ANNEX 3. MINIMUM INSPECTION REQUIREMENTS AND PRECAUTIONARY MEASURES UNDER THE INSPECTION OR CERTIFICATION SYSTEM

A. Production units
B. Preparation and packaging units
C. Imports

1. Inspection measures are necessary across the whole of the food chain to verify product labelled according to Section 3 of these guidelines conforms to internationally agreed practices. The official or officially recognized certification body or authority and the competent authority should establish policies and procedures in accordance with these guidelines.

2. Access by the inspection body to all written and/or documentary records and to the establishment under the inspection scheme is essential. The operator under an inspection should also give access to the competent or designated authority and provide any necessary information for third party audit purposes.

A. Production units

3. Production according to these guidelines should take place in a unit where the land parcels, production areas, farm buildings and storage facilities for crop and livestock are clearly separate from those of any other unit which does not produce according to these guidelines; preparation and/or packaging workshops may form part of the unit, where its activity is limited to preparation and packaging of its own agricultural produce.

4. When the inspection arrangements are first implemented, the operator and the official or officially recognized certification body or authority should draw up and sign a document which includes:

a) a full description of the unit and/or collection areas, showing the storage and production premises and land parcels and, where applicable, premises where certain preparation and/or packaging operations take place;
b) and, in the case of collection of wild plants, the guarantees given by third parties, if appropriate, which the producer can provide to ensure that the provisions of Annex 1, para 10 are satisfied;
c) all the practical measures to be taken at the level of the unit to ensure compliance with these guidelines;
d) the date of the last application on the land parcels and/or collection areas concerned of products the use of which is not compatible with Section 4 of these guidelines;
e) an undertaking by the operator to carry out operations in accordance with Sections 3 and 4 and to accept, in event of infringements, implementation of the measures as referred to in Section 6, paragraph 9 of these guidelines.

5. Each year, before the date indicated by the certification body or authority, the operator should notify the official or officially recognized certification body or authority of its schedule of production of crop products and livestock, giving a breakdown by land parcel/herd, flock or hive.

6. Written and/or documentary accounts should be kept which enable the official or officially recognized certification body or authority to trace the origin, nature and quantities of all raw materials bought, and the use of such materials; in addition, written and/or documentary accounts should be kept of the nature, quantities and consignees of all agricultural products sold. Quantities sold directly to the final consumer should preferably be accounted for on a daily basis. When the unit itself processes agricultural products, its accounts must contain the information required in B2, third dash point of this Annex.

7. All livestock should be identified individually or, in the case of small mammals or poultry, by herd or flock or in the case of bees by hive. Written and/or documentary accounts should be kept to enable tracking of livestock and bee colonies within the system at all times and to provide adequate traceback for audit purpose. The operator should maintain detailed and up-to-date records of:

a) breeding and/or origins of livestock;
b) registration of any purchases;
c) the health plan to be used in the prevention and management of disease, injury and reproductive problems;
d) all treatments and medicines administered for any purpose, including quarantine periods and identification of treated animals or hives;
e) feed provided and the source of the feedstuffs;
f) stock movements within the unit and hive movements within designated forage areas as identified on maps;
g) transportation, slaughter and/or sales.
h) extraction, processing and storing of all bee products.

8. Storage, on the unit, of input substances, other than those whose use is with paragraph 4.1(b) of these guidelines is prohibited.

9. The official or officially recognized certification body or authority should ensure that a full physical inspection is undertaken, at least once a year, of the unit. Samples for testing of products not listed in these guidelines may be taken where their use is suspected. An inspection report should be drawn up after each visit. Additional occasional unannounced visits should also be undertaken according to need or at random.

10. The operator should give the certification body or authority, for inspection purposes, access to the storage and production premises and to the parcels of land, as well as to the accounts and relevant supporting documents. The operator should also provide the inspection body with any information deemed necessary for the purposes of the inspection.

11. Products referred to in Section 1 of these guidelines which are not in their packaging for the end consumer should be transported in a manner which should prevent contamination or substitution of the content with substances or product not compatible with these guidelines and the following information, without prejudice to any other indications required by law:

- the name and address of the person responsible for the production or preparation of the product;
- the name of the product; and
- that the product is of organic status.

12. Where an operator runs several production units in the same area (parallel cropping), units in the area producing crop, crop products not covered by Section 1 should also be subject to the inspection arrangements as regards the dash points of paragraph 4 and paragraphs 6 and 8 above. Plants of indistinguishable varieties as those produced at the unit referred to in paragraph 3 above should not be produced at these units.

If derogations are allowed by the competent authority, the authority must specify the types of production and circumstances for which derogations are granted and the supplementary inspection requirements, such as unannounced site visits; extra inspections during harvest; additional documentary requirements; assessment of an operation’s ability to prevent co-mingling, etc., which are to be implemented.
Pending further review of these guidelines in accordance with Section 8, member countries can accept parallel cropping of the same variety, even if it is not distinguishable, subject to adequate inspection measures being applied.

13. In organic livestock production, all livestock on one and the same production unit must be reared in accordance with the rules laid down in these Guidelines. However, livestock not reared in accordance with these Guidelines may be present on the organic holding provided that they are separated clearly from livestock produced in accordance with these Guidelines. The competent authority can prescribe more restrictive measures, such as different species.

14. The competent authority may accept that animals reared in accordance with the provisions of these Guidelines may be grazed on common land, provided that:

a) this land has not been treated with products other than those allowed in accordance with Section 4.1 (a) and (b) of these Guidelines, for at least three years;
b) a clear segregation between the animals reared in accordance with the provisions of these Guidelines, and the other animals can be organized.

15. For livestock production, the competent authority should ensure, without prejudice to the other provisions in this Annex, that the inspections related to all stages of production and preparation up to the sale to the consumer ensure, as far as technically possible, the traceability of livestock and livestock products from the livestock production unit through processing and any other preparation until final packaging and/or labelling.

B. Preparation and packaging units

1. The producer and/or operator and should provide:

- a full description of the unit, showing the facilities used for the, preparation, packaging and storage of agricultural products before and after the operations concerning them;
- all the practical measures to be taken at the level of the unit to ensure compliance these guidelines.

This description and the measures concerned should be signed by the responsible person of the unit and the certification body.

The report should include an undertaking by the operator to perform the operations in such a way as to comply with Section 4 of these guidelines and to accept, in the event of infringements, the implementation of measures as referred to in paragraph 6.9 of these guidelines and be countersigned by both parties.

2. Written accounts should be kept enabling the certification body or authority to trace:

- the origin, nature and quantities of agricultural products as referred to in Section 1 of these guidelines which have been delivered to the unit;
- the nature, quantities and consignees of products as referred to in Section 1 of these guidelines which have left the unit;
- any other information such as the origin, nature and quantities of ingredients, additives and manufacturing aids delivered to the unit and the composition of processed products, that is required by the certification body or authority for the purposes of proper inspection of the operations.

3. Where products not referred to in Section 1 of these guidelines are also processed, packaged or stored in the unit concerned:

- the unit should have separate areas within the premises for the storage of products as referred to in Section 1 of these guidelines, before and after the operations;
- operations should 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 Section 1 of these guidelines; - if such operations are not carried out frequently, they should be announced in advance, with a deadline agreed on with the certification body or authority;
- every measure should be taken to ensure identification of lots and to avoid mixtures with products not obtained in accordance with the requirements of these guidelines.

4. The official or officially recognized certification body or authority should ensure that a full physical inspection, at least once a year, of the unit. Samples for testing of products not listed in these guidelines may be taken where their use is suspected. An inspection report must be drawn up after each visit countersigned by the person responsible for the unit inspected. Additional occasional unannounced visits should also be undertaken according to need or at random.

5. The operator should give the official or officially recognized certification body or authority or authority, for inspection purposes, access to the unit and to written accounts and relevant supporting documents. The operator should also provide the inspection body with any information necessary for the purposes of inspection.

6. The requirements in respect to the transport as laid down in paragraph A.10 of this Annex are applicable.

7. On receipt of a product referred to in Section 1 of these Guidelines, the operator shall check:

- the closing of the packaging or contained where it is required;
- the presence of the indications referred to in A.10 of this Annex. The result of this verification shall be explicitly mentioned in the accounts referred to in point B.2. When there is any doubt that the product cannot be verified according to the production system provided for in Section 6 of this Guidelines, it must be placed on the market without indication referring to the organic production method.

C. Imports

Importing countries should establish appropriate inspection requirements for the inspection of importers and of imported organic products.