EPA compliance in Ireland: what 4,724 pharma plant records show

What the EPA records are, and how to read them

Every large pharmaceutical and biopharma manufacturing site in Ireland operates under an Environmental Protection Agency licence: an Industrial Emissions licence, an Integrated Pollution Control licence or an Integrated Pollution Prevention Control licence. The EPA publishes the compliance history of each licence on its website, and our EPA manufacturing compliance register matches those histories to the companies on our pharma map.

Most records are routine. Site updates, annual environmental reports and monitoring returns are required of every licensed site as normal practice. Two categories signal that something went wrong: an incident, which the site itself reports to the EPA, and a non-compliance, which the EPA records when a licence condition was not met. A third category, complaints, records contacts from the public about a site. This report shows each separately, and a high count of routine records simply means a large, long-licensed site.

EPA compliance in Ireland: the headline pharma numbers

Incidents outnumber non-compliances three to one. That is the expected shape: sites are required to report any incident, including minor ones that are contained and cause no breach, while a non-compliance is the EPA's own finding against a licence condition. Of the 4,724 records, 3,265 are neither incidents nor non-compliances; they are the paperwork of a working licence.

Company by company

The table lists the twelve companies with the most non-compliances, with their incident and open counts and the counties where their licensed sites sit. A company with several Irish plants, such as MSD, naturally accumulates more records than a single-site operator, so the counties column is the fairest guide to scale.

Thermo Fisher Scientific's Cork site reports the most incidents, 238, against 46 non-compliances, which suggests a site that reports extensively and is mostly found compliant. Takeda tops the non-compliance list with 54 across 232 records, the highest ratio of non-compliances to records in the group. MSD, with the most records of any company at 794, has 29 non-compliances but the most open items, 10. Pfizer, by contrast, has 303 records with 28 incidents and only 4 non-compliances.

Complaints from the public are concentrated. Merck Millipore in Cork recorded 36, the highest in the group, with MSD on 14 and Hovione on 13; most companies have none. Complaints are logged by the EPA when a member of the public contacts it about a site, typically about odour or noise, and are shown separately on the register.

What the last twelve months show

The register also holds each company's most recent incidents and findings, and the subjects repeat across sites. Trigger level reached, meaning a monitored emission approached its limit, is the most common incident subject. Monitoring equipment issues, abatement equipment off-line and uncontrolled release follow. Refrigerant gas leaks, recorded as F-gas releases, appear at several sites; Pfizer's Ringaskiddy records include the loss of 72.7 kilograms of R407F refrigerant in September 2025 and 46.3 kilograms in June 2026, both closed.

Among recent non-compliances, the EPA issued Merck Millipore an emission limit value exceedance in July 2026, Hovione a bunding and materials handling finding in August 2026 and SK Biotek a non-notification of incidents finding in December 2025. MSD's open items include three uncontrolled release incidents reported between April and August 2026 and an F-gas release from July 2026. These are the EPA's own subject lines, and each has a status of open, closed or issued on the licence profile.

Why routine records dominate

A site with 500 records and few deviations is a well-documented site, not a problem site. For the same reason, two companies cannot be compared on total records alone; the incident and non-compliance columns are the ones that carry meaning, and even those must be read against the size and age of the plant. A large active pharmaceutical ingredient plant with solvent handling and wastewater treatment will generate more trigger-level reports than a tablet packaging site, because it monitors more emission points.

Open items are the most current measure. The 57 open items across all 26 sites are matters the EPA has not yet closed, whether an incident awaiting a final report or a non-compliance awaiting corrective action. MSD's 10, Alexion's 5 and Hovione's 5 account for a third of them.

Cork and Dublin carry most of the record

The counties mirror the pharma map. Cork appears against Merck Millipore, Thermo Fisher Scientific, Hovione, Recordati, Pfizer, Boston Scientific, MSD and AbbVie, reflecting the Ringaskiddy, Little Island and Carrigtwohill clusters that sit on Cork Harbour. Dublin appears against Takeda, Guerbet, SK Biotek, Ipsen, MSD and AbbVie. Roscommon's single entry, Alexion in Athlone, shows how one large biopharma plant can shape a county's environmental record, with 135 records, 32 incidents and 27 non-compliances.

How to read a single site's record

Start with the open items, which tell you what is unresolved today. Then read the non-compliances for the pattern of findings, since repeated findings on the same subject, such as bunding or emission limits, point to a persistent weakness. Treat the incident count as a measure of reporting discipline as much as of events. Finally, check the licence type and date, because an older Integrated Pollution Control licence carries different monitoring requirements from a current Industrial Emissions licence. Each company's page on our register links straight to the EPA licence profile.

Method and sources

Company names from our pharma map were matched against the EPA's LicenceProfile records by deterministic search, with a local language model used only to adjudicate ambiguous name pairs, and every match was then reviewed by hand. Not every company on our map has an EPA manufacturing licence; research-only sites and small sites fall below the licensing threshold, so 22 companies is real coverage rather than padded coverage. Counts were taken on 16 September 2026 and cover Industrial Emissions, Integrated Pollution Control and Integrated Pollution Prevention Control licences only. Incident, non-compliance, complaint and open status are the EPA's own categories, and recent incident subjects are quoted as the EPA records them. The routine figure of 3,265 is total records less incidents less non-compliances.

Reuse and citation: this analysis is published by Priya Life Science under CC BY 4.0. The source records are published by the Environmental Protection Agency under its open data licence. Cite the report using the box below; see our methodology page and corrections log.