Unilever’s approach to assuring the safety of novel nanomaterials - supporting the risk assessment scienceBobbie Bradford

Safety & Environmental Assurance Centre

Unilever’s brands

Unilever’s Mission is to add Vitality to life.

160 million times a day, someone will choose one of our foods, home or personal care brands

We meet everyday needs for nutrition, hygiene and personal care with brands that make people feel good, look good and get more out of life.

Unilever Approach to Safety & Sustainability

• Commitment defined in Code of Business Principles & Policies for:• Consumer, Occupational & Environmental Safety and

Sustainability• High ethical standards for Human Testing & elimination of Animal

Testing

• Governance is responsibility of Chief Executive Officer, supported by Safety and Environmental Assurance Centre (SEAC)

SEAC’s Mandate

• Provide independent scientific evidence and guidance so that Unilever can identify and manage:

• risks for consumers, workers and the environment

• (safety of products and supply chain technology)

• environmental impacts

• (sustainability of Unilever’s brands, products and Supply Chain)

Providing assurance to help deliver Vitality and growthin a safe and sustainable manner

Building Brands & Assuring Safety -relevance for nanotechnologies?

Unilever position

• Unilever has built a strong reputation on the use of novel science and technologies to deliver new products and improve the performance of established ones - in a responsible way.

• We believe that there is considerable potential for new benefits through the application of specific nanotechnologies, for healthier Food and better HPC products.

• The decision to apply any new technology in our products will always be taken on the basis of comprehensive safety and environmental evaluations, substantiation of benefits, regulatory compliance and consideration of consumer acceptance.

Supporting the Unilever position

• The debate around Human and Environmental safety and confidence is important and we are actively participating in moving the debate forward

• We conduct our own research and have commissioned scientific research with leading experts on both health and environment, over and above our own research in these areas.

• We monitor the emerging science & regulations around nanotechnology and focus efforts in areas where we can add value or where we see gaps in Risk Assessment

• Risk Assessment Framework

Risk Assessment FrameworkGeneration of enhanced physico-chemical data package

including shape, surface area and potential for biopersistence of the nanomaterial as supplied.

Physico-chemical characterisation of the material in intermediate and final

product formats.

Exposure scenarios from product manufacture, distribution and use.

Quantification of exposure.Determine hazards relevant to the route(s) of exposure.

ConsumerAdverse effects due to

particle characteristics (e.g. shape, surface area & chemistry), potentially

increased/ altered biodistribution .

OccupationalIncreased potential for

exposure due to particle characteristics.

Increased potential for chemical reactivity,

flammability and instability.

EnvironmentalAdverse effects due to particle characteristics (e.g. shape, size

& chemistry), potentially increased/different

bioavailability and/or mode of action.

Comparison of hazards and exposures to characterise

COE risks.

Supporting the Unilever position

Our focus so far has been in:

• Consumer & Occupational safety – particularly inhalation toxicology

• Environmental safety

• Developing measurement techniques for nanomaterials to include:• Raw material• Form in product• Form in the body (eg digestibility)• Distribution in the body & environment

• Areas where we consider may be additional concerns

• Engineered nanomaterials that are insoluble & biopersistent

Internal Research

Main internal focus Ecotoxicity• Algal and Daphnia acute and chronic studies.

• Sludge adsorption experiments.

3A: Control image with light microscope.

3B: Control SEM image of Daphnia section, overlaid with a titanium map

3C: SEM image of Daphniasection after exposure to 1.0 mg/l TiO2 for 21 hours.

3A: Control image with light microscope.

3B: Control SEM image of Daphnia section, overlaid with a titanium map

3C: SEM image of Daphniasection after exposure to 1.0 mg/l TiO2 for 21 hours.

• Measurement Science Unit

• TEM

• SEM

Sectioned Daphnia and algal cells overlaid with titanium dioxide maps

Lung Exposure Assessment

Use nanosizer to determine if exposure to nanoparticles

External Research

• Consumer safety

• Studentship at Imperial College - Investigation of the effects of nanomaterialson the alveolar epithelium and systemic translocation

• BBSRC project at Kings College London – Investigation of the translocation and toxicology of nanomaterials in the nasal epithelium

• Studentship at Aston - Use of bronchial epithelial cell in benchmarking responses to particulates

• Collaboration with Health & Safety Laboratory on in vitro approaches for inhalation toxicity

• Environmental safety

• PhD (completed) at York University/Central Science Laboratory - Fate and bioavailability of nanomaterials in the environment, measurement techniques

• Several papers on this work have already been published

• PhD ongoing at Napier University - Bioavailability, uptake and translocation of nanoparticles in aquatic organisms.

Transmission & Scanning electron microscopy & chemical analysis

TiO2 Powder in H20

Au colloids & NOM

TiO2 ENP in lake water

Chemical analysis by energy dispersive X-ray spectrometry (EDX)

Development of hydrodynamic chromatography-ICPMS

Size separation of particles between 5 - 300 nm

Multi-element & isotope analysis of size fractions by ICP-MS

Fast, robust, sensitive & minimal sample alteration

Simultaneous analysis of metal & metal oxide particles in complex aqueous media

Conclusions

• Unilever – Big Brands across Foods & HPC products

• Unilever R&D are investigating use of nanotechnologies

• Any new technology in our products will always be taken on the basis of comprehensive safety and environmental evaluations

• SEAC are supporting the use of nanomaterials by sponsoring external & internal research to close any data gaps relevant to Risk Assessment

• Using standard toxicology studies to identify hazards • Modifications if necessary

• For human & environmental safety we consider major gap is in measurement.

• Guidance from Regulators will be followed to adapt Risk Assessment as appropriate