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Table 2 Key information useful for an essentiality assessment that should be in an application for authorisation

From: The essential-use concept: a valuable tool to guide decision-making on applications for authorisation under REACH?

Key elements for essentiality assessment

Description of the applicant’s tasks and ECHA’s recommendations for an application for authorisation

References

Technical function provided by the substance in the use applied for

Identification of the function of the SVHC of interest

AfA1 (Sect. 3.4. Page 45–46)

Explanation of if and how the final product would be affected by a change in substance/process and the use of an alternative. Consideration of implications of a lower quality of the product due to the use of an alternative substance

AfA (Sect. 3.5.1. Page 47)

SEA2 (Sect. 3.8. Page 95)

Information on any potential customer and/or legal requirements on the end product

AfA (Sect. 3.5.1. Page 47)

Necessity of the technical function for health, safety and functioning of society

Consideration of the whole supply chain, including the production of a consumer good/service and the benefits provided by it

SEA (Sect. 2.0. and 2.2.1 Pages 30. 33 and 34)

Comparison between the socio-economic impacts from a granted authorisation to those of a refused authorisation

SEA (Sect. 3.2.2. Page 49)

Presentation of qualitative conclusions on the expected severity and extent of the impacts of a granted or refused authorisation in case a quantification is not possible

SEA (Sect. 2.4.2 Page 45 and Sect. 3.3.4.3. page 65)

Qualitative health or environmental impacts from not having certain functionality (e.g., increased risk for fire accidents) due to a refused authorization

SEA (Sect. 3.3.2.1. Page 57 and Sect. 3.8 page 95)

Evaluation of additional consumer costs and/or a loss of welfare because of a ceasing supply/decreased quality of consumer goods

SEA (Sect. 3.4.2. Page 75 and Sect. 3.5.1. Page 83)

Consideration of the costs to the private sector and the costs to society as a whole

SEA (Sect. 3.4.1. Page 74)

Consideration of the impacts of granted or refused authorisation on the supply chain of the available alternatives

SEA (Sect. 3.4.2. Page 79)

Availability of safer alternatives

Consideration of all types of alternatives including other manufacturers’/importers’ portfolios

AfA (Sect. 3.3 Page 43 and Sect. 3.10. page 82)

Consideration of any hazards (including physical hazards) when comparing the risk of potential alternatives. Inclusion of data contained in registration dossiers plus any relevant data that are available, including QSAR and read-across if needed

AfA (Sect. 3.7.1. and 3.7.2. Page 60–62)

Ideally, provision of a "life cycle thinking" in the comparison of risk between alternatives

AfA (Sect. 3.7.3. Page 64)

Consideration of using the "best available technique" framework to compare the risk of the substance to the environment (e.g., persistency) with other hazards and environmental impacts

AfA (Sect. 3.7.4.2. Page 71)

Consideration of human health and environmental impacts of using an alternative that does not reduce the risk

SEA (Sect. 3.8. Page 94)

  1. 1AfA: Information taken from the ECHA Guidance on the preparation for an application for authorisation [18]
  2. 2SEA: Information taken from the ECHA Guidance on the preparation of socio-economic analysis as part of an application for authorisation [19]