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Note for Guidance for Food Contact Materials
Page 24 of 126
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Studies on long-term toxicity/carcinogenicity, normally in two species

These studies should be carried out according to prevailing EU or OECD guidelines,
including "Good Laboratory Practice". The substances tested should be of the same
specification as described in section 1.
Health information on people exposed occupationally would be regarded as useful
ancillary information.
8.3
Reduced core set
Under certain circumstances the core set of tests may not be required and only the tests
indicated below may have to be provided.

8.3.1 In cases where migration is in the range from 0.05 - 5 mg/kg of food / food simulant, the
following data are needed:
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The 3 mutagenicity tests mentioned in point 8.2
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A 90-day oral toxicity study
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Data to demonstrate the absence of potential for accumulation in man

8.3.2 In cases where migration is below 0.05 mg/kg of food / food simulant the following data
are needed:
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The 3 mutagenicity tests mentioned in point 8.2.

8.4 Special
investigations/additional
studies
If the above-mentioned studies or prior knowledge or structural considerations indicate
that other biological effects such as peroxisomal proliferation
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, neurotoxicity,
immunotoxicity or endocrinological events may occur, additional studies may be
required.
At present no validated methods are available for studies in laboratory animals which
would allow assessment of a substance's potential to cause intolerance and/or allergic
reactions in susceptible individuals following oral exposure. However, studies on dermal
or inhalation sensitisation may give information relevant for possible hazards from
occupational exposure and could be helpful in assessing consumer safety.

Under certain circumstances, particularly those relating to the chemical nature of the
substance to be used in food contact materials, the tests normally to be provided for the
safety evaluations and risk assessments may be modified as outlined below.

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5
Peroxisome studies are no longer relevant to the evaluation of substances for Food Contact Materials