Adaptations to the standard information requirements

An adaptation means that instead of performing a test, you provide a justification either based on certain general or specific rules.

In general, adaptations can be done for three different reasons:

  1. Testing is not scientifically necessary
  2. Testing is not technically possible
  3. Testing is not needed because of demonstrated low exposure

These general rules are detailed in REACH Annex XI. The specific rules and adaptation possibilities for each information requirement are detailed in column 2 of REACH Annexes VII to X. Every adaptation you use instead of submitting the standard information needs a valid and documented justification.

New tests on vertebrate animals shall only be conducted as a last resort when all other data sources have been exhausted. However, keep in mind that not testing on animals should not compromise the safe use of your substance.

Testing for specific pieces of information can be avoided if it is technically not possible to conduct the test due to the properties of the substance. See indicative list below:

Property of substance Test not needed
Gases 7.3. Boiling point
7.4. Relative density
7.14. Granulometry
Liquids 7.14. Granulometry
Inorganic substances 7.8. Partition coefficient
7.9. Flash point
9.2.1.1. Ready biodegradability
Organic peroxides 7.13. Oxidising properties
Spontaneously flammable in air or in contact with water or moisture at room temperature 8.1. Skin corrosion/ irritation
8.2 Serious eye damage/ eye irritation
8.3 Skin sensitisation
Strong acid/base 8.1. Skin corrosion/ irritation
8.2. Serious eye damage/ eye irritation
8.3. Skin sensitisation

 

Some test results or conditions of use mean that a test does not need to be performed. See indicative list below:

Test result or condition of use Test not needed
Melting point is above 300°C 7.5. Vapour pressure
Readily oxidisable in water 7.7. Water solubility
Classified as not acutely toxic in contact with skin 8.1. Skin corrosion/irritation
Classified as corrosive to the skin 8.5 Acute toxicity
Adequate information for environmental classification and labelling is available 9.1.1. Short term toxicity for invertebrates
No emission to a sewage treatment plant 9.1.4. Activated sludge respiration inhibition