COMMISSION DELEGATED DIRECTIVE (EU) .../… of 11.8.2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices

Following an application for this exemption in 2018, the EU launched a technical and scientific study which included a consultation. The assessment concluded that manufacturing new parts not containing the substances (phthalates) rather than reusing existing spare parts, produces carbon dioxide emissions, introduces heavy metals in the market and leads to the generation of hazardous and non-hazardous waste. Overall their assessment concluded that the total negative environmental health and consumer safety impacts of substituting the four phthalates were likely to outweigh the benefits.

Topic  Agriculture 
Department  DEFRA 
Council Reference   
COM Reference   
SEC Reference   
PE Cons   
JOIN   
SWD   
C Reference  C(21)5866 

Associated file(s)


  1. C(2021)5866 - 263 KB - pdf
  2. C(2021)5866 + Add 1 - 124 KB - pdf
  3. EM C(2021)5866 - 147 KB - pdf

Search by reference numbers or topic