COMAH, DSEAR and laboratory safety, UK wide
Pharmaceutical and Laboratory Health and Safety
A pharmaceutical plant or research laboratory concentrates flammable solvents, potent active ingredients and biological agents into a small footprint, usually with people working alone at a bench. AL23 Safety helps manufacturers, contract laboratories, research facilities and chemical sites control those hazards and evidence compliance across the UK.
Why it matters in pharmaceuticals and laboratories
The risks are real and so are the duties
The most commonly cited laboratory breach is local exhaust ventilation that has run past its thorough examination date. Regulation 9 of the Control of Substances Hazardous to Health Regulations 2002 fixes that interval at 14 months.
HSE completed more than 13,200 inspections in 2024/25, over 7,000 of them health led, issuing more than 4,400 enforcement notices. Of 246 prosecutions completed, 96 per cent ended in conviction. Fee for Intervention runs at £188 per hour from 1 April 2026 and at £218 per hour for COMAH work.
The main risks
Where the harm comes from
Flammable solvents
Decanting, distillation and drying release vapour that can form an explosive atmosphere in a room or an enclosure.
Potent compounds and sensitisers
Actives at the higher exposure bands need containment rather than dilution. Respiratory sensitisers cause irreversible disease before anyone smells anything.
Biological agents
Work with listed agents needs a containment level matched to the hazard group and physical measures that back it up.
Ventilation drift
Fume cupboards lose face velocity as filters load and building pressures change. Nobody notices without measurement.
Ageing plant and change
COMAH findings land repeatedly on mechanical integrity, management of change and process safety leadership.
Contractors at shutdown
Turnaround compresses hot work, confined space entry and breaking of containment into weeks, using people who do not know the plant.
The regulations that apply
Your legal framework, in plain terms
The Health and Safety at Work etc. Act 1974 and the Management of Health and Safety at Work Regulations 1999 sit under everything. The Control of Substances Hazardous to Health Regulations 2002 govern chemical and biological exposure, with limits published in EH40/2005. The Dangerous Substances and Explosive Atmospheres Regulations 2002 govern flammable and explosive risk. The Control of Major Accident Hazards Regulations 2015 apply where your inventory crosses a Schedule 1 threshold.
COMAH is enforced by a Competent Authority of HSE with the Environment Agency, Natural Resources Wales or the Scottish Environment Protection Agency. Every establishment in scope needs a major accident prevention policy. Upper tier establishments also need a safety report and an on site emergency plan, with the local authority producing the off site plan. Safety reports are reviewed at least every five years.
DSEAR and its Approved Code of Practice L138 require hazardous area classification wherever a flammable atmosphere is foreseeable. HSE's classification guidance addresses laboratory operations directly and small quantities do not put you outside the regime. Equipment in a classified zone must conform to the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016, which in Great Britain means UKEX marking.
Biological work runs through Schedule 3 of COSHH, the Approved List of biological agents and Advisory Committee on Dangerous Pathogens guidance on containment levels 1 to 4. Contained use of genetically modified organisms falls under the Genetically Modified Organisms (Contained Use) Regulations 2014, notified on form CBA1. Animal pathogens bring in SAPO licensing.
Good manufacturing practice sits alongside these duties rather than replacing them. The MHRA inspects GMP and GDP against the EU GMP annexes, notably Annex 1 for sterile products. GMP wants positive pressure cleanrooms to protect the product. Containment for potent actives wants negative pressure to protect the operator. Cascade design, airlocks, isolators and independent verification of both regimes settle that tension.
Fire safety in pharmaceutical and laboratory buildings
Solvent load and process risk belong in one assessment
Fire and process risk are one conversation on a chemical site. The Regulatory Reform (Fire Safety) Order 2005, as amended by section 156 of the Building Safety Act 2022, requires the responsible person to record the fire risk assessment in full, record the fire safety arrangements, identify any other responsible person sharing the premises and co-operate with them. On a multi tenant science park that last duty is the usual weak point.
The technical work is what separates a laboratory from an office. Solvent quantities at the bench and in the flammable store drive the fire load. Interlocked airlocks that protect the product can slow an evacuation. Extract systems move smoke between rooms unless dampers and shutdown logic are proven. Gas cylinders, waste solvent and DSEAR zoning belong in the assessment rather than in a separate file.
AL23 Safety provides BAFE SP205 third-party certified fire risk assessments, independently certificated by SSAIB.
How we help
Built around your operation
We work at the level your site runs at, from a single teaching laboratory to an upper tier COMAH establishment. Most engagements open with a gap review, then move to the work that closes what it finds. On COMAH sites that extends into mechanical integrity and management of change.
- Task based COSHH assessments for chemical, biological and potent compound work, applying EH40/2005 limits where they exist.
- Hazardous area classification and DSEAR risk assessment for decanting, drying and bulk storage, with a zone drawing an electrical contractor can work from.
- Fume cupboard and LEV testing and thorough examination at the 14 month interval, measuring face velocity against the BS EN 14175 range of 0.3 to 0.5 metres per second.
- Containment verification for levels 1 to 4, covering room pressure, airflow direction, filter integrity and written procedure.
- Solvent and flammable liquid storage review, covering quantities at the point of use, cabinet specification and external store separation.
- Health surveillance scoping for sensitisers, giving occupational health real exposure information rather than a job title.
- Permit to work and contractor control for shutdown, covering hot work, confined space entry and isolation.
Why AL23 Safety
Sector-aware support that gets used
Accountable
When something is non-compliant, we say so clearly and set out the fix. An overdue fume cupboard examination is reported as overdue.
One team, three disciplines
Health and safety, fire safety and fire engineering, all in-house. Solvent storage does not fall between two suppliers.
Practical, not just compliant
We write assessments a laboratory manager can hand to a bench scientist.
Nationwide
We support pharmaceutical sites and laboratories across the UK.
Get in touch
Bring us in before the inspection, not after
Whether you hold a COMAH safety report or a single fume cupboard, we will tell you where you stand. Call +44 161 399 2523 or email info@al23safety.com.
Common questions
Answers, up front
Cannot see your question? Get in touch and we will answer it directly.
Contact usIt depends on the quantities of named and categorised dangerous substances you hold against the Schedule 1 thresholds. Most laboratories sit well below lower tier. Aggregation rules can still pull a site into scope where no single substance would on its own. We found no amendment to COMAH 2015 during 2025 or 2026. The 2015 thresholds remain the ones to work from.
Regulation 9 of COSHH requires thorough examination and test of local exhaust ventilation at least once every 14 months, with records kept for five years. Performance testing to BS EN 14175 and a working airflow indicator sit alongside that examination.
No. GMP protects the patient and the product. Health and safety law protects the worker. An MHRA inspection will not test whether containment protects the operator. Where the two conflict, usually over pressure cascades, you need a documented decision that satisfies both.
Cost is driven by the number of laboratories, the hazard profile, how many extraction systems are in scope and whether COMAH duties apply. A single laboratory building review is often a one or two day visit plus reporting. An upper tier COMAH site is a programme rather than a visit.
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