Food Packaging Comes Under Increased Scrutiny in Europe
Printers, ink manufacturers and other suppliers are preparing for regulations regarding food packaging.
By Sean Milmo
Ink makers and other suppliers in the European food packaging chain are beginning to feel
Approximately two million liters of Nestle’s Nidinia and Latte Mion milk brands were withdrawn from the Italian market after traces of 2-isopropyl thioxanthone (ITX) were found in the product.
An investigation found that the presence of ITX in the milk was due to set-off or the accidental transfer of the milk onto an adjacent sheet in the reel during the manufacturing of the packaging by Tetra Pak, the Swedish-based international packaging company.
Amidst a range of initiatives to prevent a repeat of the incident, much attention has been focused on improving the efficiency of systems for package manufacturing. But it has also aroused renewed concerns about the dangers of ingredients in inks migrating through the packaging into food products.
In particular, there are worries about leaching of photoinitiator materials as a result of inefficient UV curing of inks on packaging.
Consequently, retailers and brand owners have already been introducing their own restrictions on the use of specific photoinitiators, including ITX. Both themselves and government have also been drawing up rules to ensure that ink makers, printers and others in the packaging supply chain follow manufacturing protocols to ensure the packaging is safe.
The European Union has approved rules on Good Manufacturing Practice (GMP) for materials intended to come into contact with food. These will come into force on Aug. 1, 2008, when they will apply to the whole food packaging chain, including ink producers, although not makers of ink raw materials.
Some national authorities are compensating for the lack of regulations specific to food packaging inks by applying to food packaging rules in the EU’s Plastics Directive, which after being approved five years ago has now been incorporated into the legislation of the Union’s 27 member states. The directive has a positive list of ingredients allowed in plastic products, some of which are relevant to inks in plastic food packaging.
The government in Switzerland, which is not an EU member, has caused consternation in the ink and packaging sectors by announcing its intention to draw up a law on the use of inks in food packaging. This will be based on a resolution passed two years ago by the Council of Europe, an organization with 47 member countries in Europe including Russia, which is mainly concerned with human rights but also makes recommendation on a range of matters, including safety issues.
“The resolution on which the Swiss government wants to base its new law was under discussion in the Council of Europe for years,” said a senior executive in the European inks sector. “It would be disastrous if it was implemented because it is out of date and derived from incomplete safety data. It would mean that half of modern inks could not be used for food packaging.”
The Swiss government is aiming to issue, possibly by the end of this year, a draft positive list of substances which will be allowed to be used in printing inks for food packaging. This list will then be subject to a lengthy consultation with ink producers, raw material suppliers, printers, converters and food processors.
Legislation in Switzerland on the issue would almost certainly have to be in line with regulations on food packaging inks in the EU. Otherwise the country could be considered to be erecting unnecessary trade barriers with its main trading partner.
The European Commission, the executive of the EU which approves legislation, usually in the form of directives to be applied by all its member states, has indicated that it wants to put forward regulations specifically aimed at ensuring the safe use of inks in food packaging. The first step in this process as been the regulation on Good Manufacturing Practice, which was approved late last year.
“The Commission is now telling us that although it is still an objective, a directive on inks in food packaging is currently being superceded by the need for regulations on other topics which they regard as having a higher priority,” said Martin Kanert, executive director of the European Printing Inks Association (EuPIA).
Members of EuPIA, which comprises the vast majority of producers of conventional inks in Europe, already comply with the association’s voluntary GMP code. So in the inks sector, the new regulation should have an impact only a number of small ink makers, and also producers of inkjet inks and possibly toners.
The regulation, which applies to packaging sold in the EU, including imports, is effectively an extension of EU legislation passed in 2004 covering materials and articles intending to come into contact with food.
This three-year-old regulation stipulates that “under normal or foreseeable conditions of use,” materials should not migrate into foods in quantities likely to endanger human health, bring an unacceptable change in the composition of the food or degrade the food’s organoleptic or sensory characteristics.
The new GMP regulation obliges companies to apply manufacturing practices, including quality control systems, which ensure that packaging materials “comply with the rules applicable to them.”
The compulsory GMP standard is likely to have the biggest effect on the production methods of printers and converters in Europe, many of whom do not at present follow good manufacturing codes.
In a statement issued in June, EuPIA pointed to an annex to the regulation which states that inks applied to the non food-contact side of packaging “shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side” in concentrations breaching existing food legislation.
“We want to stress that the implementation of the GMP regulation is a responsibility of both ink manufacturers and printers or converters,” said Mr. Kanert. “Ink producers can ensure that their inks are formulated to high safety standards but they do not control their application. That is why converters also have their responsibilities.”
EuPIA has issued its own guidelines on printing inks for non-food contact applications. These not only include its GMP code but also advice on the selection of raw materials so that chemicals which are toxic or very toxic, carcinogenic and mutagenic are excluded.
“We are confident that with the implementation of our guidelines and the GMP regulation, a case like the one involving ITX in Italy can in the future be prevented,” said Mr. Kanert.
The association is also a member of PI-JITF, a newly created joint industry task force for packaging inks which includes organizations representing food packers, plastic, aluminum and light metal converters and producers of can coatings, as well as printing inks. Its job is to improve the flow of information down the chain and to assess migration characteristics of low molecular weight materials.
“The root causes (of the ITX case) show a lot of room for improvement,” said Francois Chastellain, head of quality management at Nestle, which has introduced its own packaging safety code for suppliers.
“(There has been) a lack of knowledge, lack of monitoring and insufficient partnership,” he added. “It is in the interest of all partners in the value chain to have a full knowledge of the products they sell, including the raw materials they purchase.”
The activities of the PI-JITF appear to have convinced the European Commission that it does not need to hurry with the introduction of an Inks Directive.
“The Commission is a firm believer in this type of joint industry group because of the way it helps information pass up and down the chain,” said Mr. Kanert.
EuPIA is also expecting by the end of the year to complete an inventory list of all raw materials used in food packaging inks, mainly in response to requests for this information from regulatory bodies and end-users.
Once the list has been finalized, toxicological data on materials will have to be collected for evaluation for the possible setting of specific migration limits (SMLs). Currently, the European packaging sector tends to follow limits in the Plastics Directive, which restricts migration of non-evaluated substances to a 10 parts per billion (ppb). At levels of 10-50 ppb, the substance must pass three standard mutagenicity tests while materials of above 50 ppb must first be evaluated with a full toxicological profile.
Evaluation of substances would provide the means for creating a positive list of materials permitted in inks for food packaging with, if necessary, SMLs for specific materials. This list could form the basis for any future Inks Directive.
“It will take a long time to draw up a positive list with SMLs,” Mr. Kanert noted. “The positive list for the Plastics Directive is still not complete even though work started on it more than 10 years ago.”
The EU’s new REACH scheme for the registration, evaluation and authorization of chemicals, which started to come into force last month, could help in the supply of toxicological information on substances on EuPIA’s inventory list. REACH requires producers and importers to provide safety data on 30,000 chemicals used in Europe.
On the other hand, REACH could hamper the gathering of toxicological information since the plan allows companies to sell data required for the registration of chemicals.
“With REACH, toxicological data acquires a value which will be lost if an owner of the information gives the data to a project like the creation of a positive list for printing inks,” said an R&D executive in one ink company.
The REACH process is scheduled to be finished in 11 years, so the creation of complete toxicological profiles on all substances in food packaging inks could take as long or even longer.