to the point: Healthcare & Life Sciences Q3/2026

Food labelling may be sanctioned under general consumer law 

Andreas Natterer / Sarah Sayahpour

In Case C 301/25, the CJEU ruled that misleading food information may be sanctioned under national laws implementing the Unfair Commercial Practices Directive, even if the same conduct is also covered by the food information regulation. The case concerned pasta packaging that emphasised an Italian origin, although the wheat was sourced from both EU and non-EU countries.

The case involved a range of pasta products made from durum wheat semolina that had been marketed in packaging highlighting the Italian origin of the products and stating that Italy was the country in which the wheat had been milled. However, the wheat used to produce the semolina was of "EU and non-EU" origin, meaning that the pasta was produced from wheat blends containing a significant proportion of wheat that had not been produced in Italy.

The complaint concerned food packaging that prominently highlighted the Italian origin of the products, leading the consumer to believe, or giving them reason to believe, that the statement in question also referred to the origin of the raw materials used in their manufacture. To ensure that consumers receive adequate information, any use of raw materials from abroad must be highlighted just as clearly through notices placed near statements referring to the Italian origin of the product. At a minimum, a corresponding statement must appear on the same side of the packaging as those statements. The question arose as to whether the scope of Regulation No 1169/2011 on food information precludes a penalty under Directive 2005/29 on unfair commercial practices in the internal market.

The Court held that the two regimes complement each other and protect different consumer interests. Food businesses should therefore assess packaging and origin claims un-der both food information rules and general consumer law.

Side note: This judgment is fully in line with the jurisprudence of the Austrian courts, which appears to give little value to correct labelling where the design of the package is potentially misleading.

Mandatory food discounts breach EU law

Andreas Natterer / Sarah Sayahpour

In Case C 658/24, the CJEU struck down a Hungarian emergency decree that forced large food retailers to cut prices on basic foods. Hungary had declared an emergency linked to the Ukraine conflict and, in May 2023, adopted Government Decree 162/2023 to combat food price inflation. The decree required retailers with annual turnover above HUF 1bln (approximately EUR 2.5m) to sell at least one product per specified category at a price at least 15 % below the lowest price applied in the preceding 30 days. They also had to maintain minimum daily stock levels based on 2022 averages. Penny Market, a subsidiary of the German REWE group, was fined approximately EUR 10,000 after inspectors found that two promotional items (apples and mineral water) were not on the shelves during an inspection in February 2024.

The CJEU found the scheme incompatible with Regulation (EU) No 1308/2013 on the common organisation of agricultural markets. Free price formation based on fair competition is a core component of the Regulation, and the Hungarian measure directly interfered with those principles. Although the Court accepted that combating inflation and protecting disadvantaged consumers could, in principle, justify such interference, the measure failed the proportionality test. It applied only to large retailers, which are typically located in urban areas, and therefore did not reach a significant portion of disadvantaged consumers. As a result, the measure did not pursue its stated aims in a coherent and systematic manner.

The measure also contravened the Services Directive, as discriminatory requirements based directly or indirectly on nationality are strictly prohibited. The CJEU found that all retailers below the turnover threshold were Hungarian-owned, while all retailers affected by the decree were foreign-owned.

If the national court confirms this, the measure would amount to indirect discrimination without any possible justification. Apart from the discrimination, mandatory price reductions in the form of fixed tariffs would also have to comply with the principle of proportionality.

The importance of this decision extends beyond the specific case and sets boundaries for politically motivated pricing measures affecting consumer goods.

Mandatory health claims disclaimers need not to be repeated in printed advertising

Andreas Natterer / Sarah Sayahpour

In Case C-657/24, the CJEU clarified two key questions regarding Regulation No 1924/2006 (Health Claims Regulation).

The packaging of a food supplement in capsule form bore a statement required under Article 10(2)(a) of the Health Claims Regulation concerning the importance of a varied and balanced diet and a healthy lifestyle. A print advertisement for this food supplement featured health claims such as "Lose weight healthily" and "Contributes to weight loss as part of a low-calorie diet". However, the advertisement did not contain the mandatory statement required under Article 10(2)(a) of the Health Claims Regulation.

A consumer protection association brought an action for an injunction, and the German Federal Court of Justice referred two questions to the CJEU for a preliminary ruling:

1.    Does the term "labelling" in Article 10(2) of Regulation No 1924/2006 also cover written advertising?

2.    Must the mandatory information also appear in advertising if the product labelling already contains it?

The CJEU clarified that the terms "labelling", "presentation" and "advertising" each have a distinct meaning. Written advertising for a food supplement does not fall within the definition of "labelling".

The phrase "if such labelling is absent" indicates a relationship of subsidiarity. Presentation and advertising only come into play as a supplementary measure when labelling is absent.

"Labelling" serves an informative purpose by providing information when the product is supplied to the end consumer, whereas "advertising" serves a sales and promotional purpose.

The mandatory information must primarily be provided on the labelling. Only where the information is absent from the labelling must it also be included in the presentation and advertising.

M&A news and trends in the food sector

Elena Todorova

M&A activity in emerging food, beverage and supplement brands has surged in 2026, marked by high-value acquisitions, fast growth and unconventional financing.

Recent deals include Barilla's acquisition of pasta brand Goodles, reportedly valued at between EUR 260m and EUR 523m, and the EUR 218m raise by David Protein's parent company to fuel its expansion. These transactions sit alongside other major moves, including Ferrero acquisition of Purely Elizabeth, Danone's absorption of Huel, Lactalis' acquisition of Protein Works, Unilever's addition of Grüns and merger of its food business with McCormick, Aurelius' acquisition of Hain, Intersnack's purchase of UTZ Brands, Valeo Foods' acquisition of Prestige-96, and P&G's pending purchase of Thorne.

Three patterns define this wave:

• Category lines are blurring: everyday nutrition, active nutrition and supplements increasingly share the same "healthy ageing plus indulgence" proposition, reshaping marketing strategies to reflect demographics.
• The targets are typically fast-growing, digitally native brands with already significand revenues, acquired just as they are ready for global scale.
• Incumbents are simultaneously trimming other holdings (Nestlé's supplement divestments, Unilever's food exits) to refocus portfolios around wellness trends and GLP-1-driven shifts in consumption.

Financing in the sector is also evolving. IM8 secured a USD 1bln financing facility tied to customer acquisition rather than equity, while corporates such as pasta producer La Molisana are joining funding rounds at an early, as seen in Brami's USD 33m raise. This is creating a feedback loop in which exits attract further investment.

Notably, many of these "healthy" brands rely on processed products. Medici Brands, led by the founder of RxBar (sold to Kellogg's in 2017), exemplifies this shift. Having built its reputation on minimal-ingredient foods, the same founder now markets David Protein bars with roughly 15 ingredients, with the brand on track to exceed USD 300m in revenue by 2026.

Pest traces can prove food hygiene breaches

Andreas Natterer/ Sarah Sayahpour

In Case C 483/24, the CJEU ruled that evidence of pest traces or droppings in food stores and warehouses – particularly on items, fittings and equipment that come into contact with food, as well as raw materials and ingredients held in stock at a food business – may be sufficient to prove breaches of EU hygiene rules. Authorities are not also required to demonstrate that the operator failed to take every possible preventive measure. Repeated findings may indicate that adequate pest control procedures are lacking.

A different standard applies to the General Regulations for Premises Handling Food. In this case, the authorities must prove that a company's premises where food is handled do not ensure good food hygiene.

Why extended producers' responsibility cannot extend to food suppliers 

Elena Todorova/ Alexandra Minioti

The European Union's Packaging and Packaging Waste Regulation (PPWR) is reshaping how food reaches the shelves. From August 2026, new rules on recycled content, reuse targets, labelling and extended producer responsibility (EPR) will apply across the supply chain. The question is: who bears these obligations?

Under the PWR, compliance duties are assigned by role. Manufacturers bear conformity assessment and technical documentation responsibilites. Producers must register for EPR schemes and fund end-of-life packaging management. Distributors are required to verify upstream compliance before placing products on the market. Operators who fill transport or e-commerce packaging must meet reuse and empty-space targets. Each obligation is tied to a specific function in the chain.

Yet a familiar pattern is emerging. Large producers and buyers are drafting contract clauses that shift packaging redesign costs, EPR contributions, recycled-content sourcing and labelling expenses onto their agricultural and food suppliers. This is where Directive (EU) 2019/633 on unfair trading practices in the agricultural and food supply chain becomes directly relevant. 

The Directive prohibits practices that grossly deviate from good commercial conduct, are contrary to good faith, and are unilaterally imposed by one trading partner on another. Its blacklist bans requiring payments from suppliers that are not related to the sale of their products. Its grey list prohibits charging suppliers for stocking, listing or promotional costs unless agreed in clear and unambiguous terms beforehand. Commercial retaliation against suppliers who resist such demands (for instance through delisting or order reductions) is also expressly forbidden.

When a buyer forces a food supplier to absorb packaging compliance costs that the PPWR assigns to the buyer in its statutory capacity, that conduct risks constituting an unfair trading practice. The argument is straightforward: these costs should be borne by the party the law has designated as responsible. Contractual creativity should not override regulatory design.

Food suppliers and their advisors should map every PPWR obligation to the correct statutory role before accepting new contractual terms. The green transition must not become a vehicle for cost-shifting dressed up as compliance.

New rules for tobacco, nicotine and beyond: Austria overhauls its regulatory framework 

Sarah Rosenthaler

Austria has amended its Tobacco and Non-Smokers Protection Act (Tabak- und Nichtraucherinnen- bzw. Nichtraucherschutzgesetz, TNRSG), with most changes having entered into force on 20 August 2026. The reform significantly expands the regulatory framework for tobacco, nicotine and related products.

Broader product scope. The TNRSG now covers tobacco-free nicotine products, such as nicotine pouches, as well as tobacco-free nicotine substitute products, including caffeine-based or herbal oral pouches, introducing specific ingredient, labelling, advertising and distribution requirements.

Ban on disposable e-cigarettes. Disposable e-cigarettes, with or without nicotine, are banned. Existing stock may be supplied to retailers until 31 August 2026 and sold to consumers until 31 December 2026.

New notification obligations. Manufacturers and importers must electronically notify newly regulated products at least six months before placing them on the market, providing ingredient lists, toxicological data and, where applicable, nicotine dosage information. Products already on the market before 20 August 2026 must be notified by 31 December 2026.

Stricter product, youth protection and advertising rules. Tobacco-free nicotine products are limited to 16.6 mg nicotine per gram and 1.6 grams per consumption unit. Newly regulated products are subject to mandatory health warnings and restrictions on flavour designations and advertising. Distance selling is prohibited. The existing ban on sales to persons under 18 now expressly extends to all newly regulated product categories.

Enhanced enforcement. New powers include mystery shopping, particularly in distance selling.

Transitional provisions. Certain non-compliant products manufactured or placed on the market before 20 August 2026 may be supplied to retailers until 31 December 2026 and sold to consumers until 30 June 2027. Certain pre-existing contractual obligations remain exempt from advertising restrictions until 29 February 2028.

Bulgaria's SAC draws red line: medical device suppliers cannot be made to cover public bugdet gaps

Alexandra Minioti 

In a landmark ruling issued on 13 July 2026, a five-member panel of the Supreme Ad-ministrative Court (SAC) upheld the annulment of a controversial cost-control mechanism adopted by the National Health Insurance Fund (NHIF) for the 2023 budget year.

The mechanism was designed to keep the NHIF medical devices budget in check. When-ever actual hospital consumption of fully reimbursed medical devices exceeded forecast volumes, the NHIF would automatically reduce the prices paid to wholesale suppliers through progressive cuts of 10 %, 20 % and 30 %. Crucially, the reduction was spread equally among all suppliers within each device group, regardless of whether a particular supplier had contributed to the overspend.

The SAC confirmed several key legal principles:

1. The court held that transferring the financial risk of inaccurate budget forecasting onto private market participants is incompatible with the constitutional guarantee of free economic initiative and equal treatment of economic operators under Articles 19(1) and 19(2) of the Bulgarian Constitution.
2. The ruling stressed that solidarity-based price reductions applied irrespective of in-dividual supplier behaviour create internal inequality among market participants operating under identical legal conditions.
3. The court emphasised that maintaining budgetary discipline is a legitimate public interest objective. However, it cannot be pursued through mechanisms that effectively relieve a public body of its statutory payment obligation while shifting the shortfall onto suppliers.

The decision sends a clear signal across the healthcare sector: cost containment must respect the proportionality principle and may not turn forecast-driven spending caps into instruments that penalise compliant businesses for systemic planning failures. The sector will be watching closely to see whether the decision will also affect pharmaceutical reimbursements.

Raising prices in Bulgaria's euro era: what every business needs to know

Marin Demirev

Bulgaria adopted the euro on 1 January 2026. During the dual-display period (8 August 2025 – 8 August 2026), traders were prohibited from unjustifiably increasing consumer prices under the Euro Introduction Act. When that period expired, the legislature extended the prohibition through new provisions in the Consumer Protection Act (CPA). These new rules entered into force on 9 August 2026 and will apply until 9 August 2027.

The CPA does not flatly prohibit price increases. Rather, it prohibits increases in consumer prices that are not economically justified. An increase is economically justified only where it has a direct and proportionate causal link to one or more objective economic factors. The CPA identifies six specific categories: (i) increase in supply or production costs; (ii) increase in labour costs; (iii) changes in the prices of energy, fuel or raw-material prices; (iv) changes in taxes, fees or other public obligations; (v) changes in foreign-exchange rates or external economic conditions; and (vi) other factors beyond the trader's control that materially affect costs or the conditions of supply. The assessment is made for each specific good or service and, where relevant, by trader, location, sales channel, territory or consumer group.

A draft methodology, expected to be adopted by the Council of Ministers shortly, sets out a four-stage review: relevance, causation, quantification and proportionality. Justification must be documented for each specific good or service. Promotional prices are excluded. Shared costs should ordinarily be allocated using a pre-established or customary, consistent and verifiable method. А retrospective method is not automatically barred if it is objectively justified and reproducible. Offsetting effects and double counting must be addressed. Changes in trade margins, profit targets, competitor alignment or general references to inflation are not, by themselves, objective economic factors.

According to the draft methodology, during an inspection, the Commission for Consumer Protection (CCP) may require traders to provide information and evidence justifying the price before and after the increase, including every price component and its value. If a trader fails to provide the information, or provides it incompletely, the increase is presumed to be economically unjustified. Businesses should therefore maintain contemporaneous, granular records of pricing, cost inputs, allocation methods and offsetting effects.

Enforcement is active. In the year to August 2026, the CCP carried out more than 14,500 inspections and imposed total sanctions exceeding EUR 1.3m for violations of the Euro Introduction Act. Under the new CPA price-increase regime, fines range from EUR 1,000 to EUR 10,000 for individuals and from EUR 10,000 to EUR 100,000 for sole traders and legal entities. Each product, service or trading location may constitute a separate violation.

The practical takeaway is not that all fee adjustments are prohibited. Traders should test each proposed increase against the statutory factors, document a direct and proportionate cost impact, calculate the increase in euro without intermediate rounding, exclude promotional prices, and be prepared to produce supporting records within the statutory deadlines.

Digital health update: Say hello to e-SănătateaMeas 

Oana Grecu 

The e-SănătateaMea portal is now live, with online booking becoming mandatory from 1 October 2026.

What has changed: Law No. 157/2026 adds new paragraphs to Article 280 of Law No. 95/2006 on healthcare reform, giving the patient-facing digital portal a statutory home within the Health Insurance IT Platform. From the second half of 2026, CNAS must develop, manage and make available the "e-SănătateaMea" portal, offering secure access to medical information, electronic interaction with providers, and health-monitoring tools. The law also introduces an electronic appointment-booking module, mandatory for all contracted healthcare providers from Q4 2026, after an initial pilot.

Where things stand: CNAS launched the portal (portal.esanatateamea.ro) on 1 September 2026 as a single digital front door for patients and providers. Enrolled patients can view their insured status and benefits, prescriptions from the last five years, 10-year medical history, reimbursement history and health card status, and can book appointments with specialists already online. Access is via ROeID, while the old health card continues to work in parallel.

The booking module becomes operational on 1 October 2026, while other modules are in progress. The obligations relating to the booking module sit with providers, not patients: hospitals, clinics and practices must post their availability, while patients can still book by phone or in person as before. In its communications, CNAS has struck a pragmatic note, acknowledging that not every provider will be ready immediately and confirming that no penalties will apply at the outset.

Why this matters: Healthcare providers under contract with the health insurance house must request booking-module credentials from their health insurance local house, while patients gain a convenient, secure place to manage their health information and appointments.