EU Food Contact Materials Regulation (EC) No 1935/2004: What Machine Contact Surfaces Must Meet

Machine Parts Are "Food Contact Materials" Too

Many people think food contact materials only mean packaging bags and meal boxes. In fact, the scope of Article 1 of EU Regulation (EC) No 1935/2004 covers all materials and articles "intended to be brought into contact with food," and the text's examples include equipment such as coffee machines. In a food factory, the hopper, screw, nozzles, forming molds, cutters, and conveyor belt of an encrusting machine, and the scraper and outlet of a divider, are all within scope as long as they touch dough or filling.

So for machines sold to Europe, besides CE for machinery safety (see CE marking), the contact surface materials must also comply with the food contact material rules. The food machinery hygiene requirements in Annex I of the Machinery Directive also explicitly require materials in contact with food to comply with the relevant legislation.

Article 3: General Requirements

Article 3 of 1935/2004 sets out the principles all food contact materials must follow: materials must be manufactured according to good manufacturing practice so that, under normal or foreseeable conditions of use, they don't transfer their constituents to food in quantities that could:

• Endanger human health
• Bring about an unacceptable change in the composition of the food
• Deteriorate the food's organoleptic characteristics such as smell and taste

This is an "outcome requirement" and doesn't prescribe any particular material. The 304 and 316 stainless steels, food-grade plastics, and rubbers commonly used in food machinery must all be shown to meet these principles under actual conditions of use.

Good Manufacturing Practice: (EC) No 2023/2006

The details of the good manufacturing practice mentioned in Article 3 are set out in (EC) No 2023/2006. It applies to all stages of manufacturing, processing, and distribution of food contact materials (except the production of starting substances), and requires businesses to establish a documented quality assurance system and keep paper or electronic records. For machine manufacturers, this means keeping traceable records of the material sources, machining methods, and cleaning treatments for contact parts.

Specific Materials Have More Detailed Rules

1935/2004 is a framework regulation, and some materials have additional "specific measures." The one most often encountered is for plastics: (EU) No 10/2011 sets the authorized substances and migration limits for plastic food contact materials and requires a written declaration of compliance at every marketing stage other than retail. Plastic parts on machines (such as plastic scrapers, plastic hoppers, and some conveyor belts) require this declaration from the material supplier.

Metals and rubber currently have no EU-level specific measures and are subject to the general requirements of Article 3; some member states have their own national rules, so check the destination country's requirements before exporting.

Which Documents to Give Customers

When European food factories buy machines, they often ask for:

• Declaration of conformity: Under Article 16, it's a legal document only where specific measures require it (for example, plastic parts). Many buyers still ask the manufacturer for a declaration covering all contact surfaces stating compliance with 1935/2004 and related legislation.
• Materials list: Listing the material of each contact part, such as stainless steel grade and plastic type.
• Test reports: Migration test reports for plastic parts, usually provided by the material supplier.
• Traceability information: Under Article 17, businesses must be able to identify which supplier contact materials came from and which customers they were sold to.

Labeling Requirements

Article 15 requires materials and articles not yet in contact with food, when placed on the market, to be labeled "for food contact," with a specific indication of their use, or with the glass-and-fork symbol. Labeling isn't needed if the article's characteristics clearly show it's intended for food contact. Dedicated nozzles and forming molds on machines mostly fall into this category, but individual cases are judged by the destination country's authorities.

Practical Steps for Taiwanese Exporters

• Create a materials list for contact parts, cross-referenced to part drawing numbers
• Obtain material certificates and food contact declarations from stainless steel, plastic, and rubber material suppliers
• For plastic parts, confirm the supplier issues a declaration of compliance under (EU) No 10/2011
• If lubricants might incidentally contact food, choose food-grade lubricants and state this in the instructions
• Keep records of cleaning and passivation treatments after machining

Taiwan also has its own Sanitation Standard for Food Utensils, Containers and Packaging (食品器具容器包裝衛生標準) governing utensil materials used domestically; for exports, the destination country's regulations apply.

FAQ

Q: What must contact surfaces on machines sold to Europe comply with?
A: Article 3 of (EC) No 1935/2004: under normal use, constituents transferred to food must not endanger health or change the composition or organoleptic qualities of the food; manufacturing follows the good manufacturing practice in (EC) No 2023/2006. Plastic parts must also comply with (EU) No 10/2011.

Q: Do machine parts count as food contact materials?
A: Yes. 1935/2004 applies to all materials and articles intended to contact food, and its examples include equipment such as coffee machines; nozzles, hoppers, and conveyor belts are all within scope.

Q: Which documents should we give customers?
A: Commonly a materials list for contact surfaces, a declaration of conformity, and migration test reports for plastic parts. The legally required written declaration of compliance mainly applies to materials with specific measures, such as plastics.

Q: Does stainless steel need migration testing?
A: The EU currently has no specific measures for metals, so the general requirements apply; some member states have national rules, so confirm the destination country's requirements and the buyer's specifications before exporting.