Contaminated Nestlé formula seized following Italian Judge's order Italian government threatens to sue Nestle CEO, Peter Brabeck EFSA rebukes Brabeck for misusing its statement Press release 22 November 2005 - update 24 November and 9 December. According to reports in the Italian and international media, Nestlé ready-to-feed infant milks are being seized by the police in Italy following a ruling from a Judge in the town of Ascoli. A total of 30 million litres are reportedly involved. Italian officials reportedly say they seized 2 million litres of Nestlé milk at the beginning of November when this was also found contaminated with isopropylthioxanthone (ITX), a component in the ink used on the packaging. Italian officials have said all affected products (Nidina 1 and 2 baby milks, Mio and Mio cereali) with a sell-by date of September 2006 have to be removed from sale. Nestlé was quick to claim that the substance is not harmful and claims that the comapny is recalling the milk as a precautionary measure. Yet, according to the Guardian (23 November 2005) the problem has been known for some time and an alert requiring 'immediate action' was issued on 8 September 2005. The current 'sequestration order [was] issued by a prosecutor in the east coast town of Ascoli.' This is not the first time that Nestlé has been slow to take action over a known contamination problem (see below), nor the first time it has presented action forced upon it as its own responsible response. Update 24 November: It has been reported that Nestle knew of the contamination in July. Nestle Chief Executive Officer, Peter Brabeck-Letmathe, has claimed the company had permission to carry on selling it, which the Italian health ministry has denied and is threatening to sue Mr. Brabeck. According to Forbes : "The Italian health ministry said last night it was 'dismayed' by the 'completely false' statement by Brabeck and denied 'all contact' with Nestle about the agreement described by the Nestle chief executive." Nestlé issued a statement when the contamination became public knowledge claiming the European Food Standards Agency (EFSA) "has determined that the chemical found should not cause a toxic threat in the levels detected. It has deemed the milk as posing 'no immediate health risk'.". EFSA wrote to Mr. Brabeck on 1 December and took the highly unusual step of making its letter public (see http://www.efsa.eu.int/science/afc/afc_documents/1233_en.html). This states: "EFSA maintains this statement, which implies endorsement of the safety of Nestlé's products currently on the market, does not reflect the nature of the scientific advice given to date by the authority and is potentially misleading. EFSA has not been able to 'determine' the safety of ITX but rather made a very preliminary statement on the basis of its initial evaluation of the very limited scientific data available. We have indicated that, based on current knowledge, ITX does not appear to present an immediate health risk at the levels reported in foods. EFSA's Scientific Panel expects to issue further advice in the next two weeks following more extensive review of all available data. The Panel intends to publish its formal opinion on the risks of ITX no later than March 2006." The Panel issued a statement on 9 December, which generated headlines such as Nestlé vindicated by EU safety finding with Dow Jones stating: "Nestle can feel vindicated by the EU finding that ink from baby milk packaging isn't harmful, says Kepler Equities, and lauds Nestle's quick action in addressing issue. "This always seemed like a storm in a teacup" for food companies like Nestle and Numico (37561.AE), says Kepler, with issue getting blown out of proportion." This ignores the fact that Nestlé knew of the contamination for months and only began a recall when Italian police began seizing formula following a court order. Baby Milk Action wonders who spun this as the EFSA advice is once again more circumspect, particularly when considering the impact on infants (see http://www.efsa.eu.int/press_room/press_release/1258_en.html): "EFSA advises that the presence of ITX in foods, whilst undesirable, does not give cause for health concern at the levels reported... The Panel gave special attention to the exposure of infants and young children. Infants who are not exclusively breastfed may be fed with ready-to-feed formulae packed in cartons. A large number of beverages consumed by young children are likely to be packed in cartons, particularly milk-based products and fruit juice in small volume packages. The potential dietary exposure of infants and young children could therefore be higher than that of adults. Following the review of available genotoxicity studies, the Panel concluded that the findings from animal studies did not indicate a genotoxic potential for ITX. EFSA therefore advises that ITX does not give cause for health concern at the levels reported. There are no data available at present on aspects other than genotoxicity. If contamination of foods with ITX was to continue, the Panel would wish to make recommendations about further studies that may be needed." Mr. Brabeck has indicated Nestlé continued to sell the formula knowing it was contaminated. It is disputed whether he had an agreement with the Italian Ministry of Health to do this. Without the Italian court forcing a recall, some parents would have continued to feed contaminated formula to their infants without being informed by Nestlé or the authorities of the contamination, effectivley a mass uncontrolled trial performed without parental consent. This may only have come to public light if other health impacts became noticeable in the infants fed on the formula. With an eye on its profits, Nestlé has said, according to reports, that the recall will not have a significant impact on the company's results at group level. Again according to reports, the Italian Agriculture Minister Gianni Alemanno has demanded tests to see if any harm may have been caused to infants fed over a prolonged period with the milks. See ABC, CNN and ANSI (in Italian) Mike Brady, Campaigns and Networking Coordinator at Baby Milk Action, said: "Unfortunately, there is a long list of problems of contamination, inevitable with a mass-produced, artificial product which is centrally manufactured - or in this case manufactured in more than one country - and then transported across national borders. Authorities have to be vigilant in their monitoring to protect the public. When cases like this occur government authorities need to quickly give information on risks which can be trusted. "It is an all too common occurence that scratching the surface of reassuring statements about Nestlé's business activities reveals facts distorted, organisations misrepresented and lives put at risk for profit. "Breastmilk is freshly produced, when and where it is needed and protects infants against infections and contaminants in the environment. "Following a similar recall in China, where iodine levels were outside government safety limits, Nestle is currently aggressively promoting its affected range of Neslac milks by putting doctors in supermarkets, despite the World Health Assembly ban on seeking contact with mothers. Nestle should not be allowed to use a re-launch as an excuse to flout marketing regulations in China or in Europe." In May 2005 Nestlé's infant formula was removed from supermarket shelves in China after health authorities found that it contained excess iodine. Nestlé belatedly apologized for deviating from the national standard after media reports. Initially it blamed its milk suppliers. An online survey showed that 87% of consumers said they would stop purchasing Nestlé products, primarily because of the firm’s lukewarm response. China Daily (10 June 2005) says that many people believe that Nestlé reacted "with the speed and alacrity of a sailor drunk on shore leave." Nestlé is now relaunching the Neslac range with an aggressive promotional campaign. Free samples are currently being distributed in supermarkets and doctors have been placed in stores to promote the products to customers (China Daily 17 October 2005). Such tactics violate the World Health Assembly International Code of Marketing of Breastmilk Substitutes. In April 2002 Nestlé Beba 1 and Beba 2 formulas were removed from sale in Belgium and Luxembourg following the death of a 5-day-old child from meningitis, linked tocontamination of the formula with Enterobacter Sakazakii during the manufacturing process. On that occassion formula from the same batch remained on sale in Switzerland after the recall in Belgium and Luxembourg. See Update 30. Media contact: Mike Brady on 07986 736179.