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 II	Abattoir	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	Abattoir	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
		Freezing vessel	Freezing of fishery products after bleeding, heading, gutting, and removal of fins and, where necessary, followed by wrapping or packaging.	LA
		Processing Plant	Processing of fishery products	LA
		Fresh fishery products Plant	Handling of unprocessed fishery products that have not undergone any treatment to ensure preservation other than chilling	LA
		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
		Processing Plant	Processing of egg products	LA
		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.

Enforcement Responsibilities at FSS Approved Establishments
	Local Authority	Food Standards Scotland	Comments
Approval Process
Regulation (EC)853/2004			Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Hygiene Regulations
Regulation 852/2004 Regulation 853/2004 Regulation 2073/2005 Regulation 2015/1375 Regulation 2019/624 Regulation 2017/625 Regulation 2019/625 Regulation 2019/627 Regulation (EC)m2019/628			Regulation 5 (2) of Food Hygiene (Scotland) Regulations 2006
Sampling
Microbiological criteria			Regulation (EC) 2073/2005
Contaminants in Food			Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990
Traceability
Regulation (EC) 178/2002			See Regulations 3 and 6 of General Food Regulations 2004
Regulation (EU) 931/2011			Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002
Food Information
Food Information (Scotland) Regulations 2014			Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990
Country of Origin			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			Regulation (EC) 853/2004
Beef and Veal Labelling			Enforced by Scottish Government
Composition
Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations			Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990
Material in contact with Food
Materials and Articles in Contact with Food			Enforced by Food Authority as defined in Section 5(2) of Food Safety Act 1990
Waste
Waste – ABP in slaughterhouses, AGHEs and cutting plants			The Animal By-Products (Enforcement) (Scotland) Regulations 2013; Regulation (EC) 1069/2009
TSE
TSE controls in slaughterhouses and cutting plants			The Transmissible Spongiform Encephalopathies (Scotland) Regulations 2010 Regulation (EC) 999/2001
Animal Welfare
Welfare of animals at the time of killing			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