How to Conduct EN 71-3 Testing?

Introduction:

For toys exported to the EU, en 71-3 is often the most challenging hurdle in chemical safety. It regulates the migration limits of 19 specific elements in toy materials, ranging from lead and cadmium to hexavalent chromium and organic tin. Each element and material category has strict limits. Many toy manufacturers stumble not because of high toxic substance content, but due to a misunderstanding of EN 71-3 limits or unfamiliarity with testing conditions—for example, the limit for aluminum was tightened in 2021, yet some manufacturers still submit samples using the outdated standard.

What is EN 71-3?

EN 71-3 is the third part of the EU toy safety standard EN 71 series, fully titled Safety of toys — Migration of certain elements. It is the harmonized standard for the EU Toy Safety Directive 2009/48/EC. The currently effective version is EN 71-3:2019+A1:2021 (with subsequent revisions such as A2:2024).

It regulates the amount of specific elements that can migrate from toy materials when children lick, bite, suck, or have prolonged skin contact with them. Note that the focus is on the "migratable amount," not the "total content"—how much of the substance is present in the material is not as important as how much can migrate out under simulated conditions and whether it can be ingested by children.

The 19 regulated elements are: Aluminum, Antimony, Arsenic, Barium, Boron, Cadmium, Chromium (III), Chromium (VI), Cobalt, Copper, Lead, Manganese, Mercury, Nickel, Selenium, Strontium, Tin, Organic Tin, and Zinc. It covers all accessible parts of toys, and toys intended for children aged 0 to 14 must be tested.

Three Categories of Materials with Significantly Different Limits

EN 71-3 divides toy materials into three categories, each with completely different limits. This is the most common area for mistakes:

• Category I: Dry, brittle, powder-like, or pliable materials (e.g., pigment powders, modeling clay, dry paints).

• Category II: Liquid or sticky materials (e.g., watercolors, liquid paints, adhesives).

• Category III: Scraped-off materials (e.g., paint coatings, printing inks, sticker surfaces).

The limit for the same element across these three categories can vary by several to dozens of times. If a material is incorrectly classified during sample submission, the compliance judgment will be entirely wrong.

Quick Reference Table for Migration Limits of 19 Elements (EN 71-3:2019+A1:2021)

The table below shows the migration limits for core elements in mg/kg. Note that the limits for aluminum are the new values effective from May 20, 2021 (the old values were 5625 / 1406 / 70000). Always verify that the new limits are being used before submitting samples:

Three Key Reminders:

1. Strict Lead Limits: The lead limit for Category I materials is only 2 mg/kg. Lead exceedance in paints and printing inks is the most common reason for failure.

2. Extremely Strict Chromium VI Limits: The limit for Category II materials is merely 0.005 mg/kg (i.e., 5 ppb), making it the most stringent among the 19 elements. It must be tested using specific speciation analysis methods.

3. Tightened Aluminum Limits: Since May 20, 2021, the limits for aluminum have been significantly reduced (e.g., dropped from 5625 to 2250 mg/kg for Category I). Manufacturers still using the old standard need to be cautious.

How is the EN 71-3 Test Conducted?

EN 71-3 simulates the gastric environment after a child accidentally swallows a toy to measure the migratable amount. The core process involves:

• Sampling: Test portions are taken separately for each material and color. The sample quantity must be representative of the entire batch.

• Sample Preparation: Category I and Category III materials are cut or scraped into particles of specified dimensions. Materials containing grease or wax must be de-waxed first.

• Migration Testing: Samples are mixed proportionally with a 0.07 mol/L hydrochloric acid solution (pH approx. 1.2). The mixture is agitated at 37°C ± 2°C for migration (typically for 1 hour) and then allowed to stand (glass, ceramic, and metal materials require longer standing times). The mixture is then filtered to obtain the migration solution.

• Elemental Analysis: The migration solution is analyzed using instruments like ICP-OES and ICP-MS to quantify the 19 elements. Hexavalent Chromium (Chromium VI) must be tested separately using speciation analysis methods such as Ion Chromatography-Inductively Coupled Plasma Mass Spectrometry (IC-ICP-MS).

• Result Evaluation: The measured migratable amount of each element is compared against the limit for its respective material category. A sample is considered compliant only if all elements fall below their respective limits.

Top 5 Pitfalls When Submitting Samples

1. Incorrect Material Classification: Testing a surface coating as a Category I material leads to the wrong evaluation criteria, with limits differing by dozens of times.

2. Using Outdated Limits: The limit for aluminum was tightened in 2021. Submitting samples or accepting goods based on the old standard will lead to inaccurate conclusions.

3. Failing to Test Chromium VI Separately: Standard ICP only measures total chromium. Chromium VI requires speciation analysis via IC-ICP-MS. Mixing them up may cause non-compliant Chromium VI levels to go undetected.

4. Testing Only the Main Material: Paints, inks, stickers, textiles, plastics, and wood must all be covered individually. Missing a single component can lead to compliance failures.

5. Unrepresentative Samples: The submitted samples do not match mass production. If paints, inks, or raw materials are changed, re-testing is mandatory.

JJR LAB: CMA/CNAS Dual Qualifications, Specializing in Chemical Testing for Toys and Children's Products

• Testing Services: EN 71-3 Migration of certain elements (19 elements, including IC-ICP-MS speciation analysis for Chromium VI), specialized Organic Tin testing, alongside complementary EN 71-1 (Mechanical and Physical Properties) and EN 71-2 (Flammability).

• Complementary Standards: GB 6675 (Domestic Toys), ASTM F963 (USA), cpsia Lead Content, RoHS, svhc, Phthalates, etc. A single set of samples can be tested against multiple standards simultaneously, fulfilling both domestic sales and export requirements in one go.

• Applicable Scenarios: EU certification for toy manufacturers, product listing on cross-border e-commerce platforms (European/UK sites), re-testing after changing paints or raw materials, and procurement compliance.

• Turnaround Time: Standard 5-7 working days; expedited services are negotiable.