Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
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July 2021 Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs Reproductive Health Supplies Coalition www.devsolutions.org office@devsolutions.org 17/109 (BASEMENT), VIKRAM VIHAR, LAJPAT NAGAR IV, NEW DELHI 110024
Study Objectives Objective 1: Develop policy guidance for harmonization of technical benchmarks for disposable and reusable sanitary pads in South Asia and Africa – focus countries India, Nepal, Kenya and Uganda Objective 2: Build consensus around policy recommendations for the enforcement of quality standards for disposable and reusable menstrual health pads at the state level in India
Methodology • Primarily qualitative data collection methodology with in-depth interviews with key stakeholders • Supplemented by secondary review of standards in LMICs (primarily Africa and South Asia) and review of procurement documents for regional state Government procurement in India • Supplementary insights were incorporated from a technical consultation conducted by MH Hub with social enterprises in focus countries – 2 SMEs India and Uganda were included Stakeholders Qualitative Sample Objective 1 Manufacturers 10 Disposable sanitary pad manufacturers 8 Reusable sanitary pad manufacturers NGOs/CSOs/advocacy groups UNICEF, UNFPA PSB, UNHCR-UNFPA, UNAIDS WASH United, MH Hub, GirlUp, GIZ Nepal, WoMENA, Irise UK, AMREF Health Africa, WSSCC (now Sanitation and Hygiene Fund) WASH Alliance Kenya, MHM Partners Alliance (Nepal), African Coalition on MHM (ACMHM), Independent MHH experts; Consultation report shared by WHO identifying areas of interest Technical Experts 3 Microbiologists, 4 Material Scientists, 1 Medical Doctor, 2 Laboratories Regulatory/monitoring stakeholders Uganda National Bureau of Standards Bureau of Indian Standards Swedish Institute of Standards (SIS) Informal interactions with KeBS and BIS
Why are standards are needed? Consumer Trust and Empowerment Enhance access by creating market entry pathways for Consumers new product categories • have access to quality products through the open market • Create a framework for market entry of new categories • are better positioned to assess the product quality and like reusable products where manufacturers cannot invest access redressal mechanisms in marketing and awareness • Include all product categories into policy discussions and unlock Govt. funding – taxation, free distribution etc. which have been disproportionately focused on disposable pads Establish a common definition Reduce cost of giving of QUALITY Product • Government, donors and NGO • Products with stronger QC gain Quality programs can use national and a competitive advantage international standards for • Allow for free flow of products Need for standards procurement for across regional and free/subsidized distribution international borders, thereby Product Product reducing cost for consumers Choice Access
Standards Landscape: Africa (East) Type of Menstrual Country Standard Year of Issue Authority Product ES: 6345- Sanitary Pads- Specification- Disposable Sanitary Napkins Ethiopian Standards Ethiopia Disposable 2018 Agency ES: 6346- Sanitary Pads- Specification- Reusable Reusable Sanitary Napkins DKS: 2881- Disposable Maternity Pads- Disposable Sanitary Napkins 2018 Specification Kenya Kenya Bureau of Standards KS 2925:2020- Kenya Standard-Textiles-Reusable Reusable Sanitary Napkins 2020 Sanitary Towels-Specification First Edition MS 890:2013 SANITARY TOWELS – Disposable Sanitary Napkins 2013 SPECIFICATION (First edition) Malawi Bureau of Malawi MS 1445:2018- Reusable sanitary towels- Standards Reusable Sanitary Napkins 2018 Specification (First edition) TZS: 1659- Disposable Sanitary Towels - Specifications Disposable Sanitary Napkins 2014 Tanzania Tanzania Bureau of Standards TBS: 6136- Reusable Sanitary Towels – Specifications (2nd Reusable Sanitary Napkins 2019 Edition) UBS: 1782- Disposable Sanitary Towels - Disposable Sanitary Napkins Specifications Uganda National Bureau of Uganda 2017 Standards US: 1782- Reusable sanitary towels — Specification Reusable Sanitary Napkins
Standards Landscape: Africa (South) Type of Menstrual Country Standard Year of Issue Authority Product SANS: 1043 Disposable Sanitary Napkins 2010 South Africa Bureau of South Africa Standards (SABS) SANS: 1812 Reusable Sanitary Napkins 2019 HS Code: 4818.40 (import guidelines) Disposable Sanitary Napkins 2011 Zambia Bureau of Zambia Standards Under Development Reusable Sanitary Napkins Under Development ZWS: 730- Manufacture of Sanitary Pads Disposable Sanitary Napkins 2015 Standards Association of Zimbabwe Zimbabwe ZWS 1023: Reusable sanitary pads Reusable Sanitary Napkins 2019
Standards Landscape: Africa (West and Central) Country Standard GS 1248:2019: Specification for single-use disposable sanitary towels (pads) for external use Ghana Reusable Sanitary Napkins – advocacy ongoing Nigeria NIS 291 (2018) Disposable Sanitary Pads Central African Republic Chad Mali CAR, Liberia: No standards body Chad: no website for ATNOR Mali: no website for AMANORM Gambia Gambia: Standard catalogue unavailable for TGSB Senegal: Website under construction for ASN; no info Liberia Senegal
Standards Landscape: Africa (Regional) Type of Menstrual Year of Country Standard Authority Product Issue EAS 96-1: Sanitary towels Disposable Sanitary Napkins 2008 East African Community (EAC)- Specification- Disposable East African Standards (Burundi, Kenya, Rwanda, South Sudan, FDEAS:96- Sanitary towels- Reusable Sanitary Napkins Committee Tanzania, Uganda) 2019 Specification- Reusable ARSO DARS 653:2017 Disposable Sanitary Napkins 2019 African Organization for (36 member countries- UNECA and DARS 1575:2017 Reusable Sanitary Napkins 2019 Standardization (ARSO) AU) UNECA: United Nations Economic Commission for Africa AU: African Union
Standards Landscape: South Asia Country Standard Type of Menstrual Product Year of Issue Authority BDS 1261:2016 Sanitary Towels Mandatory Disposable Sanitary Napkins 2016 Bangladesh Standards Bangladesh and Testing Institute - Reusable Sanitary Napkins - 1980 IS 5405:2019 Disposable Sanitary Napkins Revised in 2019 Bureau of Indian India Standards IS 17514:2021 Reusable Sanitary Napkins 2021 Guidelines Notification by Education, Disposable Sanitary Napkins 2020 Nepal Bureau of Science and Technology Ministry Nepal Standards and - Reusable Sanitary Napkins - Metrology PS: 1449-1979 Disposable Sanitary Napkins 1979 Pakistan Standards and Pakistan Quality Control Authority - Reusable Sanitary Napkins -
Standards Landscape: East and South-East Asia Country Standard Type of Menstrual Product Year of Issue Authority CNS 9324:2004 Feminine sanitary napkins Disposable Sanitary Napkins 2004 Bureau of Standards, China Metrology and - Reusable Sanitary Napkins - Inspection PFSB No. 0325-17: Standards for Approval Disposable Sanitary Napkins 2015 of Sanitary Napkins Japanese Industrial Japan Standards - Reusable Sanitary Napkins - MFDS Quasi-drugs Group 1 (A) Disposable Sanitary Napkins 2009 Korean Ministry of Food South Korea and Drug Safety - Reusable Sanitary Napkins - TCVN 10585:2014 Sanitary Pads for Directorate for Disposable Sanitary Napkins 2014 Vietnam Women Standards, Metrology - Reusable Sanitary Napkins - and Quality (TCVN) 2000 SNI 16-6363-2000: Sanitary Pads National Standardization Disposable Sanitary Napkins Was taken under (based on Japan standard) Agency of Indonesia Indonesia revision in 2015 (Badan Nasional - Reusable Sanitary Napkins - Standardisasi - BSN) Singapore, Cambodia, Malaysia, Thailand, Myanmar, Brunei, Timor-Leste, Laos do not have standards. Some like Laos do not have a standards authority. Multiple Some have import requirements e.g., Indonesia and Thailand require compliance to ISO 13485 for the manufacturing facility
Standards Landscape: Reference Standards Country Standard Type of Menstrual Product Year of Issue Authority Technical Specifications for Disposable Sanitary Napkins 2021 Disposable Sanitary pads UNGM UNICEF, UNFPA, UNHCR (Applicable internationally) Technical Specifications for Reusable Sanitary Napkins 2021 Reusable Menstrual Pads (and Menstrual Cups) C(2014) 7735: EU Ecolabel Disposable Sanitary Napkins 2014 EU Ecolable European Union Reusable Sanitary Napkins N/A N/A (and Menstrual Cups) Disposable Sanitary Napkins Menstrual Tampons and Pads: United States of America Information for Premarket 2005 US FDA Notification Submissions (510(k)s) Reusable Sanitary Napkins (and Menstrual Cups) Disposable Sanitary Napkins AS 2869:2008 Tampons - Menstrual 2008 (Tampons and Absorbents) Australia Standards Australia Therapeutic Goods (Standard for Reusable Sanitary Napkins– does not Menstrual Cups) Order 2018 exist 2018 (Therapeutic Goods Order 99) (Menstrual Cups)
Standards Landscape: Reference Standards Country Standard Type of Menstrual Product Year of Issue Authority US N/A INDA Disposable sanitary Napkins N/A EU N/A EDANA
Current Standards Landscape • Most standards exist in the East and Southern African region, for both disposable and reusable sanitary pads • Joint advocacy by ACMHM members has pushed catapulted efforts in the region • Regional African standards hold potential for faster adoption amongst other countries – especially in West and Central Africa, where joint advocacy has begun • Few South Asian and South-East Asian countries have disposable sanitary pad standards, and only India has released standards for reusable pads (in 2021) • Joint advocacy has not yet happened in the region and there is scope for strengthening the same • South Asia and ASEAN can be potentially separate focus areas, given that each region has separate trade associations • Stronger linkages with Chinese and Japanese regulations may be required given high degree of product flow from China and South East Asian countries to other countries within the region, especially on herbal therapeutic materials
Current Standards Landscape • Data could not be retrieved for Latin American countries, however, interactions showed, limited advocacy focus on quality and standards in the region, and scope for strengthening remains • Developed country norms have been used for reference e.g. US FDA and EU and standards from the same region e.g. EAC for Africa and India for South Asia have also been used • Other technical industry references also exist e.g. INDA and EDANA, and can be referenced during standards development • Japanese and Chinese standards can also be used as references as QC is strong in these regions. However, language has posed a barrier till now • Technical exchange with experts from the region is also limited to LMICs, despite high degree of product flow from these South and SE Asia to the rest of the world
Section II Process for Standards Creation
Process Lessons 1. Need for Sensitization 2. Lack of stakeholder diversity Limited knowledge of ‘Who’ and lack of logistics Uninformed policymakers and need for Govt. funding limits neutral and diverse champions to formally request a standard stakeholders on the table –bias from med/large manufacturers - Leverage advocacy on SRHR, gender, WASH to find champions Joint advocacy for inclusive representation - Conduct situation analysis to develop through neutral parties i.e. coalitions, CSOs and common vision and define clear outcomes with ‘Why’ of diverse groups (see next slide) policymakers - Support standards request to regulator
Who should be at the table and Why? Stakeholders Potential Guidance Small and mid scale manufacturers, • Ensure that QC protocols are practical and include sufficient guidance for social enterprises implementation by small scale manufacturers Advocacy groups (ACMHM, MHAI, • Assimilate secondary evidence Nepal MHM Alliance etc.) and • Ensure representation from all stakeholders researchers working on MHH • Advise if testing parameters are practical enough for inclusion in MHH policy policy frameworks Technical experts: Microbiologists • Guide process and test specifications for raw materials and final product for and biotechnologists, Material ensuring product hygiene scientists (manufacturer and • Guide specifications and methods for determining material safety, especially independent) given high costs of testing Gynaecologists • Share evidence on reproductive health parameters e.g, impact of use of different products on vaginal flora and risk of RTI/UTIs, pH of vagina etc. Fibre suppliers • Guide on how raw material quality and safety can best be determined User groups • Representative of buyers from across SECs given the diversity in LMICs
Process Lessons 3. Funding limitations 4. Enforcement and Compliance - Limited guidance beyond standard creation Regulators’ funding limited to convening meetings, - Limited knowledge with SMEs everything else is voluntary from committee stakeholders -Standards paid and inaccessible - Low consumer awareness Donor support and TA needed - Democratize access through pooled resources - Stakeholder identification & logistics - Operational guidance & capacity building - Secondary evidence incl. access to reference standards - Improved access to labs – common facilities, subsidies, information - Independent testing - Situate within MHH policies - Primary evidence generation - Consumer awareness - Engagement with research bodies, MoH
Section III Technical Specifications: Deep Dive Detailed technical specifications retrieved from the standards landscape have been included as Annexure
Parameter Landscape: Material and Design (Disposables) Manufacturing, Material: Material: Middle Material: Bottom Country / Organisation workmanship and Sizes (length) Sizes (Width) Top Layer (Absorbent) Layer (Leakproof) Layer finish United Nations (UNGM) Association of Non-Woven Fabrics Industry (USA) Standard Publicly Inaccessible EDANA European Union (EU) United States of America Australia East African Community (EAC) African Organization for Standardization (ARSO) Standard Publicly Inaccessible Ethiopia Kenya Malawi Standard Publicly Inaccessible Tanzania Uganda South Africa Standard Publicly Inaccessible Zambia Standard Publicly Inaccessible Zimbabwe Standard Publicly Inaccessible Ghana Standard Publicly Inaccessible Bangladesh Standard Publicly Inaccessible India Nepal Pakistan Standard Publicly Inaccessible Sri Lanka Standard Publicly Inaccessible China Standard Publicly Inaccessible Japan South Korea Standard Publicly Inaccessible Indonesia Standard Publicly Inaccessible Vietnam Standard Publicly Inaccessible Parameter Present with testing details Parameter / Details Absent Standard is not publicly accessible
Parameter Landscape: Performance (Disposables) Hygiene: Country / Organisation Absorbency Absorbency Rate pH Value Microbiological Biocompatibility Compostability Requirement United Nations Association of Non-Woven Fabrics Industry (USA) Standard Publicly Inaccessible EDANA European Union (EU) Absorbency Rate not United States of America (FDA) mentioned Absorbency Rate not Australia mentioned East African Community (EAC) African Organization for Standardization (ARSO) Standard Publicly Inaccessible Ethiopia Kenya Malawi Standard Publicly Inaccessible Tanzania Uganda South Africa Standard Publicly Inaccessible Zambia Standard Publicly Inaccessible Zimbabwe Standard Publicly Inaccessible Ghana Standard Publicly Inaccessible Bangladesh Standard Publicly Inaccessible India Nepal Pakistan Standard Publicly Inaccessible Sri Lanka Standard Publicly Inaccessible China Standard Publicly Inaccessible Japan South Korea Standard Publicly Inaccessible Indonesia Standard Publicly Inaccessible Vietnam Standard Publicly Inaccessible Parameter Present with testing details Parameter / Details Absent Standard is not publicly accessible
Parameter Landscape: Material and Design (Reusables) Manufacturing, Material: Middle Material: Top Material: Bottom Sizes Sizes Country / Organisation workmanship (Absorbent) Layer (Leakproof) Layer (Length) (Width) and finish Layer United Nations (UNGM) United States of America (FDA) East African Community (EAC) African Organization for Standardization (ARSO) Standard Publicly Inaccessible Ethiopia Kenya Standard Publicly Inaccessible Malawi Standard Publicly Inaccessible Tanzania Uganda South Africa Zambia Standard Under Development Zimbabwe Standard Publicly Inaccessible Ghana Advocacy Ongoing India Parameter Present with testing details Parameter / Details Absent Standard is not publicly accessible
Parameter Landscape: Performance (Reusables) Microbiologi Colour Biocompatibi Usage and Drying Biodegradability / Country / Organisation Absorbency pH Value cal Fastness lity Durability Time Compostability Requirement United Nations United States of America (FDA) East African Community (EAC) African Organization for Standardization (ARSO) Standard Publicly Inaccessible Ethiopia Kenya Standard Publicly Inaccessible Malawi Standard Publicly Inaccessible Tanzania Uganda South Africa Zambia Standard Under Development Zimbabwe Standard Publicly Inaccessible Ghana Advocacy Ongoing India Parameter Present with testing details Parameter / Details Absent Standard is not publicly accessible
Technical Specifications: Expert Perspectives 1. Material and Design 2. Performance • Included in almost all country standards but not • Absorbency + retention + dispersion + re-wet in guidelines like INDA/EDANA need to be considered together – most standards • Material/sizes source of innovation and stringent look at the first two limitations are detrimental to consumer choice- • Is 30 mL absorption appropriate? For reusable for both disposables and reusables products also? • Softness included as guidance but determined by • Perceived specifications like colour should be cost and preference, hence, physical test should avoided be included if mentioned • Testing agents also need to be considered – ‘Largest disposable napkin sizes are sold in Japan potassium dichromate sol. Etc., coloured water, contrary to intuition. Product design is driven by artificial blood, alternatives? consumer preferences and need flexibility within • For reusables – drying time under varying standards.‘ conditions and dimensional stability should be - R&D specialist, MNC quantitatively mentioned ‘In Maharashtra state, products meeting minimum 30 mL criteria were procured and found to be insufficient as per consumer feedback. Absorbent capacity was then enhanced for future procurement.’ - Government representative, India
Technical Specifications: Expert Perspectives 3. Hygiene 4. Material Safety • pH first level test for hygiene • Biocompatibility testing advised for all products – • Duration of use – 6-8 hours? raw material certifications can be used as proxy • Bio-burden testing (overall and specific) required • One-time testing or when process or raw for both disposable materials are changed - MNCs conduct more frequent testing, but may be prohibitive for SMEs • Majority experts stress need for bio-burden testing for reusables (test with no. of washes) • SMEs can benefit from pooled raw material procurement from verified suppliers • Moisture content of raw material also important • Evidence on material risk is unavailable in public • Process guidance also suggested – domain and needs independent investigation sterilization/dehydration of raw materials & final product, storage guidance (moisture, space etc.) • Japan standards can be used as reference • Need for evidence on risk of BV, PID etc. when • For reusables – colour fastness is an additional pad used for long hours necessary criteria • SABS includes that banned, harmful toxic dyes as per ISO 14362-1 not to be used
Technical Specifications: Expert Perspectives 5. Environmental Safety • Claims of biodegradability/compostability rampant • Oxo-degradable products sold under this claim and are more harmful • Compostability testing included in Ethiopia, Nepal, India and UNGM specs Biodegradable • ISO 17088 tests for compostable plastics but under industrial conditions Oxo- • Compostability testing should include parallel Compostable degradable policy guidance on composting solutions • Data needed on impact on soil and water quality e.g done by HECAF-GIZ for vermi-composting • Can menstrual waste lead to growth of microbes in water system etc.?
Technical Specifications: Expert Perspectives 6. Other Considerations • Evaluate product lifecycle to prescribe minimum burden of testing and enhance compliance • SMEs should not be excluded, but supported for better compliance Standards for menstrual products are not unique and • Pooling resources can help SMEs e.g. they exist for many sectors, hence it is not reinventing common testing facilities, pooled anything. It is not a massive cost (~$200) and shouldn't procurement stand in the way of a serious company conducting • Subsidies or support for TA can be provided business. The tests are not very high-tech and drip tests under MHH policies to local/women-led etc. are simple to conduct. businesses - Standardization advocate, procurement stakeholder
Section IV Harmonization
Need for Harmonization Need for Harmonization Pathways • Duplication of efforts at country level for • Regional leaders taking an active role in country standards creation – amidst resource level standards constraints • Engage with regional manufacturer/trade groups • Classification varies across geographies and for advocacy in WCA, LAC, SA, SEA impacts enforcement; standards are usually • Wider dissemination of UNGM specs voluntary • Situating standards with global actors like WHO, • Variance in technical specs across geographies UN bodies, donors, CI, World Bank – within – has implications for international trade existing priorities of education, health and trade • Lack of evidence and data on key technical • Syndicated fund for joint advocacy, evidence aspects as a barrier to standards creation generation and technical assistance • Close coordination with SIS and facilitation of LMIC member states to contribute to new ISO Copolco proposal for MH product standards • Potential for inputs by WHO, UN agencies, RHSC etc.
Harmonization: Global Collaboration Countries Multilateral Organisations (UN Bodies, WHO, ISO) • Develop in-country standards within robust MHH policies – • Standardization for multi-country/global product health, education, environment, livelihoods procurement • Contribute to regional and global standards • Overarching frameworks for national standards development • Dissemination of standards locally and support for • Evidence generation on menstrual product use in LMICs compliance through information, subsidies etc. • Facilitate sharing best practices among countries and regions Global and Regional Collaboration Manufacturers Advocacy Institutions (Coalitions, RHSC) • Access to new markets and consumer confidence • Represent unbiased consumer and industry interests for development • Small and mid-sized manufacturers to voice concerns and • Cross-share learnings regionally and globally demand assistance for subsidies, upskilling and technical • Advocate for product choice within government policy/schemes support • Advocate for grievance redressal avenues for consumers • Knowledge sharing among SMEs for enhanced enforcement • Ease of doing business within and across borders • Engagement of large MNCs and trade groups in global advocacy efforts
Standards Advocacy Lifecycle Making the case Standards creation • Sensitization of Govt and regulatory • Ensure right stakeholders are on the table stakeholders • Offer context-appropriate references and in- • Identification of champions country evidence throughput the process • Facilitate participation of non industry technical experts, if possible Dissemination and Enforcement Harmonization • Situating within policy frameworks for wider • Advocacy for adoption of international and adoption regional standards within local policies • Sensitization of procurement stakeholders • Ensure country standards are in line with • Advocacy for making standard ‘mandatory’ regional standards, especially trade partners • Consumer awareness and strengthened for the product category redressal mechanisms (with Consumer • Advocate through regional trade platforms International etc.) • Guidance on QC protocols and labs
Next Steps 1. Triangulation with supply chain study 2. Advocacy with • Regional and country level advocacy stakeholders – through AAWG, Consumers International • ISO through SIS • WHO, UN, WB – Global Menstrual Collective, MHMiEWG, others • Manufacturer and trade groups – RHSC Manufacturers group? • Donors and impact investors – specific investment areas • Advocacy tools • Web hosting of database of standards • Advocacy guide
Thank you Conversations lead to solutions. Look forward to talking. www.devsolutions.org office@devsolutions.org Get in touch with us at: 011-41061879
Annexure Technical Specifications
Technical Specifications Disposable Sanitary Napkins
Technical Specifications: Size East African UNGM Community (EAC) Tanzania Uganda* South Africa* Kenya Ethiopia India Nepal Standards Regular: Length- 180mm Regular Regular Small Length- Length Length: Length 240+-20 Length 180mm (min.) Length 200 ± 20 mm Length 200 ± 20 mm; Length 180 to 260 240 mm 180mm (min.) Regular ≤ 210 mm (min) to 220mm Width- 60mm (min.) Width 70 ± 5 mm; Width 70 ± 5 mm; mm Width- 65 Width- 60mm mm Width 60 to 80 mm mm (min.) Width 60 to 75 Large: Large Large Large 211 to mm (min) Length 220mm Length 240 ± 20 mm Length 240 ± 20 mm; Medium 240 mm to 260mm Width 70 ± 5 mm; Width 70 ± 5 mm; Length 180 to 270 Standard mm Extra-large Thickness 15mm Extra Large: Extra large Extra large Width: 60 to 90 241 to 280 mm +-2 Length 260mm Length 280 ± 20 mm; Length 280 ± 20 mm; mm XXL ≥ 281 mm to 300mm Width 70 ± 5 mm; Width 70 ± 5 mm; Large Standard Standard Standard Thickness 15 Standard Thickness 15 ± Length 230 to 300 Width 55 mm Width 60mm– ± 2 mm 2 mm mm (min) 100mm Width 60 to 100 (excluding mm wings) XL Length 270 to 330 mm Width 90 to 110 mm *Data based on publicly available draft documents
Technical Specifications: pH and Absorption East African Standards UNGM Community (EAC) Tanzania Uganda* South Africa* Kenya Ethiopia India Nepal Standards pH 6-8.5 5.5-8.5 5.5-8.5 5.5-8.5 6.0-8.0 5.5-8 5.5-8.5 5.5-8.0 6-8.5 EN ISO 3071, EN ISO 3071, EAS 261- Method ES ISO 3071, pH Method B EAS 261- Method B Method B test method SANS B (method not KS ISO 3071, Method B- (method Determination (method not (method not (method not 3071 (method not IS 1390 IS 1390 accessible to Method B1 not accessible to Method accessible to accessible to public) accessible to accessible to public) public) public) public) public) No leakage (30 ml Small 5 ml (min) No leakage (30 No leakage No leakage from a height of Medium 10 ml (min) ml from a height No leakage (30 ml of (30 ml of 2mm) using No leakage (30 ml No leakage (30 Large 15 ml (min) No leakage (30 ml Absorbency of 2mm) using (30 ml from a coloured coloured colored water or from a height of ml from a height XL 20 ml (min) from a height of Performance potassium height of distilled water distilled water oxalated sheep or 2mm) of 2mm) using Masson's light 2mm) dichromate in 2mm) from a height from a height goat blood or test green stain in water at distilled water of 2mm) of 2mm) fluid ambient temperature Absorbency 10 seconds 10 seconds 10 seconds 10 seconds (max) 10 seconds (max) 10 seconds (max) 10 seconds (max) 10 seconds (max) 10 seconds (max) Rate (max) (max) (max) *Data based on publicly available draft documents
Technical Specifications: Biocompatibility East African South Standards UNGM Community (EAC) Tanzania Uganda* Kenya Ethiopia India Nepal Africa* Standards For any pad materials that are The manufacture bleached during processing, the The manufacture shall ensure that supplier should identify the All materials, dyes shall ensure that raw material All materials, dyes bleaching process used and chemicals used raw material used used for Biocompatibility and chemicals used in the manufacture for manufacturing manufacturing Evaluation — in the manufacture Shall be free from formaldehyde, Not publicly Not publicly Not publicly Not of sanitary pads the final product the final product Cytotoxicity, of sanitary towels heavy metals, polycyclic available available available mentioned shall not cause any are safe for user are safe for user Irritation and shall not cause any aromatic hydrocarbons (PAHs) undesirable effects based on its known based on its Skin Sensitization undesirable effects phthalates, dioxins, acrylic to the skin and toxicological known to the skin. monomers, reproductive & female genitalia. characteristics at toxicological developmental toxins and other intended use. characteristics at carcinogens intended use. ISO 10993 Part-5&10: Evaluation and Testing to assess the safety (procedures not accessible to Heavy Metals: public) ES ISO 17294-2 IS/ISO 10993 Part 5 ES ISO 11083 IS/ISO 10993 Part Elemental Chlorine-Free (ECF) or 10 Tests / Totally Chlorine-Free (TCF) and Not publicly Not publicly Not publicly Not Phthalates: Not mentioned Not mentioned Certification shall provide safety data. available available available mentioned ES ISO 14389 (procedures not accessible to Shall be compliant as per as per (procedures not public) REACH regulations (preferable to accessible to have a REACH compliant public) certificate issued by the competent authority). *Data based on publicly available draft documents
Technical Specifications: Microbiological Requirements East African South India Standards UNGM Community Tanzania Uganda* Kenya Ethiopia Nepal Africa* (Optional) (EAC) Standards a) The total a) The total viable a) The total viable bacterial viable bacterial a) The total viable a) The total count bacterial count bacterial count viable bacterial
Technical Specifications: Compostability East African India Standards UNGM Community Tanzania Uganda* South Africa* Kenya Ethiopia Nepal (Optional) (EAC) Standards ISO 17088:2008- Specifications for IS/ISO 17088. compostable plastics or The information IS/ISO 17088 The sanitary pad equivalent. whether the At least 90% must be made of product is degradable biodegradable or EU Ecolabel, Sustainable, biodegradable, within 6 months Not compostable Compostability recycled, re-used or Not mentioned Not mentioned Not mentioned Not mentioned compostable or (testing is mentioned material. reusable materials for oxy-degradable performed and packaging and the shall be marked conformed at a Testing method manufacturer of the on every packet recognised not mentioned disposable pad preferably of sanitary laboratory) shall be in compliance with napkin ISO 14001. *Data based on publicly available draft documents
Technical Specifications Reusable Sanitary Napkins
Technical Specifications: Sizes and pH East African Community Nepa UNGM Tanzania Uganda South Africa Kenya Ethiopia Malawi Zimbabwe India (EAC) l Standards Regular- Light flow Small: length = 281 mm exist Thickness 15 ± 2 Length (mm) 230 to Extra large: mm Super maxi (extra- 300; above 260 mm; Width: minimum large): length 260 to Width (mm): 60 to 100 60 - 75 mm 60 mm Extra large 300mm Length 280 ± 20 width 60 to100 mm Very Heavy flow Period Panty: 230- mm excluding wings. Length (mm) 270 to 300 mm L and 80- Width 70 ± 5 mm 330; 140 W (absorbent Thickness 15 ± 2 Width (mm): 90 to 110 core only) mm pH 6 to 8.5 6 to 8 6.5 to 7.5 6 to 8 6 to 8 6.5 to 7.5 5.5 to 8 Not Does Not Not Not US ISO:3071- accessibl not TZS-26 Method 1 SANS 3071: (not accessible accessible pH Test EN ISO 3071, accessible (not ES ISO 3071, e exist (not available for accessible for public IS 1390 Method Method B for public accessible for Method B public view) view) view public view)
Technical Specifications: Absorption, Durability and Wear time East African Zimbabw UNGM Community Tanzania Uganda South Africa Kenya Ethiopia Malawi India Nepal e (EAC) Standards Regular: 15 ml minimum* Light Flow / Small: 5 Maxi: 20 ml minimum* S and M: 10 ml No leakage on ml Supermaxi: 30 ml L and XL: 30 ml pouring 8 ml of Total volume Total volume Regular Flow / minimum* Light Flow: 15 ml the test fluid at Light: 4 ml (2 Light: 4 ml (2 Medium: 10 ml Normal Flow: 20 Test by 4ml/min from a ml/min) ml/min) Heavy Flow /Large: *for a coloured water or Not ml Not Not colored Does not Absorption height of 2 mm Regular: 8 ml Regular: 8 ml 15 ml oxalated sheep or goat accessible Heavy Flow: 30 accessible accessible distilled water exist (4ml/min) (4ml/min) Very Heavy Flow / blood or test fluid when ml and show no Test Fluid: Heavy: 16 ml Heavy: 16 ml XL: 20 ml poured on to the centre of leakage Potassium (8ml/min) (8ml/min) the napkin (at the rate of Absorbency rate (Annex B Test Dichromate Absorbency Rate 15 ml per minute) >10 ml/sec Method)
Technical Specifications: Color Fastness East African Zimbabw UNGM Community (EAC) Tanzania Uganda South Africa Kenya Ethiopia Malawi India Nepal e Standards To Rubbing a) dry: 4 or better b) wet: 3 or better To Rubbing To Rubbing colour/ fabric To Rubbing a) dry: 4 or better a) dry: 4 or better To Prespiration colour/ fabric dye of dye of the a) dry: 4 or b) wet: 4 or better b) wet: 3-4 or better a) Color Change: 4 the materials shall not materials better Not or better; Color come out during shall not come Not b) wet: 3 or Not Does not 4 and above To Prespiration To Prespiration accessibl b) Staining: 4 or Fastness washing out during accessible better accessible exist 4 or better 4 or better e better washing No value mentioned No value To Washing To Washing To Washing To Washing mentioned a) 4 or better 4 or better 4 or better a) Color Change: 4 or better; b) Staining: 4 or better" SANS 105-C10/ISO ES ISO 105- Test for ISO 105- Not IS / ISO 105-X12 TZS 43, Textiles 105-C10 Not C10, Textiles Not Does not Color C10:2006 - Not Declared Not Declared accessibl IS / ISO 105-E04 TZS 138, Textiles SANS 105-X12/ISO accessible ES ISO 105- accessible exist Fastnes Textiles e IS/ ISO 105-C06 105-X12 X12
Technical Specifications: Biocompatibility East African South Standards UNGM Community (EAC) Tanzania* Uganda* Kenya Ethiopia* India Nepal Africa* Standards The materials The materials used in the used in the manufacture of The manufacture The pads shall be free from acids The materials used in manufacture of reusable shall ensure that and alkali, free from dust and the manufacture of The materials reusable sanitary sanitary towels raw material used Biocompatibility particulate matter, free from bad reusable sanitary shall not cause Be smooth, soft towels shall not shall not harm for manufacturing Evaluation — odour, no bleeding of colour, and towels shall not harm any harm (skin Not when felt by hand harm the skin in the skin in the final product Cytotoxicity, free from shedding fibres. It shall be the skin in contact, all rashes and/or available and pleasant wearing Does not exist contact, all outer contact, all are safe for user Irritation and free from chemical residues like outer layers of the irritations) to publicly with no skin layers of the outer layers of based on its known Skin Sensitization chlorine, herbicides, pesticides, product should be fit the skin in irritations. product should the product toxicological heavy metals, azo dyes etc as per for direct contact with contact be fit for direct should be fit characteristics at REACH regulations. the skin contact with the for direct intended use. skin contact with the skin IS/ISO 10993 Part 5 IS/ISO 10993 Part Shall be compliant as per as per Not 10 Tests / Not Not Does not exist REACH regulations (preferable to Not mentioned Not mentioned available Not mentioned Certification mentioned mentioned have a REACH compliant publicly (procedures not certificate issued by the accessible to competent authority). public) *Data based on publicly available draft documents
Technical Specifications: Hygiene and Skin East African India Standards UNGM Community Tanzania Uganda* South Africa* Kenya Ethiopia Nepal (Optional) (EAC) Standards a) The total a) The total viable a) The total viable a) The total viable a) The total viable viable bacterial total viable bacterial bacterial count bacterial count bacterial count bacterial count
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