Ozonated oil: many propose it, many advertise it, many think it is all the same; we produce it and we know that not everything is the same.

Innovares is a direct producer of quality ozonated oil thanks to an innovative proprietary technology, for which it was awarded by the Emilia Romagna Region in Italy. Quality ozonated oil is produced through a controlled reaction between the oil and a mixture of Oxygen - Ozone; the quality in the process determines a high, standardized concentration of Ozonides, the stability of the final product and the absence of unwanted compounds. Below are our ozonated oils, to be used as characterizing components in cosmetic formulas and medical devices.

What you should know about ozonated oil used.
The “REACH Regulation” is the acronym for Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.
REACH regulates chemicals at European level, introducing a system based on four fundamental elements: registration, evaluation, authorisation and restrictions, with the aim of ensuring a high level of protection of human health and the environment by improving knowledge of the hazards and risks arising from chemicals.
The registration process requires registrants (manufacturers, importers or only representatives) to provide information on all chemical substances produced or imported into the European Union in quantities equal to or greater than one tonne per year. Each substance (> 1 metric ton/year) must have its own registration.
For the purposes of registration, the registrant must submit a technical dossier with data on the properties of the substance, as well as on its uses.
In Europe, the European Chemicals Agency (ECHA) works to promote the safe use of chemicals. It implements the EU chemicals legislation, which benefits human health, the environment, innovation and competitiveness in Europe.
Definition of UVCB substance according to the Reach Regulation:
“The acronym UVCB indicates substances of unknown or variable composition, products of a complex reaction or biological materials.
UVBC substances are formed by many different constituents, some of which may be unknown.
Their composition may be variable or difficult to predict”.
First observation: it is of fundamental importance to know their toxicity, because “first of all do no harm”.
And it would be essential to know its toxicity regardless of the quantity placed on the market!
Ozonated sunflower seed oil is a UVCB substance and its registration number at the European Chemicals Agency obtained by Innovares as Lead Registrant is
EC N. 924-751-7.
Whoever first registers a UVCB substance with ECHA (Lead Registrant), will have the substance assigned an Identification Code (EC Number), but only after having directly carried out and submitted to ECHA for approval several OECD chemical-physical, toxicological and ecotoxicological characterization studies, according to GLP practices.
Innovares is the Lead Registrant of the only sunflower seed oil registered in Europe with ECHA, falling under the registered trademark
Ozonia 3000 Sunflower.
The production process of Ozonia 3000 Sunflower has been the subject of a patent (Title: “stabilized composition including ozonides and its use in the cosmetic, dermatological, medical, agricultural and veterinary fields”).
Subsequent registrants will instead be able to make use of the studies carried out by the Lead Registrant, if ECHA deems the substance similar to that of Lead.
However, similar does not mean equal and in fact the chemical characteristics could be very different between substances with the same ECHA identification code.
In the case of ozonated oils, the degree of ozonation of the triglycerides contained therein is particularly important, in fact the higher this index, the more Ozone will have been "incorporated" into the oily matter, giving rise to Ozonides, whose concentration is the mirror image of the Peroxide Index of the substance.
The Peroxide Index is associated with the biological action of the substance itself and its stability over time and can be very different despite the same EC Number.
The amount of Ozone incorporated depends on the technology and the production method, to which various parameters must be respected, well-defined parameters and well described in the production patent.
It follows that any variation of these parameters, such as the reaction time, represents an important discriminant in determining the similarity of two UVCB substances.
In conclusion: various ozonated sunflower seed oils may have the same EC Number BUT the EC Number DOES NOT express the equality in the level of Ozonides contained therein. The only way to verify this is to correctly apply the Peroxide Index Analysis Method described by ISCO3.
Innovares in Italy is ISO22716 - GMP certified to produce ozonized oils.
To get a successful result, the process request knowledge, dedication and specific technologies.
Innovares loads ozone into oily matrices, getting a stable and well characterized active ingredient, to be used in formulations for therapeutic and cosmetic applications.
Ozonia 3000 Sunflower, Ozonia 3000 Sesame and Ozonia 1500 Olive are the name of the highly ozonized sunflower, sesame and olive oil respectively, developed and produced in-house by Innovares. The ozonated GMO-free sunflower, sesame and olive oil have a Peroxide Index not lower than 3000 and 1500 mEqO2/Kg respectively. On the basis of scientific literature, it is important to underline that the stability and the effectiveness properties of ozonated oils are attributed to the concentration of ozonides, which are indirectly quantified through the evaluation of the Peroxide Index. Innovares is the leader in this sense, as it constantly strives to characterize its products to ensure a thorough knowledge and an exact and elevated Peroxide Index.
The plants, the process and the method of analysis carried out for mentioned process are part of the Innovares know-how.
We believe that passion, hard work and professionality are the bases to create something which is unique; we want to involve you in this process with transparency and simplicity, letting you know the specific characteristics of our product.

IMPORTANT NEWS - DECEMBER 2022: OZONIA 3000 SUNFLOWER HAS BEEN REGISTRED AT ECHA.
Ozonia 3000 Sunflower has become the only ozonated sunflower seed oil registered with the European Chemicals Agency ECHA.
This means that it is the only one to have established, after numerous OECD Studies carried out according to GLP, its chemical composition and its toxicological profile as a guarantee for downstream users.

Following the aforementioned registration Ozonia 3000 Sunflower was marked with the EC Number 924-751-7, identification number, which cannot be assigned or used in any other compound of the same species.

For further information visit our dedicated website www.ozonia3000.com.