| Guvnor

Enforced by: FSA, Food Standards Scotland
Status: Amended (in force with amendments)
Penalty ceiling: Prosecution 1 of 13 obligations carry an unlimited fine. 12 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Operator2 Trader1 Applicant1 Any Person1

Plus 8 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.

Operator — also bound by 746 other Acts

Regulation (EU) No 965/2012 (Air Operations) 203 duties

Commission Implementing Regulation (EU) 2018/2066 of 19 December 2018 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council and amending Commission Regulation (EU) No 601/2012 (Text with EEA relevance) 121 duties

Commission Regulation (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) 112 duties

Space Industry Regulations 2021 76 duties

Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (Text with EEA relevance) 66 duties

Trader — also bound by 825 other Acts

Value Added Tax Regulations 1995 416 duties

Companies Act 2006 243 duties

The Large and Medium-sized Companies and Groups (Accounts and Reports) Regulations 2008 133 duties

Companies Act 1985 85 duties

Insolvency (England and Wales) Rules 2016 62 duties

Applicant — also bound by 307 other Acts

Insolvency (England and Wales) Rules 2016 46 duties

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

Any Person — also bound by 2340 other Acts

Human Medicines Regulations 2012 184 duties

Merchant Shipping Act 1995 144 duties

Insolvency (England and Wales) Rules 2016 104 duties

Communications Act 2003 92 duties

Road Traffic Act 1988 92 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.004 Procedure for determination of novel food status Regulated

Check and verify if your food product is classed as 'novel'Operator

s.006 Requirement for authorisation Regulated

Only sell or use authorised novel foodsTrader

s.007 General conditions for authorisation of novel foods Regulated

Other duties (1) — Crown / regulator

Appropriate authority must ensure novel foods meet safety and transparency criteriaStatutory regulator

s.009 Obligations of the appropriate authority in relation to the procedure for determining authorisation status and content of an authorisation Regulated

Other duties (1) — Crown / regulator

FSA/FSS must determine novel food status and set authorisation conditionsStatutory regulator

s.011 Opinion of the Food Safety Authority Regulated

Other duties (1) — Crown / regulator

Food Safety Authority must provide a safety opinion on novel food applicationsStatutory regulator

s.012 Authorisation of a novel food ... Regulated

Other duties (1) — Crown / regulator

UK authorities must determine novel food applications within seven monthsCrown / Minister / Government department

s.015 Procedure for notifying the placing on the market of a traditional food from a third country Regulated

Other duties (1) — Crown / regulator

Appropriate authority must process and authorise traditional food notificationsStatutory regulator

s.017 Opinion of the Food Safety Authority on a traditional food from a third country Regulated

Other duties (1) — Crown / regulator

Food Safety Authority must issue an opinion on traditional food applicationsStatutory regulator

s.018 Authorisation of a traditional food from a third country ... Regulated

Other duties (1) — Crown / regulator

Government must decide on traditional food authorisations within three monthsCrown / Minister / Government department

s.023 Confidentiality of applications for authorisation Regulated

Request and justify confidential treatment for novel food applicationsApplicant

s.025 Additional information requirements Regulated

Report new safety info or overseas restrictions on novel foodsOperator

s.029 Penalties Prosecution

Fail to comply with novel foods authorisation requirementsAny Person

Unlimited fine

s.art003 Domestic list of authorised novel foods Regulated

Other duties (1) — Crown / regulator

FSA must maintain and publish a list of authorised novel foodsStatutory regulator

26 other provisions — procedural and definitional

s.001 Subject matter and purpose

s.002 Scope

s.003 Definitions

s.005 Implementing power concerning the definition of novel food

s.008 Initial establishment of the Union list

s.010 Procedure for determining authorisation status

s.013 Implementing acts laying down administrative and scientific requirements for applications

s.014 Notification of a traditional food from a third country

s.016 Application for the authorisation of a traditional food from a third country

s.019 Application of provisions to authorised traditional foods from third countries

s.020 Implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries

s.021 Additional information concerning risk management

s.022 Extension of time periods

s.024 Post-market monitoring requirements

s.026 Authorisation procedure in case of data protection

s.027 Authorisation of a novel food ... based on protected proprietary scientific evidence or scientific data

s.028 Authorisation procedure in case of a parallel application for the authorisation of a health claim

s.030 Committee procedure

s.031 Engineered nanomaterials

s.032 Exercise of the delegation

s.033 Amendments to Regulation (EU) No 1169/2011

s.034 Repeal

s.035 Transitional measures

s.036 Entry into force

s.determination of authorisation status Determination of authorisation status

s.regulations and devolved powers Regulations and devolved powers

Help complying

Guvnor’s practical routes through this instrument.

Novel foods authorisation in Great Britain

How to determine whether your food product requires novel food authorisation in Great Britain, and how to apply. Covers the definition of …

1 more guide that reference this instrument

Food and drink business licensing and compliance

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.

Regulation (EU) 2015/2283 on novel foods

Does it bind you?

Other Acts binding the same actors

What it requires

Help complying

Novel foods authorisation in Great Britain