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Document 22013D0228
2013/228/EU: Decision No 1/2012 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 17 December 2012 on the inclusion in Annex 1 of a new Chapter 20 on explosives for civil use, the amendment of Chapter 3 on toys and the update of legal references listed in Annex 1
2013/228/EU: Decision No 1/2012 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 17 December 2012 on the inclusion in Annex 1 of a new Chapter 20 on explosives for civil use, the amendment of Chapter 3 on toys and the update of legal references listed in Annex 1
2013/228/EU: Decision No 1/2012 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 17 December 2012 on the inclusion in Annex 1 of a new Chapter 20 on explosives for civil use, the amendment of Chapter 3 on toys and the update of legal references listed in Annex 1
OJ L 136, 23.5.2013, p. 17–28
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Date of entry into force unknown (pending notification) or not yet in force.
23.5.2013 |
EN |
Official Journal of the European Union |
L 136/17 |
DECISION No 1/2012 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT
of 17 December 2012
on the inclusion in Annex 1 of a new Chapter 20 on explosives for civil use, the amendment of Chapter 3 on toys and the update of legal references listed in Annex 1
(2013/228/EU)
THE COMMITTEE,
Having regard to the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (‘the Agreement’) and in particular Articles 10(4), 10(5) and 18(2) thereof;
Whereas:
(1) |
The Parties to the Agreement have agreed to modify Annex 1 to the Agreement to include a new chapter on explosives for civil use; |
(2) |
The European Union has adopted a new Directive on the safety of toys (1) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent under Article 1(2) of the Agreement to the above mentioned European Union legislation; |
(3) |
Chapter 3, Toys, of Annex 1 should be amended to reflect these developments; |
(4) |
It is necessary to update certain legal references in the Annex to the Agreement; |
(5) |
Article 10(5) of the Agreement provides that the Committee may, on a proposal from one of the Parties, modify the Annexes to the Agreement, |
HAS DECIDED AS FOLLOWS:
1. |
Annex 1 to the Agreement is modified in order to include a new Chapter 20 on explosives for civil use (excluding ammunition) in accordance with the provisions set out in Attachment A annexed to this Decision. |
2. |
Chapter 3, Toys, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment B annexed to this Decision. |
3. |
Annex 1 on to the Agreement is amended in accordance with the provisions set out in Attachment C annexed to this Decision. |
4. |
This Decision, done in duplicate, shall be signed by representatives of the Committee who are authorised to act on behalf of the Parties. This Decision shall be effective from the date of the later of these signatures. |
Signed at Bern, 17 December 2012.
On behalf of the Swiss Confederation
Christophe PERRITAZ
Signed at Brussels, 12 December 2012.
On behalf of the European Union
Fernando PERREAU DE PINNINCK
(1) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).
ATTACHMENT A
In Annex 1, Product Sectors, the following Chapter 20 on Explosives for civil use (excluding ammunition) shall be introduced:
‘CHAPTER 20
EXPLOSIVES FOR CIVIL USE
Legislative, regulatory and administrative provisions
Provisions covered by Article 1 paragraph 2
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Conformity assessment bodies
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
Designating authorities
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
Special rules relating to the designation of conformity assessment bodies
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Article 6(2) of Directive 93/15/EEC and its Annex III.
Supplementary provisions
1. Identification of products
Both Parties shall ensure that undertakings in the explosives sector which manufacture or import explosives or assemble detonators shall mark explosives and each smallest packaging unit with a unique identification. Where an explosive is subject to further manufacturing processes, manufacturers shall not be required to mark the explosive with a new unique identification unless the original unique identification is no longer marked in compliance with Directive 2008/43/EC and/or the Explosives Ordinance.
The unique identification shall comprise the components prescribed in the Annex to Directive 2008/43/EC and Annex 14 to the Explosives Ordinance and shall be mutually recognised by both parties.
Each undertaking in the explosives sector and/or manufacturer shall be attributed a three-digit code by the Member State’s or Swiss national authority where it is established. This three-digit code shall be mutually recognised by both Parties if the manufacturing site or the manufacturer is located in the territory of one of the Parties.
2. Provisions governing the supervision of transfers between the European Union and Switzerland
1. |
Explosives covered by this Chapter may be transferred between the European Union and Switzerland only in accordance with the following paragraphs. |
2. |
Controls performed pursuant to European Union law or national law in the event of transfers of the explosives governed by section V.2 shall solely be performed as part of the normal control procedures applied in a non-discriminatory fashion throughout the territory of the European Union or Switzerland. |
3. |
Approval to transfer explosives shall be obtained by the consignee from the recipient competent authority. The competent authority shall verify that the consignee is legally authorised to acquire explosives and that he is in possession of the necessary licenses or authorisations. The person responsible for the transfer must notify the competent authorities of the transit Member State or Member States or Switzerland of movements of explosives through this or these States or Switzerland, whose approval shall be required. |
4. |
Where a Member State or Switzerland considers that there is a problem regarding the verification of the entitlement to acquire explosives referred to in paragraph 3, that Member State or Switzerland shall forward the available information on the subject to the European Commission which will put the matter before the Committee provided for in Article 13 of Directive 93/15/EEC without delay. The European Commission shall inform Switzerland accordingly through the Committee established under Article 10 of this Agreement. |
5. |
Where the recipient competent authority approves a transfer, it shall issue to the consignee a document which includes all the information referred to in paragraph 7. Such a document must accompany the explosives until they arrive at their stated destination. It must be produced at the request of the relevant competent authorities. A copy of this document shall be retained by the consignee who shall present it for examination by the recipient competent authority, at the latter’s request. |
6. |
Where the competent authority of a Member State or Switzerland considers that special security requirements such as those referred to in paragraph 5 are unnecessary, explosives can be transferred on their territory or part thereof without prior provision of information within the meaning of paragraph 7. The recipient competent authority shall then grant an approval for a fixed period and liable to suspension or withdrawal at any time on the basis of a reasoned justification. The document referred to in paragraph 5, which must accompany the explosives until they arrive at their destination, shall refer solely to the abovementioned approval. |
7. |
Where transfers of explosives must be specially supervised in order to comply with special security requirements in the territory or part of the territory of a Member State or Switzerland, prior to the transfer the following information shall be provided by the consignee to the recipient competent authority:
Recipient competent authorities shall examine the conditions under which the transfer may take place, with particular regard to the special security requirements. If the special security requirements are satisfied, approval for the transfer shall be granted. In the event of transit through the territory of other Member States or Switzerland, those States or Switzerland shall likewise examine and approve, in the same conditions, the particulars concerning the transfer. |
8. |
Without prejudice to the normal checks which the country of departure shall carry out in its territory, at the request of the competent authorities concerned, the consignees and the operators concerned in the explosives sector shall forward to the authorities of the country of departure and to those of country of transit all relevant information they possess concerning the transfer of explosives. |
9. |
No supplier may transfer explosives unless the consignee has obtained the necessary authorisations for the transfer in accordance with the provisions of paragraphs 3, 5, 6 and 7. |
10. |
For the purposes of implementing paragraph 4, where a measure provided for in Article 13 of Directive 93/15/EEC is adopted regarding products from Swiss undertakings in the explosives sector and/or Swiss manufacturers, it shall be communicated immediately to the Committee established under Article 10 of this Agreement.
If Switzerland disagrees with this measure, the application of the measure shall be deferred for three months from the date of communication. The Committee established under Article 10 of this Agreement shall hold consultations with a view to reaching a settlement. If a settlement is not reached within the period referred to in this paragraph, either Party may suspend the chapter in part or in full. |
11. |
For the purposes of implementing paragraphs 5 and 6, the provisions of Decision 2004/388/EC shall apply. |
3. Information exchange
In accordance with the general provisions of this Agreement, the Member States and Switzerland shall keep at each other’s disposal any relevant information needed to ensure a proper implementation of Directive 2008/43/EC.
4. Location of the manufacturer
For the purpose of this Chapter, it shall be sufficient that the undertaking in the explosives sector, the manufacturer, an authorised representative or, where neither of these is present, the person responsible for placing the product on the market, is established in the territory of one of the Parties.’
(1) This Chapter shall not apply to explosives intended for use, in accordance with national law, by the armed forces or the police, to pyrotechnical articles and to ammunition.
ATTACHMENT B
In Annex 1, Product Sectors, Chapter 3, Toys should be deleted and replaced by the following:
‘CHAPTER 3
TOYS
Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
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Switzerland |
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Conformity assessment bodies
The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.
Designating authorities
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.
Special rules relating to the designation of conformity assessment bodies
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and with Article 24 of Directive 2009/48/EC.
Supplementary provisions
1. Exchange of information concerning the certificate of conformity and the technical documentation
The market surveillance authorities of the Member States or Switzerland may, on reasoned request, ask for the technical documentation, or a translation of parts thereof from a manufacturer based in the territory of either Switzerland or a Member State. The market surveillance authorities of the Member states and Switzerland may request from a Swiss or a European Union-based manufacturer the relevant part of the technical documentation into an official language of the requesting authority or in English.
When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may set a deadline for receipt of 30 days, unless a shorter deadline is justified in the case of serious and immediate risk.
If the manufacturer based on the territory of either Switzerland or a Member State does not comply with this provision, the market surveillance authority may require it to have a test performed by a designated body at its own expense within a specified period in order to verify compliance with the harmonised standards and essential requirements.
2. Information requests to designated bodies
The market surveillance authorities of the Member States and of Switzerland may request a designated body in Switzerland or in a Member State to provide information relating to any type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.
3. Information obligations of designated bodies
In accordance with Article 36(2) of Directive 2009/48/EC, designated bodies shall provide the other bodies designated under this Agreement which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.
4. Exchange of experience
Swiss national authorities may take part in the exchange of experience between the Member States’ national authorities responsible for the notification procedure referred to in Article 37 of Directive 2009/48/EC.
5. Coordination of designated bodies
Designated Swiss conformity assessment bodies may take part in the coordination and cooperation mechanisms and sectoral groups or groups of notified bodies provided for in Article 38 of Directive 2009/48/EC, directly or by means of designated representatives.
6. Market access
Importers based in the European union or Switzerland shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, when that is not possible, on its packaging or in a document accompanying the toy.
The Parties mutually recognise this indication of the coordinates of the manufacturer and importer, registered trade name or registered trade mark and the address at which they can be contacted, which must be mentioned as above. For the purpose of this specific obligation, “importer” shall mean any natural or legal person established within the territory of either the European Union or Switzerland who places a toy from a third country on the European Union or on the Swiss market.
7. Harmonised standards
Switzerland recognises harmonised standards conferring a presumption of conformity with the legislation referred to in Section 1 of this Chapter. Where Switzerland considers that compliance with a harmonised standard does not entirely satisfy the requirements which are set out in the legislation listed in Section I, it shall bring the matter before the Committee and give its reasons.
The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 14 of Directive 2009/48/EC. The Committee shall be informed of the result of the procedure.
8. Procedure for dealing with toys presenting a non-compliance that is not restricted to their national territory (1)
Pursuant to Article 12(4) of this Agreement, in cases where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that a toy covered by Section I of the present Chapter presents a risk to the health or safety of persons, and if they consider that the non-compliance is not restricted to their national territory, they shall inform each other and the European Commission immediately of:
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the results of the evaluation they have carried out and of the actions which they have required the relevant economic operator to take; |
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provisional measures taken to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it when the relevant economic operator does not take adequate corrective action. This includes the details set out in Article 42(5) of Directive 2009/48/EC. |
The market surveillance authorities of the Member States or Switzerland other than the one initiating this procedure shall inform without delay the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned.
The Parties shall ensure that appropriate restrictive measures in respect of the toy concerned, such as withdrawal of the toy from their market, are taken without delay.
9. Safeguard procedure in case of objections against national measures
Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.
Where, on completion of the procedure set out in paragraph 8 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State respectively, or where the European Commission considers a national measure to be non-compliant with the legislation referred to in this Chapter, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure in order to determine if it is justified or not.
In case of an agreement between the Parties on the results of their investigations, the Member States and Switzerland shall take the measures necessary to ensure that appropriate restrictive measures are taken in respect of the toy concerned, such as the withdrawal of the toy from their market, without delay.
In case of a disagreement between the Parties on the results of their investigations, the issue will be forwarded to the Committee, which may decide to have an expert study carried out.
Where the Committee considers that the measure is:
(a) |
unjustified, the national authority of the Member State or Switzerland which took the measure shall withdraw it; |
(b) |
justified, the Parties shall take the measures necessary to ensure that the non-compliant toy is withdrawn from their market.’ |
(1) This procedure does not imply an obligation of the European Union to grant Switzerland access to the Community Rapid Information System (‘RAPEX’) under Article 12(4) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).
ATTACHMENT C
Amendments to Annex 1
Chapter 1 (Machinery)
In Section I, Legislative regulatory and administrative provisions, Provisions covered by Article 1(2), the reference to Swiss provisions should be deleted and replaced by the following text:
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Chapter 7 (Radio Equipment and Telecommunications Terminal Equipment)
In Section I, Legislative, regulatory and administrative provisions, Provisions covered by Article 1(2), the reference to Swiss provisions should be deleted and replaced by the following text:
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Chapter 12 (Motor vehicles)
Section I, Legislative regulatory and administrative provisions should be deleted and replaced by the following:
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Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
European Union |
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Switzerland |
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Chapter 13 (Agricultural and Forestry Tractors)
Section I, Legislative regulatory and administrative provisions should be deleted and replaced by the following:
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Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
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Switzerland |
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Chapter 14 (Good Laboratory Practice, GLP)
In Section I, Legislative regulatory and administrative provisions, Provisions covered by Article 1(2), the reference to Swiss provisions should be deleted and replaced by the following text:
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Chapter 15 (Medicinal products GMP Inspection and batch certification)
Section I, Legislative regulatory and administrative provisions should be deleted and replaced by the following:
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Legislative, regulatory and administrative provisions
Provisions covered by Article 1(2)
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DECLARATION FROM THE EUROPEAN COMMISSION
In order to ensure the effective implementation of Chapter 3, Toys, and in accordance with the Council Declaration on Swiss attendance of committees (1), the European Commission will consult Swiss experts in the preparatory stage of draft measures to be submitted subsequently to the Committee established by Article 47(1) of Directive 2009/48/EC.