- Three suggested principles
- Strategy for defining and defending the uses applied for
- Major steps in the preparation of the Application
- Indicative timeline in the preparation of the Application
- Chemical Safety Report
- Analysis of Alternatives
- Substitution Plan
- Socio-Economic Analysis
- Administrative information
- Public Consultation on Alternatives
- RAC and SEAC opinion
- EU Commission Decision
- The Authorisation is granted: what now?
Spotlight on the elements of the Application for Authorisation
► Analysis of Alternatives
The Analysis of Alternatives (AoA) is to help determine if there are any suitable alternative substances or technologies
The suitability and availability of alternatives is considered from a triple perspective
- Risks from alternatives
- Technical feasibility of substitution
- Economic feasibility of substitution
Great efforts should be invested in guaranteeing robustness and credibility of the analysis. This may require the involvement of third parties and peer review.
What is an alternative? Possible replacement for an Annex XIV substance in the function that the substance performs or making this function redundant
How to identify possible alternatives?
- - Need to understand the precise function performed by the substance
- - Understand the process in which the substance is involved
- - Imagine other ways of performing the function
- - Consult within and outside the supply chain
The AoA is a precious source of input for the Socio-Economic Analysis particularly regarding the socio-economic consequences of substitution. Included would be societal costs and benefits if suitable/unsuitable alternatives would have to be implemented (risks, technical and economic impacts).
The steps for an AoA
- 1. Identify possible alternatives for each use applied for
- 2. Assess the suitability and availability of possible alternatives, on the basis of their technical and economic feasibility, reduction in risk to the environment and to human health and accessibility
- 3. Identify relevant R&D that is appropriate to the analysis
- 4. Determine actions and timescales that may be required to make possible alternatives suitable and available for the applicant. This is useful for discussing the review period.
Key elements of the AoA will be part of the Broad Information on Uses (BIU) package to be published on ECHA’s website to launch public consultation on alternatives.
The AoA or part of it may be included in a confidential Annex (not to be published on ECHA’s website). This could avoid unwanted scrutiny of information that may be sensitive on business strategies, specific use aspects, technologies and so on.