Extract from REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686 / EEC

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(5) Regulation (EC) No 765/2008 of the European Parliament and of the Council (6) defines the accreditation rules for conformity assessment bodies, a framework for the surveillance of products placed on the market and for the control of products from third countries, as well as the general principles of CE marking.

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(6) Decision No 768/2008 / EC of the European Parliament and of the Council (1) establishes common principles and benchmarks intended to be applied to all sectoral legislation. For the sake of consistency with other sectoral product laws, certain provisions of this Regulation should be aligned with that Decision, provided that the particularities of the sector concerned do not require a different solution. Consequently, certain definitions, general obligations of economic operators, presumption of conformity, EU declaration of conformity, rules applicable to CE marking, requirements concerning conformity assessment bodies and notification procedures, procedures conformity assessment and the provisions relating to the procedures to be followed in relation to PPE presenting a risk should be adapted to that decision.

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(7) Regulation (EU) No 1025/2012 provides for a procedure for raising objections to harmonized standards where these do not fully meet the requirements of this Regulation.

(8) This Regulation applies to PPE which is new to the Union market when it is placed on that market; it is either new PPE produced by a manufacturer established in the Union, or PPE, new or used, imported from a third country.