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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
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Last updated:
10/07/2008
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