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- Practical Guide -
Page 56 of 153
10. Other issues of EU plastic regulation
Other problems have been considered at EU level, even though there may not be specific
rules on them yet. Further information on the current status of these discussions is given
10.1. Fat (consumption) Reduction Factor (FRF)
As a first step towards introducing consumption-related reduction factors, the European
professional organisations requested that the Commission introduce a Fat (consumption)
Reduction Factor (FRF). They asked that it should take into account that at least 95% of
the population consumes less than 200 g of fat per day as a long term average. A task force
was constituted by the Commission services to analyse the implications of the industry
proposal and to propose a workable formula on which the SCF could be consulted.
In December 2002 the SCF expressed an opinion favourable to the introduction of FRFs
variables from 1 to 5 in accordance with the quantity of fat) present in the fatty foodstuffs
(i.e if the fat content is 20% the FRF = 1, if the fat content is 100% the FRF = 5. However
the factor will only be applied to lipophilic substances in certain prescribed situations
(see SCF opinion:
During 2003, the Commission services will examine the problems raised by the SCF and
by certain Member States that concern the introduction of the FRF in Directive
2002/72/EC to find a legislative solution.
10.2. Threshold of Regulation
The "Threshold of Regulation" (ToR) was introduced by the US-FDA and means a
concentration of a migrating substance calculated for the whole diet (= 0.5 ppb) below which
the FDA assumes that the risk for human health becomes negligible even when the substance
is highly toxic. Extremely toxic compounds (e.g. carcinogens) are excluded, however.
For a compound migrating into foods in a quantity representing less than 0.5 ppb in the
whole diet, the petitioner no longer needs a formal approval from the FDA. He only needs to
"notify" the new substance to the FDA, accompanied by a reduced technical dossier
The identity data of the substance;
The migration data;
A literature research on the toxicity data for the substance examined.
If there is no opposition from the FDA on the use of the substance, the latter may be
marketed after 90 days. The substance is listed in a specific FDA document.
Concept of "no migration"
Repeatedly, the Commission services were requested to accept that the use of a substance,
which is not detectable in food or food simulants by an "agreed sensitive analytical
method", is permitted without toxicological investigation and without authorisation. This
request will be re-considered in future.