Yam, Kit L. (ed.). The Wiley encyclopedia of packaging technology

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Multiplying the tolerant limit and product weight to

obtain

Maximum allowable O

¼ð5  10

6

Þð100Þ¼5  10

4

which is the amount of O

allowed to enter into the

package before the product becomes unacceptable. Be-

cause the molecular weight of O

= 32 and 1 g mole of

= 22400 cc, the unit of maximum allowable value may

be converted from weight to volume

Maximum allowable O

¼ð5 10

4

Þð22400Þ=32

¼0:35 cc

may be assumed to be zero since the product is

vacuum packed. P

may be assumed to be 0.21 atm, the

normal partial pressure of O

in air. Therefore, the shelf

life may be estimated by Equation (3) as

2; max

PA P

 P

ðÞ

0:35ðÞ10ðÞ

0:12=100ðÞ80ðÞ0:21 0ðÞ

¼174 days:

REFERENCES

1. D.S. Lee, K.L. Yam, and L. Piergiovanni, Food Packaging

Science and Technology, CRC Press, Boca Raton, 2008, pp.

85–86.

ETHYLENE–VINYL ALCOHOL COPOLYMERS

RONALD H. FOSTER

EVAL Americas, Houston,

Texas

Ethylene–vinyl alcohol copolymers are hydrolyzed copoly-

mers of ethylene and vinyl alcohol. The polymer poly(vinyl

alcohol) has exceptionally high barrier properties to var-

ious gases, solvents, and chemicals, but it is water-soluble

and difﬁcult to process. By copolymerizing vinyl alcohol

with ethylene, the high barrier properties are retained

and improvements are achieved in moisture resistance

(EVOH is not water-soluble) and processability.

The resulting EVOH copolymer has the following mo-

lecular structure:

(CH

)

(CH

CH)

Ethylene unit Vinyl alcohol unit

There are currently two global suppliers of EVOH copoly-

mers. Kuraray Company Ltd. (EVALt resins) and Nippon

Gohsei (Soarnol resins) are both Japanese companies with

manufacturing facilities in Japan, Europe, and the United

States. Chang Chun Group of Taipei, Taiwan has recently

announced the startup of an EVOH production facility in

Taiwan and is reportedly in the process of providing initial

product samples to the market. Manufacturing capacity

for EVOH resins worldwide is approximately 220 million

lb annually. Table 1 lists the range of EVOH resins

available.

EVOH copolymer resins ﬁrst became commercially

available in 1972 in Japan. However, widespread use of

these resins did not occur until 1983 when U.S. food

producers started using the resin for all-plastic, squeez-

able bottles.

The primary use of these resins is still food packaging,

where the excellent gas-barrier properties are utilized to

prevent oxygen degradation of food products. This has

ultimately led to the replacement of many metal and glass

food packages with the beneﬁt of reduced weight and

improved ease of use. In addition, usage has broadened

due to EVOH’s superior resistance to solvents, chemicals,

and hydrocarbons, expanding into nonpackaging indus-

trial applications such as the agricultural chemical, auto-

motive, appliance, and protective-clothing areas.

EVOH copolymers are highly crystalline in nature, and

their properties are dependent on the relative concentra-

tion of the comonomers. Figure 1 shows the relationship

between comonomer concentration and moisture and gas

transmission barrier properties, and Figure 2 shows the

relationship between relative humidity and oxygen trans-

mission rate.

It is this combination of exceptional barrier properties

that permit the use of thin layers of these materials in

multilayer packaging and nonpackaging structures.

Table 1. Range of EVOH Resins

Property Range

Melt index (g/10 min) 0.7–20

Density (g/mL) 1.12–1.22

Ethylene content (mol%) 24–48

Melting point (1C) 156–196

Figure 1. Comonomer concentration vs barrier properties.

418 ETHYLENE–VINYL ALCOHOL COPOLYMERS

EVOH COPOLYMER PROPERTIES

The general characteristics of EVOH copolymer resins are

discussed in the following paragraphs.

Gas-Barrier Properties

EVOH resins are best known for their outstanding barrier

to the permeation of gases such as oxygen, carbon dioxide,

nitrogen, and helium. The use of EVOH copolymers in a

packaging structure enhances ﬂavor and quality retention

by preventing oxygen from penetrating the package. For

packages utilizing modiﬁed-atmosphere packaging (MAP)

technology, EVOH resins effectively retain the carbon

dioxide, oxygen, or nitrogen used to enhance the product.

(See also Barrier polymers.)

Table 2 compares the gas transmission properties of

EVOH copolymers with other commonly used packaging

materials.

Hydrocarbon and Solvent Resistance

EVOH resins have a very high resistance to hydrocarbons

and organic solvents. The weight-percent (wt%) increase

in EVOH resins after immersion for 1 year at 201Cin

various solvents is 0% for solvents such as cyclohexane,

xylene, petroleum ether, benzene, and acetone; 2.3% for

ethanol; and 12.2% for methanol.

Table 3 shows the performance of protective gloves

containing an EVOH layer, and Table 4 reﬂects the

resistance of EVOH to various fuels. These properties

make EVOH resins an excellent choice for the packaging

of oily foods, edible oils, agriculture pesticides, organic

solvents, and other industrial applications.

Flavor, Fragrance, and Odor Protection

Protecting food products has become increasingly impor-

tant, especially with the current trend away from product

additives and the move toward smaller portion-size packa-

ging. Protection can mean different things in different

situations. One of the areas receiving increased attention

in food packaging is the ﬂavor–aroma barrier (see Aroma

Barrier Testing).

The food industry is becoming increasingly aware of the

importance of ﬂavor barriers in containing natural ﬂavors

and preventing extraneous ﬂavors from contaminating

the product. Some food products are notorious for their

ability to absorb extraneous ﬂavor or aromas. Another

important ﬂavor consideration is commonly called ‘‘ﬂavor

scalping,’’ in which some plastics, such as polyoleﬁns,

selectively absorb certain ﬂavor constituents from the

product.

EVOH resins provide excellent protection to the migra-

tion of ﬂavors and the absorption of

D-limonine, which is

the primary ﬂavor constituent in citrus juices, as can be

seen in Table 5 and Figure 3.

Where food products are concerned, aroma barrier is

somewhat analogous to ﬂavor barrier. Food products must

be protected from outside aromas in the distribution

chain, grocery store, and home. Other food and nonfood

products such as garlic, agricultural chemicals, pesticides,

insecticides, or perfumes can be highly aromatic. In this

Figure 2. Oxygen transmission rate versus relative humidity.

Table 2. Gas Transmission Rate

(mL mil)/(100 in.

24 h atm) (mL 25 mm)/(m

24 h atm)

He O

32 mol% EVOH 0.02 0.002 0.06 18.8 0.31 0.03 1.0 291.2

38 mol% EVOH 0.03 0.005 0.15 22.0 0.39 0.08 2.3 341.3

44 mol% EVOH 0.08 0.008 0.23 25.3 1.2 0.12 3.5 391.5

PVDC 0.15 0.01 1.1 27.3 2.3 0.19 17.4 423.2

Oriented nylon 3.6 1.4 13.2 232.0 55.2 21.7 205.2 3596

Oriented PET 4.6 0.46 19.6 180.0 71.3 7.1 303.8 2790

At 231C (731F), 65% rh.

ETHYLENE–VINYL ALCOHOL COPOLYMERS 419

case, the desire is to retain the aroma in the package and

not let it escape into the surrounding environment.

As shown in Table 6, EVOH can provide protection to

aroma migration.

Mechanical and Optical Properties

Although not intended for use as structural resins, EVOH

resins have high mechanical strength, elasticity, and sur-

face hardness, and excellent weatherability. These ﬁlms

are highly antistatic in nature, preventing the buildup of

dust and/or static charges. EVOH ﬁlms have a very high

gloss and low haze, resulting in outstanding clarity char-

acteristics. Table 7 compares the mechanical and other

properties of EVOH resins.

Processability

EVOH resins are thermoplastic polymers easily processed

on conventional fabrication equipment without special

modiﬁcations. Using commercially available equipment,

EVOH resins, in conjunction with other resins, are suita-

ble for use in the following processes:

. Blow ﬁlm

. Cast ﬁlm

. Sheet extrusion

. Blow molding

. Proﬁle extrusion

. Extrusion coating

Table 3. Protective Glove Performance

Chemical or Solvent Time Chemical or Solvent Time

Acetone 1440 MMA 1440

Acetonitrile 1440 MEK 1440

Aniline 1440 Methylene chloride 1440

Benzene 1440 Nitrobenezene 1440

Carbon disulﬁde 1440 Sodium hydroxide 1440

Chloroform 1440 Styrene 1440

Diethylamine 60 Sulfuric acid 93% 1440

DMF 1440 Tetrachloroethylene 1440

Ethyl acetate 1440 Toluene 1440

n-Hexane 1440 Trichlorethylene 1440

Methanol 1440 Xylene 1440

Breakthrough time in minutes (1440 min = 24 h).

Source: Evaluated by ASTM F739.

Table 4. Resistance to Fuels

[(g mil)/(100 in.

24 h atm) at 401C]

Fuel or Component 32% EVOH 27% EVOH Nylon HDPE

REF Fuel C 0.0009 0.0008 0.015 208

CM15 0.61 0.46 5.0 168

MTBE15 0.0007 0.0006 0.012 166

MTBE100 0.0002 — 0.003 26

Toluene 0.001 — — 301

Isooctane 0.003 — — 24

Note: REF Fuel C—100% hydrocarbon; CM15—REF Fuel C + 15% metha-

nol; MTBE15—REF Fuel C + 15% MTBE.

Figure 3. D-Limonene sorption.

Table 5. Flavor Permeability

Permeation [g/(m

24 h)]

731F, 0% rh 731F, 75% rh

Structure

D-Limonene Methyl Salicylate D-Limonene Methyl Salicylate

A 0.001 0.001 0.01 0.01

B 0.001 0.0003 0.01 0.002

C 0.0003 0.0002 — —

D 0.040 0.009 0.01 0.002

E 0.032 2.16 0.01 6.79

F 0.040 0.87 0.01 2.15

Note: A—HDPE/tie/EVOH/tie/EVA; B—LDPE/tie/PA/EVOH/PA/tie/LDPE; C—PA/tie/EVOH/tie/LDPE; D—LDPE/tie/EVOH/tie/LDPE; E—PP/LDPE/tie/

PETG/tie/LDPE/PP; F—PVDC concentrated OPP.

420 ETHYLENE–VINYL ALCOHOL COPOLYMERS

Depending on the requirements, EVOH resins can be

coextruded with all types of polyoleﬁns, nylon, polystyr-

ene, polyvinyl chloride, and polyester. Downstream pro-

cessing such as thermoforming, vacuum forming, and

printing is easily accomplished with EVOH resin- or

ﬁlm-containing structures.

Regulatory Approvals

Depending on the resin grade, EVOH resins and ﬁlms

have FDA approval for direct food contact as speciﬁed

in the code of Federal Regulations, Title 21, Section

177.1360. EVOH resins and ﬁlms can also be used in

high-temperature laminates (retortable applications), pro-

vided that a functional barrier layer is used to separate

the EVOH layer from the food product.

Various other approvals related to the use of EVOH

resins and ﬁlms in meat and cheese products and in other

countries such as Latin America, Canada, and Europe

have been granted by the appropriate regulatory agencies.

EVOH resins are considered nontoxic according to the

USP Class VI test protocol.

PACKAGING STRUCTURES

Throughout the world today, the primary use for EVOH

resins and ﬁlms is food packaging. All plastic multilayer

structures containing EVOH provide a cost-effective alter-

native to traditional forms of packaging such as glass or

metal. In addition, they also offer other advantages such

as convenience of use and source reduction of packaging

materials.

Rigid and semirigid containers such as bottles, trays,

bowls and tubes, ﬂexible ﬁlms, and paperboard cartons

containing EVOH as the functional barrier layer are

commercially available today. These structures utilize

the multilayer concept to protect the barrier layer

(EVOH) from the effects of moisture. This concept is also

used to produce an economical structure by using rela-

tively inexpensive materials, such as polyoleﬁns, as the

bulk of the structure. Most multilayer structures used

today have ﬁve to nine layers. Multilayer structures

can be produced by either coextrusion and lamination

technology.

When using EVOH in multilayer structures, it is

necessary to use an adhesive layer to gain adequate

bonding strength to the other polymers. Commercially

available adhesive resin such as Admer (Mitsui Petro-

chemical Industries Ltd.), Plexar (Equistar), Tymor (Mor-

ton Chemical), or Bynel (DuPont Company) are suitable

for use with EVOH resins.

Rigid and Semirigid Containers

The most common methods of producing these containers

are thermoforming, blow molding, and proﬁle extrusion.

Most thermoformed containers are produced in a two-step

process. First a coextruded multilayer sheet is produced.

This sheet, containing a barrier layer (EVOH), is then

formed into the ﬁnal container using either melt-phase or

solid-phase thermoforming technology. There are two

Table 6. Aroma Protection

Days to Aroma Leakage

Construction Thickness (mm) Vanillin (Vanilla) Menthol (Peppermint) Piperonal (Heliotropin) Camphor

PET/EVOH/LDPE 12/15/50 15 25 27 W30

OPP/EVOH/LDPE 18/15/50 30 W30 27 W30

PET/EVOH 12/15 W30 W30 30 W30

PET/LDPE 12/50 2 16 5 W30

OPP/LDPE 17/50 6 2 1 13

Table 7. Mechanical Properties of EVOH Resins

Property Unit EVOH Resin Grades

Ethylene content mol % 27 32 38 44 48

Melting point 1C 191 181 175 164 156

Crystalization temperature 1C 167 161 151 142 134

Glass-transition temperature 1C 72 69625548

Melt index at 2101C g/10 min 3.0 3.8 3.8 13.0 14.7

Density g/mL 1.20 1.19 1.17 1.14 1.12

Tensile strength, break psi 10,385 10,385 6,685 7,395 5,405

Tensile strength, yield psi 13,655 11,235 9,385 8,535 6,260

Elongation, break % 200 230 280 380 330

Elongation, yield % 6 8 6 7 3

Young’s modulus psi 10

45.5 38.4 34.1 29.9 29.1

Rockwell hardness M 104 100 93 88 —

Tabor abrasion mg — 1.2 1.2 2.0 2.2

ETHYLENE–VINYL ALCOHOL COPOLYMERS 421

exceptions to the two-step process: the use of rotary

thermoforming and the ‘‘omni’’ process originated by

American National Can, which is a variation of the

injection blow-molding process.

Multilayer bottles are produced using either extrusion

blow-molding or injection blow-molding technology. Like-

wise, tubes can be produced using direct-proﬁle coextru-

sion, heat sealing of extruded sheet, or blow-molding

coextrusion processes.

Figure 4 shows typical multilayer structures used for

rigid and semirigid containers.

Flexible Films

Flexible ﬁlms consume the largest volume of EVOH of any

package structure. Flexible ﬁlms are produced by several

methods. These include solution coating, laminating coex-

trusion coating, and coextruding either tubular or ﬂat

(cast) ﬁlms. Converting operations such as vacuum form-

ing, printing, form, ﬁll, seal, and heat sealing are used to

fabricate packaging structures from these ﬁlms. Figure 4

shows typical multilayer ﬂexible-ﬁlm constructions.

Monolayer EVOH ﬁlms, either biaxially oriented or non-

oriented, can be used in conjunction with the laminating

or coextrusion coating process to also produce ﬂexible

ﬁlms.

Paperboard Containers

In recent years, the use of EVOH to replace aluminum foil

as the barrier layer in paperboard cartons has grown

rapidly. These containers, used primarily for juice pro-

ducts but also for nonfood products, utilize the EVOH in

several ways. Besides serving as an oxygen barrier, the

EVOH layer can also be used to prevent ‘‘ﬂavor scalping’’

(fresh juice) or as an aroma barrier (laundry products).

Coextrusion coating onto paperboard is the primary

Figure 4. Barrier constructions.

Table 8. EVOH Film Properties

EVALt EVOH Grades

Property Unit EF-XL EF-F EF-E

Oriented

Polyamide

PVDC-Coated

Polypropylene

Thickness mils 0.6 0.6 0.8 0.6 0.9

Tensile strength at break MD psi 29,700 11,600 10,150 23,450 24,100

TD 28,300 7,550 6,400 31,290 31,200

Elongation at break MD % 100 180 260 90 140

TD 100 140 190 90 60

Young’s modulus MD psi 10

51.0 28.4 28.4 24.2 28.4

TD 51.0 27.0 27.0 21.3 37.0

Tear strength MD g 260 380 460 500 300

MD 330 300 440 450 200

Dimensional stability at 141C, 1 h MD % 4.0 2.7 1.6 1.5 10.4

TD 0.5 0.9 1.2 0.9 12.5

Melting point 1C 181 181 164 220 165

transmission rate at 201C mL/100 in.

65% 24 h atm 0.01 0.02 0.08 1.92 0.55

85% 0.04 0.08 0.17 5.4 0.55

100% 0.23 1.0 0.52 19.0 0.55

O transmission rate 401C, 90% rh g/100 in.

2.6 6.5 2.3 16.8 0.3

24 h atm

422 ETHYLENE–VINYL ALCOHOL COPOLYMERS

process for producing these containers. Typical structures

may be seen in Figure 4.

EVOH FILMS

In addition to EVOH resins, monolayer EVOH ﬁlms are

also available. These ﬁlms, either biaxially oriented or

nonoriented, provide a unique balance of attractive ap-

pearance of toughness, dimensional stability, barrier prop-

erties, and economics. When combined with other types of

polymeric ﬁlms in a laminating or laminating–coating

process, the resulting structure provides properties simi-

lar to those of a coextruded structure. Table 8 lists the

properties of several monolayer EVOH ﬁlms.

APPLICATIONS

Since the introduction of EVOH resins and ﬁlms in Japan

during the 1970s and in the United States and Europe in

the 1980s, the use of these materials has continued to

grow. Table 9 shows a portion of the commercial applica-

tions utilizing EVOH as a barrier layer.

Economics

To determine the most economical barrier polymer, the

price of obtaining the barrier needed for a given applica-

tion at a given set of use conditions and a given packaging

structure must be compared. Factors such as price per

pound of the polymer, polymer yield, oxygen transmission

rate, and the use of recycled scrap must be considered.

When the low barrier cost of EVOH resins is combined

with their recyclability and the new developments in

coextrusion technology, the packaging specialists has

available a means to design a packaging structure that

will not only compete with glass and metal containers on a

performance basis but also provide a deﬁnite economic

advantage.

BIBLIOGRAPHY

General References

M. Salame, ‘‘The Use of Low Permeation Thermoplastics in Food

& Beverage Packaging,’’ in Coatings and Plastics Preprints of

the 167th Meeting of the American Chemical Society, Division

of Organic Coatings and Plastics Chemistry, 34(1), 515 (April

1974).

R. Foster, ‘‘Plastics Barrier Packaging—The Future is Bright,’’ in

Proceedings of the Society of Plastics Engineers, Inc., Regional

Technical Conference, April 1984.

C. R. Finch, ‘‘Coextrusion Economics,’’ in Coextrusion Comes of

Age, Society of Plastics Engineers, Extrusion Division Regio-

nal Technical Conference, Chicago Section, June 1981.

K. Ikari, ‘‘Oxygen Barrier Properties and Applications of Kuraray

EVAL Resins,’’ in Proceedings of the Second Annual Interna-

tional Conference on Coextrusion Markets and Technology,

Schotland Business Research, Inc., Princeton, NJ, Nov. 1982.

S. Sonsino, Packaging Design, Van Nostrand Reinhold, New York,

1990.

Table 9. EVOH Applications

Fabrication Process Application Structure

Cast coextrusion Processed meats, natural cheese, snacks, bakery PP/nylon/EVOH/nylon/LLDPE

Nylon/nylon/EVOH/nylon/Surlyn

Nylon/EVOH/Surlyn

PET/LDPE/EVOH/Surlyn

Blown coextrusion Processed meats, bag-in-box, red meat, pouches Nylon/LLDPE/EVOH/LLDPE

LLDPE/EVOH/LLDPE

LLDPE/EVOH/LLDPE/Surlyn

Nylon/EVOH/LLDPE

Lamination Coffee, condiments, snacks, lidstock OPET/EVOH/LDPE/LLDPE

PP/nylon/EF-XL/nylon/LLDPE

OPET/EVOH/OPET/PP

Coextrusion coating Juice, bakery, laundry products LDPE/paperboard/LDPE/EVOH/LDPE

LDPE/paperboard/LDPE/EVOH/LDPE/

EVOH

OPP/LDPE/EVOH/LDPE/EVA

Thermoforming Vegetables, fruit sauce, entrees, pudding PP/regrind/EVOH/regrind/PP

PS/EVOH/LDPE

Coextrusion blow

molding

Ketchup, sauces, cooking oil, salad dressing, agricultural chemicals,

juice

PP/regrind/EVOH/PP

HDPE/regrind/EVOH/HDPE

HDPE/regrind/EVOH

PET/EVOH/PET/EVOH/PET

Proﬁle coextrusion Cosmetics, toothpaste, condiments, pharmaceuticals LDPE/EVOH/LDPE

LDPE–LLDPE/EVOH/LDPE–LLDPE

Surlyn

is a registered trademark of E. I. Dupont de Nemours & Co, Inc.

Note: Tie layers are used between any layers of EVOH and either PE or PP. These are omitted from the table for clarity.

ETHYLENE–VINYL ALCOHOL COPOLYMERS 423

EUROPEAN PACKAGING LEGISLATION

LUIGI ROSSI

European Commission; and

Strategic Advisor for Keller and

Heckman LLP

At the end of the 1950s, following the issue of U.S. Food

and Drug Administration (FDA) Act on food contact

materials (FCM, 1958), some European countries began

adopting the ﬁrst regulations and recommendations. All

these new European rules were designed to avoid exces-

sive release into foodstuffs of the substances contained in

the materials, especially in plastics, and above all to rule

out the possibility of a health hazard to the consumer as a

result of the toxicity of some of the substances used to

manufacture these materials.

In the European Union (EU) the differences in the

provisions adopted at national level were sources of

problems for packaging companies, which were forced to

adjust production to the country of destination and apply

for authorization to use a new material. This led to a

growing need to approximate (‘‘harmonize’’) the various

laws and thereby remove legal barriers to community

trade in packaged food which, with the abolition of cus-

toms duty and the new systems of sales (supermarkets)

and lifestyles (pre-packaged food), were developed

extensively.

In 1960 the Council of Europe (CoE) takes the initiative

to harmonize the rules on plastics (see later). In 1972

the European Commission (EC) drew up a broad program

of action designed to harmonize all existing national

laws in the ﬁeld of FCM (plastics, paper, ceramics, rubber,

etc.). Because this attempt is not yet ﬁnished, depend-

ing by the material considered, rules derived from EU

or national authorities or CoE exist in Europe, making

the description of European Packaging Legislation extre-

mely difﬁcult. Therefore this note describes brieﬂy

the main aspects of current legal situation in Europe

summarizing the rules on the basis of the material and

the origin.

EU LEGISLATION

The legal binding acts ( = laws) are called ‘‘measures’’ and

can be adopted under a directive or regulation*. These

measures can be divided into three categories:

. Measures applicable to all materials and articles

. Measures applicable to one category of materials and

articles

. Measures relating to individual or groups of

substances

All the measures adopted and mentioned here may be

found in all EU ofﬁcial languages in EC website

and

summarized in Figure 1.

Measures Applicable to All FCM

Framework Legislation. The Framework measure, Reg-

ulation (EC) 1935/2004, adopted in 2004 replaces those

adopted in 1976 and 1989. It establishes for all FCM:

. The deﬁnition of the scope

. The obligation to manufacturing the FCM following

the ‘‘good manufacturing practice’’

. The interdiction of an ‘‘unsafe’’ migration of the con-

stituents of the materials or articles (safety clause)

. The prevention of any unacceptable contamination of

the foods even if this contamination does not imply

health problems (inertness clause)

. The prevention of any deterioration in the organo-

leptic characteristics of foods (i.e., taste, odor, or

texture of the foods)

. The information, through an appropriate labeling

(‘‘for food contact’’) or a symbol (

) to the consumer

or food industry of the suitability of the materials and

articles to come in contact with food (labeling clause)

. The obligation for the business operators to trace

FCM i.e. to identify the businesses from which, and

to which, the FCM are supplied (traceability clause)

. The procedures for the authorization of substances

and materials

. The obligation to consult the European Food Safety

Authority (EFSA) if the speciﬁc measure deals with

aspects having an impact on the consumer health

. The safeguard measures to be taken in certain

dangerous situations

. The public access to the technical dossier made

available by the business operator when the author-

ization of a substance is required

. The right of the business operator to require a

certain conﬁdentiality on the management by EC or

EFSA of certain data, the disclosure of which may

signiﬁcantly harm its competitive position

. The possibility to share data of the technical dossier

needed to obtain the authorization of a substance to

avoid

. The obligation to have declaration of compliance for

materials and articles covered by speciﬁc legislation

. The obligation for the MS to check the conformity of

FCM to the related laws (control clause)

. The establishment of a Community Reference La-

boratory (CRL) for food contact materials (see later)

Regulation on Good Manufacturing Practice (GMP). The

obligation to apply the rules of GMP is included in general

terms in the framework regulation. To ensure a

* Directives are binding acts that require the transposition in the

national laws.

Regulations are directly applicable legal acts.

http://ec.europa.eu/food/food/chemicalsafety/foodcontact/legisl_

list_en.htm

424 EUROPEAN PACKAGING LEGISLATION

Paper and Board

Waxes

Metals and alloys

Ion-exchange resins

Cork

Glass

Active and intelligent

materials

Wood

Textiles

Adhesives

Printing inks

Silicones

Varnishes and

coatin

372/2007/EC

Transitional migration

limits for plasticizers in

gaskets in lids

1935/2004/EC

Framework

2023/2006/EC

Good Manufacturin

practice

(applicable to all

Food Contact)

Elastomers and

Rubbers

93/11/EEC

Nitrosamines

2007/42/EC

Regenerated

Cellulose Film

84/500/EEC

Ceramics

2005/31/EC

amendment

+ Coatings

1895/2005/EC

BADGE/BFDGE/NOGE

97/48/EC

amendment

82/711/EEC

Migration Testing

93/8/EEC

amendment

85/572/EC

List of simulants

Plastic Materials

78/142/EEC

Vinyl Chloride

80/766/EEC

VC in PVC

analysis

81/432/EEC

VC in food

analysis

2004/1/EC

amendment

2002/72/EC

Monomers

Additives

2004/19/EC

amendment

2005/79/EC

amendment

2007/19/EC

amendment

2008/39/EC

amendment

Recycled Plastics

Figure 1.

Overview of community legislation.

EUROPEAN PACKAGING LEGISLATION 425

harmonized application of GMP throughout the EU and

throughout the different business sectors, the basic prin-

ciples of GMP are detailed in Regulation (EC) No. 2023/

2006. These requirements, applicable as of August 1, 2008,

have to be applied at all stages of production of FCM and

in all sectors. All aspects of the GMP need to be adequately

documented, and the documentation should be available

to control authorities. Imports from third countries should

also apply adequate GMP systems in their production. For

two materials, GMP requirements have been further

detailed— that is, for printing inks and for recycled

plastics.

Speciﬁc Measures on A FCM

Measures on speciﬁc materials deal with the groups of

FCM mentioned in Table 1. Until now, only four groups of

materials have been regulated by EU measures: regener-

ated cellulose ﬁlms, ceramics, plastics, and recycled

plastics. Some general rules exist also for active and

intelligent materials.

Directive on Regenerated Cellulose Film (RCF). Directive

93/10/EEC, which codiﬁed two previous directives, regu-

lated the regenerated cellulose ﬁlm. It establishes (a) a list

of authorized substances and (b) the restrictions on the

composition of the material.

In 2004 a new amendment, Directive 2004/14/EC,

authorized a new type of regenerated cellulose ﬁlm with

a coating consisting of plastics, which is compostable and

biodegradable in accordance with the requirement of

packaging waste Directives.

Ceramics. Directive 84/500/EEC sets out migration lim-

its for lead and cadmium and the method of analysis.

Moreover, it speciﬁes the requirement of the declaration

of compliance as well as the supporting documentation to

be made available to the national competent authorities on

request. This documentation shall contain the results of the

analysis carried out, the test conditions and the name and

the address of the laboratory that performed the testing.

Directive on Plastics Materials. Finally, the Commission

began to draw up rules for plastic materials. Due to the

wide divergence of national regulations, their poor scien-

tiﬁc basis and the need to reach a large agreement

between Member States, the Commission was obliged to

take a very cautious, step-by-step approach toward har-

monization. Therefore the main provisions are dispersed

in numerous directives and amendments. They are mainly

regulated by three measures:

. Directive 2002/72/EC, which set out the main

provisions

. Directives 82/711/EEC and 85/572/EEC, which set

out the basic rules to checking the compliance with

the quantitative restrictions and speciﬁcations in-

serted in the Directive 2002/72/EC

Their main provisions are related to:

. The overall migration limit (OML), which for all the

plastics have the same value, that is, 60 mg/kg (of

food/food simulant) or 10 mg/dm

(of surface area in

contact with food)

. The positive lists of monomers and additives (for

additives as of January 1, 2010), which collect all

the substances authorized and then prevent the use

of monomers and additives not listed

. The quantitative restrictions or speciﬁcations applic-

able to the substance(s) (e.g., SML, QM and QMA)

. The functional barrier (FB), which is a layer permit-

ting the use of nonauthorized substances in the

layer(s) not in direct contact with food, provided

that (a) their migration in food or food simulant

does not exceeds 0.01 mg/kg (of food/food stimulant)

and (b) the substances are not classiﬁed in EU as

proved or suspect ‘‘carcinogenic’’ ‘‘mutagenic’’ or

‘‘toxic to reproduction’’

. Certain more restrictive provisions for young children

. The rules on the choice of food simulants in relation

to food in contact and the conditions of contact

(duration and temperatures) in the conventional,

standardized migration testing

The ﬁeld of application is quite limited because it applies

only to materials and articles made up of one or more

layers exclusively of plastics material. The multi layers

consisting of at least one layer other than plastic are

excluded even if the material in contact with food is

made of plastic.

Recycled Plastics. Regulation (EC) No. 2008/1016,

which applies to mechanical recycling of plastics, foresees

the individual authorization of the recycling process at the

community level based on the safety evaluation of the

recycling process performed by EFSA. Because the recy-

cling processes are unique based on technology applied,

individual authorization dedicated to the applicant will be

issued. All recycling processes shall be accompanied by an

adequate quality assurance system that should be audited

by member states. Recycled plastic as well as the

Table 1. Groups of Materials Including Recycled

Materials which May Require an EU Legislation

Active and intelligent materials and articles

Adhesives

Ceramics

Cork

Rubbers

Glass

Ion-exchange resins

Metals and alloys

Paper and board

Plastics

Printing inks

Regenerated cellulose

Silicones

Textiles

Varnishes and coatings

Waxes

Wood

426 EUROPEAN PACKAGING LEGISLATION

materials and articles containing recycled plastics need to

be accompanied by a declaration of compliance.

Directives Concerning Individual or Groups of Substances

While legislating on a broad scale (i.e., in relation to

various sectors of production), the Commission has also

been obliged to lay down rules for individual substances

that have been the cause of considerable public concern.

This applies to the individual measures related to vinyl

chloride monomer used in PVC, mono- (MEG) and diethy-

lene glycol (DEG) used in regenerated cellulose ﬁlm, N-

nitrosamines and N-nitrosatable substances from rubber

teats and soothers, certain epoxy derivatives in plastics,

azodicarbonamide in plastics, and some plasticizers in

gaskets in lids.

NATIONAL LAWS

The national laws are not yet fully harmonized at the EU

level, whereas, additional national laws remain in place.

In these cases a possible option to avoid technical obsta-

cles to the trade in the EU is given by the application of

the so-called Principle of mutual recognition, set out in

Articles 28 and 30 of the Treaty. It states that any product

lawfully produced and marketed in one member state

must be admitted to the market of any other member

state. Therefore it is important to know the additional

national laws in force in member states. Due the complex-

ity of this issue, it is necessary to consult directly national

legislations. Useful references can be found in the SANCO

website* and on the Internet.

COUNCIL OF EUROPE (COE)

In the absence of national laws or also, sometimes in their

presence, the resolutions of the CoE may be useful to

export in EU or in the marketing between member states.

CoE is a European international institution that was

created before the EU and is independent from it. CoE

adopts resolutions, guidelines, and technical documents

(TD) on FCM not covered by EU law. These documents are

not binding texts unless the countries transpose (partially

or totally) them into national law. Numerous resolutions,

guidelines, and TD regarding various types of materials

such as paper, inks, coatings, rubber, silicones, ions resin

exchange, cork, and metals have been adopted. Some have

been recently transposed into national legislation of some

EU countries. All CoE adopted texts are reported in the

CoE website.

OTHER (CEN, JRC)

Other European organizations set out not binding guide-

lines in the ﬁeld of the method.

The Commission Agency, Joint Research Center (JRC),

was selected as CRL. Its activity is described in its

website.

The European Committee for Standardization (‘CEN’)

produces harmonized standards to develop and validate

test methods. It established several validated method of

analysis for the determination of overall and speciﬁc

migration limits. All the methods adopted by CEN are

described in the CEN website.

FINAL CONCLUSIONS

Harmonization of legislation at the community level is

moving forward quite slowly for various reasons. However,

the harmonization continues and will continue as neces-

sary to remove the technical barriers to the exchange and

ensure more safety in the use of FCM.

EXPORT PACKAGING

FRANK W. GREEN

Point O’View

Export shipments have been a major business for thou-

sands of years. Even today, export cargo is carried by

surface ships in the holds and on decks. Since the world-

wide acceptance of containerization, a large percentage of

exports is moved in cargo containers. A smaller, but

growing, quantity of high-value and high-priority items

is shipped by air as break bulk or in air containers.

There are no standards, rules or regulations, codes,

references, or guidelines for the export packaging of speciﬁc

products. In a sense, every item, destination, and form of

shipment dictates the requirements. When packaging for

export, every detail must be carefully considered. The

products and packages will be completely out of the control

of the shipper, and they may be ‘‘somewhere out there’’ for

weeks. Export shipping is the test. The package fails at its

weakest point. It is almost impossible to overpack. Export

shipments must arrive in good order. They may have taken

months to arrange and to produce. They cannot be easily

replaced or repaired at destination.

HAZARDS OF EXPORT SHIPMENTS

The packaging engineer must understand and meet the

requirements and hazards of various forms of shipments

(see the Distribution hazards article).

1. Break bulk cargo in the holds and on the docks of

oceangoing surface vessels of many types, sizes,

ﬂags, and ages.

* http://ec.europa.eu/food/food/chemicalsafety/foodcontact/

index_en.htmt

www.foodcontactmaterials.com

http://www.coe.int/T/E/Social_Cohesion/soc-sp/Public_Health/

Food_contact/

http://crl-fcm.jrc.it/

http://www.cen.eu/catweb/67.250.htm

EXPORT PACKAGING 427