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Scientific and regulatory approach to nanotechnologies applying to specialty food ingredients FoodDrinkEurope 4th Nanotechnology Stakeholder Dialogue Day 5 October 2011 Federation of EU Specialty Food Ingredients Industries

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Page 1: Scientific and regulatory approach to nanotechnologies ... · Scientific and regulatory approach to nanotechnologies applying to specialty food ingredients ... specialty food ingredients

Scientific and regulatory approach to

nanotechnologies applying to

specialty food ingredients

FoodDrinkEurope – 4 t h Nanot echnology St akeholder Dialogue Day – 5 Oct ober 2011

Federat ion of EU Specialt y Food Ingredient s Indust ries

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The ELC is t he voice of t he Specialt y Food Ingredient s

Indust ries in Europe. We aim t o creat e a safe and suit able

regulat ory environment and represent t he indust ry wit h EU-

decision-makers.

It is our object ive t o ensure t hat all st akeholders – f rom

manufact urers and ret ailers t o regulat ory aut horit ies and

consumers – are correct ly informed of t he use and safet y of

specialt y food ingredient s and t heir advant ages.

ELC at a glance

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ELC at a glance (cont’d)

More t han 200 EU companies represent ed eit her by direct

membership or t hrough a member associat ion

ELC membership (2011)

20

21

Association members

Corporate members

ECU

INEC

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ELC at a glance (cont’d)

Wit h t heir t echnological, nut rit ional and healt h relat ed

funct ions, specialt y food ingredient s t ypically make food t ast y,

pleasant t o eat , safe, healt hy and af fordable.

To name but a few: vit amins, minerals, enzymes, specif ic

prot eins, f ibres, addit ives, specif ic carbohydrat es, cult ures

et c.

3-8 % of EU specialt y food ingredient s manufact urers’

t urnover is dedicat ed t o R&D, depending on t he sect ors. Overall

t he average invest ment is bet ween 4-5 % of revenue.

The specialt y food ingredient s indust ry represent s around

€ 35 billion of t he global food ingredient s market – of which 40

% (around € 15 billion) is in Europe.

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Food Information Package

Art . 2 (1) ( t ) Def init ion:

" engineered nanomat erial" means any int ent ionally produced mat erial t hat has one or more dimensions of t he order of 100 nm or less or t hat is composed of discret e funct ional part s, eit her int ernally or at t he surface, many of which have one or more dimensions of t he order of 100 nm or less, including st ruct ures, agglomerat es or aggregat es, which may have a size above t he order of 100 nm but ret ain propert ies t hat are charact erist ic of t he nanoscale.

Propert ies t hat are charact erist ic of t he nanoscale include:

( i) t hose relat ed t o t he large specif ic surface area of t he mat erials considered; and/ or

( ii) specif ic physico-chemical propert ies t hat are dif ferent f rom t hose of t he non-nanoform of t he same mat erial.

We conclude the following:

Foods and food ingredients manufactured by standard processes do not fall under this definit ion.

Almost all processed foods would fall under such a definit ion since they contain nanostructures.

Original intent ion of legislator for labeling of ENMs was about newly developed materials.

Thus the definit ion was developed under the novel food regulat ion which excluded all materials produced or using technologies established before May 1997.

A broad definit ion wouldn„t meet consumer„s percept ion of nanomaterials.

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Food Information Package

Art . 18 (3) Labeling

„All ingredients present in the form of engineered nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word "nano" in brackets.“

Nanomaterials have st ill to be present as nanomaterial in the final food applicat ion.

If the ENM is dissolved in the food into its ionic or molecular form, it has not to be considered as ENM anymore and consequently has not to be labeled.

If the ENM builds up larger structures with other food components during food processing, it has not to be considered as ENM anymore and not to be labeled.

We conclude that for a clear enforcement only newly developed, insoluble and biopersistent ENM„s should be regulated under the European legislat ion

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Novelty of the material or technology used is

essent ial in the development of a definit ion!

Original intention of legislator was to establish a definition under the

novel food regulation which excluded all materials produced or using

technologies established before May 1997.

A cut-off date is needed for legal certainty to produce and use

materials produced using established standard technologies.

Natural and engineered nanomaterials have to be treated in the same way.

There are no safety reasons to differentiate between natural or engineered

materials.

There are no reasons why products produced since decades in the same

way and have positively assessed by risk assessments bodies, should

now be considered as ENMs based on a newly developed definition,

although nothing has changed.

We conclude that a definition on ENMs has to be seen in the context of a

new technology/new materials which is covered by Novel Food

Regulation. The cut-off date of this legislation has to be maintained.

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Draft definit ion as discussed

as an overarching definit ion

1. Nanomaterial: means a material that consists of particles, with one or more external dimensions in the size range 1 nm - 100 nm for more than x % of the number size distribution, which belong to at least one of the following categories:

i. Particles, unbound;

ii. Particles, aggregated;

iii. Particles or aggregates, agglomerated;

2. Where technically feasible, conformity with Article 2(1) may be determined on the basis of the specific surface area by volume. The criterion is met when the specific surface area by volume of the material is greater than 60 m2 / cm3. This paragraph can only be used to determine that the criterion in Article 2(1) is met, but not to disqualify a material that complies with Article 2(1) from the definition of nanomaterial.

3. End products containing nanomaterials are not themselves nanomaterials.

4. Particle: means a minute piece of matter with defined physical boundaries.

5. Aggregates: means a particle comprising of strongly bound or fused particles.

6. Agglomerates: means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components

We additionally propose that such a definition should focus on insoluble, biopersistent materials and exclude standard technologies already used

for many years.

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Dissolved nanomaterials lose

their nano-characterist ics

A regulatory definition on nanomaterials should focus on

nanoparticles that are insoluble and biopersistent under

physiological conditions.

When solubilized, the nanomaterials lose their nano-characteristic

properties and a potential hazard is only dependent on the amount of

the substance entering the body and the toxicity resulting from its

chemical structure.

EFSA 2011:

"In this ENM Guidance the term non-nanoform refers to a material

that is either in ionic or molecular form (i.e. generally smaller than

the nanoform) or in bulk form (i.e. larger size than the nanoform,

which can include aggregated nanomaterials).“

We conclude that every material that is dissolved under

physiological conditions should not fall under a regulatory

definition of nanomaterials.

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Is increased bioavailability always an issue?

The bioavailability of nutrients depends on various different

factors.

Diet factors such as the content of fat in a food, the content and nature of fibres,

the absorption of equivalent nutrients, competitive interaction/ mutual influences

among various nutrients;

Food matrix such as the localization of the nutrient in the raw material of the food,

the degree to which the food was processed, heat treatment, particle size of the

nutrients (especially influences added nutrients);

Biochemical and metabolic factors such as isomer ratios in foods, interindividual

variability in humans;

Individual characteristics such as malabsorption syndrome, nutrient status in

general, menstruation cycle, health condition, life-style factors (alcohol, smoking,

etc.).

We conclude that as long as the bioavailability of a nutrient from

formulated products is not substantially different to what can be

achieved from foods under optimal conditions, it should not be

treated differently.

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A definit ion on nanomaterials has to

consider the realit ies

Every natural food already contains various nanostructures and nanoparticles.

Nearly every food except e.g. staple foods from agricultural production is engineered.

Food processing (by definition) transforms raw ingredients into food or transforms food into other forms for consumption by humans.

Food processing is done either „at home“ or by „food“ industry.

Food processing includes reams of technologies.

The transformation of raw materials or foods is often significant and includes macroscopic and microscopic changes. Technologies applied have usually effects on the microstructures and the size of certain particles in the processed food.

Food processing technologies are used by consumers themselves, by food ingredients and food industry.

Consumers produce nanostructures in their own kitchen!

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European food legislat ion acknowledges the necessity of food processing

technologies for food ingredients

Annex III of Reg. (EC) 1333/2008

“Union list of food additives including carriers approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.”

Examples from Annex III:

Emulsifiers permitted as carriers in food colours or fat-soluble antioxidants

Lecithins, Polysorbates, Magnesium salts of fatty acids, Mono- and diglycerides of fatty acids, Acetic acid esters of mono- and diglycerides of fatty acids, Citric acid esters of mono- and diglycerides of fatty acids, Mono and diacety tartaric acid esters of mono- and diglycerides of fatty acids, Sucrose esters of fatty acids, etc.

Bulking agents permitted as carriers in food additives:

Oxidized starch, Monostarch phosphate, Distarch phosphate, Phospated distarch phosphate, Acetylated distarch phosphate, Acetylated starch, Acetylated distarch adipate, Hydroxy propyl starch, Hydroxy propyl distarch phosphate, Starch sodium octenyl succinate, etc.

Anticaking agents permitted as carriers in food colours:

Silicon dioxide, Calcium silicate, Talc, Beeswax (white and yellow), Calcium phosphate, Calcium carbonate, etc.

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Carriers/ Addit ives

in Addit ives/ Enzymes/ Flavours/ Nutrients

Every combination of permitted food additives and carriers fulfilling the requirements of Annex III can be used.

Standard technologies used so far to provide stable food additives, enzymes, flavourings and nutrient preparations can be used without any limitation taking into account general food safety requirements from Reg. (EC) 178/2002.

Technologies used for that include (not exhaustive list):

Emulsification/Homogenisation/

Grinding/milling/precipitation

Drying/spray-drying/freeze-drying/encapsulation

Extrusion technologies

...

These technologies might result in small particle sizes of ingredients or small structures in the nanosize comparable to foods.

Food ingredients industry needs the same flexibility to use different technologies such as food industry.

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Examples of standard technologies:

Emulsificat ion

FOODS

Many foods are emulsified such as milk, butter, margarine, frozen desserts, meat products

E.g. milk, casein micelles size distribution: 10-300 nm

FOOD INGREDIENTS ( incl.

Addit ives)

E.g. colour emulsions,

dist ribut ion of droplet size

f rom 60-300 nm

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A regulatory definit ion of nanomaterials in foods

should consider more than size

Food processing technologies are used in foods and in similar ways in food ingredients (incl.

food additives).

Flexibility is needed! Not every new product formulation is new!

Currently used food processing technologies result already in structures in the nanoscale.

A differentiation between foods and food ingredients is not justified.

Food ingredients and additives obtained by established standard processes are not novel and

should not be considered as ENMs under a regulatory definition

Current approaches for labeling purposes may endanger standard foods and food ingredients to

be considered as nanomaterials.

A definition for nanomaterials in foods should focus on

particles

and have to consider additional factors than size such as:

novel properties, novel process, solubility, biopersistence etc.

to differentiate between foods/food ingredients obtained by “standard” processes and novel

nanotechnological processes.

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Thank you for your at t ent ion

www.elc-eu.org

[email protected]

Federat ion of European Specialt y Food Ingredient s Indust ries