EFSA

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     The activity of the European Food Safety Authority(EFSA) in the area of food safety is constantly high. As a result of these activities, new legislation can be implemented or existing legislation can be amended. The goal is to guarantee the consumer buys a safe product. ⁽¹⁾.
     One of the most significant threats to food safety are the remaining chemical and biological contaminants in food. They are found in food for example due to human activities in the agricultural industry, or are metabolites of living organisms present in the environment. Their excessive levels can significantly jeopardize food safety and, consequently, consumer’s health.  This is the reason why everyone involved in food production in the EU, must know and comply with the requirements of the European Commission Regulation (EC) No. 1881/2006, setting maximum levels for certain contaminants in food stuffs ⁽²⁾. On the basis of EFSA's long-standing studies and observations, as well as the scientific opinions it has issued, the following types of contaminants have been listed, and their levels remain limited:

  - Nitrates

  - Mycotoxins, which include aflatoxins, ochratoxin A,patulin, deoxynivalenol, zearalenone, fumonisins, T2 and HT-2 toxins, citrinin, ergot alkaloids

  - Heavy metals

  - 3-monochloropropane-1,2-diol (3-MCPD)

  - Dioxins and polychlorinated biphenyls (PCBs)

  - Polycyclic aromatic hydrocarbons.

The aforementioned contaminants are assigned to product groups strictly defined by the regulations. They are specified on the basis of the risk analysis carried out, which is handled by relevant institutions such as: EFSA, the European Commission, the Council of Europe or the European Parliament.

All the detailed product groups and their assigned contaminant limits can be found in the annex to Regulation 1881/2006 of December 19, 2006 ⁽²⁾.
    It is interesting to note that in addition to the groups of raw materials, the regulation lists a separate group of dietary supplements. As a result, a finished product that has the status of a dietary supplement must meet the regulation's requirements for limits on heavy metals and polycyclic aromatic hydrocarbons. Special attention should also be paid to the raw materials that go into such a supplement. Ideally, the requirements for the level of contaminants in raw materials should be met at the design stage of the finished product. This will guarantee the production of a safe, European-compliant final product.
     Ensuring food safety is an ongoing priority for government bodies and consumers. Continuous work is underway to expand the list of limited contaminants in food. On December 11, 2020. The EU Commission issued a regulation amending Regulation 1881/2006 with regard to maximum levels of pyrrolizidine alkaloids ⁽³⁾. This means that another contaminant has been added to the group of controlled contaminants in food. The decision to consider this group of contaminants as a food safety risk was supported by EFSA's scientific opinion. The potential threat of cumulative alkaloid compounds applies mainly to teas, but also to dietary supplements containing herbal ingredients. From 01.07.2022, the content of pyrrolizidine alkaloids in these product groups is limited. The European Commission's attention has also been drawn to tetrahydrocannabinol(THC) levels in hemp seed foods. EFSA has already issued a positive opinion on the establishment of maximum limits for Delta-9-THC in hemp seeds and products derived from them. This means that another group of contaminants that threaten food safety will soon be added ⁽⁴⁾.

It should be kept in mind that the regulation covers the European Union. Non-EU countries may have other legislation, which is not always comparable to the EU countries. From the point of view of a European manufacturer, raw materials coming from non-EU countries may not meet the requirements assumed by the European law. Therefore, it is worth asking the question: Where do my raw materials come from? Non-European materials can of course be used and distributed and it is obvious that restricting trade to the borders of the EU would demolish the idea of it. However, if we want to source raw materials from all over the world and market them within EU countries, steps must be taken to confirm their compliance with EU contaminant limits, as specified in the relevant legislation.

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RASFF

     Sourcing raw materials from distant and exotic countries may seem like a big risk. This is because there are legitimate concerns that raw materials will not meet the requirements of the European regulations. However, there are tools to eliminate such risks. Establishing a pre-release testing plan for each raw material allows us to ensure that all requirements under Regulation 1881/2006⁽²⁾and other legislation (if applicable) are met. It may be helpful to conduct a risk analysis in determining the scope of testing. This is because not every raw material requires a full range of tests to be performed. If the manufacturer declares compliance with the requirements of the regulation, it is worth considering whether there is a need to test each batch of raw material. If the supplier is a trusted one, there is no reason not to rely on the test results presented by such a supplier.

     The Rapid Alert System for Food and Feed (RASFF) is helpful in conducting risk analysis. It is a system that is an essential element of food safety strategy. The principle of its operation is based on the fastest possible collection and release of information about raw materials and food products that threaten human or animal health⁽⁵⁾. On the basis of the alerts generated by the RASFF system, it is possible, among other things, to track the risks associated with the import of raw materials from outside of the EU. If there are repeated reports of contaminant exceedances in RASFF alerts, the source can be determined and the existing problem can be taken into account in building the supply chain. Recently, the main contaminant appearing in RASSF alerts has been ethylene oxide.

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Contamination of raw material with ethylene oxide

Since 2020, the presence of ethylene oxide in food has continually occupied the largest percentage of reported risks in RASFF alerts. Ethylene oxide, due to its carcinogenic properties, is fully banned in the EU. Due to its classification as a pesticide in some non-EU countries and its authorization for use in India to reduce potential microbial contamination, there is a risk that raw materials sourced from these areas will be contaminated with the substance ^{(6, 7, 8)}.
     Analysis of RASFF alerts has shown that ethylene oxide contaminated products are usually those containing raw materials from Asia and countries where its use is permitted. Correct analysis of RASFF alerts and drawing correct conclusions made it possible to stop the uncontrolled import of raw materials contaminated with ethylene oxide into the EU. This is a classic example confirming that RASFF is a very good tool to support risk analysis ⁽⁸⁾.

Due to the large amount of sourced raw materials contaminated with ethylene oxide, further steps have been taken to prevent the import of such raw materials. In order to confirm the absence of raw material contamination, declarations are required from suppliers confirming the correct quality of the raw material. Why is such a declaration desirable, but it cannot be taken for granted? The problem is much more complex and often does not lie directly with the manufacturer. Deeper analysis has shown that ethylene oxide is also used to disinfect containers in shipping. The permeability of ethylene oxide is very high, so that it easily penetrates the subsequent layers of raw material packaging, to finally contaminate the material itself⁽⁷⁾ . Suppliers in their statements declare ethylene oxide-free production, but no longer take responsibility for transportation. For this reason, limited trust should be applied to suppliers' statements. It is good practice to test raw material for this contaminant after delivery to your warehouse. On several occasions, ethylene oxide contamination was confirmed in samples for which the supplier provided results confirming the absence of contamination in material. In all cases, the supplier provided documentation of samples taken at the production site. Samples of the raw material taken after delivery, gave a completely different result on the EtO test. In the case of Ethylene oxide, the best approach is to apply the principle of limited trust.

Summary

     As food law defines a dietary supplement as a food stuff, it is important to be aware that both the finished products and also ingredients must meet the requirements defined by regulations, directives and national law. The list of contaminants affecting food safety is constantly extended. European government institutions have identified a number of other possible contaminants that may be present in food and are conducting intensive research to confirm their harmfulness. Product safety will certainly remain one of the most important aspects related to food.

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