- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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)
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.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
There are currently no known outstanding effects for the Commission Implementing Regulation (EU) No 503/2013, Division 3..
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
For a particular food or feed material, the methodological steps shall include the methods for DNA extraction and the subsequent quantification in a real-time Polymerase Chain Reaction (PCR) System. In such a case, the whole process from extraction up to the PCR-technique shall constitute a method. The applicant shall provide information about the whole method.
In that case, the applicant shall provide experimental data from an in-house validation in which the method module has been successfully applied in the context of the application for authorisation.
The method(s) shall be specific to the transformation event (hereafter referred to as ‘event-specific’) and thus shall only be functional with the genetically modified organism or genetically modified based product considered and shall not be functional if applied to other transformation events already authorised; otherwise the method cannot be applied for unequivocal detection/identification/quantification. This shall be demonstrated with a selection of non-target transgenic authorised transformation events and conventional counterparts. This testing shall include closely related transformation events.
The method(s) shall be applicable to samples of the food or feed, to the control samples and to the certified reference material.
The applicant shall take into consideration the following documents for the development of the detection method:
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions: ISO 24276;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction: ISO 21571;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods: ISO 21570;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods: draft European standard ISO 21569.
The method shall also take into consideration the more detailed requirements set out in the common criteria set by the [F1reference laboratory]F2... for minimum performance requirements for analytical methods for GMO testing. These criteria are part of the guidance provided by the [F1reference laboratory].
Textual Amendments
F1Words in Annex 3 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 56(b); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Annex 3 para. 3.1 point C(4) omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 56(c); 2020 c. 1, Sch. 5 para. 1(1)
The following points shall be clearly addressed by the applicant:
Scientific basis: the applicant shall provide an overview of the principles of how the method works. This overview shall include references to relevant scientific publications.
Scope of the method: the applicant shall indicate the matrix(es) (for example, processed food, raw materials), the type of samples and the percentage range to which the method may be applied.
Operational characteristics of the method: the required equipment for the application of the method shall be specified, with regard to the analysis as such and the sample preparation. Further information of any specific aspects crucial for the application of the method shall also be included.
Protocol: the applicant shall provide a complete optimised protocol of the method. The protocol shall present all the details as required to transfer and apply the method independently in other laboratories.
A prediction model (or a similar tool) needed to interpret results and to make inferences shall be described in full details. Instructions for the correct application of the model shall be provided by the applicant.
Breeding schemes that are to be applied for the production of genetically modified food and feed and their impact on the interpretation of results shall be provided by the applicant.
primer pairs tested and probe, if appropriate, including a justification as to how and why the proposed primer pair has been selected;
stability testing, which shall be established through the submission of experimental results from testing the method with different plant varieties;
specificity, which shall be established through the submission of the full sequence of the insert(s) in a standardised electronic format, together with the base pairs of the host flanking sequences so as to enable the [F1reference laboratory] to assess the specificity of the proposed method by running homology searches in a molecular database;
precision, the relative repeatability standard deviation shall be less than or equal to 25 % related to mass fraction over the whole dynamic range of the method.
participating laboratories, time of the analysis and outline of the experimental design, including the details about the number of runs, samples, replicates, etc.;
description of the laboratory samples (such as size, quality, date of sampling), positive and negative controls as well as certified reference material, plasmids and alike used;
description of the approaches that have been used to analyse the test results and outliers;
any particular points observed during the testing;
references to relevant literature or technical provisions used in the testing.
For the purpose of implementing Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003, the applicant shall, together with the information required under Sections 1, 2 and 3 of this Annex, also provide samples of the food and feed and their control samples of a type and amount to be specified by the [F1reference laboratory] for the specific application for authorisation.
The information accompanying the control samples shall include information on the breeding of the plant which has been used for the production of the control samples and on the zygosity of the insert(s).
The applicant may use the same raw material for the production of certified reference material and for the production of control samples.
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?
Y Rhestrau 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?
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys