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News

Roche to phase out SVHCs within ten years of listing

Nigel Rowe

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Pharmaceutical giant announces global commitment

12 November 2015 / United States, Global, Alternatives assessment / substitution

Global pharmaceutical and diagnostic company Hoffmann-La Roche has committed to a goal of phasing out the use of substances of very high concern (SVHCs) – where technically feasible – within ten years of their listing.

To implement the goal, the company will first identify SVHCs used in products or their manufacture on a global basis. This will be conducted with the aid of “enterprise-resource-planning software” that will soon include a material declaration tool.

The company has also undertaken an awareness campaign among its R&D staff, who "are key if you want to ensure that SVHCs will not be used in any future processes or products", Dr Jan Backmann, the company’s head of chemical legislation, told Chemical Watch.

The ten-year time frame was selected, he said, in order to “strike a good balance between realism and ambition, while taking into account the lifecycle of products and processes in our company”.

He added that this timeline is "very ambitious", as diagnostics and pharmaceuticals are highly regulated and require approval by various authorities.

To avoid "regrettable substitutions", Roche is emphasising close collaboration between its regulatory experts and toxicologists and ecotoxicologists while evaluating product and process development.

Dr Backmann added that the company has also made investments “to theoretically evaluate and test several potential alternative process aids”. These would be cross-linked with the green chemistry and ecodesign teams within the company.

With regards to the technical feasibility aspect of the goal, Dr Backmann said that it is “very strictly defined”, and does not just mean “hard to achieve”.

He added that an example of technical impossibility would be cobalt chloride. This is a nutrient in fermentation and a co-factor of certain enzymes and therefore cannot be substituted.

Apart from situations where it is technically impossible to replace an SVHC, such as in cases where a substance is "essential on a molecular level", the company is committed to avoiding the "temptation" to take advantage of exemptions that exist within REACH for the pharmaceutical and diagnostics industry, he says.

Dr Backmann says the company does see potential to improve the procedures related to SVHCs and authorisation. "More could be done to deliver on the promise of REACH to create an atmosphere in which scientific and technological innovation and manufacturing can really thrive in the European Union,” he says.

He added that there have been several motives behind the establishment of the SVHC goal. These include:

  • protecting the health of customers and employees, as well as the environment;

  • ensuring supply chain continuity of raw materials;

  • allowing processes to be more easily moved to another site globally, including to the EU;

  • making products more attractive to customers and giving the company a competitive advantage in the marketplace; and

  • maintaining a high sustainability rating.

 

Roche sustainability