5.2. Assessment of allergenicity of the whole genetically modified plant

            3. 1.5.3. Conclusion of the allergenicity assessment

          6. 1.6. Nutritional assessment

            1. 1.6.1. Nutritional assessment of the genetically modified food

            2. 1.6.2. Nutritional assessment of the genetically modified feed

            3. 1.6.3. Conclusion of the nutritional assessment

        2. 2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE

        3. 3. RISK CHARACTERISATION

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

        5. 5. ENVIRONMENTAL ASSESSMENT

        6. 6. ENVIRONMENTAL MONITORING PLAN

        7. 7. ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED...

      4. PART III CARTAGENA PROTOCOL

      5. PART IV LABELLING

      6. PART V METHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL

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

      8. PART VII SUMMARY OF APPLICATIONS

        1. 1. GENERAL INFORMATION

          1. 1.1. Details of application

            1. (a) Member State of application

            2. (b) Application number

            3. (c) Name of the product (commercial and any other names)

            4. (d) Date of acknowledgement of valid application

          2. 1.2. Applicant

            1. (a) Name of applicant

            2. (b) Address of applicant

            3. (c) Name and address of the representative of the applicant established...

          3. 1.3. Scope of the application

            1. (a) Genetically modified food

            2. (b) Genetically modified feed

            3. (c) Genetically modified plants for food and feed use

          4. 1.4. Is the product or the uses of the associated plant...

          5. 1.5. Has the genetically modified plant been notified under Part B...

          6. 1.6. Has the genetically modified plant or derived products been previously...

          7. 1.7. Has the product been subject to an application and/or authorised...

          8. 1.8. General description of the product

            1. (a) Name of the recipient or parental plant and the intended...

            2. (b) Types of products planned to be placed on the market...

            3. (c) Intended use of the product and types of users

            4. (d) Any specific instructions and recommendations for use, storage and handling,...

            5. (e) If applicable, geographical areas within the Union to which the...

            6. (f) Any type of environment to which the product is unsuited...

            7. (g) Any proposed packaging requirements

            8. (h) Any proposed labelling requirements in addition to those required by...

            9. (i) Estimated potential demand

            10. (j) Unique identifier in accordance with Regulation (EC) No 65/2004.

          9. 1.9. Measures suggested by the applicant to take in the case...

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

          1. 2.1. Complete name

            1. (a) Family name

            2. (b) Genus

            3. (c) Species

            4. (d) Subspecies

            5. (e) Cultivar/breeding line

            6. (f) Common name

          2. 2.2. Geographical distribution and cultivation of the plant, including the distribution...

          3. 2.3. Information concerning reproduction (for environmental safety aspects)

            1. (a) Mode(s) of reproduction

            2. (b) Specific factors affecting reproduction

            3. (c) Generation time

          4. 2.4. Sexual compatibility with other cultivated or wild plant species (for...

          5. 2.5. Survivability (for environmental safety aspects)

            1. (a) Ability to form structures for survival or dormancy

            2. (b) Specific factors affecting survivability

          6. 2.6. Dissemination (for environmental safety aspects)

            1. (a) Ways and extent of dissemination

            2. (b) Specific factors affecting dissemination

          7. 2.7. Geographical distribution within the Union of the sexually compatible species...

          8. 2.8. In the case of plant species not normally grown in...

          9. 2.9. Other potential interactions, relevant to the genetically modified plant, of...

        3. 3. MOLECULAR CHARACTERISATION

          1. 3.1. Information relating to the genetic modification

            1. (a) Description of the methods used for the genetic modification

            2. (b) Nature and source of the vector used

            3. (c) Source of donor nucleic acid(s) used for transformation, size and...

          2. 3.2. Information relating to the genetically modified plant

            1. 3.2.1. Description of the trait(s) and characteristics which have been introduced...

            2. 3.2.2. Information on the nucleic acid(s) sequences actually inserted or deleted...

              1. (a) The copy number of all detectable inserts, both complete and...

              2. (b) In the case of deletion(s), size and function of the...

              3. (c) Subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in...

              4. (d) The organisation of the inserted genetic material at the insertion...

              5. (e) In the case of modifications other than insertion or deletion,...

            3. 3.2.3. Information on the expression of the insert

              1. (a) Information on developmental expression of the insert during the life...

              2. (b) Parts of the plant where the insert is expressed

            4. 3.2.4. Genetic stability of the insert and phenotypic stability of the...

            5. 3.2.5. Information (for environmental safety aspects) on how the genetically modified...

              1. (a) Mode(s) and/or rate of reproduction

              2. (b) Dissemination

              3. (c) Survivability

              4. (d) Other differences

            6. 3.2.6. Any change to the ability of the genetically modified plant...

              1. (a) Plant to bacteria gene transfer

              2. (b) Plant to plant gene transfer

        4. 4. COMPARATIVE ANALYSIS

          1. 4.1. Choice of the conventional counterpart and additional comparators

          2. 4.2. Experimental design and statistical analysis of data from field trials...

          3. 4.3. Selection of material and compounds for analysis

          4. 4.4. Comparative analysis of agronomic and phenotypic characteristics

          5. 4.5. Effect of processing

        5. 5. TOXICOLOGY

          1. (a) Toxicological testing of newly expressed proteins

          2. (b) Testing of new constituents other than proteins

          3. (c) Information on natural food or feed constituents

          4. (d) Testing of the whole genetically modified food and feed

        6. 6. ALLERGENICITY

          1. (a) Assessment of allergenicity of the newly expressed protein

          2. (b) Assessment of allergenicity of the whole genetically modified plant

        7. 7. NUTRITIONAL ASSESSMENT

          1. (a) Nutritional assessment of the genetically modified food

          2. (b) Nutritional assessment of the genetically modified feed

        8. 8. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE

        9. 9. RISK CHARACTERISATION

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

        11. 11. ENVIRONMENTAL ASSESSMENT

          1. 11.1. Mechanism of interaction between the genetically modified plant and target...

          2. 11.2. Potential changes in the interactions of the genetically modified plant...

            1. (a) Persistence and invasiveness

            2. (b) Selective advantage or disadvantage

            3. (c) Potential for gene transfer

            4. (d) Interactions between the genetically modified plant and target organisms

            5. (e) Interactions of the genetically modified plant with non-target organisms

            6. (f) Effects on human health

            7. (g) Effects on animal health

            8. (h) Effects on biogeochemical processes

            9. (i) Impacts of the specific cultivation, management and harvesting techniques

          3. 11.3. Potential interactions with the abiotic environment

          4. 11.4. Risk characterisation

        12. 12. ENVIRONMENTAL MONITORING PLAN

          1. (a) General (risk assessment, background information)

          2. (b) Interplay between environmental risk assessment and monitoring

          3. (c) Case-specific genetically modified plant monitoring (approach, strategy, method and analysis)...

          4. (d) General surveillance of the impact of the genetically modified plant...

          5. (e) Reporting the results of monitoring

        13. 13. DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT

        14. 14. INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT...

          1. 14.1. History of previous releases of the genetically modified plant notified...

            1. (a) Notification number

            2. (b) Conclusions of post-release monitoring

            3. (c) Results of the release with respect to any risk to...

          2. 14.2. History of previous releases of the genetically modified plant carried...

            1. (a) Release country

            2. (b) Authority overseeing the release

            3. (c) Release site

            4. (d) Aim of the release

            5. (e) Duration of the release

            6. (f) Aim of post-releases monitoring

            7. (g) Duration of post-releases monitoring

            8. (h) Conclusions of post-release monitoring

            9. (i) Results of the release with respect to any risk to...

    2. ANNEX II

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

      1. I. INTRODUCTION

        1. 1. DEFINITIONS

        2. 2. SPECIFIC CONSIDERATIONS

          1. 2.1. Insertion of marker genes and other nucleic acid(s) sequences not...

          2. 2.2. Risk assessment of genetically modified food and feed containing stacked...

      2. II. SCIENTIFIC REQUIREMENTS

        1. 1. HAZARD IDENTIFICATION AND CHARACTERISATION

          1. 1.1. Information relating to the recipient or (where appropriate) parental plants...

            1. 1.1.1. The applicant shall provide comprehensive information relating to the recipient...

            2. 1.1.2. For the purposes referred to in point 1.1.1, the applicant...

          2. 1.2. Molecular Characterisation

            1. 1.2.1. Information relating to the genetic modification

              1. 1.2.1.1. Description of the methods used for the genetic modification

              2. 1.2.1.2. Nature and source of vector used

              3. 1.2.1.3. Source of nucleic acid(s) used for transformation, size and intended...

            2. 1.2.2. Information relating to the genetically modified plant

              1. 1.2.2.1. General description of the trait(s) and characteristics which have been...

              2. 1.2.2.2. Information on the sequences actually inserted/deleted

              3. 1.2.2.3. Information on the expression of the insert(s)

              4. 1.2.2.4. Genetic stability of the insert and phenotypic stability of the...

              5. 1.2.2.5. Potential risk associated with horizontal gene transfer

            3. 1.2.3. Conclusions of the molecular characterisation

          3. 1.3. Comparative analysis

            1. 1.3.1. Choice of the conventional counterpart and additional comparators

            2. 1.3.2. Experimental design and statistical analysis of data from field trials...

              1. 1.3.2.1. Description of the protocols for the experimental design

                1. (a) Principles of experimental design

                2. (b) Specific protocols for experimental design

              2. 1.3.2.2. Statistical analysis

            3. 1.3.3. Selection of material and compounds for analysis

            4. 1.3.4. Comparative analysis of composition

            5. 1.3.5. Comparative analysis of agronomic and phenotypic characteristics

            6. 1.3.6. Effects of processing

            7. 1.3.7. Conclusion

          4. 1.4. Toxicology

            1. 1.4.1. Testing of newly expressed proteins

            2. 1.4.2. Testing of new constituents other than proteins

            3. 1.4.3. Information on altered levels of food and feed constituents

            4. 1.4.4. Testing of the whole genetically modified food and feed

              1. 1.4.4.1. 90-day feeding study in rodents with whole genetically modified food/feed...

              2. 1.4.4.2. Animal studies with respect to reproductive and developmental toxicity testing...

              3. 1.4.4.3. Other animal studies to examine the safety and the characteristics...

              4. 1.4.4.4. Interpretation of relevance of animal studies

            5. 1.4.5. Conclusion of the toxicological assessment

          5. 1.5. Allergenicity

            1. 1.5.1. Assessment of allergenicity of the newly expressed protein

            2. 1.5.2. Assessment of allergenicity of the genetically modified food or feed...

            3. 1.5.3. Adjuvanticity

            4. 1.5.4. Conclusion of the allergenicity assessment

          6. 1.6. Nutritional assessment

            1. 1.6.1. Objectives of the nutritional assessment

            2. 1.6.2. Points to consider for the nutritional assessment of genetically modified...

            3. 1.6.3. Nutritional studies of genetically modified food

            4. 1.6.4. Nutritional studies of genetically modified feed

            5. 1.6.5. Conclusion of the nutritional assessment

          7. 1.7. Standardised guidelines for toxicity tests

        2. 2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE

        3. 3. RISK CHARACTERISATION

          1. 3.1. Introduction

          2. 3.2. Issues to be considered for risk characterisation

            1. 3.2.1. Molecular characterisation

            2. 3.2.2. Comparative analysis

            3. 3.2.3. Food and feed safety in relation to intake

          3. 3.3. The result of risk characterisation

    3. 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

      1. 1. INTRODUCTION

        1. 1. For the purposes of implementing Article 5(3)(i) and (j) and...

        2. 2. The applicant must include information on the method as such...

        3. 3. The applicant shall also consider further guidance and information about...

      2. 2. DEFINITIONS

      3. 3. METHOD VALIDATION

        1. 3.1. Information about the method

          1. A. The method(s) shall refer to all the methodological steps needed...

          2. B. The applicant shall be allowed to refer to validated protocols,...

          3. C. The applicant shall demonstrate that the method(s) fulfils the following...

          4. D. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of...

          5. E. The applicant shall provide a complete and detailed description of...

        2. 3.2. Information about the method testing carried out by the applicant...

          1. A. The applicant shall provide all the available and relevant data...

          2. B. The applicant shall ensure that the provided information demonstrates the...

          3. C. The applicant shall provide the following information about the method...

          4. D. The applicant shall, in addition to the information required under...

        3. 3.3. Samples of the food and feed and their control samples...

      4. 4. CERTIFIED REFERENCE MATERIAL

Back to top

Options/Help

Print Options

You have chosen to open the Whole Regulation

The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources