The process we took to review the measures and propose the IHS for microorganisms, biological products derived from animals, and cell lines.
There are feedback questions throughout this webpage that will help guide your submission, but we welcome feedback on any part of the draft IHS and this risk management proposal.
We must get your submission with your feedback by 5pm on 25 August 2026.
Find out about the consultation and how to make a submission
The proposed IHS will cover most, if not all, animal products imported for research use in New Zealand.
It will include the following commodities:
A review of the requirements is necessary to ensure the biosecurity risk is managed effectively and to ensure that the requirements are appropriate.
The previous requirements for importing biological products needed to be updated to align with risk management principles or to align with updated risk assessment to ensure that trade of safe commodities could occur.
There are many pieces of specific risk advice for individual imports. To maximise the value and return on effort of this risk work, it needs to be incorporated into the standard. This ensures the requirements for similar imports are consistent.
Grouping the commodities in one new IHS will simplify the import process. The combined IHS provides requirements for microorganisms, biological products derived from animals, and cell cultures.
Some requirements were adjusted under equivalence by Chief Technical Officers (CTO directions) and published to the previous IHS. This amendment proposes to formally incorporate these requirements into the IHS and is an opportunity for importers to provide feedback on the changes and new requirements.
The following 3 sections describe the process used to review and propose new import requirements for microorganisms, biological products derived from animals, and cell lines.
Microorganisms, biological products derived from animals, and cell lines are risk commodities with the potential to harbour exotic viral and bacterial diseases.
Risk analysis was completed in 2005 for the entire portfolio of biological products imported for use in New Zealand and formed the basis of the requirements in the previous IHS for Biological Products.
Additional risk analysis in the form of technical advice has been consistently produced for microorganisms, biological products derived from animals, and cell lines on an as-needed basis, typically when a permit application for a product that requires further risk assessment is received.
The risk conclusions in the technical advice inform the proposed requirements for similar groups of products the advice is applicable to.
Therefore, the proposed IHS contains requirements for a wider range of products than the previous standards specified. Most of these products were previously imported with a permit, supported by a technical assessment and risk advice. The new IHS specifies the requirements for those types of products to improve transparency and reduce the need to reassess the same types of products for different importers or as permits expire.
The needs of researchers and industries to import the products covered under the scope of this IHS may change in unpredictable ways over time. To address this, we have built in options for new products that are not covered explicitly in Section 2 to be specifically assessed for import, according to the nature of the product and its intended use.
In general, the import requirements for a product are determined by the level of risk associated with importing that product:
Risk assessment considers the intended end use of the products. Different end uses confer different levels of biosecurity risk and may necessitate different import requirements.
Section 2 of the new IHS for biological products is arranged into sections based on end use. This approach allows for requirements to be adjusted based upon risk and aims to provide clarity of the restrictions on end use for imported products.
The previous IHS for biological products required most products to be imported for laboratory use only and specified some products were not for use in/on animals. For some of these products, it was required that manufacturers make declarations of the use of the product. In many cases, products may be imported, cleared, and later delinked from the declaration they were imported with, and from the intended end use.
Use of imported biological products on animals, whether laboratory animals or research animals in the field, confers higher risk of passing on animal diseases if they exist in the imported product than any other use for products in this IHS. MPI considers it necessary to ensure that products imported for use in animals are assessed specifically for that purpose.
Biological products that are imported for uses not in/on animals will often be subject to less stringent requirements, since the end use contributes to the risk management of the product. It would be unnecessarily restrictive to assess every biological product imported for laboratory use as if it would be used in an animal.
To strike this balance, MPI proposes to manage end use for these products by requiring importer declarations of the use for cleared products that are not imported to a transitional or containment facility.
Importers are responsible for providing honest declarations, and there are legal consequences for providing false, misleading or incomplete information. Since importers are most familiar with the use of their imported products, any declaration of the use of a product should come from the institution/importer responsible for its use.
It is expected that these declarations will be made electronically through MPI’s website. Importers may need to upload their declaration when submitting the consignment for screening.
Some products may be imported for any use because the requirements completely manage the risk even if the products were inadvertently exposed to an animal. Such products do not require importer declarations.
This RMP presents the draft IHS for microorganisms, biological products derived from animals, and cell lines, and its scope covers most animal products imported for research use in New Zealand. It also includes a narrow range of products containing animal material for use in commercial environments, but it excludes products that are intended for human or animal consumption.
It will include the following commodities:
Are there any additional products you regularly import that should be included in the draft IHS? If so, describe the products, what they are imported for, and how they are imported to New Zealand.
Is the proposed scope suitable for your importing needs? Why or why not?
MPI has taken a practical approach to risk management decisions for products eligible for import under the IHS. This approach reflects that most products imported under the proposed IHS are manufactured using good manufacturing practices in reputable facilities that comply with traceability and quality standards; and that the products are imported for a specific end use in New Zealand.
MPI considers the end use of a product part of the risk mitigation and import requirements are not as stringent if the product is used in a way that minimises exposure to the environment.
Importers need to provide honest declarations of how the imported product will be used and implement processes to ensure that imported products are used in the manner declared at the time of import, even when some time has passed between import and use. Targeted engagement with importers and reviews of import data indicates that, under the current standard, most commodities were imported by reputable companies with a legitimate purpose for the products, so it is reasonable to expect that importers will provide declarations that accurately reflect the use of the products imported. It is also an offence under the Biosecurity Act to provide false, misleading or incomplete information about imported goods.
The end use of products is specified in the relevant sections of the IHS. Many products, regardless of their import requirements, have specified end uses. Some products have different requirements according to their end use.
All products imported under the proposed IHS have undergone a product assessment, where the nature of the product has been assessed against the general risk management principles of the IHS.
Where the risk is managed by declarations about the nature of the products, declarations are required for import.
Where the risk of the product can vary depending on the source species or nature of the processing, a permit is required to allow the product assessment to occur prior to import.
For products that are not described explicitly in the IHS, but which fit within the scope of the IHS, a product assessment may be undertaken under the relevant section according to the product’s end use. This is intended to provide flexibility for researchers and other importers who have import needs that change with short notice and allow for new and as-yet-unknown products to be imported without requiring a lengthy amendment to the IHS.
The outcome of the product assessment determines whether the product can receive clearance or whether it must be directed to and used within a transitional or containment facility.
Manufacturer's declarations provide assurance to MPI border inspectors that the products meet the specific requirements of the IHS.
Manufacturer's declarations are used for commodities that are low risk and do not require a specific product assessment prior to import.
MPI recommends that manufacturer’s declarations reference the specific section of the IHS the products are eligible for import under, to help facilitate rapid and accurate clearance of products that meet the relevant requirements.
Importer's declarations provide assurance to MPI that the imported products will be used for a specific purpose.
Importer's declarations have been used in the current IHS, but their use is proposed to be expanded in the draft IHS.
Since importers are typically the end users of products, and manufacturers are disconnected from the use of their products once shipped, MPI is taking the approach of requiring declarations from the importer regarding use of the products and using manufacturer’s declarations for confirming specifications of the product itself, where required.
In some cases, importers may be distributors who import products in large quantities to sell domestically. For most of the importer declarations proposed, there are options for distributors to ensure that they label the products indicating its use.
Do you agree with MPI's approach to manage end use through importer declarations? If not, how would you propose end use to be managed?
Model veterinary certificates for products that were previously imported under the Specified Animal Products IHS have been transferred to the new IHS and are eligible for trade.
Specified Animal Products IHS [PDF, 563 KB]
Veterinary certificates that were previously negotiated for bovine serum require updates. There will be a 4-month transition period to allow for trade to continue.
The veterinary certificate that was previously negotiated for game (wildlife) trophies from the EU has been transferred to the proposed IHS and does not need renegotiation.
The proposed IHS does not specify the validity period of import permits. The validity period will be determined by MPI when the IHS comes into force and will not be less than 12 months.
Products for import on an import permit may additionally require a manufacturer’s declaration or other documentation as specified in the IHS.
This section outlines the risk management principles used in the different sections of the proposed IHS and describes the rationale for significant changes to requirements.
To understand all the proposed requirements in detail, refer to the draft IHS.
The sections below sometimes refer to the current IHSs that contain the current requirements. The links are included below for your reference:
Products in this section are typically highly processed products that can originate from any species, unless specified, and may be imported from any country. The risk is managed through the processing or extractive techniques used to manufacture the products.
This section is designed to cover the range of biological products derived from animals that are used during typical work in laboratories. Products imported under this section are required to be accompanied by an importer’s declaration that confirms the commodity is for laboratory use only, and not for use in/on animals. If the importer is not the end user of the product, the declaration must confirm the products are labelled for laboratory use only, and not for use in/on animals.
For the purposes of the IHS, laboratory use means use within a laboratory as part of a clearly defined research or analytical process. A laboratory is defined as a place within a scientific institution, school, or university that is built for the purpose of carrying out laboratory procedures separate from the environment that is accredited and operates under and maintains records of standard operating procedures (SOPs) and is subject to regular auditing by / approval from an independent body.
Products that are imported for laboratory use only are to be used within laboratories and disposed of in a way that prevents exposure to the environment or animals.
Products in this section are not for human use or consumption and are not for use on animals.
Commodities listed below have significant changes proposed, with a brief outline of the risk management rationale. The full proposed requirements can be found in the draft IHS.
Are there any products you regularly import for laboratory use that are not covered by this category?
Non-replicative viral vectors are used by laboratories to deliver molecular constructs into eukaryotic cells. They are widely used in research and have been imported using permits for biological products not otherwise listed. The requirements proposed in the IHS are the same as the current requirements for these products, which are treated as laboratory products with a known risk, managed by their specified end use, if they cannot replicate.
Sometimes laboratories may want to import replicative viral vectors to engineer their own construct delivery systems. Replicative viral vectors that do not contain any modified genetic material may be imported into a transitional facility, to manage the risk to the environment. Replicative viral vectors that contain genetically modified material need to be imported under a relevant HSNO approval and comply with the conditions of that approval.
An import permit is no longer required for these products. The permit assessment for these products involved assessing whether the specified declarations required applied to the product. MPI can trust that the supplier of a commercial product would only make accurate declarations of their product status, and if the specified requirements are met, then the product may be imported. Removing the requirement for an import permit reduces costs and barriers to importers of these products.
Previous requirements were added under CTO direction for a specific import. The requirements have been clarified to ensure that the end use contributes to managing the risk of these products. When products are not commercially manufactured, a declaration from the importer of their use and disposal is appropriate. The declaration is required to state the species the product is derived from for border monitoring and to ensure that the declaration applies to the specific product imported.
Requirements were added by multiple CTO directions because the demand for these products is high and ongoing, and the lower risk of commercially purified antibodies does not justify the need for an import permit for these products. Risk assessment determined that the affinity chromatography process used for purifying antibodies is highly specific and likely to remove microorganisms from the final product.
The draft IHS proposes to simplify the requirements for purified antibodies and antisera by acknowledging that the purification process provides effective risk mitigation such that a specific assessment for a permit is not required when the product will be used in a laboratory. Permits are only required for non-purified antibodies from the indicated species for laboratory use.
To facilitate compliance for purified antibodies, there are 2 options to meet the requirements: either packaging indications and an importer’s declaration, or a manufacturer’s declaration.
Antibodies and antisera imported to be used in animals may be eligible for import under section 2.3 of the IHS. The reason for the separation is the assessment of the commodity is different depending on its end use.
These products have been imported under the current Biological Products IHS, subject to an assessment. These items are regularly imported, so for clarity and transparency the requirements are stated in the proposed IHS.
The requirements depend on a technical assessment of the treatment the panel has undergone. The draft IHS has been updated to specify these requirements. It is not anticipated that these requirements will impact trade, since the requirements align with those already in place.
Will these proposed requirements mean your required products are eligible for import?
Are these requirements suitable for your veterinary laboratory to import the materials you need?
Do you regularly import panels from the same manufacturer?
These products are currently imported under schedule 4, category 24 of the biological products IHS for biological products not specifically listed.
These cards are used to store samples, usually blood but occasionally other fluids, for long periods of time. The material is dried, and the card is infused with chemicals to protect the DNA from degradation for future analysis. Risk assessment has determined that the risk is effectively managed for nearly all infectious organisms through the preservative action of the chemicals in the preservation card.
An import permit is required to allow for an assessment of the type of card, its preservative chemicals, and the type of sample preserved on the card. There are a small number of infectious agents (for example, infectious bursal disease) that are not inactivated by these cards, so samples need to be assessed to determine whether they may contain these organisms.
Currently, small volumes of fetal bovine serum or bovine serum albumin for laboratory use only can be imported on import permits or as part of test kits. This usually occurs through providing import permits for these products, and consequently the import options for specific bovine serum products may not be clear.
The proposed requirements indicate that small amounts of fetal bovine serum or bovine serum albumin for laboratory use only may be imported, provided the requirements are met. The fetal bovine serum or bovine serum albumin must be filtered to 0.22 microns, and risk advice determined that this treatment manages the risk associated with these products, provided a manufacturer’s declaration attests to the quality of the manufacturing facility and the processing and sterility of the fetal bovine serum or bovine serum albumin, and the importer provides a declaration about the facility where the products will be used and their destruction. This manages the risk by ensuring the product is likely to be contained.
This section does not apply to bovine serum products derived from non-fetal sources because of the risk of contamination with BSE-risk material.
The requirements for raw bovine serum to be imported to a transitional facility were based on a comprehensive import risk analysis document that assessed the risks of bovine serum from the US and Australia. Under the previous IHS, Biological Products, the only country to negotiate certificates for importing bovine serum products to New Zealand was Australia. Additional risk work completed as part of this project identified that the processing requirements proposed to clear bovine serum products are sufficient to manage the risks associated with bovine serum products from all countries.
The wording of the model certificate has been updated to better reflect the manufacturing requirements for import and remove the need for countries to evaluate their systems to ensure compliance. Some wording has been added to ensure alignment with the WOAH requirements for bovine serum derived from non-fetal sources. It is intended that these changes will make certificate negotiations more feasible, thus enabling trade.
Existing certificates will need to be renegotiated to align with the new IHS. A transition period of 4 months is proposed to allow for trade to continue while certificate negotiations take place.
Products in this section are typically highly processed, finished products for specific commercial uses in the building or environmental industry.
Products imported under this section are not for human use or consumption. Products for human use may be eligible for import under the proposed IHS for Specified Animal Products for Human Consumption.
Products in this section are not restricted to laboratory use and therefore may be used on animals, unless specified. Additional ACVM requirements may apply if the product is used on animals.
Many of the products in this section were previously imported under the IHS for Specified Animal Products. Most of the products have no change to the requirements, and existing model certificates that did not require negotiation have been transferred to the proposed IHS.
IHS for Specified Animal Products [PDF, 563 KB]
Commodities listed below have significant changes proposed, with a brief outline of the risk management rationale. The full proposed requirements can be found in the draft IHS.
Additional risk assessment evaluated the risks associated with bovine serum products from all countries and determined the level of irradiation required to ensure any risk organisms would be inactivated. This risk advice determined that exposure to doses of gamma irradiation totalling 40 kGy would be sufficient to likely inactivate all risk organisms that could be present, with some uncertainty around Borna disease virus for which no gamma irradiation parameters are determined. Similar irradiation doses are used as import requirements in other countries, and the additional requirements for manufacturing, processing, and certification further give assurance that the proposed treatment is sufficient to effectively mitigate the risk associated with importing these products. In addition, before imports from a country can occur, a veterinary certificate must be negotiated with MPI. If there are any concerns regarding presence of a risk organism in a country, these can be addressed during the negotiation process.
Under the Biological Products IHS, the only country to negotiate a certificate for treated bovine serum products was Australia. This certificate contained 2 different options for filtering and irradiating the product. Analysis of import data revealed that both filtering options are used, so this option was retained for Australia to protect existing trade, since the risk management of both options was assessed during certificate negotiations. For all other countries, the model certificate allows for the filtering and irradiation treatment option that does not include testing, since the testing requirements depend on the status of the organisms in the exporting country, as well as the exporting country’s systems for certifying its tests.
The wording of the model certificates have been updated to better reflect the manufacturing requirements for import and remove the need for countries to evaluate their systems to ensure compliance. Some wording has been added to ensure alignment with the WOAH requirements for bovine serum derived from non-fetal sources. It is intended that these changes will make certificate negotiations more feasible, thus enabling trade. Existing certificates will need to be renegotiated to align with the new IHS. A 4-month transition period will allow for existing trade to continue while certificate negotiations take place.
Requirements were added by CTO direction to the Biological Products IHS in response to requests by importers who required sterilised culture media for environmental monitoring and other uses outside a laboratory. Sterilisation mitigates the risk posed by any of the media components, since the sterilisation process renders any contaminating microorganisms non-viable. Therefore, a manufacturer’s declaration attesting that the media being imported has been sterilised is required.
Products in this section are specifically assessed for use on animals. Commodities eligible for import under this section include a range of products used by veterinarians or researchers where the imported biological product has direct or indirect contact with an animal.
This end use has the highest impact if a contaminated product is inadvertently imported and used, so the assessments for products in this section comprehensively assess the risk of diseases or contamination during manufacturing.
Some products eligible for import under this section require authorisation under the ACVM Act. These products receive biosecurity assessment and approval as part of their ACVM authorisation – for example, if a product requires an ACVM authorisation, that authorisation will include the biosecurity requirements.
For other products, additional guidance has been added to provide information about the nature and type of assessments required to import products that will be used on animals. It is not expected that these changes would significantly change what is currently imported under the Biological Products IHS for use on animals.
The requirements for importing catgut suture have been updated to be more transparent, and to ensure the requirements align with WOAH recommendations, whilst also facilitating ongoing trade. The risk organisms that require management for importing catgut suture are bovine spongiform encephalopathy (BSE) on bovine-derived catgut suture, and scrapie on ovine- and caprine- derived catgut suture. These diseases have different pathologies and require different risk management.
Bovine-derived catgut suture may be BSE risk material, unless the product is prepared from the serosal layer of bovine intestines from which the distal ileum has been discarded by the raw material supplier, or during manufacturing. There are many different suppliers and source countries, each with different risk profiles depending on the BSE risk. An import permit is required, subject to an assessment of the manufacturing process and supplier, to ensure that the commodity does not pose a BSE risk to New Zealand if imported.
Ovine- and caprine-derived catgut suture can pose a scrapie risk. There is less known about the pathophysiology and disease spread of scrapie and the localisation of the scrapie prion in tissues. It is not possible to ensure that ovine- or caprine-derived catgut suture is not a scrapie risk through eliminating tissues as for bovine-derived material.
WOAH recommendations indicate that a veterinary certificate attesting that the ovine or caprine material is derived from animals that were raised in a scrapie-free country, zone or establishment, according to the WOAH Terrestrial Code 14.8.3. Importers of catgut suture have previously indicated that attaining veterinary certificates for their material can be difficult, since the manufacturing of catgut suture is typically separated from source abattoirs. It is therefore proposed that the competent authority of the exporting country provide assurance through an official letter or similar means that the ovine and caprine materials were derived from animals raised in a scrapie-free country, zone, or establishment.
Products imported under this section were previously imported under the IHS for Biological Products or the IHS for Specified Animal Products.
IHS for Biological Products [PDF, 464 KB]
Items in this section may be whole animals, parts of animals, tissue on microscope slides or other samples.
All items imported under this section are expected to be preserved in a way that mitigates any risk from contaminating organisms or diseases present in the animal or its tissue since they are cleared without specific end use requirements.
Apart from reorganising the commodities, the requirements remain the same as the previous IHS, with the inclusion of additional preservation methods that have been assessed to be equivalent to preservation in 10% formalin. These additional preservation methods were added to the current Biological Products IHS through CTO direction.
Do the proposed requirements in section 2 of the draft IHS meet your importing needs?
Are there any other ways the risk could be managed in a way that makes importing more feasible?
Are there any products you would not be able to import under these proposed requirements?
Commodities in this section were previously imported under the IHS for Microorganisms from all countries.
IHS for Microorganisms [PDF, 338 KB]
Changes to this IHS have been incorporated by CTO direction in response to changing importer demands, specifically for importing proficiency panels for quality assurance testing that contain live microorganisms.
Although the changes are already in place due to urgent requirements for import, consultation is an opportunity for importers and stakeholders to provide feedback on the suitability of these requirements in terms of import feasibility and risk management.
It is intended that this section contains the requirements for all microorganisms imported to New Zealand, regardless of whether they are pure cultures or contained within a product or a sample. Other standards for products that may contain microorganisms will refer to this IHS for the requirements that the microorganisms contained in the product must meet.
Under the current IHS, permit assessments for microorganisms that are present in New Zealand, and not unwanted or regulated organisms involved crosschecking databases that list organisms’ status. It was determined by CTO direction that an importer who is or represents a researcher at a scientific institution or equivalent laboratory could declare the status of an organism, and this would provide equivalent risk management to the permit assessment for these organisms, when the microorganism is imported for laboratory use only. The declaration is confirmed by MPI at the time of import. The end use aligns with the risk management principles for similar products – when an organism is imported for a specific purpose in a laboratory setting, the likelihood of that organism escaping into the environment is low. In addition, because the organisms are already present in New Zealand and not unwanted or regulated, the impact of escape is minimal.
Microorganisms that meet the criteria for import under section 3.1.1 but are imported for uses outside the laboratory may be imported with an import permit, subject to an assessment of the status of the organism and its intended use in New Zealand.
The requirements in 3.1.1(2) apply to products containing microorganisms, which require a permit to enable a thorough product assessment to be undertaken. Importers of pure cultures of microorganisms that are not new, unwanted or regulated organisms, who are not the end user of the microorganisms, may also import under 3.1.1(2). This applies to scientific distributors and other importers who import products to sell in New Zealand.
Do you agree with the risk management measures for microorganisms that are present in New Zealand and not unwanted?
Specific requirements for proficiency panels were added to the current IHS MICROIC.ALL by CTO direction. These panels contain mixtures of microorganisms that are received by veterinary and diagnostic laboratories around New Zealand by reputable providers. Receiving laboratories are required to run the samples according to their standard test procedure and report a result within a specified time to gain and maintain accreditation to provide diagnostic tests.
It was difficult for importing laboratories to meet previous requirements without providers identifying the organisms in the panel in advance, which prevents the laboratories from using the panels for their intended purpose.
The type of organisms present on the panel determines whether the declaration is provided by the importing facility or the provider, and the specifics of the declaration.
For proficiency panels that contain unwanted organisms, permission under sections 52/53 of the Biosecurity Act is not required until the organism is identified. The risk of importing an unknown unwanted organism is managed through the declaration provided by the importing facility that they are appropriately equipped and trained to handle potentially unwanted organisms. The importer also declares that if an unwanted organism is identified, it will either be destroyed immediately, or the lab must hold the appropriate section 52/53 permission.
The requirements for panels containing new organisms were developed in response to the Environmental Protection Authority (EPA) issuing a conditional release approval for specific facilities that are not containment facilities to use panels containing new organisms for the purposes of gaining or maintaining accreditation. The only new organisms that cannot be imported to facilities that are not MPI-approved are the organisms that New Zealand claims to be free from. Imports of these organisms to non-MPI approved facilities may have unintended consequences for New Zealand exports.
Microorganisms from all countries IHS [PDF, 338 KB]
Do the proposed requirements suit your needs for importing proficiency panels?
Do you agree with the risk management proposed for imports of these panels?
This section clarifies the requirements for test kits containing animal products and viable microorganisms. The microorganisms need to meet the requirements in section 3.1.1; and the test kit components need to meet the requirements of section 2.1.4. Guidance has been added to indicate that test kits containing components derived from plants also need to meet the requirements of the IHS for Research Samples (excluding animal samples) RESEARCH.IHS [PDF, 323 KB]
The Biological Products IHS previously required that animal samples were from animals that were clinically healthy, until a CTO direction determined that the risk management provided by importing the samples to a transitional facility was sufficient to manage the risk of animal samples from any animal, even if they were not clinically healthy.
Biological Products IHS [PDF, 464 KB]
Under the previous arrangement, animal samples could only be imported if they were non-viable, and culturing of microorganisms from animal samples imported under the Biological Products IHS was not possible. The new IHS arrangement means that animal samples can be imported into a transitional facility for any type of research.
Researchers must be aware that if a new organism is identified, the Environmental Protection Authority (EPA) must be notified, and if an unwanted organism is identified, the sample must be destroyed if the laboratory does not hold a valid permission under sections 52/53 of the Biosecurity Act.
If you have any questions about this risk management proposal or the draft IHS, email mobiocell.consultation2026@mpi.govt.nz
For information about providing submissions, refer to the consultation page on the draft import health standard
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