Labelling of skin sensitizers: the new European Dangerous Preparations Directive.
The new Dangerous Preparations Directive (DPD, 1999/45/EC) introduces a special labelling requirement for skin sensitizers in products that are regulated under this Directive. The packaging of products containing 0.1% of a sensitizer must bear the inscription "Contains 'name of sensitizer'. May produce an allergic reaction." The aim is to protect individuals already sensitized by providing information which enables them to avoid products containing ingredients which may elicit their allergy. However, this is only of benefit where such sensitized individuals do exist in the population. Moreover, this labelling requirement does not take into account the potency of the skin sensitizer. For each sensitizer and type of skin exposure, there will be levels below which it will not elicit allergic contact dermatitis reactions in individuals who are sensitized to that chemical. We therefore propose that within the new DPD, it should be possible to override this labelling requirement with well-documented data, to ensure that information provided to the consumer on the product label is not misleading. The current implementation in the DPD of what is in principle a good idea means that further action (legislative changes; scope for derogation) is needed if the potential benefits are not to be lost.
Roggeband
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R
Procter and Gamble Eurocor, Strombeek-Bever, Belgium.
Basketter
D A
DA
De Groot
A C
AC
Robinson
M K
MK
Gerberick
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GF
D000485:Allergens / Q000737:chemistry; D003879:Dermatologic Agents / Q000737:chemistry / Q000494:pharmacology*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration; D004348:Drug Labeling; D005060:Europe; D012867:Skin / Q000187:drug effects*
D000485:Allergens; D003879:Dermatologic Agents