A Mandatory BIS Scheme X – OTR certification - machinery for filling, closing, sealing, labelling bottles, packing or wrapping. 

BIS Certification Must for Filling & Packing Machines Under Scheme X

Vincular
3 min read

If you are a manufacturer or importer of packaging and bottling machinery, this regulation is crucial and should not be overlooked.

Under the BIS Scheme X – Omnibus Technical Regulation (OTR), it will soon become mandatory to obtain BIS certification for machinery used in filling, closing, sealing, labelling, packing, or wrapping. This regulation covers not only the full machines but also their assemblies, sub-assemblies, and components.

The scope includes widely used packaging equipment, such as:

  • Capping machines
  • Induction sealing machines
  • Shrink wrapping machines
  • Labelling machines

These machines are essential across multiple sectors, including food and beverage, pharmaceuticals, cosmetics, and FMCG, where automated packaging processes are critical to production and delivery.

Applicable HSN Codes

If your products fall under the following HSN codes, this regulation directly applies to you:

  • 842220
  • 842230
  • 842240
  • 842290

Important Dates

  • Regulation in Effect From: 28th August 2024
  • Compliance Deadline: 1st September 2026

This means that all applicable machinery must be BIS certified before the deadline to continue manufacturing, importing, or selling within India.

Exemptions to Note

This regulation does not apply to any equipment already covered under another Quality Control Order (QCO) issued by BIS. However, if your machinery falls under this new OTR scope and isn’t regulated elsewhere, you must obtain a BIS license to stay compliant.

We advise manufacturers and importers not to wait until the last minute. Initiating the certification process early ensures uninterrupted operations, avoids penalties, and enhances market trust.

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