Holle Baby Porridge Voluntary Withdrawal and Recall

Please note: The withdrawal mentioned in this article is no longer current. This article has been left on the site as a matter of historical record. Update: October 2017 After a question about this issue was asked of us, we contacted Holle for an update . Here is their Quality Manager's statement: "Thank you very much for your question and for asking us directly about this issue. Please, first I will explain what happened: In late 2013 and early 2014 production we and plenty of other producers of organic millet and buckwheat products, had founds traces of Tropane alkaloids. These Tropane alkaloids are naturally produced by some plants to fight feeding predators. In some harvest events it was possible that sap of these plants had ended up in the millet and buckwheat seed harvest. In opposite of conventional farmers, organic farmers does not have the possibility to kill these plants by usage of broad band pesticides. But this is not the problem. In 20.000 years history of plant growing, these plant metabolites has been often and fully eaten by humans. The traces that has been found in our products for example are 200 times lower than a pharmaceutical active dose for infants. So what happened? In these months in 2013/14, due to new techniques, the laboratories where able to find Tropane alkaloids in very low concentrations. This was new and German authorities just didn't know how to handle it. We had only found two Tropane alkaloids, and there was absolutely no indication for any harm to the babies. After explanations and arrangements with the German authorities regarding how to react, some other eastern European authorities misunderstood the situation such that they published an alert, and that was spread virally all over the world. In this case we had no other option; we must recall all products containing millet and buckwheat. Seven or eight other organic producers followed. In this example you can see how powerful media can be. Since then, we have set EU maximum values for these traces, and every batch is monitored, plenty of times, to avoid Tropane alkaloids in our products! From that point in 2014 on, we never found any of these metabolites again. Hopefully your fears are allayed a bit. If you have further questions do not hesitate to ask us." Original Blog Published: 16th December 2014. Apologies in advance for the length of this article. I write at length so as to give concerned parents full information about a voluntary limited withdrawal of some baby porridges by Holle baby food. It is worth reading in total as the most useful background and current information for parents is sadly missing from official UK statements. Due to new testing methods a minute amount of chemicals in the tropane alkaloids family have been found in three past batches of millet based Holle baby porridges. However, Holle are very aware of their responsibilities to parents to produce consistently safe food for young babies. As a result they immediately issued a voluntary withdrawal of subsequent batches while they work to further improve their already stringent production processes and to work with their independent testing facilities to incorporate any new testing methodologies that may be necessary.

Testing for Tropane Alkaloids in Foods

Tropane alkaloids have been present in human food ever since agriculture has been practiced. They come from the seeds of wild plants that may grow in cultivated fields as undesirable competition to a crop. In October 2013, the EFSA (European Food Safety Authority) conducted a study on tropane alkaloids with the aim of coming to a conclusion as to whether to set a limit when it comes to atropine and scopolamine (the two relevant chemicals) contained in food or not. As a result of this study, the EFSA recommended an acute reference dose (ARfD). At the beginning of 2014, however, the European Union decided not to set an official permitted maximum limit for tropane alkaloids due to unclear and unstandardised and non-validated analysis methods. In other words, according to the present state of accepted knowledge, so far a maximum permitted level for tropane alkaloids set by the European Union does not exist. It is also worth mentioning that the World Health Organisation (WHO) has not published any comment on the subject. It is only very recently that a laboratory of the government of one of the German federal states has developed an in-house method to detect and quantify tropane alkaloids. It is accepted within the scientific community that it is not known how valid this method currently is, since it has not been validated and there have not been interlaboratory comparison tests (ring trials). It was this agency that detected the presence of the tropane alkaloids and subsequently issued an alert notification. In a statement from November 2013, the German Federal Institute for Risk Assessment (BfR) noted that they were not aware of any cases of health impairments in babies, toddlers, or consumers of other age groups, caused by the consumption of food containing traces of tropane alkaloids. I should emphasise that the German authorities who came up with this alert notification neither demanded Holle to do an official recall directly to the end-consumer nor to recall all Holle porridges containing millet from the shelves at any time. Further, an official worldwide withdrawal was not requested. This remains the case.

The Food Standard Agency Response

However, despite this history and the voluntary withdrawal of current porridges of the same varieties as those affected in the one past batch, the UK Food Standards Agency decided to institute an official recall of four Holle porridges. I shall reproduce their recall below. A similar mistaken recall was issued by a number of other similar agencies in Europe and elsewhere around the world. Authorities in Ireland, for example, have subsequently admitted their mistake and have corrected it with immediate effect. Despite promptings to do so the UK FSA have refused to correct their initial statement. As a major importer of Holle baby foods I am sure officials from the FSA will be reading this article and I invite them, in the spirit of openness, to submit their response in the comment section below. I emphasise again. Holle has voluntarily withdrawn four baby porridges despite them not being shown to have been affected by this issue. They know how important it is to make the safest possible baby food and this voluntary withdrawal allows them to make sure everything possible is being done to keep up with all possible latest findings, even though they have not been validated within the wider scientific community. To me that says a great deal about their values-based ethical approach and I feel they have acted honourably throughout.

The Food Standard Agency Statement in Full

The following is taken from the FSA website.

Holle branded and Lebenswert branded baby foods recalled Last updated: 12 December 2014 Holle Baby Food GmbH Serviceburo is recalling all batches of specific Holle branded and Lebenswert branded baby foods due to the presence of atropine and scopolamine. All batches of the following products are being recalled:

• Holle Organic Millet Porridge Apple-Pear (pack size: 250g)
• Holle Organic Millet Porridge with Rice (pack size: 250g)
• Holle Organic Millet Porridge (pack size: 250g)
• Holle Organic Holle Organic 3-Grain Porridge (pack size: 250g)
• Millet and Rice Whole Wheat Porridge (Lebenswert bio Hirse & Reis Vollkornbrei)

The FSA is investigating how these products have been distributed in the UK and is requesting any food businesses who stock this product to recall it from sale. If you have bought this product, do not feed it to your infant. Consumption of the affected products may cause short-term adverse effects, for example, dilated pupils, change of heart rate, dryness of the mouth, constipation, urinary retention, and flushed skin. The chemicals present will be excreted from the body and therefore there are no long term health effects.

This limited statement gives little background information and doesn't tell parents anything about any potential likelihood that their baby may have been affected. I thought I would leave that to the FSA of Ireland with this official statement taken from their website:

Baby Food Recall December 2014 Holle Baby Food Gmbh Serviceburo is recalling the Holle branded and Lebenswert branded baby foods listed below due to the presence of the chemicals atropine and scopolamine. What products are recalled? Holle Organic Millet Porridge Apple-Pear (250g) Holle Organic Millet Porridge with Rice (250g) Holle Organic Milk Porridge Millet (250g) Holle Organic Holle Organic 3-Grain Porridge (250g) Millet and Rice Whole Wheat Porridge (Lebenswert bio Hirse & Reis Vollkornbrei); All batch codes, all best before dates Country of Origin: Switzerland Are all of the products affected? No, just some batches are implicated, but all are being recalled as a precautionary measure. Are these products sold in all shops? No, they are primarily sold in health food stores. In-store recall notices will be displayed in outlets that sold the affected products. What chemicals are present? Atropine and scopolamine. These chemicals are tropane alkaloids that can occur naturally in certain plants and can have pharmacological properties (effects on the nervous system). How did they get into the product? There is no confirmation yet as to how these chemicals got into the product. However, as the country of origin is Switzerland, it is being investigated by the Authorities there. What are the effects of consuming these chemicals? Consuming these chemicals may cause short term adverse effects, for example, dilated pupils, change of heart rate, dryness of the mouth, constipation, urinary retention, and flushed skin. Symptoms usually occur 30-60 minutes after consumption. The chemicals present will be excreted from the body and therefore there are no long term health effects. This usually occurs in 12 to 48 hours. Consumption of implicated products is unlikely to cause these effects but it cannot entirely be excluded. My baby has consumed this product. Has he/she been poisoned? It your baby has consumed any of the implicated products, and did not display any of the symptoms listed above within 30 minutes – up to 24hrs of eating the product, it is unlikely he/she has been affected. The levels found in these products have been quite low, and are below levels associated with causing effects. Consumption of implicated products is unlikely to cause any effects. What should I do if my baby displays these symptoms? The chemicals present will be excreted from the body within 12 to 48 hours. There are no long term health effects. However, if you are concerned, it is advisable to seek medical advice. My baby has been eating these products for a number of weeks/months. It is unlikely that all, if any, of the products that your baby consumed were affected. Even if your baby consumed these products over a period of time, the chemicals don't build up in the body but are excreted within 12 to 48 hours. There are no long term health effects. What should I do if I have this product? You should not feed the product to your baby. You should either dispose of the product or return it to the store where you bought it.

Holle Baby Food Response

I thought it only fair that I also present the Holle baby food response to these events. Again, I quote in full from their webpage:

Product withdrawal: Holle baby food millet porridges

A German state laboratory detected traces of natural tropane alkaloids in samples of Holle Organic Millet Porridge, Holle Organic Millet with Rice Porridge and Holle Organic Millet Porridge Apple-Pear. We want to be on the safe side, we want to avoid any risk for very small children and we also want to avoid any damage to our own good reputation over different laboratories' disputes about their results and evaluations. This is why we are voluntarily withdrawing three batches from the market. This voluntary withdrawal affects the following lots and products:

• Holle Organic Millet Porridge, lot number L13219 with best-before date 30.04.2015
• Holle Organic Millet with Rice Porridge , lot number L14103 with best-before date 30.11.2015
• Holle Organic Millet Apple-Pear Porridge, lot number L13239 with best-before date 30.04.2015

The goods we have on stock are blocked and will not be delivered. Our retail partners are instructed to take the products from the shelves immediately. Customers who already bought Holle millet porridges and have them at home can of course return them for a refund in the shop. Background information: Currently, there are no officially verified standard measuring methods to detect tropane alkaloids. Based on its own new in-house measuring method, a German state laboratory detected traces of tropane alkaloids in Holle millet porridges. Tropane alkaloids are natural substances of weed seeds in millet crops. Careful cultivation helps eliminating them. One year ago, the European Food Safety Authority (EFSA) and its German equivalent, the Federal Institute for Risk Assessment (BfR), raised the issue of traces of such seeds, such as the seeds of henbanes, that have always been present in food. They categorized them as undesirable and evaluated their risks. As a consequence, official laboratories targeted these alkaloids to develop their own in-house reference methods. The traces they are reporting with these methods are now the subject of warnings and withdrawals. A valid standard method does not yet exist. In a statement from November 2013, the Federal Institute for Risk Assessment (BfR) noted that they were not aware of any cases of health impairments in babies, toddlers, or consumers of other age groups, caused by the consumption of food containing traces of tropane alkaloids. We regret the current situation very much and would like to apologize for any inconvenience this may have caused. Should you require any further information, please don't hesitate to contact the Holle baby food service team: service@holle.ch

Holle's Frequently Asked Questions on Tropane Alkaloids in Baby Food

In the interests of completeness and openness I provide the latest list of frequently asked questions from Holle's website. These provide even more of the background and useful information missing from the FSA.

Frequently asked questions and their answers:

What is this about? An official analysis detected traces of plant substances called tropane alkaloids. Unfortunately, both the risk assessment and the analytical methods to detect tropane alkaloids are not very clear. As a precaution and to avoid any risk for very small children, Holle baby food GmbH has therefore decided to voluntarily withdraw three batches of Holle Organic Millet Porridge products from the market. Which method was applied for the analysis? Currently, there are no valid standard methods to detect tropane alkaloids, and no certified reference materials. The test results of our independent, accredited laboratory all show no or only very small contaminations. Also, the test results for all other Holle products show no traces of tropane alkaloids. What are tropane alkaloids? The main tropane alkaloids are atropine and scopolamine. They are natural substances of the solanaceous herb or nightshade plant family, including thornapple, deadly nightshade, and angel's trumpet. The plants produce them in order to deter potential herbivores. Have cases of impairments been reported? Unfortunately, the assessment of the risk connected to tropane alkaloids is not very clear. In November 2013, the German Federal Institute for Risk Assessment (BfR) published a statement about tropane alkaloids. They note that they were not aware of any cases of acute or chronic health impairments in consumers of all age groups caused by tropane alkaloids in food products. Which amounts were detected? The detected amounts of tropane alkaloids are very minimal. They are within nanogram or microgram range (one microgram is equal to one millionth of a gram). Tropane alkaloids such as atropine are also employed for medicinal purposes. According to relevant literature, up to 40 micrograms of atropine are used therapeutically in children. The traces detected in Holle products are at least 40 times less. How do tropane alkaloids get into food products? Seeds containing tropane alkaloids are included in the harvest directly on the field; they are later sorted out by modern filtering techniques. Unfortunately, the family of tropane alkaloid producing plants is very large, and similarities between their seeds and the actual crop are always possible, so they might not be sorted out. Tropane alkaloid producing plants have been harvested along the actual crops ever since agriculture developed. The filtering techniques of today have of course improved a lot, but so have the laboratory methods to analyze crops. Nowadays, even the most minimal amounts of tropane alkaloids are detectable. Which efforts is Holle baby food GmbH making to keep tropane alkaloid concentrations even lower in the future? We at Holle baby food GmbH and our production partners have already established a broad monitoring program for tropane alkaloids, which has been in use for several months. We have also promoted the improvement of technical and physical methods to eliminate the seeds of plants containing tropane alkaloids.

Conclusion

Once again, I apologise for the length of this article. I felt it important though that parents be given the opportunity to fully aware of the background and current information. Even given the unofficial nature of the test that has identified these naturally occuring chemicals in foods and the lack of any official European or worldwide standards on maximum levels of such chemicals Holle has voluntarily acted to ensure that they continue to provide parents with consistently safe food for their babies. The past batch that was identifed was voluntarily withdrawn, despite the relevant official bodies not requesting such a withdrawal or being aware of any cases of acute or chronic health impairments in consumers of all age groups caused by tropane alkaloids in food products. As a supplier of Holle baby foods and as a mother who has fed my children Holle baby foods I personally am glad that Holle has taken such an precautionary approach. It merely underlines for me the seriousness in which they hold our children's safety and general health. I am also saddened though that UK authorities have failed to give a comprehensive account of the situation to concerned parents and invite them again to leave their response below. I will continue to monitor this situation carefully and if any thing new comes to light will let you know via the website.