Medical Devices:
European Commission Confirms Continued Use of Titanium Dioxide in Medicinal Products
Background
On 6 August 2025, the European Commission published a Staff Working Document reaffirming the continued use of titanium dioxide (TiO₂) in medicinal products, despite its ban as a food additive in the EU. The document is based on the European Medicines Agency’s (EMA) updated assessment of the feasibility of replacing the substance in pharmaceuticals.
Titanium dioxide is currently used in over 91,000 human and more than 1,600 veterinary medicinal products as a whitener, opacifier, and UV protector, especially in solid oral dosage forms. Its regulatory status came under scrutiny after EFSA reclassified it as unsafe for use in food due to concerns about potential genotoxicity.
EMA Evaluation and Industry Feedback
Following EFSA’s 2021 opinion, the Commission asked EMA to assess whether titanium dioxide could be substituted in medicines without compromising safety, availability, or quality. A 2024 update of EMA’s review, based on new data submitted by stakeholders, concluded that no suitable alternatives exist that perform equally well across all key functions.
The evaluation highlighted several key challenges:
- Reduced opacity in coatings without TiO₂, requiring increased amounts of alternative materials.
- Limited colour range for film coatings, affecting patient recognition and product security.
- Poorer photostability of TiO₂-free coatings, especially for light-sensitive medicines.
- Lower production yields and longer processing times, raising costs and technical barriers.
- Long reformulation timelines (estimated at 7–12 years per company), with potential risks of product withdrawal or shortages.
Safety Considerations
Although EFSA flagged genotoxicity risks in food, EMA’s review of pharmaceutical-grade titanium dioxide found no relevant safety concerns for medicinal use. Exposure levels are much lower than in food, and the form used in pharmaceuticals is highly purified.
An industry-submitted safety review also found negligible carcinogenic risk, and this conclusion was endorsed by EMA’s CHMP, ECHA and EFSA. However, EMA stressed that the assessment was not a full safety evaluation under its procedures.
Commission Conclusion
The Commission concluded that continuing the use of titanium dioxide in medicinal products is justified, as:
- No suitable technical alternatives are available.
- A ban would jeopardize medicine availability and patient safety.
- Reformulation would be costly, time-consuming, and harmful to supply continuity.
The Commission will not proceed with a restriction under Regulation (EU) 2022/63. However, it encourages manufacturers to:
- Keep monitoring scientific developments and explore alternatives.
- Justify the use of excipients like TiO₂ in new marketing authorisation applications.
European Commission Publishes Study on AI Deployment in Healthcare
Background
On August 8, 2025, the Directorate-General for Health and Food Safety (DG SANTE) published a report titled “Study on the Deployment of AI in Healthcare”, offering a comprehensive overview of the opportunities and challenges associated with integrating artificial intelligence (AI) into clinical practice across the EU.
Key Findings
The study highlights that, despite AI’s strong potential to:
- improve operational efficiency,
- reduce administrative burdens, and
- enhance diagnostic and therapeutic capabilities,
its actual deployment in real-world healthcare settings remains limited. The slow uptake is attributed to a combination of technological, regulatory, organisational, and cultural barriers.
Barriers Identified
Among the main challenges, the report identifies:
- Limited interoperability of digital systems;
- Concerns about data quality, privacy, and security;
- A lack of trust and digital skills among healthcare professionals;
- Gaps in regulatory clarity for AI-based medical devices and services.
Enabling Factors and EU Role
The study also explores successful use cases (“accelerators”) where AI has been effectively implemented, drawing lessons to inform broader strategies. It calls for a coordinated EU approach to support the safe, effective, ethical, and equitable deployment of AI technologies in healthcare.
In particular, the document stresses the EU’s role in:
- Promoting interdisciplinary collaboration,
- Strengthening governance frameworks for AI in health,
- Ensuring inclusive innovation that benefits all patient populations.
Source: https://health.ec.europa.eu/publications/study-deployment-ai-healthcare-publications-office-eurep_en
MedTech Europe Calls for Simplified, Coherent EU Digital Regulations
A closer look
MedTech Europe has released a position paper (28 August 2025) urging the simplification of EU digital legislation as it applies to medical technologies—such as connected devices, diagnostic software, and AI-powered solutions. The paper underscores the need for a streamlined regulatory framework that aligns with existing sectoral laws.
Key Message
The industry body warns that the current patchwork of regulations results in unnecessary complexity, duplicated obligations, and administrative burdens. To foster innovation, support patient care, and maintain regulatory coherence, MedTech Europe recommends that digital legislation be harmonized with the existing Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and European Health Data Space (EHDS).
Rationale
Digital medical technologies are critical for:
- Early diagnosis
- Remote patient monitoring
- Personalized treatments
However, inefficiencies and conflicting requirements threaten to slow innovation and disrupt patient access to emerging solutions.
Proposed Approach
MedTech Europe calls for a “mind‑shift” toward regulation consolidation, including:
- Coordinating digital legislation across existing legal frameworks
- Preventing overlapping obligations
- Preserving safety, effectiveness, and legal clarity
Cosmetics:
CJEU Upholds Annulment of Titanium Dioxide Inhalation Classification
On 1 August 2025, the Court of Justice of the European Union (CJEU) dismissed appeals from both France and the European Commission, affirming the annulment of the classification of titanium dioxide (powder forms) as a suspected carcinogen by inhalation (Category 2 CMR). This decision invalidates a previous harmonised classification under the CLP Regulation, which had listed certain powder forms of titanium dioxide as Category 2 carcinogenic, mutagenic or toxic for reproduction (CMR).
Background
- In 2020, the classification of specific forms of titanium dioxide in powder form as a suspected inhalation carcinogen (Category 2 CMR) had been enacted.
- However, this classification was subsequently annulled by an earlier ruling, prompting appeals from France and the European Commission to reinstate it.
- The CJEU’s latest judgment confirms the annulment remains effective.
Outcome and Implications
- No CMR classification applies to titanium dioxide powder forms at present.
- The decision provides regulatory clarity for manufacturers and downstream users of titanium dioxide products subject to inhalation exposure.Inizio modulo
Biocides:
Biocides Review Update: Approval Interest for Lavandin Oil Withdrawn
Use of Lavender, Lavandula hybrida, ext. / Lavandin oil in Product-Type 19 at Risk
ECHA has announced that companies have withdrawn their interest in supporting the approval of Lavender (Lavandula hybrida) extract / Lavandin oil under the Biocidal Products Regulation (BPR) for product-type 19 — preservatives for repellents and attractants.
This means that, unless another company steps in to take over the role of applicant:
- The substance will no longer be supported in the Review Programme for PT 19.
- Its continued use in repellents and attractants may no longer be permitted under EU biocides legislation.
Companies currently placing products containing this substance on the EU market for PT 19 uses should urgently assess the regulatory implications and consider whether to submit an interest themselves or seek alternative active substances.
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REACH:
Updated PFAS Restriction Proposal Published by Five Member States
On 25 August 2025, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden announced the publication of their updated PFAS restriction proposal. This marks another significant step in the ongoing REACH restriction process targeting the entire group of per- and polyfluoroalkyl substances (PFAS).
The revised Background Document reflects an in-depth evaluation of more than 𝟱,𝟲𝟬𝟬 𝘀𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗮𝗻𝗱 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀. It now includes 𝗲𝗶𝗴𝗵𝘁 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝗶𝗲𝘀 not previously addressed:
- Printing & sealing applications
- Machinery and technical textiles
- Pharmaceuticals, military, explosives
- Broader industrial uses (e.g. solvents, catalysts)
This update follows one of the largest restriction proposals ever submitted under REACH, with the aim of curbing environmental and health impacts from thousands of PFAS chemicals.
Germany Withdraws Intention to Restrict 1,4-Dioxane in Surfactants
Context
On August 20, 2025, Germany officially withdrew its intention to propose a REACH restriction on 1,4-dioxane in surfactants. The decision was made to allow authorities to:
- Assess new data on emission pathways
- Re-evaluate the most appropriate regulatory approach
Further updates will be made available on the German REACH helpdesk website once the reassessment is complete.
Call for Evidence: RP-HP Screening Report
ECHA has launched a call for evidence on the reaction products of:
- 1,3,4-thiadiazolidine-2,5-dithione
- Formaldehyde
- 4-heptylphenol (branched and linear)
These substances — collectively referred to as RP-HP — are under scrutiny for their use in articles. As part of a screening under REACH Article 69(2), ECHA is assessing whether their use is adequately controlled or if a restriction is needed.
Stakeholders are invited to submit comments and information relevant to the ongoing investigation.
CLP:
Harmonised Classification and Labelling (CLH): Public Consultations Open
ECHA Seeks Comments on CLH Proposals
ECHA has launched a public consultation on several harmonised classification and labelling (CLH) proposals under the CLP Regulation. Stakeholders are invited to submit comments by 24 October 2025.
Substances Open for Consultation
ECHA is currently gathering input on proposed classifications for the following substances:
- 3-Aminopropyldiethylamine
- EC: 203-236-4
- CAS: 104-78-9
- 3-Aminopropyldimethylamine
- EC: 203-680-9
- CAS: 109-55-7
- Reaction products of boric acid with didecylamine and ethylene oxide
- (EC and CAS numbers not yet assigned)
New CLH Proposals Submitted
Two new proposals for harmonised classification and labelling have also been submitted to ECHA:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
- (EC and CAS numbers to be confirmed)
- Aqueous ethanol extract from wood of Vitis vinifera (Vitaceae)
- (Name, EC, and CAS to be confirmed)
