Creating innovative children’s products — developmental cards, board games, interactive books and educational materials — is one of the most inspiring and fastest-growing business sectors. In my legal practice I increasingly meet authors, publishers and entrepreneurs who have developed an excellent educational concept and refined visual design, but then face a serious regulatory maze: are developmental cards treated as a “toy”? Is CE marking mandatory? Which parts of the EN 71 standard apply, and which documents may a market-surveillance authority require?
Following the comprehensive legal structuring and advice provided to a client launching a large early-childhood-development project, I have summarised the critical safety and testing requirements that every manufacturer, publisher or importer in the European Union should consider.
Author: Attorney-at-law Gabriela Ivanova | Ivanova Legal Solutions
1. Legal framework: when are educational materials classified as a “toy”?
The core European instrument is Directive 2009/48/EC on the safety of toys. In Bulgaria it is implemented through the Ordinance on the Essential Requirements and Conformity Assessment of Toys, while market surveillance is carried out by the State Agency for Metrological and Technical Surveillance.
Under Article 2(1) of the Ordinance and Article 2(1) of Directive 2009/48/EC, a toy is any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age.
A key legal point: an educational, training or developmental function does not automatically remove a product from the toy category. If cards, puzzles or books have play value and are directed at children, they fall under the full toy-safety regime.
The statutory exemptions for educational products, listed in Annex 1 to the Ordinance, are narrowly construed. They cover only:
- products for educational purposes in schools and kindergartens, used under the constant and direct supervision of an adult teacher or instructor; and
- specific functional educational equipment operating at a voltage above 24 volts.
When educational cards or games are freely sold in stores, bookshops or online directly to parents for home use, they are subject to certification and CE marking as children’s toys.
2. EN 71 – the technical pillars of safety
To demonstrate that a product meets the essential safety requirements, the manufacturer should ensure conformity with the harmonised European standards in the EN 71 series. They address the potential risks to a child’s health:
- EN 71-1 (Mechanical and physical properties): the foundational test for strength and physical safety. It assesses resistance to tearing, bending and compression, as well as the absence of sharp edges and points. The small-parts test, performed with a special test cylinder, is critical: for products intended for children under 36 months, small parts that can be swallowed or cause choking must not detach.
- EN 71-2 (Flammability): limits the use of highly flammable materials and sets permissible flame-spread rates in the event of accidental contact with a small ignition source.
- EN 71-3 (Migration of certain elements): measures toxic heavy metals, including lead, cadmium, mercury, arsenic, barium, chromium and selenium, that may migrate from cardboard, inks, protective varnishes or plastic through contact with saliva, gastric juice or skin.
- EN 71-9 to EN 71-11 (Organic chemical compounds): set limits and testing methods for certain organic compounds, solvents, volatile substances, preservatives and plasticisers used in printing and manufacture.
3. Additional EU requirements: chemicals and electronics
EN 71 compliance does not exhaust every legal obligation of a trader:
- REACH Regulation (EC) No 1907/2006: EN 71 does not cover every hazardous chemical. Annex XVII to REACH contains direct restrictions on phthalates, lead, cadmium and polycyclic aromatic hydrocarbons (PAHs) in articles intended for children.
- General Product Safety Regulation (GPSR – Regulation (EU) 2023/988): introduces stronger requirements for full supply-chain traceability, a postal and electronic contact address for the responsible person in the EU, and clear feedback and defect-reporting channels.
- Interactive and hybrid sets (cards + electronic reader or pen): where a set includes a digital or electrical device, such as a talking pen, sound reader or lights, it enters a higher regulatory class and may require additional testing under EN IEC 62115 for electrical toys, Directive 2014/30/EU (EMC), Directive 2011/65/EU (RoHS) and battery standards (IEC 62133 / UN38.3). The battery compartment should be protected and openable only with a tool or by two independent simultaneous movements, while acoustic pressure at the child’s ear should be limited under EN 50332 / EN 71-1.
4. Practical cases: product families and age grading
Two questions commonly arise from authors and publishers.
Must every individual deck of cards be laboratory-tested?
Legal answer: No separate test is needed for every thematic deck — for example animals, professions or numbers — if the cards are produced from exactly the same raw materials (same card type, grammage, inks and varnish) and through the same manufacturing process. In that case, an accredited laboratory such as SGS, TÜV, Intertek or Eurofins may test a representative sample and its reports may cover the entire “product family”.
How does combining cards with an electronic reader affect age grading?
Legal answer: If cards are sold separately and have passed EN 71-1 testing for the absence of small parts and resistance to compression, they may carry an age mark of 1+ or 2+. Where they are sold in a single box with an electronic reader containing small buttons or accessories rated 3+, the entire combined set must adopt the most restrictive age designation: 3+.
5. Mandatory documentation and marking: the manufacturer’s roadmap
Before a product is offered on the physical or online EU market, the manufacturer — or the person placing it on the market under their own name or trade mark — should hold a complete technical file, including:
- Test reports: issued by an accredited laboratory and demonstrating successful testing under the applicable parts of EN 71 and REACH;
- Risk assessment: analysis of potential mechanical, chemical and flammability risks against intended and reasonably foreseeable use by children;
- EC Declaration of Conformity: an official legal document signed by the company’s manager, accepting full legal responsibility for product safety;
- Technical file, retained for 10 years: including complete drawings, material specifications, production schemes and copies of the declaration and test reports.
Mandatory Bulgarian-language labels and markings on the box include:
- the CE graphic symbol, at least 5 mm high;
- a trade name and batch or serial number for traceability;
- the full name and precise postal contact address of the EU manufacturer/importer;
- an age group and specific safety warnings, for example the 0–3 choking-hazard symbol; and
- safe-use instructions and packaging-recycling symbols.
6. New EU horizons: a digital passport and sustainable packaging
Businesses should also anticipate strategic European-law developments:
- Regulation (EU) 2025/2509 on toy safety: provides for a Digital Product Passport through a QR code on packaging. It will replace paper declarations and give customs authorities and consumers direct electronic access to safety data, with a transition period to 2030.
- Regulation (EU) 2025/40 on packaging and packaging waste (PPWR): imposes stricter requirements for heavy metals in product and courier boxes, design for recycling, and a maximum 50% empty space in e-commerce parcels.
How can we help?
Launching an educational or children’s project requires a precise combination of creativity and regulatory confidence. Ivanova Legal Solutions provides end-to-end legal support for creative and commercial children’s-product projects, including:
- preliminary legal classification of a product as a toy, educational material or publication;
- coordination with accredited testing laboratories and structuring the technical file;
- drafting EC Declarations of Conformity and reviewing required labels, warnings and instructions;
- full intellectual-property protection — trade-mark registration for the name and mascot before the Bulgarian Patent Office and EUIPO, including up to 75% grant support through the SME Fund, copyright and industrial-design protection; and
- manufacturing and printing agreements, including NNN agreements for overseas manufacturers, e-commerce terms and GDPR policies for children’s digital platforms.
Planning to launch a children’s game, cards or educational product?
Contact us for legal advice and a regulatory audit: givanova@ivanovalegalsolutions.com.
This article is provided for general information and is not individual legal advice. Before a particular product is placed on the market, the applicable requirements should be assessed against its characteristics, age group and route to market.