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Welcome to the new edition of to the point: Healthcare & Life Sciences – a format designed to keep you informed about legal and regulatory developments shaping the sector across Europe.
As temperatures rise and calendars fill with out-of-office replies, the regulatory landscape – entirely unfazed by anyone's vacation plans – has once again remained busy this quarter.
Welcome to the Q2 2026 edition of our Healthcare & Life Sciences newsletter. While many are looking forward to a well-earned summer break, legislators and courts have remained busy, delivering a steady stream of developments across the healthcare and life sciences sector.
At the EU level, the European Health Data Space continues to take shape, with MyHealth@EU set to enable medical records to be shared across borders more seamlessly than ever before. The CJEU has also confirmed that Member States may not prohibit the online sale of non-prescription medicines. Separately, the EU has adopted a land-mark regulation on new genomic techniques, introducing a more science-based approach to agricultural biotechnology. A referral from Austria is asking the Court to clarify when food should be regarded as "unfit for human consumption" – a question that may resonate with anyone planning a few summer barbecues. The new EU-Mercosur safeguard regulation also introduces an "emergency brake" designed to protect European farmers from import surges under the agreement.
Turning to recent case law, the CJEU has clarified what distributors of CE-marked medical devices are required to verify and which responsibilities remain with the manufacturer. In a related judgment illustrating that not every healthcare activity falls within the EU marketing authorisation regime, the Court's Almirall judgment confirms that genuinely non-industrial, patient-facing pharmacy compounding remains outside those rules, leaving Member States discretion to define their own limits. It also underscores that cross-border telemedicine is no shortcut around national pharmacy requirements. In the M&A arena, Merck's nearly EUR 10bln acquisition of Bio-Techne demonstrates that life sciences dealmaking remains strong. The European Life Sciences Coalition has also published an open letter urging EU leaders to close the investment gap before more innovation moves elsewhere.
At Member State level, Bulgaria is preparing for significant changes, with two new bills set to reshape food pricing and retail through an unprecedented degree of regulatory intervention, while telemedicine has finally received its own comprehensive legal framework. The Czech Republic has enacted amendments to its medical devices legislation introducing new shortage-prevention obligations for manufacturers. Poland is overhauling its food law with a focus on reducing administrative burdens, strengthening enforcement, and significantly expanding financial penalties. Romania, in turn, has updated its medical advertising rules by conditionally lifting the blanket prohibition on comparative claims and has transposed the EU's anti-greenwashing directive, with the new rules applying from 27 September 2026. As our colleagues in Bucharest note, September is approaching faster than it may seem.
Before switching on your out-of-office, we invite you to take a few minutes to explore this quarter's key developments. We hope this edition provides a useful overview of the latest legal and regulatory changes.
We hope you enjoy the read and have a restful summer.
The Schoenherr Healthcare & Life Sciences Team
Europe
Bulgaria
Czech Republic
Poland
Romania
Are your health records going digital across Europe?
Marin Demirev
The EU is developing a system designed to let your medical records travel with you across Europe. Called MyHealth@EU, this digital platform will allow doctors in any EU country to access your patient summary, prescriptions and test results, no matter where you normally receive care.
The backbone of this effort is the European Health Data Space (EHDS), established by Regulation (EU) 2025/327. The Regulation entered into force on 26 March 2025 and will apply in phases from 26 March 2027. Under the EHDS timetable, cross-border exchange of patient summaries and electronic prescriptions and dispensations via MyHealth@EU becomes mandatory from 26 March 2029, while laboratory results, medical imaging and hospital discharge reports follow from 26 March 2031.
To put this into practice, the European Commission is drafting two sets of detailed technical rules. The first sets out how the MyHealth@EU platform will operate, covering everything from cybersecurity standards to how each country's health system connects to the network. The second addresses identity verification: how the system confirms that a patient is who they claim to be, and that a healthcare professional is genuinely authorised to access their records.
In May 2026, the European Data Protection Supervisor issued formal comments on two draft instruments: one concerning the operation of MyHealth@EU and another focusing on cross-border identification and authentication of patients, health professionals and healthcare providers. The comments centred on data protection implications, including safeguards for sensitive health data, security and compliance with data minimisation principles.
For patients, the expected benefits include better care when travelling abroad, electronic prescriptions that work across Member State borders, and the right to control who accesses their health data. However, challenges remain. Several countries, including Bulgaria, still need to upgrade their digital health infrastructure significantly. Cybersecurity is also a concern, as connecting hospital systems to a Europe-wide network creates new risks, particularly where outdated software remains in use.
The system is ambitious, but establishing robust technical and privacy foundations will be essential before it goes live for millions of Europeans.
CJEU clarifies distributor obligations for CE-marked medical devices
Sarah Rosenthaler
On 4 June 2026, the Court of Justice of the European Union (CJEU) provided guidance on distribu-tors' obligations under the EU Medical Devices Regulation (MDR) in Dürr Dental v. Cattani Deutschland (Case C-10/24). The case concerned oil-free compressors used in dental practices that had been placed on the market with a CE marking as medical devices. The key issue was whether distributors must verify that a manufacturer has correctly classified a product under the MDR.
The CJEU confirmed that distributors must exercise appropriate diligence before making a medical device available on the market. They are required to verify certain formal compliance elements, including the presence of a CE marking and an EU Declaration of Conformity. However, distributors are generally not required to carry out their own detailed technical or regulatory assessment of whether a product has been correctly classified as a medical device.
The Court also clarified how distributors should respond to potential compliance concerns. A warning letter from a competitor may give rise to doubts about a product's conformity and must be considered as part of the distributor's duty of care. However, where the distributor consults the manufacturer and receives confirmation that the product complies with the MDR, it may generally rely on that assessment unless the explanation is manifestly implausible. Likewise, a reasoned and une-quivocal statement from the competent authority rejecting the alleged non-compliance dispels any remaining doubts regarding the product's conformity.
The judgment provides valuable guidance on the scope of distributors' obligations under the MDR. While distributors must remain vigilant and perform reasonable compliance checks, they are not expected to assume the role of notified bodies or regulatory experts. Responsibility for the correct classification of a product and its conformity with the MDR remains primarily with the manufacturer.
EU adopts new regulatory framework for new genomic techniques
Monika Voldánová
On 17 June 2026 the European Union adopted a landmark regulation on plants produced by new genomic techniques (NGTs), marking a significant shift in the bloc's approach to agricultural biotechnology.
NGTs, including targeted mutagenesis and cisgenesis, allow breeders to alter plant genetic material with greater speed, precision and efficiency than conventional methods. The techniques can produce crops more resilient to climate change, less dependent on pesticides and fertilisers, and with improved nutritional profiles.
For years, NGT-derived plants were subject to the same stringent rules as genetically modified organisms (GMOs). The new framework introduces a risk-proportionate, science-based system that distinguishes between two categories of NGT plants.
Two-Category System
The new framework moves away from a one-size-fits-all approach. Category 1 NGT plants — those carrying genetic changes that could also occur naturally or through conventional breeding — will, following a verification procedure, be treated in the same way as conventional plants and will no longer be subject to GMO authorisation requirements. Category 2 NGT plants, which involve more complex modifications, will remain under the GMO regime, requiring a full risk assessment, authorisation, traceability and labelling.
It should be noted that the new framework does not extend to all genomic techniques. Only targeted mutagenesis and cisgenesis, as applied to plants, are covered. Transgenic plants, other NGTs, and any application of these techniques to animals or microorganisms remain subject to the current GMO rules.
Transparency and Monitoring
The regulation introduces transparency measures, including seed labelling for Category 1 plants, GMO labelling for Category 2 plants, public databases, and provisions on patent monitoring.
Looking Ahead
The new rules will enter into force 20 days after publication in the Official Journal and will apply two years thereafter. They are expected to boost competitiveness in European plant science and reduce the EU's reliance on imported agricultural technology.
"Health is Wealth": Europe's Life Sciences Community Calls on EU Leaders
Niklas Kerschbaumer
On 26 June 2026, the European Life Sciences Coalition (launched in February 2026 with Invest Europe) and its signatories published an open letter to EU leaders. The ELSC is a coalition established in association with Invest Europe, bringing together leading European venture capital firms, research institutions and other stakeholders across the life-sciences value chain. Its mission is to mobilise greater public and private investment and remove the structural barriers that hold back Europe's ability to finance, scale and retain its life-sciences innovation. Their message: Europe must act now to protect its leadership in life sciences, a sector contributing about 9.4% of EU GDP and nearly EUR 1.5 trln in value.
The letter warns that Europe produces world-class science but struggles to scale and retain its best companies, capturing just 7% of global life-sciences venture capital versus 63% for the US. Coalition members have backed over 1,400 companies and manage more than EUR 25bln in life-sciences assets.
Their call to action includes closing the investment gap, mobilising pension and institutional capital, building deeper EU capital markets and simplifying regulation to speed up clinical trials and approvals. For investors and founders in the space, it is a clear signal of where the policy debate is heading.
Read the full open letter here.
Merck's €10 Billion Bet on Life Sciences: The Bio-Techne Deal
Niklas Kerschbaumer
On 25 June 2026, Merck, the German DAX-listed pharmaceutical and technology group, has announced one of the largest acquisitions in its history, agreeing to buy the US life-sciences specialist Bio-Techne for close to EUR 10bln. Bio-Techne shareholders will receive USD 73 per share in cash, valuing the Minneapolis-based company at around USD 11.3bln. The target makes tools and analytical technologies for life-sciences research, with FY2025 revenue of more than USD 1.2bln and roughly 3,000 employees worldwide.
For Merck, the deal strengthens its laboratory business in high-growth areas such as cell and gene therapies and precision diagnostics. It is the first major acquisition under new CEO Kai Beckmann, who called it a "milestone". Closing is expected in late 2026 or early 2027, subject to regulatory and shareholder approval. Markets reacted well, with Merck shares up 5%.
Another sign that healthcare and life sciences remain a hotspot for large-scale M&A and a space we follow closely.
Online sale of non-prescription medicinal products: CJEU confirms Member States' obligation to allow it
Monika Voldánová
On 21 May 2026, the Court of Justice of the European Union (CJEU) delivered its judgment in the case of Farmakeio YZ & Sia OE (C-604/24) (the "Judgment"), addressing the compatibility of national legislation restricting the online sale of non-prescription medicinal products with EU law, specifically Directive 2001/83/EC.
The case originated in Greece, where national legislation prohibited online pharmacies from selling non-prescription medicinal products to the public, with the exception of a certain subcategory of such products.
Key findings
Conclusion
The Judgment in Farmakeio YZ & Sia OE (C-604/24) provides important clarification of the scope of Article 85c of Directive 2001/83. The CJEU has unequivocally confirmed that Member States are obliged to allow the online sale of all non-prescription medicinal products and that national legislation which — even for reasons of public health protection — prohibits such sales is incompatible with EU law.
It is worth noting that the conclusions of the Judgment apply equally to cross-border and to purely domestic mail-order dispensing of non-prescription medicinal products.
Pharmacy Preparation – medicine outside EU authorisation and cross-border effects in healthcare provision
Hristo Hadzhiiliev
The CJEU's recent judgment in Almirall (Case C-589/24) is a useful reminder that not every medicine-related activity automatically falls within the EU's marketing authorisation regime. The case concerned Dutch pharmacies preparing Psorinovo, a psoriasis medicine containing dimethyl fumarate, while Almirall marketed the authorised product Skilarence. The dispute concerned whether pharmacy-prepared medicines could be limited by a national numerical threshold, in this case a 50-patient-per-month criterion.
The Court's answer was practical and driven by strict interpretation of the applicable legislation. Article 3 (2) of Directive 2001/83 excludes the "official formula" from the Directive where the product is prepared in a pharmacy, follows a pharmacopoeia and is supplied directly to patients served by that pharmacy. These are the exhaustive EU conditions. If they are met, the product will sit outside Directive 2001/83's marketing and manufacturing authorisation framework.
That does not create a regulatory vacuum. Quite the opposite: because the product is outside the Directive, Member States retain space to regulate. National authorities may impose their own control requirements, including quantitative limits, as a matter of national law. Likewise, the Bulgarian Medicinal Products in Human Medicine Act (MPHMA) excludes medicinal products prepared from a pharmacopoeia from the national authorisation and manufacturing regime. The national definition of "pharmacopoeia" follows the same set of requirements as apply to that in the EU Directive. For Bulgaria, the message is that pharmacy compounding, where it is genuinely non-industrial and patient-facing, remains primarily subject to the Bulgarian regulation of pharmacy operations and to professional and patient-safety rules.
The findings of the court can be tied into the cross-border provision of telemedicine, where a doctor in one EU country may in principle treat a patient in another and issue prescriptions. But Almirall shows that the next step – the preparation and supply of the medicine – may be governed by a different legal layer. Cross-border telemedicine provision is not a shortcut around local pharmacy controls. For OTC products, prescriptions are usually irrelevant. For Rx medicines, by contrast, prescription validity and dispensing rules as well as pharmacy preparation regulations and limits, EU law implementation and local legislation all need to be checked before designing a compliant service.
The EU's Mercosur safeguard Regulation: what it means for European agriculture
Alexandra Minioti
On 19 March 2026, the EU published Regulation 2026/687, establishing a safeguard mechanism to protect EU farmers from sudden surges in agricultural imports under the EU-Mercosur trade deal. The regulation allows the European Commission to temporarily suspend preferential tariffs granted to Mercosur countries (Argentina, Brazil, Paraguay, and Uruguay) on agricultural imports if those imports cause, or threaten to cause, serious harm to EU producers.
Think of it as an emergency brake: if "cheap" Mercosur beef suddenly floods the EU market and pushes European cattle farmers' prices below sustainable levels, the Commission can step in and raise tariffs back to normal rates.
How does it work? Sensitive products (including beef, poultry, rice, sugars, eggs, honey, garlic and citrus) are subject to continuous monitoring. An investigation is triggered when imports rise by more than 5 % compared to the previous three-year average and are priced at least 5 % below comparable EU products. Provisional safeguard measures can be imposed within 21 days for sensitive products. The Commission must also report to the Parliament every six months on import impacts.
The Commission proposed Regulation 2026/687 on 8 October 2025. The Parliament, led by rapporteur Gabriel Mato (EPP of Spain), halved the original trigger thresholds from 10 % to 5 % and expanded the reference period to three years. Following a trilogue agreement in December 2025, the Parliament agreed in February 2026 on a provisional text (484 votes in favour) and the Council formally adopted it in March 2026.
The new regulation matters, because under the trade deal, 99,000 tonnes of Mercosur beef – about 1.5 % of total EU beef production – can enter the EU at a reduced 7.5 % duty. Without safeguards, even modest surges could depress prices across the supply chain. The regulation gives farmers and processors predictability.
Alongside the safeguard regulation, the EU has established a EUR 6.3bln fund for affected agricultural markets. For food businesses, the message is clear: trade liberalisation is proceeding with concrete, enforceable mechanisms to prevent market disruption in Europe's most sensitive agricultural sectors.
When is food "unfit for human consumption"? The CJEU will decide
Andreas Natterer, Maria Angeles Dias Lopez
A question about EU food safety law is now before the Court of Justice of the European Union (CJEU). In Case C-803/25, the Regional Administrative Court of Upper Austria has referred a preliminary ruling request that could redefine when food may be classified as "unfit for human consumption" under Regulation (EC) No 178/2002 (EU Food Regulation).
The case concerns a product containing 500 mg of curcuminoids per capsule alongside black pepper extract. The European Food Safety Authority (EFSA) has set the acceptable daily intake (ADI) for curcumin at 3 mg/kg — approximately 210 mg per day for a 70 kg adult. The product exceeded this threshold by approximately 238 % and also contained piperine, a bioenhancer that significantly increases curcumin's bioavailability. Adverse health reports, including cases of hepatitis, were noted in France and Italy. The Austrian authority found the product to be "unfit for human consumption" under Articles 14(2)(b) and 14(5) of the EU Food Regulation.
The company challenged the decision, arguing that "unfitness" under Article 14 only covers situations involving contamination, putrefaction, deterioration or decay — and that exceeding the ADI cannot justify such a classification.
The Austrian court has referred three questions to the CJEU: (i) whether the list of grounds in Article 14(5) is exhaustive; (ii) if not, whether exceeding the ADI alone suffices to classify a food as unfit; and (iii) whether the EU Food Regulation precludes national provisions declaring food unfit on grounds beyond those in Article 14(5).
A broad interpretation could enable authorities to classify products as unfit based on formulation or dosage concerns, while a narrow one could limit action to cases of physical spoilage. The ruling will also clarify the extent to which Member States may adopt stricter national criteria.
New Bulgarian bills reshaping food pricing and retail: what you need to know
Elena Todorova
Two interconnected bills amending the Competition Protection Act and the Consumer Protection Act were tabled before the Bulgarian Parliament on 11 May 2026, with further amendments introduced on 27 May 2026. They create an unprecedented level of regulatory intervention in pricing across the food supply chain. If you run a food production, wholesale or retail business, the practical impact on your day-to-day operations could be significant.
Pricing under scrutiny. The bills prohibit "excessively high prices" by dominant or jointly dominant undertakings, assessed against cost-plus, comparative, historical and economic-value benchmarks. A new presumption of joint dominance is triggered where the undertakings concerned hold a combined market share of 60 %, shifting the burden of proof to those undertakings. Parallel price movements driven by the same objective cost factors, such as increase in feed or energy prices, may be regarded as evidence of collective dominance. Any increases in retail prices must be justified as "economically substantiated", with the burden of proof resting on the retailer.
Heavy fines and interim measures. Sanctions for excessive-pricing violations may reach up to 10 % of the undertaking's total annual turnover. Under the Consumer Protection Act, fines range from EUR 5,000 to EUR 100,000 per product per outlet and are doubled for repeat offences. The competition authority may also impose interim measures, including orders to change pricing policy.
Transparency obligations. A new electronic Central Supply-Chain Traceability Register will require every "business operator" (including importers and grain traders above 50 tons annually) to report each first placement and subsequent wholesale distribution of agricultural and food products. Retailers with turnover above EUR 5,112,919 must publish individual product prices daily by 7:00 a.m. in machine-readable format. Although formally informational in nature, a public "fair price" indicator will benchmark every retailer's price in the eyes of consumers and the media.
Act now. Compliance deadlines are tight: supply contracts must be aligned within two months of the bill's entry into force (with phased implementation following the second parliamentary reading). Management boards should immediately assess exposure to the presumption of joint dominance, conduct a review of audit pricing documentation, and prepare data-reporting systems for the new register(s).
On 5 May 2026, Ordinance No. Н-5 of 28 April 2026 on the Provision of Remote Medical Assistance was published in the State Gazette (issue 41) and entered into force. For the first time, Bulgaria now has a comprehensive regulatory framework for telemedicine, setting rules for every medical establishment wishing to offer remote healthcare services.
What does this mean for telemedicine providers?
The Ordinance covers preventive, diagnostic, therapeutic and rehabilitative activities carried out without in-person contact between a medical professional and the patient, as well as interspecialist consultations. Each service may only be delivered based on the clinician's professional judgement, and the treating specialist bears full professional responsibility.
Providers must obtain informed consent from the patient, document every consultation via an elec-tronic health record in the National Health Information System (NHIS) within prescribed deadlines, and authenticate all records with a qualified electronic signature (QES). As data controllers, medical establishments are also obliged to carry out a Data Protection Impact Assessment (DPIA).
Five-step action plan
For healthcare managers, the path to compliance involves five key steps:
Oversight is exercised by the Executive Agency "Medical Supervision", so preparations should not be delayed. Ordinance Н-5 is not a mere legal formality; it signals that telemedicine in Bulgaria has entered a mature regulatory phase.
Czech President Signs Medical Devices Act Amendment Implementing EU Requirements
Monika Voldánová
Since 1 January 2026, Section 40d of Act No. 48/1997 Coll., on Public Health Insurance, has introduced a new mechanism allowing health insurance companies to centralise public procurement of certain medicinal products for healthcare providers.
Health insurance companies may now centralise public procurement for supplies of medicinal products intended for providers that have been granted the status of a centre of highly specialised healthcare. The measure is therefore targeted at tertiary level facilities dealing with complex, often oncological or rare disease treatments, rather than routine outpatient care.
A covered "medicinal product" is:
This means that the new centralised procurement applies only to products without generic competitors on the market, i.e. largely originator or niche products where price competition at the level of substitutes is absent.
From a policy perspective, the amendment can be seen as an attempt to insert health insurers into the procurement chain for high budget, often monopoly type medicines, using competitive tendering to influence price levels without directly regulating prices administratively. However, limiting the amendment to drugs without generic competition raises questions about its real impact. In the absence of therapeutic substitutes, the scope for meaningful price competition is narrow, and the mechanism may primarily shift procurement decisions from hospitals to insurers rather than significantly reducing costs.
Poland overhauls food law: less paper, more enforcement
Kacper Gabryjańczyk
Poland is working on amendments to the Act on Food Safety and Nutrition and the Act on the State Sanitary Inspectorate. The draft law of 13 April 2026 focuses on simplifying administrative procedures, moving food-related filings fully online and strengthening the enforcement powers of sanitary authorities.
Simpler GIS notifications
One of the most practical changes concerns notifications to the Chief Sanitary Inspector ("GIS"). Under the current rules, operators may be required to notify both the intention to place certain products on the market and the actual first placement. The draft removes the reference to an "intention to place" a product on the market. As a result, notification will be required only when the product is actually placed on the market for the first time.
Clearer rules for expert opinions
The draft introduces statutory deadlines where the GIS questions a product's classification and requests an expert opinion. Operators will have 14 days to request such an opinion and, in principle, six months to submit it (extendable to 12 months). Missing the 14-day deadline will trigger an adverse presumption against the operator's proposed classification. Until the opinion is submitted, no new notification may be filed for a product with an identical composition.
Food establishment procedures go digital
Registration and approval of food establishments will be handled exclusively through the SEPIS IT system and the e-Sanepid platform. Paper-based procedures will be eliminated, and the register of food establishments will be maintained electronically, with selected data made publicly available.
Higher penalties and stronger enforcement
The draft significantly increases financial penalties, with the current cap of 30 times the average national monthly salary rising to 100 times that amount (approx. EUR 208,000). Placing a product on the market without notifying the GIS would become subject to an administrative monetary penalty, replacing the current petty-offence regime. Penalties would also cover food labelling, advertising and promotion breaches.
The draft law entered the public consultation stage on 11 June 2026. The exact effective date is therefore not yet known, although the draft provides that the new rules would apply six months after publication.
Romania's new medical advertising rules: what Decision No. 21/2026 means for healthcare providers
Oana Grecu
On 10 June 2026, the Decision of the Romanian College of Physicians No. 21/2026 was published, repealing and replacing Decision No. 20/2025. Several key changes were first introduced by the intermediate Decision No. 14/2026 (in force from 30 April to 9 June 2026) and have now been consolidated. Here is what matters.
Comparative advertising benefits from a conditional relaxation
The former blanket ban on comparative and superlative claims has been lifted. Medical units may now use comparative advertising, provided that any comparison is objective, verifiable and neither misleading nor disparaging. Defamatory comparisons remain prohibited under the unfair competition rules set out in Law No. 11/1991.
A new framework for discounts and promotions
Previously, the rules prohibited linking a doctor's image to financial incentives but did not specifically address discounts. The new Article 7, introduced by Decision No. 14/2026, now expressly regulates the conditions for discount campaign. Discounts must not be associated with a doctor's image, compromise professional independence, encourage unjustified recourse to medical acts or influence a patient's free and informed choice through means contrary to professional ethics.
500-metre rule for street advertising eliminated
Decision No. 21/2026 removes the previous distance restriction for billboards and signage, replacing it with a qualitative test. Advertising must serve a strictly informative purpose, remain proportionate and be consistent with the dignity of the medical profession.
Use of doctors' names and images more clearly framed
While the substance of the restrictions has not materially changed, the new decision articulates the underlying rationale more explicitly: the doctor's professional authority should not be used as a marketing tool to steer patient decisions.
Additional substantive requirements apply
All advertising must comply with the principles of evidence-based medicine, and the use of conspiratorial messaging is expressly prohibited. Explicit references to Law No. 11/1991 on unfair competition and Competition Law No. 21/1996 further anchor medical advertising within the broader competition framework.
Healthcare providers should review their advertising materials, promotional campaigns and any content featuring doctors' names or images in light of these changes.
Green by proof, not by promise
Oana Grecu, Teodora Burduja
Romania's new anti-greenwashing rules apply from 27 September 2026. Here is what you need to know.
Romania transposed the EU Empowering Consumers for the Green Transition Directive (Directive (EU) 2024/825) through Emergency Government Ordinance No. 18/2026, published on 26 March 2026, i.e. one day before the deadline. The ordinance amends Law No. 363/2007 on combating unfair commercial practices and introduces, among others, 12 new per se prohibited commercial practices. No consumer harm needs to be shown – if you engage in any of them, the practice is deemed unfair.
What is banned?
Five practices target green claims directly: displaying self-certified sustainability labels; using generic terms like "eco", "green" or "sustainable" without recognised excellent environmental performance; claiming a product is entirely sustainable when only one aspect qualifies; relying solely on carbon offsets for "climate neutral" claims; and dressing up legal requirements as selling points. Three further practices address software updates and designed obsolescence: failing to inform consumers about negative software update impacts, presenting optional updates as necessary, and marketing products with features designed to limit durability. Four additional practices cover false durability or repairability claims, premature consumable replacement and spare parts misinformation.
Beyond the blacklist, forward-looking claims ("net zero by 2030") are now a statutory category of misleading practice unless backed by a published, time-bound implementation plan with independent verification.
EGO 18/2026 also expands the list of "main characteristics" of a product that can ground a finding of misleading commercial practice under Article 6 of Law 363/2007. Environmental and social characteristics, circularity aspects such as durability, repairability and recyclability, as well as the composition of a product, are now expressly included. In practice, this means that any misleading representation about these features, even one that falls outside the 12 blacklisted practices, can be assessed as an unfair commercial practice under the general test. Thus, the new rules reach beyond the 12 prohibited practices.
What are the consequences?
The National Consumer Protection Authority will enforce. Under the existing sanctions framework of Law 363/2007, fines range from RON 20,000 to RON 100,000 and are doubled where more than 100 consumers are affected. For widespread infringements falling under Regulation (EU) 2017/2394, turnover-based fines of 0.1 % to 4 % of the trader's annual turnover in Romania may apply, or up to EUR 2m where turnover data is unavailable.
What should you do now?
Audit every environmental claim across packaging, websites and social media – including visual cues such as green colour schemes and leaf imagery. Verify that any sustainability label is based on a scheme certified by a public authority or independently. Remove or substantiate generic claims. Back up future commitments with concrete plans.
Neither the Directive nor the Romanian act provides for any grace period for products already on the market, so this applies from 27 September 2026. September is closer than it looks.
Sarah
Rosenthaler
Attorney at Law
austria vienna