India Reach Regulation for Various Sectors

ICMSR (India REACH)

India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. ICMSR is also known as India REACH.  

Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the ICMSR need to be registered. 

The ICMSR (India REACH) is expected to be notified to WTO in 2022 and come into force after 60 days of notification. India REACH will require Indian manufacturers and importers to comply with the regulation which includes notification and substance registration. For foreign manufacturers, they may appoint an Authorized Representation (AR) on their behalf to comply with the ICMSR (India REACH).  

BIS Certification

The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.  

The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards

BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. 

Product certification includes two schemes: 

  • Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI)
  • Scheme 2 - Compulsory registration scheme (CRS). 

The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.  

For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:  

  1. Documentation and application submission  
  2. Factory inspection by Indian auditor 
  3. Provision of test samples by the AIR and execution of the tests 
  4. Marking and labelling of products with the standard or ISI marks for BIS certification 

 

Food And Drug Administration
Request For Regulation
Introduction

The Indian Aspect

The Food and Drug Administration in India is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. There are two individual bodies in India that regulate the markets for Food safety and Drug Regulation. Those bodies are:

  1. FSSAI(Food Safety and Standard Authorities of India) and
  2. CDSCO(Central Drugs Standard Control Organization)

These regulatory bodies control the manufacture, storage, distribution, sale and import of food and drugs to ensure availability and safety of the same for human consumption.

Need for the Regulation
  • Removal of multiple
  • Harmonization with the international
  • Framing of regulatory requirements based on science and risk
  • Facilitating trade without compromising consumer safety and bringing in safe innovation in
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA (FSSAI)

The Food Safety and Standards Authority of India (FSSAI) has been established under Food Safety and Standards, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

FSSAI has been mandated by the FSS Act, 2006 for performing the following functions Why is FSSAI Registration/License Required?
  • Every food business operator involved in the manufacturing, processing, storage distribution and sale of food products must compulsorily obtain FSSAI Registration or License. FSSAI Registration is different from FSSAI License in the sense that depending on the size and nature of the business, FBO (Food Business Operator) should obtain the necessary registration or license. It is a 14-digit registration or a license number which is printed on all the food 
  • This registration procedure is aimed to create more accountability on the FBO to maintain the quality of the food 
FSSAI Registration/ License Procedure

FSSAI registration or license is based on the business volume and premises. Depending upon the installed capacity or turnover or location, applicant premises are eligible for the license such as central license, state license, registration, railway etc.

FSSAI Registration is a basic license and it is required for all the FBOs involved in the small-scale food business. This category covers the following business:

  • Pettyretailer dealing in food 
  • Anyperson who manufactures or sells any food article by 
  • Foodsale done by the temporary stall 

Any individual who distributes food in any religious or social gathering except a caterer.

Small-scale or cotage industries dealing in the food business and the following
Sr.No. Business Capacity
1 Food production capacity(other than milk and meat) Up to 100Kg/ltr per day
2 Procurement, handling and collection of milk Up to 500 ltr per day
3 Slaughtering Capacity 2 large animals or 10 small animals or 50 poultry birds per day
Procedure for Obtaining FSSAI Registration

Common documents required for obtaining FSSAI registration:

  • FormA – completed and signed
  • PhotoIdentity of FBO
  • Proofof possession of premises (e.g. Rental Agreement)
  • PartnershipDeed / Certificate of Incorporation / Articles of Association 
  • Listof food products to be dealt with
  • Foodsafety management system plan
Procedure for Obtaining FSSAI License
  • For all other FBO apart from small-scale business, FSSAI license must be obtained. FSSAI License canbe classified into two categories e. State FSSAI License & Central FSSAI License based on the size of the business whether it is a medium scale or large-scale business.
  • Generally, FBOs who are large manufacturers, importers, exporters dealing in large-scale food businessneed to obtain FSSAI license from central government and FBOs with small to medium sized manufacturing units, transporters, marketers, traders, , need to take FSSAI registration from the state government.
Documents Required for obtaining the Central license:
  • FormB duly completed and
  • Planof the processing unit showing the dimensions and operation-wise area
  • Listof Directors/ Partners/ Proprietor with address, contact details, and photo
  • Nameand list of equipment and machinery used with the number and installed
  • Listof food category to be
  • Authorityletter from manufacturer with name & address of the nominated responsible person .
  • Analysisreport of water to be used in the process to confirm the
  • Sourceof raw material for milk, meat
  • Recallplan wherever
  • Ministryof Commerce Certificate for 100% EOU (Export Oriented Unit).
  • NOCdocument issued by
  • IEcode document issued by
  • FormIX (nomination of persons by a company).
  • Certificatefrom Ministry of
  • Proofof possession of
  • Partnership deed/ affidavit of
  • NOC and copy of License from the
    • Food safety management system plan or certificate.
    • NOC from the municipality or local body.
  • Supporting document for proof of turnover and transportation.
  • Declaration Form.
Fee Structure for FSSAI Registration/ Central Licensing: Fee Structure for FSSAI STATE Licensing
  • For Renewal of License: Depends upon the number of years
  • Modification of License: Fees of 1 year per licensemodification.
  • Duplicate of License: 10% of the applicable license
Consequences of Non-Compliance Food safety officer generally conducts the inspection of the food business operator’s facility and identifies the level of compliance with the regulation using a checklist. Based on the compliance level, the food safety officer marks it as:
  • Compliance(C)
  • Non-compliance(NC)
  • Partial compliance(PC)
  • Not applicable/Not observed(NA)
Based on the above, the food safety officer might issue an improvement notice where ever required per32 of the FSS Act, 2006 Provisions for non-target country like appointment of OR
  • The FSSAI regulatory body is independent of appointment of OR as registration and licensing procedurefor the target country and non-target country is
  • Although,assistance on registration can be provided by uploading information for the registration as a Food Business Operator/ Petty Good
Pre-registration or extended deadline for registration :
  • Thereis no pre-registration or registration deadline for obtaining the central and state licensing and registration.

Although the license/registration certificate can be registered up to maximum 5 years, aGer which renewal of license/registration certificate is required.

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