Onion Peel Extract: Regulatory & Compliance

Manufacturing Standard: GMP & FSSAI

Start with where and how the material is made. A credible onion peel extract is produced under GMP conditions, by a manufacturer holding FSSAI registration in India, with a documented quality system behind each batch. These are baseline expectations, not premium features — ask for the certificates during supplier qualification, and confirm that the facility actually manufactures (rather than only repacks) the extract.

Onion (Allium cepa) is a widely-consumed food, which simplifies its standing in most jurisdictions relative to novel botanicals. Even so, the extract form, the intended use and any concentrated quercetin claim can change how a regulator treats it — always confirm status for your specific market and application.

Contaminant Limits That Belong on the CoA

Because onion peel is an agricultural by-product, contaminant control is where a CoA earns its keep. Insist on tested limits for heavy metals and microbiology on every batch:

These limits reflect SV Botanica's current batch documentation; destination markets may set tighter thresholds, so reconcile the CoA against your own market's rules before import. Which assay sits alongside these contaminant lines — native ratio or standardised quercetin — is explained in quercetin HPLC vs UV testing.

Labelling: Avoid the Common Traps

Most compliance problems with onion peel extract are labelling problems, not safety problems:

• Do not claim a quercetin percentage a native grade cannot support. A 10:1 native extract is quercetin-rich but is not certified to a specific percentage. If your label states a quercetin figure, you must source a standardised, HPLC-assayed grade — see the buyer's guide.
• Name the plant part. Label and documentation should specify "onion outer peel / skin (Allium cepa)," not a generic "onion extract" that blurs peel and bulb.
• Keep health claims market-legal. Permitted structure/function and health claims differ by jurisdiction. Position the ingredient as a dietary flavonoid / quercetin source and verify any specific claim against local rules. SV Botanica supplies characterised raw material and does not provide medical claims.
• Declare allergens and carriers accurately. State any excipient or carrier, and the non-GMO / non-irradiated status, exactly as the CoA supports.

Export Documentation from India

For shipments leaving India, a complete documentation pack should travel with the goods:

• Batch-specific Certificate of Analysis — identity, grade, physical, heavy-metal and microbial results for the exact lot.
• MSDS / Safety Data Sheet.
• Declarations — Non-GMO, allergen statement, BSE/TSE-free, non-irradiation status.
• Country of Origin certificate and, where required, phytosanitary or import-specific certificates for your market.
• Specification sheet and traceability — batch number, manufacture and expiry dates, 36-month shelf life basis.

Confirm in advance which additional certificates your destination customs and regulator require, so a shipment is not held at the border. For the full sourcing and specification picture, return to the onion peel buyer's guide.