Better Regulation Workshop 10/6/16 Medical Subgroup - Summary Participants: Bertein, Jamers, Pizzato, Hilgers, Sesana, Abello, Verstegen, Grinberg, Zänker, Stijntjes, Boeije (moderator) Written input by ESCD (European Society of Contact Dermatitis)

Hazard Icons Regulatory hazard icons are – in general - poorly understood by the consumer (this is true for CLP as well as DPD). People understand there is a need to take care but not what is the underlying hazard. Hazard icons do not (and are not designed to) help consumers adopt safe use, or to determine the right first-aid measures in case of an accident. The only serve to identify the hazard (which they fail to do for the consumer – cf. above) Presence of too many icons is confusing CLP / GHS: diamond shape leads to smaller graphic for same icon size !

Hazard Icons – “corrosive” CLP has created confusion with the ‘corrosive’ icon. Consumers no longer know what to do when a product is labeled corrosive, the label is now so common that it has lost the specific meaning it had under DPD (and which was understood). The icon is now seen as ‘just another hazard icon’. PCCs can no longer base treatment guidance on presence of the corrosive icon, additional information is required to identify the hazard (e.g. pH and alkaline / acid reserve) This is due to a political decision to combine workplace and consumer under GHS. Driven by US. However, only Europe adopts this in consumer labeling. Introduce an icon for eye irritation ?

P-phrases Prevention Treatment Key message is not prominent e.g. “keep out of reach of children” all are correct but some are irrelevant because they cannot be acted on e.g. “wear eye protection”. No advice should be given that cannot be realistically achieved (and is not really needed) Treatment all are relevant and correct but there is too much text to be effective nothing critical is missing Single most important message = “CALL PCC” Key message is not prominent Improve formatting, contrast,… ? But the key message is ‘drowned’ in the amount of text

Safe-use Icons P-phrases = too much text to be effective Can icons be used instead of P-phrases, to make the message come across more effectively ? PCCs judge clearly yes – icons are better than text COM thinks that some people do read the full label Some icons are crystal clear, others less so

Ingredient Labeling ESCD (Dermatologists) PCCs Allergens to be labeled (prevention + diagnostic) Recommend to have the full label on pack, following the Cosmetics Regulation approach (INCI names, no level ranges, all ingredients) Recommend standardized typography (larger text, no CAPS, contrast) Online (smartphone app) is attractive but on pack label still needed PCCs do not require an ingredient label on pack – the medical data sheet (online) they have access to is sufficient. Key condition is easy product identification (UFI correctly implemented and product notified) Agreement that exact ingredient level disclosure is only needed to the extent it is toxicologically relevant (i.e. only new UFI registrations needed if composition change is toxicologically relevant)

Safety Data Sheets Difficulties to correctly link a SDS to a product / brand name Guidance on SDS is often incorrect (usually content is created by software algorithms) e.g. “upon ingestion: give 2 glasses of water; do not induce vomiting” – whereas giving this amount of water will actually trigger vomiting Need to have SDSs reviewed by competent personnel. TBD whether this is to be a medical doctor or a toxicologist.