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REF_N
CAS_N
NAME
SYNONIM
DIR
RESTRICTIONS
AND
SPECIFICATIONS
SCF
List
EFSA/SCF_OP
PL
CT
201
(MBT)
The Committee has received a request to
comment on the safety of the proposed CEN
extraction limit for MBT from rubber
materials used for soothers and teats.
- Considering that on the basis of well-
conducted genotoxicity studies the
previously expressed concern of possible
carcinogenic effects related to the migration
of low amounts of MBT from finished
products can now be discounted.
- Considering that based on the limit of 8 mg
MBT/kg rubber extracted over 24 hours as
proposed by CEN, a worst case exposure to
MBT was calculated not to exceed 22 ug/kg
b.w. for a baby weighing 2 kg, fed 8 times a
day using a new teat of 5 g at each occasion
and
- In view of the existing toxicological
studies, albeit insufficient for establishing a
TDI, which show a NOAEL of 94 mg/kg
b.w. from a 90-day oral mouse study leading
to a margin of safety of around 4200,
The Committee concludes that the potential
oral exposure to MBT resulting from
materials in compliance with the proposed
CEN limit of 8 mg/kg rubber extracted over
a 24 hour period does not constitute a health
hazard.
However, the Committee is aware that MBT
has been reported, primarily in occupational
settings, to induce sensitisation after dermal
contact. As this issue is not related to food
safety it is considered to be outside the remit
of the Committee.
Therefore the SCF recommends that the
Commission seeks appropriate advice to
consider whether direct contact exposure to
MBT, through teats and soothers, constitutes
a sensitisation hazard.