UPCOMING QCO ON TEXTILE GOODS BY MINISTRY OF TEXTILE
BIS Certification for Disposable Baby Diaper IS 17509
Indian Standard IS-17509:2021 specifies the quality, safety, and performance requirements for disposable baby diapers manufactured or sold in India. Since baby diapers remain in direct and prolonged contact with an infant’s sensitive skin, the standard places special emphasis on the safety and suitability of raw materials used in their construction. All materials used in disposable baby diapers must comply with the requirements of Clause 3 of IS 17509:2021 and must also undergo biocompatibility evaluation as specified under Clause 7.4.
The biocompatibility evaluation of raw materials is required to be carried out at least once for existing materials and must be repeated whenever there is any change in the raw material composition or the source of supply. Conformity of raw materials to the standard may be established through supplier test certificates, test reports issued by BIS-recognized or empanelled laboratories, reports from NABL-accredited laboratories, or valid in-house testing carried out by the manufacturer.
IS 17509 specifies the quality parameters or characteristics of the Disposable Baby Diaper
- (i) Top cover / top sheet for skin contact comfort
- (ii) Absorbent core for liquid retention
- (iii) Outer protective barrier and back sheet
- (iv) Types, sizes, and shapes of diapers
- (v) pH value to ensure skin friendliness
- (vi) Rate of absorption, rewet under load, and minimum absorption capacity
- (vii) Fastening and securing mechanism
- (viii) Limits for bacterial and fungal bioburden
Mandate for ISI Mark Certification of Disposable Baby Diaper (IS 17509)
The Government of India, after due consultation with the Bureau of Indian Standards (BIS), has introduced mandatory compliance requirements for disposable baby diapers in the interest of public health and consumer safety. These requirements are issued under the relevant provisions of the Bureau of Indian Standards Act, 2016, empowering the authorities to regulate the quality of notified products.
Process Required for BIS ISI Mark Certification for Baby Diapers (IS 17509)
To obtain the BIS ISI Mark for disposable baby diapers under Indian Standard IS 17509:2021, manufacturers must comply with the Product Certification Scheme (Scheme I) of BIS. A key requirement of this certification is the establishment of a dedicated in-house testing laboratory as per the Scheme of Inspection and Testing (SIT). This ensures that every production batch meets prescribed safety, hygiene, and quality standards before being released into the market.
Estimated Timeline: The BIS ISI certification process for domestic manufacturers generally takes around 30 to 45 days, subject to factory readiness, inspection scheduling, and laboratory test results.
Step-by-Step Certification Process
- Application Submission: File Form-V through the BIS Manak Online portal by providing product details, applicable Indian Standard (IS 17509), factory layout, manufacturing process, and list of machinery.
- In-House Laboratory Setup: Establish and equip an in-house testing laboratory with all mandatory testing equipment specified under IS 17509. All instruments must be calibrated and supported with valid calibration certificates.
- Factory Inspection and Audit: A BIS officer conducts an on-site audit to verify the manufacturing process, quality control system, testing facilities, and the competency of quality control personnel.
- Sample Drawing and Testing: During inspection, product samples are sealed by the BIS officer. One set of samples is tested in the manufacturer’s in-house laboratory, while another set is sent to a BIS-recognized third-party laboratory for independent testing.
- Grant of BIS License: If the test results conform to IS 17509 and the factory audit is satisfactory, BIS grants the Certification Marks License (CM/L). The manufacturer is then authorized to use the ISI Mark on disposable baby diapers.
Requirements to Obtain BIS License for Disposable Baby Diaper (IS 17509)
- Conformity of raw materials used in manufacturing as per the requirements of Indian Standard IS-17509.
- Availability of an in-house testing laboratory capable of performing all mandatory tests specified under IS 17509.
- Appointment of competent and qualified Quality Control personnel to oversee testing and production quality.
- Strict adherence to BIS guidelines and the Scheme of Inspection and Testing (SIT) applicable to disposable baby diapers.
To obtain BIS certification for disposable baby diapers under Product Certification Scheme-I, manufacturers are required to submit documents broadly classified into the following categories:
- Administrative Details: Business registration, factory address proof, GST, PAN, and related legal documents.
- Technical Details: Product specifications, raw material details, manufacturing process flow, and test parameters.
- Quality Control Personnel Details: Qualification, experience, and appointment details of QC staff.
- Commercial Details: Brand details, trademark information, and authorization documents.
Cost of BIS Certification for Disposable Baby Diaper (IS 17509)
The following are indicative government and related charges involved in obtaining BIS certification for disposable baby diapers under Product Certification Scheme-I. All statutory fees are payable directly to the Bureau of Indian Standards (BIS).
| S. No. | Particular | Amount (INR) | Remarks |
|---|---|---|---|
| 1 | Application Fee | ₹1,000 | Payable to BIS |
| 2 | Audit Fee | ₹7,000 | Payable to BIS |
| 3 | Sample Testing Fee | As applicable | Depends on lab & product |
| 4 | Marking Fee | As per actual | Varies by IS |
Important Note: Product testing is a critical stage of the BIS certification process and determines compliance with IS 17509. Manufacturers are required to invest in suitable in-house testing facilities. In certain cases, a pre-visit to the factory may be conducted to assess readiness and conformity with BIS requirements. All charges mentioned above are exclusive of any additional laboratory or inspection-related expenses.
Benefits of Getting ISI Mark Certification for Disposable Baby Diaper
Obtaining the ISI Mark for disposable baby diapers under Indian Standard IS 17509 offers significant legal, commercial, and brand-related advantages. ISI certification confirms that the product meets government-prescribed quality and safety standards and is fit for sale in the Indian market.
1. Mandatory Legal Compliance
Disposable baby diapers are a notified product under Indian regulations, making ISI Mark certification compulsory. Certified manufacturers and importers can legally manufacture, import, and sell diapers in India, while non-compliant products are subject to penalties, fines, and seizure.
2. Increased Market Acceptance
ISI certification significantly improves the acceptance of disposable baby diapers in the Indian market. Retailers, distributors, and e-commerce platforms prefer certified products, increasing the chances of wider market reach and long-term business growth.
3. Enhanced Consumer Trust and Safety Assurance
Parents and caregivers tend to choose ISI-certified baby products as the mark assures compliance with safety, hygiene, and quality requirements. Certified diapers inspire confidence by demonstrating that the product is safe for prolonged contact with infant skin.
4. Strong Brand Credibility and Reputation
Consistent product quality backed by ISI certification helps build a positive brand image. Satisfied customers contribute to word-of-mouth promotion, allowing manufacturers to establish credibility and trust within the competitive baby care market.
5. Competitive Advantage and Premium Positioning
ISI-certified disposable baby diapers stand out from uncertified alternatives. Certification allows manufacturers to benchmark product quality, justify pricing, and position their brand as a reliable and standard-compliant choice in the Indian market.
