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CBUUS M. MI1UK
WIUUM H. BOIOIEUKI. «IB.

TtUPBOBI

"WASHINGTON, D- C. 20036

BOB

WiTXI V. BLACK

June 22, 1972

DAVID L. HILL

Mt'HOO

CAm.i isDBics "ixuair1

BOBKBT B. TllUUir

■f ,.

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M1BTDI W. BEBCOV1CI
MABC K. SHAT*
U1AHD J. BUn

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t

SPI Food, Drug and Cosmetic
Packaging Materials Committee
Re:

GRAS Comments and Dutch Regu­
lations for Food Additives

Gentlemen:

In our recent GRAS comments we proposed
that incidental additives, with certain exceptions
such as heavy metals and the like, should be
considered GRAS if the migration of such addi­
tives was sufficiently low (we proposed .5 parts
per million as the cut-off point).
It is in­
teresting, that shortly after we filed these
comments, we received through the very great
courtesy of Dr. J. H. DeWilde of Shell in The
Hague an amplification and more detailed explana­
tion of the Dutch "new look" in food packaging
regulations which, in effect, seems aimed at
achieving a very similar end result.
You may recall that at our last meeting
Bob Miller of Hercules reported on the new Dutch
proposals for dealing with the question of inci­
dental food additives. A summary of Bob's pre­
sentation was sent to Dr. DeWilde and he has
very kindly sent to us a copy of his letter to
Bob Miller which amplifies and clarifies the
Dutch "new look."
Not only are we being provided with
Dr. DeWilde's very careful explanation of the
thinking that went into this "new look," but
he also included copies of a paper which was
presented in Rome by Dr. D. G. Aldershoff which
also discusses the "new look." Included with
Dr. Aldershoff's paper are two attachments—Annex
A which is a sample regulation for polystyrene

ASI-PR 0001410

June 22, 1972
Page Two

(in English translation), and Annex B for glass
and glass-based ceramics (in French).
As you review the enclosures you will
note that the Dutch government is directing its
concern to the quantity of a substance that might
actually migrate to a packaged food—not to how
much is put into the packaging material.
In
order to be practical and minimize unnecessary
work, the government arbitrarily set a figure of
60 (mg/day, ppm)!/ as the maximum amount of any
indirect additive (except selected plasticizers)
that will be permitted to enter the food of an
average consumer regardless of how safe or inert
it might be.
Based upon toxicological testing on
animals and the use of appropriate safety fac­
tors, a packaging acceptable daily intake (PADI)
is established for each substance permitted in
a packaging material and a list of substances
with its PADI is prepared. Any substance whose
PADI is in excess of 60 mg will require no
special considerations; but each substance
whose PADI is below 60 mg will require specific
analytical attention.
The entire process requires that gross
migration tests be conducted with foodsimulating solvents.
If the total amount ex­
tracted is less than 60 mg/5 dm2 (or 6 dm2)!/

y Dr. DeWilde explains why 60 ppm in the gross
extraction test is also equivalent to 60 mg/day
intake of extractives.
It should be noted, too,,
that this reduces to 24 ppm in the whole diet,
based upon the reasonable assumptions which were
used.
The maximum total surface of packaging material
that might reasonably contact the total daily food
intake of a consumer has been estimated by the
Dutch to be 5 sq. decimeters, and by EEC person­
nel to be 6 sq. decimeters.
In any case, the
numerator then represents the maximum quantity

y

ASI-PR 0001411

June 22, 1972
Page Three

then no specific tests will be required for
any component whose PADI is above 60 mg, since
the PADI of these substances cannot have been
exceeded.
However, those components whose
PADI are below 60 mg must be given specific
analytical attention; and no such substance
may be present in an amount (in mg/5 dnr) that
exceeds its PADI.
Even this amount of work may be mini­
mized in some cases, since no specific tests
are required for any substance whose PADI is
above the gross extractives that are actually
found.
'■

J

x3
\\
/j

Finally, a modification of the Frawley
doctrine is included in the scheme because
additives migrating to an extent less than
0.05 mg/5 dm^ are exempted even though no
toxicological data is available (unless government toxicologists consider that the structure
makes such substances suspect).
There can be controversy about some
of the details of this "new look," indeed
there is a difference of opinion between Dutch
and EEC personnel regarding whether the area
used for calculating migration should be
5 dm^ or 6 dm2; but the entire approach appears
to us to be the result of considerable study.
It very carefully balances toxicological con­
siderations against the amount of an additive
that might enter the diet.
It requires
careful (and expensive) analytical work only
( ,tfor those cases where a health hazard could
conceivably exist and would seem to signal a
i ^
constructive move away from the devotion of
time, effort, and money to those cases where
there is no health problem.

, 'j 1

2/ (cont'd) of total extractives that could
enter a person's diet if everything he ate
that could be packaged were packaged in the mate­
rial being considered.

ASI-PR 0001412

June 22, 1972
Page Four

While the adoption of a scheme such as
the "new look" by the FDA would require a more
extensive revision of the American regulatory
scheme than seems politically possible in the
near future, it is good to note that this very
careful blending of law, science, and common
sense is being implemented somewhere.
The only thing missing from the infor­
mation we now have, and by this copy of this
letter we are requesting Dr. DeWilde to please
send us such additional information if he can
do so, is an understanding of how new materials
will be added to the Dutch regulations.
In
other words, what procedure should be followed
if a manufacturer, supplier, or user wishes
to have a new material added to the list in
an existing regulation?
Here in the United States, as you all
well know, the petition-regulation procedure
is quite complex and extremely time consuming;
thus, it would be most interesting and valuable
to us to learn how the Dutch are planning to
handle this aspect of the regulatory problem.
Wte hope you find this information as
interesting as we did, and that it will prove
to be a valuable guide to contemporary European
thinking and practice in this area.
If you
have any questions or comments, please do not
hesitate to contact us.

Enclosures

ASI-PR 0001413

L

9th June, 1972

Sr. R.M. Miller
Chairman of the SPI
Food, Drug and Cosmetic Packaging
Committee
c/o Hercules Inc.
910 Market Street

c

Dear Bob,
Somebody forwarded to me a copy of the summary of the
speech you gave on the occasion of the SPI's Food,
Drug and Cosmetic Packaging Committee*s meeting in
the Shoreham Hotel on March 19th, 1972.
In offering a few comments I would like to start with
complimenting you with the excellent way in which you
summarized the Dutch "new look",
The new approach has not been invented merely to
resolve the differences between the Latin and the
German philosophy but in the first place because the
old system is not susceptible to any control. In some
countries such as the U.S.A., industry might be so
lawful that every company will strictly adhere to the
' FDA-regulations, but one cannot assume that this
ethical behavior is common to industry in every country.
Our "new look", moreover, is directly correlated with
the aspects of public health. Technological aspects
which were a strong point in the old approach, have
been omitted as much as possible, the philosophy being
that the Government should not interfere with industry
and the way industry wants to formulate food packaging
compositions. Allowing 0,2% of a certain additive in,
aay, PP has no correlation whatsoever with public health
since the amount of the additive migrating into the
packaged foodstuff depends to a very large extent on the
composition of the PP film, its crystallinity, whether
stretched and/or coated or not, etc.
The "new look" speciflesi on account of public health
considerations we don't want more than x mg per day
of this additive to be ingested by the average Dutch­
man.
*/2

ASI-PR 0001414

I

Dr. R.M. Miller
Vilmingt n
O.S.A.

9.6*1972

Industry Is free to use any quantity of that additive In
their PP film, but they are responsible for ensuring
that not more than x mg is consumed per day per person.
The figure "x" is related to the "no-effect level" found
In animal tests. Since 2-year tests with rats are needed
to establish an ADI (FAO/WHO suggestion) and the
Netherlands Government for obvious reasons agreed that
90-day feeding tests would suffice in the case of
additives used in food packaging materials, we have
denominated "x" as PADI (Packaging ADI).

-s

^

1

,

c

The only thing which is needed to make the "new look"
work is to establish a PADI for each of the additives
used and to develop analytical methods to assess
quantitatively the specific migration of each migrating
additive in foodstuffs. The first part has been accepted
by the Council of Europe. The British Government
representative, Dr. P. Ellas, insisted on establishing
PADI's for each additive and Dr. G.J. van Esch (Dutch)
has been charged in making "toxicological data-sheets"
for each additive. He finished his commitment just before
this month's meeting of the Council of Europe and will
request the toxicologists of the other countries to
fill in the gaps.
The second part, the search for analytical methods is
actively being pursued by analytical groups in the
various countries. Several of the 24 communications
given at the Rome symposium dealt with this subject. All
vhn-fe has baen said and done in Rome has been collected
JIA AUVQU

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requested xo indicate the number of copies we would Ilk
to purchase but no price has been indicated as yet.
There is one other thing that has worried me for the
past few years and that seems near a solution now.
The correlation between PADI and the amount of migrated
additive (expressed in mg per dm2) has never been laid
down. One of the reasons to accept 90-day animal feeding
tests has been the Government assumption that the
additive might be used in all packaging materials coming
In contact with our dally food. This was assumed to be
$ dm2 _Dfi3C-dav (Council of Europe 6 dm2 j Germany 10 dm2,
U.S.A.30 dm2). There obviously may be a difference in
migration.into aqueous and into fatty foodstuffs. Taking
this into account would Involve a system of "food factors”

3Dr. R.M. Hiller
Wilmington
U.S.A.

v.

9*6.1972

which, however. Is less suitable for harmonisation.
Ve therefore suggested quite recently to abandon "food
factors" and to multiply the number of mg per dm2 of
migrants with six.
Food simulants are usedi distilled water. 3% acetic
acid. 10% ethanol and arachls oil. coconut oil or the
Unilever synthetic fat HB 307.
Conditions of temperature and time should be chosen
as closely as possible approaching actual conditions.
Since it has been demonstrated that the migration
approaches the asymptote in 6 - 8 days, the testing
period not necessarily should exceed, say, 10 days.
The French law still demands 30 days; even the not
yet published new "directive for applying approval etc.".
To limit the amount of work, the arbitrary number of 60
has been accepted. To the French and Italians this
means the limit where above the food will be considered
contaminated. To the Dutch it means that no PADI has
to be calculated of additives that can be consumed in
larger quantities than 60 mg per day. There consequently
is no need for policing these as long as the "gross
migration" is lower than 60 mg per 3 dm2 (6 dm2).
In the case of plastics this is always so except for
plastics containing plasticizers. A total quantity of
100 ppm of defined plasticizers on the packaged food
parcel is allowed. Whether this figure will be maintained
in the future remains to be seen since plasticizers may
not be always that safe. Additives migrating less than
0,03 mg per 9 dm2 are exempted (Frawley doctrine) even
although no toxicity data are known (except when their
structure seems suspect to our Government toxicologists).
The figure of 9 dm (6 dm to follow the Council of
Europe*s advise) has been accepted as the average surface
coming into contact with the 1 kg non-dry packed food
consumed daily per person.
t
Please,find attached the communication Dr* Aldershoff
submitted at the Rome symposium. Included as annexe "A"
is the English translation of schedule 2s polystyrene
mixed and copolymers. You will note that only a few
additives have to be policed which makes the whole
scheme workable. The control laboratory will first make
a ^qualitative analysis of the packaging material to
assess which additives are present and whether the
-A

ASI-pR 0001416

Dr. R.M. Killer
Wilmington
D.S.A.

9.6.1972

composition complies with the "positive list". Only for
reasons of easier control we adhere to separate lists for
each separate type of plastics - otherwise one could
accept the alphabetical Italian list.

c

B.I.T.M.P. and S.I.I.C* are making an attempt to convince
the Council of Europe that a) monomers are different
from additives in that they are reactive and their
presence in the end-product can be expected in exceptional
cases only that can be listed or regulated)
b) process chemicals are used in small quantities, will
partly break-down or combine with the polymer so that
their specific analysis in the migrate is not needed.
If Governments want to play safe, analysis of groups'
(e.g. peroxides) or heavy metal traces can be Incorporated.
Annexe "B" shows that the same system works with glass.
We have almost finalized paper and board, elastomers,
glass, ceramics, metals and are now working on a "coating
list".
I cannot support your statement that the Netherlands'
■new look" will not be of much help to you in your
negotiations with FDA. In contrary, this "new look" may
offer you an unique opportunity to get your FDA system
changed and simplified, to the benefit of both public
health and industry!

c

I apologize if I have not been able to make the
essentials of the "new look" clear in this letter; a
ersonal discussion would be much more efficient.
o you plan to visit the Netherlands in the near future?
Please, let me know.

S

With kindest regards,
cordially yours,

oc.l Mr. J.H. Heckman, Washington, D.C., U.S.A.
Ir. M.C. Dleleman, Hercules N.V., The Hague

ASI-PR 0001417

The

New Look

of

for foodstuffs

Dutch Regulations
and Proposals

for

by Drs.

for lh^kaging Materials ,

the Contro^of

W.G.

etc.

Ihul-products .

Aldershoff

presented on behalf of the Dutch Delegation.

I. The New Look

of

for foodstuffs
trolling the

A.

The main

the Dutch Regulations
in

order

to decrease the

analytical

purpose

of the

reglemcntation which is

present

that

contact with foodstuffs,

come

into

consumer of the
more

from the

The

foodstuff is

especially as

"old"

materials

effect

the

ceramics,

may be used for its

a result

etc.

the health

a result

of

of the

this

con­

of the migration of substances

etc.

into the

foodstuffs.

purpose mentioned for the various

glass,

etc)

the

etc.

kinds

of

are being made

components

or addititves

which

fabrication have been listed on a so-called

list".

In principle an additive

or component was

migration data and results
conclusion

that

compounds

such that a
the

that

not hasarded as

from which packaging materials,

(plastics,

Of many

is

utensils,

in

system

In order to

the

con­

in The Netherlands

for packaging materials,

packaging materials,

"positive

for

of the Regulations

preparation at

tact,

burden

etc,

end-product.

The main pint

B.

for Packaging Materials,

its

additive

in

the results

the

harmful

of toxicological

list

of use"

-

list)

if

led

expressed in

in order to prevent

to

to human health.

investigations

composite material"-had to be

(also mentioned in the

on the

of toxicological investigations

use would not be

"maximum level

placed

"

were

$ - weight

of

prescribed
that

as

a result

of a "too large migration" - larger than corresponding with the
A.D.I.^ of the additive - human health might be affected.

The migration data which were made

availabel

in order to

enable

the decision of whether an additive

could be

accepted on

the

or not,
sample

1)

mostly referred
of the

"A.D.I.":

to -

or:

were restricted to

packaging material of only one

-

specific

tests

list
on a

composition

acceptable jdaily ^intake.

ASI-PR 0001418

- often a sanJple manufactured

in the

not necessarily have

the

properties

is made

and used

in

the

plant

Another aspect
different

were used,

As

to

the

of material

the

migration of

as

the

Such samples
material,

that

for various

compounds

of use"

had

to be

in which

the

relevant

the

the height

of the

generally fixed at

the

sample

sent

compounds

prescribed

the value at which the

additives

appeared
_

"maximum permitted level

in for testing,

that

practice.

the different materials.

was

have

levels

type

because
for

in actual

old system is,

"maximum permitted

according to

different

of the

same

laflWtatory.

to

be

.

of use":

this

additive was "used

even if toxicological

in

data would

permitted a higher value.

These

old regulations

. ■.labour-intensive

involve

a

tremendous

analytical work as

•end-products.
In the

regards

of the

" which a maximum permitted level

the

of time-consuming
of

the

large number of additives

for

■

first place becuse

amount

control

.

of use

had

to be

fixed

(more

than

"200 compounds), but also because the isolation of the additives
often requires
nature

of

different

analytical

techniques

according to

the

the material in which they are used.
/

■

*
C. The New Look

* ■

,,iI

"f

*■

*

Circa half a year ago
modifications have

this

system has

been abandoned.

been introduced.

The

first Modification

The

"maximum permitted

•

Two main

1

"

level

of use"

list.

is

not mentioned anymore

on the

'

From toxicological data - mostly obtained from animal feeding tests
lasting 90 days using safety factors varying from
been calculated how much of the
in by a person of 60 kg daily.
referred to
verted

compound may on an average
This

"Packaging A.D.IV

or

quantity,

packaging material

expressed

"P.A.D.I.",

into a maximum permitted level

from the
mg/l

as

100 - 500-it has

of simulant.1'

taken

in mg,

may

and has been con­

of migration of the

or article

be

/

expressed in mg/5

compound
dm

2

or

ASI-PR 0001419

1 ^The following assumptions were made for this conversion:

An adult

person consumes daily 2-5 kg food, consisting of 1 kg liquids and
1*5 kg "solid" foodstuffs. Half of the 1.0 kg liquids is packed.
The liquid that daily is taken in thus has a net contact area with
packaging materials
a r ^
j_
\

of 2.75 dm^.

(An

"1-1-bottle"has

an

inner surfr

This maximum permitted

level

of migration

now

n w version of the

lists

of permitted substances

"maximum permitted

level

of use".

styrene mixed and
The

copolymers

Sec

to

has

introduced consisting in

been

level

reduce

time being

that

proposed

the

amount

the

the

in meetings

as

limit

of the

of

Council

the

for the

permissible

fixation of a

limit has

involves

anymore

that no

In general

dm

the number of tests
the

of

*

intended to

much is

to be

(maximum permitted migration

to be

carried

out will be

migration has

smaller than

the values

to meet

the

The amount
with

the

The fixed

in the

that
it

the

to be

exami

of the

actual

foodstuff as

regarding migration.

of analytical work is

ed

■ •

■7
reglementation

simply mentions
a result

manufacturer how to make

reguirements

smaller:

...

clearly expresses

the

•

■

safeguard public health:

to

been

made

.

(specific)

maximum tolerable

tion leaving it

the

“
have

the new system

The new version more
is

the

of foodstuffs

migration found during testing.

Advantages

at

has

or 60 mg/l.

than those with a P.A.D.I,
gross

for

or article.

with a P.A.D.I.

other substances

(p.A.)

contamination

specific migration tests

of substances

level) ^elow 60 mg/5

pf no

limit

been fixed

of Europe

*
This

second modification

namely 60 mg/kg of foodstuff in direct

contact with the material

the

how

of migra­

product

and

■

considerably reduced

as

comparei

old version.
"maximum permitted level

of migration"

or P.A.D.I.

a certain compound is valid for all packaging materials
the relevant
cent.

the

the Annexes A and D for poly­

of control work a

height

by migrating substances,

3.

of

the

migration.

For the

2.

instead

on

and glass.

In order

1.

indicated

second modification

gross

-D.

is

Ojjalf of the

additive

for

in which

is used.

1.5 kg solid food is packed but half also consists

o:

dry foodstuffs in which no migration is expected. The result is that
0.375 kg of the daily solid food has a contact area with packaging
materials of 2.25 din . (l kg of solid non-dry foodstuff is packed
in 6 dm
packaging material).
The overall result is that of the 2.5 kg daily diet
circa i kg is contact with packaging materials in such a wjjy that migration may
occur.the net contact area amounting to 5 dm .

ASI-PR 0001420

-4II.

Proposals
In the

for the

control

foregoing it

utensils

etc.

has

coming

certain requirements
a.

the use

b.

gross

c.

the

The

control

packaging materials,

contact with foodstuffs

have

to meet

regarding

permitted additives

as

to whether

comprise

purpose:

during manufacture

the

components.

these requirements

following tests:

are

met

or not

must

(See Annex C)

Gross

migration

determine
Specific
Main

determination of the qualitative

composition of

product

Main purpose:

check that

the

60 ppm limit
a

is

not

surpassed

"specific migration

and

test"is

neec

migration test

purpose:

Regarding

test

for which additives

of additives

A.

explained that

Composition analysis

the

C.

into

migration of specific

Main

B.

been

end-products

migration

therefore
A.

of

of

these

check on the migration of volatile
for which a P.A.D.I.
three

tests

the

has

been

compound

and

fixed.

following annotations

are

made:

Composition analysis
This

analysis

in

the first place

serves

other additives

or constituents

have been used.

Furthermore it serves

the presence
a.

substances
vant

b.

to

than those

check whether no
that

to provide

are

permitted

information

on

of
for which a P.A.D.I.has been indicated in the

rel*

list

volatile substances.

The above figures may vary somewhat in accordance with variatioi
in daily diet from country to country, but calculations show
that the variations in the figures are minor only.
The above is based on the starting point that for the judgment <
the migration of a component from a packaging material it is
assumed that the packed foodstuffs of the daily diet are all
packed in this material only.
, .

ASI-PR 0001421

This

information is

stances

specific

necessary in

migration

ord<^ to know for which sub­

tests

must

be

made

paragraph).

Gross

migration

a.

Food

Simulants

From

technical-analytical
to make

and

gross

temperature

The

controlling

under actual

under conditions

This

that

tests

tests

conditions

and

of use

foodstuffs

the

tests

however,

actual

proper unde

in
be

poss

the

foodstu

carried

conditions

out

of use

as

possible.

involves

1.

food

2.

conditions

a proper

simulants

and

choice

of

of

, ;

of temperature

and

time

*

for the test.

m

m

*

,* .

Food Simulants
Apart

from dry food,

aqueous,

acid,

For these
'

it very rarely is

in the

should,

'

.

of test

replacing the

simulate

*

1 .

time

considerations

migration

of actual use.

much as

relevant

test

conditions
actual

the

•.

B.

ble

(see

foodstuffs

alcoholic

categories

may roughly be

divided

into

and fatty foods.'

the

following Food Simulants

have

been

proposed:

As

distilled water
*

for aqueous

3 $ acetic acid

for acid foodstuffs

10 # ethanol

for alcoholic

triglyceride(s)

for fatty foodstuffs

regards

the

simulants

and fats

or purpose

only)

the relevant
if,

however,
has

to be

2. Conditions

no

it

is

carried

seems

appropriate

1.

materials

etc.

tested is

(e.g.

sufficient

destined for one

for contact with oils
to do

the

testing with

only
purpose or use

is

indicated

testing

out with all four food simulants.

of Temperature

It

to be

only

simulant
special

foodstuffs

to be used during tests:

if the material or article
single use

foodstuffs

and

time during migration

tests

to distinguish between

that

are used

only once

and after use

are-

thrown away
2.

utensils,

objects

etc.

kitchen

utensils,

are used

repeatedly.

like

dishes,

cups,

soft drink bottles

plates,

pans

and milk bottles,
ASI-PR

0001422

and
that

1•

Materii»s

1.

used

Tho

conditions

in

temperature

only once
of contact with foodstuffs
and

time.

In the

scheme below the

ranges

have been distinguished:

A.low

temperature

(incl.

vary considerably

following

range:

temperatures

up to

+

applied in

five

main

temperature

5°C

the

manufacturing and

storage

of quick frozen products)
proposed
2.

test

temperature:

Room temperature
proposed

3.

test

Temperatures
These

hold

temperature:

This

of products

like

(soup-tureens)

etc.

5.

temperature

Temperatures
foods

The

in ovens

proposed

that

are

several

occurs

of

150°C
are

test

-

and marmelades,

in* the

house­

during

the

175°C

Films

to

temperatures

sterilization

these

and

process.

used during baking
temperatures.

times

or have

are very close

to

countries.
simulating conditions
to be used in tests

and

time

up to

max.

a few months

5°c

10 days

room temperature

max.

a few months

1»0°C

10 days

70°C -

relatively short

100°c

2 hours

short time, followed
by gradual cooling
down to room temp.

120°C

30
minutes

1

175°C

2 hours

+

5°C

100°C

-

175°C

Articles
“

1

1

those

already been proposed

temperature

150°C

hot

100°C.

already being applied

120°C

^

jams

exposed

Conditions of temperature
time in actual practice

2.

100°C

occur during pasteurisation processes

proposed test temperature:
Temperature of 120°C

k.

40°C

between 70°C and

temperatures

filling

v,.

5°C.

+

that are
1

hr

temperature

in

ovens

used more

'

time

time

than once

:

>

With repeated and prolonged use

"f

from these

u)

1. decreas '

the migration of substances

articles may
•
•

2.

remain constant

3*

increase

‘

*■ '

‘
■

ASI-PR 0001423

in

Therefore

for

these

articles

that mentioned above has
It is

proposed

three

consecutive

and

1.

times
pans
3

and

3

or

3. bottles

If iii the

test,

course

are
at

controlled

appropriate

used

by at

least

temperatures

for cooking and baking

each lasting 2 hours

at

100°C

(baking).

cups

etc,

tests,

for soft

consecutive

than

following lines:

150°C

consecutive

3

migration tests

plates,

scheme

followed.

articles

other utensils

consecutive

dishes,

to be

these

along the

(cooking)
2.

that

another testing

used

at

temperatures

each lasting 2 hours,

drinks,

milk,

etc,

used

at

tests,

each lasting 3 days,

of the

three

consecutive

at

up

tests

1Q0°C

100°C.

room

at

to

temperature

^0°C.
the, gross

migra­

tion
-

increases

the

inacceptable
- decreases

relevant

material must be

considered

to be

for repeated prolonged use

the

intended use

relevant
if at

material may be

least

low compared with the

accepted

for the

the gross migration in is

P.A.D.X.

already in

sufficient

the first

test

a.

- remains

constant,

migration is

b.

the relevant material

sufficiently low as

is

acceptable

compared with the

if the

P.A.D.I.

Volatile Components
Volatile

Components

gross migration
tests have

The

test,

to be

in the material
presence

are not quantitatively measured
so

that

the

results

corrected if volatile

of gross

components

in the

migration
are

present

tested.

of volatile

components

is

indicated by the

compo­

sition analysis.
The

amount

of migrating volatiles

gross

migration tests

tests

on their specific migration.

c. Shape,
Films

size

etc,

should be

like bottles,
they

In case

of the

and tins

filled up to

of film results

of "containers"

•

to be

ob.jects

tested in a

cups

should be

have

for which the

corrected follows

to be

should be

of the

from the

tested

"Maturi-cell",

1

results

while

tested as

"containers"
such whereby

cm below the brim.

should be

expressed in mg/5dm

in mg/volume used,

whereafter it may

2
:

in case

converted

ASI-PR 0001424

into mg/l
with

Films

in order

the

facilitate

consisting of laminates
sealing sachets

Other films
if more

comparison

of the

test

results

P.A.D.I.

either by

taken

to

from the

("homogeneous

convenient.

The

should be

films")

total

tested at

material
may be

surface

one

side

only,

or in a Maturi

cell.

tested at

area may

two

sides,

then have

to be

into account.

Specific

migration

Specific

migration tests have

only in order to

to be

obtain data to

made

correct

for volatile
the

results

components

of gross

migration tests.
Furthermore

they have

the P.A.D.I.
is

smaller

lies

than

during the

below the

the

gross

to be made

amount

simulants
gross

and under the

components

"observed gross

for which

migration"

of material migrated

migration

Specific migration tests

for those

as

(i.e,

determined

tests).

should be
test

carried

out

using the

conditions mentioned

migration tests.

.

‘

•

.

above

food
for

'

*;* i ■

*

•

Final Remarks
1.

Gross

Migration

Though it
limit

as

is

If

the

tide

.

advisable

much as

utensils,

2.

limit

apply the

possible

exceptions

actual

to

the

test

to be

of use

differ widely from the

mentioned,

'
same

gross

migration

for all packaging materials

may have

conditions

;

and

made.

of a packaging material

or a:

standard-test-conditions

conditions

may have

to be varied accor­

dingly.

3.

In borderline

cases

-

as

far as

under standard conditions
to

carry out

additional

are

the

results

of control

concerned - it may be

control

tests

under actual

advisble
condition

of use.
m
»

.

*

*"

r '

.•

*

29 February

tests

1972

ASI-PR 0001425

2. Polystyrene mixed and copolymers
2.1. description:
the products obtained by the polymerisation of
styrene together with one or more of the monomers
mentioned below, or by mixing polystyrene with
polymers or copolymers of the monomers mentioned
below. The only monomers that may be used are:
acrylonitrile
acrylic acid and its methyl, ethyl, butyl and
octyl esters
butadiene

divinylbenzene, para
ethylene
isobutene
isoprene
methacrylic acid and its methyl, ethyl and
butyl esters
©4-methylstyrene

.

' . • ' .‘

styrene
vinylacetate
vinylpropionate

.■

The total content of styrene and/or ^-methylstyrene
used to obtain the end-product must be more than
5056 on total monomers.

•

*

2.2. specification:
2.2.1. the additives added to polystyrene must be
of good technical quality. No additives or
substances other than those listed in this
schedule may be present in the end-product.
N-.B.-Tho otatod weight percentage -additiyc,
calculated on the end-produpt^sllould be
.

considered as a suggestg-d-^maximum
quantity. This qugnti/ty has, in a few
analysed samples, not given raise to
surpas>irfg of the maximum allowable
-quantity, -indioatod--under—2-. 3.
a. initiators;

■

ammoniumperoxodisulphate
azobiscyclohexanecarbonitrile
'

\

-

•

ASI-PR 0001426

2,2,-azobisisobutyronitrile
bls(4-tert,butylcyclohexyl)peroxydicarbonate
1.3-bis(tert.butylperoxyisopropyl)benzene
1.3-bis(^~hydroperoxyisopropyl)benzene
1.4-bis(i<— hydroperoxyisopropyl)benzene
bis(3,5,5-trimethylhexanoyl)peroxide
tert. butylhydroperoxide
tert. butylperoxyacetate
tert. butylperoxybenzoate
tert. butylperoxybutyrate
tert. butylperoxydiethylacetate
tert. butylperoxy-2-ethylhexanoate
tert. butylperoxyisobutyrate

^

tert, butylperoxyisopropylcarbonate
tert. butylperoxypivalate
tert. butylperoxypropionate
tert. butylperoxy-3»5»5-trimethylhexanoate
cumylhydroperoxide
diacetylperoxide
cliacylperoxide
dibenzoylperoxide
di-tert. butylperoxide
2,2-di-tert.butylperoxybutane
1.1-di-tert.butylperoxycyclohexane
2.2-di-tert.butylperoxyhexane
1,1-di-tert.butylperoxy-3,3» 5-trimethylcyclohex
dicumylperoxide
diisopropylperoxydicarbonate
dipropionylperoxide
p-^-hydroperoxyisopropyl) cumene
potassiumperoxodisulphate
p-menthanehydroperoxide

-

b. emulsifying agents:
alkyl (Cq-C^q) benzenesulphonate, sodium salt
alkyl (Cg-C^g) sulPha-te» sodium salt
alkyl (Cg-C^g) sulphonate, sodium salt
poly(etheneoxide)(=polyethyleneglycol),
rf-

’ .

'

*

+‘f

‘ —,

‘

* *• ' *

* *

•.

aSI"PR

0001427

molecular weight > 200, containing max. 0,3%
of ethanediol and/or bis(2-hydroxyethyl)
ether
poly(etheneoxlde) (8-14), esterified with
lauric-, oleic-, rlcinoleic- and/or stearic
acid
c, emulsion stabilizers:

.

bariun^ulphate
bentonite
carboxymethylcellulose* sodium salt
ethylhydroxyethylcelliillose
gelatine

„

hydroxyethylcellulose
methylcellulose
polyvinylalcohol (viscosity of

solution

in water at 20° C ait least 20 cP)
polyvinylpyrrolidon (viscosity of 5% solution
in water at 20° C alt least 34 cP)
vinylpyrrolidon-polyeUteneoxide copolymer,
molecular v/eight y H000
d. blowing agents:
...
adipic acid
alkanes and cyclo-alkanes, boiling point 0-100(
azodicarbonamide '
;
succinic acid
carbonates of ammonium,, potassium and sodium
citric acid
glutaric acid
levulinic acid
lactic acid
tartaric acid
e. lubricants*
bis(2-ethylhexyl)phthalate
di-n-octylphthalate
NjN’-dipalmitoylethylBiediamine and/or
N, N * -dis tearoyle thylene diamine
epoxidised soya-oil with an oxiran content
between 6,4 and 896
morpholine
‘

ASI-PR 0001428

organopolysiloxanes, containing two methylgroups on every siliciumatom (silicones)
paraffin, microcrystalline, of which the
absorption of UV light shall meet the
requirements as described in Chapter X
(Methods of Investigation)
paraffin, solid, Including synthetic, of v/hich
the absorption of UV light shall meet the
requirements as described in Chapter X
(Methods of Investigation)
paraffin, liquid (refined mineral oil), v/hich
meets the following specification:
colour less than Standard Saybolt 30
odour absent
the absorption of UV light shall meet the
requirements as described in Chapter X
(Methods of Investigation)
polyethylene, molecular weight } 200
ricinolamid
fatty acids, straight chain, saturated and
unsaturated, with even number of carbon atom
Cq-C22» with a maximum content of‘
of
unsaponifiable matter
fatty acids, as described above, esterified
with alcohols, monovalent, primary, straight
chain, saturated, C4“C18» and oleylalcohol
fatty acids, as described above, esterified
with glycerol to mono-, di- and triglyceride
fatty acids, as described above, salts v/ith
aluminium, ammonium, calcium, potassium,
magnesium and sodium
fatty acids, as described above, salts with
morpholine
zinc stearate
f. antioxidants:
antioxidants as prescribed in schedule 31
ASI-PR 0001429

-5-

butylated, styrenated cresols, produced by
reacting equal moles of isobutylene, styrene
and a metacresol, paracresol mixture. The
mixture of cresols has a distillation range
of 3° C, which includes 202° C. The final
product contains 20-2455 of butylated cresols,
23.5-28.5/5 of styrenated cresols, 42-48% of
butylated, styrenated cresols, and meets the
following specifications: acidity not more
than 0.0356, and refractive index at 25° C
of 1.5500-1.5600, as determined by ASTM,
D1218-61. Allowed up to a maximum of 0.5/6 and
exclusively in polystyrene homopolymer and
copolymers, and polyolefins, provided the
foods and beverages do not come into contact
with the packaging containing this anti­
oxidant at a temperature exceeding 65° C.
g. antistatics:
bis(2-hydroxyethyl)-2-hydroxy-3-dodecoxypropylmethylammoniumchloride
N,N,N',N'-tetrakis(2-hydroxypropyl)diarainoethane
fatty acids, as described above, as combinations
with bis(2-hydroxyethyl)amine
h. UV-absorbers and -stabilizers:
2,5-bis(5t-tert.butylbenzoxazolyl-2')thiophene
2(2’-hydroxy-5'-methylphenyl)benztriazole
2-hydroxy-4-n-octoxy benzophenone
i. colorants and pigments, as prescribed in
schedule 30
glues, inks and solvents, provided the endproduct meets sect. 2, sub. £, e and f
of the Packaging and Food-utensils
Regulation (Food Law)
k* other substances:
calciun^arbonate, chalk
chloride of calcium, potassium and sodium
colophonium (gum, wood or tall rosins),
ASI-PR 0001430

•

whether or not modified by catalytic disproportioning and entirely, partly or nonsaponified to potassium- or sodiumsoaps.
The product after catalytic disproportioning
must contain max. 0.15?o substituted
phenantrene (as retene)
dibutylphthalate, blend with sucrose acetate
isobutyrate
dodecylmei'captane

'

ethylenediaminetetraacetic acid, sodium salt
phosphates of calcium and sodium
glycerol

,

■

.

sodium acetate
sodium sulphate
octadecanol .
1,2-propanediol
sucrose acetate isobutyrate
zinc-2-ethylhexanoate
zincoxide
zincsulphate
2.2,2. decomposition products of substances other than
those listed in 2,2.1. must not be present.
2.3. specification of the end-oroduct (packaging material
respectively food-utensils):
2.3.1. the infrared spectrum must contain the peaks
which are characteristic for polystyrene
2.3.2. the amount of volatile matter of the endproduct must not exceed 0.5%~
2.3.3. total gross migration of constituents of the
end-product in the packaged food or beverage
(determined with food simulants according
p

Chapter X) must not exceed 12 mg per dm

or

60 mg per 1 food simulant
2.3.4. specific migration of the below mentioned
. constituents of the end-product in food
simulants must not exceed the mentioned
• quantities (in mg per 5 dm
' per 1 food simulant)

surface or in mg

asi-pr

0001431

mercaptanes: not detectable
peroxides: not detectable
acrylamid and methacrylamid

1

acrylonitrile and methacrylonitrile

0,3

alkyl(Cq-C^q )benzenesulphonates
alkyl(Cq-C18)sulphates
alkyl(C8-C18)sulphonates

:

bis(2-hydroxyethyl)-2-hydroxy-3dodecoxypropyl-methylaramoniumchloride
phthalic acid diesters of fatty alcohols

30

40

2-(2 *-hydroxy-5 *-methylphenyl)-benztriazole
butylated, styrenated cresols

10

ricinolarald
1,1,3-tris(2-methyl-4-hydroxy)-5-tert.

x

6

'1

butylfenyl)butane
fatty acid compositions of (2-hydroxyethyl)

♦

amine
zinc-2-ethylhexanoate

The quantity of migrating components must be
determined using the methods published' in
Chapter X (Methods of Investigation)

the allov/able maximum migration is not yet known;
unless data, leading to the establishment of the
maximum permissible migration are made available
before 1.1.1975, the additives cannot be permitted
any more after that date.
ASX-PR 0001432

3

ANNKX U

29 fdvrier 1972

Pro .let
comme annexe au projet de l'arretd Emballages et objets
usuels (Loi sur 1'alimentation)

Chanitre V: Le Verre et la Ceramique & base de verre
1.

description
un materiau anorganique, obtenu en fondant du sable de
quartz avec principalement des composes de metaux
alcalins et de metaux alcalino-terreux avec ou sans
oxydes d'autres dldments;
le produit non cristallin peut Stre du verre mais
aussi du cristal, le produit entierement ou partiellement
cristallisd est de la ceramique h base de verre.

1.1. types
verre d'emballage: destlnd comme emballage des denrdes
alimentaires ou des boissons pour une ou plusieurs fois;
*.

verre de table: aussi nommd verre de service ou verre
de mdnage: objets d'usage courant destines h un emploi
rdpdte;
cristal: objets d'usage courant (par exeraple des verres
et des carafes) destines k un emploi repetd;
verre resistant au feu: objets d'usage courant, destines
& entrer en contact avec des denrees alimentaires ou des
boissons & des temperatures dlevdes et qui sont destines
& 1'usage repdte;
cdramique & base de verre: objets d'usage courant
destines a l'usage rdpdtd.
■

2.

specification

4

"

.

2.1. le verre qui peut entrer en contact avec des denrees
alimentaires ou des boissons, peut contenir des
constituents, qui sont ddrivds des combinaisons
suivantes:

ASI-PR 0001433

2-

oxyde d*aluminium
oxyde (III) d'antimoine
oxyde (III) d'arsene
oxyde de baryum
oxyde de bore
oxyde de calcium
oxyde de cadmium
oxyde (IV) de cerium
oxyde (III) de chrome
oxyde (Ill)de cobalt
pentoxyde de phosphore
fluor
oxyde de potassium

oxyde de cuivre
oxyde de lithium
oxyde de magnesium
oxyde (II) de manganese
oxyde de sodium
oxyde de nickel
oxyde de rubidium
oxyde de silicium
oxyde (IV) detain
oxyde de titane
oxyde (III) de fer
oxyde de zinc
oxyde de zirconium
tri oxyde de soufre

2.2. Pour arriver a certaines qualit^s d'autres adjuvants
sont permis & une concentration maximum de 0.259^
(a 1‘exception des combinaisons de mercure).
2.3. Pour la preparation de cristal 1*usage de 1?oxyde
(II) de plomb est permis.
■
•
2.4. Pour les noms des differentes categories de cristal .
et les prescriptions concernant leur composition
il faut se r^f^rer aux Directives du Conseil des :
Communautds Europeennes du 15.12.1969 (Publication
des Communautes Europeennes No. L 326/36 du 29.12.1969)
3.

traitement
le verre peut subir un traitement de surface exteme
afin d'am^liorer la solidity,

3.1. pour un traitement h. des temperatures £lev£es
(jusqu’l. la temperature d’incandescence): l'usage
des combinaisons detain ou de titane plus ou moins
volatiles qui r^agissent avec la surface du verre est
permis.
ASI-PR 0001434

*4

I

-3-

3.2. pour un traiteraent jusqu’& quelques centaines °C:
les prodults sont seringu^s avec une solution ou
unc Emulsion aoueuse de
sel de potassium d’acide oleique
polyoxyethylene (= polyethylene glycol), poids
moleculaire > 200
le stearate de polyoxyethylene (8-14)
polypropylene
4.

migration de constituants

4.1. La migration globale des constituants du produit
final dans les simulants d*alimentation ne doit pas
6tre plus elevde que 1*equivalent de 12 mg par dm£
ou 60 mg par £ litre simulant
4.2. La migration specifique dec substances suivantes
du produit final dans les simulants d*alimentation
ne doit pas §tre superieure & 1'equivalent des
p
quantites nommees cl-dessous (mg par 5 dnr ou mg
par & litre simulant):
■

5»

antimoine

0.05

fluor

arsene
baryum
bore
cadmium
cobalt
chrome

0.05
0.1

cuivre
mercure
plorab
manganese
s£l£nium
zinc

1.5*
absent
0.05
0.05

1.5
1.0
absent
0.05
0.1
0.01
5.0

methodes de determination de la migration
Les conditions decrites ci-dessous ont pour but de
donner une indication de la migration, dans un
usage normal,des constituants du verre dans des
denr^es alimentaires ou boissons avec lesquels
ils vont entrer en contact.
■

* en attendant de nouvelles donn^es, quantity
fix£e provisoirement.

ASI-PR 0001435

V
I

-A*

*

5.1. pour les objets qui peuvent entrer en contact avec des
denr£es alimentaires et des boissons & des temperatures
moindres de 70 °C:
a. verre d’emballage:
les determinations de migration sont faites avec
de l'eau distiliee ou 3% d'acide acetique a une
temperature de 70° + 1° C pendant une heure;
b. verre de table:
les determinations de migration sont faites avec
de l'eau distiliee & 70° + 1° C pendant une heure;
©

c. cristal:
les determinations de migration sont faites avec
AO?S d'ethanol dans de l'eau & A0° + 1° C pendant
tine heure.
5.2, pour le verre, qui peut entrer en contact avec des
denrees alimentaires ou des boissons 5. des
.temperatures qui peuvent £tre plus eievees que 70° C:
a. verre d'emballage:
les determinations de migration sont faites avec
de l'eau distiliee ou 3% d'acide acetique dans
une autoclave dont la temperature est tenue 3l
120° + 1° C pendant line heure;

^

b. verre de table:
Idem;
•
c. verre resistant au feu et ceramique 5. base de verre:
Idem.
*

La quantite des constituents migrants doit Stre
deterrainee& l'aide des methodes publies au
Chapitre X (Methodes de Recherche).

N.B. & Stre discute lors du Colloque de Rome: les conditions
pour la determination de la migration, p.e. les pots
destines pour contenir de la confiture, doivent-ils
fitre analyses pendant 10 jours a 40° C pour determiner
la migration eventuelle?
.

ASI-PR 0001436

Ainrex c

SCHEME FOR COHTROLL

ASI-PR 0001437