Rubber Food Contact

5/17/2018 Rubber Food Contact

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IMechE.

Rubber and Food Contact.

13/11/12

Paul Marchant CSci MIMMM


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ARTIS - Polymer R&Dlaboratory part of AvonRubber plc.

Based n Semn!ton"lts#re.

Specalse n $lastomers. %ffer materal R&D testn!

and analytcal solutons. 'ave s!nfcant e(perence

n t#e food contact areao)n! to nvolvement nAvon Rubber Darybusness * Avon Aerosol!as+et busness.

Rubber and ,ood ontact.


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Avon /10 llonSales.

anufacturer ofrespratory protecton

products. 34056Dary Products 7

"orlds 8eadn!suppler of Dary8ners. 34056


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'ope to !ve a bref overve) of:

8e!slaton on t#e use of rubber n food contact.

Bot# ;S * $uropean.

Implcatons of t#s.

#allen!es for t#e future.


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,DA 8e!slaton.

T#e ;SA ,ood and Dru! Admnstraton 3,DA6 consder t#ree dfferentfood addtve types Drect food addtves -components added to t#e food. Secondary drect food addtves - omponents t#at are added as part of a

treatment or process suc# as an e(tracton process.

Indrect food addtves - substances t#at may come nto contact )t# foodbut not ntended to be added drectly to food 3pac+a!n! * food processeupment etc6

ode of ,ederal 8e!slaton 21 ,R 1 7 covers polymers as ndrectfood addtvesC.

ost specfc ,DA le!slaton for rubber s ,R 21 ,DA 1.2@00rubber artcles ntended for repeated useC.

ust comply )t# t#ese rules f supplyn! food contact product nto t#e;S mar+et.

ustomers n ot#er natonal states also often as+ for complance )t#t#ese rules.


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,DA 8e!slaton 21 ,R 1.2@00.

Reco!nses specfc food types 3fatty * aueous6 ontans a lst of permtted materals )t# caveats on t#er use.

$ssentally a lst of permtted base elastomersC vulcanaton materalsCacceleratorsC retardersC actvatorsC anto(dantsC plastcersC fllersCcolourantsC emulsfersC and ot#er mscellaneousC addtves.

an aveats on use:

Accelerators E 1.


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,DA 8e!slaton 21 ,R 1.2@00.

In!redents lsted n 1.2@00 3c96 may be used 7 provded t#eycomply )t# re!ulaton and reurements lsted n sectons 19-1F&1>.9 of ,R 21 may also be usedn rubber artcles subHect to provsons of t#e re!ulatons.


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,DA 8e!slaton 21 ,R 1.2@00.

Product e(tracton lmts 3per unt SA product6 nplace for eac# food type.

,atty foods 7 n-#e(ane e(tract lmt 3m!*suare nc#620 mll!rams * suare nc# 7 1st #ours1 mll!ram * suare nc# 7 ne(t 2 #ours.

Aueous foods 7 )ater e(tract1< mll!rams * suare nc# 7 1st #ours9 mll!ram * suare nc# 7 ne(t 2 #ours.

It s possble to des!n a formulaton around t#e

compoundn! rules 7 )#c# fals to meet producte(tracton reurements.

1.2@00 also reures rubber products to bet#orou!#ly cleansed pror to frst use.


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,DA 8e!slaton 21 ,R 1.2@00.

ery sensble approac#

But lst s n some need of up-datn! J

Some materal nastesC populate t#e lst J

Asbestosand K-nap#t#ylamne ncluded so t#e

compounder or mporter of rubber-food contact

products does #ave to ta+e care J


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,DA 8e!slaton.

Revsed and updated edtons of ode of ,ederal

Re!ulatons 3,R6 21 re-ssued Aprl n eac# year.

%nlne access can be found at :#ttp:**ecfr.!poaccess.!ov*c!*t*te(t*te(t-d(LcMecfr&sdMd@fbc9f2ce&r!nMdv


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$; 8e!slaton.

T)o types of le!slaton e(st:$; Drectves 7 Implemented by t#e member state ?overnment.$; Re!ulatons 7 Immedate $uropean 8a).

Re!ulaton 1>


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$; 8e!slaton 1>


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1919

$; ,ood ontact 8e!slaton.

%nly specfc le!slaton n $urope for rubber s for rubber feedn! teats *soot#ers - Drectve >*11*$$.

'o)ever 1>


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BfR Recommendaton 21.

T#e man am of t#e ?erman BfR Insttute s to )or+ toma+e a maHor contrbuton to ensurn! t#at foodsubstances and products become safer.

BfR recommendaton OOI covers natural * synt#etc rubber.

Separate recommendatons are n place for ot#er foodcontact materals for e(ample slcone rubber 3O6 orpolyet#ylene 3III6.

T#ese are recommendatons and not la).


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BfR recommendaton 21 ontans a !eneral lst of permttedn!redents for four product cate!ores ate!ory 1 s t#e most strn!ent 3for lon! term contact6

ate!ory 9 least strn!ent 3s#ort term contact6.

ate!ory 1 lst s lmted under eac# cate!ory an ncreasn! numberof n!redents are permtted.

,or e(ample Stora!e contaners for stora!e of foodstuffs for bet)een29#rs and several mont#s come under cate!ory 1. l+ lners * tubescome under cate!ory 3s#orter contact tme6.

,ormulaton #as to be des!ned to use eac# n!redent belo) anyspecfed t#res#old levels.


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Strn!ent product m!raton * analyss lmts are n place ,or cate!ory :

8mt on nc content * lead content =-ntrosamne e(tracton Amne e(tract nc-dbenyl dt#ocarbamate e(tract

Approved laboratores underta+e producttests to prove complance of t#e formulaton * product. ;sually reuest a copy of t#e formulaton 7 for c#ec+n! * audt.

8aboratores )ll also as+ for food contact statements for n!redents used n a formulaton. RA8 3?eman nsttute for ualty assurance * certfcaton6 can t#en certfy complance. Dsplay t#e ?erman 7 +nfe * for+ symbol on t#e product.


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Procedure s n place for ntroducton of ot#er n!redents. =e) n!redents can be proposed. ust be very a)are of any announcementsC a!anst any BfR recommendaton. ,or e(ample one recent announcement a!anst recommendaton 21 c#an!ed t#e

procedure for #o) a product e(tracton test s to be run. T#ese are publs#ed n t#e unde!"e!undheit!blatt#

3?erman #ealt# scences Hournal6

Be careful 7 It s possble to develop a formulaton )#c# meets t#e BfR compoundreurements but fals to meet product e(tract reurementsJ


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2020

,uture #allen!es - R$A'.

B! c#allen!e n $urope n t#e future s R$A' 3$uropean re!ulaton$ 1>0*200@6.

F00Q Pa!e document Deals )t# t#e Re!straton $valuaton Aut#oraton and Restrcton

of c#emcal substances.

ame nto force on 1stune 200. an ams are to:

o Improve t#e protecton of #uman #ealt# and t#e envronment from t#e rs+st#at can be posed by c#emcals

o $n#ance t#e compettveness of t#e $; c#emcals ndustry.o Promote alternatve met#ods for t#e assessment of #aards of substances

o S#arn! of c#emcal safety nformaton .


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All data for c#emcals stored by t#e $uropean #emcals A!ency 3$'A6 )#o )ll alsorun t#e $valuaton process.

All manufacturers or mporters of c#emcals #ave to re!ster t#em. P#ase nC substances 7 )ere manufactured or mported before R$A' came nto force.

T#ese #ad to be pre-re!stered before 1stDecember 200F. 0*11*10 7 "as frst re!straton deadlne for p#ase n substances.

From this date onwards, it will be against the law to continue to manufacture or import anyunregistered substances covered by this deadline

Substances manufactured or imported at 1 ! per year or more

"arcinogenic, mutagenic or toxic to reproduction substances at above 1! per year#

Substances dangerous to the environment at above 1 ! per year#

$1*0


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,uture #allen!es - R$A'. ;nder R$A' - ;se of some c#emcals s already restrcted. ,or e(ample p#t#alates

not permtted for use n soft toys for c#ldren. 3Anne( 1 - Restrctons6.

8st of substances of very #!# concern 3S'6 #as been produced and ben! added to.

S' lst #!#l!#ts materals )#ere current restrctons may not be adeuate.

=umber of p#t#alate plastcsers are on t#at lst ncludn! D%P and DBP.

;se of t#ese )ll become more restrcted for e(ample use of D%P )ll be subHect toaut#oraton.

;se of D%P after t#e 21*02*1< sunset dateC )ll be banned unless t#e use s aut#ored.

T#ese materals are on bot# BfR * ,DA lstn!s as approved plastcsers.


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anufacturers can #ave to notfy $'A 7 f S' are present n products 0.15depends on certan condtons ben! met one ben! )#et#er t#e use #as beenre!stered.

Products contann! S' at above t#e t#res#old lmt must declare t#ey contan t#smateral on pac+a!n!.

8e!al obl!aton to provde nformaton to customers on t#e presence of S' n artcles3E9< days from reuest6.


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,ood ontact - ,uture #allen!es.

olatle Ra) materals mar+et: eans can be #ard to source approved food contact materals. Ra) materal manufacturn! locatons c#an!n! at s#ort notce.

#an!e process n food contact arena #as to be mana!ed n a professonal and controlled manner.

Some e(tract lmts n place are nto t#e realms of part per bllon.

urrently 7 close to analytcal lmt of detecton test repeatablty ssues.

Developments n analytcal tec#nolo!yG. And ne)er tec#nues mean e(tract lmts n place may come do)nfurt#er.

,ood contact formulatons )t# a lon! #story of use could suddenly stru!!le or fal to meet e(tractonreurements or become obsolete or restrcted due to R$A' mplcatons.

,urt#er $; le!slaton !overnn! t#e use of rubber n food contact applcatons s to be e(pected. Specfceasures for Rubber


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Any UuestonsL

Dsclamer

!his presentation is intended for general information purposes only#

%rtis accepts no liability for the accuracy of this information and shall not accept any

liability whatsoever to any person in relation to the contents of this presentation and

any reliance placed on it#

Rubber Food Contact

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