CE Marking: What Food Machinery Needs to Sell in the EU

Does Food Machinery Need CE?

Yes. The EU sets out the safety requirements for "machinery" before it's placed on the market in the Machinery Directive 2006/42/EC, and food machinery that is power-driven and has moving parts, such as encrusting machines, dividers, and bun machines, falls within its scope. Before a machine is placed on the EU market or put into service, the manufacturer must complete the conformity procedure and affix the CE marking to the machine.

CE isn't a quality certification or a certificate issued by some body; it's the manufacturer's public declaration that "this machine meets the essential requirements of the relevant EU legislation." Responsibility for the declaration lies with the manufacturer (or the importer or authorized representative in the EU), who is liable if there's a problem.

Note the timing: the Machinery Directive will be replaced by the new Machinery Regulation (EU) 2023/1230 on January 20, 2027. Machines exported now still follow 2006/42/EC; machines placed on the market after 2027 must follow the new regulation. For details on the differences, see the EU machinery regulation overhaul.

Six Things the Manufacturer Must Do

Article 5(1) of the Machinery Directive requires the manufacturer, before placing a machine on the market, to:

1. Ensure the machine meets the "essential health and safety requirements" in Annex I
2. Prepare the technical file specified in Annex VII
3. Provide the necessary information, such as the instructions
4. Carry out the conformity assessment procedure under Article 12
5. Draw up and sign the EC declaration of conformity under Annex II and supply it with the machine
6. Affix the CE marking under Article 16

What's in the Technical File

The technical file is kept by the manufacturer and must be produced when requested by the authorities. It generally includes:

• A general description of the machine, overall drawings, and control circuit diagrams
• Detailed drawings and calculations needed to verify compliance with the essential requirements
• Risk assessment: Identifying the machine's hazards and the protective measures taken
• The harmonized standards and other technical specifications applied
• Test reports
• The instructions
• The EC declaration of conformity

The technical file must be kept for at least 10 years from the date of manufacture of the last unit.

Hygiene Requirements Specific to Food Machinery

Section 2.1 of Annex I sets out hygiene requirements specifically for foodstuffs machinery. Key points include:

• Materials in contact with food must comply with the relevant legislation and be cleanable before each use; where that's not possible, disposable parts must be used
• Contact surfaces must be smooth, without ridges or crevices that could harbor dirt, and the same goes for joints; projections, edges, and recesses should be minimized, and inside corners must have sufficient radii for easy cleaning
• Liquids and gases from food, cleaning fluids, and rinsing fluids must be able to drain completely
• Material or insects must be prevented from entering areas that can't be cleaned
• Lubricants and other auxiliary substances must not come into contact with food
• The instructions must specify recommended cleaning, disinfecting, and rinsing methods, including for hard-to-reach areas

These requirements are closely tied to the design for daily disassembly and washing of an encrusting machine. Whether the nozzles, hopper, and conveyor belt are easy to remove and wash is exactly what the CE hygiene requirements care about.

Commonly Used Harmonized Standards

Designing and manufacturing according to harmonized standards published by the EU gives a "presumption of conformity" with the corresponding essential requirements. Standards commonly used for food machinery include:

• EN ISO 12100: General principles of machinery safety for risk assessment and risk reduction
• EN 60204-1: Safety of electrical equipment of machines
• EN 1672-2: Hygiene requirements for food processing machinery
• Type-C standards for specific machines, such as EN 453 for dough mixers and EN 454 for planetary mixers

Versions of harmonized standards follow publication in the Official Journal of the EU; confirm which version applies before using one.

Self-Declaration or a Notified Body?

Under Article 12 of the Machinery Directive:

• Machines not in Annex IV: Use the "internal checks on manufacture" in Annex VIII; the manufacturer assesses and declares conformity itself, with no notified body involvement needed.
• Machines in Annex IV: If manufactured fully according to harmonized standards, the manufacturer may self-declare or submit the machine to a notified body for EC type-examination or full quality assurance; if not fully according to harmonized standards, a notified body is mandatory.

The only food-related items in Annex IV are saws such as "circular saws and band saws for working with meat" with manual loading or unloading. Encrusting machines, dividers, and bun machines aren't in Annex IV and can generally be self-declared through internal checks on manufacture. Many buyers still ask for third-party test reports; that's a commercial requirement, not a legal one.

Other Rules That May Also Apply

• Electrical: Annex I of the Machinery Directive already covers electrical safety objectives, and the machine's electrical risks are assessed under the Machinery Directive.
• EMC Directive 2014/30/EU: To be considered for machines with inverters or electronic controllers.
• RoHS Directive 2011/65/EU: Restricts hazardous substances such as lead, mercury, and cadmium in electrical and electronic equipment, but has exclusions for large-scale stationary industrial tools and others, so it must be assessed case by case.
• Food contact materials: Contact surface materials must also comply with (EC) No 1935/2004; see EU food contact material rules.

There are also requirements on the language of the instructions; see What Export Customers Ask About Manuals, Parts, and Warranty. For the current status of Dong-Yih Machinery's CE documentation, please call 06-257-4644 or reach us through our contact information page.

FAQ

Q: Does food machinery sold in Europe have to have CE?
A: Yes. Food machinery with power and moving parts falls within the EU Machinery Directive and must complete the conformity procedure and bear the CE marking before being placed on the market.

Q: Which documents are needed for CE?
A: The technical file (including risk assessment, drawings, test reports, and instructions), the EC declaration of conformity, and the instructions. The technical file must be kept for at least 10 years.

Q: Can CE for an encrusting machine be self-declared?
A: Yes. Encrusting machines aren't in Annex IV of the Machinery Directive and can be self-declared by the manufacturer through internal checks on manufacture; the only food-related machines in Annex IV are manually loaded or unloaded circular saws and band saws for meat.

Q: Is CE a certificate?
A: No. CE is the manufacturer's declaration of compliance with EU legislation, and responsibility lies with the manufacturer; third-party test reports are supporting evidence, not CE itself.