Non-EU Importation
Non-EU Importation of Machinery and Partly Completed Machinery.
Purchasing machinery from a non-EU supplier, such as China, Taiwan, India, or other countries, is a common practice in the Italian manufacturing industry. However, it entails specific and often underestimated responsibilities. Anyone importing machinery from outside the European Union automatically assumes the role of manufacturer under the new Regulation (EU) 2023/1230. MTM Consulting guides companies through this process, which is often more complex than expected.
importer liability
When importing machinery from a non-EU country, the importer must ensure the product’s compliance with European directives and regulations. In practice, this means:
- Verifying that the machinery complies with the Essential Health and Safety Requirements (EHSR) of the Machinery Regulation
- Ensuring that a complete and compliant technical file exists
- Verifying or preparing the instructions for use in the language of the country where the machinery is imported (for example, Italian).
- Verifying that the EU declaration is correct and signed by the manufacturer. The declaration may contain references to the importer.
- Ensuring that the affixed CE marking is correct and not misleading
- Ensuring that the technical file is available for at least 10 years from the date of importation and can be presented to the Supervisory Authority upon request
The concrete risks of poorly managed compliance
The CE marking affixed by a Chinese or non-European supplier is not, in itself, a guarantee of compliance. Many non-EU manufacturers affix the CE marking without having correctly completed the conformity assessment process. In the event of an accident, authorities trace back the chain of responsibility, and the Italian importer finds themselves exposed to sanctions, as well as civil and criminal liability. MTM has managed hundreds of cases of documentary verification on imported machinery.
How MTM Consulting supports importers
- Documentary audit of the CE compliance of the imported machinery
- Verification of the completeness and correctness of the technical file created by the non-EU manufacturer
- Analysis of the applicable EHSRs and verification of coverage in the documentation
- Drafting or integration of the EU Declaration of Conformity (until recently known as the EC Declaration of Conformity)
- Translation and adaptation of the instructions for use
- Definition of corrective actions in case of non-compliance
- Support in managing post-import modifications
The transition to Regulation (EU) 2023/1230
With the new Machinery Regulation (EU) 2023/1230, mandatory from January 20, 2027, the responsibilities of importers are further strengthened. The regulation introduces specific obligations for economic operators established in the EU who import from third countries. MTM Consulting supports companies in the transition, evaluating the implications of the new regulatory framework for each imported machine.
RESOURCES.
- Directive 2006/42/EC - Machinery Directive
- Machinery Regulation (EU) 2023/1230
- Directive 2014/34/EU - ATEX Directive
- Directive 2014/68/EU - PED Directive
- Directive 2014/35/EU - Low Voltage Directive
- Directive 2014/30/EU - Electromagnetic Compatibility Directive
- Directive 2012/19/EU - WEEE Directive
- Directive 2011/65/EU - RoHS Directive
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