This document presents the definitive text of 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).
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.
The Protocol provides for the mutual acceptance of industrial products that operates on the basis of the acquis communautaire that has been transposed by the partner country, in the same way as it would apply to products placed on the market of a Member State. It allows industrial products covered by it and attested as compliant according to the procedures of the European Union to be placed on the Israeli market without having to undergo any further approval procedures, and vice versa. At present one sector is included: good manufacturing practice (GMP) for pharmaceutical products.
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 also implies the mutual recognition of the results of obligatory conformity assessment of industrial products.
In order to achieve full conformity in the sectors covered by this Agreement, Israel's national law should be substantially aligned with relevant EU law.
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.
The purpose shall be met through:
- the adoption and implementation by Israel of national technical regulations, standards and conformity assessment procedures which are equivalent to those of relevant EU law;
- the implementation by Israel of a regulatory and technical infrastructure which is equivalent to that in place in the Member States of the EU;
- 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;
- 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.
Safeguard clause: the Protocol comprises a safeguard clause which stipulates that 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.
It should be noted that more specific details as regards the mutual recognition mechanism of products established by this Protocol are set out in the former initial proposal of 22/10/2009.