SAFETY PRODUCTS & PPE : WALSH – BLYTH & TURTON
OBLIGATIONS & REQUIREMENTS Obligations on “ Economic Operators ”
The Regulation ( EU ) 2016 / 425 uses a new term “ Economic Operators ” which it defines as anyone “ intervening in the supply and distribution chain or PPE Products ”. It includes manufacturers , authorised representatives , importers and distributors ( including online vendors for the first time ) and requires them to take appropriate actions to ensure their PPE products are fully in conformity with the Standard claimed .
There will be new obligations upon manufacturers , importers and distributors to :
• hold copies of PPE Technical Files , Product Type Examination Certificates and Declarations of Conformity and keep records of these documents for at least 10 years ;
• ensure User Instructions are provided with each product and in the correct language ;
• ensure that transport and storage do not harm the PPE ’ s efficacy or Conformity ;
• indicate on the PPE their Product Code or I . D . and postal address where they may be contacted .
Note : Distributors and Importers who place PPE on the market under their own Name or Brand take on ALL the obligations of the manufacturer . All economic operators will have an obligation to :
• Take corrective actions in case of noncompliance and inform the competent authorities where PPE presents a risk ;
• Cooperate with authorities and provide all the information necessary to demonstrate compliance in a language which can easily be understood by that authority .
Manufacturers and authorised representatives shall keep the technical file and the EU Declaration of Conformity available for 10 years after PPE is placed on the market .
Importers also need to keep the documents for 10 years and ensure the technical file can be made available .
Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the PPE Regulation .
Manufacturers and importers shall , if necessary , carry out sample testing of the PPE made available in the market , keep a register of complaints and keep distributors informed of such monitoring . How this should be done will also need to be addressed in the accompanying guidance .
PRODUCT CATEGORISATION Products Changing Category
The definitions of which category PPE falls into are similar to how they are grouped in the current Directive , but some products will move from Cat II to Cat III , including those protecting against :
• Biological risks
• Bullet wounds and knife stabs
• Cuts by hand-held chain saws
• High pressure jet cutting
• Risk of drowning
• Harmful noise
For private use , oven gloves are now included , but contrary to proposals , dish washing gloves are not . Products remain within Categories I , II or III , but the Regulation defines them in terms of risk , e . g . rather than refer to life jackets it identifies ‘ risk of drowning ’, and instead of hearing protection it refers to ‘ harmful noise ’.
All PPE , including Cat I products , will require a technical file , the contents of which are defined in more detail . CE marking and certification requirements are similar but the references will change .
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HSE INTERNATIONAL