Index of /enm/images/dokumen

(1)

i *;;-l

coMMtsstoN

oF

rHE

EUROPEAN

coMMUNlrlES

lq:tl

l**l

_ld*l

I d,\n I

l' : l

Brussels, xxx

C(2009) yyy linal

!'t?-3

Dral't

COMMfSSION DECISION

of

reqriring

tr'IetDber Stlrtcs to cnsurc

thrt

products c0utairring lhc [riocidc dimetbylfunraratc

ire

not placcd ol. madc rvailable 0l) thc tnarket

(2)

I)rif1

CONIN{ISSION DECISION

OI

rcquiring l'Iember Statcs to etrsurc that _Pr'oductsco[lairting tlrc hiocidc rlinrcthylfunrarate arc uot placed or mrdc lvailahle 0n tlr.e rurt ket

(Tiixt

\rith

EIJ.{ rclcvance)

TIIE COKf MISS ION OF THE EIJ IIOPI.i\N COVl \,1IJNI'I'I 1]S,

I{aving rcgard to the'frc,!ry estalrlishing tbc J:iuropcarl Comlnunit-v'

l.laving icgard to Dir'ectivc 2001/95iEC

of

the Eumpcan Parlianeflt arld oll the Cor.rncii of'

I

DecJnbcr 2O0t on gcneral procluct safetyr, and iu paniculal Adicle

lj

thereof,

Having consultcd the Mentber States, Where as:

(t)

a)

Q)

(4)

Pursuant to l)ir,:ctivr: 200ir'95lLlC prod'.tt'crs a.le obligetl Lo _llaceonL) sitfe cousunrer'

products olr the n larli(t.

Furniture and footrvcar available

on

le lnaJket in scvercl Metrtlrcr Statcs havs been

identjfi€d as the cause

of

clarnage

to

the health

of

consunlers

in

l'rance, I'oland, Firrland, Sw'eden and thc UI(.

A.ccording

t(r

cli.nical

testt the

heallh darnaec,r' was t:attsed

by

thc

c,h( 1ical

tlincthylfunralatc (DI\rlF), a biociclc prcvuuting $louldl; thaL nlay detcrior'iltc lL:ather

fi.x]]ilxre or footwear duriDg storagc oI transPort in a humid cliDratc

DMI

rvas most often contained in little por-rcltes tixed inside the fumiturL: or addecl lo

thc fbotrvear L.oxes. [t thus cvaporated arrd inrplegnatcd thc product. f]rotecting ir from moulcJs. Howr:vcr,

it

thcn also aflecled consunrcrs rvho were

in

contact tlitLr thc produuts. DMF perretrated thtough lhr: clotllcs olrto consul))crs'skiLr2 rvhcr'c

it

causecl

painful skin contact dcrmatitis ilch'rding itchirrg, irriret'ion. rcdnt:s:;, end burtrs; itl sotrte

casss! acute 'respiratory lroublos rvcrc rcpolled.

-llre

dernatitjs rvas particulatiy difficrh to treat, The prssehce of DN4F is tlrus a serious risk.

L.lodcr

Anicle

l3

of

ljirective 200l,rg-{iEc,

if

the Eruope:ur Comlnission beclrnrcs

a\'.,arc thrt ccrtain prodricts prrscnt a scriou'^ risk lo thc heallh ancl .';lfelv of constulers'

OJ i.

ll.

I s.1.20C.1, _F.4.

i{riLjr'i;t:.lDl,,,:', al (2008) AJr ourbrra,i ot lrn !luri) dcrr.talitir

ili

dr.

i-r.K.

Blttir;h J,:,u'uli ofl

ller,.,3!(\icgy 159: 23.J 2.:i4.

(3)

f

i1 nlay, subjccl to ccrtain coDdirions, adopt a dcoisioD requiring i\.Icrnber Sules to t:lke measutes intcndc':d itr particuliu to rL.stl-ict ot rnake srrbject 10 specjiic crtnclilir:n.s tbe

availability or.r the rnarkst of suclr proilucts.

(6]

'

Such

a

decision may be adopted

if

(a) ir.{eu:ber Starcs dilTcr significantly

on

the

approiLch adoptcd oI to be adopted to deal wirh thc risk r:oncerned: (b) rhe risk ctyrn6t,

in vicw of 1he natrn'c ol the safery issuc, bc dcah \,vi1h in a n;urner c.ompatjble with the

dcgree

oI

urgcnc),

ol'

Ihc cJJc ur)dcr orl:cr prroccdurr:s _{iirid iiowrr}

hy

_rhcsp,:i:ific

Comrnunity lcgislation applicab)c to _{rl)e Product}conesrnc,l: arld (c) thc risk caur be

eliminatcd

cffectivciy r:nly

by

adopling appropli;rte rneasures applicabie at

Community levcl,

in

order to ensur.e a consistent and high level

of

proleclion of tbc health and sa{ety of r:onsumcrs and the proper _{iirnctioning ofthe}_internal_market.

(7)

,,\

clinic'l

study on iruntursl (ptrlch tcsls) r,vitb lcather lurniture iurcl pat:hes of pure

Dluli

showed sl.rong reaclions in the most severc cilsc dourr to

j

tr.)g;kg. On the basis

,r1-ihis siudy, Ijriutce adoptcd a dccrer:' rvhjch bans thc in:Dorution ancl r_rlacing oD thc

markct of sexti.g iutJ ib()t*car L-o'lairiJr!

DMI:.

lhc

Fr.rnr:h LIecfualso rcqtircs tJrc recall

of

all sea.ting and footwear rvhich visibly contains. or. rhc pailegirrg

oi

r.vhjch

visibly _{contains, DIVII:. The druation}

ol

_re_decrcc

is lirliteci

to

_I_year.

-

_I3elgium

issued a decree'. on the basis of the same study, which brurs the plircing

on

re nrarket

of all articles and products containing DMF.

-

Spain issucd measurcst ban::ing Dlr4F'

in all consunrer protlucts conring into contitct wirh the skirr.

(8)

Belgium, Spuin antl lirarrcc irre the oLrlv \,lcurlrcr Starm having adoprcd sl,ccitic

regujatL\ry measures 10 addrcss ths scriorrs rjsk to consumer ht:alth fiom the biocide

DN.{F.

(9)

Under

Anicle Z(l)(a)

o1'Diri)crivc 98/8iEC oL the Europcan l,arliamort and

of

rird

Council

of

16 lrebrr.rary 1998 concl-rning thc placing

of

biocidai products

o[

Lhe markel ("the Biocidcs Dircctive");, biocida) products alc det'ined as ec.rive substances a.r:d preparatioDs containilg or)e ol. r)orc ac

tiyi'

substances. lvhjch arc inrendecl ro

destroy, deter, rcnder harlrless, prevel)t the lr.-.tion ol. or clthenvjs., cxort a contrqlling offeot oD iury

harmill

orgarnism bv chernical or biological mcans.

i\rticle

3(l)

of thc

Iliocides Dilective requires lvJenrber Sutes to p;esr.ribc tbat a biocidal producr {ihal,l.

not bc placecl on thc rttarket and used in their re.rritory unle.ss it has fueen autfroliser1 i:r accordance wiLh lbe Directive; and Ar-ticle 5(l

Xbxiii)

of the Dili:ctive provir-les tl]xl Membei'Slates shall authorise a bir:t--.idal prociuct only it', arr:oDg:;t otlrer thilrgs, ir has

no unacceptablc cffe.:ts itself ,rl as a result of ils rcsjdues, on itunatl itoxlth. ilirectly or

RantaneD T (2008) The causc oi the Chincse sofa/thaf dem)ltitis epi,jerDjc ls likcJ;, 1a bc c6q11x61

allergy !o diftethylfumaratc, a novel poteDt co0tacf scnsirizor. CoDqise cotnnrunicarjon. British Journnl

of Dematology 159: 218-22 l.

VliDistry fof llte l-lcolromy, Indushv and []mplo]meD1, Ddcree

ofJ

Der:enrber 2003 suspeidine the

pLacr|rg on the natk(lr ofsears.u)d tbol\yc&r contaiuing Dl\lr tiom the norkrt. Ffench Ot'fi{:ial .lournol.

l0 Dcccmbcr 200fi, Trxr l7 uf Ilrs.

The Mintster for Public Health and the lvlinister I'or cons nter prorcctjotr. _Mitisterial_Decrec

:o:":qilg

rhe. prohibi(ioD of ptaciDg;nriclcs and proitucrs co|raining DiltF on the marker. ltclgiiln

Official Jounral. l2-1.2009

Resolution of 22 Decenlbc. !003 of rhc Nrlional Consumer hlsljtl)te. Sparrish Ofll r rrj J Lru) r)irl ,lo I _{S, -l}I

(4)

iliil:ll];,tJlT;;:lir"T*'

Tatelv standarcls havc

to

uc hrllllled bct'oLc

a

biocidar

( l0)

3::;'lri

[*ij::.jll.:::,l:ll*

]l;vn

,,," ,,nr ,il,lhori,icrt ,l Ul (rIl5a:ft

ir

||l ll,c (.omnru,,rr\ ,,r :rL,(.or(tan!c

::jl,]l: li':i,l::

Dir.ccljvc. t'tru:,. rriuciil;rt _lx.rrrtucrs_ct_coutaxtrng_f)lv{l:'_arer

not lcgally availablc _inLhc _{Cornrlunirv lbr}

tl

vv.ulrrrr:i

r-/rvrl' urc no1 lcgally

bro.lfi.i h.n.,,r.,^i,,-^.{ j_-

;r

,.,1e treatl-trent ofprodr.rcts agaiust loulcls, arld thu.!

l];

:i:::ff1":'Tli1"ilf*

il'l*

.u *,'

i.s;iiv'"';ffi;'Liiii:'iiii:Ji':,

illJ.J"l;

fi'i::::l"*,n

iKl:.-l:.:'*'

''

p'JJ".''r*',#'#;;i;,J ;$,'"'J;*i

i,i:

;:

imporled inro the Conrmunity.

(lt)

(t 2)

(13)

(t 4)

$lliil'i,;;iln,il

Tsili.8lTli"llr

x..J3:i:1,l:.!N,1,,

::i:#,!'11:

Registration.

'.,alu.tion.

r\urhrr.isati.n

"n.f

n",,t;"iiiu,-olj

Ct,.,r.,ri"nl, (llt-,A[.J{i, establishi'g

a

riurope.t

_{chemicars- Agcncy.,}_{,r''r.,Ji,rg'}

r_r1*ctivc r 999,..15./Iic _ancl

rr:pcaling _{Council Ilertrrialion}

flifC:;

Noigfi,jl ,,"i

Cl*rrirr_t

_{Rcgu/arjorr rljc-,j No}

l+88J94

as

wct

as

_coLrucir

nirccrive

,c,icdirf

"r,'i

'ir"u,,,,r"q.io,,

[)i'cL:rir,..s

:]1frr,T!9i

e.3i67IEEC,

nr1lsli.c

*,,r u

oooiiiii:i,

iol

i ,Z

jo$ri.2006)d _rvould

trc rmpossible _in_rhe_shod_term_anrJ.\^,ould

,fr* noi1,,i"i"

"*uf, _{,"rat o}_ro_{ihc urltmcy} ofthe preserrt _risk_{l,Ir;.rnaserrrent ncecl.}

In the.se circumstances- ,\4enrber .Statc"s.shDuld _be_{tequit:tJ lo}_ersurer

,r.ll

r?(r prddlcl-\

::i:Tli]g,

D&1t ,arc p,lacecl or ,l'"de, ouailabie

;;

il;;.i;,

r;

()r.dcr ro prcvcnr rhe

iil,o,r"i,l,to t o."O bi, rhcse products ro consruners. uulil a p*ura'errr solutiun becorrt s

l he prcsence _of_{Dv{F in}_products

shou,r bc _{cretcrnrinccr Rgainst}_{the nraxim.rm}_limit

of

l:1"i]g-P*1a,rl'r

kg of

pro(ucr or paft 0i.[h€ producr. .fhjs

is

_{considcrett 1o}

bc

s

Ilrclently bclow thc. conccnral

patch testi

,"",i";:1";;;;;',,1;:"",:l#fliil]iil,ili:l:i_:il',1,'L-.,':?:r[],;lTl,;

addresses _{the serious}_r-isk_{frorn DNIF in}

prnducls.

"'

"

'

'"ul^,

Accordingly, thc anall,lical _melhotl_emp,loycrl

shor.rld bc able to rehably cluanrify 0.1

ne

Dlllr

pcr.kg

of

prod'ucr _or_purt_o1_rl-r"_proaual-

ri$.-n''"I,'s

rhat the mctrrod,s

qu:urtification _limit_shoukl

be 0.1 rrLg,,kg or lcss.

M^euber Slales lnust cany oul markel _{-survgillarc.t: rrnd eulbrccrrr(:nt}

activitics to prevent _tisl(s_poscd_by_unsaii:

pr1s{ng15 ro rrre

n"rri,

_{ana su.",y:}

,,i,,.r,r,

_u.,"r,,.

(t 5J

(1 6)

*J]lij1l'lf::lfl,l.llll1llil.ii,.ry

in the inrcrests of borrr trri A4cmbcr Srarcs, rr,bo

ff:"1T::*i*:,^?.^".:':."

wir

be eppricd,

"".i;;J;;;i,?,:ti,iliJ,i',ii;Jl,li

il:,,j""1,,:.:y,,:ol:::::11.11*;;.i[;i;*;ffi

;';,H:iJl[THi ji;;:.]l.,t.

slonesI pL):rsibjc _{trinsirion pcriod}_i

,.,",lwr

pr,-,Dru/L _{..'rsrLlon ucrr.d}_rs_apprcpriate,

co'sisleDt wi0L

t'e

neerl to pa"r:a,rt

firrther _{incidcnts ofscrrous}_iamage

to the health ond saforv ni,.nn..,.-^*- --..r , _- ,.-proportronalit-v. to the health old safety of consunrcrs uncl {o onsure

(17)

The nteasures provided _{ftrr. in.}_thi..

?.?:i:n

arc, in accordance lvrth the (.rjrilion _<:1.r/rc

Comrnitt,:e _{esrablished by}_.,\rticl"

t:

of

lirectiu"

;ft;iig;;a.

I