# L_2018060EN.01001601.xml

| 2.3.2018 | EN | Official Journal of the European Union | L 60/16 |
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2.3.2018

EN

Official Journal of the European Union

L 60/16

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/309

of 1 March 2018

concerning the non-renewal of approval of the active substance propineb, 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 2003/39/EC (2) included propineb as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2003/39/EC (2) included propineb 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). |
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(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 propineb, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019. |
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(3)

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

| (4) | An application for the renewal of the approval of propineb 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. |
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(4)

An application for the renewal of the approval of propineb 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. |
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(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 1 October 2015. |
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(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 1 October 2015.

| (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. |
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(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 15 November 2016 the Authority communicated to the Commission its conclusion (6) on whether propineb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that the consumer risk assessment through dietary intake cannot be conducted for the products of plant and animal origin. Based on the data available in the dossier it was not possible to complete the assessment of relevant metabolites of propineb. |
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(8)

On 15 November 2016 the Authority communicated to the Commission its conclusion (6) on whether propineb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority concluded that the consumer risk assessment through dietary intake cannot be conducted for the products of plant and animal origin. Based on the data available in the dossier it was not possible to complete the assessment of relevant metabolites of propineb.

| (9) | In addition, the Authority underlined a critical area of concern for propineb related to the endocrine-disrupting properties of the relevant metabolite 4-methylimidazolidine-2-thione (PTU) which is classified as toxic for reproduction category 2 and has the thyroid as a target organ for toxicity. |
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(9)

In addition, the Authority underlined a critical area of concern for propineb related to the endocrine-disrupting properties of the relevant metabolite 4-methylimidazolidine-2-thione (PTU) which is classified as toxic for reproduction category 2 and has the thyroid as a target organ for toxicity.

| (10) | Moreover, the Authority could not finalise the assessment of the risk to honeybee brood and concluded that a high risk to honeybee brood development could not be excluded for propineb. |
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(10)

Moreover, the Authority could not finalise the assessment of the risk to honeybee brood and concluded that a high risk to honeybee brood development could not be excluded for propineb.

| (11) | The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined. |
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(11)

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

| (12) | However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated. |
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(12)

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

| (13) | Based on these identified risks, it has not been established with respect to one or more representative uses of at least one plant protection product 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 propineb in accordance with Article 20(1)(b) of that Regulation. |
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(13)

Based on these identified risks, it has not been established with respect to one or more representative uses of at least one plant protection product 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 propineb in accordance with Article 20(1)(b) of that Regulation.

| (14) | Commission Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(14)

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

| (15) | Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing propineb. |
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(15)

Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing propineb.

| (16) | For plant protection products containing propineb, 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 22 June 2019. |
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(16)

For plant protection products containing propineb, 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 22 June 2019.

| (17) | Commission Implementing Regulation (EU) 2018/84 (7) extended the expiry date of propineb to 31 January 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 has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible. |
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(17)

Commission Implementing Regulation (EU) 2018/84 (7) extended the expiry date of propineb to 31 January 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 has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

| (18) | This Regulation does not prejudice the submission of a further application for the approval of propineb pursuant to Article 7 of Regulation (EC) No 1107/2009. |
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(18)

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

| (19) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(19)

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 propineb is not renewed.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 54, on propineb, is deleted.

Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing propineb as active substance by 22 June 2018 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 22 June 2019 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, 1 March 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Commission Directive 2003/39/EC of 15 May 2003 amending Council Directive 91/414/EEC to include propineb and propyzamide as active substances (OJ L 124, 20.5.2003, p. 30).

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(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).

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(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), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance propineb. EFSA Journal 2016;14(11):4605, 26 pp. doi:10.2903/j.efsa.2016.4605.

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EFSA Journal

(7)  Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ L 16, 20.1.2018, p. 8).

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