Examples of assessment reports in applications for authorisation

Disclaimer:

These examples illustrate different practices of how applications for authorisation have been prepared. They are neither endorsed by, nor should they be considered as binding on, the ECHA Committees and their assessment of future applications. ECHA does not take any responsibility and shall not be held liable for any of the statements made in the examples. Any responsibility for the preparation of applications remains solely with the applicants. Any intellectual property rights in the examples provided remain with their respective holders.

 

Example Type? Comment?
Use of diglyme as solvent in the manufacturing process of an intermediate for further conversion into a pharmaceutical compound used in medicinal products for treatment of respiratory diseases  [PDF] CSR This is an example of a chemical safety report for the use of a threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride [PDF] CSR This is an example of a chemical safety report for the use of a non-threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
Industrial use of diglyme as solvent in the manufacturing process of cryptand intermediates for further conversion into cryptand 221 and cryptand 222 [PDF] CSR This is an example of a chemical safety report for the use of a threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin.  [PDF] CSR This is an example of a chemical safety report for the use of a non-threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane [PDF] CSR This is an example of a chemical safety report for the use of a non-threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems [PDF] CSR This is an example of a chemical safety report for the use of a non-threshold substance where the RAC opinion concluded that the operational conditions and risk management measures were appropriate and effective and did not recommend conditions or monitoring arrangements to address uncertainties in the exposure assessment.
Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems [PDF] SEA This socio-economic analysis has a structured argumentation for a temporary shutdown. It also presents an example on how the economic infeasibility of existing alternatives can be demonstrated.
The use of Chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional electroplating with decorative character) [PDF]

The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process [PDF]
AoA These analyses are examples of a downstream user application for two uses which are partly interrelated. The reports are clearly written. The applicant screened for a broad range of alternatives, including alternative technologies. Facts are referenced by studies or other evidence-supporting materials. The non-suitability of the alternatives is justified.
The use of Chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional electroplating with decorative character)

The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process
 [PDF]
SEA This socio-economic analysis has a structured argumentation in a downstream user application. This is also an example of how costs could be estimated if authorisation was not granted, leading to closure of the EU manufacturing plants and relocation of operations to out-of-EU facilities.
Dibutyl phthalate used in propellants [PDF] AoA This analysis is an example of an upstream applicant assessing the suitability of alternatives from both their perspective and their downstream users' perspectives. It is written clearly and the analysis is documented and referenced. This analysis follows the first version of the ECHA templates (thereby referencing an annex containing confidential information).
Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth [PDF]

Use of trichloroethylene as a solvent in a process to recover and purify resin from process water [PDF]
AoA These analyses are examples of a downstream user application for two uses which are partly interrelated. The reports are clearly written. Tables and diagrams are used to illustrate processes and other key information. Additional information is provided in appendices. The non-suitability of the alternatives is justified.
Uses of TCE as a solvent for the removal, recovery and purification of a resin used in the manufacture of dyed cloth [PDF] SEA This socio-economic analysis has a structured argumentation in a downstream user application. The impacts to humans through the environment are clearly described. This is also an example of how the costs could be estimated if authorisation was not granted.
Industrial use of TCE as process chemical (enclosed systems) in Alcantara Material production [PDF] AoA This analysis is an example of a "bridging" application for a specific period of time by a downstream user. Here, the applicant has identified a feasible alternative but it takes some time to implement it fully. This is an example of how possible alternatives are assessed and what the basis of their exclusion has been, showing transparently how the applicant had used the criteria.
Use of trichloroethylene as extraction solvent for bitumen in asphalt analysis [PDF] AoA This analysis is an example of an upstream applicant assessing the suitability of alternatives from both their own and their downstream users' perspectives. The applicant analysed the substance function within their process and screened for a broad range of alternatives, including alternative technologies. The analysis of alternatives is clearly described and documented.
Use of trichloroethylene as a processing aid in the biotransformation of starch to obtain betacyclodextrin [PDF] AoA This is an example of a downstream user analysis of alternatives. Possible alternative substances are assessed in detail and their exclusion is reasoned. Referenced studies (such as existing assessments of alternative solvents and processes) or verifiable facts/laboratory tests are the predominant basis for the analysis.
Industrial use of trichloroethylene as an extraction solvent for the purification of caprolactam from caprolactam oil [PDF] AoA This is an example of a downstream user analysis of alternatives. The applicant provides a concise summary of substance function based on a series of technical criteria. The assessment of the technical feasibility of alternative substances is then assessed against these criteria. The methodology and data used for the assessment of economic feasibility are set out. Conclusions are linked to the analysis and the applicant makes good use of summary tables.

 

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