Possible risk assessment for Nano-particles in Food Contact Materials

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Millicent Phillips
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1 Possible risk assessment for Nano-particles in Food Contact Materials 4 th Nanotechnology Dialogue FoodDrinkEurope Brussels 5 th October 2011 P.K.T. Oldring Valspar Corporation 1

2 Nanotechnology and FCM - 1 Until there is an agreed definition of nano then it is not possible to say what is and what is not nano. Today, nano materials used in Food Contact Materials (FCM) could be intended for food packaging or equipment / machinery which contacts / processes foodstuffs or articles in close proximity for food storage e.g. fridge. PROVIDED regulation permits them!!!!!!!! Engineered nanoparticles (ENP) are the focus of attention rather than naturally occurring ones. 2

Food packaging applications nano-composites

properties Intelligent & Smart packaging

monitor condition of the food Concerns potential

3 Food packaging applications nano-composites plastics (including biopolymers) incorporating nanomaterials to improve durability, temperature/ moisture stability, barrier properties Active materials plastics incorporating nanomaterials with antimicrobial properties Intelligent & Smart packaging Examples packaging incorporating nanosensors to monitor condition of the food Concerns potential risks due to migration of ENPs into food and drinks Courtesy of L. Castle & Q. Chaudry Fera

4 Nanotechnology and FCM - 2 In some cases certain materials traditionally used in FCM have a particle size distribution which does or could extend into the nano range (depending on definition of nano) Pigments are one example The PIM (Plastic Implementation Measure) only applies to plastics. How can non-plastics be handled? What about inks, coatings and paper where some materials used for many years could be classified as nano? 4

5 Nanotechnology and FCM PIM - 1 The Plastics Implementation Measure (PIM) Regulation (EU) No. 10/2011 mentions nano in various places Whereas (23) & (27) Articles 9, 11 & 14 Table 1, Annex 1, lists the authorised substances with restrictions. There is only one mention of a nano substance. 5

6 Nanotechnology and FCM PIM Whereas (23) New technologies engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles. These different properties may lead to different toxicological properties and therefore these substances should be assessed on a case-by-case basis by the Authority as regards their risk until more information is known about such new technology. Therefore it should be made clear that authorisations which are based on the risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles.

7 Nanotechnology and FCM PIM - 3 Whereas (27) functional barrier is a layer within food contact materials or articles preventing the migration of substances provided they fulfil certain criteria and their migration remains below 0,01 mg/kg. Substances that are mutagenic, carcinogenic or toxic to reproduction should not be used without authorisation and are not covered by the functional barrier concept. Nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology. Therefore, they should not be covered by the functional barrier concept. 7

8 Nanotechnology and FCM PIM - 4 The PIM explicitly authorises the use of only one named nano material - FCM #807 titanium nitride, but with restrictions and a defined particle size. agglomerates with a diameter of nm consisting of primary titanium nitride nanoparticles; primary particles have a diameter of approximately 20 nm. There are two other substances which have particle sizes of ENPs which are indirectly authorised in the PIM carbon black and fumed silica. 8

9 Nanotechnology and FCM PIM - 5 FCM #411 carbon black with a defined particle size distribution, because arguably when the SCF/EFSA evaluated the dossier the specification included a particle size distribution which covered nano. This is in the specification in the PIM. Primary particles of nm which are aggregated to a size of nm which may form agglomerates within the size distribution of 300 nm mm. 9

10 Nanotechnology and FCM PIM - 6 FCM #504 Fumed silica - synthetic amorphous silicon dioxide: primary particles of nm which are aggregated to a size of 0,1 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size. Some clays (e.g. montmorillonite) are nano if exfoliated and can be used in polymer clay composites for improved gas barrier properties in e.g beer bottles. 10

11 Nanotechnology Active & Intelligent - 1 Antimicrobial nanoparticles of metals (silver, zinc oxide, magnesium oxide) can be used as active packaging to inhibit the growth of microorganisms. Active and Intelligent Packaging regulation EC No. 450/2009 excludes nanoparticles (substances deliberately engineered to a particle size which exhibit functional, physical and chemical properties that significantly differ from those at a larger scale). 11

12 Nanotechnology Active & Intelligent - 2 These antimicrobials in nano form can also be used as surface-active biocides in non-active FCMs such as conveyor belts and other repeateduse articles where there is no intention to act on the food but rather to help keep the contact surface clean and aid cleanability 12

13 13 Risk assessment of Nanotechnology in FCM - 1 Initially nano seems to offer many advantages, both for the consumer and innovative industry. Nano is seen by some as not natural. Today, we seem to have a situation where emotion rules good science. There are other examples in the EU, including GMOs. What can be done to ally fears and emotion? Industry, politicians, regulators and scientific advisory bodies need an agreed approach to evaluate safety of new materials or modifications of existing ones.

14 14 Risk assessment of Nanotechnology in FCM - 2 Risk = hazard x exposure to the hazard Hazard = the potential to cause harm Risk = (probability of event occurring) x (impact of event) Emerging risk (EFSA definition):- An emerging risk to human, animal and/or plant health is understood as a risk resulting from a newly identified hazard to which a significant exposure may occur or from an unexpected new or increased significant exposure and/or susceptibility to a known hazard.

15 Risk assessment of Nanotechnology in FCM - 3 The first issue is how does one define the toxicology of nanoparticles? The toxicology of the substance of normal size is normally known. Does being orders of magnitude smaller increase the risk? Only toxicologists can answer this question. However, there are circumstances where a toxicological opinion may not be needed. Paracelsus stated that the dose makes the poison. 15

16 16 Risk assessment of Nanotechnology in FCM - 4 If there is no exposure to nanoparticles, then there is no risk whatever their toxicological profile. How can there be no exposure? Particles degrade on entering food Particles do not migrate (Question is the 10 µg/kg (10 ppb) LOD for functional barrier adequate for ENP?). Particles are transformed (before ingestion or in the gastro-intestinal tract) into non-nano form, then look at non-nano tox data. The ENP persists then then available tox data needs to be evaluated and if necessary additional testing undertaken.

17 17 Risk assessment of Nanotechnology in FCM - 5 No FCM is completely inert. We arguably lack some of the tools to measure nanoparticle migration into foods / simulants. We lack the full understanding to interpret any migration results what is a safe level? Currently, we are only be able to evaluate applications that demonstrate the no migration principle. This approach was used in the case of titanium nitride This no migration status was established using existing and new migration modelling approach

18 Risk assessment of Nanotechnology in FCM - 6 It is generally recognised based on theoretical calculations, that when nanoparticles are incorporated into most types of plastic they are effectively immobilised and they cannot migrate by diffusion. The Outlook For Nanotechnologies In Food. Edited by Q. Chaudhry, L. Castle & R. Watkins. Royal Society of Chemistry, 2009, in press. Migration of engineered nanoparticles from polymer packaging to food a physicochemical view. P. Simon, Q. Chaudhry and D. Bakos. Journal of Food and Nutrition Research, 2008, 47,

19 Risk assessment of Nanotechnology in FCM - 7 For many other types of FCM Thresholds are at last beginning to be recognised (e.g. ESCO/EFSA, EFSA, ILSI etc) The questions remain as to whether Thresholds can be used for nano. It is certain that as technology advances and new materials are introduced, new approaches to assessing their safety are required rather than time consuming and sometimes ambiguous (results) animal testing. 19

20 Conclusions* - 1 Molecules larger than 1,000 Daltons are of little (or even no) toxicological concern since they are not absorbed. But NPs are even bigger It will be necessary to measure NP migration into foods to confirm the no-migration predictions Current methods can already place an upper limit on migration Still need to decide if, e.g NPs / kg food would be of any concern or not. * Courtesy L. Castle, Fera

21 Conclusions - 2 The concern about aggregation either self or with food constituents may be misplaced - the physical state / size after the food is digested is what probably matters. The fate of the organic modifiers may be of more interest It is clear that unless the difficulties surrounding the acceptance of nano-technology by ALL can be resolved fairly quickly, a technology which offers many advantages will disappear.

22 How can Exposure be estimated - 1 To evaluate exposure it is necessary to know the concentration of the substance in the foodstuffs and how much of each foodstuff is eaten. The FACET (Flavours, Additives and food Contact materials Exposure Task) is a 7 th Framework EU funded (~ 6 Mio) project to estimate exposure to food flavourings, additives and food contact materials, which finishes August The final product will be a stochastic model, freely available to all, which will run stand alone on a PC

23 How can Exposure be estimated - 2 If the concentration of a nano substance (i.e. food ingredient or contaminant) in a food is known, then it would be possible to estimate the exposure to it for any percentile consumer using FACET in the advanced user mode. FACET will be a major tool in the risk manager s armoury FACET WEB SITE

24 The input of Laurence Castle, Fera (UK) is acknowledged and much appreciated. Thank you for your attention 24

Active Intelligent. Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent

Active Intelligent. Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent ก : Active intelligent ก ก 2552 Active intelligent (Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food) : ก Active Intelligent