Packaging Compliance/Requirements in the EU and the US ... · Non-Intentionally Added Substances (=NIAS) defined in Plastics Regulation as “an impurity in the substances used or

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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

[email protected]

│ 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


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


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


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


Agenda






• Exemptions?



V. Conclusions


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


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


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


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


Agenda






• Exemptions?



V. Conclusions


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


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


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


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


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


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


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


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


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


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


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


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)


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


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


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


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


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


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


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


Applications of interest in the EU (extract

from 5th amendment to PR (Reg 2015/174)


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


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)


Agenda






• Exemptions?



V. Conclusions


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)


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


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


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


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


Agenda






• Exemptions?



V. Conclusions


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


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


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


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)


Agenda






• Exemptions?



V. Conclusions


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

[email protected]

Documents

Packaging Compliance/Requirements in the EU and the US ... · Non-Intentionally Added Substances (=NIAS) defined in Plastics Regulation as “an impurity in the substances used or