UN Mark IIP Certificate for Toxic & Infectious Substances

To obtain IIP Certificate for Class 6 Toxic and Infectious Substances, the following documents must be submitted to the certifying authority:

The table below shows the IIP UN Mark Certification fees for packaging materials under Normal, Combine, and Tatkal modes. These fees are particularly helpful for businesses seeking IIP Certification for Class 6 Toxic and Infectious Substances, allowing them to plan and understand the certification costs clearly in advance.

Note: The above fee structure represents the Normal Mode, Combined Mode, and Tatkal Mode charges for testing and certification of packaging materials for UN Certificates. If you obtain Combined Tatkal Mode Certification, the Government fee will be 1.5x the Normal Mode charges.

Note: Professional Fee for IIP UN Mark certification Registration Normal mode starts from ₹24,999 whereas the Combine mode (Air & Sea) Fee is ₹37,499.

The packaging used to transport hazardous materials, specifically toxic substances (Class 6.1) and infectious substances (Class 6.2), must meet the strict safety requirements set by the United Nations Recommendations on the Transport of Dangerous Goods. A UN Mark IIP Certificate for Toxic and Infectious Substances is an internationally recognized certification that attests to this.

Infectious substances contain pathogens such as bacteria, viruses, or other microorganisms that can cause diseases in humans or animals, whereas toxic substances are chemicals that can be harmful or fatal if inhaled, consumed, or come into contact with the skin. The UN requires that these materials be transported in certified, secure packaging because of the significant health risks they pose.

For the safe handling of toxic and infectious materials during air, road, sea, or rail transportation, as well as for customs clearance and legal compliance, the UN Mark IIP Certificate is necessary.

The UN Mark IIP Certification is a globally recognized packaging certification used to transport hazardous goods. It ensures compliance with United Nations (UN) regulations for the safe handling, storage, and transportation of dangerous materials. Here are the key benefits:

• Enhanced Safety: Certified packaging passes the actual tests such as dropping, pressure, and leakproof efficacy in handling hazardous products that may result in spills, leaks, or contamination.
• International Trade Facilitation: UN certification is accepted by most of the regulatory bodies around the world and reduces the time taken to complete the customs formalities for transporting hazardous materials across borders with minimum legal complications.
• Increased Market Credibility:Certification shows the company’s dedication to quality, safety, and reliability, improving the overall image and perception of the business by its customers, suppliers, and other authorities while enhancing the overall market access.
• Cost Savings: UN approved packages help to avoid fines, legal consequences, and rejected shipments, certification lowers general expenses that are related to compliance violations, damaged goods, and potential danger.
• Competitive Advantage: Obtaining an IIP UN Mark certificate allows businesses to become more competitive and find more customers and partners due to compliance with the requirements for operating at a high level of safety and quality.

Packing groups (PG) denote the degree of danger presented by the substance. It defines packaging strength and test performance required during shipment. Class 6.2, however, is not divided by packing groups but instead uses Category or Group A based on risk of infection.

Packing Group Criteria for Class 6.1 Toxic Substances.

• Packing Group I : Substances with high toxicity, e.g. cyanides) requires the strongest packaging.
• Packing Group II : Moderate toxicity levels. Requires UN-approved packaging with intermediate performance tests.
• Packing Group III : Low toxicity levels. Minimum strength requirements still apply.

Unlike Class 6.1, Class 6.2 infectious substances are not classified by packing groups. Instead, they are assigned to one of two categories based on the risk of infection:

Category A Infectious substance capable of causing permanent disability, life-threatening illness, or fatal disease in otherwise healthy humans or animals on exposure. Category A includes two UN numbers depending on the host affected:

• UN2814 affects humans (or both humans and animals). Examples: Ebola virus, Variola (smallpox), Mycobacterium tuberculosis cultures, Bacillus anthracis cultures.
• UN2900 affects animals only. Examples: African swine fever virus cultures, Foot-and-mouth disease virus cultures, Classical swine fever virus cultures.

Category B Infectious substances that do not meet the criteria for Category A. Assigned UN3373. Commonly includes patient diagnostic specimens, clinical samples, and laboratory specimens transported for routine testing or analysis.

Class 6 includes substances that pose serious health risks. Toxic substances can cause harm or death when inhaled, ingested, or absorbed, while infectious substances contain pathogens that can cause disease in humans or animals.

1. Toxic Substances (Poisonous or harmful to humans and animals even in small amounts)
   • Heavy Metals & Compounds: Arsenic, Mercury Compounds, Lead Compounds, Thallium Compounds, Barium Compounds
   • Cyanides & Toxic Gases: Hydrogen Cyanide, Potassium Cyanide, Sodium Cyanide, Phosgene
   • Organic & Industrial Chemicals: Chloroform, Carbon Tetrachloride, Formaldehyde, Phenol, Methanol (Highly Toxic if Ingested), Tetrachloroethylene, Ethylene Oxide, Acrylonitrile
   • Agricultural & Biological Toxins: Nicotine, Parathion (Agricultural Pesticide), Strychnine, Dioxins
2. Infectious Substances (Contain pathogens that cause disease in humans or animals)
   • Viruses: Ebola Virus, Hepatitis B and C, HIV (Human Immunodeficiency Virus), COVID-19 (SARS-CoV-2), Influenza Virus (Highly Pathogenic Strains), Dengue Virus, Poliovirus, Smallpox (Variola Virus), SARS Virus
   • Bacteria & Pathogens: Anthrax (Bacillus anthracis), Tuberculosis (Mycobacterium tuberculosis), Foot-and-Mouth Disease Virus, Cholera Bacteria (Vibrio cholerae), Brucella Species (Brucellosis), Plague (Yersinia pestis)

The World Health Organization (WHO) classifies infectious agents into four biological risk groups based on their pathogenicity, mode of transmission, and the availability of preventive or therapeutic measures.

• Risk Group 1: Includes microorganisms that present little or no risk to human or animal health and generally comprise common environmental organisms.
• Risk Group 2: Includes pathogens that can cause disease in humans or animals but are unlikely to pose a serious hazard to the community. Examples include Salmonella spp., Hepatitis B virus, and certain strains of Escherichia coli.
• Risk Group 3: Consists of pathogens capable of causing serious disease in individuals but which generally present a lower risk of widespread community transmission when effective control measures are implemented. Examples include Human Immunodeficiency Virus (HIV), Mycobacterium tuberculosis, and West Nile Virus.
• Risk Group 4: Includes highly dangerous pathogens that cause severe or fatal diseases, and for which effective treatment or preventive measures may be limited or unavailable. Examples include Ebola virus, Marburg virus, and Variola virus (Smallpox).

Class 6.2 infectious substances are further categorized under international transport regulations based on their potential to cause disease during transportation.

• Category A Infectious Substances: Are materials known or reasonably expected to contain pathogens capable of causing permanent disability, life-threatening illness, or fatal disease in otherwise healthy humans or animals upon exposure. Infectious substances affecting humans are assigned UN2814, while those affecting animals only are assigned UN2900. Due to the significant hazards associated with these materials, Category A substances are subject to the most stringent packaging, testing, and transport requirements, including compliance with applicable IIP UN Mark certification standards.
• Category B Infectious Substances: Are infectious materials that do not satisfy the criteria for Category A classification. These substances are assigned to UN3373 and commonly include diagnostic specimens, clinical samples, laboratory samples, and biological materials transported for testing or analysis. Although Category B substances are considered less hazardous than Category A materials, they must still be packaged, marked, and transported in accordance with applicable regulatory requirements to ensure safety throughout the transport chain.

• PI 620 – Category A Infectious Substances: Category A infectious substances include those having the potential to cause permanent disability and/or serious life-threatening illness in both animals and humans after exposure. PI 620 requires triple packaging that includes primary packages consisting of an absorbent layer within them, secondary packaging, and third packaging that is rigid. The primary packaging should be constructed using either glass, metal, or plastic.
• P650 – Category B Infectious Substances: Category B infectious substances are those not meeting Category A criteria but still pose a health hazard. P650 allows simple packaging with dual-layer containment: primary leak-proof receptacles combined with secondary packaging that is rigid and absorbent. Primary containers must be plastic or glass; secondary packaging ensures puncture resistance. Outer packaging requirements are less stringent than Category A.

Class 6.1 refers to toxic substances which are hazardous in nature and can lead to death, injury, or harm to human health if swallowed, inhaled, or absorbed. These toxic substances are identified by 4-digit UN numbers to ensure safe handling, storage, and emergency response.

Common Class 6.1 UN numbers include:

• UN2810 Toxic organic liquid, NOS
• UN2811 Toxic organic solid, NOS
• UN2902 Pesticides, liquid, toxic
• UN3286 Flammable liquid, toxic
• UN1583 Chloropicrin mixtures

Key Class 6.2 UN numbers are:

• UN2814 Infectious substance, affecting humans — Category A
• UN2900 Infectious substance, affecting animals only — Category A
• UN3373 Biological substance, Category B — most common for diagnostic samples/clinical specimens

Validity of toxic substances (class 6.1) and infectious substances (class 6.2) depends on the manufacture’s ISO status. Extension beyond 18 or 9 months is strictly non-extendable. Upon expiration of the certificate, manufacturers must submit new samples and repeat testing processes to obtain a fresh IIP certificate for Toxic and Infectious Substances.

• ISO 9000 Certified Manufacturers: Valid for 18 months
• General Category (Non-ISO) Manufacturers: Valid for 9 months