In August of last year, an EU regulation on Good Manufacturing Practice (GMP) for the production of food contact materials and articles came into force. But it covers inks only in an annex on the application of printing inks.
However, Switzerland, one of the few Western European states which is not an EU member, has broken ranks with the rest of European countries by bringing in legislation laying down a positive list of substances to be used specifically in food packaging inks.
The Swiss legislation is derived from a set of voluntary guidelines on packaging materials drawn up by the Council of Europe, which is entirely separate from the EU and whose members include virtually all European states, including Russia and Turkey.
The government in Switzerland has effectively turned what was a voluntary inventory into the basis for a set of mandatory rules.
The Swiss legislation, in the form of an ordinance, was enacted in April 2008, but it allowed for a two-year transition period before being due to be enforced in April next year.
During this time, the Swiss Federal Office of Public Health (FOPH) has taken the opportunity to work with the European Printing Inks Association (EuPIA), representing ink makers throughout Europe, in updating the Council of Europe’s inventory.
EuPIA had previously claimed that the Council of Europe’s guidelines on food packaging inks were unworkable, not comprehensive and did not reflect current practice in the industry. By collaborating with the FOPH, it has ensured that the Swiss ordinance is consistent with the operations of the food packaging supply chain.
Now there is speculation, particularly among ink producers and the rest of the food packaging sector in Europe, that the Swiss ordinance will effectively become the standard for food packaging inks in Europe.
The positive list is divided into two – an A list for evaluated substances and a B list for unevaluated ones. Since less than a third of the substances have so far been evaluated by the Swiss government, the legislation effectively sets up a system for official approval of substances as they are moved to the A from the B list. The A list could become the safety benchmark for the European food packaging market.
“It seems to be the wish of the Swiss government that the ordinance should set the European standard,” explained Matthias Baumberger, director of the Swiss paints and printing inks association (VSLF).
Other European countries are expected to consider taking similar regulatory action if the Swiss ordinance proves to be an effective legislative tool.
“We would expect that the regulatory authorities across Europe will monitor the implementation and impact of the new legislation,” said Paul Hunt, Sun Chemical’s European technical director for liquid and packaging inks. “As a result, they will decide whether similar measures would be advisable and necessary within the broader European scene.”
For Europe’s ink producers and their customers, there is now a confusing array of regulations and voluntary initiatives covering the safety of inks in food packaging.
EuPIA has endeavored to take a comprehensive approach to all the safety issues associated with printed inks in food packaging by introducing a series of voluntary plans. It has drawn up its own GMP code for the production of packaging inks, which was amended earlier this year to make it consistent with EU regulations on GMP.
The association, which is part of the European council of paints and printing inks producers (Cepe), also just issued a new version of its guideline on the application of non-food contact surfaces in packaging.
The guidance deals with the key matter of migration, or the possible movement of small molecules from the food contact materials, including inks, into the packaged food product. With ink components, migration can occur either through the substrate, through set-off to the food contact side of substrate during storage, or by gas-phase transfer.
Public Inventory List
One of the most ambitious of EuPIA projects is the publication of a public inventory list of all the raw materials and substances used in printing inks for food packaging. The objective is to provide “a transparent tool for packaging converters and brand owners that will include all data necessary to enhance consumer protection and product safety,” according to EuPIA.
It hopes to complete the inventory by next April after tackling the problem of resin manufacturers wanting to keep their formulations confidential. EuPIA is currently making use of a data collection system devised by the food contact additives (FCA) group representing approximately 40 companies within the European Chemical Industry Council (Cefic), the European trade association for chemical producers.
The FCA has devised an online database system which enables resin and other formulators to provide details of the substances within their formulations while safeguarding confidentiality.
Overshadowing the whole process of gathering information on food packaging inks is the European Union’s REACH project for the registration, evaluation and authorization of the vast majority of chemicals produced in and imported into Europe.
Under the 11-year plan, which will be completed in 2018, the estimated 4,000 substances used in food packaging materials, including inks, will have to registered together with safety data on their use in packaging.
The impetus behind the drawing up of the Swiss ordinance was a health scare in Italy nearly four years ago, when traces of a UV inititator – 2-isopropyl thioxanthone (ITX) – were found in two milk brands of Nestle, the Swiss-based multinational food conglomerate.
An investigation concluded that the presence of ITX in the milk was to due to set-off, or the accidental transfer of the substance onto an adjacent food contact sheet in the reel during the manufacture of the packaging.
However, much of the effectiveness of the Swiss legislation will, initially at least, be influenced by REACH, in particular its system for the submission of registration dossiers with safety data. These dossiers will contain tests and other data, which producers and importers making or supplying the same substances have exchanged with each other in return for fees.
The Swiss authorities are hoping that many of the substances on the ordinance’s B unevaluated list will be transferred to the A evaluated list after chemical companies have submitted safety data on their products used in food packaging printing inks to FOPH.
“In my opinion, this transfer of substances from the B to A list will be delayed because of REACH,” said Mr. Baumberger. “The drawing up of dossiers for evaluation by the Swiss government will be expensive because plenty of safety data could be required. It is likely that companies will delay doing this in order first to use the data for the creation of REACH dossiers from which they will be able to earn money from the information.
“We urged the Swiss government to delay the implementation of the ordinance in order to take into account the schedule for the preparation of REACH registration dossiers, but it decided not to hold it back,” he added.
On the other hand, companies with substances on the unevaluated list will have an incentive to place their products on the A list as soon as possible. Substances on the B list will have to comply with a strict migration limit of 0.01 milligrams per kilogram (mg/k), or 10 parts per billion. This is in line with the EuPIA guidance, which sets a 10 ppb limit for substances with insufficient toxicological data. For components with favorable toxicological data, the limit could be above 50 ppb.
However, ink producers that are members of EuPIA believe that the difficulties with the Swiss ordinance will be downstream from the manufacture of the food packaging inks. Large ink producers already tend to have migration data on their inks.
“The lists on the Swiss ordinance are a reflection of those substances already being used by EuPIA companies in their food packaging inks in Europe,” said Chris Whitehead, product innovation director at the Flint Group. “The legislation will not pose major problems for EuPIA members, but it could be a difficulty for non-EuPIA companies and for others in the food packaging supply chain.”
The similarities in content, although not in implementation, between EuPIA’s own inventory and the Swiss ordinance’s list will alert downstream operators to the complexities of ink technologies in food packaging and the need to work more closely with their ink suppliers.
“(The Swiss) legislation for individual substances may require a rethinking of current packaging design and the specifications to achieve them,” said Mr. Hunt. “The majority of the variables influencing migration from printed packaging are not controlled by the ink manufacturer – e.g. pack design, use of inner and outer wrappings, substrate selection, material barrier properties, extent of curing and drying, opportunities for set-off, storage conditions, nature of the packaging foodstuff, etc.
“The same ink printed under different conditions of use, on different pack designs and substrates, can have completely different migration performances,” he added.
More converters and food packagers will have to test their packaging to show compliance with the new migration limits, and may have to change packaging designs to use low migration inks. The Swiss ordinance may ultimately be good news for ink producers with new, safer technologies.