Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs

Page created by Casey Hines
 
CONTINUE READING
Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
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
Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
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
Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
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
Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
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
Development and compliance of quality standards for disposable and reusable menstrual health pads in LMICs
Section I
Current Standards Landscape
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
You can also read