Speak with One Voice

The Canmaker
April 2003

In the second of two articles covering the threat presented by scares about alleged migration of products from coatings into canned foods, Peter Oldring* details how the industry is responding to the challenge of meeting confusing regulations

The can coatings industry in Europe is faced with a conundrum. It’s not enough that the coatings are legally compliant. To satisfy public opinion they have to be better than the regulations. It is unique to Europe... and to canned foods.

Europe has no harmonised legislation for coatings, so in its absence national regulations prevail, which causes confusion as to which ‘rules’ should be applied. In some cases the Plastics Directive 90/128/EEC and its amendments and latest codification 2002/72/EC are quoted for compliance, even though can coatings are legally excluded.

The precautionary principle prevails. This means that a substance is assumed to be harmful unless proved otherwise. So issues surrounding migrants from can coatings are not easily resolved using regulations.

Not so long ago, food contact issues were a low priority in companies’ future strategies. But in Europe that’s changed, and it has outside Europe. Food contact issues are integral to future planning for can coatings suppliers and their customers.

With the canned food industry now increasing-ly global, legislation, restrictions or issues in one region impacts other regions, sooner rather than later. National or local issues rapidly become global issues, fuelled by media attention, and arguably without under-standing the science and technology or putting risk into perspective. This situation is further compounded by developments in analytical equipment and methodology, with more and more of less and less being found. Again the issues are rarely put into perspective.

The questions facing the canned food supply chain include: • How does it manage this situation? • How does it ensure that development effort is not directed towards the wrong projects? • How can it be ahead or level with the changes, rather than forever chasing them? • Why is the approach of the US Food & Drug Administration (FDA) not accepted by the European Union? • How does it avoid adverse publicity, even if it is innocent? Canmakers, along with everyone else in the supply chain, are no less concerned about the safety of their products than the general public. Canned foods offer micro-biologically safe and healthy products enabling storage for years without refrigeration or deterioration in quality or safety. Canmakers take migration issues very seriously, but their challenge is to convince consumers that these issues should be put into perspective and in the context of the healthiness of canned food.

In the past, US FDA food contact legislation was viewed by many as the main legislative requirement for a can coating. Today the minimum requirement is both FDA 175.300 and specific European or future European requirements. The over-riding item of EU food contact legislation relating to migrants into foods is the Framework Directive 89/109/EEC and in particular article 2, which in essence states: Articles for food contact should not transfer constituents to foodstuffs in quantities which could; 1. Endanger human health, or 2. Bring about an unacceptable change in the com-position of the foodstuffs or a dete-rioration of its organoleptic properties. The second condition is rel-atively easy to prove. Unac-ceptable whilst being subjective is reasonably well understood by all. For exam-ple, no one ever complains about the ‘unacceptable flavour’ of Cognac, wine or whisky that are aged in wooden casks. The first condition is also subjective: it is very difficult to prove when no suitable technique exists to demonstrate that human health is not being endangered. So with the precautionary principle, arguably being mis-applied, we have today’s dynamic situation. How do you prove a negative? It is only too easy to claim that something is harmful, without proof, especially if the identity and potential toxicity of a migrant is unknown. Yet consumers are willing to accept it.

Many from outside of Europe find its approach and its legislation confusing. The public perception of government, regulators and industry differs completely between the US and the EU. In the US the opinion of authorities is believed, unlike Europe where the NGO’s position is believed by far more of the population than that of either industry or authority

The discovery of high levels of Badge (Bisphenol A Diglycidyl Ether) in some canned fish in oil in 1996 in Switzerland ignited interest in migrants from can coatings and has acted as a catalyst to revolutionise the approach to migrants. Some consumer groups subsequently picked up on some of these issues, notably Badge and related substances. And newspaper articles, television and radio programmes in many European countries undermined the canned food industry’s cause.

It could be argued that industry was slow to react to the Badge issue. Since then European industry has reorganised to respond to sudden issues and to be actively involved in the regulatory process.

About five years ago, the European can industry and its suppliers formed a Joint Industry Group (JIG) to handle Badge and related issues. Three trade associations were initially involved, namely European epoxy suppliers (APME-ERC), European can coating suppliers (CEPE) and European can-makers (SEFEL). Today JIG has been expanded to also include substrate suppliers
(steel and aluminium), resins suppliers other than epoxy and most importantly packers and fillers. JIG has a counterpart in US — inter-industry group (IIG) — on which the original JIG concept was based.

JIG consists of a steering committee (SJIG) and a technical committee (T-JIG). As different tasks are identified, smaller sub groups are formed and anyone with relevant expertise is invited to attend.

JIG is also active in a wider trade association organisation, representing many different trade associations involved in the European packaged food industry. With the JIG, this group — the Vision Group — is actively developing workable and harmonised regulations for coatings in direct contact with foods, without putting cans at a disadvantage.

But what happens until these regulations are completed? It is necessary to be pro-active and for trade association bodies to have dialogue with regulators and official bodies. Adverse publicity based upon ill-informed and often biased reports is a major challenge. Quite rightly the consumer is concerned.

Articles about chemicals coming from can linings which will affect childrens’ health, hormone system and sexuality, worry any  responsible parent. Today we live in a World of sound bites. No one has the time to dig behind the headlines. First impressions are critical.

Brand name protection is paramount and understandably adverse publicity with a ‘name and shame’ campaign in the media makes brand holders very nervous.Consequently they require their products to be not only legal, but substantially better than any existing — or foreseen — legislation. In some cases they require products free of substances that come under continuing scrutiny by the media.

Bisphenol A (BPA), which is a building block for about 90 percent of can coatings, is typical. Whilst the legal limit for BPA is 0.6 mg/kg (0.6 ppm, having been recently reduced from 3 ppm), a typical requirement for can coating suppliers is that it’s non-detectable at a limit of 0.02 mg/kg (20 ppb). All of this despite the fact that the weight of scientific evidence has not substantiated the claims of adverse affects at low levels.

The Scientific Committee for Food (SCF) reviews toxicological data for substances not necessarily used in can coatings and allocates them to Lists 0-4, with any relevant restrictions. The restrictions do not necessarily represent toxicity of a substance, because they are allocated according to either toxicity or the amount of data submitted. For example an SML of 0.05 mg/kg (50 ppb) is allocated either because its toxicity is above this level or the petitioner has submitted a reduced dossier which would only support this level. If the petitioner were to pay for more extensive testing then it is possible
that the limit would be 5 mg/kg (5 ppm) or higher. Substances that have not yet been fully approved are allocated into other lists and in most cases, additional data are required before the SCF is able to fully assess the sub-stance. Failure to supply these data will result in them not being listed at some time in the future. FDA approval, unless to the current SCF protocols, is unacceptable.

As was discussed by Paul Marsal (CM, March 2003), a major issue within the EU is that realistic exposure is not taken into account when limits are assigned. It is assumed that everyone eats 1 kg of food packed into a container (a cube with a surface area of 6 sq dm) every day of their life. Therefore migration at 0.05 mg/kg (50 ppb) of food is assumed to be exposure at 0.05 mg/person/day. This is clearly a large over-estimate of actual exposure.

In the absence of any data on the consumption foodstuffs in other types of packaging the canmaking industry took the initiative with research. An estimate(1) of the amount of canned foodstuffs consumed was significantly less than the EU assumption, being 62 g/person/day packaged
in an area of 0.55 sq dm/person/day, albeit on a per capita basis. So there is an additional safety margin applied to any restriction where a substance is specific to use in can coatings. This is the first attempt by any European packaging sector to derive estimates of exposure from migrants. The European can industry leads all other European food packaging industries with this initiative.

Many believe that if these consumption data were available earlier, the Badge issue would not have arisen because the actual estimated exposure is very low. Indeed, exposure data were used to extend the deadline for Badge in 2002/16/EC for another year to the end of 2005 to enable the toxicological data to be fully evaluated by the SCF.

My company, Valspar, and other manufacturers to a greater or lesser
extent, approaches the management of these issues in two distinct ways: Trade association participation with relevant regulating bodies and authorities, and development of ‘next generation’products.

Active participation in all of the relevant associations ensures that everyone is taking a similar common position. Industry is speaking with ‘one voice’. This avoids fragmentation and one form of packaging being exploited to the detriment of others.

Next generation coatings with lower levels of unknown or known migrants are being formulated. This does not mean that today’s coatings are ‘dirty’. They provide protective barriers in one of the safest forms of packaging, have decades of safe pack history and comply with all relevant legislation. This is believed, by Valspar, to be the way forward under ‘good product stewardship’. It removes, at best, and minimises, at worst, the focus on migrants from canned foodstuffs.

This should minimise adverse publicity. An added bonus is that it helps reassure everyone in the canned food supply chain that the industry is protecting the long-term future of the can as an important form of food packaging.

However, this approach is resource intensive, because not only formulators but analytical services are fully stretched. The latest analytical equipment, which is fundamental to a better understanding of migrants, is expensive, as are the necessary experts required to effectively use it. Requirements for lower migration coatings may force manufacturers to use more costly platform technologies.

Surely this is better than having no can coatings, due to the industry being hounded into extinction through the focus on migrants. The industry is confident that it can overcome any challenges to modify existing chemistries or develop new ones to ensure the longevity of the can as a key form of food packaging.

Without harmonised European food contact legislation for coatings in contact with food, these issues will proliferate. Coping with rapidly changing and evolving regulations and more restrictive customer requirements is very demanding and resource intensive. Failure to cope will result in failure of the industry.

Everyone involved must co-operate and understand each other’s problems and work together. Most importantly the industry must be seen to speak with one voice.