appendix b.6(b) environmental impact assessment report and … · 2018-07-10 · fao: jerry...

IMIL IED Licence Review Application AWN Consulting Ltd _____________________________________________________________________________________________________

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Appendix B.6(b)

DOCUMENTS PROVIDED IN SEPARATE FOLDER

Environmental Impact Assessment Report and Appropriate Assessment

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Appendix B.6(c)

Correspondence from FCC Confirming Planning Application is Under Consideration

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B6thar an Gharrain, Baile Bhlalnselr, Atha Cliath 15 I Grove Road, Blanchardstown, Dublin 15 Blanchardstown Office t: (01) 870 8436 f: (01) 890 5832 e: bl_aDJ:[email protected]_

Bosca 174, Aras an Chontae, Sord, Fine Gall, Co. Bhaile Atha Cliath I P.O. Box 174, County Hall, Swords, Fingal, Co. Dublin Swords Office t: Registry (01) 890 5541 Decisions (01) 890 5670 Appeals (01) 890 5724 f: (01) 890 6779

e: [email protected] www.fingal.ie

21-Apr-2017

Permission

IPSEN Manufacturing

Park, Ipsen Manufacturing, Blanchardstown Industrial Snugborough Road, Blanchardstown, Dublin 15.

The construction of a new process vent abatement plant: to include pipebridge extension, access stair and single storey access platform, storage tanks, hard standing, monitoring station (area C. 15 m2), vent stack, access roadways, ground level plant & equipment (all of varying heights not to exceed 12.9m), perimeter palisade fencing (2.4m height) and all ancillary and associated site development works. This application is accompanies by an Environmental Impact Statement (EIS). The Application relates to a development which comprises of an activity requiring an Industrial Emissions licence. IED Licence no P0117-91.

FW17A/0064

PLANNING & DEVELOPMENT ACTS 2000, AS AMENDED

Date: 2 May, 2017

An Roinn um Pleanail agus lnfrastruchtur stralteiseach Planning and Strategic Infrastructure Department

Date Received:

Application Type:

Applicant:

Location:

Development:

Register Reference:

Jerry Corcoran, Joseph Doyle Architects 5 Adelaide Street Dun Laoghaire Co Dublin

Comhairle Contae Fhine Gall Fingal County Council

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~~o for Senior Executive Officer

If in the event that the site notice and appropriate fee is found not to comply, the application will be declared invalid and returned to the applicant.

This acknowledgement is issued pursuant to the Planning and Development Regulations 2006, and is subject to the site notice and appropriate fee complying with the said Regulations.

With reference to the above, I wish to acknowledge receipt of your recent planning application received on 21-Apr-2017.

Dear Sir/ Madam

Yours faithfully

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Comhalrtt' ieontao fih'l'lte·Giil!I fingal 1(QQ:Rl)i' eounm

1

Elaine Neary

From: Patricia Kennedy <[email protected]>Sent: 08 May 2017 17:10To: Elaine NearySubject: RE: Emailing - JDA - Ipsen - Planning Dept. Acknowledgement of Receipt - 2017.05.02.pdf

Hello Elaine, When an acknowledgement is issued for a planning application, it means that the application has been validated. This effectively means that Reg. Ref. FW17A/0064 is under consideration and a decision for it is due on June 15th. I trust that this electronic confirmation will suffice for the EPA. Regards, Trish Trish Kennedy¦Senior Staff Officer Planning and Strategic Infrastructure Department¦Fingal County Council¦Grove Road¦Blanchardstown¦Dublin 15¦Phone 01 870 8431¦Mob 087 0509 309

From: Elaine Neary [mailto:[email protected]] Sent: 08 May 2017 15:22 To: Patricia Kennedy Subject: Emailing - JDA - Ipsen - Planning Dept. Acknowledgement of Receipt - 2017.05.02.pdf Hi Patricia, I spoke with your colleague Eoin Moroney earlier today and he suggested that I contact you with my query. My client has recently lodged a planning application ref. no. FW17A/0064.

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Appendix B.6(d)

Letter from FCC regarding Past Permissions and EIS

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Bosca 174, Aras an Chontae, Sord, Fine Gall, Co. Bhaile Atha Cliath P.O. Box 174, County Hall, Swords, Fingal, Co. Dublin t: (01) 890 5000 f: (01) 890 6779 e: [email protected]

Harry Mclauchlan Senior Executive Planner Planning and Strategic Infrastructure Department - Blanchardstown Office

\

\ Yours sincerely,

The Planning Authority did not require an Environmental Impact Stateme~t to be submitted as part of the following planning applications: Reg. Ref. 92A/1751; 93A/0939; F95A/0458; F98A/0007; F98A/1121; F01A/1258; F02A/0376; F03A/0109; F04A/0200; F04A/1109; FW13A/0019 and FW14A/0063. '

\ The following planning applications included an Environmental lmP,act,'Statement: F94A/0532 and FW1 SA/0015. \

Further to your recent correspondence concerning the above I wish to confirm the following.

Dear Mr Corcoran, 0

RE: Ipsen Manufacturing Ireland Ltd, Blanchardstown Industrial Park, Snugborough Rd, Dublin 15. Industrial Emissions Licence Application - Previous Permissions and EIS (SI 282:2012) .·

Date: 1 oth May zoi 7_ . FAO: Jerry Corcoran MRIAI

John Doyle Architects 5 Adelaide Street, Dun Laoghaire, Co. Dublin.

...... Our Ref: GEN.01


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Bosca 174, Aras an Chontae, Sord, Fine Gall, Co. Bhaile Atha Cliath P.O. Box 174, County Hall, Swords, Fingal, Co. Dublin t: (01) 890 5000 f: (01) 890 6779 e: [email protected]

Harry Mclauchlan Senior Executive Planner Planning and Strategic Infrastructure Department - Blanchardstown Office

The Planning Authority did not require an Environmental Impact Statement to be submitted as part of the following planning applications: Reg. Ref. 92A/1751; 93A/0939; F95A/0458; F98A/0007; F98A/1121; F01A/1258; F02A/0376; F03A/0109; F04A/0200; F04A/1109; FW13A/0019 and FW14A/0063.

\

The following planning applications included an Environmental lm~act1'~tatement: F94A/0532 and FW1 SA/0015.

Further to your recent correspondence concerning the above I wish to confirm the following.

Dear Mr Corcoran, 0

RE: Ipsen Manufacturing Ireland Ltd, Blanchardstown Industrial Park, Snugborough Rd, Dublin 15. Industrial Emissions Licence Application - Previous Permissions and EIS (SI 282:2012) ..

Date: 1 oth May 201. 7_ . FAO: Jerry Corcoran MRIAI

John Doyle Architects 5 Adelaide Street, Dun Laoghaire, Co. Dublin.

Our Ref: GEN.01

\· Yours sincerely,


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Appendix B.6(f)

Confirmation of Revocation of Temporary Discharge Licence

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s~lurth&llri f Dl<enors: Mtchael MtNtcholo; IChiiorma"i 8re"4an M1>1phy. Moch•el O'Suitvar< ~rryGrant. Catr..il Mailey Oll!t.Chi.r•[th•, Repnr..t Oflk:r. reacn (olv!il,, l4-<6Sr<li<i f!UibO~ Batl~·Ama (loath 1. DOI NP86 / (OMii Hou~. 24-21; Talbo~ $1r~t. Duillln , 'D~I NPB& Is ruldeacht<l ghnlomhakxhta ainmn1me at.I laot theoraiM >-!a~e~nno ~ lli~ i.creann J Ml&h W..ter isa deslgnated.,1Cll\;1ty oornipany. 11m•ted ty~h¥~ Ulmhr~ Chliralthe ill ~lrinnl Registered In Ireland Na.: S30363

Environmental Policy and Licensing Support,

Asset Management

Yours Sincerely,

Please do not hesitate to contact us if you require any further information regarding the above licence to discharge to sewer.

I wish to advise you that further to the ceasing of the discharge from the above licensed site that your licence to discharge to sewer "IW-DTS-741013-01 Ipsen Manufacturing Ireland Limited, Blanchardstown, Industrial Park, Snugboro Road, Blanchardstown, Dublin 15" has been revoked.

Dear Mr. Rafferty,

Re: S16 DTS Licence Number IW-DTS-741013-01

26/04/2017

T; • 3'>3 1 89 25000 F: +3$3 1 89 25001 www.water.&e

Irish Water POBox6000 Dublin 1 Ireland

Ulsce Elreann Bosca OP 6000 Ba le Atha Clrath 1 Eire

Mr. Tony Rafferty, Program Director, Ipsen Manufacturing Ireland Limited, Blanchardstown Industrial Park, Snugboro Road, Blanchardstown, Dublin 15

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Appendix B.7

Letter from Irish Water (Confirmation of Capacity)

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StiUrth6iri I Directors: Michael Mc Nicholas (Chairman), Brendan Murphy, Michael O'Sullivan, Jerry Grant Oifig Chliiraithe I Registered Office: Teach Cofvlll, 24-26 Staid Thalb6id, Baile Atha Cliath 1 / Cotvill House, 24-26 Talbot Street, Dublin 1 Is cuideachta phrrobhatdeach faoi theorainn scaireanna e Uisce Eireann/ Irish Water is a private company limited by shares Uimhir Chlilraithe in Eirinn I Registered in Ireland No.: 530363

www.water.ie

Irish Water PO Box860 South City Delivery Office Cork City

Uisce Eireann Bosca OP 860 Oifig Sheachadta na Cathrach Theas Cathair Chorcar

•

Mr David McDermott AWN Consulting Tecpro Building, Clonshaugh Business & Technology Park, Dublin 17 22nd February 2017 Dear Sir, Re: CUST17032 pre-connection enquiry – Subject to contract | Contract denied - Increased discharge via existing Wastewater connection for Ipsen Manufacturing Irish Water has reviewed your pre-connection enquiry in relation to a wastewater connection at Blanchardstown Industrial Park, Dublin 15 (the Premises). Based upon the details you have provided with your pre-connection enquiry and on the capacity currently available as assessed by Irish Water, we wish to advise you that, subject to a valid connection agreement being put in place, your proposed connection to the Irish Water network can be facilitated. You are advised that this correspondence does not constitute an offer in whole or in part to provide a connection to any Irish Water infrastructure and is provided subject to a connection agreement being signed at a later date. A connection agreement can be applied for by completing the connection application form available at www.water.ie/connections. Irish Water’s current charges for water and wastewater connections are set out in the Water Charges Plan as approved by the Commission for Energy Regulation. If you have any further questions, please contact us on 1850 278 278 or +353 1 707 2828, 8.00am-4.30pm, Mon-Fri or email [email protected]. For further information, visit www.water.ie/connections

Yours sincerely,

Maria O’Dwyer Connections and Developer Services

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Appendix B.9

Site Notice, Newspaper Advertisement and Copy of the notice given to FCC of the intention to apply for an EPA licence for the facility.

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SITE NOTICE

APPLICATION TO THE ENVIRONMENTAL PROTECTION AGENCY FOR THE REVIEW

OF A LICENCE

Ipsen Manufacturing Ireland Ltd, Blanchardstown Industrial Park, Snugborough Road, Blanchardstown, Dublin 15, Ireland. D15 Y363 is applying to the Environmental Protection Agency for a review of its Industrial Emissions Licence (P0117-01) for the operation of a proposed new process vent abatement system on the site of its existing facility at Blanchardstown Industrial Park, Snugborough Road, Dublin 15 (National Grid Reference E306826, N240787).

The classes and nature of the Industrial Directive activities applicable to the facility in accordance with the First Schedule to the Environmental Protection Agency Act 1992 as amended will continue to be as follows: Class 5.16: The production of pharmaceutical products including intermediates.

A planning application was submitted to Fingal County Council for the proposed development (Planning Reference FW17A/0064) on the 21st April 2017 and was accompanied by an Environmental Impact Statement (EIS) together with a Natura Impact Screening Statement. The EIS has subsequently been updated in accordance with the 2014 EIA Directive (2014/52/EU) which was enacted on the 16th May 2017 and the document is now referred to as an Environmental Impact Assessment Report (EIAR). The licence review application is accompanied by the updated EIS (now EIAR) together with the Natura Impact Screening Statement which will be submitted to the Agency.

The EIAR and any further information relating to the effects on the environment of the emissions from the activity which may be furnished to the Agency in the course of the Agency’s consideration of the application, will be available for inspection at the headquarters of the Agency.

A copy of the application for the licence may be inspected on the Agency’s website www.epa.ie or inspected at or obtained from the headquarters of the Agency as soon as is practicable after the receipt by the Agency of the application for the licence.

Date Erected: 14th June 2017

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Newspaper notice text:

For publication in : THE IRISH EXAMINER on 14th June 2017

APPLICATION TO THE ENVIRONMENTAL PROTECTION AGENCY FOR THE REVIEW OF A LICENCE

Ipsen Manufacturing Ireland Ltd, Blanchardstown Industrial Park, Snugborough Road, Blanchardstown, Dublin 15, Ireland D15 Y363 is applying to the Environmental Protection Agency for a review of its Industrial Emissions Licence (P0117-01) for the operation of a proposed new process vent abatement system on the site of its existing facility at Blanchardstown Industrial Park, Snugborough Road, Dublin 15 (National Grid Reference E306826, N240787).

The classes and nature of the Industrial Directive activities applicable to the facility in accordance with the First Schedule to the Environmental Protection Agency Act 1992 as amended will continue to be as follows: Class 5.16: The production of pharmaceutical products including intermediates.

A planning application was submitted to Fingal County Council for the proposed development (Planning Reference FW17A/0064) on the 21st April 2017 and was accompanied by an Environmental Impact Statement (EIS) together with a Natura Impact Screening Statement. The EIS has subsequently been updated in accordance with the 2014 EIA Directive (2014/52/EU) which was enacted on the 16th May 2017 and the document is now referred to as an Environmental Impact Assessment Report (EIAR). The licence review application is accompanied by the updated EIS (now EIAR) together with the Natura Impact Screening Statement which will be submitted to the Agency. The EIAR and any further information relating to the effects on the environment of the emissions from the activity which may be furnished to the Agency in the course of the Agency’s consideration of the application, will be available for inspection at the headquarters of the Agency. A copy of the application for the licence may be inspected on the Agency’s website www.epa.ie or inspected at or obtained from the headquarters of the Agency as soon as is practicable after the receipt by the Agency of the application for the licence.

(323 words)

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Directors: Joseph Doyle MRIAI & Thomas Murphy

1 EPA IPC Licence Application Form V2/l 5; SectiPTI B6

r Joseph Doyle Architects

n MRIAI

"'(ours Sincer€1 ,

Should you n~quire any clarification, please do not hesitate to contact me by phone on 2711300 or by email

at [email protected]

I also attach a copy letter that I obtained from our EIS consultants, AWN, from a previous project {unrelated) for guidance and look forward to your response in due course.

I have spokefl with your colleague, Eoin Mororey in this regard and he has suggfsted that I write to you

outlining my request.

"Where an £15 was not required by the Planni.ng Authority/An Bord Pleanala for a planning permission, you must provid€ confirmation in writing from the planning authority or An Bord Plean61a that an environmental impact assessment was not required by or umier the Planning and Development Act 2000 for each planning permission granted. This information should be included in Attachment NP. B.6111

In order to (idvance the EPA application documents, we are required to obtain a letter from Fingal County Council, in respect of the planning history on ttle site, confirming the following:

My client, 1µsen Manufacturing Ireland Ltd, is in the process of finalizing the documentation in respect of a proposed pl;mning application to Fingal CountY Council. The application will alsP be subject to a review, by the EPA, of the existing Industrial Emissions uc.ence attaching to the site.

Dear Sir,

Re; lpsefl Manufacturing Ireland Ltd, Blanc=hardstown Industrial Park, Snugborough Rd, Dublin 15. Industrial Emissions Licence Appllcatlc!" Previous Permissions and EIS (~I 282:2012)

For the atter'ltion of: Mr Harry Mclauchlan, Senior Executive Planner.

Fingal CountY Council Grove Road, BlanchardstcJwn, Dublin 15

22nd March ;017

MRIAI Joseph Doyle

e: [email protected]

t: +353 11} 271 t 300

w:: www.jdorchilecture.com JD 5 Adelaide' streel. Dun looghoire. Co. Dublin.

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Appendix B.12

F-Gas Register

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Equipment No. /Tag Tech ID No. Refrigerant Weight Weight (kg) CO2 Equivalent (Tonnes) Location Description Manufacture Year Notes10001539 CHL/U/1 R407C 68Kg 68 120.63 External Chiller Compound B1 Chiller Compressor 1 CIAT LC 2400 Z 200810001539 CHL/U/1 R407C 63Kg 63 111.76 External Chiller Compound B1 Chiller Compressor 2 CIAT LC 2400 Z 200810001538 CHL/P/1 R407C 47Kg 47 83.38 External Chiller Compound B1 Chiller Compressor 1 CIAT LC 20002210001538 CHL/P/1 R407C 47Kg 47 83.38 External Chiller Compound B1 Chiller Compressor 2 CIAT LC 20002210009697 CHL-442-001 R410A 34Kg 34 70.99 External Chiller Compound B2/B3 chiller Compressor 1 CIAT Aquaciatpower LDC15 200810009697 CHL-442-001 R410A 34Kg 34 70.99 External Chiller Compound B2/B3 chiller Compressor 2 CIAT Aquaciatpower LDC15 2008CHL-442-002 N/A R410A 34Kg 34 70.99 External Chiller Compound B2/B3 chiller Compressor 1 CIAT Aquaciatpower LDC16CHL-442-002 N/A R410A 34Kg 34 70.99 External Chiller Compound B2/B3 chiller Compressor 2 CIAT Aquaciatpower LDC1610027410 N/A R404A 2Kg 2 7.84 Chiller Building Lauda XT550 - Synthesis - Reactor Bay 1 LAUDA XT550 201310027408 N/A R404A 2Kg 2 7.84 Chiller Building Lauda XT550 - Synthesis - Reactor Bay 2 LAUDA XT551 201310027407 N/A R404A 2Kg 2 7.84 Chiller Building Lauda XT550 - Synthesis - Reactor Bay 3 LAUDA XT552 201310027412 N/A R404A 2Kg 2 7.84 Chiller Building Lauda XT550 - Synthesis - Reactor Bay 4 LAUDA XT553 201310027409 N/A R404A 2Kg 2 7.84 Chiller Building Lauda XT550 - Synthesis - Resin Reactor LAUDA XT554 201310027411 N/A R404A 2Kg 2 7.84 Chiller Building Lauda Varicool - Synthesis Rotavap LAUDA Varicool 201310027413 N/A R404A 2Kg 2 7.84 Chiller Building Lauda Varicool - PI Rotavap LAUDA Varicool 201310002150 CHL/X/2 R404A 2.5Kg 2.5 9.81 Chiller Building LAUDA Integral T4600 LAUDA Integral T460010002149 CHL/X/1 R404A 2.5Kg 2.5 9.81 Chiller Building LAUDA Integral T4600 LAUDA Integral T4600N/A CHL/I/1 R22 3Kg 3 5.43 Chiller Building Tricool - PII - Flash Evaporator Tricool Not in use - to be disposed of N/A CHL/D/3 R22 3Kg 3 5.43 Chiller Building Spare Tricool Not in use - to be disposed of New R410A 13.5kg 13.5 28.19 Outside Chiller Building Aggreko Chiller Aggreko

10002148 CHL/V/1 R404A 3.5Kg 3.5 13.73 Pilot Lab APID Glycol Chiller LAUDA T700010015392 N/A R404A 3.5Kg 3.5 13.73 Pilot Lab APID Glycol Chiller LAUDA T700010002189 AIR/W/1 R134a 0.95Kg 0.95 1.36 Boiler House Compressed Air Dryer Ingersoll-Rand Compact 45 Air Dryer10001810 PRO/AS/1 R407C 44oz 1.25 2.21 CLR/A/1 Virtis Lyophilizer Virtis (SP Industries) 25ELN/A CHL/K/1 R134A 60g 0.06 0.09 Tech Services Benchtop Chiller Lauda RM610001860 PRO/AC/1 CLR2 R404A 16Kg 16 62.75 CLR/A/2 Usifroid Lyophiliser Usifroid CL-41010001860 PRO/AC/1 CLR2 R404A 16Kg 16 62.75 CLR/A/2 Usifroid Lyophiliser Usifroid CL-41010001801 PRO/AR/1 R407C 44oz 1.25 4.89 CLR/A/3 Virtis Lyophilizer Virtis (SP Industries) 35ELCMP-053-049 IE11-02-CMP-053-049 R404A 8.6Kg 8.6 33.73 Clean room 4& 5 Tech Space Clean Room 5 SP Lyo HP Circuit 1 CopelandCMP-053-249 IE11-02-CMP-053-249 R404A 8.6Kg 8.6 33.73 Clean room 4& 5 Tech Space Clean Room 5 SP Lyo HP Circuit 2 CopelandCMP-055-051 IE11-02-CMP-055-051 R404A 8.6Kg 8.6 33.73 Clean room 4& 5 Tech Space Clean Room 4 SP Lyo HP Circuit 1 CopelandCMP-055-066 IE11-02-CMP-055-066 R404A 8.6Kg 8.6 33.73 Clean room 4& 5 Tech Space Clean Room 4 SP Lyo HP Circuit 2 Caryle10014748 N/A R407C 13oz 0.37 0.65 OEB 3 Lab OEB 3 Lyo - Benchtop Lyophilizer Virtis Advantage Plus Lyophilizer10001799 PRO/AE/3 Tech. Ser. R407C 13oz 0.37 0.65 OEB 3 Lab OEB 3 Lyo - Benchtop Lyophilizer Virtis Advantage Plus Lyophilizer EL85 (Wisard 2.0)10027093 R407C 13oz 0.37 0.65 OEB 4 Lab OEB 4 Lyo Virtis Advantage Plus Lyophilizer EL-8510038562 N/A R407C 2.95Kg 2.95 5.23 Top of stairs into Mezz B1 Lab Leaders Office Conditioning Unit MITSUBISHI PUH-P4YGAA10038563 N/A R407C 2.95Kg 2.95 5.23 Top of stairs into Mezz B1 Cleanrm 4 & 5 Tech Space Conditioning Unit MITSUBISHI10038564 N/A R407C 29.5Kg 29.5 52.33 Roof over reception B1 Admin Office A Conditioning Unit Daikin REYP20KJY110038565 N/A R410A 1.2Kg 1.2 2.51 Roof over reception B1 Admin Office B Conditioning Unit Daikin RXS35J2V1B 201210038566 N/A R410A 1.2Kg 1.2 2.51 Roof over reception B1 Admin Office C Conditioning Unit Daikin RXS35J2V1B 201210001495 AIR/X/1 R410A 2Kg 2 4.18 Roof Over Main Corridor B1 B1 IPL Boardroom MITSUBISHI10003024 N/A R410A 0.9Kg 0.9 1.88 Roof Over Main Corridor B1 B1 IPL Manager Office MITSUBISHI10003025 N/A R410A 0.9Kg 0.9 1.88 Roof Over Main Corridor B1 B1 IPL Open Office Unit 1 MITSUBISHI10003026 N/A R410A 0.9Kg 0.6 1.25 Roof Over Main Corridor B1 B1 IPL Open Office Unit 2 MITSUBISHI10003027 N/A R410A 0.9Kg 0.6 1.25 Roof Over Main Corridor B1 B1 IPL Store MITSUBISHIN/A N/A R404A 4.4Kg 4.4 17.26 Roof Over Main Corridor B1 B1 Canteen Grab & Go Unit 1 2014N/A N/A R404A 4.4Kg 4.4 17.26 Roof Over Main Corridor B1 B1 Canteen Grab & Go Unit 2 201410038578 N/A R410A 5.4Kg 5.4 11.28 Roof Over Main Corridor B1 B1 Canteen HVAC Dx Units MITSUBISHI 201410038582 N/A R410A 270g 0.27 0.56 B1 First Aid Room B1 First Aid Room Conditioning Unit Challenge 2015

10003002 N/A R404A 5Kg 5 19.61 B2 Plant Room B2 Walk in Freezer (QC) VINDON TAJ4517ZHR10003001 N/A R404A 5Kg 5 19.61 B2 Plant Room B2 Walk in Coldroom (QC) VINDON TAJ4517ZHR10000200 N/A R404A 18Kg 18 70.60 Building 2 Lyophilizer Lyophillizer Compressor 1 Usifroid SMH60010000200 N/A R404A 18Kg 18 70.60 Building 2 Lyophilizer Lyophillizer Compressor 2 Usifroid SMH60010003029 N/A R410A 2.8Kg 2.8 5.85 B2 Plant Room B2 IT server room Hitachi PV-2VJA10003030 N/A R410A 1Kg 1 2.09 B2 Plant Room B2 IT server room Daikin RAS-4HVRNSE1003876 N/A R410A 3.5kg 3.5 7.31 B2 External at Electrical Switch Room B2 Stability Lab Conditioning Unit MITSUBISHI

Building 2

Refrigerant Gas Register

External

Building 1

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1003874 N/A R410A 3.5Kg 3.5 7.31 B2 Plant Room B2 Autoclave Room Conditioning Unit MITSUBISHI PUHZ-RP60VHA41003875 N/A R410A 3.7Kg 3.7 7.73 B2 Plant Room B2 Lyo Equipment Rm Conditioning Unit Daikin RXS35F2V1B

10038577 N/A R410A 3Kg 3 6.26 B3 Rooftop B3 Coms Room Conditioning Unit MITSUBISHI10024105 N/A R404A 5Kg 5 19.61 Building 3 Logistics FRM Fridge MSO J&E HALL JEHS-0500-M-310024107 N/A R404A 3Kg 3 11.77 Building 3 Logistics FIM Fridge MSO J&E HALL JEHS-0350-M-310024109 N/A R404A 3Kg 3 11.77 Building 3 Logistics FIC Fridge APID J&E HALL JEHS-0250-M-3

10038572 N/A R410A 1Kg 1 2.09 B4 Project Cabin B4 Project Cabin Conditioning Unit Aermac 201510038573 N/A R410A 1Kg 1 2.09 B4 Project Cabin B4 Project Cabin Conditioning Unit Aermac 201510052147 N/A R410A 14kg 14 29.23 B4 Project Cabin B4 Project Cabin Conditioning Unit Aermac 2015

N/A R134A 94Kg 94 134.42 B4 External Chiller 1 (2x47Kg) B4 Chiller 1 2 Circuits Aermac 2015N/A R134A 94Kg 94 134.42 B4 External Chiller 2 (2x47Kg) B4 Chiller 2 2 Circuits Aermac 2015N/A R507 50Kg 50 199.25 B4 Ground Floor Tech Space Lyo 1 Compressor Set 1 Telstar - Kobelco 2015N/A R507 50Kg 50 199.25 B4 Ground Floor Tech Space Lyo 1 Compressor Set 2 Telstar - Kobelco 2015N/A R507 50Kg 50 199.25 B4 Ground Floor Tech Space Lyo 1 Compressor Set 3 Telstar - Kobelco 2015N/A R507 50Kg 50 199.25 B4 Ground Floor Tech Space Lyo 1 Compressor Set 4 Telstar - Kobelco 2015

Building 4

Building 3

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_____________________________________________________________________________________________________

Appendix B.13.1

Alteration of Licence Request

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Envitonmental Protection Agency

~ epa

Screening Report

No. Question Answer

1 Does the proposed alteration require a new class of activity or process? No

2 Does the proposed alteration cause a new / additional main emission point? Yes

3 Does the proposed alteration increase or change specified emissions significantly? No

4 Does the proposed alteration increase significantly the overall total emission from the installation/facility? No

5

Does the proposed alteration involve development or proposed development that has already been granted planning permission or requires a grant of planning permission and was/is subject to EIA by the Planning Authority or An Bord Pleanála?

Yes

6 Did the proposed alteration require the preparation of a Natura Impact Statement (NIS) for consideration by any Planning or Public Authority? No

7 Does the proposed alteration indicate that the EPA should conduct an Appropriate Assessment (on foot of a screening for Appropriate Assessment)? No

8 Does the proposed change conflict with BAT as set out in the relevant BAT Conclusions? See here No

9 Does the proposed alteration adversely affect the energy efficiency of the installation/facility? No

10 Does the proposed alteration adversely affect the environmental risk of the installation/facility significantly? No

Alteration Details

Licence P0117-01 Ipsen Manufacturing Limited

Licensee Ipsen Manufacturing Ireland Limited

Title of Alteration Installation of new Process Vent Abatement Plant and other changes

Licence Change Request CR03784 P0117-01

Licence Alteration Request

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http://eippcb.jrc.ec.europa.eu/reference/

Envitonmental Protection Agency

~ epa

11 Does the proposed alteration cause an increase above the capacity limitations specified in the licence? No

12Does the proposed alteration require an extension of operating hours (where controlled by the licence) for an installation/facility where the public is likely to have an interest in such an extension?

No

13Does the proposed alteration involve the incineration or co-incineration of waste materials displaying hazardous properties that were not previously authorised (as per the WID/IED)?

No

14Does the proposed alteration introduce materials of techniques which adversely alter the probability, magnitude and duration or complexity of the site transboundary impact?

No

15 Does the proposed alteration constitute a substantial change? Yes

16 Does the proposed alteration require a change to a condition or schedule of the Licence? Yes

Recommendation

Based on your responses to the forgoing questions the recommended option is for you to submit a 'Licence Review' application for this proposed alteration.

To progress this request you are required to go to the EPA website (www.epa.ie), complete the relevant Licence Application Form and follow the licensing application process. The application should be submitted to the EPA as specified in the licence application form or any associated instructions for applicants.

Recommendation Date: 09/05/2017

Licence Change Request CR03784 P0117-01

Licence Alteration Request

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_____________________________________________________________________________________________________

Appendix B.13.2

List of all variations or adjustments to the existing licence

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DATE OF REQUEST DETAILS OF REQUEST OUTCOME DATE OF OUTCOME

1996 To change the frequency of monitoring of Suspended Solids at (Sewer) Emission Point (SE2) from daily to weekly. Approved. EPA letter reference M117 13/12/1996

1998To change the frequency of monitoring of Organic Solvents at (Sewer) Emission Point (SE2) from quarterly to annually.

Approved. EPA letter reference M117/AK 06/05/1998

1998 To change frequency of reporting emissions to atmosphere monitoring results from monthly to annually Approved. EPA letter reference M117/GC/21 11/09/1998

2000 To change frequency of reporting emissions to water monitoring results from monthly to quarterly Approved. EPA letter reference M117/GC29vp 19/05/2000

16/04/2008Request approval to add Kommunekemi A/S to the approved waste facilities. It is intended to use Kommunekemi A/S as a second hazardous waste recovery/disposal facility (in addition to AVG Hamburg) dealing with bulk mixed solvent waste stream.

Approved subject to conditions; 1. European Waste Catalogue Code of waste stream in question. 2. Approximate tonnage and frequency of transfer. 3. Registration No. of the waste permit or waste licence to which it is proposed to transfer waste to. 5. Name of the waste carrier(s) and details of their collection permit(s) under the Waste Management (Collection Permit) Regulations, 2001. 6. Written consent from the operator of each permitted or licenced facility will accept the waste for recovery or disposal from the licensee and specifying the waste types that will be accepted inclusive of weekly and monthly tonnage quotas where possible. 7. Contact details of the permitting or licencing authority if this authority is not within the state. 8. For waste leaving the state details on the relevant codes and descriptions of the waste taken from the Annex II, III or IV of Council Regulation (EEC) No. 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community.

06/05/2008

14/05/2008 Request approval to use N.V. Antwerp as an additional hazardous waste contractor for the facility.

Approved subject to conditions. 1. Compliance with all national & European legislation. 2. The requirements of Licence Register Number P0117-01. 3. The carrier of the waste must have appropriate and valid waste collection permit. 4. Copies of waste licences and/or waste permits shall be maintained at your facility office. 5. The register of facilities agreed by the Agency shall be updated accordingly.

19/06/2008

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17/10/2008Approval sought to use the new extension building to provide additional lyophilisation capacity, as part of the licenced activity. The approval as sought under Condition 1.2 of the IPC licence P0117-01, for an alteration to the facility which does not result in a material change in the nature or quantity of any emission.

Approved subject to conditions. 1. The process waste drain and bund shall comply with Condition 9.4. 2. All inlets and outlets to the process waste tank shall be inside the bunded area. 3. The replacement groundwater point reference MW-3 shall be downstream of the new extension, as proposed in drawing plan "Groundwater Monitoring Points" dated 19.11.08. 4. A maintenance programme for the new boilers based on manufacturer/supplier instructions shall be established. implemented and appropriate records retained. 5. The licensee shall review all process related activities in the new extension in relation to Condition 2.1 of the licence and include them in the company's Environmental Management Programme. 6. The new extension shall be included in the facility's Environmental Liability Risk Assessment. 7. Compliance with all licence conditions.

21/11/2008

28/07/2009 Request approval to send Chlorinated waste stream (EWC Code 07 05 03) to BIP Organics Ltd. in the UK

Approved subject to conditions. 1. Compliance with all national & European legislation. 2. The requirements of Licence Register Number P0117-01. 3. The carrier of the waste must have appropriate and valid waste collection permit. 4. Copies of waste licences and/or waste permits shall be maintained at your facility office. 5. A record of all relevant documentation shall be available on site for inspection by authorised persons of the agency during subsequent inspections and audits. 6. The above agreement may be revoked at any time by the Agency.

17/08/2009

18/12/08 & 02/02/09 Request approval to send flammable waste (EWC Code 07 05 03) to N.V. Indaver site in Antwerp as a contingency in the event of an incident at the AVG Hamburg site Germany.


10/02/2009

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22/09/2009Request for approval to send spent carbon waste (EWC Code 15 02 02) from carbon bed absorber to Nehlsen, Bremen, Germany.


09/10/2009

12/10/2009 Request to send used batteries (EWC Code 20 01 33) to Returnbatt, Kildare Enterprise Centre Melitta Road, Co. Kildare.


14/10/2009

No request on file. Prior approval for changes under Conditions 7.3 and 7.5 of IPPC Reg. No. P0117-01.

12/11/2009

14/01/2010Installation of a fumehood in Purification I laboratory. The fumehood will involve the use of a new minor emission point. The extract will be routed through an existing unused vent connection to the roof which has been capped and not in use since 1995.

Approved18/01/2010

08/02/10 & 12/03/2010

Changes occuring in the Chemical Process Development (CPD) area of site and the installation of new minor emission points. The manufacturing area of CPD is being re-developed to provide (a) additional capacity and (b) a high containment area, an equipment storage area and interconnecting lobbies. The expansion does not involve changes to the existing manufacturing process or the addition of new substances. Additional footprint is being provided and containment in the area is being improved.

Approved

19/03/2010

2010 To change frequency of reporting emissions to water monitoring results from quarterly to annually Approved. EPA letter reference P0117-01/rr01ec 16/04/2010

17/01/2011 & 03/02/2011Approval required for new Project B2X. The extension to the Building 2 is a 744m2 two storey facility to the south end of the existing Building 2. An additional boiler is (boiler3) is installed as part of the B2X project.

Approved 15/02/2011

18/04/2011Approval required for new Building 3 project (Engineering Warehouse building). In addition to Building 3 the construction of a new drum store has taken place at the site. The store is located on the East side on the existing tank farm.

Approved 04/05/2011

Email date 20/06/2011 Request for the discharge of water from firewater pond to the foul sewer in accordance with Condition 9.2. Approved 21/06/2011

22/05/2012 & 19/07/2012Installation of a Purified water generation, storage and distribution system. The system is housed in a purpose built generation and sanitisation room located to the north of Building 1. The new system has resulted in new vent points being on the north eastern end of Building 1 which do not result in unacceptable emissions.

Approved 13/09/2012

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15/05/2012, 20/06/2012 & 19/05/2012

Request for approval for the removal off site of flammable liquid waste (EWC Code 07 05 03*) to Veolia Environmental Services Technical Solutions Ltd. by BP McKeefry Ltd.

Approved subject to conditions. 1. Compliance with all national & European legislation. 2. The requirements of Licence Register Number P0117-01. 3. The carrier of the waste must have appropriate and valid waste collection permit. 4. Copies of waste licences and/or waste permits shall be maintained at your facility office. 5. The above agreement may be revoked at any time by the Agency. 6. A record of all relevant documentation shall be available on site for inspection by authorised persons of the agency during subsequent inspections and audits.

25/06/2012

20/06/2012Request for approval to send a chlorinated waste stream (EWC Code 07 05 03*) for ultimate recovery at Indaver Antwerp, the Netherlands, via Indaver Ireland Ltd.

03/07/2012Request for approval to send waste carbon (EWC Code 15 02 02) from carbon bed absorber for recovery at ATM B.V, the Netherlands, via Indaver Ireland Ltd.

18/07/2012Request for approval to send a liquid waste stream (EWC Code 07 05 03*) for recovery at Indaver Antwerp, the Netherlands via Indaver Ireland Ltd.

27/07/2012 Tank farm expansion project

Approved subject to - The licensee shall review the impact of the tank farm expansion project on the site firewater retention plan. The Agency notes that notification of this and the purified water project occurred after their completion and reminds of Condition 1.2.

13/09/2012

28/08/2013

High Containment Peptide Manufacturing suite upgrade project. The development is located within the envelope of the existing Building 1. There are a number of new emission points to atmosphere resulting from the upgrade to the area.

Approved subject to conditions. 1. The four new minor emission points are assigned emission point reference numbers. 2. Site drawings are updated to reflect the changes made to the site. 3. The HEPA filters on the new minor emissions points are added to the site's internal maintenance programme, the integrity of the HEPE filters is confirmed on an annual basis, and records of this testing are maintained onsite for inspection. 4. The four new minor emissions points are included in any future programme for the rationalisation of emission points. 5. Compliance with all licence conditions, as set out in IPPC Licence Register Number P0117-01.

02/10/2013

11/09/2013Carry out remedial works on the asbestos roof of Building 1 following observations that the roof had some signs of degradation on the external surface in 2012. No written approval on file. Notification submitted 11/09/2013.

Approved subject to conditions. 1. Compliance with all national & European legislation. 2. The requirements of Licence Register Number P0117-01. 3. The carrier of the waste must have appropriate and valid waste collection permit. 4. Copies of waste licences and/or waste permits shall be maintained at your facility office. 5. The above agreement may be revoked at any time by the Agency. 6. A record of all relevant documentation shall be available on site for inspection by authorised persons of the agency during subsequent inspections and audits.

19/07/2012

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16/12/2014Approval to construct a new API manufacturing area within the existing building including the construction of a drum charge room with a drum booth which will be vented to the existing minor emission point A3-5.

Approval subject to 1. The new minor emission point is included in any future program for the rationalisation of emission points. 2. Site drawings are updated to reflect the changes made to the site. 3. The spend activated carbon waste is disposed/recovered in accordance with all National and European legislation and protocols. 4. Compliance with all licence conditions as set out in IE licence register number P0117-01.

06/02/2015

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_____________________________________________________________________________________________________

Appendix B.13.3

Copies of the Technical Amendments and IED Amendment

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eQgotecboo Aqency An Ghnfomhaireacht um ChaomhntJ Comhshaoil

Headquarters

P.O. Box 3000

Johnstown Castle Estate

County Wexford

Ireland

AMENDMENT A

TO

INTEGRATED POLLUTION PREVENTION &

CONTROL LICENCE (in pursuance of Section 82(11) of the Environmental Protection Agency

Acts 1992 and 2003)

Licence Register Number: P0117-01

Licensee: Kinerton Limited

Location of Installation: Blanchardstown Industrial Park

Blanchardstown

Dublin 15

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of 5

Reason for the Amendment of Conditions

The Environmental Protection Agency has examined the terms of licence Reg. No.

P0117-01 as required by the provisions of Section 82 (10) (a) of the Environmental

Protection Agency Acts 1992 and 2003, and determined that the licence can be

brought into conformity with the provisions and requirements of Council Directive

96/61/EC by the exercise of the powers conferred by Section 82 (11) of the

Environmental Protection Agency Acts 1992 and 2003.

The Environmental Protection Agency is satisfied, on the basis of the information

available, that subject to compliance with the conditions of licence Reg. No. P0117-01

granted on the 26th

September 1996 as well as any amendments noted herein, any

emissions from the activity will comply with and not contravene any of the

requirements of Section 83(5) of the Environmental Protection Agency Acts, 1992

and 2003.

Amendment of Conditions

In pursuance of the powers conferred on it by Section 82(11) of the Environmental

Protection Agency Acts, 1992 and 2003, the Agency amends Licence Reg. No.

P0117-01, granted to Kinerton Limited for an installation located at Blanchardstown

Industrial Park, Blanchardstown, Dublin 15.

Henceforth, IPPC Licence Register No. P0117-01 (granted 26th

September 1996) shall

be read in conjunction with the amendments set out below.

This amendment is limited to the following Glossary of Terms/Schedule/Conditions

of Licence Reg. No. P0117-01:

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Amendments

Glossary of Terms

BAT Best Available Techniques.

To be inserted into the Glossary of the existing licence.

Incident The following shall constitute an incident for the purposes of this

licence:

(i) an emergency;

(ii) any emission which does not comply with the requirements of

this licence;

(iii) any trigger level specified in this licence which is attained or

exceeded; and,

(iv) any indication that environmental pollution has, or may have,

taken place.

To be inserted into the Glossary of the existing licence.

Schedule of Activities Licensed

5.16 The use of a chemical or biological process for the production of basic

pharmaceutical products.

To be inserted after the Glossary of the existing licence.

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New Conditions and Amended Conditions

2.7 Resource Use and Energy Efficiency

2.7.1 The licensee shall carry out an audit of the energy efficiency of the site

within one year of the date of grant of this amendment. The audit shall:-

(i) identify all opportunities for energy use reduction and efficiency,

(ii) be carried out in accordance with the guidance published by the

Agency; “Guidance Note on Energy Efficiency Auditing” and

(iii) be repeated at intervals as required by the Agency.

The recommendations of the audit will be incorporated into the

Environmental Management Programme under Condition 2.1 above.

2.7.2 The licensee shall identify opportunities for reduction in the quantity of

water used on site including recycling and reuse initiatives, wherever

possible. Reductions in water usage shall be incorporated into the

Environmental Management Programme.

2.7.3 The licensee shall undertake an assessment of the efficiency of use of raw

materials in all processes, having particular regard to the reduction in waste

generated. The assessment should take account of best international

practice for this type of activity. Where improvements are identified, these

shall be incorporated into the Environmental Management Programme.

Insert after Condition 2.6 of the existing licence.

Reason: To make provision for management of the activity on a planned basis having

regard to the desirability of ongoing assessment, recording and reporting of

matters affecting the environment and to provide for the efficient use of

resources and energy in all site operations.

Replace the original reason in the existing licence with the above reason.

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12.2 The licensee shall, within twelve months of date of this amendment, ensure that a

documented Accident Prevention Policy is in place, which will address the

hazards on-site, particularly in relation to the prevention of accidents with a

possible impact on the environment. This procedure shall be reviewed annually

and updated as necessary.

12.3 Incidents

12.3.1 In the event of an incident the licensee shall immediately:-

(i) carry out an investigation to identify the nature, source and cause

of the incident and any emission arising therefrom;

(ii) isolate the source of any such emission;

(iii) evaluate the environmental pollution, if any, caused by the

incident;

(iv) identify and execute measures to minimise the

emissions/malfunction and the effects thereof;

(v) identify the date, time and place of the incident;

(vi) notify the Agency and other relevant authorities.

12.3.2 The licensee shall provide a proposal to the Agency for its agreement

within one month of the incident occurring or as otherwise agreed by

the Agency to:-

(i) identify and put in place measures to avoid reoccurrence of the

incident; and

(ii) identify and put in place any other appropriate remedial action.


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7.8 Decommissioning & Residuals Management

7.8.1 Following termination, or planned cessation for a period greater than

six months, of use or involvement of all or part of the site in the

licensed activity, the licensee shall, to the satisfaction of the Agency,

decommission, render safe or remove for disposal/recovery, any soil,

subsoils, buildings, plant or equipment, or any waste, materials or

substances or other matter contained therein or thereon, that may result

in environmental pollution. The licensee shall carry out such tests,

investigation or submit certification, as requested by the Agency, to

confirm that there is no risk to the environment.


Reason: To provide for the disposal/recovery of waste and for the protection of the

environment in the event of the cessation of the activity, or part thereof, and the

return of the site to a satisfactory state.

Replace the original reason in the existing licence with the above reason

This Amendment shall be cited as Amendment A (in pursuance of Section 82(11) of

the Environmental Protection Agency Acts 1992 and 2003) to IPPC licence Reg. No.

P0117-01 which was granted on 26th

September 1996.

Sealed by the seal of the Agency on this the 22nd

day of August, 2006.

PRESENT when the seal of the Agency

was affixed hereto:

________________________________________

Dr. Padraic Larkin, Director

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-~:T~~j;:~

r' t[G'\ ';_ ·-~.· -·~ ,·r--

;:: ~ ·:-,,~-~'.- .: ,·~

-'.fi);i.- · .. \'''-"'·,, A/!JJ. ..

Licence Register Number: POl 17-01

Licensee: Kinerton Manufacturing Limited

Location of Installation: Blanchardstown Industrial Park Blanchardstown Dublin 15

AMENDMENTB To

INTEGRATED POLLUTION PREVENTION & CONTROL LICENCE

Headquarters P.O. Box 3000

Johnstown Castle Estate County Wexford

Ireland

eQQotection Agency A11Ghnlamhaireachtum(haomhnUComhshaail

l

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Amendment POJ 17-01/B

Henceforth, IPPC Licence Register No. POI 17-01 shall be read in conjunction with Amendment A issued on 22nd August 2006 and the amendments set out below.

In pursuance of the powers conferred on it by Section 96(1 )( c) of the Environmental Protection Agency Acts, 1992 and 2003, the Agency amends Licence Reg. No. POl 17-01, granted to Kinerton Limited, Blanchardstown Industrial Park, Blanchardstown, Dublin 15.

Amendments

The Environmental Protection Agency is satisfied, on the basis of the information available, that subject to compliance with the conditions of licence Reg. No. POI 17- 01 granted on the 261h September 1996, and amended on 22nd August 2006, as well as any amendments noted herein, any emissions from the activity will comply with and not contravene any of the requirements of Section 83(5) of the Environmental Protection Agency Acts, 1992 and 2003.

The Environmental Protection Agency has examined licence Reg. No. POll 7-01 for the purposes of, and in accordance with, the provisions of Section 96(1)(c) of the Environmental Protection Agency Acts 1992 and 2003, and has determined that the description of the activity being carried on should be amended in order to best describe the activities that are being carried on at the installation and thus facilitate the operation of the licence.

Reasons for the Decision

1

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Amendment POJ 17-01/B

Dr. Padraic Larkin, Director/Authorised Person

PRESENT when the seal of the Agency was affixed hereto

~jJ[J._

Sealed by the Seal of the Agency on this the 23rd day of May, 2007

This amendment shall be cited as Amendment B to IPPC licence Reg. No. POl 17- 01.

5.16 The use of a chemical or biological process for the production of basic pharmaceutical products.

Schedule of Activities Licensed

Amendment No. 2

···~·~J)ib.~¢1• ih~ .. :,·~¢i~t'¢d·d~scfiftttofiiof••th~·····~&iivify 111•···•··1he· .·Pri·~Hn• d "'"'"''···"'"' · · · · .. ···· ~g§cripf~~n.q}a.ctivtiy'._·· ·

- the use of a chemical or biological process for the production of basic pharmaceutical products

[)elete• the ··a,bove. despripiion ofthei a~t~vi~ :ifr th~.p~~e ibe4~~iq.'~J3nvi~9l1111eiltal . Prqt~qJi'gg· .A.gene)' Act,.· '1992· INIT'EGRATEID:[email protected]©N e®NillR@t;

· c'lliI@E;"N".q:E::=Decision of Ag~iiq~,·· lniifef ·Se.otiq):i ;83(1) ori-t~e.Enyirdnmental ·· · .· -Pl"ote¢tion Agency A:ct, 1992.'' §f'~xisttliglice~'.¢~ .. ·. · · · · · · · · · · ·· · ·.

- the manufacture of pharmaceutical products

Amendment No. 1

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Licence Register Number: P0117-01

Licensee: Ipsen Manufacturing Ireland Limited Blanchardstown Industrial Park

Location of Installation: Blan chards town Dublin 15 Dublin

Section 82A{l 1) Amendment to

Industrial Emissions Licence

Headquarters P.O. Box 3000

Johnstown Castle Estate County Wexford

Ireland

eg,gotectIDo Agoocy An Ghnfomhoireocht um Choomhnu Comhshooil

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Pagel

This amendment is limited to the following Glossary of Terms or Interpretation, Conditions and Schedules of Licence Reg. No. POl 17-01:

From the date of this amendment, Licence Reg. No. POll 7-01 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 (11) of the Environmental Protection Agency Act 1992 as amended, the Agency hereby amends Licence Reg. No. P0117-01, granted to Ipsen Manufacturing Ireland Limited, Blanchardstown Industrial Park, Blanchardstown, 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. POl 17- 01, granted on 26/09/1996, 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. PO 117-01 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 2010/75/EU by the exercise of the powers conferred by Section 82A(l 1) of the Environmental Protection Agency Act 1992 as amended.

Reason for the Decision

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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.

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Waste

Industrial Emissions Directive

Groundwater

BAT reference document

BAT conclusions

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

Amend Glossary of Terms or the Interpretation as follows

Amendments

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Page3

PRESENT when the seal of the Agency

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

This amendment shall be cited as a Section 82A(l 1) Amendment and should be read in conjunction with Licence Reg. No. POll 7-01, granted on 26/09/1996 and any other amendments made to the licence.

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

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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 following additional conditions at the end of Condition 2 of the licence:

New Conditions

The production of pharmaceutical products including intermediates (production means the production on an industrial scale by chemical or biological processing)

5.16

The licensed activities are amended to be as follows:

Amend the 'Schedule of Activities Licensed' as follows:

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appendix b.6(b) environmental impact assessment report and … · 2018-07-10 · fao: jerry...

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