Azeco Cosmeceuticals

1.4 AZCO 99 and the standard ISO16128 AZCO 99 is completely obtained from a vegetable raw material (High Oleic Sunflower oil) with a new proprietary chemical process in agreement with the “green chemistry” principles (https://www.epa.gov/greenchemistry ). According to the standard ISO 16128 and its two parts: 1) Part 1 - ingredient characterization; 2) Part 2 - approaches to determine indexes that apply to the ingredient categories defined in Part 1. Framework to determi - ne the natural, natural origin, organic and organic origin content of products based on the ingredient characterization. 1.5 Shelf life, storage stability and retest date of AZCO 99 AZCO 99 is stable for at least 3 years if maintained closed in the original packing (see the paragraph 5) as supplied. This shelf has been evaluated according to the ICH (Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Pro- ducts. The stability tests have been carried out at room temperature at also at 40 °C (accelerated testing, up to 12 months). The accelerated testing, in addition to long-term stability studies, can be used to assess longer term chemical effects at non- accelerated conditions and to evaluate the effect of short-term excursions outside the label storage conditions such as might occur during shipping. In particular three primary batches of AZCO 99 representative of the quality of the material to be made on a production scale have been tested using the same container closure system of the packaging proposed for storage and distribution (see section …of this document) Considering the proposed containers are impermeable to moisture and solvents, the sensitivity to moisture or potential for solvent loss is not a concern for AZCO 99. Thus, the stability studies were conducted under any controlled or ambient humidi- ty condition. The table herein below contains the obtained data. According to them the Retest Date, the date after which samples of the active ingredient should be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given finished cosmetic product, has been fixed after 36 months of its manufacturing date and its Retest period, the period of time during which the active ingredient is expected to remain within its specification and, therefore, can be used in the manufacture of a given cosmetic product, provided that the active ingredient has been stored under the recom- mended conditions, is then fixed at 36 months. After this period, a batch of the active ingredient, destined for use in the manufacture of a cosmetic product should be retested for compliance with the specification and then used immediately. A batch of the active ingredient can be retested multiple times and a different portion of the batch used after each retest, as long as it continues to comply with the specification. AZCO 99 can be defined as a derived natural ingredient with 100% of renewable carbon content.

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