{"hq_id":"hq-p-spe-000024","name":"Menstrual cup and disc","category":{"primary":"personal_care","secondary":"menstrual_products","tags":["menstrual cup","period cup","reusable menstrual product","sustainability","silicone","TPE"]},"product_tier":"SPE","overall_risk_level":"low","description":"Reusable menstrual collection devices made from medical-grade silicone or thermoplastic elastomer (TPE). Inserted into vagina to collect menstrual fluid. Devices are reusable and require cleaning between use. No chemical exposure from menstrual fluid, but material safety and cleaning methods are relevant.","synthesis":{"derived_risk_level":"insufficient_data","synthesis_confidence":0,"synthesis_method":"none","context_source":null,"compounds_resolved":0,"compounds_total":0,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"people with silicone allergies or sensitivities","overall_risk":"low","primary_concerns":["Potential phthalate exposure if TPE material is used; bacterial contamination risk if cup is not properly cleaned"],"exposure_routes":"vaginal contact"},"exposure":{"routes":["dermal"],"contact_types":["vaginal_contact"],"users":["menstruating_person"],"duration":"hours_to_days","frequency":"monthly","scenarios":["Dermal contact during handling of Menstrual cup and disc (hours_to_days contact)"],"notes":"Device is in contact with vaginal tissue and menstrual fluid for up to 12 hours per day during menstrual cycle. Exposure is cyclical (monthly) rather than continuous."},"consumer_guidance":{"red_flags":[{"indicator":"Menstrual cup material is unknown or not disclosed; marketing does not specify silicone vs. TPE","meaning":"Cannot assess phthalate risk or biocompatibility; purchase from reputable manufacturer with full material disclosure.","action":"Contact manufacturer to request material specifications. Choose cup with transparent disclosure."},{"indicator":"Cup has visible cracks, tears, or discoloration; odor or discoloration that does not rinse away","meaning":"Material degradation may release phthalates or other chemicals; cup is compromised.","action":"Replace cup immediately. Do not use damaged cups."},{"indicator":"User develops vaginal irritation, itching, or discharge shortly after starting cup use","meaning":"May indicate allergy to silicone or TPE, or bacterial contamination from improper cleaning.","action":"Discontinue use; wash thoroughly and allow vaginal tissue to heal. If symptoms persist, consult gynecologist."}],"green_flags":[{"indicator":"Cup is explicitly medical-grade silicone or clearly labeled phthalate-free","meaning":"Eliminates phthalate exposure; ensures biocompatible material.","verification":"Check labeling and manufacturer specifications; request test documentation if available."},{"indicator":"Manufacturer provides detailed sterilization and cleaning instructions","meaning":"Indicates responsible approach to hygiene and safety.","verification":"Instructions are clear and detailed; manufacturer offers sterilizing tablet or cup wash options."},{"indicator":"Cup comes with clear sizing guidance and multiple size options","meaning":"Proper fit reduces discomfort and insertion difficulties; shows attention to user needs.","verification":"Manufacturer provides sizing chart based on age, parity, and cervical height."}],"what_to_ask":[{"question":"Is this cup made from medical-grade silicone or TPE? If TPE, is it phthalate-free?","why_it_matters":"Medical-grade silicone is inert and phthalate-free; TPE may contain phthalates which are endocrine-disrupting.","good_answer":"Medical-grade food-safe silicone (platinum-cured); or phthalate-free TPE with test documentation.","bad_answer":"Unknown material; TPE without phthalate status clarification; 'BPA-free' claim (BPA not typically in menstrual products)."},{"question":"Has the cup undergone biocompatibility testing? Can you provide ISO 10993 documentation?","why_it_matters":"Biocompatibility testing ensures material will not cause allergic reaction or tissue irritation.","good_answer":"Yes, biocompatibility tested per ISO 10993 standards; test reports available upon request.","bad_answer":"No testing performed; 'safe' claim without documentation; unclear quality assurance."}],"alternatives":[{"name":"Pads (cloth or disposable) with no chemical exposure concerns","notes":"Traditional menstrual management; lower TSS risk than tampons; higher environmental impact if disposable"},{"name":"Period underwear with embedded absorbent material","notes":"Reusable; growing market with various material options"},{"name":"Menstrual discs (similar to menstrual cups but flat design)","notes":"Alternative to cups; different insertion and removal technique; similar biocompatibility concerns apply"}],"notes":"Menstrual cups are an excellent sustainable alternative to tampons if made from biocompatible materials and properly cleaned. Material choice is critical."},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"FDA — Medical Device Classification (Class II or III depending on claims)","citation":"21 CFR 884.5000, 884.5250","requirements":"If marketed as medical device, requires 510(k) clearance or PMA depending on claims; if marketed as general menstrual product, less regulated","compliance_status":"Varies; FDA guidance still evolving","effective_date":"Ongoing; FDA issued updated guidance in 2022","enforcing_agency":"FDA - CDRH","penalties":"Market withdrawal if misclassified or unsafe","source_ref":null},{"jurisdiction":"USA","regulation":"CPSIA — Phthalate Restrictions (if product is deemed toy or children's product)","citation":"16 CFR 1307-1309","requirements":"Phthalate restrictions apply only if product is classified as toy or children's product; menstrual products typically exempt as adult products","compliance_status":"Likely exempt as adult product","effective_date":"2008-2017","enforcing_agency":"CPSC","penalties":"Not applicable to menstrual cups","source_ref":null},{"jurisdiction":"EU","regulation":"REACH — Chemical Safety (phthalate restrictions)","citation":"Directive 2015/863/EU","requirements":"Restrictions on phthalates in products; applies to menstrual cups sold in EU","compliance_status":"Required for EU products","effective_date":"2015 onwards","enforcing_agency":"EU Member State authorities","penalties":"Market prohibition, product recall","source_ref":null}],"certifications":[{"name":"FDA 510(k) Clearance (if applicable)","issuer":"FDA","standard":"Medical Device Clearance","scope":"If marketed as medical device with TSS or infection-prevention claims"},{"name":"ISO 10993 Biocompatibility","issuer":"ISO","standard":"Biological Evaluation of Medical Devices","scope":"Biocompatibility testing for vaginal contact devices"},{"name":"CE Mark (EU)","issuer":"Notified Body","standard":"EU Medical Device Regulation","scope":"Products sold in EU (if classified as medical device)"}],"labeling":{"required_disclosures":["Material composition and biocompatibility information","Instructions for sterilization and cleaning","Warnings about TSS risk (if claiming protection)","Instructions for insertion and removal","Size and capacity information"],"prop65_warning":{"required":false,"chemicals":[],"endpoint":null,"notes":"Not typically required for menstrual products."},"ghs_labeling":{"required":false,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":"Not applicable to menstrual products."},"hidden_ingredients":{"trade_secret_protected":false,"categories_hidden":[],"estimated_count":0,"known_concerns":"Material composition is generally disclosed; no trade secret concerns.","notes":"Manufacturers should clearly disclose whether cup is silicone or TPE, and whether silicone is food-grade, medical-grade, or pharmaceutical-grade."},"notes":"Clear material disclosure is essential for consumers with known sensitivities or preferences."},"recalls":[],"regulatory_gap":"FDA classification status for menstrual cups is unclear; some products marketed as medical devices, others as general products. Phthalate restrictions do not clearly apply.","notes":"Regulatory oversight for menstrual cups is evolving; biocompatibility and safety data should be prioritized."},"lifecycle":{"recyclable":true,"disposal_guidance":"Menstrual cups are reusable for 3-10 years. At end of life, compost (if truly compostable silicone product) or dispose as regular waste.","hazardous_waste":false,"expected_lifespan":"3-10_years"},"formulation":{"form":"solid","key_ingredients":[{"hq_id":null,"name":"Medical-grade silicone","role":"base_material","concentration_pct":"95-99"},{"hq_id":null,"name":"Colorant pigment (medical-grade)","role":"colorant","concentration_pct":"0.5-2"}],"certifications":[]},"materials":{"common":[{"material_id":null,"material_name":"Medical-grade silicone","component":"cup body and rim","prevalence":"very_common","notes":"Food and medical-grade silicone is hypoallergenic and biocompatible"},{"material_id":"hq-m-str-000035","material_name":"Thermoplastic elastomer (TPE)","component":"alternative material for some cups","prevalence":"common","notes":"Flexible polymer; biocompatible; may contain phthalates as plasticizers","hq_id":"hq-m-str-000035"}],"concerning":[{"material_id":null,"material_name":"TPE plasticizers (phthalates)","concern":"If TPE-based cup contains phthalates, potential endocrine-disrupting exposure","compounds_of_concern":[],"source_refs":[]},{"material_id":null,"material_name":"Improper cleaning — bacterial contamination","concern":"Non-sterilized cup may harbor bacteria causing infection","compounds_of_concern":[],"source_refs":[]}],"preferred":[{"material_id":null,"material_name":"Medical-grade silicone cups (phthalate-free)","why_preferred":"Eliminates phthalate exposure; silicone is inert and non-reactive","tradeoffs":"Silicone cups may cost more than TPE alternatives"}]},"compound_composition":[{"hq_id":null,"compound_name":"Phthalates (if TPE material contains plasticizers)","role":"endocrine disruptor","typical_concentration":null}],"identifiers":{"common_names":["menstrual cup","period cup","menstrual disc","reusable menstrual product"],"aliases":["menstrual collector","cup-based menstrual product"],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"Generic Mass-Market Brand A","manufacturer":"Consumer Products Corporation","market_position":"mass_market","notable":"Widely available mass-market option"},{"brand":"Generic Mass-Market Brand B","manufacturer":"Consumer Goods Ltd","market_position":"mass_market","notable":"Popular budget alternative"},{"brand":"Premium Brand A","manufacturer":"Premium Consumer Inc","market_position":"premium","notable":"Upscale premium positioning"},{"brand":"Professional Brand","manufacturer":"Professional Products Co","market_position":"professional","notable":"Professional/salon-grade option"},{"brand":"Specialty Eco-Brand","manufacturer":"Natural Products Ltd","market_position":"premium","notable":"Sustainable/natural product line"}],"sources":[{"id":"src_001","type":"journal","title":"Menstrual cups — safety, efficacy, and user satisfaction","url":"https://doi.org/10.1111/fcp.12382","accessed":"2026-03-23","year":2018,"notes":"Systematic review of menstrual cup safety and user outcomes; low TSS risk compared to tampons"},{"id":"src_002","type":"regulation","title":"FDA — Guidance for Industry: Menstrual Products","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/menstrual-products","accessed":"2026-03-23","year":2022,"notes":"FDA updated guidance on classification and regulation of menstrual products"},{"id":"src_003","type":"journal","title":"Phthalate exposure from menstrual product use — chemical analysis","url":"https://doi.org/10.1016/j.chemosphere.2019.124538","accessed":"2026-03-23","year":2019,"notes":"Chemical analysis of TPE-based menstrual cups; phthalate content varies by manufacturer"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-02T18:19:22.941Z"}}