As a natural sesquiterpene widely used in food, cosmetics, fragrances and other fields, Caryophyllene Oxide (CAS 1139-30-6) has attracted much attention for its compliance. For practitioners in related industries, clarifying compliance issues is the premise of safe application. This article sorts out 7 core compliance questions and gives professional answers based on international regulatory standards and authoritative certification information.
1. Is Caryophyllene Oxide compliant with major international regulatory standards?
Yes, it meets the requirements of multiple international regulatory systems. It has been approved for food use by the US Food and Drug Administration (FDA) and is included in the FDA's food additive list (21 CFR 172.515). In the European Union, it is included in the list of flavoring substances managed by the Council of Europe. Its EC number is 214-519-7, which confirms its legal status in the EU market. At the same time, it is not included in the restricted or unacceptable lists of authoritative institutions such as the Environmental Working Group (EWG).
2. Can Caryophyllene Oxide be used as a food additive?
It can be used as a food additive and flavoring substance. In addition to FDA approval, it has also obtained the FEMA number 4085 and JECFA number 1575, which are important symbols of its compliance in the global food industry. Its acute oral LD50 in rats is greater than 5 g/kg, and it has low toxicity, which can ensure the safety of use within the specified concentration range. It is often used to enhance the stability of food flavors and has no adverse impact on the original taste of food.
3. Are there any restrictions on the use of Caryophyllene Oxide in cosmetics?
There are clear concentration limits for its use in cosmetics, and it can be used safely when used in accordance with the standards. According to relevant data, the maximum allowable concentration in perfumes is 0.4%, 0.06% in soaps, 0.006% in detergents, and 0.02% in creams and lotions. In addition, studies have shown that it has no phototoxicity or photoallergenicity, and no sensitization reaction was found in human repeated insult patch tests, which meets the safety requirements for cosmetic ingredients.
4. Does Caryophyllene Oxide have GRAS certification?
Yes, it has obtained the Generally Recognized As Safe (GRAS) certification recognized by the FDA. GRAS certification is an important guarantee for food ingredients, indicating that it is generally recognized as safe by experts in the field when used in accordance with conventional and intended purposes. This certification also provides strong support for its application in the food and daily chemical industries.
5. What international compliance certifications can Caryophyllene Oxide obtain?
In addition to GRAS certification, high-quality Caryophyllene Oxide products can also obtain multiple international certifications, such as Kosher and Halal certification. Some manufacturers also pass the FSSC 22000 certification, which covers the whole process of production and quality control, ensuring the traceability and compliance of products from raw materials to finished products. These certifications help products enter global markets such as the Middle East and Europe.
6. Is there any risk of genotoxicity or other adverse effects of Caryophyllene Oxide?
Relevant toxicological studies have shown that it has no genotoxic potential. In the Ames test with metabolic activation, no mutagenic activity was found. At the same time, it does not show phototoxic potential (PIF=0.38) in cell experiments, and has no significant impact on cell DNA. The Environmental Working Group (EWG) evaluates it as having low concern for general systemic/organ effects, confirming its high safety.
7. What documents are required to prove the compliance of Caryophyllene Oxide in commercial applications?
In commercial applications, the following compliance documents are usually required: Certificate of Analysis (COA) to confirm product purity and quality indicators; Safety Data Sheet (SDS) to clarify safety precautions and environmental impact; Relevant certification documents (GRAS, Kosher, Halal, etc.); Traceability documents of raw materials to prove that the source of raw materials is compliant. Professional manufacturers can also provide characterization data that meets regulatory guidelines to support customers' compliance verification work.
In conclusion, Caryophyllene Oxide has complete international regulatory recognition and sufficient safety data, and can be applied safely and compliantly in multiple fields on the premise of abiding by concentration limits and relevant regulations. For enterprises, choosing products from regular manufacturers with complete certification documents is the key to ensuring compliance.
Post time:2025-12-30