T he G enera l P ro duc t S a fety
D irec tive
2001/95/E C (‘G P S D ’)
O c ta via n V a s ile
E u r o p e a n C o m m is s io n
D ir e c to r a te G e n e r a l H e a lth a n d C o n s u m e r s
P r o d u c t a n d S e r v ic e S a fe ty U n it
M a in to pic s
A p p lic a tio 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 lic a tio n
In te r n a tio n a l c o o p e r a tio n
D ir e c tiv e 8 7 /3 5 7 /E E C
R e la tio n s h ip b e tw e e n G P S D a n d N L F
1. The application of the GPSD
T he G enera l P roduc 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 tiv 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 ty
L e g a l p illa r o f c o n s u m e r p r o d u c t s a fe ty
Harmonis ed
products
N o nha rm o nis ed
pro duc ts
GPSD
2010
R e g u la tio n 7 6 5 /2 0 0 8
D e c is io n 7 6 8 /2 0 0 8
C ontent
O b je c tiv e /s c o p e /d e fin itio n s – C h a p te r 1
G e n e r a l s a fe ty r e q u ir e m e n ts – 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 lig a tio n s o f p r o d u c e r s a n d d is tr ib u to r s – C h a p te r 3
O b lig a tio 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 fo r m a tio n / R A P E X – C h a p te r 5
C o m m itte e p r o c e d u r e s – C h a p te r 6
O bjec tives – C ha pter 1
C o n s u m e r p r o d u c ts 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 tio n in g o f th e in te r n a l m a r k e t
S c ope – C ha pter 1
A p p lie s to c o ns um er produc ts (m ig r a te d fr o m
p r o fe s s io n a l u s e ,
s u p p lie d w ith in a s e r v ic e )
- its entirety to c o n s u m e r p r o d u c ts n o t c o v e r e d b y “s e c to r ”
le g is la tio n
- pa rtia lly to c o n s u m e r p r o d u c ts c o v e r e d b y “s e c to r ”
le g is la tio n
R eleva nt definitions – C ha pter 1
P ro d u c t
S a fe p r o d u c t
D a n g e ro u s p ro d u c t
S e r io u s r is k
P ro d u c e r
D is tr ib u to r
R e c a ll
W ith d r a w a l
G enera l S a fety R equirem ents – C ha pter 2
P r o d u c ts 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 ite r ia :
S p e c ific C o m m u n ity p r o v is io n s
N a tio n a l le g is la tio n
H a r m o n is e d E u r o p e a n s ta n d a r d s p u b lis 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 tio n a l s ta n d a r d s
r e c o m m e n d a tio n s , g u id e lin e s , c o d e s o f g o o d p r a c tic e
E uro pea n s ta nda rds – C ha pter 2
P r e s u m p tio n o f c o n fo r m ity fo r E U s ta n d a r d s p u b lis h e d in th e
OJ
V o lu n ta r y n a tu r e o f E U s ta n d a r d s
P ro c e d u re
S p e c ific r e q u ir e m e n ts fo r p r o d u c ts
- D e c is io n o n
M a n d a te fr o m th e C o m m is s io n
w in d o w s a n d
A d o p tio n o f m a n d a te
- D e c is io n o n
P u b lic a tio n in th e O J
ba th tubes
c h ild p r o o f lo c k ing devic es fo r
b a lc o n y d o o r s (2 0 1 0 /1 1 /E C )
ba th ring s , ba thing a ids ,
a nd s ta nds fo r in fa n ts
(2 0 1 0 /9 /E C )
- D e c is io n o n pers o na l m us ic pla yers
(2 0 0 9 /4 9 0 /E C )
- D e c is io n o n reduc ed ig nitio n pro pens ity
c ig a rettes (2 0 0 8 /2 6 4 /E C )
O blig a tio ns of produc ers a nd dis tributors –
C ha pter 3
A r tic le 5 (1 ) - p r o d u c e r s
A r tic le 5 (2 ) - d is tr ib u to r s
A r tic le 5 (3 ) a n d (4 ) – p r o d u c e r s a n d d is tr ib u to r s
D
is tributors
P
roduc
ers
a nd dis tributors
P roduc
ers
• T o s upply o nly s a fe produc ts
•
•
•
•
• N otific a tio n o blig a tion
c e o nly s a fe produc ts o n th e m a r k e t
•• T oT opla
p a sas tion
o n in fotor mcaotioopera
n o n pte
r o dw
u cith
t r isck o
s m petent
O
blig
e n s u r e pro per la belling o f p r o d u c ts
• T oTa outho
k eep
a ndo pro
the
rities
n a cvide
tio n s ta
k e ndo
to caum
v o identa
r is k stio
p ons e d b y
T onp erinocdfo
mr sotreralvsc euinspgpa lie
b oedu otbrryigisthink seo:mf p r o d u c ts
eusrcsmtsa rthys oefold
th
ppropria
• T oT ota ck eooapera
te in te
th eaacctions
tio n s tawk he en n b ryispk rso ad ruec e r s o r
d isa uc othvoerritie
e d s to a v o id r is k s
O blig a tio ns a nd pow ers of M S – C ha pter 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 tr ib u to r s c o m p ly w ith th e ir
o b lig a tio n s
M S p e r fo r m m a r k e t s u r v e illa n c e (a u th o r itie s , p o w e r s ,
re s o u rc e s )
D iffe r e n t n a tio n a l m a r k e t s u r v e illa n c e n e tw o r k s a n d
p ro c e d u re s
P r e v e n tiv e a n d r e s tr ic tiv e m e a s u r e s (s a le s b a n , w ith d r a w a l
fr o m
th e m a r k e t, r e c a ll fr o m c o n s u m e r s )
C u s to m s a u th o r itie s
D a ng erous produc ts
I nform a tion exc ha ng e m ec ha nis m s –
C ha pter V
A r tic le 1 1 – p r o d u c ts p o s in g n o n -s e r io u s r is k s
A r tic le 1 2 – p r o d u c ts 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 tic ip a tio n
A im – to e n s u r e e q u a l a n d c o n s is te n t h ig h le v e l o f c o n s u m e r
h e a lth a n d s a fe ty p r o te c tio n
C om m is s ion’s ta s k s
M o n ito r th a t M e m b e r S ta te s m e e t th e ir o b lig a tio n s
S u p p o r t c o u n tr ie s a n d b u s in e s s in m a k in g s u r e th a t o n ly
s a fe
p r o d u c ts 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 illa n c e p r o je c ts (A r tic le 4 )
Ta k e e m e r g e n c y m e a s u r e s (A r tic le 1 3 )
E m erg enc y m ea s 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 lig in g M S to
ban
d a n g e r o u s p r o d u c ts 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 itio n s :
s e r io u s r is k to th e h e a lth a n d s a fe ty o f c o n s u m e r s
M S d iffe r s ig n ific a n tly o n th e a p p r o a c h to d e a l w ith th e r is k
u r g e n c y (th u s n o r m a l p r o c e d u r e s c a n n o t b e a p p lie d )
r is k s c a n b e e lim in a te d o n ly b y m e a s u r e s a d o p te d a t E U le v e l
V a lid ity – 1 y e a r (p o s s ib le e x te n s io n s )
E x p o r t to th ir d c o u n tr ie s p r o h ib ite d – u n le s s d e c is io n
p r o v id e s
o th e r w is e
E x a m p le s : a ) D e c is io n o n c hild res is ta nt a n d novelty lig hters
(2 0 0 6 /5 0 2 /E C )
D erm a titis from D M F
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.
Williams JDL, et al (2008) An outbreak of furniture dermatitis in the U.K. . British
Journal of Dermatology 159: 233-234.
G P S D C om m ittee - A rtic le 15
C o m m itte e u n d e r th e G P S D
R e p r e s e n ta tiv e s o f M S + o b s e r v e r s fr o m c a n d id a te
c o u n tr ie s a n d c o n s u m e r o r g a n is a tio 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 ty is s u e s (m a in ly m a r k e t
s u r v e illa n c e , s ta n d a r d is a tio n , R A P E X , in te r n a tio n a l
c o o p e r a tio n )
V o tin g p o w e r s (r e q u ir e m e n ts fo r p r o d u c ts , A r tic le 1 3
D e c is io n s )
2. The revision of the GPSD
 IMPACT ASSESSMENT
 Based principally on questionnaires to all stakeholders
 Economic operators (including SMEs): estimates of
cost/benefit analysis of uniform product safety rules for nonharmonised 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
1
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.)
Simplification of EU legislation
2
3
4
Standardisation
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 predetermined 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
Market surveillance cooperation/
coordination (1)
5
6
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
Market surveillance cooperation /
coordination (2)
7
8
RAPEX
Enhance 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 online
Tackle 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)
T ha nk yo u for your a ttention