No C 102/4 Official Journal of the European Communities 14.4.84 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive laying down the list of simulants to be used for testing 
migration of constituents of plastic materials and articles intended to come into contact 
with foodstuffs 
COM(84) 152 final 
(Submitted by the Commission to the Council on 2 April 1984) 
(84/C 102/05) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES 
Having regard to the Treaty establishing the 
European Economic Community, 
Having regard to Council Directive 82/711/EEC of 
18 October 1982 laying down the basic rules 
necessary for testing migration of the constituents of 
plastic materials and articles intended to come into 
contact with foodstufs ('), and in particular Article 
2 (3) thereof, 
Having regard to the proposal from the Commission, , 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Commitee, 
Whereas, by virtue of Article 2 (3) of, together with 
the first indent of Chapter I (2) of the Annex to 
Directive 82/711/EEC, appropriate simulants to 
carry out migration tests should be indicated for 
plastic materials and articles intended to come into 
contact with a single foodstuff or a specific group of 
foodstuffs, 
Whereas, in determining appropriate simulants, 
account must be taken in particular of the chemical 
composition of the foodstuff and its physical prop­
erties, 
Whereas, for some foodstuffs containing fat, the 
result obtained in migration tests with the simulant is 
higher than that obtained in migration tests with the 
foodstuff itself; whereas, therefore, the result should 
be corrected by applying a 'reduction factor' appro­
priate to the particular situation; 
Whereas the adaptation of this Directive to technical 
progress constitutes an implementing measure, the 
adoption of which, in order to simplify and accelerate 
(') OJ No L 297, 23. 10. 1982, p. 26. the procedure, should in principle be the respon­
sibility of the Commission; 
Whereas in all cases in which the Council confers on 
the Commission authority to implement the 
provisions relating to plastic materials and articles 
intended to come into contact with foodstuffs, a 
procedure should be laid down establishing close 
cooperation between Member States and the 
Commission within the Standing Committee for 
Foodstuffs, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Pursuant to Article 2 (3) of Directive 82/711/EEC, 
the simulants to be used for testing migration of the 
constituents of plastic materials and articles intended 
to come into contact with a single foodstuff or 
specific group of foodstuffs and the concentration of 
these simulants shall be those indicated in the Annex. 
Article 2 
Adaptations to be made to the Annex to this Directive 
in the light of progress in scientific and technical 
knowledge shall be adopted in accordance with the 
procedure laid down in Article 10 of Council 
Directive 76/893/EEC (2). 
Article 3 
Member States shall take all measures necessary to 
comply with this Directive not later than such time as 
they take the measures to implement Directive 
82/711/EEC. 
Article 4 
This Directive is addressed to the Member States. 
o OJ No L 340, 9. 12. 1976, p. 19. 
14. 4. 84 Official Journal of the European Communities No C 102/5 
ANNEX 
LIST OF SIMULANTS 
1. In the following tables the simulants to be used in migration tests with a particular foodstuff or 
group of foodstuffs are identified by the letters shown: 
Simulant A: distilled water or the equivalent, 
Simulant B:- 3 % (w/v) acetic acid in aqueous solution, 
Simulant C: 15 % (v/v) ethanol in aqueous solution, 
Simulant D: rectified olive oil ('): if for technical reasons it proves impossible to determine 
migration in olive oil, the latter is replaced by sunflower oil or by a standard 
mixture of synthetic triglycerides (2). 
2. Only the simulant(s) indicated by an 'X' is(are) to be used for each heading or subheading; a 
new sample should be used for each liquid. Where no 'X' appears, no migration test is required 
for the heading or subheading concerned. 
3. When 'X' is followed by a stroke and a figure, the result of the migration tests should be divided 
by the number indicated. In the case of certain types of fatty foodstuffs this, figure, known as the 
'reduction factor', is used to take account of the greater extractive capacity of the simulating 
liquid for such foodstuffs. 
4. Where the letter 'a' is shown in brackets after the 'X', only one of the two simulants given 
should be used: 
— if the pH value of the foodstuff is higher than 5, simulant A should be used, 
— if the pH value of the foodstuff is 5 or less, simulant B should be used. 
5. Where a foodstuff is listed under both a specific and a general heading, only the simulant(s) 
indicated under the specific heading is(are) to be used. 
('). Characteristics of rectified olive oil,: 
— iodine number (Wijs numbers) = 80 to 88, 
— refractive index at 25° C = 1,4665 to 1,4679, 
— acidity (expressed as % oleic acid) = 0,5 maximum, 
— number of peroxides (expressed as oxygen milli-equivalents per kilogram of oil) = 10 maximum. 
(2) Characteristics of the HB 307 standard mixture of synthetic triglycerides: see K. Figge, Fd. Cosmet. Toxicol., 
10, 1972, p. 815. 
No C 102/6 Official Journal of the European Communities 14. 4. 84 
TABLE 
Reference 
No Description of foodstuffs Simulants to be used Reference 
No 
A B C D 
01 Beverages 
01.01 Beverages of an alcoholic strength lower than 
5 % (v/v): 
Waters, ciders, fruit or vegetable juices of normal 
strength or concentrated, musts, fruit nectars, 
lemonades and mineral waters, syrups, bitters, 
infusions, coffee, tea, liquid chocolate, camomile, lemonades and mineral waters, syrups, bitters, 
infusions, coffee, tea, liquid chocolate, camomile, 
beers and other X(a) X(a) 
01.02 Beverages of an alcoholic strength equal to or 
exceeding 5 % (v/v): 
Beverages shown under heading 01.01 but with 
an alcoholic strength exceeding 5 %, wines, un-
denatured ethyl alcohol, potable spirits, 
concentrated extracts; liqueurs and other X(a) X(a) X 
02 Cereals, cereal products, baker's and pastrycook's 
wares 
02.01 Starches 
02.02 Cereals, unprocessed, puffed, in flakes (including 
popcorn, corn flakes and the like) 
02.03 Cereal flours and meals 
02.04 Pasta products 
02.05 Baker's and pastrycook's wares, dry: 
A. With fatty substances on the surface 
B. Other X/5 • 
02.06 Pastrycook's wares, fresh: 
A. With fatty substances on the surface 
B. Other X X/5 
• 03 Chocolate, sugar and products thereof 
Confectionery products: 
03.01 Chocolate, chocolate-coated products, substitutes 
and products coated with substitutes X/5 
03.02 Confectionery products: 
A. In solid form: 
I. With fatty substances on the surface 
II. Other 
B. In paste form: 
I. With fatty substances on the surface 
II. Semi-solid X X/5 
X/3 
03.03. Sugar and sugar products: 
A. In solid form 
B. Honey and the like 
C. Molasses and sugar syrups X 
X 
14. 4. 84 Official Journal of the European Communities No C 102/7 
Reference 
No Description of foodstuffs Simulants to be used Reference 
No 
A B C D 
04 Fruit, vegetables and products thereof 
04.01 Whole fruit, fresh or chilled 
04.02 Processed fruit: 
A. Dried or dehydrated fruit whole or in the 
form of flour or powder 
B. Fruit in the form of chunks, puree or paste 
C. Fruit preserves (jams and similar products — 
whole fruit or chunks or in the form of flour 
or powder preserved in a liquid): 
I. In an aqueous medium X(a) 
X(a) X(a) 
X(a) 
II. In an oily medium X(a) X(a) X 
III. In an alcoholic medium (> 5 % (v/v) 
alcohol) X(a) X(a) X 
04.03 Nuts (peanuts, chestnuts, almonds, hazelnuts, 
walnuts, pine kernels and other): 
A. Shelled, dried 
B. Shelled and roasted 
C. In paste or cream form X X/5 
X/3 
04.04 Whole vegetables, fresh or chilled 
04.05 Processed vegetables: 
A. Dried or dehydrated vegetables whole or in 
the form of flour or powder 
B. Vegetables, cut, in the form of purees 
C. Preserved vegetables: 
I. In an aqueous medium X(a) 
X(a) X(a) 
X(a) 
II. In an oily medium X(a) X(a) X 
III. In an alcoholic medium (> 5 % (v/v) 
alcohol) X(a) X(a) X 
05 Fats and oils 
05.01 Animal and vegetable fats and oils, whether 
natural or treated (including cocoa butter, lard, 
melted butter) X 
05.02 Margarine, butter and other fats and oils 
emulsified in water X(a) X(a) X/2 
06 Animal products and eggs 
06.01 Fish: 
A. Fresh, chilled, salted, smoked 
B. In the form of paste X 
X X/3 (') 
X/3 (>) 
06.02 Crustaceans and molluscs (including oysters, 
mussels, snails) not naturally protected by their Crustaceans and molluscs (including oysters, 
mussels, snails) not naturally protected by their 
shells X 
(') The test with simulant D is to be used only for foodstuffs with fatty substances on the surface. 
No C 102/8 Official Journal of the European Communities 14. 4. 84 
Reference Description of foodstuffs Simulants to be used 
No A B C D 
06.03 Meat of all zoological species (including poultry 
and game): 
A. Fresh, chilled, salted, smoked 
B. In the form of paste, creams X 
X X/3 (') 
X/3 0) 
06.04 Processed meat products (ham, salami, bacon and 
other) X X/3 (>) 
06.05 Preserved and part-preserved meat and fish: 
A. In an aqueous medium 
B. In an oily medium X(a) 
X(a) X(a) 
X(a)^ X 
06.06 Eggs not in shell: 
A. Powdered or dried 
B. Other X 
' 06.07 Egg yolks: 
A. Liquid 
B. Powdered or deep-frozen X X/3 
66.08 -Dried white of egg 
07 Grocery products ' 
07.01 Vinegar X 
07.02 Cocoa: 
A. Cocoa powder 
B. Cocoa paste X/5 
X/3 
. 07.03 Coffee, whether roasted or not, decaffeinated or 
soluble, coffee substitutes, granulated or pow­
dered 
07.04 Liquid coffee extracts X 
07:05 Aromatic herbs and medical herbs: 
Chamomile, mallow, mint, tea, lime blossom tea 
and other 
07.06 Yeasts and raising agents: 
A. In paste form 
B. Dried X(a) X(a) 
07.07 Edible salt -
07.08 Sauces: 
A. Without fatty substances on the surface 
B. Mayonnaise, sauces derived from mayonnaise, 
salad creams and other oil in water emulsions 
C. Not emulsified water/oil sauces X(a) 
X(a) 
X(a) X(a) 
X(a) 
X(a) X/3 
X 
07.09 Spices and seasonings in the natural state: 
Cinnamon, cloves, powdered mustard, pepper, 
vanilla, saffron and other 
(') The test with simulant D is to be used only for foodstuffs with fatty substances on the surface. 
14. 4. 84 Official Journal of the European Communities No C 102/9 
Reference Description of foodstuffs Simulants to be used 
No Description of foodstuffs No Description of foodstuffs 
A B C D 
08 Milk products 
08.01 Milk: 
A. Whole 
B. Dried or partly dried 
C. Skimmed or partly skimmed X(a) 
• X(a) 
X(a) X(a) 
X(a) 
X(a) 
08.02 Fermented milk such as yoghourt, buttermilk and 
such products in association with fruit and fruit 
products X(a) X(a) 
08.03 Cream X(a) X(a) 
08.04 Cheeses: 
A. Whole, with rind 
B. Soft cheeses X(a) X(a) 
C. All others X(a) X(a) X/3 (') 
08.05 Rennet: 
A. In liquid or viscous form 
B. Powdered or dried X(a) X(a) 
09 Food preparations 
09.01 Fried or roasted foods: 
A. Fried potatoes, fritters and the like 
B. Of animal origin X/5 
X/3 
09.02 Preparations for soups, stews and broths; pre­
pared soups, stews and broths (extracts, 
concentrates); homogenized composite food prep­pared soups, stews and broths (extracts, 
concentrates); homogenized composite food prep­
arations, prepared dishes: 
A. Powdered or dried: 
I. With fatty substances on the surface X/5 
II. Other • 
B. Liquid or thick: 
I. With fatty substances on the surface X(a) X(a) X/3 
II. Other X(a) X(a) 
09.03 Mustard (except powdered mustard under 
heading 07.09) X(a) X(a) X/3 
09.04 Spread bread, sandwiches, toasted bread and the 
like containing any kind of foodstuff: 
A. With fatty substances on the surface 
B. Other X/5 
10 Miscellaneous products 
10.01 Ice-creams 
10.02 Dried foods: 
A. With fatty substances on the surface 
B. Other X/5 
10.03 Deep-frozen or quick-frozen foods 
(') If it can be demonstrated by means of an appropriate test that there is no 'fatty contact' with the plastic, the 
test with simulant D may be dispensed with.