The Materials and Articles in Contact with Food (Scotland) Regulations 2012

• (c) the name and the address of the laboratory that performed the testing.

• (4) Paragraphs (1), (2) and (3) do not apply in relation to a ceramic article which is second-hand.

• (5) The documentation specified in paragraph (3)(a), (b) and (c) is not required where documentary evidence is provided to show that the materials used to make the ceramic article did not contain lead or cadmium.

SCHEDULE 3 — BASIC RULES FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM

1

Test liquid (‘simulant’) 4 % (v/v) acetic acid, in a freshly prepared aqueous solution.

2

Test conditions

• (a) Carry out the test at a temperature of 22 ± 2 °C for a duration of 24 ± 0,5 hours

• (b) When the migration of lead is to be determined, cover the sample by an appropriate means of protection and expose it to the usual lighting conditions in a laboratory. When the migration of cadmium or of lead and cadmium is to be determined, cover the sample so as to ensure that the surface to be tested is kept in total darkness.

3

Filling

• (a) Samples which can be filled—

Fill the article with a 4 % (v/v) acetic acid solution to a level no more than 1 mm from the overflow point; the distance is measured from the upper rim of the sample. Samples with a flat or slightly sloping rim should be filled so that the distance between the surface of the liquid and the overflow point is no more than 6 mm measured along the sloping rim.

• (b) Samples which cannot be filled—

The surface of the sample which is not intended to come into contact with foodstuffs is first covered with a suitable protective layer able to resist the action of the 4 % (v/v) acetic acid solution. The sample is then immersed in a recipient containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with foodstuffs is completely covered by the test liquid.

4

Determination of the surface area The surface area of the articles in category 1 in regulation 10(5) is equal to the surface area of the meniscus formed by the free liquid surface obtained by complying with the filling requirements set out in paragraph 3.

SCHEDULE 4 — METHODS OF ANALYSIS FOR DETERMINATION OF THE MIGRATION OF LEAD AND CADMIUM

Object and field of application

1

The method allows the specific migration of lead or cadmium (or both) to be determined.

Principle

2

The determination of the specific migration of lead or cadmium (or both) is carried out by an instrumental method of analysis that fulfils the performance criteria of paragraph 4.

Reagents

3

All reagents must be of analytical quality, unless otherwise specified.

4

Performance criteria of the instrumental method of analysis

• (a) The detection limit for lead and cadmium must be equal to or lower than— 0,1 mg/litre for lead, 0,01 mg/litre for cadmium.

The detection limit is defined as the concentration of the element in the 4 % acetic acid solution, as referred to in paragraph 3(a) which gives a signal equal to twice the background noise of the instrument.

• (b) The limit of quantification for lead and cadmium must be equal to or lower than— 0,2 mg/litre for lead, 0,02 mg/litre for cadmium.

• (c) Recovery - the recovery of lead and cadmium added to the 4 % acetic acid solution, as referred to in paragraph 3(a) must lie within 80-120 % of the added amount.

• (d) Specificity - the instrumental method of analysis used must be free from matrix and spectral interferences.

5

Method

• (a) Preparation of the sample

The sample must be clean and free from grease or other matter likely to affect the test.

Wash the sample in a solution containing a household liquid detergent at a temperature of approximately 40 °C. Rinse the sample first in tap-water and then in distilled water or water of equivalent quality. Drain and dry so as to avoid any stain. The surface to be tested is not to be handled after it has been cleaned.

• (b) Determination of lead or cadmium (or both)

The sample prepared in accordance with paragraph 5(a) is tested under the conditions laid down in schedule 3.

Before taking the test solution for determining lead or cadmium (or both), homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested.

Carry out a blank test on the reagent used for each series of determinations.

Carry out determinations for lead or cadmium (or both) under appropriate conditions.

SCHEDULE 5 — DECLARATION OF COMPLIANCE

1

The declaration referred to in regulation 10A must contain the following information—

• (a) the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into the United Kingdom,

• (b) the identity of the ceramic article,

• (c) the date of the declaration, and

• (d) the confirmation that the ceramic article meets relevant requirements in these Regulations and Regulation (EC) No 1935/2004.

2

The declaration must permit an easy identification of the goods for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration of lead and cadmium.

SCHEDULE6 — LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

1

In this schedule “regenerated cellulose film” means a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

2

Notes—

—The percentages in this schedule, in the first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.

—The usual technical denominations are given in square brackets.

—The substances used shall be of good technical quality as regards the purity criteria.