the general product safety directive 2001/95/ec (‘gpsd’) za saradnju sa eu/mr_ octavian...

The G enera l Produc t S a fety D irec tive

2001/95/E C (‘G PS D’)

Oc tavian V as ile E u r o p e a n C o m m is s io n

D ir e c t o r a t e G e n e r a l H e a l t h a n d C o n s u m e r sP r o d u c t a n d S e r v ic e S a fe t y U n it

A p p l ic a t io n o f G P S D

R e v is io n o f G P S D

B u s in e s s A p p l ic a t io n

I n te r n a t io n a l c o o p e r a t io n

D ir e c t iv e 8 7 /3 5 7 /E E C

R e la t io n s h ip b e tw e e n G P S D a n d N L F

M ain topic s

The G enera l Produc t S a fety D irec tive (2001/95/E C )

A d o p te d o n 3 December 2001 In fo r c e s in c e 15 January 2004 R e p la c e d D ir e c t iv e 9 2 /5 9 /E E C o n g e n e r a l p r o d u c t

s a fe t y

L e g a l p i l la r o f c o n s u m e r p r o d u c t s a fe t y

1. The application of the GPSD

G P S D

D e c is io n 7 6 8 /2 0 0 8

2010R e g u la t io n 7 6 5 /2 0 0 8

Harmonised products

N on-harmonis ed

produc ts

C ontent

O b je c t iv e /s c o p e /d e f in i t io n s – C h a p te r 1

G e n e r a l s a fe t y r e q u i r e m e n t s – C h a p te r 2

E u r o p e a n S ta n d a r d s – C h a p te r 2

O b l ig a t io n s o f p r o d u c e r s a n d d is t r ib u t o r s – C h a p te r 3

O b l ig a t io n s a n d p o w e r s o f M e m b e r S ta te s – C h a p te r 4

E x c h a n g e o f in f o rm a t io n / R A P E X – C h a p te r 5

C o m m it t e e p r o c e d u r e s – C h a p te r 6

Objec tives – C hapter 1

C o n s u m e r p r o d u c t s p la c e d o n th e m a r k e t a r e s a fe

P r o p e r fu n c t io n in g o f th e in t e r n a l m a r k e t

S c ope – C hapter 1 A p p l ie s to c ons umer produc ts (m ig r a t e d f r o m

p r o f e s s io n a l u s e , s u p p l ie d w it h in a s e r v ic e )

- it s entirety to c o n s u m e r p r o d u c t s n o t c o v e r e d b y “s e c t o r ” le g is la t io n

- partia lly to c o n s u m e r p r o d u c t s c o v e r e d b y “s e c t o r ” le g is la t io n

Relevant definitions – C hapter 1

P r o d u c t

S a fe p r o d u c t

D a n g e r o u s p r o d u c t

S e r io u s r is k

P r o d u c e r

D is t r ib u t o r

R e c a l l

W it h d r a w a l

G enera l S a fety Requirements – C hapter 2

P r o d u c t s p la c e d o n th e m a r k e t h a v e to b e s a fe

A s s e s s m e n t c r i t e r ia : S p e c i f ic C o m m u n i t y p r o v is io n s

N a t io n a l le g is la t io n

H a rm o n is e d E u r o p e a n s ta n d a r d s p u b l is h e d in th e O J

E u r o p e a n s ta n d a r d s

n a t io n a l s ta n d a r d s

r e c o m m e n d a t io n s , g u id e l in e s , c o d e s o f g o o d p r a c t ic e

European s tandards – C hapter 2

P r e s u m p t io n o f c o n fo rm i t y fo r E U s ta n d a r d s p u b l is h e d in th e O J

V o lu n t a r y n a tu r e o f E U s ta n d a r d s

P r o c e d u r e S p e c i f ic r e q u ir e m e n ts fo r p r o d u c t s

M a n d a te f r o m th e C o m m is s io n

A d o p t io n o f m a n d a te

P u b l ic a t io n in th e O J

- D e c is io n o n c h i ld p r o o f loc king devic es f o r w in d o w s a n d b a lc o n y d o o r s (2 0 1 0 /1 1 /E C )

- D e c is io n o n bath ring s , bathing a ids , bath tubes and s tands fo r in f a n t s (2 0 1 0 /9 /E C )

- D e c is io n o n pers ona l mus ic players (2 00 9 /4 9 0 /E C )

- D e c is io n o n reduc ed ig nition propens ity c ig arettes (2 00 8 /2 6 4 /E C )

Oblig ations of produc ers and dis tributors – C hapter 3

A r t ic le 5 (1 ) - p r o d u c e r s

A r t ic le 5 (2 ) - d is t r ib u t o r s

A r t ic le 5 (3 ) a n d (4 ) – p r o d u c e r s a n d d is t r ib u t o r s

Produc ers• T o plac e only s a fe produc ts o n th e m a r k e t

• T o e n s u r e proper labelling o f p r o d u c t s• T o in f o rm th e m s e lv e s a b o u t r is k s :

• T o ta k e appropria te ac tions w h e n r is k s a r e d is c o v e r e d

Dis tributors• T o s upply only s a fe produc ts• T o p a s s o n in f o rm a t io n o n p r o d u c t r is k s

• T o keep and provide the doc umentation n e c e s s a r y fo r t r a c in g th e o r ig in o f p r o d u c t s

• T o c ooperate in t h e a c t io n s ta k e n b y p r o d u c e r s o r a u th o r i t ie s to a v o id r is k s

Produc ers and dis tributors• N otific a tion oblig a tion• Oblig ation to c ooperate w ith c ompetent

authorities o n a c t io n s ta k e n to a v o id r is k s p o s e d b y p r o d u c t s s o ld o r s u p p l ie d b y t h e m

Oblig ations and powers of M S – C hapter 4

M S e n s u r e th a t p r o d u c e r s a n d d is t r ib u t o r s c o m p ly w it h th e ir o b l ig a t io n s

M S p e r f o rm m a r k e t s u r v e i l la n c e (a u th o r i t ie s , p o w e r s , r e s o u r c e s )

D if f e r e n t n a t io n a l m a r k e t s u r v e i l la n c e n e tw o r k s a n d p r o c e d u r e s

P r e v e n t iv e a n d r e s t r ic t iv e m e a s u r e s (s a le s b a n , w it h d r a w a l f r o m th e m a r k e t , r e c a l l f r o m c o n s u m e r s )

C u s to m s a u th o r i t ie s

J o in t a c t io n s

Dang erous produc ts Information exchang e mechanis ms – C hapter V

A r t ic le 1 1 – p r o d u c t s p o s in g n o n -s e r io u s r is k s

A r t ic le 1 2 – p r o d u c t s p o s in g s e r io u s r is k s (R A P E X )

M a n d a to r y p a r t ic ip a t io n

A im – to e n s u r e e q u a l a n d c o n s is t e n t h ig h le v e l o f c o n s u m e r h e a lt h a n d s a fe t y p r o t e c t io n

C ommis s ion’s tas ks

M o n it o r t h a t M e m b e r S ta t e s m e e t th e i r o b l ig a t io n s

S u p p o r t c o u n t r ie s a n d b u s in e s s in m a k in g s u r e t h a t o n ly s a fe p r o d u c t s a r e p u t o n th e m a r k e t in E u r o p e

R e c o g n is e s ta n d a r d s

J o in t S u r v e i l la n c e p r o je c t s (A r t ic le 4 )

Ta k e e m e r g e n c y m e a s u r e s (A r t ic le 1 3 )

E merg ency meas ures – A rtic le 13

C o m m is s io n h a s p o w e r s to a d o p t a d e c is io n o b l ig in g M S to b a n d a n g e r o u s p r o d u c t s o n th e E U m a r k e t

N e c e s s a r y c o n d i t io n s : s e r io u s r is k to t h e h e a l t h a n d s a fe t y o f c o n s u m e r s

M S d if f e r s ig n i f ic a n t ly o n th e a p p r o a c h to d e a l w i t h th e r is k

u r g e n c y (th u s n o rm a l p r o c e d u r e s c a n n o t b e a p p l ie d )

r is k s c a n b e e l im in a te d o n ly b y m e a s u r e s a d o p t e d a t E U le v e l

V a l id i t y – 1 y e a r (p o s s ib le e x t e n s io n s )

E x p o r t t o th ir d c o u n t r ie s p r o h ib i t e d – u n le s s d e c is io n p r o v id e s o th e rw is e

E x a m p le s : a ) D e c is io n o n child res is tant a n d novelty lig hters (2 0 0 6 /5 0 2 /E C )

b ) D e c is io n o n ma g netic toys (2 0 0 8 /3 2 9 /E C ) c ) D e c is io n o n p r o d u c t s w it h DM F (2 0 0 9 /2 5 1 /E C )

Rantanen T (2008) The cause of the Chinese sofa/chair dermatitis epidemic is likely to be contact allergy to dimethylfumarate, a novel potent contact sensitizer. Concise communication. British Journal of Dermatology 159: 218-221.

Dermatitis from DM F

Williams JDL, et al (2008) An outbreak of furniture dermatitis in the U.K. . British Journal of Dermatology 159: 233-234.

G PS D C ommittee - A rtic le 15

C o m m it t e e u n d e r t h e G P S D

R e p r e s e n ta t iv e s o f M S + o b s e r v e r s f r o m c a n d id a t e c o u n t r ie s a n d c o n s u m e r o r g a n is a t io n s (A N E C , B E U C )

D is c u s s io n o n p r o d u c t s a fe t y is s u e s (m a in ly m a r k e t s u r v e i l la n c e , s t a n d a r d is a t io n , R A P E X , in t e r n a t io n a l c o o p e r a t io n )

V o t in g p o w e r s (r e q u ir e m e n t s fo r p r o d u c t s , A r t ic le 1 3 D e c is io n s )

IMPACT ASSESSMENT Based principally on questionnaires to all stakeholders

Economic operators (including SMEs): estimates of cost/benefit analysis of uniform product safety rules for non-harmonised and harmonised consumer products

Member States: questions on the impacts of single and uniform rules on enforcement and enhanced cooperation and notification mechanisms

Consumers: possible impacts of the new uniform regime on safety perceptions

2. The revision of the GPSD

Alignment with New Legislative Framework Alignment of definitions and competences of market surveillance authorities (Reg. (EC) No. 765/2008)

- Extension of enforcement and reporting mechanisms to the non-harmonised area (e.g. the power to enter business premises for inspection purposes, the obligations to establish market surveillance plans, the obligation to monitor accidents and harm to health which are suspected to have been caused by those products)

Alignment of obligations of economic operators (Decision 768/2008/EC)

- Extension of product safety obligations of economic operators to non-harmonised area (e.g. the obligation of manufacturers, importers and distributors to accompany the product with safety instructions; obligation of manufacturer and importer to identify themselves and the product etc.)

1

Simplification of EU legislationStandardisation

Modernise standardisation machinery within the GPSD - Ensure faster adoption of European standards- Provide for easier takeover of international or widely

recognised standards

EU “emergency” measures (Novelty Child Resistant Lighters, DMF Decision)

Provide for more flexibility to avoid existing confusion- Make the period of validity dependent on a certain pre-

determined condition subsequent- Direct effect on economic operators

Food-Imitating Products Directive (87/357/EEC)Move the food-imitating product under the general product safety regime

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3

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Market surveillance cooperation/ coordination (1)

Market surveillance cooperation Provide permanent platform for cooperation among market surveillance authorities, e.g. for performance of joint actions

- Extend positive effects impacts of joint actions (such as sunbeds, childcare articles, lighters)

- Provide for better coordination of Member States in the field of checks and inspections

Market surveillance coordination Avoid and/or resolve divergences in testing, risk management and risk assessment

- Prevent divergent safety evaluations of an identical product in different Member States

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6

Market surveillance cooperation / coordination (2)

RAPEXEnhance functioning of RAPEX

- Align with the notification criteria in the NLF- Ensure better fulfilment of obligation of Member States

related to RAPEX obligations

Unsafe products sold onlineTackle unsafe consumer products sold on the Internet

- Explore the necessity for providing guidelines on how to apply enforcement measures against dangerous products sold online more effectively (or even specific provisions in general product safety rules)

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Thank you for your attention