The Toy Safety Directive 2009/48/EC and CE marking

03.02.2021

The Toy Safety Directive 2009/48/EC defines the essential safety requirements for toys to comply with before they can be placed on the EEA market (EEA = Member States of the European Union plus Norway, Iceland and Liechtenstein). These essential requirements cover:

General risksParticular risks

Safety and health of children, and other people, e.g., parents and caregivers

Physical;
Mechanical;;
Chemical;
Electrical;
Flammability;
Hygiene,
Radioactivity (if applicable).

You can only certify your toys and place them on the EEA market, when your toys comply with the relevant essential requirements. Are you a manufacturer, importer or a distributor, then it is very important for you to find out how to obtain a CE marking!

Please note: a CE marking is not considered to be a quality mark for toys.

Which products fall within the scope of the Toy Safety Directive?

The Toys Safety Directive applies to products that are designed or intended, whether or not exclusively, for use in play by children below the age of 14.

This is box title

indicates that even if a product was manufactured for other purposes, it can still be used as a toy, e.g., a keychain with a teddybear, or a sleeping bag in the shape of a stuffed animal. These products have not primarily been designed and intended for use in play, but are still classified as toys. After all, children are able to play with them.

For use in play

this is the most interesting point of discussion concerning this Directive. Children can play with almost anything. In accordance with the Directive a product is only considered a toy when the manufacturer intentionally assigns a play value to it, as in the examples above. The manufacturer’s declaration is important, but above all it is the reasonably intended use of the product that is most important.

Which products do not fall within the scope of the Toy Safety Directive?

In the scope of article 2, paragraph 2 are mentioned the following products:

Playground equipment intended for public use;
Automatic playing machines whether coin operated or not, intended for public use;
Toy steam engines;
Toy vehicles equipped with combustion engines;
Slings and catapults.

In the scope of Annex I a limitative list of products that do not fall within the scope of this Directive, such as:

decorative objects for festivities and celebrations;
products for collectors;
sports equipment for children with a body weight of more than 20 kg,
dangerous products, such as fireworks.

When is certifying a toy mandatory?

The moment you are planning to place a toy on the EEA market, it will become mandatory to affix a CE marking to this toy.

A toy without a CE marking may be shown at trade fairs and exhibitions, provided that it is accompanied by a sign indicating that this toy does not comply (as yet) with the Toy Safety Directive. If the toy is then placed on the market, it wil become mandatory to affix a CE marking.

How do you obtain a CE marking?

Before you place toys on the EEA market, they must meet the requirements of the Toy Safety Directive and be affixed with a CE marking. The Directive defines the obligations which must be taken into account by each economic operator (manufacturer, importer or distributor).

Manufacturer

Do you manufacture toys? Then you must follow the next steps to obtain a CE marking:

1. Product classification2. Classificatie marktdeelnemer3. Conformity assessment procedure4. Technical Documentation5. Declaration of Conformity6. CE Marking

determine whether your toy falls within the scope of the Toy Safety Directive; please refer to article 2 and Annex I of the Directive;
determine for which age category the toy was designed.

determine the role you will take in the scope of the Toy Safety Directive: manufacturer, importer or distributor. Please refer to article 3 of the Directive;
are you a manufacturer? Then please follow the next steps.

The conformity assessment procedure consists of a number of substeps, defined in articles 4, 10, 11, 18, and 19 of the Directive:

conduct testing procedures in accordance with European harmonised standards;
establish procedures to ensure conformity for series production;
ensure identification of the toy by placing, e.g., type, batch, serial or model number, as well as your (trade or registered) name and contact address on the toy or its packaging;
draft instructions for use, safety information and warnings in a language that is easily understood by consumers.Warnings must be placed on a clear spot, in a legible, accurate manner and in a language easily understood, preceded by the word “Warning” or “Warnings”;
develop corrective measures, such as sample testing, a register of complaints, and toy recalls

compile technical documentation (TD); please refer to article 21 and Annex IV of the Directive;
the TD indicates conformity of the toy with the Directive and contains, among other things, a list of the materials and components used in manufacturing the toy, a description of the conducted safety assessments and an instruction for use;
the Technical Documentation must be maintained for a period of 10 years after the product has been placed on the market.

draft a CE Declaration of Conformity (also referred to as CE certificate or EU Declaration of Agreement);
the DoC confirms product conformity with the Toy Safety Directive;
as a manufacturer you will take upon you the responsibility for the toy’s conformity;
the DoC must meet the requirements of Annex III of the Directive;
the DoC must be signed and kept for a period of 10 years after the toy has been placed on the market;
you are required to provide the market surveillance authority with a copy of the DoC, on their request.

after completing all the previous steps, you are now allowed to affix the CE marking to the toy;
the marking must be affixed visibly, legibly and indelibly to the toy, the label or the package. Further instructions for affixing the CE marking are included in article 17 of the Directive.

Importer

Are you an importer of toys? In that case you are only allowed to place toys on the EEA market that comply with the Directive’s requirements. Article 6 of the Directive will then apply to you and refers to your obligations. You will see to it:

That the manufacturer has carried out the correct conformity assessment procedure, has compiled the Technical Documentation, has affixed the correct markings to the toy, and that the toy is accompanied by the required documentation;
That your (trade or registered) name and contact information are placed on the product or its packaging;
That the instructions for use and information are in a language that is easily understood by consumers;
That you will take responsibility for safe transport and storage of the toy during the period that the toy is under your responsibility;
That you have established corrective measures;
That you are in possession of a copy of the CE Declaration of Conformity.

Distributor

Are you a distributor of toys? In that case article 7 of the Directive will be applicable to you, and in short, your obligations will be as follows. Your will see to it:

That you will handle accurately;
That, before making the toy available on the market, you will verify whether it bears the CE marking, and is accompanied by the required documents and instructions in a language that is easily understood by consumers;
That you will take responsibility for safe transport and storage of the toy during the period that the toy is under your responsibility;
That you have established corrective measures.

Please note: are you an importer or distributor and are you placing toys on the market under your own (trade or registered) name, then you will be regarded as a manufacturer in the scope of the Toy Safety Directive.

Who is in charge of supervising the regulatory compliance with the Toy Safety Directive?

The Netherlands Food and Product Safety Authority (NVWA) is responsible for supervising regulatory compliance with the Toy Safety Directive in The Netherlands.

Who is responsible for the conformity assessment procedure?

As a manufacturer, importer or distributor you yourself are responsible for this procedure. You can therefore carry out this procedure yourself, but you can also enlist the assistance of an experienced company. Our experts at Certification Company are capable of providing you with all the necessary guidance and assistance! Please feel free to submit an inquiry or contact us by telephone or by email.