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www.khlaw.com • www.packaginglaw.com
Packaging Compliance/Requirements in the
EU and the US: Two Worlds Apart?
5 June 2015
Hazel O’Keeffe Counsel
Keller and Heckman LLP
Avenue Louise 523
1050 Brussels, Belgium
+ 32 (0) 2 645 5076
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 2
KH Facts
KH is a pioneer in the use of interdisciplinary approaches to problem-solving
Recognized world leading law firm in the sectors of food, food-contact materials and chemicals
• Food contact practice is not a new or recent practice of the Firm
• It is an old practice and one of the strongest
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 3
Lawyers Working with In-House Scientists
Currently, Keller and Heckman has over twenty staff scientists, including: • Five senior chemists and toxicologists from Center for Food
Science and Applied Nutrition at U.S. Food and Drug Administration (FDA)
• Two senior scientists from U.S. Environmental Protection Agency (EPA)
• Former European Commission's Principal Administrator for the food contact materials sector
• One former scientist of research institute TNO Quality of Life in
the Netherlands – Another one working on a case-by-case basis
Most have advanced degrees in analytical chemistry
Integrated into the various practices of the Firm
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 4
What we do
E.g.:
Opinion Letters
GMP Audits and Advice
Test Protocols
Filings in the US, EU and China, including: • Food Contact Substance Notifications in the US (FDA)
• Food Contact Petitions in the EU (before EFSA & national authorities)
• Grandfathering petitions in China (MoH; ~250 petitions filed)
Advocacy with Agencies and Legislative Officials
Product recall and liability
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 5
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 6
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 7
EU Regulatory Philosophy
Certain M&A specifically regulated at EU level, while
others subject to Member State legislation and the
mutual recognition principle
• For components of M&A subject to positive list
requirements at the EU level – European Food Safety
Authority (‘EFSA’) safety evaluation and formal clearance
by European Commission
– Clearances not proprietary
– EFSA assesses risk based on migration
• Packaging must be manufactured under good
manufacturing practice (GMP)
• Recycling processes for food-contact plastics must be
assessed by EFSA
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 8
US Regulatory Philosophy
FDA regulates food packaging materials as potential
“food additive”
• Clearances established in the US via FDA’s Code of
Federal Regulations (‘CFR’), food contact notifications
(‘FCNs’), and Threshold of Exemption Regulations
(‘TORs’)
• FCNs proprietary clearances
• FDA assesses risk based on calculated dietary exposure
to potential migrants
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 9
US Regulatory Philosophy
End test specifications required to ensure
material complies with regulation (differs from
migration testing)
Packaging must be manufactured under good
manufacturing practice (GMP)
Recycled material assessment by FDA not
required
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 10
Safety and other fundamental principles
EU
Article 3.1 of the EU’s
Framework Regulation
1935/2004:
• M&A must not
– Endanger human health
– Bring about an
unacceptable change in
the composition of the
food
– Bring about a deterioration
in the organoleptic
properties of the food
US
Federal Food Drug and
Cosmetic Act (‘FDCA’)
prohibits the adulteration of
food:
• Food packaging may adulterate
food
– if unsafe
– If it makes the food unfit for
human consumption (e.g. by
imparting an off-taste or odor)
– If it qualifies as a food additive
and is not subject to pre-
market clearance by the FDA
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 11
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 12
Overview of Structure of EU Food-Contact Legislation
Framework Reg 1935/2004 GMP Reg
2023/2006
Paper
and
board Metals
And
Alloys Printing inks
Future
Regulation on
biocides in
FCM
Coatings
Adhesives
Silicones
Cork
Ion-
exchange
resins Wood
Waxes
Rubber
Glass
Mutual recognition applies in non-harmonized areas
Other EU measures for specific materials or substances
E.g. Plastics Reg 10/2011
Recycled Plastics Reg. 282/2008
Regenerated Cellulose Dir. 2007/42
Active and Intelligent packaging (Reg. 450/2009)
Ceramics Dir. (84/500) …
Textiles
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 13
EU - Plastic M&A - Monomers
EU Plastics Regulation 10/2011 includes
positive list for constituent monomers
• Business operators may use any polymer that can
be produced from listed monomers, provided that:
– Specific Migration Limits (‘SMLs’) and/or Quantitative
limits (if any) for constituent monomers are met
– Specifications (if any) are met
• Exemption from positive listing for those
monomers used behind a functional barrier
(meeting all requirements to avail of exemption)
– except vinyl chloride monomer
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 14
US – Plastic M&A - Polymers
By contrast, U.S. establishes clearances for polymers
• Clearance lists specific polymer, often with limits on
concentration of various monomers
• Example: Section 177.1520 listing for olefin polymer:
“Olefin basic copolymers consist of basic copolymers
manufactured by the catalytic copolymerization of two or more of
the 1-alkenes having 2 to 8 carbon atoms. Such olefin basic
copolymers contain not less than 96 weight-percent of polymer
units derived from ethylene and/or propylene.”
• Exception: Section 175.105 (Adhesives) and 176.180
(Paper and paperboard in contact with dry food)
which includes list of permitted monomers
– but clearance still applies to polymers
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 15
EU - Plastic M&A - Additives
In the EU, additives must be listed on the Plastic
Regulation’s Union List unless exempted
• Additive defined as a substance “intentionally added
to plastics to achieve a physical or chemical effect
during processing of the plastics or in the final article;
it is intended to be present in the final material or
article”
• Migration test often required to ensure SML limit met
• Some substances are subject to additional
restrictions or limits
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 16
EU - Plastic M&A - Additives
Colorants specifically exempted from Plastic
Regulation’s positive list requirement
• Subject to Member State legislation and the mutual
recognition principle
• Many Member States maintain purity requirements for
colorants used in plastic M&A
Aids to polymerization and polymerization
production aids subject to different definitions &
requirements
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 17
US - Plastic M&A - Additives
In the U.S., additives are cleared in various
regulations, FCNs, and TORs
• May be listed in standalone regulation or in polymer
regulation
• Clearance may list maximum concentration, polymer,
conditions of use, and/or type of food limits
• End tests often do not apply
• Function of additive often identified in clearance
• Mixture doctrine may apply
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 18
Various Types of Use Limitations - CFR
Example:
• Functionality of substance:
– Dimethylpolysiloxane (DMPS) cleared under 21 CFR 181.28
as “release agent”
– DMPS as “defoaming agent” in making coatings on paper
and in making paper (21 CFR 176.200 & 176.210)
– DMPS as a “defoaming agent” in processing food (21 CFR
173.340 (“Defoaming agents”))
• What about as defoamer in making coatings for
polypropylene film? No explicit clearance
Other types of use restrictions include intended
use, condition of use, food types
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 19
EU – Plastic M&A - PPAs
In the EU, substances used to provide suitable
medium for polymer or plastic manufacturing
regulated as “polymer production aid” or PPA
• PPA’s not intended to be present nor have a physical
or chemical effect in the final material or article
• Union List includes PPAs (and if included must meet
SML or other restriction); however Plastics
Regulation does not require PPAs to be listed
• Non-listed PPAs and solvents subject to national law
– Mutual recognition principle applies
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 20
EU - Examples of Polymer Production Aids
Commission Guideline on plastic M&A identifies the
following as PPAs:
• Anti-foam reagents*
• Degassing agents*
• Anti-cluster
• Anti-crusting agent
• Anti-scaling
• Buffering agents
• Build-up suppressants
• Dispersing aids
• Emulsifiers*
• Flow control agents
• Nucleating agents
• pH regulators
• Preservative*
• Solvents
• Surfactants
• Suspension agents
• Stabilizers
• Thickening agents
• Water treatment reagents
* Necessary during the manufacturing process
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 21
US – Plastic M&A - PPAs
In the U.S., substances used in the manufacture
of a polymer are not regulated differently based
on their specific function
• If meet food additive definition, must be subject of a
clearance covering its intended use and comply with
any applicable limitations
• If not reasonably expected to become a component of
food (the “no migration exemption”) or subject to
another applicable exemption to the food additive
definition, then do not require specific clearance
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 22
EU – Plastic M&A - Aids to Polymerization
In the EU, substances which initiate
polymerization and/or control the formation of
the macromolecular structure are considered
“Aids to Polymerization” Not included in Union List
Must comply with Article 3 of Framework Regulation
Assessed in accordance with internationally recognized scientific
principles on risk assessment
Recital 19 to Plastics Regulation indicates that aids to
polymerization are used in minute amounts and are not
intended to remain in final article
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 23
EU – Plastic M&A - Aids to Polymerization
Commission Guideline on Regulation of Plastics
identifies the following as aids to polymerization:
• Accelerators
• Catalysts
• Catalyst deactivators
• Catalyst supports
• Catalyst modifiers
• Chain scission reagents
• Chain transfer or extending
agents*
• Chain stop reagents*
• Cross-linking agents*
• Cross-linking catalysts
• Desensitizing agents
• Initiators and promoters
• Molecular weight regulators
• Polymerization inhibitors
• Redox agents
* (that are not incorporated in the polymer)
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 24
US – Aids to Polymerization - Basic Resin
Substances
In the U.S., substances necessary to produce
the basic polymer are generally considered
subsumed in the listing for the polymer
Clearances in Food Additive Regulations generic and
do not list manufacturing process to produce polymer
“Basic Resin Doctrine”
• Used at relatively low levels
• Incorporated into the polymer or removed to a sufficient
extent
• Necessary for the production of the polymer
• Must not adversely impact suitable purity of the
polymer
Applies to polymers cleared by Regulation only
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 25
EU - Impurities in Plastic M&A
Non-Intentionally Added Substances (=NIAS) defined in Plastics Regulation as “an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product”
May be present provided compliant with Article 3 of Framework Regulation 1935/2004 Combined reading of Article 6.4 and Article 19 of
Plastics Regulation
Increasing focus on safety evaluation of NIAS
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 26
Impurities in the US
Under 21 CFR 174.5, a food-contact substance
must be “of a purity suitable for its intended use”
Conduct assessment to ensure potential
migrants do not:
Present any health or safety concern; or
Impart adverse taste or odor to foods
The existence of an FDA clearance for a
material does not relieve a manufacturer from
conducting the safety assessment
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 27
EU - Substances in Nano Form in Plastic M&A
No EU definition in Plastics Regulation
Recital 23: nano engineered substances
Substances in nanoform used as monomers,
starting substances or additives not permitted if
not listed as such
Do not benefit from the functional barrier concept
Commission Recommendation 2011/696/EU on
the definition of a nanomaterial
• Referenced in Commission’s Guidance document on
the Plastics Regulation
• Includes substances naturally occuring in nano form
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 28
Substances in Nano Form in the US
FDA guidance document issued in June 2014
No regulatory definition of nanotechnology
In the absence of a formal definition, FDA considers:
• Whether material is engineered to have at least one
dimension in the nanoscale range (approximately 1 nm to
100 nm); or
• Whether material is engineered to exhibit properties or
phenomena, including physical or chemical properties or
biological effects, that are attributable to dimension(s), even
if dimensions fall outside nanoscale range (up to one
micrometer).
FDA applies these considerations to all FDA-
regulated products, including food-contact
substances
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 29
Applications of Interest - US
Separate clearances for substances permitted
for use in single service and repeated use
applications
In general, substances permitted in single service
applications also permitted in repeated use
applications; not vice versa
Some substances permitted for use in limited
applications
Section 177.1680 (“Polyurethane resins”) – only
covers contact with bulk quantities of dry food
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 30
Applications of interest in the EU
Traditionally, monomers/additives simply
listed subject to SMLs or other restrictions
• 6dm2/kg food is default surface area to
volume of food assumption (6dm2/3 kg food
for repeated use applications)
Increasing trend of including specific
restrictions on use in listings on PR
• E.g. limitations on type of polymer, oligomer
restrictions for monomers and polymeric
additives
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 31
Applications of interest in the EU (extract
from 5th amendment to PR (Reg 2015/174)
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 32
EU – Plastics Regulation - Functional Barrier
Under Plastics Regulation, functional barrier is
defined as a barrier that prevents detectable
migration of non-listed monomer/additive using
detection limit of 10 ppb (in food)
Migration will depend on
• concentration of uncleared substance in non-food
contact layer
Identity of uncleared substance
Thickness and composition of barrier layer
Functional barrier cannot be relied upon for
nano substances or CMRs
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 33
Functional Barrier in the US
Substances separated from food by barrier that
prevents migration to food are not properly
considered food additives
Not all barriers are functional barriers
Relevant considerations: molecular weight migrant,
thickness, diffusivity of polymer, intended conditions
of use
Examples
Aluminum foil (but not vapor deposited aluminum)
Some PET films (>1 mil at room temp., >2 mils at hot-
filled conditions)
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 34
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 35
Other potential exemptions in US
Exemptions from listing requirement to be
considered in evaluations
• Aside from functional barrier and basic resins
doctrines, also
– Housewares exemption
– “No migration” exemption
– Prior sanction
– Generally Recognized as Safe (GRAS)
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 36
Exemptions in the EU
For monomers and additives used in the
manufacture of plastics, only exemption (unless
there is an absolute barrier to migration) is
functional barrier doctrine
• Except for vinyl chloride monomer
M&A or substances specifically regulated at
Member State level
• Member States may maintain specific requirements
including positive lists
– But mutual recognition applies
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 37
Consumption and food type distribution
factors
Both used by the US –
• Consumption factor (‘CF’): fraction of daily diet
contacted by specific type of packaging
– Default CFs provided in FDA’s Chemistry
Recommendations
– Helps calculate dietary exposure: Migration x CF =
Dietary Exposure
• Food-type distribution factor (fT)
– Developed by FDA for each packaging material to
reflect the fraction of all food contacting each
material that is aqueous, acidic, alcoholic and fatty
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 38
Consumption and food type distribution
factors
Not currently used in the EU, notably as food
consumption patterns are not as homogenous
as in the US
• Matrix database
– provides alternatives to EU 6dm2 surface area to 1kg volume
of food default assumption for certain polymers
• Facet (Flavourings, Additives and food Contact
materials Exposure Tool)
• Neither database yet endorsed by the Commission or
by the EFSA
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 39
Compliance testing
US
• Usually based on gross extraction or solubility
(e.g., total nonvolatile extractives)
• Sensitivity often relatively crude (e.g., 50 ppm
in food)
• Differ from migration tests
EU
• SML/residual limits applicable to individual
substances
• Overall migration limit
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 40
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 41
Comparison of EU and US Systems
European Union United States Safety Standard 1935/2004, Article 3.1a) FFDCA § 402(a), 409(c)
Positive Lists Plastics, limited others All FCM that are “food
additives”
GMP Required Yes – Reg. No. 2023/2006 Yes – 21 CFR § 174.5
Clearance System Dossier;
risk assessment/risk
management functions split
Petition (old)/Notification (now);
risk assessment and
management decisions same
Toxicity
Requirements
Similar to US; thresholds based
on migration levels
Similar to EU; thresholds based
on dietary exposure
Declaration of
Compliance
Required for some harmonized FCM
EU: e.g. Plastics
Some Member States: All other FCM
Not legally required
Customer driven
Enforcement Member States FDA and other federal agencies
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 42
EU vs. US Plastics Regulation
European Union United States Reference Reg. No. 10/2011, as amended 21 CFR Parts 177; FCNs
Listings Monomers Finished polymers
Additives Listed;
Limits typically based on SML
Listed (Part 178, etc.);
Limits based on intended uses
PPAs Some listed on PR (not
required)
Member State requirements
Some listed, may be exempt
from premarket clearance
Aids to
polymerization
Not required to be listed “Basic Resin Doctrine”
(i.e., subsumed within
clearance for polymer)
Compliance Testing Required for OML;
Required for SML if no other
options workable
Similar to testing needed to obtain
clearance
Likely required;
Often gravimetric only;
Ensures FCM similar to what
FDA cleared
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 43
EU vs. US Paper Regulation
European Union United States Reference Reg. No. 1935/2004;
National legislation
BfR Recommendation XXXVI
21 CFR Parts 176; FCNs
Listings Categorized by function Alphabetical and/or
chronological listings; not
categorized by function
Specialized
Applications
National legislation (e.g., NL,
Italy)
German BfR recommendations
for different end uses
Single regulation, limits
embedded in specific clearance
Compliance Testing Set at Member State level
E.g. Same testing requirements
as for plastics in NL
Testing of finished article likely
required; gravimetric extraction
of finished food-contact article;
solvents/temperatures depends
on use
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 44
Other Food-Contact Materials
European Union United States Coatings Limited EU (No. 1895/2005);
MS: e.g. Netherlands, Spain,
Italy, Belgium (soon)
21 CFR § 175.300 (can enamels)
21 CFR § 175.320 (polyolefins)
21 CFR § 177.1630 (polyesters)
FDA regulation permits reaction
among listed substances
Adhesives No EU Specific Measure;
MS: Italy, Spain
21 CFR § 175.105 (adhesives);
§ 175.125 (pressure sensitive)
§ 177.1390/1395 (laminates)
Functional barrier may be
required
Printing Inks DRAFT German regulation;
Swiss ordinance
No specific listing of printing
inks; components must meet
other regulations or be exempt
Offset and transfer must be
considered
FDA is concerned about offset
and transfer (GMP issue)
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 45
Agenda
I. Comparison of regulatory philosophy
II. Focus on plastic food contact materials and
articles (‘M&A’) to illustrate different approach
III. Other relevant considerations in determining
food contact compliance
• Exemptions?
• Compliance testing
IV. Snapshot of regulation of some other M&A
V. Conclusions
│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 46
Conclusion
Different philosophical approach
Need to be fully familiar with requirements in
both jurisdictions
Sometimes, same concepts may be used but
with a different meaning
Need to plan ahead if intending on marketing
M&A in both jurisdictions (e.g. to ensure
compliance testing is sufficient)
www.khlaw.com • www.packaginglaw.com
Thank You!
Hazel O’Keeffe Counsel
Keller and Heckman LLP
Avenue Louise 523
1050 Brussels, Belgium
+ 32 (0) 2 645 5076