Views: 0 Author: Peter Cui Publish Time: 2026-05-25 Origin: Mitour Silicone
TL;DR — EN 71 is the European safety standard for toys, enforced under the EU Toys Safety Directive (2009/48/EC). For silicone baby toys sold in EU member states, compliance with EN 71-1 (mechanical and physical safety), EN 71-2 (flammability), and EN 71-3 (migration of 19 chemical elements) is mandatory. A 2024 update added preliminary PFAS-related provisions to the broader EU chemical safety framework that intersects with EN 71. At Mitour Silicone, we produce EN 71-compliant silicone baby toys for EU market brands and maintain current third-party test reports at our 4,500 m² Shenzhen facility.
EN 71 applies to all toys intended for children under 14 — including silicone teethers, bath toys, stacking rings, sensory toys, and any play-oriented silicone product.
Three parts are most relevant for silicone baby toys: EN 71-1 (mechanical/physical), EN 71-2 (flammability), EN 71-3 (migration of 19 elements from toy materials).
EN 71-3 tests 19 elements including antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium — for toy materials that can be ingested (Category I and II materials).
Silicone passes EN 71-3 reliably when formulated with inorganic pigments and without heavy-metal colorants — the base PDMS polymer contains none of the regulated elements.
The 2024 PFAS development: The EU's PFAS restriction proposal under REACH (submitted 2023, advancing in 2024) does not directly affect standard silicone (PDMS), but certain fluorosilicone formulations used in specialty applications may be impacted. Standard baby-grade silicone is not PFAS-affected.
CE marking is mandatory for toys sold in the EU; EN 71 compliance is the primary technical basis for CE marking on baby toys.
Mitour Silicone's sample lead time is 7 days; EN 71 test reports from accredited labs take 10–15 business days.
The EU Toys Safety Directive (Directive 2009/48/EC) is the overarching legal framework governing toy safety in the European Union. It establishes essential safety requirements and mandates CE marking for all toys placed on the EU market. EN 71 is the harmonized standard under this directive — demonstrating compliance with EN 71 creates a presumption of conformity with the directive's essential requirements.
The EN 71 standard is structured as multiple parts, each addressing different hazard categories. For silicone baby toys specifically, three parts are the primary compliance targets:
EN 71-1: Mechanical and physical properties
EN 71-2: Flammability
EN 71-3: Migration of certain elements (chemical safety)
Additional parts exist (EN 71-4 through EN 71-14) covering experimental chemistry sets, projectile toys, electric toys, and other specialized categories. These rarely apply to standard silicone baby toys.
Who is responsible for EN 71 compliance? The manufacturer (if EU-based) or the importer/brand owner (if the toys are produced outside the EU, as with Shenzhen-manufactured silicone). If you are a brand owner importing silicone baby toys from China to the EU, EN 71 compliance is your regulatory responsibility. Your factory can produce compliant product and provide test reports; the legal obligation to CE mark and maintain technical documentation rests with you as the importer.
EN 71-1 tests whether a toy can cause physical harm through sharp edges, small parts that can be swallowed or aspirated, fragile materials that generate hazardous fragments, or construction failures during use.
Small parts test (torque and pull tests)
For toys intended for children under 36 months, EN 71-1 includes a "small parts cylinder" test: any part that can be separated from the toy under defined force conditions (4.5 Nm torque, 90 N pull) must not fit entirely within the test cylinder (inner diameter 31.7 mm, depth 57.1 mm), as objects that fit in the cylinder represent an aspiration/choking risk.
For silicone toys, the concern is component detachment. A silicone teether with a fabric attachment loop, a plastic clip, or a wooden ring must be tested for whether those components detach under bite and pull forces consistent with infant use. The silicone itself, being a single-piece molded elastomer, does not have detachment risk in well-designed geometries — but assembly joints with non-silicone components do.
Bite force and deformation
EN 71-1 does not specify a direct "bite force" test for soft elastomers, but the standard's deformation and durability tests (drop tests, compression tests) are applied. For thin-walled silicone products (wall thickness under 0.8 mm), the risk of tearing under repeated bite stress is evaluated. We design teethers with a minimum wall thickness of 1.2 mm and a Shore A hardness of 40–55 for bite-resistance durability that easily passes EN 71-1 cycle testing.
Sharp edge and sharp point test
Post-mold mold flash on silicone can create sharp edges. EN 71-1 tests sharp edges with a stylus force gauge — any edge that cuts through the gauge film is classified as a sharp edge and is a failure criterion. At Mitour Silicone, our baby-category products have mold flash specifications of ≤0.1 mm, below the threshold that produces detectable sharp edges in EN 71-1 testing. We gate our molds at positions that minimize flash in contact areas.
EN 71-2 tests a toy's resistance to ignition and the rate at which it burns. Silicone has excellent inherent flame resistance — a key material advantage in the baby toy category.
Polydimethylsiloxane (PDMS) silicone does not sustain combustion in the standard EN 71-2 test conditions. The silicone inorganic backbone (Si-O-Si) does not propagate a flame; when silicone is exposed to a test flame, the surface chars but does not continue burning after the flame source is removed. This is fundamentally different from organic plastics (polyethylene, polypropylene, ABS), which can sustain combustion.
EN 71-2 classifies materials by their burning rate:
Category A materials (highly flammable): Burn at >30 mm/s. Prohibited in toys.
Category B materials (flammable): Burn at 30 mm/s or slower but do not self-extinguish. Restricted.
Slow-burning or non-flammable materials: Pass EN 71-2 without restriction.
Standard baby-grade silicone (both LSR and HTV) reliably passes EN 71-2 with no burning rate measured — the material self-extinguishes. This is one of silicone's intrinsic safety advantages for baby products. We do not need to add flame retardant additives to our baby-grade silicone compounds, and we do not — any flame retardant additive in a baby-contact material introduces unnecessary chemical exposure risk.
EN 71-3 is the most technically complex of the three primary EN 71 parts for silicone toys. It tests whether potentially toxic chemical elements can migrate from toy materials into a simulated biological fluid (0.07 M hydrochloric acid, pH approximately 1.5, mimicking stomach acid).
EN 71-3 tests migration of these elements across three toy material categories:
Element | Category I Limit (mg/kg) | Category II Limit (mg/kg) | Category III Limit (mg/kg) |
Aluminum (Al) | 5,625 | 1,406 | 70,000 |
Antimony (Sb) | 45 | 11.3 | 560 |
Arsenic (As) | 3.8 | 0.9 | 47 |
Barium (Ba) | 4,500 | 1,125 | 56,000 |
Boron (B) | 1,200 | 300 | 15,000 |
Cadmium (Cd) | 1.3 | 0.3 | 17 |
Chromium (III) (Cr III) | 37.5 | 9.4 | 460 |
Chromium (VI) (Cr VI) | 0.02 | 0.005 | 0.2 |
Cobalt (Co) | 10.5 | 2.6 | 130 |
Copper (Cu) | 622.5 | 156 | 7,700 |
Lead (Pb) | 13.5 | 3.4 | 160 |
Manganese (Mn) | 1,200 | 300 | 15,000 |
Mercury (Hg) | 7.5 | 1.9 | 94 |
Nickel (Ni) | 75 | 18.8 | 930 |
Selenium (Se) | 37.5 | 9.4 | 460 |
Strontium (Sr) | 4,500 | 1,125 | 56,000 |
Tin (Sn) | 15,000 | 3,750 | 180,000 |
Organic Tin (as Sn) | 0.9 | 0.2 | 12 |
Zinc (Zn) | 3,750 | 938 | 46,000 |
Category I: dry, brittle, powder, or pliable toy materials; Category II: liquid or sticky; Category III: scraped-off.
The polydimethylsiloxane base polymer contains none of the regulated elements — silicon (Si) itself is not on the list, and the PDMS backbone is a silicon-oxygen polymer without heavy metal content.
The risk vector in silicone baby toys is the colorant system. Some inorganic pigments historically used in silicone (cadmium red, chromium oxide green, lead-based pigments) contain regulated elements. A silicone teether colored with a cheap cadmium-based red pigment would fail EN 71-3 for cadmium migration.
At Mitour Silicone, all pigments used in baby-category products are sourced from our approved pigment supplier list, which requires:
Supplier Certificate of Compliance confirming absence of cadmium, lead, chromium VI, mercury, arsenic
Compatibility testing with platinum-cure silicone (some pigment systems can poison platinum catalysts, causing cure inhibition)
SGS or Intertek EN 71-3 migration test on the colored compound, not just the pigment
We ran into a pigment-related EN 71-3 issue in 2020 when a batch of coral-colored baby plates was found to have manganese migration slightly above Category I limits — the manganese came from a manganese-based orange pigment in the coral blend. We switched to an iron oxide-based formula for that colorway, retested, and passed. That incident is now part of our pigment qualification checklist.
For soft, pliable silicone toys (teethers, stacking rings, bath toys), the applicable material category under EN 71-3 is Category I (dry, brittle, powder, or pliable materials). This has the strictest limits for most regulated elements.
A common mistake: some factories test only the outer colorway under Category III (scraped-off material), which has much looser limits. If an inspector later applies Category I limits to the same material, previously "compliant" products can fail. Always specify Category I testing for pliable silicone baby toys.
Per- and polyfluoroalkyl substances (PFAS) are a class of synthetic chemicals that have attracted significant EU regulatory attention. The EU PFAS restriction under REACH Annex XVII (proposed January 2023, under review in 2024) seeks to restrict approximately 10,000 PFAS compounds across a wide range of applications.
Does the PFAS restriction affect standard silicone baby toys?
Standard silicone (polydimethylsiloxane, PDMS) is not a PFAS compound. PDMS is a silicon-oxygen polymer without fluorine atoms — the defining chemical characteristic of PFAS. Standard silicone baby toys are not affected by PFAS restrictions.
However, there is one category of silicone that is relevant to the PFAS discussion: fluorosilicone. Fluorosilicone elastomers incorporate trifluoropropyl groups in the PDMS backbone, giving them superior resistance to fuels and solvents. Fluorosilicone compounds are used in industrial seals and tubing — not in baby toys or food-contact baby products. We do not use fluorosilicone in any baby-category product.
The 2024 regulatory development that does require attention for EU baby toy compliance is the update to EN 71-3 itself and the EU's ongoing work on nano-material provisions in toy safety. Brands should monitor the European Commission's toy safety regulation updates for the anticipated revision to Directive 2009/48/EC, which is expected to expand substance restrictions beyond the current 19-element EN 71-3 panel.
After the 2024 EU REACH update process began, we re-reviewed our baby-category compound library for SVHC (Substance of Very High Concern) candidates. No SVHC were identified in our standard baby compounds. SVHC declarations are included in our documentation package for all baby-category orders.
CE marking is the visible symbol on EU toy packaging that indicates the product meets the essential safety requirements of the Toys Safety Directive. The process for a brand owner importing silicone baby toys from China:
Identify applicable EN 71 parts — for silicone baby toys, typically EN 71-1, EN 71-2, EN 71-3 at minimum
Commission third-party testing at an accredited notified body lab (SGS, Intertek, Bureau Veritas, TÜV Rheinland — all are EU-recognized for EN 71)
Receive test reports — 10–15 business days standard
Review test reports for compliance — ensure all limits are met under the correct material category
Prepare Technical Documentation File (TDF) — required document package including product description, drawings, risk assessment, test reports, and declaration of conformity
Issue Declaration of Conformity (DoC) — signed by the EU-market responsible person (the importer if you are importing from China)
Apply CE mark to product and packaging
Maintain records for 10 years after last production
For a U.S. or UK brand importing silicone baby toys from China to EU customers, the "responsible person" for EU product liability purposes is typically either:
The EU importer of record (your EU subsidiary or distributor)
An EU-registered authorized representative
This is a legal role, not just a paperwork role. The responsible person bears EU market liability for product compliance. Ensure your EU commercial structure addresses this before you ship.
At Kind+Jugend 2023 in Cologne, I had a conversation with a German baby brand buyer that crystallized why EN 71-3 testing specificity matters. She showed me a test report from a competing supplier — the report showed EN 71-3 testing had been done, and all elements passed. But the test category used was Category III (scraped-off material). The product was a soft silicone teether. Category I limits are substantially stricter than Category III for most elements. The product may or may not have passed under Category I — the report simply did not test for it.
We ran our own equivalent product against EN 71-3 Category I. It passed. But the competitor's report, as written, could not make that claim. The buyer chose to require Category I retesting from her existing supplier at her own cost — and switched two SKUs to us for the following season's production.
The lesson: when reviewing EN 71-3 test reports from any factory, check the material category column. If it says Category III for a pliable silicone toy, ask for Category I retesting.
Before Commissioning Production
Confirm which EN 71 parts apply (EN 71-1, EN 71-2, EN 71-3 for standard silicone toys)
Request factory's existing EN 71 test reports — verify they cover the same compound and colorway as your product
Verify pigment system is heavy-metal-free (cadmium, lead, chromium VI, mercury, arsenic)
Confirm material category for EN 71-3 test is Category I for pliable silicone products
Confirm factory uses platinum-cure silicone (no organotin catalyst risk for EN 71-3)
During Sample Qualification
Commission EN 71-1, EN 71-2, EN 71-3 testing on approved sample + colorway
Confirm lab is an EU-recognized notified body or accredited under ISO 17025 for EN 71
Check EN 71-1 small-parts test results for any assemblies with non-silicone components
Verify EN 71-2 result confirms non-flammability (no burn rate measured)
For CE Marking
Prepare Technical Documentation File
Issue Declaration of Conformity (signed by EU responsible person)
Apply CE mark to product and all retail packaging
Retain records for 10 years
EN 71 applies specifically to toys — products designed primarily for play by children under 14. Silicone baby feeding products (spoons, plates, bibs used for eating) are not toys and are instead governed by food-contact regulations (LFGB/BfR XV in the EU). Some products are dual-category: a silicone teether is both a chew item (food contact) and a toy (EN 71). For these, both regulatory frameworks apply simultaneously.
Category I covers dry, brittle, powder, or pliable toy materials — this includes soft silicone. Category III covers scraped-off surface materials. Category I has stricter limits for most regulated elements. Pliable silicone toys must be tested under Category I; accepting a Category III report for pliable silicone is a compliance documentation error.
For most standard silicone baby toys, self-certification against EN 71 is permitted — you do not need a notified body to issue the CE mark, only accredited third-party test reports and your own Declaration of Conformity. However, if a toy contains electronic components or is a functional toy with specific hazard categories, notified body involvement may be required. Consult your EU regulatory counsel.
Standard silicone (PDMS) is not a PFAS compound — it contains no fluorine atoms. The PFAS restriction under REACH does not affect standard silicone baby toys. The only silicone type with PFAS-adjacent chemistry is fluorosilicone, which is not used in baby products. Monitor the EU REACH Annex XVII update for ongoing developments.
Full EN 71-1, EN 71-2, EN 71-3 test panel: approximately EUR 600–1,200 per sample at accredited labs (SGS, Bureau Veritas, TÜV Rheinland). Turnaround: 10–15 business days standard; 5–7 business days expedited. For EN 71-3 specifically, each colorway may need separate testing if different pigment systems are used across a product line.
Yes, for orders using our standard baby-category compound library and approved pigment systems, we can provide existing EN 71 test reports with your sample delivery. For new colorways or custom compounds, we coordinate EN 71 testing during sample qualification — typically 10–15 business days alongside sample development.
No. EN 71-3 tests lead migration into 0.07 M hydrochloric acid (Category I limit: 13.5 mg/kg). CPSIA Section 101 tests total lead content in the material (limit: 100 ppm for surface coatings, 100 ppm for substrate by weight). These are different methods with different measurement bases. A product that passes EN 71-3 for lead does not automatically pass CPSIA lead testing, and vice versa. Both must be run separately for products sold in both the U.S. and EU.
We have in-house QC capabilities for dimensional inspection, Shore A hardness, color measurement, and mechanical screening. EN 71-3 migration testing requires specialized analytical chemistry equipment (ICP-MS for elemental analysis) that we do not maintain in-house — this testing is conducted at accredited third-party labs (SGS, Intertek) on our behalf. Results are provided to customers as part of the standard compliance documentation package.
If you are launching or sourcing silicone baby toys for the EU market and need EN 71-compliant manufacturing with full documentation:
Review our certifications portfolio: mymitour.com/oem-odm/certifications.html
See our baby toy product range: mymitour.com/solutions/baby-childcare.html
Quality control process detail: https://www.mymitour.com/quality-control.html
Request a quote or sample: https://www.mymitour.com/contactus.html| yfsalee@mymitour.com | +86 199 2529 4106
OEM/ODM Certifications — EN 71, FDA, LFGB, CPSIA documentation
Baby & Childcare Solutions — silicone baby toy product range
Quality Control Process — inspection standards and QC protocols
Contact / Request a Quote — sample and RFQ submissions
Peter Cui | 21 years of silicone manufacturing experience | 4,500 m² Shenzhen facility | Walmart-, Target-, and Disney-approved supplier | Contact: yfsalee@mymitour.com
