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EN 71
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European standard EN 71 specifies safety requirements for toys.[1] It is harmonised with the Toy Safety Directive (Council Directive 2009/48/EC) and compliance with the standard is legally required for toys sold in the European Union.[2]
The standard has been published in 14 parts:
- EN 71-1: Mechanical and physical properties
- EN 71-2: Flammability
- EN 71-3: Specification for migration of certain elements
- EN 71-4: Experimental sets for chemistry and related activities
- EN 71-5: Chemical toys (sets) other than experimental sets
- EN 71-6: Graphical symbols for age warning labelling
- EN 71-7: Finger paints
- EN 71-8: Swings, slides and similar activity toys for indoor and outdoor family domestic use
- EN 71-9: Organic chemical compounds – Requirement
- EN 71-10: Organic chemical compounds – Sample preparation and extraction
- EN 71-11: Organic chemical compounds – Methods of analysis
- EN 71-12: N-Nitrosamines and N-Nitrosatable Substances
- EN 71-13: Olfactory board games, cosmetic kits and gustative games
- EN 71-14: Trampolines for domestic use
References
[edit]- ^ BS EN 71 Series. Safety of toys Archived 2016-03-05 at the Wayback Machine, BSI website
- ^ Directive 2009/48/EC, Toy Safety
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EN 71
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EN 71 is a multi-part European standard developed by the European Committee for Standardization (CEN) that establishes essential safety requirements for toys intended for children under 14 years old, addressing potential risks such as mechanical injuries, chemical exposure, flammability, and microbial contamination. In 2025, the EU adopted a new Toy Safety Regulation replacing Directive 2009/48/EC, which bans or restricts additional dangerous chemicals including endocrine disruptors. Harmonized with this EU Toy Safety Regulation, it ensures that toys placed on the market in the European Economic Area comply with strict criteria to protect children's health and safety, with compliance demonstrated through testing and the affixing of the CE mark.[1][2][3]
The standard is divided into several parts, each focusing on specific hazards. EN 71-1 covers mechanical and physical properties, including requirements for edges, points, small parts, and reasonable foreseeable abuse to prevent choking, cuts, or entrapment. EN 71-2 addresses flammability, specifying materials and constructions that minimize burn risks, particularly for toys like costumes and soft-filled items. EN 71-3 regulates the migration of certain elements such as lead, cadmium, and mercury from toy materials, setting permissible limits to avoid toxic exposure through mouthing or skin contact. Additional parts extend coverage to specialized products and risks: EN 71-4 for chemistry sets, EN 71-5 for chemical toys like modeling clays, EN 71-7 for finger paints, EN 71-8 for activity toys such as swings and slides, EN 71-12 for N-nitrosamines in elastomers, EN 71-13 for olfactory and gustative games, and EN 71-14 for domestic trampolines.[4][5][6]
EN 71 standards are regularly updated to incorporate scientific advancements and emerging risks, with significant revisions in 2025 across nearly all parts to align with evolving regulatory needs under the Toy Safety Regulation. Compliance involves third-party testing by notified bodies, technical documentation, and risk assessments by manufacturers, importers, and distributors. Non-compliance can result in market withdrawal, fines, or legal action, underscoring the standard's role in fostering a safe play environment across the EU and associated countries.[7][1][2]
These limits, derived from scientific opinions by the Scientific Committee on Health and Environmental Risks (SCHER) and the European Food Safety Authority (EFSA), prioritize protection against neurodevelopmental and carcinogenic risks from heavy metals.[37]
The test method simulates gastric conditions using 0.07 mol/L hydrochloric acid at 37 ± 1 °C for 2 hours, with vigorous shaking for the first 10 minutes followed by standing to mimic digestion.[38] Sample preparation varies by category: Category I materials are cut into pieces no larger than 6 mm or pulverized if necessary; Category II materials are used directly or diluted; Category III involves scraping the surface to obtain approximately 100 mg of material that passes through a 125 μm sieve.[39] Post-extraction, the migrates are analyzed quantitatively, typically using inductively coupled plasma mass spectrometry (ICP-MS) for most elements, atomic absorption spectrometry (AAS) as an alternative, ion chromatography coupled with ICP-MS for chromium speciation, and gas chromatography-mass spectrometry (GC-MS) for organic tin compounds.[34]
Amendment A2:2024, published in December 2024 and effective as a harmonized standard by June 2025, introduces specific migration limits for chromium (VI) across all categories (e.g., 0.02 mg/kg for Category I), refines boron limits to better align with updated toxicological data, and expands aluminum testing requirements to include more precise composite material assessments while removing the dewaxing step for improved reproducibility.[15] These changes enhance the standard's alignment with ongoing EU risk assessments under the Toy Safety Directive 2009/48/EC, focusing on emerging concerns like hexavalent chromium's carcinogenicity without altering core limits for legacy elements like lead and cadmium.[40] The rationale remains rooted in simulating realistic exposure pathways to prevent bioaccumulation, drawing from RIVM exposure models and EFSA tolerable daily intakes.[41]
Introduction
Scope and Purpose
EN 71 is a series of harmonized European standards developed by the European Committee for Standardization (CEN) to specify safety requirements for toys, implementing the essential safety objectives of the EU Toy Safety Directive 2009/48/EC.[8] These standards address a comprehensive range of potential hazards to ensure toys are safe for children when used as intended or under reasonably foreseeable conditions of normal use. The scope of EN 71 applies to all toys defined as any product or material designed or clearly intended, whether or not exclusively, for use in play by children under 14 years of age.[8] This includes a wide array of items such as dolls, puzzles, construction sets, and outdoor play equipment intended for home use, like swings and slides.[8] However, it excludes certain categories listed in Annex I of the Directive, such as playground equipment intended for public use, bicycles, slingshots, toy vehicles equipped with combustion engines, and scale models or puzzles with more than 500 pieces primarily for children aged 14 years or older.[8] The primary purposes of EN 71 are to protect children's health and safety by mitigating risks from mechanical and physical properties, flammability, chemical substances, and other biological or hygiene-related hazards.[8] It adopts a risk assessment-based approach, requiring manufacturers to evaluate and address potential dangers throughout the toy's lifecycle, from design to foreseeable misuse by children.[8] Compliance with the EN 71 series is mandatory for affixing the CE marking on toys placed on the EU market, providing a presumption of conformity with the Directive's safety requirements.[1]History and Development
The EN 71 series originated in the late 1980s as a key component of the European Union's harmonization initiatives for consumer product safety, directly supporting the Council Directive 88/378/EEC of 3 May 1988, which aimed to approximate member states' laws on toy safety by establishing essential requirements for mechanical, physical, and chemical hazards.[9] Developed by the European Committee for Standardization (CEN) through its Technical Committee TC 52 "Safety of toys",[10] the standards sought to provide uniform testing methods to ensure toys posed no undue risk to children's health when used as intended. The foundational parts—EN 71-1 on mechanical and physical properties (first published in 1988), EN 71-2 on flammability (also 1988), and EN 71-3 on migration of certain elements (1988, revised in 1994)—were introduced between 1988 and 1995 to address core safety needs, including physical injuries, fire risks, and elemental toxicity from materials like paints and plastics.[11] These early developments were influenced by growing awareness of toy-related accidents and the need for evidence-based limits derived from emerging toxicological research on substance exposure in children.[12] Significant milestones marked the evolution of EN 71 in response to regulatory shifts and safety incidents. The series was substantially revised to align with the Toy Safety Directive 2009/48/EC, which repealed the 1988 directive and entered into force on 20 July 2011, introducing expanded chemical restrictions such as bans on certain phthalates (DEHP, DBP, BBP) in toys for children under three years following widespread 2007 recalls of imported toys due to lead and phthalate leaching.[13] This alignment prompted 2011 updates, including enhancements to EN 71-9 on organic chemical compounds, which incorporated stricter migration limits for phthalates and other volatiles based on bioavailability studies and incident data showing risks from mouthing behaviors.[14] By the 2010s, further refinements addressed scientific advancements in toxicology, such as improved detection methods for elemental migration, culminating in the 2019 revision of EN 71-3 (with Amendment A2 published in December 2024) that expanded test scopes for 19 elements, including updated limits for aluminum, antimony, and chromium(VI), to better reflect long-term exposure risks.[15] Conflicting national standards were required to be withdrawn by June 2025 to ensure uniform application.[16] In 2025, a comprehensive CEN standardization request (M/581) drove revisions to nearly all EN 71 parts, with a deadline for adoption of October 25, 2025, reflecting ongoing responses to chemical safety incidents and toxicological progress, such as concerns over preservatives, flame retardants, and microbial contamination in aqueous toy media.[7] New standards published that year included EN 71-15:2025 (March) for formamide content in foam materials, EN 71-16:2025 for three flame retardants (TCPP, TCEP, TEP), and EN 71-17:2025 for four preservatives (bronopol, 5-chloro-2-methyl-4-isothiazolin-3-one, etc.), each specifying migration limits and test methods to mitigate inhalation and dermal exposure risks.[17] EN 71-19:2024 (published early 2025) addressed bisphenol A migration from toy materials for children under 36 months, setting a 0.04 mg/kg limit, while EN 71-20:2025 (approved mid-2025) introduced microbiological safety requirements for toys with accessible liquids, mandating limits on bacteria like Pseudomonas aeruginosa and preservative efficacy tests.[18] Concurrently, EN 71-9 was fully withdrawn by 2025, with its core requirements on organic compounds integrated into updated parts like EN 71-3 and the new chemical-specific standards to streamline compliance without gaps.[19] These changes underscore EN 71's adaptive framework, prioritizing incident-driven enhancements—such as post-2007 chemical recalls—and interdisciplinary toxicology to safeguard vulnerable users.[14]Relation to EU Legislation
EN 71 serves as a series of harmonized standards under the European Union's Toy Safety Directive 2009/48/EC, which establishes essential safety requirements for toys placed on the market.[1] Compliance with the relevant parts of EN 71 provides manufacturers with a presumption of conformity to these requirements, facilitating the demonstration that toys meet the directive's criteria for mechanical, physical, chemical, and flammability safety. The directive mandates that all toys intended for children under 14 years must undergo assessment against these standards before market entry, encompassing aspects of design, production, and labeling to prevent risks such as choking, chemical exposure, or fire hazards.[20] The CE marking process is central to compliance, requiring manufacturers to affix the CE mark on toys that satisfy the directive's provisions, either through self-assessment or involvement of a notified body for third-party verification, particularly for higher-risk products.[21] Technical documentation, retained for 10 years, must detail conformity assessments and explicitly reference applicable EN 71 parts, including test reports and risk analyses.[22] Non-compliance can trigger corrective actions, such as product withdrawals or recalls coordinated through the Rapid Alert System for dangerous non-food products (RAPEX), which enables rapid information sharing among EU member states to address unsafe toys. The directive's scope extends to all stages of a toy's lifecycle within the EU, from initial design to post-market surveillance, ensuring ongoing safety monitoring. Recent updates to EN 71 standards in 2025, including revisions to parts like EN 71-3 for migration of elements, align with these requirements and prepare for the forthcoming Toy Safety Regulation, adopted in October 2025, which will replace the 2009 directive approximately 54 months after entry into force to impose stricter chemical limits and enhanced digital traceability.[7][2] Internationally, EN 71 influences global toy safety frameworks, such as the U.S. ASTM F963 standard, by sharing core principles on mechanical and chemical testing, though adaptations account for regional differences; toys exported to the EU must fully comply with EN 71 to meet import obligations.[5] Enforcement falls to national market surveillance authorities in EU member states, who conduct inspections, testing, and investigations, with penalties for violations varying by country but potentially including fines, product bans, or criminal charges for severe cases.[23] The Market Surveillance Regulation (EU) 2019/1020 complements this by strengthening border controls and online platform accountability to curb non-compliant imports.[24]General Safety Requirements
Mechanical and Physical Properties (EN 71-1)
EN 71-1 specifies requirements and test methods to ensure that toys intended for children up to 14 years of age do not present mechanical or physical hazards during normal or reasonably foreseeable use, including abuse that might result from children's behavior. This standard applies to a wide range of toys, excluding items like playground equipment, public amusement structures, and toy vehicles with combustion engines, while emphasizing protection against risks such as choking, cuts, entrapment, and falls. It covers all aspects of toy design, construction, and packaging to minimize injury based on child development stages and anthropometric data.[25] Key requirements focus on preventing small parts that could cause choking, particularly for children under 36 months, where no detachable or non-detachable parts may fit entirely into the small parts cylinder—a cylinder with an internal diameter of 31.7 mm and depth of 57.1 mm—to simulate a child's throat. For toys intended for children aged 36 to 72 months, small parts are permitted only with appropriate warnings, and exemptions apply to functional miniatures like toy vehicles under specific size limits. Sharp edges and points must not pose an injury risk after testing, with edges required to be rounded to a radius of at least 1 mm or smoothed, while protruding points must withstand force without fracturing into hazardous fragments. Stability is mandated for ride-on toys and larger items that could tip over, ensuring they remain upright under applied forces up to 120 N without releasing dangerous parts. These measures draw from child anthropometry to address vulnerabilities like grasping ability and exploratory mouthing.[25][26] Test methods simulate real-world stresses to verify compliance. The small parts test involves subjecting the toy to torque (0.34 Nm for 10 seconds), tension (50 N for parts ≤6 mm or 90 N for larger attachments, held for 10 seconds), and drop impacts before checking cylinder fit. Drop tests require dropping the toy from 850 mm onto a steel surface five times in its most likely orientation to assess for breakage or hazardous detachment. For edges and points, an edge tester applies force to measure radius, while accessibility probes gauge openings to prevent finger or limb entrapment, with gaps sized to avoid risks based on child hand dimensions (e.g., no openings allowing probe entry beyond 5 mm without full passage). Impact tests for moving parts involve dropping a 1 kg weight from 100 mm, and compression tests apply 110 N via a 30 mm disc to check surface integrity. Stability testing for ride-on toys includes applying horizontal forces or tilting to 10 degrees without overturning.[25][27] The 2025 revision of EN 71-1, effective following the October 25, 2025, adoption deadline, introduces clarifications for activity toys to better align with EN 71-8, including enhanced stability criteria for items bearing children, and expanded tests for modular toys to evaluate interconnection durability under repeated assembly. New provisions address toys imitating food, mandating additional choking risk assessments, and incorporate prolonged exposure simulations like saliva and sweat soaking for materials in close contact. These updates aim to reflect evolving play patterns and reduce emerging hazards without altering core mechanical tests.[7][28]Flammability (EN 71-2)
EN 71-2 establishes flammability requirements for toys to reduce fire risks from small ignition sources, such as matches or lighters, by prohibiting certain highly hazardous materials and setting limits on burn rates and flame persistence. The standard applies to all toys as defined under the Toy Safety Directive 2009/48/EC, excluding items like candles, chemical toys covered under EN 71-5, and toys intended for professional use, with a primary focus on evaluating the rate of burn and flame spread in materials likely to contact a child's skin or clothing during play.[29][30] Prohibited materials include celluloid (except in varnishes, paints, glues, or table tennis balls), highly flammable solids that ignite easily or burn intensely, materials exhibiting surface flash, and extremely or highly flammable liquids or gels unless contained in sealed volumes of 15 ml or less for specific applications. Toys must not incorporate flammable gases or materials that produce ignitable vapors under normal conditions, ensuring that no part of the toy presents an undue fire hazard. For permitted materials, key requirements mandate that toys do not ignite readily; where ignition occurs, the flame must self-extinguish quickly, with durations limited to 2 seconds for head-worn items and no burning droplets or molten material that could cause contact burns. Burn rates are capped at 30 mm/s for soft-filled toys and disguise costumes, with self-extinction required if rates exceed these thresholds.[29][31] Test methods simulate realistic play scenarios using a small flame (20 mm ± 2 mm height) applied according to the specific test procedure (e.g., until ignition or for a defined duration). The horizontal burn test applies to disguise costumes, toys intended to be worn or entered by a child, and soft-filled toys: specimens are ignited via a wick, and the burn rate is measured over a 50 mm gauge length, requiring ≤30 mm/s or self-extinction within the test area. For suspended head-worn items like long beards or wigs protruding >50 mm, the vertical string test suspends the sample and applies the flame at the base, limiting flame duration to ≤2 seconds post-ignition and burnt length to <50% of samples ≥150 mm or <25% for shorter ones. Shorter beards, wigs, or molded masks undergo a direct flame application test, with flame duration ≤2 seconds and burnt distance ≤70 mm. Brush or cane elements in headwear, such as in toy wigs, are tested similarly post-washing to simulate use, ensuring no rapid propagation. All head-worn toys are conditioned (including washing for fabric masks) before testing to reflect real-world wear.[29][32] Material categories receive tailored scrutiny: textile-based or sleepwear-like toys, such as disguise costumes, must use slow-burning fabrics with a burn rate ≤30 mm/s to prevent flashover during play. Plastic components, common in molded masks or toys, are required to self-extinguish without dripping flammable material, avoiding secondary ignition sources. Soft-filled toys, like plush animals, follow similar horizontal test criteria to ensure fillings do not accelerate burning. These distinctions prioritize high-risk items where flames could trap heat near the body.[29][31] The 2020+A1:2025 amendment introduces clarifications to enhance test realism, including updated procedures for applying the test flame to masks with openings, a specified range of water hardness (0-250 mg/L CaCO₃) for washing simulations of fabric headwear, and guidance for testing combined specimens with limited material availability. These changes align EN 71-2 with related standards like EN 71-5 and EN 71-13, without altering core limits, and support harmonized enforcement across EU member states by June 2026.[30][33] The standard's rationale stems from documented fire incidents involving toys, particularly those with synthetic materials or near ignition sources, which have caused burns to children through rapid flame spread or prolonged contact with hot residues. By targeting these behaviors in high-contact scenarios, EN 71-2 mitigates risks not immediately apparent to caregivers, emphasizing prevention over post-incident response.[29][31]Migration of Elements (EN 71-3)
EN 71-3 specifies requirements and test methods for the migration of 19 certain elements from toy materials, including aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin, and zinc.[34] The standard applies to all toy materials that may be mouthed or come into prolonged contact with a child's skin, simulating potential ingestion or absorption risks for children under 36 months or other age groups based on intended use.[8] Exemptions include parts that are inaccessible during normal or foreseeable use, such as those inside batteries or fixed to the toy without play value, or materials too large or heavy to be sucked, licked, or swallowed.[35] Toy materials are classified into three categories to reflect varying ingestion risks: Category I for dry, brittle, powder-like, or pliable materials (e.g., plastics, textiles); Category II for liquid or sticky materials (e.g., slimes, paints); and Category III for scraped-off materials (e.g., surface coatings).[15] Migration limits are expressed in milligrams per kilogram (mg/kg) of toy material and vary by category to account for daily ingestion assumptions of 100 mg for Category I, 400 mg for Category II, and 8 mg for Category III, ensuring exposures remain below toxicological thresholds for chronic effects.[36] Representative limits for key elements include:| Element | Category I (mg/kg) | Category II (mg/kg) | Category III (mg/kg) |
|---|---|---|---|
| Lead | 90 | 13.5 | 17 |
| Cadmium | 4.5 | 0.9 | 75 |
| Antimony | 60 | 15 | 750 |