- Latest available (Revised)
- Original (As adopted by EU)
Commission Implementing Regulation (EU) 2017/2469Show full title
Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (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 to legislation:
There are currently no known outstanding effects for the Commission Implementing Regulation (EU) 2017/2469, Article 5.
Changes to Legislation
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.
Article 5U.K.Scientific data requirements
1.The dossier submitted in support of an application for the authorisation of a novel food shall enable a comprehensive risk assessment of the novel food.
2.Where the application for the authorisation of a novel food involves the use of engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283, the applicant shall provide detection and characterisation test methods in compliance with the requirements of Article 10(4) of that Regulation.
3.The applicant shall provide a copy of the documentation on the procedure and strategy followed when gathering the data.
4.The applicant shall provide a description of the safety evaluation strategy and the corresponding toxicological testing strategy and shall justify the inclusion or exclusion of specific studies or information.
5.The applicant shall provide on request the raw data for the individual studies, published and unpublished, undertaken by the applicant, or on their behalf, to support their application. This information includes data used to generate the conclusions of the individual studies and results of examinations.
6.Where it cannot be excluded that a novel food intended for a particular group of the population would be also consumed by other groups of the population the safety data provided shall also cover those groups.
7.For each biological or toxicological study, the applicant shall clarify whether the test material conforms to the proposed or existing specification. Where the test material differs from that specification, the applicant shall demonstrate the relevance of those data to the novel food under consideration.
Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC or F1... they shall follow the OECD Principles of Good Laboratory Practice. The applicant shall provide evidence of compliance with those requirements and shall justify any deviation from the standard protocols.
8.The applicant shall propose an overall conclusion on the safety of the proposed uses of the novel food. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
Textual Amendments
F1Words in Art. 5(7) omitted (31.12.2020) by virtue of The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 55; 2020 c. 1, Sch. 5 para. 1(1)
Options/Help
Print Options
PrintThe Whole Regulation
PrintThis Article only
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.