Requirements for Food Machinery: Connecting the Machinery Directive with EU 1935/2004 and §277

If you manufacture machinery or equipment that comes into contact with food, you are likely already familiar with the various European laws and regulations in this field—such as Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

But how do these regulations connect with the Machinery Directive and the declaration for a machine or partly completed machinery?

You start in the Machinery Directive under Section 2: ’SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY’.

Briefly stated, this section specifies that parts used in your machinery that come into contact with food must be selected and designed accordingly (along with additional requirements).

A directive is, by nature, often quite general. Therefore, to understand how to prove compliance with these requirements, you need to consult the Guide to application of the Machinery Directive 2006/42/EC, specifically the following section:

§277 Hygiene requirements for machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products

Regarding documentation, §277 explicitly states:

Where the materials intended to be in contact with foodstuffs incorporated into machinery are accompanied by a written declaration (such as the Declaration of compliance foreseen by Article 16 of Regulation (EC) No 1935/2004) that declaration must be included in the technical file for the machinery according to the ninth indent of Annex VII A 1 (a).

By his signature on the EC Declaration of Conformity, the manufacturer states that all contact materials in the machine are in compliance with the relevant legislation (e.g. Regulation 1935/2004), and that the documentation is kept in the technical file and will be forwarded to the relevant authority on due request. Such declarations should not be mentioned in the EC Declaration of Conformity of the machinery. (Guide to application of the Machinery Directive 2006/42/EC - Edition 2.3)

In short: If you manufacture a machine where components come into contact with food, the declaration for your machine (or partly completed machinery) serves as your GUARANTEE that all relevant food safety regulations have been complied with.

In your risk assessment, you have identified that your machine is intended for food processing and must comply with all applicable rules and legislation (which, by the way, also applies to animal feed). Subsequently, you have identified the specific parts and contact materials involved.

Your guarantee is contingent upon having gathered all relevant documentation and filed it in your technical file. For instance, all material certificates for gaskets, pumps, pipes, etc.

Combining different areas of legislation, as is required for food processing machinery and plant equipment, is often a complex task. However, if you are ever in doubt about where to find the specific machinery rules, refer to the sections mentioned above.

While this post has focused on documentation and the declaration of conformity, please also refer to §89 and §383, point 4 in the Guide to application of the Machinery Directive when your machinery is covered by other applicable legislation, such as food safety. Also, remember to always consult local food safety authorities, as requirements can vary greatly from country to country.

Written by: Jesper Deleuran Larsen

Last updated: 26/07/2026

Sources:

• Machinery Directive 2006/42/EC
• Guide to application of the Machinery Directive 2006/42/EC - Edition 2.3

Disclaimer
_{The information provided in this blog post is for general informational and educational purposes only. It does not constitute, nor should it be considered, professional engineering advice or technical assistance. For specific projects or concrete machinery installations, obtaining an individual professional evaluation is always recommended. While we strive to keep the information as up-to-date as possible, always verify that all standards, executive orders, regulations, directives, etc., are the latest applicable versions.}