Dostosowanie do wymogów w zakresie standardowych informacji

Claiming an “adaptation” means that it is possible to omit a test based on certain general rules or specific rules that apply for just one information requirement.

General rules for adaptations can be based on three different reasons:

  1. Testing is not scientifically necessary.
  2. Testing is not technically possible.
  3. Testing is not needed based on absence of or no significant exposure.

These general rules are explained further in Annex XI.

In addition, specific rules for each information requirement are detailed in column 2 of Annexes VII to X.

Depending on the substance properties and available information, some tests / studies cannot or do not need to be performed:

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 examples of how a certain test result or use conditions mean that a test does not need to be conducted:

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 toxic in contact with skin 8.1. Skin corrosion / irritation
Classified as causing serious eye damage 8.2. Serious eye damage / eye irritation
Adequate information for environmental classification and labelling is available 9.1.1. Short term toxicity for invertebrates
No emission to a sewage treatment plant exists 9.1.4. Activated sludge respiration inhibition

 

For a full overview, consult the ‘Practical guide for SME managers and REACH coordinators’ and Annexes VII to X to REACH.

Importantly, omitting testing on animals must not compromise the safe use of substances. Therefore, every adaptation you use instead of submitting the standard information needs a valid and documented justification.

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