Ensuring the traceability of food contact materials 441 Boundaries of traceability

As shown in Fig. 4.3, the traceability chain ends at the retailer. The other end of the chain, the starting point for traceability of a food contact material or article, is logically placed at the point at which it or its components or ingredients are first put on the market with the intention of being 'for food contact use'. For materials or articles, or their components/ingredients that are imported from outside the European Union, traceability shall extend back to the importer responsible for putting them on the EU market for the intended food-contact application. One of the questions that has been raised is the traceability of repeated use household goods, such as plastic containers, wooden spoons, glass items, trays, etc. Although these materials or articles can follow the same procedure as disposable goods up to retailing, it is very difficult to set up systems of traceability for their entire lifetime. Even labelling or marking of each single item can hardly help, as repeated washing and handling may delete it or make it unreadable. On the other hand, if the objective of the European Commission, while setting rules for traceability, was to protect consumers from chemical contamination caused by migration, repeated use of materials and articles would reduce migration and make the need for traceability less and less important as use proceeds. For this reason, in the preparation of the Industry Guidelines, it was decided to limit the downstream boundary to retailers.

4.4.2 Industrial practice

Traceability within stakeholders' operations Incoming starting materials

To attain a suitable level of traceability, each business operator must ensure that the incoming starting materials that he uses are supplied with information from the relevant supplier in order to ensure full and unequivocal identification of the starting material to be made. In the case of a converting or producing operation, such information should include:

1. The name of the supplier and the type or grade of the starting material.

2. The place and date of production, batch number or another equivalent identification number that will unequivocally identify the starting material.

3. In the specific case of starting materials for food contact plastics, documentation of compliance with details of the legislation with which they are complying.

4. Documented analysis that, depending on the nature of the starting materials, reports the key attributes against the agreed specifications.

Procedures for qualification of starting materials and suppliers are normally requested by all quality systems, both ISO and GMP. Qualification includes the confirmation of technical suitability for the intended use, as well as control of compliance with the relevant legislation, either general safety requirements in Regulation 1935/2004/EC or, in the case of plastics, in Directive 2002/72/EC and its amendments and, as appropriate, the relevant legislation of the EU Member Countries. As far as the technical attributes are concerned, such qualification is often carried out through audits with the aim of ensuring that the supplier's process is under control, and therefore the relevant technical attributes of the starting materials are constantly maintained. Audits may be also backed up by further analyses to confirm such suitability. These procedures and practices ensure that all measures are taken to guarantee that, if a starting material has a defect that may cause negative effects in the finished product, this defect is identified before it can cause problems. This provides, via traceability, a backup system addressing defects that may have escaped the quality control and quality assurance processes.

The process described above is applicable in particular to business operators that produce or convert materials and articles for food contact. However, the concept of 'starting material' is different depending on the position of an operator in the supply chain. For example, for a polymer-producing company monomers and additives represent starting materials, while plastic pellets, as well as additives, adhesives, printing inks, etc., are starting materials for a company producing plastic goods. Finally, the finished plastic material may be seen as a starting material for food companies that use it for packaging food. The level of modification that the starting materials undergo within each operation also defines the level of accuracy of the internal traceability needed to fulfil the requirement of Article 17. It is evident that complex processes, such as those used in plastics converting, require accurate records of the different steps (as will be described in section 4.5), whilst a lower degree of internal rework, such as cutting and sealing of the same plastic operated by a food packer, would certainly require a less sophisticated record system. However, regardless of the complexity of the internal rework, it is worth noting that internal systems of traceability are absolutely necessary to obtain complete materials traceability, and that simply fulfilling Article 17 (i.e. tracing 'one step back and one step forward') can hardly serve the objective of identifying critical starting materials at the retail level.

Shipped materials and articles

To fulfil the requirements of Article 17 of Regulation 1935/2004/EC, food contact materials or articles must be unequivocally identified when they are shipped to the next operator in the value chain that is a food company or a retailer. The converters or the producers have to ensure that information capable of operating such identification is transferred to customers. The necessary information consists of: (i) name and address of converter or producer; (ii) commercial name and grade/number of the material or article; (iii) production date and identification of the product.

The product's identification may consist of the lot number or another equivalent code, e.g., identification of the production shift, reel number, etc. The material or article, and/or its container, and/or the accompanying documentation shall always report the information mentioned above.

Several tools capable of carrying such information can be used, such as alphanumeric descriptions, bar codes, labels, RFID tags or the freight documentation that accompanies the shipped goods. The use of these tools depends on cost and on the further use of the material. Some examples are:

• the usual means of identification for food and beverage metal cans such as labelling, bar-coding and inkjet coding, applied either to individual cans or to batches according to feasibility and appropriateness;

• the label used as an information-conveying tool for transport packaging containing rigid packaging such as plastic trays, glass containers, PET pre-forms etc.;

• in the case of plastic cutlery, the information printed on its container (usually a plastic bag) or onto a label stuck to it;

• in the case of film reels that will be further cut before being used, the information on a label stuck on the wrapping or in the core, or printed on the conveying tool.

It must be pointed out that it is not important how the information is conveyed to the next stakeholder in the distribution chain, but it is of fundamental importance that it is complete, unambiguous and maintained along the chain.

Traceability along the supply chain

Besides the implementation of internal systems of traceability within each operator in the supply chain, an important concept that must be introduced here is that traceability is achieved only if each single operator of the chain respects the rules of identification enabling it to go back to its supplier(s). In other words, the information that accompanies the materials and articles when they leave the manufacturing company must be maintained downstream to the retail stage. This may not be an easy exercise, because different identification rules may apply for distributors and fillers with respect to manufacturers. In an ideal supply chain, composed entirely of companies operating under ISo 9000, traceability will always be guaranteed, as every single step of the chain will be documented. of course, this is not the case as not all distribution chains are composed entirely of certified companies. However, since companies operating under a certified quality system are required to control their suppliers and to ensure that the supplied products are appropriately identified, the system of traceability tends to be widened because suppliers (including distributors) and transport companies doing business with these companies will also be required to implement equivalent systems.

Traceability along the whole supply chain is a key point. If the information provided by a business operator to the next one in the chain is not appropriately maintained, managed and propagated, then traceability will be inevitably lost, and the effort of the supplying operator will be wasted regardless of the internal degree of accuracy. In other words, one single point of break can put at risk the whole work of the supply chain. This is indeed a weak point of the system that must be very carefully taken into consideration by control authorities whenever detecting failures. If a failure in the traceability system is detected by the authority, it might be easier for the authority to ask for more burden to be put on the concerned material or article, e.g., manufacturing information and a product's or manufacturer's identification printed on each single item introduced to the market. If the problem resides with lack of accuracy in the propagation of the identification from one operator to another, this may simply not be the solution, as free riders will break the law anyway.

It must be clear for the control authorities that Article 17 represents a challenge for the operators of the food contact materials and articles chain not only to align, harmonise and deepen their internal and inter-chain system of product tracing and recall, but also to control appropriately, identify and penalise illegal behaviour. As outlined in section 4.2.1, there are three types of food contact materials and articles for which traceability must be ensured: (i) materials and articles already in contact with food, (ii) those manufactured for food use but not yet in contact with food at the retail stage, and (iii) those that can reasonably be expected to be brought into contact with food or to transfer their constituents to food under foreseeable conditions of use. The traceability for these three categories can be different, in particular in relation to the traceability of food set forth by Article 18 of 178/2002/EC.

Materials and articles already in contact with food For materials and articles sold to the final consumer already in contact with food, filling represents the boundary to the downstream end of traceability. In fact, when they are filled with food, their identification overlaps that of the food itself, which must be guaranteed through Article 18 of the above mentioned Regulation 178/2002/EC (Fig. 4.4). In practice, 'best-before' date (mandatory for all foodstuffs), date of packaging and/or lot number are expected to contain, or link to, information relative to the food contact material or article. It is, however, necessary that the fillers maintain records of the specific references of the material or article that has been used for each foodstuff, and that the link between the two flows is not interrupted. It is not important how the link between food and the material used for its packaging is maintained by each body in the chain, whether it consists, for instance, of document filing or electronic archiving, as long as it is proven that it is unequivocal and unambiguous. For example, companies may choose to archive the material's shipment documentation with its reference lot number, or to put in a spreadsheet the material's reference codes versus time, if the process is continuous.

Materials and articles not yet in contact with food

These are materials and articles in a stage of their production and marketing prior to the stage at which they are brought into contact with food, or alternatively materials and articles sold as such in the retail stage without being in contact with food. For this reason their identification system does not overlap with the food identification system. In this case, it is necessary that the identification

Fig. 4.4 Merging of traceability of food packaging materials into food traceability.

(e.g. manufacturer's name, date and place of production, code, etc.) be maintained up to the retail stage. The tools already employed for the identification of food contact materials can be also used for food contact articles.

Material and articles that can reasonably be expected to be brought in contact with food or to transfer their constituents to food under foreseeable conditions of use

In relation to the previous two sections, this is not a separate category of food contact materials and articles when it comes to traceability information and its flow in the supply chain. The peculiarity here is the point at which the material or article is identified as coming into contact with food, and the fact that this contact can be indirect. Therefore the starting point of the traceability chain can be quite different from that of more traditional food contact materials and articles, but the end point still is the retailer, at which point the material is either in contact with food or not. Thus the previous two paragraphs apply, depending on the circumstances.

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