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Traceability and Mass Balance

Preserving the integrity of organically produced products is one of the fundamental principles of organic farming legislation, and ensuring that organic or in-conversion products do not show any non-compliance that affects their characteristics at any stage of production, preparation and distribution is only possible by providing traceability and monitoring capability at every stage.
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Maintaining the integrity of organically produced products is one of the fundamental principles of organic farming legislation, and ensuring that organic or in-conversion products do not show any non-compliance that affects their characteristics at any stage of production, preparation and distribution is only possible by providing traceability and monitoring capability at every stage.

In recent years, in order to maintain the integrity of organically produced products, many Regulations and standards that have been updated/strengthened have introduced as the most important concept for this purpose, ‘traceability’ and subsequently ‘mass balance’.

Below we share with you some Regulation definitions and articles on this subject:

(EU) 2021/1698 – Commission Delegated Regulation (EU) 2021/1698 of 13 July 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council with procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified organic and on organic products in third countries and with rules on their supervision and the controls and other actions to be performed by those control authorities and control bodies , based on the classification criteria in Article 22(3)(b), the control authority or control body may classify non-compliance situations as minor, major or critical.

When the category of non-compliance is minor or major; the traceability system can identify the affected product(s) in the supply chain. When the category of non-compliance is critical; no information from the traceability system to locate the affected product(s) in the supply and the products cannot be prevented from being imported from a third country for the purpose of placing that product on the market within the Union with reference to organic production. (See (EU) 2021/1698 Annex IV)

If no information can be obtained from the traceability system to locate the affected product(s) in the supply chain, reference to organic production shall not be made on their labels and advertising, and their sale shall be prohibited. In addition, depending on the situation, the operator’s certificate may be restricted, suspended, or withdrawn.

In Article 9 General provisions on control; one of the most important stages of the controls carried out by the control bodies to verify compliance with Regulation (EU) 2018/848 by operators and group operators in third countries is specified as ‘traceability’ control in all respects.

In Article 11 Methods and techniques for controls; among the control methods and techniques applied by a control authority or control body, the examination of traceability and its records has an important place. Article 11.2 states that the annual physical on-the-spot inspection shall be carried out by means of checks of documentary accounts and of any other relevant element deemed necessary by the control authority or control body, and shall include traceability and mass balance control. Article 11.3 states that For the purpose of the traceability check and the mass balance check, the selection of products, groups of products and period under verification shall be based on a risk assessment by the control authority or control body. According to Article 11.4; Besides any other relevant element deemed necessary by the control authority or control body, the traceability check shall cover the following elements justified by appropriate documents including stock and financial records:

  • the name and address of the supplier and, where different, of the owner or the seller, or the exporter of the products;

  • the name and address of the consignee and, where different, of the buyer or importer of the products;

  • the certificate of the supplier in accordance with an implementing act adopted pursuant Article 45(4) of Regulation (EU) 2018/848;

  • the information referred to in the first paragraph of point 2.1 of Annex III to Regulation (EU) 2018/848 (information required to be given during packaging of the products and their transport to other operators or units);

  • the appropriate lot identification;

  • in the case of processors, the necessary information to allow internal traceability and guarantee the organic status of ingredients.

According to Article 11.5; The mass balance check shall cover the following elements justified by appropriate documents including stock and financial records, where relevant:

  • the nature and the quantities of products delivered to the unit and, where relevant, of materials bought and the use of such materials, and, where relevant, the composition of products;

  • the nature and the quantities of products held in storage at the premises including at the time of the physical on-the-spot inspection;

  • the nature and quantities of the products that have left the unit of the operators or groups of operators to the consignee’s premises or storage facilities;

  • in case of operators or groups of operators who buy or sell the product(s) without storing or physically handling the product(s), the nature and the quantities of products that have been bought and sold;

  • the yield of the products obtained, collected or harvested over the previous year;

  • the estimated or actual yield of the products obtained, collected or harvested over the current year;

  • the number and/or weight of livestock managed over the current and previous year;

  • any losses, increase or decrease in quantity of products at any stage of production, preparation and distribution;

  • the total output of the holding in terms of organic and non-organic products.

An example of a mass balance calculation form can be found under the ‘documents’ section on our website.

(EU) 2021/279 – Commission Implementing Regulation laying down detailed rules for the implementation of Regulation (EU) 2018/848 of the European
Parliament and of the Council on controls and other measures ensuring traceability and compliance in organic production and the labelling of organic products; according to Article 1-2(b); When the operator informs the competent authority or, where appropriate, the control authority or control body in
accordance with Article 28(2)(d) of Regulation (EU) 2018/848 about a substantiated suspicion or when the suspicion cannot be eliminated, one of the most important steps for the operator is to provide full traceability of the affected product.

In the ‘Turkish Regulation on the Principles and Implementation of Organic Farming’ published in the Official Gazette No. 27676, under Article 5 General Rules of Organic Farming; it is stated that ‘Traceability shall be ensured by recording all stages of organic farming activities’.

Under Article 42 Responsibilities of the operator and sanctions to be applied; it is explained that the operator is obliged to keep all kinds of records related to the traceability of all organic farming activities and to present them to the authorized body during inspection, and that if this is not fulfilled, the process to be carried out by the control body is described.

The United States Department of Agriculture National Organic Program (USDA-NOP)
With the SOE (Strengthening Organic Enforcement) effective from March 19, 2024, added ‘Supply chain traceability audit’ to the definitions and included the requirement that the control should also cover risk-based traceability and mass balance audit (see § 205.501 General requirements for accreditation).

Accordingly, Supply chain traceability audit: The process of identifying and tracking the movement, sale, custody, handling, and organic status of an agricultural product along a supply chain to verify the agricultural product’s compliance with USDA NOP.

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