Environmental prescription status: when PBT and PMT substances can require Rx-only
Your product's supply status can now depend on its ERA.
Article 54(1)(f) of the agreed directive text allows a medicine to be made prescription-only where its active substance is PBT, vPvB, PMT or vPvM and prescription is needed to minimise environmental risk, unless other circumstances of use justify otherwise. Environmental hazard becomes a supply classification question.
Environmental risk can require Rx-only
Antihistamine
Pharmacy shelf today
Antihistamine
Rx-only on environmental grounds
Prescription status has turned on clinical criteria. The agreed text adds a ground: prescription can be required as an environmental risk minimisation measure, unless other circumstances of use justify otherwise.
An environmental hazard conclusion becomes a commercial event
For OTC products, reclassification under Art. 54(1)(f) would remove an entire sales channel. Screening substances against the hazard classes now shows which products are exposed.
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Hazard classes that can support Rx-only status: PBT, vPvB, PMT and vPvM
Art. 56
Authorities must re-examine prescription status when new facts come to their attention, so a hazard conclusion can reopen an OTC classification
2023
Year the CLP Regulation gained the PBT, vPvB, PMT and vPvM hazard classes the directive refers to
Environmental prescription: old vs new
Article 54(1)(f) adds environmental hazard as a ground for prescription status, a category that doesn't exist in Directive 2001/83/EC.
Rx classification basis
Clinical criteria only: danger without medical supervision, misuse, parenteral use, need for further investigation. Environmental profile not a factor.
A PBT, vPvB, PMT or vPvM active substance plus a need for prescription as an environmental risk minimisation measure (Art. 54(1)(f)). Not automatic: other circumstances of use can justify non-prescription status.
Who triggers reclassification
No mechanism linking environment to supply classification.
Competent authorities examine and amend prescription status when new facts come to light (Art. 56). An ERA hazard conclusion is the most likely source.
ERA interaction
ERA required in applications since 2005 but has no bearing on supply status.
The ERA must state hazard classes (Art. 23(2)), which feed the Art. 54(1)(f) assessment. ERA quality now has commercial consequences.
Affected product types
Environmental hazard not linked to supply status.
Any product whose active substance meets the hazard criteria, including established OTC brands. Member States may also limit quantities or prescription validity (Art. 54(2)).
The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.
See which OTC products the hazard rules reach
Workbench answers environmental prescription questions against the agreed text and reads your ERA. Atlas shows where each product is registered, and Alerts catches the notices that could reopen its classification.
What's up next?Our OTC antihistamine's active substance may meet the PMT criteria. Could an authority make it prescription-only on environmental grounds alone, and what should we do now?
- understanding your question…
Environmental prescription · current rules against the agreed text
- Based on the agreed text, which is not yet in the Official Journal. Dates count from entry into force.
1. Short answer
Not automatically. Art. 54(1)(f) needs both a PBT, vPvB, PMT or vPvM substance and a need for prescription to minimise environmental risk, and other circumstances of use can justify keeping it non-prescription.
2. What changes
3. What to do now
- Screen each active substance against the PBT, vPvB, PMT and vPvM criteria.
- List the OTC registrations by market for any substance that may qualify.
- Prepare the circumstances-of-use case for keeping non-prescription status.
Atlas
Keeps each product's registrations across markets in one record, so the OTC registrations behind a flagged substance are a list you pull, and any review sits on the timeline with an owner.
See AtlasAlerts
Watches EMA and the national authorities for ERA guidance and prescription status notices, matches each one to the products it affects, and proposes an action with an owner and date.
See AlertsWorkbench
Answers Art. 54(1)(f) questions against the agreed text, and reads your ERA and SmPC to say which hazard classes are stated and what a case for non-prescription status rests on, with every point cited.
See WorkbenchA 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets
Environmental hazard becomes a commercial event
For products with OTC revenue, reclassification under Art. 54(1)(f) would remove a sales channel.
OTC
Reclassification to Rx removes pharmacy shelf access, with immediate revenue impact for established brands
Art. 54(2)
Member States can add conditions for these products: limited quantities or restricted prescription validity
Agreed directive text
Early
ERA data submitted early can shape hazard conclusions. Teams who find out after a decision miss this window
Environmental prescription: what teams ask most
Does Art. 54(1)(f) apply to existing OTC products?
The agreed text applies to products already authorised (Art. 221(3)), and authorities must review prescription status when new facts come to their attention (Art. 56). An existing OTC product whose substance meets the hazard criteria could be reclassified where prescription is needed to minimise environmental risk. It is a case-by-case assessment, not an automatic switch.
Who initiates the Rx reclassification?
The competent authority, through a review of prescription status. For centrally authorised products, classification is part of the Commission decision on the MA. An MAH can also propose a change itself through a variation.
Can we challenge a hazard classification?
Hazard conclusions rest on data, so updated ERA studies and CLP evidence matter. Art. 54(1)(f) also allows other circumstances of use to justify keeping a product non-prescription, so the case covers both the hazard and whether Rx is the right risk minimisation measure.
Does a PBT or PMT property mean definite reclassification?
No. Art. 54(1)(f) needs both the hazard property and a need for prescription as an environmental risk minimisation measure, unless other circumstances of use justify otherwise. But a hazard conclusion is a leading indicator that needs close monitoring.
How does Art. 54(1)(f) interact with ERA (Art. 23 to 25)?
Art. 23 makes the ERA report hazard classes and keep the assessment current. Art. 54(1)(f) is the supply classification consequence. A weak ERA doesn't protect you, because hazard classes can also be established under the CLP Regulation.
Related reading
- A hazard flag only helps once it has an owner, which is the point of turning regulatory requirements into product action plans.
- OTC products per substance and market come from licence portfolio management in Atlas.
- The hazard classes come from the ERA itself, covered in ERA gap screening for legacy medicines.
- Environmental prescription is one of ten changes covered in our guide to the new EU pharmaceutical directive.
- Dates that depend on publication are tracked on the EU pharma package legislative timeline.
Sources
Article numbers refer to the Council's position at first reading of 28 September 2026 (ST 7106/2/26 REV 2 for the directive, ST 7105/2/26 REV 2 for the regulation), which reflects the political agreement of December 2025. Numbering may change in the act published in the Official Journal.
- Council of the EU: Directive on the Union code relating to medicinal products for human use, Council position at first reading, 28 September 2026 (ST 7106/2/26 REV 2), Articles 23, 54 and 56
- EUR-Lex: Commission Delegated Regulation (EU) 2023/707 adding hazard classes, including PBT, vPvB, PMT and vPvM, to the CLP Regulation
- EUR-Lex: Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
- European Medicines Agency: Environmental risk assessment of medicinal products for human use, scientific guideline (EMEA/CHMP/SWP/4447/00 Rev. 1)
- EUR-Lex: Directive 2001/83/EC on the Community code relating to medicinal products for human use (current prescription criteria)
- Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025)
- Council of the EU: The pharma package, new EU rules on medicines (policy page)
- European Commission: Reform of the EU pharmaceutical legislation
- EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192)
- EUR-Lex: Procedure 2023/0131/COD, Regulation on Union procedures for the authorisation and supervision of medicinal products (COM(2023) 193)
Know your environmental Rx exposure before an authority acts
Reclassification under Art. 54(1)(f) matters most for OTC products. Start with the active substances that may meet the PBT, vPvB, PMT or vPvM criteria and the markets where those products are sold without prescription.
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