After many years of relatively disjointed regulation of inks and other food contact materials in Europe, ink producers could gain soon from a much more harmonized approach to the issue.

However, a number of uncertainties will first have to be resolved in the assessment and management of risks of contamination of food stuffs in packaging due to the migration of chemicals in printing inks.

The European Commission, the Brussels-based executive of the European Union that is responsible for drawing up EU regulations to be approved by the European Parliament and Council of Ministers representing member state governments, has announced it is proposing new rules on food contact materials. The objective is to harmonize for the first time at the EU level a variety of rules in Europe on the use of inks in food packaging.

The German Printing Ink Ordinance

The Commission’s move follows the German government’s issuing of its latest draft of a Printing Ink Ordinance on food contact materials, which has been evaluated by the Commission and the governments of the other EU member states. This has been done under a two-year-old system under which new national technical regulations have to be assessed in the EU context to ensure that are compatible with Union law and do not undermine the Union’s single market.

At least eight member states have expressed concerns about the German Ordinance, with a major worry being that it introducing a set of national regulations on the use of inks and varnishes in food packaging which would disrupt the EU’s internal market.

For the last seven years, the only cross-border rules laying down specific limits on printing ink migration in food packaging has been a national ordinance introduced by Switzerland, which is not even an EU member. Although it is only obligatory in Switzerland, it has been applied outside the country as a voluntary standard across Europe.

Owners of international food brands, in particular, found its specific migration limits a useful standard, such as that non-evaluated substances may only be applied to packaging if no transfer to food occurs at a detection limit of 0.01 micrograms per kilogram of foodstuffs.

Currently its rules are being tightened up, with stricter controls, for example, on the use of carcinogenic, mutagenic and reprotoxic (CMR) substances in printing inks for food packaging.

The European Commission had dismissed claims, largely with the support of EU member states, that there was a need for EU mandatory migration limits on inks in food packaging as well as other ink-specific legal controls. The ink industry had for a while been calling for a EU-based regulation as an alternative to the Swiss Ordinance.

The Commission had argued that an existing EU regulation on food contact materials for plastic substrates, as well as another on good manufacturing practice (GMP) in food packaging, was sufficient, even though the two pieces of legislation did not contain any measures specific to inks.

Pressure on the European Commission to take legislative action on inks had been increasing as the German Printing Ink Ordinance edged closer not only to becoming a national law but also, once implemented, to being another pan-European standard to compete with the Swiss rules.

The European Parliament in the fall of last year passed a resolution urging that with food contact materials, the Commission “should forthwith prioritize the drawing-up of specific EU measures for paper and board, varnishes and coatings, metals and alloys, printing inks and adhesives.”

The Parliament called for “special attention to be paid to those food contact materials – whether directly or indirectly in contact with food – with a higher risk of migration, such as materials surrounding liquids and high-fat foods, and to materials that are in contact with food for a long period of time.”

In addition to the printing ink sector, other industries in the packaging supply chain have also been expressing concern about the lack of specific and detailed legislative controls at the EU level.

“The Commission has acknowledged that it has do something,” explained Martin Kanert, executive director of European Printing Inks Association (EuPIA). “We have long been wanting harmonization. Our big fear has been that the patchwork of different regulations on migration on food packaging in Europe would get worse.”

The German government has suspended the implementation of its Printing Ink Ordinance while the European Commission works on its new legislation.

“But it has not withdrawn it completely,” added Kanert. “If the Commission or the EU considerably delays the introduction of uniform rules on printing inks in food packaging, or for other reasons it is not being applied in the way they want, the German government is saying it will consider reviving the ordinance.”

The content and provisions of the ordinance is likely to considerably influence what goes into the EU legislation. Like the Swiss Ordinance, the German Printing Ink Ordinance is based on a positive list of chemicals that will be allowed in food contact materials.

A major difference between the two regulations is that the Swiss ordinance focuses on the interaction of printing inks with the outside of the surfaces of the packaging, so that any contact with food is as a result indirect.

The German Ordinance deals with printing inks and other materials that have both direct and indirect contact with food and not necessarily just in packaging. It covers, for example, inks on the printed surfaces of napkins, which may come into contact with food.

Also, Germany’s Ordinance does not contain any provision for mutual recognition of risk assessments outside the country, which have concluded that certain chemicals and materials in printing ink formulations are safe. These substances would still have to be evaluated and approved by the German Federal Office of Consumer Protection and Food Safety (BVL).

Substances which have not undergone a proper risk assessment because, for example, of a lack of data, will be allowed to be used in printing inks in Germany on surfaces with indirect contact with foodstuffs if they do not migrate at detectable levels of 0.01mg/kg of food or more.

Carcinogenic, mutagenic and reprotoxic (CMR) substances may not be used if no safety assessment is available to justify their use.

The ordinance also bans the use of nanoparticles in printing ink substances unless a risk assessment explicitly shows that they are safe as a food contact material.

In preliminary work on the new EU proposed legislation, the European Commission has been using the German Ordinance to identify what should be the key elements of the regulation, according to reports of meetings of the Commission’s advisory committees with responsibilities for food contact materials.

The Commission’s main focus will almost certainly be on a positive list – what type of positive list, how risk assessments will be made on substances and how mutual recognition will be ensured. It will also have to decide what will constitute compliance with a positive list and how this will be enforced.

“We don’t know for certain exactly what approach the Commission is taking but it seems to be highly likely that it will be one based on a positive list system,” Kanert said. “We want to see a harmonized positive list system in place in the EU.”

One major problem is that official assessments of all the substances used in printing inks that are or could be applied in food packaging would be virtually impossible. EuPIA estimates that the substances used in printing ink formulations number around 6,000, of which only around 15% have been adequately assessed for risks for adverse health effects from migration into food.

By the time Germany’s draft law was notified to the Commission in mid-2016, the positive list of the German Ordinance contained only 535 substances.

The solution to this problem being proposed by EuPIA and other organizations including the European Parliament is that, in addition to official evaluations, substances could also be assessed by the printing industry itself.

The European Parliament has suggested a self-assessment scheme similar to that operated under the EU’s REACH legislation, under which individual industrial chemicals have to be registered with the Helsinki-based European Chemicals Agency (ECHA) with safety profiles drawn up by industry groups.

“We would like a pragmatic policy to be taken by the European Commission with its printing inks regulation,” said Kanert. “After all, there is a precedent in the way that REACH operates a self-assessment scheme.”

The Commission is confident that it can move ahead quickly with the new legislation. It is hoping to complete the final draft later this year, ready for approval by the Parliament and Council by mid-2018. This would be taking a piece of EU legislation through the drafting stages to adoption at above-average speed. 

European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.