prEN 1186-3

SLOVENSKI STANDARD
oSIST prEN 1186-3:2020
01-april-2020

Materiali in predmeti v stiku z živili - Polimerni materiali - 3. del: Preskusne metode

Materials and articles in contact with foodstuffs - Plastics - Part 3: Test methods for

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1186-3:2020 E

European foreword ....................................................................................................................................................... 3

1 Scope .................................................................................................................................................................... 4

2 Normative references .................................................................................................................................... 4

3 Terms and definitions ................................................................................................................................... 4

4 Test method ...................................................................................................................................................... 5

4.1 Principle ............................................................................................................................................................. 5

4.1.1 General ................................................................................................................................................................ 5

4.1.2 Method 1: total immersion (in conventional oven or at reflux) ..................................................... 6

4.1.3 Method 2: cell.................................................................................................................................................... 6

4.1.4 Method 3: fillable pouch ............................................................................................................................... 6

4.1.5 Method 4: reverse pouch .............................................................................................................................. 6

4.1.6 Method 5: filling a container ....................................................................................................................... 6

4.2 Reagents ............................................................................................................................................................. 6

4.3 Materials and apparatus ............................................................................................................................... 7

4.3.1 General ................................................................................................................................................................ 7

4.3.2 Common materials and apparatus for all methods ............................................................................ 7

4.3.3 Common materials for methods other than filling a container ...................................................... 7

4.3.4 Materials for method 1a (total immersion in conventional oven) ................................................ 7

4.3.5 Materials for method 1b (total immersion at reflux) ........................................................................ 8

4.3.6 Materials for method 2 (cell) ...................................................................................................................... 8

4.3.7 Materials for method 3 (fillable pouch) and method 4 (reverse pouch) .................................... 8

4.3.8 Materials for method 5 (filling a container) .......................................................................................... 8

4.4 Test specimens ................................................................................................................................................. 8

4.4.1 General ................................................................................................................................................................ 8

4.4.2 Preparation of test specimens and determination of the area in contact .................................. 9

4.5 Exposure to food simulants ...................................................................................................................... 11

4.5.1 Method 1a: total immersion in conventional oven .......................................................................... 11

4.5.2 Method 1b: total immersion at reflux ................................................................................................... 11

4.5.3 Method 2: cell................................................................................................................................................. 12

4.5.4 Method 3: fillable pouch ............................................................................................................................ 12

4.5.5 Method 4: reverse pouch ........................................................................................................................... 12

4.5.6 Method 5: filling a container .................................................................................................................... 12

4.5.7 Rinsing of test specimens and the containers of the blanks ......................................................... 13

4.5.8 Repeated exposure ...................................................................................................................................... 13

4.5.9 General recommendations ....................................................................................................................... 13

4.5.10 General requirements ................................................................................................................................ 13

4.6 Determination of migrating amount ..................................................................................................... 13

4.6.1 Preparation of dishes ................................................................................................................................. 13

4.6.2 Evaporation method ................................................................................................................................... 14

4.6.3 Distillation method ...................................................................................................................................... 14

4.7 Expression of results ................................................................................................................................... 15

4.7.1 General ............................................................................................................................................................. 15

4.7.2 Calculation methods .................................................................................................................................... 15

4.7.3 Analytical tolerances and precision ...................................................................................................... 17

5 Test report ...................................................................................................................................................... 18

Annex A (normative) Alcohol dilution table...................................................................................................... 19

Annex B (informative) Precision data.................................................................................................................. 22

Bibliography ................................................................................................................................................................. 23

This document (prEN 1186-3:2020) has been prepared by Technical Committee CEN/TC 194 “Utensils

This document implements European Commission Regulation on plastic materials and articles intended

to come into contact with food with regards to the determination of the overall migration in food

simulants. This regulatory text is subject to change, it is therefore strongly recommended that users of

this document refer to the latest relevant published regulatory texts, before commencement of any of the

test or tests described in this document, looking to the European Commission website.

This document supersedes EN 1186-3:2002, EN 1186-5:2002, EN 1186-7:2002, EN 1186-9:2002,

In comparison with the previous editions, the following technical modifications have been made:

— removed the regulatory provisions put in the document to avoid the document being obsolete after

— gathered in one document the 8 previous standards that use evaporable simulants and which are

This document specifies methods for measuring overall migration of plastic materials and articles

intended to come into contact with foodstuffs by contacting test specimens with evaporable food

simulants at temperatures greater than or equal to 4 °C and not exceeding the reflux temperature.

The overall migration from a sample of the plastics is determined as the loss in mass of non-volatile

According to the type of materials or articles, contacting with the food simulant is carried out on a single

This document does not cover the interpretation of the results which is expected to account for regulatory

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 8442-2:1997, Materials and articles in contact with foodstuffs — Cutlery and table hollowware —

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

thermostatically controlled heat chamber where the air within is heated and this heat is then transferred

to the food through the plastic as opposed to a microwave oven where the food itself is heated directly

receptacle of a defined size, manufactured in the film under test and which, once filled with food simulant,

exposes the side of the film to be in contact with foodstuffs to such a food simulant or to a test medium

pouch manufactured such that the surface to be in contact with foodstuffs is the outer surface

Note 1 to entry: All sides are sealed to prevent inner surfaces from coming into contact with the food simulant.

The reverse pouch is to be completely immersed in the food simulant or in the test medium.

device in which the film under test can be mounted and which, when assembled and filled with food

simulant, exposes the side of the film to be in contact with foodstuffs to such a food simulant or to a test

Alternative and screening simulants/solvents for example, isooctane and 95 % ethanol

The overall migration of a material or a ready-to-use article made of plastic in contact with foods, is

determined by putting test specimens in contact with evaporable food simulants in test conditions chosen

on the basis of the worst case scenario of use and by weighing the dry residue of the evaporated food

The conditions of exposure of the test specimens are between 4 °C up to the highest temperature given

According to the type of sample, the tests are conducted based on one of the following contacting

Test specimens of known surface are immersed in the food simulant. This method is most suitable for

samples in the form of films and sheets, but can also be applied to a wide range of articles or containers

This method is suitable for tests between 4 °C up to the highest temperature given by the regulation.

This method is only suitable for tests at the boiling point of the food simulant and generally for short

Test specimens of known surface are placed in contact with the food simulant in a cell. This method is

most suitable for plastics in the form of films or sheets in which only one side is to be in contact with

Test specimens of known surface and in the form of pouches are filled with the food simulant; this method

is suitable for plastics in the form of films or sheets in which the surface to be in contact with foodstuffs

(printed, multi-layer materials) can be sealed by applying heat or pressure, to form a pouch.

Test specimens of known surface and in the form of reverse pouches are immersed in the food simulant;

this method is suitable for plastics in the form of films or sheets in which the surfaces can be sealed by

applying heat or pressure to form reverse pouches. If the sample material allows, the reverse pouches

shall be used instead of the fillable pouches when the temperature of the food simulant is greater than or

equal to 70 °C, because of the pressure of the food simulant that can break the sealing of the pouches at

Test specimens of known surface are filled in with the food simulant; this method is most suitable for

The reagents specified hereinafter shall be evaporable at atmospheric pressure and at a temperature less

than or equal to 105 °C and shall produce a non-volatile residue of less than 5 mg/l when evaporated to

dryness and desiccated until a constant mass is obtained at a temperature between 105 °C and 110 °C.

The non-volatile residue of a food simulant shall be less than 5 mg/l when evaporate to dryness and

desiccated until a constant mass is obtained at a temperature between 105 °C and 110 °C.

— 3 % acetic acid (w/v) in aqueous solution: The solution is prepared, for example, by diluting 30 g of

— Hydroalcoholic solutions (10 %, 20 %, 50 % and 95 %) are prepared according to Annex A, Table A.1;

NOTE Other kinds of evaporable liquids can be used as simulants of foods if permitted by the regulation.

Equipment used for testing shall not have properties which interfere with the measurements. The total

mass transfers by the equipment shall be less than 5 mg/l of food simulant. The equipment shall be

4.3.2.2 Thermostatically controlled oven, incubator or refrigerator, capable of maintaining the

4.3.2.3 Glass, glass ceramic, ceramic, stainless steel, nickel, aluminium, platinum, platinum alloy, gold

dishes, 50 mm to 90 mm diameter and maximum mass 100 g, for evaporation of food simulants and

weighing of residues. Glass, glass ceramic or ceramic dishes may be used provided that the surface

characteristics are such that the masses of the dishes after evaporation of any specified food simulants

4.3.2.4 Steam bath, hot plate, distillation apparatus or rotary evaporator for evaporation of food

4.3.3.1 Cutting slab, clean smooth glass, metal or plastic slab of suitable area to prepare test specimens

4.3.3.3 Cutting implement: scalpel, scissors, sharp knife or other suitable implement

4.3.3.6 Glass containers for containing the food simulant and test specimens, for example test tubes,

ground neck, with an internal diameter of approximately 35 mm and length in the range of 100 mm to

4.3.3.7 Pipettes, 50 ml and 100 ml, conforming to the requirements of ISO 648 Class B or automatic

4.3.4.1 Specimen supports, for example made of stainless steel, capable of holding and keeping the test

pieces apart and at the same time ensuring complete contact with the food simulant.

4.3.4.2 Gauze, for example, fine stainless steel gauze, mesh size 1 mm, approximately 25 mm x 100 mm

4.3.4.3 Glass rods, for example 2 mm to 3 mm in diameter and approximately 100 mm long, for

4.3.5.3 Heating device for maintaining the food simulants at reflux temperature during exposure.

4.3.5.5 Device to prevent the test specimen to come in contact with the heated glass flask

— minimum of 0,5 dm of contact area for the test specimen using a number of cells to reach at least

The test specimens shall be clean and free from surface contamination (many plastics can readily attract

dust due to static charges). Before preparing test specimens, remove any surface contamination from the

sample by gently wiping it with a lint-free cloth, or by brushing with a soft brush or with a compressed

As a general rule, do not wash the test specimens with water or solvent. However, if the articles are

accompanied by instructions for use intended for the user advising cleaning before use, these instructions

should be followed for the test, unless they advise rubbing the article with oil: in this case, the instructions

should not be followed insofar as the oil would be included in the overall migration.

For articles with individual surface areas less than 1 dm , use a sufficient number of articles to provide a

Determine the surface area of each test specimen to the nearest 0,01 dm and record.

If the result is to be expressed in mg/kg, determine the contact surface area and the volume of the article

The test specimens shall be clean and free from surface contamination (many plastics can readily attract

NOTE Before preparing test specimens, any surface contamination can be removed by gently wiping it with a

Cut out test specimens of 1 dm (±0,01 dm ) using a cutting template If this is not possible, cut out pieces

suitable for obtaining test specimens having a surface area of approximately 1 dm .

Ensure that the test pieces are well separated and that their surfaces are freely exposed to the food

simulant during the test, using gauze, glass rods and/or specimen holders as required.

For the method in a conventional oven, cut each test specimen into four pieces measuring

For the method at reflux, if necessary, cut each test specimen into smaller pieces.

Cut pieces from the walls of the container or article to give test specimens each approximately 1 dm in

surface area. For articles with individual surface areas less than 1 dm , use a sufficient number of articles

to provide to provide a surface of 1dm . Measure the dimensions of each test specimen to the nearest

Calculate the surface area of each test specimen to the nearest 0,01 dm and record. If necessary, cut each

test specimen into smaller pieces to enable them to fit into the glass test tubes. The test specimens or

pieces are placed on the specimen holders or, if the test specimens are sufficiently rigid, they can be tested

Select representative portions of the article, or multiples of the article for small articles, to give five

dimensionally identical test specimens Surface area of each test specimen should be least 1 dm . Measure

only the surface area of the test specimens intended to come into contact with foodstuffs to the nearest

0,05 dm using the Schlegel Method, as described in EN ISO 8442-2:1997, Annex B, the method described

by Mieth and Hoekstra (JRC-2013) or any other suitable method. Record the surface area of each test

Lay the sample on the cutting slab with the surface to be in contact with the food simulant uppermost.

Cut out a test specimen of suitable dimensions for the cell using the cutting implement.

Prepare a pouch suitable for obtaining an internal contact area of 2 dm and containing a volume of

For example, fold over a sheet measuring 120 mm by 240 mm, with the surface under test facing inward,

and seal the 3 other sides such that the area inside the seals defines a square measuring 100 mm by

100 mm, then cut one corner of the pouch in order to be able to fill it with food simulant (after filling, the

An alternative method consists of only sealing 2 sides and sealing the final side after filling with food

In any case, remove any air bubbles when sealing the filling pouch for the final time.

Measure and record the surface area of the pouch which will be in contact with the food simulant.

Remove excess film from the sealed area (to reduce the area of film not directly exposed to food simulant),

For sealable films in which only one surface is to be tested, the reverse pouch method may be used.

Pouches of dimensions other than 100 mm × 100 mm can be used for this test. These pouches shall have,

Prepare pouches so that the surface area intended to come into contact with the food simulants is the

outer face. The pouches shall have a contact surface area of 2 dm , for example by folding over a sheet

measuring 120 mm by 240 mm, with the side under test facing inward and by sealing the 2 parallel edges

such that the inside area shall define a square measuring 100 mm by 100 mm. Then, reverse the pouch,

An alternative method consists of taking two sheets measuring 120 mm by 120 mm, creating 3 seals,

Measure the external dimensions of the pouches prepared and calculate the exposed areas to the nearest

To test for leaks, it is possible to put into the reverse pouches, a piece of filter paper of an adequate size.