EU additive panel opinion on BADGE
with the additive panel at Europe's food watchdog concluding that
BADGE, and its chlorohydrins, do not raise concern for
carcinogenicity and genotoxicity.
At the request of the European Commission the 'Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food' (AFC) evaluated substances intended for use in materials in contact with food. In particular, the panel was asked to advise the Commission on the implications for human health of the use of Bisphenol A diglycidyl ether (BADGE) in epoxy resins and vinylic organosols used in internal can coatings.
"In view of the lack of genotoxicity in vivo, the panel considers that the current restriction of 1 mg/kg of food remains appropriate," said the European Food Safety Authority's (EFSA) expert panel in a recent statement.
BADGE is a monomer used in the production of plastic food contact materials. On-going concerns over its safety led to a first evaluation by the European Commission's Scientific Committee on Food (SCF) in 1986. At that time it was classified into List 4A as a suspect genotoxic agent, in other words chemical substances known to damage DNA, thereby potentially causing mutations or cancer.
With new research available, the SSCF later re-examined the compound - in 1996 - and downgraded it to a lower toxicological category, List 7.
Following a subsequent request from the European Commission to provide a more detailed explanation with respect to the change in classification and the inclusion of the hydrolysis products in the upper limit for the temporary restriction of the specific migration, in June 1997 the SCF published a further opinion, noting that chlorohydrins as reaction products of BADGE had been detected in some special can coatings and in foodstuffs processed in epoxyresin-coated cans, and that these substances were of concern because of theirstructural analogy to the genotoxic chlorohydrins.
New data evaluated in the SCF opinion on BADGE issued in 1999 results of analytical surveysconducted in Europe from 1997-1998, showed a dramatic reduction of migrationvalues of BADGE in canned food. The SCF concluded that consumers exposure was expected to be low.
The latest AFC panel assessment- presented in a 40 page opinion - is based on new data from several toxicological studies carried out in the last five years.
