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Commission Regulation (EC) No 641/2004Show full title
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Text with EEA relevance)
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- Revised 28/06/20130.62 MB
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Changes over time for: Division E.
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E.The applicant shall provide a complete and detailed description of the method. The following points shall be clearly addressed.U.K.
1.
Scientific basis: An overview of the principles of how the method works, such as DNA molecular biology based (e.g. for real-time PCR) information must be provided. It is recommended to provide references to relevant scientific publications.
2.
Scope of the method: Indication of the matrix (e.g. processed food, raw materials), the type of samples and the percentage range to which the method can be applied.
3.
Operational characteristics of the method: The required equipment for the application of the method shall be clearly mentioned, with regard to the analysis per se and the sample preparation. Further information of any specific aspects crucial for the application of the method shall also be mentioned here.
4.
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. It is recommended to use a protocol template, which can be obtained from the [F1RL]. The protocol shall include details of:
analyte to be tested,
working conditions, instructions and rules,
all the materials needed, including an estimation of their amounts and storage and handling instructions,
all the equipment needed, including not only the main equipment such as a PCR system or centrifuge but also small items such as micropipettes and reaction tubes with an indication of their appropriate sizes, etc.,
all the steps of the operative protocol, clearly described,
instructions for the data recording (e.g. the programme settings or parameters to be included).
5.
The prediction model (or alike) needed to interpret results and to make inferences must be described in full details. Instructions for the correct application of the model should be provided.
Textual Amendments
F1Word in Annex 1 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 46(h); 2020 c. 1, Sch. 5 para. 1(1)
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