Systems and machines that are used in the processing of pharmaceutical products or foodstuffs, or generally in hygienically critical environments, must meet certain criteria. These are defined in Europe, at least for the food sector:

The EC1935/2004 - general regulation

The European Parliament issued Regulation EC1935/2004 on this in 2004. It replaces Directives 80/590/EEC and 89/109/EEC. The purpose of this regulation is to protect consumers from health risks. It relates primarily to food, but in practice is often applied to other sensitive applications, such as the production of pharmaceutical products.

Accordingly, materials that come into contact with food must be manufactured in such a way that „under normal or foreseeable conditions of use, they do not transfer constituents to food in quantities that are likely to

endanger human health;
bring about an unacceptable change in the composition of the food;
cause an impairment of the organoleptic food properties (editor's note: such as smell, taste, appearance, color, etc.).“
This also means that the labeling, advertising and presentation of materials and articles must not mislead the consumer.

In addition to the general regulation, EC1935/2004 contains information on individual measures, individual national measures, the authorization of substances and labeling when placing on the market.

Declaration of conformity

The materials and objects in question must be accompanied by a written declaration that they comply with the applicable regulations. It must also be possible to prove this with suitable documentation if necessary.

Traceability

In order to facilitate controls and the recall of defective products, the supply chains must be traceable via systems or procedures.

Symbol for food conformity

FDA food directive

The FDA food regulations apply exclusively to materials and articles imported into the USA. The FDA (Food and Drug Administration) is the authority responsible for the market surveillance of food, drugs and medical devices in the USA. Although it is of course not legally applicable in Europe, it plays a role for many European companies due to the importance of the American market. It goes without saying that European companies in the USA must comply with the same guidelines as American companies.

The FDA therefore specifies which devices, products, materials etc. may come into contact with food and monitors compliance with the regulations. The same principle applies with regard to the criteria to be fulfilled as with EC1935/2004.

The NMPA (National Medical Product Administration) plays the same role for China.