Commission Directive 2005/31/EC of 29 April 2005 amending Council Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2005-04-29
Institutions: European Commission
Subjects: analytical chemistry, cadmium, ceramics, food safety, lead, marketing, product safety

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COMMISSION DIRECTIVE 2005/31/EC

of 29 April 2005

amending Council Directive 84/500/EEC as regards a declaration of compliance and performance
criteria of the analytical method for ceramic articles intended to come into contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to 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 (1),
and in particular Article 5(2) thereof,

Whereas:

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 (2) is a specific measure within
the meaning of Article 5 of Regulation (EC) No
1935/2004. It concerns the possible migration of lead
and cadmium from ceramic articles which,
in their
finished state, are intended to come into contact with
foodstuffs, or which are in contact with foodstuffs, and
are intended for that purpose.

Article 16 of Regulation (EC) No 1935/2004 provides
that the specific measures are to require that materials
and articles covered by those measures are accompanied
by a written declaration stating that they comply with
the rules applicable to them.

That requirement has not yet been set out in Directive
84/500/EEC. There is a need to lay down that obligation
for all ceramic articles which are not yet in contact with
foodstuffs to clearly distinguish them from decorative
articles.

The national competent authorities should have access to
articles
documents demonstrating that
the
comply with the migration limits
lead and
cadmium. Therefore, the manufacturer or importer into
the Community should make information concerning
analysis carried out available to them on request.

ceramic
for

(1)

(2)

(3)

(4)

(5)

possible methods. This Directive should take techno-
logical progress into account and establish a set of
performance criteria that
the analytical method must
comply with having regard to Commission Directive
2001/22/EC of 8 March 2001 laying down the
sampling methods of analysis for the official control of
the levels of lead, cadmium, mercury and 3-MCPD in
foodstuffs (3).

In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of the
basic objective of ensuring the free movement of
ceramic articles intended to come into contact with food-
stuffs to lay down rules for a correct enforcement of
Directive 84/500/EEC. This Directive does not go
to achieve the
beyond what
is necessary in order
objectives pursued,
third
paragraph of Article 5 of the Treaty.

in accordance with the

Directive 84/500/EEC should therefore be amended
accordingly.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

(6)

(7)

(8)

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 84/500/EEC is amended as follows:

1. The following Article 2a is inserted:

‘Article 2a

1.
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
the
the European Parliament
1935/2004 of
Council (*).

and of

the
Directive 84/500/EEC lays down a method for
lead and cadmium. Technological progress
analysis of
has been made in that area and the analytical method
set out in that Directive is only one amongst several

That declaration shall be issued by the manufacturer or by a
seller established within the Community and shall contain
the information laid down in Annex III to this Directive.

(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 277, 20.10.1984, p. 12.

(3) OJ L 77, 16.3.2001, p. 14. Directive as last amended by Directive

2005/4/EC (OJ L 19, 21.1.2005, p. 50).

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the
Appropriate documentation to demonstrate that
2.
ceramic articles comply with the migration limits for lead
and cadmium set out in Article 2 shall be made available by
the manufacturer or the importer into the Community to the
national competent authorities on request. That documen-
tation shall contain the results of the analysis carried out,
the test conditions and the name and the address of the
laboratory that performed the testing.

___________
(*) OJ L 338, 13.11.2004, p. 4.’

2. Annex II is replaced by the text in Annex I to this Directive.

3. A new Annex III, the text of which is set out in Annex II to

this Directive, is added.

Article 2

1. Member States shall adopt and publish, by 20 May 2006
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

They shall apply those provisions in such a way as to:

(a) permit the trade in and use of ceramic articles complying

with this Directive, from 20 May 2006;

(b) prohibit

the manufacture

and importation into the
Community of ceramic articles which do not comply with
this Directive, from 20 May 2007.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 29 April 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

‘ANNEX II

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.

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5.2. Determination of lead and/or cadmium

— The sample thus prepared is tested under the conditions laid down in Annex I.

— 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.’

ANNEX II

‘ANNEX III

DECLARATION OF COMPLIANCE

The written declaration referred to in Article 2a(1) 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 this Directive 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.’