Hygienic design

Standards and regulations

Numerous standards and regulations govern practically all aspects of the hygienic design and the hygienic production of foods, pharmaceuticals and medical products. Here are some of the most important directives, regulations and standards.

Directives

Directive 90/128/EEC
Provides a complete directive with regulations and a positive list of suitable plastics for sustained contact with foods.

Directive 98/37/EC
Deals with safety and health requirements for protection of the operating personnel of various types of machines. Appendix I, 2.1 contains hygiene regulations for food machinery.

Directive 2002/72/EC
On materials and objects made of plastic that are designed for contact with foods.

Regulations

Regulation (EC) No. 1935
Europe-wide regulation on materials and objects that are designed for contact with foods.

Regulation (EC) No. 852
This regulation contains specific hygiene regulations for foods of animal origin.

Standards

DIN EN 1672-2
This standard plays a key role for food machinery. It recommends that manufacturers furnish proof of the proper design of their systems and components and also conduct a documented risk analysis. This standard focuses especially on the design of systems, machines and their components. Surfaces must be corrosion-resistant, non-toxic and easy to clean, and the materials or coatings used may neither contaminate the food nor transfer unwanted odors and dyes or flavorings. Gaps, cracks and other dead spaces in which parts of the food or cleaning substances could accumulate are prohibited; connecting elements such as screws or rivets should be avoided or have to be able to be cleaned, and bearings and shaft holes must be located outside of the food area, if possible, and be lubricated with lubricants that are suitable for use with foods.

DIN EN ISO 14159
Contains hygiene requirements for the design of machines. This international standard is nearly identical to DIN EN 1672-2 and defines the requirements for the design of machines. However, its area of application is not limited to food machines.

DIN EN ISO 21469
Draft of standard for lubricants with non-foreseeable contact with product.

DIN 11483 (Part 1 and 2)
A standard for cleaning and disinfection.

DIN 10516
Deals with regulations for cleaning and disinfection.