TiO₂ Free Capsules

TiO₂ Free Capsules‌ are pharmaceutical/health supplements capsules ‌without titanium dioxide‌, a common whitening additive. Safer chemical profile‌ and ‌EU-compliant‌ (post-2022 regulations). Ideal for ‌clean-label brands, health-conscious consumers, and markets with strict additive bans‌ (e.g. Europe)

▶EQUIPPED WITH PTS PRODUCTION LINES

Fully-automatic double-head production line, production capacity greatlyincreased AB PLC. ensuring the stability of the control system, improving product uniformity and stability.

 

▶NEW CAPSULE MOLD

The size of new capsule mold matches with existing mainstream filling machine. Professional technical service team for the service from pre-sale to after-sales to help to improve capsule filling rate.

 

▶STERILIZATION WITHOUT ETHYLENE OXIDE

With Class-D clean area or Class-B clean area of local parts in the workshops; the number of air exchange between the capsule production workshop being 40 times/hour, which effectively reduces the pollution of microorganisms; strict indoor cleaning, microorganisms monitoring, ethylene oxide-free sterilization is achieved for capsules.

 

▶AUTOMATIC TRANSFER OF GLUE AND CAPSULE

Automatic guided vehicle system is used to transfer the capsules in the whole process of capsule production, which adopts closed pipe transmission to minimize personnel contact.

 

▶SMART SOL-GEL

Fully-automatic operation of sol gel and viscosity, core technology to ensure the quality of gel liquid.Process traceability for more stable quality.

 

▶INFORMATIZATION MANAGEMENT

Designed by lBM for the informatization management of the enterprise, including ERP,MES, SCADA, LIMS, WMS and other related systems.

• At KornnacCaps, we are committed to delivering the highest quality empty capsules to our global customers. Every step of our production process strictly follows international pharmaceutical excipients GMP standards, and we have been certified under ISO 9001 Quality Management System. This ensures our operations are scientific, standardized, and consistently high-quality.

 

Control

At KornnacCaps, high-quality products are the result of rigorous quality management. We strictly follow GMP standards throughout every stage-from raw materials to semi-finished and finished products-ensuring full-process quality control and eliminating any risk of quality issues.

Our product complies with the standards of the Chinese Pharmacopoeia and has passed international certifications such as HALAL, Kosher, FDA, ISO9001 and ISO22000.

After-Sales Services

• PE bag+Aluminum foil bag+Six surface foam board+5 ply corrugated carton;

 

• Carton size 60x73x40cm,volume 0.18 cubic meters, gross weight is about 15kgs per box;

 

• Storage Condition: Temperature: 15℃~ 25℃, Humidity: 35%~65%;

 

• 20' Refrigerator Container: 140 cartons empty capsules;

 

• 40' Refrigerator Container: 345 cartons empty capsules.

 

Available for customization according to the customer's requirements.

Regulations and Market Applications of TiO₂-Free Capsules

As global consumers grow more conscious of what goes into their bodies, regulatory authorities and industries are responding with increased scrutiny over food and pharmaceutical excipients. One such ingredient under growing restriction is Titanium Dioxide (TiO₂), a widely used whitening agent and opacifier in capsules and other oral dosage forms. This has led to the rapid rise of TiO₂-free capsules in both regulatory-compliant and consumer-driven markets.

Regulatory Developments
European Union (EU)
The most significant regulatory shift came from the European Commission, which banned TiO₂ as a food additive (E171) in 2022 following a re-evaluation by the European Food Safety Authority (EFSA). EFSA concluded that TiO₂ could no longer be considered safe due to potential genotoxicity concerns, even though conclusive evidence of harm was lacking.

Although the ban initially targeted food applications, the pharmaceutical and dietary supplement industries were strongly impacted, as many capsule shells use TiO₂ for its excellent opacity and protection against UV light. While TiO₂ is still temporarily allowed in medicines under EU regulation (pending further review), there is growing pressure to reformulate products preemptively, especially as consumers show a preference for "clean label" and TiO₂-free solutions.

France and Other Markets
France was the first EU member state to suspend the use of TiO₂ in food in 2020, prompting manufacturers across Europe to begin looking for alternatives. Outside the EU, countries like Switzerland, Norway, and some parts of Asia-Pacific are monitoring the TiO₂ debate closely and may follow suit.

Meanwhile, the U.S. Food and Drug Administration (FDA) still permits TiO₂ in food and drugs within specified limits, but many brands are voluntarily moving toward TiO₂-free formulations to future-proof their products.

Market Applications
Pharmaceutical Industry
Pharmaceutical companies are under increasing pressure to develop TiO₂-free capsule options, especially for global markets. While replacing TiO₂ is technically challenging-since it provides excellent whiteness, light protection, and uniformity-manufacturers are now adopting alternative opacifiers such as calcium carbonate, iron oxides, or specially designed plant-based pigments. These capsules are especially important in pediatric, geriatric, and long-term therapies, where safety concerns are paramount.

Nutraceuticals & Dietary Supplements
The demand for TiO₂-free capsules is surging in the nutraceutical and dietary supplement sectors, particularly among clean-label, vegan, organic, and natural health brands. These markets are highly responsive to consumer perception, and "No TiO₂" is now considered a selling point alongside other labels like "non-GMO," "gluten-free," or "vegan-certified."

Functional Foods and Export Markets
In markets like the EU and Middle East, where Halal and clean-label standards intersect, TiO₂-free capsules have become a default choice. Moreover, brands looking to export to Europe must now ensure compliance with EU additive bans, giving TiO₂-free capsules an edge in international trade.

Conclusion
The shift away from Titanium Dioxide is both regulation-driven and market-driven. With the EU setting the tone and global consumers demanding transparency and safety, TiO₂-free capsules are rapidly becoming the new industry standard. For manufacturers aiming to stay competitive and future-ready, investing in TiO₂-free capsule solutions is no longer optional-it's a strategic necessity.

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