French Public Health Code
In forceI.-The studies mentioned in II of Article L. 3512-17 are intended to examine, for each additive, whether it :
1° Contributes to the toxicity or addictive effect of the products in question and whether this results in a significant or measurable increase in the toxicity or addictive effect of one of the products concerned;
2° Produces a characteristic flavour;
3° Facilitates the inhalation or absorption of nicotine;
4° Leads to the formation of substances that have carcinogenic, mutagenic or toxic properties for human reproduction and in what quantities, and if this has the effect of significantly or measurably increasing the carcinogenic, mutagenic or toxic properties for human reproduction of one of the products concerned.
II-The in-depth studies take account of the intended use, and in particular:
1° The combustion process involving the additive;
2° The interaction of the additive with other ingredients in the product.
III - Manufacturers and importers shall draw up a report on the results of the studies, which shall be sent with them. This report includes a summary and a detailed presentation of the scientific publications available concerning this additive and summarising the data relating to its effects.
IV -When an additive is used in different products of comparable composition, manufacturers and importers may produce a joint study.
V.-The public establishment mentioned in I of article L. 3512-17 may:
1° Request additional information concerning the additive from the manufacturers and importers;
2° Assess the completeness of the studies, their methodology and their conclusions.
These requests do not affect the deadline mentioned in II of article L. 3512-17.
