- Latest available (Revised)
- Original (As adopted by EU)
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)
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
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.
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 over time for: Division 4.
Changes to legislation:
There are outstanding changes not yet made to Commission Implementing Regulation (EU) No 503/2013. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
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 legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to the whole legislation item and associated provisions
- Signature words omitted by S.I. 2019/705 reg. 53
- Annex 1 Pt. 7 para. 1.1(a) omitted by S.I. 2019/705 reg. 54(e)(iii) (This amendment not applied to legislation.gov.uk. Reg. 54(e) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(b))
- Annex 1 Pt. 7 para. 1 substituted by S.I. 2019/705, reg. 54(e)(iv) (as substituted) by S.I. 2020/1504 reg. 17(10)(b)
- Annex 1 Pt. 1 para. 2 words substituted by S.I. 2019/705 reg. 54(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 1 para. 4(c) words substituted by S.I. 2019/705 reg. 54(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 1 para. 8 words substituted by S.I. 2019/705 reg. 54(a)(iii) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 2 para. 1.1(b) words substituted by S.I. 2019/705 reg. 54(b)(i) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 2 para. 1.1(e)(v) words substituted by S.I. 2019/705 reg. 54(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 2 para. 1.1(e)(vi) words substituted by S.I. 2019/705 reg. 54(b)(iii) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 2 para. 7 words substituted by S.I. 2019/705 reg. 54(b)(iv) (This amendment not applied to legislation.gov.uk. Reg. 54(a)(b) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(a))
- Annex 1 Pt. 7 para. 1.8(h) words substituted by S.I. 2019/705 reg. 54(e)(iv) (This amendment not applied to legislation.gov.uk. Reg. 54(e) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(10)(b))
- Annex 1 Pt. 1 para. 2 words substituted by S.I. 2019/705, reg. 54(a)(i) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 1 para. 4 words substituted by S.I. 2019/705, reg. 54(a)(ii) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 1 para. 8 words substituted by S.I. 2019/705, reg. 54(a)(iii) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 2 para. 1 words substituted by S.I. 2019/705, reg. 54(b)(i) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 2 para. 1 words substituted by S.I. 2019/705, reg. 54(b)(ii) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 2 para. 1 words substituted by S.I. 2019/705, reg. 54(b)(iii) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 2 para. 7 words substituted by S.I. 2019/705, reg. 54(b)(iii) (as substituted) by S.I. 2020/1504 reg. 17(10)(a)
- Annex 1 Pt. 7 para. 1 words substituted by S.I. 2019/705, reg. 54(e)(iii) (as substituted) by S.I. 2020/1504 reg. 17(10)(b)
- Annex 3 para. 1 words omitted by S.I. 2019/705 reg. 56(a)(ii)
- Annex 3 point C para. 3.1(4) words omitted by S.I. 2019/705 reg. 56(c)
- Annex 3 para. 1(3) words substituted by S.I. 2019/705 reg. 56(a)(i)
- Annex 2 s. 2 para. 1.3.1 words omitted by S.I. 2019/705 reg. 55(a)(ii)
- Annex 2 s. 2 para. 2 words omitted by S.I. 2019/705 reg. 55(a)(ix)(aa)
- Annex 2 s. 2 para. 1.1.2(b) words substituted by S.I. 2019/705 reg. 55(a)(i)
- Annex 2 s. 2 para. 1.3.2.1 words substituted by S.I. 2019/705 reg. 55(a)(iii)
- Annex 2 s. 2 para. 1.3.2.2 words substituted by S.I. 2019/705 reg. 55(a)(iv)
- Annex 2 s. 2 para. 2 words substituted by S.I. 2019/705 reg. 55(a)(ix)(bb)
- Annex 2 s. 2 para. 1.4.2 words substituted by S.I. 2019/705 reg. 55(a)(v)
- Annex 2 s. 2 para. 1.4.4.1 words substituted by S.I. 2019/705 reg. 55(a)(vi)
- Annex 2 s. 2 para. 1.5 words substituted by S.I. 2019/705 reg. 55(a)(vii)
- Annex 2 s. 2 para. 1.6.4 words substituted by S.I. 2019/705 reg. 55(a)(viii)
- Art. 4(1)(b) words substituted by S.I. 2019/705 reg. 49 (This amendment not applied to legislation.gov.uk. Reg. 49 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 17(9))
- Art. 4(1)(b) words substituted by S.I. 2019/705, reg. 49 (as substituted) by S.I. 2020/1504 reg. 17(9)
4.CERTIFIED REFERENCE MATERIALU.K.
The certified reference material shall be produced under ISO Guide 34 (General requirements for the competence of reference material producers) by a producer accredited to ISO Guide 34.
The applicant shall provide information as regards the place where the certified reference material can be accessed. This shall be accompanied by adequate information demonstrating that the availability of the certified reference material will be maintained throughout the period of validity of the authorisation. For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories) shall be used.
Uncertainties shall be estimated according to the ISO Guide to the Expression of Uncertainty in Measurement (GUM).
The main characteristics of those internationally accepted technical provisions are the following:
1.
Genetically modified reference material containers:
(a)
genetically modified reference material container (such as bottles, vials, ampoules) shall be tight and contain not less than the stated amount of material;
(b)
the commutability of the genetically modified reference material must be assured;
(c)
packaging shall be appropriate to the purpose;
(d)
labelling shall be of good aspect and quality.
2.
Homogeneity testing:
(a)
samples shall have appropriate homogeneity;
(b)
between-bottle homogeneity shall be examined;
(c)
any possible between-bottle heterogeneity shall be accounted for in the overall estimated reference material uncertainty. This requirement shall apply even when no statistically significant between-bottle variation is present. In this case, the method variation or the actual calculated between-bottle variation, whichever is larger, shall be included in the overall uncertainty.
3.
Stability testing:
(a)
samples shall have appropriate stability;
(b)
stability shall be positively demonstrated by appropriate statistical extrapolation for the genetically modified reference material shelf-life to be within the stated uncertainty; the uncertainty related to this demonstration is part of the estimated reference material uncertainty. Assigned values are valid only for a limited time and shall be subject to a stability monitoring.
4.
Batch characterisation:
1.
The methods used for verification and for certification shall:
(a)
be applied under metrologically valid conditions;
(b)
have been properly technically validated before use;
(c)
have precision and trueness compatible with the target uncertainty.
2.
Each set of measurements shall:
(a)
be traceable to the stated references;
(b)
be accompanied by an uncertainty statement whenever possible.
3.
Participating laboratories shall:
(a)
have the required competence for the execution of the task;
(b)
be able to achieve traceability to the required stated references;
(c)
be able to estimate their measurement uncertainty;
(d)
have in place a sufficient and appropriate quality assurance system.
5.
Final storage:
1.
To avoid degradation after sample production, all samples shall be stored under conditions designated for the final storage of the genetically modified certified reference material before measurements are started.
2.
Otherwise, they shall be transported from door to door keeping them at all times under such storage conditions for which it has been demonstrated that there is no influence on the assigned values.
6.
Establishment of a certificate for certified reference material:
A certificate complemented by a certification report shall be established, containing all information relevant to and needed by the user.
The certificate and report shall be made available when the genetically modified certified reference material is distributed.
The information accompanying the certified reference material shall include information on the breeding of the plant which has been used for the production of the certified reference material and on the zygosity of the insert(s).
The certified value of the GMO content shall be given in mass fraction and, where available, in copy number per haploid genome equivalent.
Certified values (such as quantity of genetically modified material expressed in mass fraction) shall be traceable to stated references and be accompanied by an expanded uncertainty statement valid for the entire shelf-life of the genetically modified certified reference material.
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Annex
PrintThis Division only
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?
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.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: 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.
Opening Options
Different options to open legislation in order to view more content on screen at once
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
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.
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
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.