- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Applicant1
Plus 2 duties on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Applicant — also bound by 325 other Acts
Human Medicines Regulations 2012
42 duties
The Land Registration Rules 2003
25 duties
Regulation (EU) No 1178/2011 (Aircrew)
20 duties
Value Added Tax Regulations 1995
18 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
s.art005
Scientific data requirements
Regulated
- Provide comprehensive scientific dossier for novel food authorisationApplicant
s.art006
Verification of the validity of an application
Regulated
Other duties (1) — Crown / regulator
- Regulator must verify and rule on novel food application validityStatutory regulator
s.art007
Information to be included in the opinion of the Authority
Regulated
Other duties (1) — Crown / regulator
- Authority must include full scientific assessment in novel food opinionsStatutory regulator
31 other provisions — procedural and definitional
s.annex ii para.1
This Annex shall be updated during the application procedure each...
s.annex ii para.2
Where the production process contains confidential data, a non-confidential summary...
s.annex i para.1
To the appropriate authority
s.annex i para.10
(name(s), address(es)…)
s.annex i para.11
…
s.annex i para.12
…
s.annex i para.13
…
s.annex i para.14
submit(s) this application for a determination of authorisation status in...
s.annex i para.15
Identity of the novel food (information on the identity of...
s.annex i para.16
…
s.annex i para.17
…
s.annex i para.18
Confidentiality. Where appropriate, state whether the application includes confidential data...
s.annex i para.19
Yes No
s.annex i para.20
Data Protection. Where appropriate, state whether the application includes a...
s.annex i para.21
Yes No
s.annex i para.22
Yours sincerely,
s.annex i para.23
Signature …
s.annex i para.24
Enclosures:
s.annex i para.25
Complete dossier Summary of the dossier List of the parts...
s.annex i para.4
Unit
s.annex i para.5
Date: …
s.annex i para.6
Subject: Application for authorisation of a novel food in accordance...
s.annex i para.7
(Please indicate clearly by ticking one of the boxes)
s.annex i para.8
Application for an authorisation of a new novel food. Application...
s.annex i para.9
The Applicant(s) or their Representative(s) in Great Britain
s.art001
Scope and subject matter
s.art002
Definitions
s.art003
Structure, content and presentation of an application
s.art004
Administrative data requirements
s.art008
Transitional measures
s.art009
Entry into force and application
Help complying
Guvnor’s practical routes through this instrument.
1 more guide that reference this instrument
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.