In this exclusive interview with Anna Gergely, Director, EHS Regulatory from Steptoe and Johnson, one of this year's expert speakers of Plastics & Paper in Contact with Foodstuffs, we asked about the application and regulations surrounding nanomaterials in contact with food.
Meet the expert: Anna Gergely, Director, EHS Regulatory from Steptoe and Johnson
Anna Gergely has been touched by the potentials of nanotechnology in the early 1990s during her time at university when her colleagues started to rave about it. Once she joined the industry, she was instantly smitten by the potentials of the technology and has enchanted by it ever since! Many refer to nanotechnology now as a new industrial revolution, which Gergely recalls as the exact terminology she used when she had first explained to her children about what was happening in the labs.
"The limit is really our imagination. I knew from the beginning that due to its unique properties these materials will represent a huge challenge though from a regulatory point of view and I have devoted some part of the previous 15 years of my carrier to contribute to this understanding."
You chair the Nanotechnologies Task Force of AmCham EU and the Regulation Working Group of NANOfutures, what are the current aims of these groups? Are they currently considering nanomaterials in contact with food?
These groups have one goal in common: providing a forum for a dialogue between industry, authorities and the general public to facilitate the development of nanotechnology in Europe in a proper regulatory environment.
The AmCham Nano Task Force includes several member companies of American parentage who are interested in nanotechnology across a very broad range of industry sectors. We have contribution from manufacturers, as well as users of nanomaterials in many consumer applications, hence there is great interest that the regulatory developments for nanomaterials in Europe would evolve in a well balanced way in line with the international consensus.
The Regulation Working Group of NANOfutures is engaged in the assistance of selected value chains utilising nanotechnologies in Europe via defining the regulatory hurdles and identifying specific actions to overcome them. The manufacturing of food contact materials has not been the focus of our activities in any of these two groups, maybe partially because there are no regulatory concerns related specifically to the utilisation of nanomaterials in these applications. To the contrary, the Union list of authorised monomers and additives in food contact plastics applications falling under the Plastics a Regulation (EC) 10/2011 already contains several materials in nano forms, demonstrating that the regulatory channel for the authorisation of these application is open.
My presentation at the Conference in December will discuss in details the conditions for the application of nanomaterials in food contact applications and highlight the remaining regulatory issues and their potential solutions.
A lot is happening on the front of the definition of nanomaterials and changes in the REACH registration dossiers for the nanoforms of substances registered in their bulk form, and you will cover this in detail in December, but could you summarise the main changes that you have seen over the last two years?
There are indeed major developments in the considerations of nanomaterials under the REACH Regulation. First, the definition of nanomaterials under the present Commission Recommendation is scheduled to be revisited in December 2014 and the JRC of the Commission, as well as some Commission sponsored projects are reviewing all the available new scientific arguments for any recommendations to modify this definition. Clearly, any change in the definition, while not legally binding, will have a major impact on the regulatory consideration for these materials, not just under REACH, but also under the food contact regulatory regime.
The actual modification of the REACH Annexes to accommodate better data requirements for the registration of substances in nano forms under REACH will have an equally important impact on their food contact regulatory status. I hope that these modifications will occur in the right direction, reducing the existing regulatory discrepancies between the two regulatory regimes.
We may claim that the arrival of nanotechnology was a breakthrough, but it's application and embracement in the different sectors is actually happening slowly, step-by-step. So there were no great changes in the last two years, rather there were many small steps, all demonstrating the benefits of the technology, without any apparent safety concerns. The hype is hopefully over - both in the positive and in the negative direction - and the technology is now expanding into the available space, driven by innovation and market forces and hopefully supported by a regulatory safety net, suited for its application. I am all supportive of these developments.
What progress do you think will have been made in this area in five years' time?
I hope in five years we will have no separate session on nanomaterials, they will be part of the common landscape. They will be used for their benefits and regulated in line with their potential risks. And I hope their benefits will be fully recognised and exploited; supported - and not hindered - by reasonable regulatory requirements
You are joining the session in Munich alongside a presentation from Dr Roland Franz on migration of nanoparticles from food contact plastics - experimental data and migration modelling - are you familiar with Dr Franz's work? Has this contributed to the work that you are undertaking?
I know and appreciate the work of Dr. Franz and his colleagues for - I might say now - decades... His lab has always produced leading edge results, be it in the area of migration modelling, recycled plastics application or nanomaterials. His work on migration testing of nanomaterials was crucial; it has provided the scientific certainty both the authorities and the consumers were waiting for: do these small particles migrate into food from the packaging materials and then may they enter the body in nano forms, requiring a different scale of risk assessment? The results of Dr. Franz showed that the particles tested in his applications did not move. Hence, EFSA could also conclude that the potential presence of these nano particles in the packaging material does not cause any health concerns, even if the hazards of the particles might not be fully described. This conclusion is the recognition of a risk based approach, which was made possible by the reliable data coming out of Dr. Franz's research group.
Your involvement with Smithers Pira's food contact events goes back a long way; what do you think sets them apart from other events and what are you particularly looking forward to about Munich this year?
The December (Smithers) PIRA events became the gold standard for the food contact plastics and paper community. They are always well represented, interesting, informative and very well organised! I hope to learn new things in Munich from colleagues, meet new people and old friends and discuss some of the challenging issues with like-minded people from the four corners of Europe and even the Globe.
In a session dedicated to nanomaterials and biocides regulations - the impact on food packaging, experts in their fields will bring you up-to-date with regulations and developments of nanomaterials and biocidal products in relation to food packaging.
This session's leading presentations include:
- Latest developments in the regulation of nanomaterials; the definition of nanomaterials and changes in the REACH registration dossiers for the nanoforms of substances registered in their bulk form
Anna Gergely, Director, EHS Regulatory, Steptoe and Johnson LLP
- Migration of nanoparticles from food contact plastics - experimental data and migration modelling
Dr Roland Franz, Head of Business Unit Compliance of Packaging Materials, Fraunhofer IVV
- Impact of Biocidal Products Regulation on Packaging: Update on Requirements for Treated Articles
Sebastien Louvion, Counsel, Mayer Brown