Jung Han. Innovations in Food Packaging

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468

Innovations in Food Packaging

water-resistant corrugated fiberboard shipping cases (hence the name "boxed" beef)

for shipment to foodservice operations. By the mid-1970s, this process had been suc-

cessfully introduced to retail supermarkets, thus reducing the number of butchers

required to serve consumer-size cuts, and subsequent packaging.

Processed meats

During the early 1950s, vacuum packaging of cured meats such as frankfbrters, hams,

ham slices, bologna, etc. was developed using nylon-based thermofonning webs of flex-

ible oxygen-barrier materials. The processed meat was placed within the formed web

and heat-sealed with a second gas-barrier material while drawing a vacuum or, later,

back-flushing with inert gas. This concept was later applied to employ carbon dioxide

flushing to displace oxygen and to prolong the quality retention of aged cheese.

Bakery

goods

In the mid-1 960s, the British Flour Milling and Bakery Research Association investi-

gated the use of elevated carbon dioxide to retard mold growth on the surfaces of per-

ishable bakery products. After the late 1970s, when the West German Government

instituted a regulation to declare all food additives on the package label, many com-

mercial bread bakers opted for air-sealed barrier packages containing elevated carbon

dioxide and reduced oxygen to permit the desired shelf life of preservative-free prod-

ucts. In the mid-1980s, the principles were applied to meat-filled sandwiches in both

the United States and Canada. Those sandwiches containing cured meat fillings, e.g.

sausage, retained their quality under modified atmospheres for many weeks (at chilled

temperatures), stimulating a small, but solid and growing, product niche. Instructions

to consumers are given to heat the product before eating, which is a simple process

that partially overcomes the staling effects

the bakery product over long storage.

Retail

red meat

During the 1960s, investigations by Kalle, a German plastic film converter, demon-

strated that fresh red meat could be preserved under refrigeration with its desirable

"cherry red" oxymyoglobin color if a high carbon dioxidelhigh oxygen environment

were present. The presence of high oxygen levels was contrary to normal practice

because common belief had been that high oxygen accelerates microbial growth, res-

piration, and fat oxidation. Elevated carbon dioxide was shown to be sufficiently

effective in retarding microbial growth, and so the adverse oxidative effects of the

high oxygen could be compensated. These findings were put into practice in West

Germany, where thermoform/vacuum/gas flush-seal packaging systems with high

oxygen-barrier materials were employed.

Pasta

During the 1980s, a small New York store initiated the integration of excellent sanitation

of both ingredients and process plus modified atmosphere within sealed plastic packages

to enable it to distribute 30% moisture pasta under chilled conditions. These measures

Commercial uses of active food packaging and modified atmosphere packaging systems

469

permitted prolongation of safe quality up to

days. More importantly, this concept

encouraged others to apply the principles for entrees, side dishes and meatlfish salads.

Red

meat

Of the

39 000

million pounds of red meat produced in the US annually, approximately

63%

is beef,

36%

is pork, and the remainder is lamb, veal, etc. About two-thirds ofAmerican

pork enters further processing (to form cured meats such as hams, bacon, and sausages).

Only

12%

of beef is processed further. Of the

21 000

million pounds of beef that is not

processed further, approximately

40%

(or

8500

million pounds) becomes ground beef.

Therefore, about

500M000

million pounds of beef cuts are generated, and overwhelm-

ingly cut and packaged at retail grocery level. Most of this beef is cut and air-packaged

in the supermarket backroom, employing expanded polystyrene trays with plasticized

PVC

flexible-film ovenvrap plus paper labels.

addition, nearly

5000

million pounds of

ground beef is marketed through retail stores, largely in expanded polystyrene trays with

PVC

wraps. Almost

all

ofthis ground beef is coarsely ground at federal government-regulated

factory level. It is distributed under low-oxygen conditions, packaged in flexible barrier-

liner chub casings, and sent under refrigeration to retail stores, where final grinding and

retail packaging occurs. Almost

500

million pounds of beef is finely ground in factories

into barrier-film chub packaging, also under low-oxygen conditions, for retail sale.

Table

25.5

depicts the current case-ready red meat situation

about

2000

million

package units out of nearly

9000

million total fresh red meat packages, or slightly more

than

20%

market share in

2003.

It incorporates the data of chub packages of ground beef,

sub-primal cut pouches sold at retail, and expanded polystyrene trays overwrapped

with

PVC

film that have been packaged at a remote location but are distributed with

no special secondary packaging. To date, a relatively small proportion of intact muscle

beef cuts have converted into case-ready, and these are found largely at Wal-Mart

Super Center outlets.

Perhaps up to

100

million pounds annually from all the major pork packers, or

about

of the total, is centrally packaged, including master packaged and vacuum

packaged, some with added antioxidants.

Table

25.5

Case-ready

meat

packaging

units (million

packages,

2003)

Barrier trays

elevated own

Expanded polystyrene-barrier 185

Solid plastic 955

Ovetwrap trays

with mastetpack

Expanded polystyrene 630

Overwrap trays

no masterpack

700

New technology

Vacuum/reduced oxygen

Chubs 300

Pouches for subprimals

Total 2880

Source: Brody and Bieler (2001).

Case Ready Meat Packaging.

Packaging Strategies. Reproduced with

permission (see www.packstrat.com).

470

Innovations

FooA packaginp

Poultry

It is remarkable that case-ready red meat technology has effectively transferred to the

centralized packaging of poultry. Nearly one-third of the rapidly expanding US poul-

try market

which now exceeds beef

is centrally prepackaged and branded. Until

the early 1980s, nearly all poultry products were dressed whole birds packaged in ice

in wire-bound wood crates. In the retail store backroom, poultry were removed from

the ice by the butcher, cut, and repackaged in expanded polystyrene trays with plasti-

cized PVC film overwrap, before adding an adhesive store label. As a result of the

introduction of chill pack followed by MAP in master packs, the concept of "shelf-

ready" poultry emerged, where the retailer removes the factory prepackaged poultry

from the master pack and places it on the shelf. Today, 2000 million pounds of poul-

try are master packed, about half of them are under modified atmosphere in the PVC

film-wrapped expanded polystyrene trays.

Precooked and fresh-ground poultry represents a 200+ million pound market, and

20% of this is packaged on

thermoform/vacuum/back-gas

flush machines such as

Multivac or Tiromat, using barrier expanded polystyrenelethylene vinyl alcohol film-

laminated trays with heat-sealed flexible lids. Most of the remainder is packaged in

conventional expanded polystyrene trays overwrapped with co-extruded barrier film

on horizontal flow wrapping equipment. The internal atmosphere for precooked poul-

try is high carbon dioxide, or high oxygenlcarbon dioxide for fresh ground poultry, to

retard microbial growth and retain red color. Partly as a result of employing central-

ized

MAP

coupled with controlled distribution and modern marketing, poultry has

overtaken red meat as the animal protein source of choice.

Fish

Per capita consumption of seafood remains low at close to 14 pounds, with relatively

limited prospects for major growth in the near future. Owing to concerns about the

potential growth of pathogenic anaerobes such as type

Clostridium botulinum,

which can grow and produce toxin at low temperatures, regulatory officials have dis-

couraged reduced oxygen packaging of fish. Some seafood products are vacuum skin

packaged and frozen for retail slackout, which gains some of the benefits of low-oxygen

packaging and somewhat skirts the regulations.

Fruits

and

vegetables

The strongest growth segment for

MAP

from the 1990s through 2003 has been fresh-

cut produce, also regarded as the fastest-growing food product category in the country.

Starting in the mid-1980s with vacuum packaging of fresh-cut lettuce for use by quick

foodservice chains in their penetration into the salad market, expansion has continued

into the US retail market, with $4 billion retail value in 2003

representing nearly

10% of fresh produce sales. The foodservice market is valued at about $10 US billion.

The major product within the category, with about two-thirds of the volume, is fresh-

cut lettuce valued at $2.4 US billion, with up to 15% of the produce

some form of pack-

aging under

MAP.

Other important products include broccoli and cauliflower florets,

diced onions, baby carrots, sliced peppers, and a series of fresh-cut vegetables packed

with meat, pasta, croutons, salad dressing, etc. to create a complete salad-based meal.

Commercial uses of active food packaging anA iodified atmosphere packaging system<

A71

From a technological perspective, most fresh-cut produce is cut, cleaned, and cooled

using chlorinated water. It is packaged on vertical form-fill-seal machines for retail

distribution, and on preformed bag fillers such as CVP Systems or M-Tek for food-

service distribution. Relatively little is packaged with gas mixtures, but the bag systems

evacuate the air so that the product contents consume the residual oxygen and produce

carbon dioxide. Anaerobic respiration is minimized by employing high surface-to-

volume ratio pouches in the case of bulk packages, and high gas permeability plastics

for both bulk and retail size pouches. Gas permeabilities are around

3000

is axiomatic that the materials have low water vapor permeabilities and that generally,

for the retail sizes, antifog agents are incorporated in the film to permit visibility.

One major category of MAP produce is pallet wrapping of prepackaged strawber-

ries in both Florida and California. In the latter, almost all of the produce exported

from the state, either to other states or to other countries, is shrouded in high-density

ethylene vinyl acetatelpolyethylene film, evacuated to give a vacuum, and the air

replaced by a mixture of carbon dioxide and nitrogen to suppress mold growth. Probably

as many as

100000

pallets annually are treated to effect the modified atmosphere

condition within the pallet wrap.

For bulk packs, mono-layer high-density ethylene vinyl acetate films are often

employed, although CVP Systems uses co-extrusion to achieve its requirement of gas

permeabilities. For consumer packs, laminations of styrene block copolymer and

metallocene-based low-density polyethylene, or polypropylene plus metallocene-

based polyethylene, are used. The California packer Fresh Western uses FreshHold

mineral-filled polypropylene over large orifices in the polyethylene film substrate to

achieve high oxygen permeation. Increasingly, co-extrusions incorporating metallocene

polythylenes are being applied to gain some economies.

Cut pineapple is largely packaged with high carbon dioxide levels, vacuum pack-

aging, or in air followed by passive equilibrium atmosphere. Cut melons (which are

low acid), table grapes, and fresh-cut apples can be treated with chemical antioxidants

such as ascorbic acid to retard browning. Modified atmosphere packaging has been

tested with almost every fruit consumed as convenience snacks, such as strawberries,

peaches, and pears. Almost

$250

million worth of MAP fruits were retailed in

2003.

Soft

bakery

goods

Breads, rolls, cakes, and muffins are subject to rapid quality loss, with the most preva-

lent deteriorative vectors being moisture loss, staling, and mold growth. Staling

is a partially reversible crystallization of starch leading to texture hardening.

Microbiological deterioration in soft bakery goods is mostly mold growth on surface

and crumb. Moisture loss can be retarded by packaging in low water-vapor perme-

ability materials, such as low-density polyethylene film. Use of such materials retains

water vapor within the package, but can create conditions optimal for mold growth.

Extending the shelf life of soft bakery products can:

Reduce the number and percentage of returned goods

Extend the distribution range of bakery goods

472

Innovations in Food Packaging

Reduce the frequency of delivery

Permit a bakery to produce a broader range of products.

Reduction of oxygen and its replacement with an inert atmosphere is ineffective

unless the oxygen content of the internal atmosphere is reduced to below

1%.

The

most common reduced-oxygen packaging system for bakery goods uses horizontal

form-fill-seal with PVdC-coated oriented polypropylene film in a single web. This

bakery packaging system requires extensive gas flushing while forming and sealing

the flexible pouch. The system is used for relatively simple breads, such as German

rye meal. In vacuum-packaging systems, twin-web thermoform-vacuum/gas flush-

seal systems require more expensive packaging materials and equipment

than

horizontal

fill-seal systems, but deliver better seals. Multivac and Tiromat thermofodvac-

uum/gas flush-seal equipment is used for

MAP

of specialty goods such as crumpets.

interesting

MAP

product concept is brown-and-serve French bread. The commercial

baker partially bakes the loaves and places them into a thermoformed plastic cavity on

a thermoform/vacuum/gas flush-seal machine. While still hot, and expelling the carbon

dioxide of baking, the packages are closed and cooled. The carbon dioxide-saturated

packages a shelf life of over

months at ambient temperature. The consumer then

places the loaf in a conventional oven, where a brown crust is developed and the

crumb remoisturized. The result is comparable to

freshly baked French baguette.

In Canada, crumpets (similar to English muffins) are modified atmosphere packaged

on thermoform/vacuum/gas flush-seal equipment, with carbon dioxide back-flushed,

on a commercial scale. Sandwiches are packaged under vacuum using similar sys-

tems, but the sandwiches are distributed under refrigeration to preserve the fillings.

Several American companies are packaging sandwiches for refrigerated distribu-

tion on a regional basis. These products may appear in cured meat or special refrigerated

displays, with or without expiration dates. Perhaps the most widely commercialized

applications are the little-known MAP of sausage and biscuits, and of precooked ham-

burgers. About 90 days of actual refrigerated shelf life is achieved by MAP on Multivac

thermoform/vacuum/gas flush-seal equipment, with a target expiration date of about

days. Since sausage is cured meat, problems of microbiological safety are mini-

mized. The instruction to the consumer to heat the product drives moisture from the meat

into the biscuit to refresh it. All such products are nationally distributed in the US.

Prepared foods

The arena of prepared foods under

MAP

is led by the very successful high-moisture

pastas that are now packaged, with pasta sauces, under reduced oxygen by virtue of

hot filling. Probably

$1.5

US billion worth of such products are in widespread chilled

distribution, but after significant growth over several years the category appears to

have reached maturity. The three major technologies employed include oxygen

replacement, in which nitrogen is the sole gas injected after evacuation. This system,

used by Kraft for its DiGiorno brand pastas, also incorporates internal oxygen scav-

enger sachets affixed to the interior of the bottom tray to remove residual oxygen. This

system claims 90 days of actual shelf life under refrigeration.

Commercial uses of active food packaging and modified atmosphere packaging systems

473

The second system, used by most producers, is displacement of the internal envi-

ronmental oxygen with a mixture of at least

25%

carbon dioxide plus nitrogen with no

further active packaging. This system is claimed to be microbial-satisfactory for up to

90 days of refrigerated shelf life. All systems rely on the sanitation of the initial prod-

uct, process, and packaging, with chilling. They further integrate product formulation

to ensure a sufficiently low water activity to minimize the likelihood of the growth of

pathogenic anaerobic micro-organisms. This product category is one of several in

which natural antimicrobials and/or natural antioxidants are incorporated into the for-

mulation to complement the basic food preservation actions.

The third system, applied to the sauces, is hot filling, in which the condensation of

steam generates a vacuum that inhibits aerobic spoilage micro-organisms together

with the heat and subsequent refrigerated distribution.

Most pasta is packaged on thermoform/vacuumlgas flush-seal machines such as

Multivac or Tiromat, using semi-rigid PVC as the thermoformed web and a lamina-

tion of polyesterPVdC and polyethylene as the flat sealing web. The pasta sauces are

usually in polypropylene tubs with flexible polypropylene heat-seal closures. Some

pasta sauces, as well as many other soups and pumpable foods, are packaged in flexi-

ble barrier pouches fabricated from the structures of polyester and/or nylon plus lin-

ear low-density polyethylene. These pouches may be distributed in paperboard sleeves

to help protect them

from

abuse and damage. Beyond pasta and pasta sauces, a con-

servative estimate would place the size of the prepared foods

MAP

market at well over

100 million units and growing at more than 9% annual rate.

Another category for prepared foods under reduced oxygen and chilled distribution

is cook-chill bulk packaging for pumpable foods such as pasta sauces, soups, and

chili. The product is packaged hot into nylon/polyethylene pouches capable of hold-

ing about one gallon. The hot packaged product is immediately chilled in cold water

and distributed at temperatures of about 0°C to satellite foodservice outlets for reheat-

ing and serving. This 10+ million unit market is technologically very similar to the

sous-vide. Most cook-chill is made and applied internally by mass feeding operations

and central commissaries, and so is under a single control throughout its short distri-

bution cycle. Retail consumers almost never see or are exposed to cook-chill pouches

of food, and so specific rules governing this technology alone are not in effect.

Related to cook-chill technology, there are products that are inserted into high

oxygen-barrier pouches, sealed, cooked to pasteurization temperatures, chilled, and

subsequently distributed under chilled conditions to the many delicatessen operations.

These products are effectively vacuum packaged, and must be chilled to ensure micro-

bial safety and retail quality. This product category includes roast beef, turkey, and

similar solid pack products in which cooking and pasteurization are effected by the

same cook cycle.

More than 90% of the beef in the United States is shipped from meat packers to

retailers and foodservice operations in the form of vacuum-packaged primal cuts.

About half of all fresh poultry in North America is master packed in bulk under mod-

ified atmospheres for distribution to retail grocery and foodservice outlets.

growing

retail category is precooked poultry packaged under modified atmosphere or vacuum,

and marinated and precooked poultry packaged under vacuum. Virtually all cured or

474

Innovations

Food Packaging

processed meat and cured cheese products in retail distribution are packaged under

either vacuum or inert (i.e. nitrogen) atmospheres. Most cured and cooked meats for

in-store delicatessens are vacuum or inert atmosphere packaged. Twenty percent of all

lettuce and more than 80% of all California strawberries are distributed under modi-

fied atmosphere conditions. About one-third of all retail supermarkets display case-

ready fresh beef, mostly ground beef. Sausage and biscuits, sandwiches, and lunch kits

are atmosphere packaged. Fresh pasta is distributed under

MAP.

The spectrum of vacuum

packaging, CAP, and MAP extends from fresh red meat through precooked meals and

embraces most of the categories of perishable and minimally processed products cur-

rently in the food chain.

The magnitude of the MAP food market is approaching 10000 million package

units, containing nearly 100000 million pounds of food contained. The growth is

5-10% annually. The most significant

MAP

items in North America are fresh-cut veg-

etables, 30% moisture pasta, sausage and biscuits, lunch kits, and precooked poultry.

Further reading

Anonymous (1988).

Modijied Atmosphere Packaging: The Quiet Revolution Begins.

Packaging Strategies, West Chester, PA.

Anonymous (1990).

Modijied Atmosphere Packaging.

Food Development Division,

Agriculture Canada, Ottawa, Canada.

Brody, A.

(1989).

Controlled/Modijied AtmosphereNacuum Packaging of Foods.

Food

Nutrition Press, Trumbull, CA.

Brody,

(1995).

In:

Proceedings of the MA Pack Leading Edge Conference on

Modijied Atmosphere Packaging of Foods.

Institute of Packaging Professionals,

Herndon, VA.

Brody,

L. (1997). A Vision of Packaging for the 21st Century. Paper presented at the

Refrigemted Foods Association Annual Meeting,

Orlando, FL.

Brody, A.

(1997). The impact of minimally processed

and oRen minimally packaged

foods on packaging.

In:

Proceedings of Packaging Strategies Conference.

Atlanta, GA.

Brody,

(2002).

Active Packaging Beyond Barriers.

BRGTownsend, Inc., Mt Olive, NJ.

Brody, A.

L.,

and Bieler, A. (2001).

Case-Ready Meat Packaging.

Packaging Strategies,

West Chester, PA.

Brody, A.

and Shepherd,

(1987).

Controlled/Modijied Atmosphere Packaging: An

Emergent Food Marketing Revolution.

Scotland Business Research, Princeton, NJ.

Blakistone, B. (1998).

Principles and Applications of MAP of Food,

2nd edn. Blackie,

Glasgow,

UK.

Delaney, C. (2003).

Retail Fresh-Cut Produce Sales Approaching

Billion a Yeal:

Fresh

Cut, November.

Food and Drug

Administration

approach to regulating

intelligent and active

packaging components

Yoon S. Song and

Mark

Hepp

Introduction

.................................

The food additive petition process

................

Food contact substance notifications

.............

...

Special considerations for antimicrobial food additives

.........

Other active or intelligent packaging materials

....................................

Conclusions

Introduction

Items manufactured for use in contact with food in the US, whether for home or com-

mercial use, fall under the jurisdiction of the Federal Food, Drug, and Cosmetic Act

(FFDCA, Title 21 United States Code

348)

whenever they are intended to be marketed

in interstate commerce. Section 201(s) of the FFDCA provides a definition for the term

"food additive" that includes components of food-contact articles like packaging mate-

rials whenever they migrate (or are reasonably expected to migrate) to food as a result

of their intended use, or if they otherwise affect the characteristics of food. Generally,

food-packaging materials are not intended to have any technical effect in the food, and

are considered food additives because their components cin migrate to the food that

contacts the packaging. In the case of active packaging, however, sometimes the package

Innovations in Food Packaging

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476

Innovations in Food Packaging

may be designed to deliver a chemical to the food for the purpose of exerting some effect

in the food.

The food additive provisions of the FFDCA provide a fi-amework to ensure the safe

use of all chemicals that fall within the scope the food additive definition. These food

additive provisions became law in 1958, and may be found mostly in section 409 of the

FFDCA. The Food and Drug Administration (FDA) administers the main part of the

FFDCA, including section 409. The FDA's administration of the food additive provi-

sions of the FFDCA focuses mainly on reviewing the proposed uses and safety infor-

mation relating to new food additives and, once a safety determination has been made,

writing regulations, or allowing food contact notifications to become effective that stip-

ulate conditions of safe use for the new food additive. The FFDCA also provides a

standard of safety and a standard of review to which FDA must adhere.

In addition to the definition of a food additive in section 20 1 (s), other important pro-

visions of the FFDCA that relate to the regulation of food packaging materials include:

Section 409(a), which provides that the use of a food additive is unsafe unless that

use conforms to a food additive regulation, a food contact substance notification,

or an exemption (consequently, all uses of food additives are deemed to be unsafe

until FDA has completed a review on the safety of its use)

Section 402, Adulterated Food, which provides that a food is adulterated if it is (or

if it contains) any food additive that is unsafe

Section 301, Prohibited Acts, which prohibits the introduction or delivery into

interstate commerce of any food that is adulterated or misbranded.

Together, these sections of the FFDCA provide a mechanism for FDA to take enforce-

ment action against unsafe food additive products in the marketplace.

Although the definition of the term "food additive" broadly includes any substance

that is reasonably expected to result, directly or indirectly, in its becoming a component

of (or otherwise affecting) the characteristics of any food, the definition also provides

exceptions to that term. For example, substances that are generally recognized as safe

(GRAS) do not fall within the scope of that definition. Substances that are GRAS are

those that are generally recognized, among experts qualified in scientific training and

experience to evaluate their safety, as having been shown through scientific proce-

dures (or in the case of a substance used in food prior to 1 January 1958, through

either scientific procedures or experience based on common use in food) to be safe under

the conditions of its intended use. Section 201(s) also excludes pesticide chemicals, pes-

ticide chemical residues, color additives, substances approved for use prior to 1958, new

animal drugs, and dietary supplements from the food additive definition. Although

such substances may become components of food, they are regulated under provisions

of the FFDCA other than section 409.

The FDA generally classifies food additives by whether or not they have an

intended technical effect in food. Federal food additive regulations are listed in Parts

170 through 189 of Title 2 1 Code of Federal Regulations (CFR) (Government Printing

Office, Pittsburgh, 2004). Direct food additives are substances that are added directly to

the food and have

intended technical effect in the food. They usually result in higher

Food and Drug Administration

477

exposures and require more safety data to arrive at a safety determination. Examples

of direct food additives include preservatives for food, high-intensity sweeteners, and

flavoring agents, to name just a few. Direct food additive approvals are obtained

through a food additive petition process, and result in a food additive regulation.

Indirect food additives are those substances that are components of food contact sub-

stances, like food packaging, and may migrate to food, but they have no intended tech-

nical effect in the food. The indirect food additive regulations contain listings for

substances that may be used in the manufacture of packaging, including Part 175

(Adhesives and Components of Coatings), Part 176 (Paper and Paperboard Components),

Part 177 (Polymers), and Part 178 (Adjuvants Production Aids and Sanitizers). Part 179

contains regulations governing the safe use of radiation in the production, processing,

and handling of food, including components of packaging that may be irradiated inci-

dental to the irradiation of prepackaged food. Indirect food additives generally result

in much lower exposures, and a safety determination is usually based upon much sim-

pler data packages. The food contact substance approval is obtained through a food-

contact notification process. Section 409 describes both the petition process and the food

contact notification processes.

The

food additive petition process

Section 409 of the FFDCA provides that any person may petition the FDA to issue a

regulation prescribing the conditions under which a new food additive may be safely

used. Such a petition should contain information relating to the safety of such use,

including an unambiguous chemical identity of the proposed new additive, its impu-

rities and contaminants, a clear description of the proposed conditions of use, and data

relating to its technical effect. The statement of use should include enough detail to

estimate

a probable human exposure to the additive, and its impurities. The probable

human exposure to chemicals migrating from food-contact substances is often esti-

mated using the results of migration studies of the additive into food simulation solvents.

Data relating to the technical effect are used to determine the minimum amount of the

additive that is required to accomplish the intended technical effect either in the food,

the food-contact substance in the case of an indirect food additive. These data are

used to ensure that the human exposure to the food additive is not more

than

is necessary.

Food additive petitions also contain an analytical method for

quantifying

the addi-

tive (such methods can be used for enforcement purposes), and complete reports relat-

ing to the safety of the proposed use of the additive. Such reports generally include

relevant toxicological testing studies on the additive and its impurities. Information on

the manufacturing methods used to produce the additive is also provided so that the

FDA may anticipate possible contaminants or impurities in the additive.

Section 409 of the FFDCA also has provisions relating to the FDA's required

actions on the petition. The FDA is required to complete its review of a food additive

petition within 180 days, and must at that time either establish a regulation stipulating

conditions of safe use for the new food additive, or deny the petition. The FDA may