Commission Regulation (EC) No 345/2008 of 17 April 2008 laying down detailed rules for implementing the arrangements for imports from third countries provided for in Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs (Recast) (Text with EEA relevance)
Date: 2008-04-17
Institutions: European Commission
Subjects: access to information, agricultural product, foodstuff, import policy, marketing, organic farming, third country

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COMMISSION REGULATION (EC) No 345/2008

of 17 April 2008

laying down detailed rules for implementing the arrangements for imports from third countries
provided for in Council Regulation (EEC) No 2092/91 on organic production of agricultural
products and indications referring thereto on agricultural products and foodstuffs

(Recast)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

The measures provided for in this Regulation are in
accordance with the opinion of the Committee referred
to in Article 14(1) of Regulation (EEC) No 2092/91,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 2092/91 of
24 June 1991 on organic production of agricultural products
and indications referring thereto on agricultural products and
foodstuffs (1), and in particular Article 11(4) thereof,

Whereas:

Commission Regulation (EEC) No 94/92 of 14 January
1992 laying down detailed rules for implementing the
arrangements for imports from third countries provided
in Regulation (EEC) No 2092/91 on organic
for
production of agricultural products and indications
referring thereto on agricultural products and food-
stuffs (2)
several
times (3). Since further amendments are to be made,
it
should be recast in the interests of clarity and rationality.

substantially

amended

been

has

HAS ADOPTED THIS REGULATION:

Article 1

The list of third countries referred to in Article 11(4) of Regu-
lation (EEC) No 2092/91 is set out in Annex I to this Regu-
lation.

This list gives all the information deemed necessary in respect of
each third country to permit
the identification of products
covered by the rules laid down in Article 11(3) and (4) of
Regulation (EEC) No 2092/91 and particularly:

(a)

the authority or the body or bodies responsible in the third
country for issuing inspection certificates with a view to
importing into the Community;

Regulation (EEC) No 2092/91 stipulates that products
which are imported from a third country may be
marketed where they originate in a third country
applying production rules
and inspection measures
equivalent to those in the Community and appearing in
a list to be drawn up by the Commission.

That list should be drawn up. Furthermore, detailed rules
should be laid down for the procedure for examining an
application by a third country with a view to its
inclusion in the list.

(b) the inspection authority or authorities in the third country
and/or the private bodies recognised by the said third
country to carry out supervision.

Furthermore, where relevant, the list may state:

— the preparation units and exporters subject to the system of

inspection,

For the operation of the regime for each third country,
the bodies
issuing the certificate of
inspection referred to in Article 11(3)(d) of Regulation
(EEC) No 2092/91 should be identified.

responsible for

— the products covered by the rules.

(1) OJ L 198, 22.7.1991, p. 1. Regulation as

last amended by
Commission Regulation (EC) No 123/2008 (OJ L 38, 12.2.2008,
p. 3).

(2) OJ L 11, 17.1.1992, p. 14. Regulation as last amended by Regu-

lation (EC) No 956/2006 (OJ L 175, 29.6.2006, p. 41).

(3) See Annex II.

Article 2

1.
The Commission shall consider whether to include a third
country in the list in Annex I upon receipt of an application for
inclusion from the
third country
representative of
concerned.

the

(1)

(2)

(3)

(4)

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2. Within a period of six months from its receipt, the appli-
cation for inclusion shall be completed by a technical dossier,
established in one of the official Community languages and
comprising all the information needed for the Commission to
ensure that the conditions set out in Article 11(3) of Regulation
(EEC) No 2092/91 are met for products intended for export to
the Community.

(iv) the information needed on the organisation of

the
monitoring of compliance with the rules governing
production and the inspection system,
including the
issue of certificates; the name and the particulars of
the authority responsible for the said monitoring;

In particular,
mation:

it shall comprise the following detailed infor-

(v) the list of processing units and exporters

to the
Community; the number of producers and the area in
cultivation;

(a)

the types and, if possible, an estimate of the quantities of
agricultural products and foodstuffs intended for export to
the Community under the rules set out in Article 11(3) and
(4) of Regulation (EEC) No 2092/91;

(b) the rules of production applied in the third country,

in

particular:

(i) the basic principles as set out in Annex I to Regulation

(EEC) No 2092/91;

(ii) the products authorised for use during the agricultural
production stage, namely plant protection products,
detergents, fertilisers or soil improvement products;

(iii) the ingredients of non-agricultural origin authorised in
processed products, and the processes and treatments
authorised during processing;

(c)

the rules on the inspection system and the organisation of
the implementation of this system in the third country:

(i) the name of any authority responsible for inspection in
the third country and/or the private bodies in charge of
carrying out inspections;

(ii) detailed rules for inspections on agricultural holdings
and in preparation units, and the penalties which may
be imposed in the event of infringements;

(iii) the name(s) and address(es) of the authority or the body
or bodies responsible in the third country for issuing
certificates for imports into the Community;

(d) if available, the on-the-spot examination reports established
by independent experts on the effective implementation of
the production rules and inspection rules referred to in (b)
and (c).

an application for

3. When examining
inclusion the
Commission may request any further information needed to
establish that the rules governing production and inspection
in the third country are equivalent to those laid down in Regu-
lation (EEC) No 2092/91, including the presentation of on-the-
spot examination reports established by experts whose inde-
pendence was recognised by the Commission. Furthermore,
where necessary, the Commission may proceed to an on-the-
spot examination by experts designated by it.

4.
The inclusion of a third country in the list in Annex I may
be linked to the condition that regular on-the-spot examination
reports established by independent experts be presented on the
effective implementation of the production rules and inspection
rules
third country concerned. Moreover, where
necessary, the Commission may organise an on-the-spot exa-
mination by experts designated by it.

in the

If, after a third country has been included in the list in
5.
Annex I, any changes are made to the measures in force in the
third country or their implementation, that third country shall
notify the Commission thereof. In the light of such information,
inclusion
a decision may be taken to amend the details of
relating to the third country in Annex I or to withdraw the
entry of that country, in accordance with the procedure referred
to in Article 14(2) of Regulation (EEC) No 2092/91; a similar
decision may also be made where a third country has not
supplied information required under this paragraph.

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If, after a third country has been included in the list in
6.
Annex I, the Commission obtains information raising doubts as
to the actual implementation of the measures described, it may
ask the third country concerned for any information required,
including the presentation of on-the-spot examination reports
established by independent experts, or it may proceed to enable
on-the-spot examination by experts designated by it. In the light
of such information and/or reports, a decision may be made to
suspend inclusion, in accordance with the procedure referred to
in Article 14(2) of Regulation (EEC) No 2092/91; a similar
decision may also be made in cases where a third country
has not supplied the information requested by the final date
specified in the Commission’s request or where a third country
has not agreed to an on-the-spot
investigation to establish
compliance with the conditions for inclusion.

Article 3

Regulation (EEC) No 94/92 is repealed.

References to the repealed Regulation shall be construed as
references to this Regulation and shall be read in accordance
with the correlation table in Annex III.

Article 4

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 April 2008.

For the Commission
The President

José Manuel BARROSO

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ANNEX I

LIST OF THIRD COUNTRIES AND RELEVANT SPECIFICATIONS

ARGENTINA

1. Product categories:

(a) unprocessed crop products and livestock and unprocessed livestock products within the meaning of Article 1(1)(a)

of Regulation (EEC) No 2092/91, with the exception of:

— livestock and livestock products, bearing or intended to bear indications referring to conversion;

(b) processed agricultural crop and livestock products intended for human consumption within the meaning of

Article 1(1)(b) of Regulation (EEC) No 2092/91, with the exception of:

— livestock products bearing or intended to bear indications referring to conversion.

2. Origin: Products of category 1(a) and organically produced ingredients in products of category 1(b) that have been

produced in Argentina.

3.

Inspection bodies:

— Instituto Argentino para la Certificación y Promoción de Productos Agropecuarios Orgánicos SRL (Argencert),

— Organización Internacional Agropecuaria (OIA),

— Letis SA,

— Food Safety SA.

4. Certificate issuing bodies: as at point 3.

5. Duration of the inclusion: 30 June 2013.

AUSTRALIA

1. Product categories:

(a) unprocessed crop products within the meaning of Article 1(1)(a) of Regulation (EEC) No 2092/91,

(b) foodstuffs composed essentially of one or more ingredients of plant origin within the meaning of Article 1(1)(b) of

Regulation (EEC) No 2092/91.

2. Origin: products of category 1(a) and organically grown ingredients in products of category 1(b) that have been

grown in Australia.

3.

Inspection bodies:

— Australian Quarantine and Inspection Service (AQIS) (Department of Agriculture, Fisheries and Forestry),

— Bio-dynamic Research Institute (BDRI),

— Organic Food Chain Pty Ltd (OFC),

— National Association of Sustainable Agriculture, Australia (NASAA),

— Australian Certified Organic Pty. Ltd.

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4. Certificate issuing bodies: as at point 3.

5. Duration of the inclusion: 30 June 2013.

COSTA RICA

1. Product categories:

(a) unprocessed crop products within the meaning of Article 1(1)(a) of Regulation (EEC) No 2092/91;

(b) processed crop products intended for human consumption within the meaning of Article 1(1)(b) of Regulation

(EEC) No 2092/91.

2. Origin:

Products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced
in Costa Rica.

3.

Inspection bodies: Eco-LOGICA and BCS Oko-Garantie.

4. Certificate issuing bodies: Ministerio de Agricultura y Ganadería.

5. Duration of the inclusion: 30 June 2011.

INDIA

1. Product categories:

(a) unprocessed crop products within the meaning of Article 1(1)(a) of Regulation (EEC) No 2092/91;

(b) foodstuffs composed essentially of one or more ingredients of plant origin within the meaning of Article 1(1)(b) of

Regulation (EEC) No 2092/91.

2. Origin: products of category 1(a) and organically grown ingredients in products of category 1(b) that have been

grown in India.

3.

Inspection bodies:

— Bureau Veritas Certification India Pvt. Ltd,

— Ecocert SA (India Branch Office),

— IMO Control Private Limited,

— Indian Organic Certification Agency (Indocert),

— Lacon Quality Certification Pvt. Ltd,

— Natural Organic Certification Association,

— OneCert Asia Agri Certification private Limited,

— SGS India Pvt. Ltd,

— Control Union Certifications,

— Uttaranchal State Organic Certification Agency (USOCA),

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— APOF Organic Certification Agency (AOCA),

— Rajasthan Organic Certification Agency (ROCA).

4. Certificate issuing bodies: as at point 3.

5. Duration of the inclusion: 30 June 2009.

ISRAEL

1. Product categories:

(a) unprocessed crop products within the meaning of Article 1(1)(a) of Regulation (EEC) No 2092/91;

(b) foodstuffs composed essentially of one or more ingredients of plant origin within the meaning of Article 1(1)(b) of

Regulation (EEC) No 2092/91.

2. Origin: Products of category 1(a) and organically produced ingredients in products of category 1(b) that have been

produced in Israel or that have been imported into Israel:

— either from the Community,

— or from a third country in the framework of a regime which is recognised as equivalent in accordance with the

provisions of Article 11(4) of Regulation (EEC) No 2092/91.

3.

Inspection bodies:

— Skal Israel Inspection & Certification,

— AGRIOR Ltd-Organic Inspection & Certification,

— IQC Institute of Quality & Control,

— Plant Protection and Inspection Services (PPIS) (Ministry of Agriculture and Rural Development).

4. Certificate issuing bodies: as at point 3.

5. Duration of the inclusion: 30 June 2013.

SWITZERLAND

1. Product categories:

(a) unprocessed crop products and livestock and unprocessed livestock products within the meaning of Article 1(1)(a)

of Regulation (EEC) No 2092/91, with the exception of:

— products, produced during the conversion period, as referred to in Article 5(5) of that Regulation;

(b) processed agricultural crop and livestock products intended for human consumption within the meaning of

Article 1(1)(b) of Regulation (EEC) No 2092/91, with the exception of:

— products, as referred to in Article 5(5) of that Regulation, containing an ingredient of agricultural origin

produced during the conversion period.

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2. Origin: Products of category 1(a) and organically produced ingredients in products of category 1(b) that have been

produced in Switzerland or that have been imported into Switzerland:

— either from the Community,

— or from a third country in the framework of a regime which is recognised as equivalent in accordance with the

provisions of Article 11(4) of Regulation (EEC) No 2092/91,

— or from a third country for which a Member State has recognised,

in accordance with the provisions of
Article 11(6) of Regulation (EEC) No 2092/91, that the same product has been produced and inspected in
that country under the same arrangements as accepted by the Member State,

— or from a third country whose production rules and inspection system have been recognised by Switzerland as

being equivalent to those established under Swiss legislation.

3.

Inspection bodies:

— Institut für Marktökologie (IMO),

— bio.inspecta AG,

— Schweizerische Vereinigung für Qualitäts- und Management-Systeme (SQS),

— Bio Test Agro (BTA),

— ProCert Safety AG.

4. Certificate issuing bodies: as at point 3.

5. Duration of the inclusion: 30 June 2013.

NEW ZEALAND

1. Product categories:

(a) unprocessed agricultural crop products,

livestock and unprocessed livestock products within the meaning of

Article 1(1)(a) of Regulation (EEC) No 2092/91, with the exception of:

— livestock and livestock products bearing or intended to bear indications referring to conversion,

— products from aquaculture;

(b) processed agricultural crop and livestock products intended for human consumption within the meaning of

Article 1(1)(b) of Regulation (EEC) No 2092/91, with the exception of:

— livestock products bearing or intended to bear indications referring to conversion,

— products containing products from aquaculture.

2. Origin:

Products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced
in New Zealand or that have been imported into New Zealand:

— either from the Community,

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— or from a third country within the framework of a regime which is recognised as equivalent in accordance with

the provisions of Article 11(4) of Regulation (EEC) No 2092/91,

— or from a third country whose rules of production and inspection system have been recognised as equivalent to
the MAF Food Official Organic Assurance Programme on the basis of assurances and information provided by this
country’s competent authority in accordance with the provisions established by MAF and provided that only
organically produced ingredients intended to be incorporated, up to a maximum of 5 % of products of agricultural
origin, in products of category 1(b) prepared in New Zealand are imported.

3.

Inspection bodies:

— AsureQuality Ltd,

— BIO-GRO New Zealand.

4. Certificate issuing body: Ministry of Agriculture and Forestry (MAF) — New Zealand Food Safety Authority

(NZFSA).

5. Duration of the inclusion: 30 June 2011.

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ANNEX II

Repealed Regulation with list of its successive amendments

Commission Regulation (EEC) No 94/92
(OJ L 11, 17.1.1992, p. 14).

Commission Regulation (EC) No 522/96
(OJ L 77, 27.3.1996, p. 10).

Commission Regulation (EC) No 314/97
(OJ L 51, 21.2.1997, p. 34).

Commission Regulation (EC) No 1367/98
(OJ L 185, 30.6.1998, p. 11).

Commission Regulation (EC) No 548/2000
(OJ L 67, 15.3.2000, p. 12).

Commission Regulation (EC) No 1566/2000
(OJ L 180, 19.7.2000, p. 17).

Commission Regulation (EC) No 1616/2000
(OJ L 185, 25.7.2000, p. 62).

Commission Regulation (EC) No 2426/2000
(OJ L 279, 1.11.2000, p. 19).

Commission Regulation (EC) No 349/2001
(OJ L 52, 22.2.2001, p. 14).

Commission Regulation (EC) No 2589/2001
(OJ L 345, 29.12.2001, p. 18).

Commission Regulation (EC) No 1162/2002
(OJ L 170, 29.6.2002, p. 44).

Commission Regulation (EC) No 2382/2002
(OJ L 358, 31.12.2002, p. 120).

Commission Regulation (EC) No 545/2003
(OJ L 81, 28.3.2003, p. 10).

Commission Regulation (EC) No 2144/2003
(OJ L 322, 9.12.2003, p. 3).

Commission Regulation (EC) No 746/2004
(OJ L 122, 26.4.2004, p. 10).

Commission Regulation (EC) No 956/2006
(OJ L 175, 29.6.2006, p. 41).

Article 1 only

Article 2 only

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ANNEX III

Correlation table

Regulation (EEC) No 94/92

This Regulation

Article 1, first paragraph

Article 1, first paragraph

Article 1, second paragraph, introductory wording

Article 1, second paragraph, introductory wording

Article 1, second paragraph, first indent

Article 1, second paragraph, point (a)

Article 1, second paragraph, second indent

Article 1, second paragraph, point (b)

Article 1, third paragraph

Article 1, third paragraph

Article 2(1)

Article 2(1)

Article 2(2), first sentence

Article 2(2), first subparagraph

Article 2(2), introductory words

Article 2(2), second subparagraph, introductory wording

Article 2(2)(a)

Article 2(2)(a)

Article 2(2)(b), introductory wording

Article 2(2)(b), introductory wording

Article 2(2)(b), first indent

Article 2(2)(b), second indent

Article 2(2)(b), third indent

Article 2(2)(b)(i)

Article 2(2)(b)(ii)

Article 2(2)(b)(iii)

Article 2(2)(c), introductory wording

Article 2(2)(c), introductory wording

Article 2(2)(c), first indent

Article 2(2)(c), second indent

Article 2(2)(c), third indent

Article 2(2)(c), fourth indent

Article 2(2)(c), fifth indent

Article 2(2)(d)

Article 2(3) to (6)

—

Article 3

Annex

—

—

Article 2(2)(c)(i)

Article 2(2)(c)(ii)

Article 2(2)(c)(iii)

Article 2(2)(c)(iv)

Article 2(2)(c)(v)

Article 2(2)(d)

Article 2(3) to (6)

Article 3

Article 4

Annex I

Annex II

Annex III