Documents · article / lot files
Food-grade silicone mold documents buyers actually receive
Use this checklist to request documentation that matches the selected silicone, finished article and intended use. Send the destination market and any customer-specific testing requirements before production.
WYD (Room 201, Building N, Licheng Technology Industrial Park Phase III, Xinhe Avenue, Shajing, Baoan District, Shenzhen, since 2006) supplies available 21 CFR 177.2600 extractives and/or LFGB files for the selected compound and destination. Ask for the current quality-management documentation relevant to your supplier review. Confirm the certificate holder, scope and validity dates. Product-specific test reports are reviewed separately. Food-contact files are not a CAD modeling fee. Tray RFQs stay on /custom-food-silicone-molds/.
What you can actually receive
Ask for the specimen that matches production - color, thickness, post-cure - not a white-plaque PDF reused on a red tray.
| Document | What it is | What it is not |
|---|---|---|
| Compound / material report | Grade, lot, platinum vs peroxide, Shore, intended-use language | 177.2600 by itself |
| 21 CFR 177.2600 extractives | Water and n-hexane reflux of a finished rubber article | An FDA-approved factory, FDA-approved mold, or 21 CFR 111 |
| LFGB / BfR XV (EU path) | Volatiles / extractables, often plus sensory on the article | A US letter with a German filename |
| GB 4806.11 | China food-contact silicone path if you sell there | Covered by a US PDF |
| ISO 9001:2015 certificate | Historical QMS file on record (Sailway SW21Q20552R0S; validity ended May 2026 — not shown as current) | Product food approval |
| Color / post-cure note | Specimen was the production thickness and pigment | A white-plaque PDF reused on a red tray |
177.2600 typical limits (the regulation, not a WYD lot): aqueous - not more than 20 mg/in² in the first 7 hours, then 1 mg/in² in the next 2 hours; fatty (n-hexane) - 175 mg/in² then 4 mg/in². Gummies that get oiled need the fatty flask asked for.
Common mix-up: factory stamp vs article extraction
21 CFR 177.2600 does not inspect Bao'an. It limits extractives from a rubber article intended for repeated food contact. A gum-supplier letter, a platinum TDS, or "BPA-free" is not that flask. Ask for the file that matches your color. The materials hub is /silicone-materials-compliance/. Use that hub for material families; this page lists article files to request.
Failure: QA rejects a carton marked food grade
Symptom: Retailer QA wants method, specimen, lab, date, and numbers. The supplier sent a COA titled FDA.
Confirm: Does the PDF name 177.2600, aqueous and/or fatty, the article (not the drum), color, thickness, and post-cure?
Fix: Spec the specimen on the PO: production color, post-cure at thickness, food type (aqueous vs fatty), market. Do not change pigment later and reuse the white-plaque file.
Illustrative scenario: red 2.2 g pectin tray, US plus EU
Hypothetical path - not a named customer file
US retail plus an EU listing, red platinum tray, oiled pectin. The RFQ would name 177.2600 aqueous and fatty plus LFGB / BfR XV language on that red article after post-cure. We would charge ~$50 CAD to lock the pocket, prototype in 3-7 days after CAD lock, and tie docs to the production color. We would not file ISO 9001 as food approval. We would not call the plant FDA-approved.
Document-pack RFQ: copy this list
- Article: food tray or OEM part (not an RTV glove)
- Markets: US 177.2600 (aqueous / fatty) · EU LFGB · GB 4806.11
- Color and post-cure at production thickness
- Contact food: gelatin / pectin / oiling / chocolate / ice / bake
- First-use wash
- CAD modeling or modification typically around US$50 and tray qty (MOQ 20) if the tool is on the same PO
Send market + color + whether you oil to /contact/ - info@wydsilicone.com · +86 180 3814 7782. We will name the files we can put on that lot.
Typical shop values for the document conversation
Typical shop values - not a named lot
| Item | Typical shop value |
|---|---|
| CAD / tray commercial | CAD modeling or modification typically around US$50; MOQ 20; proto 3-7 days after CAD lock |
| 177.2600 aqueous (regulation) | 20 mg/in² then 1 mg/in² |
| 177.2600 fatty (regulation) | 175 mg/in² then 4 mg/in² |
| QMS | ISO 9001:2015 Sailway SW21Q20552R0S (QMS file on record; validity ended May 2026 — not shown as current) |
| Plant | Bao'an / Shajing since 2006 |
Document packs we will not file as-is
A compound COA is not 177.2600, and a factory stamp is not food contact. We will not write "FDA-approved factory," reuse a white-plaque PDF on a new pigment, treat ISO 9001 as article extractives, or send a catalog-shop badge as the retailer file.
When this document page is the wrong route
- You need the food tray itself: /custom-food-silicone-molds/
- Medical / ISO 10993 device files: not a gummy-tray pack - stay off this page
- Craft or resin dumps that never see food: skip 177.2600
- Who tools a gummy line: /custom-gummy-mold-manufacturer/
- Cost model or RFQ intake: /silicone-mold-cost/ · /custom-silicone-mold-quote/ · /contact/
Polycarbonate chocolate tools are a different polymer. We would not quote PC and we would not paste rubber extractives onto it. Geometry can override: a 12 mm frame plus a 1.5 mm logo web is a different specimen than a 2 mm plaque.
Document FAQ
- Are your molds FDA approved?
- No. 21 CFR 177.2600 is extraction of the finished article. We can supply available reports for the compound and specimen you buy. We do not stamp the factory. ISO 9001:2015 Sailway SW21Q20552R0S is a QMS file on record; validity ended May 2026 — not shown as current.
- Will ISO 9001 satisfy a US retailer?
- It shows how the QMS is audited. It does not replace extractives. Send both, labeled as different objects.
- Do you test every color?
- A new pigment is a new specimen. Do not assume a natural-plaque PDF covers a red production tray.
- What if we oil the gummies?
- Ask for the fatty (n-hexane) flask as well as aqueous. A water-only report on a natural slab is the wrong specimen for a pigmented, oiled pectin tray.
- Who do I email for the file list?
- info@wydsilicone.com · +86 180 3814 7782. Name US / EU / CN and whether you oil or coat. If you still need the tray itself, start at /custom-food-silicone-molds/.
Name the market, the color, and whether you oil
We will list the files we can put on that lot - extractives and/or LFGB - not a factory stamp.