6. Registration Processes

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General Foods
EU

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

None

6.2 Product Registration

None

6.3 Other Notes or Requirements

Product Notification

None

Product Registration

None

6.4 Manufacturing Site Registration

According to Regulation (EC) No 853/2004 [1], a manufacturing license is required for manufacturing sites handling unprocessed animal-origin ingredients, because it is considered an establishment subject to approval. A manufacturing site handling only processed ingredients of animal origin and ingredients of plant origin is not required to be approved by the EU for importing food to the EU.

All processed ingredients of animal origin (e.g. cheese) contained in the composite products (e.g. frozen cheese snacks), must come from EU-approved establishments located in countries authorized to export such processed products of animal origin to the EU. Please refer to Section 8 - Safety Parameters - for further details.

An export health certificate (EHC) is an official document that confirms one’ export meets the health requirements of the destination country. FBO must apply for an EHC if it is exporting or moving live animals or animal products from GB (England, Scotland, and Wales) [2] to, or through:

The EU
Non-EU Countries
Northern Ireland

A transit EHC is also needed to transit through an EU country.

A transit EHC may be needed to transit through a non-EU country. Check with the competent authority (the equivalent of Defra) in that country.

An EHC is needed for each:

type of animal or animal product being exported from Great Britain;
product type - if the exported consignment includes a mix of products.

6.4.1 Standard/Rules for Manufacturing Site

There are specific standards and rules applicable to food manufacturing sites in the European Union (EU) to ensure the safety and quality of food products. These standards and rules aim to protect consumer health, maintain food safety, and ensure the integrity of the food supply chain. Regulation (EC) 852/2004 [3] establishes comprehensive hygiene requirements for food business operators in the EU to ensure the production of food products that are safe for consumers.

Good Manufacturing Practice (GMP) - Food manufacturing sites in the EU must adhere to GMP principles outlined in Regulation (EC) No 852/2004 on the hygiene of foodstuffs. GMP covers various aspects of food production, including premises, equipment, personnel hygiene, process controls, and documentation. Buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them and to facilitate the protection of materials and products from contamination or deterioration.

Hazard Analysis and Critical Control Points (HACCP) - Article 5 of regulation (EC) 852/2004 requires Food business operators to implement a Hazard Analysis and Critical Control Points (HACCP) system to identify, evaluate, and control hazards at critical points in the food production process.

Food Safety Management Systems - Some food manufacturing sites may implement Food Safety Management Systems based on international standards such as ISO 22000:2018 [4]. These systems provide a framework for managing food safety risks and demonstrating compliance with regulatory requirements.

Waste Management - Food business operators must have procedures in place for the safe handling and disposal of waste generated during food production. This includes separating waste streams, maintaining cleanliness in waste storage areas, and ensuring compliance with environmental regulations

Allergen Management - EU regulations require food manufacturers to identify and manage allergenic ingredients in their products to prevent cross-contamination and protect consumers with food allergies. This includes proper labeling of allergens on food packaging.

Water Supply & Quality - Food premises must have access to potable water for use in food production and cleaning processes. Water quality must meet specified standards to prevent contamination of food products.

Traceability & Recall Procedures - Food manufacturing sites must have systems in place to trace the origin of raw materials, ingredients, and finished products throughout the supply chain. In the event of a food safety issue, manufacturers must be able to initiate product recalls promptly.