EFSA

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The activity of the European Food Safety Authority (EFSA) in the area of food safety activities is consistently high. As a result of these actions, it is possible to implement new legal acts or amend existing ones. The result is an extension of the area guaranteeing the production of a product that is safe for the consumer ⁽¹⁾.
One of the most important risks to food safety is the remaining chemical and biological contaminants. They are found in food, among others due to human activities in the agricultural industry or are metabolites of living organisms, present mainly in the environment. Too high a level can significantly endanger food safety and, consequently, the health of the consumer. This is why any operator involved in the production of food 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 foodstuffs ⁽²⁾. On the basis of long-term studies and observations carried out by EFSA and the scientific opinions issued by EFSA, the following types of pollutants have been identified, the levels of which must 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 abovementioned pollutants are assigned to product groups strictly defined by the Regulations. They have been identified on the basis of a risk analysis carried out by the relevant institutions such as EFSA, the European Commission, the Council of Europe or the European Parliament.

All specific product groups and their associated pollution limits are set out in the Annex to Regulation 1881/2006
dated 19 December 2006 ⁽²⁾.
It is interesting that apart from the groups of raw materials, a separate group of dietary supplements is specified in the regulation. As a result, the finished product having the status of a dietary supplement must comply with the requirements of the Regulation on limits for heavy metals and polycyclic aromatic hydrocarbons. Particular attention should also be paid to the raw materials that are part of such a supplement. Ideally, at the design stage of the finished product, the requirements for the level of impurities in the raw materials are met. This will guarantee the production of a safe, European-compliant final product.
Ensuring food safety is an ongoing priority for governments and consumers. Continued work is underway to expand the list of limited contaminants in food. On 11 December 2020, the EU Commission issued a regulation amending Regulation 1881/2006 as regards maximum levels for pyrrolizidine alkaloids ⁽³⁾. That is, another has been added to the group of controlled contaminants in food. The decision to recognise this group of contaminants as posing a threat to food safety was supported by a scientific opinion from EFSA. The potential danger of accumulated alkaloid compounds mainly concerns teas, but also 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 the levels of tetrahydrocannabinol (THC) in hemp seed foods. EFSA has already issued a positive opinion on the establishment of maximum limits for delta-9-THC in cannabis seeds and products derived from them. This means that another group will soon be added to the group of contaminants that threaten food safety ⁽⁴⁾.

It should be borne in mind that the regulation covers the countries of the European Union.
In countries outside the EU, other legal acts may apply, which are not always identical to the requirements addressed to EU countries.
From the point of view of the European producer, raw materials from countries outside the EU may not meet the requirements established by European law. So it is worth asking yourself: What about the origin of raw materials from other countries and continents? This does not mean that the raw material cannot be used and distributed. Narrowing trade to the EU's borders would destroy his idea. However, if we want to source raw materials from all over the world and place them on the market in EU countries, measures must be taken to confirm their compliance with the pollution limits in force in the EU, as set out in the relevant legislation.

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RAFF

Sourcing raw materials from distant and exotic countries may seem like a big risk. There are legitimate concerns that raw materials will not meet the requirements of European regulations. However, there are tools that allow you to eliminate such risks. The establishment of a testing plan for each raw material prior to its release on the market allows us to ensure that all the requirements of Regulation 1881/2006 are met ⁽²⁾ and other legal acts (if applicable). A risk analysis may be helpful in determining the scope of research. Not every raw material requires a full range of research. In the event that the manufacturer declares compliance with the requirements of the regulation, it is worth considering whether it is necessary to test each batch of raw material. If the supplier is trusted, then there are no contraindications to rely on the test results presented by him.

RASFF (Rapid Alert System for Food and Feed), or Early Warning System for Hazardous Food and Feed, is helpful in carrying out risk analysis. It is a system that is an essential element of a food safety strategy. The principle of its operation is based on the collection and provision as soon as possible of information on raw materials and food products that endanger 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 the EU. If there are repeated reports of pollution exceedances in RASFF alerts, the source can be identified and the existing problem taken into account in the construction of the supply chain. Recently, the main pollutant appearing in RASSF alerts was ethylene oxide.

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Ethylene oxide contamination of raw material

Since 2020, the presence of ethylene oxide in food has consistently accounted for the highest percentage of reported hazards in RASFF alerts. Ethylene oxide, due to its carcinogenic properties, is completely banned in the EU. Due to its authorisation in some non-EU countries as a pesticide and its use in India to limit potential microbial contamination, there is a risk that raw materials obtained from these areas will be contaminated with this substance ^{(6, 7, 8)}.
Analysis of RASFF alerts showed that contaminated with ethylene oxide are typically products containing raw materials originating in Asia and countries where its use is permitted. The correct analysis of RASFF alerts and the rapid drawing of conclusions made it possible to stop the uncontrolled import of raw materials contaminated with ethylene oxide into the EU countries. This is a classic example confirming that RASFF is a very good tool to support risk analysis ⁽⁸⁾.

Due to the large amount of extracted raw materials contaminated with ethylene oxide, further steps have begun to be taken to prevent the import of such raw materials. In order to confirm the absence of contamination of raw materials, declarations confirming the correct quality of the raw material are required from suppliers. Why is such a statement desirable, but not a full-fledged declaration? The problem is much more complex and often does not lie directly on the side of the manufacturer. A deeper analysis showed that ethylene oxide is also used to disinfect containers
in maritime transport. The permeability of ethylene oxide is very high, due to which it easily penetrates
into successive layers of packaging with raw material, from where there is already a short way to contamination of the raw material itself ⁽⁷⁾. Suppliers in the statements declare production free of ethylene oxide, but no longer take responsibility for transportation. For this reason, limited confidence in the information declared by the provider should be maintained. It is a good practice to test the raw material for this contamination as soon as it has been delivered to the destination warehouse. Ethylene oxide contamination was confirmed several times in samples for which the supplier provided results confirming the absence of contamination in the raw material. In all cases, the supplier provided documentation of the samples taken at the production site. The same raw materials taken from the target warehouse already gave a completely different answer on the contamination of the raw material. In this case, the best solution is to apply the principle of limited trust in the supplier.

summary

In connection with the definition by food law that a dietary supplement is a food product, it should be borne in mind that both finished products and the raw materials included in them must meet the requirements defined by regulations, directives and national law. The list of contaminants affecting food safety is constantly growing. European government institutions are targeting other contaminants that may be present in food and are conducting intensive research to confirm their harmfulness. Product safety has been, is and will certainly remain one of the most important aspects related to food.

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