Medical Professionals Subgroup Discussion Better Regulation A I

Medical Professionals Subgroup Discussion Better Regulation A. I. S. E. Workshop June 10, 2016 Brussels

Questions to be addressed Today’s situation: what works, what doesn’t ? Future: what is needed to make the regulation better ? 2 ● Better Regulation Workshop

ESCD Perspective (European Society for Contact Dermatitis) • Widespread exposure to product category - Ingredient information (relevant + legible) about skin sensitizers is essential • Allergic reactions are inevitable, but not obvious to identify the cause - Patch test: baseline series + specific products or ingredients Need complete + accurate ingredient information to conduct patch test • Recommendations - 3 ● Better Regulation Workshop Full ingredient labeling Improved label readability

ESCD Recommendation: Full Ingredient Labeling • Cosmetics regulation - covers this need very well (INCI nomenclature, all ingredients) ESCD suggest to apply this also to detergents confidentiality ? this has been feasible for cosmetics • Full labeling helps - Consumer: avoid “his” allergen Dermatologists: diagnostic work Industry: post market surveillance • Electronic information - 4 ● Increasingly attractive (e. g. via smart phone) But entire population must be covered = information must also be on the label Better Regulation Workshop

ESCD Recommendation: Improved Readability Yazar et al. , 2014: Readability can be significantly improved by applying broadly recognized typographical rules and principles 5 ● Better Regulation Workshop

Prevention – regulatory icons CLP health hazard icons: do people know the meaning ? DPD health hazard icons: did people know the meaning ? 6 ● Better Regulation Workshop

Prevention – regulatory icons CLP physical hazard icons: do people know the meaning ? DPD physical hazard icons: did people know the meaning ? 7 ● Better Regulation Workshop

Prevention - can people act on P phrases Keep out of reach of children. Wear protective gloves/protective clothing/eye protection/face protection. Wash hands thoroughly after handling. Do not breathe spray. Do not spray toward face and eyes. Keep away from heat/sparks/open flames/hot surfaces. — No smoking. Do not spray on an open flame or other ignition source. Dispose of contents/container to … Avoid release to the environment. 8 ● Better Regulation Workshop

First aid - can people act on P phrases IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. IF ON SKIN: [Take off immediately all contaminated clothing. ] Wash with plenty of water. IF SWALLOWED: Immediately call a POISON CENTER/doctor. IF SWALLOWED: rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER/doctor. If medical advice is needed, have product container or label at hand. 9 ● Better Regulation Workshop

Prevention and First aid Is any information currently missing ? What is the most important information currently on pack ? If provided as part of PCC notification: what elements could be removed from pack ? 10 ● Better Regulation Workshop

Prevention and First aid How effective is text (P phrases) versus icons ? Prevention Treatment 11 ● Better Regulation Workshop

Ingredient information ESCD recommendation that full ingredient list is needed for allergy prevention • Current situation of CLP + Detergent regulation Ingredient label needs for other medical needs ? • For prevention • For first-aid treatment by consumer • For treatment by medical doctor INCI nomenclature (cf. cosmetics) versus national languages ? 12 ● Better Regulation Workshop

Ingredient information - alternatives Label • What is essential to ensure prevention Point of sale • Is this an option to provide full transparency also for those without online access ? On-Line / data base • • 13 ● Full ingredient disclosure – already implemented Best linked to UFI ? Or based on brand / variant name ? Better Regulation Workshop