Grade is a curing system before it is a label
"Food grade" and "medical grade" are market labels, not specifications. What a buyer can actually specify is the curing system, the hardness and the colour:
- Platinum-cured compounds use a platinum catalyst. They are the usual choice where the part touches food, skin or a child's mouth, because the cure leaves fewer extractable by-products.
- Peroxide-cured compounds cost less and suit general-purpose parts where contact is not a consideration.
- Hardness is quoted on the Shore A scale. It decides how a part feels, how it seals and how easily it demoulds — and it changes the cycle time, so it changes the price.
Ask for the grade in writing on the quotation. A part quoted as "silicone" without a curing system or hardness is not yet a specification.
The document each market asks for
| Market | Framework | What the buyer receives |
|---|---|---|
| European Union | Toy Safety Directive 2009/48/EC · EN 71-1/-2/-3 · CE marking | Declaration of conformity plus supporting test reports |
| United Kingdom | Toys (Safety) Regulations 2011 · BS EN 71-1/-2/-3 · UKCA marking | UK declaration of conformity plus supporting test reports |
| United States | ASTM F963-23 · CPSIA lead and phthalate limits · CPC | Children's Product Certificate, issued by the seller on the basis of test reports |
| Canada | CCPSA · SOR/2011-17 | Test reports against the applicable Canadian requirements |
A report covers one model
This is the point most often lost in a supplier conversation. A test report names the sample it was tested on: model number, material, sometimes colour. It does not transfer to a different shape, a different compound or a different hardness. When a supplier says "we are CE certified", the useful follow-up is: which model, which standard, which laboratory, which report number.
What to request with a purchase order
- The declaration of conformity or certificate whose model line matches your SKU
- The underlying test report, not only the one-page declaration
- The material data sheet for the compound actually used
- A statement of which standards were not tested
The fourth item is the one that prevents surprises at customs or at a marketplace compliance review. A supplier who can list the gaps is describing a real testing programme; one who claims blanket coverage is describing a brochure.