If you want to sell your silicone baby plates in the European and American markets, you must provide relevant safety testing reports and compliance certificates. The following certificates are the most widely used and necessary:
EU market requirements
1.REACH Regulation (EC) No. 1907/2006:
Control the production, use, and safety of chemical substances. a key:
Substances of Very High Concern (SVHC): When the SVHC content in a product exceeds 0.1% w/w, safety information (SCIP notification) must be provided to downstream users and consumers as required.
Appendix 17 Restricted Substances: Contains various prohibited or restricted substances, particularly important for children's products
Phthalates: The total content of DEHP, DBP, BBP, and DIBP in child care products (including plates) shall not exceed 0.1% (1000ppm). DINP, DIDP, and DNOP are also limited to no more than 0.1% of items that children can put in their mouths.
2. EN 14372:2004- Children's use and care products - Tableware and feeding utensils - Safety requirements and testing:
This is the core safety standard for children's tableware (including silicone plates).
Test content:
Mechanical and physical properties:
Small component testing (to prevent suffocation risk).
Sharp edge and tip testing.
Strength testing (such as tensile strength, tear resistance).
Anti torsion test (whether the component will be twisted down).
Tensile strength test (whether the component will be pulled down).
Compression resistance test (simulated bite).
Drop test (simulating a drop from the height of a dining chair).
Chemical properties:
Specific element migration (heavy metals such as lead, cadmium, mercury, chromium, barium, selenium, arsenic, antimony - usually refer to the testing methods and limits in EN 71-3).
Formaldehyde emissions.
Volatile compound content.
Phthalate content (consistent with REACH requirements).
Content of nitrosamines and nitroso substances (important for rubber/elastomers).
The release amount of phenol.
Sensory testing (odor and taste).
3. German LFGB (Lebensmittel -, Bedarfsgegenst ä nde - und Futtermittelgesetzbuch):
The German Food and Daily Necessities Act is more stringent than the general requirements of the European Union, especially in sensory testing and certain chemical substances.
The key tests are 30, 31 LFGB and its accompanying regulations (such as BfR Recommendations, particularly BfR XXI for silicone).
Comprehensive migration testing: Use different simulants (water, 3% acetic acid, 10% ethanol, olive oil, or substitutes) to test the overall substance migration under specific conditions (usually limited to 10 mg/dm ² or 60 mg/kg food).
Specific migration testing: targeting specific harmful substances such as peroxides, primary aromatic amines, heavy metals, volatile organic compounds, etc.
EU Compliance Certificate/Document:
Declaration of Conformity (DOC):This is a mandatory core document. Drafted by the manufacturer or responsible person within the European Union, declaring that the product complies with all applicable EU regulations (such as REACH, EN 14372, etc.). DOC must include product information, list of applicable regulatory standards, manufacturer/responsible person information, signature, etc.
Test report: A detailed test report issued by a qualified third-party laboratory (such as SGS, T Ü V, Intertek, Bureau Veritas) based on the above standards (especially EN 14372, REACH SVHC/restricted substances) as supporting evidence for the DOC. It must be retained in the technical documents.
Technical file: including product design, manufacturing process, risk assessment, test report DOC、 All documents proving product compliance, including material specifications. It must be kept for at least 10 years and provided when required by regulatory agencies.
CE marking: Although EN 14372 is a coordinated standard, there is currently no mandatory EU CE marking directive for children's tableware (such as the Toy Directive). Compliance is mainly reflected through DOC and compliance with relevant product safety regulations (such as the General Product Safety Directive GPSD). CE marking is not required on the product, but there must be a DOC. However, if the product contains electronic components or has other risks, CE marking for other directives may be required.
US market requirements
The US Food and Drug Administration (FDA):
21 CFR (Code of Federal Regulations) Parts 175-178: Regulate the compliance of substances in contact with food.
Specific requirements for silicone:
Usually according to 21 CFR 177.2600- Rubber articles intended for repeated use. This chapter specifies the requirements for rubber products (including silicone) that can be reused, including:
Through specific migration testing (using different food simulants).
Limit certain extracts (such as total extracts, chloroform soluble extracts).
Meet specific formula requirements (using substances listed in the license list).
Declaration of Conformity: Suppliers (usually referring to suppliers of silicone collagen materials) should be able to provide a declaration letter proving that their materials comply with 21 CFR 177.2600 (or other applicable sections) of the US Food and Drug Administration. As a finished product manufacturer, you need to provide similar compliance statements to your customers (B-end buyers) and retain supporting evidence (guarantees from raw material suppliers and/or your own test reports).
Consumer Product Safety Commission (CPSC):
Consumer Product Safety Improvement Act (CPSIA): Mandatory requirements for all children's products (12 years and under):
Lead content limit: The lead content in the substrate shall not exceed 100 ppm. The lead content of the surface coating shall not exceed 90 ppm.
Phthalate restriction: DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP in toys and child care products that can be placed in the mouth must not exceed 0.1% (1000 ppm) each. Baby plates are almost certainly considered as "mouth safe" child care products.
Mandatory third-party testing and Children's Product Certification (CPC): This is a core requirement.
Products must be tested by third-party laboratories accredited by CPSC (such as UL, SGS, Intertek) in accordance with applicable standards.
Based on qualified test reports, manufacturers or importers must issue Children's Product Certificates (CPC). CPC must include product information, applicable regulations/standards list, manufacturer information, testing laboratory information, contact address, production date and location, testing date and location, etc.
Small parts ban (16 CFR Part 1501): applicable to toys and products for children under 3 years old. The dining plate itself or its detachable components (if any) must pass a small component test cylinder (with a diameter of approximately 3.17 centimeters) to prevent the risk of suffocation. The silicone plate body is usually fine, but attention should be paid to additional decorations, small parts on the silicone lid, etc.
Sharp and sharp edge requirements (16 CFR Part 1500.48&. 49): The product must not have dangerous sharp edges or tips.
Tracking label requirements: Products and their packaging must have permanent tracking information, including manufacturer/proprietary brand name, production location and date, batch number, etc., for traceability and recall purposes.
3.US Compliance Certificate/Document:
Children's Product Certificate (CPC): Mandatory document. Based on testing reports from third-party laboratories accredited by CPSC (applicable physical requirements for CPSIA lead, phthalates, as well as small components, sharp edges, etc.).
Declaration/Warranty of Compliance with FDA: Declare to the customer that the product complies with FDA 21 CFR 177.2600 (or other applicable sections).
Test report: Third party laboratory report supporting CPC and FDA declarations.
More related information refer to following :
4、 Suggestions for you
Choose an authoritative laboratory: collaborate with internationally recognized third-party testing organizations in Europe and America, such as SGS, T Ü V S Ü D/Rheinland, Intertek, UL, Bureau Veritas, Eurofins, to conduct testing. They are familiar with the latest standards and testing methods.
Clear testing scope: Provide complete product information (material composition, color, all components, production process such as vulcanization/molding temperature) to the laboratory, and require them to provide detailed testing plans and quotations based on the target market (EU, US, or both). Different colors (especially bright colors) and components may require separate testing.
Obtain raw material compliance certificate: Require your silicone raw material supplier to provide a declaration letter and relevant migration test report or formula compliance statement that complies with EU 10/2011 and/or FDA 21 CFR 177.2600. This is the foundation of your product compliance.
Prepare compliance documents:
EU: Draft a comprehensive DOC, summarizing all applicable regulatory standards ( REACH, EN 14372, LFGB/BfR, etc.), and attach all supporting test reports. Establish and maintain complete technical documentation.
USA: Ensure that CPSIA testing (lead, phthalates, small parts, sharp edges) is completed by CPSC accredited laboratories, and issue CPCs based on this. Prepare a declaration that complies with FDA regulations. Assess Prop 65 risks and add warnings if necessary.
Pay attention to labels and packaging: Ensure that product labels and packaging comply with target market requirements (food contact labeling, tracking information, warning language, instructions for use, age labeling, compliance statements such as "FDA Compliant", Prop 65 warning (if required)). The material of the label itself also needs to meet the requirements for food contact.
Continuous compliance: When there are any changes in raw material suppliers, formulas, production processes, colors, etc., compliance must be reassessed and new testing may be required. Regulatory standards will also be updated and need to be closely monitored.
Consider specific country requirements: Although the EU is a unified market, countries like Germany (LFGB) and France (DGCCRF) may have stricter or additional concerns. Each state in the United States, especially California Prop 65, also has special requirements.
In general, compliance is the ticket to entering the B2B markets in Europe and America. Investing the necessary resources for rigorous testing, obtaining accurate certification documents, and ensuring transparency and traceability in the supply chain are the foundations for the successful sale of your products and building long-term customer trust. Make sure to incorporate compliance costs into your product pricing and marketing strategies.
Post time: Aug-11-2025