• Protocol

Approved Establishments Scottish National Protocol

Content: Protocol

3. Legislation

3.1. Most food law operating in the UK is derived from EU law. Following EU Exit, these EU Food regulations were assimilated and codified into our domestic food law. From 1st January 2024, any references to EU Regulations should be read as referring to  EU assimilated law which is published on legislation.gov.uk.

The following assimilated EU Food Law is relevant to the Approval process:

3.2. Regulation (EC) 178/2002 – General Food Law Regulation: This regulation provides a framework for food and feed law in the EU and applies to Member States and food and feed business operators. It applies to all stages of production, processing and distribution of food and feed, but does not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. The principal aim of the regulation is to protect public health and consumers’ interests in relation to food. 

3.3. Regulation (EC) 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs: This sets out general hygiene rules that apply to all registered and approved food businesses including structural requirements and the implementation of procedures based on hazard analysis and critical control point (HACCP) principles. The regulation sets out objectives for ‘good hygiene practices’ to protect consumers. 

3.4. Regulation (EC) 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin: This includes requirements for businesses producing Products of Animal Origin (POAO) that apply in addition to those set out in Regulation (EC) 852/2004, including the requirement for establishments to be approved. 

3.5. Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs. This provides the microbiological parameters for foods. 

3.6. Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (Official Controls Regulation): As of 14 December 2019, this regulation repealed and replaced Regulation (EC) 882/2004 and Regulation (EC) 854/2004. This regulation includes procedures to be followed concerning the approval of establishments as required under Regulation (EC) 853/2004. It also includes the specific requirement for inspection and auditing activities by the CA to be carried out in relation to establishments that require approval under Regulation (EC) 853/2004. 

3.7. Commission Delegated Regulation (EU) 2019/624 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs (LBMs) in accordance with Regulation (EU) 2017/625: This regulation, made under Article 18(7) of Regulation (EU) 2017/625, includes - but is not limited to - minimum training requirements for tasks relating to official controls and criteria and conditions to determine, by way of derogation, when: ante-mortem inspection (AMI) in certain slaughterhouses may be performed under the supervision or under the responsibility of an Official Veterinarian (OV); when AMI may be performed outside the slaughterhouse in case of emergency slaughter; when AMI may occur at the holding of provenance and when post-mortem inspection (PMI) and auditing activities may be performed under the responsibility of an OV.  

3.8. Commission Implementing Regulation (EU) 2019/627 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625: This regulation, made under Article 18(8) of Regulation (EU) 2017/625, includes specific requirements for the performance and uniform minimum frequency of official controls for POAO; the practical arrangements of AMI and PMI to ensure that sufficient guarantees are met when the controls are performed under the responsibility of the OV; conditions for the classification and monitoring for LBMs and technical requirements of the health mark and practical arrangements for its application.

Did you find this helpful? We would love to hear from you.
Thank you for your feedback!