Labelling of skin sensitizers: the new European Dangerous Preparations Directive

Abstract

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.

Proposal for a risk assessment methodology for skin sensitization based on sensitization potency data

“…Therefore, it has been widely recommended that sensitization thresholds obtained in LLNA, HRIPT or HMT should be expressed as the area dose (Boukhman and Maibach, 2001;Robinson et al, 2000;Roggeband et al, 2001). The area dose can either be given as the molar area dose (i.e., in units of lmol/cm 2 ) or as the specific area dose (i.e., in units of lg/cm 2 ).…”

“…Current regulation uses qualitative systems to classify chemicals and mixtures/formulations as either sensitizers or non-sensitizers Kimber et al, 2001;OECD, 1999OECD, , 2001Roggeband et al, 2001). Hazard identification constitutes a first, fundamental step in protecting workers and consumers.…”

“…From research done during the last 15 years, e.g., using experimental human sensitization to 2,4-dinitrochlorobenzene (DNCB) (Friedmann et al, 1983;White et al, 1986;reviewed in Friedmann, 1990), we know today that skin sensitization as well as allergy elicitation only occur above threshold doses and follow predictable dose-response relationships (Basketter, 1998;Boukhman and Maibach, 2001;Kimber et al, 1999Kimber et al, , 2002Marzulli and Maibach, 1974;Roggeband et al, 2001;Scott et al, 2002;Van Och et al, 2001). It has become clear that skin sensitization is not different from other toxicological effects in this respect.…”

Letter to ESCD members

“…These actions are positive. However, other initiatives appear to have lost some impetus, such as full ingredient labelling of household products, or to have taken such a ‘shotgun’ approach that they risk being discredited (8). The ESCD, perhaps via appropriate working groups, can provide a powerful professional voice in such areas and one which is capable of great influence upon European Commission, but it is up to you, the membership, to drive the establishment of working groups focused on these and other issues which are important to the Society and to your patients/consumers.…”