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Safe Lab Expansion Under COMAH

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COMAH Support at Irish Pharmaceutical Facility

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Environmental ConsultingEnvironmental Consulting

Industry

Clinical & Diagnostic Labs

Location

Ireland

AWN Consulting Ltd, a Trinity Consultants team, specialises in Significant Modifications Assessment and risk modelling for facilities regulated under major accident hazard legislation. Their approach helps operators of COMAH sites systematically evaluate proposed changes to processes or installations, ensuring compliance with regulatory requirements while maintaining safe operations. For this project, the client required confirmation that planned expansion works complied with Health and Safety Authority (HSA) guidance.

Challenge

A pharmaceutical manufacturing facility in Ireland, classified as a Lower Tier COMAH site, planned to expand its existing laboratory space. The challenge was to determine whether this modification would constitute a ‘significant modification’ under the Chemicals Act 2015 (COMAH Regulations 2015). This required assessing whether the expansion could increase major accident risks to personnel or the environment, potentially triggering additional regulatory obligations.

Solutions

AWN was engaged to conduct a Significant Modifications Assessment in line with HSA guidance. A two-stage methodology was applied: a preliminary analysis to screen for risk increases, followed by a detailed assessment if required. Hazard endpoints such as thermal radiation, overpressure, and toxic exposure were considered in relation to potential fire, explosion, or toxic release scenarios. The proposed expansion involved only small quantities of hazardous chemicals and no increase in staffing levels, allowing the assessment to focus on whether these limited changes introduced new accident scenarios or risk pathways.

Services Performed

AWN conducted a full-scale COMAH Significant Modifications Assessment including identification of potential major accident scenarios, quantitative evaluation of risk endpoints, and review of regulatory compliance. The assessment ensured that off-site risk to personnel, infrastructure, and the environment remained within allowable limits and that the laboratory expansion could proceed safely.

Results

The assessment concluded that the laboratory expansion did not introduce any major accident scenarios or increase risks to personnel or the environment. Since there was no rise in workforce numbers and only minor quantities of hazardous substances were involved, the modification was not classified as significant under the COMAH Regulations. As a result, no further detailed risk assessments or additional technical safety measures were necessary. The facility complied with regulatory obligations by maintaining documentation on-site for inspection, ensuring continued safe operation while enabling the planned expansion.