The business operator shall establish and maintain appro-
priate documentation in paper or electronic format with respect
to records covering the various manufacturing operations
performed which are relevant to compliance and safety of the
finished material or article and with respect to the results of the
quality control system.
The documentation shall be made available by the
business operator to the competent authorities at their request.
Entry into force
This Regulation shall enter into force on the 20th day following
that of its publication in the
Official Journal of the European
It shall apply from 1 August 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 December 2006.
For the Commission
Member of the Commission
Official Journal of the European Union