Regulation 6
SCHEDULE 2
PART IPROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS
A. General provisions
1. When the results of the migration tests specified in this Schedule are analytically determined the specific gravity of any simulants used shall be assumed to be 1, so that milligrams of any substance released per litre of simulant will correspond numerically to milligrams of that substance released per kilogram of that simulant.
2. Where any migration test specified in this Schedule is carried out on any sample taken from any plastic material or article and the quantities of food or simulant placed in contact with the sample differ from those employed in the actual conditions under which the plastic material or article is used or is to be used, the results obtained should be corrected by applying the following formula:
M is the migration in mg/kg;
m is the mass in mg of substance released by the sample as determined by the migration test;
a1 is the surface area in square decimetres of the sample in contact with the food or simulant during the migration test;
a2 is the surface area in square decimetres of the plastic material or article in actual conditions of use;
q is the quantity in grams of food in contact with the plastic material or article in actual conditions of use.
3.—(1) Subject to sub-paragraph (2) below, any testing of migration from any plastic material or article shall be carried out on that plastic material or article.
(2) In any case where determination in accordance with sub-paragraph (1) above is impracti-cable, such testing shall be carried out, using either specimens taken from that plastic material or article or, where appropriate, specimens representative of that plastic material or article.
(3) Any sample used for such testing shall be placed in contact with the simulant or food, as the case may be, in a manner representing the contact conditions in actual use, and, for this purpose, the testing shall be carried out in such a way that only those parts of the sample intended to come into contact with food in actual use will be in contact with the simulant or food.
(4) Any migration testing of caps, gaskets, stoppers or similar devices for sealing shall be carried out on these articles by applying them to the containers for which they are intended in a manner which corresponds to the conditions of closing in normal or foreseeable use.
4.—(1) Any sample of a plastic material or article shall be placed in contact with the appropriate simulant or the food for a period and at a temperature which are chosen by reference to the contact conditions in actual use in accordance with the provisions of this Schedule.
(2) At the end of the period referred to in sub-paragraph (1) above, analytical determination of the total quantity of substances (overall migration), each specific quantity of a substance (specific migration) or, as the case may be, both that total and that specific quantity released by the sample shall be carried out on the simulant or food, as the case may be.
5. Where a plastic material or article is intended to come into repeated contact with food, any migration test shall (subject to paragraph 7 below) be carried out three times on a single sample in accordance with the conditions laid down in this Schedule using separate samples of the simulant or, as the case may be, food on each occasion, and the level of the migration found in the third test shall be treated as the level relevant to that test.
B. Special provisions relating to overall migration
6.—(1) Subject to the following sub-paragraphs of this paragraph, any method of analytical determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.
(2) In any proceedings for an offence under regulation 3 comprising excess of an overall migration limit, it shall be a defence for the person charged to prove that—
(a)if an aqueous simulant specified in this Schedule had been used, and the analytical determination of the total quantity of substances released by a sample of the plastic material or article tested had been carried out by evaporation of the simulant and weighing of the residue, or
(b)if rectified olive oil or any of its substitutes had been used as a simulant and—
(i)a sample of the plastic material or article had been weighed before and after contact with the simulant,
(ii)the simulant absorbed by the sample had been extracted and determined quantitatively,
(iii)the quantity of simulant so found had been subtracted from the weight of the sample measured after contact with the simulant, and
(iv)the difference between the initial and corrected final weights had been determined to represent the overall migration of the sample examined,
there would have been no such excess so determined.
7.—(1) Where a plastic material or article is intended to come into repeated contact with food and it is technically impossible to carry out the test described in paragraph 5 above, the test shall be so modified as to enable the level of migration occurring during the third such test to be determined and, subject to sub-paragraph (2) below, such a determination may be used to prove excess of an overall migration limit in relation to a plastic material or article.
(2) In any procedures for an offence under regulation 3 comprising excess of an overall migration limit as determined under sub-paragraph (1) above, it shall be a defence for the person charged to prove that, if—
(a)three identical samples of the plastic material or article had been procured,
(b)one of them had been subjected to the appropriate test according with paragraph 4 above and the overall migration determined (M1),
(c)the second and third samples had been subjected to the same conditions of temperature but the period of contact had been two and three times that specified and overall migration had been determined in each case (M2 and M3, respectively), and
(d)the plastic material or article had been deemed to comply with the overall migration limit relevant to it provided that either M1 or M3 − M2 did not exceed that overall migration limit,
the plastic material or article would not have been deemed to exceed that limit.
8.—(1) Any plastic material or article which exceeds its overall migration limit by an amount not exceeding the analytical tolerance specified in sub-paragraph (2) below shall be deemed for the purposes of these Regulations not to exceed its overall migration limit.
(2) The following analytical tolerances shall be applied for limits of overall migration—
(a)20 mg/kg or, as the case may be, 3 milligrams per square decimetre in migration tests using as a simultant rectified olive oil or substitutes,
(b)6 mg/kg or, as the case may be, 1 milligram per square decimetre in migration tests using other simulants referred to in this Schedule.
PART IISIMULANTS TO BE USED IN MIGRATION TESTS
1. Subject to the provisions of this Schedule, the simulants which may be used in migration testing are as follows—
Simulant A: distilled water or water of equivalent quality;
Simulant B 3% acetic acid (w/v) in aqueous solution;
Simulant C 15% ethanol (v/v) in aqueous solution;
Simulant D: Rectified olive oil, save that if for technical reasons connected with the method of analysis it is necessary to use a different simulant, rectified olive oil shall be replaced by a mixture of synthetic triglycerides or by sunflower oil.
2. The particulars of simulant D referred to in paragraph 1 above are as hereinafter described:
(a)the characteristics of rectified olive oil shall be as follows—
| Iodine value (Wijs) | =80 to 88 |
| Refractive index at 25°C | = 1.4665 to 1.4679 |
| Acidity (expressed as % of oleic acid) | = 0.5% maximum |
| Peroxide number (expressed as oxygen milliequivalents per kg of oil) | = 10 maximum |
(b)the composition of the synthetic triglycerides mixture shall be as follows—
(i)fatty acid distribution
No of C—atoms in fatty acid
| residue ... ... ... ... | 6 | 8 | 10 | 12 | 14 | 16 | 18 | others |
| GLC area (%) ... ... ... ... | ~1 | 6—9 | 8—11 | 45—52 | 12—15 | 8—10 | 8—12 | <=1 |
(ii)purity
| Content of monoclycerides (enzymatically) | ≤0.2% |
| Content of diglyceride(enzymatically) | ≤2.0% |
| Unsaponifiable matter | ≤0.2% |
| Iodine value (Wijs) | ≤0.1% |
| Acid value | ≤0.1% |
| Water content (K. Fischer) | ≤0.1% |
| Melting point | 28±2°C |
(iii)typical absorption spectrum (thickness of layer: d=1 cm; Reference: water at 35°C)
| Wavelength (nm) | 290 | 310 | 330 | 350 | 370 | 390 | 430 | 470 | 510 |
| Transmittance (%) | ~2 | ~15 | ~37 | ~64 | ~80 | ~88 | ~95 | ~97 | ~98 |
At least 10% light transmittance at 310 nm (cell of 1 cm, reference: water at 35°C)
(c)characteristics of sunflower oil shall be as follows—
Iodinevalue (Wijs) = 120 to 145 Refractive index at 20°C = 1.474 to 1.476 aponification number = 188to 193 Relative density at 20°C 0.918 to 0.925 Unsaponifiablematter = 0.5% to 1.5%
PART IIISPECIFICATION OF SIMULANTS TO BE USED
1.—(1) Subject to the provisions of this Part of this Schedule, capability of migration into food shall be treated for the purposes of these Regulations as being determined by carrying out the migration test described in this Schedule—
(a)in any case where a simultant is specified in the Table to this Schedule, either on the simulant or on the food; and
(b)in any case where the food is not specified in that table, either on the simulant which corresponds most closely in extractive capacity to the food or on the food.
(2) A simulant is specified in relation to a food for the purposes of this paragraph where ‘X’ is placed in the column headed by that simulant opposite the food in the Table to this Part of this Schedule, and the Table shall be read in conjunction with the notes thereto and the following paragraphs of this Part of this Schedule.
(3) Where more than one simulant is to be used in relation to a migration test, a new sample of the plastic material or article shall be used for each such test.
2. Where, in the Table to this Part of this Schedule, “X” is followed by an oblique stroke and a figure, the result of any migration test on the simulant shall be divided by the number indicated.
3. Where, in the Table to this Part of this Schedule, the letter “a” is shown in brackets after the “X”, only one of the two simulants specified shall be used in the migration test, that is to say—
(a)if the pH value of the food is higher than 4.5, simulant A shall be used,
(b)if the pH value of the foodstuff is 4.5 or less, simulant B shall be used.
4. Where a food is listed in the Table to this Part of this Schedule under both a specific and a general heading, the simulant relating to the specific heading is the simulant which falls to be used for the migration test.
Table
| Simulants to be used | |||||
|---|---|---|---|---|---|
| Reference Number | Description of food | A | B | C | D |
(**) If it can be demonstrated under regulation 10 or proved by means of an appropriate test that there is to be no fatty contact with the plastic material or article, simulant D shall not be used. | |||||
(*) Simulant B shall not be used where the pH is more than 4.5. | |||||
| 01 | Beverages | ||||
| 01.01 | Non-alcoholic beverages or alcoholic beverages of an alcoholic strength lower than 5% vol.:
| X(a) | X(a) | ||
| 01.02 | Alcoholic beverages of an alcoholic strength equal to or exceeding 5% vol.:
| X((**)) | X((*)) | ||
| 01.03 | Miscellaneous undenatured ethyl alcohol | X((**)) | X((*)) | ||
| 02 | Cereals, cearal products, pastry, biscuits, cakes and other bakers' wares | ||||
| 02.01 | Starches | ||||
| 02.02 | Cereals, unprocessed, puffed, in flakes (including popcorn, cornflakes and the like) | ||||
| 02.03 | Cereal flour and meal | ||||
| 02.04 | Macaroni, spaghetti and similar products | ||||
| 02.05 | Pastry, biscuits, cakes and other bakers' wares, dry: | ||||
A. With fatty substances on the surface | X/5 | ||||
B. Other | |||||
| 02.06 | Pastry, cakes and other bakers' wares, fresh: | ||||
A. With fatty substances on the surface | X/5 | ||||
B. Other | X | ||||
| 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:
| ||||
I.With fatty substances on the surface | X/5 | ||||
II.Other | |||||
B. In paste form: | |||||
I.With fatty substances on the surface | X/3 | ||||
II.Moist | X | ||||
| 03.03 | Sugar and sugar products | ||||
A. In solid form | |||||
B. Honey and the like | X | ||||
C. Molasses and sugar syrups | X | ||||
| 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, purée or paste | X(a) | X(a) | |||
C. Fruit preserves (jams and similar products–whole fruit or chunks or in the form of flour or powder, preserved in a liquid medium): | |||||
I.In an aqueous medium | X(a) | X(a) | |||
II.In an oily medium | X(a) | X(a) | X | ||
III.in an alcoholic medium (≥5% vol.) | X((**)) | X | |||
| 04.03 | Nuts (peanuts, chestnuts, almonds, hazalnuts, walnuts, pine kernels and others) | ||||
A. Shelled, dried | |||||
B. Shelled and roasted | X/5((*)) | ||||
C. In paste or cream form | X | 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 purées | X(a) | X(a) | |||
C. Preserved vegetables: | |||||
I.In an aqueous medium | X(a) | X(a) | |||
II.In an oily medium | X(a) | X(a) | X | ||
III.In an alcoholic medium (≥5% vol.) | X((**)) | X | |||
| 05 | Fats and oils | ||||
| 05.01 | Animal and vegetable fats and oils, whether natural or treated (including cocoa butter, lard, resolidified butter) | X | |||
| 05.02 | Margarine, butter and other fats and oils made from water emulsions in oil | X/2 | |||
| 06 | Animal products and eggs | ||||
| 06.01 | Fish: | ||||
A. Fresh, chilled, salted, smoked | X | X/3((**)) | |||
B. In the form of paste | X | X/3((**)) | |||
| 06.02 | Crustaceans and mulluscs (including oysters,mussels, snails) not naturally protected by their shells | X | |||
| 06.03 | Meat of all zoological species (including poultry and game): | ||||
A. Fresh, chilled, salted, smoked | X | X/4 | |||
B. In the form of paste, creams | X | X/4 | |||
| 06.04 | Processed meat products (ham, salami, bacon and other) | X | X/4 | ||
| 06.05 | Preserved and part-preserved meat and fish: | ||||
A. In an aqueous medium | X(a) | X(a) | |||
B. In an oily medium | X(a) | X(a) | X | ||
| 06.06 | Eggs not in shell: | ||||
A. Powdered or dried | |||||
B. Other | X | ||||
| 06.07 | Egg yolks: | ||||
A. Liquid | X | ||||
B. Powdered or frozen | |||||
| 06.08 | Dried white of egg | ||||
| 07 | Milk products | ||||
| 07.01 | Milk: | ||||
A. Whole | X | ||||
B. Partly dried | X | ||||
C. Skimmed or partly skimmed | X | ||||
D. Dried | |||||
| 07.02 | Fermented milk such as yoghurt, buttermilk and such products in association with fruit and fruit products | X | |||
| 07.03 | Cream and sour cream | X(a) | X(a) | ||
| 07.04 | Cheeses: | ||||
A. Whole, with rind | |||||
B. Processed cheeses | X(a) | X(a) | |||
C. All others | X(a) | X(a) | X/3((**)) | ||
| 07.05 | Rennet: | ||||
A. In liquid or viscous form | X(a) | X(a) | |||
B. Powdered or dried | |||||
| 08 | Miscellaneous products | ||||
| 08.01 | Vinegar | X | |||
| 08.02 | Fresh or roasted foods: | ||||
A. Fried potatoes, fritters and the like | X/5 | ||||
B. Of animal origin | X/4 | ||||
| 08.03 | Preparations for soups, broths in liquid, solid or powder form (extracts, concentrates), homogenized composite food preparations, prepared dishes:
| ||||
I.With fatty substances on the surface | X/5 | ||||
II.Other | |||||
B. Liquid or paste: | |||||
I.With fatty substances on the surface | Z(a) | X(a) | X/3 | ||
II.Other | X(a) | X(a) | |||
| 08.04 | Yeasts and raising agents: | ||||
A. In paste form | X(a) | X(a) | |||
B. Dried | |||||
| 08.05 | Salt | ||||
| 08.06 | Sauces: | ||||
A. Without fatty substances on the surface | X(a) | X(a) | |||
B. Mayonnaise, sauces derived from mayonnaise, salad creams and other oil in water emulsions | X(a) | X(a) | X/3 | ||
C. Sauce containing oil and water forming two distinct layers | X(a) | X(a) | X | ||
| 08.07 | Mustard (except powdered mustard under heading 08.17) | X(a) | X(a) | X/3((**)) | |
| 08.08 | Sandwichs, toasted bread and the like containing any kind of foodstuff: | ||||
A. With fatty substances on the surface | X/5 | ||||
B. Other | |||||
| 08.09 | Ice-cream | X | |||
| 08.10 | Dried foods: | ||||
A. With fatty substances on the surface | X/5 | ||||
B. Other | |||||
| 08.11 | Frozen or deep-frozen foods | ||||
| 08.12 | Concentrated extracts of an alcoholic strength equal to or exceeding 5% vol. | X((*)) | X | ||
| 08.13 | Cocoa: | ||||
A. Cocoa powder | X/5((**)) | ||||
B. Cocoa paste | X/3((**)) | ||||
| 08.14 | Coffee, whether or not roasted, decaffeinated or soluble, coffee substitutes, granulated or powdered | ||||
| 08.15 | Liquid coffee extracts | X | |||
| 08.16 | Aromatic herbs and other herbs: Camomile, mallow, mint, tea, lime blossom and others | ||||
| 08.17 | Spices and seasonings in the natural state: Cinnamons, cloves, powdered mustard, pepper, vanilla, saffron and other | ||||
PART IVTEST CONDITIONS (TIMES AND TEMPERATURES)
1. Subject to paragraph 2 below—
(a)the migration tests shall be carried out, selecting from the times and temperatures specified in the Table to this Part of this Schedule those which correspond most closely to the normal or foreseeable conditions of contact for the plastic material or article being studied;
(b)if a plastic material or article is intended to be used successively at short intervals in several of the conditions of contact referred to in column 1 of the table, migration will be determined by subjecting that plastic material or article successively to each correspond ing test condition specified in column 2, using the same simulant;
(c)where the plastic material or article may in actual use be employed under any conditions of contact time or temperature, the 10-day tests at 40°C and the two-hour tests at 70°C shall be carried out to test migration, except that, where simulant D is used (rectified olive oil or any of its substitutes), only the 10-day test at 40°C shall be carried out.
2. If it is found that carrying out the tests required by paragraph 1 above under the conditions specified in the table causes physical or other changes in the plastic material or article, the migration tests shall be carried out under conditions more appropriate to the specific case.
3. The Table to this Part of this Schedule shall be read with the footnotes to it.
Table
Test conditions to be chosen, according to conditions of contact in actual use (times (t) and temperatures (T))
| Conditions of contact in actual use | Test conditions | |
|---|---|---|
| 1 | 2 | |
(1) For plastic materials in contact with foodstuffs for which a preservation temperature of less than 20°C is specified on the labelling or by law, the test conditions will be 10 days at 20°C. | ||
(2) Use only simulant D at these temperatures, in addition to simulants A, B and C as appropriate, at 100°C or at reflux temperature. | ||
* or reflux temperature. | ||
| 1. | Contact time: t >24 hours | |
| 1.1 T ≤5°C | 10 days at 5°C | |
| 1.2 5°C <T ≤40°C(1) | 10 days at 40°C | |
| 2. | Contact time: two hours ≤ t ≤24 hours | |
| 2.1 T <5°C | 24 hours at 5°C | |
| 2.2 5°C <T ≤40°C | 24 hours at 40°C | |
| 2.3 40°C<T ≤70°C | 24 hours at 70°C | |
| 2.4 70°C <T ≤100°C | 24 hours at 100°C | |
| 3. | Contact time: t <two hours | |
| 3.1 T ≤5°C | Two hours at 5°C | |
| 3.2 5°C <T ≤40°C | Two hours at 40°C | |
| 3.3 40°C <T ≤70°C | Two hours at 70°C | |
| 3.4 70°C <T ≤100°C | One hour at 100°C* | |
| 3.5 1000°C <T ≤121°C(2) | 30 minutes at 121°C | |
| 3.6 121°C <T ≤130°C(2) | 30 minutes at 130°C | |
| 3.7 130°C <T ≤150°C(2) | 30 minutes at 150°C | |
| 3.8 T >150°C | 30 minutes at 175°C | |