Council Decision 2012/828/EU

law://eu/dec/2012/828@2026-11-12

Contents

THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4), in conjunction with Article 218(6)(a)(v) thereof,Having regard to the proposal from the European Commission,Having regard to the consent of the European Parliament^note,Whereas:

(1)The Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand^note entered into force on 1 January 1999^note.

(2)In accordance with Council Decision 2011/464/EU^note, the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) was signed by the Commission on 23 February 2012, subject to its conclusion.

(3)As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community.

(4)The Agreement should be concluded,

HAS ADOPTED THIS DECISION:

Article 1 #

The Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (‘the Agreement’) is hereby approved on behalf of the Union.The text of the Agreement is attached to this Decision.

Article 2 #

The President of the Council shall designate the person empowered to proceed, on behalf of the Union, to transmitting the diplomatic notes provided for in Article 2 of the Agreement, in order to express the consent of the Union to be bound by the Agreement^note.

Article 3 #

This Decision shall enter into force on the day of its adoption.

Annex I

NEW TECHNOLOGIES & IT NETWORKS
Member State & project code	Expenditure planned in the national fisheries control additional programme	Expenditure for projects selected under this Decision	Maximum Union contribution
(EUR)
BE/12/08	30000	30000	27000
BE/12/09	4250	4250	3825
BE/12/10	100000	0	0
*Subtotal*	*134250*	*34250*	*30825*
BG/12/02	30678	30678	27610
*Subtotal*	*30678*	*30678*	*27610*
DK/12/20	336419	0	0
DK/12/22	269136	0	0
DK/12/23	538271	0	0
DK/12/24	134568	134568	121111
DK/12/25	95637	0	0
DK/12/26	158911	0	0
DK/12/27	275864	275864	248278
DK/12/28	272500	272500	245250
DK/12/29	281265	281265	250000
DK/12/30	282592	282592	250000
DK/12/31	280439	280439	250000
DK/12/32	296049	296049	250000
DK/12/33	262407	262407	235870
DK/12/34	269136	269136	242222
DK/12/35	22000	22000	19800
DK/12/36	405000	405000	250000
DK/12/37	375000	375000	250000
DK/12/38	163500	163500	147150
*Subtotal*	*4718694*	*3320319*	*2759681*
DE/12/23	400000	400000	360000
DE/12/24	165000	0	0
DE/12/25	250000	0	0
DE/12/27	358000	0	0
DE/12/28	110000	0	0
DE/12/29	350000	0	0
DE/12/30	95000	0	0
DE/12/31	443100	0	0
DE/12/32	650000	0	0
DE/12/33	970000	0	0
DE/12/34	275000	0	0
DE/12/35	420000	0	0
*Subtotal*	*4486100*	*400000*	*360000*
IE/12/06	20000	0	0
IE/12/08	70000	0	0
*Subtotal*	*90000*	0	0
EL/12/11	180000	180000	162000
EL/12/12	750000	750000	675000
EL/12/13	180000	180000	162000
EL/12/14	26750	26750	24075
EL/12/15	110000	110000	99000
*Subtotal*	*1246750*	*1246750*	*1122075*
ES/12/02	939263	939263	845336
ES/12/03	974727	974727	877255
ES/12/05	795882	795883	716294
ES/12/06	759305	759305	683375
ES/12/08	163250	163250	146925
ES/12/09	72000	72000	64800
ES/12/10	100000	100000	90000
ES/12/11	379000	379000	341100
ES/12/12	490000	490000	441000
ES/12/13	150000	150000	135000
ES/12/15	150000	0	0
ES/12/18	54000	54000	48600
ES/12/19	290440	290440	261396
ES/12/21	17500	17500	15750
ES/12/22	681000	0	0
ES/12/23	372880	372880	335592
ES/12/24	415254	0	0
*Subtotal*	*6804501*	*5558247*	*5002423*
FR/12/08	777600	777600	699840
FR/12/09	870730	870730	783656
FR/12/10	229766	229766	206789
FR/12/11	277395	277395	249656
FR/12/12	230363	230363	207327
FR/12/13	197403	197403	177663
FR/12/14	450000	450000	405000
FR/12/15	211500	0	0
FR/12/16	274330	274330	246897
FR/12/17	254350	0	0
*Subtotal*	*3773437*	*3307587*	*2976828*
IT/12/13	135000	135000	121500
IT/12/15	125000	125000	112500
IT/12/16	withdrawn	0	0
IT/12/17	250000	250000	225000
IT/12/18	250000	0	0
IT/12/19	630000	630000	567000
IT/12/21	1500000	1500000	1350000
IT/12/22	311000	0	0
IT/12/23	38000	0	0
IT/12/24	1900000	0	0
*Subtotal*	*5139000*	*2640000*	*2376000*
LV/12/02	6732	6732	6058
LV/12/03	58350	58350	52515
*Subtotal*	65082	65082	58573
LT/12/04	150462	150462	135416
*Subtotal*	*150462*	*150462*	*135416*
MT/12/04	30000	30000	27000
MT/12/07	261860	261860	235674
*Subtotal*	*291860*	*291860*	*262674*
NL/12/07	250000	250000	225000
NL/12/08	278172	0	0
NL/12/09	277862	0	0
NL/12/10	286364	0	0
NL/12/11	276984	0	0
NL/12/12	129398	0	0
NL/12/13	129500	0	0
NL/12/14	200000	0	0
NL/12/15	230000	0	0
NL/12/16	136329	0	0
NL/12/17	19300	0	0
NL/12/18	36120	0	0
NL/12/19	89860	0	0
NL/12/20	299550	0	0
*Subtotal*	*2639439*	*250000*	*225000*
AT/12/01	128179	128179	115361
AT/12/02	280923	0	0
*Subtotal*	*409102*	*128179*	*115361*
PL/12/08	103936	0	0
PL/12/10	41028	0	0
PL/12/11	15955	0	0
PL/12/07	40500	0	0
PL/12/08	1000000	1000000	900000
PL/12/09	172600	0	0
PL/12/10	1505000	0	0
PL/12/11	208760	0	0
PL/12/12	227350	0	0
PL/12/13	240300	0	0
PL/12/14	323000	323000	290700
PL/12/15	181000	0	0
PL/12/16	416000	0	0
*Subtotal*	*4475429*	*1323000*	*1190700*
PT/12/08	25000	25000	22500
PT/12/10	105000	150000	135000
PT/12/11	150000	0	0
*Subtotal*	*325000*	*175000*	*157500*
FI/12/11	1000000	1000000	900000
FI/12/12	1000000	1000000	900000
FI/12/13	280000	280000	252000
FI/12/14	280000	0	0
*Subtotal*	*2560000*	*2280000*	*2052000*
SE/12/07	850000	850000	765000
SE/12/08	750000	750000	675000
SE/12/09	300000	300000	270000
SE/12/10	1000000	1000000	900000
SE/10/11	80000	0	0
*Subtotal*	*2980000*	*2900000*	*2610000*
UK/12/51	122219	122219	109997
UK/12/52	564086	0	0
UK/12/54	50141	50141	45127
UK/12/55	43873	43873	39486
UK/12/56	122219	122219	109997
UK/12/73	12535	12535	11282
UK/12/74	162958	162958	146662
*Subtotal*	*1078032*	*513945*	*462551*
Total	41397816	24615360	21925217

Annex II

AUTOMATIC LOCALISATION DEVICES
Member State & project code	Expenditure planned in the national fisheries control additional programme	Expenditure for projects selected under this Decision	Maximum Union contribution
(EUR)
DE/12/22	25000	25000	22500
*Subtotal*	*25000*	*25000*	*22500*
ES/12/17	1256340	0	0
ES/12/20	326124	0	0
*Subtotal*	*1582464*	0	0
IT/12/12	240000	240000	216000
IT/12/14	130000	0	0
IT/12/20	3400000	0	0
*Subtotal*	*3770000*	*240000*	*216000*
MT/12/03	146200	0	0
MT/12/05	400000	400000	360000
*Subtotal*	*546200*	*400000*	*360000*
Total	5923664	665000	598500

III

ELECTRONIC RECORDING AND REPORTING SYSTEMS
Member State & project code	Expenditure planned in the national fisheries control additional programme	Expenditure for projects selected under this Decision	Maximum Union contribution
(EUR)
BE/12/07	60000	60000	54000
*Subtotal*	*60000*	*60000*	*54000*
DK/12/19	201852	201852	181666
DK/12/21	134567	0	0
*Subtotal*	*336419*	*201852*	*181666*
IE/12/05	1000000	1000000	900000
*Subtotal*	*1000000*	*1000000*	*900000*
ES/12/14	1207352	1207352	1086617
ES/12/25	263488	263488	237139
*Subtotal*	*1470840*	*1470840*	*1323756*
FR/12/18	42000	42000	37800
*Subtotal*	*42000*	*42000*	*37800*
LT/12/01	11273	11273	10146
*Subtotal*	*11273*	*11273*	*10146*
MT/12/06	260000	260000	234000
*Subtotal*	*260000*	*260000*	*234000*
PL/12/03	170948	170948	153853
PL/12/05	22793	22793	20514
*Subtotal*	*193741*	*193741*	*174367*
PT/12/09	75000	75000	67500
*Subtotal*	*75000*	*75000*	*67500*
Total	3449274	3314706	2983235

Annex IV

COMPOSITION AND VALUATION RULES FOR THE BALANCE SHEETDisclosure relating to euro banknotes in circulation, remuneration of net intra-Eurosystem claims/liabilities resulting from the allocation of euro banknotes within the Eurosystem, and monetary income should be harmonised in NCBs published annual financial statements. The items to be harmonised are indicated with an asterisk in Annexes IV, VIII and IX.

ASSETS
Balance sheet item^note	Categorisation of contents of balance sheet items	Valuation principle	Scope of application^note
1	1	Gold and gold receivables	Physical gold, i.e. bars, coins, plates, nuggets in storage or “under way”. Non-physical gold, such as balances in gold sight accounts (unallocated accounts), term deposits and claims to receive gold arising from the following transactions: (a) upgrading or downgrading transactions; and (b) gold location or purity swaps where there is a difference of more than one business day between release and receipt	Market value	Mandatory
2	2	Claims on non-euro area residents denominated in foreign currency	Claims on counterparties resident outside the euro area including international and supranational institutions and central banks outside the euro area denominated in foreign currency
2.1	2.1	Receivables from the International Monetary Fund (IMF)	(a)Drawing rights within the reserve tranche (net)National quota minus balances in euro at the disposal of the IMF. The No 2 account of the IMF (euro account for administrative expenses) may be included in this item or under the item “Liabilities to non-euro area residents denominated in euro”	(a)Drawing rights within the reserve tranche (net)Nominal value, translation at the foreign exchange market rate	Mandatory
(b)SDRsHoldings of SDRs (gross)	(b)SDRsNominal value, translation at the foreign exchange market rate	Mandatory
(c)Other claimsGeneral arrangements to borrow, loans under special borrowing arrangements, deposits made to trusts under the management of the IMF	(c)Other claimsNominal value, translation at the foreign exchange market rate	Mandatory
2.2	2.2	Balances with banks and security investments, external loans and other external assets	(a)Balances with banks outside the euro area other than those under asset item 11.3 “Other financial assets”Current accounts, fixed-term deposits, day-to-day money, reverse repo transactions	(a)Balances with banks outside the euro areaNominal value, translation at the foreign exchange market rate	Mandatory
(b)Security investments outside the euro area other than those under asset item 11.3 “Other financial assets”Notes and bonds, bills, zero bonds, money market paper, equity instruments held as part of the foreign reserves, all issued by non-euro area residents	(b)(i)Marketable securities other than held-to-maturityMarket price and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(ii)Marketable securities classified as held-to-maturityCost subject to impairment and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(iii)Non-marketable securitiesCost subject to impairment and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(iv)Marketable equity instrumentsMarket price and foreign exchange market rate	Mandatory
(c)External loans (deposits) outside the euro area other than those under asset item 11.3 “Other financial assets”	(c)External loansDeposits at nominal value translated at the foreign exchange market rate	Mandatory
(d)Other external assetsNon-euro area banknotes and coins	(d)Other external assetsNominal value, translation at the foreign exchange market rate	Mandatory
3	3	Claims on euro area residents denominated in foreign currency	(a)Security investments inside the euro area other than those under asset item 11.3 “Other financial assets”Notes and bonds, bills, zero bonds, money market paper, equity instruments held as part of the foreign reserves, all issued by euro area residents	(a)(i)Marketable securities other than held-to-maturityMarket price and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(ii)Marketable securities classified as held-to-maturityCost subject to impairment and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(iii)Non-marketable securitiesCost subject to impairment and foreign exchange market rateAny premiums or discounts are amortised	Mandatory
(iv)Marketable equity instrumentsMarket price and foreign exchange market rate	Mandatory
(b)Other claims on euro area residents other than those under asset item 11.3 “Other financial assets”Loans, deposits, reverse repo transactions, sundry lending	(b)Other claimsDeposits and other lending at nominal value, translated at the foreign exchange market rate	Mandatory
4	4	Claims on non-euro area residents denominated in euro
4.1	4.1	Balances with banks, security investments and loans	(a)Balances with banks outside the euro area other than those under asset item 11.3 “Other financial assets”Current accounts, fixed-term deposits, day-to-day money. Reverse repo transactions in connection with the management of securities denominated in euro	(a)Balances with banks outside the euro areaNominal value	Mandatory
(b)Security investments outside the euro area other than those under asset item 11.3 “Other financial assets”Equity instruments, notes and bonds, bills, zero bonds, money market paper, all issued by non-euro area residents	(b)(i)Marketable securities other than held-to-maturityMarket priceAny premiums or discounts are amortised	Mandatory
(ii)Marketable securities classified as held-to-maturityCost subject to impairmentAny premiums or discounts are amortised	Mandatory
(iii)Non-marketable securitiesCost subject to impairmentAny premiums or discounts are amortised	Mandatory
(iv)Marketable equity instrumentsMarket price	Mandatory
(c)Loans outside the euro area other than those under asset item 11.3 “Other financial assets”	(c)Loans outside the euro areaDeposits at nominal value	Mandatory
(d)Securities other than those under asset item 11.3 “Other financial assets”, issued by entities outside the euro areaSecurities issued by supranational or international organisations, e.g. the European Investment Bank, irrespective of their geographical location	(d)(i)Marketable securities other than held-to-maturityMarket priceAny premiums or discounts are amortised	Mandatory
(ii)Marketable securities classified as held-to-maturityCost subject to impairmentAny premiums or discounts are amortised	Mandatory
(iii)Non-marketable securitiesCost subject to impairmentAny premiums or discounts are amortised	Mandatory
4.2	4.2	Claims arising from the credit facility under ERM II	Lending according to the ERM II conditions	Nominal value	Mandatory
5	5	Lending to euro area credit institutions related to monetary policy operations denominated in euro	Items 5.1 to 5.5: transactions according to the respective monetary policy instruments described in Annex I to Guideline ECB/2011/14 of 20 September 2011 on monetary policy instruments and procedures of the Eurosystem^note
5.1	5.1	Main refinancing operations	Regular liquidity-providing reverse transactions with a weekly frequency and normally a maturity of one week	Nominal value or repo cost	Mandatory
5.2	5.2	Longer-term refinancing operations	Regular liquidity-providing reverse transactions with a monthly frequency and normally a maturity of three months	Nominal value or repo cost	Mandatory
5.3	5.3	Fine-tuning reverse operations	Reverse transactions, executed as ad hoc transactions for fine-tuning purposes	Nominal value or repo cost	Mandatory
5.4	5.4	Structural reverse operations	Reverse transactions adjusting the structural position of the Eurosystem vis-à-vis the financial sector	Nominal value or repo cost	Mandatory
5.5	5.5	Marginal lending facility	Overnight liquidity facility at a pre-specified interest rate against eligible assets (standing facility)	Nominal value or repo cost	Mandatory
5.6	5.6	Credits related to margin calls	Additional credit to credit institutions, arising from value increases of underlying assets regarding other credit to these credit institutions	Nominal value or cost	Mandatory
6	6	Other claims on euro area credit institutions denominated in euro	Current accounts, fixed-term deposits, day-to-day money, reverse repo transactions in connection with the management of security portfolios under the asset item 7 ‘Securities of euro area residents denominated in euro’, including transactions resulting from the transformation of former foreign currency reserves of the euro area and other claims. Correspondent accounts with non-domestic euro area credit institutions. Other claims and operations unrelated to monetary policy operations of the Eurosystem including Emergency Liquidity Assistance. Any claims stemming from monetary policy operations initiated by an NCB prior to joining the Eurosystem	Nominal value or cost	Mandatory
7	7	Securities of euro area residents denominated in euro
7.1	7.1	Securities held for monetary policy purposes	Securities issued in the euro area held for monetary policy purposes. ECB debt certificates purchased for fine-tuning purposes	(a)Marketable securities other than held-to-maturityMarket priceAny premiums or discounts are amortised	Mandatory
(b)Marketable securities classified as held-to-maturityCost subject to impairment (cost when the impairment is covered by a provision under liability item 13 (b) “Provisions”)Any premiums or discounts are amortised	Mandatory
(c)Non-marketable securitiesCost subject to impairmentAny premiums or discounts are amortised	Mandatory
7.2	7.2	Other securities	Securities other than those under asset item 7.1 “Securities held for monetary policy purposes” and under asset item 11.3 “Other financial assets”; notes and bonds, bills, zero bonds, money market paper held outright, including government securities stemming from before EMU, denominated in euro. Equity instruments	(a)Marketable securities other than held-to-maturityMarket priceAny premiums or discounts are amortised	Mandatory
(b)Marketable securities classified as held-to-maturityCost subject to impairmentAny premiums or discounts are amortised	Mandatory
(c)Non-marketable securitiesCost subject to impairmentAny premiums or discounts are amortised	Mandatory
(d)Marketable equity instrumentsMarket price	Mandatory
8	8	General government debt denominated in euro	Claims on government stemming from before EMU (non-marketable securities, loans)	Deposits/loans at nominal value, non-marketable securities at cost	Mandatory
—	9	Intra-Eurosystem claims⁺)
—	9.1	Participating interest in ECB⁺)	Only an NCB balance sheet itemThe ECB capital share of each NCB in accordance with the Treaty and the respective capital key and contributions in accordance with Article 48.2 of the Statute of the ESCB	Cost	Mandatory
—	9.2	Claims equivalent to the transfer of foreign reserves⁺)	Only an NCB balance sheet itemEuro-denominated claims on the ECB in respect of initial and additional transfers of foreign reserves under Article 30 of the Statute of the ESCB	Nominal value	Mandatory
—	9.3	Claims related to the issuance of ECB debt certificates⁺)	Only an ECB balance sheet itemIntra-Eurosystem claims vis-à-vis NCBs, arising from the issuance of ECB debt certificates	Cost	Mandatory
—	9.4	Net claims related to the allocation of euro banknotes within the Eurosystem⁺)^note	For the NCBs: net claim related to the application of the banknote allocation key i.e. including the ECB’s banknote issue related intra-Eurosystem balances, the compensatory amount and its balancing accounting entry as defined by Decision ECB/2010/23 of 25 November 2010 on the allocation of monetary income of the national central banks of Member States whose currency is the euro^noteFor the ECB: claims related to the ECB’s banknote issue, in accordance with Decision ECB/2010/29	Nominal value	Mandatory
—	9.5	Other claims within the Eurosystem (net)⁺)	Net position of the following sub-items:
(a)net claims arising from balances of TARGET2 accounts and correspondent accounts of NCBs, i.e. the net figure of claims and liabilities — see also liability item 10.4 “Other liabilities within the Eurosystem (net)”	(a)Nominal value	Mandatory
(b)claim due to the difference between monetary income to be pooled and redistributed. Only relevant for the period between booking of monetary income as part of the year-end procedures, and its settlement on the last working day in January each year	(b)Nominal value	Mandatory
(c)other intra-Eurosystem claims denominated in euro that may arise, including the interim distribution of ECB income^note	(c)Nominal value	Mandatory
9	10	Items in the course of settlement	Settlement account balances (claims), including the float of cheques in collection	Nominal value	Mandatory
9	11	Other assets
9	11.1	Coins of euro area	euro coins if an NCB is not the legal issuer	Nominal value	Mandatory
9	11.2	Tangible and intangible fixed assets	Land and buildings, furniture and equipment including computer equipment, software	Cost less depreciationDepreciation rates:computers and related hardware/software and motor vehicles: 4 yearsequipment, furniture and plant in building: 10 yearsbuilding and capitalised major refurbishment expenditure: 25 yearsCapitalisation of expenditure: limit based (below EUR 10000 excluding VAT: no capitalisation)	Recommended
9	11.3	Other financial assets	Participating interests and investments in subsidiaries; equities held for strategic/policy reasonsSecurities, including equities, and other financial instruments and balances (e.g. fixed-term deposits and current accounts), held as an earmarked portfolioReverse repo transactions with credit institutions in connection with the management of securities portfolios under this item	(a)Marketable equity instrumentsMarket price	Recommended
(b)Participating interests and illiquid equity shares, and any other equity instruments held as permanent investmentsCost subject to impairment	Recommended
(c)Investment in subsidiaries or significant interestsNet asset value	Recommended
(d)Marketable securities other than held-to-maturityMarket priceAny premiums or discounts are amortised	Recommended
(e)Marketable securities classified as held-to-maturity or held as a permanent investmentCost subject to impairmentAny premiums or discounts are amortised	Recommended
(f)Non-marketable securitiesCost subject to impairmentAny premiums or discounts are amortised	Recommended
(g)Balances with banks and loansNominal value, translated at the foreign exchange market rate if the balances or deposits are denominated in foreign currencies	Recommended
9	11.4	Off-balance-sheet instruments revaluation differences	Valuation results of foreign exchange forwards, foreign exchange swaps, interest rate swaps, forward rate agreements, forward transactions in securities, foreign exchange spot transactions from trade date to settlement date	Net position between forward and spot, at the foreign exchange market rate	Mandatory
9	11.5	Accruals and prepaid expenditure	Income not due in, but assignable to the reported period. Prepaid expenditure and accrued interest paid (i.e. accrued interest purchased with a security)	Nominal value, foreign exchange translated at market rate	Mandatory
9	11.6	Sundry	Advances, loans and other minor items.Revaluation suspense accounts (only balance sheet item during the year: unrealised losses at revaluation dates during the year, which are not covered by the respective revaluation accounts under the liability item “Revaluation accounts”). Loans on a trust basis. Investments related to customer gold deposits. Coins denominated in national euro area currency units. Current expense (net accumulated loss), loss of the previous year before coverage. Net pension assets	Nominal value or cost	Recommended
Revaluation suspense accountsRevaluation difference between average cost and market value, foreign exchange translated at market rate	Mandatory
Investments related to customer gold depositsMarket value	Mandatory
Outstanding claims arising from the default of Eurosystem counterparties in the context of Eurosystem credit operations	Outstanding claims (from defaults)Nominal/recoverable value (before/after settlement of losses)	Mandatory
Assets or claims (vis-à-vis third parties) appropriated and/or acquired in the context of the realisation of collateral submitted by Eurosystem counterparties in default	Assets or claims (from defaults)Cost (converted at the foreign exchange market rate at the time of the acquisition if financial assets are denominated in foreign currencies)	Mandatory
—	12	Loss for the year		Nominal value	Mandatory

LIABILITIES
Balance sheet item^note	Categorisation of contents of balance sheet items	Valuation principle	Scope of application^note
1	1	Banknotes in circulation^note	(a)Euro banknotes, plus/minus adjustments relating to the application of the banknote allocation key in accordance with Decision ECB/2010/23 and Decision ECB/2010/29	(a)Nominal value	Mandatory
(b)Banknotes denominated in national euro area currency units during the cash changeover year	(b)Nominal value	Mandatory
2	2	Liabilities to euro area credit institutions related to monetary policy operations denominated in euro	Items 2.1, 2.2, 2.3 and 2.5: deposits in euro as described in Annex I to Guideline ECB/2011/14
2.1	2.1	Current accounts (covering the minimum reserve system)	euro accounts of credit institutions that are included in the list of financial institutions subject to minimum reserves in accordance with the Statute of the ESCB. This item contains primarily accounts used in order to hold minimum reserves	Nominal value	Mandatory
2.2	2.2	Deposit facility	Overnight deposits at a pre-specified interest rate (standing facility)	Nominal value	Mandatory
2.3	2.3	Fixed-term deposits	Collection for liquidity absorption purposes owing to fine-tuning operations	Nominal value	Mandatory
2.4	2.4	Fine-tuning reverse operations	Monetary policy-related transactions with the aim of liquidity absorption	Nominal value or repo cost	Mandatory
2.5	2.5	Deposits related to margin calls	Deposits of credit institutions, arising from value decreases of underlying assets regarding credits to these credit institutions	Nominal value	Mandatory
3	3	Other liabilities to euro area credit institutions denominated in euro	Repo transactions in connection with simultaneous reverse repo transactions for the management of securities portfolios under asset item 7 “Securities of euro area residents denominated in euro”. Other operations unrelated to Eurosystem monetary policy operations. No current accounts of credit institutions. Any liabilities/deposits stemming from monetary policy operations initiated by a central bank prior to joining the Eurosystem	Nominal value or repo cost	Mandatory
4	4	Debt certificates issued	Only an ECB balance sheet item — for the NCBs a transitional balance sheet item.Debt certificates as described in Annex I to Guideline ECB/2011/14. Discount paper, issued with the aim of liquidity absorption	CostAny discounts are amortised	Mandatory
5	5	Liabilities to other euro area residents denominated in euro
5.1	5.1	General government	Current accounts, fixed-term deposits, deposits repayable on demand	Nominal value	Mandatory
5.2	5.2	Other liabilities	Current accounts of staff, companies and clients including financial institutions listed as exempt from the obligation to hold minimum reserves (see liability item 2.1 “Current accounts”); fixed-term deposits, deposits repayable on demand	Nominal value	Mandatory
6	6	Liabilities to non-euro area residents denominated in euro	Current accounts, fixed-term deposits, deposits repayable on demand including accounts held for payment purposes and accounts held for reserve management purposes: of other banks, central banks, international/supranational institutions including the European Commission; current accounts of other depositors. Repo transactions in connection with simultaneous reverse repo transactions for the management of securities denominated in euro.Balances of TARGET2 accounts of central banks of Member States whose currency is not the euro	Nominal value or repo cost	Mandatory
7	7	Liabilities to euro area residents denominated in foreign currency	Current accounts. liabilities under repo transactions; usually investment transactions using foreign currency assets or gold	Nominal value, translation at the foreign exchange market rate	Mandatory
8	8	Liabilities to non-euro area residents denominated in foreign currency
8.1	8.1	Deposits, balances and other liabilities	Current accounts. Liabilities under repo transactions; usually investment transactions using foreign currency assets or gold	Nominal value, translation at the foreign exchange market rate	Mandatory
8.2	8.2	Liabilities arising from the credit facility under ERM II	Borrowing in accordance with the ERM II conditions	Nominal value, translation at the foreign exchange market rate	Mandatory
9	9	Counterpart of special drawing rights allocated by the IMF	SDR-denominated item which shows the amount of SDRs that were originally allocated to the respective country/NCB	Nominal value, translation at the market rate	Mandatory
—	10	Intra-Eurosystem liabilities⁺)
—	10.1	Liabilities equivalent to the transfer of foreign reserves⁺)	Only an ECB balance sheet item denominated in euro	Nominal value	Mandatory
—	10.2	Liabilities related to the issuance of ECB debt certificates⁺)	Only an NCB balance sheet itemIntra-Eurosystem liability vis-à-vis the ECB, arising from the issuance of ECB debt certificates	Cost	Mandatory
—	10.3	Net liabilities related to allocation of euro banknotes within the Eurosystem⁺)^note	Only an NCB balance sheet item.For the NCBs: net liability related to the application of the banknote allocation key, i.e. including the ECB’s banknote issue related intra-Eurosystem balances, the compensatory amount and its balancing accounting entry as defined by Decision ECB/2010/23	Nominal value	Mandatory
—	10.4	Other liabilities within the Eurosystem (net)⁺)	Net position of the following sub-items:
(a)net liabilities arising from balances of TARGET2 accounts and correspondent accounts of NCBs, i.e. the net figure of claims and liabilities — see also asset item 9.5 “Other claims within the Eurosystem (net)”	(a)Nominal value	Mandatory
(b)liability due to the difference between monetary income to be pooled and redistributed. Only relevant for the period between booking of monetary income as part of the year-end procedures, and its settlement at the last working day in January each year	(b)Nominal value	Mandatory
(c)other intra-Eurosystem liabilities denominated in euro that may arise, including the interim distribution of ECB income^note	(c)Nominal value	Mandatory
10	11	Items in course of settlement	Settlement account balances (liabilities), including the float of giro transfers	Nominal value	Mandatory
10	12	Other liabilities
10	12.1	Off-balance-sheet instruments revaluation differences	Valuation results of foreign exchange forwards, foreign exchange swaps, interest rate swaps, forward rate agreements, forward transactions in securities, foreign exchange spot transactions from trade date to settlement date	Net position between forward and spot, at the foreign exchange market rate	Mandatory
10	12.2	Accruals and income collected in advance	Expenditure falling due in a future period but relating to the reported period. Income received in the reported period but relating to a future period	Nominal value, foreign exchange translated at market rate	Mandatory
10	12.3	Sundry	Taxation suspense accounts. Foreign currency credit or guarantee cover accounts. Repo transactions with credit institutions in connection with simultaneous reverse repo transactions for the management of securities portfolios under asset item 11.3 “Other financial assets”. Compulsory deposits other than reserve deposits. Other minor items. Current income (net accumulated profit), profit of the previous year before distribution. Liabilities on a trust basis. Customer gold deposits. Coins in circulation in the event that an NCB is the legal issuer. Banknotes in circulation denominated in national euro area currency units that have ceased to be legal tender but are still in circulation after the cash changeover year, if not shown under liability item “Provisions”. Net pension liabilities	Nominal value or (repo) cost	Recommended
Customer gold depositsMarket value	Customer gold deposits: mandatory
10	13	Provisions	(a)For pensions, for foreign exchange rate, interest rate, credit and gold price risks, and for other purposes, e.g. expected future expenses, provisions for national euro area currency units that have ceased to be legal tender but are still in circulation after the cash changeover year if these banknotes are not shown under liability item 12.3 “Other liabilities/Sundry”The contributions from NCBs to the ECB in accordance with Article 48.2 of the Statute of the ESCB are consolidated with the respective amounts disclosed under asset item 9.1 “Participating interest in the ECB”⁺)	(a)Cost/nominal value	Recommended
(b)For counterparty or credit risks arising from monetary policy operations	(b)Nominal value	Mandatory
11	14	Revaluation accounts	Revaluation accounts related to price movements for gold, for every type of euro-denominated securities, for every type of foreign currency-denominated securities, for options; market valuation differences related to interest rate risk derivatives; revaluation accounts related to foreign exchange rate movements for every currency net position held, including foreign exchange swaps/forwards and SDRsThe contributions from NCBs in accordance with Article 48.2 of the Statute of the ESCB to the ECB are consolidated with the respective amounts disclosed under asset item 9.1 “Participating interest in the ECB”⁺)	Revaluation difference between average cost and market value, foreign exchange translated at market rate	Mandatory
12	15	Capital and reserves
12	15.1	Capital	Paid-up capital — the ECB’s capital is consolidated with the capital shares of the NCBs	Nominal value	Mandatory
12	15.2	Reserves	Legal reserves and other reserves. Retained earningsThe contributions from NCBs to the ECB in accordance with Article 48.2 of the Statute of the ESCB are consolidated with the respective amounts disclosed under asset item 9.1 “Participating interest in the ECB”⁺)	Nominal value	Mandatory
10	16	Profit for the year		Nominal value	Mandatory

Iva

Products referred to in Articles 14a and 31(1) Natural gas and other gaseous hydrocarbons

HS code	Description
2709 00 10	Natural gas condensates
2711 11 00	Natural Gas – in liquefied state
2711 21 00	Natural Gas – in gaseous state
2711 12	Propane
2711 13	Butanes
2711 19 00	Other".

Annex V

TRAINING & EXCHANGE PROGRAMMES
Member State & project code	Expenditure planned in the national fisheries control additional programme	Expenditure for projects selected under this Decision	Maximum Union contribution
(EUR)
IE/12/07	15000	0	0
*Subtotal*	*15000*	0	0
ES/12/16	40000	0	0
Subtotal	*40000*	0	0
UK/12/58	2507	0	0
UK/12/59	14416	0	0
UK/12/60	1253	0	0
UK/12/61	877	0	0
UK/12/62	2507	0	0
UK/12/63	3384	0	0
UK/12/64	11282	0	0
UK/12/65	17549	0	0
UK/12/66	11282	0	0
UK/12/67	9401	9401	8461
UK/12/68	9401	0	0
UK/12/69	11281	0	0
UK/12/70	9401	9401	8461
UK/12/71	9401	0	0
UK/12/72	12535	12536	11282
*Subtotal*	*144030*	*31338*	*28204*
Total	199030	31338	28204

Annex VI

AMOUNTS RELATED TO PILOT PROJECTS AND TO THE ACQUISITION OR MODERNISATION OF PATROL VESSELS AND AIRCRAFT THAT WERE REJECTED
Type of expenditure	Expenditure planned in the national fisheries control additional programme	Expenditure for projects selected under this Decision	Maximum Union contribution
(EUR)
*Subtotal*	*693523*	0	0
0	0
*Subtotal*	*52392525*	0	0
*Total*	53086048	0	0

Via

Key equipment and technology referred to Articles 8, 10(1)(c) and 31(1)
HS code	Description
	– Casing, tubing and drill pipe, of a kind used in drilling for oil or gas:
7304 22	– Drill pipe of stainless steel
7304 23	– – Other drill pipe
7304 24	– – Other, of stainless steel
7304 29	– – Other
ex 7305	Other tubes and pipes (for example, welded, riveted or similarly closed), having circular cross-sections, the external diameter of which exceeds 406,4 mm, of iron or steel, with a chrome content of 1 % or more and with a cold resistance that can go below -120°C
	– Line pipe of a kind used for oil or gas pipelines:
7306 11	– – Welded, of stainless steel
7306 19	– – Other
	– Casing and tubing of a kind used in drilling for oil or gas:
7306 21 00	– – Welded, of stainless steel
7306 29 00	– – Other
	Containers for compressed or liquefied gas, of iron or steel:
7311 00 99	– Other, of a capacity of 1000 l or more
ex 7613	Aluminium containers for compressed or liquefied gas, of a capacity of 1000 l or more".

Vib

Key equipment and technology referred to in Articles 10a, 10b, 10c and 31(1)
HS code	Description
8406 10 00	Steam turbines for marine propulsion
ex 8406 90	Parts of steam turbines for marine propulsion
8407 21	Marine propulsion engines, outboard motors
ex 8407 29	Marine propulsion engines, other
8408 10	Marine propulsion engines
ex 8409 91 00	Parts suitable for use solely or principally with machines of subheadings 8407 21 or 8407 29
ex 8409 99 00	Parts suitable for use solely or principally with machines of subheading 8408 10
ex 8411 81	Other gas turbine of a power not exceeding 5000 kW, for marine propulsion
ex 8411 82	Other gas turbines of a power exceeding 5000 kW, for marine propulsion
ex 8468	Machinery and apparatus for soldering, brazing or welding whether or not capable of cutting, other than those of heading 8515; gas-operated surface tempering machines and appliances:
ex 8483	Transmission shafts (including cam shafts and crank shafts) and cranks; bearing housings and plain shaft bearings; gears and gearing; ball or roller screws; gear boxes and other speed changers, including torque converters; flywheels and pulleys, including pulley blocks; clutches and shaft couplings (including universal joints), designed for the propulsion of vessels at the maximum possible deadweight tonnage at scantling draught of 55000 dwt or more
8487 10	Ships' or boats' propellers and blades therefor
ex 8515	Electric (including electrically heated gas), laser or other light or photon beam, ultrasonic, electron beam, magnetic pulse or plasma arc soldering, brazing or welding machines and apparatus, whether or not capable of cutting; electric machines and apparatus for hot spraying of metals or cermets:
ex 9014 10 00	Direction finding compasses, solely for the maritime industry
ex 9014 80 00	Other navigational instruments and appliances, solely for the maritime industry
ex 9014 90 00	Parts and accessories of subheadings 9014 10 00 and 9014 80 00, solely for the maritime industry
ex 9015	Surveying (including photogram metrical surveying), hydro graphic, oceanographic, hydrological, meteorological or geophysical instruments and appliances, excluding compasses; rangefinders, solely for the maritime industry ".

Viia

Software for integrating industrial processes referred to in Article 10d, 10e, 10f and 31(1)

1.Enterprise Resource Planning software, designed specifically for use in nuclear, military, gas, oil, navy, aviation, financial and construction industries.

Explanatory note: Enterprise Resource Planning software is software used for financial accounting, management accounting, human resources, manufacturing, supply chain management, project management, customer relationship management, data services, or access control.".

Viib

Graphite and raw or semi-finished metals referred to in Articles 15a, 15b, 15c and 31(1)

Introductory note: The inclusion of goods in this Annex is without prejudice to the rules applicable to the goods included in Annexes I, II and III.

1.Graphite
HS code	Description
2504	Natural graphite
3801	Artificial graphite; colloidal or semi-colloidal graphite; preparations based on graphite or other carbon in the form of pastes, blocks, plates or other semi-manufactures
6815 10	Non-electrical articles of graphite or other carbon, incl. carbon fibres
6903 10	Retorts, crucibles, mufflers, nozzles, plugs, supports, cupels, tubes, pipes, sheaths, rods and other refractory ceramic goods. Other than those of siliceous fossil meals or of similar siliceous earths, containing, by weight, more than 50 % of graphite, or other carbon or of a mixture of these products
8545	Carbon electrodes, carbon brushes, lamp carbons, battery carbons and other articles of graphite or other carbon, with or without metal, of a kind used for electrical purposes

2.Iron and Steel
HS code	Description
7201	Pig iron and spiegeleisen in pigs, blocks or other primary forms
7202	Ferro-alloys
7203	Ferrous products obtained by direct reduction of iron ore and other spongy ferrous products, in lumps, pellets or similar forms; iron having a minimum purity by weight of 99,94 %, in lumps, pellets or similar forms
7204	Ferrous waste and scrap; remelting scrap ingots of iron or steel
7205	Granules and powders, of pig iron, spiegeleisen, iron or steel
7206	Iron and non-alloy steel in ingots or other primary forms
7207	Semi-finished products of iron or non-alloy steel
7218	Stainless steel in ingots or other primary forms; semi-finished products of stainless steel
7224	Other alloy steel in ingots or other primary forms; semi-finished products of other alloy steel

3.Copper and articles thereof
HS code	Description
7401 00 00	Copper mattes; cement copper (precipitated copper)
7402 00 00	Unrefined copper; copper anodes for electrolytic refining
7403	Refined copper and copper alloys, unwrought
7404 00	Copper waste and scrap
7405 00 00	Master alloys of copper
7406	Copper powders and flakes
7407	Copper bars, rods and profiles
7410	Copper foil (whether or not printed or backed with paper, paperboard, plastics or similar backing materials) of a thickness (excluding any backing) not exceeding 0,15 mm
7413 00 00	Stranded wire, cables, plaited bands and the like, of copper, not electrically insulated

4.Nickel and articles thereof
HS code	Description
7501	Nickel mattes, nickel oxide sinters and other intermediate products of nickel metallurgy
7502	Unwrought nickel
7503 00	Nickel waste and scrap
7504 00 00	Nickel powders and flakes
7505	Nickel bars, rods, profiles and wire
7506	Nickel plates, sheets, strip and foil
7507	Nickel tubes, pipes and tube or pipe fittings (for example, couplings, elbows, sleeves)

5.Aluminium
HS code	Description
7601	Unwrought aluminium
7602	Aluminium waste and scrap
7603	Aluminium powders and flakes
7605	Aluminium wire
7606	Aluminium plates, sheets and strip, of a thickness exceeding 0,2 mm
7609 00 00	Aluminium tube or pipe fittings (for example, couplings, elbows, sleeves)
7614	Stranded wire, cables, plaited bands and the like, of aluminium, not electrically insulated

6.Lead
HS code	Description
7801	Unwrought lead
7802 00 00	Lead waste and scrap
7804	Lead plates, sheets, strip and foil; lead powders and flakes

7.Zinc
HS code	Description
7901	Unwrought zinc
7902 00 00	Zinc waste and scrap
7903	Zinc dust, powders and flakes
7904 00 00	Zinc bars, rods, profiles and wire
7905 00 00	Zinc plates, sheets, strip and foil

8.Tin
HS code	Description
8001	Unwrought tin
8002 00 00	Tin waste and scrap
8003 00 00	Tin bars, rods, profiles and wire

9.Other base metals, cermets, articles thereof
HS code	Description
ex 8101	Tungsten (wolfram) and articles thereof, including waste and scrap, other than anti-cathodes for x-ray tubes
ex 8102	Molybdenum and articles thereof, including waste and scrap, other than articles specifically designed for use in dentistry
ex 8103	Tantalum and articles thereof, including waste and scrap, other than dental instruments and surgical tools and articles specially designed for orthopaedic and surgical purposes
8104	Magnesium and articles thereof, including waste and scrap
8105	Cobalt mattes and other intermediate products of cobalt metallurgy; cobalt and articles thereof, including waste and scrap
ex 8106 00	Bismuth and articles thereof, including waste and scrap, other than that specially prepared for the preparation of chemical compounds for pharmaceutical use
8107	Cadmium and articles thereof, including waste and scrap
8108	Titanium and articles thereof, including waste and scrap
8109	Zirconium and articles thereof, including waste and scrap
8110	Antimony and articles thereof, including waste and scrap
8111 00	Manganese and articles thereof, including waste and scrap
ex 8112	Beryllium, chromium, germanium, vanadium, gallium, hafnium, indium, niobium (columbium), rhenium and thallium, and articles of these metals, including waste and scrap, other than windows for X-ray tubes
8113 00	Cermets and articles thereof, including waste and scrap".

Annex A

Annex B

Financial control as regards swiss participants in activities of the european aviation agreement

Article 1Direct communicationThe Agency and the Commission shall communicate directly with all persons or entities established in Switzerland and participating in activities of the Agency, as contractors, participants in Agency programmes, recipients of payments from the Agency or the Community budget, or subcontractors. Such persons may send directly to the Commission and to the Agency all relevant information and documentation which they are required to submit on the basis of the instruments referred to in this Decision and of contracts or agreements concluded and any decisions taken pursuant to them.

Article 2Checks1.In accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities^note and the Financial Regulation adopted by the Management Board of the Agency on 26 March 2003, with Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities^note and with the other instruments referred to in this Decision, contracts or agreements concluded and decisions taken with beneficiaries established in Switzerland may provide for scientific, financial, technological or other audits to be conducted at any time on the premises of the beneficiaries and of their subcontractors by Agency and Commission officials or by other persons mandated by the Agency and the Commission.2.Agency and Commission officials and other persons mandated by the Agency and the Commission shall have appropriate access to sites, works and documents and to all the information required in order to carry out such audits, including in electronic form. This right of access shall be stated explicitly in the contracts or agreements concluded to implement the instruments referred to in this Decision.3.The European Court of Auditors is to have the same rights as the Commission.4.The audits may take place until five years after the expiry of this Decision or under the terms of the contracts or agreements concluded and the decisions taken.5.The Swiss Federal Audit Office is to be informed in advance of audits conducted on Swiss territory. This information will not be a legal condition for carrying out such audits.

Article 3On-the-spot checks1.Under this Agreement, the Commission (OLAF) is authorised to carry out on-the-spot checks and inspections on Swiss territory, under the terms and conditions set out in Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities^note.2.On-the-spot checks and inspections shall be prepared and conducted by the Commission in close cooperation with the Swiss Federal Audit Office or with other competent Swiss authorities appointed by the Swiss Federal Audit Office, which shall be notified in good time of the object, purpose and legal basis of the checks and inspections, so that they can provide all the requisite help. To that end, the officials of the competent Swiss authorities may participate in the on-the-spot checks and inspections.3.If the Swiss competent authorities concerned so wish, the on-the-spot checks and inspections may be carried out jointly by the Commission and the Swiss competent authorities.4.Where the participants in the programme resist an on-the-spot check or inspection, the Swiss authorities, acting in accordance with national rules, shall give the Commission inspectors such assistance as they need to allow them to discharge their duty in carrying out an on-the-spot check or inspection.5.The Commission shall report as soon as possible to the Swiss Federal Audit Office any fact or suspicion relating to an irregularity which has come to its notice in the course of the on-the-spot check or inspection. In any event the Commission is required to inform the aforementioned authority of the result of such checks and inspections.

Article 4Information and consultation1.For the purposes of proper implementation of this Annex, the competent Swiss and Community authorities shall exchange information regularly and, at the request of one of the Parties, shall conduct consultations.2.The competent Swiss authorities shall inform the Agency and the Commission without delay of any fact or suspicion which has come to their notice relating to an irregularity in connection with the conclusion and implementation of the contracts or agreements concluded in application of the instruments referred to in this Decision.

Article 5ConfidentialityInformation communicated or acquired in any form whatsoever pursuant to this Annex will be covered by professional confidentiality and protected in the same way as similar information is protected by the national legislation of Switzerland and by the corresponding provisions applicable to the Community institutions. Such information shall not be communicated to persons other than those within the Community institutions, in the Member States, or in Switzerland whose functions require them to know it, nor may it be used for purposes other than to ensure effective protection of the financial interests of the Contracting Parties.

Article 6Administrative measures and penaltiesWithout prejudice to application of Swiss criminal law, administrative measures and penalties may be imposed by the Agency or the Commission in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 and Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 and with Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities' financial interests^note.

Article 7Recovery and enforcementDecisions taken by the Agency or the Commission within the scope of this Decision which impose a pecuniary obligation on persons other than States shall be enforceable in Switzerland.The enforcement order must be issued, without any further control than verification of the authenticity of the act, by the authority designated by the Swiss government, which must inform the Agency or the Commission thereof. Enforcement must take place in accordance with the Swiss rules of procedure. The legality of the enforcement decision is subject to control by the Court of Justice of the European Union.Judgments given by the Court of Justice of the European Union pursuant to an arbitration clause are enforceable on the same terms.

Sectoral annex on medicinal products gmp inspection and batch certification to the european community – new zealand agreement on mutual recognition in relation to conformity assessment

Scope and coverage

1.The provisions of this Sectoral Annex cover all medicinal products which are industrially manufactured in New Zealand and in the European Union, and to which Good Manufacturing Practice (GMP) requirements apply.For medicinal products covered by this Sectoral Annex, each Party will recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.In addition, the manufacturer’s certification of the conformity of each batch to its specifications will be recognised by the other Party without re-control at import.‘Medicinal products’ means all products regulated by the pharmaceutical legislation in the European Union and New Zealand referred to in Section I. The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma, pre-mixes for the preparation of veterinary medicated feedingstuffs, and, where appropriate, vitamins, minerals, herbal remedies and homoeopathic medicinal products.‘GMP’ is that part of quality assurance which ensures that products are consistently produced and controlled during manufacture to the quality standards appropriate to their intended use and as required by the marketing authorisation granted by the importing Party. For the purpose of this Sectoral Annex it includes the system whereby the manufacturer receives the specification of the product and/or process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification (equivalent to Qualified Person certification in the European Union).

2.With respect to medicinal products covered by the legislation of one Party (‘regulating Party’) but not the other, the manufacturing company may request the authority nominated by the relevant contact point of the regulating Party listed in point 12 of Section III, for the purpose of this Agreement, that an inspection be made by the locally competent inspection service. This provision will apply, inter alia, to the manufacture of active pharmaceutical ingredients and intermediate products and products intended for use in clinical trials, as well as jointly determined pre-marketing inspections. Operational arrangements are detailed under point 3(b) of Section III.

Certification of manufacturers

3.At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products will certify that the manufacturer:

—is appropriately authorised to manufacture the relevant medicinal product or to carry out the relevant specified manufacturing operation;

—is regularly inspected by the authorities, and

—complies with the national GMP requirements recognised as equivalent by the two Parties, referred to in Section I. Where different GMP requirements are used as a reference (in line with the provisions in point 3(b) of Section III), this is to be mentioned in the certificate.

The certificates will also identify the site(s) of manufacture (and contract testing laboratories, if any). The format of the certificate will be decided by the Joint Sectoral Group.Certificates will be issued expeditiously, and the time taken should not exceed 30 calendar days. In exceptional cases, such as when a new inspection has to be carried out, this period may be extended to 60 calendar days.

Batch certification

4.Each batch exported will be accompanied by a batch certificate prepared by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active constituents and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation. This certificate will attest that the batch meets its specifications and will be kept by the importer of the batch. It will be made available upon request of the competent authority.When issuing a certificate, the manufacturer will take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytical methods and the analytical results. It will contain a statement that the batch processing and packaging records were reviewed and found to be in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Union the ‘qualified person’ as referred to in relevant European Union legislation. In New Zealand, the responsible person is named on the licence to manufacture issued under the relevant New Zealand legislation.

Section I — legislative, regulatory and administrative requirements

Subject to Section III, general GMP inspections will be carried out against the GMP requirements of the exporting Party. The applicable legislative, regulatory and administrative provisions related to this Sectoral Annex are set out in the Table.

However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, will be those of the relevant product marketing authorisation granted by the importing Party.

Applicable legislative, regulatory and administrative provisions for the European Union	Applicable legislative, regulatory and administrative provisions for New Zealand
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, as amendedDirective 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amendedDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amendedCommission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as amendedRegulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amendedGuide to Good Distribution Practice (94/C 63/03)Volume 4 — Guidelines for good manufacturing practices for medicinal products for human and veterinary use	Medicines Act, 1981Medicines Regulations, 1984New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5Agricultural Compounds and Veterinary Medicines Act, 1997Agricultural Compounds and Veterinary Medicines Regulations, 2001Agricultural Compounds and Veterinary Medicines (ACVM) Standard for Good Manufacturing PracticeAgricultural Compounds and Veterinary Medicines (ACVM) Guideline for Good Manufacturing Practiceand any legislation adopted on the basis of, or that amends, the above legislation

Applicable legislative, regulatory and administrative provisions for the European Union

Applicable legislative, regulatory and administrative provisions for New Zealand

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products, as amendedDirective 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amendedDirective 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amendedCommission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as amendedRegulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amendedGuide to Good Distribution Practice (94/C 63/03)Volume 4 — Guidelines for good manufacturing practices for medicinal products for human and veterinary use

Medicines Act, 1981Medicines Regulations, 1984New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods, Parts 1, 2, 4 and 5Agricultural Compounds and Veterinary Medicines Act, 1997Agricultural Compounds and Veterinary Medicines Regulations, 2001Agricultural Compounds and Veterinary Medicines (ACVM) Standard for Good Manufacturing PracticeAgricultural Compounds and Veterinary Medicines (ACVM) Guideline for Good Manufacturing Practiceand any legislation adopted on the basis of, or that amends, the above legislation

Section II — official inspection services

The lists of official inspection services related to this Sectoral Annex have been jointly determined by the Parties and will be maintained by them. If a Party requests from the other Party a copy of its latest lists of official inspection services, the requested Party will provide the requesting Party with a copy of those lists within 30 calendar days of the date of receipt of the request.

Section III — operational provisions

1. Transmission of inspection reports

Upon reasoned request, the relevant inspection services will forward a copy of the last inspection report of the manufacturing or control site, in the case where analytical operations are contracted out. The request may concern a ‘full inspection report’ or a ‘detailed report’ (see point (2). Each Party will deal with these inspection reports with the degree of confidentiality requested by the Party of origin.

If the manufacturing operations of the medicinal product in question have not been inspected recently, i.e. when the last inspection dates back to more than two years or a particular need to inspect has been identified, a specific and detailed inspection may be requested. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 calendar days should a new inspection be carried out.

2. Inspection reports

A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate. A ‘detailed report’ responds to specific queries about a firm by the other Party.

3. Reference GMP

(a)Manufacturers will be inspected against the applicable GMP of the exporting Party (see Section I).

(b)With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party. This will also be the case when the locally applicable GMP are not considered equivalent, in terms of quality assurance of the finished product, to the GMP of the importing Party.

Equivalence of GMP requirements for specific products or classes of products (e.g. investigational medicinal products, starting materials) will be determined according to a procedure established by the Joint Sectoral Group.

4. Nature of inspections

(a)Inspections will routinely assess the compliance of the manufacturer with GMP. These are called general GMP inspections (also regular, periodic, or routine inspections).

(b)‘Product- or process-oriented’ inspections (which may be ‘pre-marketing’ inspections as relevant) focus on the manufacture of one or one series of product(s) or process(es) and include an assessment of the validation of and compliance with specific process or control aspects as described in the marketing authorisation. Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) will be provided in confidence to the inspectorate.

5. Inspection/establishment fees

The regime of inspection/establishment fees is determined by the manufacturer’s location. Inspection/establishment fees will not be charged to manufacturers located on the territory of the other Party for products covered by this Sectoral Annex.

6. Safeguard clause for inspections

Each Party reserves the right to conduct its own inspection for reasons identified to the other Party. Such inspections are to be notified in advance to the other Party, which has the option of joining the inspection. Recourse to this safeguard clause should be an exception. Should such an inspection take place, inspection costs may be recovered.

7. Exchange of information between authorities and approximation of quality requirements

In accordance with the general provisions of this Agreement, the Parties will exchange any relevant information necessary for the ongoing mutual recognition of inspections. For the purposes of demonstration of capability in cases of significant changes to regulatory systems in either of the Parties, additional specific information may be requested by either Party in relation to an official inspection service. Such specific requests may cover information on training, inspection procedures, general information and document exchange, and transparency of agency audits of official inspection services relevant to the operation of this Sectoral Annex. Such requests should be made through and managed by the Joint Sectoral Group as part of an ongoing maintenance programme.

In addition, the relevant authorities in New Zealand and in the European Union will keep each other informed of any new technical guidance or changes to inspection procedures. Each Party will consult the other before their adoption.

8. Official batch release

The official batch release procedure is an additional verification of safety and efficacy of immunological medicinal products (vaccines) and blood derivatives, carried out by the competent authorities before the distribution of each batch of product. This Agreement does not encompass this mutual recognition of official batch releases. However, when an official batch release procedure applies, the manufacturer will provide, at the request of the importing Party, the official batch release certificate if the batch in question has been tested by the control authorities of the exporting Party.

For the European Union, the official batch release procedure for medicinal products for human use is published by the European Directorate for the Quality of Medicines & HealthCare. For New Zealand, the official batch release procedure is specified in document ‘WHO Technical Report Series, No 822, 1992’.

9. Inspectors’ training

In accordance with the general provisions of this Agreement, training sessions for inspectors, organised by the authorities, will be accessible to inspectors of the other Party. The Parties will keep each other informed of these sessions.

10. Joint inspections

In accordance with the general provisions of this Agreement, and by mutual arrangement between the Parties, joint inspections may be authorised. These inspections are intended to develop common understanding and interpretation of practice and requirements. The setting up of these inspections and their form will be established through procedures approved by the Joint Sectoral Group.

11. Alert system

Contact points will be designated by the Parties to permit competent authorities and manufacturers to inform the authorities of the other Party with the appropriate speed in case of quality defects, batch recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the batch. A detailed alert procedure will be jointly established.

The Parties will ensure that any suspension or withdrawal (total or partial) of a manufacturing authorisation, based on non-compliance with GMP and which could affect the protection of public health, is communicated to the other Party with the appropriate degree of urgency.

12. Contact points

For the purpose of this Sectoral Annex, the contact points for any technical question, such as exchange of inspection reports, inspector training sessions, technical requirements, will be:

FOR NEW ZEALAND:	For medicinal products for human use:Group ManagerMedicines and Medical Devices Safety Authority (Medsafe)PO Box 5013WellingtonNew ZealandTel. 64-4-819 6874Fax 64-4-819 6806
For medicinal products for use in animals:Director, Approvals and ACVM StandardsMinistry of Agriculture and Forestry(MAF) PO Box 2526Wellington 6140New ZealandTel. 64-4-894 2541Fax 64-4-894 2501
FOR THE EUROPEAN UNION:	The Director of the European Medicines Agency7 Westferry CircusCanary WharfLondon E14 4HBUnited KingdomTel. 44-171-418 8400Fax 44-171-418 8416

13. Joint Sectoral Group

A Joint Sectoral Group made up of representatives of the Parties will be established under this Sectoral Annex. It will be responsible for the effective functioning of this Sectoral Annex. It will report to the Joint Committee as the Joint Committee will determine.

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

14. Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of inspection reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

Section IV — changes to the list of official inspection services

The Parties recognise the need for this Sectoral Annex to accommodate change, particularly with regard to the entry of new official inspection services or changes in the nature or role of established competent authorities. Where significant changes have occurred with regard to official inspection services, the Joint Sectoral Group will consider what, if any, additional information is required to verify programmes and establish or maintain mutual recognition of inspections, in accordance with point 7 of Section III.’.

I.The person and entities listed below shall be added to the list set out in Annex IX to Regulation (EU) No 267/2012:"I.Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of IranPerson| Name | Identifying information | Reasons | Date of listing1. | Babak Zanjani | Date of birth: 12 March 1971 | Babak Zanjani is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. Zanjani is a key facilitator for Iranian oil deals and transferring oil-related money. Zanjani owns and operates the UAE-based Sorinet Group, and some of its companies are used by Zanjani to channel oil-related payments. | 22.12.2012EntitiesNameIdentifying informationReasonsDate of listing1.National Iranian Oil Products Distribution Company (NIOPDC)No.1, Tehran, Iranshahr Ave.Shadab.St,P.O.Box: 79145/3184Tel: +98-21-77606030Website: www.niopdc.irSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20122.Iranian Oil Pipelines and Telecommunications Company (IOPTC)No.194, Tehran, Sepahbod Gharani Ave.Tel: +98-21-88801960/+98-21-66152223Fax: +98-21-66154351Website: www.ioptc.comSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20123.National Iranian Oil Engineering and Construction Company (NIOEC)No.263, Tehran, Ostad Nejatollahi Ave.P.O.Box: 11365/6714Tel: +98-21-88907472Fax: +98-21-88907472Website: www.nioec.orgSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20124.Iran Composites InstituteIran Composites Institute,Iranian University of Science and Technology,16845-188, Tehran, Iran,Telephone: 98 217 3912858Fax: 98 217 7491206E-mail: ici@iust.ac.irWebsite: http://www.irancomposites.orgIranian Composites Institute (ICI, aka Composite Institute of Iran) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of 2011 ICI had been contracted to provide EU-designated Iran Centrifuge Technology Company (TESA) with IR-2M centrifuge rotors.22.12.20125.Jelvesazan Company22 Bahman St., Bozorgmehr Ave, 84155666, Esfahan, IranTel: 98 0311 2658311 15Fax: 98 0311 2679097Jelvesazan Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2012 Jelvesazan intended to supply controlled vacuum pumps to EU-designated Iran Centrifuge Technology Company (TESA).22.12.20126.Iran Aluminium CompanyArak Road Km 5, Tehran Road, 38189-8116, Arak, IranTel: 98 861 4130430Fax: 98 861 413023Website: www.iralco.netThe Iran Aluminium Company (aka IRALCO, Iranian Aluminium Company) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of mid-2012 IRALCO had a contract to supply aluminium to EU-designated Iran Centrifuge Technology Company (TESA).22.12.20127.Simatec Development CompanySimatec Development Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2010 Simatec was contracted by UN-designated Kalaye Electric Company (KEC) to procure Vacon inverters to power uranium enrichment centrifuges. As of mid-2012 Simatec was attempting to procure EU-controlled inverters.22.12.20128.Aluminat

1.Parcham St, 13^th Km of Qom Rd 38135 Arak (Factory)

2.Unit 38, 5^th Fl, Bldg No 60, Golfam St, Jordan, 19395-5716, TehranTel: 98 212 2049216 / 22049928 / 22045237Fax: 98 21 22057127Website: www.aluminat.com

Aluminat is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. In early 2012 Aluminat had a contract to supply 6061-T6 aluminium to EU-designated Iran Centrifuge Technology Company (TESA).22.12.20129.Organisation of Defensive Innovation and ResearchThe Organisation of Defensive Innovation and Research (SPND) is assisting designated persons and entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. The IAEA has identified SPND with their concerns over possible military dimensions (PMD) to Iran's nuclear programme over which Iran continues to refuse to co-operate. SPND is run by UN-designated Mohsen Fakhrizadeh and is part of the Ministry of Defence For Armed Forces Logistics (MODAFL, designatedby the EU in May 2011). Davoud Babaei was designated by the EU in December 2011 in his role as SPND's head of security, in which he is responsible for preventing the disclosure of information including to the IAEA.22.12.201210.First Islamic Investment BankBranch: 19A-31-3A, Level 31 Business Suite, Wisma UOA, Jalan Pinang 50450, Kuala Lumpur; Kuala Lumpur; Wilayah Persekutuan; 50450Tel: 603-21620361/2/3/4, +6087417049/ 417050, +622157948110Branch: Unit 13 (C), Main Office Tower, Financial Park Labuan Complex, Jalan Merdeka, 87000 Federal Territory of Labuan, Malaysia; Labuan F.T; 87000Investor Relations: Menara Prima 17^th floor Jalan Lingkar, Mega Kuningan Blok 6.2 Jakarta 12950 – Indonesia; South Jakarta; Jakarta; 12950First Islamic Investment Bank (FIIB) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. FIIB is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.22.12.201211.International Safe OilInternational Safe Oil (ISO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. ISO is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.22.12.201212.Sorinet Commercial TrustSCT Bankers CompanyBranch: No.1808, 18th Floor, Grosvenor House Commercial Tower, Sheik Zayed Road, Dubai, UAE, P.O.Box 31988Tel: 0097 14 3257022-99E-mail: INFO@SCTBankers.comDubai SWIFT Code: SCTSAEA1Branch: No.301, 3^rd Floor Sadaf Building Kish Island, Iran, P.O.Box 1618Tel: +98 764 444 32 341-2Fax: +98 764 444 50 390-1Sorinet Commercial Trust (SCT) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. SCT is part of the Sorinet Group owned and operated by Babak Zanjani. It is being used to channel Iranian oil-related payments.22.12.201213.Hong Kong Intertrade Company LtdHong Kong Intertrade Company, Hong KongHong Kong Intertrade Company Ltd (HKICO) is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. HKICO is a front company controlled by EU-designated National Iranian OilCompany (NIOC). In mid-2012 HKICO was scheduled to receive millions of dollars from NIOC oil sales.22.12.201214.Petro SuissePetro SuisseAvenue De la Tour-Halimand 6, 1009 Pully, SwitzerlandPetro Suisse is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. It is a front company controlled by EU-designated NIOC. NIOC set up Petro Suisse as a company and would use Petro Suisse accounts to make and receive payments. Petro Suisse continued to be in contact with NIOC in 2012.22.12.201215.Oil Industry Pension Fund Investment CompanyNo 234, Taleghani St, Tehran IranIran's Oil Industry Pension Fund Investment Company (OPIC, aka the Oil Pension Fund, NIOC Pension Fund, Petroleum Ministry Pension Fund) is providing financial support to the government of Iran. OPIC operates under the Iranian Ministry of Petroleum and the National Iranian Oil Company (NIOC), both of which are EU-designated. It holds shares in a number of EU-designated entities.22.12.201216.CF Sharp and Company Private LimitedThis entity has been assisting the Irano-Hind Shipping Company (IHSC) (designated by the United Nations on 9 June 2010) in circumventing the sanctions adopted against it. Following its designation, IHSC has tried to conceal its ownership of three tankers, by placing them under the management of Noah Ship Management and then Marian Ship Management. CF Sharp and Co. has contributed to this arrangement by concluding a personnel management contract with IHSC covering the crew of those three tankers. That contract was performed by Noah Ship Management and Marian Ship Management.22.12.201217.Sharif University of TechnologyAzadi Ave, 11365-8639, Tehran, IranTel: 98 21 66022727Fax: 98 21 66036005Website: www.sharif.irSharif University of Technology (SUT) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is providing support to Iran's proliferation sensitive nuclear activities. As of late 2011 SUT had provided laboratories for use by UN-designated Iraniannuclear entity Kalaye Electric Company (KEC) and EU-designated Iran Centrifuge Technology Company (TESA).22.12.201218.Moallem Insurance Company (also known as:Moallem Insurance; Moallem Insurance Co.; M.I.C; Export and Investment Insurance Co.)No. 56, Haghani Boulevard, Vanak Square, Tehran 1517973511, Iran PO Box 19395-6314, 11/1 Sharif Ave, Vanaq Square, Tehran 19699, IranPhone: (98-21) 886776789, 887950512, 887791835Fax: (98-21) 88771245Website: www.mic-ir.comMain insurer of IRISL22.12.2012"

II.The entries for the entities set out in Annex IX to Regulation (EU) No 267/2012 listed below shall be replaced by the entries below:B.Entities| Name | Identifying information | Reasons | Date of listing1. | Technology Cooperation Office (TCO) of the Iranian President's Office (a.k.a.Center for Innovation and Technology (CITC)) | Tehran, Iran | Responsible for Iran's technological advancement through relevant foreign procurement and training links. Supports the nuclear and missile programmes. | 26.07.20102. | Sureh (a.k.a. Soreh) Nuclear Reactors Fuel Company (a.k.a. Nuclear Fuel Reactor Company; Sookht Atomi Reactorhaye Iran; Soukht Atomi Reactorha-ye Iran) | Head Office: 61 Shahid Abtahi St, Karegar e Shomali, TehranComplex: Persian Gulf Boulevard, Km20 SW Esfahan Road, Esfahan | A company subordinate to the UN-sanctioned Atomic Energy Organisation of Iran (AEOI) consisting of the Uranium Conversion Facility, the Fuel Manufacturing Plant and the Zirconium Production Plant. | 23.05.20113. | Tidewater (a.k.a. Tidewater Middle East Co; Faraz Royal Qeshm Company LLC) | Postal address: No 80, Tidewater Building, Vozara Street, Next to Saie Park, Tehran, Iran | Owned or controlled by IRGC | 23.01.2012

III.The entities listed below shall be deleted from the list set out in Annex IX to Regulation (EU) No 267/2012:

1.CF Sharp Shipping Agencies Pte Ltd

2.Soreh (Nuclear Fuel Reactor Company).

The Annex to Implementing Regulation (EU) No 837/2012 is replaced by the following:

Sectoral annex on medical devices to the european community — new zealand agreement on mutual recognition in relation to conformity assessment

Scope and coverage

The provisions of this Sectoral Annex will apply to the following products:

Products for export to the European Union	Products for export to New Zealand
(1)All medical devices:(a) manufactured in New Zealand; and(b) subject to third party conformity assessment procedures, both product and quality systems-related; and(c) provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; and(d) provided for in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended.	(1)All medical devices:(a) manufactured in the European Union; and(b) subject to third party conformity assessment procedures, both product and quality systems-related, or subject to other requirements under the legislation listed in Section I, as amended.
(2)For the purposes of paragraph 1:(a) medical devices provided for in the Appendix are excluded; and(b) unless otherwise provided for or by mutual arrangement by the Parties, manufacture of a medical device does not include: (i)restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or(ii)operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or(iii)quality control inspections alone; or(iv)sterilisation alone.	(2)For the purposes of paragraph 1:(a) medical devices provided for in the Appendix are excluded; and(b) unless otherwise provided for or by mutual arrangement by the Parties, manufacture of a medical device does not include: (i)restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or(ii)operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or(iii)quality control inspections alone; or(iv)sterilisation alone.

Products for export to the European Union

Products for export to New Zealand

(1)All medical devices:(a) manufactured in New Zealand; and(b) subject to third party conformity assessment procedures, both product and quality systems-related; and(c) provided for in Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; and(d) provided for in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended.

(1)All medical devices:(a) manufactured in the European Union; and(b) subject to third party conformity assessment procedures, both product and quality systems-related, or subject to other requirements under the legislation listed in Section I, as amended.

(2)For the purposes of paragraph 1:(a) medical devices provided for in the Appendix are excluded; and(b) unless otherwise provided for or by mutual arrangement by the Parties, manufacture of a medical device does not include: (i)restoration or renovation processes such as repairing, re-conditioning, overhauling or refurbishing; or(ii)operations such as pressing, labelling, ticketing, packaging and preparation for sale, conducted alone or in combination with each other; or(iii)quality control inspections alone; or(iv)sterilisation alone.

Section I — legislative, regulatory and administrative requirements

The legislative, regulatory and administrative requirements of the European Union with which New Zealand-designated conformity assessment bodies will assess compliance	The legislative, regulatory and administrative requirements of New Zealand with which European Union-designated conformity assessment bodies will assess compliance
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amendedCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amendedand any European Union legislation adopted on the basis of these Directives	Radiocommunications Act 1989 and Regulations made pursuant to that ActElectricity Act 1992 and Regulations made pursuant to that ActMedicines Act 1981Medicines Regulations 1984Medicines (Database of Medical Devices) Regulations 2003and any legislation adopted on the basis of, or that amends, the above legislation

Section II — the authorities responsible for designating conformity assessment bodies under this sectoral annex

For the conformity assessment bodies designated by New Zealand	For the conformity assessment bodies designated by the European Union
—Ministry of Health	BelgiumMinistère de la Santé publique, de l’Environnement et de l’Intégration socialeMinisterie van Volksgezondheid, Leefmilieu en Sociale IntegratieAgence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en GezondheidsproductenBulgariaДържавна агенция за метрологичен и технически надзорCzech RepublicÚřad pro technickou normalizaci, metrologii a státní zkušebnictvíDenmarkIndenrigs- og SundhedsministerietLægemiddelstyrelsenGermanyZLG — Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, BonnZLS — Zentralstelle der Länder für Sicherheitstechnik, MünchenEstoniaMajandus- ja KommunikatsiooniministeeriumIrelandDepartment of HealthIrish Medicines BoardGreeceΥπουργείο Υγείας και Κοινωνικής ΑλληλεγγύηςΕθνικός Οργανισμός ΦαρμάκωνSpainMinisterio de Sanidad, Política Social e IgualdadAgencia Española de Medicamentos y Productos SanitariosFranceMinistère de la SantéAgence Française de Sécurité Sanitaire des produits de SantéAgence Nationale du Médicament VétérinaireItalyMinistero della Salute – Dipartimento dell’ Innovazione – Direzione Generale Farmaci e Dispositivi MediciCyprusThe Drugs Council, Pharmaceutical Services (Ministry of Health)Veterinary Services (Ministry of Agriculture)LatviaZāļu valsts aģentūraVeselības ministrijaLithuaniaLietuvos Respublikos sveikatos apsaugos ministerijaLuxembourgMinistère de la SantéDivision de la Pharmacie et des MédicamentsHungaryOrszágos Gyógyszerészeti IntézetMaltaDirettorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandardsNetherlandsMinisterie van Volksgezondheid, Welzijn en SportInspectie voor de GezondheidszorgAustriaBundesministerium für GesundheitBundesamt für Sicherheit im GesundheitswesenPolandMinisterstwo ZdrowiaUrząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów BiobójczychPortugalINFARMED:I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.)RomaniaMinisterul Sănătății – Departament Dispozitive MedicaleSloveniaMinistrstvo za zdravjeJavna agencija Republike Slovenije za zdravila in medicinske pripomočkeSlovakiaÚrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republikyFinlandSosiaali- ja terveysministeriöSosiaali- ja terveysalan lupa- ja valvontavirasto (Valvira)SwedenStyrelsen för ackreditering och teknisk kontroll (SWEDAC)United KingdomMedicines and Healthcare products Regulatory Agency

For the conformity assessment bodies designated by New Zealand

For the conformity assessment bodies designated by the European Union

—Ministry of Health

BelgiumMinistère de la Santé publique, de l’Environnement et de l’Intégration socialeMinisterie van Volksgezondheid, Leefmilieu en Sociale IntegratieAgence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en GezondheidsproductenBulgariaДържавна агенция за метрологичен и технически надзорCzech RepublicÚřad pro technickou normalizaci, metrologii a státní zkušebnictvíDenmarkIndenrigs- og SundhedsministerietLægemiddelstyrelsenGermanyZLG — Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, BonnZLS — Zentralstelle der Länder für Sicherheitstechnik, MünchenEstoniaMajandus- ja KommunikatsiooniministeeriumIrelandDepartment of HealthIrish Medicines BoardGreeceΥπουργείο Υγείας και Κοινωνικής ΑλληλεγγύηςΕθνικός Οργανισμός ΦαρμάκωνSpainMinisterio de Sanidad, Política Social e IgualdadAgencia Española de Medicamentos y Productos SanitariosFranceMinistère de la SantéAgence Française de Sécurité Sanitaire des produits de SantéAgence Nationale du Médicament VétérinaireItalyMinistero della Salute – Dipartimento dell’ Innovazione – Direzione Generale Farmaci e Dispositivi MediciCyprusThe Drugs Council, Pharmaceutical Services (Ministry of Health)Veterinary Services (Ministry of Agriculture)LatviaZāļu valsts aģentūraVeselības ministrijaLithuaniaLietuvos Respublikos sveikatos apsaugos ministerijaLuxembourgMinistère de la SantéDivision de la Pharmacie et des MédicamentsHungaryOrszágos Gyógyszerészeti IntézetMaltaDirettorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandardsNetherlandsMinisterie van Volksgezondheid, Welzijn en SportInspectie voor de GezondheidszorgAustriaBundesministerium für GesundheitBundesamt für Sicherheit im GesundheitswesenPolandMinisterstwo ZdrowiaUrząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów BiobójczychPortugalINFARMED:I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.)RomaniaMinisterul Sănătății – Departament Dispozitive MedicaleSloveniaMinistrstvo za zdravjeJavna agencija Republike Slovenije za zdravila in medicinske pripomočkeSlovakiaÚrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republikyFinlandSosiaali- ja terveysministeriöSosiaali- ja terveysalan lupa- ja valvontavirasto (Valvira)SwedenStyrelsen för ackreditering och teknisk kontroll (SWEDAC)United KingdomMedicines and Healthcare products Regulatory Agency

Section III — procedures for designating conformity assessment bodies

The procedures to be followed by New Zealand in designating conformity assessment bodies to assess products against the European Union’s requirements	The procedures to be followed by the European Union in designating conformity assessment bodies to assess products against New Zealand’s requirements
Conformity assessment bodies to be designated for the purposes of this Sectoral Annex will meet the requirements of the Directives listed in Section I, taking into account Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, and be designated on the basis of the procedures defined in the Annex to this Agreement. This may be demonstrated through:(a) Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.(b) Quality System certification bodies operating according to the requirements of EN 45012 or ISO Guide 62, and either: accredited by JAS-ANZ, orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.(c) Inspection bodies operating according to the requirements of ISO/IEC 17020, and either: accredited by the Testing Laboratory Registration Council of New Zealand or any other body established by law in New Zealand which replaces it and which has the same functions, orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.	1. The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to this Agreement.2. The following procedures are deemed to be consistent with those set out in the Annex to this Agreement: (a)Certification bodies:accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement (MLA) for certification of products,members of the Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE) CB Scheme,accredited by an accreditation body with which JAS-ANZ has a mutual recognition agreement, orable to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.(b)Testing laboratories:accredited by accreditation bodies which are signatories to the EA MLA for calibration and testing laboratories,recognised within the IECEE CB Scheme, orable to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

The procedures to be followed by New Zealand in designating conformity assessment bodies to assess products against the European Union’s requirements

The procedures to be followed by the European Union in designating conformity assessment bodies to assess products against New Zealand’s requirements

Conformity assessment bodies to be designated for the purposes of this Sectoral Annex will meet the requirements of the Directives listed in Section I, taking into account Annex II to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, and be designated on the basis of the procedures defined in the Annex to this Agreement. This may be demonstrated through:(a) Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40, and either: accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.(b) Quality System certification bodies operating according to the requirements of EN 45012 or ISO Guide 62, and either: accredited by JAS-ANZ, orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.(c) Inspection bodies operating according to the requirements of ISO/IEC 17020, and either: accredited by the Testing Laboratory Registration Council of New Zealand or any other body established by law in New Zealand which replaces it and which has the same functions, orable to demonstrate competence by other means in accordance with Sections A and B of the Annex to this Agreement.Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

1. The procedures for designating conformity assessment bodies will be consistent with the principles and procedures set out in the Annex to this Agreement.2. The following procedures are deemed to be consistent with those set out in the Annex to this Agreement: (a)Certification bodies:accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement (MLA) for certification of products,members of the Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE) CB Scheme,accredited by an accreditation body with which JAS-ANZ has a mutual recognition agreement, orable to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.(b)Testing laboratories:accredited by accreditation bodies which are signatories to the EA MLA for calibration and testing laboratories,recognised within the IECEE CB Scheme, orable to demonstrate competence by other means in accordance with Section A and B of the Annex to this Agreement.Pursuant to point 5.2 of Section IV, designation for high-risk devices listed in point 5.1 of that Section will occur on the basis of a confidence-building programme.

Section IV — additional provisions

1. New legislation

The Parties note New Zealand’s intention to introduce new legislation concerning medical devices, and jointly decide that the provisions of this Sectoral Annex will apply to this legislation upon its entry into force in New Zealand.

The Parties jointly declare their intention to extend the scope of this Sectoral Annex to in vitro diagnostic devices as soon as New Zealand’s new legislation concerning medical devices is in place.

2. Exchange of information

—certificates withdrawn, suspended, restricted or revoked, and

—any legislation or amendment to existing legislation adopted on the basis of the legal texts listed in Section I.

The Parties will inform each other of incidents in the context of the medical device vigilance procedure, or with regard to matters concerning product safety. The Parties will also inform each other of:

The contact points through which the information can be passed are:

New Zealand:	The ManagerMedicines and Medical Devices Safety Authority (Medsafe)PO Box 5013WellingtonNew ZealandTel. 64-4-819 6874Fax 64-4-819 6806andGroup ManagerEnergy Safety and Radio Spectrum ManagementMinistry of Economic Development (MED)P.O. Box 1473WellingtonNew ZealandTel. 64-4-472-0030Fax 64-4-471-0500
European Union	European CommissionDirectorate-General for Health and ConsumersRue de la Loi/Wetstraat 200B-1049 BrusselsTel. 32-2-299 11 11

The Parties may exchange information on the consequences of the establishment of the European Database on Medical Devices (Eudamed).

In addition, the Medicines and Medical Devices Safety Authority will advise of any certificates issued.

3. Subcontracting

Where required by New Zealand legislative, regulatory and administrative provisions, European Union conformity assessment bodies subcontracting all or part of the testing will subcontract only to testing laboratories accredited in accordance with point 2 of Section III.

4. Recording of approvals granted

In addition to the requirements imposed by the Annex to this Agreement on the designation of a conformity assessment body, the relevant European Union designating authority will provide to New Zealand, in respect of each designated conformity assessment body, details of the method that such conformity assessment body intends to adopt to record the fact that an approval required by the Secretary under the Electricity Act 1992 (and Regulations made pursuant to that Act) for fittings or appliances to be sold or offered for sale in New Zealand has been granted.

5. Confidence-building with respect to high-risk devices

5.1.A confidence-building process for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the following medical devices:

—active implantable devices as defined in the legislation referred to in Section I;

—devices that are classified as class III devices under the legislation referred to in Section I;

—medical devices that are implantable intra-ocular lenses;

—medical devices that are intra-ocular visco elastic fluids, and

—medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.

5.2.The Parties will establish a detailed programme to this effect involving the Medicines and Medical Devices Safety Authority and the European Union’s competent authorities.

5.3.The confidence-building period will be reviewed after two years commencing from the date this Sectoral Annex, as amended, becomes effective.

5.4.Additional specific requirements for regulatory progress:

5.4.1.In pursuance of Articles 2, 7(1), 8(1) and 9(1) of this Agreement, either Party may request additional specific requirements in relation to the conformity assessment bodies for the purposes of demonstration of experience in the evolving regulatory systems.

5.4.2.These specific requirements may include training, observed conformity assessment body audits, visits and information and document exchange, including audit reports.

5.4.3.These requirements may likewise be applicable in relation to the designation of a conformity assessment body in accordance with this Agreement.

6. Joint Sectoral Group

The Joint Sectoral Group will determine its own rules of procedure. It will take its decisions and adopt its recommendations by consensus. It may decide to delegate its tasks to subgroups.

7. Divergence of views

Both Parties will use their best endeavours to resolve any divergence of views concerning, inter alia, compliance of manufacturers and conclusions of conformity assessment reports. Unresolved divergences of view will be referred to the Joint Sectoral Group.

Identification number of the additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a18	DSM Nutritional Products	6-phytase (EC 3.1.3.26)	Additive compositionPreparation of 6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae(DSM 22594) with a minimum activity of:10000 FYT/g in solid form20000 FYT/g in liquid formCharacterisation of the active substance6-phytase (EC 3.1.3.26) produced by Aspergillus oryzae (DSM 22594)Analytical methodFor quantification of 6-phytase in feed:Colorimetric method measuring the inorganic phosphate released by the 6-phytase from phytate (ISO 30024:2009)	PoultryPigs for fatteningPiglets(weaned)	—	500 FYT	—	1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kilogram of complete feed for:poultry, piglets (weaned) and pigs for fattening: 500-4000 FYT,sows: 1000-4000 FYT.3.For use in feed containing more than 0,23 % phytin-bound phosphorus.4.For safety: breathing protection, glasses and gloves shall be used during handling.5.For use in weaned piglets up to 35 kg.	9 October 2022
Sows	1000 FYT

Standard import values for determining the entry price of certain fruit and vegetables

CN code	Third country code^note	Standard import value
(EUR/100 kg)
07020000	AL	56,9
MA	79,5
TN	111,9
TR	123,6
ZZ	93,0
07070005	AL	87,0
TR	136,9
ZZ	112,0
07099310	MA	110,2
TR	137,7
ZZ	124,0
08051020	MA	61,3
TR	63,0
ZA	51,2
ZZ	58,5
08052010	MA	69,9
ZZ	69,9
08052030, 08052050, 08052070, 08052090	IL	86,6
JM	129,1
MA	98,7
TR	84,1
ZZ	99,6
08055010	TR	79,2
ZZ	79,2
08081080	BA	56,8
CA	156,3
CN	174,8
MK	40,0
US	132,7
ZA	123,7
ZZ	114,4
08083090	CN	72,9
TR	135,1
US	182,0
ZZ	130,0

Non-exhaustive list of elements to be included in medical prescriptions

Headings appearing in bold in this Annex are not required to feature in prescriptions

Identification of the patient

Surname(s)

First name(s) (written out in full, i.e. no initials)

Date of Birth

Authentication of the prescription

Issue date

Identification of the prescribing health professional

Surname(s)

First name(s) (written out in full, i.e. no initials)

Professional qualification

Details for direct contact (email and telephone or fax, the latter both with international prefix)

Work address (including the name of the relevant Member State)

Signature (written or digital, depending on the medium chosen for issuing the prescription)

Identification of the prescribed product, where applicable

(a)the prescribed product is a biological medicinal product, as defined in point 3.2.1.1.(b) of Annex I (Part I) to Directive 2001/83; or

(b)the prescribing health professional deems it medically necessary; in that case the prescription shall shortly state the reasons justifying the use of the brand name

‘Common name’ as defined by Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

The brand name if:

Pharmaceutical formulation (tablet, solution, etc.)

Quantity

Strength, as defined in Article 1 of Directive 2001/83/EC

Dosage regimen

I.The person and entities listed below shall be added to the list set out in Annex II to Decision 2010/413/CFSP:"I.Persons and entities involved in nuclear or ballistic missile activities and persons and entities providing support to the Government of IranPerson| Name | Identifying information | Reasons | Date of listing1. | Babak Zanjani | Date of birth: 12 March 1971 | Babak Zanjani is assisting designated entities to violate the provisions of the EU regulation on Iran and is providing financial support to the government of Iran. Zanjani is a key facilitator for Iranian oil deals and transferring oil-related money. Zanjani owns and operates the UAE-based Sorinet Group, and some of its companies are used by Zanjani to channel oil-related payments. | 22.12.2012EntitiesNameIdentifying informationReasonsDate of listing1.National Iranian Oil Products Distribution Company (NIOPDC)No.1, Tehran, Iranshahr Ave.Shadab.St,P.O.Box: 79145/3184Tel: +98-21-77606030Website: www.niopdc.irSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20122.Iranian Oil Pipelines and Telecommunications Company (IOPTC)No.194, Tehran, Sepahbod Gharani Ave.Tel: +98-21-88801960/+98-21-66152223Fax: +98-21-66154351Website: www.ioptc.comSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20123.National Iranian Oil Engineering and Construction Company (NIOEC)No.263, Tehran, Ostad Nejatollahi Ave.P.O.Box: 11365/6714Tel: +98-21-88907472Fax: +98-21-88907472Website: www.nioec.orgSubsidiary of the National Iranian Oil Refining and Distribution Company (NIORDC)22.12.20124.Iran Composites InstituteIran Composites Institute,Iranian University of Science and Technology,16845-188, Tehran, Iran,Telephone: 98 217 3912858Fax: 98 217 7491206E-mail: ici@iust.ac.irWebsite: http://www.irancomposites.orgIranian Composites Institute (ICI, aka Composite Institute of Iran) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of 2011 ICI had been contracted to provide EU-designated Iran Centrifuge Technology Company (TESA) with IR-2M centrifuge rotors.22.12.20125.Jelvesazan Company22 Bahman St., Bozorgmehr Ave, 84155666, Esfahan, IranTel: 98 0311 2658311 15Fax: 98 0311 2679097Jelvesazan Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2012 Jelvesazan intended to supply controlled vacuum pumps to EU-designated Iran Centrifuge Technology Company (TESA).22.12.20126.Iran Aluminium CompanyArak Road Km 5, Tehran Road, 38189-8116, Arak, IranTel: 98 861 4130430Fax: 98 861 413023Website: www.iralco.netThe Iran Aluminium Company (aka IRALCO, Iranian Aluminium Company) is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of mid-2012 IRALCO had a contract to supply aluminium to EU-designated Iran Centrifuge Technology Company (TESA).22.12.20127.Simatec Development CompanySimatec Development Company is assisting designated entities to violate the provisions of UN and EU sanctions on Iran and is directly supporting Iran's proliferation sensitive nuclear activities. As of early 2010 Simatec was contracted by UN-designated Kalaye Electric Company (KEC) to procure Vacon inverters to power uranium enrichment centrifuges. As of mid-2012 Simatec was attempting to procure EU-controlled inverters.22.12.20128.Aluminat

1.Parcham St, 13^th Km of Qom Rd 38135 Arak (Factory)

2.Unit 38, 5^th Fl, Bldg No 60, Golfam St, Jordan, 19395-5716, TehranTel: 98 212 2049216 / 22049928 / 22045237Fax: 98 21 22057127Website: www.aluminat.com

II.The entries for entities set out in Annex II to Decision 2010/413/CFSP listed below shall be replaced by the entries below:B.Entities| Name | Identifying information | Reasons | Date of listing1. | Technology Cooperation Office (TCO) of the Iranian President's Office (a.k.a.Center for Innovation and Technology (CITC)) | Tehran, Iran | Responsible for Iran's technological advancement through relevant foreign procurement and training links. Supports the nuclear and missile programmes. | 26.07.20102. | Sureh (a.k.a. Soreh) Nuclear Reactors Fuel Company (a.k.a. Nuclear Fuel Reactor Company; Sookht Atomi Reactorhaye Iran; Soukht Atomi Reactorha-ye Iran) | Head Office: 61 Shahid Abtahi St, Karegar e Shomali, TehranComplex: Persian Gulf Boulevard, Km20 SW Esfahan Road, Esfahan | A company subordinate to the UN-sanctioned Atomic Energy Organisation of Iran (AEOI) consisting of the Uranium Conversion Facility, the Fuel Manufacturing Plant and the Zirconium Production Plant. | 23.05.20113. | Tidewater (a.k.a. Tidewater Middle East Co.; Faraz Royal Qeshm Company LLC) | Postal address: No 80, Tidewater Building, Vozara Street, next to Saie Park, Tehran, Iran | Owned or controlled by IRGC | 23.01.2012

III.The entities listed below shall be deleted from the list set out in Annex II to Decision 2010/413/CFSP:

1.CF Sharp Shipping Agencies Pte Ltd

2.Soreh (Nuclear Fuel Reactor Company).

Appendix

—medical devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;

—medical devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;

—medical devices incorporating tissues or tissue derivatives of human origin;

—medical devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;

—medical devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and

—medical devices that are intended by the manufacturer specifically to be used for chemical disinfection of another medical device, except for sterilisers using dry heat, moist heat or ethylene oxide.

The provisions of this Sectoral Annex will not apply to the following devices:

Both Parties may decide by common arrangement to extend the application of this Sectoral Annex to the aforementioned medical devices.

For the purposes of this Agreement:

—By virtue of the Treaty of Lisbon, entered into force on 1 December 2009, the European Union shall replace and succeed the European Community;

—Wherever acts specified in this Annex contain references to Member States of the European Community, as replaced by the European Union, or a requirement for a link with the latter, the references shall, for the purpose of the Agreement, be understood to apply equally to Switzerland or to the requirement of a link with Switzerland;

—The references to Council Regulations (EEC) No 2407/92 and (EEC) No 2408/92 made in the Articles 4, 15, 18, 27 and 35 of the Agreement, shall be understood as references to Regulation (EC) No 1008/2008 of the European Parliament and of the Council;

—Without prejudice to Article 15 of this Agreement, the term "Community air carrier" referred to in the following Community directives and regulations shall include an air carrier which is licensed and has its principal place of business and, if any, its registered office in Switzerland in accordance with the provisions of Regulation (EC) No 1008/2008. Any reference to Regulation (EEC) No 2407/92 shall be understood as reference to Regulation (EC) No 1008/2008;

—Any reference in the following texts to Articles 81 and 82 of the Treaty or to Articles 101 and 102 of the Treaty on the Functioning of the European Union shall be understood to mean Articles 8 ad 9 of this Agreement.

1. Aviation liberalisation and other civil aviation rules

No 1008/2008

Regulation of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community

No 2000/79

Council Directive of 27 November 2000 concerning the implementation of the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation concluded by the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA)

No 93/104

—Directive 2000/34/EC

Council Directive of 23 November 1993 concerning certain aspects of the organisation of working time, as amended by:

No 437/2003

Regulation of the European Parliament and of the Council of 27 February 2003 on statistical returns in respect of the carriage of passengers, freight and mail by air

No 1358/2003

Commission Regulation of 31 July 2003 implementing Regulation (EC) No 437/2003 of the European Parliament and of the Council on statistical returns in respect of the carriage of passengers, freight and mail by air and amending Annexes I and II thereto

No 785/2004

—Commission Regulation (EU) No 285/2010

Regulation of the European Parliament and of the Council of 21 April 2004 on insurance requirements for air carriers and aircraft operators, as amended by:

No 95/93

—Regulation (EC) No 793/2004

Council Regulation of 18 January 1993 on common rules for the allocation of slots at Community airports (Articles 1-12), as amended by:

No 2009/12

Directive of the European Parliament and of the Council of 11 March 2009 on airport charges (to be applied by Switzerland as from 1 July 2011)

No 96/67

Council Directive of 15 October 1996 on access to the groundhandling market at Community airports

(Articles 1-9, 11-23, and 25)

No 80/2009

Regulation of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89

2. Competition rules

No 3975/87

—Council Regulation (EC) No 1/2003 (Articles 1-13, 15-45)

Council Regulation of 14 December 1987 laying down the procedures for the application of the rules on competition to undertakings in the air transport sector (Article 6(3)), as last amended by:

No 1/2003

Council Regulation of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (Articles 1-13, 15-45)

(To the extent that this Regulation is relevant for the application of this agreement. The insertion of this Regulation does not affect the division of tasks according to this agreement)

Regulation No 17/62 has been repealed by Regulation No 1/2003 with the exception of Article 8(3) which continues to apply to decisions adopted pursuant to Article 81(3) of the Treaty prior to the date of application of this Regulation until the date of expiration of those decisions.

No 773/2004

—Commission Regulation (EC) No 1792/2006

—Commission Regulation (EC) No 622/2008

Commission Regulation of 7 April 2004 relating to proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty, as amended by:

No 139/2004

(1)With regard to a concentration as defined in Article 3 of Regulation (EC) No 139/2004 which does not have a Community dimension within the meaning of Article 1 of that Regulation and which is capable of being reviewed under the national competition laws of at least three EC Member States and the Swiss Confederation, the persons or undertakings referred to in Article 4(2) of that Regulation may, before any notification to the competent authorities, inform the EC Commission by means of a reasoned submission that the concentration should be examined by the Commission.

(1)The European Commission shall transmit all the relevant documents pursuant to Articles 4(4) and (5), Articles 9(2) and (6) and Article 22(2) to the competent Swiss competition authority without delay.

(2)The European Commission shall transmit all submissions pursuant to Article 4(5) of Regulation (EC) No 139/2004 and the previous paragraph to the Swiss Confederation without delay.

(2)The calculation of the time limits referred to in Articles 4(4) and (5), Articles 9(2) and (6), and Article 22(2) of Regulation (EC) No 139/2004 shall start, for the Swiss Confederation, upon receipt of the relevant documents by the competent Swiss competition authority.

(3)Where the Swiss Confederation has expressed its disagreement as regards the request to refer the case, the competent Swiss competition authority shall retain its competence, and the case shall not be referred from the Swiss Confederation pursuant to this paragraph.

Council Regulation of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation)

(Article 1-18, 19(1)-(2), and 20-23)

With respect to Article 4 (5) of the Merger Regulation the following shall apply between the European Community and Switzerland:

With respect to time limits referred to in Articles 4(4) and (5), Articles 9(2) and (6), and Articles 22(2) of the Merger Regulation:

No 802/2004

—Commission Regulation (EC) No 1792/2006

—Commission Regulation (EC) No 1033/2008

Commission Regulation of 7 April 2004 implementing Council Regulation (EC) No 139/2004 on the control of concentrations between undertakings (Articles 1-24), as amended by:

No 2006/111

Commission Directive of 16 November 2006 on the transparency of financial relations between Member States and public undertakings as well as on financial transparency within certain undertakings

No 487/2009

Council Regulation (EC) No 487/2009 of 25 May 2009 on the application of Article 81(3) of the Treaty to certain categories of agreements and concerted practices in the air transport sector.

3. Aviation safety

No 216/2008

(a)Article 12 is amended as follows:

(i)in paragraph 1, the words "or Switzerland" shall be inserted after the words "the Community";

(ii)in paragraph 2(a), the words "or Switzerland" shall be inserted after the words "the Community";

(iii)in paragraphs 2 points (b) and (c) are deleted;

(iv)the following paragraph is added:"3.Whenever the Community negotiates with a third country in order to conclude an agreement providing that a Member State or the Agency may issue certificates on the basis of certificates issued by the aeronautical authorities of that third country, it shall endeavour to obtain for Switzerland an offer of a similar agreement with the third country in question. Switzerland shall, in turn, endeavour to conclude with third countries agreements corresponding to those of the Community".

(b)In Article 29, the following paragraph shall be added:"4.By way of derogation from Article 12(2)(a) of the Conditions of Employment of Other Servants of the European Communities, Swiss nationals enjoying their full rights as citizens may be engaged under contract by the Executive Director of the Agency."

(c)In Article 30, the following paragraph is added:"Switzerland shall apply to the Agency the Protocol on the Privileges and Immunities of the European Union, which is set out as Annex A to the present Annex, in accordance with the Appendix to Annex A.”

(d)In Article 37, the following paragraph is added:"Switzerland shall participate fully in the Management Board and shall within it have the same rights and obligations as European Union Member States, except for the right to vote".

(e)In Article 59, the following paragraph shall be added:"12.Switzerland shall participate in the financial contribution referred to in paragraph 1(b), according to the following formula:S 0,2/100 + S 1 – a + b0,2/100c/Cwhere:Sthe part of the budget of the Agency not covered by the fees and charges mentioned in paragraph 1 (c) and (d)athe number of Associated Statesbthe number of EU Member Statescthe contribution of Switzerland to the ICAO budget,Cthe total contribution of the EU Member States and of the Associated States to the ICAO budget."

(f)In Article 61, the following paragraph is added:"The provisions relating to financial control by the Community in Switzerland concerning the participants in the activities of the Agency are set out in Annex B to the present Annex."

(g)Annex II to the Regulation shall be extended to include the following aircraft as products covered by Article 2(3)(a)(ii) of Commission Regulation (EC) No 1702/2003 of 24 September 2003 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations^note:

A/c - [HB-IDJ] – type CL600-2B19

A/c - [HB-IKR, HB-IMY, HB-IWY] – type Gulfstream G-IV

A/c - [HB-IMJ, HB-IVZ, HB-JES] – type Gulfstream G-V

A/c - [HB-XJF, HB-ZCW, HB-ZDF] – type MD900.

—Commission Regulation (EC) No 690/2009,

—Regulation (EC) No 1108/2009

Regulation of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC, as amended by:

The Agency shall enjoy also in Switzerland the powers granted to it under the provisions of the Regulation.

The Commission shall enjoy also in Switzerland the powers granted to it for decisions pursuant to Article 11(2), Article 14(5) and (7), Article 24(5), Article 25(1), Article 38(3)(i), Article 39(1), Article 40(3), Article 41(3) and (5), Article 42(4), Article 54(1) and Article 61(3).

Notwithstanding the horizontal adaptation provided for in the second indent of the Annex to the Agreement between the European Community and the Swiss Confederation on Air Transport, the references to the “Member States” made in Article 65 of the Regulation or in the provisions of Decision 1999/468/EC mentioned in that provision shall not be understood to apply to Switzerland.

Nothing in this Regulation shall be construed so as to transfer to the EASA authority to act on behalf of Switzerland under international agreements for other purposes than to assist in the performance of its obligations pursuant to such agreements.

The text of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

No 1108/2009

Regulation of the European Parliament and of the Council of 21 October 2009 amending Regulation (EC) No 216/2008 in the field of aerodromes, air traffic management and air navigation services and repealing Directive 2006/23/EC

No 805/2011

Commission Regulation of 10 August 2011 laying down detailed rules for air traffic controllers' licences and certain certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council

No 1178/2011

—Commission Regulation (EU) No 290/2012

Commission Regulation of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council, as amended by:

No 91/670

Council Directive of 16 December 1991 on mutual acceptance of personnel licences for the exercise of functions in civil aviation

(Articles 1-8)

No 3922/91

—Regulation (EC) No 1899/2006,

—Regulation (EC) No 1900/2006,

—Commission Regulation (EC) No 8/2008,

—Commission Regulation (EC) No 859/2008

Council Regulation of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation (Articles 1-3, 4(2), (5-11, and 13), as amended by:

No 996/2010

Regulation of the European Parliament and of the Council of 20 October 2010 on the investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC

No 2004/36

—Commission Directive 2008/49/EC

Directive of the Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports (Articles 1-9, and 11-14), as last amended by:

No 351/2008

Commission Regulation of 16 April 2008 implementing Directive 2004/36/EC of the European Parliament and of the Council as regards the prioritisation of ramp inspections on aircraft using Community airports

No 768/2006

Commission Regulation of 19 May 2006 implementing Directive 2004/36/EC of the European Parliament and of the Council as regards the collection and exchange of information on the safety of aircraft using Community airports and the management of the information system

No 2003/42

Directive of the European Parliament and the Council of 13 June 2003 on occurrence reporting in civil aviation (Articles 1-12)

No 1321/2007

Commission Regulation of 12 November 2007 laying down implementing rules for the integration into a central repository of information on civil aviation occurrences exchanged in accordance with Directive 2003/42/EC of the European Parliament and of the Council

No 1330/2007

Commission Regulation of 24 September 2007 laying down implementing rules for the dissemination to interested parties of information on civil aviation occurrences referred to in Article 7(2) of Directive 2003/42/EC of the European Parliament and of the Council

No 736/2006

Commission Regulation of 16 May 2006 on working methods of the European Aviation Safety Agency for conducting standardisation inspections

No 1702/2003

—Commission Regulation (EC) No 335/2007,

—Commission Regulation (EC) No 381/2005,

—Commission Regulation (EC) No 375/2007,

—Commission Regulation (EC) No 706/2006,

—Commission Regulation (EC) No 287/2008,

—Commission Regulation (EC) No 1057/2008,

—Commission Regulation (EC) No 1194/2009,

—Commission Implementing Regulation (EU) No 90/2012

Regulation of 24 September 2003 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations, as amended by:

For the purposes of this Agreement, the provisions of the Regulation shall be read subject to the following adjustment:

Article 2 is amended as follows:

In paragraphs 3, 4, 6, 8, 10, 11, 13 and 14, the date "28 September 2003" shall be replaced by "the date of entry into force of the Decision the Community/Switzerland Air Transport Committee which incorporates Regulation (EC) No 216/2008 into the Annex to the Regulation."

No 2042/2003

—Commission Regulation (EC) No 707/2006,

—Commission Regulation (EC) No 376/2007,

—Commission Regulation (EC) No 1056/2008,

—Commission Regulation (EU) No 127/2010,

—Commission Regulation (EU) No 962/2010,

—Commission Regulation (EU) No 1149/2011,

—Commission Regulation (EU) No 593/2012

Commission Regulation of 20 November 2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks, as amended by:

No 104/2004

Commission Regulation of 22 January 2004 laying down rules on the organisation and composition of the Board of Appeal of the European Aviation Safety Agency

No 593/2007

—Commission Regulation (EC) No 1356/2008,

—Commission Regulation (EU) No 494/2012

Commission Regulation of 31 May 2007 on the fees and charges levied by the European Aviation Safety Agency, as last amended by:

No 2111/2005

Regulation of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier, and repealing Article 9 of directive 2004/36/EC

No 473/2006

Commission Regulation of 22 March 2006 laying down implementing rules for the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council

No 474/2006

—Commission Implementing Regulation (EU) No 295/2012^note

Commission Regulation of 22 March 2006 establishing the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council, as last amended by:

No 1332/2011

Commission Regulation of 16 December 2011 laying down common airspace usage requirements and operating procedures for airborne collision avoidance

No 646/2012

Commission Implementing Regulation of 16 July 2012 laying down detailed rules on fines and periodic penalty payments pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council

No 748/2012

Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations

4. Aviation Security

No 300/2008

Regulation of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002

No 272/2009

—Commission Regulation (EU) No 297/2010,

—Commission Regulation (EU) No 720/2011,

—Commission Regulation (EU) No 1141/2011

Commission Regulation of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council, as amended by:

No 1254/2009

Commission Regulation (EU) of 18 December 2009 setting criteria to allow Member States to derogate from the common basic standards on civil aviation security and to adopt alternative security measures

No 18/2010

Commission Regulation (EU) of 8 January 2010 amending Regulation (EC) No 300/2008 of the European Parliament and of the Council as far as specifications for national quality control programmes in the field of civil aviation security are concerned

No 72/2010

Commission Regulation (EU) of 26 January 2010 laying down procedures for conducting Commission inspections in the field of aviation security

No 185/2010

—Commission Regulation (EU) No 357/2010,

—Commission Implementing Regulation (EU) No 711/2012,

—Commission Implementing Regulation (EU) No 1082/2012

—Commission Regulation (EU) No 358/2010,

—Commission Regulation (EU) No 573/2010,

—Commission Regulation (EU) No 983/2010,

—Commission Regulation (EU) No 334/2011,

—Commission Implementing Regulation (EU) No 859/2011,

—Commission Implementing Regulation (EU) No 1087/2011,

—Commission Implementing Regulation (EU) No 1147/2011,

—Commission Implementing Regulation (EU) No 173/2012,

Commission Regulation (EU) of 4 March 2010 laying down detailed measures for the implementation of the common basic standards on aviation security, as amended by:

No 2010/774

—Commission Decision 2010/2604/EU,

—Commission Decision 2010/3572/EU,

—Commission Decision 2010/9139/EU,

—Commission Implementing Decision 2011/5862/EU,

—Commission Implementing Decision 2011/8042/EU,

—Commission Implementing Decision 2011/9407/EU,

—Commission Implementing Decision 2012/1228/EU,

—Commission Implementing Decision 2012/5672/EU,

—Commission Implementing Decision 2012/5880/EU.

Commission Decision (EU) of 13 April 2010 laying down detailed measures for the implementation of the common basic standards on aviation security containing information as referred to in Point (a) of Article 18 of Regulation (EC) No 300/2008, as amended by:

5. Air traffic management

No 549/2004

—Regulation (EC) No 1070/2009

Regulation of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the Single European Sky (the Framework Regulation), as amended by:

The Commission shall enjoy in Switzerland the powers granted to it pursuant to Articles 6, 8, 10, 11 and 12.

Article 10 shall be amended as follows:

In paragraph 2, the words "at Community level" should be replaced by words "at Community level, involving Switzerland".

Notwithstanding the horizontal adjustment referred to in the second indent of the Annex to the Agreement between the European Community and the Swiss Confederation on Air Transport, the references to the “Member States” made in Article 5 of Regulation (EC) No 549/2004 or in the provisions of Decision 1999/468/EC mentioned in that provision shall not be understood to apply to Switzerland.

No 550/2004

(a)Article 3 shall be amended as follows:In paragraph 2, the words "and Switzerland" shall be inserted after the words "the Community".

(b)Article 7 is amended as follows:In paragraph 1 and paragraph 6, the words "and Switzerland" shall be inserted after the words "the Community".

(c)Article 8 is amended as follows:In paragraph 1, the words "and Switzerland" shall be inserted after the words "the Community".

(d)Article 10 is amended as follows:In paragraph 1, the words "and Switzerland" shall be inserted after the words "the Community".

(e)Article 16(3) is replaced by the following:"3.The Commission shall address its decision to the Member States and inform the service provider thereof, in so far as it is legally concerned."

—Regulation (EC) No 1070/2009

Regulation of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the Single European Sky (the Service Provision Regulation), as amended by:

The Commission shall enjoy towards Switzerland the powers granted to it pursuant to Articles 9a, 9b, 15a, 16 and 17.

The provisions of the Regulation shall, for the purposes of this Agreement, be amended as follows:

No 551/2004

—Regulation (EC) No 1070/2009

Regulation of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the Single European Sky (the Airspace Regulation), as amended by:

The Commission shall enjoy in Switzerland the powers granted to it pursuant to Articles 3a, 6 and 10.

No 552/2004

(a)Article 5 is amended as follows:In paragraph 2, the words "or Switzerland" shall be inserted after the words "the Community".

(b)Article 7 is amended as follows:In paragraph 4, the words "or Switzerland" shall be inserted after the words "the Community".

(c)Annex III shall be amended as follows:In section 3, second and last indents, the words "or Switzerland" shall be inserted after the words "the Community".

—Regulation (EC) No 1070/2009

Regulation of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the Interoperability Regulation), as amended by:

The Commission shall enjoy in Switzerland the powers granted to it pursuant to Articles 4, 7 and 10(3).

The provisions of the Regulation shall, for the purposes of this Agreement, be amended as follows:

No 2150/2005

Commission Regulation of 23 December 2005 laying down common rules for the flexible use of airspace

No 1033/2006

—Commission Regulation (EU) No 929/2010

Commission Regulation of 4 July 2006 laying down the requirements on procedures for flight plans in the pre-flight phase for the Single European Sky, as last amended by:

No 1032/2006

—Commission Regulation (EC) No 30/2009

Commission Regulation of 6 July 2006 laying down requirements for automatic systems for the exchange of flight data for the purpose of notification, coordination and transfer of flights between air traffic control units, as last amended by:

No 1794/2006

—Commission Regulation (EU) No 1191/2010

Commission Regulation of 6 December 2006 laying down a common charging scheme for air navigation services (to be applied by Switzerland as from the entry into force of the relevant Swiss legislation but at the latest as from 1 January 2012), as last amended by:

No 2006/23

Directive of the European Parliament and of the Council of 5 April 2006 on a Community air traffic controller licence

No 730/2006

Commission Regulation of 11 May 2006 on airspace classification and access of flights operated under visual flight rules above flight level 195

No 219/2007

—Council Regulation (EC) No 1361/2008

Council Regulation of 27 February 2007 on the establishment of a Joint Undertaking to develop the new generation European air traffic management system (SESAR), as last amended by:

No 633/2007

—Commission Regulation (EU) No 283/2011

Commission Regulation of 7 June 2007 laying down requirements for the application of a flight message transfer protocol used for the purpose of notification, coordination and transfer of flights between air traffic control units, as amended by:

No 1265/2007

Commission Regulation of 26 October 2007 laying down requirements on air-ground voice channel spacing for the Single European Sky

No 482/2008

Commission Regulation of 30 May 2008 establishing a software safety assurance system to be implemented by air navigation service providers and amending Annex II to Regulation (EC) N^o 2096/2005

No 29/2009

Commission Regulation of 16 January 2009 laying down requirements on data link services for the Single European Sky

The text of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

"Switzerland UIR" is added in Annex I, part A.

No 262/2009

Commission Regulation of 30 March 2009 laying down requirements for the coordinated allocation and use of Mode S interrogator codes for the Single European Sky

No 73/2010

Commission Regulation of 26 January 2010 laying down requirements on the quality of aeronautical data and aeronautical information for the Single European Sky

No 255/2010

Commission Regulation of 25 March 2010 laying down common rules on air traffic flow management

No 691/2010

—Commission Implementing Regulation (EU) No 1216/2011

Commission Regulation of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) N^o 2096/2005 laying down common requirements for the provision of air navigation services, as amended by:

Corrective measures adopted by the Commission under Article 14 paragraph 3 of the Regulation are mandatory for Switzerland after having been adopted by a decision of the Joint Committee

No 2010/5134

Commission Decision of 29 July 2010 on the designation of the Performance Review Body of the Single European Sky

No 2010/5110

Commission Decision of 12 August 2010 on the designation of a functional airspace blocks system coordinator in the context of the Single European Sky

No 176/2011

Commission Regulation of 24 February 2011 on the information to be provided before the establishment and modification of a functional airspace block

No 2011/121

Commission Decision of 21 February 2011 setting the European Union-wide performance targets and alert thresholds for the provision of air navigation services for the years 2012 to 2014

No 677/2011

Commission Regulation of 7 July 2011 laying down detailed rules for the implementation of air traffic management (ATM) network functions and amending Regulation (EU) No 691/2010

No 2011/4130

Commission Decision of 7 July 2011 on the nomination of the Network Manager for the air traffic management (ATM) network functions of the single European sky

No 1034/2011

Commission Implementing Regulation of 17 October 2011 on safety oversight in air traffic management and air navigation services and amending Regulation (EU) No 691/2010

No 1035/2011

Commission Implementing Regulation of 17 October 2011 laying down common requirements for the provision of air navigation services and amending Regulations (EC) No 482/2008 and (EU) No 691/2010

No 1206/2011

Commission Implementing Regulation of 22 November 2011 laying down requirements on aircraft identification for surveillance for the single European sky

The text of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

"Switzerland UIR" is added in Annex I.

No 1207/2011

Commission Implementing Regulation of 22 November 2011 laying down requirements for the performance and the interoperability of surveillance for the single European sky

6. Environment and noise

No 2002/30

Directive of the European Parliament and of the Council of 26 March 2002 on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Community airports (Articles 1-12, and 14-18)

(The amendments to Annex I, arising from Annex II, Chapter 8 (Transport policy), Section G (Air transport), point 2 of the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, shall apply).

No 89/629

Council Directive of 4 December 1989 on the limitation of noise emissions from civil subsonic jet aeroplanes

(Articles 1-8)

No 2006/93/EC

Directive of the European Parliament and of the Council of 12 December 2006 on the regulation of the operation of aeroplanes covered by Part II, Chapter 3, Volume 1 of Annex 16 to the Convention on International Civil Aviation, second edition (1988).

7. Consumer protection

No 90/314

Council Directive of 13 June 1990 on package travel, package holidays and package tours.

(Articles 1-10)

No 93/13

Council Directive of 5 April 1993 on unfair terms in consumer contracts.

(Articles 1-11)

No 2027/97

—Regulation (EC) No 889/2002

Council Regulation of 9 October 1997 on air carrier liability in the event of accidents (Articles 1-8), as amended by:

No 261/2004

Regulation of the Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91

(Articles 1-18)

No 1107/2006

Regulation of the European Parliament and of the Council of 5 July 2006 concerning the right of disabled persons and persons with reduced mobility when travelling by air.

8. Miscellaneous

No 2003/96

Council Directive of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity

(Article 14(1)(b), and Article 14(2).

9. Annexes

AProtocol on the Privileges and Immunities of the European UnionBProvisions on financial control by the European Union as regards Swiss participants in activities of the EASA

Appendix

Procedures for the application in switzerland of the protocol on privileges and immunities of the european union

1. Extension of application to Switzerland

Wherever the Protocol on the privileges and immunities of the European Union (hereinafter called "the Protocol") contains references to Member States, the references are to be understood to apply equally to Switzerland, unless the following provisions determine otherwise.

2. Exemption of the Agency from indirect taxation (including VAT)

Goods and services exported from Switzerland are not to be subject to Swiss value added tax (VAT). In the case of goods and services provided to the Agency in Switzerland for its official use, in accordance with the second paragraph of Article 3 of the Protocol, exemption from VAT is by way of refund. Exemption from VAT shall be granted if the actual purchase price of the goods and services mentioned in the invoice or equivalent document totals at least 100 Swiss francs (inclusive of tax).

The VAT refund is to be granted on presentation to the Federal Tax Administration's VAT Main Division of the Swiss forms provided for the purpose. As a rule, refund applications must be processed within the three months following the date on which they were lodged together with the necessary supporting documents.

3. Procedures for the application of the rules relating to the Agency's staff

As regards the second paragraph of Article 12 of the Protocol, Switzerland shall exempt, according to the principles of its national law, officials and other servants of the Agency within the meaning of Article 2 of Regulation (Euratom, ECSC, EEC) No 549/69^note from federal, cantonal and communal taxes on salaries, wages and emoluments paid to them by the European Union and subject to an internal tax for its own benefit.

Switzerland shall not be considered as a Member State within the meaning of point 1 above for the application of Article 13 of the Protocol.

Officials and other servants of the Agency and members of their families who are members of the social insurance system applicable to officials and other servants of the European Union are not obliged to be members of the Swiss social security system.

The Court of Justice of the European Union shall have exclusive jurisdiction in any matters concerning relations between the Agency or the Commission and its staff with regard to the application of Council Regulation (EEC, Euratom, ECSC) No 259/68^note and the other provisions of the European Union law laying down working conditions.

TACs applicable to EU vessels in areas where TACs exist by species and by area

The following tables set out the TACs and quotas (in tonnes live weight, except where otherwise specified) by stock, and conditions functionally linked thereto, where appropriate.

Fish stocks are referred to following the alphabetical order of the Latin names of the species. For the purposes of this Regulation, the following comparative table of Latin names and common names is provided:

Scientific name	Alpha-3 code	Common name
Psetta maxima	TUR	Turbot
Sprattus sprattus	SPR	Sprat

SpeciesTurbotPsetta maxima	ZoneEU waters in the Black SeaTUR/F37.4.2.C.
Bulgaria	43,2	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Romania	43,2
Union	86,4^note
TAC	Not relevant

SpeciesSpratSprattus sprattus	ZoneEU waters in the Black SeaSPR/F37.4.2.C
Bulgaria	8032,5	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Romania	3442,5
Union	11475
TAC	Not relevant

The references to fishing zones are references to ICES zones, unless otherwise specified.

PART 1 — Definition of species and species groups

2.For the purposes of this Regulation, ‘deep-sea sharks’ means the following list of species:Common name | Alpha-3 code | Scientific nameDeep-water catsharks | API | Apristurus spp.Frilled shark | HXC | Chlamydoselachus anguineusGulper shark | GUP | Centrophorus granulosusLeafscale gulper shark | GUQ | Centrophorus squamosusPortuguese dogfish | CYO | Centroscymnus coelolepisLongnose velvet dogfish | CYP | Centroscymnus crepidaterBlack dogfish | CFB | Centroscyllium fabriciiBirdbeak dogfish | DCA | Deania calceaKitefin shark | SCK | Dalatias lichaGreater lanternshark | ETR | Etmopterus princepsVelvet belly | ETX | Etmopterus spinaxBlackmouth catshark (Blackmouth dogfish) | SHO | Galeus melastomusMouse catshark | GAM | Galeus murinusBluntnose six-gill shark | SBL | Hexanchus griseusSailfin roughshark (Sharpback shark) | OXN | Oxynotus paradoxusKnifetooth dogfish | SYR | Scymnodon ringensGreenland shark | GSK | Somniosus microcephalus

PART 2 — Annual fishing opportunities applicable for EU vessels in areas where TACs exist by species and by area (in tonnes live weight)

SpeciesDeep-sea sharks	ZoneEU and international waters of V, VI, VII, VIII and IX (DWS/56789-)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Germany	0	0
Estonia	0	0
Ireland	0	0
Spain	0	0
France	0	0
Lithuania	0	0
Poland	0	0
Portugal	0	0
United Kingdom	0	0
Union	0	0
TAC	0	0

SpeciesDeep-sea sharks	ZoneEU and international waters of X (DWS/10-)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Portugal	0	0
Union	0	0
TAC	0	0

SpeciesDeep-sea sharks, Deania hystricosa and Deania profundorum	ZoneInternational waters of XII (DWS/12INT-)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Ireland	0	0
Spain	0	0
France	0	0
United Kingdom	0	0
Union	0	0
TAC	0	0

SpeciesBlack scabbardfishAphanopus carbo	ZoneEU and international waters of I, II, III and IV (BSF/1234-)
Year	2013	2014	Precautionary TAC
Germany	3	3
France	3	3
United Kingdom	3	3
Union	9	9
TAC	9	9

SpeciesBlack scabbardfishAphanopus carbo	ZoneEU and international waters of V, VI, VII and XII (BSF/56712-)
Year	2013	2014	Analytical TAC
Germany	35	46
Estonia	17	22
Ireland	87	113
Spain	174	226
France	2440	3172
Latvia	113	147
Lithuania	1	1
Poland	1	1
United Kingdom	174	226
Others^note	9	12
Union	3051	3966
TAC	3051	3966

SpeciesBlack scabbardfishAphanopus carbo	ZoneEU and international waters of VIII, IX and X (BSF/8910-)
Year	2013	2014	Analytical TAC
Spain	12	12
France	29	29
Portugal	3659	3659
Union	3700	3700
TAC	3700	3700

SpeciesBlack scabbardfishAphanopus carbo	ZoneEU and international waters of CECAF 34.1.2. (BSF/C3412-)
Year	2013	2014	Precautionary TAC
Portugal	3674	3490
Union	3674	3490
TAC	3674	3490

SpeciesAlfonsinosBeryx spp.	ZoneEU and international waters of III, IV, V, VI, VII, VIII, IX, X, XII and XIV (ALF/3X14-)
Year	2013	2014	Analytical TAC
Ireland	10	9
Spain	70	67
France	19	18
Portugal	203	193
United Kingdom	10	9
Union	312	296
TAC	312	296

SpeciesRoundnose grenadierCoryphaenoides rupestris	ZoneEU and international waters of I, II and IV (RNG/124-)
Year	2013	2014	Precautionary TAC
Denmark	1	1
Germany	1	1
France	10	10
United Kingdom	1	1
Union	13	13
TAC	13	13

SpeciesRoundnose grenadierCoryphaenoides rupestris	ZoneEU and international waters of III (RNG/03-)^note
Year	2013	2014	Precautionary TAC
Denmark	643	515
Germany	4	3
Sweden	33	26
Union	680	544
TAC	680	544

SpeciesRoundnose grenadierCoryphaenoides rupestris	ZoneEU and international waters of Vb, VI, VII (RNG/5B67-)
Year	2013^note	2014^note	Analytical TAC
Germany	8	8
Estonia	63	63
Ireland	279	279
Spain	70	70
France	3539	3539
Lithuania	81	81
Poland	41	41
United Kingdom	208	208
Others^note	8	8
Union	4297	4297
TAC	4297	4297

SpeciesRoundnose grenadierCoryphaenoides rupestris	ZoneEU and international waters of VIII, IX, X, XII and XIV (RNG/8X14-)
Year	2013^note	2014^note	Analytical TAC
Germany	23	21
Ireland	5	4
Spain	2573	2317
France	119	107
Latvia	41	37
Lithuania	5	4
Poland	805	724
United Kingdom	10	9
Union	3581	3223
TAC	3581	3223

SpeciesOrange roughyHoplostethus atlanticus	ZoneEU and international waters of VI (ORY/06-)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Ireland	0	0
Spain	0	0
France	0	0
United Kingdom	0	0
Union	0	0
TAC	0	0

SpeciesOrange roughyHoplostethus atlanticus	ZoneEU and international waters of VII (ORY/07-)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Ireland	0	0
Spain	0	0
France	0	0
United Kingdom	0	0
Others	0	0
Union	0	0
TAC	0	0

SpeciesOrange roughyHoplostethus atlanticus	ZoneEU and international waters of I, II, III, IV, V, VIII, IX, X, XII and XIV (ORY/1CX14)
Year	2013	2014	Analytical TACArticle 3 of Regulation (EC) No 847/96 shall not apply.Article 4 of Regulation (EC) No 847/96 shall not apply.
Ireland	0	0
Spain	0	0
France	0	0
Portugal	0	0
United Kingdom	0	0
Union	0	0
TAC	0	0

SpeciesRed seabreamPagellus bogaraveo	ZoneEU and international waters of VI, VII and VIII (SBR/678-)
Year	2013	2014	Analytical TAC
Ireland	6	5
Spain	156	143
France	8	7
United Kingdom	20	18
Others^note	6	5
Union	196	178
TAC	196	178

SpeciesRed seabreamPagellus bogaraveo	ZoneEU and international waters of IX (SBR/09-)
Year	2013^note	2014^note	Analytical TAC
Spain	614	614
Portugal	166	166
Union	780	780
TAC	780	780

SpeciesRed seabreamPagellus bogaraveo	ZoneEU and international waters of X (SBR/10-)
Year	2013	2014	Analytical TAC
Spain	9	8
Portugal	1004	904
United Kingdom	9	8
Union	1022	920
TAC	1022	920

SpeciesGreater ForkbeardPhycis blennoides	ZoneEU and international waters of I, II, III and IV (GFB/1234-)
Year	2013	2014	Analytical TAC
Germany	9	9
France	9	9
United Kingdom	13	13
Union	31	31
TAC	31	31

SpeciesGreater ForkbeardPhycis blennoides	ZoneEU and international waters of V, VI and VII (GFB/567-)
Year	2013^note	2014^note	Analytical TAC
Germany	10	10
Ireland	260	260
Spain	588	588
France	356	356
United Kingdom	814	814
Union	2028	2028
TAC	2028	2028

SpeciesGreater ForkbeardPhycis blennoides	ZoneEU and international waters of VIII and IX (GFB/89-)
Year	2013^note	2014^note	Analytical TAC
Spain	242	242
France	15	15
Portugal	10	10
Union	267	267
TAC	267	267

SpeciesGreater ForkbeardPhycis blennoides	ZoneEU and international waters of X and XII (GFB/1012-)
Year	2013	2014	Analytical TAC
France	9	9
Portugal	36	36
United Kingdom	9	9
Union	54	54
TAC	54	54