Content guide

Table 1. Commodities and activities that require approval
Table 2. Maximum amounts considered as small quantities for individual products of animal origin.
Table 3. Situations where a change in FBO, between different business entities, requires a new approval or where the approval can be retained are detailed below.
Table 4. Enforcement Responsibilities at FSS Approved Establishments.

14. Annex 1

Table 1. Commodities and activities that require approval

Product	Relevant Annex of 853/2004	Establishment Type	Operation for which establishment may be approved	CA
Red Meat	Annex III, Section I	Abattoir	Slaughter of Domestic Ungulates	FSS
Red Meat	Annex III, Section I	Cutting Plant	Red Meat Cutting	FSS
Poultry and Lagomorphs	Annex III, Section I	Abbatoir	Slaughter of Poultry and Lagomorphs	FSS
Poultry and Lagomorphs	Annex III, Section II	Cutting Plant	Cutting of Poultry and Lagomorphs	FSS
Farmed Game	Annex III, Section III	Abbatoir	Slaughter of Farmed Game	FSS
Wild Game	Annex III, Section IV	Game Handling Establishment	Processing of Wild Game	FSS
Minced meat, meat preparations and mechanically separated meat	Annex III, Section V	Processing Plant	Producing minced meat, meat preparations and mechanically separated meat	LA (FSS if co-located with Slaughter or Cutting)
Meat products	Annex III, Section VI	Processing Plant	Production of meat products	LA (FSS if co-located with Slaughter or Cutting)
Live Bivalve Molluscs	Annex III, Section VII	Dispatch Centre	Reception, conditioning, washing, cleaning, grading, wrapping and packaging of LBMs	LA
Live Bivalve Molluscs	Annex III, Section VII	Purification Centre	Purification of LBMs in tanks fed by clean seawater for the time necessary to reduce contamination to make them fit for human consumption	LA
Fishery products	Annex III, Section VIII	Factory vessel	Filleting, slicing, skinning, shelling, shucking, mincing or processing of fishery products on board	LA
Fishery products	Annex III, Section VIII	Freezing vessel	Freezing of fishery products after bleeding, heading, gutting, and removal of fins and, where necessary, followed by wrapping or packaging.	LA
Fishery products	Annex III, Section VIII	Processing Plant	Processing of fishery products	LA
Fishery products	Annex III, Section VIII	Fresh fishery products Plant	Handling of unprocessed fishery products that have not undergone any treatment to ensure preservation other than chilling	LA
Fishery products	Annex III, Section VIII	Auction hall	Storing and displaying of fishery products for auction sale	LA
Raw Milk & Dairy Products	Annex III, Section IX	Collection centre	Collection of raw milk where it is cooled and filtered	LA
Raw Milk & Dairy Products	Annex III, Section IX	Processing Plant	Treating, processing and/or wrapping of dairy products (milk or any milk- based product)	LA
Eggs and Egg Products	Annex III, Section X	Packing Centre	Packing and grading of eggs by quality and weight	LA
Eggs and Egg Products	Annex III, Section X	Processing Plant	Processing of egg products	LA
Eggs and Egg Products	Annex III, Section X	Liquid egg plant	Handling of unprocessed egg contents after removal of shell	LA
Frogs Legs and Snails	Annex III, Section XI	Processing Plant	Slaughter and Processing	LA
Rendered animal fats and greaves	Annex III, Section XII	Storage	Intermediate storage of rendered animal fats and greaves	LA (FSS if co-located with Slaughter or Cutting)
Treated stomachs, bladders and intestines (Processing Plant)	Annex III, Section XIII	Processing Plant	Processing of treated stomachs, bladders and intestines	LA (FSS if co-located with Slaughter or Cutting)
Gelatine	Annex III, Section XIV	Processing Plant	Processing of gelatine	LA (FSS if co-located with Slaughter or Cutting)
Gelatine	Annex III, Section XIV	Collection Centre / Tannery	Authorisation - not approval	LA (FSS if co-located with Slaughter or Cutting)
Collagen	Annex III, Section XV	Processing Plant	Processing of collagen	LA (FSS if co-located with Slaughter or Cutting)
Collagen	Annex III, Section XV	Collection Centre / Tannery	Authorisation - not approval	LA (FSS if co-located with Slaughter or Cutting)
Highly Refined Products	Annex III, Section XVI	Processing Plant	Production and processing of highly refined POAO	LA
General POAO	N/A	Cold store	Storage of products of animal origin	LA (FSS if co-located with Slaughter or Cutting)
General POAO	N/A	Wholesale Market	Establishment that includes separate sub-units operating independently as food business, but sharing common facilities	LA
General POAO	N/A	Re-wrapping and re-packaging Establishment	Re-wrapping and re-packaging of products of animal origin	LA (FSS if co-located with Slaughter or Cutting)
General POAO	N/A	Re- packaging Establishment	Re-packaging of products of animal origin	LA (FSS if co-located with Slaughter or Cutting)
General POAO	N/A	Reefer Vessel	Storage of products of animal origin	LA

Table 2. Maximum amounts considered as small quantities for individual products of animal origin.

Products	Maximum amounts
Milk	Not applicable in Scotland
Eggs	Less than 360 eggs (i.e. less than one full case) per week. Note: This exemption only applies to the producer supplying directly to the final consumer from the farm and farmers markets and door to door. If the producer sells the eggs, to other food businesses (e.g. local shops, restaurants or bakeries etc.), they must first be graded as Class A; and, therefore, the establishment must be approved and authorised as a packing centre for activity unless they meet the exemption in Regulation (EC) 853/2004, Article 5 (b) (ii).
Fishery products	Up to 25 tonnes in a calendar year
Live Bivalve Molluscs	Up to 25 tonnes in a calendar year, but subject to maximum limits for individual species as set out below: Cockles - 25 tonnes Oysters - 5 tonnes King Scallops - 10 tonnes Queen Scallops - 10 tonnes Mussels - 20 tonnes Other Live Bivalve Molluscs – 10 tonnes Marine Gastropods – 20 tonnes

Table 3. Situations where a change in FBO, between different business entities, requires a new approval or where the approval can be retained are detailed below.

Existing FBO (as per approval documentation)	Change of FBO (in each case assuming no other changes to the business)	Approval status	Comments	Re-approval required
Sole trader, Partnership or incorporated company (e.g. Ltd, PLC, etc.)	Different sole trader, partnership or incorporated company takes over	Expires	Discontinuation of operator/s	Yes
Limited Company	Company take over or buy-out. Limited Company remains the same	Retained	Continuation of operator	No
Sole trader or Partnership	Company incorporated (and registered), Sole trader or partner/s becomes Director/s	Expires	Creation of a Company so the company is responsible not the individual/s	Yes
Sole trader	Creation of a partnership where the sole trader is one of the partners	Retained	Continuation of operator	No
Partnership	Dissolved and one of the partners takes over sole ownership and becomes a sole trader	Retained	Continuation of operator	No
Partnership	New partner joins or a partner leaves (also refer to dissolved partnership) as long as there is a continuation of at least one partner	Retained	Continuation of operator/s	No
Incorporated company	Company goes into administration and is being run as a going concern by the administrators	Retained	Continuation of operator/s	No
Incorporated company in administration	Company taken over from administrators by a different sole trader, partnership or incorporated company	Expires	Discontinuation of operator/s	Yes
Sole trader, Partnership or Incorporated company	Bankruptcy, insolvency or in liquidation (wound up / dissolved)	Expires	Discontinuation of operator/s, approval expires	N/A

Other business types such as cooperatives, registered charities and other specialised types of organisations will need to be treated on a case by case basis to identify the change in natural person or legal person required to be compliant with food law within the food business under their control. When unsure the CA should seek legal advice.

Table 4. Enforcement Responsibilities at FSS Approved Establishments.

Approval Process	Local Authority	Food Standards Scotland	Comments
Regulation (EC) 853/2004	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006

Hygiene Regulations	Local Authority	Food Standards Scotland	Comments
Regulation (EC) 852/2004	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EC) 853/2004	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EC) 2073/2005	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU) 2015/1375	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU) 2019/624	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU) 2017/625	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU) 2019/625	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU) 2019/627	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Regulation (EU)2019/628	No	Yes	Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006

Sampling	Local Authority	Food Standards Scotland	Comments
Microbiological criteria	No	Yes	Regulation (EC) 2073/2005
Contaminants in Food	Yes	No	Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990

Traceability	Local Authority	Food Standards Scotland	Comments
Regulation (EC) 178/2002	Yes	Yes	See Regulations 3 and 6 of General Food Regulations 2004
Regulation (EU) 931/2011	No	Yes	Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002

Food Information	Local Authority	Food Standards Scotland	Comments
Food Information (Scotland) Regulations 2014	Yes	No	Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990
Country of Origin	No	Yes	The Country Of Origin Of Certain Meats (Scotland) Regulations 2016 Regulation (EU) 1169/2011 Commission Implementing Regulation (EU) No. 1337/2013
Identification Mark/Health Mark	No	Yes	Regulation (EC) 853/2004
Beef and Veal Labelling	No	No	Enforced by Scottish Government

Composition	Local Authority	Food Standards Scotland	Comments
Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations	Yes	No	Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990

Material in contact with Food	Local Authority	Food Standards Scotland	Comments
Materials and Articles in Contact with Food	Yes	No	Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990

Waste

Local Authority

Food Standards Scotland

Comments

Waste – ABP in slaughterhouses, AGHEs and cutting plants

No

Yes

The Animal By-Products (Enforcement) (Scotland) Regulations 2013;

Regulation (EC) 1069/2009

TSE

Local Authority

Food Standards Scotland

Comments

TSE controls in slaughterhouses and cutting plants

No

Yes

The Transmissible Spongiform Encephalopathies (Scotland) Regulations 2010

Regulation (EC) 999/2001

Animal Welfare

Local Authority

Food Standards Scotland

Comments

Welfare of animals at the time of killing

No

Yes

The Welfare Of Animals At The Time Of Killing (Scotland) Regulations 2012

Regulation (EC) 1099/2009

The Mandatory Use of Closed Circuit Television in Slaughterhouses (Scotland) Regulations 2020

Approved Establishments Scottish National Protocol

Approved Establishment Scottish National Protocol - May 2026

Approved Establishment Scottish National Protocol - Summary of Changes

Content guide

14. Annex 1

Table 1. Commodities and activities that require approval

Table 2. Maximum amounts considered as small quantities for individual products of animal origin.

Table 3. Situations where a change in FBO, between different business entities, requires a new approval or where the approval can be retained are detailed below.

Table 4. Enforcement Responsibilities at FSS Approved Establishments.