ERA-GUI-100.pdf - Europa

Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011
on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0
7.6.2 I have my residence outside the EU
According to the recital (7) of ECM Regulation, “Certificates issued by certification bodies in third
countries appointed under equivalent criteria and meeting equivalent requirements to those
contained in this Regulation should normally be accepted as being equivalent to the ECM
certificates issued in the Union”. No other provision of the ECM Regulation deals with certificates
issued by certification bodies in third countries.
This means that Member States should accept under certain conditions ECM certificates issued by
certification bodies established in third countries. In doing so, the Member States should in
principle:
• Ensure that such certification bodies comply with the general criteria and
principles set out in Annex II of the ECM Regulation and any subsequent
accreditation scheme and;
• Ensure that decisions taken by certification bodies established in third countries
are subject to judicial review (as required under Art 6(3) of the ECM
Regulation), and;
• Ensure that such certification bodies are themselves accredited by a national
accreditation body in the sense of Regulation 765/2008.
Regulation No 765/2008 also allows for accreditation of non-EU certification bodies by non
EU national accreditation bodies (See in particular the reference made to “a peer evaluation
system among national accreditation bodies from the Member States and other European
countries” in recital (23) of this Regulation).
Article 11(2) of Regulation 765/2008 provides that “National authorities shall recognise the
equivalence of the services delivered by those accreditation bodies which have successfully
undergone peer evaluation under Article 10, and thereby accept, on the basis of the
presumption referred to in paragraph 1 of this Article, the accreditation certificates of those
bodies and the attestations issued by the conformity assessment bodies accredited by
them”. This means that accreditation certificates delivered by a recognized
accreditation body and certificates issued by accredited certification bodies should
be recognized within the EU.
Even if certification bodies established in third countries are not directly governed by the
ECM Regulation, they still need to comply with the obligations and tasks imposed on
certification bodies by the ECM regulation so that the certificates delivered to entities in
charge of the maintenance for freight wagons used in the EU be recognised as valid.
For a certification body granting an ECM certificate or an accreditation body accrediting a
certification body, the following cases may apply:
• The certification body has its residence inside or outside the EU;
• The accreditation body has its residence inside or outside the EU.
The table below presents the possible scenarios:
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