The Notion of Dangerous Food in Europe

Page 1

The Notion of Dangerous Food in Europe - A Recent Alert Considered as an Example I Prof. Dr. Alfred H. Meyer IA Case Study An alert issued on 21/11/2014, Ref. 2014.1596, reported atropine (12.1 µg/ kg - ppb) contamination in porridge in baby food from Switzerland that had been manufactured in Germany and contained raw material from Austria. The contaminated food was recalled without this having been required by the authorities. Was this necessary? Although, in principle, a health risk for babies, small children and consumers of all ages might possibly arise where foods contaminated with tropane alkaloids are consumed, while taking into account the current – albeit unsatisfactory – data where the acute reference dose (ARfD) is exceeded, based on the current data there are no corresponding indications at the present time. Furthermore, at the present time no standardized method or one validated by round robin tests is available in order to provide proof. Tropane alkaloids are natural ingredients of certain plants such as hyoscyamus, Jimson weed and deadly nightshade (belladonna). Through the contamination of cereals with the seeds of hyoscyamus or Jimson weed, tropane alkaloids can also be found in cereal-based foods. More than 200 tropane alkaloids have been identified so far. However, the German Federal Institute for Risk Assessment (BfR) remarked in its opinion on the content of tropane alkaloids in cereal-based products (title in German “Hohe Tropanalkaloidgehalte in Getreideprodukten: Bei Menschen mit Herzproblemen sind gesundheitliche Beeinträchtigungen möglich”, No. 035/2014 of November 13, 2013) that at the present time no standardized or validated methods

Reunir a los abogados del mundo I 1 ■

2015

were available for proving the content of tropane alkaloids in foods; nor was certified reference material available. These findings were also made by EFSA in its opinion published in late 2013 (EFSA Journal 2013: 11(10):3386). Moreover, the existing data on consumption merely suffices to estimate the exposure and analyze the risk regarding the two substances hyoscyamine and scopolamine for small children between the ages of 1-3 years. Yet even this data used to estimate the exposure is incomplete; only 124 food samples were analyzed. The ingredients in the samples included wheat, maize, rye, oats and rice, permitting the conclusion that various cereal-based products could be contaminated. However, the degree to which other foods contribute to the exposure has not yet been clarified. For healthy small children, where consumption is average, approximately twice the acute reference dose is exceeded, and approximately five times that dose where consumption is high. In these cases, the German BfR considers it possible that slight to medium health problems will arise, yet severe health problems are considered unlikely. However, according to the German BfR, where there is heightened sensitivity, e.g. owing to cardio-vascular disease, severe health problems could arise where the acute reference dose is significantly exceeded. The German BfR believes that efforts are necessary to improve the basis of data concerning the existence of tropane alkaloids in various categories of food and their consumption by consumers of all ages. EFSA concurred with this view and is therefore compiling data on the content of tropane alkaloids in foods up to the end of 2016 (EFSA-Q-2014-00320).

The above-mentioned recall of products did not take place on legal grounds, but, rather, as a measure of consumer protection taken at the responsibility of the enterprise. The enterprise stated that in order to avoid harming its good reputation in view of a dispute among laboratories concerning their results and the evaluation thereof, it would voluntarily remove all products within the relevant portfolio from the stores as a precautionary measure.

I P roduct Recall, Art.

19 General Regulation (EC) No. 178/2002

Although they were contaminated with tropane alkaloids, the specific foods were not dangerous in the sense of Art. 14 of the general Regulation (EC) No. 178/2002; furthermore, there was no information about the foods posing a serious direct or indirect risk to human health (Art. 50(2), Regulation (EC) No. 178/2002. It is often the case that legal requirements of food safety are sacrificed in the face of exaggerated protection afforded to consumers and health, not only with respect to complex matters such as the one mentioned above. The duty to withdraw and recall products and to provide notification pursuant to Art. 19(1), Regulation (EC) 178/2002, affects food enterprises that are aware or have reason to assume that a food they have put on the market is unsafe (Art. 14 Regulation (EC) 178/2002) because is is harmful to health (Art. 14(2)(a) Regulation (EC) 178/2002) or not fit for human consumption (Art. 14(2) (b) Regulation (EC) 178/2002). However, it is frequently overlooked that a product (only) has to be recalled when

41 41


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.