Materials in Contact with Foodstuffs (Amendment) Regulations,

L.N. 226 of 2006

FOOD SAFETY ACT

(CAP. 449)

Materials in Contact with Foodstuffs (Amendment) Regulations,

IN exercise of the powers conferred by article 10 of the Food Safety

Act, the Minister of Health, the Elderly and Community Care has made

the following regulations>-

(1) The title of these regulations is the Materials in Contact Citation and

commencement.

with Foodstuffs (Amendment) Regulations, 2006, and they shall be read

and construed as one with the Materials in Contact with Foodstuffs

Regulations, 2003, hereinafter referred to as “the principal regulations”. L.N. 138 of 2003.

(2) These regulations shall enter into force on the 20 May,

2007.

These regulations implement the provisions of Commission Scope.

Directive 2005#31#EC of the 29 April, 2005.

The Third Schedule to the principal regulations shall be Amends the Third

Schedule to the

amended as follows>

principal

regulations.

(a) in the provisions under the heading “Ceramics”,

immediately after paragraph 8 thereof, there shall be added the

following paragraphs>–

“9. At the marketing stages up to and including the

retail stage, ceramic articles which are not yet in contact with

foodstuffs shall be accompanied by a written declaration in

accordance with Article 16 of Regulation (EC) No 1935#2004

of the European Parliament and of the Council.

That declaration shall be issued by the manufacturer or

by a seller established within the Community and shall contain

the information laid down in Part C to this Schedule.

Appropriate documentation to demonstrate that the

ceramic articles comply with the migration limits for lead

and cadmium set out in paragraphs 4 to 8 shall be made

available by the manufacturer or the importer into the

Community to the Food Safety Commission on request. That

documentation shall contain the results of the analysis carried

out, the test conditions and the name and address of the

laboratory that performed the testing.”<

(b) for Part B thereof, there shall be substituted the

following>-

“PART B

Methods of analysis for determination of the migration of lead

and cadmium

1. Object and field of application

The method allows the specific migration of lead and#or cadmium

to be determined.

2. Principle

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 point 4.

3. Reagents

– All reagents must be of analytical quality, unless otherwise

specified.

– Where reference is made to water, it shall always mean

distilled water or water of equivalent quality.

3.1.

4 % (v#v) acetic acid, in aqueous solution

Add 40 ml of glacial acetic acid to water and make up to 1 000 ml.

3.2.

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 point 3.1.

4. Performance criteria of the instrumental method of

analysis

4.1. 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 point 3.1, which gives a

signal equal to twice the background noise of the instrument.

4.2. 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.

4.3. Recovery. The recovery of lead and cadmium added to the 4

% acetic acid solution, as referred to in point 3.1, must lie within 80-

120 % of the added amount.

4.4. Specificity. The instrumental method of analysis used must

be free from matrix and spectral interferences.

5. Method

5.1.

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.

5.2.

Determination of lead and#or cadmium

– The sample thus prepared is tested under the conditions

laid down in PART A.

– 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.

– Carry out a blank test on the reagent used for each series

of determinations.

– Carry out determinations for lead and#or cadmium under

appropriate conditions.”< and

(c) immediately after Part B thereof, there shall be added

the following new Part C>-

“PART C

DECLARATION OF COMPLIANCE

The written declaration referred to in paragraph 9 shall contain the

following information>

1. the identity and address of the company which manufactures

the finished ceramic article and of the importer who imports it into the

Community<

2. the identity of the ceramic article<

3. the date of the declaration<

4. the confirmation that the ceramic article meets relevant

requirements in these regulations and Regulation (EC) No 1935#2004.

The written declaration shall 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.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press