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Europe: questions on new import rules

A new Council regulation, EC1991/2006 for entry of organic products into the European Union from third countries, was published in December 2006. This regulation has since been incorporated into Regulation EC834/2007 published in June 2007 which will replace the existing Regulation EC2092/1991 at the beginning of 2009.

Although the detailed implementation rules referenced in the regulation are still to be finalised during 2008, we know enough to be confident that the IOAS will have a role in assessment of the work of certification bodies outside Europe to facilitate product access. The answers below should be taken as our best understanding of how the system will work. Definitive answers cannot be provided until the detailed rules have been published.

ACCREDITATION OR NOT?
Q. Will I have to be accredited to work as a certification body (CB) in Europe?
A. Yes. Up to now formal accreditation was not required by the Regulation. Under the new rules, all CBs based in EU Member States will have to be accredited against ISO/IEC65 by the national accreditation body (AB) (the revised 'New Approach' under separate legislation will mean that there will only be one body able to perform the accreditation in each Member State). This accreditation will be the basis for approval by the competent authority.

Q. Will I have to be accredited to certify product exported to Europe?
A. Not necessarily. Although formal accreditation will not be required for the equivalence option, comparable measures must be in place as well as ongoing supervision by an independent body regardless of whether or not you are based in a third country recognised as equivalent.

COMPLIANCE AND EQUIVALENCE
Q. As a non EU CB what are my options?
A. Regulation 834/2007 sees two main routes; compliance as outlined in article 32 and equivalence in article 33.

Q. What is the compliance route?
A. Compliance means that all requirements of EC834/2007 are fully met including any relating implementing rules and that the control body is formally accredited against EN45011 (ISO/IEC 65) with ongoing surveillance. This accreditation will be the basis for approval by the Commission with assistance from the Member State authorities. At a meeting at Biofach 2007, the Commission clarified that compliance will mean precise compliance with all parts of the regulation and implementing rules and may not be an achievable option for non-EU CBs e.g. the need for a seed database maintained by your government. Transaction certificates will not be required but should be available if requested.

Q. What is the equivalence route?
A. In fact there are two equivalence routes. One is the existing system of recognition of a Third Country and the published list of recognised Third Countries ( Article 33.2). The other is new (Article 33.3) and allows for individual CBs based anywhere in the world to apply for recognition as providing equivalent controls. Recognition will require submission of evidence of equivalence of the standards being applied as well as equivalence to both ISO guide 65 and the special inspection measures specified in the regulation. The CB must also provide evidence that it is subjected to on-site assessment, surveillance and reassessment by a supervisory body similar to that carried out in formal accreditation. This assessment will form the basis for approval by the Commission assisted by the Member States. Under the equivalence route, transaction certificates are obligatory.

FOREIGN ACTIVITY
Q. As an EU CB with activity outside of Europe, will the accreditation by my national AB be sufficient?
A. The Commission has recognised the loophole that has allowed EU-based CBs to use their accreditation to cover their foreign activity when the scope is usually limited to their activity within their home country. Under the new rules, EU-based CBs will have to demonstrate compliance or equivalence for foreign activity in the same way as third country CBs.

Q. As a non-EU CB based in a recognised Third Country but with activity outside my home country, will the Third Country recognition cover that activity.
A. No. As above the Commission wish to ensure that surveillance covers at least a sample of foreign activity and such activity is generally not within the remit of your national authority.

Q. How will it be made known that a CB is recognised?
A. The Commission will publish lists corresponding with the three routes described above; one for compliance and two for equivalence. A CB may appear on more than one list.

IOAS ROLE
Q. How will the IOAS be involved?
A. The IOAS expect to be primarily involved in assisting CBs with demonstrating their equivalence under Article 33.3. This will apply to 1) all non-EU CBs not in a recognised Third Country; 2) all EU CBs with foreign activity not covered by their national AB; and 3) all non-EU CBs based in a recognised Third Country but with activity outside of the scope and region of the recognition. It is not yet clear whether the IOAS will assess compliance outside Europe.

Q. Why would I choose the IOAS to perform this service?
A. Many reasons. We have been involved in accreditation of organic CBs for 15 years, we already work on an international level and our commitment is to organic integrity. We can now offer various accreditations (IFOAM, Canada, EU, ISO65) based on one assessment and at costs well below that for individual accreditations. For example an EU CB with international activity may also need Canadian accreditation. We believe we will be able to offer that Canadian accreditation combined with equivalency oversight for the EU exports more economically than any other option available

Q. What are the options if I apply to IOAS for an equivalence assessment under the European import regime?
A. There are two options. The first is a formal accreditation against ISO/IEC65 with a scope of equivalence to the EU regulation. The second is not a formal accreditation but an assessment of equivalence against both ISO/IEC65 and the EU regulation. Both involve similar procedures of assessment and surveillance but the latter option allows more flexibility relating to certification body requirements.

COST
Q. What will these two options cost?
A. Both options will cost the same. As an existing IOAS client, adding this accreditation or assessment will cost an application fee of US$2000 and depending on the timing of your application relative to your accreditation cycle, 1 or 2 days extra visit fees.

Q. And if I am not already an IOAS client?
A. If you are not already an IOAS client there is an application fee of US$5000 and a visit fee based on the number of site visit days which is typically in the region of US$5000. Please consult our fee schedule available at www.ioas.org/fees.htm for full details.

WHEN TO APPLY
Q. When should I apply?
A. The Commission hope to finalise the implementing rules under a separate regulation by October 2008 and the current draft (March 25, 2008) anticipates a period of 12 months for initial applications for equivalence and 3 years for compliance. The Commission will be assisted in the assessment of the applications by the Member States after which the initial lists will be published. Therefore in order to be ready for this and appear on the first listing, CBs should contact the IOAS as soon as possible to discuss their needs so that we can provide a timely service.

Q. How will the new rules be introduced?
A. In order not to upset market supply and the livelihoods of suppliers, the Commission will phase out the old system of import authorisations. Member State Competent Authorities will continue to be able to issue import authorisations for a period of 12 months after publication of the first lists. No authorisations will be valid for more than 24 months after the first lists are published.

For more information, contact info@ioas.org

Last updated: 10/07/2008

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