Pure Capsules®Size 4 White Body and Top Separated Gelatin Capsules , Pill Capsules For Self Supplements DIY

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Important Notice to EU Customers

Notice: “For EU customers, you are not allowed to purchase this capsule if you intend to use it for food supplements. If you proceed with the purchase, we will assume that the capsules are being bought for medical use only.”

Detailed Explanation of Regulatory Changes and Guidelines

1. Titanium Dioxide (TiO₂) Ban in Food Products

• EU Ban on TiO₂ as a Food Additive (E171):
  On February 18, 2022, the European Commission enforced a regulation banning the use of Titanium Dioxide (TiO₂) as a food additive under the designation E171. This decision was based on findings by the European Food Safety Authority (EFSA) which raised concerns over the potential genotoxicity of TiO₂, meaning it could potentially cause damage to DNA and possibly lead to cancer.
• Scope of the Ban:
  The ban specifically applies to the use of TiO₂ as a colorant in food products. This includes, but is not limited to, products such as confectionery, chewing gum, sauces, and food supplements. As a result, TiO₂ is no longer permitted as an ingredient in these types of products within the EU market.

2. Exemptions and Permitted Uses

• Pharmaceuticals (Medicinal Products):
  Despite the ban on TiO₂ in food products, its use is still permitted in medicinal products. The European regulation explicitly exempts pharmaceuticals from this ban. The reasoning behind this exemption lies in the fact that the safety assessment for TiO₂ in pharmaceuticals is handled separately. Within this context, TiO₂ is deemed safe for use as a colorant, particularly in capsules and tablet coatings where it serves essential functions like enhancing visual appeal and protecting the active ingredients from light exposure.The European Medicines Agency (EMA) has verified that TiO₂ can continue to be used in medicinal products, ensuring that its safety is thoroughly evaluated for each specific medication.
• Food Supplements in Capsules or Tablet Form: While the ban covers food products, including supplements, the regulatory environment surrounding TiO₂ in food supplements in capsule or tablet form remains somewhat ambiguous. The EU regulation does not categorically ban TiO₂ in these forms; however, due to the broad scope of the ban on food products, manufacturers and distributors are encouraged to avoid the use of TiO₂ in food supplements to prevent potential regulatory complications.
• Regulatory Advice:
  Given the regulatory environment, it is advised that any use of capsules containing TiO₂ in food supplements should be approached with caution. For this reason, if capsules containing TiO₂ are purchased, it is assumed they are intended for medical use, where TiO₂ is still legally permissible.

Shipping Information:

We dispatch all orders from the UK within 24 hours.

• For UK Customers:

  • If you need next-day delivery, please select Express.
  • If you’re happy to receive your order within 1-3 working days, please choose Normal Postage.

• For Customers Outside the UK:

  • If you need delivery within 1-3 days, please select Express.
  • If you’re happy with delivery within 3-15 working days, please choose Normal Postage.
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