Combination Weigher Safety Standards and Compliance 2026

Combination Weigher Safety Standards and Compliance 2026

Why understanding combination weigher compliance matters

Combination weighers are central to high-speed packaging lines across food, pharmaceuticals, and non food industries. Ensuring these machines comply with current safety, metrology, and food contact rules reduces legal risk, avoids product recalls, improves uptime, and protects worker safety. As technology and regulatory focus evolve toward automation, data integrity, and hygiene, any buyer or operator of a combination weigher must understand the applicable standards and practical steps to demonstrate compliance by 2026 and beyond.

Key categories of compliance for the combination weigher

Compliance for a combination weigher typically spans five domains. Each domain has specific standards and practical measures to meet legal and customer requirements.

• Machine safety and functional safety
• Metrological accuracy and verification
• Food contact materials and hygiene (for food/edible products)
• Electrical safety, EMC, and environmental rules
• Cybersecurity, traceability, and data integrity

Machine safety and functional safety standards for combination weigher

Machine safety prevents operator injury and unintended machine behavior. For combination weighers this includes guarding, safe access panels, emergency stops, risk assessments, and safe control system design. Key standards to follow include ISO 12100 for risk assessment and design, ISO 13849-1/2 for safety-related parts of controls, and IEC 62061 for functional safety of electrical/electronic/programmable safety-related systems. Electrical panel and control safety commonly reference IEC 60204-1 for electrical equipment of machines.

Practical actions for compliance:

• Conduct and document a risk assessment using ISO 12100 methodology.
• Specify required performance levels (PL) or Safety Integrity Levels (SIL) for safety functions and validate with tests and diagnostic coverage metrics.
• Provide mechanical guarding, interlocks, and safe manual access consistent with the risk assessment.
• Include emergency stop circuits tested for required PL or SIL.
• Keep design and validation records as part of the technical file for CE marking or equivalent approvals.

Metrological performance and legal-for-trade considerations

Combination weighers must meet accuracy and repeatability requirements for weighing and filling. Depending on jurisdiction and application, legal-for-trade rules may apply. Standards and directives to consider are OIML recommendations (for example OIML R51 for automatic gravimetric filling equipment and guidance on multihead or combination systems), and regional regulations such as EU Non-automatic Weighing Instruments Directive 2014/31/EU (NAWI). For non-EU markets, local weights and measures authorities publish verification requirements and calibration intervals.

Practical actions:

• Confirm whether the combination weigher is subject to legal-for-trade verification in the target market.
• Design systems and software so that calibration data, adjustment records, and history are stored and auditable.
• Implement scheduled calibration and verification with traceable standards and documented procedures.

Food contact materials and hygienic design

For food packaging lines, materials, surface finishes, and machine geometry must prevent contamination and support cleaning. Key regulatory references include EU Regulation 1935/2004 on materials intended to come into contact with food and applicable national rules. In the US, food contact requirements under FDA food contact guidance and relevant CFR sections apply. Industry food safety schemes such as HACCP, BRCGS, and SQF expect hygienic design and documented cleaning regimes.

Practical actions:

• Specify food-grade materials for product contact parts, such as stainless steel 304/316 where appropriate, and confirm compliance with food contact regulations.
• Design to minimise crevices and dead zones, enable easy access for cleaning, and choose appropriate surface roughness to reduce bacterial retention.
• Provide cleaning-in-place (CIP) or easy removal options, and document cleaning validation procedures.
• Include traceability features to identify batches and product runs when integrated with upstream software.

Standards comparison table for combination weigher compliance

The table below maps common standards and their applicability so engineers and procurement teams can prioritise compliance activities.

Sources for the table are standardised documents published by ISO, IEC, OIML, and EU/FDA regulations. See source list at the end of the article.

Electrical safety, EMC and environmental rules

Electrical safety and electromagnetic compatibility are necessary for reliable operation and regulatory approval. Typical applicable standards include IEC 60204-1 for electrical safety, IEC 61000 series for EMC, and country-specific standards such as UL 508A for control panels in North America. Environmental requirements can include RoHS and REACH for restriction of hazardous substances and chemicals used in components and paints.

Cybersecurity and data integrity for modern combination weighers

As combination weighers become networked and integrated with MES, ERP, and cloud services, cybersecurity and data integrity are now part of compliance. Industry-standard frameworks such as IEC 62443 help structure an approach to secure device development and operational procedures. For food and pharmaceutical manufacturers, maintaining auditable records and preventing tampering can be essential for recall readiness and regulatory inspections.

Practical compliance roadmap for manufacturers and buyers of combination weigher

The following stepwise roadmap helps both equipment manufacturers and procurement teams achieve and demonstrate compliance.

1. Define intended use and jurisdictions. Determine whether the weigher is for legal-for-trade, food contact, hazardous areas, or other regulated contexts.
2. Perform a documented risk assessment in accordance with ISO 12100 and identify required PL/SIL levels.
3. Design to standards: apply ISO 13849/IEC 62061 for control systems, IEC 60204-1 for electrical, and relevant EMC tests.
4. Specify materials and hygienic design features for food contact, with documented supplier declarations and material certificates.
5. Plan metrological verification and schedule calibration intervals aligned with OIML and local weights-and-measures guidance.
6. Implement cybersecurity practices based on IEC 62443; secure communications, role-based access, and audit logs.
7. Undertake third-party testing where required, prepare technical documentation, and obtain CE, UKCA, or other marks as applicable.
8. Document maintenance, spare parts, training, and validation procedures. Keep records to demonstrate ongoing compliance.

Checklist for procurement teams evaluating a combination weigher

When selecting a combination weigher, include these questions in the RFP and supplier evaluation:

• Which safety and metrology standards does the machine meet? Can the supplier provide declarations and test reports?
• Are product contact materials certified for food contact in the target markets?
• Is the machine legal-for-trade where required and is verification support provided?
• What is the documented cleaning regime and are parts removable without tools?
• Does the control system support secure access control, data logging, and integration with factory systems?
• What training, calibration, and after-sales support are provided?

Maintenance, calibration and lifecycle compliance

Compliance is not a one-time activity. Regular maintenance and calibration are essential to preserve safety and metrological performance. Operators should implement a documented maintenance plan that includes preventive maintenance, calibration intervals, periodic functional safety revalidation after modifications, and documented operator training.

Records and traceability

Maintain the following traceable records for audits:

• Technical file and risk assessment
• Test reports and certificates for electrical, EMC, and metrology
• Material declarations for food contact parts
• Calibration certificates and measurement system analysis (MSA)
• Maintenance and training logs

How Kenwei supports combination weigher compliance and performance

Kenwei is a powerful manufacturer of multi-head weighers. We are committed to the development and manufacturing of metal detectors, multi-head weighers, linear weighers, and check weighers. Our machines are characterized by high speed and high precision. We also provide our customers with one-stop automated weighing and packaging solutions to meet our customers customization requirements. Guangdong Kenwei is located in Fusha High-tech Industrial Park, Zhongshan City, Guangdong Province. The company is equipped with an automated weighing and packaging system and has comprehensive capabilities in design and development, manufacturing, marketing, installation and commissioning, technical training, and after-sales service. It has established a good brand image and a reputation for thoughtful and fast service in the packaging machinery industry.

Our vision is to become the world's leading weighing packing machine manufacturer. Kenwei designs combination weighers and multihead systems with hygienic materials, robust electrical cabinets, and modular control architectures that simplify compliance. We supply technical documentation, assist with verification and calibration planning, and offer training and lifecycle support to help customers meet regulatory and customer audit requirements.

Kenwei product highlights and core strengths

Kenwei core products include Check Weigher, multihead weigher packing machine, multihead weigher, linear weigher, metal detector, packing machine, counting machine, combination weigher, food packaging machine, and food packing machinery. Key competitive advantages:

• High speed and high precision machines suited for demanding production lines.
• Integrated solutions from metal detection to final check weighing for complete QA coverage.
• Strong R&D capabilities and customization to meet specific hygienic, metrological, or safety requirements.
• Comprehensive after-sales support including installation, commissioning, and technical training.

To learn more about Kenwei and our compliant combination weighers, visit https://www.kenweigroup.com/ or contact your local Kenwei representative for detailed technical files and factory acceptance testing options.

Frequently Asked Questions (FAQ)

Q1: Is a combination weigher subject to legal-for-trade rules?

A: It depends on the jurisdiction and use. For products where filled quantity is declared for sale by weight, legal-for-trade rules may apply. Check local weights and measures authority guidance and consult the supplier for calibration and verification options.

Q2: Which standard should be used for guarding and risk assessment?

A: ISO 12100 provides the framework for risk assessment and basic safety principles. For control and safety-related parts, apply ISO 13849 or IEC 62061 depending on control architecture and complexity.

Q3: What materials are required for food contact zones of a combination weigher?

A: Use food-grade stainless steel and materials compliant with local food contact regulations such as EU 1935/2004 and relevant FDA guidance. Suppliers should provide material declarations and certificates.

Q4: How often should a combination weigher be calibrated?

A: Calibration intervals depend on production environment, usage hours, and regulatory requirements. Establish calibration frequency based on measurement uncertainty, historical drift, and guidance from national metrology institutes. Document and keep traceable calibration certificates.

Q5: What cybersecurity measures are recommended for networked weighers?

A: Implement role-based access, secure communication protocols, network segmentation, patch management, and utilize principles from IEC 62443. Maintain audit logs to trace changes to recipes and calibration settings.

Q6: Who is responsible for compliance when purchasing a combination weigher?

A: Responsibility is shared. The manufacturer must design and supply machines conforming to applicable standards and provide technical documentation. The buyer must install, use, maintain, and operate the machine according to instructions and keep records for inspections and verification.

Contact Kenwei or view compliant combination weigher products

If you need a compliant, high-speed combination weigher or an integrated weighing and packaging solution, contact Kenwei for technical consultation, product brochures, and factory acceptance testing. Visit https://www.kenweigroup.com/ or contact Kenwei sales to request product specifications, compliance documentation, and customised solutions.

Sources and references

Key standards and guidance documents referenced in this article include:

• ISO 12100: Safety of machinery - General principles for design - Risk assessment and risk reduction
• ISO 13849-1: Safety of machinery - Safety-related parts of control systems
• IEC 62061: Safety of machinery - Functional safety of safety-related electrical/electronic/programmable electronic control systems
• IEC 60204-1: Safety of machinery - Electrical equipment of machines
• IEC 61000 series: Electromagnetic compatibility
• IEC 62443: Industrial communication networks - Network and system security
• OIML recommendations, including guidance on automatic gravimetric filling and weighing instruments
• EU Regulation 1935/2004 on materials and articles intended to come into contact with food
• EU Non-automatic Weighing Instruments Directive 2014/31/EU (NAWI)
• FDA guidance on food contact substances and relevant CFR sections
• Codex Alimentarius HACCP principles and major food safety scheme guidelines (BRCGS, SQF)