I. Definition & Safety Requirements of the Toy Safety Directive
The safety of toys in the EU is regulated by the Toy Safety Directive 2009/48/EC, which sets the rules on the safety of toys and allows their free movement within the EU borders. It came into force on July 20th 2011 by replacing the former 20 years old Directive 88/378/EEC.
The Toy Safety Directive contains all essential legal requirements which toys must conform with before they can be placed on the EU market. These safety requirements are divided into two groups: general risks and particular risks. The general criteria mainly relate to the children’s health and safety, while the particular ones are primarily linked to the toys properties (e.g. flammability, radioactivity, and electrical, chemical, physical and mechanical properties).
II. Scope of the Directive
The Directive applies to products designed or intended for use in play by kids under 14 years of age. Within the scope of the Directive fall products that can be defined as toys except for the following ones:
- Playground equipment designed for public use;
- Automatic playing machines intended for public use;
- Toy steam engines;
- Toy vehicles armed with combustion engines;
- Catapults and slings.
Products that cannot be considered as toys within the meaning of the Toy Safety Directive are, as follows:
- Decorative objects intended for festivities and celebrations;
- Products for collectors of +14 years of age (e.g. historical replicas of toys and folk or decorative dolls);
- Sports equipment designed for children with a weight of 20+ kg;
- Bicycles which saddle height of 435+ mm;
- Scooters and any other means of transport intended for sport or travel on public roads/ pathways;
- Puzzles that consist of more than 500 pieces;
- Electronic equipment (e.g. computers and game consoles);
- Babies’ soothers;
- Electrical transformers for toys;
- For a full list of all products excluded from the Directive’s scope and which aren’t considered as toys, check Annex II.
Some products can be defined as toys and fall within the scope of the Toy Safety Directive providing they meet specific criteria are, such as:
- Colouring & painting articles – these products are considered as toys as long as they are not used for artistic purposes and sold in shops specialised in artists’ equipment. Examples: chalk, colour pencils, wax crayons, toy stamps, finger paints, etc.
- Writing & drawing articles – articles used for both play and writing are regarded as toys. Examples: animal-shaped pens, blowing bubbles pens, etc.
- Others – stationary objects are considered to be toys only when there is play value introduced by the manufacturer. Examples: toy sharpeners or erasers in the form of a toy.
III. Obligations of economic operators
Economic operators that can have explicit obligations under the Toy Safety Directive 2009/48/EC are manufacturers and their authorised representatives, importers and distributors. Referring to Article 8 of the Directive, the listed below obligations of manufacturers of toys apply to importers or distributors if they place a toy on the EU market under their name or trademark or modify an already marketed toy in such a way that its CE compliance may be affected.
Manufacturers’ responsibilities can be summarised in the following way:
- The product’s design and manufacture is in accordance with the Directive’s criteria laid down in Article 10 and Annex II;
- All applicable conformity assessments, including third-party assessments, must be carried out;
- Draw up and store for a period of 10 years a technical file and Declaration of Conformity;
- The toy bears a batch, type or serial number or any other element allowing its identification;
- Contact and identification information of the manufacturer must be placed on the toy or its packaging, or in the accompanying documents;
- Ensure the product has instructions for use and safety information;
- Provide all complying documentation to the national market authorities when requested.
Authorised representatives of manufacturers are responsible at least for:
- Keeping the product’s technical documentation and declaration of conformity for at least 10 years;
- Providing the national authorities with all the support they need to validate the conformity of the product.
Importers of toys bearing the CE marking are obliged to:
- Place only CE compliant toys on the EU market;
- Their name, registered trademark and address must be indicated on the toy’s surface or its packaging or in the documentation that accompanies it;
- Ensure that the toy has instructions for use and safety information;
- The storage and transportation of the toy is in accordance with the requirements specified in Article 10 and Annex II;
- When necessary, perform sample testing of the product to validate its compliance;
- Keep a copy of the product’s Declaration of Conformity for 10 years;
- Provide the national authorities with all the documentation required to demonstrate the toy’s compliance with the EU legislation.
Distributors’ obligations are, as follows:
- Ensure the toy is compliant with the relevant EU legislation and bears the CE marking;
- The toy is stored and transported in a way that its compliance is not jeopardised;
- Provide the authorities with the documentation needed to validate the product’s compliance.
IV. Conformity procedures
There are two conformity assessment procedures which manufacturers can use to demonstrate their toys’ CE compliance.
In many cases, especially when assessing the compliance of soft toys, manufacturers may use a procedure called ‘self-verification’ to ensure the conformity of their products with the essential requirements of the Toy Safety Directive. All they need to do is to apply relevant harmonised standards published in the Official Journal of the EU and carry out Module A assessment procedure (internal production control).
However, when the self-verification is not possible, manufacturers need to submit their toys to EC-type examination carried out by a third-party conformity assessment body. This type of conformity procedure is required when:
- Harmonised standards covering all relevant safety criteria for the toy do not exist;
- The existing applicable harmonised standards are not applied or applied only partially;
- The harmonised standards are published with some restriction;
- The manufacturer considers that the toy’s nature, design or purpose necessitates third-party conformity verification.
Despite the type of conformity procedure needed, manufacturers of toys must always perform an analysis of all hazards (i.e. particular risks) that the toy may present and an assessment of the potential exposure to such dangers.
Compliance management of toys
Clever Compliance, previously CECHECK, is a Swedish provider of certification services and compliance software solutions since 2016. The company has developed a compliance management system providing its users with the following assistance:
- Compliance tools for a quick inventory of legal provisions (e.g. Legislation finder, UL standards finder, EU harmonised standards finder, Global markings, etc.)
- Custom dashboards and reports
- Notification alert system
- Regulatory monitoring
- Product compliance workflow maps
- Documentation generator and depository, and more.
Get in touch with Clever Compliance's team at firstname.lastname@example.org to learn more and get the help you need.