Certification

Quality you can document

We operate by the standards of national and international regulatory agencies. Azeco Cosmeceuticals prioritises quality, safety and responsibility for people and the environment. That is why we hold the certifications and statements that guarantee our quality to our clients.

Azepur99® is manufactured and handled according to ISO 9001:2015. It is obtained using a continuous process that ensures availability and eliminates batch to batch inconsistencies. Azepur99® has a European, 100 percent biobased and palm free origin and is REACH compliant.

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From European sunflower fields to a certified, continuous process

Certification

Statements available on request

Next to our certifications we provide the statements that regulatory and purchasing teams need for their own dossiers:

  • ISO 9001:2015 certificate
  • COSMOS approval (Ecocert)
  • Halal statement
  • Non-GMO statement
  • TSE/BSE statement
  • Naturally derived ingredient statement
  • Vegan compliance statement
  • REACH registration information
  • Certificate of analysis and safety data sheet per batch

Registered users find the current versions in the VIP library. Missing a document? Our team sends it within one working day.

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Documentation is part of the product. Every batch of Azepur99® ships with a certificate of analysis and a safety data sheet, and every statement is available within one working day.

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Frequently asked questions about quality and compliance

Answers on regulatory status, documentation, sourcing and sustainability.

Yes. Azeco offers free samples of Azepur99® so you can evaluate the material in your own laboratory before committing to a larger order. Contact service@azeco-cosmeceuticals.com to request a sample.

Azelaic acid is approved worldwide as an Active Pharmaceutical Ingredient (API) for the treatment of acne and rosacea. Pharmaceutical (drug) products typically contain 20% (acne) or 15% (rosacea) azelaic acid and require a doctor's prescription. For cosmetic use, a concentration below roughly 15% by weight is generally used, and no prescription is required. Pharmaceutical-grade azelaic acid requires a purity above 99%, which Azepur99® meets.

Yes. Azelaic acid is listed in the main pharmacopoeias, and a dedicated monograph is also available in the Indian Pharmacopoeia.

In pure form, azelaic acid is a mild skin and eye irritant. According to the specific classification limits in its REACH registration dossier, finished products containing up to 15% by weight of azelaic acid are not classified as irritant. Azelaic acid has no CMR (carcinogenic, mutagenic or reprotoxic) properties.

Regulation varies by country. In some Asian markets, whitening creams in general (including those based on azelaic acid) are not treated as ordinary cosmetics but as quasi-drug products, which require pre-market notification or approval. In a number of countries azelaic acid is not listed as a permitted cosmetic ingredient at all. Because the rules differ significantly per market, we recommend confirming the local regulatory status before planning a launch. Azeco can support exports to markets where azelaic acid is permitted.

The U.S. FDA does not pre-approve cosmetic ingredients other than prohibiting certain substances. Azelaic acid is not prohibited and may be used in cosmetic and personal care products, including at higher concentrations. As always, the manufacturer is responsible for the safety of the finished product.

Yes. Under EU Commission Regulation (EC) No 1223/2009, azelaic acid can be used in cosmetic products without a specific concentration restriction.

Azeco supplies extensive quality, technical and regulatory documentation to support your product development and compliance work, including specifications, certificates of analysis, safety data sheets and supporting regulatory information. Customers also gain access to Azeco's knowledge library with formulation guidance and background documentation. Contact service@azeco-cosmeceuticals.com to request documentation.

Azeco operates under an ISO 9001:2015 certified quality management system and provides COSMOS-approved, REACH-compliant material. This combination supports consistent batch-to-batch quality and reliable supply for professional buyers.

Yes. Azepur99® is vegan, halal-suitable and GMO-free. Because it is derived from sunflower oil and contains no animal-derived materials, it fits a wide range of certified and clean-label product positionings.

Yes. Azepur99® is REACH compliant. Azeco maintains the relevant registration documentation and shares the supporting regulatory information with customers on request.

Yes. Azepur99® is COSMOS approved, which makes it suitable for use in certified natural and organic cosmetic formulations.

Yes. Azepur99® is 100% biobased and palm-free, made from high-oleic sunflower oil rather than petrochemical or palm-derived feedstock. This supports clean-label and sustainability positioning for finished cosmetic products.

Azepur99® is of European origin and is produced from European high-oleic sunflower oil. Azeco Cosmeceuticals is based in the Netherlands and supplies customers in more than 40 countries across Europe, the Americas, Australia and Asia.

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