Change in working method regarding the obligation to report MRL exceedances in food

The Netherlands Food and Consumer Product Safety Authority ("NVWA") has announced a change in the working method with regard to the notification of exceedances of the maximum residue limit ("MRL") in respect of pesticide residues in food. In relation to their notification obligation, companies are now allowed to take a measurement uncertainty into account in the analysis results of pesticide residues in food. With this new approach, the Netherlands follows the approach of the European Commission.

Notification obligation

Pursuant to article 19 of the General Food Law Regulation (EG) 178/2002 ("GFLR") any company involved in the production, storage and trading of food has a notification obligation. This obligation means that the company must notify the competent authority, in the Netherlands the NVWA, if food is not in compliance with the food safety requirements. When the measured amount of pesticide residue in food exceeds the MRL, in principle a notification must be made to the competent authority.[1] For more information about the notification obligation we refer to the article of our colleague Marijn van Tuijl "The NVWA notification obligation in the context of food safety".

Measurement uncertainty

In the past, companies were not allowed to take into account a measurement uncertainty with regard to the analysis results of pesticide residues in food. However, from now on, when determining whether companies must notify the NVWA of an exceedance of the MRL, they may take into account a measurement uncertainty of 50% in the analysis results of pesticide residues in food. This is under the condition that the food is not (potentially) harmful to health. In addition, the measurement uncertainty may not be applied in cases involving substances other than pesticide residues.

Working method

In order to determine whether a company should notify the NVWA of an exceedance of the MRL, the NVWA has drawn up a flow chart. The NVWA distinguishes three situations. If the analysis results are lower than or equal to the MRL, the company does not have to notify the NVWA. If the analysis results exceed the MRL and, after deduction of the measurement uncertainty of 50%, still exceed the MRL, the company is obligated to notify the NVWA. If the analysis results exceed the MRL but, after deduction of the measurement uncertainty of 50%, is equal to or lower than the MRL, the company only has to notify the NVWA if the product is harmful to the health of the consumer.

In determining whether the product is harmful to the health of the consumer, the company must check whether the toxicological reference values are not exceeded. This concerns two limit values, namely the Acute Reference Dose ("ARfD") and the Acceptable Daily Intake ("ADI"). The ARfD is the amount of a certain substance that can be consumed over a short period of time without posing health risks. The ADI is an estimate of the amount of a certain substance that can be ingested over a long period of time. These limit values can be found in the European Commission's Pesticide Database. It is important to note that the measurement uncertainty may not be taken into account when assessing whether a product is harmful to the health of the consumer. Therefore, the analysis results without deduction of the measurement uncertainty should be used as a basis for the assessment whether or not the toxicological reference values are exceeded. If the toxicological reference values are indeed exceeded, the company must notify the NVWA. This even applies in the event that the analysis results with measurement uncertainty of 50% is lower than the MRL.

If no ARfD or ADI has been determined, it should be assessed whether the substance in question is a carcinogen (causing cancer), mutagen (causing genetic mutations) or reprotoxic (harmful to reproduction) substance, in short CMR substance. The European Commission's Pesticide Database indicates whether the substance is a CMR substance. If it concerns a CMR substance of the type 1a or 1b, the company should notify the NVWA of the exceedance of the MRL. This even applies if the analysis result with the measurement uncertainty of 50%, is lower than the MRL.

Implications for practice

With this new working method, the Netherlands follows the working method of the European Commission and various EU Member States. For many companies, the new working method could be of great importance with regard to whether a product may be placed on the market or not and whether a notification to the NVWA must be made or not. Whereas under the old working method a product would not be allowed to be placed on the market because the MRL was exceeded, companies now have the opportunity to – if the analysis results after deduction of the measurement uncertainty are lower than the MRL – determine that the product is not harmful to the health of the consumer. If it can be determined that the toxicological reference values are not exceeded, the product can then be placed on the market and the company does not have to notify the NVWA.

About Ploum’s International Trade, Customs and Food Safety & Product Compliance team

The specialists of our International Trade, Customs and Food Safety & Product Compliance team will be happy to assist you if you have any questions on this topic, or in respect of other issues related to International Trade, Customs or (organic) Food safety/law. Thanks to our many years of experience in the Customs and Food safety practice, we can serve you quickly and effectively. If you have any questions on this topic (in general or in discussions with the NVWA), or in respect of other issues related to International Trade, Customs or (organic) Food safety/law, please contact one of our team members or contact Marijn van Tuijl (m.vantuijl@ploum.nl) or Mirjam Louws (m.louws@ploum.nl) directly.