Articles for the ‘Life Sciences’ Category

Food company Mowi Poland successfully challenged the European Commission’s new hygiene rules governing ‘stiffening’—a specialised fish processing technique—on the grounds that the Commission failed to obtain mandatory scientific consultation. While the Commission defended its approach by characterising the measures as mere “clarification” of existing law and citing industry guidelines as support, the EU General Court rejected this argument in its judgment of 24 September 2025 (T-354/24). Siding with the food business operator, the Court determined that the regulation imposed substantive new obligations requiring a scientific basis and consequently annulled the contested fish stiffening rules.

As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies—are becoming increasingly vital, especially in treating complex diseases like cancer. These therapies promise improved clinical outcomes through synergistic mechanisms of action. However, the reimbursement process for such therapies presents significant regulatory and legal challenges, particularly in the area of information sharing between pharmaceutical companies. Recognising this issue, the Belgian Competition Authority (the “BCA”) has issued on 10 September 2025 a communication clarifying how companies can cooperate without breaching competition law.

The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator’s interpretation of the underlying science? This question came up in Joined Cases C‑71/23 P and C‑82/23 P concerning the classification of titanium dioxide – a chemical used in products like cosmetics and medicinal products – as a suspected human carcinogen. The Commission’s decision was based on technical input from the European Chemicals Agency (ECHA). After the General Court (GC) struck down the classification, criticizing the technical input, the Commission and France appealed. They argued that the General Court had overstepped its judicial role. The Court of Justice (ECJ) upheld the annulment, confirming the Court’s power to review the technical reasoning behind a regulatory decision.

Under the EU’s REACH Regulation 1907/2006, substances must be registered with the European Chemicals Agency before being imported. The duty to register lies with the importer. In practice, the act of ‘importing’ often involves multiples actors, including the seller, the buyer and various intermediaries who move the goods across borders. So, who then should register the substance, who is the ‘importer’, and is it possible to shift the responsibility? In the Triferto case (C-654/22), the EU Court of Justice (ECJ) clarified that a person other than the buyer may present itself as the importer and assume the registration obligation.

The European Commission has authorised a new food health claim recognising the digestive health benefits of green kiwifruit. The claim—“Consumption of green kiwifruit contributes to normal bowel function by increasing stool frequency”—has recently been added to the Union list of permitted claims under Regulation (EU) No 432/2012, following a five-year authorisation process.