Initial Application to market in the EU organic products
from third Countries according to Article 19 Regulation
(EC) No. 1235/2008
Cert. no.:
Ref. no.:
IMPORTANT
 Before you start to complete this form, please read
the Notes for Guidance carefully.
 Please complete this form by a computer or use
block letters and black ink.
 Send the completed form, together with all the
required supporting documentation to the:
Ministry of Environment and Food of Denmark
The Danish AgriFish Agency
Administrative Area Control, Organic Farming
Nyropsgade 30
DK-1770 Copenhagen V
Denmark
Tel.
(+45) 3395 8000
E-mail: [email protected]
Section 1 – Details of the importer
1. Company
name
Country:
Full postal
address
Contact name
Telephone
Fax
Email address
Certification no.
Page 1 out of 11
Section 2 – Details of the first consignee in the EU
If it is not yet know which company/unit is going to receive the
products in Denmark, this has to be revealed together with the
arrival of the goods before their release.
Same as importer.
The first consignee is not yet known.
2. Company
name
Country:
Full postal
address
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
*delete as appropriate
Email address
3. Name of the
inspection body
of the first
consignee
The same inspection body as importer.
Name:
Full postal
address
Country:
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
Email address
Page 2 out of 11
*delete as appropriate
Section 3 – Details of product(s) to be imported
4. Third country from which the products
are to be imported:
5. Product list: Details of the agricultural products and/or feedstuffs which
are to be imported and estimated annual quantities.
English name
(Scientific) Name
CN-Code
*Please indicate start of the conversion period.
If necessary continue or attach the product list according to
item 4 on a separate sheet and tick this box.
If the product is composed of more than one ingredient, give
details of the ingredients and processing aids of each product
on the product specification sheet (Annex A). Use a separate
sheet for each product, attach the product label to it and tick
this box.
Page 3 out of 11
In conversion (C)*
Organic (O)
Estimated annual
quantity
(please specify
SI-unit: t, kg, l)
Product list (continued) in annex no. ___
Multi-ingredient product, see Annex A.
Section 4 – Details of the exporter in the third country
6. Company
name
Country:
Full postal
address
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
*delete as appropriate
Email address
7. Name of the
inspection body
of the exporter
Name:
Date of last inspection:
Full postal
address
Country:
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
*delete as appropriate
Email address
Proof of compliance with ISO 65 / EN 45011:
Confirmation/Accreditation
certificate enclosed.
Please provide evidence how equivalence of the certification
held by the suppliers of the exporter to Reg. (EC) No. 834/2007
and Reg. (EC) No. 889/2008 as amended is assessed by the
inspection body of the exporter.
Information
enclosed as annex no.___
If the exporter is inspected by more than one inspection body,
please provide name and address of all the other inspection bodies.
Information
enclosed as annex no.___
Page 4 out of 11
Only if different to question 6, give the name and address
of the third country body responsible for issuing the certificates of
inspection (Reg. (EC) No. 1235/2008 as amended) for the products
to be imported to the EU.
Not applicable.
8. Company
name
Country:
Full postal
address
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
*delete as appropriate
Email address
Section 5 – Details of the operator carrying out the most recent
production/processing operation in the third country
Please tick this box if the exporter and the operator carrying
out the most recent preparation operation in the third country
are identical. Then you do not need to complete section 4.
Same as exporter.
9. Company
name
Country:
Full postal
address
Contact name
*Mr/Mrs/Miss/Ms/Other (please specify)
Telephone
(+
)
Fax
(+
)
*delete as appropriate
Email address
10. Name of the
inspection body
of this operator
Same as for the exporter.
In other cases:
Name:
Date of last inspection:
Proof of compliance with ISO 65 / EN 45011:
Page 5 out of 11
Confirmation/Accreditation
certificate enclosed.
Section 6 – Details of the production/processing unit(s) and agricultural
holding(s) in the third country
Please tick the box below if more than three production/processing units and/or eight agricultural holdings are
involved. In this case, please attach a flowchart indicating the product flow and all preparation units as well as
agricultural holdings involved including the following information:
1. Production/processing units:
Name and address, third country, inspection body in the third country, date of last inspection. Please attach
copies of certificates.
2. Agricultural holdings:
Name and address, third country, inspection body in the third country, organic area, area under conversion
and conventional area, start of conversion period, date of first and last inspection
Please attach copies of certificates
If you enclose a flowchart including the necessary information to this application,
you do not need to complete item 11 and 13. However do not forget to complete item 12 and 14.
Flowchart enclosed as annex no. ___
11. Production/Processing units
Name and address
Third country
Date of last
inspection
A
Type of production/processing
Inspection Body
Tick if copy of certificate for
unit enclosed
Same as for the exporter.
Full Name
Address
Name and address
Proof of ISO 65 compliance*
Third country
Date of last
inspection
B
Type of production/processing
Inspection Body
Tick if copy of certificate for
unit enclosed
Same as for the exporter.
Full Name
Address
Name and address
Proof of ISO 65 compliance*
Third country
C
Page 6 out of 11
Date of last
inspection
Type of production/processing
Inspection Body
Full Name
Tick if copy of certificate for
unit enclosed
Same as for the exporter.
Address
Proof of ISO 65 compliance*
*Proof of ISO 65 – compliance for the inspection body:
Please quote numbers:
1: Option 1 (Accreditation EA/IAF-member)
2: Option 2 (Competent authority in the third country)
3: Option 3 (Competent EU-authority)
12. Production rules and inspection measures for production/processing units
in the third country
Please indicate whether there are differences between the
production rules and inspection measures in the third country
and the provisions of Reg. (EC) No. 834/2007 and Reg. (EC)
No. 889/2008.
No differences.
Differences see annex ___
13. Details of the agricultural holding(s)
Name(s) and address(es)
D
Organic, in conversion and
conventional area (ha)
Start of conversion
period
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
H
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
G
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
F
Date of last inspection
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
E
Date of first
inspection
Organic:
In conversion:
Conventional:
Page 7 out of 11
Tick if copy of
certificate for holding
enclosed
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
I
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
J
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
K
Tick if copy of
certificate for holding
enclosed
Organic:
In conversion:
Conventional:
Products produced / Status (Conventional (CO), in conversion (C), Organic (O))
Inspection Body
Full Name
Tick if copy of
certificate for holding
enclosed
Same as for the exporter.
Address
Proof of ISO 65 compliance*
*Proof of ISO 65 – compliance for the inspection body:
Please quote numbers:
1: Option 1 (Accreditation EA/IAF-member)
2: Option 2 (Competent authority in the third country)
3: Option 3 (Competent EU-authority)
14. Production rules and inspection measures for agricultural production units
in the third country
Do cooperatives, grower groups or contract growers
produce the product(s)?
No.
Yes, Annex B enclosed.
Please indicate whether there are differences between the
production rules and inspection measures in the third country
and the provisions of Reg. (EC) No. 834/2007 and Reg. (EC)
889/2008.
No differences.
Differences see annex ___
Section 7 – Supporting documentation
15. Documentation enclosed
Please enclose the latest inspection reports of the inspection body in the third country/third countries of the
companies and holdings involved. Documentation enclosed of:
The exporter
The production/processing unit(s)
The agricultural holding(s)
Page 8 out of 11
Section 8 – Declarations
16. Declaration of the inspection body of the exporter in the third country
The units and holdings mentioned in section 4 and 5 of this application are subject to production
rules as well as to control procedures regarding the production of organic products:

For every product mentioned in section 3 supplied by the exporter and received from the
suppliers mentioned in section 4 and 5, differences of the applied production rules and
control procedures from the requirements in Regulation (EC) No. 834/2007 and Regulation
(EC) No. 889/2008 as amended have been identified and examined.

Taking into account these differences, we consider the applied production rules to be at least
equivalent to those of Regulation (EC) No. 834/2007 and Regulation (EC) No. 889/2008 as
amended and the inspection measures to be as effective as the inspection measures
according to Regulation (EC) No. 834/2007 and Regulation (EC) No. 889/2008 as amended.
The inspection measures are permanently applied.

Feeding stuff, compound feedstuffs and feed materials are produced and labelled according
to Regulation (EC) No. 834/2007 and Regulation (EC) No. 889/2008.

A permanent system to ensure the non-utilization of GMO and GMO-derivatives is in place
on all stages of the production chain submitted to the inspection measures.
________________________
Date
Signature
Position in the company
Stamp
Name in block letters:
17. Declaration of the Danish importer:
I declare that:

I am familiar with the legal basis for imports of organic products from third countries and the
contents of the Notes for Guidance.

I am aware that every shipment has to be announced to the Danish AgriFish Agency,
Department of Organics, 24 hours or at least one complete working day before its release for
free circulation by the customs authorities.

The importer is at all times responsible for the observation of current organic rules either
provided by the EU or by the Danish legal system.

The importer has the responsibility to inform the Danish AgriFish Agency of any changes in
the production or inspection rules of the inspection bodies during the validity period of the
import authorization.

The importer accepts that import information is going to be published and stored in a national
database and in the EU-database OFIS with access limited to competent authorities and
control bodies.

The information provided in this application is correct to the best of my knowledge.
________________________
Date
Signature
Position in the company
Name in block letters:
Page 9 out of 11
Annex A
ONLY FOR USE IN THE CASE OF PRODUCTS WITH MORE THAN ONE INGREDIENT
AND/OR UTILIZATION OF PROCESSING AIDS
Name of the product:
Recipe of the product at the time of processing:
Name of ingredients
% weight
Organic agricultural
ingredients:
Sum
--------------------------------------------------------
Non-organic agricultural
ingredients:
Sum
--------------------------------------------------------
Ingredients of nonagricultural origin
(Reg. (EC) No. 889/2008 as
amended)
INS-No.
Sum
Total
100%
List of processing aids and other products used:
Processing aids and other
products (Reg. (EC)
No. 889/2008 as amended)
Page 10 out of 11
Annex B
ONLY FOR USE IN THE CASE OF GROWER GROUPS
18. Details of the grower group
Type of group:
Co-operative
Contract growers
Other (please specify), see annex___
Number of small-scale farmers at the date of last inspection:
19. Internal control system (ICS)
Note: Tick the corresponding box. If Yes: please include a page reference to the last
Inspection report of the external inspection body responsible for the grower group.
Grower contracts covering compliance with organic standards and ICS available?
Yes, see _________
No
Defined responsibilities in the management of the grower group for the ICS?
Yes, see _________
No
Description of each small-scale farm including maps of land parcels, preparation and
storage facilities available?
Yes, see _________
No
Technical Assistance and internal inspection separated?
Yes, see _________
No
Internal inspection conducted at least one a year, covering 100% of small-scale farmers
per year?
Yes, see _________
No
Sanctions imposed by the grower group itself on members due to irregularities?
Yes, see _________
No
20. External inspection
Note: Tick the corresponding box. If Yes: please include a page reference to the last
report of the external inspection body responsible for the grower group.
Number of small-scale farmers externally inspected at the date of last inspection:
Percentage of small-scale farmers externally inspected at the date of last inspection:
ICS evaluated by the inspection body?
Yes, see _________
No
Functionality and effectiveness of the ICS confirmed by the inspection body?
Yes, see _________
No
Page 11 out of 11
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