EU Toy Safety Testing (EN 71 / 2009/48/EC)

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Update time : 2026-06-09

In European Union countries, the current toy safety directive is 88/378/EEC; if the harmonized standards EN 71 and EN 62115 are met, it can be presumed that the toy complies with the essential safety requirements of this directive.

EN 71 is the normative standard for toy products in the EU market. Children are the group that the whole society cares for and protects the most, and the toy market, which is universally loved by children, is developing rapidly. At the same time, injuries to children caused by various toy quality issues occur from time to time; therefore, countries around the world are making their requirements for toys on their domestic markets increasingly strict. Many countries have established their own safety regulations for these products, and manufacturing companies must ensure their products meet the relevant standards before being sold in those regions. Manufacturers must be held responsible for accidents caused by production defects, poor design, or the use of inappropriate materials. Hence, the introduction of the EN 71 certification decree for toys in Europe is significant; through the technical specifications of the en 71 standard for toy products entering the European market, it aims to reduce or avoid injuries to children from toys.

Overview of EN 71 Standards

1. EN 71 Part 1:2005+A4:2007 - Physical & Mechanical Test

(a) Without Sound module
(b) With Sound module
(c) Earphone with Sound
(d) 7000 Cycles Switch Test for Chest
(e) Ride-on Toys
(f) Mouth-actuated Toys

2. EN 71 Part 2:1993 - Flammability Test

(a) Finished Product
(b) Pile fabric or material

3. EN 71 Part 3:1994 - Toxic Elements Test

(8 Toxic Elements Results)

4. EN 71 Part 4: Experimental Set for Chemistry

5. EN 71 Part 5: Chemistry Toys (Sets) Other than Experimental Sets

6. EN 71 Part 6: Graphical Symbol for Age Warning Labelling

7. EN 71 Part 7: Finger Paints

(a) Colorants
(b) Preservatives
(c) Binding agents, extenders, humectants and surfactants, ingredient review
(d) Limits for the transfer of certain elements
(e) Limits for primary aromatic amines
(f) Ethanol
(g) pH value
(h) Product information & Container

en 71-9: General Requirements for Organic Chemical Compounds

This section specifies the total migration limit of toxic compounds present in each toy or toy material through the following exposure routes: mouth contact; possible ingestion; skin contact; eye contact; inhalation. The scope of restricted substances is particularly broad, including flame retardants, colorants, aromatic amines, monomer substances, solvent migration, inhalable solvents, wood preservatives (indoor and outdoor), other preservatives, and plasticizers.

Detailed Explanation of en 71-3

1. Structure of the Standard

The EN 71-3 (1994) standard consists of ten clauses and four annexes. It has two fewer standard clauses than EN 71-3 (1988), but by adding four annexes, the standard is easier to understand and master. Specifically, Annex D (Background and rationale for the test methods) allows readers to clearly understand the background and theoretical basis for the standard's revision. The EN 71-3 (2000) standard is essentially the same as EN 71-3 (1994) but with one less annex, which was the acidity requirement and determination method for 1,1,1-trichloroethane. This change was primarily due to environmental protection requirements, as 1,1,1-trichloroethane (a halogenated hydrocarbon) depletes the ozone layer and has cumulative toxic effects on the human body. The new EN 71-3 (2000) standard replaced 1,1,1-trichloroethane with n-heptane (n-C7H16).

2. Scope of Testing

The EN 71-3 (1994, 2000) standards added glass, ceramics, leather, bone, and other toy materials. All toys intended to be in contact with or close to the mouth, cosmetic toys, toy writing instruments, and toys intended for children under 6 years of age are stipulated as falling within the scope for assessing sucking, licking, or swallowing.

3. Definitions

The EN 71-3 (1994, 2000) standards added three new definitions: other materials, paper, and paperboard. The boundary is set at a maximum mass per unit area of 400 g/m². Materials exceeding this limit per unit area are treated as "other materials"; naturally, these can include fiberboard or hardboard.

Toy materials do not necessarily include packaging materials unless they are part of the toy or have play value. This applies unless a part of the toy refers to the packaging box of a jigsaw puzzle or the packaging case of a game set with instructions, etc. Simple transparent plastic blister packaging is excluded. Wood, leather, and bone have been added to the "other materials" category.

4. Limit Requirements

The EN 71-3 (1994, 2000) standards modified the barium limit for toy materials (excluding modeling clay and finger paints) from 500 mg/kg to 1000 mg/kg. This is primarily to account for the formation of non-bioavailable colloidal BaSO4 crystals in the filtrate, which causes the surface soluble barium content to exceed 500 mg/kg.

The EN 71 standard stipulates the testing of soluble harmful elements in toy materials. The test conditions determine that the resulting data is not absolute or exact, leading to relatively large deviations in laboratory results. If a test result is close to the maximum permissible limit specified by the standard (i.e., near the limit), different judgments could be made on whether a toy passes or fails based on that result. Therefore, EN 71-3 (1994, 2000) mandates that test results must be adjusted and specifies individual correction factors for the eight elements (practical application of uncertainty). Materials with adjusted test results lower than or equal to the specified limit are deemed compliant; otherwise, they are non-compliant.

Example:

Lead (Pb) analysis result: 120 mg/kg
Analytical correction factor: 30%
Adjusted analytical result = 120 - 120 × 30% = 120 - 36 = 84 mg/kg
The figure 84 mg/kg is considered to meet the requirements of the EN 71-3 (1994, 2000) standard (Lead limit is 90 mg/kg).

In reports, careful attention must be paid to the distinction between "mg/kg" and "mg/L" units. If the sample is a solid material, "mg/kg" is preferred; if the sample is a liquid, "mg/L" is appropriate.

5. Reagents and Apparatus

The EN 71-3 (1994, 2000) standard specifies precision requirements for 0.07 and 0.14 mol/L hydrochloric acid, so their concentrations must be standardized.

6. Selection and Preparation of Test Portions

The EN 71-3 (1994, 2000) standard states that samples containing more than one material or more than one color are not permitted to be tested together unless they cannot be separated by physical means (i.e., each material is calculated as a separate test group). Materials weighing less than 10 mg are exempt from testing.

The standard requires the pH of the extract to be adjusted to between 1.0 and 1.5. When the extract is analyzed the following day, it must be stabilized with HCl so that the concentration of the stored solution is approximately C(HCl) = 1 mol/L.

For testing glass, ceramics, and metallic materials, first determine according to the EN 71-1 standard whether these materials fit entirely within the small parts cylinder and are accessible. If the toy or component fits entirely into the small parts cylinder and contains accessible glass, ceramic, or metallic materials, chemical performance testing is required. Conversely, if even one condition is not met, testing is unnecessary.

For the extraction of glass, ceramic, and metallic materials, the sample must be placed in a glass container 60 mm high and 40 mm in diameter, covered with 0.07 mol/L hydrochloric acid sufficient to submerge the toy and its components, and left to stand at 37±2°C for 2 hours.

Regarding the extraction of grease, oils, and waxes from toy materials, EN 71-3 (1994) canceled the EN 71-3 (1988) requirement of 10 extractions with 1,1,1-trichloroethane. Because extraction efficiency varies depending on the toy material, extraction temperature, and extraction speed when using 1,1,1-trichloroethane, testers must ensure that grease, oil, and similar components are thoroughly extracted during sample processing.

The EN 71-3 (1994, 2000) standard requires the instrument's detection limit to reach one-tenth of the specified limit without mandating a specific type of instrument, whereas EN 71-3 (1988) required the use of Atomic Absorption (AA).

Detailed Explanation of EN 71-9

EN 71-9 lists certain specific organic chemical compounds used in toys. EN 71-9 will be used in conjunction with EN 71-10 and EN 71-11. The contents are as follows:

EN 71-9: 2005 Organic chemical compounds — Requirements
EN 71-10: 2004 Organic chemical compounds — Sample preparation and extraction
EN 71-11: 2005 Organic chemical compounds — Methods of analysis

EN 71-9 Organic Chemical Compounds — Requirements

EN 71-9 was published by CEN (European Committee for Standardization) and was adopted by European national standards bodies in August 2005. (Member states such as the UK, Germany, Spain, and Italy have officially implemented this standard).

Scope

Specific materials contained in the following types of toys and toy components are subject to this standard:

Toys intended to be mouthed by children under 3 years of age. (Example: Teethers)
Toys or accessible toy components weighing less than 150g, intended to be held in the hands by children under 3 years of age.
Toys and accessible toy components designed specifically for children under 3 years of age.
Mouthpiece components of mouth-actuated toys. (Example: Whistles and novelty imitation teeth toys, excluding inflatable toys—unless the inflated toy still requires mouth actuation).
Inflatable toys with a surface area greater than 0.5 m² when fully inflated.
Toys worn over the mouth and nose. (Example: Masks)
Toys that children can enter.
Components of writing instruments sold as toys or used in toys. (Example: Plastic erasers on the ends of pencils).
Toys and components intended for indoor use.
Toys and components intended for outdoor use.
Toys or toy components mimicking food. (Example: Toys mimicking the appearance of food, which could be mistakenly eaten by children, making them more likely to be licked or sucked).
Solid toy materials intended to leave a trace. (Example: Solid paints, crayons, colored pencil cores, chalk, etc. Excluding graphite cores in pencils).
Accessible colored liquids in toys.
Accessible colorless liquids in toys.
Modeling clay, toy clay, and similar substances, excluding substances listed in EN 71-5. (Oven-hardening PVC modeling kits are excluded, as they are covered by EN 71-5).
Materials used for balloons.
Imitation tattoos with adhesive. (Adhesives in contact with the skin should be addressed using the Cosmetics Directive 76/768/EEC).
Imitation jewelry toys.

Exemptions

Phthalates (Covered by 2005/84/EC)
Experimental sets for chemistry and related activities (Covered by EN 71-4)
Chemical toys (sets) other than experimental sets (Covered by EN 71-5)
Finger paints (Covered by EN 71-7)
Imitation cosmetics used for toys. (Technically not an exemption, but this interpretation follows the same principle as Annex A.11; the toy material should comply with the ingredient requirements for cosmetics under the Cosmetics Directive 76/768/EEC. It is foreseeable that children might apply these imitation cosmetics to their own skin).

EN 71-9 Exemption Explanations

1. Phthalates (Covered by 2005/84/EC)

Directive 2005/84/EC officially took effect on January 16, 2007. The new EU regulations specify that DEHP, DBP, and BBP will be restricted in PVC materials used in all children's toys, clothing, and other articles; correspondingly, DINP, DIDP, and DNOP are restricted in children's toys, clothing, and all articles that could potentially be placed in the mouth. The content of the above 6 components must not exceed 0.1%, and those exceeding 0.1% cannot be sold in the EU market. The products covered by the new regulations include not only toys, clothing, and care products for infants under 36 months but also all articles used by children of other ages that could potentially be placed in the mouth.

2. Experimental sets for chemistry and related activities (Covered by EN 71-4)

EN 71-4 specifies the limits for chemical substances used in chemical experimental sets and related activity equipment, including experimental toys in fields like chemistry, biology, physics, microbiology, and environmental science. It also stipulates relevant requirements for labels, chemical substance usage lists, and instruction manuals.

3. Chemical toys (sets) other than experimental sets (Covered by EN 71-5)

EN 71-5 specifies restrictions and requirements for the use of hazardous substances in chemical toys. It primarily applies to plaster and stucco in molding and casting sets; ceramic and vitreous enameling materials supplied in miniature workshop sets; oven-hardening plasticized PVC modeling clay sets; plastic casting sets; embedding sets; photographic processing sets; and adhesives, paints, varnishes, thinners, and cleaning agents supplied with model sets.

4. Finger paints (Covered by EN 71-7)

EN 71-7 lists the permitted colorants and preservatives in finger paints alongside their limits. It sets migration limits for 8 heavy metals and restrictions on the use of primary aromatic amines, while also stipulating the physical property requirements for finger paints.

5. Imitation cosmetics used for toys.

Technically, this is not an exemption, but this interpretation aligns with the principles in Annex A.11 of EN 71-9 (the possibility exists that children will apply the cosmetics to their own skin). In general, the toy material should comply with the ingredient requirements for cosmetics outlined in the Cosmetics Directive 76/768/EEC.

(Note: The exemptions only list the application scope of each category. The specific uses and restrictions of organic compounds involved are numerous and not conveniently listed one by one).

Requirements

The primary requirements are listed in the general tables, including limits for various substances. It should be noted that:

When a toy or toy component is governed by more than one group of requirements, it must meet each of these requirements separately.
(Example: A dyed textile mask designed specifically for children under 3 years old must meet the requirements for: Flame retardants (Table 2A), Colorants (Table 2B), Primary aromatic amines (Table 2C), and Solvents (inhalable) (Table 2F)).
Polymeric materials must not contain a polymer coating thicker than 500 μm.
"Action limits" require the substance content to be lower than the detection limits of test method EN 71-11.
The limits for monomer substances, solvent migration in toy materials, and plasticizers are all based on the content detected in EN 71-11 simulants.
After the EN 71-11 test method is published and takes effect, the classification of inhalable solvents can be easily determined.
These limit tables only apply to toys and toy materials for which limits have already been calculated. These limits might not be entirely suitable for unspecified toys or toy materials; therefore, a deeper professional toxicity/exposure assessment is required before application.

Accessible liquids in toys must not contain the following substances:

Substances meeting any of the following criteria:

Very toxic
Toxic
Harmful
Corrosive
Sensitizing
Irritant (Note: Writing inks are classified as "R36 Irritating to eyes").

Containing any of the following substances will classify it as:

Carcinogenic substance, Category 1 or 2.
Mutagenic substance, Category 1 or 2.
Substance toxic to reproduction, Category 1 or 2.
R65 Harmful: may cause lung damage if swallowed. (Example: Petroleum distillates and other low-viscosity non-aqueous liquids).

Substances with a pH less than 3 or greater than 10. Inks are an exception.

For toys explicitly designed for children under 3 years of age, the formaldehyde content in accessible materials must meet the following standards:

Textiles: 30 mg/kg (Free formaldehyde and hydrolyzed formaldehyde)
Paper: 30 mg/kg
Resin-bonded wood components: 80 mg/kg

Detailed Explanation of EN 62115

The EN 62115 standard covers all electric toys and also applies to Electric Construction Sets, Electric Functional Toys, Experimental Sets, and Video Toys.

According to the EN 62115 standard, Anbotek provides relevant testing services for all electric toy manufacturers and exporters.

The main contents of EN 62115 include: