6. Registration Processes

General Foods
EU

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

6.1 Product Notification

Notification is not generally requested for foodstuffs at the EU level. For some specific food categories (e.g. food supplements, fortified foods, food for special medical purposes, etc.), a notification is requested at the national level for some Member States.

6.2 Product Registration

Registration is not generally requested for ordinary foods. Registration is requested for geographical indications following the procedures established by the European Commission which are specific for agricultural products, wine products, and spirit drinks. 

6.3 Other Notes or Requirements

Product Notification

None.

Product Registration

None.

6.4 Manufacturing Site Registration

Food business operator’s registration is generally requested and managed at the national level. Procedures, costs, etc. should be investigated on a country-by-country basis. 

6.4.1 Standard/Rules for Manufacturing Site

Food Hygiene standards set by Regulation (EC) 852/2004 [1] apply. Other specific requirements related to specific food categories (e.g. gluten-free) and other national provisions may be relevant.

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 [1] 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 [2]. 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.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

None.

6.5 References

1. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004

https://eur-lex.europa.eu/eli/reg/2004/852/oj

2. Food Safety Management Systems ISO 22000:2018

ISO 22000:2018(en), Food safety management systems — Requirements for any organization in the food chain