Responsibilities of Importers Under ATEX Directive 2014/34/EU

When explosion-protected equipment is manufactured outside the European Union and first placed on the EU market, the economic operator responsible for that placement may be an importer under Directive 2014/34/EU (ATEX).

An importer is not simply a logistics or purchasing intermediary. Article 8 of the ATEX Directive assigns specific responsibilities to importers before and after products are placed on the Union market, including verification of conformity assessment, documentation, markings, instructions, product identification, and storage or transport conditions.

These obligations are different from those of the manufacturer, Authorised Representative, and distributor. Understanding the distinction is important when reviewing the compliance of explosion-protected equipment supplied from outside the European Union.

What Is an Importer Under the ATEX Directive?

Article 3 of Directive 2014/34/EU defines an importer as a natural or legal person established in the Union who places a product from a third country on the Union market.

In practical terms, an EU-established company that introduces explosion-protected equipment from a non-EU country onto the EU market can become the importer for that product.

The importer is an economic operator under the ATEX Directive and has specific obligations independent of the manufacturer's responsibilities.

Importer Responsibilities Before Placing an ATEX Product on the Market

The main obligations arise before the importer places the product on the Union market. Article 8 requires the importer to verify that the manufacturer has completed the applicable conformity and documentation requirements.

1. Verify the Appropriate Conformity Assessment Procedure

The importer must ensure that the appropriate conformity assessment procedure under Article 13 has been carried out by the manufacturer.

The importer does not perform that conformity assessment itself. The responsibility is to verify that the applicable procedure has been completed and that the required conformity documentation is available.

Depending on the equipment, protective system, category, and applicable conformity assessment route, the supporting documentation may involve a Notified Body certificate or other conformity assessment documents.

2. Ensure the Technical Documentation Has Been Prepared

The importer must ensure that the manufacturer has drawn up the required technical documentation.

This does not mean that the importer becomes responsible for preparing the technical file. The manufacturer remains responsible for establishing the technical documentation under Article 6.

The importer must, however, be able to ensure that the documentation can be made available to market surveillance authorities when required.

3. Verify the CE Marking

Where applicable, the importer must ensure that the product bears the CE marking.

The importer should also check that the marking is consistent with the product identification and accompanying conformity documentation.

4. Check the EU Declaration of Conformity or Attestation of Conformity

The importer must ensure that the product is accompanied by the applicable EU Declaration of Conformity or, where applicable, an attestation of conformity and the other documents required by the Directive.

The importer should check that the documentation identifies the relevant product or product model and is consistent with the manufacturer's identity and product information.

5. Verify Manufacturer Identification and Required Information

The importer must ensure that the manufacturer has complied with the applicable requirements concerning product identification and required information under Article 6.

This includes checking the manufacturer's name, registered trade name or trademark, and the postal address at which the manufacturer can be contacted, subject to the specific conditions in the Directive.

6. Check Instructions and Safety Information

The importer must ensure that the product is accompanied by the required instructions and safety information in a language that can be easily understood by end-users, as determined by the Member State concerned.

For ATEX equipment, this is particularly important because installation, commissioning, operation, maintenance, and limitations of use can directly affect the safe use of the equipment in potentially explosive atmospheres.

What If the Importer Suspects Nonconformity?

If an importer considers or has reason to believe that a product does not comply with the essential health and safety requirements of Annex II, the importer must not place the product on the market until it has been brought into conformity.

Where the product presents a risk, the importer must also inform the manufacturer and the relevant market surveillance authorities.

This means an importer cannot rely solely on the manufacturer's declaration if there is a reasonable basis to suspect that the product is non-compliant.

Importer Identification Requirements

When placing a product on the Union market, the importer must indicate its name, registered trade name or registered trade mark, and postal address at which it can be contacted.

This information should normally appear on the product. Where the size or nature of the product makes this impossible, the information may instead be provided on the packaging or in a document accompanying the product.

The contact information must be in a language that can be easily understood by end-users and market surveillance authorities.

Storage and Transport Responsibilities

The importer's responsibility does not end with documentation checks. While the product is under the importer's responsibility, its storage and transport conditions must not jeopardise compliance with the essential health and safety requirements in Annex II.

For explosion-protected equipment, appropriate handling can include protection against conditions that could damage the product or alter characteristics relevant to its conformity.

Examples may include:

• Preventing mechanical damage during transport.
• Protecting equipment from conditions that could compromise its conformity.
• Maintaining appropriate packaging and protection.
• Preventing unauthorised modification while the product is under the importer's responsibility.

Sample Testing by Importers

Article 8 also provides for sample testing where this is considered appropriate with regard to the risks presented by the product.

This is not an automatic requirement to test every ATEX product. Where appropriate, the importer may carry out sample testing of products made available on the market and investigate the results.

Where relevant, importers may also need to maintain records of complaints, non-conforming products, and product recalls and keep distributors informed of monitoring activities.

Corrective Action and Product Recall

If an importer considers or has reason to believe that a product already placed on the market is not in conformity with the ATEX Directive, the importer must take the necessary corrective measures.

Depending on the circumstances, this can include:

• Bringing the product into conformity.
• Withdrawing the product from the market.
• Recalling the product where appropriate.
• Informing the manufacturer.
• Informing the competent national authorities where the product presents a risk.

Where authorities need information about the product or corrective action, the importer must cooperate with them.

Importer Documentation Retention

Importers must keep a copy of the EU Declaration of Conformity or, where applicable, the attestation of conformity at the disposal of market surveillance authorities for 10 years after the product has been placed on the market.

The importer must also ensure that the technical documentation can be made available to market surveillance authorities upon request.

This is an important distinction: the importer is not necessarily required to maintain the manufacturer's complete technical file as its own document set, but must ensure that the documentation can be made available to authorities when required.

Cooperation With Market Surveillance Authorities

Following a reasoned request from a competent national authority, the importer must provide the information and documentation necessary to demonstrate product conformity.

The importer must also cooperate with competent national authorities on actions taken to eliminate risks posed by products that the importer has placed on the Union market.

This makes traceability and communication with the manufacturer important parts of the importer's compliance responsibilities.

When Does an Importer Become the Manufacturer?

An importer is not automatically the manufacturer simply because it imports a product.

However, Article 10 provides an important exception. An importer or distributor is treated as the manufacturer for the purposes of the ATEX Directive when it:

• Places the product on the market under its own name or trademark; or
• Modifies a product already placed on the market in such a way that compliance with the Directive may be affected.

In these circumstances, the economic operator assumes the obligations of the manufacturer under Article 6.

Importer vs Manufacturer vs Authorised Representative vs Distributor

Role	Primary Responsibility
Manufacturer	Designs/manufactures the product and is responsible for conformity assessment, technical documentation, EU Declaration of Conformity, and applicable markings.
Authorised Representative	Performs specified legally delegable tasks under a written mandate from the manufacturer.
Importer	Places a product from a third country on the Union market and verifies the manufacturer's compliance before doing so.
Distributor	Makes a product available on the market after it has been placed on the market and must act with due care regarding ATEX requirements.

Practical ATEX Importer Compliance Checklist

Before placing an imported explosion-protected product on the EU market, an importer can use the following checklist:

• Confirm the manufacturer's identity and contact information.
• Confirm the applicable ATEX conformity assessment procedure has been completed.
• Check the CE marking where applicable.
• Check the ATEX/product marking against the product documentation.
• Obtain the applicable EU Declaration of Conformity or attestation of conformity.
• Confirm that the manufacturer has prepared the required technical documentation.
• Confirm that required instructions and safety information accompany the product.
• Ensure importer identification is provided on the product, packaging, or accompanying documentation as permitted.
• Check that storage and transport conditions do not jeopardise conformity.
• Maintain the required conformity documentation for the applicable 10-year period.
• Establish a process for handling complaints, non-conforming products, corrective actions, and recalls where appropriate.
• Maintain sufficient traceability to respond to market surveillance authorities.

Common Misunderstandings About ATEX Importers

Does the Importer Have to Re-Certify the Product?

No. The importer must ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. The importer does not automatically perform a new ATEX conformity assessment.

Does the Importer Have to Prepare the Technical File?

No. The manufacturer is responsible for drawing up the technical documentation. The importer must ensure that the documentation has been prepared and that it can be made available to market surveillance authorities upon request.

Is an Importer the Same as an Authorised Representative?

No. An Authorised Representative acts under a written mandate from the manufacturer for specified tasks. An importer is an EU-established economic operator that places a product from a third country on the Union market and has separate obligations under Article 8.

Must an Importer Test Every Product?

No. The Directive provides for sample testing where considered appropriate with regard to the risks presented by the product. It does not require routine testing of every imported ATEX product.

Does Importing a Product Automatically Make the Company the Manufacturer?

No. The importer becomes subject to the manufacturer's obligations under Article 10 if it places the product on the market under its own name or trademark, or modifies the product in a way that may affect compliance.

Key Points

• An ATEX importer is an EU-established economic operator that places a product from a third country on the Union market.
• The importer must place only compliant products on the market.
• Before market placement, the importer must verify that the appropriate conformity assessment procedure has been carried out by the manufacturer.
• The importer must ensure that the manufacturer has prepared the required technical documentation.
• The importer must check the applicable CE marking, EU Declaration of Conformity or attestation of conformity, and required documentation.
• The importer must ensure that required instructions and safety information accompany the product.
• The importer must identify itself on the product, packaging, or accompanying documentation as permitted by the Directive.
• Storage and transport under the importer's responsibility must not jeopardise product conformity.
• Where appropriate based on product risk, the importer may need to conduct sample testing and monitor complaints or non-conforming products.
• The importer must take corrective action when it identifies nonconformity and notify authorities when the product presents a risk.
• The importer must retain a copy of the EU Declaration of Conformity or attestation of conformity for 10 years and ensure technical documentation can be made available upon request.
• An importer can assume manufacturer obligations under Article 10 if it uses its own name/trademark or makes modifications that may affect conformity.

References

• Directive 2014/34/EU – Article 3, Definitions.
• Directive 2014/34/EU – Article 6, Obligations of manufacturers.
• Directive 2014/34/EU – Article 7, Authorised representatives.
• Directive 2014/34/EU – Article 8, Obligations of importers.
• Directive 2014/34/EU – Article 9, Obligations of distributors.
• Directive 2014/34/EU – Article 10, Cases in which obligations of manufacturers apply to importers and distributors.
• Directive 2014/34/EU – Article 11, Identification of economic operators.
• Directive 2014/34/EU – Article 13, Conformity assessment procedures.