FLUIDINOVA is certified according to ISO9001 standard in the scope of "Development and Manufacturing of Calcium Phosphate Nanoparticle based Products" by SGS.
All products sold by FLUIDINOVA to EEA customers are compliant with REACH regulatory requirements. All substances of the FLUIDINOVA portfolio have been registered under REACH or are exempt from REACH registration.
REACH Registration number: 01-2119490075-38-0021.
The NATRUE Label is a guarantee for consumers and producers because it sets a high standard that ensures that only high-quality natural and organic cosmetics with the highest levels of natural and organic ingredients can be NATRUE certified.
nanoXIM Oral Care products are NATRUE approved raw materials, classified as 100% nature-identical.
The nanoXIM•CarePaste manufactured by FLUIDINOVA is now the only nano-hydroxyapatite in the world scrutinized and approved as safe for oral care cosmetics by the Scientific Committee on Consumer Safety (SCCS) European authorities.
The SCCS adopted and published on 23rd of March 2023 the Final Opinion SCCS/1648/22 on hydroxyapatite (nano) safety regarding its use in oral care products. Based on the data provided for nanoXIM•CarePaste over the past decade by FLUIDINOVA, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.
This safety evaluation only applies to the hydroxyapatite (nano) with the characteristics of nanoXIM•CarePaste, namely:
• Composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;
• The particles are not coated or surface modified.
This Opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles.
The incorporation of 10% nano-HAp for toothpastes corresponds to 64.5% nanoXIM•CarePaste, while 0.465% nano-HAp for mouthwashes corresponds to 3% nanoXIM.CarePaste, given that nanoXIM.CarePaste contains 15.5% nano-HAp in its composition.
This Final Opinion SCCS/1648/22 and safe use conclusions apply only to nanoXIM•CarePaste product referred to in the studies and manufactured by FLUIDINOVA.
nanoXIM•CarePaste product is compliant with the restrictions outlined in
reference number 372 of Annex III of Regulation (EC) No 1223/2009 of the European Parliament and of the Council regarding the use of the hydroxyapatite nanomaterial in cosmetics products.
