Environment and Planning

Key points

The most significant development for the life sciences sector is the emergence of legal challenges to the recast Urban Wastewater Treatment Directive, which introduces an extended producer responsibility model requiring producers of human medicines and cosmetics to fund at least 80% of the cost of quaternary water-treatment for micropollutants. The Irish proceedings, together with the parallel challenge taken by the Polish state, mean that the scope and durability of this regime remain under close scrutiny.
The Environment (Miscellaneous Provisions) Act 2026 introduced targeted reforms to the EPA licensing process, including aspirational decision-making timelines and a limited licence review mechanism. While not transformative, these changes may improve procedural efficiency for pharmaceutical operators seeking to amend or expand existing licensed activities. These reforms have not yet commenced and will need to be subject to a commencement order by the Minister to take effect.
At EU level, the Commission’s omnibus environmental package signals a broader effort to streamline assessment and permitting requirements. If progressed, the proposed reforms could reduce administrative burden for pharmaceutical and other industrial operators, particularly where projects trigger multiple overlapping environmental assessment and licensing obligations.
At the same time, regulation continues to tighten for pollutants of emerging concern, including several which relate to the life sciences industry. Amendments to the Water Framework Directive and associated laws have recently been introduced, which address pharmaceutical pollutants (among others), and the European Commission is considering further restrictions on PFAS.

Challenge to Urban Wastewater Treatment (Recast) Directive (“UWWTD”)

In October 2025, Irish Pharmaceutical Healthcare Association Limited (“IPHA”) and Alliance of Medicines for Ireland CLG (“MFI”) lodged judicial review proceedings in the Irish Planning and Environment Court, concerning the transposition and implementation of the UWWTD. The UWWTD requires Member States to progressively introduce new quaternary treatment at urban wastewater plants to remove micropollutants from urban wastewater. It requires producers of human medicines and cosmetics to cover at least 80% of the costs of this quaternary treatment, through an Extended Producer Responsibility (“EPR”) Scheme. The UWWTD does not extend this obligation to the producers of other products. Member States are required to transpose the UWWTD by 31 July 2027 and the national EPR Schemes must be operational by 31 December 2028. The applicants argue that the EPR Scheme is invalid as a matter of EU law because human medicine and cosmetic products are being treated differently to comparable sectors which also give rise to micropollutants in urban wastewater. Following an application for a preliminary reference, the Irish High Court has decided to refer a question as to the validity of the Extended Producer Responsibility (“EPR”) system under the UWWTD to the Court of Justice of the European Union. Arthur Cox is advising IPHA and MFI on these proceedings.

Separately, challenges to the UWWTD were taken by the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and a number of generic pharmaceutical companies to the General Court of the European Union. These cases were dismissed on 18 February 2026 because they did not have sufficient legal ‘standing’ to bring the challenge. Appeal proceedings concerning this refusal have been commenced in some of these cases. These rulings do not affect the status of the Irish proceedings.

Poland is also directly challenging the UWWTD before the CJEU as a Member State. That case is ongoing and will run parallel to the Irish proceedings. Arthur Cox is continuing to monitor the Polish proceedings.

Environment (Miscellaneous Provisions) Act 2026

The Environment (Miscellaneous Provisions) Act 2026 was signed into law on 12 March 2026. The Act introduces certain reforms to the EPA licensing process, including the following:

Aspirational decision-making timelines: The Minister is empowered under the Act to set non-binding time limits within which the EPA must “endeavour” to determine licence applications and licence reviews.
Limited Licence Review: The Act introduces a new procedure for licence reviews, whereby the EPA can focus on the specific proposed changes rather than conducting a full review of the licence. This will only apply where EIA is not required, and the proposed changes to the licence are not considered to be “substantial”.
EIA Exemptions in Civil Emergency/Exceptional Circumstances: The Act provides for limited exemptions from EIA requirements in the case of civil emergency, defence of the State, or exceptional circumstances, where EIA would adversely affect the purpose of the project. However, these exemptions are narrow and expected to arise rarely. EIA remains the default position for most licence applications.

European Commission’s proposed regulation on speeding up environmental assessments

This proposal is part of an omnibus package on environmental legislation. It is intended to streamline environmental assessments and will be applicable to pharmaceutical companies seeking to develop or expand industrial facilities.

Where a plan, programme or project attracts obligations to assess the effects on the environment, or perform a screening assessment, under different EU law directives, Member States will be required to coordinate the various individual assessments into one combined assessment.

This is to streamline the consenting process, but does not negate the obligation on the competent authority to comply with the specific requirements of the EU law directives.

This allows Member States to introduce regulations preventing arguments from being raised before a court where they were not raised during the administrative stage.

However, this provision is expressly stated to be ‘without prejudice to the right of access to justice’, and on this basis we would not expect the provision to affect eNGOs who are entitled to take challenges on environmental law grounds under the Aarhus Convention.

Article 5 of the proposed Regulation states that changes or extensions of projects, such as repurposing of pipelines or of industrial sites, and extension of their operation period and modifications to ensure decarbonisation, shall only be subject to screening by the competent authorities in order to determine if they are likely to have significant effects on the environment.

This is as opposed to full environmental assessment. It goes on to state that environmental assessment only needs to be carried out if the change or extension consists of major works that pose risks to the environment greater than or equal to those posed by the original project.

This is an interesting provision which will have to be considered in more detail once it is debated. In particular, to understand its intended relationship with Annex 1, Class 24, and Annex II, Class of the EIA Directive, and how these classes have been transposed into Irish law.

Maximum timelines for impact assessment under the EIA and SEA Directives are defined. In exceptional cases, timelines can be extended by a maximum of 30 days. However, it is not clear whether there would be consequences for a competent authority in failing to meet these timelines, or what these consequences would be.

European Commission’s proposed amendments to industrial emissions licencing and medium combustion plant licensing

This proposal also forms part of the omnibus environmental package and is targeted at reducing administrative burdens arising from onerous licensing regimes.

Environmental Management Systems: The proposal would simplify the content of Environmental Management Statements, which holders of Industrial Emissions licences are obliged to prepare per each individual facility that they operate within a member state. The new proposal would instead permit one Environmental Management Statement to be prepared in respect of all facilities in that member state. The proposal also provides for more flexibility in relation to how these Environmental Management Statements are implemented, in particular, the deadline for implementation is to be postponed from 2027 until 2030 and the auditing requirements lightened.

Amendments to the Medium Combustion Plant Directive: The proposed amendments seek to ease the permitting process for MCPs, particularly those transitioning to oxy-fuel or hydrogen-based combustion by providing competent authorities with flexibility to assess compliance with emission limit values as opposed to rigid limit values, and by setting a new operational time-limit below which periodic monitoring would be less frequent.

There are new “exception” rules allowing for (1) negative short-term impacts on water bodies, or (2) projects and activities that have a negative impact on water bodies due to relocation of water or sediments containing pollutants.

Amendments to the Water Framework Directive (WFD), Groundwater Directive and the Environmental Quality Standards Directive

There is a new definition of Deterioration of Status, as follows, which reflects the position as established by case law: “Deterioration of Status of a body of water” means the lowering of the status of at least one of the quality elements, within the meaning of Annex V [of the WFD], by one class, even if that lowering does not result in a fall in the classification of the body of water as a whole; however, if a quality element is already at the lowest class, any further deterioration of that element constitutes a deterioration of the status of the body of water”.

There are new “exception” rules allowing for (1) negative short-term impacts on water bodies, or (2) projects and activities that have a negative impact on water bodies due to relocation of water or sediments containing pollutants. These exceptions are subject to strict conditions and relying on them in practice will not be straightforward.

There are additions to the lists of pollutants that need to be monitored and controlled, including pharmaceutical substances such as Ibuprofen and Diclofenac. The amendments put a stronger focus on substances of emerging concern, such as PFAS, pharmaceuticals, industrial substances, microplastics, antimicrobial resistance indicators, and pesticides.

The directive also requires the Commission to publish a report evaluating the feasibility of extended producer responsibility. This would mean that producers who place products containing specified substances on the market could have to contribute to the costs of monitoring the levels of those substances in EU waterbodies. Certain pharmaceutical substances are in scope. This report will “take into account experience gained in particular from implementing the provisions concerning extended producer responsibility in the Union legislation on urban waste-water treatment, waste, and single-use plastics”.

The amendments came into force on 10 May 2026 and Member States will have until 21 December 2027 to transpose the amendments into domestic law.

Proposed simplification of EU Chemicals Legislation

The ‘One Substance, One Assessment’ process has come into force. The objective is to reduce administrative burden on companies manufacturing chemicals. Specifically, it (a) ensures that a chemical is assessed only once, even if it falls under different regulations (e.g., cosmetics, toys, pesticides), preventing redundant evaluations, and (b) creates a common data platform. The platform will present data on chemical hazards, uses, and emissions in one central location, replacing the current system whereby the data is scattered across multiple sources serving different purposes. It will be accessible to everyone, hosted by the ECHA and operational within the next three years.
The Digital Product Passport (DPP) will be introduced in phases, starting with batteries, textiles and electronics in 2026/2027 and extending to detergents, chemical products, paints and lubricants from 2028-2030. The DPP is intended to be a digital, product specific dataset (typically a QR code) containing various information on the product which will be accessible on a central registry. Companies should anticipate convergence between DPP, safety data sheets, and OSOA data sharing over time which should lead to a more integrated, transparent, and digitally driven chemicals compliance framework.

PFAS

On 26 March 2026, the European Chemicals Agency (ECHA) announced that its Risk Assessment Committee and Socio-Economic Analysis Committee support an EU-wide restriction on the manufacture, marketing, and use of PFAS, subject to specific derogations where no suitable alternatives exist and the socio-economic benefits outweigh the risks, provided strict emission minimisation and risk management measures are applied. The Socio-Economic Analysis Committee’s draft opinion was open to public consultation, which concluded on 25 May 2026. This final opinion, once published, will inform the European Commission’s approach to PFAS restrictions.

What's next?

The next steps in the Irish UWWTD proceedings will be important in determining whether the validity of the Directive is considered by the CJEU. In parallel, Poland’s direct challenge before the CJEU will remain relevant to the broader legal and policy debate around the allocation of wastewater treatment costs to the pharmaceutical and cosmetics sectors. This will inform other policy areas, such as the possibility of extended producer responsibility for monitoring costs under the recently revised Water Framework Directive.

The Commission’s proposed omnibus reforms on environmental assessments, industrial emissions and medium combustion plants will progress through the legislative process. If adopted in their current form, they could offer more streamlined consenting and compliance pathways for life sciences businesses operating, developing, repurposing or decarbonising facilities.

The amendments to the Water Framework Directive, Groundwater Directive and Environmental Quality Standards Directive have now entered into force, with Member States required to transpose them by December 2027. Businesses should incorporate these heightened requirements into their standard processes, particularly for environmental assessments.

Regulatory scrutiny of PFAS, chemicals and product-level environmental data is likely to intensify further. For life sciences companies, the practical focus should now be on horizon-scanning for new restrictions and auditing their supply-chain exposure to both prohibited and not-yet prohibited PFAS.

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