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 Licence. 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 Licence, 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 (For ISI Mark Scheme)


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 & Textile Date of Implementation
1 IS 252: 2013 Caustic Soda -Specification 2018.04.03
2 IS 10116: 2015 Boric Acid – Specification 2019.05.16
3 IS 15573 Poly Aluminum Chloride 2020.02.01
4 IS 695 Acetic Acid 2024.08.03
5 IS 2833 Aniline 2024.08.03
6 IS 517 Methanol 2024.08.03
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 2024.08.01
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 2023.12.22
24 IS 336: 1973 Ether 2021.12.22
25 IS 5295: 1985 Ethylene Glycol 2021.12.22
26 IS 537: 2011 Toluene 2024.12.22
27 IS 15030: 2001 Terephthalic Acid 2023.06.22
28 IS 14707: 1999 Methyl Acrylate 2025.03.31
29 IS 14708: 1999 Ethyl Acrylate 2025.03.31
30 IS 12345: 1988 Vinyl Acetate Monomer 2025.03.31
31 IS 4105: 2020 Styrene (Vinyl Benzene) 2024.04.24
32 IS 5149: 2020 Maleic Anhydride, Technical 2024.04.24
33 IS 12540: 1988 Acrylonitrile 2024.04.24
34 IS 17265: 2019 100 Percent. Polyester Spun Grey and White Yarn (PSY) 2023.10.05
35 IS 17261: 2019 Polyester Continuous Filament Fully Drawn Yarn (FDY) 2023.10.05
36 IS 17264: 2019 Polyester Industrial Yarn (IDY) 2023.07.03
37 IS 17262: 2019 Polyester Partially Oriented Yarn (POY) 2023.10.05
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) 2024.01.05
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 2024.04.03
44 IS 7686: 2020 3(N, N-Diethyl) Aminophenol 2021.11.22
45 IS 4566: 2020 Methylene Chloride (Dichloromethane) 2023.11.20
46 IS 2012: 2006 Red Phosphorus 2021.11.23
47 IS 17077 : 2019/ISO 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 2024.04.24
55 IS 12029: 1986 Acid Oil 2024.04.24
56 IS 12067: 1987 Palm Fatty Acids 2024.04.24
57 IS 12068: 1987 Rice Bran Fatty Acids 2024.04.24
58 IS 12069: 1987 Coconut Fatty Acids 2024.04.24
59 IS 12124: 1987 Rubber Seed Fatty Acids 2023.10.24
60 IS 12361: 1988 Hydrogenated Rice Bran Fatty Acids 2024.04.24
Newly Added Petrochemicals
61 Poly vinyl chloride (PVC) homopolymer IS 17658: 2021 24.08.2024
62 Polypropylene (PP) materials for moulding and extrusion IS 10951: 2020 24.08.2024
63 Diesel engines – NOx Reduction Agent AUS 32 IS 17042 (Part-1): 2020/ISO 22241-1: 2019 24.08.2024

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

Total WTO Notified Chemical QCOs by the Department of Chemical & Petrochemicals in previous year

Chemical QCOs Indian Standard Date of WTO notification Schemes of BIS as per Schedule-II
2 Chemical QCOs notified to WTO in August (Both will be covered under Scheme-I)
Poly vinyl chloride (PVC) homopolymers (CAS No. 9002-86-2) IS 17658: 2021 11.08.2023 Scheme-I
Polypropylene (PP) materials for moulding and extrusion (CAS No. 9003-07-0) IS 10951: 2020 15.08.2023 Scheme-I
9 chemical QCOs notified to WTO in September for Scheme-I
Diesel engines – NOx Reduction Agent AUS 32 (CAS No. 57-13-6) same as Urea IS 17042 (Part-1): 2020/ISO 22241-1: 2019 13.09.2023 Scheme-I
Alumina calcined (CAS No. 1344-28-1) IS 17441 (Part 1): 2021 13.09.2023 Scheme-I
Toluene Diisocyanate (CAS No. 26471-62-5) IS 17916: 2022 13.09.2023 Scheme-I
Sodium Cyanide (CAS No. 143-33-9) IS 11782: 1986 13.09.2023 Scheme-I
Monocrotophos (CAS No. 6923-22-4) IS 8025: 1990 13.09.2023 Scheme-I
Industrial Grade Urea (57-13-6) IS 1781: 2022 13.09.2023 Scheme-I
Captafol (CAS No. 2425-06-1) IS 10300: 2023 13.09.2023 Scheme-I
Ethylene oxide (CAS No. 75-21-8) IS 5573: 1984 13.09.2023 Scheme-I
Anhydrous Ammonia (CAS No. 7664-41-7) IS 662: 2020 13.09.2023 Scheme-I

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


Major Differences Scheme-I Scheme-II
Application Form Main Application Form-V as specified in BIS (Conformity Assessment) Regulations, 2018 Scheme-I Main Application Form-I as specified in BIS (Conformity Assessment) Regulations, 2018-Scheme-II
Inspector Audit BIS grants a licence after conducting an inspection visit to the factory location. BIS grants a licence to the manufacturer based on self-declaration of conformity of the product.
Forms for AIR Appointment Foreign Manufacturers need to appoint/nominate an Authorized Indian representative through Form No. VI & VII as specified in BIS (Conformity Assessment) Regulations, 2018, Scheme-I Foreign manufacturers, required to nominate an Indian representative are specified in Form – IIIA, Form – IIIB, and Form – IV under BIS (Conformity Assessment) Regulations, 2018, Scheme-II
Mode of Application Submission The process of Application Submission to BIS is available in Manual Mode In case of Scheme-II, the online portal (CRS is designed) for Application submission.
Timeline for Grant of Licence The process of granting of licence is expected to be completed within 90 working days provided all the documentation and conformity of the product is established as satisfactory at the first instance. The process of granting of licence is expected to be completed within 20 working days provided all the documentation and conformity of the product is established as satisfactory at the first instance.
Marking Scheme After the Grant of Licence, ISI marks shall be used and annual marking to be paid in advance.ISI认证标志 After the Grant of Licence, the Standard Mark shall be issued to the manufacturer.CRS认证标志
Marking & Labelling Color Scheme not applicable for the ISI mark as per Scheme-1 The color scheme of the Standard Mark shall be in accordance with Annexure-III, annexed to Scheme-II.
Chemical Listed Currently, Scheme-1 includes 60 chemicals under the heading of Chemicals, Fertilizers, Polymers & Textiles Currently, Scheme-II includes three chemicals.

Validity:

The Licence, under Scheme-I, is initially granted for up to 2 years. After which, the licence needs to be renewed for up to 5 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 Licence 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 Licence
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 Licence ₹50,000
3. Applications with more than one test report shall be additionally charged ₹20,000 for each additional test report
4. Annual Licence 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 licence.

 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 Licence Granted
  • Customized Training

For other services, please visit https://www.reach24h.com/en/industrial-chemicals.

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