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This consultation is directed at business operators active in
manufacturing, trading or retailing ceramic articles intended for food
contact. There is also a possible extension of the legislation to glass.
Currently the limits for the release
of metals from ceramic materials and articles into food are set out by Council
Directive 84/500/EEC. Under this Directive, only Lead and Cadmium are
regulated. EFSA published in 2009 and 2010 opinions on these two metals. From
these opinions it follows that the limits under the Directive are too high to
adequately protect the health of consumers.
The current limits in force are
0.3mg/l food for cadmium and 4mg/l food for lead. These values should be
interpreted as the maximum amount of cadmium or lead migrating into 1 litre of
food stimulant using a standard migration test.
In addition to the EFSA opinions, the
Commission received indications from the Member States that also the limits for
other metals would need regulation in the scope of a new measure, and that
other materials, in particular glass, may need to be added as well.
To achieve these objectives, the
Commission has adopted a two phase approach:
In the first phase new limits for lead and cadmium will be laid down in
a new measure under Article (5) of Regulation (EC) No 1935/2004 on materials
and articles intended to come into contact with food. This new measure will
supersede the current Directive.
the second phase other objectives including new limits for metals other than
lead and cadmium and materials other than ceramic material (notably glass) will
The current time line foresees
adoption of the new measure laying down new limits for lead and cadmium in the
second quarter of 2013. The value of the limits and the entry into force of the
limits is subject of this consultation.
Proposed values for Cadmium and Lead
In the context of the first phase,
the Commission considers to propose the values of 5 μg/kg food for the
release of cadmium into food and of 10 μg/kg food for lead as new
These proposed values
are based on health based guidance values set in EFSA opinions:
Lead: EFSA defines a Benchmark Dose Lower Confidence
Limit (BMDL01) of 0.5 μg / kg body weight (b.w.) / day
Cadmium: EFSA defines a Tolerable Weekly Intake (TWI)
of 2.5 μg / kg b.w.
Subsequently the conventional
assumptions to calculate release limits for food contact materials have been
applied to these values. According to these assumptions a 60 kg adult consumes
daily 1 kg of food in contact with ceramic materials.
Because the total exposure to all
sources of these metals (e.g. from the consumption of food) is in the range of
the guidance values set by EFSA, an allocation factor of 10% is applied for
food contact materials.
Thus release limits for cadmium of 2 μg/kg food and lead of 3 μg/kg food, result.
The experts of the Member States
indicated that these release limits would provide largely adequate limits on
the basis of the toxicology and exposure. However from their comments it
becomes clear that in particular the limit for lead maybe too high, because of
the high exposure of the population to lead from other sources. This would
justify an allocation factor lower than the applied 10%.
To derive the proposed
limits the following factors were also taken into account:
expected analytical difficulties in determining lead
and cadmium concentrations at the low levels;
difficulties for industry to comply;
consistency with the limits set in the Drinking Water
Directive (DWD, Council Directive 98/83/EC10 on the quality of water intended
for human consumption).
Based on these considerations the
Commission considers proposing the above mentioned values of 5 μg/kg
food for cadmium and 10 μg/kg food for lead as new specific migration
proposal would reduce the limits currently in force by a factor 60 for
and a factor 400 for lead.
Comments are to be sent on
Wednesday 5th September 2012
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