إجراء مقترح من الاتحاد الأوروبي

This proposal accompanies the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938, which establishes a legislative framework to strengthen the competitiveness of the health biotechnology sector. For the new framework to operate effectively within the existing acquis, targeted updates are required in two pieces of sectoral legislation. Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms The proposal amends Directive 2010/53/EU (organ processing) to expressly include processing alongside donation, testing, characterisation, procurement, transport and transplantation, and to clarify that where organs are used for research purposes, the Directive applies only where they are intended for transplantation into the human body. A new Article 6a is introduced to require transplantation centres to obtain prior authorisation from the competent authority before applying a processed organ to a recipient, oblige transplantation centres to perform a benefit–risk assessment of the processing