nanotechnology in multi-layer food packaging

www.khlaw.comWashington, D.C. ● Brussels ● San Francisco ● Shanghai

Kelly R. StarostaAssociate

Keller and Heckman LLP1001 G Street, NW

Washington, DC 20001202-434-4265

[email protected]

Nanotechnology inMulti-Layer Food Packaging

Regulatory Update: Nanotechnology in the European Union

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The Enlarged Europe


What is Nanotechnology?

Depends on who you ask!

“Nanotechnology is the study of phenomena and fine-tuning of materials at atomic, molecular and macromolecular scales, where properties differ significantly from those at a larger scale.”

– European Commission Nanotechnology Website http://ec.europa.eu/nanotechnology/index_en.html

http://ec.europa.eu/nanotechnology/index_en.html


Properties of Nanoscale Materials

Increased surface area to mass ratio• Surface area of 100 g of lead:

– Conventional particle size (2.6 cm diameter) = 0.002 m2

– 50 nm particle size = 1,000 m2

Result • Nanoscale materials may be more reactive with

materials around them (chemicals and biological systems)


Unique Properties = Unique Regulatory Considerations

Is my product “nano” under the EU regulatory framework?

Is there nano-specific legislation for my application? • Food Packaging• Foods• Cosmetics

What are the relevant nano-specific considerations when preparing dossiers?

• Depends on the nanomaterial and the application

Questions to Ask:


Is my product “nano” under the EU regulatory framework?

There is currently no single official definition of “nanomaterial” for regulatory purposes in the EU

Recent Development:• Scientific Committee on Emerging and Newly Identified Health

Risks (SCENIHR) pre-consultation opinion, 6 July 2010, entitled: Scientific Basis for the Definition of the Term “Nanomaterial”

– http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf

• European Commission opened public consultation on 12 July 2010; comments due 15 September 2010

http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf

http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf


Scientific Basis for the Definition of the Term “Nanomaterial”

Purpose of the opinion is to provide European Commission with recommendations for use in the developing a definition for the term “nanomaterial” for regulatory purposes

• Opinion recognizes that a working definition of “nanomaterial” is necessary in order to:

– Ensure consistency of forthcoming regulatory developments– Guide effective implementation of existing regulation

Parameters considered for possible inclusion as elements of the definition:• Size• Size distribution• Specific surface area• Other physico-chemical characteristics, e.g., crystallinity, redox potential, radical

formation potential, water solubility, etc.• Nanocomposites• Persistence• Manufactured versus natural


SCENIHR Opinion Recommendations

SCENIHR pre-consultation opinion recommends that the term “nanomaterial” should include:

– A defined size range, i.e., a lower (1 nm) and upper (100 nm?) limit, in one or more dimensions

– Referring to one or more external dimensions or an internal structure within the specified range (to include aggregates, agglomerates and multi-component assemblies)

– Consideration of size distribution and a determination as to the percentage of the material, based on number concentration, that must have a size within the range

– Volume specific surface area (VSSA) limitation as a complimentary qualifier for dry solid powders

– “Engineered/manufactured” may be used to designate purposefully made nanomaterials, but has to include processing (grinding or milling resulting in size reduction) of materials


SCENIHR Threshold Approach

Category 1: median size > 500 nm

• Median size of the material > 500 nm – It is assumed that the size distribution at the lower end will always be above

the designated lower threshold of 100 nm.

• No further information regarding possible nanospecific properties needed

• Classical risk assessment can be performed taking into consideration the particulate nature of the material



Category 2: median size < 500 nm (and > 100 nm)• Median size is < 500 nm and > 100 nm

– Material is considered to be a nanomaterial

– More detailed nanospecific risk assessment is necessary taking into consideration possible nanospecific characteristics of the material if:

• Number size distribution demonstrates > 0.15% (or any specified percentage) of the number size distribution is <100 nm

• For dry materials, the volume specific surface area (VSSA) (>60 m2/cm3) may be used as an additional qualifier

– If these criteria are not met, classical risk assessment can be performed



Category 3: median size < 100 nm and > 1 nm

• The material is considered to be a nanomaterial and nanospecific risk assessment has to be performed when >0.15% (or a specified percentage) of the number size distribution is <100 nm

• For dry materials, the VSSA (>60 m2/cm3) may be used as an additional qualifier


SCENIHR Threshold ApproachFigure 1: Risk Assessment on nanomaterials, tiered approach

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Scientific basis for the definition of the term “nanomaterial”, Pre-consultation opinion, 6 July 2010.


Is There Nano-Specific Legislation For My Application?

Overview of Regulatory Updates Specific to:

• Food Packaging Materials

• Food Additives

• Cosmetics


Nanomaterials in Food PackagingFramework Regulation (EC) No 1935/2004• Overarching regulation ensuring the safety of food-contact materials• Article 3: Materials and articles reasonably expected to contact food

must not:– Endanger human health;– Bring about unacceptable changes in composition of food; or– Change the organoleptic characteristics of the food

• No nanospecific provisions; requirements would apply equally to nanomaterials

Plastics Directive 2002/72/EC• Major piece of legislation governing plastics used in contact with food• Positive lists for monomers and additives, overall migration limit,

declaration of compliance, etc.• Does a listing for a conventional scale material allow for use of a

nanoscale material?– No specific provision on nanomaterials – not expressly prohibited– Listings are the result of EFSA risk assessment evaluations– Newer packaging legislation is explicit, nanomaterials treated differently


Nanomaterials in Food Packaging

New Active and Intelligent Packaging Regulation (EC) No 450/2009

• Nano-engineered substances must always be included in EU positive list of substances authorized as components of active and intelligent packaging

• Functional barrier exclusion not applicable!– “Substances deliberately engineered to particle size which

exhibit functional physical and chemical properties that significantly differ from those at a larger scale” cannot benefit from the functional barrier exclusion



Future Regulation

• Draft Plastics Implementing Measure (PIM)– General Goals of PIM

• Consolidate the Plastics Directive (2002/72/EC) with all of its amendments

• Expansion and clarification on the scope of EU legislation • Updates to migration testing requirements

• Also contains provisions specific to nanoparticles!



Draft PIM – Provisions Relevant to Nano

• Excludes nanoparticle and nanoform materials from automatic clearance via conventional scale counterparts

– Preamble• (23) “. . . 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.”

– Article 9, Specific requirements• (2) “Unless explicitly mentioned in the specifications in Annex I the use

of substances in nanoform shall not be authorised.”



Draft PIM – Provisions Relevant to Nano• Functional barrier exclusions not applicable!

– Article 12, Plastic multi-layer materials and articles• (2)(b) “a plastic layer which is not in direct contact with food and is

separated from the food by a functional barrier, may be: manufactured with substances other than those included in the Community list or in the provisional list”

• (4)(b) “The substances referred to in paragraph 2(b) shall not belong to substances in nanoform”

– Article 13, Multi-material multi-layer materials and articles• (2) “in a multi-material multi-layer material or article a plastic layer

which is not in direct contact with food and is separated from the food by a functional barrier, may be manufactured with substances other than those included in the Community list or the provisional list.”

• (3)(b) “The substances referred to in paragraph 2 shall not belong to substances in nanoform”



Will we see the PIM published in 2010?• Work on the PIM has been finalized at the Commission level

• Member State Committee vote scheduled for 12 July 2010 was postponed until September meeting of the appropriate Standing Committee

– Standing Committee for Food Chain and Animal Health

• Now unlikely that the PIM will be published in the EC Official Journal by the end of the year

– Need time for Parliament review, etc.


Nanotechnology in Food

Current Legislation

• EU General Food Law Regulation (EC) No 178/2002– Food must not be placed on the market if considered unsafe– Applies to nano-engineered foods/food ingredients

(implicitly), but not specific provisions on nanomaterials

• Regulation (EC) No 1333/2008 on Food Additives(Article 12)

– Changes to the particle size (e.g., through nanotechnology) of a food additive already appearing on a positive list will result in a different additive

• A new entry or change in specifications will be required prior to marketing


Nanotechnology in Food

Future Regulation – New Novel Food Reg• Novel Food Regulation (EC) No 258/97 under revision

• “New Novel Food Regulation” proposed by Commission is currently in front of European Parliament and European Council

• Parliament wants:• Nanotechnologies banned from food until the health and

environmental risks they might pose are better understood • Clear labeling for ingredients present in the form of

nanomaterials [nano]


Nanotechnology in Cosmetic Products

Regulation (EC) No 1223/2009 - Cosmetic Products

• Consists of positive and negative lists of ingredients and obligation for manufacturer to conduct a risk assessment

• Defines nanomaterial!– ‘Nanomaterial’ means an insoluble or biopersistent and intentionally

manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm

• Requires labeling for nano-containing products– Article 19, Labeling

• “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets”

www.khlaw.comWashington, D.C. ● Brussels ● San Francisco ● Shanghai

Kelly R. StarostaKeller and Heckman LLP

1001 G Street, NWWashington, DC 20001

[email protected]

Thank you!

nanotechnology in multi-layer food packaging

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