# Official Journal L 171/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 171 |
| | |
| English edition | Legislation | Volume 582 July 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 171

English edition

Legislation

Volume 582 July 2015

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2015/1051 of 1 July 2015 on the modalities for the exercise of the functions of the online dispute resolution platform, on the modalities of the electronic complaint form and on the modalities of the cooperation between contact points provided for in Regulation (EU) No 524/2013 of the European Parliament and of the Council on online dispute resolution for consumer disputes | 1 |
| | * | Commission Regulation (EU) 2015/1052 of 1 July 2015 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (
  1
  ) | 5 |
| | * | Commission Implementing Regulation (EU) 2015/1053 of 1 July 2015 concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH) (
  1
  ) | 8 |
| | | Commission Implementing Regulation (EU) 2015/1054 of 1 July 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 12 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2015/1055 of 30 June 2015 concerning the consistency of certain targets included in the national or functional airspace block plans submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period
  (notified under document C(2015) 4403)

   (
  1
  ) | 14 |
| | * | Commission Implementing Decision (EU) 2015/1056 of 30 June 2015 concerning the inconsistency of certain targets included in the national or functional airspace block plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period and setting out recommendations for the revision of those targets
  (notified under document C(2015) 4407)

   (
  1
  ) | 18 |
| | * | Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (
  1
  ) | 23 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 1/2015 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 14 April 2015 on the amendment of Chapter 16 on construction products, Chapter 18 on biocidal products and the update of legal references listed in Annex 1 [2015/1058] | 25 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2015/1051 of 1 July 2015 on the modalities for the exercise of the functions of the online dispute resolution platform, on the modalities of the electronic complaint form and on the modalities of the cooperation between contact points provided for in Regulation (EU) No 524/2013 of the European Parliament and of the Council on online dispute resolution for consumer disputes

1

*

Commission Regulation (EU) 2015/1052 of 1 July 2015 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (
  1
  )

1

5

*

Commission Implementing Regulation (EU) 2015/1053 of 1 July 2015 concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH) (
  1
  )

Enterococcus faecium

1

8

Commission Implementing Regulation (EU) 2015/1054 of 1 July 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

12

DECISIONS

*

Commission Implementing Decision (EU) 2015/1055 of 30 June 2015 concerning the consistency of certain targets included in the national or functional airspace block plans submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period
  (notified under document C(2015) 4403)

   (
  1
  )

(notified under document C(2015) 4403)

1

14

*

Commission Implementing Decision (EU) 2015/1056 of 30 June 2015 concerning the inconsistency of certain targets included in the national or functional airspace block plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period and setting out recommendations for the revision of those targets
  (notified under document C(2015) 4407)

   (
  1
  )

(notified under document C(2015) 4407)

1

18

*

Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (
  1
  )

1

23

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 1/2015 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 14 April 2015 on the amendment of Chapter 16 on construction products, Chapter 18 on biocidal products and the update of legal references listed in Annex 1 [2015/1058]

25

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| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 2.7.2015 | EN | Official Journal of the European Union | L 171/1 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1051

of 1 July 2015

on the modalities for the exercise of the functions of the online dispute resolution platform, on the modalities of the electronic complaint form and on the modalities of the cooperation between contact points provided for in Regulation (EU) No 524/2013 of the European Parliament and of the Council on online dispute resolution for consumer disputes

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Regulation on consumer ODR) (1), and in particular Articles 5(7), 7(7) and 8(4) thereof,

After consulting the European Data Protection Supervisor,

Whereas:

| (1) | Regulation (EU) No 524/2013 provides for the establishment of an online dispute resolution platform at Union level (ODR platform). The ODR platform should take the form of an interactive and multilingual website offering a single point of entry to consumers and traders seeking to resolve out-of-court disputes concerning contractual obligations stemming from online sales and service contracts. |
| --- | --- |

(1)

Regulation (EU) No 524/2013 provides for the establishment of an online dispute resolution platform at Union level (ODR platform). The ODR platform should take the form of an interactive and multilingual website offering a single point of entry to consumers and traders seeking to resolve out-of-court disputes concerning contractual obligations stemming from online sales and service contracts.

| (2) | Article 8(1) of Regulation (EU) No 524/2013 provides that the electronic complaint form shall be user-friendly. Therefore, complainants should be able to complete the electronic complaint form as a draft before submitting a complaint. It should be ensured that drafts that are not submitted by complainants are automatically deleted from the ODR platform after an appropriate period of time. |
| --- | --- |

(2)

Article 8(1) of Regulation (EU) No 524/2013 provides that the electronic complaint form shall be user-friendly. Therefore, complainants should be able to complete the electronic complaint form as a draft before submitting a complaint. It should be ensured that drafts that are not submitted by complainants are automatically deleted from the ODR platform after an appropriate period of time.

| (3) | In order to ensure the proper functioning of the ODR platform, it is necessary to establish how the respondent party should be informed that a complaint has been submitted to the ODR platform as well as what information should be used from the electronic complaint form to facilitate the identification of the competent alternative dispute resolution entities (ADR entities). |
| --- | --- |

(3)

In order to ensure the proper functioning of the ODR platform, it is necessary to establish how the respondent party should be informed that a complaint has been submitted to the ODR platform as well as what information should be used from the electronic complaint form to facilitate the identification of the competent alternative dispute resolution entities (ADR entities).

| (4) | For the same purpose and in order to ensure the consistent application of Regulation (EU) No 524/2013, it is necessary to clarify at which point ADR entities should provide information to the ODR platform concerning the handling of a dispute. |
| --- | --- |

(4)

For the same purpose and in order to ensure the consistent application of Regulation (EU) No 524/2013, it is necessary to clarify at which point ADR entities should provide information to the ODR platform concerning the handling of a dispute.

| (5) | It is necessary to establish the date of conclusion of certain disputes where a complaint cannot be processed further, in order to ensure that personal data related to those disputes can be deleted at the latest six months after that date of conclusion. This includes disputes where the parties cannot agree on an ADR entity due to the lack of response from the respondent party or when an ADR entity refuses to deal with a dispute. |
| --- | --- |

(5)

It is necessary to establish the date of conclusion of certain disputes where a complaint cannot be processed further, in order to ensure that personal data related to those disputes can be deleted at the latest six months after that date of conclusion. This includes disputes where the parties cannot agree on an ADR entity due to the lack of response from the respondent party or when an ADR entity refuses to deal with a dispute.

| (6) | National competent authorities should notify to the Commission and update the list of national ADR entities in a uniform way to streamline the registration of these entities with the ODR platform under Regulation (EU) No 524/2013. |
| --- | --- |

(6)

National competent authorities should notify to the Commission and update the list of national ADR entities in a uniform way to streamline the registration of these entities with the ODR platform under Regulation (EU) No 524/2013.

| (7) | It is appropriate to determine when the parties to a dispute handled through the ODR platform should be able to provide their feedback on the functioning of the ODR platform and on the ADR entity which has handled their dispute. |
| --- | --- |

(7)

It is appropriate to determine when the parties to a dispute handled through the ODR platform should be able to provide their feedback on the functioning of the ODR platform and on the ADR entity which has handled their dispute.

| (8) | Regulation (EU) No 524/2013 provides for the designation of one ODR contact point in each Member State to provide support to the parties involved in a dispute and to the ADR entities handling a dispute through the ODR platform. In order to facilitate the cooperation between the ODR contact points it is appropriate to define a common set of principles to underpin that cooperation. |
| --- | --- |

(8)

Regulation (EU) No 524/2013 provides for the designation of one ODR contact point in each Member State to provide support to the parties involved in a dispute and to the ADR entities handling a dispute through the ODR platform. In order to facilitate the cooperation between the ODR contact points it is appropriate to define a common set of principles to underpin that cooperation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Committee on Online Dispute Resolution, set up under Article 16(1) of Regulation (EU) No 524/2013, |
| --- | --- |

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Online Dispute Resolution, set up under Article 16(1) of Regulation (EU) No 524/2013,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down the modalities for:

| (a) | the electronic complaint form; |
| --- | --- |

(a)

the electronic complaint form;

| (b) | the exercise of the functions of the ODR platform; |
| --- | --- |

(b)

the exercise of the functions of the ODR platform;

| (c) | the cooperation between the ODR contact points. |
| --- | --- |

(c)

the cooperation between the ODR contact points.

Article 2

Electronic complaint form

The electronic complaint form to be submitted to the ODR platform shall be accessible to consumers and traders in all the official languages of the institutions of the Union. The complainant party shall be able to save a draft of the electronic complaint form on the ODR platform. The draft shall be accessible and editable by the complainant party prior to submission of the final fully completed electronic complaint form. The draft of the electronic complaint form that is not fully completed and submitted shall be automatically deleted from the ODR platform six months after its creation.

Article 3

Informing the respondent party

Upon receipt of the fully completed electronic complaint form, the ODR platform shall transmit a standard electronic message to the respondent party's electronic address indicated by the complainant party in the electronic complaint form, informing that a complaint has been submitted against it and making available the information according to Article 9(3) of Regulation (EU) No 524/2013.

Article 4

Identification of the alternative dispute resolution (ADR) entity

1.   The ODR platform shall display to the respondent party an indicative list of ADR entities, where no competent ADR entity is identified in the electronic complaint form, to facilitate the identification of the competent ADR entity. This list shall be based on the following criteria:

| (a) | the geographical address of the parties to the dispute as provided for in the electronic complaint form pursuant to the Annex to Regulation (EU) No 524/2013; and |
| --- | --- |

(a)

the geographical address of the parties to the dispute as provided for in the electronic complaint form pursuant to the Annex to Regulation (EU) No 524/2013; and

| (b) | the sector that the dispute relates to. |
| --- | --- |

(b)

the sector that the dispute relates to.

2.   The parties shall at any time have access to the list of all ADR entities registered with the ODR platform pursuant to Article 5(6) of Regulation (EU) No 524/2013. A search tool, offered by the ODR platform, shall help the parties to identify the ADR entity competent to deal with their dispute among the ADR entities registered with the ODR platform.

Article 5

Information to be provided by ADR entities

1.   ADR entities to which a complaint has been transmitted through the ODR platform and which have agreed to deal with a dispute shall, without delay upon receipt of the complete complaint file related to that dispute, transmit to the ODR platform the date of receipt of the complete complaint file and the subject matter of the dispute.

2.   The date of receipt of the complete complaint file starts the 90-calendar day period referred to in point (e) of Article 8 of Directive 2013/11/EU of the European Parliament and of the Council (2).

3.   ADR entities to which a complaint has been transmitted through the ODR platform and which refuse to deal with a dispute shall transmit the refusal to the ODR platform without delay upon taking that decision in line with Article 5(4) of Directive 2013/11/EU.

4.   ADR entities to which a complaint has been transmitted through the ODR platform shall, without delay upon conclusion of the dispute, transmit to the ODR platform the date of conclusion of the ADR procedure as well as its result. This shall include the situation where both or one of the parties withdraw from the procedure in accordance with point (a) of Article 9(2) of Directive 2013/11/EU.

Article 6

Conclusion of certain disputes and deletion of personal data

1.   A dispute submitted through the ODR platform shall not be processed further in particular where:

| (a) | the respondent party states that it is not willing to use an ADR entity; |
| --- | --- |

(a)

the respondent party states that it is not willing to use an ADR entity;

| (b) | the parties fail to agree on an ADR entity to deal with their dispute within 30 calendar days after submission of the electronic complaint form; |
| --- | --- |

(b)

the parties fail to agree on an ADR entity to deal with their dispute within 30 calendar days after submission of the electronic complaint form;

| (c) | the ADR entity agreed on by the parties refuses to deal with the dispute, |
| --- | --- |

(c)

the ADR entity agreed on by the parties refuses to deal with the dispute,

and shall be considered as concluded. The date of the occurrence of any of the events referred to in points (a) to (c) shall be the date of conclusion of the respective dispute.

2.   The personal data related to the disputes referred to in points (a) to (c) of the first paragraph shall be deleted from the platform at the latest six months after their conclusion.

Article 7

Electronic notification of the list of ADR entities

1.   Competent authorities as defined under point (i) of Article 4(1) of Directive 2013/11/EU, in order to notify the list of ADR entities referred to in Article 20(2) of Directive 2013/11/EU, shall use a standardised electronic form provided by the Commission.

2.   The completed standardised electronic form will include the information as referred to in Article 20(2) of Directive 2013/11/EU and the information on the average length of the ADR procedure as referred to in point (d) of Article 9(5) of Regulation (EU) No 524/2013 and point (e) of Article 19(1) of Directive 2013/11/EU.

Article 8

Feedback system

The ODR platform shall give the possibility to the parties involved in a dispute to give their feedback pursuant to point (g) of Article 5(4) of Regulation (EU) No 524/2013 upon conclusion of the ADR procedure and for six months thereafter.

Article 9

Cooperation between ODR contact points

1.   ODR contact points shall provide support to the resolution of disputes relating to complaints submitted through the ODR platform as provided for by Article 7(2) of Regulation (EU) No 524/2013 to the best of their ability.

2.   ODR advisors shall without delay provide assistance to and exchange information with advisors in other ODR contact points in order to facilitate the performance of their functions listed in Article 7(2) of Regulation (EU) No 524/2013.

3.   ODR advisors who have access to information concerning a dispute including personal data shall grant access to this information to advisors in other ODR contact points in so far as it is necessary for the purpose of fulfilling the functions referred to in Article 7(2) of Regulation (EU) No 524/2013.

Article 10

Entry into force

This Regulation shall enter into force on the twentieth day following that 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.

Done at Brussels, 1 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 165, 18.6.2013, p. 1.

1

(2)  Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63).

2

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| 2.7.2015 | EN | Official Journal of the European Union | L 171/5 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/5

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COMMISSION REGULATION (EU) 2015/1052

of 1 July 2015

refusing to authorise certain health claims made on foods and referring to the reduction of disease risk

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 17(3) thereof,

Whereas:

| (1) | Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims. |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

| (2) | Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’. |
| --- | --- |

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

| (3) | Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned. |
| --- | --- |

(3)

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

| (4) | The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. |
| --- | --- |

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

| (5) | Following an application from SANOFI-AVENTIS FRANCE submitted pursuant to Article 19(1) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL-cholesterol. That health claim has been authorised, pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, by Commission Regulations (EC) No 983/2009 (2) and (EU) No 384/2010 (3). The applicant requested an extension of the conditions of use, as provided for in Regulation (EC) No 983/2009 as amended by Regulation (EU) No 376/2010 (4) and in Regulation (EU) No 384/2010 in its original version, to powder supplements to be diluted in water at a dose of 2 g per day, which would lower blood LDL-cholesterol concentrations by ‘5,4-8,1 %’ after six weeks of daily consumption. |
| --- | --- |

(5)

Following an application from SANOFI-AVENTIS FRANCE submitted pursuant to Article 19(1) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on the modification of the authorisation of a health claim related to plant sterol esters and lowering blood LDL-cholesterol. That health claim has been authorised, pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, by Commission Regulations (EC) No 983/2009 (2) and (EU) No 384/2010 (3). The applicant requested an extension of the conditions of use, as provided for in Regulation (EC) No 983/2009 as amended by Regulation (EU) No 376/2010 (4) and in Regulation (EU) No 384/2010 in its original version, to powder supplements to be diluted in water at a dose of 2 g per day, which would lower blood LDL-cholesterol concentrations by ‘5,4-8,1 %’ after six weeks of daily consumption.

| (6) | On 21 February 2014, the Commission and the Member States received a scientific opinion from the Authority (Question No EFSA-Q-2013-00595) (5) which concluded that while plant sterols added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts, including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol concentrations in a large number of studies, the effective dose of plant sterols (as powder diluted in water) needed to achieve a given magnitude of effect in a given timeframe, as requested by the applicant, cannot be established with the data provided. |
| --- | --- |

(6)

On 21 February 2014, the Commission and the Member States received a scientific opinion from the Authority (Question No EFSA-Q-2013-00595) (5) which concluded that while plant sterols added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts, including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol concentrations in a large number of studies, the effective dose of plant sterols (as powder diluted in water) needed to achieve a given magnitude of effect in a given timeframe, as requested by the applicant, cannot be established with the data provided.

| (7) | In accordance with the second paragraph of Article 16(6) of Regulation (EC) No 1924/2006, the applicant or members of the public may make comments to the Commission on opinions published by the Authority pursuant to the first paragraph of Article 16(6) of that Regulation. On 14 April 2014, the Commission requested the Authority to respond to the scientific comments received from the applicant according to Article 16(6) of Regulation (EC) No 1924/2006. The comments were related to the scientific evaluation of the Authority on the extension of the conditions of use to plant sterol esters in powder, in particular to the intervention study on which the conclusion of the adopted scientific opinion was based and to a new published meta-analysis which was submitted with the comments. |
| --- | --- |

(7)

In accordance with the second paragraph of Article 16(6) of Regulation (EC) No 1924/2006, the applicant or members of the public may make comments to the Commission on opinions published by the Authority pursuant to the first paragraph of Article 16(6) of that Regulation. On 14 April 2014, the Commission requested the Authority to respond to the scientific comments received from the applicant according to Article 16(6) of Regulation (EC) No 1924/2006. The comments were related to the scientific evaluation of the Authority on the extension of the conditions of use to plant sterol esters in powder, in particular to the intervention study on which the conclusion of the adopted scientific opinion was based and to a new published meta-analysis which was submitted with the comments.

| (8) | On 21 May 2014, the Commission received the Authority's response to the comments on the scientific opinion (Question No EFSA-Q-2014-00310) (6) in which the Authority reiterated the conclusion of its scientific opinion (Question No EFSA-Q-2013-00595) with respect to the intervention study. The Authority added that the new published meta-analysis does not provide additional information for the scientific substantiation of the extension of the conditions of use to plant sterol esters in powder. Accordingly, as under the requested conditions of use the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(8)

On 21 May 2014, the Commission received the Authority's response to the comments on the scientific opinion (Question No EFSA-Q-2014-00310) (6) in which the Authority reiterated the conclusion of its scientific opinion (Question No EFSA-Q-2013-00595) with respect to the intervention study. The Authority added that the new published meta-analysis does not provide additional information for the scientific substantiation of the extension of the conditions of use to plant sterol esters in powder. Accordingly, as under the requested conditions of use the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (9) | Following an application from Jemo-pharm A/S submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on a health claim related to the effect of CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract (Question No EFSA-Q-2013-00649) (7). The claim proposed by the applicant was worded as follows: ‘Prevent adhesion of E. coli to the uroepithelial cells in women which is a risk factor for developing urinary tract infections’. |
| --- | --- |

(9)

Following an application from Jemo-pharm A/S submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on a health claim related to the effect of CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract (Question No EFSA-Q-2013-00649) (7). The claim proposed by the applicant was worded as follows: ‘Prevent adhesion of E. coli to the uroepithelial cells in women which is a risk factor for developing urinary tract infections’.

| (10) | On 5 May 2014, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship has not been established between the consumption of CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(10)

On 5 May 2014, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship has not been established between the consumption of CranMax® and reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (11) | The comments received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation. |
| --- | --- |

(11)

The comments received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.

Article 2

This Regulation shall enter into force on the twentieth day following that 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.

Done at Brussels, 1 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 404, 30.12.2006, p. 9.

1

(2)  Commission Regulation (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health (OJ L 277, 22.10.2009, p. 3).

2

(3)  Commission Regulation (EU) No 384/2010 of 5 May 2010 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to the reduction of disease risk and to children's development and health (OJ L 113, 6.5.2010, p. 6).

3

(4)  Commission Regulation (EU) No 376/2010 of 3 May 2010 amending Regulation (EC) No 983/2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children's development and health (OJ L 111, 4.5.2010, p. 3).

4

(5)  EFSA Journal 2014;12(2):3577.

5

(6)  EFSA supporting publication 2014:EN-596.

6

(7)  EFSA Journal 2014;12(5):3657.

7

---

ANNEX

Rejected health claims

| Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
| --- | --- | --- | --- |
| Modification, pursuant to Article 19, of an Article 14(1)(a) health claim referring to a reduction of a disease risk. | Plant sterol esters | Plant sterol esters presented as food supplement in powder sachet have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. | Q-2013-00595 |
| Article 14(1)(a) health claim referring to a reduction of a disease risk. | CranMax® | Prevent adhesion of E. coli to the uroepithelial cells in women which is a risk factor for developing urinary tract infections. | Q-2013-00649 |

Application — Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Modification, pursuant to Article 19, of an Article 14(1)(a) health claim referring to a reduction of a disease risk.

Plant sterol esters

Plant sterol esters presented as food supplement in powder sachet have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

Q-2013-00595

Article 14(1)(a) health claim referring to a reduction of a disease risk.

CranMax®

Prevent adhesion of E. coli to the uroepithelial cells in women which is a risk factor for developing urinary tract infections.

Q-2013-00649

---

| 2.7.2015 | EN | Official Journal of the European Union | L 171/8 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/8

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1053

of 1 July 2015

concerning the authorisation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs and amending Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 (holder of authorisation Chevita Tierarzneimittel-GmbH)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | The preparation of Enterococcus faecium DSM 10663/NCIMB 10415 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), for calves by Commission Regulation (EC) No 255/2005 (4), for piglets by Commission Regulation (EC) No 1200/2005 (5), for turkeys for fattening and dogs by Commission Regulation (EC) No 1520/2007 (6). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The preparation of Enterococcus faecium DSM 10663/NCIMB 10415 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), for calves by Commission Regulation (EC) No 255/2005 (4), for piglets by Commission Regulation (EC) No 1200/2005 (5), for turkeys for fattening and dogs by Commission Regulation (EC) No 1520/2007 (6). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening and dogs and, in accordance with Article 7 of that Regulation, for a new use for cats, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 as a feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening and dogs and, in accordance with Article 7 of that Regulation, for a new use for cats, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 March 2014 (7) and 21 May 2014 (8) that, under the proposed conditions of use, the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 does not have an adverse effect on animal health, human health or the environment. The Authority further concluded that the use of that preparation has the potential to improve zootechnical performance of calves for rearing, piglets (suckling and weaned), chickens for fattening and turkeys for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 March 2014 (7) and 21 May 2014 (8) that, under the proposed conditions of use, the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 does not have an adverse effect on animal health, human health or the environment. The Authority further concluded that the use of that preparation has the potential to improve zootechnical performance of calves for rearing, piglets (suckling and weaned), chickens for fattening and turkeys for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | Since small but significant effects on faecal quality were observed by the EFSA in cats and dogs, it is considered sufficient to confirm the efficacy in these species. |
| --- | --- |

(5)

Since small but significant effects on faecal quality were observed by the EFSA in cats and dogs, it is considered sufficient to confirm the efficacy in these species.

| (6) | The assessment of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of the preparation of Enterococcus faecium DSM 10663/NCIMB 10415 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (7) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 should be amended accordingly. |
| --- | --- |

(7)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1259/2004, (EC) No 255/2005, (EC) No 1200/2005 and (EC) No 1520/2007 should be amended accordingly.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Amendments to Regulation (EC) No 1259/2004

Regulation (EC) No 1259/2004 is amended as follows:

| (1) | Article 1 is deleted. |
| --- | --- |

(1)

Article 1 is deleted.

| (2) | Annex I is deleted. |
| --- | --- |

(2)

Annex I is deleted.

Article 3

Amendment to Regulation (EC) No 255/2005

In Annex I to Regulation (EC) No 255/2005, the entry on E 1707, Enterococcus faecium DSM 10663/NCIMB 10415, is deleted.

Article 4

Amendment to Regulation (EC) No 1200/2005

In Annex II to Regulation (EC) No 1200/2005, the entry on E 1707, Enterococcus faecium DSM 10663/NCIMB 10415, is deleted.

Article 5

Amendments to Regulation (EC) No 1520/2007

Regulation (EC) No 1520/2007 is amended as follows:

| (1) | Articles 2 and 3 are deleted. |
| --- | --- |

(1)

Articles 2 and 3 are deleted.

| (2) | Annexes II and III are deleted. |
| --- | --- |

(2)

Annexes II and III are deleted.

Article 6

Transitional measures

(1)   The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 22 January 2016 in accordance with the rules applicable before 22 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for calves, piglets, chickens for fattening and turkeys for fattening.

(2)   The preparation specified in the Annex and feed containing that preparation, which are produced and labelled [for dogs] before 22 July 2017 in accordance with the rules applicable before 22 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for dogs.

Article 7

Entry into force

This Regulation shall enter into force on the twentieth day following that 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.

Done at Brussels, 1 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  Commission Regulation (EC) No 1259/2004 of 8 July 2004 concerning the permanent authorisation of certain additives already authorised in feedingstuffs (OJ L 239, 9.7.2004, p. 8).

3

(4)  Commission Regulation (EC) No 255/2005 of 15 February 2005 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 45, 16.2.2005, p. 3).

4

(5)  Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 195, 27.7.2005, p. 6).

5

(6)  Commission Regulation (EC) No 1520/2007 of 19 December 2007 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 335, 20.12.2007, p. 17).

6

(7)  EFSA Journal 2014; 12(3):3602.

7

(8)  EFSA Journal 2014; 12(6):3727.

8

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers. |
| 4b1707 | Chevita Tierarzneimittel-GmbH | Enterococcus faecium
  DSM 10663/NCIMB 10415 | Additive composition

  Preparation of Enterococcus faecium

  DSM 10663/NCIMB 10415 containing a minimum of: | powder and granulated forms:
  3,5 × 1010 CFU/g additive; |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers.

4b1707

Chevita Tierarzneimittel-GmbH

Enterococcus faecium

DSM 10663/NCIMB 10415

Additive composition

Preparation of Enterococcus faecium

DSM 10663/NCIMB 10415 containing a minimum of:

powder and granulated forms:

3,5 × 1010 CFU/g additive;

| | coated form:
  2 × 1010 CFU/g additive; |
| --- | --- |

coated form:

2 × 1010 CFU/g additive;

| | liquid form:
  1 × 1010 CFU/g additive |
| --- | --- |

liquid form:

1 × 1010 CFU/g additive

Characterisation of the active substance

Viable cells of Enterococcus faecium

DSM 10663/NCIMB 10415

Analytical method
   (1)

Enumeration: spread plate method using bile esculin azide agar (EN 15788)

Identification: Pulsed- Field Gel Electrophoresis (PFGE)

Calves for rearing

Piglets

(suckling and weaned)

Chickens for fattening

Turkeys for fattening

Cats

Dogs

—

1 × 109

—

| 1. | In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.

| 2. | Recommended dose for suckling piglets: 1 × 109/piglet/day. |
| --- | --- |

2.

Recommended dose for suckling piglets: 1 × 109/piglet/day.

| 3. | The use is permitted in feed for chickens for fattening and turkeys for fattening containing the authorised coccidiostats: semduramicin sodium, diclazuril, robenidine hydrochloride, maduramicin ammonium, decoquinate, lasalocid A sodium or halofuginone. |
| --- | --- |

3.

The use is permitted in feed for chickens for fattening and turkeys for fattening containing the authorised coccidiostats: semduramicin sodium, diclazuril, robenidine hydrochloride, maduramicin ammonium, decoquinate, lasalocid A sodium or halofuginone.

| 4. | For use in weaned piglets until approximately 35 kg. |
| --- | --- |

4.

For use in weaned piglets until approximately 35 kg.

22 July 2025

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

---

| 2.7.2015 | EN | Official Journal of the European Union | L 171/12 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/12

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1054

of 1 July 2015

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

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

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.

Done at Brussels, 1 July 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 32,3 |
| MA | 139,7 |
| MK | 31,3 |
| ZZ | 67,8 |
| 0707 00 05 | TR | 106,1 |
| ZZ | 106,1 |
| 0709 93 10 | TR | 116,8 |
| ZZ | 116,8 |
| 0805 50 10 | AR | 99,2 |
| BO | 144,3 |
| UY | 130,0 |
| ZA | 146,2 |
| ZZ | 129,9 |
| 0808 10 80 | AR | 114,9 |
| BR | 98,2 |
| CL | 128,2 |
| NZ | 144,5 |
| US | 164,6 |
| ZA | 124,2 |
| ZZ | 129,1 |
| 0809 10 00 | IL | 315,1 |
| TR | 243,7 |
| ZZ | 279,4 |
| 0809 29 00 | TR | 301,3 |
| ZZ | 301,3 |
| 0809 40 05 | IL | 241,9 |
| ZZ | 241,9 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

32,3

MA

139,7

MK

31,3

ZZ

67,8

0707 00 05

TR

106,1

ZZ

106,1

0709 93 10

TR

116,8

ZZ

116,8

0805 50 10

AR

99,2

BO

144,3

UY

130,0

ZA

146,2

ZZ

129,9

0808 10 80

AR

114,9

BR

98,2

CL

128,2

NZ

144,5

US

164,6

ZA

124,2

ZZ

129,1

0809 10 00

IL

315,1

TR

243,7

ZZ

279,4

0809 29 00

TR

301,3

ZZ

301,3

0809 40 05

IL

241,9

ZZ

241,9

---

(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

---

DECISIONS

| 2.7.2015 | EN | Official Journal of the European Union | L 171/14 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/14

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/1055

of 30 June 2015

concerning the consistency of certain targets included in the national or functional airspace block plans submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period

(notified under document C(2015) 4403)

(Only the French, German and Italian texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Agreement between the European Community and the Swiss Confederation on Air Transport (the Agreement) (1),

Having regard to Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2), as incorporated into the Agreement, and in particular Article 11(3)(c) thereof,

Whereas:

| (1) | Pursuant to Regulation (EC) No 549/2004, as incorporated into the Agreement, the Member States and Switzerland are to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the Commission is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Commission may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in Commission Implementing Regulation (EU) No 390/2013 (3). |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 549/2004, as incorporated into the Agreement, the Member States and Switzerland are to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the Commission is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Commission may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in Commission Implementing Regulation (EU) No 390/2013 (3).

| (2) | Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (4). |
| --- | --- |

(2)

Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (4).

| (3) | Switzerland submitted to the Commission the performance plan, at FAB level, in this case FAB Europe Central (‘FABEC’), on 30 June 2014. For its assessment, the Commission has based itself on the information submitted in the performance plan. |
| --- | --- |

(3)

Switzerland submitted to the Commission the performance plan, at FAB level, in this case FAB Europe Central (‘FABEC’), on 30 June 2014. For its assessment, the Commission has based itself on the information submitted in the performance plan.

| (4) | The Performance Review Body, which is charged with assisting the Commission in the implementation of the performance scheme pursuant to Article 3 of Implementing Regulation (EU) No 390/2013, submitted an initial assessment report to the Commission on 7 October 2014 and an updated version of that report on 15 December 2014. The Commission further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Implementing Regulation (EU) No 390/2013. |
| --- | --- |

(4)

The Performance Review Body, which is charged with assisting the Commission in the implementation of the performance scheme pursuant to Article 3 of Implementing Regulation (EU) No 390/2013, submitted an initial assessment report to the Commission on 7 October 2014 and an updated version of that report on 15 December 2014. The Commission further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Implementing Regulation (EU) No 390/2013.

| (5) | Concerning the key performance area of safety, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, regarding the effectiveness of safety management and the application of severity classification on the basis of the Risk Analysis Tool (RAT) methodology has been assessed, in accordance with the principles laid down in point 2 of Annex IV to Implementing Regulation (EU) No 390/2013. That assessment has demonstrated that those targets are consistent with the relevant Union-wide performance target. |
| --- | --- |

(5)

Concerning the key performance area of safety, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, regarding the effectiveness of safety management and the application of severity classification on the basis of the Risk Analysis Tool (RAT) methodology has been assessed, in accordance with the principles laid down in point 2 of Annex IV to Implementing Regulation (EU) No 390/2013. That assessment has demonstrated that those targets are consistent with the relevant Union-wide performance target.

| (6) | Concerning the key performance area of environment, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, has been assessed, in accordance with the principles laid down in point 3 of Annex IV to Implementing Regulation (EU) No 390/2013, by using the respective FAB reference values for horizontal en route flight efficiency of the actual trajectory that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that those targets are consistent with the relevant Union-wide performance target. |
| --- | --- |

(6)

Concerning the key performance area of environment, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, has been assessed, in accordance with the principles laid down in point 3 of Annex IV to Implementing Regulation (EU) No 390/2013, by using the respective FAB reference values for horizontal en route flight efficiency of the actual trajectory that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that those targets are consistent with the relevant Union-wide performance target.

| (7) | Therefore, the Commission considers that the targets included in the performance plan drawn up by Switzerland as regards FABEC are consistent with the Union-wide performance targets in the key performance areas of safety and environment. Therefore, in relation to all those targets, there is no need to issue recommendations that the national supervisory authority concerned propose revised targets. With respect to the targets submitted by Switzerland in the key performance areas of capacity and cost-efficiency, as laid down in the FABEC performance plan, that are not consistent with the relevant Union-wide performance targets, the Commission has issued recommendations to revise those targets, as set out in the Commission Implementing Decision concerning inconsistency of targets submitted by Switzerland. |
| --- | --- |

(7)

Therefore, the Commission considers that the targets included in the performance plan drawn up by Switzerland as regards FABEC are consistent with the Union-wide performance targets in the key performance areas of safety and environment. Therefore, in relation to all those targets, there is no need to issue recommendations that the national supervisory authority concerned propose revised targets. With respect to the targets submitted by Switzerland in the key performance areas of capacity and cost-efficiency, as laid down in the FABEC performance plan, that are not consistent with the relevant Union-wide performance targets, the Commission has issued recommendations to revise those targets, as set out in the Commission Implementing Decision concerning inconsistency of targets submitted by Switzerland.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Single Sky Committee, |
| --- | --- |

(8)

The measures provided for in this Decision are in accordance with the opinion of the Single Sky Committee,

HAS ADOPTED THIS DECISION:

Article 1

The performance targets concerning the key performance areas of safety and environment included in the FABEC performance plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004, as incorporated in the Agreement, listed in the Annex, are consistent with the Union-wide performance targets for the second reference period set out in Implementing Decision 2014/132/EU.

Article 2

This Decision is addressed to the Swiss Confederation.

Done at Brussels, 30 June 2015.

For the Commission

Violeta BULC

Member of the Commission

---

(1)  OJ L 114, 30.4.2002, p. 73.

1

(2)  OJ L 96, 31.3.2004, p. 1.

2

(3)  Commission Implementing Regulation (EU) No 390/2013 of 3 May 2013 laying down a performance scheme for air navigation services and network functions (OJ L 128, 9.5.2013, p. 1).

3

(4)  Commission Implementing Decision 2014/132/EU of 11 March 2014 setting the Union-wide performance targets for the air traffic management network and alert thresholds for the second reference period 2015-19 (OJ L 71, 12.3.2014, p. 20).

4

---

ANNEX

Performance targets in the key performance areas of safety, environment, capacity and cost-efficiency included in the national or functional airspace block plans submitted by Switzerland pursuant to Regulation (EC) No 549/2004 found to be consistent with the Union-wide performance targets for the second reference period

KEY PERFORMANCE AREA OF SAFETY

Effectiveness of Safety Management (EOSM) and the application of the severity classification based on the Risk Analysis Tool (RAT) methodology

| MEMBER STATE | FAB | EOSM | ATM Ground Level % (RAT) | ATM overall Level % (RAT) |
| --- | --- | --- | --- | --- |
| | STATE Level | ANSP Level | 2017 | 2019 | 2017 | 2019 |
| | SC | Other MO | SMI | RIs | ATM-S | SMI | RIs | ATM-S | SMI | RI's | ATM-S | SMI | RIs | ATM-S |
| Switzerland | FAB EC | C | C | D | ≥ 80 | ≥ 80 | ≥ 80 | 100 | 100 | 100 | ≥ 80 | ≥ 80 | ≥ 80 | ≥ 80 | ≥ 80 | 100 |
| (Belgium) |
| (Luxembourg) |
| (The Netherlands) |
| (France) |
| (Germany) |

MEMBER STATE

FAB

EOSM

ATM Ground Level % (RAT)

ATM overall Level % (RAT)

STATE Level

ANSP Level

2017

2019

2017

2019

SC

Other MO

SMI

RIs

ATM-S

SMI

RIs

ATM-S

SMI

RI's

ATM-S

SMI

RIs

ATM-S

Switzerland

FAB EC

C

C

D

≥ 80

≥ 80

≥ 80

100

100

100

≥ 80

≥ 80

≥ 80

≥ 80

≥ 80

100

(Belgium)

(Luxembourg)

(The Netherlands)

(France)

(Germany)

Abbreviations:

| ‘SC’ | : | Management objective ‘safety culture’ as referred to in point 1.1(a) of Section 2 of Annex I to Implementing Regulation (EU) No 390/2013 |
| --- | --- | --- |
| ‘other MO’ | : | Management objectives as listed in point 1.1(a) of Section 2 of Annex I to Implementing Regulation (EU) No 390/2013 other than ‘safety culture’ |
| ‘RIs’ | : | Runway incursions |
| ‘SMI’ | : | Separation minima infringements |
| ‘ATM-S’ | : | ATM-specific occurrences |

‘SC’

:

Management objective ‘safety culture’ as referred to in point 1.1(a) of Section 2 of Annex I to Implementing Regulation (EU) No 390/2013

‘other MO’

:

Management objectives as listed in point 1.1(a) of Section 2 of Annex I to Implementing Regulation (EU) No 390/2013 other than ‘safety culture’

‘RIs’

:

Runway incursions

‘SMI’

:

Separation minima infringements

‘ATM-S’

:

ATM-specific occurrences

KEY PERFORMANCE AREA OF ENVIRONMENT

Horizontal en route flight efficiency of the actual trajectory

| MEMBER STATE | FAB | FAB TARGET ENVIRONMENT |
| --- | --- | --- |
| 2019 |
| (Belgium/Lux) | FAB EC | 2,96 % |
| (France) |
| (Germany) |
| (The Netherlands) |
| Switzerland |

MEMBER STATE

FAB

FAB TARGET ENVIRONMENT

2019

(Belgium/Lux)

FAB EC

2,96 %

(France)

(Germany)

(The Netherlands)

Switzerland

---

| 2.7.2015 | EN | Official Journal of the European Union | L 171/18 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/18

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/1056

of 30 June 2015

concerning the inconsistency of certain targets included in the national or functional airspace block plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period and setting out recommendations for the revision of those targets

(notified under document C(2015) 4407)

(Only the French, German and Italian texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Agreement between the European Community and the Swiss Confederation on Air Transport (‘the Agreement’) (1),

Having regard to Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2), as incorporated into the Agreement, and in particular Article 11(3)(c) thereof,

Whereas:

| (1) | Pursuant to Regulation (EC) No 549/2004, as incorporated into the Agreement, the Member States and Switzerland are to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the Commission is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Commission may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in Commission Implementing Regulation (EU) No 390/2013 (3). |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 549/2004, as incorporated into the Agreement, the Member States and Switzerland are to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the Commission is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Commission may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in Commission Implementing Regulation (EU) No 390/2013 (3).

| (2) | Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (4). |
| --- | --- |

(2)

Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (4).

| (3) | Switzerland submitted to the Commission the performance plan, at FAB level, in this case FAB Europe Central (‘FABEC’), on 30 June 2014. For its assessment, the Commission has based itself on the information submitted in the performance plan. |
| --- | --- |

(3)

Switzerland submitted to the Commission the performance plan, at FAB level, in this case FAB Europe Central (‘FABEC’), on 30 June 2014. For its assessment, the Commission has based itself on the information submitted in the performance plan.

| (4) | The Performance Review Body, which is charged with assisting the Commission in the implementation of the performance scheme pursuant to Article 3 of Implementing Regulation (EU) No 390/2013, submitted an initial assessment report to the Commission on 7 October 2014 and an updated version of that report on 15 December 2014. The Commission further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Implementing Regulation (EU) No 390/2013. |
| --- | --- |

(4)

The Performance Review Body, which is charged with assisting the Commission in the implementation of the performance scheme pursuant to Article 3 of Implementing Regulation (EU) No 390/2013, submitted an initial assessment report to the Commission on 7 October 2014 and an updated version of that report on 15 December 2014. The Commission further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Implementing Regulation (EU) No 390/2013.

| (5) | Concerning the key performance area of capacity, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, for en route Air Traffic Flow Management (ATFM) delay has been assessed, in accordance with the principle laid down in point 4 of Annex IV to Implementing Regulation (EU) No 390/2013, by using the respective FAB reference values for capacity that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that those targets are not in conformity with the respective reference values and therefore not consistent with the relevant Union-wide performance target. |
| --- | --- |

(5)

Concerning the key performance area of capacity, the consistency of the targets submitted by Switzerland, as laid down in the FABEC performance plan, for en route Air Traffic Flow Management (ATFM) delay has been assessed, in accordance with the principle laid down in point 4 of Annex IV to Implementing Regulation (EU) No 390/2013, by using the respective FAB reference values for capacity that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that those targets are not in conformity with the respective reference values and therefore not consistent with the relevant Union-wide performance target.

| (6) | Concerning the key performance area of cost-efficiency, the targets expressed in en route determined unit costs submitted by Switzerland, as laid down in the FABEC performance plan, have been assessed, in accordance with the principles laid down in point 5, in conjunction with point 1, of Annex IV to Implementing Regulation (EU) No 390/2013, by taking account of the trend of en route determined unit costs over the second reference period and the combined period of the first and the second reference period (2012-2019), the number of service units (traffic forecast) and the level of en route determined unit costs in comparison to Member States having a similar operational and economic environment. That assessment has demonstrated that those targets are not consistent with the relevant Union-wide performance target, for the following reasons. |
| --- | --- |

(6)

Concerning the key performance area of cost-efficiency, the targets expressed in en route determined unit costs submitted by Switzerland, as laid down in the FABEC performance plan, have been assessed, in accordance with the principles laid down in point 5, in conjunction with point 1, of Annex IV to Implementing Regulation (EU) No 390/2013, by taking account of the trend of en route determined unit costs over the second reference period and the combined period of the first and the second reference period (2012-2019), the number of service units (traffic forecast) and the level of en route determined unit costs in comparison to Member States having a similar operational and economic environment. That assessment has demonstrated that those targets are not consistent with the relevant Union-wide performance target, for the following reasons.

| (7) | As regard Switzerland, its targets are based on a planned reduction of its en route determined unit costs over the second reference period by only 1,0 % per year on average. This is significantly below the targeted reduction of the average Union-wide en route determined unit costs over the second reference period (– 3,3 % per year). Also over the combined period of the first and the second reference period the planned en route determined unit costs do not decrease in line with the Union-wide trend (– 0,6 %, compared to – 1,7 %). In addition, the target for 2019 is based on planned en route determined unit costs in 2019 that are substantially above (+ 26,6 %) the average en route determined unit costs of the Member States having a similar operational and economic environment to that of Switzerland and around 41 % above the Union-wide performance target in 2019. |
| --- | --- |

(7)

As regard Switzerland, its targets are based on a planned reduction of its en route determined unit costs over the second reference period by only 1,0 % per year on average. This is significantly below the targeted reduction of the average Union-wide en route determined unit costs over the second reference period (– 3,3 % per year). Also over the combined period of the first and the second reference period the planned en route determined unit costs do not decrease in line with the Union-wide trend (– 0,6 %, compared to – 1,7 %). In addition, the target for 2019 is based on planned en route determined unit costs in 2019 that are substantially above (+ 26,6 %) the average en route determined unit costs of the Member States having a similar operational and economic environment to that of Switzerland and around 41 % above the Union-wide performance target in 2019.

| (8) | It is therefore appropriate for the Commission to issue recommendations concerning the necessary measures to be taken by Switzerland to ensure that its national supervisory authority proposes revised performance targets, which address the inconsistencies identified in this Decision. Pursuant to Regulation (EC) No 549/2004 and Implementing Regulation (EU) No 390/2013, it is then for Switzerland to adopt the revised performance targets and to notify them to the Commission within four months of the notification of this Decision. |
| --- | --- |

(8)

It is therefore appropriate for the Commission to issue recommendations concerning the necessary measures to be taken by Switzerland to ensure that its national supervisory authority proposes revised performance targets, which address the inconsistencies identified in this Decision. Pursuant to Regulation (EC) No 549/2004 and Implementing Regulation (EU) No 390/2013, it is then for Switzerland to adopt the revised performance targets and to notify them to the Commission within four months of the notification of this Decision.

| (9) | In order to address the inconsistencies in relation to the key performance area of capacity, it should be ensured that the revised performance targets are, as a minimum, in conformity with the FAB reference values for capacity set out in the Network Operations Plan. The revision of those performance targets should take account of the remediation or mitigation measures designed to ensure that the relevant FAB reference values are respected, specified in the Network Operations Plan.. |
| --- | --- |

(9)

In order to address the inconsistencies in relation to the key performance area of capacity, it should be ensured that the revised performance targets are, as a minimum, in conformity with the FAB reference values for capacity set out in the Network Operations Plan. The revision of those performance targets should take account of the remediation or mitigation measures designed to ensure that the relevant FAB reference values are respected, specified in the Network Operations Plan..

| (10) | In order to address the inconsistencies in relation to the key performance area of cost-efficiency, the cost-efficiency performance targets of Switzerland expressed in en route determined unit costs should be revised downwards, so as to be in line with the reduction of the average en route determined unit costs on Union level over the second reference period and over the combined period of the first and the second reference period. |
| --- | --- |

(10)

In order to address the inconsistencies in relation to the key performance area of cost-efficiency, the cost-efficiency performance targets of Switzerland expressed in en route determined unit costs should be revised downwards, so as to be in line with the reduction of the average en route determined unit costs on Union level over the second reference period and over the combined period of the first and the second reference period.

| (11) | In addition, when revising the cost-efficiency performance targets, the relevant traffic forecasts on which those targets are based should also be revised. For Switzerland, the forecasted service units over the second reference period should be increased, in light of the increase in traffic observed in 2014. |
| --- | --- |

(11)

In addition, when revising the cost-efficiency performance targets, the relevant traffic forecasts on which those targets are based should also be revised. For Switzerland, the forecasted service units over the second reference period should be increased, in light of the increase in traffic observed in 2014.

| (12) | The Commission has consulted Switzerland on the recommendations set out in this Decision, in accordance with Article 14(3) of Implementing Regulation (EU) No 390/2013 and Article 19(2) of the Agreement. |
| --- | --- |

(12)

The Commission has consulted Switzerland on the recommendations set out in this Decision, in accordance with Article 14(3) of Implementing Regulation (EU) No 390/2013 and Article 19(2) of the Agreement.

| (13) | The measures provided for in this Decision are in accordance with the opinion of the Single Sky Committee, |
| --- | --- |

(13)

The measures provided for in this Decision are in accordance with the opinion of the Single Sky Committee,

HAS ADOPTED THIS DECISION:

Article 1

The performance targets concerning the key performance areas of capacity and cost-efficiency included in the FABEC performance plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004, as incorporated into the Agreement, listed in the Annex, are inconsistent with the Union-wide performance targets for the second reference period set out in Implementing Decision 2014/132/EU.

Article 2

Switzerland, as regards FABEC, should take the necessary measures to ensure that its national supervisory authority proposes revised performance targets concerning the key performance areas of capacity and cost-efficiency, in accordance with Articles 3 and 4.

Article 3

The performance targets in the key performance area of capacity submitted by Switzerland as regards FABEC should be revised downwards. As a minimum, those targets should be in accordance with the respective FAB reference values set out in the Network Operations Plan. The revision of those performance targets should take account of the remediation or mitigation measures designed to ensure that the relevant FAB reference values are respected, specified in the Network Operations Plan.

Article 4

The performance targets in the key performance area of cost-efficiency expressed in en route determined unit costs submitted by Switzerland as regards FABEC should be revised downwards to a level that is in line with the reduction of the average en route determined unit costs on Union level over the second reference period and over the combined period of the first and the second reference period. That downwards revision should include a reduction in en route determined costs over the second reference period and a revision of the forecasted traffic expressed in service units.

Article 5

This Decision is addressed to the Swiss Confederation.

Done at Brussels, 30 June 2015.

For the Commission

Violeta BULC

Member of the Commission

---

(1)  OJ L 114, 30.4.2002, p. 73.

1

(2)  OJ L 96, 31.3.2004, p. 1.

2

(3)  Commission Implementing Regulation (EU) No 390/2013 of 3 May 2013 laying down a performance scheme for air navigation services and network functions (OJ L 128, 9.5.2013, p. 1).

3

(4)  Commission Implementing Decision 2014/132/EU of 11 March 2014 setting the Union-wide performance targets for the air traffic management network and alert thresholds for the second reference period 2015-19 (OJ L 71, 12.3.2014, p. 20).

4

---

ANNEX

Performance targets in the key performance areas of capacity and cost-efficiency included in the national or functional airspace block plans submitted by Switzerland pursuant to Regulation (EC) No 549/2004 found to be inconsistent with the Union-wide performance targets for the second reference period

KEY PERFORMANCE AREA OF CAPACITY

En route Air Traffic Flow Management (ATFM) delay in min/flight

| MEMBER STATE | FAB | FAB TARGET EN ROUTE CAPACITY |
| --- | --- | --- |
| 2015 | 2016 | 2017 | 2018 | 2019 |
| (Belgium/Lux) | FAB EC | 0,48 | 0,49 | 0,48 | 0,47 | Consistent (0,43) |
| (France) |
| (Germany) |
| (The Netherlands) |
| Switzerland |

MEMBER STATE

FAB

FAB TARGET EN ROUTE CAPACITY

2015

2016

2017

2018

2019

(Belgium/Lux)

FAB EC

0,48

0,49

0,48

0,47

Consistent (0,43)

(France)

(Germany)

(The Netherlands)

Switzerland

KEY PERFORMANCE AREA OF COST-EFFICIENCY

Legend:

| Key | Item | Units |
| --- | --- | --- |
| (A) | Total en route Determined Costs | (in nominal terms and in national currency) |
| (B) | Inflation rate | (%) |
| (C) | Inflation index | (100 = 2009) |
| (D) | Total en route Determined Costs | (in real 2009 prices and in national currency) |
| (E) | Total en route Services Units | (TSUs) |
| (F) | En route Determined Unit Cost (DUC) | (in real 2009 prices and in national currency) |

Key

Item

Units

(A)

Total en route Determined Costs

(in nominal terms and in national currency)

(B)

Inflation rate

(%)

(C)

Inflation index

(100 = 2009)

(D)

Total en route Determined Costs

(in real 2009 prices and in national currency)

(E)

Total en route Services Units

(TSUs)

(F)

En route Determined Unit Cost (DUC)

(in real 2009 prices and in national currency)

FAB EC

| Charging Zone: Switzerland — Currency: CHF |
| --- |
| | 2015 | 2016 | 2017 | 2018 | 2019 |
| (A) | 155 368 493 | 156 819 377 | 158 799 337 | 159 144 368 | 160 894 397 |
| (B) | 0,5 % | 1,0 % | 1,0 % | 1,0 % | 1,0 % |
| (C) | 100,8 | 101,8 | 102,8 | 103,9 | 104,9 |
| (D) | 154 139 443 | 154 038 465 | 154 438 925 | 153 242 061 | 153 393 253 |
| (E) | 1 418 755 | 1 428 660 | 1 440 060 | 1 454 424 | 1 470 383 |
| (F) | 108,64 | 107,82 | 107,24 | 105,36 | 104,32 |

Charging Zone: Switzerland — Currency: CHF

2015

2016

2017

2018

2019

(A)

155 368 493

156 819 377

158 799 337

159 144 368

160 894 397

(B)

0,5 %

1,0 %

1,0 %

1,0 %

1,0 %

(C)

100,8

101,8

102,8

103,9

104,9

(D)

154 139 443

154 038 465

154 438 925

153 242 061

153 393 253

(E)

1 418 755

1 428 660

1 440 060

1 454 424

1 470 383

(F)

108,64

107,82

107,24

105,36

104,32

---

| 2.7.2015 | EN | Official Journal of the European Union | L 171/23 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/23

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/1057

of 1 July 2015

amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (1), and in particular Article 111b(1) thereof,

Whereas:

| (1) | In accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to assess whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health. |
| --- | --- |

(1)

In accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to assess whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.

| (2) | Israel requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. In exercising this equivalence assessment, account was taken of the agreement on conformity assessment and acceptance of industrial products (2), as referred to in Article 51(2) of that Directive, between Israel and the Union. |
| --- | --- |

(2)

Israel requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. The equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. In exercising this equivalence assessment, account was taken of the agreement on conformity assessment and acceptance of industrial products (2), as referred to in Article 51(2) of that Directive, between Israel and the Union.

| (3) | Brazil requested, by letter dated 4 October 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed by Brazil on 12 March 2015, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled. |
| --- | --- |

(3)

Brazil requested, by letter dated 4 October 2012, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed by Brazil on 12 March 2015, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled.

| (4) | Commission Implementing Decision 2012/715/EU (3) should therefore be amended accordingly, |
| --- | --- |

(4)

Commission Implementing Decision 2012/715/EU (3) should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.

Article 2

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

Done at Brussels, 1 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  Council Decision 2013/1/EU 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) (OJ L 1, 4.1.2013, p. 1).

2

(3)  Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L 325, 23.11.2012, p. 15).

3

---

ANNEX

‘ANNEX

List of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union

| Third country | Remarks |
| --- | --- |
| Australia | |
| Brazil | |
| Israel (1) | |
| Japan | |
| Switzerland | |
| United States of America | |

Third country

Remarks

Australia

Brazil

Israel (1)

Japan

Switzerland

United States of America

---

(1)  Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.’

1

---

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 2.7.2015 | EN | Official Journal of the European Union | L 171/25 |
| --- | --- | --- | --- |

2.7.2015

EN

Official Journal of the European Union

L 171/25

---

DECISION No 1/2015 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT

of 14 April 2015

on the amendment of Chapter 16 on construction products, Chapter 18 on biocidal products and the update of legal references listed in Annex 1 [2015/1058]

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 European Union has adopted a new Regulation on construction products (1) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent to that European Union legislation under Article 1(2) of the Agreement; |
| --- | --- |

(1)

The European Union has adopted a new Regulation on construction products (1) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent to that European Union legislation under Article 1(2) of the Agreement;

| (2) | Chapter 16, Construction products, of Annex 1 should be amended to reflect these developments; |
| --- | --- |

(2)

Chapter 16, Construction products, of Annex 1 should be amended to reflect these developments;

| (3) | The European Union has adopted a new Regulation on biocidal products (2) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent to that European Union legislation under Article 1(2) of the Agreement; |
| --- | --- |

(3)

The European Union has adopted a new Regulation on biocidal products (2) and Switzerland has amended its legislative, regulatory and administrative provisions deemed equivalent to that European Union legislation under Article 1(2) of the Agreement;

| (4) | Chapter 18, Biocidal products, of Annex 1 should be amended to reflect these developments; |
| --- | --- |

(4)

Chapter 18, Biocidal products, of Annex 1 should be amended to reflect these developments;

| (5) | It is necessary to update the legal references in Chapter 14, Good Laboratory Practice (GLP) and in Chapter 15, Medicinal products GMP Inspection and Batch Certification, of Annex 1 to the Agreement; |
| --- | --- |

(5)

It is necessary to update the legal references in Chapter 14, Good Laboratory Practice (GLP) and in Chapter 15, Medicinal products GMP Inspection and Batch Certification, of Annex 1 to the Agreement;

| (6) | 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, |
| --- | --- |

(6)

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. | Chapter 16, Construction products, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment A annexed to this Decision. |
| --- | --- |

1.

Chapter 16, Construction products, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment A annexed to this Decision.

| 2. | Chapter 18, Biocidal products, of Annex 1 to the Agreement is amended in accordance with the provisions set out in Attachment B annexed to this Decision. |
| --- | --- |

2.

Chapter 18, Biocidal products, 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 to the Agreement is amended in accordance with the provisions set out in Attachment C annexed to this Decision. |
| --- | --- |

3.

Annex 1 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. |
| --- | --- |

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.

On behalf of the Swiss Confederation

Christophe PERRITAZ

Signed at Berne, 14 April 2015

On behalf of the European Union

Fernando PERREAU DE PINNINCK

Signed at Brussels, 7 April 2015

---

(1)  Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonized conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5).

1

(2)  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

2

---

ATTACHMENT A

In Annex 1, Product Sectors, Chapter 16, Construction products should be deleted and replaced by the following:

‘CHAPTER 16

CONSTRUCTION PRODUCTS

SECTION I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2):

| European Union | 1. | Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5), as last amended by Commission Delegated Regulation (EU) No 574/2014 from 21 February 2014 (OJ L 159, 28.5.2014, p. 41), as well as implementing and delegated acts of the Commission adopted under this regulation until 15.12.2014 (hereinafter together referred to as Regulation (EU) No 305/2011) |
| --- | --- | --- |

European Union

1.

Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5), as last amended by Commission Delegated Regulation (EU) No 574/2014 from 21 February 2014 (OJ L 159, 28.5.2014, p. 41), as well as implementing and delegated acts of the Commission adopted under this regulation until 15.12.2014 (hereinafter together referred to as Regulation (EU) No 305/2011)

| 2. | Commission Decision 94/23/EC of 17 January 1994 on common procedural rules for European technical approval (OJ L 17, 20.1.1994, p. 34). |
| --- | --- |

2.

Commission Decision 94/23/EC of 17 January 1994 on common procedural rules for European technical approval (OJ L 17, 20.1.1994, p. 34).

| 2(a). | Commission Decision 94/611/EC of 9 September 1994 implementing Article 20 of Directive 89/106/EEC on construction products (OJ L 241, 16.9.1994, p. 25). |
| --- | --- |

2(a).

Commission Decision 94/611/EC of 9 September 1994 implementing Article 20 of Directive 89/106/EEC on construction products (OJ L 241, 16.9.1994, p. 25).

| 2(b). | Commission Decision 95/204/EC of 31 May 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 129, 14.6.1995, p. 23). |
| --- | --- |

2(b).

Commission Decision 95/204/EC of 31 May 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 129, 14.6.1995, p. 23).

| 3. | Commission Decision 95/467/EC of 24 October 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 268, 10.11.1995, p. 29). |
| --- | --- |

3.

Commission Decision 95/467/EC of 24 October 1995 implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 268, 10.11.1995, p. 29).

| 4. | Commission Decision 96/577/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fixed fire-fighting systems (OJ L 254, 8.10.1996, p. 44). |
| --- | --- |

4.

Commission Decision 96/577/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fixed fire-fighting systems (OJ L 254, 8.10.1996, p. 44).

| 5. | Commission Decision 96/578/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards sanitary appliances (OJ L 254, 8.10.1996, p. 49). |
| --- | --- |

5.

Commission Decision 96/578/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards sanitary appliances (OJ L 254, 8.10.1996, p. 49).

| 6. | Commission Decision 96/579/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards circulation fixtures (OJ L 254, 8.10.1996, p. 52). |
| --- | --- |

6.

Commission Decision 96/579/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards circulation fixtures (OJ L 254, 8.10.1996, p. 52).

| 7. | Commission Decision 96/580/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards curtain walling (OJ L 254, 8.10.1996, p. 56). |
| --- | --- |

7.

Commission Decision 96/580/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards curtain walling (OJ L 254, 8.10.1996, p. 56).

| 8. | Commission Decision 96/581/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards geotextiles (OJ L 254, 8.10.1996, p. 59). |
| --- | --- |

8.

Commission Decision 96/581/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards geotextiles (OJ L 254, 8.10.1996, p. 59).

| 9. | Commission Decision 96/582/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural sealant glazing systems and metal anchors for concrete (OJ L 254, 8.10.1996, p. 62). |
| --- | --- |

9.

Commission Decision 96/582/EC of 24 June 1996 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural sealant glazing systems and metal anchors for concrete (OJ L 254, 8.10.1996, p. 62).

| 10. | Commission Decision 96/603/EC of 4 October 1996 establishing the list of products belonging to classes A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 267, 19.10.1996, p. 23). |
| --- | --- |

10.

Commission Decision 96/603/EC of 4 October 1996 establishing the list of products belonging to classes A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 267, 19.10.1996, p. 23).

| 11. | Commission Decision 97/161/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal anchors for use in concrete for fixing lightweight systems (OJ L 62, 4.3.1997, p. 41). |
| --- | --- |

11.

Commission Decision 97/161/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal anchors for use in concrete for fixing lightweight systems (OJ L 62, 4.3.1997, p. 41).

| 12. | Commission Decision 97/176/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural timber products and ancillaries (OJ L 73, 14.3.1997, p. 19). |
| --- | --- |

12.

Commission Decision 97/176/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural timber products and ancillaries (OJ L 73, 14.3.1997, p. 19).

| 13. | Commission Decision 97/177/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal injection anchors for use in masonry (OJ L 73, 14.3.1997, p. 24). |
| --- | --- |

13.

Commission Decision 97/177/EC of 17 February 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal injection anchors for use in masonry (OJ L 73, 14.3.1997, p. 24).

| 14. | Commission Decision 97/462/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards wood-based panels (OJ L 198, 25.7.1997, p. 27). |
| --- | --- |

14.

Commission Decision 97/462/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards wood-based panels (OJ L 198, 25.7.1997, p. 27).

| 15. | Commission Decision 97/463/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards plastic anchors for use in concrete and masonry (OJ L 198, 25.7.1997, p. 31). |
| --- | --- |

15.

Commission Decision 97/463/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards plastic anchors for use in concrete and masonry (OJ L 198, 25.7.1997, p. 31).

| 16. | Commission Decision 97/464/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water engineering products (OJ L 198, 25.7.1997, p. 33). |
| --- | --- |

16.

Commission Decision 97/464/EC of 27 June 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water engineering products (OJ L 198, 25.7.1997, p. 33).

| 17. | Commission Decision 97/555/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cements, building limes and other hydraulic binders (OJ L 229, 20.8.1997, p. 9). |
| --- | --- |

17.

Commission Decision 97/555/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cements, building limes and other hydraulic binders (OJ L 229, 20.8.1997, p. 9).

| 18. | Commission Decision 97/556/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) (OJ L 229, 20.8.1997, p. 14). |
| --- | --- |

18.

Commission Decision 97/556/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) (OJ L 229, 20.8.1997, p. 14).

| 19. | Commission Decision 97/571/EC of 22 July 1997 on the general format of European Technical Approval for construction products (OJ L 236, 27.8.1997, p. 7). |
| --- | --- |

19.

Commission Decision 97/571/EC of 22 July 1997 on the general format of European Technical Approval for construction products (OJ L 236, 27.8.1997, p. 7).

| 20. | Commission Decision 97/597/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards reinforcing and prestressing steel for concrete (OJ L 240, 2.9.1997, p. 4). |
| --- | --- |

20.

Commission Decision 97/597/EC of 14 July 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards reinforcing and prestressing steel for concrete (OJ L 240, 2.9.1997, p. 4).

| 21. | Commission Decision 97/638/EC of 19 September 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fasteners for structural timber (OJ L 268, 1.10.1997, p. 36). |
| --- | --- |

21.

Commission Decision 97/638/EC of 19 September 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fasteners for structural timber (OJ L 268, 1.10.1997, p. 36).

| 22. | Commission Decision 97/740/EC of 14 October 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards masonry and related products (OJ L 299, 4.11.1997, p. 42). |
| --- | --- |

22.

Commission Decision 97/740/EC of 14 October 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards masonry and related products (OJ L 299, 4.11.1997, p. 42).

| 23. | Commission Decision 98/143/EC of 3 February 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards systems of mechanically fastened flexible roof waterproofing membranes (OJ L 42, 14.2.1998, p. 58). |
| --- | --- |

23.

Commission Decision 98/143/EC of 3 February 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards systems of mechanically fastened flexible roof waterproofing membranes (OJ L 42, 14.2.1998, p. 58).

| 24. | Commission Decision 97/808/EC of 20 November 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards floorings (OJ L 331, 3.12.1997, p. 18). |
| --- | --- |

24.

Commission Decision 97/808/EC of 20 November 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards floorings (OJ L 331, 3.12.1997, p. 18).

| 25. | Commission Decision 98/213/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal partition kits (OJ L 80, 18.3.1998, p. 41). |
| --- | --- |

25.

Commission Decision 98/213/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal partition kits (OJ L 80, 18.3.1998, p. 41).

| 26. | Commission Decision 98/214/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural metallic products and ancillaries (OJ L 80, 18.3.1998, p. 46). |
| --- | --- |

26.

Commission Decision 98/214/EC of 9 March 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards structural metallic products and ancillaries (OJ L 80, 18.3.1998, p. 46).

| 27. | Commission Decision 98/279/EC of 5 December 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards non load-bearing permanent shuttering kits/systems based on hollow blocks or panels of insulating materials and, sometimes, concrete (OJ L 127, 29.4.1998, p. 26). |
| --- | --- |

27.

Commission Decision 98/279/EC of 5 December 1997 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards non load-bearing permanent shuttering kits/systems based on hollow blocks or panels of insulating materials and, sometimes, concrete (OJ L 127, 29.4.1998, p. 26).

| 28. | Commission Decision 98/436/EC of 22 June 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards roof coverings, roof lights, roof windows and ancillary products (notified under document number C(1998) 1598) (OJ L 194, 10.7.1998, p. 30). |
| --- | --- |

28.

Commission Decision 98/436/EC of 22 June 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards roof coverings, roof lights, roof windows and ancillary products (notified under document number C(1998) 1598) (OJ L 194, 10.7.1998, p. 30).

| 29. | Commission Decision 98/437/EC of 30 June 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal and external wall and ceiling finishes (OJ L 194, 10.7.1998, p. 39). |
| --- | --- |

29.

Commission Decision 98/437/EC of 30 June 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal and external wall and ceiling finishes (OJ L 194, 10.7.1998, p. 39).

| 30. | Commission Decision 98/456/EC of 3 July 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards post-tensioning kits for the prestressing of structures (OJ L 201, 17.7.1998, p. 112). |
| --- | --- |

30.

Commission Decision 98/456/EC of 3 July 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards post-tensioning kits for the prestressing of structures (OJ L 201, 17.7.1998, p. 112).

| 31. | Commission Decision 98/457/EC of 3 July 1998 concerning the test of the Single Burning Item (SBI) referred to in Council Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 201, 17.7.1998, p. 114). |
| --- | --- |

31.

Commission Decision 98/457/EC of 3 July 1998 concerning the test of the Single Burning Item (SBI) referred to in Council Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 201, 17.7.1998, p. 114).

| 32. | Commission Decision 98/598/EC of 9 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards aggregates (OJ L 287, 24.10.1998, p. 25) |
| --- | --- |

32.

Commission Decision 98/598/EC of 9 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards aggregates (OJ L 287, 24.10.1998, p. 25)

| 33. | Commission Decision 98/599/EC of 12 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards liquid applied roof waterproofing kits (OJ L 287, 24.10.1998, p. 30). |
| --- | --- |

33.

Commission Decision 98/599/EC of 12 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards liquid applied roof waterproofing kits (OJ L 287, 24.10.1998, p. 30).

| 34. | Commission Decision 98/600/EC of 12 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards self-supporting translucent roof kits (except glass-based kits) (OJ L 287, 24.10.1998, p. 35). |
| --- | --- |

34.

Commission Decision 98/600/EC of 12 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards self-supporting translucent roof kits (except glass-based kits) (OJ L 287, 24.10.1998, p. 35).

| 35. | Commission Decision 98/601/EC of 13 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards road construction products (OJ L 287, 24.10.1998, p. 41). |
| --- | --- |

35.

Commission Decision 98/601/EC of 13 October 1998 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards road construction products (OJ L 287, 24.10.1998, p. 41).

| 36. | Commission Decision 99/89/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards prefabricated stair kits (OJ L 29, 3.2.1999, p. 34). |
| --- | --- |

36.

Commission Decision 99/89/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards prefabricated stair kits (OJ L 29, 3.2.1999, p. 34).

| 37. | Commission Decision 1999/90/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards membranes (OJ L 29, 3.2.1999, p. 38). |
| --- | --- |

37.

Commission Decision 1999/90/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards membranes (OJ L 29, 3.2.1999, p. 38).

| 38. | Commission Decision 1999/91/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards thermal insulating products (OJ L 29, 3.2.1999, p. 44). |
| --- | --- |

38.

Commission Decision 1999/91/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards thermal insulating products (OJ L 29, 3.2.1999, p. 44).

| 39. | Commission Decision 1999/92/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards light composite wood-based beams and columns (OJ L 29, 3.2.1999, p. 49). |
| --- | --- |

39.

Commission Decision 1999/92/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards light composite wood-based beams and columns (OJ L 29, 3.2.1999, p. 49).

| 40. | Commission Decision 1999/93/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards doors, windows, shutters, blinds, gates and related building hardware (OJ L 29, 3.2.1999, p. 51). |
| --- | --- |

40.

Commission Decision 1999/93/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards doors, windows, shutters, blinds, gates and related building hardware (OJ L 29, 3.2.1999, p. 51).

| 41. | Commission Decision 1999/94/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards precast normal/light-weight autoclaved aerated concrete products (OJ L 29, 3.2.1999, p. 55). |
| --- | --- |

41.

Commission Decision 1999/94/EC of 25 January 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards precast normal/light-weight autoclaved aerated concrete products (OJ L 29, 3.2.1999, p. 55).

| 41a) | Commission Decision 1999/453/EC of 18 June 1999 amending decision 96/579/EC and 97/808/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards circulation fixtures and floorings respectively (OJ L 178, 14.7.1999, p. 50). |
| --- | --- |

41a)

Commission Decision 1999/453/EC of 18 June 1999 amending decision 96/579/EC and 97/808/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards circulation fixtures and floorings respectively (OJ L 178, 14.7.1999, p. 50).

| 42. | Commission Decision 1999/454/EC of 22 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fire stopping, fire sealing and fire protective products (OJ L 178, 14.7.1999, p. 52). |
| --- | --- |

42.

Commission Decision 1999/454/EC of 22 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards fire stopping, fire sealing and fire protective products (OJ L 178, 14.7.1999, p. 52).

| 43. | Commission Decision 1999/455/EC of 22 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards timber frame and log prefabricated building kits (OJ L 178, 14.7.1999, p. 56). |
| --- | --- |

43.

Commission Decision 1999/455/EC of 22 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards timber frame and log prefabricated building kits (OJ L 178, 14.7.1999, p. 56).

| 44. | Commission Decision 1999/469/EC of 25 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards products related to concrete, mortar and grout (OJ L 184, 17.7.1999, p. 27). |
| --- | --- |

44.

Commission Decision 1999/469/EC of 25 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards products related to concrete, mortar and grout (OJ L 184, 17.7.1999, p. 27).

| 45. | Commission Decision 1999/470/EC of 29 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards construction adhesives (OJ L 184, 17.7.1999, p. 32). |
| --- | --- |

45.

Commission Decision 1999/470/EC of 29 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards construction adhesives (OJ L 184, 17.7.1999, p. 32).

| 46. | Commission Decision 1999/471/EC of 29 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards space heating appliances (OJ L 184, 17.7.1999, p. 37). |
| --- | --- |

46.

Commission Decision 1999/471/EC of 29 June 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards space heating appliances (OJ L 184, 17.7.1999, p. 37).

| 47. | Commission Decision 1999/472/EC of 1 July 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards pipes, tanks and ancillaries not in contact with water intended for human consumption (OJ L 184, 17.7.1999, p. 42). |
| --- | --- |

47.

Commission Decision 1999/472/EC of 1 July 1999 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards pipes, tanks and ancillaries not in contact with water intended for human consumption (OJ L 184, 17.7.1999, p. 42).

| 48. | Commission Decision 2000/147/EC of 8 February 2000 implementing Council Directive 89/106/EEC as regards the classification of the reaction to fire performance of construction products (OJ L 50, 23.2.2000, p. 14). |
| --- | --- |

48.

Commission Decision 2000/147/EC of 8 February 2000 implementing Council Directive 89/106/EEC as regards the classification of the reaction to fire performance of construction products (OJ L 50, 23.2.2000, p. 14).

| 49. | Commission Decision 2000/245/EC of 2 February 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(4) of Council Directive 89/106/EEC as regards flat glass, profiled glass and glass block products (OJ L 77, 28.3.2000, p. 13). |
| --- | --- |

49.

Commission Decision 2000/245/EC of 2 February 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(4) of Council Directive 89/106/EEC as regards flat glass, profiled glass and glass block products (OJ L 77, 28.3.2000, p. 13).

| 50. | Commission Decision 2000/273/EC of 27 March 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards seven products for European Technical Approvals without Guideline (OJ L 86, 7.4.2000, p. 15). |
| --- | --- |

50.

Commission Decision 2000/273/EC of 27 March 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards seven products for European Technical Approvals without Guideline (OJ L 86, 7.4.2000, p. 15).

| 51. | Commission Decision 2000/367/EC of 3 May 2000 implementing Council Directive 89/106/EEC as regards the classification of the resistance to fire performance of construction products, construction works and parts thereof (OJ L 133, 6.6.2000, p. 26). |
| --- | --- |

51.

Commission Decision 2000/367/EC of 3 May 2000 implementing Council Directive 89/106/EEC as regards the classification of the resistance to fire performance of construction products, construction works and parts thereof (OJ L 133, 6.6.2000, p. 26).

| 52. | Commission Decision 2000/447/EC of 13 June 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards prefabricated wood-based load-bearing stressed skin panels and self-supporting composite lightweight panels (OJ L 180, 19.7.2000, p. 40). |
| --- | --- |

52.

Commission Decision 2000/447/EC of 13 June 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards prefabricated wood-based load-bearing stressed skin panels and self-supporting composite lightweight panels (OJ L 180, 19.7.2000, p. 40).

| 53. | Commission Decision 2000/553/EC of 6 September 2000 implementing Council Directive 89/106/EEC as regards the external fire performance of roof coverings (OJ L 235, 19.9.2000, p. 19). |
| --- | --- |

53.

Commission Decision 2000/553/EC of 6 September 2000 implementing Council Directive 89/106/EEC as regards the external fire performance of roof coverings (OJ L 235, 19.9.2000, p. 19).

| 53(a). | Commission Decision 2000/605/EC of 26 September 2000 amending Decision 96/603/EC establishing the list of products belonging to class A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 258, 12.10.2000, p. 36). |
| --- | --- |

53(a).

Commission Decision 2000/605/EC of 26 September 2000 amending Decision 96/603/EC establishing the list of products belonging to class A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 258, 12.10.2000, p. 36).

| 54. | Commission Decision 2000/606/EC of 26 September 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards six products for European Technical Approvals without Guideline (OJ L 258, 12.10.2000, p. 38). |
| --- | --- |

54.

Commission Decision 2000/606/EC of 26 September 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards six products for European Technical Approvals without Guideline (OJ L 258, 12.10.2000, p. 38).

| 55. | Commission Decision 2001/19/EC of 20 December 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards expansion joints for road bridges (OJ L 5, 10.1.2001, p. 6). |
| --- | --- |

55.

Commission Decision 2001/19/EC of 20 December 2000 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards expansion joints for road bridges (OJ L 5, 10.1.2001, p. 6).

| 56. | Commission Decision 2001/308/EC of 31 January 2001 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards ventures (OJ L 107, 18.4.2001, p. 25). |
| --- | --- |

56.

Commission Decision 2001/308/EC of 31 January 2001 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards ventures (OJ L 107, 18.4.2001, p. 25).

| 56(a). | Commission Decision 2001/596/EC of 8 January 2001 amending Decisions 95/467/EC, 96/578/EC, 96/580/EC, 97/176/EC, 97/462/EC, 97/556/EC, 97/740/EC, 97/808/EC, 98/213/EC, 98/214/EC, 98/279/EC, 98/436/EC, 98/437/EC, 98/599/EC, 98/600/EC, 98/601/EC, 1999/89/EC, 1999/90/EC, 1999/91/EC, 1999/454/EC, 1999/469/EC, 1999/470/EC, 1999/471/EC, 1999/472/EC, 2000/245/EC, 2000/273/EC, 2000/447/EC on the procedure for attesting the conformity of certain construction products pursuant to Article 20 of Council Directive 89/106/EEC (OJ L 209, 2.8.2001, p. 33). |
| --- | --- |

56(a).

Commission Decision 2001/596/EC of 8 January 2001 amending Decisions 95/467/EC, 96/578/EC, 96/580/EC, 97/176/EC, 97/462/EC, 97/556/EC, 97/740/EC, 97/808/EC, 98/213/EC, 98/214/EC, 98/279/EC, 98/436/EC, 98/437/EC, 98/599/EC, 98/600/EC, 98/601/EC, 1999/89/EC, 1999/90/EC, 1999/91/EC, 1999/454/EC, 1999/469/EC, 1999/470/EC, 1999/471/EC, 1999/472/EC, 2000/245/EC, 2000/273/EC, 2000/447/EC on the procedure for attesting the conformity of certain construction products pursuant to Article 20 of Council Directive 89/106/EEC (OJ L 209, 2.8.2001, p. 33).

| 57. | Commission Decision 2001/671/EC of 21 August 2001 implementing Council Directive 89/106/EEC as regards the classification of the external fire performance of roofs and roof coverings (OJ L 235, 4.9.2001, p. 20). |
| --- | --- |

57.

Commission Decision 2001/671/EC of 21 August 2001 implementing Council Directive 89/106/EEC as regards the classification of the external fire performance of roofs and roof coverings (OJ L 235, 4.9.2001, p. 20).

| 58. | Commission Decision 2002/359/EC of 13 May 2002 on the procedure for attesting the conformity of construction products in contact with water intended for human consumption, pursuant to Article 20(2) of Council Directive 89/106/EEC (OJ L 127, 14.5.2002, p. 16). |
| --- | --- |

58.

Commission Decision 2002/359/EC of 13 May 2002 on the procedure for attesting the conformity of construction products in contact with water intended for human consumption, pursuant to Article 20(2) of Council Directive 89/106/EEC (OJ L 127, 14.5.2002, p. 16).

| 59. | Commission Decision 2002/592/EC of 15 July 2002 amending Decisions 95/467/EC, 96/577/EC, 96/578/EC and 98/598/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EC as regards gypsum products, fixed fire-fighting systems, sanitary appliances and aggregates respectively (OJ L 192, 20.7.2002, p. 57). |
| --- | --- |

59.

Commission Decision 2002/592/EC of 15 July 2002 amending Decisions 95/467/EC, 96/577/EC, 96/578/EC and 98/598/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EC as regards gypsum products, fixed fire-fighting systems, sanitary appliances and aggregates respectively (OJ L 192, 20.7.2002, p. 57).

| 60. | Commission Decision 2003/43/EC of 17 January 2003 establishing the classes of reaction-to-fire performance for certain construction products (OJ L 13, 18.1.2003, p. 35). |
| --- | --- |

60.

Commission Decision 2003/43/EC of 17 January 2003 establishing the classes of reaction-to-fire performance for certain construction products (OJ L 13, 18.1.2003, p. 35).

| 61. | Commission Decision 2003/312/EC of 9 April 2003 on the publication of the reference of standards relating to thermal insulation products, geotextiles, fixed fire-fighting equipment and gypsum blocks in accordance with Council Directive 89/106/EEC (OJ L 114, 8.5.2003, p. 50). |
| --- | --- |

61.

Commission Decision 2003/312/EC of 9 April 2003 on the publication of the reference of standards relating to thermal insulation products, geotextiles, fixed fire-fighting equipment and gypsum blocks in accordance with Council Directive 89/106/EEC (OJ L 114, 8.5.2003, p. 50).

| 62. | Commission Decision 2003/424/EC of 6 June 2003 amending Decision 96/603/EC establishing the list of products belonging to Classes A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 144, 12.6.2003, p. 9). |
| --- | --- |

62.

Commission Decision 2003/424/EC of 6 June 2003 amending Decision 96/603/EC establishing the list of products belonging to Classes A “No contribution to fire” provided for in Decision 94/611/EC implementing Article 20 of Council Directive 89/106/EEC on construction products (OJ L 144, 12.6.2003, p. 9).

| 63. | Commission Decision 2003/593/EC of 7 August 2003 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance of certain construction products (OJ L 201, 8.8.2003, p. 25). |
| --- | --- |

63.

Commission Decision 2003/593/EC of 7 August 2003 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance of certain construction products (OJ L 201, 8.8.2003, p. 25).

| 64. | Commission Decision 2003/629/EC of 27 August 2003 amending Decision 2000/367/EC establishing a classification system for resistance-to-fire performance for construction products, as regards the inclusion of smoke and heat control products (OJ L 218, 30.8.2003, p. 51). |
| --- | --- |

64.

Commission Decision 2003/629/EC of 27 August 2003 amending Decision 2000/367/EC establishing a classification system for resistance-to-fire performance for construction products, as regards the inclusion of smoke and heat control products (OJ L 218, 30.8.2003, p. 51).

| 65. | Commission Decision 2003/632/EC of 26 August 2003 amending Decision 2000/147/EC implementing Council Directive 89/106/EEC as regards the classification of the reaction-to-fire performance of construction products (OJ L 220, 3.9.2003, p. 5). |
| --- | --- |

65.

Commission Decision 2003/632/EC of 26 August 2003 amending Decision 2000/147/EC implementing Council Directive 89/106/EEC as regards the classification of the reaction-to-fire performance of construction products (OJ L 220, 3.9.2003, p. 5).

| 66. | Commission Decision 2003/639/EC of 4 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards pins for structural joints (OJ L 226, 10.9.2003, p. 18). |
| --- | --- |

66.

Commission Decision 2003/639/EC of 4 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards pins for structural joints (OJ L 226, 10.9.2003, p. 18).

| 67. | Commission Decision 2003/640/EC of 4 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards kits for exterior wall claddings (OJ L 226, 10.9.2003, p. 21). |
| --- | --- |

67.

Commission Decision 2003/640/EC of 4 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards kits for exterior wall claddings (OJ L 226, 10.9.2003, p. 21).

| 68. | Commission Decision 2003/655/EC of 12 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards watertight covering kits for wetroom floors and walls (OJ L 231, 17.9.2003, p. 12). |
| --- | --- |

68.

Commission Decision 2003/655/EC of 12 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards watertight covering kits for wetroom floors and walls (OJ L 231, 17.9.2003, p. 12).

| 69. | Commission Decision 2003/656/EC of 12 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards seven products for European technical approvals without Guideline (OJ L 231, 17.9.2003, p. 15). |
| --- | --- |

69.

Commission Decision 2003/656/EC of 12 September 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards seven products for European technical approvals without Guideline (OJ L 231, 17.9.2003, p. 15).

| 70. | Commission Decision 2003/722/EC of 6 October 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards liquid-applied bridge deck waterproofing kits (OJ L 260, 11.10.2003, p. 32). |
| --- | --- |

70.

Commission Decision 2003/722/EC of 6 October 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards liquid-applied bridge deck waterproofing kits (OJ L 260, 11.10.2003, p. 32).

| 71. | Commission Decision 2003/728/EC of 3 October 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal frame building kits, concrete frame building kits, prefabricated building units, cold storage room kits and rockfall protection kits (OJ L 262, 14.10.2003, p. 34). |
| --- | --- |

71.

Commission Decision 2003/728/EC of 3 October 2003 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards metal frame building kits, concrete frame building kits, prefabricated building units, cold storage room kits and rockfall protection kits (OJ L 262, 14.10.2003, p. 34).

| 72. | Commission Decision 2004/663/EC of 20 September 2004 amending Commission Decision 97/464/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water engineering products (OJ L 302, 29.9.2004, p. 6). |
| --- | --- |

72.

Commission Decision 2004/663/EC of 20 September 2004 amending Commission Decision 97/464/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards waste water engineering products (OJ L 302, 29.9.2004, p. 6).

| 73. | Commission Decision 2005/403/EC of 25 May 2005 establishing the classes of external fire performance of roofs and roof coverings for certain construction products as provided for by Council Directive 89/106/EEC (OJ L 135, 28.5.2005, p. 37). |
| --- | --- |

73.

Commission Decision 2005/403/EC of 25 May 2005 establishing the classes of external fire performance of roofs and roof coverings for certain construction products as provided for by Council Directive 89/106/EEC (OJ L 135, 28.5.2005, p. 37).

| 74. | Commission Decision 2005/484/EC of 4 July 2005 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cold storage building kits and cold storage building envelope kits (OJ L 173, 6.7.2005, p. 15). |
| --- | --- |

74.

Commission Decision 2005/484/EC of 4 July 2005 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cold storage building kits and cold storage building envelope kits (OJ L 173, 6.7.2005, p. 15).

| 75. | Commission Decision 2005/610/EC of 9 August 2005 establishing the classes of reaction-to-fire performance for certain construction products (OJ L 208, 11.8.2005, p. 21). |
| --- | --- |

75.

Commission Decision 2005/610/EC of 9 August 2005 establishing the classes of reaction-to-fire performance for certain construction products (OJ L 208, 11.8.2005, p. 21).

| 76. | Commission Decision 2005/823/EC of 22 November 2005 amending Decision 2001/671/EC implementing Council Directive 89/106/EEC as regards the classification of the external fire performance of roofs and roof coverings (OJ L 307, 25.11.2005, p. 53). |
| --- | --- |

76.

Commission Decision 2005/823/EC of 22 November 2005 amending Decision 2001/671/EC implementing Council Directive 89/106/EEC as regards the classification of the external fire performance of roofs and roof coverings (OJ L 307, 25.11.2005, p. 53).

| 77. | Commission Decision 2006/190/EC of 1 March 2006 amending Decision 97/808/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EC as regards floorings (OJ L 66, 8.3.2006, p. 47). |
| --- | --- |

77.

Commission Decision 2006/190/EC of 1 March 2006 amending Decision 97/808/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EC as regards floorings (OJ L 66, 8.3.2006, p. 47).

| 78. | Commission Decision 2006/213/EC of 6 March 2006 establishing the classes of reaction-to-fire performance for certain construction products as regards wood flooring and solid wood panelling and cladding (OJ L 79, 16.3.2006, p. 27). |
| --- | --- |

78.

Commission Decision 2006/213/EC of 6 March 2006 establishing the classes of reaction-to-fire performance for certain construction products as regards wood flooring and solid wood panelling and cladding (OJ L 79, 16.3.2006, p. 27).

| 79. | Commission Decision 2006/600/EC of 4 September 2006 establishing the classes of reaction-to-fire performance for certain construction products as regards double skin metal faced sandwich panels for roofs (OJ L 244, 7.9.2006, p. 24). |
| --- | --- |

79.

Commission Decision 2006/600/EC of 4 September 2006 establishing the classes of reaction-to-fire performance for certain construction products as regards double skin metal faced sandwich panels for roofs (OJ L 244, 7.9.2006, p. 24).

| 80. | Commission Decision 2006/673/EC of 5 October 2006 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance for certain construction products as regards gypsum plasterboards (OJ L 276, 7.10.2006, p. 77). |
| --- | --- |

80.

Commission Decision 2006/673/EC of 5 October 2006 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance for certain construction products as regards gypsum plasterboards (OJ L 276, 7.10.2006, p. 77).

| 81. | Commission Decision 2006/751/EC of 27 October 2006 amending Decision 2000/147/EC implementing Council Directive 89/106/EC as regards the classification of the reaction-to-fire performance of construction products (OJ L 305, 4.11.2006, p. 8). |
| --- | --- |

81.

Commission Decision 2006/751/EC of 27 October 2006 amending Decision 2000/147/EC implementing Council Directive 89/106/EC as regards the classification of the reaction-to-fire performance of construction products (OJ L 305, 4.11.2006, p. 8).

| 82. | Commission Decision 2006/893/EC of 5 December 2006 on the withdrawal of the reference of standard EN 10080:2005 “Steel for the reinforcement of concrete — Weldable reinforcing steel — General” in accordance with Council Directive 89/106/EC (OJ L 343, 8.12.2006, p. 102). |
| --- | --- |

82.

Commission Decision 2006/893/EC of 5 December 2006 on the withdrawal of the reference of standard EN 10080:2005 “Steel for the reinforcement of concrete — Weldable reinforcing steel — General” in accordance with Council Directive 89/106/EC (OJ L 343, 8.12.2006, p. 102).

| 83. | Commission Decision 2007/348/EC of 15 May 2007 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance for certain construction products as regards wood-based panels (OJ L 131, 23.5.2007, p. 21). |
| --- | --- |

83.

Commission Decision 2007/348/EC of 15 May 2007 amending Decision 2003/43/EC establishing the classes of reaction-to-fire performance for certain construction products as regards wood-based panels (OJ L 131, 23.5.2007, p. 21).

| 84. | Commission Decision 2010/81/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards adhesives for ceramic tiles (OJ L 38, 11.2.2010, p. 9). |
| --- | --- |

84.

Commission Decision 2010/81/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards adhesives for ceramic tiles (OJ L 38, 11.2.2010, p. 9).

| 85. | Commission Decision 2010/82/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards decorative wallcoverings in roll and panel form (OJ L 38, 11.2.2010, p. 11). |
| --- | --- |

85.

Commission Decision 2010/82/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards decorative wallcoverings in roll and panel form (OJ L 38, 11.2.2010, p. 11).

| 86. | Commission Decision 2010/83/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards air drying jointing compounds (OJ L 38, 11.2.2010, p. 13). |
| --- | --- |

86.

Commission Decision 2010/83/EU of 9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards air drying jointing compounds (OJ L 38, 11.2.2010, p. 13).

| 87. | Commission Decision 2010/85/EU-9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards cementitious screeds, calcium sulphate screeds and synthetic resin floor screeds (OJ L 38, 11.2.2010, p. 17). |
| --- | --- |

87.

Commission Decision 2010/85/EU-9 February 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards cementitious screeds, calcium sulphate screeds and synthetic resin floor screeds (OJ L 38, 11.2.2010, p. 17).

| 88. | Commission Decision 2010/679/EU of 8 November 2010 amending Decision 95/467/EC implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 292, 10.11.2010, p. 55). |
| --- | --- |

88.

Commission Decision 2010/679/EU of 8 November 2010 amending Decision 95/467/EC implementing Article 20(2) of Council Directive 89/106/EEC on construction products (OJ L 292, 10.11.2010, p. 55).

| 89. | Commission Decision 2010/683/EU of 9 November 2010 amending Decision 97/555/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cements, building limes and other hydraulic binders (OJ L 293, 11.11.2010, p. 60). |
| --- | --- |

89.

Commission Decision 2010/683/EU of 9 November 2010 amending Decision 97/555/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards cements, building limes and other hydraulic binders (OJ L 293, 11.11.2010, p. 60).

| 90. | Commission Decision 2010/737/EU of 2 December 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards steel sheets with polyester coating and with plastisol coating (OJ L 317, 3.12.2010, p. 39). |
| --- | --- |

90.

Commission Decision 2010/737/EU of 2 December 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards steel sheets with polyester coating and with plastisol coating (OJ L 317, 3.12.2010, p. 39).

| 91. | Commission Decision 2010/738/EU of 2 December 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards fibrous gypsum plaster casts (OJ L 317, 3.12.2010, p. 42). |
| --- | --- |

91.

Commission Decision 2010/738/EU of 2 December 2010 establishing the classes of reaction-to-fire performance for certain construction products as regards fibrous gypsum plaster casts (OJ L 317, 3.12.2010, p. 42).

| 92. | Commission Decision 2011/14/EU of 13 January 2011 amending Decision 97/556/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) (OJ L 10, 14.1.2011, p. 5). |
| --- | --- |

92.

Commission Decision 2011/14/EU of 13 January 2011 amending Decision 97/556/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards external thermal insulation composite systems/kits with rendering (ETICS) (OJ L 10, 14.1.2011, p. 5).

| 93. | Commission Decision 2011/19/EU of 14 January 2011 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards sealants for non-structural use in joints in buildings and pedestrian walkways (OJ L 11, 15.1.2011, p. 49). |
| --- | --- |

93.

Commission Decision 2011/19/EU of 14 January 2011 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards sealants for non-structural use in joints in buildings and pedestrian walkways (OJ L 11, 15.1.2011, p. 49).

| 94. | Commission Decision 2011/232/EU of 11 April 2011 amending Decision 2000/367/EC establishing a classification system for resistance-to-fire performance for construction products, construction works and parts thereof (OJ L 97, 12.4.2011, p. 49). |
| --- | --- |

94.

Commission Decision 2011/232/EU of 11 April 2011 amending Decision 2000/367/EC establishing a classification system for resistance-to-fire performance for construction products, construction works and parts thereof (OJ L 97, 12.4.2011, p. 49).

| 95. | Commission Decision 2011/246/EU of 18 April 2011 amending Decision 1999/93/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards doors, windows, shutters, blinds, gates and related building hardware (OJ L 103, 19.4.2011, p. 114). |
| --- | --- |

95.

Commission Decision 2011/246/EU of 18 April 2011 amending Decision 1999/93/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards doors, windows, shutters, blinds, gates and related building hardware (OJ L 103, 19.4.2011, p. 114).

| 96. | Commission Decision 2011/284/EU of 12 May 2011 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards power, control and communication cables (OJ L 131, 18.5.2011, p. 22). |
| --- | --- |

96.

Commission Decision 2011/284/EU of 12 May 2011 on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards power, control and communication cables (OJ L 131, 18.5.2011, p. 22).

| 97. | Commission Implementing Decision 2012/201/EU of 26 March 2012 amending Decision 98/213/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal partition kits (OJ L 109, 21.4.2012, p. 20). |
| --- | --- |

97.

Commission Implementing Decision 2012/201/EU of 26 March 2012 amending Decision 98/213/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards internal partition kits (OJ L 109, 21.4.2012, p. 20).

| 98. | Commission Implementing Decision 2012/202/EU of 29 March 2012 amending Decision 1999/94/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards precast normal/lightweight/autoclaved aerated concrete products (OJ L 109, 21.4.2012, p. 22). |
| --- | --- |

98.

Commission Implementing Decision 2012/202/EU of 29 March 2012 amending Decision 1999/94/EC on the procedure for attesting the conformity of construction products pursuant to Article 20(2) of Council Directive 89/106/EEC as regards precast normal/lightweight/autoclaved aerated concrete products (OJ L 109, 21.4.2012, p. 22).

Switzerland

| 100. | Federal law of 21 March 2014 on construction products (RO 2014 2867) |
| --- | --- |

100.

Federal law of 21 March 2014 on construction products (RO 2014 2867)

| 101. | Ordinance of 27 August 2014 on construction products (RO 2014 2887) |
| --- | --- |

101.

Ordinance of 27 August 2014 on construction products (RO 2014 2887)

| 102. | Ordinance of the Federal office for Building and Logistics on the designation of European implementing and delegated acts regarding construction products of 10 September 2014 as last amended on 2 February 2015 (RO 2015 515) |
| --- | --- |

102.

Ordinance of the Federal office for Building and Logistics on the designation of European implementing and delegated acts regarding construction products of 10 September 2014 as last amended on 2 February 2015 (RO 2015 515)

| 103. | Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 1 July 2014 (RO 2014 1411) |
| --- | --- |

103.

Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 1 July 2014 (RO 2014 1411)

| 104. | Accord intercantonal sur l'élimination des entraves techniques au commerce du 23 octobre 1998 (RO 2003 270) |
| --- | --- |

104.

Accord intercantonal sur l'élimination des entraves techniques au commerce du 23 octobre 1998 (RO 2003 270)

SECTION II

Conformity assessment bodies

| 1. | For the purposes of this Chapter, and according to the Parties' legislation in Section I of this Chapter, “Conformity assessment bodies” mean the bodies designated to carry out tasks in the process of assessment and verification of constancy of performance (AVCP) as well as Technical Assessment Bodies (TABs) which are members of the European Organisation for Technical Assessment (EOTA). |
| --- | --- |

1.

For the purposes of this Chapter, and according to the Parties' legislation in Section I of this Chapter, “Conformity assessment bodies” mean the bodies designated to carry out tasks in the process of assessment and verification of constancy of performance (AVCP) as well as Technical Assessment Bodies (TABs) which are members of the European Organisation for Technical Assessment (EOTA).

| 2. | 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 this Agreement, a list of the conformity assessment bodies. |
| --- | --- |

2.

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 this Agreement, a list of the conformity assessment bodies.

SECTION III

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 and the competent authorities notified by the Parties.

SECTION IV

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 this Agreement.

SECTION V

Supplementary provisions

1.   Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Regulation (EU) No 305/2011 adopted after 15.12.2014 without delay after their publication in the Official Journal of the European Union.

Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation.

2.   Implementation

The Parties' competent authorities and the organisations in charge of determining, in accordance with Regulation (EU) No 305/2011, the:

| — | essential characteristics for which the manufacturer shall declare the performance of products, |
| --- | --- |

—

essential characteristics for which the manufacturer shall declare the performance of products,

| — | classes of performance and threshold levels in relation to the essential characteristics of construction products, |
| --- | --- |

—

classes of performance and threshold levels in relation to the essential characteristics of construction products,

| — | conditions on which a construction products shall be deemed to satisfy a certain level or class of performance, or |
| --- | --- |

—

conditions on which a construction products shall be deemed to satisfy a certain level or class of performance, or

| — | AVCP-systems applicable to a given construction product, |
| --- | --- |

—

AVCP-systems applicable to a given construction product,

shall mutually respect the regulatory needs of the Member States and Switzerland.

3.   European harmonised standards for construction products

| (a) | For the purpose of this Agreement, after their publishing in the Official Journal of the European Union according to Article 17(5) of the Regulation (EU) No 305/2011, Switzerland will publish the reference of the European harmonised standards for construction products, providing methods and criteria for assessing the performance of construction products, including:






  — | classes of performance and threshold levels in relation to the essential characteristics of construction products, |
| --- | --- | --- |

(a)

For the purpose of this Agreement, after their publishing in the Official Journal of the European Union according to Article 17(5) of the Regulation (EU) No 305/2011, Switzerland will publish the reference of the European harmonised standards for construction products, providing methods and criteria for assessing the performance of construction products, including:

—

classes of performance and threshold levels in relation to the essential characteristics of construction products,

| — | conditions under which construction products are deemed to satisfy a certain level or class of performance without testing. |
| --- | --- |

—

conditions under which construction products are deemed to satisfy a certain level or class of performance without testing.

| (b) | When Switzerland considers that a harmonised standard does not entirely satisfy the requirements set out in the legislation listed in Section I, the Swiss competent authority may ask the European Commission to consider the case in accordance with the procedure provided for in Article 18 of Regulation (EU) No 305/2011.
  Switzerland may bring the matter before the Committee, giving its arguments. The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 18 of Regulation (EU) No 305/2011. |
| --- | --- |

(b)

When Switzerland considers that a harmonised standard does not entirely satisfy the requirements set out in the legislation listed in Section I, the Swiss competent authority may ask the European Commission to consider the case in accordance with the procedure provided for in Article 18 of Regulation (EU) No 305/2011.

Switzerland may bring the matter before the Committee, giving its arguments. The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 18 of Regulation (EU) No 305/2011.

4.   European Technical Assessments (ETAs)

| (a) | Switzerland shall be entitled to designate TABs to issue ETAs. It shall make sure that designated TABs become members of EOTA and participate in its work, in particular for developing and adopting European Assessment Documents according to Article 19 of Regulation (EU) No 305/2011.
  Procedures and decisions of EOTA shall also apply for the purpose of this Agreement. |
| --- | --- |

(a)

Switzerland shall be entitled to designate TABs to issue ETAs. It shall make sure that designated TABs become members of EOTA and participate in its work, in particular for developing and adopting European Assessment Documents according to Article 19 of Regulation (EU) No 305/2011.

Procedures and decisions of EOTA shall also apply for the purpose of this Agreement.

| (b) | European Assessment Documents issued by EOTA, and ETAs issued by the TABs are recognised by both Parties for the purpose of this Agreement. |
| --- | --- |

(b)

European Assessment Documents issued by EOTA, and ETAs issued by the TABs are recognised by both Parties for the purpose of this Agreement.

| (c) | Where a TAB receives a request for a ETA for a product not fully covered by a harmonised standard as in Article 21(1) of Regulation (EU) No 305/2011, it shall inform EOTA and the Commission of the content of the request and of the reference to a relevant Commission legal act for assessment and verification of constancy of performance which the TAB intends to apply for that product, or of the lack of such a legal act. |
| --- | --- |

(c)

Where a TAB receives a request for a ETA for a product not fully covered by a harmonised standard as in Article 21(1) of Regulation (EU) No 305/2011, it shall inform EOTA and the Commission of the content of the request and of the reference to a relevant Commission legal act for assessment and verification of constancy of performance which the TAB intends to apply for that product, or of the lack of such a legal act.

| (d) | If the TABs do not agree upon the European Assessment Document within the time limits provided for, EOTA shall submit this matter to the Commission. In case of a disagreement involving a Swiss TAB, the Commission may consult the Swiss designating authority when it resolves a matter pursuant to Article 23 of Regulation (EU) No 305/2011. |
| --- | --- |

(d)

If the TABs do not agree upon the European Assessment Document within the time limits provided for, EOTA shall submit this matter to the Commission. In case of a disagreement involving a Swiss TAB, the Commission may consult the Swiss designating authority when it resolves a matter pursuant to Article 23 of Regulation (EU) No 305/2011.

| (e) | When Switzerland considers that a European Assessment Document does not entirely satisfy the requirements to be met in relation to the basic requirements for construction works set out in the legislation in Section I of this Chapter, the Swiss competent authority may ask the European Commission to act in accordance with the procedure in Article 25 of Regulation (EU) No 305/2011.
  Switzerland may bring the matter before the Committee, giving its arguments. The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 25 of Regulation (EU) No 305/2011. |
| --- | --- |

(e)

When Switzerland considers that a European Assessment Document does not entirely satisfy the requirements to be met in relation to the basic requirements for construction works set out in the legislation in Section I of this Chapter, the Swiss competent authority may ask the European Commission to act in accordance with the procedure in Article 25 of Regulation (EU) No 305/2011.

Switzerland may bring the matter before the Committee, giving its arguments. The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 25 of Regulation (EU) No 305/2011.

5.   Information exchanges

| (a) | In accordance with Article 9 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this Chapter. |
| --- | --- |

(a)

In accordance with Article 9 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this Chapter.

| (b) | Pursuant to Article 12(3) of this Agreement, Member States and Switzerland shall designate Product Contact Points for Construction, which shall exchange relevant information upon request. |
| --- | --- |

(b)

Pursuant to Article 12(3) of this Agreement, Member States and Switzerland shall designate Product Contact Points for Construction, which shall exchange relevant information upon request.

| (c) | Should Switzerland have regulatory needs, it may propose the adoption of provisions, in particular so as to determine essential characteristics for which the performance shall be declared, or as to establish classes of performance, threshold levels in relation to essential characteristics of construction products, or conditions under which construction products are deemed to satisfy a certain level or class or performance without testing, as in Article 3 and Article 27 of Regulation (EU) No 305/2011. |
| --- | --- |

(c)

Should Switzerland have regulatory needs, it may propose the adoption of provisions, in particular so as to determine essential characteristics for which the performance shall be declared, or as to establish classes of performance, threshold levels in relation to essential characteristics of construction products, or conditions under which construction products are deemed to satisfy a certain level or class or performance without testing, as in Article 3 and Article 27 of Regulation (EU) No 305/2011.

6.   Market access and technical documentation

| (a) | For the purpose of this Chapter, the following definitions shall apply:
  —   importer: any natural or legal person established within the European Union or Switzerland who places a construction product from a third country on the European Union or the Swiss market,
  —   authorised representative: any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf in relation to specific tasks,
  —   distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer who makes a construction product available on the European Union or on the Swiss market. |
| --- | --- |

(a)

For the purpose of this Chapter, the following definitions shall apply:

—   importer: any natural or legal person established within the European Union or Switzerland who places a construction product from a third country on the European Union or the Swiss market,

—   authorised representative: any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf in relation to specific tasks,

—   distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer who makes a construction product available on the European Union or on the Swiss market.

| (b) | Pursuant to the legislation in Section I of this Chapter, manufacturers and importers shall indicate on the construction product or, where that is not possible, on its packaging or in a document accompanying it, their name, registered trade name or trade mark and their contact address. |
| --- | --- |

(b)

Pursuant to the legislation in Section I of this Chapter, manufacturers and importers shall indicate on the construction product or, where that is not possible, on its packaging or in a document accompanying it, their name, registered trade name or trade mark and their contact address.

| (c) | It shall be sufficient for manufacturers, their authorised representative or importers to keep the declaration of performance and the technical documentation at the disposal of national authorities for the period required by the legislation in Section I after the date of placing the product on either Party's market. |
| --- | --- |

(c)

It shall be sufficient for manufacturers, their authorised representative or importers to keep the declaration of performance and the technical documentation at the disposal of national authorities for the period required by the legislation in Section I after the date of placing the product on either Party's market.

| (d) | Manufacturers, their authorised representatives, or importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the construction product with the declaration of performance and its compliance with other applicable requirements in this Chapter in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by construction products which they have placed on the market. |
| --- | --- |

(d)

Manufacturers, their authorised representatives, or importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the construction product with the declaration of performance and its compliance with other applicable requirements in this Chapter in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by construction products which they have placed on the market.

7.   Exchange of experience

Swiss national authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 54 of Regulation (EU) No 305/2011.

8.   Coordination of designated notified bodies

Swiss notified bodies may take part in the coordination and cooperation mechanisms provided for in Article 55 of Regulation (EU) No 305/2011, directly or by means of designated representatives.

9.   Procedure for dealing with construction products presenting a risk caused by non-compliance that is not restricted to their national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that, owing to a non-compliance with the provisions of the legislation referred to in Section I of this Chapter, a construction product presents a risk caused by non-compliance that they consider not restricted to their national territory, they shall inform each other and the European Commission without delay:

| — | of the results of the evaluation they have carried out and of the actions which they have required the relevant economic operator to take, |
| --- | --- |

—

of the results of the evaluation they have carried out and of the actions which they have required the relevant economic operator to take,

| — | where the relevant economic operator does not take adequate corrective action, of appropriate provisional measures taken to prohibit or restrict the making available of the construction product on their national market, to withdraw the construction product from that market or to recall it. This information shall include the details set out in Article 56(5) of Regulation (EU) No 305/2011. |
| --- | --- |

—

where the relevant economic operator does not take adequate corrective action, of appropriate provisional measures taken to prohibit or restrict the making available of the construction product on their national market, to withdraw the construction product from that market or to recall it. This information shall include the details set out in Article 56(5) of Regulation (EU) No 305/2011.

Member States or Switzerland 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 construction product concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken without delay in respect of the construction product concerned, such as withdrawal of the construction product from their market.

10.   Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in Paragraph 9 above, it shall inform the European Commission of its objections within 15 working days of receipt of the information.

Where, on completion of the procedure set out in Paragraph 9 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be non-compliant with the relevant legislation referred to in Section I, the Commission shall, without delay, enter into consultation with the Member States, Switzerland and the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

| — | justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant construction product is withdrawn from their markets, and shall inform the Commission accordingly, |
| --- | --- |

—

justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant construction product is withdrawn from their markets, and shall inform the Commission accordingly,

| — | unjustified, the Member State concerned or Switzerland shall withdraw it. |
| --- | --- |

—

unjustified, the Member State concerned or Switzerland shall withdraw it.

In both cases, a Party may forward the issue to the Committee, pursuant to Paragraph 12.

11.   Compliant construction products which nevertheless present a risk to health and safety

Where a Member State or Switzerland finds that, although a construction product has been made available on the EU and on the Swiss market in compliance with the legislation referred to in Section I of this Chapter, the construction product presents a risk for the fulfilment of the basic requirements for construction works, to the health or safety of persons or to other aspects of public interest protection, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the construction product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and the relevant economic operator(s) and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not.

A Party may forward the issue to the Committee, pursuant to Paragraph 12.

12.   Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in Paragraph 10 and 11 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

| (a) | justified, the Parties shall take the measures necessary to ensure that the product is withdrawn from their market; |
| --- | --- |

(a)

justified, the Parties shall take the measures necessary to ensure that the product is withdrawn from their market;

| (b) | unjustified, the national authority of the Member State or Switzerland shall withdraw it. |
| --- | --- |

(b)

unjustified, the national authority of the Member State or Switzerland shall withdraw it.

DECLARATION FROM THE EUROPEAN COMMISSION

In order to ensure the effective application and implementation of the Chapter on construction products in Annex 1 to the Agreement and in so far as Switzerland has adopted the relevant EU acquis or equivalent measures under the Chapter on construction products, the Commission will, in accordance with the Council Declaration on Swiss attendance of committees (1) and Article 100 of the Agreement on the European Economic Area, consult Swiss experts in the preparatory stages of draft measures to be submitted subsequently to the Committee established by Article 64 of Regulation (EU) No 305/2011 to assist the Commission in the exercise of its executive powers.

The Commission also notes that the Chairman of the Committee established pursuant to Article 64 of Regulation (EU) No 305/2011 may decide to invite Swiss experts to talk on particular matters, at the request of a member or on his or her own initiative, in particular in those matters of direct relevance to Switzerland.’

---

(1)  Declaration on Swiss attendance of committees (OJ L 114, 30.4.2002, p. 429).

1

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ATTACHMENT B

In Annex 1, Product Sectors, Chapter 18, Biocidal products should be deleted and replaced by the following:

‘CHAPTER 18

BIOCIDAL PRODUCTS

SCOPE AND COVERAGE

| 1. | The provisions of this Sectoral Chapter apply to active substances, biocidal products, biocidal product families, and treated articles, as defined in Article 3 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (“the Biocidal Products Regulation”, hereinafter referred to as “BPR”), subject to the procedures of the BPR and equivalent Swiss provisions, with the exemption of:






  — | biocidal products which are or which contain genetically modified micro-organisms, and |
| --- | --- | --- |

1.

The provisions of this Sectoral Chapter apply to active substances, biocidal products, biocidal product families, and treated articles, as defined in Article 3 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (“the Biocidal Products Regulation”, hereinafter referred to as “BPR”), subject to the procedures of the BPR and equivalent Swiss provisions, with the exemption of:

—

biocidal products which are or which contain genetically modified micro-organisms, and

| — | avicides, piscicides and biocides for control of other vertebrates. |
| --- | --- |

—

avicides, piscicides and biocides for control of other vertebrates.

| 2. | Commission implementing acts pursuant to Article 9, 14(4) and 15(1) of the BPR regarding the approval of active substances, and delegated acts pursuant to Article 28(1) and 28(3) of the BPR, regarding the inclusion of active substances into Annex I of the BPR, are part of this Chapter. |
| --- | --- |

2.

Commission implementing acts pursuant to Article 9, 14(4) and 15(1) of the BPR regarding the approval of active substances, and delegated acts pursuant to Article 28(1) and 28(3) of the BPR, regarding the inclusion of active substances into Annex I of the BPR, are part of this Chapter.

| 3. | Switzerland is free to limit access to its market according to the requirements of its legislation existing at the date of entry into force of this Chapter concerning:






  — | biocidal products containing octylphenol or its ethoxylates, and |
| --- | --- | --- |

3.

Switzerland is free to limit access to its market according to the requirements of its legislation existing at the date of entry into force of this Chapter concerning:

—

biocidal products containing octylphenol or its ethoxylates, and

| — | aerosol dispensers containing substances stable in the air. |
| --- | --- |

—

aerosol dispensers containing substances stable in the air.

SECTION I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

| European Union | 1. | Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR) (OJ L 167, 27.6.2012, p. 1), as last amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 (OJ L 103, 5.4.2014, p. 22), as well as implementing and delegated acts of the Commission adopted under this regulation until 10.10.2014. |
| --- | --- | --- |

European Union

1.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR) (OJ L 167, 27.6.2012, p. 1), as last amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 (OJ L 103, 5.4.2014, p. 22), as well as implementing and delegated acts of the Commission adopted under this regulation until 10.10.2014.

Switzerland

| 100. | Federal Law of 15 December 2000 for the protection against dangerous substances and preparations (RO 2004 4763), as last amended on 13 June 2006 (RO 2006 2197) |
| --- | --- |

100.

Federal Law of 15 December 2000 for the protection against dangerous substances and preparations (RO 2004 4763), as last amended on 13 June 2006 (RO 2006 2197)

| 101. | Federal Law of 7 October 1983 relating to the protection of the Environment (RO 1984 1122), as last amended on 1 August 2010 (RO 2010 3233) |
| --- | --- |

101.

Federal Law of 7 October 1983 relating to the protection of the Environment (RO 1984 1122), as last amended on 1 August 2010 (RO 2010 3233)

| 102. | Ordinance of 18 May 2005 concerning the making available on the market and the use of biocidal products (Ordinance on Biocidal Products, RO 2005 2821), as last amended on 15.7.2014 (RO 2014 2073) (hereinafter “OPBio”) |
| --- | --- |

102.

Ordinance of 18 May 2005 concerning the making available on the market and the use of biocidal products (Ordinance on Biocidal Products, RO 2005 2821), as last amended on 15.7.2014 (RO 2014 2073) (hereinafter “OPBio”)

| 103. | Ordinance of 15 August 2014 of the Department of Home Affairs on implementing rules related to the Ordinance on Biocidal Products (RO 2014 2755). |
| --- | --- |

103.

Ordinance of 15 August 2014 of the Department of Home Affairs on implementing rules related to the Ordinance on Biocidal Products (RO 2014 2755).

SECTION II

Conformity assessment bodies

For the purposes of this Chapter, “Conformity Assessment Bodies” means the authorities of the European Union and competent authorities of EU Member States and of Switzerland responsible for the application of the legislation in Section I.

The contact details of the competent authorities of the Parties can be found on the websites indicated below.

European Union

Biocides:

| — | “Competent Authorities and other Contact Points”
  http://ec.europa.eu/environment/chemicals/biocides/regulation/comp_authorities_en.htm |
| --- | --- |

—

“Competent Authorities and other Contact Points”

http://ec.europa.eu/environment/chemicals/biocides/regulation/comp_authorities_en.htm

| — | http://www.echa.europa.eu/regulations/biocidal-products-regulation |
| --- | --- |

—

http://www.echa.europa.eu/regulations/biocidal-products-regulation

Switzerland

Federal Office of Public Health, Notification Authority for Chemicals: www.bag.admin.ch/biocide

SECTION III

Supplementary provisions

1.   Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Regulation (EU) No 528/2012 adopted after 10 October 2014 without delay after their publication in the Official Journal of the European Union.

Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation.

2.   Procedures of the BPR and its implementing acts that apply between the Parties

| (a) | For the purpose of this Chapter, the subsequently specified procedures of the BPR and of its delegated and implementing acts as referred to in Section I apply as common procedures to complement provisions deemed equivalent.
  In this Paragraph, a reference to “Member State(s)” or their competent authorities in articles of the BPR that “shall apply between the Parties” shall be understood to include, in addition to its meaning in the Regulation, Switzerland. For the purposes of this Chapter,






  — | “Authorisation holders” and persons referred to in Article 95 of the BPR may be established within the European Union or Switzerland. |
| --- | --- | --- |

(a)

For the purpose of this Chapter, the subsequently specified procedures of the BPR and of its delegated and implementing acts as referred to in Section I apply as common procedures to complement provisions deemed equivalent.

In this Paragraph, a reference to “Member State(s)” or their competent authorities in articles of the BPR that “shall apply between the Parties” shall be understood to include, in addition to its meaning in the Regulation, Switzerland. For the purposes of this Chapter,

—

“Authorisation holders” and persons referred to in Article 95 of the BPR may be established within the European Union or Switzerland.

| — | Applicants shall use the Register for Biocidal Products (hereinafter “Register”) to submit applications and data for all procedures as foreseen in Article 71(3) of the BPR. Applicants do not need to be established within the European Union or Switzerland. |
| --- | --- |

—

Applicants shall use the Register for Biocidal Products (hereinafter “Register”) to submit applications and data for all procedures as foreseen in Article 71(3) of the BPR. Applicants do not need to be established within the European Union or Switzerland.

The procedures of the BPR and the implementing and delegated acts listed below shall apply between the Parties:

| — | Chapters II and III and Commission Delegated Regulation (EU) No 1062/2014, as regards the approval of active substances. Applicants may propose the Swiss Competent authority as the evaluating competent authority. |
| --- | --- |

—

Chapters II and III and Commission Delegated Regulation (EU) No 1062/2014, as regards the approval of active substances. Applicants may propose the Swiss Competent authority as the evaluating competent authority.

| — | Article 27 as regards biocidal products authorised according to the simplified procedure. |
| --- | --- |

—

Article 27 as regards biocidal products authorised according to the simplified procedure.

| — | Articles 32-34 and Commission Delegated Regulation (EU) No 492/2014 as regards mutual recognition of authorisations and their renewals. |
| --- | --- |

—

Articles 32-34 and Commission Delegated Regulation (EU) No 492/2014 as regards mutual recognition of authorisations and their renewals.

| — | Articles 35-37 on objections and derogations. |
| --- | --- |

—

Articles 35-37 on objections and derogations.

| — | Articles 43-46 on Union authorisations, with the following adaptations: when the Commission grants a biocidal product a Union authorisation or renews, amends, decides not to grant the Union authorisation, cancels, or refuses to renew the Union authorisation, Switzerland shall, notwithstanding legal recourse, take a decision within 30 days in accordance with Article 14a OPBio on granting, renewing, cancelling or amending an authorisation for that product. |
| --- | --- |

—

Articles 43-46 on Union authorisations, with the following adaptations: when the Commission grants a biocidal product a Union authorisation or renews, amends, decides not to grant the Union authorisation, cancels, or refuses to renew the Union authorisation, Switzerland shall, notwithstanding legal recourse, take a decision within 30 days in accordance with Article 14a OPBio on granting, renewing, cancelling or amending an authorisation for that product.

| — | Articles 47-50 and Commission Implementing Regulation (EU) No 354/2013 as regards the notification of adverse effects and rules on cancellation or amendments. |
| --- | --- |

—

Articles 47-50 and Commission Implementing Regulation (EU) No 354/2013 as regards the notification of adverse effects and rules on cancellation or amendments.

| — | Article 53 on parallel trade. |
| --- | --- |

—

Article 53 on parallel trade.

| — | Article 54 as regards the establishment of technical equivalence of active substances. |
| --- | --- |

—

Article 54 as regards the establishment of technical equivalence of active substances.

| — | Articles 62-63 on data sharing. In case a request has been submitted to the Swiss competent authority, the applicant shall be re-directed to the Agency and enter its request into the Register. |
| --- | --- |

—

Articles 62-63 on data sharing. In case a request has been submitted to the Swiss competent authority, the applicant shall be re-directed to the Agency and enter its request into the Register.

| — | Article 69(2) as regards the name and address of the authorisation holder and the authorisation number to be provided on labels. |
| --- | --- |

—

Article 69(2) as regards the name and address of the authorisation holder and the authorisation number to be provided on labels.

| — | Article 88 as regards measures taken on the basis of new evidence. |
| --- | --- |

—

Article 88 as regards measures taken on the basis of new evidence.

| — | Article 95 (as in Regulation (EU) No 334/2014), with the transitional period in Article 95(2) up to 1 September 2016 for making the product available on the market of Switzerland. |
| --- | --- |

—

Article 95 (as in Regulation (EU) No 334/2014), with the transitional period in Article 95(2) up to 1 September 2016 for making the product available on the market of Switzerland.

| (b) | If Switzerland intends to deviate from a decision taken pursuant to articles 36(3), 37(2), in the case of Union authorisations pursuant to articles 44(5), 46(4-5), 47-50, or decisions pursuant to article 88 of the BPR, or to adjust certain conditions specifically for its territory pursuant to article 12(2) OPBio, it may take appropriate measures and shall immediately inform the Commission, giving its reasons. Where relevant, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action. |
| --- | --- |

(b)

If Switzerland intends to deviate from a decision taken pursuant to articles 36(3), 37(2), in the case of Union authorisations pursuant to articles 44(5), 46(4-5), 47-50, or decisions pursuant to article 88 of the BPR, or to adjust certain conditions specifically for its territory pursuant to article 12(2) OPBio, it may take appropriate measures and shall immediately inform the Commission, giving its reasons. Where relevant, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action.

3.   Information exchange

In accordance with Article 9 of this Agreement, the Parties shall in particular exchange the information needed to coordinate the procedures under this Chapter as foreseen in Article 71 of the BPR.

Pursuant to Article 29(4) of the BPR, except in cases where Commission Implementing Regulation (EU) No 414/2013 applies, Switzerland shall decline the evaluation of the application if another competent authority is examining an application relating to the same biocidal product or has already authorised it.

The Parties agree that authorisations and other decisions relating to the application of this Chapter may be notified by the competent authorities directly to the applicant in the territory of the other Party.

Information shall be protected and treated by the competent authorities of the Parties in accordance with Articles 59, 64, 66, 67 of the BPR.

4.   Financial contribution for services provided by the European Chemical Agency (ECHA)

| (a) | Switzerland shall contribute to the Agency expenditure for activities mentioned in this chapter by an annual financial contribution to be added to the EU subsidy mentioned in Article 78(1) of the BPR. This annual financial contribution will be calculated in accordance with its Gross Domestic Product (GDP) as a percentage of the GDP of all participating States in accordance with the formula described in Appendix 1. The annual contribution will be paid to the Agency based on a debit note issued by ECHA. |
| --- | --- |

(a)

Switzerland shall contribute to the Agency expenditure for activities mentioned in this chapter by an annual financial contribution to be added to the EU subsidy mentioned in Article 78(1) of the BPR. This annual financial contribution will be calculated in accordance with its Gross Domestic Product (GDP) as a percentage of the GDP of all participating States in accordance with the formula described in Appendix 1. The annual contribution will be paid to the Agency based on a debit note issued by ECHA.

| (b) | The financial contribution referred to in Subparagraph (a) shall be incurred as from the day following the entry into force of this Decision. The first financial contribution shall be reduced proportionally to the remaining time in year after its entry into force. |
| --- | --- |

(b)

The financial contribution referred to in Subparagraph (a) shall be incurred as from the day following the entry into force of this Decision. The first financial contribution shall be reduced proportionally to the remaining time in year after its entry into force.

Appendix 1

Financial contribution of Switzerland for services provided by the European Chemical Agency (ECHA)

| 1. | The annual financial contribution of Switzerland to the subsidy mentioned in Article 78 of the BPR is calculated in the following way: The most updated final figures of the Gross Domestic Product (GDP) of Switzerland available on 31 March of each year shall be divided by the sum of the GDP figures of all the States participating in such activities, available for the same year. The obtained percentage will be applied to the subsidy from the Union referred to in Article 78(1)(a) of the BPR to obtain the amount of the financial contribution of Switzerland. |
| --- | --- |

1.

The annual financial contribution of Switzerland to the subsidy mentioned in Article 78 of the BPR is calculated in the following way: The most updated final figures of the Gross Domestic Product (GDP) of Switzerland available on 31 March of each year shall be divided by the sum of the GDP figures of all the States participating in such activities, available for the same year. The obtained percentage will be applied to the subsidy from the Union referred to in Article 78(1)(a) of the BPR to obtain the amount of the financial contribution of Switzerland.

| 2. | The financial contribution shall be paid in Euro. |
| --- | --- |

2.

The financial contribution shall be paid in Euro.

| 3. | Switzerland shall pay its financial contribution no later than 45 days after receiving the debit note. Any delay in payment shall give rise to the payment of default interest by Switzerland on the outstanding amount from the due date. The interest rate shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union, in force on the first calendar day of the month in which the deadline falls, increased by 1,5 percentage points. |
| --- | --- |

3.

Switzerland shall pay its financial contribution no later than 45 days after receiving the debit note. Any delay in payment shall give rise to the payment of default interest by Switzerland on the outstanding amount from the due date. The interest rate shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union, in force on the first calendar day of the month in which the deadline falls, increased by 1,5 percentage points.

| 4. | Switzerland's financial contribution shall be adapted in case the subsidy from the European Union entered in the general budget of the European Union as defined in Article 78(1)(a) BPR is increased pursuant to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002. In this case, the difference shall be due 45 days after receiving the debit note. |
| --- | --- |

4.

Switzerland's financial contribution shall be adapted in case the subsidy from the European Union entered in the general budget of the European Union as defined in Article 78(1)(a) BPR is increased pursuant to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002. In this case, the difference shall be due 45 days after receiving the debit note.

| 5. | In the event that the subsidy received by ECHA according to Article 78(1)(a) BPR related to a year N is not spent before 31 December of year N or that the ECHA budget of the year N has been lowered according to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012, the part of these unspent or lowered payment credits corresponding to the percentage of the contribution made by Switzerland is transferred to the budget of year N+1 of the agency. Switzerland's contribution to the Agency subsidy of year N+1 will be reduced accordingly. |
| --- | --- |

5.

In the event that the subsidy received by ECHA according to Article 78(1)(a) BPR related to a year N is not spent before 31 December of year N or that the ECHA budget of the year N has been lowered according to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012, the part of these unspent or lowered payment credits corresponding to the percentage of the contribution made by Switzerland is transferred to the budget of year N+1 of the agency. Switzerland's contribution to the Agency subsidy of year N+1 will be reduced accordingly.

DECLARATION FROM THE EUROPEAN COMMISSION

In order to ensure the effective application and implementation of the Chapter on Biocidal products in Annex 1 to the Agreement and in so far as Switzerland has adopted the relevant EU acquis or equivalent measures under the Chapter on Biocidal products, the Commission will, in accordance with the Council Declaration on Swiss attendance of committees (1) and Article 100 of the Agreement on the European Economic Area, consult Swiss experts in the preparatory stages of draft measures to be submitted subsequently to the Committee established by Article 82 of Regulation (EU) No 528/2012 to assist the Commission in the exercise of its executive powers.

The Commission also notes that the Chairman of the Committee established pursuant to Article 82 of Regulation (EU) No 528/2012 may decide to invite Swiss experts to talk on particular matters, at the request of a member or on his or her own initiative, in particular in those matters of direct relevance to Switzerland.

In addition, the Commission notes that Swiss experts are invited to participate in the group of Competent Authorities for the implementation of the Biocidal Products Regulation, which provides assistance to the Commission with the harmonised implementation of Regulation (EU) No 528/2012 and, as appropriate, in the Committee referred to in Article 75 of Regulation (EU) No 528/2012 and in the Coordination Group referred to in Article 35 of Regulation (EU) No 528/2012, for the matters relevant to the Chapter on biocidal products.

---

(1)  Declaration on Swiss attendance of committees (OJ L 114, 30.4.2002, p. 429).

1

---

ATTACHMENT C

Amendments to Annex 1

Chapter 14 (Good laboratory practice (GLP))

In Section I, Legislative, regulatory and administrative provisions, should be deleted and replaced by the following:

‘SECTION I

Legislative, regulatory and administrative provisions

With regard to the testing of chemicals according to GLP, the relevant parts of the legislative, regulatory and administrative provisions listed below shall apply.

Provisions covered by Article 1(2)

| European Union | | Food and feed |
| --- | --- | --- |
| 1. | Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). |
| 2. | Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 64, 11.3.2011, p. 15), as last amended by Commission implementing Regulation (EU) No 562/2012 (OJ L 168, 28.6.2012, p. 21). |
| 3. | Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1). |
| | New and existing chemicals |
| 4. | Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, as amended by Council Directive 92/32/EEC of 30 April 1992 (OJ L 154, 5.6.1992, p. 1). |
| 5. | Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1), as last amended by Commission Regulation (EU) No 895/2014 of 14 August 2014 (OJ L 244, 19.8.2014, p. 6). |
| 6. | Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1), as last amended by Commission Regulation (EU) No 605/2014 of 5 June 2014 (OJ L 167, 6.6.2014, p. 36). |
| 7. | Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1), as last amended by Directive 2006/08/EC of 23 January 2006 (OJ L 19, 24.1.2006, p. 12). |
| 8. | Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). |
| | Medicinal products |
| 9. | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ L 299, 27.10.2012, p. 1). NB: Directive 2001/83/EC has been amended and the GLP requirement is now contained in the Introduction and General Principles chapter of Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46). |
| 10. | Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). |
| | Veterinary medicinal products |
| 11. | Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1), as last amended by Commission Directive 2009/9/EC of 10 February 2009 (OJ L 44, 14.2.2009, p. 10). |
| | Plant protection products |
| 12. | Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). |
| 13. | Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1). |
| 14. | Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85). |
| | Biocidal products |
| 15. | Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). |
| | Cosmetic products |
| 16. | Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). |
| | Detergents |
| 17. | Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1). |
| Switzerland | 100. | Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), as last amended on 22 March 2013 (FF 2012 8671) |
| 101. | Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197) |
| 102. | Ordinance of 18 May 2005 on protection against dangerous substances and preparations (RO 2005 2721), as last amended on 20 June 2014 (RO 2014 2073) |
| 103. | Ordinance of 18 May 2005 on biocidal products (RO 2005 2821) as last amended on 15 July 2014 (RO 2014 2073) |
| 104. | Ordinance of 18 May 2005 on placing on the market of plant protection products (RO 2005 3035), as last amended on 11 December 2012 (RO 2013 249) |
| 105. | Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 21 June 2013 (RO 2013 4137) |
| 106. | Ordinance of 17 October 2001 on medicinal products (RO 2001 3420), as last amended on 8 September 2010 (RO 2010 4039)’ |

European Union

Food and feed

1.

Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

2.

Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 64, 11.3.2011, p. 15), as last amended by Commission implementing Regulation (EU) No 562/2012 (OJ L 168, 28.6.2012, p. 21).

3.

Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1).

New and existing chemicals

4.

Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, as amended by Council Directive 92/32/EEC of 30 April 1992 (OJ L 154, 5.6.1992, p. 1).

5.

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1), as last amended by Commission Regulation (EU) No 895/2014 of 14 August 2014 (OJ L 244, 19.8.2014, p. 6).

6.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1), as last amended by Commission Regulation (EU) No 605/2014 of 5 June 2014 (OJ L 167, 6.6.2014, p. 36).

7.

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1), as last amended by Directive 2006/08/EC of 23 January 2006 (OJ L 19, 24.1.2006, p. 12).

8.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

Medicinal products

9.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ L 299, 27.10.2012, p. 1). NB: Directive 2001/83/EC has been amended and the GLP requirement is now contained in the Introduction and General Principles chapter of Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46).

10.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

Veterinary medicinal products

11.

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1), as last amended by Commission Directive 2009/9/EC of 10 February 2009 (OJ L 44, 14.2.2009, p. 10).

Plant protection products

12.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

13.

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).

14.

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85).

Biocidal products

15.

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

Cosmetic products

16.

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

Detergents

17.

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).

Switzerland

100.

Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), as last amended on 22 March 2013 (FF 2012 8671)

101.

Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197)

102.

Ordinance of 18 May 2005 on protection against dangerous substances and preparations (RO 2005 2721), as last amended on 20 June 2014 (RO 2014 2073)

103.

Ordinance of 18 May 2005 on biocidal products (RO 2005 2821) as last amended on 15 July 2014 (RO 2014 2073)

104.

Ordinance of 18 May 2005 on placing on the market of plant protection products (RO 2005 3035), as last amended on 11 December 2012 (RO 2013 249)

105.

Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 21 June 2013 (RO 2013 4137)

106.

Ordinance of 17 October 2001 on medicinal products (RO 2001 3420), as last amended on 8 September 2010 (RO 2010 4039)’

In Section III, Designating authorities, the Contact Details of the GLP ‘Monitoring Authorities’ of the European Union should be deleted and replaced by the following:

‘For the European Community:

http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice/index_en.htm’

In Section IV, Special rules relating to the designation of conformity assessment bodies, the reference to European Union and Swiss provisions should be deleted and replaced by the following text:

| ‘European Union: | 1. | Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). |
| --- | --- | --- |
| 2. | Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28). |
| Switzerland: | 100. | Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), as last amended on 22 March 2013 (FF 2012 8671) |
| 101. | Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197) |
| 102. | Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 21 June 2013 (RO 2013 4137) |
| 103. | Ordinance of 18 May 2005 on Good Laboratory Practice (RO 2005 2795) as last amended on 11 November 2012 (RO 2012 6103)’ |

‘European Union:

1.

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

2.

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28).

Switzerland:

100.

Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122), as last amended on 22 March 2013 (FF 2012 8671)

101.

Federal law of 15 December 2000 on protection against dangerous substances and preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197)

102.

Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 21 June 2013 (RO 2013 4137)

103.

Ordinance of 18 May 2005 on Good Laboratory Practice (RO 2005 2795) as last amended on 11 November 2012 (RO 2012 6103)’

Chapter 15 (Medicinal products GMP Inspection and Batch Certification)

Chapter 15 (Medicinal products GMP Inspection and Batch Certification)

Section I, Legislative regulatory and administrative provisions should be deleted and replaced by the following:

‘SECTION I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

| European Union | 1. | Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (OJ L 316, 14.11.2012, p. 38). |
| --- | --- | --- |
| 2. | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1). |
| 3. | Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). |
| 4. | Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58). |
| 5. | Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22). |
| 6. | Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70). |
| 7. | Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p. 1). |
| 8. | EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (published on website of the European Commission) |
| 9. | Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34). |
| 10. | Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). |
| 11. | Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1). |
| Switzerland | 100. | Federal Act of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 1 July 2013 (RO 2013 1493) |
| 101. | Ordinance of 17 October 2001 on the establishment of licences (RO 2001 3399), as last amended on 1 January 2013 (RO 2012 3631) (1) |
| 102. | Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437), as last amended on 1 January 2013 (RO 2012 5651) |
| 103. | Ordinance of 20 September 2013 on clinical trials in human research (RO 2013 3407)’ |

European Union

1.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1) as last amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance (OJ L 316, 14.11.2012, p. 38).

2.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) as last amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1).

3.

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).

4.

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).

5.

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

6.

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).

7.

Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p. 1).

8.

EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (published on website of the European Commission)

9.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).

10.

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13).

11.

Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1).

Switzerland

100.

Federal Act of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended on 1 July 2013 (RO 2013 1493)

101.

Ordinance of 17 October 2001 on the establishment of licences (RO 2001 3399), as last amended on 1 January 2013 (RO 2012 3631) (1)

102.

Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437), as last amended on 1 January 2013 (RO 2012 5651)

103.

Ordinance of 20 September 2013 on clinical trials in human research (RO 2013 3407)’

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(1)  Switzerland will notify the European Union without delay of the amendment corresponding to the EU Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 343, 23.11.2013, p. 1).

1

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