Silicone Test Reports & Compliance Documents

A certificate image is useful only when the buyer knows what it actually covers.

Confirm:

applicant;
material/sample;
report number;
laboratory;
date;
test method/regulatory reference;
result;
scope/limitations;
relationship to the purchased material/article.

RUUIPON does not describe the factory itself as “FDA approved.”

Request the Document Set for Your Project

Material Test Reports

A material report may relate to:

raw silicone compound;
standard specimen;
specific color/formulation;
finished article.

Do not assume one report automatically certifies every mold, product, color, condition or market.

The current RUUIPON page identifies:

Report: PTC25070801703C-CN01 Laboratory: PTC Testing Date shown: 11 July 2025 Sample: HY-810 liquid silicone rubber Reference: 21 CFR 177.2600 total extractives Applicant: compound supplier, not RUUIPON

If this report is used for a project, confirm the proposed production material matches the report scope.

Do not relabel it as:

RUUIPON FDA certificate;
FDA-certified factory;
FDA-certified finished mold.

U.S. Food-Contact Projects

For relevant repeated-use rubber food-contact articles, 21 CFR 177.2600 may be relevant.

Define:

food/contact;
temperature;
duration;
repeated use;
material/color;
customer/retailer requirements.

EU / Germany Projects

For EU food-contact projects, Regulation (EC) No 1935/2004 provides the general framework.

For Germany, BfR Recommendation XV may be relevant technical guidance for silicones.

Do not present “LFGB” as one universal silicone certificate or BfR guidance as binding EU law.

ISO / Quality-System Evidence

The current About page displays a historical ISO 9001 certificate scan.

A historical scan should not be presented as proof of current certification unless certificate number, body, scope, validity and legal entity are verified.

If current certification is required, request the current certificate.

Raw Material vs Finished Article

Depending on the buyer, additional evidence may include:

finished-article testing;
migration/extractables;
sensory testing;
color-specific evidence;
repeated-use testing;
retailer questionnaire;
declaration;
traceability information.

Color and Formulation

If color is controlled, ask whether:

the tested sample used the same formulation;
the color system is in scope;
customer testing is color-specific;
finished-article testing is required.

What to Put in the RFQ

destination market;
product/use;
food/contact condition if relevant;
temperature/duration;
repeated-use requirement;
color/formulation;
required regulation/report/declaration;
retailer/customer questionnaire;
third-party test requirement;
finished-article test requirement if known.

FAQ

Does RUUIPON have an “FDA factory certificate”?

That is not the correct description.

Does PTC25070801703C-CN01 cover every RUUIPON mold?

No. Match it to the proposed production material/project.

Does one report cover every color?

Not automatically.

Is the ISO image proof of current ISO certification?

Not unless current validity, scope, entity and certificate details are verified.

Can RUUIPON review our compliance checklist?

Yes. Send the exact checklist with the RFQ.