CE Marking, EU 10/2011, and HACCP — What Commercial Bottlers Really Need to Know

Anyone purchasing a filling machine for commercial food use will inevitably come across the CE mark. It appears to be a mark of quality—and is interpreted as such by many buyers. The legal reality is different. CE stands for Conformité Européenne and is not an independently verified certification. It is a self-declaration by the manufacturer: the manufacturer declares that its product complies with applicable EU directives—without prior confirmation from an external testing body. The system is based on the manufacturer’s own responsibility and ex post market surveillance. The EU Machinery Directive 2006/42/EC currently applies to machines—it will be replaced by the EU Machinery Regulation (EU) 2023/1230 as of January 20, 2027. The CE marking alone does not indicate whether the machine is suitable for food contact.

Two additional EU regulations apply to parts that come into contact with food during filling: EU Regulation 1935/2004 is the framework regulation for materials and articles intended to come into contact with food. It establishes the basic requirements: Materials must not transfer substances to food that endanger human health or unacceptably alter the composition of the food. EU Regulation 10/2011 specifically regulates plastics in food contact—that is, hoses, seals, and pump housings. It defines which plastics and additives are permitted and under what conditions. A device may bear a CE mark without complying with these food-specific regulations. CE marking and food compliance are two different things.

A large proportion of the low-cost filling machines priced under €3,000—which are sold in Germany under various brand names—are manufactured by Chinese OEMs. Various retailers purchase basic machines of identical construction and resell them—which explains why these machines look visually identical under different brand labels. This leads to a specific legal problem: The technical documentation that an EU manufacturer must prepare and maintain for CE conformity often does not exist at the actual manufacturer in China in the form required by EU authorities. In many cases, the European distributor reselling the device is not the “placing-on-the-market” entity in the legal sense—and therefore does not bear the corresponding manufacturer’s liability. Material certificates in accordance with EU Regulation 10/2011—that is, proof that hoses, seals, and pump parts are in fact food-grade—are often missing entirely or are not available upon request.

Anyone who processes and packages food commercially in Germany is subject to the HACCP requirement under EU Regulation (EC) No. 852/2004—with the exception of primary production alone. The Hazard Analysis and Critical Control Points (HACCP) concept requires, among other things, documented evidence that the machinery and materials used are food-safe. At the same time, market surveillance authorities may request a CE declaration of conformity and technical documentation at any time—and food safety authorities may request proof of material compliance in accordance with EU Regulation 10/2011. Anyone who cannot provide these documents risks business interruption, fines, or, in the event of damage, serious liability issues.

Before purchasing a filling machine for food applications, it’s worth asking these specific questions—and requesting written answers: Who is the legal manufacturer as defined by the EU Machinery Directive 2006/42/EC? Is complete technical documentation available in German? Are all parts that come into contact with the product certified in accordance with EU Regulations 10/2011 and 1935/2004—and can you view the material certificates? Is the contact person for inquiries and interactions with regulatory authorities available in Germany? If a supplier cannot provide clear, written answers to these questions, that is a clear red flag.

A manufacturer that designs and manufactures its machines in the EU is directly subject to EU regulations and is liable for the conformity of its products. The technical documentation must be kept on hand and made available upon request by regulatory authorities. Fillogy® is developed and manufactured in Dresden—always in compliance with applicable regulations. Compliance with the EC Machinery Directive (2006/42/EC, Annex II A) can be demonstrated for all Fillogy® filling machines. The CE mark is located on the machines’ nameplates. The facility is also regularly inspected by food safety authorities. Material certificates in accordance with EU Regulations 10/2011 and 1935/2004 can be provided upon request.

To find out what quality really means in a filling machine, read here.

This article is intended to provide general guidance and is not a substitute for individual legal advice.