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 ? Better Regulation Workshop2

● 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 -Full ingredient labeling -Improved label readability Better Regulation Workshop3

● 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 -Increasingly attractive (e.g. via smart phone) -But entire population must be covered = information must also be on the label Better Regulation Workshop4

● ESCD Recommendation: Improved Readability Yazar et al., 2014: Readability can be significantly improved by applying broadly recognized typographical rules and principles Better Regulation Workshop5

● Prevention – regulatory icons CLP health hazard icons: do people know the meaning ? DPD health hazard icons: did people know the meaning ? Better Regulation Workshop6

● Prevention – regulatory icons CLP physical hazard icons: do people know the meaning ? DPD physical hazard icons: did people know the meaning ? Better Regulation Workshop7

● 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. Better Regulation Workshop8

● 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. Better Regulation Workshop9

● 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 ? Better Regulation Workshop10

● Prevention and First aid How effective is text (P phrases) versus icons ? Prevention Treatment Better Regulation Workshop11

● 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 ? Better Regulation Workshop12

● 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 Full ingredient disclosure – already implemented Best linked to UFI ? Or based on brand / variant name ? Better Regulation Workshop13