In the 1980s, the European Union introduced a series of measures to simplify the movement of goods throughout the European Union and some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.

The directives cover a wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user. Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product.

A Notified Body is an organization that has been appointed by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments.

The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive.

In addition a Notified Body must also be independent and impartial and have a high level of professional indemnity insurance. Each Notified Body will have a scope of accreditation detailing its competence in terms of Directives and products. A network of representatives from the Notified Bodies meets on a regular basis to ensure that the standards and legislation are being applied uniformly across Europe.

To ensure conformity

Basically there are two methods by which a manufacturer or his authorised representative can ensure that toys satisfy the essential safety requirements applicable to them. Either;

 1. Manufacture in conformity with the relevant national standards where these cover all relevant aspects of the safety of the toy.

 Where this method is used, CE marking is affixed as a declaration by the manufacturer, or his authorised representative, that, amongst other things, the toy bearing it satisfies the essential safety requirements and has been manufactured in accordance with the relevant national standards (also called self-certification).

2. Manufacture in accordance with a model which has been EC type examined. In this instance, the manufacturer or his authorised representative must submit a sample of the toy (the ‘model’), together with other information to an approved body for EC type-examination. This can be an approved body in any member State.

EC type-examination

The approved body will perform such tests and examinations as are necessary for it to decide whether or not the toy satisfies the essential safety requirements and, if so, the body will issue an EC type-examination certificate. Once an EC type-examination certificate has been issued in respect of a toy sample the manufacturer must ensure that his production toys comply with that sample. He, or his authorised representative, is then able to CE mark each production toy as a self-declaration that it has been manufactured in accordance with a specimen which is the subject of an EC type examination certificate.

Although it is open to manufacturers or their authorised representative to apply for EC type-examinations, this procedure is only legally required in certain cases - e.g. where relevant national standards do not exist for a particular area of the essential safety requirements applicable to a toy or such standards are available but are not comprehensive in that regard.