Sub menu

Information waivers for assessment certificate applications

Descriptions of information waivers and justifications you can request when applying for an assessment certificate.

On this page

Who should read this and when?

Anyone who wishes to submit a certificate application is required to provide information related to their chemical. This guidance is to assist anyone planning to submit an assessment certificate application in understanding when it is appropriate to request an information waiver and justifications that we would accept.

What are information waivers?

Information waiving refers to omitting certain required information about the chemical in a certificate application.

When applying for an assessment certificate, you need to provide information on the:

  • physical and chemical properties
  • environment-related endpoints
  • human health-related endpoints 

of the chemical you wish to introduce. We need this information for risk assessment of your chemical. The type of information you’ll need to give us depends on your application type. If requesting an information waiver on certain properties or endpoints, you will need to provide a reason or justification for not submitting the required information about your chemical. You can choose a justification from the lists below (see 'Information waiver justifications in IUCLID6' and 'Information justifications not in IUCLID6' below). Alternatively, you can provide your own justification.

Please note for specified class of introductions, the information requirements may override the information waivers in this guidance.

When we assess an application, we will consider all available information from:

  • in vitro tests 
  • in vivo tests
  • human evidence/studies
  • data from suitable analogues 
  • valid Quantitative Structure-Activity Relationship (QSAR) data on a case-by-case basis. 

Any information you provide must also comply with our policy on animal test data.

Find out more about animal test data

We recommend that you first search for any existing information before looking to commission a study. 

How to request an information waiver

You can request an information waiver in the certificate application form or in IUCLID6.

Information waiver justifications in IUCLID6

The IUCLID6 software (used for assessment certificate applications) has built-in information waiver and justification options you can choose when applying. Your information waiver options include:

  • Study technically not feasible
  • Study scientifically not necessary / other information available
  • Exposure considerations
  • Study waived due to provisions of other regulation
  • Other justification

If the first 4 options do not apply, you can choose the “Other justification” option. This will allow you to type in your own justification. We may request further information from you if required. 

See the most used information waivers for each endpoint, and their built-in justifications from IUCLID6 below. To ensure we align with international best practise, we have adopted many of the information waiver justifications a number of OECD member countries use.

Click here to skip this list and go to information waivers justifications not in IUCLID6.

We update both information waiver lists on this page from time-to-time. Make sure you check you are using the latest version of this guidance each time you request an information waiver.

IUCLID6 information waivers for physical and chemical properties 

We will also consider justifications that are not in our list or built into IUCLID. We may request further information if required.

Study technically not feasible

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted for self-reactive substances
  • the study does not need to be conducted because chemical change occurred during the melting point study

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is a gas and the transition from liquid to gas, if any, does not occur close to 20°C
  • the study does not need to be conducted because the substance is a solid which melts above 300°C
  • the study does not need to be conducted because the substance is a solid which decomposes before boiling

Study scientifically not necessary / other information available 

  • the study does not need to be conducted because the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Study technically not feasible

  • vapour pressure testing is not required because the standard boiling point is less than 30ºC, as this substance will have a vapour pressure value above the limit of measurement (i.e. 10E+05 Pa)
  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is self-reactive
  • the study does not need to be conducted for organic peroxides

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the melting point is above 300°C

Study technically not feasible

  • the study does not need to be conducted because the substance is inorganic
  • the study does not need to be conducted because the substance decomposes
  • the study does not need to be conducted because the substance has a high surface activity
  • the study does not need to be conducted because the substance reacts violently during the performance of the test
  • the study does not need to be conducted because the substance does not dissolve in water or in octanol

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours)
  • the study does not need to be conducted because the substance is readily oxidisable in water

Study technically not feasible

  • the study does not need to be conducted because the substance is a gas
  • the study does not need to be conducted because the substance is an aerosol
  • the study does not need to be conducted because the substance is inorganic
  • the study does not need to be conducted because the substance is an inorganic liquid with no covalent bonds
  • the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
  • the study does not need to be conducted because the substance only contains volatile organic components with flash-points above 100°C for aqueous solutions
  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted because decomposition occurred during the melting point study
  • the study does not need to be conducted because some impurities have an impact on the ignition source in such a way as to distort/invalidate the results

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the flash point for liquid organic peroxides is only relevant in the temperature range where the product is thermally stable. Above the SADT (self-accelerating decomposition temperature) of the product flash point determination is not relevant because decomposition products are evolved
  • the study does not need to be conducted because the flash point for liquid self-reactive substances is only relevant in the temperature range where the product is thermally stable. Above the SADT (self-accelerating decomposition temperature) of the product flash point determination is not relevant because decomposition products are evolved

Study technically not feasible

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted for liquid organic peroxides, because the vapours decompose during the execution of the test
  • the study does not need to be conducted for liquid self-reactive substances, because the vapours decompose during the execution of the test

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is a liquid non-flammable in air, e.g. no flash point up to 200°C
  • the study does not need to be conducted because the substance is a gas having no flammable range
  • the study does not need to be conducted because the substance is a solid having a melting point less than or equal to 160°C

Study technically not feasible

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted for organic peroxides
  • the study does not need to be conducted for self-reactive substances
  • the study does not need to be conducted because the substance is a solid
  • the study does not need to be conducted because the substance is a liquid
  • the study does not need to be conducted because the substance is no aerosol
  • the study does not need to be conducted for self-reactive substances / mixtures
  • the study does not need to be conducted because the substance is a gas

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is a gas and the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit.
  • the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the substance is completely molten at 160°C
  • the study does not need to be conducted because the substance undergoes exothermic decomposition at a temperature below or equal to 140°C
  • the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water
  • the study does not need to be conducted because the substance is known to be soluble in water to form a stable mixture

Other justification

  • the study does not need to be conducted because the substance is an aerosol and aerosols shall not be classified as flammable gases
  • the study does not need to be conducted because the aerosol is not submitted to the flammability classification procedures, but is classified as 'extremely flammable' (Aerosol, Category 1)

Study technically not feasible

  • the study does not need to be conducted because the substance is a gas

Study scientifically not necessary / other information available

  • the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties
  • the study does not need to be conducted because the substance contains chemical groups associated with explosive properties which include oxygen, but the calculated oxygen balance is less than - 200
  • the study does not need to be conducted because the substance is an organic substance or mixture containing chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500°C

Study technically not feasible

  • the study does not need to be conducted for explosives
  • the study does not need to be conducted for flammable aerosols
  • the study does not need to be conducted for organic peroxides
  • the study does not need to be conducted because the substance is a solid
  • the study does not need to be conducted because the substance is a liquid
  • the study does not need to be conducted because the substance is a gas

Study scientifically not necessary / other information available

  • the study does not need to be conducted for flammable gases
  • the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with oxidising properties and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the substance is pyrophoric
  • the study does not need to be conducted because the organic substance does not contain oxygen or halogen atoms and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the organic substance contains oxygen or halogen atoms which are chemically bonded only to carbon or hydrogen and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the inorganic substance does not contain any oxygen or halogen atoms and hence, the classification procedure does not need to be applied
  • the study does not need to be conducted because the substance is incapable of reacting exothermically with combustible materials
  • the study does not need to be conducted because the substance is flammable

Study technically not feasible

  • the study does not need to be conducted because the analytical method is not sensitive enough
  • the study does not need to be conducted because the substance has no ionic structure
  • the study does not need to be conducted because the substance is insoluble

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is hydrolytically unstable (half-life less than 12 hours)
  • the study does not need to be conducted because the substance is readily oxidisable in water

Study technically not feasible

  • the study does not need to be conducted because the substance is highly insoluble in water

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is readily biodegradable

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance has a low octanol water partition coefficient and the adsorption potential of this substance is related to this parameter
  • the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption
  • the study does not need to be conducted because the substance and its relevant degradation products decompose rapidly

IUCLID6 information waivers for environment related endpoints 

Study technically not feasible

  • the study does not need to be conducted because the substance is inorganic

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance has a low potential to cross biological membranes

Exposure consideration

  • the study does not need to be conducted because direct and indirect exposure of the aquatic compartment to the substance is unlikely

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because a long-term aquatic toxicity study on fish is available

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
  • the study does not need to be conducted because a long-term aquatic toxicity study on invertebrates is available

IUCLID6 information waivers for human health related endpoints 

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is classified as corrosive to the skin

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is classified as corrosive to the skin

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is classified as corrosive to the skin
  • the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Exposure considerations; study scientifically not necessary / other information available

  • the study does not need to be conducted because skin contact in production and/or use is not likely

Study technically not feasible

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is classified as acute toxicity by the dermal route (Category 1)
  • the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
  • the study does not need to be conducted because the substance is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)

Study technically not feasible

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available

  • the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)
  • the study does not need to be conducted because the substance is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)

Study technically not feasible

  • the study does not need to be conducted because the substance is spontaneously flammable in air or in contact with water or moisture at room temperature

Study scientifically not necessary / other information available

  • an in vitro cytogenicity study in mammalian cells or in vitro micronucleus study does not need to be conducted because adequate data from an in vivo cytogenicity test are available
  • an in vitro cytogenicity study in mammalian cells or in vitro micronucleus study does not need to be conducted because the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because a positive result was found in in vitro cytogenicity study in mammalian cells
  • an in vitro gene mutation study in mammalian cells does not need to be conducted because a positive result was found in in vitro micronucleus study

Information waiver justifications not in IUCLID6

 

Where the justification you wish to use is not in IUCLID6, you can also check our 'Information waiver justifications not in IUCLID6' list. You can use one of the justifications on this list for us to consider in your certificate application.

For information waiver justifications not included in IUCLID6, choose the “Other justification” option and input the justification in the free text box.   

We will also consider justifications that are not in our list or built into IUCLID. We may request further information if required.

 

Check the following:

A waiver can be applied for if your chemical:

Melting point / freezing point

  • is a salt that is only stable as an aqueous solution
  • has a melting point/freezing point less than or equal to -25 °C or greater than 300 °C
  • undergoes a chemical reaction or decomposes. In this case, the temperature of the chemical reaction/decomposition point must be provided
  • has a pour point or softening point, which is more applicable to be provided
  • is a gas at room temperature and pressure
  • is a PLC or low concern biopolymer

Boiling point    

  • is a salt that is only stable as an aqueous solution
  • has a sublimation point, which is more applicable to be provided
  • is a PLC or low concern biopolymer

Density    

  • is a gas. In this case, an estimation based on its molecular weight and the Ideal Gas Laws must be provided
  • is a PLC or low concern biopolymer

Vapour pressure    

  • has a melting point between 200 °C and 300 °C. In this case, a limit value based on measurement or a recognised calculation method must be provided
  • has a molecular weight greater than 1,000 g/mol.
  • is an ionic solid
  • is a PLC or low concern biopolymer

Partition coefficient    

  • is hydrolytically unstable (t½ less than 12 hours)
  • is expected to have log Kow greater than 7
  • has a water solubility greater than 5 g/L
  • is a PLC or low concern biopolymer

Water solubility    

  • is produced in an aqueous solution and is not available in an isolated form
  • is surface active and forms a stable emulsion in water, which cannot be separated by filtration or centrifugation methods

Flash point    

  • has an estimated flashpoint greater than 200 °C
  • has a flashpoint that can be accurately predicted by interpolation from existing characterised material
  • will be introduced at a volume less than 1000 kg per year

Auto flammability    

  • will be introduced at a volume less than 1000 kg per year

Flammability  

  • will be introduced at a volume less than 1000 kg per year

Explosiveness  

  • will be introduced at a volume less than 1000 kg per year

Oxidising properties    

  • the preliminary test indicates the chemical has oxidising properties (i.e. full test does not need to be conducted)
  • will be introduced at a volume less than 1000 kg per year

Hydrolysis as a function of pH    

  • is readily reactive in the presence of water or moisture
  • is a PLC or low concern biopolymer

Adsorption/desorption

  • is hydrolytically unstable (t½ less than 12 hours)
  • has a water solubility of less than 0.01 mg/L or the water solubility cannot be measured analytically
  • is an inorganic compound
  • is a gas at room temperature and pressure
  • is a high molecular weight polymer
  • is a PLC or low concern biopolymer
     

AICIS will not require information if your chemical:

Persistence

  • is inorganic
  • is a biological chemical

Bioaccumulation    

  • has a molecular weight greater than 1000g/mol
  • is a high molecular weight polymer with 
    • less than 25% low molecular weight oligomeric species less than 1000g/mol
    • less than 10% low molecular weight oligomeric species less than 500g/mol
  • is an inorganic chemical
  • is a gas that is not expected to partition to the aquatic compartment
  • has a solubility in water that is greater than 5 g/L, measured following an acceptable test guideline for water solubility
  • has a low potential for bioaccumulation based on log Kow less than 4.2 and a low potential to cross biological membranes
  • has a low potential for bioaccumulation based on log Kow less than 4.2

Aquatic toxicity    

  • has a molecular weight greater than 1000 g/mol and has a low cationic density
  • is a high molecular weight polymer that has a low cationic density
  • is a non-toxic, non-reactive gas that is not expected to partition to the aquatic compartment
  • is a substance covered by Entry 9 of Annex V of the REACH regulation
     

AICIS will not require information if your chemical:

Acute toxicity*

  • is severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin i.e. the chemical is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5), together with high buffering capacity (if relevant)
  • is spontaneously flammable in air or in contact with water or moisture at room temperature
  • is a high molecular weight polymer that has less than 5% by mass of molecules with molecular weight less than 1000 g/mol, or less than 2% by mass of molecules with molecular weight less than 500 g/mol
  • if a NOAEL equal to or greater than 1000 mg/kg bw/day was demonstrated in an oral subacute toxicity study on your chemical or from suitable read-across information**

*  Information required on either acute oral, dermal or inhalation toxicity
** Acute dermal or acute inhalation toxicity only

Skin corrosion/irritation    

  • is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5), together with high buffering capacity (if relevant)
  • is spontaneously flammable in air or in contact with water or moisture at room temperature
  • is acutely toxic via the dermal route (GHS Category 1)
  • is not irritating to the skin in a study conducted following OECD test guidelines 402 or draft 434 results, when tested at 2,000 mg/kg bw

Eye damage/irritation

  • is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5), together with high buffering capacity (if relevant)
  • is spontaneously flammable in air or in contact with water or moisture at room temperature

Skin sensitisation

  • is a high molecular weight polymer that:
    • contains only low concern functional groups, or
    • the only high concern functional groups are unsubstituted positions ortho and para to phenolic hydroxyl groups, or
    • has a combined functional group equivalent weight of equal to or greater than 1000 g/mol, or
  • is spontaneously flammable in air or in contact with water or moisture at room temperature.
  • exposure considerations – workplace use only; not used for consumer applications

Repeat dose toxicity    

  • is corrosive or severely irritating to the skin (GHS Category 1) or likely to be corrosive to the skin i.e. the chemical is a strong acid (pH less than or equal to 2.0) or base (pH equal to or greater than 11.5), together with high buffering capacity (if relevant), or
  • is spontaneously flammable in air or in contact with water or moisture at room temperature, or
  • is a high molecular weight polymer, or 
  • is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical.

Genetic toxicity    

  • is included in the GRAS for FDA Inventory Notice (GRAS Substances (SCOGS)) Database as a Type 1 Conclusion, unless the GRAS conclusion does not apply to the exposures expected from the industrial use of the chemical. or
  • is a high molecular weight polymer 
  • is spontaneously flammable in air or in contact with water or moisture at room temperature.
     

Related content

Last updated
Was this page helpful?
For broken links or technical issues, please provide as much detail as possible. Do not include your name, email address and other personal or commercially sensitive information.

Keep informed with updates