# Official Journal C 447/2020

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 447 |
| | |
| English edition | Information and Notices | Volume 6323 December 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 447

English edition

Information and Notices

Volume 6323 December 2020

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | Council |
| 2020/C 447/01 | Council Conclusions on Regulatory Sandboxes and Experimentation Clauses as tools for an innovation-friendly, future-proof and resilient regulatory framework that masters disruptive challenges in the digital age | 1 |
| | European Commission |
| 2020/C 447/02 | Euro exchange rates — 22 December 2020 | 4 |
| 2020/C 447/03 | Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ C 396, 30.12.2006 )
   (
  1
  ) | 5 |
| 2020/C 447/04 | Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 January 2021( OJ C 140, 21.4.2004 ) | 9 |
| 2020/C 447/05 | Commission notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period | 10 |
| | NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2020/C 447/06 | EFTA Surveillance Authority’s notice on state aid recovery interest rates and reference/discount rates for the EFTA States applicable as from 1 September 2020( OJ C 139, 14.7.2004 ) | 16 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

2020/C 447/01

Council Conclusions on Regulatory Sandboxes and Experimentation Clauses as tools for an innovation-friendly, future-proof and resilient regulatory framework that masters disruptive challenges in the digital age

1

European Commission

2020/C 447/02

Euro exchange rates — 22 December 2020

4

2020/C 447/03

Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( OJ C 396, 30.12.2006 )
   (
  1
  )

( OJ C 396, 30.12.2006 )

1

5

2020/C 447/04

Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 January 2021( OJ C 140, 21.4.2004 )

( OJ C 140, 21.4.2004 )

9

2020/C 447/05

Commission notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period

10

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2020/C 447/06

EFTA Surveillance Authority’s notice on state aid recovery interest rates and reference/discount rates for the EFTA States applicable as from 1 September 2020( OJ C 139, 14.7.2004 )

( OJ C 139, 14.7.2004 )

16

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| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2020/C 447/07 | Prior notification of a concentration (Case M.10034 — Pizarreño/Maderas Arauco/E2E JV) Candidate case for simplified procedure (
  1
  ) | 17 |
| 2020/C 447/08 | Prior notification of a concentration (Case M.10073 — Vitol/Drax Generation) Candidate case for simplified procedure (
  1
  ) | 19 |
| 2020/C 447/09 | Prior notification of a concentration (Case M.9686 – Mitsui/ Belchim Crop Protection) (
  1
  ) | 20 |
| | OTHER ACTS |
| | European Commission |
| 2020/C 447/10 | Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs | 21 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2020/C 447/07

Prior notification of a concentration (Case M.10034 — Pizarreño/Maderas Arauco/E2E JV) Candidate case for simplified procedure (
  1
  )

1

17

2020/C 447/08

Prior notification of a concentration (Case M.10073 — Vitol/Drax Generation) Candidate case for simplified procedure (
  1
  )

1

19

2020/C 447/09

Prior notification of a concentration (Case M.9686 – Mitsui/ Belchim Crop Protection) (
  1
  )

1

20

OTHER ACTS

European Commission

2020/C 447/10

Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

21

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| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

---

(1)   Text with EEA relevance.

1

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

Council

| 23.12.2020 | EN | Official Journal of the European Union | C 447/1 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/1

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Council Conclusions on Regulatory Sandboxes and Experimentation Clauses as tools for an innovation-friendly, future-proof and resilient regulatory framework that masters disruptive challenges in the digital age

(2020/C 447/01)

THE COUNCIL OF THE EUROPEAN UNION:

1.

RECALLS its Conclusions of February 2020 (1) which HIGHLIGHTED that Better Regulation is one of the key drivers of sustainable, inclusive growth, fosters competitiveness, innovation, digitalisation and job creation, increases transparency and ensures public support for EU legislation; and REITERATED the need to ensure that EU regulation is transparent and simple and is achieved at minimum cost, while always taking into account a high level of protection of consumers, employees, health, climate and the environment. REAFFIRMS its commitment to promoting the most efficient regulatory instruments, such as harmonisation and mutual recognition. (2)

2.

UNDERLINES that especially in order for the EU to emerge stronger from the COVID-19 crisis, which has had a severe impact on the majority of businesses in the EU, particularly small and medium-sized enterprises (SMEs) including micro-enterprises as well as start-ups, many of which face an existential threat, the EU regulatory framework needs to be as competitive, effective, efficient, coherent, predictable, innovation-friendly, future-proof, sustainable and resilient as possible. It needs to be evidence-based and has to protect and support both citizens and businesses in the context of the aim of a fully functioning EU Single Market without imposing new unnecessary burdens and while reducing existing unnecessary burdens.

3.

RECALLS the principles of subsidiarity and of proportionality, as well as the precautionary principle, and its Conclusions of May 2016 (3) which STRESSED that, when considering developing or updating EU policy or regulatory measures, the ‘Innovation Principle’ should be applied, which entails taking into account the impact on research and innovation in the process of developing and reviewing regulation in all policy domains; which CALLED on the Commission and Member States to include the perspective of innovation-friendly and future-proof regulation as part of their discussions on existing regulation within REFIT; and which CALLED on the Commission and Member States to explore and exchange best practices as to how regulation can be made more future-proof and enabling for research and innovation, including possibilities for experimentation and flexibility. RECALLS the Best Practice Exchange organised in 2017 by the Maltese Presidency of the Council, which revealed that many Member States already consider experimentation and other innovation-related tools in their policy-making. (4)

4.

HIGHLIGHTS that flexibility and experimentation can be important elements for an agile, innovation-friendly, future-proof, evidence-based and resilient regulatory framework which fosters competitiveness, growth, sustainability, regulatory learning as well as European technological sovereignty and leadership, and which helps to master systemic shocks and disruptive as well as long-term future challenges.

5.

NOTES that regulatory sandboxes are increasingly used in a range of sectors, for example in finance, health, legal services, aviation, transport and logistics as well as energy, often including the use of new, emerging technologies – such as artificial intelligence (AI) and blockchain/distributed ledger technologies (DLT) – or the innovative use of existing technologies. (5)

6.

NOTES the ‘Study supporting the interim evaluation of the innovation principle’ prepared for the Commission in 2019, which highlighted the need to improve the EU’s innovation-friendliness by strengthening the Commission’s approach to design experimental regulation, including regulatory sandboxes. (6) NOTES that the Commission’s Science, Research and Innovation Performance Report 2020 states that the acceleration of technological development also calls for less traditional approaches to regulation and policy, such as regulatory sandboxes. (7)

7.

RECOGNISES that the Commission announced in its Communication ‘SME Strategy for a sustainable and digital Europe’ to encourage Member States to develop proposals for regulatory sandboxes by launching a pilot. (8) NOTES that the Commission in collaboration with European Blockchain Partnership is planning a pan-European blockchain regulatory sandbox to become operational in 2021/22. NOTES that the Commission’s Directorate-General for Structural Reform Support assists the European Bank for Reconstruction and Development in supporting regulatory sandboxes in Greece, Estonia and Poland. (9)

8.

PERCEIVES regulatory sandboxes as concrete frameworks which, by providing a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. (10)

9.

UNDERSTANDS experimentation clauses as legal provisions which enable the authorities tasked with implementing and enforcing the legislation to exercise on a case-by-case basis a degree of flexibility in relation to testing innovative technologies, products, services or approaches. (11) NOTES that experimentation clauses are often the legal basis for regulatory sandboxes, and are already used in EU legislation and in many Member States’ legal frameworks.

10.

HIGHLIGHTS that regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies.

11.

UNDERLINES that regulatory sandboxes can offer significant opportunities particularly to innovate and grow for all businesses, especially SMEs, including micro-enterprises as well as start-ups, in industry, services and other sectors.

12.

UNDERLINES that regulatory sandboxes and experimentation clauses always need to respect and should foster the application of the principles of subsidiarity and of proportionality, as well as of the precautionary principle. A high level of protection of inter alia citizens, consumers, employees, health, climate and the environment, as well as legal certainty, financial stability, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.

13.

| a) | ENCOURAGES the Commission to continue considering the use of experimentation clauses on a case-by-case basis when drafting and reviewing legislation, as well as to evaluate the use of experimentation clauses in ex-post evaluations and fitness checks; |
| --- | --- |

a)

ENCOURAGES the Commission to continue considering the use of experimentation clauses on a case-by-case basis when drafting and reviewing legislation, as well as to evaluate the use of experimentation clauses in ex-post evaluations and fitness checks;

| b) | HIGHLIGHTS that experimentation clauses can be important in several current and forthcoming legislative proposals; |
| --- | --- |

b)

HIGHLIGHTS that experimentation clauses can be important in several current and forthcoming legislative proposals;

| c) | SUPPORTS the Regulatory Scrutiny Board to continue to check that due consideration is given to the impact of regulation on innovation, which may include amongst others the use of experimentation clauses, when scrutinising impact assessments, evaluations and fitness checks; |
| --- | --- |

c)

SUPPORTS the Regulatory Scrutiny Board to continue to check that due consideration is given to the impact of regulation on innovation, which may include amongst others the use of experimentation clauses, when scrutinising impact assessments, evaluations and fitness checks;

| d) | EMPHASISES its intention to assess the possible inclusion of experimentation clauses when discussing legislative proposals; |
| --- | --- |

d)

EMPHASISES its intention to assess the possible inclusion of experimentation clauses when discussing legislative proposals;

| e) | CALLS on the Commission to create an overview of the main existing experimentation clauses in EU law; |
| --- | --- |

e)

CALLS on the Commission to create an overview of the main existing experimentation clauses in EU law;

| f) | CALLS on the Commission to identify policy areas and regulations in which additional experimentation clauses could possibly help to foster innovation and advance regulation; ENCOURAGES the Commission to consult in this respect with Member States and stakeholders, for instance via the Fit for Future Platform or targeted consultations. |
| --- | --- |

f)

CALLS on the Commission to identify policy areas and regulations in which additional experimentation clauses could possibly help to foster innovation and advance regulation; ENCOURAGES the Commission to consult in this respect with Member States and stakeholders, for instance via the Fit for Future Platform or targeted consultations.

14.

| a) | establish an overview of the state of play regarding the use of regulatory sandboxes in the EU; |
| --- | --- |

a)

establish an overview of the state of play regarding the use of regulatory sandboxes in the EU;

| b) | identify experiences regarding the legal basis, implementation and evaluation of regulatory sandboxes; |
| --- | --- |

b)

identify experiences regarding the legal basis, implementation and evaluation of regulatory sandboxes;

| c) | analyse how learning from regulatory sandboxes at national level can contribute to evidence-based policy making at EU-level. |
| --- | --- |

c)

analyse how learning from regulatory sandboxes at national level can contribute to evidence-based policy making at EU-level.

15.

CALLS on the Commission to present a progress report on this exchange of information and good practices regarding regulatory sandboxes as well as on the overview of existing experimentation clauses in EU law in the first half of 2021 in order to enable its discussion in the Working Party on Better Regulation under the Portuguese Presidency of the Council; and to present the final results and analysis together with practical recommendations on the possible future use of regulatory sandboxes and experimentation clauses in the EU and at EU level in the second half of 2021 in order to enable their discussion and follow up in the Working Party on Better Regulation under the Slovenian Presidency of the Council.

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(1)  6232/20.

1

(2)  Interinstitutional Agreement on Better Law-Making, point 47.

2

(3)  9580/16.

3

(4)  WK 6474/2017.

4

(5)  Attrey, A., Lesher, M. and Lomax, C., ‘The role of sandboxes in promoting flexibility and innovation in the digital age’, Going Digital Toolkit Policy Note 2, 2020.

5

(6)  https://ec.europa.eu/info/publications/study-supporting-interim-evaluation-innovation-principle_en.

6

(7)  https://ec.europa.eu/info/publications/science-research-and-innovation-performance-eu-2020_en.

7

(8)  6783/20 (COM (2020)103).

8

(9)  Parenti, R., ‘Regulatory Sandboxes and Innovation Hubs for FinTech’, Study for the committee on Economic and Monetary Affairs, Policy Department for Economic, Scientific and Quality of Life Policies, European Parliament, Luxembourg, 2020.

9

(10)  European Commission, TOOL #21. Research & Innovation, Better Regulation Toolbox; European Commission; 6783/20 (COM (2020)103).

10

(11)  European Commission, TOOL #21. Research & innovation, Better Regulation Toolbox, point 1 on experimentation clauses, p. 151.

11

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European Commission

| 23.12.2020 | EN | Official Journal of the European Union | C 447/4 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/4

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Euro exchange rates (1)

22 December 2020

(2020/C 447/02)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2239 |
| JPY | Japanese yen | 126,52 |
| DKK | Danish krone | 7,4401 |
| GBP | Pound sterling | 0,91148 |
| SEK | Swedish krona | 10,1143 |
| CHF | Swiss franc | 1,0837 |
| ISK | Iceland króna | 156,10 |
| NOK | Norwegian krone | 10,5938 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 26,303 |
| HUF | Hungarian forint | 362,33 |
| PLN | Polish zloty | 4,5116 |
| RON | Romanian leu | 4,8665 |
| TRY | Turkish lira | 9,3325 |
| AUD | Australian dollar | 1,6191 |
| CAD | Canadian dollar | 1,5753 |
| HKD | Hong Kong dollar | 9,4885 |
| NZD | New Zealand dollar | 1,7299 |
| SGD | Singapore dollar | 1,6327 |
| KRW | South Korean won | 1 353,44 |
| ZAR | South African rand | 17,8544 |
| CNY | Chinese yuan renminbi | 8,0056 |
| HRK | Croatian kuna | 7,5420 |
| IDR | Indonesian rupiah | 17 410,10 |
| MYR | Malaysian ringgit | 4,9703 |
| PHP | Philippine peso | 58,870 |
| RUB | Russian rouble | 92,2025 |
| THB | Thai baht | 36,901 |
| BRL | Brazilian real | 6,2842 |
| MXN | Mexican peso | 24,4948 |
| INR | Indian rupee | 90,3975 |

Currency

Exchange rate

USD

US dollar

1,2239

JPY

Japanese yen

126,52

DKK

Danish krone

7,4401

GBP

Pound sterling

0,91148

SEK

Swedish krona

10,1143

CHF

Swiss franc

1,0837

ISK

Iceland króna

156,10

NOK

Norwegian krone

10,5938

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,303

HUF

Hungarian forint

362,33

PLN

Polish zloty

4,5116

RON

Romanian leu

4,8665

TRY

Turkish lira

9,3325

AUD

Australian dollar

1,6191

CAD

Canadian dollar

1,5753

HKD

Hong Kong dollar

9,4885

NZD

New Zealand dollar

1,7299

SGD

Singapore dollar

1,6327

KRW

South Korean won

1 353,44

ZAR

South African rand

17,8544

CNY

Chinese yuan renminbi

8,0056

HRK

Croatian kuna

7,5420

IDR

Indonesian rupiah

17 410,10

MYR

Malaysian ringgit

4,9703

PHP

Philippine peso

58,870

RUB

Russian rouble

92,2025

THB

Thai baht

36,901

BRL

Brazilian real

6,2842

MXN

Mexican peso

24,4948

INR

Indian rupee

90,3975

---

(1)  Source: reference exchange rate published by the ECB.

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| 23.12.2020 | EN | Official Journal of the European Union | C 447/5 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/5

---

Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006
   (1))

(Text with EEA relevance)

(2020/C 447/03)

Decisions granting an authorisation

| Reference of the decision (2) | Date of decision | Substance name | Holder of the authorisation | Authorisation number | Authorised use | Date of expiry of review period | Reasons for the decision |
| --- | --- | --- | --- | --- | --- | --- | --- |
| C(2020) 8797 | 18 December 2020 | Chromium trioxide
  EC No 215-607-8, CAS No 1333-82-0 | Chemservice GmbH; Herrnsheimer Hauptstrasse 1b 67550 Worms, Germany | REACH/20/18/0 | Formulation of mixtures exclusively for uses REACH/20/18/7 to REACH/20/18/34 | 21 September 2024 | In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health from the use of the substance and there are no suitable alternative substances or technologies. |
| Atotech Deutschland GmbH , Erasmusstraße 20, 10553, Berlin, Germany | REACH/20/18/1 |
| Boeing Distribution Inc., Schillingweg 40, 2153PL, Nieuw-Vennep, Noord-Holland, Netherlands | REACH/20/18/2 |
| Prospere Chemical Logistic OÜ , Lao 21, 74114 Maardu, Estonia | REACH/20/18/3 |
| CROMITAL S.P.A., Strada Quattro, Pal. A7, 20090, Assago (MI), Italia | REACH/20/18/4 |
| Elementis Chromium LLP, Eaglescliffe, TS16 0QG, Stockton on Tees, United Kingdom | REACH/20/18/5 |
| MacDermid Enthone GmbH, Elisabeth-Selbert-Str. 4, 40764, Langenfeld, Germany | REACH/20/18/6 |
| Chemservice GmbH | REACH/20/18/7 | Functional chrome plating where any of the following key functionalities is necessary for the intended use: wear resistance, hardness, layer thickness, corrosion resistance, coefficient of friction, or effect on surface morphology |
| Atotech Deutschland GmbH | REACH/20/18/8 |
| Boeing Distribution Inc. | REACH/20/18/9 |
| Prospere Chemical Logistic OÜ | REACH/20/18/10 |
| CROMITAL S.P.A. | REACH/20/18/11 |
| Elementis Chromium LLP | REACH/20/18/12 |
| MacDermid Enthone GmbH | REACH/20/18/13 |
| Chemservice GmbH | REACH/20/18/14 | Surface treatment for applications in the aeronautics and aerospace industries, unrelated to functional chrome plating or functional chrome plating with decorative character, where any of the following key functionalities is necessary for the intended use: corrosion resistance / active corrosion inhibition, chemical resistance, hardness, adhesion promotion (adhesion to subsequent coating or paint), temperature resistance, resistance to embrittlement, wear resistance, surface properties impeding deposition of organisms, layer thickness, flexibility, and resistivity |
| Atotech Deutschland GmbH | REACH/20/18/15 |
| Boeing Distribution Inc. | REACH/20/18/16 |
| Prospere Chemical Logistic OÜ | REACH/20/18/17 |
| CROMITAL S.P.A. | REACH/20/18/18 |
| Elementis Chromium LLP | REACH/20/18/19 |
| MacDermid Enthone GmbH | REACH/20/18/20 |
| Chemservice GmbH | REACH/20/18/21 | Surface treatment (except passivation of tin-plated steel (electrolytic tin plating – ETP)) for applications in architectural, automotive, metal manufacturing and finishing, and general engineering industry sectors, unrelated to functional chrome plating or functional chrome plating with decorative character, where any of the following key functionalities is necessary for the intended use: corrosion resistance/ active corrosion inhibition, layer thickness, humidity resistance, adhesion promotion (adhesion to subsequent coating or paint), resistivity, chemical resistance, wear resistance, electrical conductivity, compatibility with substrate, (thermo) optical properties (visual appearance), heat resistance, food safety, coating tension, electric insulation or deposition speed |
| Atotech Deutschland GmbH | REACH/20/18/22 |
| Boeing Distribution Inc. | REACH/20/18/23 |
| Prospere Chemical Logistic OÜ | REACH/20/18/24 |
| CROMITAL S.P.A. | REACH/20/18/25 |
| Elementis Chromium LLP | REACH/20/18/26 |
| MacDermid Enthone GmbH | REACH/20/18/27 |
| Chemservice GmbH | REACH/20/18/28 | Passivation of tin-plated steel (electrolytic tin plating – ETP |
| Atotech Deutschland GmbH | REACH/20/18/29 |
| Boeing Distribution Inc. | REACH/20/18/30 |
| Prospere Chemical Logistic OÜ | REACH/20/18/31 |
| CROMITAL S.P.A. | REACH/20/18/32 |
| Elementis Chromium LLP | REACH/20/18/33 |
| MacDermid Enthone GmbH | REACH/20/18/34 |

Reference of the decision (2)

Date of decision

Substance name

Holder of the authorisation

Authorisation number

Authorised use

Date of expiry of review period

Reasons for the decision

C(2020) 8797

18 December 2020

Chromium trioxide

EC No 215-607-8, CAS No 1333-82-0

Chemservice GmbH; Herrnsheimer Hauptstrasse 1b 67550 Worms, Germany

REACH/20/18/0

Formulation of mixtures exclusively for uses REACH/20/18/7 to REACH/20/18/34

21 September 2024

In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health from the use of the substance and there are no suitable alternative substances or technologies.

Atotech Deutschland GmbH , Erasmusstraße 20, 10553, Berlin, Germany

REACH/20/18/1

Boeing Distribution Inc., Schillingweg 40, 2153PL, Nieuw-Vennep, Noord-Holland, Netherlands

REACH/20/18/2

Prospere Chemical Logistic OÜ , Lao 21, 74114 Maardu, Estonia

REACH/20/18/3

CROMITAL S.P.A., Strada Quattro, Pal. A7, 20090, Assago (MI), Italia

REACH/20/18/4

Elementis Chromium LLP, Eaglescliffe, TS16 0QG, Stockton on Tees, United Kingdom

REACH/20/18/5

MacDermid Enthone GmbH, Elisabeth-Selbert-Str. 4, 40764, Langenfeld, Germany

REACH/20/18/6

Chemservice GmbH

REACH/20/18/7

Functional chrome plating where any of the following key functionalities is necessary for the intended use: wear resistance, hardness, layer thickness, corrosion resistance, coefficient of friction, or effect on surface morphology

Atotech Deutschland GmbH

REACH/20/18/8

Boeing Distribution Inc.

REACH/20/18/9

Prospere Chemical Logistic OÜ

REACH/20/18/10

CROMITAL S.P.A.

REACH/20/18/11

Elementis Chromium LLP

REACH/20/18/12

MacDermid Enthone GmbH

REACH/20/18/13

Chemservice GmbH

REACH/20/18/14

Surface treatment for applications in the aeronautics and aerospace industries, unrelated to functional chrome plating or functional chrome plating with decorative character, where any of the following key functionalities is necessary for the intended use: corrosion resistance / active corrosion inhibition, chemical resistance, hardness, adhesion promotion (adhesion to subsequent coating or paint), temperature resistance, resistance to embrittlement, wear resistance, surface properties impeding deposition of organisms, layer thickness, flexibility, and resistivity

Atotech Deutschland GmbH

REACH/20/18/15

Boeing Distribution Inc.

REACH/20/18/16

Prospere Chemical Logistic OÜ

REACH/20/18/17

CROMITAL S.P.A.

REACH/20/18/18

Elementis Chromium LLP

REACH/20/18/19

MacDermid Enthone GmbH

REACH/20/18/20

Chemservice GmbH

REACH/20/18/21

Surface treatment (except passivation of tin-plated steel (electrolytic tin plating – ETP)) for applications in architectural, automotive, metal manufacturing and finishing, and general engineering industry sectors, unrelated to functional chrome plating or functional chrome plating with decorative character, where any of the following key functionalities is necessary for the intended use: corrosion resistance/ active corrosion inhibition, layer thickness, humidity resistance, adhesion promotion (adhesion to subsequent coating or paint), resistivity, chemical resistance, wear resistance, electrical conductivity, compatibility with substrate, (thermo) optical properties (visual appearance), heat resistance, food safety, coating tension, electric insulation or deposition speed

Atotech Deutschland GmbH

REACH/20/18/22

Boeing Distribution Inc.

REACH/20/18/23

Prospere Chemical Logistic OÜ

REACH/20/18/24

CROMITAL S.P.A.

REACH/20/18/25

Elementis Chromium LLP

REACH/20/18/26

MacDermid Enthone GmbH

REACH/20/18/27

Chemservice GmbH

REACH/20/18/28

Passivation of tin-plated steel (electrolytic tin plating – ETP

Atotech Deutschland GmbH

REACH/20/18/29

Boeing Distribution Inc.

REACH/20/18/30

Prospere Chemical Logistic OÜ

REACH/20/18/31

CROMITAL S.P.A.

REACH/20/18/32

Elementis Chromium LLP

REACH/20/18/33

MacDermid Enthone GmbH

REACH/20/18/34

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(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at:http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm

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| 23.12.2020 | EN | Official Journal of the European Union | C 447/9 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/9

---

Commission notice on current State aid recovery interest rates and reference/discount rates applicable as from 1 January 2021

(Published in accordance with Article 10 of Commission Regulation (EC) No 794/2004 of 21 April 2004 (OJ L 140, 30.4.2004, p. 1))

(2020/C 447/04)

Base rates calculated in accordance with the Communication from the Commission on the revision of the method for setting the reference and discount rates (OJ C 14, 19.1.2008, p. 6.). Depending on the use of the reference rate, the appropriate margins have still to be added as defined in this communication. For the discount rate this means that a margin of 100 basispoints has to be added. The Commission Regulation (EC) No 271/2008 of 30 January 2008 amending Regulation (EC) No 794/2004 foresees that, unless otherwise provided for in a specific decision, the recovery rate will also be calculated by adding 100 basispoints to the base rate.

Modified rates are indicated in bold.

Previous table published in OJ C 436, 17.12.2020, p. 29.

| From | To | AT | BE | BG | CY | CZ | DE | DK | EE | EL | ES | FI | FR | HR | HU | IE | IT | LT | LU | LV | MT | NL | PL | PT | RO | SE | SI | SK | UK |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1.1.2021 | ... | -0,45 | -0,45 | 0,00 | -0,45 | 0,44 | -0,45 | 0,06 | -0,45 | -0,45 | -0,45 | -0,45 | -0,45 | 0,22 | 0,80 | -0,45 | -0,45 | -0,45 | -0,45 | -0,45 | -0,45 | -0,45 | 0,23 | -0,45 | 2,07 | 0,00 | -0,45 | -0,45 | 0,15 |

From

To

AT

BE

BG

CY

CZ

DE

DK

EE

EL

ES

FI

FR

HR

HU

IE

IT

LT

LU

LV

MT

NL

PL

PT

RO

SE

SI

SK

UK

1.1.2021

...

-0,45

-0,45

0,00

-0,45

0,44

-0,45

0,06

-0,45

-0,45

-0,45

-0,45

-0,45

0,22

0,80

-0,45

-0,45

-0,45

-0,45

-0,45

-0,45

-0,45

0,23

-0,45

2,07

0,00

-0,45

-0,45

0,15

---

| 23.12.2020 | EN | Official Journal of the European Union | C 447/10 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/10

---

Commission notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period

(2020/C 447/05)

Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a ‘third country’ (1).The Withdrawal Agreement (2) provides for a transition period ending on 31 December 2020. Until that date, Union law in its entirety applies to and in the United Kingdom (3). This includes the pharmaceutical acquis of the Union, in particular Directive 2001/82 (4), Directive 2001/83 (5), Commission Delegated Regulation (EU) 2016/161 (6) and Article 13 of Directive 2001/20 (7), which are of relevance for this Notice.

At the end of the transition period, Union law ceases to apply to the United Kingdom. As the Protocol on Ireland and Northern Ireland (‘the IE/NI Protocol’) starts to apply, some Union legislation (including the above mentioned legislation), its implementing, amending and replacing measures, however, becomes applicable to and in the United Kingdom in respect of Northern Ireland in accordance with Art 5 (4), Annex 2, point 20, of the IE/NI Protocol.

In practical terms, this means, in particular, that:

| — | Medicinal products (in the scope of the abovementioned legislation) placed on the market in Northern Ireland must comply with the regulatory requirements laid down in Union law (cf. Article 5 (4) of the IE/NI Protocol, read in conjunction with Annex 2 to that Protocol); |
| --- | --- |

—

Medicinal products (in the scope of the abovementioned legislation) placed on the market in Northern Ireland must comply with the regulatory requirements laid down in Union law (cf. Article 5 (4) of the IE/NI Protocol, read in conjunction with Annex 2 to that Protocol);

| — | Medicinal products must have a valid marketing authorisation in the EU or in Northern Ireland, the holder of which is located in the EU or in Northern Ireland; |
| --- | --- |

—

Medicinal products must have a valid marketing authorisation in the EU or in Northern Ireland, the holder of which is located in the EU or in Northern Ireland;

| — | Trade in medicinal products from Great Britain to Northern Ireland or to the Union constitutes an import in the sense of applicable Union law; |
| --- | --- |

—

Trade in medicinal products from Great Britain to Northern Ireland or to the Union constitutes an import in the sense of applicable Union law;

| — | Trade in medicinal products from the Union or Northern Ireland to any other part of the United Kingdom (Great Britain) or any other third country constitutes an export in the sense of applicable Union law; |
| --- | --- |

—

Trade in medicinal products from the Union or Northern Ireland to any other part of the United Kingdom (Great Britain) or any other third country constitutes an export in the sense of applicable Union law;

| — | Authorisations issued by UK authorities are, in principle, not valid under Union law, but can only be recognised in Northern Ireland if adopted in accordance with applicable Union law (cf. Article 7 (3) of the IE/NI Protocol); |
| --- | --- |

—

Authorisations issued by UK authorities are, in principle, not valid under Union law, but can only be recognised in Northern Ireland if adopted in accordance with applicable Union law (cf. Article 7 (3) of the IE/NI Protocol);

| — | Any steps in the supply of medicines which must be carried out in the Union (e.g. batch release) in order to allow for the placing on the market of medicinal products in accordance with Union law must occur in the (geographical) scope of Union law, ie in the Union or Northern Ireland, and only actions that may be carried out in third countries may occur in Great Britain. |
| --- | --- |

—

Any steps in the supply of medicines which must be carried out in the Union (e.g. batch release) in order to allow for the placing on the market of medicinal products in accordance with Union law must occur in the (geographical) scope of Union law, ie in the Union or Northern Ireland, and only actions that may be carried out in third countries may occur in Great Britain.

The Commission and the European Medicines Agency have, since 2017, actively been disseminating all relevant information in order to draw the attention of all relevant stakeholders to the impact of the United Kingdom’s withdrawal and to alert them of the need to adapt in time before the end of the transition period. The necessary changes have notably been explained in BREXIT Notices as last amended and published on 7 May 2020 for clinical trials (8) and on 13 March 2020 for medicinal products (9).

Nonetheless, some markets which have historically relied on supply of medicinal products from or through Great Britain (Cyprus, Ireland, Malta and Northern Ireland) (10), may still need some additional time to adapt supply chains and take account of the end of the transition period. Against that background, it is crucial that the Union’s pharmaceutical acquis is implemented and enforced in a manner that both prevents shortages of medicines and ensures the high level of public health protection foreseen by Union law.

The Commission has identified the following challenges (described below) as the principal difficulties for the above-mentioned markets which are historically dependent on medicines supply from or through Great Britain in complying with the Union’s pharmaceutical acquis:

| 1. | Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries; |
| --- | --- |

1.

Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries;

| 2. | Difficulties to carry out quality control testing (‘batch testing’); |
| --- | --- |

2.

Difficulties to carry out quality control testing (‘batch testing’);

| 3. | Difficulties to comply with the provisions of Directive 2001/83/EC and Commission Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier. |
| --- | --- |

3.

Difficulties to comply with the provisions of Directive 2001/83/EC and Commission Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier.

Recognising these challenges, and taking into consideration the exceptional circumstances of the COVID-19 pandemic, the Commission takes note of the request, from both private and public stakeholders in the Union and the United Kingdom, for more time in the transition towards full compliance with the Union’s pharmaceutical acquis.

1.   Lack of operators holding a manufacturing authorisation required for importing medicinal products from third countries

A.   Human and veterinary medicinal products

According to Article 40(3) of Directive 2001/83/EC and Article 44(3) of Directive 2001/82/EC, anyone placing medicinal products from third countries on the market in accordance with Union law (in the Union or in Northern Ireland) is an importer in the sense of Union law, and must therefore hold a manufacturing authorisation issued by the Member State where the importer is established or, in the case of importers established in Northern Ireland, by the UK acting in respect of Northern Ireland in accordance with Articles 41 and 42 of Directive 2001/83/EC for human medicines and/or Articles 45 and 46 of Directive 2001/82/EC for veterinary medicines. The conditions for such a manufacturing authorisation include, inter alia, the availability of a qualified person in the Union or Northern Ireland, the inspection of the manufacturer/importer and its compliance with Good Manufacturing Practices.

According to Articles 118 of Directive 2001/83/EC and Article 84(e) of Directive 2001/82/EC, competent authorities applying the Union’s pharmaceutical acquis are obliged to suspend or revoke the marketing authorisation of a medicinal product where the holder of that authorisation does not have a valid manufacturing authorisation or does not comply with one of the conditions necessary to obtain such manufacturing authorisation.

In order to allow operators in these markets historically dependent on medicines supply from Great Britain additional time to comply in full with the requirements of the Union’s pharmaceutical acquis in the exceptional circumstances of a global pandemic, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland could apply the following practice between January 2021 and 31 December 2021.

In this case, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow medicinal products to be imported from Great-Britain by wholesalers which are not in possession of a manufacturing authorisation as required by Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82; and they (ii) would not suspend or revoke the marketing authorisations of those medicinal products as required by Articles 118 of Directive 2001/83 and Articles 84(e) of Directive 2001/82, provided that the following conditions are fulfilled:

| — | The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have undergone quality control testing (‘batch testing’ (11)) either in the Union, as provided for in Article 51(3) of Directive 2001/83/EC for human medicinal products and in Article 44(3) of Directive 2001/82/EC for veterinary medicinal products, or in Great Britain in compliance with Article 20 (b) of Directive 2001/83/EC for human medicinal products and with Article 24b of Directive 2001/82/EC for veterinary medicinal products (see Section 2 of this Notice); |
| --- | --- |

—

The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have undergone quality control testing (‘batch testing’ (11)) either in the Union, as provided for in Article 51(3) of Directive 2001/83/EC for human medicinal products and in Article 44(3) of Directive 2001/82/EC for veterinary medicinal products, or in Great Britain in compliance with Article 20 (b) of Directive 2001/83/EC for human medicinal products and with Article 24b of Directive 2001/82/EC for veterinary medicinal products (see Section 2 of this Notice);

| — | The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have been subject to batch release by a Qualified Person (QP) in the Union or by a QP in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human health; |
| --- | --- |

—

The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have been subject to batch release by a Qualified Person (QP) in the Union or by a QP in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human health;

| — | The operator placing medicinal products supplied from or through Great Britain on the market in accordance with Union law (in the Union or in Northern Ireland) holds a distribution authorisation issued, before the end of the transition period, in accordance with Article 77(1) of Directive 2001/83/EC for human medicinal products and/or Article 65(1)of Directive 2001/82/EC for veterinary medicinal products; |
| --- | --- |

—

The operator placing medicinal products supplied from or through Great Britain on the market in accordance with Union law (in the Union or in Northern Ireland) holds a distribution authorisation issued, before the end of the transition period, in accordance with Article 77(1) of Directive 2001/83/EC for human medicinal products and/or Article 65(1)of Directive 2001/82/EC for veterinary medicinal products;

| — | The marketing authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the competent authority of the United Kingdom before the end of the transition period and in accordance with Union law; |
| --- | --- |

—

The marketing authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the competent authority of the United Kingdom before the end of the transition period and in accordance with Union law;

| — | The medicinal products supplied from or through Great Britain are made available to the end consumer in the same market historically dependent on medicines supply from Great Britain where they are imported, and they are not made available in other EU Member States. |
| --- | --- |

—

The medicinal products supplied from or through Great Britain are made available to the end consumer in the same market historically dependent on medicines supply from Great Britain where they are imported, and they are not made available in other EU Member States.

The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards the progress made by wholesale distributors importing medicinal products in fulfilling the conditions necessary to obtain a manufacturing authorisation laid down in Article 41 of Directive 2001/83/EC and Article 45 of Directive 2001/82/EC, including, in particular, the conclusion by those wholesale distributors of contractual relationships with qualified persons in the Union.

B.   Investigational medicinal products

According to Article 13 of Directive 2001/20/EC, the placing on the market of investigational medicinal products from third countries in accordance with Union law also requires the importer to hold a manufacturing authorisation. After the end of the transition period, this also applies to the supply of investigational medicinal products from or through Great Britain in Cyprus, Ireland, Malta and Northern Ireland. Similarly to the requirements for manufacturing authorisations pursuant to Article 41 of Directive 2001/83 and Article 44 of Directive 2001/82, Article 13(2) of Directive 2001/20/EC also requires the holder of this manufacturing authorisation to have, permanently and continuously, at his disposal the services of at least one qualified person in the scope of application of Union law, i.e. in the Union or in Northern Ireland.

In order to allow operators in these markets historically dependent on medicines supply from Great Britain additional time to comply in full with the requirements of the Union’s pharmaceutical acquis in the exceptional circumstances of a global pandemic, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland could apply the following practice between January 2021 and 31 December 2021 as regards investigational medicinal products.

In this case, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow investigational medicinal products to be imported from Great-Britain by wholesalers which are not in possession of a manufacturing authorisation as required by Article 13 of Directive 2001/20/EC, provided that the following conditions are fulfilled:

| — | The medicinal products supplied from or through Great Britain and approved for use in accordance with Union law (i.e. imported into the EU or Northern Ireland) have undergone batch release either in the Union, as provided for in Article 13(3) of Directive 2001/20, or in Great Britain in compliance with Article 13(3) of Directive 2001/20/EC; |
| --- | --- |

—

The medicinal products supplied from or through Great Britain and approved for use in accordance with Union law (i.e. imported into the EU or Northern Ireland) have undergone batch release either in the Union, as provided for in Article 13(3) of Directive 2001/20, or in Great Britain in compliance with Article 13(3) of Directive 2001/20/EC;

| — | The clinical trials authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the United Kingdom before the end of the transition period and in accordance with Union law; |
| --- | --- |

—

The clinical trials authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the United Kingdom before the end of the transition period and in accordance with Union law;

| — | The medicinal products supplied from or through Great Britain are made available to the end consumer in the same market historically dependent on medicines supply from Great Britain where they are imported, and they are not made available in other EU Member States. |
| --- | --- |

—

The medicinal products supplied from or through Great Britain are made available to the end consumer in the same market historically dependent on medicines supply from Great Britain where they are imported, and they are not made available in other EU Member States.

The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards progress made by operators importing investigational medicinal products in fulfilling the conditions necessary to obtain a manufacturing authorisation pursuant to Article 13 of Directive 2001/20/EC, including, in particular, the conclusion by those operators of contractual relationships with qualified persons in the Union.

2.   Batch testing of human and veterinary medicinal products

According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing (‘batch testing’) in the EU/EEA. The requirement of a batch release site established in the Union is a fundamental pillar of the Union system of ensuring quality of medicinal products being placed on the Union market. However, with regard to the quality control testing there may be objective reasons beyond the control of the marketing authorisation holders that may have prevented the timely transfer of such testing activities to be carried out in the Union or Northern Ireland by the end of the transition period.

In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC allow for importers placing medicinal products supplied from or through Great Britain on the market in Cyprus, Ireland, Malta or Northern Ireland or wholesale distributors placing such medicinal products on those markets as described under Section 1 above, to have, in justifiable cases, certain controls carried out in Great Britain. Taking into account the exceptional circumstances described in this Notice, the Commission considers that a ‘justifiable case’ within the meaning of Article 20(b) Directive 2001/83/EC and 24(b) of Directive 2001/82/EC occurs when the following conditions are fulfilled:

| — | Each batch of the medicinal product concerned is released by a qualified person (QP) on a site in the EU or by a QP on a site in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human or animal health, in cases falling under Section 1 above; |
| --- | --- |

—

Each batch of the medicinal product concerned is released by a qualified person (QP) on a site in the EU or by a QP on a site in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human or animal health, in cases falling under Section 1 above;

| — | The establishment designated by the third party conducting the quality control testing is supervised by a competent authority, including on-the-spot checks. Demonstrable progress towards transferring the quality control testing site to the Union or Northern Ireland is shown. Notably the batch testing site should be established within a twelve-month period after the end of the transition period, by the 31 December 2021 at the latest. |
| --- | --- |

—

The establishment designated by the third party conducting the quality control testing is supervised by a competent authority, including on-the-spot checks. Demonstrable progress towards transferring the quality control testing site to the Union or Northern Ireland is shown. Notably the batch testing site should be established within a twelve-month period after the end of the transition period, by the 31 December 2021 at the latest.

In order to make use of the derogation foreseen in Article 20(b) of Directive 2001/83/EC for human medicinal products and Article 24(b) of Directive 2001/82/EC for veterinary medicinal products, marketing authorisation holders should notify the competent authority that granted the marketing authorisation of the product concerned (Cyprus, Ireland, Malta or Northern Ireland), specifying that – and why in their view - the above criteria of a ‘justifiable case’ in the sense of Article 20 (b) of Directive 2001/83, and of Article 24 (b) of Directive 2001/82, are fulfilled. For medicinal products to be placed on the market in Northern Ireland, the competent authority is the MHRA. For centrally authorised products, the competent authority is EMA.

Any such notification should be submitted without undue delay and should be received as soon as possible after the end of the transition period, and in no case later than by 30 January 2021.

3.   Requirements relating to the placement of the unique identifier for medicinal products for human use

As the IE/NI Protocol makes Directive 2001/83 applicable to and in the United Kingdom in respect of Northern Ireland in its current version, the safety features (namely the anti-tampering device and the unique identifier) laid down in Articles 54 (o) and 54a (1) of Directive 2001/83/EC also apply to medicinal products placed on the market in Northern Ireland. Without prejudice to the application of this Union legislation to and in the United Kingdom in respect of Northern Ireland, the placing on the market of medicinal products in any other part of the United Kingdom than Northern Ireland will not require the use of these safety features, like the unique identifier, foreseen in Union law.

This means that, as from 1 January 2021, packs of medicines destined for Great Britain should be separated from packs destined for Cyprus, Ireland, Malta or Northern Ireland – even where the supply route goes through Great Britain. Like for any medicinal products placed on the market in the Union, the information of the Cypriot, Irish, Maltese and Northern Irish packs needs to be uploaded in the European hub, or the repository systems of the respective territories, but not the information of the packs with a final destination in any other part of the United Kingdom than Northern Ireland (Great Britain).

As regards packs exported from the Union to any third country like the United Kingdom, Article 22 of Commission Delegated Regulation (EU) 2016/161 obliges the economic operator exporting the medicinal products to decommission any unique identifier that may have already been affixed to the pack prior to the export.

Where medicinal products are supplied, through Great Britain, to Cyprus, Ireland, Malta or Northern Ireland, it would then, in principle, be for the importer holding a manufacturing authorisation to affix a new unique identifier on the medicinal products in question when they are placed on the market (cf. Article 4 of Commission Delegated Regulation (EU) 2016/161). Nevertheless, there are currently no importers holding a manufacturing authorisation located in Cyprus, Ireland, Malta and Northern Ireland with capacity to meet the obligation to affix a new unique identifier as required by Union law as of 1 January 2021 so that compliance would be practically impossible. At the same time, allowing medicinal products without safety features on the Union market must be prevented, in order to ensure a high level of public health protection and to avoid the presence of falsified medicinal products in the Union.

The Commission therefore intends to amend Article 22 of Commission Delegated Regulation (EU) 2016/161 to address this situation.

The economic operators responsible for the export of medicinal products (placed on the market in the Union, exported to Great Britain and then imported into Cyprus, Ireland, Malta or Northern Ireland) from the Union to Great Britain would then no longer be obliged to decommission the unique identifier in accordance with Article 22 of Commission Delegated Regulation (EU) 2016/161.

Following this approach, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow the import of medicinal products from Great Britain bearing non-decommissioned unique identifiers provided that the following conditions are fulfilled:

| — | the wholesale distributor or the marketing authorisation holder established in the Union and responsible for the export of the medicinal product to the United Kingdom has verified the unique identifier against the European repository or the national repository system; |
| --- | --- |

—

the wholesale distributor or the marketing authorisation holder established in the Union and responsible for the export of the medicinal product to the United Kingdom has verified the unique identifier against the European repository or the national repository system;

| — | the wholesale distributor importing the product into Northern Ireland, Ireland, Cyprus or Malta has verified the unique identifier against the European repository or the national repository system; |
| --- | --- |

—

the wholesale distributor importing the product into Northern Ireland, Ireland, Cyprus or Malta has verified the unique identifier against the European repository or the national repository system;

The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards the progress made by wholesale distributors importing medicinal products in fulfilling the obligations under Directive 2001/83 and Commission Delegated Regulation (EU) 2016/161 relating to placement of the unique identifier.

---

(1)  A third country is a country not member of the EU.

(2)  Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 7) (‘Withdrawal Agreement’).

(3)  Subject to certain exceptions provided for in Article 127 of the Withdrawal Agreement, none of which is relevant in the context of this notice.

(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).

(5)  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).

(6)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).

(7)  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).

(8)  https://ec.europa.eu/info/sites/info/files/brexit_files/info_site/clinical-trials_en.pdf

(9)  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en.pdf

(10)  These Member States are singled out in this Notice because of their historical dependence on the UK market for their supply of medicinal products and the fact that a large proportion of their imports of medicinal products is coming from UK.

(11)  According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing (‘batch testing’) in the EU/EEA. These provisions prescribe that in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Union, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.

---

NOTICES CONCERNING THE EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 23.12.2020 | EN | Official Journal of the European Union | C 447/16 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/16

---

EFTA Surveillance Authority’s notice on state aid recovery interest rates and reference/discount rates for the EFTA States applicable as from 1 September 2020

(Published in accordance with the rules on reference and discount rates set out in Part VII of ESA’s State Aid Guidelines and Article 10 of ESA’s Decision No 195/04/COL of 14 July 2004 (1))

(2020/C 447/06)

Base rates are calculated in accordance with the Chapter on the method for setting reference and discount rates of ESA’s State Aid Guidelines as amended by ESA’s Decision No 788/08/COL of 17 December 2008. To obtain the applicable reference rates, appropriate margins shall be added to the base rate in accordance with the State Aid Guidelines.

Base rates have been determined as follows:

| | Iceland | Liechtenstein | Norway |
| --- | --- | --- | --- |
| 1.9.2020 – | 1,80 | - 0,46 | 0,32 |

Iceland

Liechtenstein

Norway

1.9.2020 –

1,80

- 0,46

0,32

---

(1)  OJ L 139, 25.5.2006, p. 37 and EEA Supplement to the OJ No. 26/2006, 25 May 2006, p. 1.

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 23.12.2020 | EN | Official Journal of the European Union | C 447/17 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/17

---

Prior notification of a concentration

(Case M.10034 — Pizarreño/Maderas Arauco/E2E JV)

Candidate case for simplified procedure

(Text with EEA relevance)

(2020/C 447/07)

1.

This notification concerns the following undertakings:

| — | Empresas Pizarreño S.A. (‘Pizarreño’, Chile), controlled by Etex N.V. (Belgium), |
| --- | --- |

—

Empresas Pizarreño S.A. (‘Pizarreño’, Chile), controlled by Etex N.V. (Belgium),

| — | Maderas Arauco S.A. (‘Maderas Arauco’, Chile), controlled by Inversiones Angelini y Compañia Limitada (Chile), |
| --- | --- |

—

Maderas Arauco S.A. (‘Maderas Arauco’, Chile), controlled by Inversiones Angelini y Compañia Limitada (Chile),

| — | E2E S.A. (‘E2E’, Chile), jointly controlled by Empresas Pizarreño and Maderas Arauco. |
| --- | --- |

—

E2E S.A. (‘E2E’, Chile), jointly controlled by Empresas Pizarreño and Maderas Arauco.

Pizarreño and Maderas Arauco extend the product and geographic scope of their pilot joint venture, E2E, by means of a transfer of rights. As a result, E2E becomes an autonomous economic entity within the meaning of Article 3(1)(b) and 3(4) of the Merger Regulation.

2.

| — | for Pizarreño: manufacture, distribution and marketing of finished construction products, using cement and plaster or colpa, |
| --- | --- |

—

for Pizarreño: manufacture, distribution and marketing of finished construction products, using cement and plaster or colpa,

| — | for Maderas Arauco: manufacture and sale of wood and forest products, namely fiberboard panels, plywood and sawn timber, as well as operation of sawmills in Chile, Argentina, Brazil, the United States, Canada and Mexico, |
| --- | --- |

—

for Maderas Arauco: manufacture and sale of wood and forest products, namely fiberboard panels, plywood and sawn timber, as well as operation of sawmills in Chile, Argentina, Brazil, the United States, Canada and Mexico,

| — | for E2E: development, manufacture, assembly, installation of 2D panelized or 3D modular units. |
| --- | --- |

—

for E2E: development, manufacture, assembly, installation of 2D panelized or 3D modular units.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.10034 — Pizarreño/Maderas Arauco/E2E JV

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

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| 23.12.2020 | EN | Official Journal of the European Union | C 447/19 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/19

---

Prior notification of a concentration

(Case M.10073 — Vitol/Drax Generation)

Candidate case for simplified procedure

(Text with EEA relevance)

(2020/C 447/08)

1.

This notification concerns the following undertakings:

| — | Vitol Holding B.V. (‘Vitol’, the Netherlands), belonging to the Vitol group, |
| --- | --- |

—

Vitol Holding B.V. (‘Vitol’, the Netherlands), belonging to the Vitol group,

| — | Drax Generation Enerprise Limited (‘Drax Generation’, the United Kingdom), belonging to Drax Group plc. |
| --- | --- |

—

Drax Generation Enerprise Limited (‘Drax Generation’, the United Kingdom), belonging to Drax Group plc.

Vitol acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of Drax Generation.

The concentration is accomplished by way of purchase of shares.

2.

| — | for Vitol: an energy and commodities trading company which trades and distributes energy products globally, and which generates electricity at one plant in the United Kingdom, |
| --- | --- |

—

for Vitol: an energy and commodities trading company which trades and distributes energy products globally, and which generates electricity at one plant in the United Kingdom,

| — | for Drax Generation: an electricity generation and wholesale supply company that owns and operates four combined cycle gas turbine (CCGT) plants in the United Kingdom. |
| --- | --- |

—

for Drax Generation: an electricity generation and wholesale supply company that owns and operates four combined cycle gas turbine (CCGT) plants in the United Kingdom.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under the Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.10073 — Vitol/Drax Generation

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

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| 23.12.2020 | EN | Official Journal of the European Union | C 447/20 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/20

---

Prior notification of a concentration

(Case M.9686 – Mitsui/ Belchim Crop Protection)

(Text with EEA relevance)

(2020/C 447/09)

1.

This notification concerns the following undertakings:

| — | Mitsui & Co Ltd (‘Mitsui’, Japan), |
| --- | --- |

—

Mitsui & Co Ltd (‘Mitsui’, Japan),

| — | Belchim Crop Protection NV (‘Belchim’, Belgium) |
| --- | --- |

—

Belchim Crop Protection NV (‘Belchim’, Belgium)

Mitsui acquires within the meaning of Article 3(1)(b) of the Merger Regulation control of the whole of Belchim

The concentration is accomplished by way of purchase of shares.

2.

| — | for Mitsui: Mitsui is a Japanese general trading company. Its business covers several industries and products, in particular agricultural and chemical products for crop protection. Mitsui is active in crop protection in the EEA through its subsidiaries Certis, Spiess-Urania and Japan Agro Services. |
| --- | --- |

—

for Mitsui: Mitsui is a Japanese general trading company. Its business covers several industries and products, in particular agricultural and chemical products for crop protection. Mitsui is active in crop protection in the EEA through its subsidiaries Certis, Spiess-Urania and Japan Agro Services.

| — | for Belchim: Belchim is active in the development and commercialisation of agricultural products for crop protection. Belchim is active in the EEA under its own name and those of its subsidiaries Orchem, Nordisk Alkali, Protex and Proagro. |
| --- | --- |

—

for Belchim: Belchim is active in the development and commercialisation of agricultural products for crop protection. Belchim is active in the EEA under its own name and those of its subsidiaries Orchem, Nordisk Alkali, Protex and Proagro.

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved.

4.

Observations must reach the Commission not later than 10 days following the date of this publication. The following reference should always be specified:

M.9686 – Mitsui/ Belchim Crop Protection

Observations can be sent to the Commission by email, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

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OTHER ACTS

European Commission

| 23.12.2020 | EN | Official Journal of the European Union | C 447/21 |
| --- | --- | --- | --- |

23.12.2020

EN

Official Journal of the European Union

C 447/21

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Publication of an application for registration of a name pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs

(2020/C 447/10)

This publication confers the right to oppose the application pursuant to Article 51 of Regulation (EU) No 1151/2012 of the European Parliament and of the Council (1) within three months from the date of this publication.

SINGLE DOCUMENT

‘Budaörsi őszibarack’

EU No: PGI-HU-02417 – 12 April 2018

PDO ( ) PGI (X)

1.   Name(s)

‘Budaörsi őszibarack’

2.   Member State or Third Country

Hungary

3.   Description of the agricultural product or foodstuff

3.1.   Type of product

Class 1.6 Fruit, vegetables and cereals, fresh or processed

3.2.   Description of product to which the name in (1) applies

The name ‘Budaörsi őszibarack’ (Prunus persica (L.) Batsch) may be used for peaches for fresh consumption of the local varieties Schafnose and Budaörsi Vérbélű, as well as the Champion, Cresthaven, Elberta, Mariska, Redhaven, Remény, Royal, Royal Time, Summer, Sunbeam, Suncrest varieties, and all other varieties grown in the geographical area that meet the quality characteristics below.

The fruit of ‘Budaörsi őszibarack’ must have a diameter of at least 60 mm and a weight of at least 110 g. The peaches are characterised by an anthocyanic (red) colour covering more than 20 % of the fruit, total soluble solids exceeding 9,9 % and total acidity of at least 0,38 %.

The specific organoleptic characteristics of ‘Budaörsi őszibarack’ are: intense fragrance, flavoursome taste with a rich aroma and a full sweet flavour with lively citric acidity; and fruit flesh with a juicy consistency.

The flesh of ‘Budaörsi őszibarack’ is ripe to the touch, not too hard, but is still suitable for transport.

The flesh of ‘Budaörsi őszibarack’ may be white or yellow or red.

The varieties of ‘Budaörsi őszibarack’ with white or greenish white to cream-coloured flesh are Champion, Ford, Mariska, Remény, Schafnose and Shipley.

The varieties of ‘Budaörsi őszibarack’ with yellow or yellow to orange-coloured flesh are Cresthaven, Elberta, Redhaven, Royal Time, Sunbeam and Suncrest.

The flesh of the local variety Vérbelű is red.

The fruit may be freestone (the flesh of the fruit detaches easily from the stone) or clingstone (the flesh of the fruit cannot be fully detached from the stone). ‘Budaörsi őszibarack’ has a downy skin.

3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

–

3.4.   Specific steps in production that must take place in the identified geographical area

‘Budaörsi őszibarack’ is grown and harvested exclusively in the geographical area defined in point 4.

3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

–

3.6.   Specific rules concerning labelling of the product the registered name refers to

–

4.   Concise definition of the geographical area

‘Budaörsi őszibarack’ is produced in the south-western areas of Budapest and within the administrative boundaries of the following localities to the south-west of Budapest:

Alcsútdoboz, Baracska, Biatorbágy, Budajenő, Budakeszi, Budaörs, the Budatétény, Kamaraerdő and Nagytétény areas of Budapest, Diósd, Ercsi, Érd, Etyek, Gyermely, Gyúró, Herceghalom, Kajászó, Mány, Martonvásár, Páty, Perbál, Pusztazámor, Ráckeresztúr, Sóskút, Szomor, Telki, Tinnye, Tordas, Tök, Törökbálint, Vál and Zsámbék.

5.   Link with the geographical area

The link between ‘Budaörsi őszibarack’ and the geographical area is based on the quality of the peaches.

The production area of ‘Budaörsi őszibarack’ is located on rolling hills, or on the southern slopes of the Buda Hills in the case of the localities further north. The altitude is between 250 and 500 m.

The soil in the area developed on solid rock containing carbonated lime. The thin topsoil layer above the rock is rich in organic matter (5-10 %, or even more) and in microelements.

The production area of ‘Budaörsi őszibarack’ occupies a moderately warm and moderately dry climatic area. The number of hours of sunshine is high, with 800 hours in the summer period. The average annual temperature is between 9.7 and 10.6 degrees Celsius.

It has a lower annual average temperature than other agricultural regions, and the daytime to night-time fluctuation in temperature is also greater.

Annual precipitation is at least 650 mm, half of which falls in the summer ripening period.

The high number of sunshine hours, the south-facing slopes, night-time cooling and daily temperature fluctuation have a positive effect on the development of the rich aromas and on the colour of ‘Budaörsi őszibarack’ (anthocyanic colour covering more than 20 % of the fruit).

Rich in organic matter and in microelements, the topsoil helps to form secondary metabolites. This produces the richly aromatic flavour (a full sweet taste with lively citric acidity), and the intense fragrance of ‘Budaörsi őszibarack’.

Half of the annual precipitation falls during the summer ripening period, and as a result the peach develops fruit flesh with a juicy consistency.

The peach produced in the defined geographical area owes its unique quality to human cultivation and know-how:

| 1. | The varieties of peach grown in the Budaörs region are the result of a tradition of breeding peaches that dates back to the end of the 19th century. |
| --- | --- |

1.

The varieties of peach grown in the Budaörs region are the result of a tradition of breeding peaches that dates back to the end of the 19th century.

Until the end of the 19th century, peaches were generally grown only for domestic needs as a companion crop in vineyards. In response to the grape crop protection problems (the phylloxera plague) and economic difficulties that emerged at the end of the 19th century, the peach became increasingly important in the area.

Impoverished in the wake of the destruction wrought by the phylloxera plague at the end of the 19th century, vine growers were soon able to plant different varieties of peach saplings in the vineyards, obtained from nearby village tree nurseries. As a result, the peach production area grew and the quality of production improved, reviving the fruit production sector as a whole. In turn, the populace of the German-inhabited villages in the Buda area created a lucrative horticultural business from the plants scattered among the grapevines. Peach growers sold most of their produce in markets close to the capital city.

The shift from self-sufficiency to the production of goods also entailed a change of variety, as growers had to satisfy not only the need for quantity, but also consumer demand for intensely fragrant, aromatic, flavoursome and succulent fruit.

The peach growers of the production area were always keen to introduce new varieties, and were exceptionally successful in selecting and producing varieties from the Budaörs region. Today, they continue to offer a wide range of high-quality peach varieties.

The typical and non-conventional varieties of peach grown in the area are varieties introduced to the region and specially selected for the area by knowledgeable growers and breeders.

| 2. | Know-how continues to play a decisive role in the cultivation of ‘Budaörsi őszibarack’ to this day. The fruits on the trees are thinned by hand during ripening, and the degree of ripeness and the firmness of the flesh are determined by touch. The fruits are harvested by hand in the same way. |
| --- | --- |

2.

Know-how continues to play a decisive role in the cultivation of ‘Budaörsi őszibarack’ to this day. The fruits on the trees are thinned by hand during ripening, and the degree of ripeness and the firmness of the flesh are determined by touch. The fruits are harvested by hand in the same way.

Reference to publication of the specification

(the second subparagraph of Article 6(1) of this Regulation)

http://gi.kormany.hu/foldrajzi-arujelzok

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(1)  OJ L 343, 14.12.2012, p. 1.

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