Articles for the ‘Life Sciences’ Category
Titanium dioxide: General Court strikes down classification as human carcinogen and ECJ now confirms
Published 08 September 2025 by Philippe de Jong
ALTIUS Lawyers, Belgium
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.
... Read moreREACH obligation to register imported chemicals may be assumed by a person other than the buyer
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.
... Read moreTwo kiwis a day to chase constipation away – European Commission approves fruit health claim
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.
... Read moreOverview Of Changes in Information Security and Personal Data Protection Affecting Wholesale and Retail Trade of Medicinal Products in Russia
Key updates in Russian data security & healthcare CII: New rules for personal data consent (effective Sept 2025), healthcare CII categorization, and penalties for non-compliance. Essential for pharma & medical retailers
... Read moreProcurement of medical devices: New measures between the EU and China
On 30 June 2025, several measures entered into force that were imposed by the European Commission regarding the purchase of medical equipment originating from China.
The following two measures apply…
... Read more