BIS FMCS Chemical Certification in India: What You Need to Know


Overview of BIS FMCS


Foreign Manufacturer Certification Scheme (FMCS) is regulated by the Bureau of Indian Standards (BIS) in compliance with the BIS Act, 2016, and the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The certification scheme allows foreign manufacturer to continue their businesses in India after receiving the BIS License. The certification scheme is not mandatory till now for all categories of products. However, certain goods can only be imported into India with the Standard Mark and a BIS licence, as announced by the Indian government under Quality Control Orders (QCOs).

QCOs are regulated by various regulatory bodies or ministries in India under the observation of Central Government departments based on their product categories. QCOs are published on the gazette of India with their date of implementation. After the effective date of implementation of QCO, except under a valid Licence or Certificate of Conformity (CoC) from BIS, no person shall manufacture, import, distribute, sell, hire, lease, store, or exhibit for sale any product(s) covered by the QCO without a Standard Mark.

To know the date of commencement and updates of QCOs, please click here.

Competent Authority


Under the Foreign Manufacturers Certification Scheme (FMCS), the Bureau of Indian Standards manages the product certification program for foreign manufacturers.

Obligation


The manufacturers whose companies or premises are located outside of India are required to submit their Foreign Manufacturer Certification Scheme (FMCS) application to get a BIS Licence to ensure the compliance of their products to applicable Indian Standard Specifications.

Authorized Indian Representative (AIR)


In accordance with BIS Rule 16B (4) of 1987, if a foreign applicant wants to get a BIS License, first they need to designate an Authorized Indian Representative (AIR). AIR must be an Indian resident and is responsible for ensuring compliance with BIS rules and regulations on behalf of the foreign applicant.

For more info on AIR, please click here.

BIS Mandatory Certification Schemes


BIS offers four types of mandatory certification schemes.  For specific chemicals regulations, there are two schemes:

  • Scheme-I: Indian Standard Institution Mark Scheme (ISI Mark Scheme)
  • Scheme-II: Compulsory Registration Scheme (CRS)

BIS FMCS Certification Process (Scheme-I)


 

Chemicals Regulated under BIS Scheme-I & Scheme-II


Under ISI Mark Scheme (Scheme-I): List of Regulated Chemicals, Fertilizers, Polymers & Textiles

S.No. Indian Standard Specification Chemicals, Fertilizers, Polymers & Textiles Date of Implementation
2. IS 10116:2015 Boric Acid – Specification 2019.05.16
3. IS 15573 Poly Aluminium Chloride 2020.02.01
4. IS 695 Acetic Acid 2024.02.03
5. IS 2833 Aniline 2024.02.03
6. IS 517 Methanol 2024.02.03
7. IS 5158: 1987 Specification for Phthalic Anhydride, Technical 2023.06.22
8. IS 8058:2018 Pyridine 2024.03.13
9. IS 16113:2013 Gamma Picoline 2024.03.13
10. IS 16112:2013 Beta Picoline 2024.03.13
11. IS 12084: 2018 Morpholine 2024.02.01
12. IS 297:2001 Sodium Sulphide, Technical 2020.12.14
13. IS 7129:1992 Potassium Carbonate, Anhydrous 2024.03.13
14. IS 170:2004 Acetone 2024.03.13
15. IS 4581:1978 Phosphorous Trichloride, pure and Analytical Reagent 2020.12.14
16. IS 11744:1986 Phosphorous Pentachloride, Technical 2020.12.14
17. IS 11657:1986 Phosphorous Oxychloride, Technical 2020.12.14
18. IS 2080:2021 Stabilized Hydrogen Peroxide 2022.11.24
19. IS 3205:1984 Precipitated Barium Carbonate, Technical 2020.12.14
20. IS 12928:1990 Precipitated Barium for Ceramic and Glass Industry 2020.12.14
21. IS 4505:2015 Sodium Formaldehyde Sulphoxylate 2020.12.14
22. IS 6100:1984 Sodium Tripolyphosphate, Anhydrous, Technical 2024.03.13
23. IS 14709:1999 n- Butyl Acrylate 2022.12.21
24. IS 336:1973 Ether 2021.12.22
25. IS 5295:1985 Ethylene Glycol 2021.12.22
26. IS 537:2011 Toluene 2023.06.22
27. IS 15030:2001 Terephthalic Acid 2023.06.22
28. IS 14707: 1999 Methyl Acrylate 2024.02.29
29. IS 14708:1999 Ethyl Acrylate 2024.02.29
30. IS 12345:1988 Vinyl Acetate Monomer 2024.02.29
31. IS 4105:2020 Styrene (Vinyl Benzene) 2024.04.24
32. IS 5149:2020 Maleic Anhydride, Technical 2024.10.24
33. IS 12540:1988 Acrylonitrile 2024.04.24
34. IS 17265:2019 100 Percent. Polyester Spun Grey and White Yarn (PSY) 2023.07.03
35. IS 17261:2019 Polyester Continuous Filament Fully Drawn Yarn (FDY) 2023.07.03
36. IS 17264:2019 Polyester Industrial Yarn (IDY) 2023.07.03
37. IS 17262:2019 Polyester Partially Oriented Yarn (POY) 2023.07.03
38. IS 17263:2019 Polyester Staple Fibres (PSF) 2023.04.03
39. IS 7328:2020 Polyethylene Material for moulding and extrusion

(i) Low Density Polyethylene (LDPE)

(ii) Linear Low-Density Polyethylene (LLDPE)

(iii) High-Density Polyethylene (HDPE)

 

2023.10.03
40. IS 11356:2020 Styrene-Butadiene Rubber Latex 2021.10.12
41. IS 16481:2016 Synthetic Micro-Fibres for use in Cement Based Matrix 2023.04.03
42. IS 12795:2020 Linear Alkyl Benzene 2023.04.03
43. IS 13601:1993 Ethylene Vinyl Acetate (EVA) Copolymers 2023.10.03
44. IS 7686:2020 3(N, N-Diethyl) Aminophenol 2021.05.25
45. IS 4566:2020 Methylene Chloride (Dichloromethane) 2023.11.20
46. IS 2012:2006 Red Phosphorus 2021.11.23
47. IS 17077: 2019/

fISO 19062-1: 2015

Acrylonitrile Butadiene Styrene (ABS) 2023.06.12
48. IS 869:2020 Ethylene Dichloride 2024.03.12
49. IS 17370:2020 p-Xylene 2024.03.19
50. IS 14434:1998 Polycarbonate 2024.03.12
51. IS 17397 (Part 1) : 2020/ISO 16365-1 : 2014 Polyurethanes 2024.03.19
52. IS 17442:2020 Vinyl Chloride Monomer 2024.03.12
53. IS 17450: 2020 1,3 Phenylenediamine 2022.10.25
54. IS 10931 : 1984 Lauric Acid 2023.10.24
55. IS 12029: 1986 Acid Oil 2023.10.24
56. IS 12067: 1987 Palm Fatty Acids 2023.10.24
57. IS 12068:1987 Rice Bran Fatty Acids 2023.10.24
58. IS 12069: 1987 Coconut Fatty Acids 2023.10.24
59. IS 12124: 1987 Rubber seed Fatty Acids 2023.10.24
60. IS 12361:1988 Hydrogenated Rice Bran Fatty Acids 2023.10.24

The list also needs to have the hyperlink to the IS original document and the implementation date for each item.

Information source: https://www.bis.gov.in/product-certification/products-under-compulsory-certification/scheme-i-mark-scheme/

Under Compulsory Registration Scheme (Scheme-II): List of Regulated Chemicals

S. No. Indian Standard (IS) No. Products Date of Implementation
1. IS 798:2020 Orthophosphoric Acid 2022.12.10
2 IS 17439: 2020 Polyphosphoric Acid 2022.12.22
3. IS 17412: 2020 Trimethyl Phosphite 2022.10.03

General Differences Between Scheme-I and Scheme-II


Timeline:

BIS Application Indian Standard Institution Mark Scheme

(Scheme-I)

Compulsory Registration Scheme

(Scheme-II)

Timeline Over 6 months 20 days
Validity Up to two years

(After renewal, increase to five years.)

Government Fee:

  1. Indian Standard Institution Mark Scheme (Scheme-I):
S.No. Types of Fee/Charges Applicable In INR
1. Application Fee (Non-refundable) ₹1,000
2. Special Visit Expenses for Inspections Varies due to circumstances
3. Testing Fee Varies due to circumstances
4. Annual License Fee ₹1,000
5. Renewal Application Fee (Non-refundable) ₹1,000
6. Late Fee for Renewal ₹ 5,000
7. Marking Fee Varies due to circumstances
8. Issue of Duplicate License
For foreign manufacturers, a bank guarantee of 10,000 USD needs to be submitted.

For more info on fees and charges, please click here.

  1. Compulsory Registration Scheme (Scheme-II)
S.No. Types of Fee/Charges Applicable In INR
1. Application Fee (Non-refundable) ₹1,000
2. Processing Fee per Application for Grant of License ₹50,000
3. Applications with more than one test report shall be additionally charged ₹20,000 for each additional test report
4. Annual License Fee ₹1,000
5. Renewal Application Fee (Non-refundable) ₹1,000
Note: When renewal is applied for a period of more than two years, ₹25,000 shall be charged for each additional year and the fee shall be paid in advance for the validity period of the license.

 For more info on fees and charges, please click here

REACH24H\’s Services


  • Application preparation and submission to the BIS
  • Authorized Indian Representative (AIR) Appointment
  • Inquiries and Communications with Competent Authorities
  • Factory Inspection Assistance for ISI Mark Scheme
  • Renewal & Change for the Certificates
  • Marking and Labelling Support After License Granted
  • Customized Training

Why Choose REACH24H


  • Over 8,000 Satisfied Clients: To date, we have served over 8,000 chemical enterprises, providing them with comprehensive regulatory compliance services that cover a wide range of countries and regions.
  • Diverse Expertise and Language Skills: Our team of experts has diverse professional backgrounds and comprehensive language skills to provide efficient, diverse, and high-quality regulatory compliance services.
  • Multiple Regions Covered: REACH24H provides one-stop chemical compliance services covering various regions, including China, the EU, the UK, the US, Canada, Eurasia, Turkey, Japan, Korea, Thailand, Philippines, Vietnam, Malaysia, India, Singapore, Australia, New Zealand, and more.
  • Specialized Industrial Chemical Division: Our Industrial Chemical Division comprises specialized departments for REACH regulatory affairs, GHS and EHS compliance, AP chemical registration, Japan business, and technical services.