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Hygiene requirements within the European Union
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In the year 2005, the hygiene provisions of the European Union were elevated to regulation level, making them direct and applicable law in all EU member states. The new hygiene legislation is commonly referred to as the “Hygiene Package”.

What comprises the Hygiene Package?
The so-called “Basic Regulation”, Regulation (EC) 178/2002, was passed in January of 2002. Its objective, as well as the objective of all further provisions, is to create a uniform standard for food hygiene and food safety within the single European market, which will ensure a high level of consumer protection without compromising the free movement of goods.

The regulation sets down the general principles and requirements of food law; it also governs the duties of food business operators to inform and to cooperate with the authorities, as well as an obligation for product traceability. It also includes provisions for establishing the European Food Safety Authority, for laying down procedures in matters of food safety, and for the implementation of an early warning system for emergencies. On the basis of this regulation, all the others came into being.


A general regulation on food hygiene (Regulation (EC) 852/2004) governs the basic requirements for companies that manufacture, process, package or place foodstuffs on the market. Specific rules for food of animal origin are set forth in Regulation (EC) 853/2004, which is supplemented by Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs. The package is completed by the addition of two regulations on the control and inspection of foodstuffs, Regulation (EC) 854/2004 for foods of animal origin, and Regulation (EC) 882/2004 for the general control of food business operators.

Fundamental changes
By applying the same requirements, the hygiene package places food and animal feed on an equal footing for the first time ever. This is further enhanced by Regulation (EC) 183/2005 and its provisions for feed hygiene. The package also clearly assigns responsibility for food and feed safety to the food or feed business operator. The hygiene package is supplemented by the new Regulation (EC) 1935/2004 on materials and articles intended for food contact.


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