All Types of Filling, Sealing, Labelling & Packaging Machines and Components
Metal Cutting Machine Tools: Certification Strategy
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| Section | Details |
|---|---|
| Product Name | All types of machinery for filling, closing, sealing, labelling bottles, packing or wrapping and/or their assemblies/sub-assemblies/components. |
| HS Codes | 842220, 842230, 842240, 842290. |
| QCO Title | Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024 & Amendment Order, 2025. |
| Notification Numbers | Original: S.O. 3649(E), dated 28 August 2024. Amendment: S.O. 2579(E), dated 12 June 2025. |
| Issued By | Ministry of Heavy Industries, Government of India. |
| Effective Date | 1 September 2026 (for finished machines) Sub-assemblies/components: effective date to be notified separately. |
| Certification Requirement | Mandatory BIS certification under Scheme X (ISI Mark or Certificate of Conformity). |
| Pre-Certification Requirement | BIS registration, identification of applicable IS codes, technical file preparation, type testing, labeling plan. |
| Labeling Requirements | ISI mark or CoC ref, manufacturer's name and address, product model/type, specifications, and safety instructions as per Scheme X. |
| Applicable Standards | IS 16806 – Filling & closing machines IS 16811 – Labeling and packaging machines IS 12258 (Type A), IS/IEC 60204-1, IS 16569 (Type B). |
| Industries Affected | FMCG, Food & Beverage, Pharmaceuticals, Cosmetics, Logistics, Retail Packaging. |
| Target Stakeholders | Machine manufacturers, OEMs, packaging line integrators, importers, contract packers, food & pharma production units. |
| Exemptions | Goods for export only Items under other QCOs CMVR-covered machines excluded. |
| Scheme X Highlights | Includes BIS registration, product-specific testing, labeling compliance, documentation & optional BIS factory audit. |
| Enforcement Authority | Bureau of Indian Standards (BIS) — empowered to inspect, suspend, prosecute, and confiscate uncertified or mislabelled machinery. |
| Penalties for Non-Compliance (Manufacturers failing to get certified by, 1 September 2026 , face) | Cancellation of license or CoC. Product seizure & ban on sale. Disqualification from government tenders. Fines up to ₹2 lakh (₹5 lakh for repeat offences). Imprisonment (up to 2 years) and other legal action under BIS Act, 2016. |
| Next Steps for Stakeholders | Register on BIS portal, apply IS 16806/16811, prepare technical file, complete lab testing, ensure compliant labeling and apply for certification |
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QCO Title & Notification
This product category is regulated under the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024, issued by the Ministry of Heavy Industries, Government of India. The original notification is S.O. 3649(E) dated 28 August 2024, with an amendment issued via S.O. 2579(E) dated 12 June 2025. The order is backed by Sections 16, 17, and 25 of the Bureau of Indian Standards (BIS) Act, 2016 and mandates BIS certification for listed machinery.
Objective & Coverage
This QCO aims to ensure safe design, manufacture, and operation of machinery used in filling, closing, sealing, labelling, and packaging processes across industries. It applies to both finished equipment and their assemblies/sub-assemblies/components under the mentioned HS Codes. These machines are widely used in automated production lines for bottle filling, carton packing, shrink wrapping, labeling, and bag sealing.
Effective Date
The regulation will be enforced from 1 September 2026 for all finished machinery listed. Separate notification dates will be issued for enforcement concerning sub-assemblies and components.
Product Coverage, IS Standards, HS Codes, and Impacted Industries
| Product Type | HS Codes | IS Standards | Standard Type | Impacted Industries |
|---|---|---|---|---|
| Bottle filling, capping, sealing | 842220, 842230 | IS 16806, IS/IEC 60204 | Type C / B | Food & Beverage, Pharma, Cosmetics |
| Labelling & Packaging Machines | 842240, 842290 | IS 16811, IS 16569 | Type C / B | FMCG, Logistics, Retail, Contract Packing Units |
HS Code & Product Description
| HS Code | Product Description | Key Application/Function |
|---|---|---|
| 842220 | Machinery for cleaning or drying bottles or other containers | Used in bottling plants or packaging lines to wash or dry bottles, jars, or containers before filling. |
| 842230 | Machinery for filling, closing, sealing, or labelling bottles, cans, boxes, bags or other containers; capping machines | Packaging lines for liquid or solid products – filling soft drink bottles, sealing milk cartons, labelling food jars, etc. |
| 842240 | Machinery for cleaning or drying bottles, filling and sealing, labeling, or capsuling machinery (combined) | Multi-functional machines that combine two or more functions (e.g., wash + fill + seal) in one integrated unit. |
| 842290 | Parts of the above machinery | Spare parts, components or accessories specifically for 8422-series machines (like conveyors, nozzles, capping heads, etc.). |
Certification & Scheme
Manufacturers and importers must obtain BIS certification under Scheme X, either through:
- ISI mark license, or
- Certificate of Conformity (CoC) where ISI marking is not applicable.
No such product may be sold, imported, or distributed in India without BIS certification beyond the effective date.
Pre-Certification Requirement
To qualify for certification, applicants must:
- Register with BIS via the Manakonline portal
- Identify and apply the relevant Indian Standards (e.g., IS 16806, IS 16811)
- Prepare a technical file containing product design, specifications, safety measures, and risk analysis
- Undergo type testing through BIS-approved labs
- Be ready for factory inspection if directed by BIS under Scheme X
Labeling & Compliance
All certified packaging machinery must visibly carry:
- ISI mark or CoC reference number.
- Manufacturer’s name and location.
- Model/type ID.
- Technical specifications, safety symbols, and warnings.
This labeling must comply with IS 16569 (safety signs), IS/IEC 60204-1 (electrical safety), and general Scheme X requirements.
Applicable Indian Standards (IS Codes)
BIS uses a tiered structure for safety certification:
- Type A (General Safety):
- IS 12258 – Risk reduction principles in machinery design.
- Type B (Component Safety):
- IS/IEC 60204-1 – Electrical equipment safety.
- IS 16569 – Safety symbols and hazard markings.
- Type C (Product-Specific):
- IS 16806 – Packaging/filling machinery.
- IS 16811 – Machines for wrapping and labeling
If any standard overlaps, Type C takes precedence, as it contains the most specific safety and performance norms tailored to packaging and sealing machines.Â
Industries & Stakeholders Impacted
This regulation will have direct compliance obligations for:
- Machine manufacturers & OEMs in the packaging sector.
- System integrators and automated line designers.
- Importers and suppliers of labeling/filling equipment.
- End users in FMCG, pharmaceutical, food and beverage, personal care, and logistics sectors.
Exemptions
The following categories are exempt from this QCO:
- Machines manufactured only for export.
- Products already governed by other BIS QCOs.
- Machinery falling under the Central Motor Vehicles Rules, 1989 (CMVR) under MoRTH.
Legal Consequences & Penalties
Violation of the Order is punishable under the BIS Act, 2016, with the following penalties:
- Fine of ₹2 lakh for first offence.
- Fine of ₹5 lakh for subsequent offences.
- Imprisonment up to 2 years.
- Seizure of products, cancellation of license, and prohibition of sale/import.
BIS has full authority to inspect premises, collect samples, and initiate prosecution in case of non-compliance.
Summary & Next Steps
To ensure uninterrupted business operations and legal compliance:
- Stakeholders must register with BIS, identify the applicable IS (IS 16806, IS 16811), and submit for type testing.
- Certification must be obtained under Scheme X well before the 1 September 2026 deadline.
- Ensure that all products carry correct labels, warnings, and certification marks.
- Watch for future gazette notifications regarding sub-assemblies and component timelines.
Failure to comply may result in loss of BIS certification, legal enforcement, and market access restriction.
Ready to start your certification journey?
Let us help you navigate regulatory challenges and achieve certification with ease. Leave us your details, and we’ll get back to you—or request a free consultation today.