Date: 2019-02-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2019/291 of 19 February 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin, azoxystrobin, fluazifop p, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, prochloraz, prohexadione, spiroxamine, tefluthrin and terbuthylazine (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2019/291 amends Implementing Regulation (EU) No 540/2011, extending the approval periods for several active substances, including 1-naphthylacetamide, azoxystrobin, and tefluthrin, due to delays in the renewal process. The extensions range from one to three years, depending on prioritization and assessment timelines. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content:**
* **Extension of Approval Periods:**
* The approval periods for specified active substances are extended.
* The extensions are necessary because decisions on renewal applications could not be made before the original expiration dates.
* **Extension Durations:**
* Prohexadione's approval is extended by one year (until 31 December 2022).
* 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin, fluazifop-p, prochloraz, and spiroxamine approvals are extended by two years (until 31 December 2023).
* Azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, tefluthrin, and terbuthylazine approvals are extended by three years (until 31 December 2024).
* **Commission Actions:**
* The Commission retains the right to set the expiry date at the same date as before this Regulation or at the earliest date thereafter if a supplementary dossier is not submitted according to Implementing Regulation EU No 844/2012.
* The Commission will set the expiry date at the same date as before this Regulation or at the date of entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later if a Regulation is adopted that the approval of an active substance is not renewed because the approval criteria are not satisfied.
* The Commission will endeavour to set the earliest possible application date if a Regulation is adopted providing for the renewal of an active substance.
* **Regulation Amendment:**
* The Annex to Implementing Regulation (EU) No 540/2011 is amended as specified in the Annex of this regulation, reflecting the new expiration dates.
**Impact Analysis:**
* **Active Substance Manufacturers/Applicants:**
* *Impact:* Extended time to continue marketing and selling products containing these active substances, while awaiting renewal decisions.
* *Action Required:* Monitor the progress of the renewal assessment and comply with any requests for additional information.
* **Member States (Rapporteurs and Co-rapporteurs):**
* *Impact:* Continued responsibility for assessing the renewal applications for these active substances.
* *Action Required:* Continue with the assessment process, prioritizing substances according to Implementing Decision C(2016)6104, and manage workload distribution.
* **European Commission:**
* *Impact:* Responsibility for making final decisions on the renewal of approvals for these active substances.
* *Action Required:* Finalize the assessment of renewal applications and adopt regulations for renewal or non-renewal based on the assessment outcomes.
* **Users of Plant Protection Products (Farmers, etc.):**
* *Impact:* Continued availability of plant protection products containing these active substances in the short term.
* *Action Required:* Stay informed about the renewal status of these active substances and any potential changes in their approved uses.
Key Entities Referenced
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, defining the scope of EU powers.
European Parliament: The parliamentary body of the European Union, forming one half of the EU's legislature.
Council of the European Union: Also known as the Council, is a component of the legislative branch of the European Union and together with the European Parliament serves to amend and approve laws.
Regulation EC No 1107/2009: A regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Commission Implementing Regulation EU No 540/2011: A regulation implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances.
Commission Implementing Regulation EU No 844/2012: A regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009.
Brussels: The location where the Commission Implementing Regulation (EU) 2019/291 was adopted.
20.2.2019 EN Official Journal of the European Union L 48/17
COMMISSION IMPLEMENTING REGULATION (EU) 2019/291
of 19 February 2019
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval
periods of the active substances 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin,
azoxystrobin, fluazifop p, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, prochloraz,
prohexadione, spiroxamine, tefluthrin and terbuthylazine
(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 the first paragraph of Article 17 thereof,
Whereas:
(1) Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active
substances approved under Regulation (EC) No 1107/2009.
(2) The approval periods of the substances 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin, azoxystrobin,
fluazifop p, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, prochloraz, prohexadione, spiroxamine, tefluthrin
and terbuthylazine will expire on 31 December 2021.
(3) Applications for the renewal of the approval of the active substances included in this Regulation were submitted
in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those
substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on
the renewal of their approval. It is therefore necessary to extend their approval periods in accordance with
Article 17 of Regulation (EC) No 1107/2009.
(4) In view of the time and resources necessary for completing the assessment of the applications for the renewal of
approval of a large number of active substances the approvals of which will expire between 2019 and 2021,
Commission Implementing Decision C(2016) 6104 (4) established a work programme grouping together similar
active substances and setting priorities on the basis of safety concerns for human and animal health or the
environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
(5) The presumed low risk substances should be prioritised in accordance with Implementing Decision
C(2016) 6104. The approval of those substances should therefore be extended by a period as short as
possible. Taking into account the distribution of responsibilities and work among the Member States acting as
rapporteurs and co-rapporteursand the available resources necessary for assessment and decision-making, that
period should be of one year for the active substance prohexadione.
(6) For the active substances which do not fall in the prioritised categories in Implementing Decision C(2016) 6104,
the approval period should be extended by either two or three years, taking into account the current date of
expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012, the supple
mentary dossier for an active substance is to be submitted no later than 30 months before the expiry of the
approval, taking into account the need to ensure a balanced distribution of responsibilities and work among the
Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and
decision-making. It is therefore appropriate to extend the approval periods for the active substances 1-naphthyla
cetamide, 1-naphthylacetic acid, acrinathrin, fluazifop p, prochloraz and spiroxamine by two years, and to extend
the approval periods of the active substances azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen,
tefluthrin, terbuthylazine by three years.
(1) OJ L 309, 24.11.2009, p. 1.
(2) 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).
(3) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implemen
tation 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).
(4) Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of
applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC)
No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p. 9).L 48/18 EN Official Journal of the European Union 20.2.2019
(7) In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where
no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later
than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission
will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
(8) In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where
the Commission will adopt a Regulation providing that the approval of an active substance referred to in the
Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set
the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation
providing that the approval of the active substance is not renewed, whichever date is later. As regards cases
where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the
Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the
earliest possible application date.
(9) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(10) 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 Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this
Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 February 2019.
For the Commission
The President
Jean-Claude JUNCKER20.2.2019 EN Official Journal of the European Union L 48/19
ANNEX
Part B of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in the sixth column, expiration of approval, of row 4, Azoxystrobin, the date is replaced by ‘31 December 2024’;
(2) in the sixth column, expiration of approval, of row 5, Imazalil, the date is replaced by ‘31 December 2024’;
(3) in the sixth column, expiration of approval, of row 6, Prohexadione, the date is replaced by ‘31 December 2022’
(4) in the sixth column, expiration of approval, of row 7, Spiroxamine, the date is replaced by ‘31 December 2023’;
(5) in the sixth column, expiration of approval, of row 8, Kresoxim-methyl, the date is replaced by ‘31 December
2024’;
(6) in the sixth column, expiration of approval, of row 9, Fluroxypyr, the date is replaced by ‘31 December 2024’;
(7) in the sixth column, expiration of approval, of row 10, Tefluthrin, the date is replaced by ‘31 December 2024’;
(8) in the sixth column, expiration of approval, of row 11, Oxyfluorfen, the date is replaced by ‘31 December 2024’;
(9) in the sixth column, expiration of approval, of row 12, 1-naphthylacetamide, the date is replaced by ‘31 December
2023’;
(10) in the sixth column, expiration of approval, of row 13, 1-naphthylacetic acid, the date is replaced by ‘31 December
2023’;
(11) in the sixth column, expiration of approval, of row 15, Fluazifop P, the date is replaced by ‘31 December 2023’;
(12) in the sixth column, expiration of approval, of row 16, Terbuthylazine, the date is replaced by ‘31 December
2024’;
(13) in the sixth column, expiration of approval, of row 19, Acrinathrin, the date is replaced by ‘31 December 2023’;
(14) in the sixth column, expiration of approval, of row 20, Prochloraz, the date is replaced by ‘31 December 2023’.