Commission Regulation (EC) No 1336/2005 of 12 August 2005 amending Annex III to Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs   (Text with EEA relevance)
Date: 2005-08-12
Institutions: European Commission
Subjects: health control, organic farming, organic product, quality control of agricultural products

13.8.2005

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Official Journal of the European Union

L 211/11

COMMISSION REGULATION (EC) No 1336/2005

of 12 August 2005

amending Annex III to Council Regulation (EEC) No 2092/91 on organic production of agricultural
products and indications referring thereto on agricultural products and foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 food-
stuffs (1), and in particular the second indent of Article 13
thereof,

Whereas:

(1)

(2)

As a result of Article 8 of Regulation (EEC) No 2092/91
as amended by Council Regulation (EC) No 392/2004 (2),
the scope of operators' activities subject to the inspection
system provided for in Article 9 of Regulation (EEC) No
2092/91 covers all operators throughout the production,
preparation and marketing process.

To cover adequately all
the categories of operators
referred to in Article 8(1) of Regulation (EEC) No
2092/91,
it is necessary to extend the application of
the general provisions set out in Annex III to that Regu-
lation.

(3)

(4)

(5)

is appropriate to relate the frequency of random
It
inspections to the risks of non-compliance with Regu-
lation (EEC) No 2092/91.

Annex III
therefore be amended accordingly.

to Regulation (EEC) No 2092/91 should

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

HAS ADOPTED THIS REGULATION:

Article 1

Annex III
accordance with the Annex to this Regulation.

to Regulation (EEC) No 2092/91 is amended in

Article 2

This Regulation shall enter into force on the seventh 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, 12 August 2005.

For the Commission

Mariann FISCHER BOEL
Member of the Commission

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

last amended by
(EC) No 2254/2004 (JO L 385,

Commission Regulation
29.12.2004, p. 20).
(2) OJ L 65, 3.3.2004, p. 1.

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ANNEX

Annex III to Regulation (EEC) No 2092/91 is amended as follows:

1. after the title, the following is inserted:

‘The General Provisions set out in this Annex shall apply to all operators referred to in Article 8(1), to the extent that
those provisions relate to the activities carried out by the operator concerned.

In addition to the General Provisions, the Specific Provisions shall apply to those operators who carry out the activities
mentioned in the title of each subsection.’;

2. the General Provisions are amended as follows:

(a) points 3 to 6 are replaced by the following:

‘3. Initial inspection

When the inspection arrangements are first implemented, the operator responsible must draw up:

— a full description of the unit and/or premises and/or activity,

— all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure

compliance with this Regulation, and in particular with the requirements in this Annex,

— the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products
the operator’s

or substances and the cleaning measures to be taken in storage places and throughout
production chain.

Where appropriate, those description and measures may be part of a quality system as set up by the operator.

The description and measures concerned must be contained in a declaration, signed by the responsible operator.

In addition, this declaration must include an undertaking by the operator:

— to perform the operations in accordance with Articles 5, 6, 6a and, where relevant, Article 11 of this

Regulation, and/or Regulation (EC) No 223/2003,

— to accept, in the event of infringement or irregularities, the enforcement of the measures referred to in Article

9(9) of this Regulation and, where relevant, in Article 10(3) of this Regulation, and

— to accept to inform in writing the buyers of the product in order to ensure that the indications referring to the

organic production method are removed from this production.

This declaration must be verified by the inspection body or authority that issues a report identifying the possible
deficiencies and non-compliances with the provisions of this Regulation. The operator must countersign this report
and take the necessary corrective measures.

4. Communications

The operator responsible must notify any change in the description or of the measures referred to in point 3 and
in the initial inspection provisions foreseen in sections A, B, C, D and E of the Specific Provisions of this Annex to
the inspection body or authority in due time.

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5.

Inspection visits

The inspection body or authority must make a full physical inspection, at least once a year, of all operators. The
inspection body or authority may take samples for testing of products not authorised under this Regulation or for
checking production techniques not in conformity with this Regulation. Samples may also be taken and analysed
for detecting possible contamination by unauthorised products. However, such analysis must be carried out where
the use of unauthorised products is suspected. An inspection report must be drawn up after each visit, counter-
signed by the responsible person of the unit or his representative.

Moreover, the inspection body or authority shall carry out random inspection visits, announced or not, based on a
general evaluation of the risk of non-compliance with this Regulation and with Regulation (EC) No 223/2003,
taking into account at least the results of previous inspections, the quantity of products concerned and the risk for
exchange of products.

6. Documentary accounts

Stock and financial records must be kept in the unit or premises, to enable the operator to identify and the
inspection body or authority to verify:

— the supplier and, where different, the seller, or the exporter of the products,

— the nature and the quantities of products as referred to in Article 1 delivered to the unit and, where relevant, of
all materials bought and the use of such materials, and, where relevant, the composition of the compound
feedingstuffs,

— the nature and the quantities of products as referred to in Article 1 held in storage at the premises,

— the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers,
of any products as referred to in Article 1, which have left the unit or the first consignee's premises or storage
facilities,

— in case of operators who do not store or physically handle such products, the nature and the quantities of
products as referred to in Article 1 bought and sold, and the suppliers, and where different, the sellers or the
exporters and the buyers, and where different, the consignees.

The documentary accounts must also comprise the results of the verification at reception of products and any
other information required by the inspection body or authority for the purpose of proper inspection.

The data in the accounts must be documented with appropriate justification documents.

The accounts must demonstrate the balance between the input and the output.’;

(b) the title of point 7 is replaced by the following:

‘7. Packaging and transport of products to other operators or units’;

(c) after point 7, the following point 7a is inserted:

‘7a. Reception of products from other units and other operators

On receipt of a product as referred to in Article 1, the operator shall check the closing of the packaging or
container where it is required and the presence of the indications referred to in point 7. The operator shall
crosscheck the information on the label referred to in point 7 with the information on the accompanying
documents. The result of these verifications shall be explicitly mentioned in the documentary accounts referred
to in point 6.’;

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(d) point 8 is replaced by the following

‘8. Storage of products

For the storage of products, areas must be managed in order to ensure identification of lots and to avoid any
mixing with or contamination by products and/or substances not in compliance with this Regulation. Products
referred to in Article 1 must be clearly identifiable at all times.’;

3. the Specific Provisions are amended as follows:

(a)

in section A, the sixth paragraph is deleted;

(b) Section B is replaced by the following:

‘B. Units for preparation of plant and livestock products and foodstuffs composed of plant and livestock

products

This Section applies to any unit involved in the preparation, as defined in Article 4(3), of products referred to in
Article 1(1), for its own account or for account of a third party, and including in particular also:

— units involved in packaging and/or re-packaging of such products,

— units involved in labelling and/or re-labelling of such products.

1.

Initial inspection

The full description of the unit referred to under point 3 of the General Provisions of this Annex must show the
facilities used for the reception, the processing, packaging, labelling and storage of agricultural products before and
after the operations concerning them, as well as the procedures for the transport of the products.

2. Preparation units handling also products not from organic production

Where products not referred to in Article 1 are also prepared, packaged or stored in the preparation unit
concerned:

— the unit must have areas separated by place or time within the premises for the storage of products as referred

to in Article 1, before and after the operations,

— operations must be carried out continuously until the complete run has been dealt with, separated by place or

time from similar operations performed on products not covered by Article 1,

— if such operations are not carried out at regular times or on a fixed day, they must be announced in advance,

with a deadline agreed on with the inspection body or authority,

— every measure must be taken to ensure identification of lots and to avoid mixtures or exchanges with products

not obtained in accordance with the rules laid down in this Regulation,

— operations on products in accordance with the rules laid down in this Regulation must be carried out only
after cleaning of the production equipment. The effectiveness of the cleaning measures must be checked and
recorded.

3. Packaging and transport of products to preparation units

Milk, eggs and egg-products from organic farming shall be collected independently from products not produced in
accordance with this Regulation. By derogation, and subject to prior approval by the inspection body or authority,
simultaneous collection may occur, where appropriate measures are taken to prevent any possible mixture or
exchange with products not produced in accordance with this Regulation and to ensure the identification of the
products produced in accordance with the provisions of this Regulation. The operator keeps the information
relating to collection days, hours, circuit and date and time of reception of the products available to the inspection
body or authority.’;

(c)

in section E, point 6 is deleted.