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Specific Hygiene Requirements

Primary Production
Processing of Milk and Milk Products
Further Information

Food Business Operators (FBOs) carrying out any stage of production, processing and distribution of milk and milk products must comply with the relevant hygiene requirements laid down in Annexes I and II of Regulation (EC) 852/2004 as well as those set out in Annex III (Section IX) of Regulation (EC) No 853/2004. General rules on the hygiene of foodstuffs are set out in Regulation (EC) 852/2004 which apply to all stages of production, processing and distribution of food and to exports. FBOs must ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in Regulation 852/2004.

Primary Production

Annex I, Part A, to Regulation (EC) No 852/2004 covers the transport, storage and handling of raw milk at the place of production, provided that this does not substantially alter their nature as well as requiring primary producers to:

  • ensure that milk is protected against contamination, having regard to any processing it will subsequently undergo.
  • take appropriate measure to ensure the cleanliness of milk production animals.
  • keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels.
  • that staff handling milk are in good health and undergo training on health risks.
  • keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. FBOs must make relevant information contained in these records available to the competent authority and receiving food business operators on request.

Chapter I of Annex III Section IX of Regulation (EC) No 853/2004 sets out the specific requirements that apply to raw milk and colostrum production covering:

  • animal health requirements for raw milk and colostrum production
  • hygiene on milk and colostrum production holdings
  • requirements for premises and equipment
  • hygiene during milking, collection and transport
  • staff hygiene
  • criteria for raw milk and colostrum

Processing of Milk and Milk Products

The hygiene rules applicable to the processing of milk and milk products include those laid down in Annex II (all chapters except chapter III) to Regulation (EC) No 852/2004, Annex III to Regulation (EC) No 853/2004 and with the microbiological criteria set out in Annex I to Regulation (EC) 2073/2005.

Pre-requisite requirements as well as the necessity to develop and implement a documented food safety management system based on HACCP principles are addressed in Regulation (EC) No 852/2004.

Section IX of Annex III to Regulation 853/2004 covers the following aspects:

  • Chapter II – Requirements concerning dairy and colostrum-based products
    • Temperature requirements
    • Requirements for heat treatment
    • Criteria for raw cow's milk 
  • Chapter III – Wrapping and packaging
  • Chapter IV – Labelling
  • Chapter V – Identification marking
  • Annex I, Chapters I and II of Regulation (EC) 2073/2005 sets out food safety and process hygiene criteria respectively.

Further Information

Food Safety Controls on Milk on the website of Department of Agriculture, Food and the Marine
EU information on milk and milk products on the website of the EU Commission