RESTRICTION OF USE OF HAZARDOUS SUBSTANCES (ROHS)

In June 2011, the recast of the RoHS Directive (202/95/EC) was published on the Official Journal as Directive 2011/65/EU, banning six substances (lead, cadmium, chromium VI, mercury, PBB and PBDE) from electrical and electronic equipment. 4 additional substances (phthalates) were added in 2015 by the EC Delegated DIrective 2015/863:

• Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
• Butyl benzyl phthalate (BBP) (0,1 %)
• Dibutyl phthalate (DBP) (0,1 %)
• Diisobutyl phthalate (DIBP) (0,1 %)

According to RoHS II, medical imaging devices containing the six substances were no longer be allowed on the European market from 22 July 2014. The restriction on phthalates will enter into force in July 2021.

While supporting the objectives of the Directive, COCIR is concerned about two main aspects as those will generate market uncertainty and will affect ability of industry to develop new products:

• The short duration of exemptions, compared to the development cycle, hinders investments in R&D.
• The time for the EC to approve exemptions has grown from 18 months to almost 3 years, due to growing number of applications and restricted substances. Such a long period of time is not compatible with industry needs for developing and marketing products.
   

REQUESTED ADDITIONAL EXEMPTIONS

COCIR submitted additional 12 exemptions required by its members between September 2011 and May 2012. All requested exemptions have been published on the Official Journal of the European Union on 9 January 2014.

In January 2020 COCIR submitted 20+ exemption renewal requests, both in Annex III and IV.