George Misko is a Partner at Keller and Heckman LLPGeorge joined Keller and Heckman in 1989. Mr. Misko's practice focuses on food and drug matters and 

environmental concerns, including pesticide regulation, right‐to‐know laws, and toxic substance control regulations. Prior to joining Keller and Heckman, Mr. Misko was Senior Regulatory Counsel for the Chemical Specialty Manufacturers Association (now known as the Consumer Specialty Products Association), where he provided counsel on a broad range of environmental and health and safety issues. He currently writes a monthly column on regulatory issues for Food and Beverage Packagingmagazine.George attended Catholic University of America where he received a B.A. and his J.D.

2009 PLACE Conference April 30, 2009

Columbus, OH

Regulation of Antimicrobialsin Food Packaging – United

States and the European Union

Presented by: George G. Misko, Esq.PartnerKeller and Heckman LLP Copyright © 2009

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• Discussion of FDA Regulation of Food-Contact Materials

• Application to Antimicrobials• Discussion of EU Regulation of

Antimicrobials in Food Contact Materials

Presentation Overview

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Definition of a Food Additive

• A substance which, when used as intended, is reasonably expected to become a component of food, except GRAS and prior sanctioned substances (§ 201(s))

• Food additives must be the subject of a regulation or a food contact notification (§ 409)

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Definition of Food Contact Substance

• Any substance intended for use a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in food (§ 409(h)(g))

• Food Additive and Food Contact Substance definitions are not co-extensive

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Premarket Clearance

FOOD ADDITIVES REQUIRE FDA PREMARKET CLEARANCE

Uncleared Food Additives are Automatically Unsafe and Adulterated

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Three Types of Food Additives

• Direct – Food Ingredients

• Secondary Direct – Added to Food During Processing but Removed

• Indirect – Food Packaging and Other Food Contact Materials

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Definition of an Antimicrobial

Subject to Two Statutory Schemes• FIFRA (Federal Insecticide, Fungicide, and

Rodenticide Act) • FDCA (Food, Drug, and Cosmetic Act)

FIFRA: Defines when registration is requiredFDCA: Defines who regulates safety

• Pesticide Chemical: EPA under Section 408• Pesticide Chemical Residue: EPA Under Section 408• Food additive: FDA under Section 409

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Definition of an Antimicrobial

FIFRA Regulations: Defines pest to excludemicro-organisims on processed food

FDCA excludes as food additives pesticidechemicals (or residues) in RAC’s orprocessed foods

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Jurisdictional Authority over Antimicrobials Used Directly with Food

FDA: Processed food; water used in processing facility

EPA: RACs; water in contact with RAC’s, provided not a food processing facility

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Jurisdictional Authority over Antimicrobials in Food Packaging

FDA: Nonfunctional Additives. Controlsmicroorganisims in equipment andmaterials used in manufacture of foodcontact articles

• Slimicides in papermills• Bacteriostats in latex emulsionsNo intended ongoing effect in the finishedfood contact article

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Jurisdictional Authority over Antimicrobials in Food Packaging

FDA: Material Preservatives. Incorporatedinto finished article to provide ongoingprotection against discoloration,degradation, decomposition.

• No intended effect outside of the article itself• No intended effect on the surface• EPA would call this a “treated article”

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Jurisdictional Authority over Antimicrobials in Food Packaging

FDA: Sanitizing solutions and antimicrobials incorporated into packaging intendedto have an effect on the food orextend the shelf life of the food.

• H2O2 for asceptic packaging• Silver zeolites for packaging films

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Jurisdictional Authority over Antimicrobials in Food Packaging

EPA: Sanitizing solutions used onpermanent/semi-permanent foodcontact surfaces (but not packaging)

Antimicrobials incorporated intopermanent (semi-permanent foodcontact articles intended to have anon-going effect)

• Countertops• Conveyor belts

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FDA Regulation of Antimicrobials as Food Additives

• Direct Additive: Intended, ongoing preservative effect in food

• FAP required• Labeling requirements

• Secondary Direct: Effect on food, but only during processing; no residue in food

• FAP or FCN• No labeling required

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FDA Regulation of Antimicrobialsas Food Additives

Indirect additives: Effect on packagingmaterial itself either during processing orongoing.

• FCN• No labeling• Subject to exemptions applicable to

food contact articles

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Evaluating FDA Status

1. Is it Regulated (Subject of Regulation, Threshold of Regulation, or FCN)?

2. Is an Exemption Available?3. Is FDA Approval –

A. Necessary orB. Desirable for Marketing?

4. Does the Product qualify for –A. Food Contact Notification submissionB. Threshold of RegulationC. Standard Petition Processing

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Food Additive Clearances: Questions to Ask

• Does the regulatory clearance apply to your use?

• Do any limitations on food type exist?

• Do any limitations on temperature exist?

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Exemptions and Exceptions From Food Additive Regulation Requirements

• No Migration

• GRAS

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No Migration

• No migration exemption: A substance not reasonably expected to become a component of food is not a food additive

– Monsanto v. Kennedy: FDA must find a substance migrates into food in more than insignificant amounts to consider it a food additive

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No Migration

No migration –What does “no” mean?

– 50 ppb, sometimes 10 ppb or less

– Modeling or Testing

– Self-determination

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Generally Recognized as Safe (GRAS)

• Pre-1958 use – scientific procedures or experience based on common use in food

• Post-1958 – scientific procedures

• Scientific procedures –published toxicological or other data generated by accepted means

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Generally Recognized as Safe (GRAS)

• Some in Regulations (Parts 182, 184, 186), some not

• Self Determination

• Fluid Concept

• GRAS Notification Procedure

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Even More Exemptions

• Functional Barrier

• Basic Resin

• Housewares

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Food-Contact Notifications

• FCN program replaces petition process for food-contact substances

– Efficient– Proprietary– Effective

• Standard Food Additive Petition can still be required

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FCN Process – Drafting an FCN

Key components of FCN include:• Form 3480 (available at:

(http://www.cfsan.fda.gov/~dms/opa-fcn.html)

• Copies of relevant data/reports• Comprehensive Toxicology Profile• Environmental Assessment (if needed)

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FCN Process – Data Requirements

• General FCN data requirements– Chemical identity/composition of FCS– Manufacturing process– Information on impurities and breakdown

products– Intended conditions of use– Intended technical effect– Migration data and reports

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FCN Process – Data Requirements

• General FCN data requirements (cont’d)

– Estimation of exposure• (Migration) x (food type factors) x (consumption

factor) = EDI• Plus other uses – cumulative estimated dietary

intake (CEDI)– Some CEDI values are posted on FDA’s website:

http://www.cfsan.fda.gov/~dms/opa-edi.html – Can request CEDI values from FDA

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FCN Process – Data Requirements

• General FCN data requirements (cont’d)– To conduct safety assessment, CEDI values

are compared to available toxicity data on the FCS

– Toxicity data requirements (based on CEDI):• ≤0.5 ppb: no toxicity testing required• 0.5 ppb-50 ppb: 2 in vitro genotoxicity tests• 50 ppb-1 ppm: 2 90-day studies plus an in vivo

genotoxicity test• >1 ppm: full 2-year study

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FCN Process – Data Requirements

• General FCN data requirements (cont’d)

– Environmental Assessment is required unlessthe FCN is exempt under an applicable categorical exclusion, e.g.:

• <5% by weight of the finished article• Repeated-use articles• Food-contact coatings• Substances already registered as pesticides under

FIFRA

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FCN Process – “Me Too” FCNs

• FCNs are proprietary to the notifier, but others are not prohibited from filing an FCN for the same FCS

• “Me too” FCNs often require less data– Obtain original FCN through FOIA– Can often cross-reference technical effect, migration,

and toxicology data contained in original FCN– Must supply information on manufacturing process,

impurities, specifications, etc.

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Regulation of Antimicrobials for Food Packaging in the EU

Basics: Only Plastics are subject to harmonized laws.

• Additives for Plastics in process of harmonization

• Paper, other packaging materials subject to Member country laws

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Regulation of Antimicrobials in Plastic/Packaging in the EU

Nonfunctional additive: Processing orproduct aids. No ongoing effect in finishedarticle.

• Preservative in latex emulsions• Subject to Plastics Directive• Must be on positive list for plastics

additives

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Regulation of Antimicrobial in Plastic Packaging in the EU

Surface biocides: Material preservativesintended to protect food hygiene

• No preservative effect in food, per se, but ongoing effect in packaging

• No authorization criteria yet accepted• If agreed upon, likely to require labeling

and efficacy data to approve• Subject to active packaging requirements

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Regulation of Antimicrobials in Plastic Packaging in the EU

Surface Biocides: Antimicrobial in packaging intended to act as apreservative in food.

• Must be approved for direct addition to food

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Thank YouPRESENTED BY

George G. Misko, Esq.PartnerKeller and Heckman LLCmisko@khlaw.com

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