19.5.2020

Official Journal of the European Union

L 156/2

COMMISSION IMPLEMENTING REGULATION (EU) 2020/666

of 18 May 2020

amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1), and in particular Article 11(2) thereof,

Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and in particular Article 16(2) thereof,

Whereas:

(1)	Commission Implementing Regulation (EU) No 920/2013 (3) sets out a common interpretation of the main elements of the criteria for designation of notified bodies laid down in Directives 90/385/EEC and 93/42/EEC.

(2)

The COVID-19 pandemic and the associated public health crisis presents an unprecedented challenge to Member States and other actors active in the field of medical devices. The public health crisis has created extraordinary circumstances that have a significant impact on various areas covered by the Union regulatory framework for medical devices, such as the designation and work of notified bodies, as well as the availability of vitally important medical devices in the Union.

(3)

In the context of the COVID-19 pandemic, Regulation (EU) 2020/561 of the European Parliament and of the Council (4) was adopted in order to defer by one year the application of those provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (5) that would otherwise start to apply from 26 May 2020, including the provision repealing Directives 90/385/EEC and 93/42/EEC.

(4)

As a result, notified bodies designated under those Directives are able to certify medical devices for one additional year, until 25 May 2021. However, for a significant number of those notified bodies the designations will expire between 26 May 2020 and 25 May 2021. Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity, which is a necessary requirement for the lawful placing on the market or putting into service of medical devices.

(5)

To avoid shortages of vitally important medical devices, it is therefore essential that notified bodies currently designated under Directives 90/385/EEC and 93/42/EEC are able to continue to operate until the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable.

(6)	Implementing Regulation (EU) No 920/2013 sets out procedural rules and obligations for the renewal of the designation as notified body to be complied with by the designating authorities of Member States under Directives 90/385/EEC and 93/42/EEC.

(7)

The extraordinary circumstances created by the COVID-19 pandemic have a significant impact on the work of notified bodies, Member States and the Commission, regarding the renewal of the designation process. In particular, travel restrictions and public health measures, such as social distancing requirements, imposed by Member States, as well as the increased demand for resources to fight the COVID-19 pandemic and the associated public health crisis, prevent the relevant actors from carrying out the designation process in accordance with the procedural rules and obligations set out in Implementing Regulation (EU) No 920/2013. The deferral of the application of Regulation (EU) 2017/745 and the deferral of the repeal of Directives 90/385/EEC and 93/42/EEC make it necessary to renew designations of notified bodies that would otherwise expire before the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable. The adoption of those renewals of designations has to take place under considerable time constraints. Those constraints could not reasonably have been anticipated at the time of adoption of Implementing Regulation (EU) No 920/2013.

(8)

Taking into account the unprecedented challenges caused by the COVID-19 pandemic, the complexity of the tasks regarding the renewal of the designation of notified bodies, as well as the need to prevent potential shortages of vitally important medical devices in the Union, it is appropriate to amend Implementing Regulation (EU) No 920/2013 as regards the renewal of designations as notified bodies. This should allow designating authorities, in the context of the COVID-19 pandemic and the associated public health crisis, to derogate from the procedures laid down in Article 3 of that Regulation in order to guarantee the smooth and timely renewal of a designation before its expiry.

(9)

To ensure patient safety and health, those derogation measures should be limited to the renewal of already granted designations as notified bodies for which the designation process has previously been carried out, including a completed assessment of the notified body and the associated surveillance and monitoring activities. Those renewals of designations should be of temporary nature and adopted before the end of the validity period of the respective preceding designation. They should automatically become void at the latest on the date of repeal of Directives 90/385/EEC and 93/42/EEC. In deciding on a renewal of a designation, the designating authority should carry out an assessment of the notified body in order to verify its continuous competence and ability to accomplish the tasks for which it has been designated. That assessment should include a review of documents and activities related to the notified body, which enable the designating authority to verify the criteria for designation as set out in Directives 90/385/EEC and 93/42/EEC and Implementing Regulation (EU) No 920/2013.

(10)

The extraordinary circumstances created by the COVID-19 pandemic also have an impact on the surveillance and monitoring activities related to notified bodies. In particular, those circumstances may, for a certain period of time, prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits. To ensure a minimum level of control and monitoring of notified bodies, during that period of time, designating authorities should still carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the notified body’s reviews of the manufacturer’s clinical evaluations and an appropriate number of file reviews. Designating authorities should examine changes to the organisational and general requirements set out in Annex II to Implementing Regulation (EU) No 920/2013 that have occurred since the last on-site assessment and the activities the notified body has performed thereafter within the scope of its designation.

(11)

In order to ensure transparency and increase mutual trust, designating authorities should also be required to notify the Commission and each other, by means of the ‘New Approach Notified and Designated Organisations’ Information System (NANDO), of any decision on the renewal of a designation as notified body that was carried out without having recourse to the procedures laid down in Article 3 of Implementing Regulation (EU) No 920/2013. Those notifications should include the reasons for decisions on the renewal taken by a designating authority. The Commission should be able to require a designating authority to provide it with the results of the assessment supporting the decision to renew the designation of a notified body, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5 of that Implementing Regulation. Where there is doubt about the competence of the notified body, the Commission should have the possibility to investigate the individual case.

(12)

In accordance with Directives 90/385/EEC and 93/42/EEC, Member States are responsible for a decision on designation as notified body. This responsibility also extends to a decision on the renewal of designation, including such that a Member State might carry out in accordance with this amending Implementing Regulation.

(13)	Implementing Regulation (EU) No 920/2013 should therefore be amended accordingly.

(14)	The measures provided for in this Regulation are in accordance with the opinion of the Medical Devices Committee set up by Article 6(2) of Directive 90/385/EEC.

(15)	In light of the overriding need to immediately address the public health crisis associated with the COVID-19 pandemic, this Implementing Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

Implementing Regulation (EU) No 920/2013 is amended as follows:

(1)

in Article 4, the following paragraph 6 is added:

‘6. By way of derogation from paragraph 2, during the period from 19 May 2020 to 25 May 2021, the designating authority of a Member State, in extraordinary circumstances resulting from the COVID-19 pandemic and due to the adoption of Regulation (EU) 2020/561 of the European Parliament and of the Council (*1) deferring the application of certain provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (*2), may decide to renew a designation as notified body without having recourse to the procedures laid down in Article 3.

In order to decide on the renewal of a designation as notified body in accordance with the first subparagraph, the designating authority shall carry out an assessment in order to verify the continuous competence of the notified body and its ability to perform the tasks for which it was designated.

The decision on the renewal of a designation as notified body in accordance with this paragraph shall be adopted before the end of the validity period of the preceding designation and shall automatically become void at the latest on 26 May 2021.

The designating authority shall notify the Commission of its decision, giving substantive reasons therefore, on the renewal of a designation as notified body in accordance with this paragraph by means of the ‘New Approach Notified and Designated Organisations’ Information System.

The Commission may require a designating authority to provide it with the results of the assessment supporting the decision on the renewal of a designation as notified body in accordance with this paragraph, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5.

(*1) Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18)."

(*2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’;"

(2)

in Article 5, paragraph 1, the following subparagraph is added:

‘By way of derogation from the first and second subparagraphs, in exceptional circumstances relating to the COVID-19 pandemic that temporarily prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits, it shall carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the notified body’s reviews of the manufacturer’s technical documentation, including clinical evaluations. That designating authority shall examine changes to the organisational and general requirements set out in Annex II that have occurred since the last on-site assessment and the activities the notified body has performed thereafter.’.

Article 2

This Regulation shall enter into force on its day of 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, 18 May 2020.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 189, 20.7.1990, p. 17.

(2) OJ L 169, 12.7.1993, p. 1.

(3) Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8).

(4) Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (OJ L 130, 24.4.2020, p. 18).

(5) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

19.5.2020

Official Journal of the European Union

L 156/6

COMMISSION IMPLEMENTING DECISION (EU) 2020/667

of 6 May 2020

amending Decision 2012/688/EU as regards an update of relevant technical conditions applicable to the frequency bands 1 920-1 980 MHz and 2 110-2 170 MHz

(notified under document C(2020) 2816)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (1), and in particular Article 4(3) thereof,

Whereas:

(1)	Commission Decision 2012/688/EU (2) harmonised the technical conditions for using the frequency bands 1 920-1 980 MHz and 2 110-2 170 MHz for terrestrial systems capable of providing electronic communications services (ECSs) in the Union, mainly targeting wireless broadband services for end-users.

(2)

Article 6(3) of Decision No 243/2012/EU of the European Parliament and the Council (3), requires Member States to help ECS providers to regularly upgrade their networks to the latest, most efficient technology, in order to create their own spectrum dividends in line with the principles of service and technological neutrality.

(3)

The Commission’s Communication on ‘Connectivity for a competitive digital single market – towards a European gigabit society’ (4) sets out new connectivity objectives for the Union to be achieved through the widespread deployment and take-up of very high capacity networks. To that end, the Commission’s Communication ‘5G for Europe: an action plan’ (5) identifies a need for action at the EU-level, including the identification and harmonisation of spectrum for 5G based on the opinion of the Radio Spectrum Policy Group (RSPG), in order to ensure uninterrupted 5G coverage in all urban areas and major terrestrial transport paths by 2025.

(4)

In its two opinions on the ‘strategic roadmap towards 5G for Europe’ (16 November 2016 (6) and of 30 January 2019 (7)), the RSPG identified a need to ensure that the technical and regulatory conditions for all bands already harmonised for mobile networks are fit for 5G use. The paired terrestrial 2 GHz frequency band is one such band.

(5)

On 12 July 2018, pursuant to Article 4(2) of Decision No 676/2002/EC, the Commission mandated the European Conference of Postal and Telecommunications Administrations (CEPT) to review the harmonised technical conditions for certain EU-harmonised frequency bands, including the paired terrestrial 2 GHz frequency band, and to develop least restrictive harmonised technical conditions suitable for next-generation (5G) terrestrial wireless systems.

(6)

On 5 July 2019, the CEPT issued a report (CEPT report 72). It proposed EU-harmonised technical conditions for the paired terrestrial 2 GHz frequency band in terms of a frequency arrangement and a Block Edge Mask, which are suitable for use of the band with next-generation (5G) terrestrial wireless systems. CEPT report 72 concludes that the guard band of 300 kHz at the lower and upper frequency boundaries of the frequency arrangement can be removed.

(7)	It has to be noted that the spurious domain for the base stations in the frequency band 2 110 – 2 170 MHz starts 10 MHz from the band edge.

(8)

CEPT report 72 covers both active antenna systems and non-active antenna systems, which are used in systems capable of providing Wireless Broadband Electronic Communications Services (WBB ECS). It addresses the co-existence of these systems within the band and with services in adjacent bands (such as Space services below 2 110 MHz and above 2 200 MHz). Any new use of the paired terrestrial 2 GHz frequency band should continue to protect existing services in adjacent frequency bands.

(9)	The conclusions of CEPT report 72 should be applied across the Union and implemented by the Member States without delay. This should foster the availability and use of the paired terrestrial 2 GHz frequency band for 5G deployment while upholding the principles of technology and service neutrality.

(10)

The notion of ‘designating and making available the paired terrestrial 2 GHz frequency band’ in the context of this Decision refers to the following steps: (i) the adaptation of the national legal framework on frequency allocation to include the intended use of this band under the harmonised technical conditions set in this Decision, (ii) the initiation of all necessary measures in order to ensure coexistence with existing use in this band, to the extent necessary, (iii) the initiation of the appropriate measures, supported by the launch of a stakeholder consultation process where appropriate, in order to allow the use of this band in accordance with the applicable legal framework at Union level, including the harmonised technical conditions of this Decision.

(11)	Member States should have, where justified, sufficient time to adapt the existing licenses to the General Parameters of the new technical conditions.

(12)	Cross-border agreements between Member States and with third countries may be necessary to ensure that Member States implement the parameters set by this Decision in a manner which avoids harmful interference, improves spectrum efficiency and prevents fragmentation in spectrum use.

(13)	Decision 2012/688/EU should therefore be amended accordingly.

(14)	The measures provided for in this Decision are in accordance with the opinion of the Radio Spectrum Committee established by the Decision No 676/2002/EC,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2012/688/EU is amended as follows:

(1)

in Article 2, paragraphs 1 and 2 are replaced by the following:

‘1. Member States shall designate and make available, on a non-exclusive basis, the paired terrestrial 2 GHz band for terrestrial systems capable of providing electronic communications services in compliance with the parameters set out in the Annex to this Decision.

2. Until 1 January 2026, Member States need not apply the General Parameters laid down in section B of the Annex in respect of rights of use for terrestrial electronic communications networks of spectrum in the paired terrestrial 2 GHz frequency band existing on the date when this Decision takes effect, to the extent that the exercise of those rights does not prevent the use of that band according to the Annex, subject to market demand.’;

(2)	in Article 3, the following subparagraph is added: ‘Member States shall report to the Commission on the implementation of this Decision by 30 April 2021.’;

(3)	the Annex is replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 6 May 2020.

For the Commission

Thierry BRETON

Member of the Commission

(1) OJ L 108, 24.4.2002, p. 1.

(2) Commission Implementing Decision 2012/688/EU of 5 November 2012 on the harmonisation of the frequency bands 1920 – 1980 MHz and 2110 – 2170 MHz for terrestrial systems capable of providing electronic communications services in the Union (OJ L 307, 7.11.2012, p. 84).

(3) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7).

(4) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Connectivity for a Competitive Digital Single Market – Towards a European Gigabit Society’ COM(2016) 587 final.

(5) Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions ‘5G for Europe: An Action Plan’, COM(2016) 588 final.

(6) Document RSPG16-032 final of 9 November 2016, ‘Strategic Roadmap Towards 5G for Europe: Opinion on spectrum related aspects for next-generation wireless systems (5G) (RSPG 1st opinion on 5G)’.

(7) Document RSPG19-007 final of 30 January 2019, ‘Strategic Spectrum Roadmap Towards 5G for Europe: Opinion on 5G implementation challenges (RSPG 3rd opinion on 5G)’.

ANNEX

‘ANNEX

PARAMETERS REFERRED TO IN ARTICLE 2(1)

A. DEFINITIONS

Active antenna systems (AAS) means a base station and an antenna system where the amplitude and/or phase between antenna elements is continually adjusted resulting in an antenna pattern that varies in response to short term changes in the radio environment. This excludes long-term beam shaping such as fixed electrical down tilt. In AAS base stations the antenna system is integrated as part of the base station system or product.

Non-active antenna systems (non-AAS) means a base station and an antenna system that provides one or more antenna connectors, which are connected to one or more separately designed passive antenna elements to radiate radio waves. The amplitude and phase of the signals to the antenna elements is not continually adjusted in response to short term changes in the radio environment.

Equivalent isotropically radiated power (EIRP) is the product of the power supplied to the antenna and the antenna gain in a given direction relative to an isotropic antenna (absolute or isotropic gain).

Total radiated power (TRP) is a measure of how much power a composite antenna radiates. It equals the total conducted power input into the antenna array system less any losses in the antenna array system. TRP means the integral of the power transmitted in different directions over the entire radiation sphere as shown in the formula:

where P(θ,φ) is the power radiated by an antenna array system in direction (θ,φ) given by the formula:

P(θ, φ) = PTxg(θ, φ)

where PTx denotes the conducted power (measured in Watts), which is input into the array system, and g(θ,φ) denotes the array system’s directional gain along the (θ, φ) direction.

B. GENERAL PARAMETERS

Within the paired terrestrial 2 GHz band, the frequency arrangement shall be as follows:

(1)

The duplex mode of operation is Frequency Division Duplex (FDD). The duplex spacing shall be 190 MHz with terminal station transmission (FDD uplink) located in the lower part of the band starting at 1 920 MHz and finishing at 1 980 MHz (“lower band”) and base station transmission (FDD downlink) located in the upper part of the band starting at 2 110 MHz and finishing at 2 170 MHz (“upper band”).

(2)

The assigned block size shall be in multiples of 5 MHz (1). The lower frequency limit of an assigned block in the lower band of 1 920-1 980 MHz shall be aligned with or spaced at multiples of 5 MHz from its lower edge of 1 920 MHz. The lower frequency limit of an assigned block in the upper band of 2 110-2 170 MHz shall be aligned with or spaced at multiples of 5 MHz from its lower edge of 2 110 MHz. An assigned block may also have a size in the range of 4,8-5 MHz as long as it fits within the boundaries of a 5 MHz block as defined above.

(3)	The lower band of 1 920-1 980 MHz or portions thereof, can be used for uplink-only operation (2) without paired spectrum within the upper band of 2 110-2 170 MHz.

(4)	The upper band of 2 110-2 170 MHz or portions thereof, can be used for downlink-only operation (3) without paired spectrum within the lower band of 1 920-1 980 MHz.

(5)	Base station and terminal station transmission shall be in compliance with the technical conditions specified in Part C and Part D, respectively.

C. TECHNICAL CONDITIONS FOR BASE STATIONS – BLOCK EDGE MASK

The following technical parameters for base stations called Block Edge Mask (BEM) are an essential component of conditions necessary to ensure coexistence between neighbouring networks, in the absence of bilateral or multilateral agreements between operators of such neighbouring networks. Less stringent technical parameters, if agreed among all affected operators of such networks, may also be used provided that these operators continue to comply with the technical conditions applicable for the protection of other services, applications or networks and with obligations resulting from cross-border coordination.

The BEM consists of several elements given in Table 1. The in-block power limit is applied to a block assigned to an operator. The baseline power limit, designed to protect the spectrum of other operators, and the transitional region power limit, enabling filter roll-off from the in-block to the baseline power limit represent out-of-block elements.

Power limits are provided separately for non-AAS and AAS. For non-AAS, the power limits apply to the mean EIRP. For AAS, the power limits apply to the mean TRP (4). The mean EIRP or mean TRP are measured by averaging over a time interval and over a measurement frequency bandwidth. In the time domain, the mean EIRP or mean TRP is averaged over the active portions of signal bursts and corresponds to a single power control setting. In the frequency domain, the mean EIRP or mean TRP is determined over the measurement frequency bandwidth as given in Tables 2, 3 and 4 below (5). In general, and unless stated otherwise, the BEM power limits correspond to the aggregate power radiated by the relevant device including all transmit antennas, except in the case of baseline and transition requirements for non-AAS base stations, which are specified per antenna.

Block Edge Mask (BEM)

Table 1

Definition of BEM elements

BEM element	Definition
In-block	Refers to a block for which the BEM is derived.
Baseline	Spectrum within the FDD downlink frequency band used for WBB ECS, with the exception of block assigned to the operator and the corresponding transitional regions.
Transitional region	Spectrum within the FDD downlink within 0 to 10 MHz below and 0 to 10 MHz above the block assigned to the operator. The transitional regions do not apply below 2 110 MHz or above 2 170 MHz.

Table 2

In-block power limits for non-AAS and AAS base stations

BEM element

Frequency range

Non-AAS EIRP limit

AAS TRP limit

In-block

Block assigned to the operator

Not obligatory.

In case an upper bound is set by a Member State, a value of 65 dBm/(5 MHz) per antenna may be applied.

Not obligatory.

In case an upper bound is set by a Member State, a value of 57 dBm/(5 MHz) per cell (6) may be applied.

Explanatory note to Table 2:

The corresponding in-block TRP limit is determined following guidelines given in ETSI TS 138 104 V15.6.0, Annex F, sections F.2 and F.3, on the basis of an antenna gain of 17 dBi and a total of eight beam forming antenna elements (scaling factor of 9 dB):

65 dBm/(5 MHz) – 17 dBi + 9 dB = 57 dBm/(5 MHz).

Table 3

Baseline out-of-block power limits for non-AAS and AAS base stations

BEM element	Frequency range within FDD downlink	Non-AAS mean EIRP limit per antenna (7)	AAS mean TRP limit per cell (8)	Measurement bandwidth
Baseline	Frequencies spaced more than 10 MHz from the lower or upper block edge	9 dBm	1 dBm	5 MHz

Table 4

Transitional region out-of-block power limits for non-AAS and AAS base stations

BEM element	Frequency range within FDD downlink	Non-AAS mean EIRP limit per antenna (9)	AAS mean TRP limit per cell (10)	Measurement bandwidth
Transitional region	– 10 to – 5 MHz from lower block edge	11 dBm	3 dBm	5 MHz
	– 5 to 0 MHz from lower block edge	16,3 dBm	8 dBm	5 MHz
	0 to + 5 MHz from upper block edge	16,3 dBm	8 dBm	5 MHz
	+ 5 to + 10 MHz from upper block edge	11 dBm	3 dBm	5 MHz

Explanatory note to Tables 3 and 4:

In alignment with the standardisation of unwanted emission conducted power (TRP) for AAS base stations in ETSI TS 138 104 (V15.6.0), Annex F, sections F.2 and F.3, the out-of-block TRP limits are set to a value that corresponds to a total of eight beam forming antenna elements, resulting in 8 dB difference between AAS and non-AAS as for the in-block case.

D. TECHNICAL CONDITIONS FOR TERMINAL STATIONS

Table 5

Terminal station BEM in-block power limit

Maximum mean in-block power (11)

24 dBm

Explanatory note to Table 5:

Member States may relax this limit for specific deployments, e.g. fixed terminal stations in rural areas provided that protection of other services, networks and applications is not compromised and cross-border obligations are fulfilled.

’

(1) As the UMTS channel spacing is 200 kHz, the centre frequency of an assigned block used for UMTS can be offset 100 kHz from the centre of the block in the frequency arrangement.

(2) Such as Supplemental UpLink (SUL)

(3) Such as Supplemental DownLink (SDL)

(4) TRP is a measure of how much power the antenna actually radiates. EIRP and TRP are equivalent for isotropic antennas

(5) The actual measurement bandwidth of the measurement equipment used for purposes of compliance testing may be smaller than the measurement bandwidth provided in those tables.

(6) In a multi-sector base station, the AAS radiated power limit applies to each one of the individual sectors.

(7) The non-AAS BEM level is defined per antenna and applicable to base station configuration with up to four antennas per sector.

(8) In a multi-sector base station, the AAS radiated power limit applies to each one of the individual sectors.

(9) The non-AAS BEM level is defined per antenna and applicable to base station configuration with up to four antennas per sector

(10) In a multi-sector base station, the AAS radiated power limit applies to each one of the individual sectors.

(11) This power limit is specified as EIRP for terminal stations designed to be fixed or installed and as TRP for terminal stations designed to be mobile or nomadic. EIRP and TRP are equivalent for isotropic antennas. It is recognised that this value may be subject to a tolerance defined in the harmonised standards to take account of operation under extreme environmental conditions and production spread.

19.5.2020

Official Journal of the European Union

L 156/13

COMMISSION IMPLEMENTING DECISION (EU) 2020/668

of 18 May 2020

on the harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

(1)

In accordance with Article 14 of Regulation (EU) 2016/425 of the European Parliament and of the Council (2), personal protective equipment that is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, is to be presumed to be in conformity with the essential health and safety requirements set out in Annex II to that Regulation covered by those standards or parts thereof.

(2)

By letter M/031, entitled ‘STANDARDISATION MANDATE TO CEN/CENELEC CONCERNING STANDARDS FOR PERSONAL PROTECTIVE EQUIPMENT’, the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to develop and draw up harmonised standards in support of Council Directive 89/686/EEC (3).

(3)

Directive 89/686/EEC was replaced by Regulation (EU) 2016/425 as from 21 April 2018, which brought only a limited number of changes to the essential health and safety requirements set out in Annex II to Directive 89/686/EEC. The harmonised standards drafted on the basis of request M/031 have been drafted exclusively in support of essential health and safety requirements, which have remained substantially unchanged following the replacement of Directive 89/686/EEC by Regulation (EU) 2016/425.

(4)

On the basis of the request M/031, CEN and Cenelec drafted the following harmonised standards: EN 893:2019 on mountaineering equipment, EN 943-2:2019 on protective clothing against dangerous solid, liquid and gaseous chemicals, EN 1073-1:2016+A1:2018 on protective clothing against solid airborne particles including radioactive contamination and EN 14458:2018 on personal eye-equipment, in support of Regulation (EU) 2016/425.

(5)

On the basis of the request M/031, CEN and Cenelec revised harmonised standards EN 343:2003+A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 13832-2:2006, EN 13832-3:2006, EN 14594:2005, EN 388:2016, EN 943-1:2015 and EN 12277:2015, the references of which are published in the C series of the Official Journal of the European Union (4). This resulted in adoption of, respectively, harmonised standards EN 343:2019 for protective clothing against rain, EN 358:2018 for belts and lanyards for work positioning or restraint, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019 and EN ISO 11393-6:2019 for protective clothing for users of hand-held chainsaws, EN 13832-2:2018 and EN 13832-3:2018 for footwear protecting against chemicals, EN 14594:2018 for respiratory protective devices, EN 388:2016+A1:2018 for protective gloves against mechanical risks, EN 943-1:2015+A1:2019 for protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols and EN 12277:2015+A1:2018 for mountaineering equipment.

(6)	On the basis of request M/031, CEN and Cenelec amended harmonised standard EN ISO 10819:2013, the reference of which is published in the C series of the Official Journal of the European Union (5). This resulted in adoption of an amendment to that harmonised standard, EN ISO 10819:2013/A1:2019.

(7)	The Commission together with CEN and Cenelec has assessed whether those standards comply with the request M/031.

(8)

The harmonised standards EN 893:2019, EN 943-2:2019, EN 1073-1:2016+A1:2018, EN 14458:2018, EN 343:2019, EN 358:2018, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019, EN ISO 11393-6:2019, EN 13832-2:2018, EN 13832-3:2018, EN 14594:2018, EN 388:2016+A1:2018, EN 943-1:2015+A1:2019, EN ISO 10819:2013 as amended by EN ISO 10819:2013/A1:2019, and EN 12277:2015+A1:2018 satisfy the requirements which they aim to cover and which are set out in Regulation (EU) 2016/425. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

(9)

CEN and Cenelec also drafted corrigendum EN 50321-1:2018/AC: 2018-08 correcting harmonised standard EN 50321-1:2018, the reference of which is published in the C series of the Official Journal of the European Union (6). Due to the fact that this corrigendum introduces technical corrections and in order to ensure correct and consistent application of harmonised standard EN 50321-1:2018, the reference of which was previously published, it is appropriate to publish the reference of this harmonised standard together with the reference of the corrigendum in the Official Journal of the European Union.

(10)

It is therefore necessary to withdraw the references of harmonised standards EN 343:2003+A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 13832-2:2006, EN 13832-3:2006, EN 14594:2005, EN 388:2016, EN 943-1:2015, EN ISO 10819:2013, EN 12277:2015 and EN 50321-1:2018, from the C series of the Official Journal of the European Union, given that those standards have been revised, amended or corrected. In order to give manufacturers more time to prepare for applying harmonised standards EN 343:2019 EN 358:2018, EN ISO 11393-2:2019, EN ISO 11393-4:2019, EN ISO 11393-5:2019, EN ISO 11393-6:2019, EN 13832-2:2018, EN 13832-3:2018, EN 14594:2018, EN 388:2016+A1:2018, EN 943-1:2015+A1:2019, EN ISO 10819:2013 as amended by EN ISO 10819:2013/A1:2019, EN 50321-1:2018 as corrected by EN 50321-1:2018/AC: 2018-08, and EN 12277:2015+A1:2018, it is necessary to defer the withdrawal of the references of harmonised standards EN 343:2003+A1:2007/AC:2009, EN 358:1999, EN 381-5:1995, EN 381-7:1999, EN 381-9:1997, EN 381-11:2002, EN 13832-2:2006, EN 13832-3:2006, EN 14594:2005, EN 388:2016, EN 943-1:2015, EN ISO 10819:2013, EN 12277:2015 and EN 50321-1:2018.

(11)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication,

HAS ADOPTED THIS DECISION:

Article 1

The references of harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.

Article 2

The references of harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 listed in Annex II to this Decision are hereby withdrawn from the Official Journal of the European Union as from the dates set out in that Annex.

Article 3

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

Done at Brussels, 18 May 2020.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 316, 14.11.2012, p. 12.

(2) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).

(3) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18).

(4) OJ C 113, 27.3.2018, p. 41.

(5) OJ C 113, 27.3.2018, p. 41.

(6) OJ C 113, 27.3.2018, p. 41.

ANNEX I

No	Reference of standard
1.	EN 343:2019 Protective clothing – Protection against rain
2.	EN 358:2018 Personal protective equipment for work positioning and prevention of falls from a height – Belts and lanyards for work positioning or restraint
3.	EN 388:2016+A1:2018 Protective gloves against mechanical risks
4.	EN 510:2019 Specification for protective clothing for use where there is a risk of entanglement with moving parts
5.	EN 893:2019 Mountaineering equipment – Crampons – Safety requirements and test methods
6.	EN 943-1:2015+A1:2019 Protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols – Part 1: Performance requirements for Type 1 (gas-tight) chemical protective suits
7.	EN 943-2:2019 Protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols – Part 2: Performance requirements for Type 1 (gas-tight) chemical protective suits for emergency teams (ET)
8.	EN 1073-1:2016+A1:2018 Protective clothing against solid airborne particles including radioactive contamination – Part 1: Requirements and test methods for compressed air line ventilated protective clothing, protecting the body and the respiratory tract
9.	EN ISO 10819:2013 Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013) EN ISO 10819:2013/A1:2019
10.	EN ISO 11393-2:2019 Protective clothing for users of hand-held chainsaws – Part 2: Performance requirements and test methods for leg protectors (ISO 11393-2:2018)
11.	EN ISO 11393-4:2019 Protective clothing for users of hand-held chainsaws – Part 4: Performance requirements and test methods for protective gloves (ISO 11393-4:2018)
12.	EN ISO 11393-5:2019 Protective clothing for users of hand-held chainsaws – Part 5: Performance requirements and test methods for protective gaiters (ISO 11393-5:2018)
13.	EN ISO 11393-6:2019 Protective clothing for users of hand-held chainsaws – Part 6: Performance requirements and test methods for upper body protectors (ISO 11393-6:2018)
14.	EN 12277:2015+A1:2018 Mountaineering equipment – Harnesses – Safety requirements and test methods
15.	EN 13832-2:2018 Footwear protecting against chemicals – Part 2: Requirements for limited contact with chemicals
16.	EN 13832-3:2018 Footwear protecting against chemicals – Part 3: Requirements for prolonged contact with chemicals
17.	EN 14458:2018 Personal eye-equipment – High performance visors intended only for use with protective helmets
18.	EN 14594:2018 Respiratory protective devices – Continuous flow compressed air line breathing devices – Requirements, testing and marking
19.	EN 50321-1:2018 Live working – Footwear for electrical protection – Insulating footwear and overboots EN 50321-1:2018/AC:2018-08

ANNEX II

No	Reference of standard	Date of withdrawal
1.	EN ISO 10819:2013 Mechanical vibration and shock – Hand-arm vibration – Measurement and evaluation of the vibration transmissibility of gloves at the palm of the hand (ISO 10819:2013)	19 November 2021
2.	EN 343:2003+A1:2007 Protective clothing – Protection against rain EN 343:2003+A1:2007/AC:2009	19 November 2021
3.	EN 358:1999 Personal protective equipment for work positioning and prevention of falls from a height – Belts for work positioning and restraint and work positioning lanyards	19 November 2021
4.	EN 381-5:1995 Protective clothing for users of hand-held chain saws – Part 5: Requirements for leg protectors	19 November 2021
5.	EN 381-7:1999 Protective clothing for users of hand-held chainsaws – Part 7: Requirements for chainsaw protective gloves	19 November 2021
6.	EN 381-9:1997 Protective clothing for users of hand-held chain saws – Part 9: Requirements for chain saw protective gaiters	19 November 2021
7.	EN 381-11:2002 Protective clothing for users of hand-held chainsaws – Part 11: Requirements for upper body protectors	19 November 2021
8.	EN 388:2016 Protective gloves against mechanical risks	19 November 2021
9.	EN 943-1:2015 Protective clothing against dangerous solid, liquid and gaseous chemicals, including liquid and solid aerosols – Part 1: Performance requirements for Type 1 (gas-tight) chemical protective suits	19 November 2021
10.	EN 12277:2015 Mountaineering equipment – Harnesses – Safety requirements and test methods	19 November 2021
11.	EN 13832-2:2006 Footwear protecting against chemicals – Part 2: Requirements for footwear resistant to chemicals under laboratory conditions	19 November 2021
12.	EN 13832-3:2006 Footwear protecting against chemicals – Part 3: Requirements for footwear highly resistant to chemicals under laboratory conditions	19 November 2021
13.	EN 14594:2005 Respiratory protective devices – Continuous flow compressed air line breathing apparatus – Requirements, testing, marking EN 14594:2005/AC:2005	19 November 2021
14.	EN 50321-1:2018 Live working – Footwear for electrical protection – Insulating footwear and overboots	19 November 2020

19.5.2020

Official Journal of the European Union

L 156/22

DECISION NO 1/2020 OF THE EPA COMMITTEE SET UP BY THE INTERIM AGREEMENT WITH A VIEW TO AN ECONOMIC PARTNERSHIP AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND ITS MEMBER STATES, OF THE ONE PART, AND THE CENTRAL AFRICA PARTY, OF THE OTHER PART,

of 28 April 2020

adopting the rules of procedure for mediation, the rules of procedure for arbitration, and the code of conduct for arbitrators [2020/670]

THE EPA COMMITTEE,

Having regard to the Interim Agreement with a view to an Economic Partnership Agreement between the European Community and its Member States, of the one part, and the Central Africa Party, of the other part (the ‘Agreement’), signed in Brussels on 22 January 2009, and applied on a provisional basis since 4 August 2014, and in particular Articles 80(1) and 88 thereof,

Whereas:

(1)	Under the terms of the Agreement and of this Decision, the Central Africa Party is composed of the Republic of Cameroon.

(2)

Article 80(1) of the Agreement provides that dispute settlement procedures provided for under Chapter 3 (Procedures for the settlement of disputes) of Title VI (Dispute avoidance and settlement) of the Agreement are covered by the rules of procedure and the code of conduct of arbitrators, which will be adopted by the EPA Committee.

(3)	Article 88 of the Agreement provides that the EPA Committee may decide to amend Title VI (Dispute avoidance and settlement) of the Agreement and the Annexes thereto,

HAS ADOPTED THIS DECISION:

Article 1

1. The rules of procedure for mediation, as set out in Annex I to this Decision, shall be established as Annex IV to the Agreement.

2. The rules of procedure for arbitration, as set out in Annex II to this Decision, shall be established as Annex V to the Agreement.

3. The code of conduct for arbitrators, as set out in Annex III to this Decision, shall be established as Annex VI to the Agreement.

4. The rules of procedure and the code of conduct, as referred to in paragraphs 1 and 3 of this Article shall be established without prejudice to any special rules provided for in the Agreement or which may be decided by the EPA Committee.

Article 2

This Decision shall enter into force on the date of its signature.

Done at Brussels, 28 April 2020.

For the Republic of Cameroon

Alamine OUSMANE MEY

Minister for the Economy, Planning and Regional Development

For the European Union

Phil HOGAN

European Commissioner for Trade

ANNEX I

RULES OF PROCEDURE FOR MEDIATION

Article 1

Scope of application

1. The provisions contained in these rules of procedure supplement and clarify the Interim Agreement with a view to an Economic Partnership Agreement between the European Community and its Member States, of the one part, and the Central Africa Party, of the other part (‘the Agreement’), in particular Article 69 (mediation) thereof.

2. These rules of procedure are intended to enable the Parties to resolve any disputes that may arise between them through a mutually satisfying solution reached owing to a comprehensive and expeditious mediation procedure.

3. Within the meaning of these rules of procedure, ‘mediation’ means any proceeding, regardless of what that proceeding is called, in which the Parties ask a mediator to help them to settle their dispute amicably.

Article 2

Start of the proceeding

1. A Party may request, in writing and at any time, that the Parties enter into a mediation proceeding. The request must be sufficiently detailed to present clearly the concerns of the complaining Party. It must also:

(a)	identify the specific measure at issue;

(b)	provide a statement of the alleged adverse effects that the measure has, or will have, in the view of the complainting Party, on trade between the Parties;

(c)	explain how the complaining Party considers that there exist a causal link between the measure and those effects.

2. The mediation proceeding may only be initiated by mutual consent of the Parties. Where a Party requests mediation pursuant to paragraph 1, the other Party shall consider the request and reply in writing within five days of the request. Failing this, the request shall be considered to have been dismissed.

Article 3

Selection of the mediator

1. The Parties shall mutually agree on a mediator at the beginning of the mediation proceeding, and no later than 15 days after receipt of the reply to the mediation request.

2. A mediator shall not be a citizen of either Party, unless the Parties agree otherwise.

3. The mediator shall provide a written statement confirming his or her impartiality and independence and his or her availability to oversee the mediation proceeding.

4. The mediator shall comply mutatis mutandis with the code of conduct for arbitrators.

Article 4

Conduct of the mediation proceeding

1. The mediator shall assist, in an impartial and transparent manner, the Parties in bringing clarity to the measure at issue and its possible trade effects between the Parties, and in reaching a mutually satisfying solution.

2. The mediator may decide on the most appropriate approach to bringing clarity to the measure concerned and its possible impact on trade between the Parties. In particular, the mediator may organise meetings between the Parties, consult the Parties jointly or individually, seek the assistance of, or consult, relevant experts and stakeholders, and provide any additional support requested by the Parties. However, before seeking the assistance of, or consulting, relevant experts and stakeholders, the mediator shall consult the Parties. Where the mediator wishes to meet, or talk to, one of the Parties and/or its counsel separately, he or she shall inform the other Party in advance or as soon as possible after his or her unilateral meeting or discussion with the first Party.

3. The mediator may offer advice and propose a solution that he or she submits to the Parties which may accept or reject the proposed solution or even agree on a different solution. However, the mediator may not, in any way, advise or comment on the consistency of the measure at issue with the Agreement.

4. The proceeding shall take place in the territory of the Party to which the request was addressed or, by mutual agreement between the Parties, in any other location or by any other means.

5. The Parties shall endeavour to reach a mutually satisfactory solution within 60 days from the appointment of the mediator. Pending a final agreement, the Parties may consider possible interim solutions, especially if the measure relates to perishable goods.

6. The solution may be adopted by means of an EPA Committee decision. Mutually satisfactory solutions shall be made public, unless the Parties decide otherwise. However, the version disclosed to the public may not contain any information classified by either Party as confidential.

7. At the request of the Parties, the mediator shall submit in writing a draft factual report to the Parties, providing a brief summary of the measure at issue in the proceeding and any mutually satisfactory solution reached as the final outcome of the proceeding, including possible interim solutions. The mediator shall grant the Parties 15 days to comment on the draft report. After considering the comments of the Parties submitted within the deadline provided, the mediator shall submit, in writing, a final factual report to the Parties within 15 days. The factual report may not contain any interpretation of the Agreement.

Article 5

End of the mediation proceeding

The proceeding shall be terminated:

(a)	by the adoption of a solution mutually agreed between the Parties, on the date of adoption;

(b)	by a written declaration of the mediator, after consultation with the Parties, that further efforts at mediation would be to no avail, on the date of that declaration;

(c)

by a written declaration of a Party after exploring solutions mutually agreed under the mediation proceeding and after having considered any advice and proposed solutions by the mediator, on the date of that declaration. Such declaration may not be issued before the period set out in Article 4(5) of these rules of procedure has expired; or

(d)	at any stage of the proceeding by mutual agreement of the Parties, on the date of that agreement.

Article 6

Implementation of a mutually satisfactory solution

1. Where the Parties have agreed to a solution, each Party shall take the measures necessary to implement it within the agreed time limit.

2. The implementing Party shall inform the other Party, in writing and within the agreed time limit, of any steps or measures taken to implement the mutually satisfactory solution.

Article 7

Confidentiality and relationship to dispute settlement

1. All information relating to the mediation proceeding must remain confidential, unless its disclosure is required by law or required for the implementation or performance of the agreement resulting from the mediation.

2. Unless the Parties agree otherwise, and without prejudice to Article 4(6) of these rules of procedure, all steps in the proceeding, including any advice or proposed solutions, shall be kept confidential. However, either Party may disclose to the public that mediation is taking place. The obligation of confidentiality does not extend to factual information already existing in the public domain.

3. The mediation proceeding is without prejudice to the Parties’ rights and obligations under the provisions of the Agreement on dispute settlement or in any other relevant agreement.

4. The Parties shall not be required to undertake consultations before initiating the mediation proceeding. However, a Party should in principle apply the other relevant cooperation or consultation provisions of the Agreement before initiating the mediation proceeding.

5. A Party shall not rely on the following elements, or introduce them as evidence in the framework other dispute settlement proceedings under the Agreement or any other agreement, nor shall an arbitration panel take into consideration:

(a)	positions taken by the other Party in the course of the mediation proceeding or information gathered under Articles 4(1) and (2) of these rules of procedure;

(b)	the fact that the other Party has indicated its willingness to accept a solution to the measure subject to mediation; or

(c)	advice given or proposals made by the mediator.

6. Unless the Parties agree otherwise, a mediator may not be a member of an arbitration panel in the framework of dispute settlement proceedings under the Agreement or under the World Trade Organization (WTO) Agreement involving the same matter for which he or she has been a mediator.

Article 8

Application of the rules of procedure for arbitration

Article 3 (Notifications) – without prejudice to Article 4(2) of these rules of procedure –, Article 15 (Costs), Article 16 (Working language for the proceeding, translation and interpretation) and Article 17 (Calculating time limits) of the rules of procedure for arbitration shall apply mutatis mutandis.

Article 9

Review

Five years after the date of entry into force of this Decision, the Parties shall consult each other on any need to modify the mediation mechanism in light of the experience gained and the development of any corresponding mechanism in the WTO.

ANNEX II

RULES OF PROCEDURE FOR ARBITRATION

Article 1

Definitions

For the purposes of these rules of procedure:

—	‘adviser’: means a natural person retained by a Party to advise or assist that Party in connection with an arbitration proceeding,

—	‘arbitration panel’: means a panel set up under Article 71 of the Agreement,

—	‘arbitrator’: means a member of an arbitration panel set up under Article 71 of the Agreement,

—	‘assistant’: means a natural person who, under the terms of appointment of an arbitrator, conducts research for or provides assistance to the arbitrator,

—	‘day’: means a calendar day unless otherwise specified,

—	‘representative of a Party’: means an employee or any natural person appointed by a government department or agency or any other public entity of a Party who represents the Party in a dispute under this Agreement,

—	‘party complained against’: means the Party that is alleged to be in violation of the provisions referred to in Article 67 of the Agreement,

—	‘complaining Party’: means any Party that requests the setting up of an arbitration panel under Article 70 of the Agreement.

Article 2

Scope of application

1. These rules of procedure supplement and clarify the Interim Agreement with a view to an Economic Partnership Agreement between the European Community and its Member States, of the one part, and the Central Africa Party, of the other part (‘the Agreement’), in particular Articles 70 et seq. thereof on arbitration.

2. These rules of procedure are intended to enable the Parties to resolve disputes that may arise between them through a mutually satisfactory solution reached owing to the arbitration mechanism.

Article 3

Notifications

1. ‘Notification’, for the purposes of these rules of procedure, means any request, notice, written submission or other document related to the arbitration procedure, on given that:

(a)	any notification from the arbitration panel shall be sent to both Parties at the same time;

(b)	any notification from one Party which is addressed to the arbitration panel shall be copied to the other Party at the same time; and

(c)	any notification from one Party which is addressed to the other Party shall be copied to the arbitration panel at the same time, as appropriate.

2. Any notification shall be carried out by email or, where appropriate, by any other means of telecommunication that provides a record of the sending thereof. Unless proven otherwise, such notification shall be deemed to have been delivered on the date of its sending.

3. All notifications shall be addressed to the Directorate-General for Trade of the European Commission and to the Cameroonian Ministry responsible for implementing the Agreement.

4. Minor errors of a clerical nature in notification may be corrected by delivery of a new notification clearly indicating the changes that have been made.

5. If the last day for delivery of a notification is a non-working day in the Central Africa Party or in the European Union, the notification may be delivered on the next business day. No notification of any kind shall be deemed to have been received on a non-working day.

6. Depending on the nature of the issues under dispute, all notifications addressed to the EPA Committee in accordance with these rules of procedure shall also be copied to the other relevant institutional bodies.

Article 4

Appointment of arbitrators

1. If, pursuant to Article 71 of the Agreement, an arbitrator is selected by drawing lots, the Chairperson of the EPA Committee or his or her representative shall promptly inform the Parties of the date, time and venue of the drawing by lot.

2. The Parties shall be present when the lots are drawn.

3. The Chairperson of the EPA Committee or the Chairperson’s representative shall, in writing, inform each individual selected of his or her appointment as arbitrator. Each individual shall confirm his or her availability to both Parties within five days from the date on which he or she was informed of his or her appointment.

4. If the list of arbitrators referred to in Article 85 of the Agreement has not been drawn up or does not have sufficient names when a request is submitted under Article 71(2) of the Agreement, the Chairperson of the EPA Committee shall select arbitrators by drawing lots from the names of individuals officially put forward by one or both of the Parties, and who meet the conditions laid down in Article 85(2) of the Agreement.

Article 5

Consultation between the Parties and the arbitration panel

1. Unless the Parties agree otherwise, they shall meet the arbitration panel within seven days of its setting up in order to determine such matters that the Parties or the arbitration panel deem appropriate, including:

(a)	the remuneration and expenses to be paid to arbitrators, which shall be in accordance with WTO standards;

(b)	the remuneration for each arbitrator’s assistant, the total of which shall not exceed 50 per cent of the total remuneration of that arbitrator;

(c)	the timetable of the proceeding.

Arbitrators and representatives of the Parties may take part in this meeting via telephone or video conference.

2. Unless the Parties agree otherwise within five days of the date of the setting up of the arbitration panel, the terms of reference of the arbitration panel shall be:

‘to examine, in the light of the relevant provisions of the Agreement, the matter referred to in the request for the setting up of the arbitration panel, to rule on the compatibility of the measure in question with Article 67 of the Agreement, and to make a ruling in accordance with Articles 73, 83 and 84 of the Agreement.’.

3. The Parties shall notify the agreed terms of reference to the arbitration panel within three days of their agreement on the mandate.

Article 6

Written submissions

The complaining Party shall deliver its initial written submission no later than 20 days after the date of the setting up of the arbitration panel. The Party complained against shall deliver its written counter-submission no later than 20 days after the date of delivery of the initial written submission.

Article 7

Working of the arbitration panels

1. The chairperson of the arbitration panel shall preside over all meetings. An arbitration panel may delegate to its chairperson the authority to make administrative and procedural decisions in the area concerned.

2. In accordance witih Article 9 of these rules of procedure, the arbitrators and the persons requested shall attend the hearing. Unless otherwise provided in the Agreement or these rules of procedure, the arbitration panel may conduct its other activities by any means, including by telephone, fax or any electronic means.

3. Only arbitrators may take part in the deliberations of the arbitration panel, but the arbitration panel may permit its assistants to be present at its deliberations.

4. The drafting of any ruling shall be the exclusive responsibility of the arbitration panel and shall not be delegated.

5. Where a procedural question arises that is not covered by the provisions of Title VI (Dispute avoidance and settlement) of the Agreement, the arbitration panel, after consulting the Parties, may adopt an appropriate procedure that is compatible with those provisions and that ensures equal treatment between the Parties.

6. If the arbitration panel considers that there is a need to change any of the time limits for its proceedings other than the time limits set out in Title VI (Dispute avoidance and settlement) of the Agreement, or to make any other procedural or administrative adjustment, it shall inform the Parties in writing of the reasons for which the change or adjustment has been made and of the time limit or adjustment needed. The arbitration panel may adopt such change or adjustment after having consulted the Parties.

7. At the request of one of the Parties, the arbitration panel may modify the time limits applicable to the proceeding, provided that equal treatment between the Parties is ensured.

8. At the request of both Parties, the arbitration panel may suspend the proceeding at any time for a period agreed by the Parties and not exceeding 12 consecutive months. The arbitration panel shall resume the proceeding at any time at the written request of both Parties, or at the end of the agreed suspension period at the written request of one of the Parties. The chairperson of the arbitration panel and, where necessary, the other Party shall be informed of the request. If the panel’s proceeding has been suspended for over 12 consecutive months, the authority conferred for the setting up of the arbitration panel shall become invalid and the proceeding before the panel shall be terminated. The Parties may, at any time, agree to terminate the proceeding before the arbitration panel. The Parties shall jointly notify the chairperson of the arbitration panel of this agreement. In the event of suspension, the relevant time limits shall be extended by the same amount of time as the arbitration panel’s proceeding was suspended.

9. The termination of the arbitration panel’s work shall be without prejudice to the rights of the Parties in the framework of any other proceeding on the same matter under Title VI (Dispute avoidance and settlement) of the Agreement.

Article 8

Replacement

1. If an arbitrator is unable to participate in the proceeding, withdraws, or must be replaced, a replacement shall be selected in accordance with Article 71 of the Agreement.

2. Where a Party considers that an arbitrator does not comply with the requirements of the code of conduct of arbitrators and for this reason should be replaced, that Party shall notify the other Party within 15 days from the date on which it became aware of the circumstances underlying the arbitrator’s alleged failure to comply with the code of conduct.

3. The Parties shall consult each other within 15 days of the date of the notification referred to in paragraph 2 of this Article. The Parties shall inform the arbitrator of his or her alleged non-compliance and may request that the arbitrator take the steps necessary to remedy the alleged non-compliance. They may also, if they so agree, remove the arbitrator and select a new arbitrator in accordance with the procedure set out in Article 71(2) of the Agreement.

4. If the Parties fail to agree on the need to replace an arbitrator, other than the chairperson, either Party may request that such matter be referred to the chairperson of the arbitration panel, whose decision shall be final.

If, pursuant to this request, the chairperson finds that an arbitrator does not comply with the requirements of the code of conduct of arbitrators, a new arbitrator shall be selected in accordance with Article 71(3) of the Agreement.

5. If the Parties fail to agree on the need to replace the chairperson, either Party may request that this matter be referred to one of the persons on the list, of individuals selected to act as chairperson of the arbitration panel established under Article 85 of the Agreement. The name of this individual shall be drawn at random by the Chairperson of the EPA Committee. The individual thus selected shall decide whether or not the chairperson complies with the requirements of the code of conduct of arbitrators. The decision shall be final.

If it is found that the chairperson does not comply with the requirements of the code of conduct of arbitrators, the new chairperson shall be selected in accordance with Article 71(3) of the Agreement.

Article 9

Hearings

1. Based upon the timetable determined pursuant to Article 5(1), and after consulting with the Parties and the other arbitrators, the chairperson of the arbitration panel shall notify the Parties of the date, time and venue of the hearing. The Party responsible for the logistical administration of the proceeding shall make this information available to the public, subject to Article 11.

2. Unless the Parties agree otherwise, the hearing shall be held in Brussels if the complaining Party is the Central Africa Party and in Yaoundé if the complaining Party is the European Union.

3. The arbitration panel may convene additional hearings if the Parties so agree.

4. All arbitrators shall be present during the entirety of the hearing.

5. The following persons may attend the hearing, irrespective of whether or not the proceeding is open to the public:

(a)	representatives of the Parties;

(b)	advisers to the Parties;

(c)	administrative staff, interpreters, translators and court reporters;

(d)	arbitrators’ assistants;

(e)	experts, as chosen by the arbitration panel pursuant to Article 81 of the Agreement.

6. No later than five days before the date of a hearing, each Party shall deliver to the arbitration panel and to the other Party a list of the names of natural persons who will make oral arguments or presentations at the hearing on behalf of that Party and of other representatives or advisers who will be attending the hearing.

7. The arbitration panel shall ensure that the complaining Party and the Party complained against are afforded equal speaking time. It shall conduct the hearing as follows:

Argument

(a)	argument of the complaining Party;

(b)	argument of the Party complained against.

Rebuttal Argument

(a)	reply of the complaining Party;

(b)	counter-reply of the Party complained against.

8. The arbitration panel may direct questions to either Party at any time during the hearing.

9. The arbitration panel shall arrange for a transcript of the hearing to be prepared and delivered to the Parties within a reasonable time after the hearing. The Parties may comment on the transcript, and the arbitration panel may consider those comments.

10. Each Party may deliver to the arbitrators and to the other Party a supplementary written submission concerning any matter arising during the hearing within 10 days of the date of the hearing.

Article 10

Questions in writing

1. The arbitration panel may, at any time during the proceeding, address questions in writing to one or both Parties. Each of the Parties shall receive a copy of any questions put by the arbitration panel.

2. Each Party shall also provide the other Party with a copy of its written response to the questions of the arbitration panel. Each Party shall be given the opportunity to provide written comments on the other Party’s reply within five days of the date of receipt of that response.

Article 11

Transparency and confidentiality

1. Each Party and the arbitration panel shall endeavour to ensure the confidentiality of any information submitted by the other Party to the arbitration panel and which that Party has classified as confidential. Where a Party’s submission to the arbitration panel contains confidential information, that Party shall also provide, within 15 days of delivery of that communication, a non-confidential version of the submission that could be disclosed to the public.

2. Nothing in these rules of procedure shall preclude a Party from disclosing statements of its own positions to the public to the extent that, when making reference to information submitted by the other Party, it does not disclose any information classified by the other Party as confidential.

3. The arbitration panel shall meet in closed session when the submission and arguments of a Party contain confidential business information. The Parties shall maintain the confidentiality of the arbitration panel hearings when they are held in closed session.

Article 12

Ex parte contacts

1. The arbitration panel shall not meet or contact a Party in the absence of the other Party.

2. No arbitrator may discuss any aspect of the subject matter of the proceeding with a Party or the Parties in the absence of the other arbitrators.

Article 13

Amicus curiae submissions

1. Non-governmental persons established on the territory of a Party may submit amicus curiae briefs to the arbitration panel in accordance with paragraphs 2 to 5.

2. Unless the Parties agree otherwise within five days of the date of the setting up of the arbitration panel, the arbitration panel may receive unsolicited written submissions, provided that they are made within 10 days of the date of the setting up of the arbitration panel, and those submissions, including any annexes thereto, are in no case longer than fifteen typed pages, including any annexes, and that they are directly relevant to the issue under consideration by the arbitration panel.

3. Each submission shall contain a description of the person making the submission, whether natural or legal, including the nature of that person’s activities and the source of that person’s financing, and specify the nature of the interest that that person has in the arbitration proceeding. The submission shall be drafted in the languages chosen by the Parties, in accordance with Article 16(1) and (2) of these rules of procedure.

4. The submissions shall be delivered to the Parties for their comments. The Parties may submit comments, within 10 days of the delivery, to the arbitration panel.

5. The arbitration panel shall list in its ruling all the submissions it has received that conform to these rules. The arbitration panel shall not be obliged to address in its ruling the arguments made in such submissions. The arbitration panel shall submit to the Parties for their comments any submission it obtains.

Article 14

Urgent cases

In cases of urgency referred to in Article 73(2) of the Agreement, the arbitration panel, after consulting the Parties, shall adjust the time limits referred to in these rules as appropriate and shall notify the Parties of such adjustments.

Article 15

Costs

1. Each Party shall bear its costs of participation in the arbitration proceeding.

2. The Party complained against shall be responsible for the logistical administration of the arbitration proceeding, in particular for organising hearings, unless it is agreed otherwise, and shall bear all of the costs of the logistical administration of the hearing. However, the Parties shall jointly and equally bear the other administrative costs of the arbitration proceeding as well as the remuneration and expenses of the arbitrators and their assistants.

Article 16

Working language for the proceeding, translation and interpretation

1. During the consultations referred to in Article 71(2) of the Agreement, and no later than the meeting referred to in Article 5(1) of these rules of procedure, the Parties shall endeavour to agree on a common working language for the proceeding before the arbitration panel.

2. If the Parties are unable to agree on a common working language, each Party shall arrange for the translation of its written submissions into the language chosen by the other Party, unless these submissions are written in one of the official languages common to the Parties to the Agreement. The Party complained against shall be responsible for the interpretation of oral submissions into the languages chosen by the Parties, provided that the Parties have chosen one of the official languages common to the Parties. If one of the Parties chooses a language other than one of the official languages common to both Parties, the interpretation of oral submissions shall be entirely the responsibility of that Party.

3. Arbitration panel reports and rulings shall be drafted in the language or languages chosen by the Parties. If the Parties have not agreed on a common working language, the interim and final reports of the arbitration panel and its rulings shall be issued in one of the official languages common to the Parties.

4. Any costs incurred for the translation of an arbitration panel ruling into the language or languages chosen by the Parties shall be borne equally by the Parties.

5. A Party may provide comments on the accuracy of any translated version of a document drawn up in accordance with these rules.

6. Each Party shall bear the costs of the translation of its written submissions.

Article 17

Calculation of time limits

All the time limits set out in Title VI (Dispute avoidance and settlement) of the Agreement and in these rules of procedure, including the time limits for arbitration panels to notify their rulings, may be modified by mutual consent of the Parties, and shall be calculated in calendar days from the day following the act or fact to which they refer, unless otherwise specified.

Article 18

Other procedures

The time limits set out in these rules of procedure shall be adjusted in line with the special time limits provided for the adoption of a ruling by the arbitration panel in proceedings under Articles 74 to 78 of the Agreement.

ANNEX III

CODE OF CONDUCT FOR ARBITRATORS

Article 1

Definitions

For the purposes of this code of conduct:

—	‘arbitrator’: means a member of an arbitration panel set up under Article 71 of the Agreement,

—	‘assistant’: means a natural person who, under the terms of appointment of an arbitrator, conducts research for or provides assistance to the arbitrator,

—	‘candidate’: means an individual whose name is on the list of arbitrators referred to in Article 85 of the Agreement and who is under consideration for selection as an arbitrator under Article 71 of the Agreement,

—	‘mediator’: means a natural person who conducts mediation in accordance with Article 69 of the Agreement,

—	‘staff’: in respect of an arbitrator, means natural persons under the direction and control of the arbitrator, other than assistants.

Article 2

Basic principles

1. In order to preserve the integrity and impartiality of the dispute settlement mechanism, each candidate arbitrator must familiarise himself or herself with this code of conduct. He or she must:

(a)	be independent and impartial;

(b)	avoid direct or indirect conflicts of interests;

(c)	avoid impropriety and any act that lead to the presumption of impropriety or of impartiality;

(d)	observe high standards of conduct;

(e)	not be influenced by self-interest, outside pressure, political considerations, external pressure, loyalty to a Party or fear of criticism.

2. An arbitrator shall not, directly or indirectly, incur any obligation or accept any benefit that would interfere, or appear to interfere in any way with the proper performance of his or her duties.

3. An arbitrator shall not use his or her position on the arbitration panel to advance any personal or private interests. An arbitrator shall avoid actions that may lead to the presumption that others are in a special position to influence him or her.

4. An arbitrator shall not allow past or existing financial, business, professional, personal, or social relationships or responsibilities to influence his or her conduct or judgement.

5. An arbitrator shall avoid entering into any relationship or acquiring any financial interest that is likely to affect his or her impartiality or that might reasonably lead to the presumption of impropriety or of impartiality.

Article 3

Disclosure obligations

1. Prior to confirmation of his or her selection as an arbitrator under Article 71 of the Agreement, a candidate shall disclose any interest, relationship or matter that is likely to affect his or her independence or impartiality or that might reasonably lead to the presumption of impropriety or of impartiality in the framework of the proceeding. To this end, a candidate shall strive, to the extent possible, to become aware of any such interests, relationships and matters, including financial interests, professional interests, or employment or family interests.

2. The disclosure obligation under paragraph 1, being a continuing duty, arbitrators shall disclose any such interests, relationships or matters that may arise during any stage of the proceeding.

3. A candidate or an arbitrator shall communicate to the EPA Committee for consideration by the Parties any matters concerning actual or potential violations of this code of conduct as soon as possible after having become aware of them.

Article 4

Duties of arbitrators

1. Upon acceptance of his or her appointment, an arbitrator shall be available to take up his or her duties and shall perform those duties thoroughly and expeditiously throughout the course of the proceeding, and with fairness and diligence.

2. An arbitrator shall consider only those issues raised in the proceeding and necessary for a ruling and shall not delegate this duty to any other person.

3. An arbitrator shall take all necessary steps to ensure that his or her assistant and staff are aware of, and comply with, Articles 2, 3 and 6 of this code of conduct.

Article 5

Obligations of former arbitrators

All former arbitrators must avoid actions that may lead to the presumption that they were biased in carrying out their duties or derived advantage from the ruling of the arbitration panel.

Article 6

Confidentiality

1. An arbitrator or former arbitrator shall not, at any time, disclose or use any non-public information concerning a proceeding or acquired during a proceeding except for the purposes of that proceeding and shall not, in any case, disclose or use any such information to gain personal advantage or advantage for others or to adversely affect the interest of others.

2. An arbitrator shall not disclose an arbitration panel ruling or parts thereof prior to its publication in accordance with this Article 84(2) of the Agreement.

3. An arbitrator or former arbitrator shall not, at any time, disclose the deliberations of an arbitration panel, or any member’s view.

Article 7

Expenses

Each arbitrator shall keep a record and render a final account of the time devoted to the proceeding and of his or her expenses, as well as the time and expenses of his or her assistant, to the Parties.

Article 8

Mediators

This code of conduct applies mutatis mutandis to mediators.

		ISSN 1977-0677
Official Journal of the European Union		L 156

English edition	Legislation	Volume 63 19 May 2020

Contents		II Non-legislative acts	page
		REGULATIONS
	*	Commission Implementing Regulation (EU) 2020/665 of 13 May 2020 entering a name in the register of protected designations of origin and protected geographical indications (Aceite de Jaén (PGI))	1
	*	Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies ( 1 )	2
		DECISIONS
	*	Commission Implementing Decision (EU) 2020/667 of 6 May 2020 amending Decision 2012/688/EU as regards an update of relevant technical conditions applicable to the frequency bands 1 920-1 980 MHz and 2 110-2 170 MHz (notified under document C(2020) 2816) ( 1 )	6
	*	Commission Implementing Decision (EU) 2020/668 of 18 May 2020 on the harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council	13
	*	Commission Implementing Decision (EU) 2020/669 of 18 May 2020 amending Implementing Decision 2013/801/EU as regards entrusting the Innovation and Networks Executive Agency with the implementation of the Innovation Fund	20
		ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS
	*	Decision No 1/2020 of the Epa Committee set up by the Interim Agreement with a view to an Economic Partnership Agreement between the European Community and its Member States, of the one part, and the Central Africa Party, of the other part, of 28 April 2020 adopting the rules of procedure for mediation, the rules of procedure for arbitration, and the code of conduct for arbitrators [2020/670]	22
	*	Decision No 2/2020 of the EPA Committee set up by the Interim Agreement with a view to an Economic Partnership Agreement between the European Community and its Member States, of the one part, and the Central Africa Party, of the other part of 28 April 2020 concerning the adoption of the list of arbitrators [2020/671]	35