The Ceramic Articles in Contact with Food (England) Regulations 2006

Regulation 3(1)

SCHEDULE 1 Maximum quantities of lead and cadmium which may be transferred from a ceramic article (migration limits)

The quantity of lead and/or cadmium extracted during the test carried out under the conditions laid down in Schedule 2 shall not exceed the following limits—

	Lead	Cadmium
Category 1: Articles which cannot be filled and articles which can be filled, the internal depth of which, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm	0.8 mg/dm2	0.07 mg/dm2
Category 2: All other articles which can be filled	4.0 mg/l	0.3 mg/l
Category 3: Cooking ware, packaging and storage vessels having a capacity of more than three litres	1.5 mg/l	0.1 mg/l

Where a ceramic article does not exceed the above quantities by more than 50%, that article shall nevertheless be recognised as satisfying the requirements of these Regulations if at least three other articles with the same shape, dimensions, decoration and glaze are subjected to a test carried out under the conditions laid down in Schedule 2 and the average quantities of lead and/or cadmium extracted from those articles do not exceed the limits set, with none of those articles exceeding those limits by more than 50%.

Where a ceramic article consists of a vessel fitted with a ceramic lid, the lead and/or cadmium limit which may not be exceeded (mg/dm² or mg/litre) shall be that which applies to the vessel alone. The vessel alone and the inner surface of the lid shall be tested separately and under the same conditions; the sum of the two lead and/or cadmium extraction levels obtained shall be related as appropriate to the surface area or the volume of the vessel alone.

Regulation 3(2)

SCHEDULE 2

PART 1 BASIC RULES FOR DETERMINING THE MIGRATION OF LEAD AND CADMIUM

Test liquid (“simulant”)

1.  4% (v/v) acetic acid, in a freshly prepared aqueous solution.

Test conditions

2.—(1) Carry out the test at a temperature of 22° ± 2° C for a duration of 24 ± 0.5 hours.

(2) 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.

(3) 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.

Filling

3.—(1) Samples which can be filled—

(a) 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.

(b) 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.

(2) 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 receptacle containing a known volume of acetic acid solution in such a way that the surface intended to come into contact with the foodstuffs is completely covered by the test liquid.

Determination of the surface area

4.  The surface area of the articles in category 1 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.

PART 2 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 and/or cadmium to be determined.

Principle

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

Reagents

3.—(1) All reagents must be of analytical quality, unless otherwise specified.

(2) Where reference is made to water, it shall always mean distilled water or water of equivalent quality.

(3) 4 % (v/v) acetic acid, in aqueous solution: add 40 ml of glacial acetic acid to water and make up to 1000 ml.

(4) Stock solutions: prepare stock solutions containing 1,000 mg/litre of lead and at least 500 mg/litre of cadmium respectively in a 4 % acetic acid solution, as referred to in sub-paragraph (3).

Performance criteria of the instrumental method of analysis

4.—(1) The detection limit for lead and cadmium must be equal to or lower than—

(a) 0.1 mg/litre for lead;

(b) 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(3), which gives a signal equal to twice the background noise of the instrument.

(2) The limit of quantification for lead and cadmium must be equal to or lower than—

(a) 0.2 mg/litre for lead;

(b) 0.02 mg/litre for cadmium.

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

(4) Specificity: the instrumental method of analysis used must be free from matrix and spectral interferences.

Method

5.—(1) Preparation of the sample—

(a) the sample must be clean and free from grease or other matter likely to affect the test;

(b) 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.

(2) Determination of lead and/or cadmium—

(a) the sample thus prepared is tested under the conditions laid down in Schedule 1;

(b) before taking the test solution for determining lead and/or cadmium, homogenise the content of the sample by an appropriate method, which avoids any loss of solution or abrasion of the surface being tested;

(c) carry out a blank test on the reagent used for each series of determinations;

(d) carry out determinations for lead and/or cadmium under appropriate conditions.

Regulation 4

SCHEDULE 3 DECLARATION OF COMPLIANCE

1.—(1) The written declaration referred to in regulation 4(1) shall contain the following information—

(2) the identity and address of the company which manufactured the finished ceramic article or articles and (if applicable) of the importer who imports it or them into the Community;

(3) the identity of the ceramic article or articles;

(4) the date of the declaration;

(5) confirmation that the ceramic article or articles meet the relevant requirements in—

(a) these Regulations; or

(b) Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs(1) as amended by Commission Directive 2005/31/EC of 29 April 2005(2); and

(c) Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC(3).

2.  The written declaration shall permit an easy identification of the article or articles 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.

(1)

O.J. L..277 of 20.10.84 p.12.

(2)

O.J. L. 110 of 30.4.05 p.36.

(3)

O.J. L. 338, 13/11/2004 p.4-14.