Azeco Cosmeceuticals

Regulatory

45. Question: What is the highest % of Azelaic acid that can be used in cosmetics in EU and the USA. Answer: In Europe, Azelaic acid is not listed in the regulation. It can be freely used in cosmetic products without restriction. 1223/2009 EC. In the USA, Azelaic acid can be freely used in cosmetic products without restriction.

For information about the cosmetic regulatory status per country, is available upon request.

46. Question: Is Azelaic acid standardized in the US Pharmacopeia or India Pharmacopeia?

Answer: The Indian Pharmacopoeia (IP) is the only one having a monograph for Azelaic acid. In any case Azepur99® is in compliance in terms of characteristics (parameter ranges) with this monograph. 47. Question: The main CAS of the product is “123-99-9”, however, in section 11 there are 4 more CAS present (112-85-6, 57-11-4, 124-07-2, 68937-75-7). Kindly confirm are these 4 com ponents are part of the product? Answer: These four components are not present in the product. They are reported in the section 11 for the only reason that the toxicological data of those substance were used in the EU REACH registration dossier of the substance Azelaic acid to justify the covered end points.

The only classified ingredient present in the product are the ones reported in Section 3 of the SDS: then only Azelaic acid ≥ 99%.

48. Question: Is Azepur99® tested on animals?

Answer: Azepur99® was not tested on animals. A statement is available, which can be requested at any time. 49. Question: Is Azepur99® cosmetic grade TSCA (USA) and ENCS (Japan) registered?

Answer: Yes, a statement reporting the inventory status of Azelaic acid is available.

Mussenberg 1 • 6049 GZ Herten • The Netherlands

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