Why ATEX Compliance for Non-Electrical Equipment Is Critical
ATEX compliance for non-electrical equipment extends far beyond affixing a marking plate or issuing a Declaration of Conformity. It requires a structured engineering methodology ensuring that equipment installed in potentially explosive atmospheres does not create ignition sources under normal operation or foreseeable malfunction.
The regulatory transition completed in 2019, replacing EN 13463 with EN ISO 80079-36 and EN ISO 80079-37, fundamentally changed how manufacturers must assess and document explosion risks. Since 1 November 2019, EN 13463 no longer provides presumption of conformity. From 31 October 2019 onwards, equipment manufactured under that withdrawn standard could not be placed on the EU market.
Compliance therefore requires both updated documentation and a technically sound Ignition Hazard Assessment aligned with EN ISO 80079.
Regulatory Framework: Directive 2014/34/EU and Harmonised Standards
Directive 2014/34/EU governs equipment and protective systems intended for use in potentially explosive atmospheres across the European Union. It applies to industries including pharmaceuticals, chemicals, food processing, and fine chemicals.
For non-electrical equipment, compliance is primarily demonstrated through:
• EN ISO 80079-36 – Basic method and requirements
• EN ISO 80079-37 – Types of protection constructional safety “c”, control of ignition source “b”, and liquid immersion “k”
These harmonised standards introduced several critical advancements:
• A formal, documented Ignition Hazard Assessment methodology
• Clear identification of protection concepts through the “Ex h” marking
• Alignment with IEC-based explosion protection logic
• Enhanced traceability and lifecycle documentation expectations
This alignment created greater technical consistency across international markets while strengthening safety verification processes.
Ignition Hazard Assessment: The Core Technical Requirement
Under EN ISO 80079-36, manufacturers must perform and document an Ignition Hazard Assessment identifying all potential ignition sources.
Potential ignition sources may include
• Hot surfaces
• Mechanical sparks
• Electrostatic discharge
• Frictional heating
• Impact ignition
• Adiabatic compression
Each hazard must be evaluated considering:
• Normal operating conditions
• Foreseeable malfunctions
• Maintenance intervals
• Environmental influences
Risk mitigation measures may involve
• Selection of non-sparking materials
• Surface temperature limitation
• Bonding and grounding to prevent static accumulation
• Design modifications eliminating impact risks
• Monitoring systems where appropriate
This structured engineering-based evaluation replaces the more prescriptive and less harmonised framework previously used under EN 13463.
Evolution of Equipment Marking
One of the most visible changes under EN ISO 80079 is the marking structure.
Previous marking under EN 13463:
II 2D c T135°C
Current marking under EN ISO 80079:
II 2D Ex h IIIC T135°C Db
The introduction of “Ex h” identifies non-electrical protection concepts within the harmonised ISO framework.
Marking elements now clearly indicate
• Equipment group (II – surface industries)
• Category and zone suitability (2D – Zone 21 dust)
• Dust group (IIIC – conductive dust)
• Maximum surface temperature (T135°C)
• Equipment Protection Level (Db)
This revised marking improves transparency during inspections, audits, and risk classification reviews.
Impact on Pharmaceutical and Process Industries
In pharmaceutical and fine chemical manufacturing, ATEX compliance often intersects with additional regulatory frameworks such as cGMP, containment requirements, and occupational exposure limits.
Dust-generating processes including:
• Powder transfer
• Milling and micronisation
• Blending and granulation
• Tablet compression
• Intermediate discharge operations
Create potentially explosive atmospheres where non-electrical equipment must not become an ignition source.
Equipment must therefore:
• Prevent electrostatic charge accumulation
• Avoid friction-induced heating
• Maintain surface temperatures below ignition thresholds
• Operate reliably under cleaning and maintenance cycles
ATEX compliance becomes an integral part of both safety engineering and regulatory governance.
Engineering Design Controls Supporting ATEX Compliance
Explosion prevention is most effectively achieved through engineering design rather than reliance on procedural controls alone.
Critical design considerations include
• Smooth internal geometries reducing dust accumulation
• Elimination of dead spaces
• Electrostatic dissipative sealing materials where required
• External mechanical assemblies limiting friction exposure within product zones
• Proper grounding provisions
In valve systems, positioning mechanical components outside the product stream can reduce friction risks while simultaneously supporting hygienic and containment requirements in regulated industries.
Validation and Technical Documentation Requirements
ATEX compliance requires a comprehensive technical file containing:
• Ignition Hazard Assessment documentation
• Design drawings and material specifications
• Surface temperature validation data
• Risk mitigation justifications
• Marking rationale
• Declaration of Conformity
For Category 2 equipment, notified body involvement may be required depending on the conformity assessment route selected.
Ongoing conformity requires
• Formal change control procedures
• Periodic review of technical documentation
• Monitoring of harmonised standard updates
• Maintenance ensuring validated operating parameters are preserved
Compliance must be sustained throughout the entire equipment lifecycle.
Post-2019 Transition and Continuous Conformity
Following the regulatory transition in 2019, applicable equipment must be reassessed under EN ISO 80079-36 and EN ISO 80079-37.
Our transition process included:
• Completion of structured Ignition Hazard Assessments
• Updated marking formats aligned with “Ex h” requirements
• Revision of Declarations of Conformity
• Technical file restructuring according to harmonised standards
Since that transition, continuous conformity has been maintained through:
• Systematic regulatory monitoring
• Controlled engineering change management
• Periodic internal compliance audits
• Alignment with evolving harmonised standards
ATEX compliance is not a historical milestone; it is an ongoing engineering responsibility requiring vigilance and structured governance.
If your facility operates in classified zones and requires verification of compliance under the current EN ISO 80079 framework, our engineering specialists can support your review and documentation process.
See also: The Importance of CIP (Cleaning in Place) and SIP (Sterilisation in Place) in Modern Industry
Contact our technical team to ensure your non-electrical equipment remains fully compliant with Directive 2014/34/EU and current harmonised standards.
Engineering Compliance Beyond Certification
ATEX non-electrical equipment compliance represents a disciplined integration of risk assessment, validated design, structured documentation, and lifecycle monitoring.
The transition from EN 13463 to EN ISO 80079 strengthened explosion protection methodology by introducing formal ignition hazard assessment, harmonised marking, and alignment with international standards.
Organisations that treat ATEX compliance as a continuous engineering function rather than a one-time certification reduce operational risk, improve audit readiness, and protect personnel, facilities, and assets operating in explosive atmospheres.
