The evolving issue highlights the uncertainty surrounding current legislation in the EU over the food industry's use of packaging chemicals, a problem that is meant to be fixed under a proposed directive on the registration, evaluation, authorisation and restriction of chemicals (REACH), approved by the bloc's parliament earlier this month.
Currently the EU relies on a negative list to regulate the use of chemicals. This means any chemical not on the European Food Safety Authority (EFSA) blacklist can normally be used for packaging food.
While the food and ingredients industries successfully lobbied to be excluded from the main thrust of REACH, the industry will still be required under the directive to prove the chemicals used for packaging materials are safe for contact with products meant for human consumption. REACH would therefore switch the onus on to the package maker and food processor to prove that the chemical did not harm human health.
In the case of Isopropylthioxanthone (ITX), Sweden-based Tetra Pak halted using the chemical for milk packaging in October and defended its continuing use for other types of products, including juices, by referring to current EU legislation.
"The identified substance (ITX) is not on the World Health Organisation (WHO) list of substances detrimental to human health," the company said last week in defending its decision. "Furthermore, ITX is not prohibited for use in food packaging by the EU. Most importantly, available research indicates that migration of ITX represents no known health effects."
The ITX scare has been evolving since September, when a laboratory in Italy found that traces of the ink curing chemical had been found in some Nestlé milk products for babies. The chemical was found to have migrated through Tetra Pak's packaging and into the milk. However milk products with the ITX packaging still remained on the shelves.
The issue became public last week after the Italian authorities stepped in to confiscate millions of litres of the Nestlé baby milk. The health ministry also got a court order to force the company into recalling about two million litres of its Nidina and Latte Mio brands in Italy. The company extended the recall to products in France, Spain and Portugal.
Like Nestle, Numico was also ordered by the Italian government to recall its affected products from that market. In Italy Netherlands-based Royal Numico announced a recall of small batches of its milk products under the brand names 'Aptamil 2 Liquid', 'Aptamil Soya' and 'Aptamil Babymil'. The recall involves less than 100,000 litres in total of the products and were marketed under its Nutricia brand, the company said.
Numico, along with SMA Nutrition, were named by the UK's food regulator as having products on the shelves that used the same Tetra Pak packaging.
The Food Standards Agency (FSA) also said it was "likely" other other food products in the UK made by other companies may also be contaminated by ITX. The FSA noted that the European Food Safety Authority (EFSA) had given advice that the presence of ITX in food is not considered to be an "immediate" health risk.
"On the basis of current evidence the Food Standards Agency is advising parents and carers that there is no need to change their baby’s feed," the regulator stated.
SMA Nutrition has not announced any recall. The company acknowleged on its Internet site that "concerns have been raised" about the presence of trace levels of ITX in cartons of its liquid infant formula following testing in Italy.
Citing statements by independent experts and the European Food Safety Authority (EFSA) that ITX posed "no identified risk to health", the company said its affected products were safe to use.
"On the basis of the very limited data available today, the presence of ITX in food could be considered undesirable but it is not likely to present a health risk at the levels reported," the company stated.
The company added: "Parents can be reassured by expert advice that ITX presents no identifiable health risk and that baby milks sold in the UK are safe and wholesome."
Italy had originally informed the European Commission rapid alert system about the ITX problem in September. However, regulators were unhappy that there was still some product left on the shelves and under a court application got a Italian judge to demand the Nestlé recall.
The country also called on the European Commission for an inquiry into ITX. The European Food Safety Authority (EFSA), the bloc's regulator, has since said it would undertake a risk assessment of the chemical.
"On the basis of the very limited data available today, the presence of ITX in food could be considered undesirable but it is not likely to present a health risk at the levels reported," EFSA stated in the announcement. The regulator said it will provide preliminary advice in the next two weeks and expects to deliver its final opinion no later than March 2006.
Nestlé denies there was a safety risk to human health and said the recall was due to consumer concern about the products. Nestlé cited what it calls a broad scientific consensus that supports its conviction that ITX does not pose a health hazard.
On Friday the company released a letter sent by its chief executive officer, Peter Brabeck-Lemathe, who apologised to Italian health minister Francesco Storace for incorrectly claiming that a meeting between Italian authorities and Nestlé had occurred in July or August, when it really took place in September. He also said his statements did not imply there had been an agreement reached with Storace to keep the products on the market.
The incorrect date implied that Italy had been late in informing Nestlé about the problem. In a speech to investors Brabeck-Lemathe had previously described the Italian seizure of the milk and the recall's effect on the company's finances as a "storm in a teacup".
The Italian health minister Storace is considering legal action against Brabeck-Lemathe over the statements, according to reports by that country's media.
In his 24 November letter, Brabeck-Lemathe noted that Nestlé, along with Tetra Pak and the Confederation of Food and Drink Industries in the EU (CIAA) had met the EU's Directorate General for Health and Consumer Affairs (DG Sanco) on 19 September to discuss the issue.
DG Sanco reportedly agreed with the industry's view on the health safety aspect and "asked it to switch to another type of packaging as quickly as possible", Brabeck-Lemathe wrote.
He said the European Commission also agreed that there was no need for a product recall. Nestlé had stopped using the affected packaging on 14 September.
While making the apology for what he described as a "memory lapse" over the date of the meeting with Italy's regulators, Brabeck-Lemathe also continued to question the seizure of the Nestlé milk products in the face of what he said was scientific evidence that the ITX levels found did not pose a health concern.
"I am glad that the European Commission subsequently confirmed this at a press conference of 23 November," he wrote. "Consequently, if it was not a safety or health risk which triggered this spectacular and unjustified action, I must conclude that there must be other reasons."
Nestlé also ran into difficulties with Italian regulators earlier in October. Italy's antitrust authority fined seven producers of baby formula, including Nestlé, a total of €9.7 million for price fixing.
Last week a Tetra Pak spokesperson told FoodProductionDaily.com that it stopped using ITX in the packing for the affected Nestlé products in October after being informed of the problem. ITX is used in the curing process during ultraviolet printing processes. Tetra Pak has switched to using non UV inks for the products.
In an interview Tetra Pak spokeperson Patricia O'Hayer said in addition to stopping ITX use for the Nestlé products the company began reviewing its use of the curing agent throughout its packaging operations after Italy discovered the problem.
Tetra Pak's testing indicates that the migration of the chemical through the packaging occurs when the product inside is a fatty substance, like milk.
"There is a correlation between fat content and the likelihood of ITX migration," she said.
Tetra Pak also uses the chemical for packaging for water, juices, ice teas. The additional testing revealed that no migration was occurring for most of those beverages, except in the case of some citrus and milk juices. Clear juices such as apple, grape and cranberry do not seem to be affected.
"The situation with some juices is more complex," O'Hayer said. "All clear juices had no migration issues. However citrus juices such as orange and lemon might be affected. We found that the higher the citrus content the greater the possibility of migration. It seems to be a function of the recipe."
The use of ITX for the affected products will be stopped by January 2006, she said. The company uses the ITX UV curing process for between one to two per cent of its packaging operations.
The processing industry is under regulatory and consumer pressure to ensure better safety of their food products and the packaging. Health concerns about packaging chemicals, such as phthalates, have raised consumer awareness of about the risks posed by materials that may come into contact with the food they buy.