# Official Journal L 62/2019

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 62 |
| | |
| English edition | Legislation | Volume 621 March 2019 |

ISSN 1977-0677

Official Journal

of the European Union

L 62

English edition

Legislation

Volume 621 March 2019

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2019/343 of 28 February 2019 providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food for the use of certain generic descriptors (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 7 |
| | | DECISIONS |
| | * | Political and Security Committee Decision (CFSP) 2019/345 of 22 February 2019 extending the mandate of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/1/2019) | 10 |
| | * | Council Decision (CFSP) 2019/346 of 28 February 2019 appointing the European Union Special Representative for Human Rights | 12 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 3/JP/2018 of 25 January 2019 of the Joint Committee set up under the Agreement on Mutual Recognition between the European Community and Japan related to the registration of Conformity Assessment Bodies under the Sectoral Annex on Telecommunications Terminal Equipment and Radio Equipment [2019/347] | 16 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2019/343 of 28 February 2019 providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food for the use of certain generic descriptors (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

7

DECISIONS

*

Political and Security Committee Decision (CFSP) 2019/345 of 22 February 2019 extending the mandate of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/1/2019)

10

*

Council Decision (CFSP) 2019/346 of 28 February 2019 appointing the European Union Special Representative for Human Rights

12

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 3/JP/2018 of 25 January 2019 of the Joint Committee set up under the Agreement on Mutual Recognition between the European Community and Japan related to the registration of Conformity Assessment Bodies under the Sectoral Annex on Telecommunications Terminal Equipment and Radio Equipment [2019/347]

16

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

---

(1)   Text with EEA relevance.

1

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

EN

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

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

---

II Non-legislative acts

REGULATIONS

| 1.3.2019 | EN | Official Journal of the European Union | L 62/1 |
| --- | --- | --- | --- |

1.3.2019

EN

Official Journal of the European Union

L 62/1

---

COMMISSION REGULATION (EU) 2019/343

of 28 February 2019

providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food for the use of certain generic descriptors

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 1(4) thereof,

Whereas:

| (1) | Pursuant to Regulation (EC) No 1924/2006, any claim made on food which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health is to be considered as a health claim and therefore must comply with that Regulation. |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 1924/2006, any claim made on food which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health is to be considered as a health claim and therefore must comply with that Regulation.

| (2) | Article 1(4) of Regulation (EC) No 1924/2006 provides for a possible derogation from the rules applicable pursuant to Article 1(3) of that Regulation for generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health. |
| --- | --- |

(2)

Article 1(4) of Regulation (EC) No 1924/2006 provides for a possible derogation from the rules applicable pursuant to Article 1(3) of that Regulation for generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on human health.

| (3) | Applications for a term to be used as generic descriptor may be submitted by food business operators to the national competent authority of a recipient Member State. |
| --- | --- |

(3)

Applications for a term to be used as generic descriptor may be submitted by food business operators to the national competent authority of a recipient Member State.

| (4) | Pursuant to Commission Regulation (EU) No 907/2013 (2) setting the rules for applications concerning the use of generic descriptors (denominations), a valid application should be transmitted to the Commission and to all Member States; Member States concerned by the application shall provide the Commission with their opinions thereon. |
| --- | --- |

(4)

Pursuant to Commission Regulation (EU) No 907/2013 (2) setting the rules for applications concerning the use of generic descriptors (denominations), a valid application should be transmitted to the Commission and to all Member States; Member States concerned by the application shall provide the Commission with their opinions thereon.

| (5) | Following receipt of a valid application and the opinions of Member States concerned the Commission may initiate the procedure of approval of the generic descriptor pursuant to Article 1(4) of Regulation (EC) No 1924/2006. |
| --- | --- |

(5)

Following receipt of a valid application and the opinions of Member States concerned the Commission may initiate the procedure of approval of the generic descriptor pursuant to Article 1(4) of Regulation (EC) No 1924/2006.

| (6) | On 13 April 2015, the Austrian competent authority provided the Commission with an application from the Austrian Food Industries' Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Hustenbonbon’ and ‘Hustenstopper’ to be used as generic descriptors in Austria. |
| --- | --- |

(6)

On 13 April 2015, the Austrian competent authority provided the Commission with an application from the Austrian Food Industries' Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Hustenbonbon’ and ‘Hustenstopper’ to be used as generic descriptors in Austria.

| (7) | On 13 April 2015, the Austrian competent authority provided the Commission with an application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenzuckerl’ to be used as generic descriptor in Austria. |
| --- | --- |

(7)

On 13 April 2015, the Austrian competent authority provided the Commission with an application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenzuckerl’ to be used as generic descriptor in Austria.

| (8) | On 19 May 2015, the German competent authority provided the Commission with an application from the Association of the German Confectionary Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Brust-Caramellen’ to be used as generic descriptors in Germany and in Austria. |
| --- | --- |

(8)

On 19 May 2015, the German competent authority provided the Commission with an application from the Association of the German Confectionary Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Brust-Caramellen’ to be used as generic descriptors in Germany and in Austria.

| (9) | On 29 May 2015, the German competent authority provided the Commission with an application from SOLDAN Holding + Bonbonspezialitäten GmbH and from the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenmischung’ to be used as generic descriptor in Germany. |
| --- | --- |

(9)

On 29 May 2015, the German competent authority provided the Commission with an application from SOLDAN Holding + Bonbonspezialitäten GmbH and from the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenmischung’ to be used as generic descriptor in Germany.

| (10) | On 8 June 2015, the German competent authority provided the Commission with an application from SOLDAN Holding + Bonbonspezialitäten GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenperle’ to be used as generic descriptor in Germany. |
| --- | --- |

(10)

On 8 June 2015, the German competent authority provided the Commission with an application from SOLDAN Holding + Bonbonspezialitäten GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustenperle’ to be used as generic descriptor in Germany.

| (11) | On 18 June 2015, the German competent authority provided the Commission with two applications from SOLDAN Holding + Bonbonspezialitäten GmbH and the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Halsbonbon’ and ‘keelpastille’ to be used as generic descriptors in Germany (‘Halsbonbon’) and in the Netherlands (‘keelpastille’). |
| --- | --- |

(11)

On 18 June 2015, the German competent authority provided the Commission with two applications from SOLDAN Holding + Bonbonspezialitäten GmbH and the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Halsbonbon’ and ‘keelpastille’ to be used as generic descriptors in Germany (‘Halsbonbon’) and in the Netherlands (‘keelpastille’).

| (12) | On 18 November 2015, the German competent authority provided the Commission with three applications from SOLDAN Holding + Bonbonspezialitäten GmbH, Josef Mack GmbH & Co. KG and the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Hustenbonbon’, ‘hoestbonbon’, ‘rebucados para a tosse’, and ‘cough drops’, to be used as generic descriptors in Germany and in Austria (‘Hustenbonbon’), in the Netherlands (‘hoestbonbon’), in Portugal (‘rebucados para a tosse’) and in the United Kingdom (‘cough drops’). |
| --- | --- |

(12)

On 18 November 2015, the German competent authority provided the Commission with three applications from SOLDAN Holding + Bonbonspezialitäten GmbH, Josef Mack GmbH & Co. KG and the Association of the German Confectionery Industry, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the terms ‘Hustenbonbon’, ‘hoestbonbon’, ‘rebucados para a tosse’, and ‘cough drops’, to be used as generic descriptors in Germany and in Austria (‘Hustenbonbon’), in the Netherlands (‘hoestbonbon’), in Portugal (‘rebucados para a tosse’) and in the United Kingdom (‘cough drops’).

| (13) | The Austrian and German competent authorities provided all other Member States with the applications. The competent authorities of Member States concerned provided the Commission with their opinions on the applications. |
| --- | --- |

(13)

The Austrian and German competent authorities provided all other Member States with the applications. The competent authorities of Member States concerned provided the Commission with their opinions on the applications.

| (14) | The terms ‘Hustenbonbon’, ‘Hustenstopper’, ‘Hustenzuckerl’, ‘Brust-Caramellen’, ‘Hustenmischung’, ‘Hustenperle’‘Halsbonbon’, ‘keelpastille’, ‘hoestbonbon’, ‘rebuçados para a tosse’, and ‘cough drops’ fall into the scope of Regulation (EC) No 1924/2006, because they can imply a relationship between the foods bearing these terms and health. |
| --- | --- |

(14)

The terms ‘Hustenbonbon’, ‘Hustenstopper’, ‘Hustenzuckerl’, ‘Brust-Caramellen’, ‘Hustenmischung’, ‘Hustenperle’‘Halsbonbon’, ‘keelpastille’, ‘hoestbonbon’, ‘rebuçados para a tosse’, and ‘cough drops’ fall into the scope of Regulation (EC) No 1924/2006, because they can imply a relationship between the foods bearing these terms and health.

| (15) | However, evidence has been provided that these terms have been traditionally used in Germany and in Austria (‘Hustenbonbon’, ‘Brust-Caramellen’), in Germany (‘Halsbonbon’, ‘Hustenmischung’ and ‘Hustenperle’), in Austria (‘Hustenstopper’ and ‘Hustenzuckerl’), in the Netherlands (‘keelpastille’, and ‘hoestbonbon’), in Portugal (‘rebuçados para a tosse’) and in the United Kingdom (‘cough drops’) in the meaning of Article 1(4) of this Regulation, as generic descriptors to describe a class of sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, such as menthol, honey or malt. |
| --- | --- |

(15)

However, evidence has been provided that these terms have been traditionally used in Germany and in Austria (‘Hustenbonbon’, ‘Brust-Caramellen’), in Germany (‘Halsbonbon’, ‘Hustenmischung’ and ‘Hustenperle’), in Austria (‘Hustenstopper’ and ‘Hustenzuckerl’), in the Netherlands (‘keelpastille’, and ‘hoestbonbon’), in Portugal (‘rebuçados para a tosse’) and in the United Kingdom (‘cough drops’) in the meaning of Article 1(4) of this Regulation, as generic descriptors to describe a class of sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, such as menthol, honey or malt.

| (16) | In particular, the terms ‘Hustenbonbon’, ‘Brust-Caramellen’, ‘Halsbonbon’, ‘Hustenmischung’, ‘Hustenperle’, ‘Hustenstopper’, ‘Hustenzuckerl’, ‘keelpastille’, ‘hoestbonbon’, ‘rebuçados para a tosse’ and ‘cough drops’ have neither been used in Germany, in Austria, in the Netherlands, in Portugal and in the United Kingdom respectively, with the aim to indicate a health effect of this class of food nor are understood by an average consumer as claiming a health effect of this class of food. |
| --- | --- |

(16)

In particular, the terms ‘Hustenbonbon’, ‘Brust-Caramellen’, ‘Halsbonbon’, ‘Hustenmischung’, ‘Hustenperle’, ‘Hustenstopper’, ‘Hustenzuckerl’, ‘keelpastille’, ‘hoestbonbon’, ‘rebuçados para a tosse’ and ‘cough drops’ have neither been used in Germany, in Austria, in the Netherlands, in Portugal and in the United Kingdom respectively, with the aim to indicate a health effect of this class of food nor are understood by an average consumer as claiming a health effect of this class of food.

| (17) | Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptors ‘Hustenbonbon’ and ‘Brust-Caramellen’ in Germany and in Austria, ‘Halsbonbon’, ‘Hustenmischung’ and ‘Hustenperle’ in Germany, ‘Hustenstopper’ and ‘Hustenzuckerl’ in Austria, ‘keelpastille’ and ‘hoestbonbon’ in the Netherlands, ‘rebuçados para a tosse’ in Portugal and ‘cough drops’ in the United Kingdom when used in the respective Member State on sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, honey or malt. |
| --- | --- |

(17)

Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptors ‘Hustenbonbon’ and ‘Brust-Caramellen’ in Germany and in Austria, ‘Halsbonbon’, ‘Hustenmischung’ and ‘Hustenperle’ in Germany, ‘Hustenstopper’ and ‘Hustenzuckerl’ in Austria, ‘keelpastille’ and ‘hoestbonbon’ in the Netherlands, ‘rebuçados para a tosse’ in Portugal and ‘cough drops’ in the United Kingdom when used in the respective Member State on sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, honey or malt.

| (18) | On 12 January 2017, the Finnish competent authority provided the Commission with an application from the Finnish Food Industries' Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘kurkkupastilli/halspastill’ to be used as generic descriptor in Finland. |
| --- | --- |

(18)

On 12 January 2017, the Finnish competent authority provided the Commission with an application from the Finnish Food Industries' Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘kurkkupastilli/halspastill’ to be used as generic descriptor in Finland.

| (19) | The Finnish competent authority provided all other Member States with the application; it also provided the Commission with its opinion on the application. |
| --- | --- |

(19)

The Finnish competent authority provided all other Member States with the application; it also provided the Commission with its opinion on the application.

| (20) | The term ‘kurkkupastilli/halspastill’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between foods bearing this term and health. However, evidence has been provided that this term has been used traditionally in Finland, in the meaning of Article 1(4) of this Regulation, as generic descriptor to describe a class of sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners). |
| --- | --- |

(20)

The term ‘kurkkupastilli/halspastill’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between foods bearing this term and health. However, evidence has been provided that this term has been used traditionally in Finland, in the meaning of Article 1(4) of this Regulation, as generic descriptor to describe a class of sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners).

| (21) | In particular, the term ‘kurkkupastilli/halspastill’ has neither been used in Finland with the aim to indicate a health effect of this class of food nor is understood by an average consumer as claiming a health effect of this class of food. |
| --- | --- |

(21)

In particular, the term ‘kurkkupastilli/halspastill’ has neither been used in Finland with the aim to indicate a health effect of this class of food nor is understood by an average consumer as claiming a health effect of this class of food.

| (22) | Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘kurkkupastilli/halspastill’ when used in Finland on hard sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners). |
| --- | --- |

(22)

Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘kurkkupastilli/halspastill’ when used in Finland on hard sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners).

| (23) | On 13 April 2015, the Austrian competent authority provided the Commission with an application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustensirup’ to be used as generic descriptor in Austria. |
| --- | --- |

(23)

On 13 April 2015, the Austrian competent authority provided the Commission with an application from Drapal GmbH, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘Hustensirup’ to be used as generic descriptor in Austria.

| (24) | The Austrian competent authority provided all other Member States with the application; it also provided the Commission with its opinion on the application. |
| --- | --- |

(24)

The Austrian competent authority provided all other Member States with the application; it also provided the Commission with its opinion on the application.

| (25) | The term ‘Hustensirup’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between foods bearing this term and health. However, evidence has been provided that this term has been used traditionally in Austria, in the meaning of Article 1(4) of this Regulation, as generic descriptor to describe a class of confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients, ‘Hustensirup’ referring to a class of products in the form of a syrup. |
| --- | --- |

(25)

The term ‘Hustensirup’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between foods bearing this term and health. However, evidence has been provided that this term has been used traditionally in Austria, in the meaning of Article 1(4) of this Regulation, as generic descriptor to describe a class of confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients, ‘Hustensirup’ referring to a class of products in the form of a syrup.

| (26) | In particular, the term ‘Hustensirup’ has neither been used with the aim to indicate a health effect of this class of food nor is understood by an average consumer as claiming a health effect of this class of food in Austria. |
| --- | --- |

(26)

In particular, the term ‘Hustensirup’ has neither been used with the aim to indicate a health effect of this class of food nor is understood by an average consumer as claiming a health effect of this class of food in Austria.

| (27) | Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘Hustensirup’ when used in Austria on confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients in the form of syrup. |
| --- | --- |

(27)

Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘Hustensirup’ when used in Austria on confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients in the form of syrup.

| (28) | Definitions for sugars intended for human consumption have been laid down in point A of the Annex to Council Directive 2001/111/EC (3). In order to ensure legal certainty, those definitions should also apply for the purpose of this Regulation. |
| --- | --- |

(28)

Definitions for sugars intended for human consumption have been laid down in point A of the Annex to Council Directive 2001/111/EC (3). In order to ensure legal certainty, those definitions should also apply for the purpose of this Regulation.

| (29) | On 2 April 2015, the UK competent authority provided the Commission with an application from the British Soft Drinks Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘tonic’ (in English) used as part of the descriptive name of a beverage in the form of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ and substituted in the same descriptive names with ‘tonique’ (in French), ‘tónico’ or ‘tonica’ (in Italian, Spanish, and Portuguese), ‘τονωτικό’ or ‘tonotiko’ (in Greek), ‘tonik’ (in Croatian, Czech, Hungarian, Polish, Slovak and Slovenian), ‘тоник’ (in Bulgarian), to be used as generic descriptor in all Member States except in Romania. |
| --- | --- |

(29)

On 2 April 2015, the UK competent authority provided the Commission with an application from the British Soft Drinks Association, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘tonic’ (in English) used as part of the descriptive name of a beverage in the form of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ and substituted in the same descriptive names with ‘tonique’ (in French), ‘tónico’ or ‘tonica’ (in Italian, Spanish, and Portuguese), ‘τονωτικό’ or ‘tonotiko’ (in Greek), ‘tonik’ (in Croatian, Czech, Hungarian, Polish, Slovak and Slovenian), ‘тоник’ (in Bulgarian), to be used as generic descriptor in all Member States except in Romania.

| (30) | On 30 September 2015, the Romanian competent authority provided the Commission with an application from the Romanian Soft Drinks Association, submitted pursuant Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘tonic’ (in English) used as part of the descriptive name of a beverage in the form of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ and substituted in the same descriptive names with ‘tónico’, ‘tonică’ or ‘tonica’ (in Romanian), to be used as generic descriptor in Romania. |
| --- | --- |

(30)

On 30 September 2015, the Romanian competent authority provided the Commission with an application from the Romanian Soft Drinks Association, submitted pursuant Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘tonic’ (in English) used as part of the descriptive name of a beverage in the form of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ and substituted in the same descriptive names with ‘tónico’, ‘tonică’ or ‘tonica’ (in Romanian), to be used as generic descriptor in Romania.

| (31) | The UK competent authority and the Romanian competent authority provided all other Member States with the applications; Member States have provided the Commission with their opinions on these applications. |
| --- | --- |

(31)

The UK competent authority and the Romanian competent authority provided all other Member States with the applications; Member States have provided the Commission with their opinions on these applications.

| (32) | The Greek competent authority considers that the term ‘τονωτικό’ and ‘tonotiko’ (‘τονωτικό’ with Latin characters) are considered as health claims within the meaning of Regulation (EC) No 1924/2006. The Greek competent authority further considers that for non-alcoholic beverages containing quinine, the term ‘tonic’ used as part of the customary name of the food is traditionally widely used in Greece. |
| --- | --- |

(32)

The Greek competent authority considers that the term ‘τονωτικό’ and ‘tonotiko’ (‘τονωτικό’ with Latin characters) are considered as health claims within the meaning of Regulation (EC) No 1924/2006. The Greek competent authority further considers that for non-alcoholic beverages containing quinine, the term ‘tonic’ used as part of the customary name of the food is traditionally widely used in Greece.

| (33) | The German competent authority and the Austrian competent authority consider that the term ‘tonic’ used as part of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ is part of a customary name of the beverage and as such out of the scope of Regulation (EC) No 1924/2006. |
| --- | --- |

(33)

The German competent authority and the Austrian competent authority consider that the term ‘tonic’ used as part of ‘tonic water’, ‘Indian tonic water’ or ‘quinine tonic water’ is part of a customary name of the beverage and as such out of the scope of Regulation (EC) No 1924/2006.

| (34) | The French competent authority considers that the term ‘tonique’ is not used to describe a non-alcoholic carbonated beverage containing the bittering agent quinine. |
| --- | --- |

(34)

The French competent authority considers that the term ‘tonique’ is not used to describe a non-alcoholic carbonated beverage containing the bittering agent quinine.

| (35) | Certain competent authorities consider that when the term ‘tonic’ (in English) is substituted by ‘tonik’ in Croatian, Hungarian, Polish and Slovenian, it is not considered as a health claim in those respective Member States within the meaning of Regulation (EC) No 1924/2006; therefore in their views these terms are out of the scope of the Regulation. |
| --- | --- |

(35)

Certain competent authorities consider that when the term ‘tonic’ (in English) is substituted by ‘tonik’ in Croatian, Hungarian, Polish and Slovenian, it is not considered as a health claim in those respective Member States within the meaning of Regulation (EC) No 1924/2006; therefore in their views these terms are out of the scope of the Regulation.

| (36) | The term ‘tonic’ and the equivalent linguistic forms, namely, ‘tonik’, ‘tónico’, ‘tónica’ and ‘tonică’, when they are used as part of the descriptive name of a beverage, fall into the scope of Regulation (EC) No 1924/2006, because they can imply a relationship between a food bearing this term and health. However, evidence has been provided that these terms have been used traditionally, in the meaning of Article 1(4) of this Regulation, as generic descriptors to describe a class of beverages, namely, a non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings laid down in Regulation (EC) No 1334/2008 of the European Parliament and of the Council (4) on flavourings and certain food ingredients with flavouring properties for use in and on foods. |
| --- | --- |

(36)

The term ‘tonic’ and the equivalent linguistic forms, namely, ‘tonik’, ‘tónico’, ‘tónica’ and ‘tonică’, when they are used as part of the descriptive name of a beverage, fall into the scope of Regulation (EC) No 1924/2006, because they can imply a relationship between a food bearing this term and health. However, evidence has been provided that these terms have been used traditionally, in the meaning of Article 1(4) of this Regulation, as generic descriptors to describe a class of beverages, namely, a non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings laid down in Regulation (EC) No 1334/2008 of the European Parliament and of the Council (4) on flavourings and certain food ingredients with flavouring properties for use in and on foods.

| (37) | In particular, the terms ‘tonic’ and the equivalent linguistic forms, namely, ‘tonik’, ‘tónico’, ‘tónica’ and ‘tonică’, when they are used as part of the descriptive name of a beverage, have neither been used with the aim to indicate a health effect of this class of beverages nor are understood by an average consumer as claiming a health effect of this class of beverages. |
| --- | --- |

(37)

In particular, the terms ‘tonic’ and the equivalent linguistic forms, namely, ‘tonik’, ‘tónico’, ‘tónica’ and ‘tonică’, when they are used as part of the descriptive name of a beverage, have neither been used with the aim to indicate a health effect of this class of beverages nor are understood by an average consumer as claiming a health effect of this class of beverages.

| (38) | Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘tonic’ (in English), when used as part of the descriptive name of a non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings as laid down in Regulation (EC) No 1334/2008. The term ‘tonic’ (in English) may be substituted in the descriptive name by ‘тоник’ (in Bulgarian), ‘tonik’ (in Czech and in Slovak), ‘tónica’ (in Spanish and in Portuguese) ‘tonica’ (in Italian), or ‘tonică’ (in Romanian). |
| --- | --- |

(38)

Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘tonic’ (in English), when used as part of the descriptive name of a non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings as laid down in Regulation (EC) No 1334/2008. The term ‘tonic’ (in English) may be substituted in the descriptive name by ‘тоник’ (in Bulgarian), ‘tonik’ (in Czech and in Slovak), ‘tónica’ (in Spanish and in Portuguese) ‘tonica’ (in Italian), or ‘tonică’ (in Romanian).

| (39) | On 23 April 2015, the Italian competent authority provided the Commission with an application from Monviso SpA, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘biscotto salute’ to be used as generic descriptor in Italy and in Malta. |
| --- | --- |

(39)

On 23 April 2015, the Italian competent authority provided the Commission with an application from Monviso SpA, submitted pursuant to Article 1(4) of Regulation (EC) No 1924/2006, for the term ‘biscotto salute’ to be used as generic descriptor in Italy and in Malta.

| (40) | The Italian competent authority provided all other Member States with the application; the Member States concerned have provided the Commission with their opinions on the application. |
| --- | --- |

(40)

The Italian competent authority provided all other Member States with the application; the Member States concerned have provided the Commission with their opinions on the application.

| (41) | The term ‘biscotto salute’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between a food bearing this term and health. However, evidence has been provided that this term has been used traditionally in Italy, in the meaning of Article 1(4) of this Regulation, as a generic descriptor to describe a class of rusk-type bakery products. |
| --- | --- |

(41)

The term ‘biscotto salute’ falls into the scope of Regulation (EC) No 1924/2006, because it can imply a relationship between a food bearing this term and health. However, evidence has been provided that this term has been used traditionally in Italy, in the meaning of Article 1(4) of this Regulation, as a generic descriptor to describe a class of rusk-type bakery products.

| (42) | In particular, the term ‘biscotto salute’ has neither been used with the aim to indicate a health effect of this class of foods nor is understood by an average consumer as claiming the health effect of this class of food in Italy. |
| --- | --- |

(42)

In particular, the term ‘biscotto salute’ has neither been used with the aim to indicate a health effect of this class of foods nor is understood by an average consumer as claiming the health effect of this class of food in Italy.

| (43) | Malta indicated that the term ‘biscotto salute’ was not used to describe rusk-type bakery products on the Maltese market. |
| --- | --- |

(43)

Malta indicated that the term ‘biscotto salute’ was not used to describe rusk-type bakery products on the Maltese market.

| (44) | Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘biscotto salute’ when used in Italy on rusk-type bakery products. |
| --- | --- |

(44)

Derogation from Regulation (EC) No 1924/2006 should therefore be granted for the use of the generic descriptor ‘biscotto salute’ when used in Italy on rusk-type bakery products.

| (45) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(45)

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

HAS ADOPTED THIS REGULATION:

Article 1

The generic descriptors listed in the Annex to this Regulation are exempted from the application of Article 1(3) of Regulation (EC) No 1924/2006 under the conditions laid down in that Annex.

Article 2

For the purposes of this Regulation, the definitions for sugars intended for human consumption laid down in point A of the Annex to Council Directive 2001/111/EC shall apply.

Article 3

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 February 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Regulation (EU) No 907/2013 of 20 September 2013 setting up the rules for applications concerning the use of generic descriptors (denominations) (OJ L 251, 21.9.2013, p. 7).

2

(3)  Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption (OJ L 10, 12.1.2002, p. 53).

3

(4)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

4

---

ANNEX

| Class of food | Generic descriptor | Member States where the exemption is valid |
| --- | --- | --- |
| Hard and soft sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, honey or malt | Brust-Caramellen Hustenbonbon | Germany, Austria |
| Halsbonbon,
  Hustenmischung,
  Hustenperle | Germany |
| Hustenstopper,
  Hustenzuckerl | Austria |
| Cough drops | United Kingdom |
| Hoestbonbon,
  Keelpastille | Netherlands |
| Rebuçados para a tosse | Portugal |
| Hard sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) | Kurkkupastilli/ Halspastill | Finland |
| Confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients in the form of a syrup | Hustensirup | Austria |
| Non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings as laid down in Annex I to Regulation (EC) No 1334/2008 | The following terms, used as part of the descriptive name of the beverage: | ‘tonic’ (in English), substituted by ‘Tоник’ (in Bulgarian), |

Class of food

Generic descriptor

Member States where the exemption is valid

Hard and soft sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners) containing extracts of herbs, fruit or other plant substances, honey or malt

Brust-Caramellen Hustenbonbon

Germany, Austria

Halsbonbon,

Hustenmischung,

Hustenperle

Germany

Hustenstopper,

Hustenzuckerl

Austria

Cough drops

United Kingdom

Hoestbonbon,

Keelpastille

Netherlands

Rebuçados para a tosse

Portugal

Hard sweets based on sugars as well as sugar-free and calorie-reduced variants based on sweeteners (polyols and/or intense sweeteners)

Kurkkupastilli/ Halspastill

Finland

Confectionery products made of solutions of sugar, starch syrup, inverted sugar and/or honey with the addition of herbal ingredients in the form of a syrup

Hustensirup

Austria

Non-alcoholic carbonated beverage containing the bittering agent quinine in the form of the flavourings FL 14.011, FL 14.152 or FL 14.155 as referred to in the Union list of flavourings as laid down in Annex I to Regulation (EC) No 1334/2008

The following terms, used as part of the descriptive name of the beverage:

‘tonic’ (in English), substituted by ‘Tоник’ (in Bulgarian),

| | ‘tonik’ (in Czech and in Slovak), |
| --- | --- |

‘tonik’ (in Czech and in Slovak),

| | ‘tónica’ (in Spanish and in Portuguese), |
| --- | --- |

‘tónica’ (in Spanish and in Portuguese),

| | ‘tonica’ (in Italian), |
| --- | --- |

‘tonica’ (in Italian),

| | ‘tonică’ (in Romanian) |
| --- | --- |

‘tonică’ (in Romanian)

All Member States

Rusk-type bakery products

Biscotto salute

Italy

---

| 1.3.2019 | EN | Official Journal of the European Union | L 62/7 |
| --- | --- | --- | --- |

1.3.2019

EN

Official Journal of the European Union

L 62/7

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/344

of 28 February 2019

concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,

Whereas:

| (1) | Commission Directive 2007/52/EC (2) included ethoprophos as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2007/52/EC (2) included ethoprophos as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance ethoprophos, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019. |
| --- | --- |

(3)

The approval of the active substance ethoprophos, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

| (4) | An application for the renewal of the approval of ethoprophos was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of ethoprophos was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 15 February 2017. |
| --- | --- |

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 15 February 2017.

| (7) | The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public. |
| --- | --- |

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

| (8) | On 18 May 2018 the Authority communicated to the Commission its conclusion (6) on whether ethoprophos can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(8)

On 18 May 2018 the Authority communicated to the Commission its conclusion (6) on whether ethoprophos can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (9) | The Authority identified specific concerns. In particular, it was not possible to conclude on the genotoxic potential of ethoprophos and therefore health-based reference values could not be established. Consequently, the consumer and non-dietary risk assessments could not be conducted. Furthermore, a high acute risk to birds and a high risk to soil dwelling non-target arthropods and soil organisms from the use of ethoprophos were identified. In addition, the Authority concluded that several areas of the risk assessment could not be finalised including the consumer assessment with respect to residues in food of plant and animal origin, the assessment of developmental neurotoxicity, the groundwater exposure assessment, the long-term risk to birds, the assessment of secondary poisoning for birds and mammals, the risk to soil organisms from exposure to metabolites of ethoprophos and the risk to earthworms. Finally, the Authority concluded that assessment of the endocrine disrupting potential of ethoprophos could not be concluded. |
| --- | --- |

(9)

The Authority identified specific concerns. In particular, it was not possible to conclude on the genotoxic potential of ethoprophos and therefore health-based reference values could not be established. Consequently, the consumer and non-dietary risk assessments could not be conducted. Furthermore, a high acute risk to birds and a high risk to soil dwelling non-target arthropods and soil organisms from the use of ethoprophos were identified. In addition, the Authority concluded that several areas of the risk assessment could not be finalised including the consumer assessment with respect to residues in food of plant and animal origin, the assessment of developmental neurotoxicity, the groundwater exposure assessment, the long-term risk to birds, the assessment of secondary poisoning for birds and mammals, the risk to soil organisms from exposure to metabolites of ethoprophos and the risk to earthworms. Finally, the Authority concluded that assessment of the endocrine disrupting potential of ethoprophos could not be concluded.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

| (11) | However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated. |
| --- | --- |

(11)

However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

| (12) | Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing ethoprophos that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance ethoprophos in accordance with Article 20(1)(b) of that Regulation. |
| --- | --- |

(12)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing ethoprophos that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance ethoprophos in accordance with Article 20(1)(b) of that Regulation.

| (13) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(13)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (14) | Member States should be given sufficient time to withdraw authorisations for plant protection products containing ethoprophos. |
| --- | --- |

(14)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing ethoprophos.

| (15) | For plant protection products containing ethoprophos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 21 March 2020. |
| --- | --- |

(15)

For plant protection products containing ethoprophos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 21 March 2020.

| (16) | Commission Implementing Regulation (EU) 2018/917 (7) extended the approval period of ethoprophos to 31 July 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of that extended expiry date, this Regulation should apply as soon as possible. |
| --- | --- |

(16)

Commission Implementing Regulation (EU) 2018/917 (7) extended the approval period of ethoprophos to 31 July 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

| (17) | This Regulation does not prevent the submission of a further application for the approval of ethoprophos pursuant to Article 7 of Regulation (EC) No 1107/2009. |
| --- | --- |

(17)

This Regulation does not prevent the submission of a further application for the approval of ethoprophos pursuant to Article 7 of Regulation (EC) No 1107/2009.

| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(18)

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

HAS ADOPTED THIS REGULATION:

Article 1

Non-renewal of approval of active substance

The approval of the active substance ethoprophos is not renewed.

Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 155, on ethoprophos, is deleted.

Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing ethoprophos as active substance by 21 September 2019 at the latest.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 21 March 2020 at the latest.

Article 5

Entry into force

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

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 February 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (OJ L 214, 17.8.2007, p. 3).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance ethoprophos. EFSA Journal 2018;16(10):5290, 34 pp. doi:10.2903/j.efsa.2018.5290. Available online: www.efsa.europa.eu

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ L 163, 28.6.2018, p. 13).

7

---

DECISIONS

| 1.3.2019 | EN | Official Journal of the European Union | L 62/10 |
| --- | --- | --- | --- |

1.3.2019

EN

Official Journal of the European Union

L 62/10

---

POLITICAL AND SECURITY COMMITTEE DECISION (CFSP) 2019/345

of 22 February 2019

extending the mandate of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/1/2019)

THE POLITICAL AND SECURITY COMMITTEE,

Having regard to the Treaty on European Union, and in particular the third paragraph of Article 38 thereof,

Having regard to Council Decision 2014/219/CFSP of 15 April 2014 on the European Union CSDP mission in Mali (EUCAP Sahel Mali) (1), and in particular Article 7(1) thereof,

Whereas:

| (1) | Pursuant to Decision 2014/219/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of the EUCAP Sahel Mali mission, including the decision to appoint a Head of Mission. |
| --- | --- |

(1)

Pursuant to Decision 2014/219/CFSP, the Political and Security Committee (PSC) is authorised, in accordance with Article 38 of the Treaty, to take the relevant decisions for the purpose of exercising political control and strategic direction of the EUCAP Sahel Mali mission, including the decision to appoint a Head of Mission.

| (2) | On 18 September 2017, the PSC adopted Decision (CFSP) 2017/1780 (2), appointing Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 1 October 2017 to 14 January 2018. |
| --- | --- |

(2)

On 18 September 2017, the PSC adopted Decision (CFSP) 2017/1780 (2), appointing Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 1 October 2017 to 14 January 2018.

| (3) | On 9 January 2018, the PSC adopted Decision (CFSP) 2018/57 (3), extending the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 15 January 2018 to 14 January 2019. |
| --- | --- |

(3)

On 9 January 2018, the PSC adopted Decision (CFSP) 2018/57 (3), extending the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 15 January 2018 to 14 January 2019.

| (4) | On 17 December 2018, the Council adopted Decision (CFSP) 2018/2008 (4), extending the mandate of EUCAP Sahel Mali until 28 February 2019. |
| --- | --- |

(4)

On 17 December 2018, the Council adopted Decision (CFSP) 2018/2008 (4), extending the mandate of EUCAP Sahel Mali until 28 February 2019.

| (5) | On 18 December 2018, the PSC adopted Decision (CFSP) 2018/2063 (5), extending the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 15 January 2019 to 28 February 2019. |
| --- | --- |

(5)

On 18 December 2018, the PSC adopted Decision (CFSP) 2018/2063 (5), extending the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 15 January 2019 to 28 February 2019.

| (6) | On 21 February 2019, the Council adopted Decision (CFSP) 2019/312 (6), extending the mandate of EUCAP Sahel Mali until 14 January 2021. |
| --- | --- |

(6)

On 21 February 2019, the Council adopted Decision (CFSP) 2019/312 (6), extending the mandate of EUCAP Sahel Mali until 14 January 2021.

| (7) | The High Representative of the Union for Foreign Affairs and Security Policy has proposed to extend the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 1 March 2019 to 30 September 2020, |
| --- | --- |

(7)

The High Representative of the Union for Foreign Affairs and Security Policy has proposed to extend the mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali from 1 March 2019 to 30 September 2020,

HAS ADOPTED THIS DECISION:

Article 1

The mandate of Mr Philippe RIO as Head of Mission of EUCAP Sahel Mali is hereby extended until 30 September 2020.

Article 2

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

It shall apply from 1 March 2019.

Done at Brussels, 22 February 2019.

For the Political and Security Committee

The Chairperson

S. FROM-EMMESBERGER

---

(1)  
  OJ L 113, 16.4.2014, p. 21.

1

(2)  Political and Security Committee Decision (CFSP) 2017/1780 of 18 September 2017 on the appointment of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/1/2017) (OJ L 253, 30.9.2017, p. 37).

2

(3)  Political and Security Committee Decision (CFSP) 2018/57 of 9 January 2018 extending the mandate of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/1/2018) (OJ L 10, 13.1.2018, p. 14).

3

(4)  Council Decision (CFSP) 2018/2008 of 17 December 2018 amending and extending Decision 2014/219/CFSP on the European Union CSDP Mission in Mali (EUCAP Sahel Mali) (OJ L 322, 18.12.2018, p. 24).

4

(5)  Political and Security Committee Decision (CFSP) 2018/2063 of 18 December 2018 extending the mandate of the Head of Mission of the European Union CSDP mission in Mali (EUCAP Sahel Mali) (EUCAP Sahel Mali/2/2018) (OJ L 329, 27.12.2018, p. 26).

5

(6)  Council Decision (CFSP) 2019/312 of 21 February 2019 amending and extending Decision 2014/219/CFSP on the European Union CSDP Mission in Mali (EUCAP Sahel Mali) (OJ L 51, 22.2.2019, p. 29).

6

---

| 1.3.2019 | EN | Official Journal of the European Union | L 62/12 |
| --- | --- | --- | --- |

1.3.2019

EN

Official Journal of the European Union

L 62/12

---

COUNCIL DECISION (CFSP) 2019/346

of 28 February 2019

appointing the European Union Special Representative for Human Rights

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 33 and Article 31(2) thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

| (1) | On 25 July 2012, the Council adopted Decision 2012/440/CFSP (1) appointing Mr Stavros LAMBRINIDIS as the European Union Special Representative (EUSR) for Human Rights. The EUSR's mandate is to expire on 28 February 2019. |
| --- | --- |

(1)

On 25 July 2012, the Council adopted Decision 2012/440/CFSP (1) appointing Mr Stavros LAMBRINIDIS as the European Union Special Representative (EUSR) for Human Rights. The EUSR's mandate is to expire on 28 February 2019.

| (2) | A new EUSR for Human Rights should be appointed for a period of 24 months, |
| --- | --- |

(2)

A new EUSR for Human Rights should be appointed for a period of 24 months,

HAS ADOPTED THIS DECISION:

Article 1

European Union Special Representative

Mr Eamon GILMORE is hereby appointed as the European Union Special Representative (EUSR) for Human Rights until 28 February 2021. The Council may decide that the EUSR's mandate be terminated earlier, based on an assessment by the Political and Security Committee (PSC) and a proposal from the High Representative of the Union for Foreign Affairs and Security Policy (HR).

Article 2

Policy objectives

The EUSR's mandate shall be based on the policy objectives of the Union regarding human rights as set out in the Treaty on European Union, the Charter of Fundamental Rights of the European Union as well as the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy:

| (a) | enhancing the Union's effectiveness, presence and visibility in protecting and promoting human rights in the world and bringing forward a positive narrative on human rights, in particular by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations, and through action in relevant international fora; |
| --- | --- |

(a)

enhancing the Union's effectiveness, presence and visibility in protecting and promoting human rights in the world and bringing forward a positive narrative on human rights, in particular by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations, and through action in relevant international fora;

| (b) | enhancing the Union's contribution to strengthening democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide; |
| --- | --- |

(b)

enhancing the Union's contribution to strengthening democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide;

| (c) | improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union's external action. |
| --- | --- |

(c)

improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union's external action.

Article 3

Mandate

In order to achieve the policy objectives, the EUSR's mandate shall be to:

| (a) | contribute to the implementation of the Union's policy on human rights, in particular the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy, as well as the implementation of Union Guidelines, toolkits and action plans on human rights, including by formulating recommendations in this regard; |
| --- | --- |

(a)

contribute to the implementation of the Union's policy on human rights, in particular the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy, as well as the implementation of Union Guidelines, toolkits and action plans on human rights, including by formulating recommendations in this regard;

| (b) | contribute to the implementation of the Union's positions, as defined by the Council, on promoting compliance with international humanitarian law; |
| --- | --- |

(b)

contribute to the implementation of the Union's positions, as defined by the Council, on promoting compliance with international humanitarian law;

| (c) | contribute to the implementation of the Union's positions, as defined by the Council, on promoting support for international criminal justice, in particular Council Decision 2011/168/CFSP (2) on the International Criminal Court; |
| --- | --- |

(c)

contribute to the implementation of the Union's positions, as defined by the Council, on promoting support for international criminal justice, in particular Council Decision 2011/168/CFSP (2) on the International Criminal Court;

2

| (d) | help establish a stronger European voice through dialogues on human rights with governments in third countries and international and regional organisations, as well as with civil society organisations and other relevant actors in order to ensure the effectiveness and the visibility of the Union's human rights policy; lead important human rights dialogues with third countries; |
| --- | --- |

(d)

help establish a stronger European voice through dialogues on human rights with governments in third countries and international and regional organisations, as well as with civil society organisations and other relevant actors in order to ensure the effectiveness and the visibility of the Union's human rights policy; lead important human rights dialogues with third countries;

| (e) | contribute to better coherence and consistency of the Union's policies and actions in the areas of protection and promotion of human rights, in particular by providing input to the formulation of relevant policies of the Union; |
| --- | --- |

(e)

contribute to better coherence and consistency of the Union's policies and actions in the areas of protection and promotion of human rights, in particular by providing input to the formulation of relevant policies of the Union;

| (f) | contribute, in consultation with Member States, to the better coherence and consistency of the Union's positions referred to in points (b) and (c). |
| --- | --- |

(f)

contribute, in consultation with Member States, to the better coherence and consistency of the Union's positions referred to in points (b) and (c).

Article 4

Implementation of the mandate

1.   The EUSR shall be responsible for the implementation of the mandate, acting under the authority of the HR.

2.   The PSC shall maintain a privileged link with the EUSR and shall be the EUSR's primary point of contact with the Council. The PSC shall provide the EUSR with strategic guidance and political direction within the framework of the mandate, without prejudice to the powers of the HR.

3.   The EUSR shall work in close coordination with the European External Action Service (EEAS) and its relevant departments in order to ensure coherence and consistency in their respective work in the area of human rights.

Article 5

Financing

1.   The financial reference amount intended to cover the expenditure related to the EUSR's mandate for the period from 1 March 2019 to 28 February 2021 shall be EUR 2 100 270,50.

2.   The expenditure shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.

3.   The management of the expenditure shall be subject to a contract between the EUSR and the Commission. The EUSR shall be accountable to the Commission for all expenditure.

Article 6

Constitution and composition of the team

1.   Within the limits of the EUSR's mandate and the corresponding financial means made available, the EUSR shall be responsible for constituting a team. The team shall include the expertise on specific policy issues as required by the mandate. The EUSR shall keep the Council and the Commission promptly informed of the composition of the team.

2.   Member States, the institutions of the Union and the EEAS may propose the secondment of staff to work with the EUSR. The salary of such seconded personnel shall be covered by the sending Member State, the sending institution of the Union or the EEAS, respectively. Experts seconded by Member States to the institutions of the Union or the EEAS may also be posted to work with the EUSR. International contracted staff shall have the nationality of a Member State.

3.   All seconded personnel shall remain under the administrative authority of the sending Member State, the sending institution of the Union or the EEAS, respectively, and shall carry out their duties and act in the interest of the EUSR's mandate.

4.   The EUSR's staff shall be co-located within the relevant EEAS departments or Union delegations in order to ensure coherence and consistency of their respective activities.

Article 7

Security of EU classified information

The EUSR and the members of the EUSR's team shall respect the security principles and minimum standards established by Council Decision 2013/488/EU (3).

3

Article 8

Access to information and logistical support

1.   Member States, the Commission, the EEAS and the General Secretariat of the Council shall ensure that the EUSR is given access to any relevant information.

2.   The Union delegations and the diplomatic representations of Member States, as appropriate, shall provide logistical support to the EUSR.

Article 9

Security

In accordance with the Union's policy on the security of personnel deployed outside the Union in an operational capacity under Title V of the Treaty, the EUSR shall take all reasonably practicable measures, in accordance with the EUSR's mandate and on the basis of the security situation in the area of responsibility, for the security of all personnel under the EUSR's direct authority, in particular by:

| (a) | establishing a specific security plan based on guidance from the EEAS, including specific physical, organisational and procedural security measures governing the management of the secure movement of personnel to, and within, the area of responsibility, as well as the management of security incidents and providing for a contingency and evacuation plan; |
| --- | --- |

(a)

establishing a specific security plan based on guidance from the EEAS, including specific physical, organisational and procedural security measures governing the management of the secure movement of personnel to, and within, the area of responsibility, as well as the management of security incidents and providing for a contingency and evacuation plan;

| (b) | ensuring that all personnel deployed outside the Union are covered by high-risk insurance, as required by the conditions in the area of responsibility; |
| --- | --- |

(b)

ensuring that all personnel deployed outside the Union are covered by high-risk insurance, as required by the conditions in the area of responsibility;

| (c) | ensuring that all members of the EUSR's team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the area of responsibility, based on the risk ratings assigned to that area by the EEAS; |
| --- | --- |

(c)

ensuring that all members of the EUSR's team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the area of responsibility, based on the risk ratings assigned to that area by the EEAS;

| (d) | ensuring that all agreed recommendations made following regular security assessments are implemented, and providing the Council, the HR and the Commission with written reports on their implementation and on other security issues within the framework of the progress reports and the report on the implementation of the mandate. |
| --- | --- |

(d)

ensuring that all agreed recommendations made following regular security assessments are implemented, and providing the Council, the HR and the Commission with written reports on their implementation and on other security issues within the framework of the progress reports and the report on the implementation of the mandate.

Article 10

Reporting

The EUSR shall regularly provide the HR and the PSC with oral and written reports. The EUSR shall also report to Council working parties, in particular the Working Party on Human Rights, as necessary. Regular reports shall be circulated through the COREU network. The EUSR may provide the Foreign Affairs Council with reports. In accordance with Article 36 of the Treaty, the EUSR may be involved in briefing the European Parliament.

Article 11

Coordination

1.   The EUSR shall contribute to the unity, consistency and effectiveness of the Union's action and shall help ensure that all Union instruments and Member States' actions are engaged consistently, to attain the Union's policy objectives. The activities of the EUSR shall be coordinated with those of the Member States and the Commission, as well as other EUSRs, as appropriate. The EUSR shall provide regular briefings to Member States' missions and Union delegations.

2.   In the field, close liaison shall be maintained with the relevant Member States' Heads of Mission, the Heads of the Union delegations, as well as with Heads or Commanders of Common Security and Defence Policy missions and operations and other EUSRs, as appropriate. They shall make every effort to assist the EUSR in the implementation of the mandate.

3.   The EUSR shall also liaise and seek complementarity and synergies with other international and regional actors at Headquarters level and in the field. The EUSR shall seek regular contacts with civil society organisations both at Headquarters level and in the field.

Article 12

Review

The implementation of this Decision and its consistency with other contributions from the Union shall be kept under regular review. The EUSR shall present the Council, the HR and the Commission with regular progress reports and a comprehensive mandate implementation report by 30 November 2020.

Article 13

Entry into force

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

It shall apply from 1 March 2019.

Done at Brussels, 28 February 2019.

For the Council

The President

G. CIAMBA

---

(1)  Council Decision 2012/440/CFSP of 25 July 2012 appointing the European Union Special Representative for Human Rights (OJ L 200, 27.7.2012, p. 21).

1

(2)  Council Decision 2011/168/CFSP of 21 March 2011 on the International Criminal Court and repealing Common Position 2003/444/CFSP (OJ L 76, 22.3.2011, p. 56).

2

(3)  Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1).

3

---

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 1.3.2019 | EN | Official Journal of the European Union | L 62/16 |
| --- | --- | --- | --- |

1.3.2019

EN

Official Journal of the European Union

L 62/16

---

DECISION No 3/JP/2018

of 25 January 2019

of the Joint Committee set up under the Agreement on Mutual Recognition between the European Community and Japan related to the registration of Conformity Assessment Bodies under the Sectoral Annex on Telecommunications Terminal Equipment and Radio Equipment [2019/347]

THE JOINT COMMITTEE,

Having regard to the Agreement on Mutual Recognition between the European Community and Japan and in particular Article 8(3)(a) and 9(1)(b) thereof;

Whereas the Joint Committee is to take a decision to list a Conformity Assessment Body or Bodies under a Sectoral Annex;

HAS DECIDED AS FOLLOWS:

| 1. | The Conformity Assessment Body indicated below is registered under the Sectoral Annex on Telecommunications Terminal Equipment and Radio Equipment of the Agreement, for the products and conformity assessment procedures as indicated below.





  Name, acronym and contact details of the Conformity Assessment Body:
  Name: CETECOM GmbH
  Address: Im Teelbruch 116, D-45219 Essen, GERMANY

  Telephone number: +49 2054 9519 404
  Fax number: +49 2054 9519 150
  E-mail address: francis.lima@cetecom.com
  URL address: http://www.cetecom.com
  Contact person of the designated CAB: Francis Lima |
| --- | --- |

1.

Name, acronym and contact details of the Conformity Assessment Body:

Name: CETECOM GmbH

Address: Im Teelbruch 116, D-45219 Essen, GERMANY

Telephone number: +49 2054 9519 404

Fax number: +49 2054 9519 150

E-mail address: francis.lima@cetecom.com

URL address: http://www.cetecom.com

Contact person of the designated CAB: Francis Lima

| Scope of registration in terms of products and conformity assessment procedures:
  For Radio Law:
  Specified Radio Equipment specified in Article 38-2-2, paragraph (1), items i), ii), iii) of the Radio Law |
| --- |

Scope of registration in terms of products and conformity assessment procedures:

For Radio Law:

Specified Radio Equipment specified in Article 38-2-2, paragraph (1), items i), ii), iii) of the Radio Law

| 2. | This decision, done in duplicate, shall be signed by the Co-Chairs. The decision shall be effective from the date of the later of these signatures. |
| --- | --- |

2.

On behalf of Japan

Kyoichiro KAWAKAMI

Signed in Tokyo on 25 January 2019

On behalf of the European Union

Ignacio IRUARRIZAGA

Signed in Brussels on 16 January 2019

---