27. 2. 75 Official  Journal  of the European  Communities No C 46/1 
II 
(Preparatory  Acts) 
COMMISSION 
Proposal  for  a Council  Directive  on the  approximation  of the  laws  of the  Member 
States  relating  to ceramic  articles  intended  to come  into  contact  with  food  (limitation  of 
extractable  quantities  of lead  and  cadmium) 
(Submitted  to the Council  by the Commission  on  31 December  1974) 
THE  COUNCIL  OF THE  EUROPEAN  COMMUNITIES, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community,  and  in particular 
Article  100  thereof; 
Having  regard  to the proposal  from  the Commission; 
Having  regard  to the  Opinion  of the  European 
Parliament; 
Having  regard  to the Opinion  of the Economic  and 
Social  Committee; 
Whereas  the  Council  Directive  of ...  on  the 
approximation  of the  laws  of the  Member  States 
relating  to substances  intended  to come  into  contact 
with  food  provides,  in its Article  4, that  specific 
Directives  will  state  the special  provisions  applicable 
to certain  groups  of substances  and  articles; 
Whereas  in most  of the  Member  States,  ceramic 
articles  intended  to come  into  contact  with  food  are 
subject  to mandatory  provisions,  aimed  at protecting 
human  health,  relating  to the  limitation  of the 
extractable  quantities  of lead  and  cadmium; 
Whereas  these  provisions  vary  from  one  Member 
State  to  another,  thus  creating  obstacles  to 
establishment  and  functioning  of the  common 
market; Whereas  these  obstacles  may  be eliminated  if the 
placing  of ceramic  articles  on the  market  on  a 
Community-wide  basis  is made  subject  to uniform 
rules;  whereas  it is therefore  necessary  to harmonize 
the limit  values,  the test  and  analysis  methods  and 
the wording  shown  on the labels  and  markings  or the 
documents  which  accompany  ceramic  articles  when 
they are marketed; 
Whereas  the  recent  demonstration  of the  effect  of 
luminescent  radiation  on the extraction  of cadmium 
requires  the  development  of a specific  test  method 
and it will  consequently  be necessary  to provide, 
at a later  stage,  for  revision  of both  the  proposed 
method  and  the limits  in order  to take  account  of the 
results  of the studies  in progress; 
Whereas  the same  applies  to the effect  of temperature 
in the case  of vessels  for baking; 
Whereas,  irrespective  of the  number  of articles 
selected  when  official  tests  are  carried  out  in the 
Member  States,  the  limit  values  adopted  are 
maximum  values  with  which  any  article  taken 
individually  must  comply; 
Whereas  technical  progress  requires  frequent 
adaptation  of the  technical  specifications  laid  down 
in the  Annexes  to the  Directive  and  whereas  it is 
advisable  in order  to facilitate  the implementation  of 
the measures  required  for this  purpose,  to lay down  a 
No C 46/2 Official  Journal  of the  European  Communities 27. 2.75 
procedure  establishing  close  cooperation  between  the 
Member  States  and  the  Commission  within  the 
Committee  for Adaptation  to Technical  Progress  and 
in the sector  of ceramic  articles; 
Whereas  it could  happen  that  a ceramic  article  which 
is intended  to come  into  contact  with  food,  although 
conforming  to the  provisions  of this  Directive, 
endangers  public  health;  whereas  it is, therefore, 
advisable  to provide  a procedure  intended  to remove 
this danger, 
HAS  ADOPTED  THIS  DIRECTIVE: 
Article  1 
The requirements  of this  Directive  shall  apply  to 
ceramic  articles  which  are  made  according  to the 
general  principles  laid  down  in Annex  I and  are 
intended  to come  into  contact  with  food;  such 
articles  comprise:  1 
— tableware  and  kitchenware, 
— plates  specially  designed  for very  young  children, 
— cooking  ware, 
— packaging  and  storage  vessels, 
or any  other  article  which  may  be employed  for these 
purposes  except  if a direction  to the contrary  is duly 
stated  on the  article  itself  in a clear  and  perfectly 
visible  fashion.  These  articles  are  hereinafter  called 
'ceramic  articles  used  for food'. Article  3 
1. At  any  marketing  stage,  any  ceramic  article 
tested  in the manner  laid  down  in Annex  II shall  be 
such  that  the quantities  of lead  and  cadmium  do not 
exceed,  according  to the  case,  the  following  limit 
values: 
(a) Tableware  and  kitchenware: 
— flatware: 
lead 1  ± 0-05  mg/dm2, 
cadmium  0-1  ± 0-005  mg/dm2; 
— hollow  ware  articles  with  a capacity  of up to 
five litres: 
lead 
cadmium 5 ± 0-25  mg/1, 
0-5 ± 0-025  mg/1. 
(b) Plates  specially  designed  for  very  young 
children: 
2-5 ± 0-25  mg/1, 
0-25 ± 0-025  mg/1. lead 
cadmium 
(c) Cooking  ware: 
— flatware: 
lead 0'5  ± 0-025  mg/dm2, 
cadmium  0*05  ± 0-0025  mg/dm2; 
— hollow  ware  articles: 
lead 2\5  ± 0-25  mg/1, 
cadmium  0-25  ± 0-025  mg/1. 
(d) Packaging  and  storage  vessels: 
lead 2-5  ± 0'25  mg/1, 
cadmium  0-25  ± 0-025  mg/1. 
Article  2 
1. Member  States  shall  take  all  appropriate 
measures  to ensure  that  ceramic  articles  used  for food 
are not marketed  unless  they  satisfy  the requirements 
of this  Directive  and  its Annexes. 
2. They  shall  also  take  all appropriate  measures  to 
ensure  that  ceramic  articles  which  have  the 
appearance  of the  articles  listed  in Article  1, but 
which  are  not  ceramic  articles  as meant  in this 
Directive,  are  not  marketed  unless  they  bear 
appropriate  markings. 2. Ceramic  articles  used  for food  with  a capacity 
of over  five  litres  which  normally  come  within  the 
category  'tableware  and  kitchenware'  shall,  for  the 
purposes  of this  Directive,  be deemed  to be storage 
vessels. 
3. When  a ceramic  article  used  for food  consists  of 
a vessel  fitted  with  a lid, the inner  surface  of the lid 
shall  be tested  under  the  same  conditions  as the 
vessel  itself. 
In this  case  the  level  of extraction  of lead  and/or 
cadmium  shall  be calculated  by relating  the  total 
extraction  obtained  to the  vessel  alone,  adding  the 
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extraction  obtained  for  the  lid  to the  extraction 
obtained  for the vessel  alone. 
4. A  ceramic  article  used  for  food  shall  be 
recognized  as satisfying  the  requirements  of this 
Directive  as regards  limits  if, after  a single  test,  the 
quantities  of lead  and  cadmium  extracted  in the 
manner  laid  down  in Annex  II are equal  to or lower 
than  the  corresponding  limit  values  stated  in 
paragraph  1. 
5. The  method  of analysis  described  in Annex  III 
is the  reference  method  for  the  quantitative 
determination  of lead  and/or  cadmium  extracted  by 
the leaching  solution  during  the test. 
Article  4 
1. When  marketed,  ceramic  articles  within  the 
meaning  of this  Directive  shall  be labelled  or marked. 
Such  labelling  or marking  may  be  replaced  or 
supplemented  by accompanying  commercial  literature 
when  these  products  are  not  offered  for sale  to the 
final  consumer. 
2. The  labelling  'or marking  shall  contain  the 
following  information  in readily  legible  and  clearly 
visible  characters: 
(a) the  name  or trade  name  and  the  address  or, 
where  appropriate,  the  registered  trade  mark  of 
the producer  or the  importer  of the  person 
responsible  for placing  the article  on the market; 
(b) where  appropriate,  the words  'for  children'; 
(c) where  appropriate,  the words  'for  cooking'; 
(d) where  appropriate,  in the case  of packaging  sold 
empty  to the final  consumer  and  with  a capacity 
of up to five  litres,  the word  'packaging'. 
3. Member  States  may  require  that  at the  time  of 
offer  and  sale  to the  final  consumer  in their 
territories,  the  labelling  or marking  specified  in this 
Article  shall  also,  be expressed  in their  national 
languages. 
In this  case  this  requirement  shall  apply  only  to the 
labels  and  packaging  of ceramic  articles. 
Article  5 
For reasons  concerning  the extraction  limits  for lead 
and/or  cadmium  and  the  labelling  or  marking requirements,  Member  States  shall  not  prohibit  or 
impede  the placing  of ceramic  articles  on the  market 
if these  articles  satisfy  the provisions  of this  Directive 
and its Annexes. 
Article  6 
1. If  a Member  State  finds  that  a ceramic  article-
which  is intended  to come  into  contact  with  food, 
although  complying  with  the  requirements  of the 
Directive,  constitutes  a danger  to health,  that  State 
may provisionally  forbid  the placing  of the  product 
on the market  in its territory.  It shall  forthwith  inform 
the Commission  and  the other  Member  States  thereof 
and state  the reasons  for its decision. 
2. The  Commission  shall,  within  six  weeks, 
consult  the  Member  States  concerned  and  then, 
without  delay,  express  its  opinion  and  take  the 
appropriate  measures. 
3. Where  the  Commission  is of the  opinion  that 
technical  adaptations  to  the  Directive  prove 
necessary,  such  adaptations  shall  be  adopted  by 
either  the  Commission,  or by the  Council  under  the 
procedure  laid  down  in Article  8. In this  event,  the 
Member  State  having  adopted  safeguard  measures 
may maintain  them  until  such  adaptations  enter  into 
force. 
Article  7 
1. A  committee  (hereinafter  called  the 
'committee'),  is hereby  set up to adapt  to technical 
progress  Directives  which  concern  the elimination  of 
technical  barriers  to trade  in the  sector  of ceramic 
articles.  It shall  consist  of representatives  of the 
Member  States  with  a representative  of  the 
Commission  as chairman. 
2. The  committee  shall  adopt  its own  rules  of 
procedure. 
3. Amendments  needed  technically  to adapt  the 
provisions  of this  Directive  and  its Annexes  shall  be 
adopted  in accordance  with  the procedure  laid  down 
in Article  8. 
Article  8 
1. Where  the procedure  laid  down  in this  Article  is 
followed,  matters  shall  be referred  to the Committee 
by the  Chairman,  either  on his own  initiative  or at 
the request  of the representative  of a Member  State. 
No C 46/4 Official  Journal  of the  European  Communities 27. 2. 75 
2. The  representative  of the  Commission  shall 
submit  to the committee  a draft  of the measures  to be 
adopted.  The  committee  shall  deliver  its Opinion  of 
the draft  within  a time  limit  set by the  chairman, 
having  regard  to the urgency  of the matter.  Opinions 
shall  be adopted  by a majority  of 41 votes,  the votes 
of Member  States  being  weighted  as provided  in 
Article  148  (2) of the Treaty. 
The chairman  shall  not vote. 
3. (a) The  Commission  shall  adopt  the  measures 
envisaged  where  they  are in accordance  with 
the Opinion  of the committee. 
(b) If no opinion  is adopted,  the  Commission 
shall  without  delay  propose  to the Council  the 
measures  to be adopted. 
The Council  shall  act by a qualified  majority. 
(c) If, within  three  months  of the proposal  being 
submitted  to it, the Council  has not acted,  the 
proposed  measures  shall  be adopted  by the 
Commission. Article  9 
1. Member  States  shall  adopt  and  publish  before 
1 January  1977  the provisions  needed  to comply  with 
this Directive  and  shall  forthwith  inform  the 
Commission  thereof. 
They  shall  implement  these  provisions  as from  1 July 
1977. 
2. As  soon  as this  Directive  is notified,  the 
Member  States  shall  also  take  care  to inform  the 
Commission,  in time  to enable  it to make  its 
observations,  of any  proposed  provisions,  to be laid 
down  by law,  regulation  or administrative  action, 
which  they  propose  adopting  in the field  governed  by 
the Directive. 
Article  10 
This  Directive  is addressed  to the Member  States. 
ANNEX  I 
MANUFACTURE  OF CERAMIC  ARTICLES 
General  principles 
The ceramic  articles  listed  in Article  1 are manufactured  from  a mixture  of inorganic  substances 
normally  comprising  a high  proportion  of argillaceous  or siliceous  minerals.  A small  quantity  of 
organic  substance  may  be added  to this  mixture  in certain  cases. 
These  articles  are first  of all shaped  and  the  shape  thus  obtained  is permanently  fixed  by firing. 
Thereafter,  they  may  or may  not  be  coated  with  coloured  or uncoloured  glazes  and/or 
decorations. 
Ceramic  articles  manufactured  in this  way  are often  described  by the following  terms: 
faience  — pottery  — porcelain  — bone  china  — whiteware  — earthenware  — stoneware  — etc. 
27. 2. 75 Official  Journal  of the  European  Communities No C 46/5 
ANNEX  11 
TEST  METHOD 
1. Simulating  solvent 
(a) Nature: 
The simulating  solvent  to be used  in the extraction  of lead  and  cadmium  from  ceramic 
articles  used  as food  containers  is a 4 % by volume  acetic  acid  solution. 
(b) Preparation  of the solution: 
The 4 % by volume  acetic  acid  solution  is obtained  by adding  40 ml of glacial  acetic  acid 
to 960  ml of distilled  water  or water  of equivalent  quality. 
2. Preparation  of the samples 
The sample  must  be clean  and  free  from  grease  or other  matter  likely  to affect  the test. 
The sample  is accordingly  washed  at a temperature  of about  40°  C with  a solution  obtained 
from  a liquid  detergent. 
The sample  thus  washed  is first  of all rinsed  in tapwater  and  then  in distilled  water  or water 
of equivalent  quality. 
It is then  drained  and  dried  either  in a drying  oven  or by means  of a new  filter  paper  so as 
to avoid  any  stain. 
After  being  cleansed  in this  way,  the sample  must  be so handled  that  the surface  to he tested 
does  not come  into  contact  with  the hands  of the person  carrying  out the test. 
3. Filling 
To avoid  loss  of liquid  due  to accidental  spillage,  which  could  distort  the test  results,  and 
also in order  that  the sample  may  be covered  with  a suitable  means  of protection,  the level  of 
the liquid  must  be not more  than  1 mm  from  the overflow  point.  For articles  with  a flat  rim, 
the distance  between  the surface  of the liquid  and  the overflow  point  must  not be more  than 
6 mm. 
4. Flatware 
(a) Definition: 
Ceramic  articles  to be classified  as flatware  are those  of which  the  internal  depth,  as 
measured  from  the lowest  point  to the horizontal  plane  passing  through  the upper  rim, 
does  not exceed  25 mm. 
(b) Determination  of the surface  area: 
In the case  of ceramic  flatware,  the extraction  limit  for lead  and/or  cadmium  is related  to 
the surface  of the menisans  formed  by the free  liquid  surface  obtained  by complying  with 
the filling  requirements  set out in Section  3 above. 
5. Lighting 
After  being  prepared  in the manner  described  in Section  2, the sample  is placed  on a flat 
horizontal  surface,  filled  as laid  down  in Section  4 with  a 4 % by volume  acetic  acid  solution 
prepared  as described  in Section  1 (b). 
The lighting  conditions  during  the test  shall  be as follows: 
(a) Lead  extraction: 
"When  only  the  extractability  of lead  is tested,  the  article  shall  be covered  with  an 
appropriate  means  of protection  and  exposed  to the usual  conditions  of illumination  in a 
laboratory. 
No C 46/6 Official  Journal  of the  European  Communities 27. 2.75 
(b) Lead  and!or  cadmium  extraction: 
When  the  extractability  of lead  and/or  cadmium  is tested,  the  article  shall  be covered 
with  a watch  glass  of a quality  normally  employed  in chemical  analysis  laboratories  and 
exposed  to the following  conditions  of illumination: 
— for  a unit  period  of 24 hours  the  room  in which  the  test  is carried  out  shall  be 
illuminated  for five  hours,  kept  in darkness  for 14 hours  and  then  illuminated  for the 
remaining  five  hours; 
— during  the two,  five-hour  periods  of illumination,  the room  shall  be illuminated  solely 
with  fluorescent  lamps  of the  Philips  'Daylight  MCFE.33'  type  or tubes  with 
equivalent  characteristics.  These  lamps  will  have  to be placed  at a height  of some 
1-5 m above  the bench  so as to give  uniform  illumination  of approximately  1 000 ± 
10 % lux. 
6. Temperature 
An ambient  temperature  of 22 ± 2° C shall  be maintained  in the  place  where  the  test  is 
being  carried  out. 
7. Duration 
The duration  of the  test  will  be 24 hours,  in the  conditions  set out  in Section  5 (a) or (b), 
according  to the type  of test  carried  out. 
ANNEX  111 
METHOD  OF ANALYSIS 
1. Sampling  of the test  solution  for analysis 
Prior  to sampling  of the  test  solution  to determine  the lead  and/or  cadmium  concentration, 
the contents  of the  ceramic  article  to be tested  are  homogenized  by an appropriate  method 
for obviating  any  loss  of solution  and  any  abrasion  of the surface  of the article  to be tested. 
2. Method  of analysis 
The quantity  of the  lead  and/or  cadmium  extracted  by the  solvent  during  the  test  is 
determined  by the atomic  absorption  method  with  the aid of a flame  spectrophotometer,  the 
instrument  having  a sensitivity  of at least  one-tenth  of the lowest  limit  fixed  for the elements 
to be determined.  This  sensitivity  is defined  as the concentration  of elements  which  gives  rise 
to an absorption  of 1 %. 
The determinations  must  be carried  out  in correspondence  with  the  linear  part  of the 
instrument's  calibration  curve  plotted  by means  of reference  solutions.  In the  case  of the 
concentrations  of lead  and/or  cadmium  in the test  solution  which  lie outside  the linear  part 
of the calibration  curve,  prior  dilution  with  4 % by volume  acetic  acid  will  have  to be carried 
out in order  to work  with  a concentration  corresponding  to the linear  part  of the calibration 
curve. 
In order  to plot  the calibration  curve,  the reference  solutions  to be employed  will  have  to be 
prepared  prior  to each  calibration  using  concentrated  stock  solutions  (at least  1 000 ppm  for 
lead and  100  ppm  for  Qadmium)  which  are  diluted  with  freshly  prepared  4 % by volume 
acetic  acid. 
Prior  to any  calibration  or analysis,  a blank  determination  is carried  out  on a sample  of 4 % 
by volume  freshly  prepared  acetic  acid  in order  to take  into  consideration  any  quantities  of 
lead and/or  cadmium  present  in the glacial  acetic  acid  and/or  the water  employed.