| EU will not accept tolerance levels (15/10/2005) | |
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...a "blending down" to a GM content below the 0.9% threshold can be no solution to avoid labeling. The national legislation of Germany sanctions infringements with fines up to 50,000 euros ($61,000) and with prison terms. EU will not accept tolerance levels Since its implementation in April 2004, EU Regulation 1829/2003 (labeling of genetically modified food and feed) has caused both food and feed manufacturers in Europe as well as their overseas suppliers a great deal of concern. This article focuses on interpretation of the key terms of "adventitious" and "technically unavoidable" in regards to GMO content, as provided by one EU Member State’s enforcement authorities. At first it seemed that the GM labeling regulation, although disliked by the industry, would provide clarity to dealing with food and feed products and ingredients that contain genetically modified organisms (GMOs). But it soon became apparent that problems lurked in the finer print. For example, what really is an "adventitious or technically unavoidable presence of genetically modified material?" The answer to this question is essential for it can determine whether the thresholds tolerated by the regulation are reduced to the level of GMO detection – at 0.01%. Case study: German breakfast cereal manufacturer In July 2005, a German breakfast cereal mix manufacturer received a letter from an enforcement agency that had reviewed and tested the company's product, which included a soy ingredient. Knowing that the labeling requirements do not apply if food products contain material of less than 0.9% content as long as it is "adventitious" or "technically unavoidable," the enforcement agency took samples of the cereal mix that tested at 0.6 and 0.7% genetically modified DNA. They then argued that in order to determine the adventitious or technically unavoidable presence of this material the company would have to demonstrate its efforts to avoid the use of such material. A review of the company's quality management files showed that GMO tests conducted in the past resulted in 0.4 and 0.1% GM content. In addition, a lab report provided by the supplier of the raw material showed 0.3% GM content. Must demonstrate that GMOs are adventitious and technically unavoidable These facts caused the enforcement agency to state that a GM content of less than 0.1% must be considered adventious. But for values between 0.1 and the 0.9% threshold an operator would have to demonstrate that the GM presence detected is adventitious and technically unaboidable. The breakfast cereal manufacturer pointed out to the agency that they had procured the soy ingredient as "non-GMO." In the agency's opinion this was an aspect to be clarified between the two companies. What is essential, they added, is that the cereal company knowingly used a soy ingredient that contained between 0.1 and 0.9% GM DNA. They emphasized that adventitiousness must be excluded if an operator knowingly uses GM ingredients in food production. And to verify that it was technically unavoidable, the company must submit evidence proving that no equivalent ingredient at less than 0.1% GM is available on the market. Implications for food and feed manufacturers The facts of this case show important consequences for food and feed manufacturers: The EU labeling threshold of 0.9% above which is a manufacturer must label his product as containing GMOs, is irrelevant if the GM content below this threshold is not "adventitious" or "technically unavoidable". Enforcement authorities not only draw samples to be tested for GM content, they also draw conclusions based on a document review as to whether these two criteria are met. Knowingly processing ingredients above 0.1% GM content does not meet the adventitious criterion. Consequently, in such cases even GM content below 0.9% will result in labeling. Alternatively, in such cases authorities will review the criterion of technical unavoidability. This is fulfilled if there are no sources for a particular ingredient below 0.1% available on the market. Enforecemnt agencies consider the quantification level of the PCR GMO test method of 0.1% as the threshold below which GM content may be detectable and considered adventitious. Important to use certified non-GM ingredients These five conclusions illustrate the importance of using raw materials and ingredients that are practically devoid of GMOs if a food or feed manufacturer wants to avoid GM labeling. Therefore it seems highly recommendable to use raw materials certified as non-GMO, provided the certification standard has a threshold of 0.1%. Under such circumstances, even enforcement authorities must classify an occasional occurrence as adventitious. This also clarifies that a "blending down" to a GM content below the 0.9% threshold can be no solution to avoid labeling. The negative results of any presence of GM material in the raw material flow of a manufacturer wanting to avoid GM labeling is clearly documented. Operators must be aware that Art. 45 of the labeling regulation demands that "Member States shall lay down the rules on penalties applicable to infringements of the provisions," and "The penalties provided for must be effective, proportionate and dissuasive." The national legislation of Germany sanctions infringements with fines up to 50,000 euros ($61,000) and with prison terms. Jochen Koester is director of IMCOPA Europe SA |
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