The contemporary food market, and in particular the rapidly developing dietary supplements sector, operates under the shadow of stringent chemical safety standards. One of the most significant challenges currently faced by manufacturers, importers, and supervisory authorities is the issue of pesticide residues. Ensuring the purity of plant-based products is no longer merely a matter of good manufacturing practice, but above all a complex legal and analytical operation embedded in a dense network of EU regulations.<\/p>\n\n\n\n
The legal foundations and the specific nature of dietary supplements<\/strong><\/p>\n\n\n\n The foundation of the European control system is Regulation (EC) No 396\/2005, which in a casuistic manner defines Maximum Residue Levels (MRLs). This act introduces a key presumption: if no specific limit has been established for a given active substance in a particular product, a strict default level of only 0.01 mg\/kg applies.<\/p>\n\n\n\n Key legal acts:<\/strong><\/p>\n\n\n\n Regulation (EC) No 396\/2005: establishes MRL limits for over 300 food products and hundreds of active substances. If no specific limit is defined for a given substance, the so-called default level of 0.01 mg\/kg applies.<\/p>\n\n\n\n Regulation (EC) No 1107\/2009: regulates the process of placing plant protection products on the market, with a focus on risk assessment prior to the approval of substances.<\/p>\n\n\n\n The Polish Act on Food and Nutrition Safety (Journal of Laws 2006 No. 171, item 1225): a national law implementing EU directives, defining the competences of control authorities (Sanitary Inspection, IJHARS).<\/p>\n\n\n\n It is worth emphasizing that, under the law, dietary supplements are classified as food, which imposes on them the same obligations arising from the above regulation.<\/p>\n\n\n\n However, a significant interpretative difficulty arises in relation to plant extracts. Pursuant to Article 20 of Regulation 396\/2005, when assessing the compliance of a processed product, so-called processing factors must be taken into account. This means that processes such as drying or extraction may naturally concentrate pesticide residues, which requires food business operators (FBOs) not only to conduct testing but also to possess detailed technological documentation justifying the final analytical result.<\/p>\n\n\n\n Processing factors:<\/strong> pursuant to Article 20 of Regulation 396\/2005, when assessing supplements containing plant extracts, changes in residue concentrations resulting from drying or extraction processes must be taken into account.<\/p>\n\n\n\n Cross-contamination:<\/strong> multi-ingredient supplements require analysis of each component separately, taking into account its botanical origin.<\/p>\n\n\n\n Modern analytics: from extraction to precise measurement<\/strong><\/p>\n\n\n\n Detecting trace amounts of chemical substances in complex matrices such as herbs or plant oils requires technologies that go beyond standard quality tests. Currently, the gold standard in accredited laboratories is the QuEChERS method, which, thanks to multi-stage extraction and purification, allows pesticides to be isolated with minimal interference from pigments or organic acids.<\/p>\n\n\n\n A true breakthrough, however, is the application of hyphenated techniques such as liquid chromatography (LC-MS\/MS) and gas chromatography (GC-MS\/MS) combined with tandem mass spectrometry. These enable the simultaneous identification of hundreds of compounds in a single measurement cycle with extraordinary sensitivity. In a legal context, the result of such testing constitutes key evidence in the process of verifying compliance of a batch with EU requirements, particularly in cases involving border rejection of goods or proceedings before the Sanitary Inspection.<\/p>\n\n\n\n Analytical testing methodology<\/strong><\/p>\n\n\n\n Sample preparation \u2013 the QuEChERS method<\/strong><\/p>\n\n\n\n Currently, the \u201cgold standard\u201d in laboratories is the QuEChERS method (Quick, Easy, Cheap, Effective, Rugged, and Safe). This process consists of two stages:<\/p>\n\n\n\n Extraction: the use of acetonitrile and salts (e.g. magnesium sulfate) to isolate pesticides from the sample.<\/p>\n\n\n\n Clean-up (d-SPE): dispersive solid-phase extraction that removes organic acids, pigments (chlorophyll), and sugars from the extract that could interfere with the reading.<\/p>\n\n\n\n Modern analytics uses hyphenated techniques combining chromatography with mass spectrometry:<\/p>\n\n\n\n LC-MS\/MS (liquid chromatography with mass spectrometry): used for determining polar and non-volatile pesticides. It is crucial in testing dietary supplements containing thermolabile plant compounds.<\/p>\n\n\n\n GC-MS\/MS (gas chromatography with mass spectrometry): ideal for volatile and non-polar substances.<\/p>\n\n\n\n Modern Triple Quadrupole (QqQ) systems allow simultaneous monitoring of hundreds of compounds (so-called multi-residue methods) in a single measurement cycle, achieving detection limits significantly below the standard 0.01 mg\/kg.<\/p>\n\n\n\n Responsibility of operators and market surveillance<\/p>\n\n\n\n According to the principle of traceability, the manufacturer or the entity placing the product on the market bears full responsibility for ensuring that the product does not exceed MRL limits.<\/p>\n\n\n\n The RASFF system<\/strong><\/p>\n\n\n\n When laboratory tests show exceedances of limits, the information is transmitted to the RASFF (Rapid Alert System for Food and Feed). In the case of dietary supplements, the most common causes of alerts are:<\/p>\n\n\n\n The presence of ethylene oxide (a disinfecting agent banned in the EU).<\/p>\n\n\n\n Exceedances of limits in raw materials originating from third countries (e.g. India, China).<\/p>\n\n\n\n Risk analysis and sampling criteria<\/p>\n\n\n\n Control authorities (in Poland mainly the Chief Sanitary Inspectorate) apply a risk-based approach. Dietary supplements based on herbs and extracts are treated as \u201chigh-risk\u201d products due to the natural ability of plants to accumulate contaminants from soil and the technological processes that concentrate active substances.<\/p>\n\n\n\n Future challenges: synergy and the cocktail effect<\/strong><\/p>\n\n\n\n The most fascinating, and at the same time concerning, direction of the evolution of food law is the shift from examining isolated substances toward Cumulative Risk Assessment (CRA). The previous practice, in which each pesticide was assessed separately, is giving way to a holistic model. Science, followed by lawmakers, recognizes the phenomenon of the so-called \u201ccocktail effect.\u201d It consists in the fact that a mixture of several different pesticides\u2014each of which individually complies with the limits\u2014may exert a combined harmful effect on a specific organ, such as the thyroid or the nervous system.<\/p>\n\n\n\n The European Food Safety Authority (EFSA) is working on implementing Cumulative Assessment Groups (CAGs), which in the near future may force a change in the way the safety of product batches is calculated. From the perspective of a legal blog, it is worth noting that this may lead to a situation where a product that formally complies with all MRL limits is deemed unsafe due to the total toxicological dose.<\/p>\n\n\n\n Market monitoring and the early warning system<\/strong><\/p>\n\n\n\n In the risk management process, the RASFF system is an invaluable tool. Analysis of alerts from recent years shows a clear trend: most violations concern raw materials imported from third countries such as India, China, or Egypt. The problem of ethylene oxide in sesame seeds or turmeric has become a symbol of the difficulties faced by the global supply chain. For lawyers and quality managers, this means the need to abandon passive reliance on supplier certificates in favor of active monitoring of legislation and regular independent testing.<\/p>\n\n\n\n The future of food control will be based on \u201cnon-target screening\u201d methods, which instead of searching for specific known substances, will scan products for any chemical anomalies. In the era of the \u201cFarm to Fork\u201d strategy, aiming to reduce pesticide use by 50%, transparency and analytical precision are becoming the foundation of a safe food business.<\/p>\n\n\n\n Most frequently challenged raw materials (High-Risk Materials)<\/strong><\/p>\n\n\n\n Raw material \u2013 Main hazard (substance) \u2013 Country of origin (statistically) Why are these raw materials problematic?<\/strong><\/p>\n\n\n\n Ethylene oxide (EtO): this is the absolute \u201crecord holder\u201d of recent years. Although technically a fumigation (disinfection) agent, it is banned in food in the EU due to its carcinogenic properties. The problem mainly concerns raw materials from Asia, where it is used to combat Salmonella in spices.<\/p>\n\n\n\n Chlorpyrifos: this substance was withdrawn from use in the EU in 2020 (MRL reduced to the limit of detection). Since in many non-EU countries it is still a cheap and effective insecticide, it is very frequently detected in laboratory tests during import controls.<\/p>\n\n\n\n Matrix complexity: raw materials such as tea or spices have a very complex chemical composition (rich in essential oils and tannins). This complicates analysis and requires advanced sample clean-up using d-SPE to avoid false-positive results.<\/p>\n\n\n\n How to read RASFF reports in practice?<\/strong><\/p>\n\n\n\n The RASFF system divides notifications into three main categories, allowing companies to assess the severity of the issue:<\/p>\n\n\n\n Alert: a serious risk; the product is already on the market; requires immediate recall.<\/p>\n\n\n\n Information exchange: a risk has been identified, but the product may not yet be on the market or the risk is lower.<\/p>\n\n\n\n Border rejection: the safest situation for the importer\u2014the product has not been allowed into the EU, preventing costly withdrawal procedures from store shelves.<\/p>\n\n\n\n Recommendations for business (supplements and food)<\/p>\n\n\n\n To minimize the risk associated with the \u201ccocktail effect\u201d and new regulations, it is worth implementing the following steps:<\/p>\n\n\n\n Supplier audit: do not rely solely on the supplier\u2019s certificate (CoA). Conduct your own random testing in accredited laboratories in Europe.<\/p>\n\n\n\n Legislative monitoring: MRL thresholds change dynamically. A substance that is permitted today at 0.1 mg\/kg may be reduced to 0.01 mg\/kg within six months.<\/p>\n\n\n\n Multi-residue testing: always commission full-spectrum testing (so-called screening for 500+ substances), rather than tests for selected pesticides only.<\/p>\n\n\n\n This article presents only selected aspects of the discussed topic. The scope of the issues is much broader and requires in-depth, specialized analysis. The information contained herein is general and educational in nature and does not constitute legal advice or a legal opinion within the meaning of applicable laws. Each case requires an individual approach, taking into account the specifics of the given situation, and this is precisely what we address at AJ LAW.<\/p>\n\n\n\n All recommendations, comments, and materials presented are protected by law and constitute the property of their author; they may not be copied or used in a manner contrary to the law or their intended purpose.<\/p>\n\n\n\n In order to obtain binding advice tailored to your situation, it is always recommended to contact a professional advisor or lawyer.<\/p>\n\n\n\n\n
Sesame seeds \u2013 Ethylene oxide (EtO), chlorpyrifos \u2013 India, Nigeria
Turmeric and ginger \u2013 Ethylene oxide, multi-residue pesticides \u2013 India, Vietnam, China
Rice (mainly Basmati) \u2013 Carbendazim, thiamethoxam \u2013 India, Pakistan
Tea (green and black) \u2013 Anthraquinone, chlorpyrifos, acetamiprid \u2013 China, Sri Lanka
Dried herbs (e.g. coriander) \u2013 Chlorpyrifos, profenofos \u2013 Egypt, Turkey
Goji berries \u2013 Carbofuran, propargite \u2013 China<\/p>\n\n\n\n