End of December 2006 and shortly before Christmas break, the European Council decided on amending the EU Regulation regarding import.

Confusion
The firstly published Regulation (EC) No. 1997/2006 of 19th December 2006 has meanwhile been cancelled and Regulation (EG) No. 1991/2006 of 21st December 2006 (published: ABl. L 411 of 30.12.2006) has been officially reported to be the valid version.

Facts

1. The new import Regulation (EC) No. 1991/2006 came into force on 1 January 2007, however the present procedures will fully be applied during a transitional period of approx. 2 years.
2. The procedure for accepting Third Countries’ inspection systems remains (Third Country List; Art. 11.1 in the old Regulation).
3. The system of import authorizations, up to now the most common method of importing, has been taken out (former Art. 11.6), but will continue to be applied under a transitional period of probably more than 2 years.
4. The customs is not longer involved.
5. Two new systems for approving individual inspection (certification) bodies active in Third Countries have been introduced.
   a) One system is where the certification is conducted directly to the EU Regulation and
   b) The other is where the certification is carried out to an equivalent standard.

Recognition of Third Countries
Art. 11 (3) and (4)
The new system where the EU Commission can accept another country‘s inspection and certification system (including national standards) is almost the same as in article 11.1 of the previous regulation. To accept the national inspection system, the Third Country has to follow:
a) standards that are EQUIVALENT to the EU Regulation;
b) The inspection arrangements have to be EQUIVALENT.
c) The Codex Alimentarius Guidelines have to be taken into account.

Recognition of an inspection body or authority – Compliance
COMPLIANCE / KONFORMITÄT Art. 11 (2)

• The EU-Commission is directly responsible for the recognition of the inspection bodies.
• Inspection is conducted directly to the EU Regulation.
• The inspection bodies need to be accredited according ISO 65.
• Constant supervision of the inspection bodies by the Commission with the help of the member states; based on risk assessment.
• Transaction certificates are NOT required.

The first method for acceptance of an inspection body is where the production method fully complies with the EU Regulation, meaning that the scope of inspection is Regulation (EC) No. 2092/91 itself, regardless in which country the inspection is conducted. The inspection bodies have to be accredited to EN 45011/ISO 65, which implies that they have to undergo a regular on-the-spot evaluation, monitoring and multi-annual re-assessment of their activities by the accreditation body. The Commission is responsible for the recognition of the inspection bodies and can use experts for examining the performance and can be assisted by the Member States. It is also stated that the nature of the supervision of the inspection body shall be based on the risk of occurrence of fraud by the operators. A detailed description of procedures how this will be implemented is not yet in place.

Recognition of an inspection body or authority – Equivalence
EQUIVALENCE / GLEICHWERTIGKEIT Art. 11 (5)

• Commission is directly responsible for the recognition of the inspection bodies.
• Inspection is conducted according to a standard which is equivalent to the EU-Regulation.
• Constant supervision of the inspection bodies by the Commission with the help of the member states; based on risk assessment.
• Accreditation according ISO 65 is not a must but Codex Alimentarius will be taken into account.
• Transaction certificates are required.

The second possibility for acceptance of an inspection body applies for organizations, who conduct inspections to an equivalent standard to the EU Regulation. The registration procedure is quite similar to that described above for the bodies inspecting directly to the EU Regulation: the Commission is responsible for the recognition of the inspection bodies and their constant supervision. The assessment of equivalence will take Codex Alimentarius guidelines into account, however an accreditation to EN 45011/ISO65 is not stated as a requirement.

In contrary to the registration procedure of compliant inspection bodies, equivalent inspection bodies will have to provide for inspection certificates (transaction certificates), meaning that each consignment has to be accompanied by such a documents as it has been the case for all imports from Third countries so far.

Transitional system Art. 11 (6)

• No changes in the import procedures for the time being.
• The system will expire 12 months after the Commission has published the first list of inspection bodies.
• 24 month after the list is published the import authorisations (Art. 11.6) will expire.

As a matter of fact, for the time being there will be no chance in the import procedures! Until the new system is in place and inspection bodies have been officially approved by the Commission the previous system described in article 11.6 – the so called import authorizations – will continue. For all products imported from non EEC countries – with the exception of countries listed on the Third Country list – import authorizations have still to be requested from the competent authorities. The regime of transaction certificates including customs stamp and confirmation of the first consignee will be fully applied.
This system will expire 12 months after the Commission have published the first list of approved inspection bodies and authorities that are approved for working with standards deemed to be equivalent to the EU Regulation. Twenty-four months after the list is published the import authorisations to 11.6 will expire. All authorisations for
Imports that have been given before the last of December 2006 will expire at the end of December 2007.