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~~f*- Programme Officer Office of Climate, Licensing & Resource Use

Yours sincerely,

I am to advise that the Agency rejects your request for a Technical Amendment as the changes required would more appropriately be assessed as part of a licence review. In accordance with legislation, should you wish to proceed, please submit a request for a decision to review, accompanied by the fee of € 126.00 to the Office of Climate, Licensing & Resource Use.

The Agency has considered your request for a technical amendment to your existing licence, register no. P0886-0 I.

I refer to your letter of ze" October 2010 received by the Agency on 2J111 October 2010 in respect of your existing licence.

Dear Mr O'Sullivan,

Reg No: P0886-0l

Headquarters, PO Box 3000 Johnstown Castle Estate County Wexford, Ireland

Ceanncheathru, Bosca Poist 3000 Eastat Chaislean Bhaile Sheain Contae Loch Garman, Eire

T: +353 53 916 0600 F +353 53 916 0699 E: [email protected] W: www.epa.ie

LoCall: 1890 33 55 99 u" April 2011

Mr Peter O'Sullivan EHS Advisor Rottapharm Limited Damastown Industrial Park Mulhuddart Dublin 15

eQQoOcfoo Sgeocy An Ghniomhaireocht um Choamhmi Comhshooif

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(or nominated, suitably qualified and experienced deputy)

Date Signature Group/Facility manager

Declaration: All the data and information presented in this report has been checked and certified as being accurate. The

quality of the information is assured to meet licence requirements.

I Facility Information Summary I AER Reporting Year 2014 I Licence Register Number P0886-01 Name of site Rottapharm Ltd. Site Location Damastown Industrial Estate, Mulhuddart, Dublin 15 NACE Code 2110 Class/Classes of Activity 5.16, 12.2.2 National Grid Reference (6E, 6 N) 305372E, 241344N

A description of the activities/processes at Rottapharm Ltd was acquired by Meda Pharmaceuticals in 2014. The combined entity will have enhanced scale, reach and the site for the reporting year. This should profitability with 2013 pro-forma revenue and EBITDA of SEK 18 billion (€1.9 billion)[l] and SEK 5 billion (€0.5 billion) include information such as production respectively. Completion of the deal took place in Q4 2014. Rottapharm continues to primarily sell and market sachets of increases or decreases on site, any Glucosamine Sulphate {CGS) and Plantaben via its sachet lines. Organic solvent coating occurs in Area 2 where Tromalyt infrastructural changes, environmental capsules are the main products while capsules of CGS are also manufactured. The site has expanded into a pre-existing performance which was measured during module within the building but continues use the same pharmaceutical processes for manufacturing. There were four the reporting year and an overview of exceedances with the licence in 2014 at A2-1 (Regenerative Thermal Oxidiser), however, these were directly related to an compliance with your licence listing all typographical error in the original application of the 201 licence. The abatement system and process is running correctly but is exceedances of licence limits (where unable to comply with the tight emission limits set at P0886-0l. Rottapharm, until Ql 2015 was awaiting feedback from the ai;rnlicable) and what they relate to e.g. air, Licensing Department regarding the outcome of discussions regarding this error. There are no other non- compliances of the water, noise. licence to report

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Note 1: Volumetncflow shall be included as a reportable par.1meter

comments- reason for change In% rnassload

ELV tn licence or from Emission Frequency or any revision Unit of Compliant with Annual mass previous year reference no: Parameter/ Substance Monitoring therof Ucenc.e Compliance criter1a Measured value measurement lfcence limit Method of analysis load lkg) If applicable

6253.75 "'" ''"'" ... enter details in 13 Standard

AH volumetric flew Quarterlv 2000 All 1-hour averases < ELV Nm3/hour comments box) OTH N/a Used 12.18

... Tobi Organic Carbon {as No 30m[n mean can exceed 13 Standard

A2·l C) Quarterfv 20 the ELV m•1Nm3 yes OTH 13.55 Used 1.6

Nitrogen oxide.s No 30min mean can exceed A2-1 INOx/N02) Qua rte riv 100 the ELV mo/Nm3 yes EN 14792:2005 2.57

No 30mln mean aan exceed 8.4

A2·l Carbon monoxide {CO) Qua rte riv 100 the ELV mg/Nm3 yes EN 15058:2004 20

Table Al: Licensed Mass Emissions/Ambient data-periodic monitoring (non-continuous)

I Periodic/Non-Continuous Monitoring I 2 Are there any results in breach of licence requirements? !f yes please provide brief details In the comment secttOn of Due to a clerical error in the original licence, volumetrrc air

TableAl below Yes emissions for hourlv and daily rates are out of ecmclrance

Basic air 3 Was all monitoring carried out in accordance with EPA guidance monitortne All monitoring carried out using the EPA Technlcal Guidance

note AG2 and using the basic air monitoring checklist? checklist AGN2 Yes Notes

Additional rnformation

Does your site have Jlcensed air emissions? If ye.s please complete table Al and A2 below for the current I reporting year and answerfurther questions. If you do not have licenced emissions and do not complete: a

solvent management plan (table A4 and AS) you do not need to complete the tables L-~-"Ye~s'--~..L~~~~~~~~~~~~~~~~~-'

Answer all questions and comp!ete all tables where relevant

2014 Year P0886-01 Uc No: AIR-summary template

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•• an accurate record chime bypass beginning and end shou!d be logged on site and maintained for future Agency lnspectlons please refer to bypass protocol link

• this should include all dates that a, abatement system bypass occurred

: I

Date• Duration .. {hours) Location Reason for bvoass lmoact ma~nitude Corrective action 04/03/2014 0.01 AH Dust detector alarm O.J.2 k• (worst easel Process Paused 29/04/2014 0.01 A2-1 Dust detector alarm O.U !<,? {worst case~ Process Paused 05/06/2014 0.01 A2-1 Oust detector alarm 0.12 k• !worst easel Process Paused 11/10/2014 0.01 A2-1 Warm water temceratvre analoa value fault 0.12 kg (worst c:ase) Process Paused 11/10/2014 0.01 A2-1 Combustion air fan freauenc:v convertorfault 0.12 ke (worst easel Process Paused 11/10/2014 o.oi A2-l Combustion arr fan freauenc:v convertorfault 0.12 kR (worst case) Precess Paused 22/12/2014 0.01 A2-1 Purze air runtime damoerfault close 0.12 lo! <worst easel Process Paused

Bvoass nroroccl Table A3 Abatement system bypass reporting table

note 1: Volumetric flow shall be included as a reportable parameter.

Emission Parameter/ Substance Averaging Period Compliance Crlteriil Units of Annual Emission Annual maximum Monitorfng Number of ELV Comments reference no: measurement Equipment exceedcnces In

downtime (hours) current ELV in jlcence cr any reporting year revision therof

SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT

Did your site experience any abatement system bypasses? If yes please detall them in table A3 below

Table A2: Summary of average emissions -continuous monitoring

7

Do you have a proactive service agreement for each piece :if continuous monitoring .equipment?

I I

OTd continuous monitoring equipment expertence downtime? Jf yes please record downtime in table A2 below

No Does your stte carry out continuous air emissions monitoring?

Jf yes please review your continuous monitoring data and report the required fields below in Table A2 and compare it to its relevant Emission limit Value {ELV}

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Continuous Monitoring 2014 Year POBB6-0l Lio Ne: AIR-summary template

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AIR-summary template Uc No: P0886-0l Year 2014 I

Solvent use and management on site

8 Ooyou have a total Emission Limit Value of direct and fugitive emissions on site? if yes please fJI! out tablesA4 and AS SELECT

Table A4: Solvent Management Plan Summary Solvent Please refer to lfnked selveer regulatrons to

Total voe Emission limit value regul:ttions complete table 5 and 6

Reporting year Total soivent Tnput on Total voe emisstons Tot>IVDC Compliance site (kg) to Atr from entire emissions as %of

site (direct and solvent input Total Emisskm Limit Value fugiijve) (ELV) in licence or any revision

therof

2014 18314.4 7805.5 43 Yes SELECT

Table AS: Solvent Mass Balance summary

(I) Inputs (kg) ID) Outputs (kg)

Solvent Organic solvent Solvents lost in Collected waste solvent (kg) Fugitive O,e;inic Solvent released in Solvents destroyed Total emfssion of (I) Inputs (kg) emission in waste water("8) Solvent [kg) other ways e.g. bv- onstte through Solvent to air (kg)

IPA 11515.8 6909.7 0 3249 550.7 l 7233.9 20.9

Acetone 5877.l 3647.9

Alcohol 848.8 463

Total 11054.5

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Table W3: Licensed Emissions to water and /or wastewater lsewer}-periodlc monitoring {non-continuous)

Licensed Emissions to water and /or wastewater(sewer} .. periodic monitorinFg..;,(n_o_n_-c_o_n_ti_n~uo_u_s.:..) _

3 W~ there any rt!5U!t fr, brc.1c:h of lkenee requirement,;? ff ye:: elease provide brief dctaCs Jn the I I Wa, ,n mDoi,o,r,s a•ri•d o:~,~:::~~ :~·:: W3 belew ND

&1,lldan<.:c :inc:! checidlsts fer Quality or Aqueou$ Monitoring [,cti;;mal (lnt£mal

oa;::u~~=::r:;~~~: !fd~~:1~:~~~:;:~~;~~::~~ ~~~tt:,nw ~t ~v-""'------'------------------------------'

Commen~ Corrective .1dlon sourceaf

contamln:iitlon neset t!on of cont:3mln:tit!oii

Oatc of ln::pection

Location Rcfcrcne:c

•trigger valves may be agreed by the Agency out~ldc of llcentc c:ondltlon:: Table W2 Visual inspections-Please only enter details where contamination was observed.

Location ElVortrie-2:er licence

location relative to site Pfn'R Par.imeter Uccncecl Mcnltorln& level In licence Compliance Measured v.alue Unit of CompUant With Comments

reference .ictivlties Parameter date or any re11tslon uiteria

measurement licence thereef"

Total ore;a.nlt c:atbon 5W1 {TOC)(~totlltor Toti! e>rpnle 26/03/2014 .. ,

Ul'IStfeam coo ti.\ C:ubonltsCI NIA m•• ves

SW! downstre.im •H 26'0312014 NIA 4.66 r11-iunlts ves

Total or~nfc: c:ubon SWl (TOC) tu tonl C or Tot.ilOri;mlc: 26/03/2014 •. 92

U"'ltttlm coo"' l:ilrbonluC\ NIA m•IL . .,, s«: dowrutn!am DH 26/03/201~ NIA e, , cHunlt:s ves

Totil ors:anlcarbon SWl fTOC) (as teral C or Total Organic: 24/06/2014 5.27

Ul'l~1ream coo/3\ Carbon fas~ NIA m•• VO,

SW! doWnstn!:am ,H 24106h014 NIA 8 riHunlts ves

Tobi or,:anlc cirbcn SWl (TOC) (as total c or Totll orpn!c 24/06/2014 5,07

uostre:im C00/31 C11rbon iu cl N/A m•> , .. SWl downstream ,H 24'0612014 NIA • cHunlts ves

Tobi organic c::ubon SWl ifOC) (:.~ total C or To~!Organlt 24/09/2014 5.12

U"'S"tre:im C00/31 Qlrbon /;;isl"\ NIA m•• ... SW! dow~cream •H 24'09h014 NIA 7.9 cH units ves

Total oraanlt carton SW2 (TOC) (:u total Cot Total Organic 24/09/2014 5,7

uesveam C00/31 C1rbon iuc1 N/A m•IL ves SWl OoWn!:tn:-;im DH 241091201< NIA 8 oHun.lU ves

Tct::111 organic arbon SWl (TOC)(astat:a!Cot Tot:t1orz1nlt 23/12/2014 . .,.

U"strum COC/3\ carbon run N/A m•IL ves

SW! downst~am •H 23112n01• N/A B.2 r:iHunlts: "CS

Tot;)I organic: carbon SW2 (TOC) (u total C or TotllOrganTc 23/U/2014 ,.12

urstrcam cocf:!.\ c:irbont:iscl NIA m•IL ves sea down~am DH 23ll2/2014 N/A B.2 DH unTts ves

Addltlo:ial tnformlltion

uees your slte have nc:cnsed emtsslons dlreet to .:urf.:ice water or drrect to sewer? If ves I plc.isc complete table W2 3nd W3 below for the eerrent rcportlne year and answer

1 furthv- questions. If you do not have llc:enced emissions you~ need to complete table Wl :ind or W2 for storm water analvsls and vlsua! inspections ~~--'y~"'----1~~~~~~~~~~~~~~~~~~--;

Was it a requirement of your licence to carry out visual inspections on any surface water dtscharges or watcn:ourses on or near your site'? If yes please complete table: W2 below

summarising 9nlyany eyid~nci::: of cont~mio2tJon notl!d durjne v[o:ual fn-sot:c"ions '-~~v~~'----'~~~~~~~~~~~~~~~~~~--' Table Wl Storm water monitoring

2014 Yen POB86-o1 Uc No: AER Monitoring returns summary template-WATER/WASTEWATER{SEWER)

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EPA Export 23-01-2016:01:06:42

AER Monitoring returns summary template-WATER/WASTEWATER[SEWER) Uc:No: P0886-0l Ye:.r 201' I

ELVorttluerv.11ue~ Procedural

Emission Em~h:m P:iromo~r/ Froquonc:y of lntrcenc:corilny Unit of Complfant wfth Proo:dural reteeenee Annu;il m::ir.:. lo:id reterenee no: rclc:,$cd to Subst:anc11Noto 1 Tvp• of ~mplo mon!toriflD Avor,i.glno porlod revision thcrof11111•2 Ucom:o Compll:inco crilorhr, MoiSl.ltod valuo measurement lrc:cnee Method er anal sts rcfcrcncc:ourcc standard number {kg) Comments

SE1 ... ~ .... w ..... , .. C! aoo ccmpositc Month1v ::Z4hour 2000 AUvalues<E'LV 218.G67 mo/I. Ye< ' v1.m:·1p1~111 c: ll3 1665.S

SEl ... ~.cw• cr1::,,c Tempennurc c:cmposllc Monthly 24 hour 42 Allv.1lucs<ELV dezreesC ye, 1..11:.)0l\l'CQ v11vsc:n UUlC'IPC:,OC: 715

SEl VIiii) ewe c(J::,,c COD camposltc Monthly 24 hour 4000 AUv;lu:cs.<ELV 483.J m,tl. ye, :.pee top o omcwy v1.ncr pc:.t c

107 3667.6

SE1 Vllil:t.lCW,1.,.,, C F":its:, Olis: and G~ascs: composltc Monthly 24 hour 100 All values e ELV s.s m,tl. V" Gni.vlmctrk an:.fys:ls: v<e, pc: .. se

101 42.2

so SUiphate composite Monthly 24 hcut ,oo Allv;lucs<ELV 61.S m<IL yo, ..... "':', .. w~c

119 46S.9

SEl '<fW,l~\.CWill•._,,.c Suspended Solids C'Clmposlte Monthly 24hcur ieo All v::ilucs < av 66.6 mo/I. Vt< .1pe1arop~o1omc"ry umct~ca:.c: 106 510.2

Sil W:,stew.,tcr/Se Dcte71:cnu (u: MSAS) ccimpostte Monthly 24 hcur 100 AJlv3lucs<EI.V 174.S ~"'' yo, Spectrophotometrv Olhcr(plei~e

1.4 w..- !Colorlmetrvl socdM 116

Note 1: Volumctrlcflow ~h311 be Jricluded a: a rcporuble p:,nimeter Note ::Z: Whi:re Emls:lon UmltValuc~ (ELV) do t\Ot applytoyourltc:ence elease compare results 1galn:t EQS rcr Surface water or relevant rea:ptorqu:iltty mnd3;rds

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EPA Export 23-01-2016:01:06:42

"'Measures taken or proposed tc reduct er limit bypass frequcl"IC')I

Was.:. report When ms this report s1,1bmlttcdi' submlttl!d to the E?Ai'

Corrective action•

Our:.t!'on (hours) Location Resultant emissions

SELE.CT

Reuonfor bypau

Table WS: Abatement svstem bvoass reoortin'I! table

nctc 1: Volumetric flew ~an be indudcd as a reportable parameter. C1:>mments

Unlt:.cf mc.1iutcmcnt

Compliance Crherf11

Annu:it Em~s!on forc:urrc.t rle"Ortln•n1c,11rl)tnl

%dl1ngc+/-rrcm prevloui rcportlnti McnltorlnB NumbcrcfELV yc1r Equipment exceed enees ll'I

dcwntlme lhcur~\ rc:001'1-IM,: c:ar

ElVortrl;acr values In ueenee or

Emls::lon Eml:slon any rb'Jslcn Avcr.igfng reterenee no: rclc~d to Po11r1mctcrl Submncc thenof Pcrlod

I: I Ye,

Addlt!on,'![ lnform:it!on

6 :~::~"::!~ monitoring equipmentcxpericncc downtime? If yes ptease ~cord downtima in

7 :c~ou have a proactlvc servtee contractforc:ich piece of contlnuaus monitoring equipment on

3 ~:~c:i!a:ement ~stem hyi)ass occur durfng the reporting yen? If yes. please complctt table ws

Tabte W4: Summary of average emissions -continuous monitoring

lfyr; please summarise your continuous monitoring d:ib below In Thblc W4 and compMc It to Its rch1~nt Emission UmitVa!uc (ELV)

Continuous monitoring 5 Doesyour~~c carry 01,1t continuoi.a emfulons to water/:fN'cr monitcrfnB?

Year ?0886-01 2014 Uc No: AER Monitoring returns summary template-WATER/WASTEWATER(SEWER)

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EPA Export 23-01-2016:01:06:42

SELECT 5£LECT SELECT SEU CT SELECT 1ELECT SEU:CT" M:s1111r1:ilofconstruc:tlan: Str\JctUrtlD T""t'JV:lt'm l""olntt rll te-s!ln Oocsthtls1rveturth.1v, 5t'condll"'CClnt:ilnmient?

1111,crJtyr.poru m11lnt.1lnadond10?

lnl1111ltylcst f::iU11reup!::1Mtlon Correctl.,.e;ctlon Schtdulc-ddata Ro!ulll.ofrf'le!!llrlnC\lrr111nt <50wotd$ ukll!'n for retest ,e...,..rtJn .. .,ca,i

TVpeofsecond.,ry cont::r.lnmen1

2 ?lt.t~1!pro.ildelntcnrrtyt6tlnc:fr"qut'ncyptr!od •ple:ue nott:1 lntcirlty tc-~ttn1 mc.)ns w:tttrtl11,Mnc,::$ to~lln.& for procan aMI' foul plpt:1ilnt:1s (.2! rec:ulmf undar y11ur llcanc1!)

"ott~ph:irrn ~ nevt:1rtened foul pl;io\ltao.s :is It ls notstlpubted!n

tlccnceP0!!.5-01

Aro you r~uk11d by yourliconct to undorulr.111 lntegrltvl~tln1° on undercroul\d struc1i.res "-'" plpcllnrc or sum~ etc? uves elesse f\U out t::ib1o 2 bolow \ls!ln1 ;:ill 1 undorarvund nruc:wra:::s ::ind p!p1111!nn on sit a which filled tht lnte(l'1ty tut arid aU whkh have not bn!n tasted wlthlnc tho 11,ti,i:ritytut "arlod a, 1pac1"111d

ves No Not A olleable to Rott~ horm "'

•c1~frll'l~l'tdlfl0u\S'«:11'11f1'1t""'11&1'0,U°"Cllflltiflfflll'ltn<lol•C.to!lt<Jl,,T111~la- Hz inuWllytt'.:tlMll bt't't'I c;irr1od oi.t In o«or1:hincc wlth neenee t1!qulrem111nu ::ind ;re ;llstruc:ti.rt.: ttstc-d ln

15 Una with BS8007/EPA G11\d:ince? Qlrndfon aog "-liKD!l" mli9!"rlr>M 16 Au: th~MC1$/t~s!or systems to rcmote contlfflment sy:;tcm: tcU4'117 17 Aro Ch31'1nels/tr;i,uferm1aIT1~ comp!bnt In both lntcgr!ty:ind 1111111::iblc volume?

Comm111nu 17/09/'lOU Yes SELECT 2l}U{20l• Vt's Plli SELECT'

corrocuv,11cuon t:ikcn for1111nt tt' ortln~ .. c:i,, EhJnd/Cont:ilnmtnl 1truc11irt 10 ,~-. S"111d( Othtr1""• Prod11ctcoi,t.::ilnm11nt AclUIIIU"llcl1'1 ceeaen r111 ulr1d• li-...,ttofrnt"•rlNtnl Olhtr!C~l l""III

Sund I crtf:ibrlQttd Fl::imm:ibles 3.l85ml <110% Hvdr::iull(IOSt

8111\C!J rtf:ibrlc:ittd '1ammablas 3.135 ml <110% Hvdr::iutlctMl

Jn111111rltv rt"oru m~nt:i!nadon lntte,rltyt~lhUurt

Tu! dJle 1\11111 11.uutu of u,n unl~n::itkln <SO word,

RtSIJltso( r0111~t!Jr i,,

T1bl111 Bl: S11mnu1rvdot:ill~ of bund {eonuln~M ~ruct11r1 Into rltvta-st

No

It !St\lrrt'ntly not posslbloto1e~:th1t flr~tcrr11tontlo11pondtoany tt;md::ird du111toth1111::irst' 1mol,ll'\t of w11tt'fth;itwouldb111 roqulu1dtobo cont1ln111d ;nd/ordr~lru:d for 1r.:."t-<t~n.We~ltA&oncy s.uld:inct' ~ to how bcu to comp~t111 thl~~currcntlyno Stltl~hStnd.1rd 0111tln0Jthbtoours:it~faalon

ll Do all sump~ :ttid c)l:imb11~ have high le.wet l~uld al:irmi? U lfyc::s to CU! :uo thno l:illulo ,yst,ms·lndu~od In a m,1l111an.111co :,,11cl tut\1111 pro11r;MT1me7

Ytt WWfP Sump ha, hls:h lovel alarm 1nd011orflOW"'I In

Ooc:.thc- ,11c nuln:.2.ln; toi;!:ter o( bund~. 11mkr,:ro11nd plpcilincs {lnth.allns stormwater :,nd fci\lll, T:ink::, sumps and cOJit:iln,irs1 (contalner·s rofor:: to •ct-.,msto,ri:~ LI.slid In site 1mer;cncy proc:oduru 3 tvpcunltt;,ndmobl!cb1.u,c!s) l'Y-"n'--------l''"'''-''""-'''"'"'-"'"-"""''"'' e..• ---~

4 How man',' b1.ind~.;irci Ol\1lto7 l''=-'--------l'''"-''"-'"~"'"-"wwn>=:.,S::,:<m""---- S How m.2on',tof1hcsobu11d,h.2.YO boentostcdwlthlnthor~ulr.dtdtsth.edule7 l'''-------1--------- i Mow man)" mobllt bunds are on sito7 1 Arfl:homoblle~ncblru::llidodlnthc bundtastschcd'ulc7 ~N'-=o------+--------- 8 Mow ma11y o! the10 mobllo bunds h;\lr: boen ~,tt'd wlthlt, the rt'qu1rod test sd11du1c? !I Mow many,um~ on :;ltt ;~ lncluclod 1n 1hc fn.te11rlty test schodulo?

10 !-(ow many of thc.-so ,ump, are ln.tc;t!W 1~tt'd within tht' tC"Jt ,~hcdul1t? P!oas11 Ust any wmp lntc-tritir folh.1r.,, fM t.iiblo 1U

2 l>lt::1:u pro'lldo Integrity IMt\ngfroq~nr:v porlod "'

AI•you rcq~rcd by vouf llccnc:o to undcn.11:e lntc•grttytcstln; on bunds :,nd cont;lnmont stt\.lcturc!. 1 lf y~ plo:,se fHl out u,bl• Bl below l~tlng ~u new bunds and conulnmcnt strut.turn on ~Ito, In ;ddltlon to•~ bund~whrth flUcd tho lntet:rltytost-111 bulldlnr;Strli¢1\lfHWhtch flrt,d !ncludlnr; mobl!cr bi.fflcb m\lrt bo l!stcd In

1 theuble below, elrnr lre=lud .. ell tumsh e\G1[dc tbr !krrx:rd tMifTicuded (mobstc b1u1d:r11r,d chitnUtoro lnd11d1d)

1hopdow11 men11 dick lo $U OpllOM

Bund/Pipeline testing template Uc No: Vnr 201•

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EPA Export 23-01-2016:01:06:42

Upward trend in yearly average pollutant

Sample concentration over Date of location Parameter/ Monitoring Maximum Average last 5 years of

sampling reference Substance Methodology frequency Concentration Concentration unit GTV's• SELECT- monitoring data SELECT SELECT SELECT SELECT

.+ where average indicates arithmetic mean

.++ maximum concentration indicates the maximum measured concentration from all monitoring results produced during the reporting year

Table 2: Downgradient Groundwater monitoring results

Upward trend in pollutant

Sample concentration over Date of location Parameter/ Monitoring Maximum Average last 5 years of

sampling reference Substance Methodology frequency Concentration++ Concentration+ unit GTV's• SELECT .. monitoring data SELECT SELECT SELECT SELECT

Table 1: Upgradient Groundwater monitoring results

Comments

1 Are you required to carry out groundwater monitoring as part of your licence requirements? no Please provide an interpretation of groundwater monitoring data in the

2 Are you required to carry out soil monitoring as part of your licence requirements? no interpretation box below or if you require additional space please Do you extract groundwater for use on site? If yes please specify use in comment include a groundwater/contaminated land monitoring results 3 section · no interoretaion as an additional section in this AER

Do monitoring results show that groundwater generic assessment criteria such as GTVs or lGVs are exceeded or is there

4 an upward trend in results for a substance? If yes, please complete the Groundwater Monitoring Guideline Template Groundwater Report {link in cell G8) and submit separately through ALDER as a monitoring licensee return AND answer questions 5-12 below. template

5 Is the contamination related to operations at the facility (either current and/or historic)

6 Have actions been taken to address contamination issues?lf yes please summarise remediation strategies proposed/undertaken for the site

7 Please specify the proposed time frame for the remediation strategy 8 Is there a licence condition to carry out/update ELRA for the site? 9 Has any type of risk assesment been carried out for the site?

10 Has a Conceptual Site Model been developed for the site? 11 Have potential receptors been identified on and off site? 12 Is there evidence that contamination is migrating offsite? Please enter interpretation of data here

2014 Year P0886-0l Lie No: Groundwater/Soil monitoring template

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Interim Guideline Values (IGV)

Drinking water (public supply) standards

12

Drink in?. water (private supply) standards

2014

Groundwater regulations

GTV's

Uc No: P0886-01 Year ..._ __ Groundwater/Soil monitoring template

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EPA Export 23-01-2016:01:06:42

Where additional detail is required please enter it here in 200 words or less

Sample Date of location Parameter/ Monitoring Maximum Average

sampling reference Substance Methodology frequency Concentration Concentration unit SELECT SELECT

Table 3: Soil results 2014 Year ?0886·01 Lie No: Groundwater/Soil monitoring template

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8 9

10 11 12 13

7

6

5

4

3

2

ELRA initial agreement status

Submitted and a-reed by EPA

ELRA review status Review required and completed

Amount of Flnancial Provision cover required as determined by the latest ELRA €835,000 (Worst Case)

Financial Provision for ELRA status Required but not submitted

Financial Provision for ELRA- amount of cover To Be Confirmed

Environmental Impairment Liability Financial Provision for ELRA -type cover,

Financial provision for ELRA expiry date To Be Confirmed Closure plan submitted and agreed by

Closure plan initial agreement status EPA Closure plan review status Review reouired and completed

Financial Provision for Closure status Required but not submitted Financial Provision for Closure - amount of cover €1.4 Million

Financial Provision for Closure - type Other please specify Financial provision for Closure expiry date To Be Confirmed

1

Commentary

Click here to access EPA guidance on Environmental Liabilities and Financial provision

Year P0886-0l Lie No: 2014 Environmental Liabilities template

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EPA Export 23-01-2016:01:06:42

Environmental Management Programme {EMP) report Objective Category Target Status(% completed) How target was progressed Responsibility Intermediate outcomes

Improved Environmental Waste reduction/Raw material usage efficleric Increase Volumes on Cardbc O Increased awarness across sit, Section Head Management Practices

Improved Environmental Energy Efficiency/Utility conservation Energy meters installed onsi 90 Energy meters installed to me Section Head Management Practices

Improved Environmental Energy Efficiency/Utility conservation LED lighting installed in Fact 60 LED lighting installed in the fa, Section Head Management Practices

Yes Do you maintain an environmental documentation/communication system to inform the public on

environmental performance of the facility, as required by the licence 4

Yes

2 Does the EMS reference the most significant environmental aspects and associated impacts on-site 1-Y:.;e:::s~--------~e-------------------------l

Does the EMS maintain an Environmental Management Programme (EMP) as required in accordance

Do you maintain an Environmental Mangement System (EMS) for the site. If yes, please detail in additional information

1 Yes

with the licence requirements 3

Additional Information Highlighted cells contain dropdown menu click to view 2014 Year ?0886-01 Lie No: Environmental Management Programme/Continuous Improvement Programme template

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•• please explain the reason for not taking action/resolution of noise issues?

If noise limits exceeded as a result of noise attributed to site activities, please choose the corrective action from the following options? SELECT

"Please ensure that a tonal analysis has been carried out as per guidance note NG4. These records must be mafntalned onsitefor future inspection

Table Nl: Noise monitoring summary

Comments (ex. main Is site compliant with Noise sensitive ff tonal /impulsive noise was noise sources on site, & noise limits

Date of Noise location location -NSL Tonal or Impulsive identified was 5dB penalty extraneous noise ex. {day/evening/night)? monitoring Time period (on site) (if applicable) lA•s lA90 lA10 LAmax noise" (Y /NJ applied? road traffic)

22/12/2014 No Yes Traffic, planes flying Yes 22/12/2014 {16:04) NLl 61.7 59.2 63.6 61.7 overhead, trees rustling

23/12/2014 No Yes Yes

22/12/2014 i(00:25) Nll 53.6 48.9 56.l 48.9 Traffic on nearby N3

22/12/2014 No Yes Traffic, planes flying Yes 22/12/2014 (14:39] NL2 63.8 61 65.8 63.8 overhead, trees rustling

22/12/2014 No Yes Yes

22/12/2014 {23:46) NL2 56.5 51.8 59 56.5 Traffic on nearby N3

22/12/2014 No Yes Traffic, planes flying Yes 22/12/2014 (12:46) NL3 61.9 57.1 64.8 57.1 overhead, trees rustling

22/12/2014 No Yes Yes

22/12/2014 (23:00) NL3 54.8 50.1 56.7 50.1 Traffic on nearby N3

No

N/A

Yes

No

Noise Guidance note NG4

2 Was noise monitoring carried out using the EPA Guidance note, including completion of the "Checklist for noise measurement report" included in the guidance note as table 6?

3 Does your site have a noise reduction plan 4 When was the noise reduction plan last updated?

5 Have there been changes relevant to site noise emissions (e.g. plant or operational changes) since the last noise

survey?

Yes 1 Was noise monitoring a licence requirement for the AER period? If yes please fill in table Nl noise summary below

2014 Year ?0886-01 Lie No: Noise monitoring summary report

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EPA Export 23-01-2016:01:06:42

Other Recycled Incineration Landfill Total Table R3 Waste Stream Summary

• where consumption of water can be compared to overall site production please enter this information as percentage increase or decrease compared to the previous reporting year. •• where site production information is available please enter percentage lncrease or decrease compared to previous year

Table R2 Water usage on site Water Emissions Water Consumption Volume used i.e not

Production +/~ % Energy discharged to compared to Consumption+/-% Volume Discharged environment e.g.

Water extracted Water extracted previous reporting vs overall site back to released as steam

Water use Previous year m3/yr. Current year m3/yr. year"• production" environment(m3yr): m3/yr Unaccounted for Water:

Groundwater 0 0 -21%

Surface water 0 0 Public supply 9264 8563 7680 1584

Recycled water 0 0 Total

• where consumption of energy can be compared to overall site production please enter this information as percentage increase or decrease compared to the previous reporting year. •• where site production information is available please enter percentage increase or decrease compared to previous year

2014 522

2913 661

Table R1 Energy usage on site Production +/- % Energy compared to Consumption+/-% previous reporting vs overall site

Energy Use Previous year Current year year-• prcdueticn" - 0.02 % (Energy Consumption) Vs. - 21 % (Finished

Total Energy Used (MWHrs) 6897 6766.3 -21% Units)

Total Energy Generated (MWHrs) 0 0 Total Renewable Energy Generated (MWHrs) 0 0

Electricity Consumption (MWHrs) 4211.5 4225.2 Fossil Fuels Consumption: 0 0

Heavy Fuel Oil (m3) 0 0 Lieht Fuel Oil (m3) 0 0

Natural gas (MWHrs) 2685.15 2541.12 Coal/Solid fuel (metric tonnes\ 0 0

Peat (metric tonnes) 0 0 Renewable Biomass 0 0

Renewable energy generated on site 0 0

Is the site a member of any accredited programmes for reducing energy usage/water conservation such 2 as the SEAi programme linked to the right? If yes please list them in additional information

Where Fuel Oil is used in boilers on site is the sulphur content compliant with licence conditions? Please additional information

Rottapharm's energy in table 3 below Feb-15 teams carry out

SEA1" Lar ...... lndustrv

Ener&l! Network

!!J..llil. No state percentage In

Yes

When dld the site carry out the most recent energy efficiency audit? Please list the recommendations

Additional information

2014 Year P0886-0l Lie No: Resource Usage Energy e iciency summary

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23670 71400 22750 165500 Non-Hazardous [Tonnes) 0 33155.6 0 33155.6 Hazardous [Tonnes)

2014 Year P0886-0l Uc No: Resource Usage Energy e lclencv summary

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EPA Export 23-01-2016:01:06:42

nformation Table RS: Power Generation: Where power is generated onsite (e.g. power generation facilities/food and drink industry)please complete the following i Unit ID Unit ID Unit ID Unit ID Station Total

Technology Primary Fuel Thermal Efficiency Unrt Date of Commission Total Starts for year Total Running Time Total Electricity Generated (GWH) House Load (GWH) KWH per Litre of Process Water KWH per Lrtre of Total Water used on Site

I Resource Usage/ Energy efficiency summary Lie No: P0886-0l Year 2014

Table R4: Energy Audit finding recommendations

Description of Predicted energy Status and Date of audit Recommendations Measures proposed Origin of measures savings% Implementation date Responsibility Completion date comments

SELECT SELECT SELECT

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Table 2 lncidcnts sommarv Other Activity In PreventatJve

!neldent category"'please cause(please progress at time Corrective actlon<20 actlcn <20 Resolutlon Ukelihood of

Date of occurrence Incident nature Location of occurrence refer to ~uidancc Receptor Cause of lnddent specify) of incident Commt.1nic::ition occurrence words words Resolution status date rcoccurence

Thi! Regener.itlver Thermal Oxidiser l:workine:finc. The problem is that the: licence emisslon limits we.reset Incorrectly in the

Ucenced disch:.ire.c polnt Other (add oric;ln:i.l Uccncc Revll!W

Quarterly Breach of ElV (type in reference here) l.Mlnor Air details) applic:atlon Norrnalactlvltles EPA Rccurrlnr. Reciuirc:d On!!oinr. Hir.h

SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT

SELECT SELECT SELECT SEl.fCT SELECT SELECT SELECT SELECT SELECT ssucr

S£1.fCT SELECT SELECT SELECT SELECT SELECT SELECT SELECT SELECT sruer

SELECT sascr SELECT SELECT SELECT SELECT SELECT SELECT sarcr SELECT

Total number of lnddents current year 4

"'For information on how to report and v.-hat constitutes an incident VVl"li:tt i~ en ineldent

Additional informatior,

Have any lncidcnts occtmed on site in the current reporting year? Please lb:t all lnddents for current reponing I I I ear In Table 2 below "Y""es,_ .... __._

Incidents

Table 1 Complaints summarv Brief dCKrlptlon cf complaint (Free txt <20 Corrective action< 20 Further

Oate Cater.orv Other type (clease speclfv} words) words Resolution status Re$Olt.1tion date information

SELECT S£1.fCT SELECT S£1.fCT SELECT SELECT

SELECT SELECT

SELECT SELECT

Total complalnts open at start of reporting year Total new comp!a!nts received during reportinz- year Total complaints clo~during reportlnR vear Balance of complaints end of rcoortlnP year

Additional informatlon

Have you received any environmental complaints ln the current reporting year? tf v~ please complete summary\ \ I details of complaints received on site ln table l below u N'-'o-------'·------'·

Com l.iints

2014 Ye::ir POSSS-Ol Uc No: Complaints and Incidents summary template

21

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EPA Export 23-01-2016:01:06:42

I Complaints and Incidents summary template U:c:No: P08as.cll Year 2014 I Tctal number of lncldents previous vear 4 "redur:tlon/ increase 0

22

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EPA Export 23-01-2016:01:06:42

St::l..tCT l.lN1T SEU.CT UNIT SELECT UNIT

Tot11I Jhr,oo:al LincJ dl.ipoul 11ruoceuricd by ;1.rc-11txt11rltd by

WIUllt Prc-lllcttcld11t 10 cnnbndlillfflc

Aettplell ••bUtMlnttrorrlnc ft'Ar

U1heN11.tt'potatt«II forullc1ln~?

Lktnet permllf ullotos lnc-rtorncn-hn:1r-ilous Prh-111coTP1.1bllc

Optraltd Curnn.tl)•l:in.tUiOin.,: Dutl11n.alfillin,:co111mtnud

cens

Table 3 General information-landfill onlv

Rcn1•ln!ncllctntC'd c•pacity ltffld Gt

npcrllni: )'Or (n,3) ConuntnU Wnft t)'?tcs pnmltlnl Authori~lllcnu:cll 11nn.u•I lnt:iltt ror Actual lnt•kc- ror lllipou.J ltt

fordbr,09!~1 Jbpc,nl(tJ,11) rtt1ortlni:yur(l;Jt)

Table 2 Waste tvce and tonnae:e-landfill onlv !SECTION D·TO BE COMPLETED BY LANDFILL SITES ONLY

6 Docs your facllltyh;,.vc relevant nul~ance coMtro[$ ll'I pfaec? 7 Do you have an odour management system in place for your facility? Jf no why? 8 Ooyou :m:ilntaln a iluda:e n:gt:tc-r on $ite?

S Is .:i.ft waste stor.15:c lnfr.iwucturc as required byyourllcencc and approved by the Aecncy In place? lfno please nn waste no rage [nfrHtrticturc required on site

..; Is aU waste ptoce!.~tne lnfrutructure es required byyour!lecncc :ind approved by the Agency In place? If no plcuc nstwaste pro~slne:lnfr.istnJcturc rcqulrcd omltc

Ru~on for P:11::bg:fne; Content[¥.)- ClspcHVRfiovery or treatment O.~ntlty of rcd'uctton/ Increase only :app\Jcs Ir thcwutc opcr.iUOn c:arrlcd out etveve waste rcm.:i.lnln&

from previous has :a p.tcl.~zfn: .site .':Ind the descriFillon of this on slte at the rcportrnzycar component opcr.itron end of rcportlne:

ycar(tonnes)

cemments-

2014

jSECTION C·TO BE COMPLETED BY All WASTE FACILITIES {waste transfer stations, Composters, Material recovery facilities etc] EXCEPT lANDFlll SITES

Europc;in w:i~:5 .. C7t;,Jogu~ E\VC cods~

Quantity ofwutc accepted' In prcvlcus Rcdui:t.lcin/ rtportJngye11r (tonnes) tncease over

prev!ousye.1r+/-

"

Oe1cr!ptfon of waste Quantity of waete ;u:ceptcd 11a:eptcd In cvrrtnt Please enrer an aeeurate reportlnaye.ilr(tonn6) and dct.Ji1cd dc.saiption which applies to rclcwnt EWC code

tonn:,gc llmlt roryour :.ltc(1onl

tonncs/:,nnumJ

Souri:c af waste :,cccptcd E'WCcodc u~netdannu11

3 W:,:; waste acc:c-pted cinto your,!tc th.it w:,s e:eneratcd out:ldethe Rcpublfc or Ireland? lfycs ph::.i:.esbte the quantity In tonnes In :iddit!on.al lnformtidon Table 1 Details of waste accepted onto your site for recovery, disposal or treatment (do not include wastes generated at your site, as these will have been reported in your PRTR workbook]

dropdown llst elide to sec option:; Year

I:: l Old your site have11ny rejected con:.lenments of waste in the current repcrtfng year? nves plea~c e:lve a brief txp!anatlon In the additional lr,formatton

23

!SECTIONS· WASTE ACCEPTED ONTO SITE-TO BE COMPLETED BY AlL IPPC AND WASTE FACILITIES

SECTION A·PRTR ON SITE WASTE TREATMENT AND WASTE TRANSFERS TAB- TO BE COMPLETED BY ALL IPPC AND WASTE FACILITIES Uc No: WASTE SUMMARY

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EPA Export 23-01-2016:01:06:42

mECT U1tdon-silcorlon1ilcn.1l l"l'ld Powcrc.mcral«I{J\"f\V/KWI!)

Cu C1ptun:d&Trt:ilcd by LFG S)'J.tm ml

\Vuairfacccmlulon, mc11ltorlnc Jltrformcd Jurinethcrcportlnc

war'! Comn1cnt,

Commcna Lrr.d11lr (Chloride-) mua 10111? llc/o.nnun1

'SELECT

1"aeh11.1, (NH-O nm,: lo:id Old11nnum}

Wcb1te (COD) m ut loi,.d Oti:/1nm1m

•plea~ note this tndud~ dany cover erea Table 6 Leachate-Landfill only

9 I:; ltilchite trom your stte treated 1n 11 waste WaterTrntrnl!nt Plant? 10 Is leachate rc!ci,scd to surfaccwattr7 lfyes pleuecom~lete teaehate m:auJoad [nformatlol"! below

Commrnlt Art:i wllh nnal c11p to LD

SlondlrdmlhA.11 SELECT UNIT SELECT UNIT

Arn\rilhwukll1"11t sl1ouliJ bCJHffll,IJlfflllY csi,pcd to d~II!' urukr

Arc-11 U""C'll ofhtr licence \Vh1H m1ucrial,; HT utNI In d,c c:in

.+ please refer to Landtn! Man1.Jal lln~ed above for relevant landf!U Olrectlve mcnltorlng.standards Table 5 Caooin2-Landlill onlv

UllJU1e-luknu:nt Wu topo~phf under SSJ(,\)(S) or or the sllc WI\JA been

Hsve CW trli:,:.u lc-vcls Were: miiulm, llmU ,,ilucs •crttd Trllh :Nrl'C')'til in ,uhriiltltd in httnHtobUtlml: lhcAi:c-ncy (ELV.s) nrmrdncyur n-portlnt:.)'nr Cmnuru•ntJ.

201.t.l Year

Wu SW mcni!crcJ In w .. , l.111,dnll GIIJ monitored In con1r,Ilanccwltl1 LD C'llmpli:incnrllh LD JtuulartJ In JtsnWlrd in rq,ortini: renortlni:yc-ar 1-ar

Wu.m~tn-olo&,c1I manircrln~ln cempll•ncc with Lon1Hill DirN:tlVr {t..D) ,i.nd:ir,J \V•,: lc-ochatc- mcmllortd In con1pli11ncc ln n-y,orllncynr+ "1111 Llhtndnnl in "'oorllnr;)'ur

P088Ei-Cl Uc No: UlndnR M.:inu-,I-Monl1orin'" S1.11n~rd~ Table 4 Environmental mcnitcring-landflll only

WASTE SUMMARY

24

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EPA Export 23-01-2016:01:06:42

This question is only applicable if you are an IPPC or Quarry site

Do you lmpor1/accept waste onto your site for on. sile treatment (efther recovery or disposal

activities ? No

Guidance on waste im orted/ac e ted onto site 4. WAS"TE IMPOR"!EO/ACCEP"TEO ONTO SITE

3. SOLVENTS REGULATIONS IS.I. No. 543 or 2002) Is it ar<inlfcabte? Yes

Have vou been oranted an exemclion ? No If applicable which activity class applies (as per

Schedule 2 cf the renulations\? Is u,e reduction scheme compliance route betng

used?

lnstaHatlons using a chemical or biological precess for the roductlon on an industrial scale of basic harmaceutlcal roducts

Activi Name Number 2. PRTR CLASS ACTIVITIES

Address 1 Oamastown Industrial Park Address 2 Oamas1own Towriland Address 3 Mulhuddart Address 4 Dublin 15

Oub!ln ccontrv Ireland

Ccord]nates of Location '"6.4,466276553.4114601!1 River Basin District IEEA

NACE Code 2110 Main Economic Aciivit Manuracture of basic ohannaceutical creeucts

AER Returns Contact Name Sinead Power AER Retums Contact Email Address s,..owen11'lroltal"lharm.ie

AER Returns Contact Position EHSAdvisor AER Returns Contact Teleohone Number 018852746

AER Returns Contact Mobile Phone Number AER Returns Contact Fax Number

Production Volume 0.0 Production Volume Units

Number of Installations 1 Number of Coeratina Hours in Year 0

Number or EmoJovees 153 User Feedback/Comments

Web Address

~ Refer to PRTR class actlvltles below

Classes of Activit

PRTR ldentiflcalion Number P08B6 Facllit Name Retta harm Limited

Parenl Com an Name Rott.a l1arm Limited 1. FACILITY ICENTIFICATION

Vor.:lo~ 1.1.18 REFERENCE YEARj2014

AER Returns Workbook Environmental Prott.?:ction Agent~·

Guidance to compJeting 1be PBIR~

31/0312:)1520.115 I PRTRjj :P08SGj F~:yN.llTIC:Ratt.a.pharmUm.>:edl Filen..:i~ :C<1;r/ofFln:JI or.in POSSG--01 Rot1.epf,.'lnn2014AER.x~I Re\urn'l'o:ir:201-i 1

~ epa

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EPA Export 23-01-2016:01:06:42

Oc.slgnation or Molhod Code CescrJ .. tfon T<Tobl\ kalY'l':ir

Rottnnh2orm Llmi(od L.:indfl/1: stease cn~r summ;iryd:ita on the qu:inlltl~::: ermeurene ti.ired and I or utltt:::cd

For Ill• putl)OJts<ifth• H~!lor..1l lnv1ntl)l)I~ Gntnhoun G~u,, J1ndl'l.ll op•r,t,:,l'J '111'11 r~i;nuid lo 1UOYkl• 1Ylllffll,Y clU.1 an l1ncUlll on (Mltl'l~n•l tlard or Lltllhtd 0!! lh1tr t."IJltln 10 .tccomp,ny Ut1111~," rw1otll 1"41hlMI atll4"tllltd. Optr.1\onr s.houkl Olll)" 11port 111111 Hot mtth.1no. f(:H,1) 1rnluJD11 la tl'II envlronmtUl l,ltld., !(IOU!) KOl'JrlQ( !IHtlan A: ~dor&p1tUlc PRT11 pollulll\11 .1bo'tl ... ltu .. C.ftlpllll lh• Ubl• btl11W:

Additional Data Requested from Landfill operators

F111cllltyTobl C.1po1.clty m:i o~rhcur

Ml'lhcdUud

M/Cll': To::U odrnctod mcth;ino gonor.ltlol'I (111:i pOl'

Mc:~~t=::~f--------------------~~-~n°f---+-----+------+---"'"1"-'--~o .. ~(Totl.!FbrfngC:i~city)

Mcth:anci utili~ in ongrlo/1:. 0.0 0.0 (Tobi tJti'll~ C::lp:icity) Nat m11~no cmfulon {as roportfld In SK!iol'I

A111bow).._ ~o.~n _ ___,.._ ___, ___, ~Nl~A-----'

19,9 19,9 0.0 0.0 "'1 ESTIMATE Emk-..ion P~~t 1 T obi KG/Vnr A Ac:c:lrlol'ltl KGJYo:ir F Fu itNc KGNur

Moth.ad Ui!:od M/C/E Mclhed Cede Oo!.I nd'on or Qer ~n

T.~~I OIJlllfllC_C.or_l!.on (~CL _ • s.a:ocs , rtrW bydo~ble-cllda~; M the: Pol!Jllnl N~rH [CD!unln 9J lf!CII\ c&ck \l'IO 60\0lO )ld:OII

OUANTITY METHOD POLLUTANT

3~1

SECTION C: REMAINING POLLUTANT EMISSIONS fAS re ulrod In our Llconc:c

0.0

....,,__ ~- ·-- Em~,:lon Paint l N::ame M/CJE Method Ced• Ool!:l n:allcn r nc:ri lien

--·----~C.atb.9(\,.mcn9!J..d.t.(C_O). ----- _ - -~--·- M ESTIMATE • Sc:OC:111~~dcl.lbl,t,dltltn,ct1 U-..Po1h.1<2t>1,'l1rno (Cclwnn O)tllo1ldlclclha cl"lott lMlllon

02, _

POLLUTANT METHOD MfllhodUMd

No.AnnHIJ ilivc KGIYe::ar 13.6

SECTION B: REMAINING PRTR POLLUTANTS

0.0

M11lhcdU~od M/CIE M•thod odo N:im1 No.Annuli

METHOD PO[LUTANT

F Fu ilfvo l<GNur OuS nation or Co~ don M ESTIMATE ~!Ll-~:;WP.!lt:'.9.2)~--

• S.1tc:t • NW by ~di~ Goll u, .. Ponutont NIIM (Colllmn B) lnctn dlck1h1 9111• bUl!an oe

SECTION A: SECTOR SPECIFIC PRTR POLLUTANTS

Link lo prov1ou: ye:us cmrdons d::it::I 4,1 RELEASES TO A!R

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EPA Export 23-01-2016:01:06:42

3667.6 0.0 o.o 510.23 0.0 0,0 468.9 o.o 0.0

42..2 0.0 0.0 isss.a o.o o.o

, • .11 o.o o.o

3667.S 510.23

'168.9 42.2

1665.B , .• 4

CCllorlm1t,y Colorlmob)t Solvent l:)fflietion Colorlmet,y Electometry 9olpfknetry

OTH OTH OTH OTH OTH OTH

OUANTITY

~/O'Jt:Ol~:01C

DMI n21lloM or Oft~ lion Ernlsslon Point 1 Mt'thOd Code

METHOO Method Us~d

SECTION B: REMAINING POLLUTANT EM!SSlONS .:1$ re ulrcd In our Licence

obl KG/Vear A Accidcml.:il KGIYo:::i.r F Fu mw KCil'Yo:r.r T

'I Em1sslon Point 1 MfC/E

16 l Ink lo otrud2n::; Y"nt5 rmts,IM.'i datil

Nome No.Ann-exll I

SECTION A: PRTR POLLUTANTS

4.3 RELEASES TO WASTEWATER OR SEWER

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L Ink t9 prro,;nu-e: Y"i!r"' wa!:!~ (!?ta L fQI< to prnV,Oq'i yN\totW3'r'C :'il'OJOOiJCY diJID & P"'%"0lil;l"' ehOOQ"' Ljplc IP W:i;:.t,,• Gwdnnc!"

L1ndenschmldt.AZ54. 1.21.2.9 AIUed Industrial 70.11,Kromb:acher Stabe,<2- Kromb.ierlar Stabc,42·

organ!cwastes contalr1lng dangerous Eco/Sare Systems ,CP Estale,Kylmore Road.Dublin 46,.,57233 Krcuztal dat 46 ... 57233 Krauztal dot 0.23 subst;.,ncas 015 M Weighed Abroad OB-4\1 10,.,!relond Kcmbachor.Germany Komb:r.chor,Gcrmony

~boratory ehem[e:!ls, consisting of or Allied lndustn:il AGR,ESS2S2039,lm Im eontalntng d:mgerovs suastanees. Including Eco/Sare Systems ,CP Est:r.te.Kylmoro Road.Dublin Emseh~rbrueh,., •• C:56252039 Emsehe:rbruch ..... ESG252039

1.0 mbctures of labor..,.tory chemicals ors M Woighod Abra.id 084\1 ,o,.,lrelond ,Germ:r.ny ,Germ::iny

L!ndenschmld!,AZ$4., .21.2. 9 A!ncd lndu:.tri:r.l 70.11,Kromb:,cher Stabe,42· Krcmb:r.char Sb.be,42·

chemicals ecns!:.tlng of or containing Eco/Sa.fo System~ ,CP Estate,Kylmcre Road,OubRn ~6 .. ,57233 Kreuztll dal .<.6, .• 57233 Kreuztal dat 0.012 dangerous substances ors M Weighed Abroad 084\1 iO .. ,lreland Komb:ioher,Germ.iny Komb:icher.Gcrm:iny

Paeon Waste and Flng~I Bay Business RecycUng,WCP-OC...OS-i1.c9. Park.Urilt4F,Co.

11.9 pilper and cardboard R3 M Weighed Offslle inlrtland 01 Cublln,.,lretand peeen waste and Flr19:il Bay Buslnesi. Recyc~ng,WCP.OC.08~1149- Park.Unit 4F,Co.

biodegradable kMchen and cantoen waste Rl M Weighed Offs~e ln lreiland 01 Oublirl,,.lrel3nd lrlsh LornpRricyelitig Lld.,WCP·DC-OB-111 S-

disr;ardod electrical and alactronlc equipment 01,Woodstoek h1d1.1Strial Wood:;tock lndu~lrl:il other than thos11 mc!I\Uaned in 20 01 21 and Pocon Waste and Fingal Bay Business Estala,K!lkeMy Eslate,Kllkenny and 20 01 23 containing h::izardous RecycKng,WCP·DC-08-11-49- Park.Unit 4F,Co. Road,Athy,Co. Ro:id.Alhy,Co.

3. 71 eornpoMnts R4 M Wclghl!ld Orfsite in lretand 01 Dubltl,.,Jrl!lbnd Klld:ire,lre~nd KUdare,lrol3nd P:accn Waste and Fingal 93y Business RecycGng,WCP.OC.JJB-11~9- P:irlc:.Unlt 4F,Co.

0,56 ptastes R3 M Wolghad Otrsilc In lrcl3nd 01 Oublln •.• lreland Pacon Waste nnd F1n93t B.:iy Business RecyeUng,WCP-OC-OB-1149- Park.Unlt4F,Co.

47.68 mbced municipal waste 01 M Weighed Otrslte in Ireland 01 OubHn ... trotand Pa eon W:nie and F!nga.l Bay Business Reeyellng,WCP-OC.OB-1149· Parlc:,Unlt4F,Co.

7,5 milted municlp:ilwaste R1 M Welghcd Otfalte 1nlroland 01 Oublln,.,lrel::ind

Allitd lnd1ntt!::il Rccy1'uel.BE4597354SB,Zonl Zoning lndusttK!I Eslale.Kylmore Road.Dublll'L ng lndusttiol d'Ehein .. ,Engls:,B· d'Eheln..,Engis,B· 10,.,lrol:r.nd 4>180,Be!gfum 4400,Bctglum

Eco/Safe S~tems ,CP 084\1 Abroad

Ottslte\n1re1and

Recyfuel.BE45973S4S8,ZonJ Zoning lndustrlel ng lndustrlel d'Eheln ... Eng~.S· d'Ehein,.,Engli,B· 4480.Balglum 4480,Bo!glum

Aiied lndustri.il Eco/Safe Systems ,CP E:.t:ite,Kylmorc Road,Oublln 084\1 10,.,lrel3ttd Pa con Waste and Flng::il aay Business Reeycfing,WCP-OC-08~1149~ Park,UnU 4F ,Co, 01 Oubln ... treland

Otrslte in Ireland

Abroad

Zona A,Mullng;:i.r Business Soltec (trctand Ltd),NWCPO- Park ,Mulllngar Buslnus 14-11284-01 p3t1( .ce. Westmealh,lrel:md 7 .2 al.her sONcnt:. :ind sotvcnt mbrt\Jres o-s M Weighed

solld wastes conlainlng dangerous 1'L334 substaru:es 01 M Weighed

soHd wasles other than those mentioned In 71.4 07 0513 R3 M Weighed

absorbents, filter m.1terl~.ts (1ncluding oil raters not othcrwb:o $peclfied), wiping cloth:., protective ctothlng contaminated by

6.23 dangerous substances 015 M Weighed

Ele~met() Port lneiner.,tor.BS51931E.,Cluna way Limitcd,Brtdges Cleanaway Limltcd.Srldges Road.Ellesmere Port.South Ro3d.EUesmere Port.South Chcshlro,Unitcd KJngdom Chcshlrc,Unftcd Kingdom

Method Used

Nam, ar.d LlctnH I P1rmU No. And UdrongfFilolRoc:ovor.rl

Ol~pom (HAZAROOIJS W-'SlE ONLY)

~:Addt • .uoft.oic Oontlr1aUonFacmty ~Addl'o~,11!

Rac:OY111r/Dl:posorr

~:N11T10W Uc.nc•tP.nni\NoofNot

~dn,tlonFai:illty !::l:..c ~Noma1nd Lbirica/P1rrnltNoof

R1cowd01spour

loc:itfonof Treatmenl

Waste I Tre:itmont O"'-er.ation M/CIE Method Used

Quantity (Tonnes per

Ye.ir)

Acwal Nfor•~~ of Flnal Oa11\Nr.iQn Le. Flnol Ro.:0Y11ry I Ct~poul Sl:o (~OOUSWASTEONl'Y)

Haz~rdcus

To Other Countries 14 06 03 Yes

Wlthln the Country 07 OS 13 ves

Wlthl'I the Counuy 07 cs 14 Ne

To Other Counttles 15 02 02 Yos

To o:hrir Countries 1603 05 Yes

To Other Coumries 16 05 06 Ye~

To Other Count6ei. 18 01 OB Yes

Within the Counay 2001 01 Ne

Wilhln the Country 20 o, oa Ne

Within the Country 20 01 35 Yes

Wlthh the Country 20 01 39 Ne

Wlthln the Countty 20 ca 01 Ne

Wlthii the Country 20 03 01 Ne

Transrer Destination DHcricition of Waste European Waste

Cede

:n,'tl3i.tl1S20;1!: S. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE !PRllbl:POe86!F:i.e~N~rno:Ro.'1Jphm'mL.mUlldlFIOl'lomo• Co;,yorF~lOr~tNns&-01 Rti1uph.vm201.iAER;llnl Rolllrr,Yc,;,r:2c1.;1 Ple:i:e enter .ill nu:rntltlc= on th!:-.; ebeet in Tor<1nc=

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Re: Notice of Amendment for the purposes of Section 82A(11) of the Environmental Protection Agency Act 1992 as amended.

Dear Mr. O’Sullivan,

As you are aware the European Union (Industrial Emissions) Regulations 2013 made a number of amendments to the provisions of the Environmental Protection Agency Acts 1992 (as amended) and Waste Management Acts 1996 (as amended) for the purposes of giving effect to the requirements of Directive 2010/75/EU (Industrial Emissions Directive).

In this regard the provisions of these Acts have been amended to include a requirement that the Agency examine all licences granted. The purpose of the examination is to establish if licences, in respect of activities listed in the Annex I to the Industrial Emissions Directive, comply with the requirements of that Directive.

The Agency has examined the terms of the licence/revised licence granted to Rottapharm Limited on 14/01/2010 in respect of the installation located at Damastown Industrial Park, Damastown Townland, Mulhuddart, Dublin 15, Dublin for the purposes of determining if the licence is to be amended to bring it into conformity with the Industrial Emissions Directive as provided for in the legislation.

Having completed its examination, the Agency has determined that the terms of your licence Reg. No. P0886-01 are not in full conformance with the Industrial Emissions Directive. I am also to confirm that the Agency is of the opinion that conformity with the Directive can be achieved by an amendment to the licence as provided for in Section 82A(11) of the Environmental Protection Agency Act 1992 as amended.

Please find attached amendments to the conditions of your licence Reg. No. P0886-01, which are necessary to achieve the necessary conformity with the Directive. These amendments form part of your licence and must be read in conjunction with your existing licence.

However, it should be noted that no alteration to, reconstruction, or extension, in respect of, the activity or any part thereof, shall be carried out or commenced without prior notice to, and without the agreement of, the Agency as required under the provisions of Section 98A of the Environmental Protection Agency Act 1992 as amended.

Yours sincerely

Environmental Licensing Programme

Mr. Peter O’Sullivan

Rottapharm Limited

Damastown Industrial ParkMulhuddartDublin 15Dublin

18/12/2013 Licensee: Rottapharm Limited

Reg. No.: P0886-01

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Office of Climate, Licensing & Resource Use

Tel: 053-9160600

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EPA Export 23-01-2016:01:06:42

Licence Register Number: P0886-01

Licensee: Rottapharm Limited Damastown Industrial Park Damastown Townland

Location of Installation: Mulhuddart Dublin 15 Dublin

Section 82A(l 1) Amendment to

Industrial Emissions Licence

Headquarters P.O. Box 3000

Johnstown Castle Estate County Wexford

Ireland

e QQrotect;oo Ageocy An Ghnlomhaireacht um Choomhnu Comhshaoil

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Page 1

ii!;(.

This amendment is limited to the following Glossary of Terms or Interpretation, Conditions and Schedules of Licence Reg. No. P0886-01:

From the date of this amendment, Licence Reg. No. P0886-0l shall be deemed to be an Industrial Emissions Licence, granted under Part IV of the Environmental Protection Agency Act 1992 as amended.

Henceforth, the licence shall be read in conjunction with any other amendment made to the licence and the amendments set out below.

In pursuance of the powers conferred on it by Section 82A(l l) of the Environmental Protection Agency Act 1992 as amended, the Agency hereby amends Licence Reg. No. P0886-01, granted to Rottapharm Limited, Damastown Industrial Park, Damastown Townland, Mulhuddart, Dublin 15, Dublin.

Amendment

The Environmental Protection Agency is satisfied, on the basis of the information available, that subject to compliance with the conditions of Licence Reg. No. P0886- 01, granted on l 4/01/20 l 0, any amendments made to date, as well as any amendments noted herein, the carrying on of the activity will comply with and not contravene any of the requirements of Section 83( 5) of the Environmental Protection Agency Act 1992 as amended.

The Environmental Protection Agency has examined the terms of Licence Reg. No. P0886-0l as required by the provisions of Section 82A(8)(a) of the Environmental Protection Agency Act 1992 as amended, and determined that the licence can be brought into conformity with the provisions and requirements of Council Directive 2010/7 5/EU by the exercise of the powers conferred by Section 82A( 11) of the Environmental Protection Agency Act 1992 as amended.

Reason for the Decision

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Page2

Any substance or object which the holder discards or intends or is required to discard.

Industrial Emissions Directive means Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (Recast).

Has the meaning assigned to it by Regulation 3 of the European Communities Environmental Objectives (Groundwater) Regulations 2010 (S.I. No. 9 of 2010).

A document drawn up by the Commission of the European Union in accordance with Article 13 of the Industrial Emissions Directive, resulting from the exchange of information in accordance with that Article of that Directive and describing, in particular, applied techniques, present emissions and consumption levels, techniques considered for the determination of best available techniques as well as BAT conclusions and any emerging techniques.

A document containing the parts of a BAT reference document laying down the conclusions on best available techniques, their description, information to assess their applicability, the emission levels associated with the best available techniques, associated monitoring, associated consumption levels and, where appropriate, relevant site remediation measures.

Waste

Industrial Emissions Directive

Groundwater

BAT reference document

BAT conclusions

To be inserted into the Glossary or the Interpretation ofthe existing licence or where relevant replace the existing term.

Amend Glossary of Terms or the Interpretation as follows

Amendments

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Page3

Sealed by the seal of the Agency on this the 18th day of December, 2013

This amendment shall be cited as a Section 82A( 11) Amendment and should be read in conjunction with Licence Reg. No. P0886-0l, granted on 14/01/2010 and any other amendments made to the licence.

To bring the licence into conformity with the requirements of the Industrial Emissions Directive. Reason:

20

The licensee shall, where a breach of one or more of the conditions of this licence occurs, without delay take measures to restore compliance with the conditions of this licence within the shortest possible time.

The licensee shall ensure that waste generated in the carrying on of the activity shall be prepared for re-use, recycling or recovery or, where that is not technically or economically possible, disposed of in a manner which will prevent or minimise any impact on the environment.

2C

(i) an incident or accident that significantly affects the environment, and/or

(ii) the occurrence of any breach of one or more of the conditions attached to this licence.

The licensee shall, where an incident or accident that significantly affects the environment occurs, without delay take measures to limit the environmental consequences of the incident or accident and to prevent further possible incident or accident.

2B

2A The licensee shall notify the Agency, in a format as may be specified by the Agency, without delay after:

Amend the licence to insert the Jo/lowing additional conditions at the end of Condition 2 of the licence:

New Conditions

5.16

The manufacture or use of coating materials in processes with a capacity to make or use at least 10 tonnes per year of organic solvents, and powder coating manufacture with a capacity to produce at least 50 tonnes per year, not included in paragraph 12.2.1. The production of pharmaceutical products including intermediates (production means the production on an industrial scale by chemical or biological processing)

12.2.2

The licensed activities are amended to be as follows:

Amend the 'Schedule of Activities Licensed' as follows:

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Page4

(1\1.arie O'Connor, Authorised Person

PRESENT when the seal of the Agency was affixed hereto:

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\\OWL\OEE\05. Licence Enforccrncnt\lPC Licence Enforcernent.lPC DB Docurnents\PSSl-890\1'0886-01\apOlcc.~~

~~

Emer Cooney Inspector Office of Environmental Enforcement

Yours sincerely

Please quote the above reference in future correspondence in relation to this matter.

I am to advise you that while the Agency considers that continuous monitoring is not required at A2-1, you are required to carry out monitoring in accordance with Agency Air Emissions Monitoring Guidance Note AG2 (available on www.epa.ie/downloads) on a quarterly basis. This requirement may be reviewed in future following assessment of the performance of the abatement equipment and monitoring results obtained.

I refer to your proposal dated 3rd March 2010 to reduce the frequency of TOC monitoring on emission point A2- l from continuous to every two years.

Dear Mr O'Leary

Our Ref: P0886-01/apO l ec 9111 March 2010

Environmental Protection Agency Regional Inspectorate, Mccumiskey House Richview, Clcnskeaqh Road. Dublin 14, Ireland An Ghnfornhaireacht um Chaornhnu Comhshaoll Cigireacht Reigiunach, Teach Mhic Chumascaigh Dea·Radharc, B6thar Cluain Sceach Baile Atha Cliath 14, Eire

T: +353 1 268 0100 F: +353 1 268 0199 E: infogepa.ie W: www.epa.le

Mr David O'Leary EHS Advisor Rottapharrn Limited Damastown Industrial Park Mulhuddart Dublin 15

Environmental Enforcement

LoCall: 1890 33 SS 99

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