Council Regulation (EU) No 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011
CHAPTER I DEFINITIONS
Article 1
For the purposes of this Regulation, the following definitions shall apply:
- (a) ‘branch’ of a financial or credit institution means a place of business which forms a legally dependent part of a financial or credit institution and which carries out directly all or some of the transactions inherent in the business of financial or credit institutions;
- (b) ‘brokering services’ means:
- (i) the negotiation or arrangement of transactions for the purchase, sale or supply of goods and technology from a third country to any other third country, or
- (ii) the selling or buying of goods and technology that are located in third countries for their transfer to another third country;
- (c) ‘contract or transaction’ means any transaction of whatever form and whatever the applicable law, whether comprising one or more contracts or similar obligations made between the same or different parties; for this purpose ‘contract’ includes a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, and credit, whether legally independent or not, as well as any related provision arising under, or in connection with, the transaction;
- (d) ‘credit institution’ means a credit institution as defined in Article 4(1) of Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions ([^E0001]), including its branches inside or outside the Union;
- (e) ‘crude oil and petroleum products’ means the products listed in Annex IV;
- (f) ‘economic resources’ means assets of every kind, whether tangible or intangible, movable or immovable, which are not funds, but which may be used to obtain funds, goods or services;
- (g) ‘financial institution’ means:
- (i) an undertaking, other than a credit institution, which carries out one or more of the operations included in points 2 to 12 and points 14 and 15 of Annex I to Directive 2006/48/EC, including the activities of currency exchange offices (bureaux de change);
- (ii) an insurance company duly authorised in accordance with Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance ([^E0002]), insofar as it carries out activities covered by that Directive;
- (iii) an investment firm as defined in point 1 of Article 4(1) of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments ([^E0003]);
- (iv) a collective investment undertaking marketing its units or shares; or
- (v) an insurance intermediary as defined in Article 2(5) of Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation ([^E0004]), with the exception of intermediaries referred to in Article 2(7) of that Directive, when they act in respect of life insurance and other investment related services; including its branches, whether inside or outside the Union;
- (h) ‘freezing of economic resources’ means preventing their use to obtain funds, goods or services in any way, including, but not limited to, by selling, hiring or mortgaging them;
- (i) ‘freezing of funds’ means preventing any move, transfer, alteration, use of, access to, or dealing with funds in any way that would result in any change in their volume, amount, location, ownership, possession, character, destination or other change that would enable the funds to be used, including portfolio management;
- (j) ‘funds’ means financial assets and benefits of every kind, including but not limited to:
- (i) cash, cheques, claims on money, drafts, money orders and other payment instruments;
- (ii) deposits with financial institutions or other entities, balances on accounts, debts and debt obligations;
- (iii) publicly- and privately-traded securities and debt instruments, including stocks and shares, certificates representing securities, bonds, notes, warrants, debentures and derivatives contracts;
- (iv) interest, dividends or other income on or value accruing from or generated by assets;
- (v) credit, right of set-off, guarantees, performance bonds or other financial commitments;
- (vi) letters of credit, bills of lading, bills of sale;
- (vii) documents evidencing an interest in funds or financial resources;
- (k) ‘goods’ includes items, materials and equipment;
- (l) ‘insurance’ means an undertaking or commitment whereby one or more natural or legal persons are obliged, in return for payment, to provide one or more other persons, in the event of materialisation of a risk, with an indemnity or a benefit as determined by the undertaking or commitment;
- (m) ‘reinsurance’ means the activity consisting in accepting risks ceded by an insurance undertaking or by another reinsurance undertaking or, in the case of the association of underwriters known as Lloyd's, the activity consisting in accepting risks, ceded by any member of Lloyd's, by an insurance or reinsurance undertaking other than the association of underwriters known as Lloyd's;
- (n) ‘Syrian credit or financial institution’ means:
- (i) any credit or financial institution domiciled in Syria, including the Central Bank of Syria;
- (ii) any branch or subsidiary, where it falls within the scope of Article 35, of a credit or financial institution domiciled in Syria;
- (iii) any branch or subsidiary, where it does not fall within the scope of Article 35, of a credit or financial institution domiciled in Syria;
- (iv) any credit or financial institution that is not domiciled in Syria but is controlled by one or more persons or entities domiciled in Syria;
- (o) ‘Syrian person, entity or body’ means:
- (i) the State of Syria or any public authority thereof;
- (ii) any natural person in, or resident in, Syria;
- (iii) any legal person, entity or body having its registered office in Syria;
- (iv) any legal person, entity or body, inside or outside Syria, owned or controlled directly or indirectly by one or more of the above-mentioned persons or bodies;
- (p) ‘technical assistance’ means any technical support related to repairs, development, manufacture, assembly, testing, maintenance, or any other technical service, and may take forms such as instruction, advice, training, the transmission of working knowledge or skills or consulting services; including verbal forms of assistance;
- (q) ‘territory of the Union’ means the territories of the Member States to which the Treaty is applicable, under the conditions laid down in the Treaty, including their airspace;
- (r) ‘customs territory of the Union’ means the territory as defined in Article 3 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code ([^E0005]).
CHAPTER II EXPORT AND IMPORT RESTRICTIONS
Article 2
A Member State may prohibit or impose an authorisation requirement on the export, sale, supply or transfer of equipment which might be used for internal repression other than those listed in Annex IA or Annex IX, whether or not originating in the Union, to any person, entity or body in Syria or for use in Syria.
A Member State may prohibit or impose an authorisation requirement on the provision of technical assistance, financing and financial assistance related to the equipment referred to in paragraph 1, to any person, entity or body in Syria or for use in Syria.
Article 2a
It shall be prohibited:
- (a) to sell, supply, transfer or export, directly or indirectly, equipment, goods or technology which might be used for internal repression or for the manufacture and maintenance of products which might be used for internal repression, as listed in Annex IA, whether or not originating in the Union, to any person, entity or body in Syria or for use in Syria;
- (b) to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the prohibitions referred to in point (a).
By way of derogation from paragraph 1, the competent authorities in the Member States, as identified on the websites listed in Annex III, may grant, under such terms and conditions as they deem appropriate, an authorisation for a transaction in relation to equipment, goods or technology as listed in Annex IA, provided that the equipment, goods or technology are intended for food, agricultural, medical or other humanitarian purposes, or for the benefit of United Nations personnel, personnel of the Union or its Member States.
By way of derogation from paragraph 1(a), the competent authorities of the Member States, as identified on the websites listed in Annex III, may grant, under such conditions as they deem appropriate, an authorisation for sale, supply, transfer or export of equipment, goods or technology as listed in Annex IA undertaken in accordance with paragraph 10 of UN Security Council Resolution 2118(2013) and relevant decisions of the Executive Council of the Organisation for the Prohibition of Chemical Weapons (OPCW), consistent with the objective of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (Chemical Weapons Convention) and after consultation with the OPCW.
Article 2b
A prior authorisation shall be required for the sale, supply, transfer or export, directly or indirectly, of equipment, goods or technology which might be used for internal repression or for the manufacture and maintenance of products which might be used for internal repression, as listed in Annex IX, whether or not originating in the Union, to any person, entity or body in Syria or for use in Syria.
The competent authorities in the Member States, as identified on the websites listed in Annex III, shall not grant any authorisation for any sale, supply, transfer or export of the equipment, goods or technology listed in Annex IX, if they have reasonable grounds to determine that the equipment, goods or technology the sale, supply, transfer or export of which is in question is or might be used for internal repression or for the manufacture and maintenance of products which might be used for internal repression.
The authorisation shall be granted by the competent authorities of the Member State where the exporter is established and shall be in accordance with the detailed rules laid down in Article 11 of Council Regulation (EC) No 428/2009 of 5 May 2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items ([^E0006]). The authorisation shall be valid throughout the Union.
Article 2c
The rules governing the obligation to provide advance information as determined in the relevant provisions concerning summary declarations as well as customs declarations in Regulation (EEC) No 2913/92 and in Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 ([^E0007]) apply to all goods leaving the customs territory of the Union to Syria.
The person or entity who provides that information shall also present any authorisations if required by this Regulation.
The seizure and disposal of equipment, goods or technology, the supply, sale, transfer or export of which is prohibited by Article 2a of this Regulation may, in accordance with national legislation or the decision of a competent authority, be carried out at the expense of the person or entity referred to in paragraph 1 or, if it is not possible to recover these expenses from that person or entity, the expenses may, in accordance with national legislation, be recovered from any person or entity who assumes responsibility for the carriage of the goods or equipment in the attempted illicit supply, sale, transfer or export.
Article 2d
A Member State may prohibit or impose an authorisation requirement on the export to Syria of dual-use items referred to in Article 4(2) of Regulation (EC) No 428/2009.
Article 3
It shall be prohibited:
- (a) to provide, directly or indirectly, technical assistance or brokering services related to equipment, goods or technology which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression as listed in Annex IA, to any person, entity or body in Syria or for use in Syria;
- (b) to provide, directly or indirectly, financing or financial assistance related to the goods and technology listed in Annex IA, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for any provision of related technical assistance to any person, entity or body in Syria or for use in Syria;
- (c) to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the prohibitions referred to in points (a) and (b).
By way of derogation from paragraph 1, the competent authorities of the Member States, as identified on the websites listed in Annex III, may grant, under such terms and conditions as they deem appropriate, an authorisation for technical assistance or brokering services, or financing or financial assistance related to equipment, goods or technology, as listed in Annex IA, provided that the equipment, goods or technology are intended for food, agricultural, medical or other humanitarian purposes, or for the benefit of United Nations personnel, personnel of the Union or its Member States.
The Member State concerned shall inform the other Member States and the Commission, within four weeks, of any authorisation granted under the first subparagraph.
Prior authorisation from the competent authority of the relevant Member State, as identified on the websites referred to in Annex III shall be required for the provision of:
- (a) technical assistance or brokering services related to equipment, goods or technology listed in Annex IX and to the provision, manufacture, maintenance and use of such equipment, goods and technology, directly or indirectly to any person, entity or body in Syria or for use in Syria;
- (b) financing or financial assistance related to goods and technology referred to in Annex IX, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such goods and technology, or for any provision of related technical assistance to any person, entity or body in Syria or for use in Syria.
The competent authorities shall not grant any authorisation for the transactions referred to inthe first subparagraph, if they have reasonable grounds to determine that those transactions are or may be intended to contribute to internal repression or for the manufacture and maintenance of products which might be used for internal repression.
By way of derogation from points (a) and (b) of paragraph 1, the competent authorities of the Member States, as identified on the websites listed in Annex III, may grant, under such conditions as they deem appropriate, an authorisation for the provision of technical assistance, brokering services, financing or financial assistance related to equipment, goods or technology as listed in Annex IA where such technical assistance, brokering services, financing or financial assistance is provided for the sale, supply, transfer or export of such equipment, goods or technology undertaken in accordance with paragraph 10 of UN Security Council Resolution 2118(2013) and relevant decisions of the Executive Council of the OPCW, consistent with the objective of Chemical Weapons Convention and after consultation with the OPCW.
Article 3a
It shall be prohibited:
- (a) to provide, directly or indirectly, financing or financial assistance relating to the goods and technology listed in the Common Military List, including financial derivatives, as well as insurance and reinsurance and brokering services relating to insurance and reinsurance for any purchase, import or transport of such items if they originate in Syria, or are being exported from Syria to any other country;
- (b) to participate, knowingly or intentionally, in activities the object or effect of which is to circumvent the prohibitions referred to in point (a).
Article 3b
Article 3a shall not apply to the provision of financing or financial assistance, including financial derivatives, as well as insurance and reinsurance and brokering services relating to insurance and reinsurance for any import or transport of goods and technology listed in the Common Military List if they originate in Syria, or are being exported from Syria to any other country, undertaken in accordance with paragraph 10 of UN Security Council Resolution 2118(2013) and relevant decisions of the Executive Council of the OPCW, consistent with the objective of the Chemical Weapons Convention.
Article 4
It shall be prohibited to sell, supply, transfer or export, directly or indirectly, equipment, technology or software identified in Annex V, whether or not originating in the Union, to any person, entity or body in Syria or for use in Syria, unless the competent authority of the relevant Member State, as identified in the websites referred to in Annex III, has given prior authorisation.
The competent authorities of the Member States, as identified in the websites referred to in Annex III, shall not grant any authorisation under paragraph 1 if they have reasonable grounds to determine that the equipment, technology or software in question would be used for monitoring or interception, by the Syrian regime or on its behalf, of internet or telephone communications in Syria.
Annex V shall include equipment, technology or software which may be used for the monitoring or interception of internet or telephone communications.
The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article, within four weeks following the authorisation.
Article 5
It shall be prohibited:
- (a) to provide, directly or indirectly, technical assistance or brokering services related to the equipment, technology and software identified in Annex V, or related to the provision, manufacture, maintenance and use of the equipment and technology identified in Annex V or to the provision, installation, operation or updating of any software identified in Annex V, to any person, entity or body in Syria or for use in Syria;
- (b) to provide, directly or indirectly, financing or financial assistance related to the equipment, technology and software identified in Annex V, to any person, entity or body in Syria or for use in Syria;
- (c) to provide any telecommunication or internet monitoring or interception services of any kind to, or for the direct or indirect benefit of, the State of Syria, its Government, its public bodies, corporations and agencies or any person or entity acting on their behalf or at their direction; and
- (d) to participate, knowingly and intentionally, in any activity the object or effect of which is to circumvent the prohibitions referred to in point (a), (b) or (c) above;
unless the competent authority of the relevant Member State, as identified in the websites referred to in Annex III, has given prior authorisation, on the basis set out in Article 4(2).
For the purposes of paragraph 1(c), ‘telecommunication or internet monitoring or interception services’ means those services that provide, in particular using equipment, technology or software as identified in Annex V, access to and delivery of a subject's incoming and outgoing telecommunications and call-associated data for the purpose of its extraction, decoding, recording, processing, analysis and storing or any other related activity.
Article 11c
It shall be prohibited to import, export, transfer, or provide brokering services related to the import, export or transfer of, Syrian cultural property goods and other goods of archaeological, historical, cultural, rare scientific or religious importance, including those listed in Annex XI, where there are reasonable grounds to suspect that the goods have been removed from Syria without the consent of their legitimate owner or have been removed in breach of Syrian law or international law, in particular if the goods form an integral part of either the public collections listed in the inventories of the conservation collections of Syrian museums, archives or libraries, or the inventories of Syrian religious institutions.
The prohibition in paragraph 1 shall not apply if it is demonstrated that:
- (a) the goods were exported from Syria prior to 15 March 2011; or
- (b) the goods are being safely returned to their legitimate owners in Syria.
CHAPTER III RESTRICTIONS ON PARTICIPATION IN INFRASTRUCTURE PROJECTS
CHAPTER IV RESTRICTIONS ON FINANCING CERTAIN ENTERPRISES
CHAPTER V FREEZING OF FUNDS AND ECONOMIC RESOURCES
Article 14
All funds and economic resources belonging to, owned, held or controlled by the natural or legal persons, entities and bodies listed in Annex II shall be frozen.
No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of the natural or legal persons, entities or bodies listed in Annex II.
The participation, knowingly and intentionally, in activities the object or effect of which is, directly or indirectly, to circumvent the measures referred to in paragraphs 1 and 2 shall be prohibited.
Article 15
Annex II shall consist of the following:
- (a) Annex II shall consist of a list of natural or legal persons, entities and bodies who, in accordance with Article 19(1) of Decision 2011/782/CFSP, have been identified by the Council as being persons or entities responsible for the violent repression against the civilian population in Syria, persons and entities who have benefited from or supported the al-Assad regime, and natural or legal persons and entities associated with them, and to whom Article 21 of this Regulation shall not apply.
1a. The list in Annex II shall also consist of natural or legal persons, entities and bodies who, in accordance with Article 28(2) of Council Decision 2013/255/CFSP ([^E0024]) have been identified by the Council as falling within one of the following categories:
- (a) leading businesspersons operating in Syria linked to the former al-Assad regime;
- (b) members of the al-Assad or Makhlouf families;
- (c) Syrian Government Ministers in power between May 2011 and December 2024;
- (d) members of the Syrian Armed Forces of the rank of “colonel” and the equivalent or higher in post between May 2011 and December 2024;
- (e) members of the Syrian security and intelligence services in post between May 2011 and December 2024;
- (f) members of the al-Assad regime-affiliated militias; or
- (g) members of entities, units, agencies, bodies or institutions operating in the chemical weapons proliferation sector,
and natural or legal persons and entities associated with them.
1b. Persons, entities and bodies within one of the categories referred to in paragraph 1a shall not be included or retained on the list of persons, entities and bodies in Annex II if there is sufficient information that they are not, or are no longer, associated with the former al-Assad regime or do not exercise influence over it or do not pose a real risk of circumvention.
Annex II shall include the grounds for the listing of listed persons, entities and bodies concerned.
Annex II shall also include, where available, information necessary to identify the natural or legal persons, entities and bodies concerned. With regard to natural persons, such information may include names including aliases, date and place of birth, nationality, passport and ID card numbers, gender, address, if known, and function or profession. With regard to legal persons, entities and bodies, such information may include names, place and date of registration, registration number and place of business.
Article 15a
By way of derogation from Article 14(1), (2) and (3), the competent authorities of a Member State, as identified on the websites listed in Annex III, may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, to the entities listed as Number 42 and Number 43 in Annex II, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary for the cooperation between those entities and a Member State’s governmental entity or body in the areas of reconstruction, capacity-building, counter-terrorism and migration.
In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 1, that authorisation shall be considered granted.
The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraphs 1 and 2 within four weeks of such authorisation.
The participation, knowingly and intentionally, in activities the object or effect of which is, directly or indirectly, to circumvent the measures referred to in paragraphs 1, 2 and 3 shall be prohibited.
Article 16
By way of derogation from Article 14, the competent authorities in the Member States, as identified on the websites listed in Annex III, may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the funds or economic resources are:
- (a) necessary to satisfy the basic needs of natural or legal persons, entities or bodies listed in Annex II, and dependent family members of such natural persons, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;
- (b) intended exclusively for payment of reasonable professional fees and reimbursement of incurred expenses associated with the provision of legal services;
- (c) intended exclusively for payment of fees or service charges for routine holding or maintenance of frozen funds or economic resources;
- (d) necessary for extraordinary expenses, provided that the relevant competent authority has notified the grounds on which it considers that a specific authorisation should be granted to the competent authorities of the other Member States and to the Commission at least two weeks before the authorisation;
- (e) in cases not covered by Article 16b, to be paid into or from an account of a diplomatic or consular mission or an international organisation enjoying immunities in accordance with international law, insofar as such payments are intended to be used for official purposes of the diplomatic or consular mission or international organisation;
- (g) necessary to ensure human safety or environmental protection;
- (h) necessary for evacuations from Syria;
- (i) intended exclusively for payments by Syrian State-owned entities, as listed in Annex II, on behalf of the Syrian Arab Republic to the OPCW for activities related to the OPCW verification mission and the destruction of Syrian chemical weapons, including in particular payments to the OPCW Special Trust Fund for activities related to the complete destruction of Syrian chemical weapons outside the territory of the Syrian Arab Republic.
The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article within four weeks following the authorisation.
Article 16a
The prohibitions set out in Article 14(1) and (2) shall not apply to the making available of funds or economic resources necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:
- (a) the United Nations, including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;
- (b) international organisations;
- (c) humanitarian organisations having observer status with the United Nations General Assembly and members of those humanitarian organisations;
- (d) bilaterally or multilaterally funded non-governmental organisations participating in United Nations Humanitarian Response Plans, United Nations Refugee Response Plans, other United Nations appeals or humanitarian clusters coordinated by the United Nations Office for the Coordination of Humanitarian Affairs;
- (e) organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;
- (f) Member States’ specialised agencies; or
- (g) the employees, grantees, subsidiaries or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.
The prohibition set out in Article 14(2) shall not apply to funds or economic resources made available by public bodies or by legal persons, entities or bodies which receive public funding from the Union or Member States to provide humanitarian relief in Syria or assistance to the civilian population in Syria where the provision of such funds or economic resources is for the purchase or transport of petroleum products, or associated financing or financial assistance, for the sole purposes of providing humanitarian relief in Syria or to provide assistance to the civilian population in Syria in accordance with Article 6a(1).
In cases not covered by paragraphs 1 and 2 of this Article, and by way of derogation from Article 14(1) and (2), the competent authorities of the Member States may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.
In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within five working days of the date of receipt of a request for authorisation under paragraph 2, that authorisation shall be considered to be granted.
The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraph 3 and 4 within 4 weeks of such authorisation.
Article 16b
The prohibition set out in Article 14(2) shall not apply to funds or economic resources made available from the account of a diplomatic or consular mission where the provision of such funds or economic resources is for official purposes of the mission in accordance with Article 6b.
Article 17
By way of derogation from Article 14, the competent authorities in the Member States as identified on the websites listed in Annex III may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as they deem appropriate, after having determined that the provision of such funds or economic resources are necessary for the essential energy needs of the civilian population in Syria, provided that the relevant competent authority has notified for each delivery contract the grounds on which it considers that a specific authorisation should be granted to the competent authorities of the other Member States and to the Commission at least four weeks before the authorisation.
Article 18
By way of derogation from Article 14, the competent authorities in Member States, as indicated on the websites listed in Annex III, may authorise the release of certain frozen funds or economic resources, if the following conditions are met:
- (a) the funds or economic resources are the subject of an arbitral decision rendered prior to the date on which the natural or legal person, entity or body referred to in Article 14 was listed in Annex II, or of a judicial or administrative decision rendered in the Union, or a judicial decision enforceable in the Member State concerned, prior to or after that date;
- (b) the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;
- (c) the decision is not for the benefit of a natural or legal person, entity or body listed in Annex II;
- (d) recognising the decision is not contrary to public policy in the Member State concerned.
The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article.
Article 19
Article 14(2) shall not apply to the addition to frozen accounts of:
- (a) interest or other earnings on those accounts,
- (b) payments due under contracts, agreements or obligations that were concluded or arose before the date on which the account became subject to this Regulation; or
- (c) payments due under judicial, administrative or arbitral decisions rendered in a Member State or enforceable in the Member State concerned,
provided that any such interest, other earnings and payments are frozen in accordance with Article 14(1).
Article 14(2) shall not prevent financial or credit institutions in the Union from crediting frozen accounts where they receive funds transferred to the account of a listed natural or legal person, entity or body, provided that any additions to such accounts will also be frozen. The financial or credit institution shall inform the relevant competent authority about any such transaction without delay.
Article 20
By way of derogation from Article 14 and provided that a payment by a person, entity or body listed in Annex II is due under a contract or agreement that was concluded by, or an obligation that arose for the person, entity or body concerned before, the date on which that person, entity or body had been designated, the competent authorities of the Member States, as indicated on the websites listed in Annex III, may authorise, under such conditions as they deem appropriate, the release of certain frozen funds or economic resources, provided that the payment is not directly or indirectly received by a person or entity referred to in Article 14.
Article 20a
By way of derogation from Article 14, the competent authorities of the Member States, as identified on the websites listed in Annex III, may authorise, under such conditions as they deem appropriate, the transfer by or through a financial entity listed in Annex II of funds or economic resources, where the transfer is related to a payment by a person or entity not listed in Annex II in connection with the provision of financial support to Syrian nationals pursuing an education, professional training or engaged in academic research in the Union, provided that the competent authority of the relevant Member State has determined, on a case-by-case basis, that the payment will not directly or indirectly be received by a person or entity listed in Annex II.
Article 21c
By way of derogation from Article 14, the competent authorities of the Member States, as identified on the websites listed in Annex III, may authorise, under such conditions as they deem appropriate:
- (a) a transfer by or through the Commercial Bank of Syria of funds or economic resources received from outside of the territory of the Union and frozen after the date of its designation where the transfer is related to a payment due in connection with a specific trade contract for medical supplies, food, shelter, sanitation or hygiene for civilian use; or
- (b) a transfer of funds or economic resources from outside of the territory of the Union to or through the Commercial Bank of Syria where the transfer is related to a payment due in connection with a specific trade contract for the purpose of meeting essential civilian needs, including medical supplies, food, shelter, sanitation or hygiene for civilian use;
provided that the competent authority of the relevant Member State has determined, on a case-by-case basis, that the payment will not directly or indirectly be received by any person or entity listed in Annex II and provided that the transfer is not otherwise prohibited by this Regulation.
The Member State concerned shall inform the other Member States and the Commission, within four weeks, of any authorisation granted under this Article.
Article 22
The freezing of funds and economic resources or the refusal to make funds or economic resources available, carried out in good faith on the basis that such action is in accordance with this Regulation, shall not give rise to liability of any kind on the part of the natural or legal person or entity or body implementing it, or its directors or employees, unless it is proved that the funds and economic resources were frozen or withheld as a result of negligence.
CHAPTER VI RESTRICTIONS ON FINANCIAL SERVICES
CHAPTER VIA RESTRICTIONS ON TRANSPORT
CHAPTER VII GENERAL AND FINAL PROVISIONS
Article 27
No claims in connection with any contract or transaction the performance of which has been affected, directly or indirectly, in whole or in part, by the measures imposed under this Regulation, including claims for indemnity or any other claim of that type, such as a claim for compensation or a claim under a guarantee, in particular a claim for extension or payment of a bond, guarantee or indemnity, particularly a financial guarantee or financial indemnity, of whatever form, shall be satisfied, if they are made by:
- (a) designated persons, entities or bodies listed in Annex II;
- (b) any other Syrian person, entity or body, including the Syrian government;
- (c) any person, entity or body acting through or on behalf of one of the persons, entities or bodies referred to in points (a) or (b).
In any proceedings for the enforcement of a claim, the onus of proving that satisfying the claim is not prohibited under paragraph 1 shall be on the person seeking the enforcement of that claim.
This Article is without prejudice to the right of the persons, entities and bodies referred to in paragraph 1 to judicial review of the legality of the non-performance of contractual obligations in accordance with this Regulation.
Article 27a
It shall be prohibited to participate, knowingly and intentionally, in activities the object or effect of which is to circumvent the provisions of Articles 2a, 3 and 3a.
Article 28
The prohibitions set out in this Regulation shall not give rise to any liability of any kind on the part of the natural or legal person, entity or body concerned if they did not know, and had no reasonable cause to suspect, that their actions would infringe the prohibition in question.
Article 29
Without prejudice to the applicable rules concerning reporting, confidentiality and professional secrecy, natural and legal persons, entities and bodies shall:
- (a) supply immediately any information which would facilitate compliance with this Regulation, such as accounts and amounts frozen in accordance with Article 14, to the competent authority in the Member State where they are resident or located, as indicated on the websites listed in Annex III, and shall transmit such information, either directly or through the Member States, to the Commission; and
- (b) cooperate with that competent authority in any verification of this information.
Any information provided or received in accordance with this Article shall be used only for the purposes for which it was provided or received.
Article 30
Member States and the Commission shall immediately inform each other of the measures taken under this Regulation and shall supply each other with any other relevant information at their disposal in connection with this Regulation, in particular information in respect of violation and enforcement problems and judgments handed down by national courts.
Article 31
The Commission shall be empowered to amend Annex III on the basis of information supplied by Member States.
Article 32
Where the Council decides to subject a natural or legal person, entity or body to the measures referred to in Article 14, it shall amend Annex II to accordingly.
The Council shall communicate its decision on the listing referred to in paragraph 1 of this Article, including the grounds therefor, to the person, entity or body concerned, either directly, if the address is known, or through the publication of a notice, providing such person, entity or body with an opportunity to present its observations. In particular, where a person, entity or body is listed in Annex II on the basis that they fall within one of the categories of persons, entities or bodies set out in Article 15(1a), the person, entity or body may present evidence and observations as to why, although they fall within such a category, they consider that their designation is not justified.
Where observations are submitted, or where substantial new evidence is presented, the Council shall review its decision and inform the natural or legal person, entity or body accordingly.
The list in Annex II shall be reviewed at regular intervals and at least every 12 months.
Article 33
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
Member States shall notify the Commission of those rules without delay after 19 January 2012 and shall notify it of any subsequent amendment.
Article 34
Where there is, in this Regulation, a requirement to notify, inform or otherwise communicate with the Commission, the address and other contact details to be used for such communication shall be those indicated in Annex III.
Article 35
This Regulation shall apply:
- (a) within the territory of the Union, including its airspace;
- (b) on board any aircraft or any vessel under the jurisdiction of a Member State;
- (c) to any person inside or outside the territory of the Union who is a national of a Member State;
- (d) to any legal person, entity or body which is incorporated or constituted under the law of a Member State;
- (e) to any legal person, entity or body in respect of any business done in whole or in part within the Union.
Article 36
Regulation (EU) No 442/2011 is repealed.
Article 37
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX Ia
LIST OF EQUIPMENT, GOODS AND TECHNOLOGY REFERRED TO IN ARTICLE 2a
PART 1
Introductory Notes
- 1.This Part comprises goods, software and technology listed in Annex I to Regulation (EC) No 428/2009 ([^E0028]).
- 2.Unless otherwise stated, the reference numbers used in the column below entitled ‘No’ refer to the control list number and the column below entitled ‘Description’ refers to the control descriptions of dual-use items set out in Annex I to Regulation (EC) No 428/2009.
- 3.Definitions of terms between ‘single quotation marks’ are given in a technical note to the relevant item.
- 4.Definitions of terms between ‘double quotation marks’ can be found in Annex I to Regulation (EC) No 428/2009.
General Notes
- 1.The object of the controls contained in this Annex should not be defeated by the export of any non-controlled goods (including plant) containing one or more controlled components when the controlled component or components is/are the principal element of the goods and can feasibly be removed or used for other purposes.
- NB:
In judging whether the controlled component or components is/are to be considered the principal element, it is necessary to weigh the factors of quantity, value and technological know-how involved and other special circumstances which might establish the controlled component or components as the principal element of the goods being procured.
- 2.The items specified in this Annex include both new and used goods.
General Technology Note (GTN)
(To be read in conjunction with Section B of this Part)
- 1.The sale, supply, transfer or export of ‘technology’ which is ‘required’ for the ‘development’, ‘production’ or ‘use’ of goods the sale, supply, transfer or export of which is controlled in Sections A, B, C and D of this Part, is controlled in accordance with the provisions of Section E.
- 2.The ‘technology’‘required’ for the ‘development’, ‘production’ or ‘use’ of goods under control remains under control even when it is applicable to non-controlled goods.
- 3.Controls do not apply to that ‘technology’ which is the minimum necessary for the installation, operation, maintenance (checking) and repair of those goods which are not controlled or the export of which has been authorised in accordance with this Regulation.
- 4.Controls on ‘technology’ transfer do not apply to information ‘in the public domain’, to ‘basic scientific research’ or to the minimum necessary information for patent applications.
A. EQUIPMENT
| No | Description |
|---|---|
| I.B.1A004 | Protective and detection equipment and components, other than those specified in military goods controls, as follows: a. Gas masks, filter canisters and decontamination equipment therefore, designed or modified for defence against any of the following, and specially designed components therefor: 1. Biological agents ‘adapted for use in war’; 2. Radioactive materials ‘adapted for use in war’; 3. Chemical warfare (CW) agents; or 4. ‘Riot control agents’, including: a. α-Bromobenzeneacetonitrile, (Bromobenzyl cyanide) (CA) (CAS 5798-79-8); b. [(2-chlorophenyl) methylene] propanedinitrile, (ο-Chlorobenzylidenemalononitrile) (CS) (CAS 2698-41-1); c. 2-Chloro-1-phenylethanone, Phenylacyl chloride (ω-chloroacetophenone) (CN) (CAS 532-27-4); d. Dibenz-(b,f)-1,4-oxazephine (CR) (CAS 257-07-8); e. 10-Chloro-5,10-dihydrophenarsazine, (Phenarsazine chloride), (Adamsite), (DM) (CAS 578-94-9); f. N-Nonanoylmorpholine, (MPA) (CAS 5299-64-9); b. Protective suits, gloves and shoes, specially designed or modified for defence against any of the following: 1. Biological agents ‘adapted for use in war’; 2. Radioactive materials ‘adapted for use in war’; or 3. Chemical warfare (CW) agents; c. Detection systems, specially designed or modified for detection or identification of any of the following, and specially designed components therefor: 1. Biological agents ‘adapted for use in war’; 2. Radioactive materials ‘adapted for use in war’; or 3. Chemical warfare (CW) agents; d. Electronic equipment designed for automatically detecting or identifying the presence of ‘explosives’ residues and utilising ‘trace detection’ techniques (e.g. surface acoustic wave, ion mobility spectrometry, differential mobility spectrometry, mass spectrometry). Technical Note: ‘Trace detection’ is defined as the capability to detect less than 1 ppm vapour, or 1 mg solid or liquid. Note 1: 1A004.d. does not control equipment specially designed for laboratory use. Note 2: 1A004.d. does not control non-contact walk-through security portals. Note: 1A004 does not control: a. Personal radiation monitoring dosimeters; b. Equipment limited by design or function to protect against hazards specific to residential safety or civil industries, including: 1. mining; 2. quarrying; 3. agriculture; 4. pharmaceutical; 5. medical; 6. veterinary; 7. environmental; 8. waste management; 9. food industry. Technical Notes: 1A004 includes equipment and components that have been identified, successfully tested to national standards or otherwise proven effective, for the detection of or defence against radioactive materials ‘adapted for use in war’, biological agents ‘adapted for use in war’, chemical warfare agents, ‘simulants’ or ‘riot control agents’, even if such equipment or components are used in civil industries such as mining, quarrying, agriculture, pharmaceuticals, medical, veterinary, environmental, waste management, or the food industry. ‘Simulant’ is a substance or material that is used in place of toxic agent (chemical or biological) in training, research, testing or evaluation. |
| I.B.9A012 | ‘Unmanned aerial vehicles’ (‘UAVs’), associated systems, equipment and components, as follows: a. ‘UAVs’ having any of the following: 1. An autonomous flight control and navigation capability (e.g. an autopilot with an Inertial Navigation System); or 2. Capability of controlled-flight out of the direct vision range involving a human operator (e.g. televisual remote control); b. Associated systems, equipment and components, as follows: 1. Equipment specially designed for remotely controlling the ‘UAVs’ specified in 9A012.a.; 2. Systems for navigation, attitude, guidance or control, other than those specified in 7A in Annex I to Regulation (EC) No 428/2009 and specially designed to provide autonomous flight control or navigation capability to ‘UAVs’ specified in 9A012.a.; 3. Equipment and components, specially designed to convert a manned ‘aircraft’ to a ‘UAV’ specified in 9A012.a.; 4. Air breathing reciprocating or rotary internal combustion type engines, specially designed or modified to propel ‘UAVs’ at altitudes above 50 000 feet (15 240 metres). |
| I.B.9A350 | Spraying or fogging systems, specially designed or modified for fitting to aircraft, ‘lighter-than-air vehicles’ or unmanned aerial vehicles, and specially designed components therefor, as follows: Complete spraying or fogging systems capable of delivering, from a liquid suspension, an initial droplet ‘VMD’ of less than 50 μm at a flow rate of greater than two litres per minute; Spray booms or arrays of aerosol generating units capable of delivering, from a liquid suspension, an initial droplet ‘VMD’ of less than 50 μm at a flow rate of greater than two litres per minute; Aerosol generating units specially designed for fitting to systems specified in 9A350.a. and b. Note: Aerosol generating units are devices specially designed or modified for fitting to aircraft such as nozzles, rotary drum atomisers and similar devices. Note: 9A350 does not control spraying or fogging systems and components that are demonstrated not to be capable of delivering biological agents in the form of infectious aerosols. Technical Notes: 1. Droplet size for spray equipment or nozzles specially designed for use on aircraft, ‘lighter-than-air vehicles’ or unmanned aerial vehicles should be measured using either of the following: a. Doppler laser method; b. Forward laser diffraction method. 2. In 9A350 ‘VMD’ means Volume Median Diameter and for water-based systems this equates to Mass Median Diameter (MMD). |
B. TEST AND PRODUCTION EQUIPMENT
| No | Description |
|---|---|
| I.B.2B350 | Chemical manufacturing facilities, equipment and components, as follows: a. Reaction vessels or reactors, with or without agitators, with total internal (geometric) volume greater than 0,1 m3 (100 litres) and less than 20 m3 (20 000 litres), where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coating or glass lining); 4. Nickel or ‘alloys’ with more than 40 % nickel by weight; 5. Tantalum or tantalum ‘alloys’; 6. Titanium or titanium ‘alloys’; 7. Zirconium or zirconium ‘alloys’; or 8. Niobium (columbium) or niobium ‘alloys’; b. Agitators for use in reaction vessels or reactors specified in 2B350.a.; and impellers, blades or shafts designed for such agitators, where all surfaces of the agitator that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Nickel or ‘alloys’ with more than 40 % nickel by weight; 5. Tantalum or tantalum ‘alloys’; 6. Titanium or titanium ‘alloys’; 7. Zirconium or zirconium ‘alloys’; or 8. Niobium (columbium) or niobium ‘alloys’; c. Storage tanks, containers or receivers with a total internal (geometric) volume greater than 0,1 m3 (100 litres) where all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Nickel or ‘alloys’ with more than 40 % nickel by weight; 5. Tantalum or tantalum ‘alloys’; 6. Titanium or titanium ‘alloys’; 7. Zirconium or zirconium ‘alloys’; or 8. Niobium (columbium) or niobium ‘alloys’; d. Heat exchangers or condensers with a heat transfer surface area greater than 0,15 m2, and less than 20 m2; and tubes, plates, coils or blocks (cores) designed for such heat exchangers or condensers, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Graphite or ‘carbon graphite’; 5. Nickel or ‘alloys’ with more than 40 % nickel by weight; 6. Tantalum or tantalum ‘alloys’; 7. Titanium or titanium ‘alloys’; 8. Zirconium or zirconium ‘alloys’; 9. Silicon carbide; 10. Titanium carbide; or 11. Niobium (columbium) or niobium ‘alloys’; e. Distillation or absorption columns of internal diameter greater than 0,1 m; and liquid distributors, vapour distributors or liquid collectors designed for such distillation or absorption columns, where all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Graphite or ‘carbon graphite’; 5. Nickel or ‘alloys’ with more than 40 % nickel by weight; 6. Tantalum or tantalum ‘alloys’; 7. Titanium or titanium ‘alloys’; 8. Zirconium or zirconium ‘alloys’; or 9. Niobium (columbium) or niobium ‘alloys’; f. Remotely operated filling equipment in which all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; or 2. Nickel or ‘alloys’ with more than 40 % nickel by weight; g. Valves with ‘nominal sizes’ greater than 10 mm and casings (valve bodies) or preformed casing liners designed for such valves, in which all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Nickel or ‘alloys’ with more than 40 % nickel by weight; 5. Tantalum or tantalum ‘alloys’; 6. Titanium or titanium ‘alloys’; 7. Zirconium or zirconium ‘alloys’; 8. Niobium (columbium) or niobium ‘alloys’; or 9. Ceramic materials as follows: a. Silicon carbide with purity of 80 % or more by weight; b. Aluminium oxide (alumina) with purity of 99,9 % or more by weight; c. Zirconium oxide (zirconia); Technical Note: The ‘nominal size’ is defined as the smaller of the inlet and outlet diameters. h. Multi-walled piping incorporating a leak detection port, in which all surfaces that come in direct contact with the chemical(s) being processed or contained are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 3. Glass (including vitrified or enamelled coatings or glass lining); 4. Graphite or ‘carbon graphite’; 5. Nickel or ‘alloys’ with more than 40 % nickel by weight; 6. Tantalum or tantalum ‘alloys’; 7. Titanium or titanium ‘alloys’; 8. Zirconium or zirconium ‘alloys’; or 9. Niobium (columbium) or niobium ‘alloys’; i. Multiple-seal and seal-less pumps, with manufacturer’s specified maximum flow-rate greater than 0,6 m3/hour, or vacuum pumps with manufacturer’s specified maximum flow-rate greater than 5 m3/hour (under standard temperature (273 K (0 °C)) and pressure (101,3 kPa) conditions); and casings (pump bodies), preformed casing liners, impellers, rotors or jet pump nozzles designed for such pumps, in which all surfaces that come in direct contact with the chemical(s) being processed are made from any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Ceramics; 3. Ferrosilicon (high silicon iron alloys); 4. Fluoropolymers (polymeric or elastomeric materials with more than 35 % fluorine by weight); 5. Glass (including vitrified or enamelled coatings or glass lining); 6. Graphite or ‘carbon graphite’; 7. Nickel or ‘alloys’ with more than 40 % nickel by weight; 8. Tantalum or tantalum ‘alloys’; 9. Titanium or titanium ‘alloys’; 10. Zirconium or zirconium ‘alloys’; or 11. Niobium (columbium) or niobium ‘alloys’; j. Incinerators designed to destroy chemicals specified in entry 1C350, having specially designed waste supply systems, special handling facilities and an average combustion chamber temperature greater than 1 273 K (1 000 °C), in which all surfaces in the waste supply system that come into direct contact with the waste products are made from or lined with any of the following materials: 1. ‘Alloys’ with more than 25 % nickel and 20 % chromium by weight; 2. Ceramics; or 3. Nickel or ‘alloys’ with more than 40 % nickel by weight. Technical Notes: 1. ‘Carbon graphite’ is a composition consisting of amorphous carbon and graphite, in which the graphite content is eight percent or more by weight. 2. For the listed materials in the above entries, the term ‘alloy’ when not accompanied by a specific elemental concentration is understood as identifying those alloys where the identified metal is present in a higher percentage by weight than any other element. |
| I.B.2B351 | Toxic gas monitoring systems and their dedicated detecting components, other than those specified in 1A004, as follows; and detectors; sensor devices; and replaceable sensor cartridges therefor: a. Designed for continuous operation and usable for the detection of chemical warfare agents or chemicals specified in 1C350, at concentrations of less than 0,3 mg/m3; or b. Designed for the detection of cholinesterase-inhibiting activity. |
| I.B.2B352 | Equipment capable of use in handling biological materials, as follows: a. Complete biological containment facilities at P3, P4 containment level; Technical Note: P3 or P4 (BL3, BL4, L3, L4) containment levels are as specified in the WHO Laboratory Biosafety manual (3rd edition Geneva 2004). b. Fermenters capable of cultivation of pathogenic ‘micro-organisms’, viruses or capable of toxin production, without the propagation of aerosols, and having a total capacity of 20 litres or more; Technical Note: Fermenters include bioreactors, chemostats and continuous-flow systems. c. Centrifugal separators, capable of continuous separation without the propagation of aerosols, having all the following characteristics: 1. Flow rate exceeding 100 litres per hour; 2. Components of polished stainless steel or titanium; 3. One or more sealing joints within the steam containment area; and 4. Capable of in-situ steam sterilisation in a closed state; Technical Note: Centrifugal separators include decanters. d. Cross (tangential) flow filtration equipment and components as follows: 1. Cross (tangential) flow filtration equipment capable of separation of pathogenic ‘micro-organisms’, viruses, toxins or cell cultures, without the propagation of aerosols, having all of the following characteristics: a. A total filtration area equal to or greater than 1 m2; and b. Having either of the following characteristics: 1. Capable of being sterilised or disinfected in-situ; or 2. Using disposable or single-use filtration components; Technical Note: In 2B352.d.1.b. sterilised denotes the elimination of all viable microbes from the equipment through the use of either physical (e.g. steam) or chemical agents. Disinfected denotes the destruction of potential microbial infectivity in the equipment through the use of chemical agents with a germicidal effect. Disinfection and sterilisation are distinct from sanitisation, the latter referring to cleaning procedures designed to lower the microbial content of equipment without necessarily achieving elimination of all microbial infectivity or viability. 2. Cross (tangential) flow filtration components (e.g. modules, elements, cassettes, cartridges, units or plates) with filtration area equal to or greater than 0,2 m2 for each component and designed for use in cross (tangential) flow filtration equipment specified in 2B352.d.; Note: 2B352.d. does not control reverse osmosis equipment, as specified by the manufacturer. e. Steam sterilisable freeze drying equipment with a condenser capacity exceeding 10 kg of ice in 24 hours and less than 1 000 kg of ice in 24 hours; f. Protective and containment equipment, as follows: 1. Protective full or half suits, or hoods dependent upon a tethered external air supply and operating under positive pressure; Note: 2B352.f.1. does not control suits designed to be worn with self-contained breathing apparatus. 2. Class III biological safety cabinets or isolators with similar performance standards; Note: In 2B352.f.2., isolators include flexible isolators, dry boxes, anaerobic chambers, glove boxes and laminar flow hoods (closed with vertical flow). g. Chambers designed for aerosol challenge testing with ‘micro-organisms’, viruses or ‘toxins’ and having a capacity of 1 m3 or greater. |
C. MATERIALS
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