Today, the need to introduce a traceability system in Ukraine is actively discussed both in the private and public sectors. On the one hand, this is required by national legislation. On the other hand, the long-term experience of food enterprises in the EU, USA, Canada, Japan and other developed countries has proved the effectiveness of the established traceability system as a tool for protecting business and consumers.
Some Ukrainian food producers believe that the mandatory introduction of the traceability system is just another regulatory barrier, which is not true. One of the reasons for this attitude is the lack of available information on the essence of the traceability system and its benefits for business, as well as baseless statements by some Ukrainian experts about the huge costs required to build an effective traceability system, for example, to purchase satellites to communicate with space satellites for data transmission.
This publication aims to explain the concept of a traceability system in the food industry and its main components. In particular, the document contains a list of the main traceability requirements established at the international and legislative levels of the EU and Ukraine.
An effective traceability system is a means by which a food market operator can trace food products along the entire food chain. The main goal of traceability is to be able to find the source of a food safety problem as soon as possible and to take all necessary measures to recall/remove a certain food product from circulation with minimal interference in the production process. In the event of an incident with a food product in the absence of a traceability system, the process of withdrawal / recall of the food product is more complex, time-consuming and requires more effort and money than in the presence of such a system. The lack of a traceability system and, as a result, the insufficiently fast reaction of the food market operator to a certain problem can both harm the enterprise itself and pose a danger to the entire food industry sector. The trust of market operators to each other is also impossible without an effective traceability system.
Ensuring food safety is one of the most pressing issues of our time. High-profile scandals caused by the presence of melamine in baby food, outbreaks of severe poisoning associated with the bacterium Escherichia coli, dioxin and microorganisms such as salmonella or listeria in food products, as well as the spread of infectious diseases and the spread of infectious diseases such as foot-and-mouth disease and spongiform encephalopathy have increased public and scientific attention around the world to the possibility of preventing food safety problems and the need to clearly identify the source of the problem. Food trade is constantly growing and has long known no borders. The large number of players in the food market, the unpredictability of supply and the perishable nature of food products have increased the need for traceability systems to be applied on the widest possible basis in order to ensure a rapid response in the event of certain problems.
The information that is recorded during the application of the traceability system helpsе to:
improve and reduce the cost of the food recall procedure;
provide the consumer with accurate information, for example, on the origin of the food product
improve the risk assessment by the controlling (competent) authority.
It should be noted that the existing traceability system does not make the food product safe, but is a tool for solving food safety problems.
Ensuring traceability is also a guarantee that during various operations related to the food product, its certain characteristics do not change. This is important, for example, in the production of kosher, halal and organic food products.
A properly implemented traceability system makes it possible to:
focus on preventive measures rather than reacting to an existing problem;
introduce monitoring and protection against risks in real time;
make informed management decisions to reduce operating costs;
significantly reduce the time required to respond in the event of a problem with a food product;
increase consumer confidence.
In a broad sense, traceability is a tool that determines the path of a product from its source to the direct recipient and is a system of recording information about all steps in the supply chain of this product.
The form and content of traceability depend on the type of food product, production operations and other factors. This explains the lack of a single definition of the traceability system.
However, the universal concept is that the traceability system consists of three basic elements:
1). traceability of the supplier (external traceability, step back);
2). traceability of processes (internal traceability);
3). buyer traceability (external traceability, a step forward).
Recording information about the product and the ability to provide it if necessary are integral components of each of these elements.
Most legal requirements focus on the need to ensure external traceability. The introduction of internal traceability in the enterprise is regulated by the business itself by including this requirement in international and most private standards, for example, ISO 22 000, FSSC 22 000, BRC, IFS1.
The main purpose of including traceability provisions in legislation is to ensure the possibility to carry out the most accurate product recalls and to quickly provide information to the relevant state authorities in case of food safety problems. As a rule, the requirements for mandatory implementation of traceability apply to all market operators involved in the food chain, namely
In accordance with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (hereinafter – the SPS Agreement), any sanitary and phytosanitary measures (including traceability requirements) imposed by the countries – members of this international organization must meet, in particular, the following requirements
The WTO encourages Members to adopt regulations harmonized with relevant international standards, guidelines and recommendations established by
а) Codex Alimentarius Commission in the case of food safety;
б) International Office of Epizootics (OIE) in the case of animal health protection and prevention of zoonoses;
в) Secretariat of the International Plant Protection Convention (IPPC).
In the standard CAC/GL 60-2006, the Codex Alimentarius Commission provides the following definition of traceability:
“Traceability is the ability to trace the movement of a food product at specified stages of production, processing and distribution”.
In addition, in the mentioned standard, the Codex Alimentarius Commission defines the principles of traceability as a necessary tool in the framework of inspections by state competent authorities.
At the same time, the wording of the term “traceability” is also given in the standard of the International Organization for Standardization (ISO), which considers traceability as “the ability to trace the movement of feed or food at certain stages of production, processing and distribution”.
Based on the above, we can conclude that the basis for any traceability system is the ability to track and identify certain products in the process of their movement through the supply chain.
The following main elements of the traceability system can be distinguished:
It should be borne in mind that the amount of information required to ensure traceability may vary depending on the sector of production and type of product. In addition, the types of recording of such information also differ (both paper form and barcodes or certain computer programs can be used, etc.)
Currently, most countries have adopted the concept that national legislation should contain a traceability requirement based on the “step back – step forward” principle. This is a necessary basis for ensuring effective traceability in any area of production and for any type of product.
In the EU, the legal requirements for the introduction of traceability are contained in Regulation (EC) No 178/20021. Thus, paras. 28 and 29 of the preamble to this Regulation are devoted to the importance of implementing traceability procedures for food and feed:
28) Experience has shown that the proper functioning of the internal market in food and feed may be jeopardised in cases where food and feed cannot be traced. It is therefore necessary to establish a comprehensive traceability system among economic operators dealing with food and feed so that, in the event of food safety problems, it is possible to withdraw certain products from the market in a targeted and precise manner or to inform consumers or control officials about their unsafety, and thus to avoid potential and undesirable disruptions to the normal functioning of the market.
29) It shall be ensured that economic operators dealing with food and feed, including importers, are able to identify at least the economic operator from which the food, feed, animals or substances that may be used in food or feed have been supplied, and that traceability is possible at all stages in the event of an investigation”
According to Article 3 of Regulation (EC) No 178/2002, traceability means the ability to trace and follow food, feed, animals intended for the production of food or substances intended to be included or expected to be included in food or feed at all stages of production, processing and distribution.
The minimum legal requirements for traceability are defined in Article 18 of Regulation (EC) No 178/2002:
“Article 18. Traceability
Article 18 of Regulation (EC) No 178/2002 requires food market operators to introduce a “step back – step forward” approach, i.e. to be able to identify the market operator from whom they have received a certain product and the market operator to whom they have supplied a certain product. Food market operators should put in place systems and procedures to enable them to comply with this requirement and to provide the competent authority with the information necessary to ensure traceability.
According to the Guidelines on the implementation of certain articles of Regulation (EC)
No 178/2002 (hereinafter – the Guidelines)3 , food market operators shall
– introduce a system that allows them to identify the direct supplier and the direct recipient of their products
– establish a “supplier-product” link to be able to identify which product was received from a particular supplier;
– to establish the “recipient – product” connection in order to be able to determine which product was delivered to a certain recipient of the product.
In addition, part four of Article 18 requires that the food product be appropriately labelled or identified to facilitate its traceability.
The requirements of Regulation (EC) No 178/2008 are aimed more at achieving the goal of introducing traceability systems than at clarifying how these goals should be achieved.
Thus, Article 18 does not contain specific requirements as to what information should be recorded and kept by the food market operator to meet the traceability requirement.
At the same time, the Guidelines4 clarify what information should be recorded and kept by the food market operator in order to comply with Article 18 of Regulation (EC) No 178/2002:
– name and address of the supplier and identification of the product supplied;
– name and address of the recipient and identification of the product received;
– date and, if necessary, time of delivery/receipt;
– volume or quantity of the product.
Regulation (EC) No 178/2002 does not specify the period of storage of information required to ensure traceability. The Guidelines provide clarification on how long the relevant information should be kept: “a period of 5 years is sufficient to retain traceability information”. However, for food products with a “use by” date on the labelling of which is less than 3 months, or for fruits, vegetables and bulk food products intended for the final consumer, the storage period may be up to 6 months from the date of manufacture or delivery. For other food products, the labeling of which indicates a minimum expiration date (“best before”), the relevant information should be stored for the expiration date plus 6 months. For products for which no expiry date is required, such as wine, vinegar, chewing gum, the general rule of 5 years will apply.
Regulation (EC) No 178/2002 contains general requirements for traceability. Specific requirements for traceability of certain types of food products in the EU are given, in particular, in:
– Regulation (EU) No 931/2011 laying down specific traceability requirements for food of animal origin;
– Regulation (EU) No 1337/2013 laying down traceability requirements for certain types of meat;
– Regulation (EC) No 1224/2009 laying down traceability requirements for fish products9 and Regulation (EU) No 404/2011 detailing traceability requirements for fish products.
For food of animal origin, in addition to the general information specified in Regulation (EC) No 178/2002, the information specified in Article 3 of Regulation (EU) No 931/2011 is mandatory to be recorded, kept and made available at the request of the market operator to which the food is supplied or the competent authority
– an accurate description of the food product
– volume or quantity of the food product
– name and address of the food market operator from which the food product was sent;
– name and address of the consignor (owner), if it is not the food market operator from which the food product was sent;
– name and address of the food market operator to whom the food product was sent;
– name and address of the consignee (owner), if it is not the food market operator to whom the food product is addressed;
– designation that identifies the batch or consignment;
– date of dispatch.
Regulation (EU) No 1337/2013 sets out the requirements for providing information to the end consumer or catering establishments on the country or place of origin for fresh, chilled and frozen meat – pork, lamb, goat and poultry meat.
The Regulation contains requirements for meat labeling, which require the implementation of a traceability system at all stages of meat production and distribution, from slaughterhouse to meat packaging, in order to be able to establish a link between the labeled meat and the animal or group of animals from which the meat was obtained.
In order to fulfill the requirements established by this Regulation, the food market operator at each stage of production and distribution of meat must have a system of identification and registration of animals. Such a system provides a link between the meat and the animal or group of animals from which this meat was obtained. At the same time, at the stage of slaughter, the establishment of such a connection is the responsibility of the slaughterhouse.
In addition, Regulation (EU) No 1337/2013 provides requirements for the provision of information on the country in which a certain animal was bred, the country of slaughter and the meat lot number to market operators at all stages of meat production and distribution.
Article 58 of Regulation (EC) No 1224/2009 contains traceability requirements for fish products. In accordance with the requirements of this Regulation, all consignments of fish and aquaculture products must be traceable at all stages of their production, processing and distribution, from catching or harvesting to the sale of such products. In addition, Regulation (EC) No 1224/2009 stipulates that all fish and aquaculture products must be properly labelled so that each batch can be traced/traced.
Market operators must put in place systems and procedures that allow the identification of any market operator to whom their products have been supplied. Such information should be provided to the competent authorities upon request.
At the same time, Article 58 of Regulation (EC) No 1224/2009 contains a minimum list of necessary labeling and information requirements for all consignments of fish and aquaculture products:
“The minimum list of necessary labelling and information requirements for batches of fish and aquaculture products shall include
– identification number of each batch;
– external identification number and name of the fishing vessel or name of the aquaculture production unit;
– alpha-3 code for each fish species (FAO);
– date of catch and date of production;
– quantity of each species in kilograms (net weight) or quantity per piece;
– name and address of the supplier; commercial name, Latin name, geographical area and production method;
– information on whether the fish products were pre-frozen”.
An important requirement to ensure the traceability of food products is the presence in the labeling of a designation that identifies the batch number to which the food product belongs. In the EU, the issue of batch number is regulated by Directive No. 2011/91/EU.
According to this Directive, a food product may be placed on the market and be in circulation only if its labeling contains a mark identifying the batch to which it belongs.
This requirement does not apply
– to food products that, after leaving the production area, are sold or placed in warehouses for temporary storage, preparation or packaging, or transported to facilities for their processing or processing, or grouped for immediate processing or processing
– if the bulk food product is packaged at the point of sale to the final consumer, including at the request of the consumer;
– to packaging or containers, the largest side of which has an area of less than 10 cm2;
– to individual portions of ice cream. The designation identifying the batch of ice cream must be applied to the group packaging.
The batch number must be preceded by the capital letter “L” of the Latin alphabet, except when such designation clearly differs from other designations in the marking. The designation identifying the batch may not be given if the labeling indicates the minimum shelf life of the food product or the “use by” date, which consists of the day and month in a certain order and is given in an uncoded form.
Internal traceability allows to clearly identify where the raw materials and components of the finished food product are located within the production process and the enterprise. Since the final food product is made from different raw materials, processed, combined with other components, repackaged, it must have its own identifier or a certain combination of numbers and letters by which it can be traced. At the same time, in order to ensure traceability, a clear link must be established between the finished (final) product and its ingredients (for example, oil, breadcrumbs, sauces, marinades, salt and other food components) and the packaging materials used.
As an example, consider the production of infant formula. In order to ensure internal traceability, it is important to organize the storage of information about the production process, in particular regarding the development of the product, raw materials and auxiliary materials for production, which are included in the product, production control, finished product control, etc. Production facilities should record key data and parameters throughout the production process, making sure that all records are real, reliable and enable effective traceability of the food product at each link in the production chain. The requirements for such records are set by the production enterprise independently, based on what records and what degree of their detail will guarantee the safety and quality of the baby formula.
However, it should be noted that internal traceability is not mandatory under EU law.
Regulation (EC) No 178/2002 does not contain any requirements for mandatory linkage between “incoming and outgoing” products, i.e. the so-called internal traceability, or for recording information on how a batch of products was divided and a new batch or new product was formed. Regulators reserve the right for market operators to independently determine the need to implement internal traceability at a particular enterprise depending on its size, production volumes and products used in production. However, the fact that such traceability is optional is considered by many researchers of European law as a gap in the law.
In addition, the Guidelines interpret the EU legislation in such a way that the requirement of internal traceability contributes to a clearer and more targeted recall of products if necessary. Internal traceability is also a means to control and optimise production, for example by managing inventories within a particular production or by identifying reliable and unreliable suppliers.
In Ukrainian legislation, traceability requirements are contained in the Law of Ukraine “On Basic Requirements for Food Safety and Quality” dated 23 December 1997 No. 771/97-ВР as amended on 4 April 2018 (hereinafter – the Law).
Thus, according to paragraph 74 of Article 1 of the Law: “traceability is the ability to identify the market operator, time, place, object and other conditions of delivery (sale or transfer) sufficient to establish the origin of food products, animals intended for food production, materials in contact with food products, or substances intended to be included or expected to be included in food products at all stages of production, processing and circulation”.
At the same time, the term “traceability” used in the Law does not fully correspond to the term from Regulation (EC) No 178/2002. Thus, this Regulation (EC) refers to food, feed, animals intended for the production of food or substances intended to be included or expected to be included in food or feed. And the definition contained in the Law makes a link to the market operator.
The requirements for food market operators to ensure traceability are set out in Article 22 of the Law. It stipulates that market operators must be able to identify other market operators who supply them with food and other objects of sanitary measures on a “step back” basis, as well as other market operators to whom they supply food and other objects of sanitary measures on a “step forward” basis.
However, the Law does not contain requirements for the introduction of internal traceability by food market operators.
At the same time, it should be noted that in order to ensure the highest standards of food safety and the effective implementation of the “farm to table” principle, the food product must be traceable along the entire food chain, and therefore both external and internal traceability are necessary. Internal traceability is one of the elements of an effective traceability system.
In addition, the Law does not set any specific requirements for food labelling to ensure traceability.
According to the Law, the information necessary to ensure traceability must be kept for six months from the final date of sale of the food product, applied on the labeling.
Given that the Ukrainian legislation currently contains only minimal traceability requirements, market operators interested in implementing an effective traceability system can use the best European and international practices.
According to the best practices, the main steps to ensure traceability by Ukrainian market operators are
implementation of the legally established requirement “one step back – one step forward”;
consideration of the possibility of introducing internal traceability at the enterprise;
determination of the necessary information to be recorded and stored to comply with this requirement, based on the size of the enterprise, the type of products it produces and the type of food used in production;
identification by the food market operator of the batch of the food product and the batch of raw materials used for its production, in such a way as to allow tracing the physical movement of the food product along the food chain;
establishing and maintaining accurate traceability records that can be made available within a short period of time for routine inspections or investigations at the request of the competent authority.
In order to develop an effective traceability system at an individual enterprise or one of its facilities, it is possible to use the recommendations provided in the Bulletin, which suggests a two-step approach.
Step 1 – development of an operational diagram, for which it is necessary to
identify the main activities of the company;
display the main activities in the form of a production process diagram;
identify all input components/operations and the result obtained at each stage of the production process;
analyze the movement of the product and determine its main critical points:
1. operations performed;
2. all changes in the product or packaging;
3. transportation, movement, storage or write-off;
4. combination of components (components are added at a certain stage of the production process) and mixing.
It is important to determine how the continuity of information will be ensured at all stages of the production process.
Step 2 – writing procedural instructions.
For each activity shown in the flowchart:
identify the activity with a name and number;
briefly describe the activity to be performed;
identify/assign the person responsible for the activity, the information to be recorded and the documentation to be kept to ensure traceability;
explain how to record/fix the data required for traceability;
indicate where the necessary data should be stored.
Alternatively, you can use the approach outlined in the Irish Traceability Guidelines, which provides step-by-step advice on how to develop a traceability system for an individual enterprise and includes the following key points:
a) information that should accompany the food ingredients used by the food market operator;
b) information on internal processes necessary to maintain traceability during processing or preparation of food, where applicable;
c) information that should accompany the process of distribution of food products produced by the food market operator;
4. determination of the period of storage of information necessary to ensure traceability and the development of a procedure for the retrieval of records;
5. development of a procedure for verification and testing of the traceability system;
6. documenting the traceability system.
The process of introduction of food safety management systems by Ukrainian producers is constantly gaining momentum. The most popular standards among manufacturers are ISO 22 000 and FSSC 22 000.
Also, the number of manufacturers in Ukraine is increasing, which, given the prospects of entering the EU markets, plan to introduce BRC and IFS standards.
These standards provide for the mandatory implementation of an internal traceability system.
Thus, ISO 22 000 contains special requirements for the enterprise regarding traceability, namely the need to introduce such a system that makes it possible to identify the batch number of the product and its connection with the batch of raw materials, as well as with records of their processing and receipt. That is, according to this standard, the company must have both external and internal traceability. The same requirements for traceability are contained in FSSC 22 000.
BRC stipulates the need to implement a traceability system that allows you to trace the path of a batch of raw materials from the supplier through all production processes and shipment of the finished product to the buyer, as well as the return path of such a product. All traceability procedures must be documented and, in addition to the product movement records themselves, must contain a clear description of how the traceability system works, a list and explanation of the labelling used and the records to be kept. In this case, the identification of products and materials can be provided by marking both manually and with the help of computerized barcoding systems.
In order to determine and confirm the effectiveness of the traceability system implemented in production, the company must test the system at least once a year. According to this standard, the traceability system must provide all the necessary information about the product within four hours.
IFS requires external and internal traceability, emphasizing that traceability should be ensured at all stages of production, including in-process and post-production handling.