United States Mission to the European Union
Foreign Agricultural Service
United States Department Of Agriculture
Last modified: November 30, 2017

Hygiene & Traceability


U.S. Food products exported to the EU have to meet all EU food safety requirements, including the specific provisions on food hygiene and traceability.

Traceability is a basic requirement throughout EU food legislation.  Traceability is defined as the ability to trace and follow food, feed, and ingredients through all stages of production, processing and distribution.  Further guidance to the EU legislation including specifics on the traceability provisions for food has been published in the Guidance Document on the Implementation of the General Food law.

On page 18, this document clarifies the traceability obligations for exporters:  Unless there are special bilateral agreements for certain sensitive sectors or specific Community legal requirements (for example in the veterinary sector), the EU importer must only be able to identify from whom the product was exported in the third country.  When EU food business operators request trading partners to provide additional traceability information, such requests are part of the food business contractual arrangements and are not mandated by EU law.

EU food hygiene legislation covers all stages of the production, processing, distribution and placing on the market of food intended for human consumption. It includes key principles that apply to all sectors such as the primary responsibility by the food business operator and the general requirements for the use of HACCP based principles. Detailed food hygiene rules are laid down for products of animal origin.

Food imported from third countries is also covered by EU food hygiene rules.  In the case of animal origin products, the detailed level of regulation involves establishment approvals by the EU, issuance of export certificates that refer to the EU hygiene rules by the respective competent authorities and specific labeling requirements in addition to the EU’s general food labeling requirements.  For companies wishing to export animal origin products to the EU, the most practical approach to ensure that EU hygiene requirements are met is therefore to directly contact the U.S. authorities issuing the certificates or consult their websites with exporter information. (U.S. Agencies providing EU certificates).


  • Primary responsibility for food safety borne by the food business operator;
  • Food safety ensured throughout the food chain, starting with primary production;
  • General implementation of procedures based on the HACCP principles;
  • Application of basic common hygiene requirements, possibly further specified for certain categories of food;
  • Registration or approval for certain food establishments;
  • Development of Member State and EU guides to good practice for hygiene or for the application of HACCP principles as a valuable instrument to aid food business operators at all levels of the food chain to comply with the rules
  • Flexibility provided for food produced in remote areas (high mountains, remote island) and for traditional production and methods.


  • Regulation (EC) No 852/2004 on the hygiene of foodstuffs – Covers:  general provisions for primary production, general requirements for food business operators.
  • Regulation (EC) No 853/2004 lays down specific hygiene rules for food of animal origin – Covers approval of establishments, health and identification marking, imports, food chain information, animal product definitions, and specific hygiene requirements for meat, poultry, minced meat, meat products, bivalve mollusks, fishery products, dairy, eggs, frogs’ legs and snails, animal fat and greaves, treated stomachs and intestines, gelatin, collagen.
  • Regulation (EC) No 854/2004 lays down specific rules for the organization of official controls on products of animal origin intended for human consumption – Covers methods to verify compliance with 853/2004 and 854/2004.
  • Directive 2004/41/EC repeals directives that were in existence at the moment of adoption of the package.

Building on the above hygiene package developed in 2004, a set of implementing measures and transitional arrangements was adopted later on:

  • Commission Regulation (EC) No 2073/2005 sets down microbiological criteria for foodstuffs
  • Commission Regulation (EC) No 2074/2005 contains a set of implementing measures such as provisions concerning food chain information, recognized testing methods for detecting marine biotoxins, lists of establishments, model health certificates for certain products of animal origin and a derogation for foods with traditional characteristics.
  • Commission Regulation (EC) No 2075/2005 lays down the rules on official controls for Trichinella in meat.
  • Commission Regulation (EU) 2017/185 lays down some transitional arrangements to permit the transition for some outstanding issues from the regime prior to 2004 to the revised EU harmonized food hygiene framework.  This period has been extended until 31 December 2016 and covers e.g. the derogation for listing requirements for the limited number of products for which there are no harmonized import requirements.

In order to assist Member States and food business operators to better understand the food hygiene rules, several guidance documents were prepared.