Tampon Global Regulatory overview Erly Evita Product Safety & Regulatory Affairs Procter & Gamble Far East Inc. Kobe Technical Center, Japan

Agenda Regulatory Classification and registration Raw Material requirements Finished Product requirements Requirements to manage mTSS

Regulatory classification & registration United States, Canada: Medical Device (MD) class Ⅱ - registration needed Europe: Household product (Article) – no registration Japan: MD Class I (lowest class, reclassified from class II) – no registration (notification only) Australia: Therapeutic goods - registration needed Korea: Quasi Drug – registration needed China: disposable sanitary products – no registration Other Asia countries (Phil., Sing, Mal, ): general/paper/cosmetics – not regulated – no registration

Raw materials requirements Korea: approved specification for certain materials Other countries (US, Canada, Europe, Japan) : none

Finished Products Requirements Absorbency classification - Test method: syngyna -Regulated by US (FDA), Europe (EDANA, industry association), Australia (TGA), Japan (MHLW), Korea (KFDA) -China and other Asia countries: no specific requirements

Finished Product Requirements (cont.) Micro requirements: –US, Canada, Europe: none –Japan: No requirements. Japan MHLW verbally confirmed agreement to eliminate sterilization requirements from product standard. –Australia: total viable bacteria 1000 cfu, as precaution measure during manufacturing. –China : bacteria cfu; fungi – 100cfu (market not developed - under other sanitary products definition)

Finished Product Requirements (cont.) Rational why micro requirements not needed in the US and Europe (and Japan): –Non sterilized tampons are not cause of infection by toxigenic staph. aureus –Hygienic Manufacturing Standard requirements –Finished products contain so little water and nutrients that bacteria don’t multiply or grow during storage

Finished Products Requirements (cont.) Other quality related requirements: – Australia: withdrawal cord pull, water repellency. –Japan (Industry aligned - “final draft”): withdrawal cord, coloring matter, acid alkali –Korea: foreign material, dyes, acid alkali, fluorescence, absorption rate, fiber shed, withdrawal cord, blended cotton fiber composition

Requirements to manage mTSS US, Canada, Europe (EDANA Code of Practice), Japan, Australia & Korea –TSS Labeling –Absorbency labeling

Requirements to manage mTSS (cont.) TSS education of consumers - include elements of health relevant information on tampon packages –Each package must notify consumer that the pack contains important information regarding mTSS, a rare but serious illness –The notice should advise the user to read and save the leaflet TSS education of consumers and health professionals (e.g., website, school education programs) –provide relevant information on TSS to raise awareness of the important aspects of this rare but serious illness

Requirements to manage mTSS (cont.) TSS labeling –On the outside of the package TSS warning – “Attention…” –In the leaflet – TSS health information Inform consumers about TSS – definition and etiology Inform consumers that TSS is potentially fatal Provide full description of symptoms of TSS Instruct users to consult a doctor if the symptoms of TSS occur, to remove the tampon, and inform doctor that they are menstruating Advise women that if they have had TSS they should consult a doctor before future use.

Requirements to manage mTSS (cont.) Absorbency labeling –On the outside of the package Labeled with droplets indicating range of Syngina absorbency –In the leaflet Include a chart that links absorbency droplets to ranges of Syngina absorbency and to menstrual flow Advise women to use the lowest absorbency/size to suit their flow Note: Korea – not specifically required

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