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Table 1 Main obstacles to the phasing out of SVHCs

From: Experiences and consequences of phasing out substances of concern in a multinational healthcare company

Technical barriers

Market barriers

 • Lack of capacity (time slots) to produce the batches for the validation

 • Lack of available alternatives

 • Technical complexity

 • Effort to demonstrate that the change does not impact safety and function of the product

 • Contractual obligations to keep the existing formulation until the contract ends

 • Contractual necessity giving advanced notification of changes

 • Market acceptance of the products manufactured with the alternative

Economic barriers

Regulatory barriers

 • Costs to revise an existing product in comparison with the potential income which can be generated

 • Lack of capacity, essentially human resources, in R&D

 • Time consumed to find an alternative and to validate it as compared to the remaining life cycle

 • Time span to generate additional data to support change registration

 • Time span to achieve regulatory approval

 • Costs for testing, dossier generation and authority fees