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December 2006
EUROPEAN UNION
At present, the legislation controlling the use of carbon blacks in food-contact applications in the European Union is complex. There is no entry in the "monomers and additives" Directive for this material and therefore relevant national legislation applies. This means that a single grade may be acceptable for use in certain countries - possibly with a set of different use restrictions - while not being acceptable in other member states.
The EU is currently working on a further amendment to the "monomers and additives" Directive and this would add an entry covering carbon blacks. In order to be approved for use in food-contact plastics, the material would have to comply with the following purity requirements :-
- Toluene extract: < 0.1 % using ISO 6209
- UV absorption at 386 nm of cyclohexane extract: < 0.02 absorbance in a 1 cm cell or < 0.1 absorbance in a 5 cm cell using the German BfR method
- Benzo[a]pyrene content: < 250 ppb
- A maximum loading limit of 2.5 % would also apply in all cases
The proposal should have the useful effect of ensuring that there is a single purity / loading requirement which will apply in all member states : other national requirements should vanish.
As and when the proposal is adopted, it will need to be adopted into national law. In the UK, this involves the preparation of specific UK legislation and usually a one year delay : certain member states simply place an entry in their nation gazette stating that the new Directive is now law.
The proposal currently allows a two-year period during which the use of non-conforming grades in food-contact plastic applications must be phased out.
Cabot have decided to adopt a policy similar to that they use for FDA-compliant carbon blacks : as and when the proposal comes into force, a number of grades will undergo routine testing for compliance and these will be the only ones approved for food-contact plastics use in the EU.
For information as to which Cabot grades will be subject to such routine testing for food-contact use, please contact your JMB sales representative or contact us directly (details on our home-page).
USA
The use of carbon black in food-contact plastics in the USA is controlled by the FDA and authorised by 21 CFR § 178.3297. In this document, there are two entries referring to carbon black :-
A) Carbon black (channel black, prepared by the impingement process from stripped natural gas)
Such material may be used without any specific purity requirements or maximum loading restriction. Manufacture by this method is no longer economic and no supplier for such material exists.
B) High purity furnace black
Carbon black produced by this process is authorised for use in food-contact plastic applications provided :-
- total polynuclear aromatic hydrocarbon content is below 0.5 ppm
- benzo[a]pyrene content is below 5 ppb
- the maximum permitted loading is 2.5 %
All batches of Cabot grades Black Pearls 4350, Black Pearls 4750 and Monarch 4750 are subject to routine testing for conformity with the FDA requirements for high purity furnace black. Further information covering such material can be supplied on request.