Dr Alistair Irvine, principal food packaging safety consultant at Pira International, told FoodProductionDaily.com that while the system was clearly laid out in EC Regulation 450/2009, he fully expected it to evolve over the coming years as the initial template adapted to the myriad needs of the packaging industry.
Active packaging contains materials and articles that are designed to interact and extend the shelf-life, or maintain or improve the condition of packaged food. Intelligent packaging monitors and communicates information about food quality, through technology such as time-temperature indicators, radio frequency identification, ripeness indicators, and biosensors. All existing products must be approved by 21 January 2011 to stay on the market, with all new products subject to the same authorisation process.
But what will this mean in practice and what does the packaging industry need to know?
“The new regulation should spur the volumes of A&I packaging as it has removed an element of doubt and manufacturers will be able go to the market and show their product has been assessed and approved,” said Irvine.
But with the January 2011 deadline looming, the packaging specialist cautioned that time was already a factor as he laid out how the evaluation process is likely to work in practice.
“Much of this will be a case of just working through the detailed process and filling in and ticking all the boxes that EFSA asks,” Irvine added.
But issues such as the complexity of the technology, how widely it had already been evaluated and even finding laboratories to carry out the mandatory toxicology tests were all factors that could determine the application time.
One issue – both in terms of cost and time - was likely to be whether any or all of the active or intelligent substances had already been approved as a food contact material. For a product where none of the materials had been assessed by EFSA, it would be very similar to having a new plastics additive evaluated, he said.
Irvine added: “Review the guidelines as soon as possible to try and establish if it will need to be assessed as a new substance or whether it has previously been listed. That will determine the path you are likely to take.”
For substances not previously assessed by EFSA, the process at its simplest would likely include a migration study followed by a “basic set of toxicology tests” - even if the migration levels are below 50 parts per billion (ppb). If migration levels exceed this level, further toxicological analyses may have to be done.
“A study showing migration at less than 50ppb will likely cost £10-15,000 but if the substance migrates at higher levels then costs could increase significantly,” he said. “The figure for toxicological analyses could be around £15-20,000. Add in the cost for dossier preparation and the total for a new product with a straightforward evaluation, may typically be between £40-50,000 per dossier.”
Time is also an important factor as the Pira consultant estimated that a dossier for a new substance could take more than a year.
“Time is ticking. Another factor is finding a laboratory to carry out the necessary tests – especially in light of the new workload for labs generated by the REACH regulations,” he said.
Antimicrobial - point of interest
Current thinking is that applications involving oxygen and ethylene scavengers – which are already fairly well established and in some cases where the active ingredients are based on existing food or packaging chemicals – are likely to be “more straightforward”. However, temperature-time indicators and products that emit substances to food may be less straightforward, while antimicrobial active packaging is likely to be problematic, he added.
“There is some resistance to the whole concept of antimicrobial packaging in some quarters because of a belief it could encourage people to adopt sloppy food safety practices,” said Irvine. “This will be quite a point of interest.”
The most important thing for companies was to make sure they did not miss the initial 2011 deadline, he said. If a product does not appear on that first list of approved products, then it cannot be put on the market – with all the business implications that brings with regard to competitors gaining an advantage.
Evolution and innovation
The new framework would pave the way for innovation but this would occur once the initial backlog of existing products had been assessed, Irvine predicted. He added that the process would evolve in future as regulators evaluated the full range of systems likely to be submitted.
"EFSA will need to address many questions in the first few years – that is the nature of these things,” he said. “It is highly likely that as EFSA reviews cases it will become apparent that some do not fit into the regulations and the definition of active packaging will be stretched somewhat. It will take a while on some applications and we may well see this reflected in amendments the regulations.”