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30.4.2013 Official
Journal
of
the
European
Union L
118/5
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 392/2013
of 29 April 2013
amending Regulation (EC) No 889/2008 as regards the control system for organic production
THE EUROPEAN COMMISSION,
number of samples to be taken and analysed by control
authorities or control bodies every year on the basis of
the general evaluation of the risk of non-compliance with
Having regard to the Treaty on the Functioning of the European
the organic production rules. Where the control auth
Union,
orities or control bodies has suspicion that products
not authorised for organic production are used, they
should take and analyse samples of the products
Having regard to Council Regulation (EC) No 834/2007 of
concerned. In such cases no minimum number of
28 June 2007 on organic production and labelling of organic
samples should apply. Samples may also be taken and
products and repealing Regulation (EEC) No 2092/91 ( 1 ), and in
analysed by control authorities or control bodies in any
particular Article 33(2) and (3) and Article 38(c) and (d) thereof,
other case for detecting non-compliance with the Union
organic requirements.
Whereas:
(5)
In the light of the experience gained with the implemen
(1) According
to
Article
28(1)
of
Regulation
(EC)
No
834/2007, operators who produce, prepare, store, place
tation of the control system and in the interest of the
on the market, import or export products produced in
organic sector, it is appropriate to provide for the trans
compliance with the production rules laid down in that
mission of the relevant information in cases where the
Regulation must submit their undertaking to the control
operator or the subcontractors of that operator are
system referred to in Article 27 of that Regulation.
checked by different control authorities or control
Detailed rules for the application of that control system
bodies or where operators or their subcontractors
are laid down in Title IV of Commission Regulation (EC)
change their control authority or control body.
No 889/2008 of 5 September 2008 laying down detailed
Adequate exchange of information and transmission of
rules for the implementation of Council Regulation (EC)
the control files of those operators should be possible in
No 834/2007 on organic production and labelling of
order to manage the control system, while observing the
organic products with regard to organic production,
requirements of the protection of personal data as laid
labelling and control (
down in Directive 95/46/EC of the European Parliament

2 ).
and of the Council of 24 October 1995 on the
protection of individuals with regard to the processing
of personal data and on the free movement of such
(2) Under
that
control
system
the
operators
must
notify
their
data (
undertaking to the competent authority, including

3 ). Operators should accept the transmission and
exchange of their data and all information relating to
information on the relevant control body, and sign a
their activities under the control system.
declaration that they perform according to the organic

rules, including the acceptance of enforcement of
measures in case of infringements and irregularities.
(6)
In order to ensure the uniform application of the control
(3) Article
30(2)
of
Regulation
(EC)
No
834/2007
provides
system and to avoid ambiguities, a definition of the term
for the communication of information related to irregu
‘control file’ should be included in Regulation (EC) No
larities or infringements affecting the organic status of a
889/2008.
product. To enhance efficiency, operators should inform
their control authorities or control bodies of any irregu
larity or infringement affecting the organic status of their
product including organic products they receive from
other operators.
(7) Electronic
certification
is
referred
to
in
Article
29(3)
of
Regulation (EC) No 834/2007 in relation to the form of
the documentary evidence. It is appropriate to clarify that
(4)
In the light of the experience gained with the implemen
in case of electronic certification, the signature of the
tation of the control system and in the interest of the
documentary evidence is not required if the authenticity
organic sector, it is appropriate to establish a minimum
of the documentary evidence is otherwise shown by a
tamper-proof electronic method.
( 1 ) OJ L 189, 20.7.2007, p. 1.
( 2 ) OJ L 250, 18.9.2008, p. 1.
( 3 ) OJ L 281, 23.11.1995, p. 31.

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L 118/6
EN
Official Journal of the European Union
30.4.2013
(8)
The experience has shown that clarification is needed as
competent authorities over the control bodies that have
regards the exchange of information between Member
been delegated control tasks. Those provisions should be
States in cases where a Member State finds irregularities
included in the control system of the Member States set
or infringements concerning compliance of the products
up in accordance with Article 27 of Regulation (EC) No
imported in accordance with Article 33(2) and (3) of
834/2007 as uniform minimum requirements.
Regulation (EC) No 834/2007 or Article 19 of
Commission Regulation (EC) No 1235/2008 of
8 December 2008 laying down detailed rules for imple
(14) Competent
authorities
of
the
Member
States
should
have
mentation of Council Regulation (EC) No 834/2007 as
documented procedures for delegating tasks to control
regards the arrangements for imports of organic products
bodies and supervising them in order to ensure that
from third countries (
the regulatory requirements are respected.

1 ).
(15) The
exchange of information within Member States,
(9)
In addition, it is appropriate to clarify the procedure
among Member States, and between Member States and
relating to the exchange of information between
the Commission relating to the supervision carried out
Member States in cases of irregularities or infringements,
by competent authorities should be improved and
taking into account the best practices established since
uniform minimum requirements should be adopted.
2009.
(16) Regulation (EC) No 889/2008 should therefore be
(10) In
order
to
ensure
the
coherence
with
Article
33(1)
of
amended accordingly.
Commission Regulation (EU) No 65/2011 of 27 January
2011 laying down detailed rules for the implementation
of Council Regulation (EC) No 1698/2005, as regards the
(17) For the efficiency of the control arrangements, the
implementation of control procedures as well as cross-
additional elements, as added by this Regulation, which
compliance in respect of rural development support
are to be covered by the undertaking included in the
measures ( 2 ), it is important to clarify that Member
declaration to be signed by the operator as referred to
States should ensure that sufficient information on the
in Article 63(2) of Regulation (EC) No 889/2008, should
controls carried out is received by the paying agency
also apply to operators who signed that declaration
where controls are not carried out by the paying agency.
before the date of application of this Regulation.
(11) In
accordance
with
Article
44(1)(a)
of
Regulation
(EC)
No
(18) In
order to ensure the smooth transition from the
882/2004 of the European Parliament and of the Coun
current control system to the amended system, this
cil (
Regulation should apply from 1 January 2014.

3 ) Member States are required to indicate in their
annual report any amendment to their multi-annual
national control plan to take account of, inter alia, new
(19) The
measures
provided
for
in
this
Regulation
are
in
legislation. The Commission should have the necessary
accordance with the opinion of the regulatory
data and information on the supervision carried out by
Committee on organic production,
competent authorities of the Member States in relation to
organic production. Therefore, Member States should be
required to amend their national control plan in order to
HAS ADOPTED THIS REGULATION:
cover that supervision and to indicate those amendments
and the relevant organic data in the annual report
Article 1
referred to in Article 44 of Regulation (EC) No
882/2004. Member States should be allowed to present
Amendment of Regulation (EC) No 889/2008
those organic data as a separate chapter in the national
control plan and in the annual report.
Regulation (EC) No 889/2008 is amended as follows:
(1) in Article 2, the following point (s) is added:
(12) In addition to obligations relating to controls set out in
Regulation (EC) No 882/2004, Title V of Regulation (EC)
No 834/2007 and Regulation (EC) No 889/2008 set out
‘(s) “control file” means all the information and documents
more specific provisions on the controls in the organic
transmitted, for the purposes of the control system, to
sector. In case the competent authority delegates control
the competent authorities of the Member State or to
tasks to control bodies, which are private entities, Regu
control authorities and control bodies by an operator
lation (EC) No 834/2007 sets out more detailed
subject to the control system as referred to in Article 28
requirements and obligations each control body has to
of Regulation (EC) No 834/2007, including all the
fulfil.
relevant information and documents relating to that
operator or the activities of that operator held by
competent authorities, control authorities and control
(13) The
experience
has
shown
that
the
specific
provisions
on
bodies, with the exception of information or
controls of organic production need to be more detailed,
documents that have no bearing on the operation of
particularly in order to strengthen the supervision of
the control system.’;
( 1 ) OJ L 334, 12.12.2008, p. 25.
( 2 ) OJ L 25, 28.1.2011, p. 8.
(2) in the first subparagraph of Article 63(2), the following
( 3 ) OJ L 165, 30.4.2004, p. 1.
points (d) to (h) are added:

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30.4.2013 Official
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of
the
European
Union L
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‘(d) to accept, in cases where the operator and/or the
signature in box 8 of the documentary evidence shall not be
subcontractors of that operator are checked by
required if the authenticity of the documentary evidence is
different control authorities or control bodies in
otherwise shown by a tamper-proof electronic method.’;
accordance with the control system set up by
Member State concerned, the exchange of information
between those authorities or bodies;
(5) Articles 92 and 92a are replaced by the following:
(e) to accept, in cases where the operator and/or the
‘Article 92
subcontractors of that operator change their control
Exchange of information between control authorities,
authority or control body, the transmission of their
control bodies and competent authorities
control files to the subsequent control authority or
control body;
1. Where the operator and/or the subcontractors of that
operator are checked by different control authorities or
(f) to
accept,
in
cases
where
the
operator
withdraws
from
control bodies, the control authorities or control bodies
the control system, to inform without delay the
shall exchange the relevant information on the operations
relevant competent authority and control authority or
under their control.
control body;
2. Where operators and/or their subcontractors change
(g) to accept, in cases where the operator withdraws from
their control authority or control body, the change shall
the control system, that the control file is kept for a
be notified without delay to the competent authority by
period of at least five years;
the control authorities or control bodies concerned.
(h) to accept to inform the relevant control authority or
The previous control authority or control body shall hand
authorities or control body or bodies without delay of
over the relevant elements of the control file of the operator
any irregularity or infringement affecting the organic
concerned and the reports referred to in the second
status of their product or organic products received
subparagraph of Article 63(2) to the subsequent control
from other operators or subcontractors.’;
authority or control body.
(3) in Article 65, paragraph 2 is replaced by the following:
The new control authority or control body shall ensure that
non-conformities noted in the report of the previous
‘2. The control authority or control body shall take and
control authority or control body have been or are being
analyse samples for detecting of products not authorised for
addressed by the operator.
organic production, for checking production techniques not
in conformity with the organic production rules or for
3. Where the operator withdraws from the control
detecting possible contamination by products not auth
system, the control authority or control body of that
orised for organic production. The number of samples to
operator shall, without delay, inform the competent auth
be taken and analysed by the control authority or control
ority.
body every year shall correspond to at least 5 % of the
number of operators under its control. The selection of
the operators where samples have to be taken shall be
4. Where a control authority or control body finds
based on the general evaluation of the risk of non-
irregularities or infringements affecting the organic status
compliance with the organic production rules. This
of products, it shall without delay inform the competent
general evaluation shall take into account all stages of
authority of the Member State which designated or
production, preparation and distribution.
approved it in accordance with Article 27 of Regulation
(EC) No 834/2007.
The control authority or control body shall take and analyse
samples in each case where the use of products or tech
That competent authority may require, on its own initiative,
niques not authorised for organic production is suspected.
also any other information on irregularities or infringe
In such cases no minimum number of samples to be taken
ments.
and analysed shall apply.
In case of irregularities or infringements found with regard
Samples may also be taken and analysed by the control
to products under the control of other control authorities or
authority or control body in any other case for detecting
control bodies, it shall also inform those authorities or
of products not authorised for organic production, for
bodies without delay.
checking production techniques not in conformity with
the organic production rules or for detecting possible
contamination by products not authorised for organic
5. Member
States
shall
take
the
appropriate
measures
production.’;
and establish documented procedures to enable exchange
of information between all control authorities they have
designated and/or all control bodies they have approved
(4) in Article 68(1), the following subparagraph is added:
in accordance with Article 27 of Regulation (EC) No
834/2007, including procedures for the exchange of
‘In case of electronic certification as referred to in
information for the purpose of verifying documentary
Article 29(3) of Regulation (EC) No 834/2007, the
evidence referred to in Article 29(1) of that Regulation.

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L 118/8
EN
Official Journal of the European Union
30.4.2013
6. Member
States
shall
take
the
appropriate
measures
5. The
Member
State
which
sent
the
original
notification
and establish documented procedures in order to ensure
may ask the replying Member State for additional
that information on the results of inspections and visits as
information, if needed. In any case, after receiving a reply
referred to in Article 65 of this Regulation is communicated
or additional information from a notified Member State, the
to the paying agency in accordance with the needs of that
Member State which sent the original notification shall
paying agency as provided for in Article 33(1) of
make the necessary entries and updates in the system
Commission Regulation (EU) No 65/2011 (*).
referred to in Article 94(1).
Article 92a
Article 92b
Exchange of information between different Member
Publication of information
States and the Commission
Member States shall make available to the public, in an
1. Where a Member State finds irregularities or
appropriate manner including publication on the internet,
infringements relating to the application of this Regulation
the updated lists referred to in Article 28(5) of Regulation
with regard to a product coming from another Member
(EC) No 834/2007 containing updated documentary
State and bearing indications as referred to in Title IV of
evidence related to each operator, as provided for in
Regulation (EC) No 834/2007 and in Title III and/or Annex
Article 29(1) of that Regulation and using the model set
XI to this Regulation, it shall notify the Member State which
out in Annex XII to this Regulation. The Member States
designated the control authority or approved the control
shall duly observe the requirements of the protection of
body, the other Member States and the Commission
personal data as laid down in Directive 95/46/EC of the
without delay via the system referred to in Article 94(1)
European Parliament and of the Council (**).
of this Regulation.
___________
2. Where a Member State finds irregularities or
(*) OJ L 25, 28.1.2011, p. 8.
infringements as regards compliance of the products
(**) OJ L 281, 23.11.1995, p. 31.’;
imported in accordance with Article 33(2) or (3) of Regu
lation (EC) No 834/2007 with the requirements laid down
in that Regulation or Regulation (EC) No 1235/2008, it
(6) in Title IV, the following Chapter 9 is added:
shall notify the other Member States and the Commission
without delay via the system referred to in Article 94(1) of
this Regulation.
‘CHAPTER 9
Supervision by competent authorities
3. Where a Member State finds irregularities or
Article 92c
infringements as regards compliance of the products
imported in accordance with Article 19 of Regulation (EC)
Supervisory activities relating to control bodies
No 1235/2008 with the requirements laid down in that
1. The
supervisory
activities
by
competent
authorities
Regulation and Regulation (EC) No 834/2007, it shall
delegating control tasks to control bodies in accordance
notify the Member State which issued the authorisation,
with Article 27(4)(b) of Regulation (EC) No 834/2007
the other Member States and the Commission without
shall focus on the evaluation of the operational performance
delay via the system referred to in Article 94(1) of this
of those control bodies, taking into account the results of
Regulation. The notification shall be sent to the other
the work of the national accreditation body as referred to in
Member States and to the Commission in case the irregu
Article 2(11) of Regulation (EC) No 765/2008 of the
larity or infringement is found with regard to products for
European Parliament and of the Council (*).
which the Member State itself issued the authorisation
referred to in Article 19 of Regulation (EC) No 1235/2008.
Those supervisory activities shall include an assessment of
the internal procedures of the control bodies for the
4. The
Member
State
which
receives
a
notification
controls, the management and examination of control files
relating to non-compliant products in accordance with
in the light of the obligations established by Regulation (EC)
paragraph 1 or 3 or the Member State which issued the
No 834/2007 and the verification of handling of non-
authorisation referred to in Article 19 of Regulation (EC) No
conformities and the handling of appeals and complaints.
1235/2008 for a product for which an irregularity or
infringement was found, shall investigate the origin of the
irregularities or infringements. It shall take appropriate
2. The
competent
authorities
shall
require
control
bodies
action immediately.
to submit documentation on their risk analysis procedure.
The risk analysis procedure shall be designed in such a way
It shall inform the Member State which sent the notifi
that:
cation, the other Member States and the Commission of
the result of the investigation and of the action taken by
replying to the original notification via the system referred
(a) the result of the risk analysis provides the basis for
to in Article 94(1). The reply shall be sent within 30
determining the intensity of the unannounced or
calendar days from the date of the original notification.
announced annual inspections and visits;

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(b) additional random control visits carried out in
(b) that the control body has a sufficient number of suitable
accordance with Article 65(4) of at least 10 % of
qualified and experienced staff in accordance with
operators under contract in accordance with the risk
Article 27(5)(b) of Regulation (EC) No 834/2007 and
category are performed;
that training concerning risks affecting the organic
status of products has been implemented;
(c) at least 10 % of all inspections and visits carried out in
accordance with Article 65(1) and (4) are unannounced;
(c) that the control body has and follows documented
procedures and templates for:
(d) the selection of operators to be submitted to
(i) the annual risk analysis in accordance with
unannounced inspections and visits is determined on
Article 27(3) of Regulation (EC) No 834/2007;
the basis of the risk analysis and that these are
planned according to the level of risk.
(ii) preparing a risk-based sampling strategy,
conducting sampling and laboratory analysis;
3. Competent
authorities
delegating
control
tasks
to
control bodies shall verify that the staff of the control
(iii) information exchange with other control bodies
bodies has sufficient knowledge, including knowledge of
and with the competent authority;
the risk elements affecting the organic status of products,
qualifications, training and experience with respect to
(iv) initial and follow-up controls of operators under
organic production in general and with the relevant
their control;
Union rules in particular and that appropriate rules on
rotation of inspectors are in force.
(v) the application and follow-up to the catalogue of
measures to be applied in case of infringements or
irregularities;
4. Competent authorities shall have documented
procedures for the delegation of tasks to control bodies in
accordance with Article 27(5) of Regulation (EC) No
(vi) observing the requirements of the protection of
834/2007 and for the supervision in accordance with this
personal data for the operators under its control
Article, detailing the information to be submitted by control
as laid down by the Member States where that
bodies.
competent authority operates and in accordance
with Directive 95/46/EC.
Article 92d
Article 92f
Catalogue of measures in case of irregularities and
Organic data in the multi-annual national control plan
infringements
and annual report
Competent authorities shall adopt and communicate to
Member States shall ensure that their multi-annual national
control bodies that have been delegated control tasks, a
control plans referred to in Article 41 of Regulation (EC) No
catalogue at least listing infringements and irregularities
882/2004 cover the supervision of controls performed on
affecting the organic status of products and corresponding
the organic production in accordance with this Regulation
measures to be applied by control bodies in case of
and to include the specific data on that supervision, here
infringements or irregularities by operators under their
inafter referred to as “the organic data”, in the annual report
control who are involved in organic production.
referred to in Article 44 of Regulation (EC) No 882/2004.
The organic data shall cover the topics listed in Annex XIIIb
Competent authorities may include other relevant
to this Regulation.
information in the catalogue on their own initiative.
The organic data shall be based on information on the
controls performed by the control bodies and/or control
Article 92e
authorities and on audits performed by the competent auth
ority.
Annual inspection of control bodies
Competent authorities shall organise an annual inspection
The data shall be presented according to the templates
of the control bodies that have been delegated control tasks
provided for in Annex XIIIc to this Regulation as from
in accordance with Article 27(4)(b) of Regulation (EC) No
2015 for the year 2014.
834/2007. For the purposes of the annual inspection, the
competent authority shall take into account the results of
Member States may insert the organic data as an organic
the work of the national accreditation body as referred to in
chapter of their national control plan and their annual
Article 2(11) of Regulation (EC) No 765/2008. During the
report.
annual inspection, the competent authority shall, in
particular, verify:
___________
(*) OJ L 218, 13.8.2008, p. 30.’;
(a) the compliance with the control body’s standard control
procedure as submitted by the control body to the
competent authority in accordance with Article 27(6)(a)
(7) Annexes XIIIb and XIIIc, the text of which is set out in the
of Regulation (EC) No 834/2007;
Annex to this Regulation, are inserted.

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L 118/10
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Official Journal of the European Union
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Article 2
Transitional provision
Points (d) to (h) of the first subparagraph of Article 63(2) of Regulation (EC) No 889/2008 as added by
point (2) of Article 1 of this Regulation shall also apply to operators who signed the declaration referred to
in Article 63(2) of Regulation (EC) No 889/2008 before the date of application of this Regulation.
Article 3
Entry into force and application
This Regulation shall enter into force on the seventh day following that of its publication in the Official
Journal of the European Union.
It shall apply from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 April 2013.
For the Commission
The President
José Manuel BARROSO

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ANNEX
‘ANNEX XIIIb
Topics to be covered by the national competent authority in the organic data referred to in Article 92f
1. Information on the competent authority for the organic production
— which body is the competent authority
— resources available to the competent authority
— description of audits performed by the competent authority (how, by whom)
— documented procedure of the competent authority
2. Description of the control system for organic production
— system of control bodies and/or control authorities
— registered operators covered by the control system — minimum annual inspection
— how is the risk based approach applied
3. Information on control bodies/authorities
— list of control bodies/authorities
— tasks delegated to the control bodies/conferred to control authorities
— supervision of delegated control bodies (by whom and how)
— coordination of activities in case of more than one control body/authority
— training of staff performing the controls
— announced/unannounced inspections and visits

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L 118/12
ANNEX XIIIc
Templates for the organic data referred to under Article 92f
Report on official controls in the organic sector
Country:
Year:
EN
1) Information on controls of operators:

Number
Number of registered operators Number
of
annual
inspections Number
of
additional
risk
based
visits Total
number
of
inspections/visits
of
Code number registered
Aqua
Aqua
of control operators Agri culture
Agri culture
Agri
Aqua
Aqua
body or
per
cultur animal Pro
Im
Ex
Other
cul
animal Proces
Other cultural culture Proces
Other
Agri
culture
Other
control au
control
al
pro
ces
port
port
oper
tural
pro
sors
Im
Export oper
Pro
animal
sors
Im
Export
oper
cultural animal Proces
Im
Ex
oper
thority
body or Produ
duc
sors
ers
ers
ators
Pro
duc
(**)
porters
ers
ators ducers pro
(**)
porters
ers
ators
Produ produc sors (**) porters porters ators
control
cers
tion
(**)
(***) ducers tion
(***)
(*)
duction
(***)
cers (*)
tion
(***)
authority
(*)
units
(*)
units
units
units
Off
icial
MS-BIO-01
Jour
nal
MS-BIO-02
of
the
MS-BIO-…
European
Total
Union
(*) Agricultural producers include agricultural producers only, producers that are also processors, producers that are also importers, other mixed producers not elsewhere classified (n.e.c.).
(**) Processors include processors only, processors that are also importers, other mixed processors n.e.c.
(***) Other operators include traders (wholesalers, retailers), other operators n.e.c.
Number of samples
Code number
Number of registered operators Number
of
samples
analysed
indicating breach of Regulations (EC) No 834/2007
of control
and (EC) No 1235/2008
body or con
trol authority
Aquacul
Aquacul
or Name of
Agricul
Aquacul
Other op
Agricul
ture ani
Other op
Agricul
ture ani
Other
Competent
tural Pro ture animal Processors
erators
tural Pro
mal pro Processors
erators
tural Pro
mal pro Processors
operators
Authority
ducers
production
(**)
Importers Exporters
ducers
(**)
Importers Exporters
ducers
(**)
Importers Exporters
(*)
units
(***)
(*)
duction
(***)
duction
(***)
units
(*)
units
MS-BIO-01
30.4.2013
MS-BIO-02

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30.4.2013 Off
Number of samples
Code number
Number of registered operators Number
of
samples
analysed
indicating breach of Regulations (EC) No 834/2007
of control
and (EC) No 1235/2008
body or con
trol authority
Aquacul
Aquacul
or Name of
Agricul
Aquacul
Other op
Agricul
ture ani
Other op
Agricul
ture ani
Other
Competent
tural Pro ture animal Processors
erators
tural Pro
mal pro Processors
erators
tural Pro
mal pro Processors
operators
Authority
ducers
production
(**)
Importers Exporters
ducers
(**)
Importers Exporters
ducers
(**)
Importers Exporters
(*)
units
(***)
(*)
duction
(***)
duction
(***)
units
(*)
units
EN

MS-BIO-…
Total
(*) Agricultural producers include agricultural producers only, producers that are also processors, producers that are also importers, other mixed producers not elsewhere classified (n.e.c.).
(**) Processors include processors only, processors that are also importers, other mixed processors n.e.c.
icial
(***) Other operators include traders (wholesalers, retailers), other operators n.e.c.
Jour
nal
Number of registered operators Number
of
irregularities
or
infringements
found
(
Number of measures applied
1 )
Number of measures applied
of
on the lot or the production run (2 )
on the operator (3 )
the
Code number of Agri Aqua
Agri
Aqua
Agri
Aqua
Agri
Aqua
European
control body or
culture
Other
culture
Other
culture
Other
culture
Other
control authority cultural
Proces
cultural
Proces
cultural
Proces
cultural
Proces
Pro
animal
sors
Import
oper
Pro
animal
sors
Im
Export oper
Pro
animal
sors
Im
Export oper
Pro
animal
sors
Im
Export oper
ducers
pro
(**)
ers
Exporters ators ducers pro (**) porters ers ators ducers pro (**) porters ers ators ducers pro (**) porters ers ators
(*)
duction
(***)
duction
(***)
duction
(***)
duction
(***)
units
(*)
units
(*)
units
(*)
units
Union
MS-BIO-01
MS-BIO-02
MS-BIO-…
Total
(*) Agricultural producers include agricultural producers only, producers that are also processors, producers that are also importers, other mixed producers not elsewhere classified (n.e.c.).
(**) Processors include processors only, processors that are also importers, other mixed processors n.e.c.
(***) Other operators include traders (wholesalers, retailers), other operators n.e.c.
(1 ) Only irregularities and infringements which affect the organic status of products and/or have resulted in a measure being applied are included.
(2 ) Where an irregularity is found as regards compliance with the requirements laid down in this Regulation, the control authority or control body shall ensure that no reference to the organic production method is made in the labelling
L
and advertising of the entire lot or production run affected by this irregularity, where this would be proportionate to the relevance of the requirement that has been violated and to the nature and particular circumstances of the
118/13
irregular activities (as referred to in first subparagraph of Article 30(1) of Regulation (EC) No 834/2007).
(3 ) Where a severe infringement or an infringement with prolonged effect is found, the control authority or control body shall prohibit the operator concerned from marketing products which refer to the organic production method in
the labelling and advertising for a period to be agreed with the competent authority of the Member State (as referred to in second subparagraph of Article 30(1) of Regulation (EC) No 834/2007).

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L 118/14
2) Information on supervision and audits:
Number of registered operators
Document review and office audit (1 )
Number of
(Number of operator files checked)
Number of review audits (2 ) Number
witness
audits
(3 )
Code
registered
number of operators Agri
Aqua
Agri
Aqua
Aqua
Aqua
control body per control cul
culture Pro
Other
cul
culture
Other
Agri
culture
Other
Agri
culture
Other
or control
body or
tural animal ces
Im
Ex
Proces
cultural
Proces
cultural
Proces
Im
Ex
port
port
oper
tural animal
sors
Im
Export oper
Pro
animal
sors
Im
Export
oper
Pro
animal
sors
port
port
oper
EN
authority
control
Pro
pro
sors
ators
Pro
pro
porters
ers
ators
pro
porters
ers
ators
produc
ators
authority ducers duction
(**)
ers
ers
(***) ducers duction
(**)
(***)
ducers duction (**)
(***)
ducers
tion
(**)
ers
ers
(***)

(*)
units
(*)
units
(*)
units
(*)
units
MS-BIO-01
MS-BIO-02
MS-BIO-…
Off
icial
Jour
Total
nal
(*) Agricultural producers include agricultural producers only, producers that are also processors, producers that are also importers, other mixed producers not elsewhere classified (n.e.c.).
of
(**) Processors include processors only, processors that are also importers, other mixed processors n.e.c.
the
(***) Other operators include traders (wholesalers, retailers), other operators n.e.c.
(1 ) Document review of the relevant general documents describing the structure, functioning and quality management of the control body. Office audit of the control body, including checking of operator files and verification of handling
European
of non-conformities and complaints, including the minimum control frequency, the use of risk based approach, unannounced and follow-up visits, the sampling policy and the exchange of information with other control bodies and
control authorities.
(2 ) Review audit: inspection of an operator by the competent authority to verify compliance with the operating procedures of the control body and to verify its effectiveness.
(3 ) Witness audit: observation by the competent authority of an inspection by an inspector of the control body.
Union
3) Conclusions on the control system for the organic production:
Withdrawal of the approval
Code number of con
trol body or control
Actions taken to ensure effective operation of the control system for the organic production (enforcement)
authority
Yes/No
From
To
(date)
(date)
MS-BIO-01
MS-BIO-02
MS-BIO-…
30.4.2013
Statement of overall performance of the control system for the organic production:’

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Document Outline

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