Information Has Already Been Submitted!

Product Information

Solenis LLC
Performax™ MX2304 COOLING WATER TREATMENT

Contact Information

Solenis LLC
Natalia J. Ribeiro
Product Regulatory Specialist
RegulatoryRequestsNA@Solenis.com

Responsible Sourcing

Material Origin
Answer
Comment
  • Is the product or any ingredient derived from synthetic origin?

  • Is the product or any ingredient derived from vegetable origin?

    • Are genetically modified organisms (GMO) used in the manufacturing?

    • Is the product or any ingredient derived from palm (Elaeis Guineensis) oil, palm kernel oil, palm fruit oil, palm butter, or palm derivatives (plant-derived fatty acid oils)? If Yes, attach a Round Table on Sustainable Palm Oil status. If No specify origin in the Comments field.

    • Does the product contain or is it derived from plant protein?

    • Does the product contain grain, grain alcohol or grain sugars (including corn starch)?

    • Please identify the feedstock type

    • Please identify the percentage content of feedstock type:

  • Is the product or any ingredient derived from animal origin?

    • Is the product compliant with the Certification of Suitability of Monographs of the European Pharmacopoeia (CEP) established by the European Directorate for the Quality of Medicines (EDQM)?

    • Is the product compliant with the note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 - October 2003) Item 6.4 Tallow Derivatives?

    • Is the product compliant with Regulation 1774/2002/EC laying down health rules concerning animal by-products not intended for human consumption (Category 3 Material)?

    • Were the treatment condition requirements met for decreasing the risk of BSE/TSE?

    • Does the product contain any prohibited Cattle Materials per 21CFR700.27?

    • Please identify the feedstock type and % content

    • Does the product contain any prohibited Cattle Materials per 21CFR700.27?

  • Is the product or any ingredient derived from mineral origin?

Authorizer Information

Natalia J. Ribeiro
Product Regulatory Specialist
RegulatoryRequestsNA@Solenis.com

Attach Documents

No attachments