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CE Approval Guide for Manufacturers <20>

Regulatory Guide > European Area > European Union > CE Approval Guide for Manufacturers <20>
Manufacturers

Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.

If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product:

  1. Identify the applicable directive(s) and harmonised standards
  2. Verify product specific requirements
  3. Identify whether an independent conformity assessment (by a notified body) is necessary
  4. Test the product and check its conformity
  5. Draw up and keep available the required technical documentation
  6. Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).

These 6 steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.

For products that present higher safety risks such as gas boilers, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.

Product groups

Directives

If your product(s) fall(s) within the sector of pyrotechnics, it might be subject to the Directive 2013/29/EU on Pyrotechnic Articles.

Other Directives or Regulations may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2013/29/EU on Pyrotechnic Articles specifies essential safety requirements regarding high levels of consumer protection, the safety of the public and environmental protection that the product must meet in order for the manufacturer to affix the CE marking.

Directive 2013/29/EU covers equipment such as fireworks, theatrical pyrotechnic articles and pyrotechnic articles for technical purposes, such as gas generators used in airbags or in seatbelt pretensioners.

The Directive excludes pyrotechnic articles intended for non-commercial use by the armed forces, the police or fire departments, equipment falling within the scope of Directive 96/98/EC on marine equipment, pyrotechnic articles intended for use in the aerospace industry and percussion caps intended specifically for toys (Directive 2009/48/EC of 18 June 2009 applies in this case). Furthermore, explosives falling within the scope of Directive 93/15/EEC on Explosives for Civil Use and ammunition are not subject to the Directive on Pyrotechnic Articles. Finally, fireworks which are built by a manufacturer for his own use and approved for use exclusively on its territory by the Member State in which the manufacturer is established, and which remain on the territory of that Member State, are also excluded from the application of the Directive.

It is necessary to consult the Directive’s Annex I to ensure that the product complies with all the essential requirements.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or if you have to involve a Notified Body.

Directive 2013/29/EU on Pyrotechnic Articles always foresees the involvement of a Notified Body.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, references to the relevant  European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. The DoC must have the model structure set out in Annex III of the Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessments, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Directive 2013/29/EU on Pyrotechnic Articles requires a categorisation of the products in question according to their type of use, their purpose and level of hazard, including their noise level. Article 6 of the Directive lists the different categories and their details.

All pyrotechnic articles are subject to assessment by a Notified Body; the applicable conformity assessment procedures are laid out in Article 17 of the Directive.

Also, pyrotechnic articles are subject to age limits. The period depends on their category and might span from 12 to 18 years. Additionally, distributors must not sell specific pyrotechnic articles to persons without specialist knowledge, for instance in the case of pyrotechnics used for theatrical purposes of category T2 or fireworks of category F4.

With regard to assessment procedures, the Directive allows for the following:

  • EU-type examination and conformity to type assessment,
  • EU-type examination and production quality assurance assessment,
  • EU-type examination and product quality assurance assessment,
  • unit verification assessment or,
  • for fireworks of category F4 only, the full product quality assurance procedure.

All procedures are laid out in detail in Annex II to the Directive.

The manufacturer will draw up and sign the EU Declaration of Conformity.

All pyrotechnic articles require special labelling as specified in Article 10 and 11 of the Directive. The labelling must, for instance, include the minimum age limits as indicated in Article 7(1) and (2), the relevant category and some basic instructions for use, the year of production for specific fireworks categories and, where appropriate, a minimum safety distance. The labelling must also for instance include the net equivalent quantity (NEQ) of active explosive material (= net explosive content). For a detailed overview please consult Article 10 or 11. The European Harmonised Standards EN 15947-3, EN ISO 14451-3, EN 16256-4 and EN 16261-4 specifying the minimum labelling requirements for different categories of pyrotechnic articles should also be taken into account.

Technical documentation

Upon successful assessment, Directive 2013/29/EU on Pyrotechnic Articles outlines different variations for a technical documentation depending on the assessment procedure chosen, as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should basically comprise:

  • a general description of the article,
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits,
  • the descriptions and explanations necessary for the understanding of the conceptual design and manufacturing drawings, the schemes of components, sub-assemblies and circuits and the operation of the pyrotechnic article,
  • a list of the harmonised standards referred to in Article 8 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,
  • results of design calculations made and examinations carried out,
  • test reports.

Also, the file must contain a copy of the EU Declaration of Conformity.

The manufacturer is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed on the product.

The marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and to the accompanying documents. The CE marking shall consist of the initials 'CE' taking the following form:

 

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may be not smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the CE marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body has been involved in the production control phase, its identification number must also be displayed.

For consumer fireworks, according to the applicable standard, a registration number for the tracing of products shall be marked in accordance with the following structure: XXXX - YY - ZZZZ..., where XXXX refers to the registration number of the notified body issuing the certificate, YY refers to the category of firework in abbreviated format (F1, F2, or F3 for category 1, 2, or 3 respectively), and where ZZZZ... is a processing number used by the notified body.


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