COUNCIL DECISION

of 20 November 2012

on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA)

(2013/1/EU)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the functioning of the European Union, and in particular Article 207 in conjunction with Article 218(6)(a)(v) and Article 218(7) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament,

Whereas:

The Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part (1) (‘the Association Agreement’), entered into force on 20 November 1995.

Article 47 of the Association Agreement provides for the conclusion, where appropriate, of agreements on mutual recognition in the field of conformity assessment, and Article 55 of the Agreement provides for the use of best endeavours to approximate the laws of the Parties in order to facilitate the implementation of the Agreement.

The Protocol to the Association Agreement on Conformity Assessment and Acceptance of Industrial Products (CAA) (‘the Protocol’) was signed on behalf of the Union on 6 May 2010.

The Commission is responsible for ensuring the Union’s external representation in connection with the Protocol, including information and notification functions, and forwarding replies to requests in accordance with the Annexes. The Protocol will be implemented on the basis of the relevant Union legislation on accreditation, market surveillance and the marketing of products.

It is necessary to empower the Commission to make technical amendments to the Protocol,

HAS ADOPTED THIS DECISION:

Article 1

The Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) is hereby approved on behalf of the Union.

The text of the Protocol is attached to this Decision.

Article 2

The President of the Council shall transmit, on behalf of the Union, the diplomatic note provided for in Article 16 of the Protocol.

Article 3

The Commission shall be authorised to approve amendments pursuant to Articles 7, 13 and 15 of the Protocol, after consultation with the special committee appointed by the Council in accordance with Article 218(4) of the Treaty.

Article 4

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

(1) OJ L 147, 21.6.2000, p. 3.

PROTOCOL

to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA)

THE EUROPEAN UNION,

hereinafter referred to as "EU"

and

THE STATE OF ISRAEL,

hereinafter referred to as "Israel",

hereinafter together referred to as "the Parties",

WHEREAS Israel is a party to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, hereinafter referred to as "the Association Agreement" (1),

RECOGNISING that the adoption and implementation of relevant EU law by Israel provides the opportunity to extend certain benefits of the internal market and to ensure its effective operation in certain sectors,

CONSIDERING the shared commitment of the Parties to the principles of free movement of goods and to promoting product quality, so as to ensure the health and safety of their citizens and the protection of the environment, including through technical assistance and other forms of cooperation between them,

DESIRING to conclude a Protocol to the Association Agreement on Conformity Assessment and Acceptance of Industrial Products (hereafter referred to as "this Protocol") providing for the application of the mutual acceptance of industrial products which fulfil the requirements for being lawfully placed on the market in one of the Parties, including where appropriate the mutual recognition of the results of obligatory conformity assessment of industrial products,

NOTING that Article 47 of the Association Agreement provides, where appropriate, for the conclusion of a European conformity assessment Agreement and that Article 55 of the Association Agreement provides for the use of best endeavours to approximate the laws of the Parties,

CONSIDERING that, in the sectors covered by this Protocol, Israel's national law is substantially aligned with relevant EU law,

NOTING the close relationship between the European Union and Iceland, Liechtenstein and Norway under the Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel European conformity assessment Agreement between Israel and those countries equivalent to this Protocol,

BEARING IN MIND the Parties' status as Contracting Parties to the Agreement establishing the World Trade Organisation, and conscious in particular of their rights and obligations under the World Trade Organisation Agreement on Technical Barriers to Trade,

HAVE AGREED AS FOLLOWS:

Article 1

Purpose and means

1. The purpose of this Protocol is to facilitate the elimination by the Parties of technical barriers to trade in respect of certain industrial products, listed in the Annexes to this Protocol, which form an integral part of this Protocol.

2. The purpose set out in paragraph 1 shall be met through:

(a) the adoption and implementation by Israel of national technical regulations, standards and conformity assessment procedures which are equivalent to those of relevant EU law;

(b) the implementation by Israel of a regulatory and technical infrastructure which is equivalent to that in place in the Member States of the EU;

(c) the mutual acceptance on their markets by both Parties of industrial products which fulfil the requirements for being lawfully placed on the market in one of the Parties, including where appropriate the mutual recognition of the results of obligatory conformity assessment of industrial products subject to relevant EU law and to the equivalent Israeli national law;

(d) the acceptance on their markets by both Parties of industrial products which fulfil the requirements for being lawfully placed on the market in Israel and any one of the Member States of the EU, on conditions analogous to those applying to trade in goods between the Member States of the EU.

Article 2

Definitions

For the purpose of this Protocol,

(a) "Industrial products" means products, as defined by the scope of the Annexes to this Protocol;

(b) "Relevant EU law" means any legal act and implementing practice of the European Union applicable to a particular situation, risk or category of industrial products, referenced in the Annexes to this Protocol;

(c) "National law" means any legal act and implementing practice by which Israel has aligned its legislation with relevant EU law applicable to a particular situation, risk or category of industrial products;

(d) "Responsible Authority" means a body under the jurisdiction of one of the Member States of the EU or of Israel which is responsible for the effective implementation of EU and national law in a specified industrial sector, and which where appropriate has the responsibility for notifying Notified Bodies;

(e) "Notified Body" means a body notified, by a Responsible Authority under the respective jurisdiction of one of the Parties to this Protocol, to the other Party, as competent to assess conformity in relation to requirements of EU or national law;

(f) "Committee" means the Association Committee set up under Article 70 of the Association Agreement or a body set up by the Association Council under Article 73 of the Association Agreement and designated to cover trade issues.

The terms used in this Protocol shall have the meaning given in relevant EU law and Israel's national law.

Article 3

Alignment of legislation

For the purpose of this Protocol, Israel agrees to take appropriate measures, in consultation with the European Commission, to align with and maintain relevant EU law as it applies to the placing on the market of products covered by this Protocol.

In sectors covered by this Protocol where relevant EU law is based upon the use of technical standards giving presumption of conformity with essential safety requirements (known as "New Approach" sectors) Israel agrees to take appropriate measures, in consultation with the European Commission, to align with and maintain relevant EU practice in the fields of standardisation, metrology, accreditation, conformity assessment, market surveillance, general safety of products, and producers’ liability. "New Approach" sectors are indicated as such in the Sectoral Annexes.

Article 4

Technical infrastructure

For the purpose of this Protocol, Israel agrees to take appropriate measures, in consultation with the European Commission, to establish and maintain appropriate Responsible Authorities in accordance with Article 9.

In sectors covered by this Protocol where relevant EU law is based upon the use of technical standards giving presumption of conformity with essential safety requirements (known as "New Approach" sectors) Israel agrees to establish and maintain bodies that are capable of sustaining the functions of standardisation, metrology, accreditation, market surveillance, assessment of general safety of products, and assessment and enforcement of producer liability on its territory at a level broadly equivalent to those in place in the Member States of the EU.

Article 5

Mutual acceptance of industrial products including their conformity assessment

1. The Parties agree that, for the purpose of mutual acceptance, industrial products listed in the Annexes on Acceptance of Regulated Products, fulfilling the requirements for being lawfully placed on the market of a Party, may be placed on the market of the other party, if, in particular, they fulfil:

(a) the requirements of applicable legislative provisions related to the location in either of the Parties of the persons responsible for placing of products on the market; and

(b) where appropriate, applicable provisions related to the location of the bodies that are responsible for assessing compliance.

2 The Parties agree that, for the purpose of mutual acceptance, industrial products listed in the Annexes on Acceptance of Products Not Commonly Regulated, and for which no European technical regulations exist, may be traded between Israel and the EU on the basis that a product lawfully traded in the market of Israel or of one of the Member States of the EU may be lawfully traded upon that of the other Party to this Protocol.

3. Where products are subject to obligatory conformity assessment procedures to be carried out in accordance with the EU and national laws listed in the Annexes, the Parties further agree to recognise the results of such procedures without requiring them to be repeated, nor with the imposition of any additional requirements for the purposes of accepting such conformity assessment.

4 Notwithstanding paragraphs 1, 2 and 3, neither Party shall be obliged to accept products on to its market that have been lawfully placed on the market of the other Party as a consequence of an agreement similar in effect to this Protocol between either Party and a third country or party, or by virtue of a unilateral concession by either Party to a third country or party.

Article 6

Safeguard clause

Where a Party finds that an industrial product placed on the market on its territory by virtue of this Protocol, and used in accordance with its intended use, may compromise the safety or health of users or other persons, or any other legitimate concern protected by legislation identified in the Annexes, it may take appropriate measures to withdraw such a product from the market, to prohibit its placing on the market, putting into service or use, or to restrict its free movement.

The Annexes shall provide for the procedure to be applied in such cases.

Article 7

Extension of coverage

If Israel adopts and implements further national law aligning with relevant EU law, the Parties may amend the Annexes or conclude new ones, in accordance with the procedure laid down in Article 13.

Article 8

Obligations of parties as regards their responsible authorities and notified bodies

1. (a) The Parties shall ensure that Responsible Authorities under their jurisdiction which are responsible for the effective implementation of EU and national law shall continuously apply it. Further, they shall ensure that these Responsible Authorities are able to ensure the conformity of industrial products with EU or national law or to require their withdrawal from the market and, where appropriate, to notify, suspend, remove suspension and withdraw the notification of Notified Bodies. (b) The Parties shall notify each other of the names and addresses of their Responsible Authorities, and shall maintain a list of such bodies.

2. (a) The Parties shall ensure that Notified Bodies, notified under their respective jurisdiction to assess conformity in relation to requirements of EU or national law specified in the Annexes, continuously comply with the requirements of such EU or national law. Further, they shall take all necessary steps to ensure that such notified bodies maintain the necessary competence to carry out the tasks for which they are notified. (b) The Parties shall notify each other of the names and addresses of their Notified Bodies, and shall maintain a list of such bodies.

Article 9

Procedures for the recognition of responsible authorities and the notification of notified bodies

1. The following procedure shall apply for the recognition of Responsible Authorities which are responsible for the effective implementation of EU and national law, to ensure the conformity of industrial products with EU or national law or to require their withdrawal from the market and, where appropriate, are able to notify, suspend, remove suspension and withdraw the notification of Notified Bodies:

(a) a Party shall forward its nomination to the other Party in writing, stating the territory and title of the Annex to this Protocol under which the Responsible Authority is competent to carry out the tasks listed in Article 8(1), including as appropriate any limitations to such competence within the territory or the scope of that Annex;

(b) on the acknowledgement of the other Party, given in writing, the Responsible Authority shall be considered as competent to carry out the tasks listed in Article 8(1) in relation to the Annexes for which it has been recognised from that date.

2. The following procedure shall apply for the notification of Notified Bodies to assess conformity in relation to the requirements of EU or national law specified in the Annexes:

(a) a Party shall forward its notification to the other Party in writing, stating the title of the Annex to this Protocol under which the Notified Body is competent to assess conformity, and as appropriate any limitations to such competence within the scope of that Annex;

(b) on the acknowledgement of the other Party, given in writing, the body shall be considered as notified and as competent to assess conformity in relation to the said requirements specified in the Annexes from that date.

3. If a Party decides to withdraw the notification of a Notified Body under its jurisdiction, it shall inform the other Party in writing. The Notified Body will cease to assess conformity in relation to the said requirements specified in the Annexes from the date of its withdrawal at the latest. Nevertheless, conformity assessment carried out before that date shall remain valid, unless otherwise decided by the Committee.

Article 10

Verification of notified bodies

1. Each Party may request the other Party to verify the technical competence and compliance of a notified body, or a candidate notified body, under its jurisdiction. Such request shall be justified, in an objective and reasoned manner, in order to allow the Party responsible for the notification to carry out the requested verification and report speedily to the other Party. The Parties may also jointly examine the body, with the participation of the relevant responsible authorities. To this end, the Parties shall ensure the full cooperation of bodies under their jurisdiction. The Parties shall take all appropriate steps, and use whatever available means may be necessary, with a view to resolving any problems which are detected.

2. If the problems cannot be resolved to the satisfaction of both Parties, they may notify the Committee of their disagreement, giving (a) the reasons for the request supported by relevant evidence to verify the technical competence and compliance of the notified body; (b) the reasons why the problems cannot be resolved to the satisfaction of both Parties and (c) evidence showing there exists an imminent and real threat to human health and safety when relevant. The Committee may decide on appropriate action.

3. Unless and until decided otherwise by the Committee, the notification of the body and the recognition of its competence to assess conformity in relation to the requirements of EU or national law specified in the Annexes shall be suspended in part or totally from the date on which the disagreement of the Parties has been notified to the Committee.

Article 11

Exchange of information and cooperation

In order to ensure a correct and uniform application and interpretation of this Protocol, and to encourage trade in industrial goods between them, the Parties, shall:

(a) notify each other of relevant proposed and actual legislative amendments, and exchange information concerning the implementation of law and practice, including in particular on procedures to ensure the compliance of Notified Bodies on their territory with the rules applicable to them;

(b) invite each other to take part in their relevant mechanisms of information exchange, in regards to mechanisms dealing with sectors covered by the Annexes to this Protocol unless specified otherwise in the Annexes. The EU will explore the possibility of inviting Israel to participate in relevant European networks and bodies;

(c) encourage their Notified Bodies to cooperate with a view to establishing mutual recognition arrangements in the voluntary sphere.

Article 12

Confidentiality

Representatives, experts and other agents of the Parties shall be required, even after their duties have ceased, not to disclose information acquired under this Protocol which is of the kind covered by the obligation of professional secrecy. This information may not be used for purposes other than those envisaged by this Protocol.

Article 13

Management of this Protocol

1. Responsibility for the effective functioning of this Protocol shall be borne by the Committee. In particular, it shall have the power to take decisions regarding:

(a) amending and withdrawing Annexes;

(b) adding new Annexes;

(c) appointing experts to verify the technical competence of a notified body and its compliance with the requirements applicable to them, in accordance with Article 10(1);

(d) exchanging information on proposed and actual amendments to the EU law and national law referred to in the Annexes;

(e) considering new or additional conformity assessment procedures affecting a sector covered by an Annex;

(f) resolving any questions relating to the application of this Protocol;

(g) referring questions for decision to the disputes settlement mechanism set out in Article 75 of the Association Agreement or any other relevant dispute settlement mechanism set up by agreement between the Parties pursuant to the Association Agreement.

2. The Committee may delegate the above responsibilities set out under this Protocol.

3. Amendments to the annexes shall enter into force as the Committee shall decide.

Article 14

Technical cooperation

The Parties shall cooperate where necessary in order to support the effective implementation and application of this Protocol.

Article 15

Agreements with other countries

1. This Protocol may, by explicit agreement between the Parties, including by a decision of the Committee, be extended to cover the acceptance of industrial products from third countries or parties with which the EU has concluded an Agreement similar to this Protocol in corresponding sectors.

2. Where the EU notifies Israel that it has concluded an Agreement similar to this Protocol with a third country or party, that covers the acceptance of industrial products in corresponding sectors, Israel shall consider concluding an Agreement with the third country or party that provides for such an extension.

Article 16

Entry into force

This Protocol shall enter into force 30 days after the date of the later written communication, through diplomatic channels, by which the parties have notified each other that their respective internal legal requirements for the entry into force of this Protocol have been fulfilled.

Article 17

Duration

This Protocol is concluded for an unlimited period. Each of the Parties may denounce this Protocol by notifying the other Party. This Protocol shall cease to apply twelve months after the date of such notification.

During the period between the denunciation of this Protocol by one Party and its ceasing to apply, the termination of this Protocol shall not adversely effect or in any way prejudice any right or obligation accrued to or to be incurred by virtue of the application of this Protocol prior to the effective date of such termination.

Article 18

Languages

This Protocol is drawn up in two originals in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, Swedish and Hebrew languages, each text being equally authentic.

Съставено в Брюксел на шести май две хиляди и десета година. Hecho en Bruselas, el seis de mayo de dos mil diez. V Bruselu dne šestého května dva tisíce deset. Udfærdiget i Bruxelles den sjette maj to tusind og ti. Geschehen zu Brüssel am sechsten Mai zweitausendzehn. Kahe tuhande kümnenda aasta maikuu kuuendal päeval Brüsselis. Έγινε στις Βρυξέλλες, στις έξι Μαΐου δύο χιλιάδες δέκα. Done at Brussels on the sixth day of May in the year two thousand and ten. Fait à Bruxelles, le six mai deux mille dix. Fatto a Bruxelles, addì sei maggio duemiladieci. Briselē, divi tūkstoši desmitā gada sestajā maijā. Priimta du tūkstančiai dešimtų metų gegužės šeštą dieną Briuselyje. Kelt Brüsszelben, a kétezer-tizedik év május havának hatodik napján. Magħmul fi Brussell, fis-sitt jum ta' Mejju tas-sena elfejn u għaxra. Gedaan te Brussel, de zesde mei tweeduizend tien. Sporządzono w Brukseli dnia szóstego maja roku dwa tysiące dziesiątego. Feito em Bruxelas, em seis de Maio de dois mil e dez. Întocmit la Bruxelles, la șase mai două mii zece. V Bruseli šiesteho mája dvetisícdesať. V Bruslju, dne šestega maja leta dva tisoč deset. Tehty Brysselissä kuudentena päivänä toukokuuta vuonna kaksituhattakymmenen. Som skedde i Bryssel den sjätte maj tjugohundratio. 2010 За Европейския съюз Por la Unión Europea Za Evropskou unii For Den Europæiske Union Für die Europäische Union Euroopa Liidu nimel Για την Ευρωπαϊκή Ένωση For the European Union Pour l'Union européenne Per l'Unione europea Eiropas Savienības vārdā – Europos Sąjungos vardu Az Európai Unió részéről Għall-Unjoni Ewropea Voor de Europese Unie W imieniu Unii Europejskiej Pela União Europeia Pentru Uniunea Europeană Za Európsku úniu Za Evropsko unijo Euroopan unionin puolesta På Europeiska unionens vägnar За Държавата Израел Por el Estado de Israel Za Stát Izrael For Staten Israel Für den Staat Israel Iisraeli Riigi nimel Για το Κράτος του Ισραήλ For the State of Israel Pour l'État d'Israël Per lo Stato d'Israele Izraēlas Valsts vārdā Izraelio Valstybės vardu Izrael Állam részéről Għall-Istat tal-Iżrael Voor de Staat Israël W imieniu Państwa Izrael Pelo Estado de Israel Pentru Statul Israel Za Izraelský štát Za Državo Izrael Israelin valtion puolesta För Staten Israel

(1) OJ L 147 of 21.6.2000, p. 3 and "Kitvei Amana" (Israel Official Publication Journal), 1034.