Date: 2018-02-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/184 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride (Text with EEA relevance. )
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2018/184 amends Implementing Regulation (EU) No 540/2011, extending the approval periods for the active substances FEN 560 (fenugreek) and sulfuryl fluoride due to delays in the renewal assessment process. The extension for FEN 560 is until October 31, 2021, and for sulfuryl fluoride, it is until October 31, 2023. The regulation came 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:**
* FEN 560 (fenugreek/fenugreek seed powder): Approval extended to October 31, 2021.
* Sulfuryl fluoride: Approval extended to October 31, 2023.
* **Justification for Extension:**
* Renewal assessments could not be completed before the original expiration dates due to reasons beyond the applicants' control.
* The extensions are in accordance with Article 17 of Regulation (EC) No 1107/2009.
* Commission Implementing Decision C(2016)6104 established a work programme that prioritises active substances based on safety concerns.
* **Future Expiry Dates:**
* If a supplementary dossier is not submitted 30 months before the expiry date, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
* If 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.
* If the Commission will adopt a Regulation providing for the renewal of an active substance, the Commission will endeavour to set the earliest possible application date.
**Impact Analysis:**
* **European Commission:**
* *Impact:* Responsible for setting new expiry dates and adopting regulations regarding the renewal or non-renewal of active substances.
* *Action Required:* Implement the amended regulation, monitor submission of supplementary dossiers, and assess active substances for renewal.
* **Member States (Rapporteurs and Co-Rapporteurs):**
* *Impact:* Responsible for the assessment of the applications for renewal of approvals.
* *Action Required:* Distribute responsibilities, allocate resources for assessment, and participate in decision-making.
* **Applicants (Manufacturers/Producers of FEN 560 and Sulfuryl Fluoride):**
* *Impact:* Benefit from the extended approval periods, allowing continued marketing and use of these substances.
* *Action Required:* Continue working towards the renewal of approvals and ensure timely submission of supplementary dossiers (no later than 30 months before the new expiry dates).
* **Users of Plant Protection Products Containing FEN 560 and Sulfuryl Fluoride:**
* *Impact:* Continued availability of plant protection products containing these active substances.
* *Action Required:* Be aware of the new expiry dates for these substances.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
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 Commission Implementing Regulation implementing Regulation (EC) No 1107/2009 as regards the list of approved active substances.
Commission Implementing Regulation (EU) No 844/2012: A Commission Implementing Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances.
FEN 560: An active substance also called fenugreek or fenugreek seed powder.
Sulfuryl fluoride: An active substance. It is used as a fumigant insecticide to control insects and rodents in buildings, stored products, and commodities.
Brussels: The capital of Belgium and the de facto capital of the European Union, where the regulation was adopted.
L 34/10 EN Official Journal of the European Union 8.2.2018
COMMISSION IMPLEMENTING REGULATION (EU) 2018/184
of 7 February 2018
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval
periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and
sulfuryl fluoride
(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 A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active
substances deemed to have been approved under Regulation (EC) No 1107/2009.
(2) Applications for the renewal of the approval of FEN 560 (also called fenugreek or fenugreek seed powder) and
sulfuryl fluoride 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.
(3) In view of the time and resources necessary for completing the assessment of applications for the renewal of
approvals of the large number of active substances the approvals of which are expiring 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.
(4) 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 Member States acting as rapporteurs and
co-rapporteurs and the available resources necessary for assessment and decision-making, that period should be
of 1 year for the active substance FEN 560 (also called fenugreek or fenugreek seed powder).
(5) For active substances which do not fall in the prioritised categories in Implementing Decision C(2016)6104, the
approval period should be extended by either 2 or 3 years, taking into account the present date of expiry, the fact
that according to Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an
active substance shall be submitted no later than 30 months before expiry of the approval, the need to ensure
a balanced distribution of responsibilities and work among 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 period for the active substance sulfuryl fluoride by 3 years.
(6) 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.
(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).8.2.2018 EN Official Journal of the European Union L 34/11
(7) 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.
(8) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(9) 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, 7 February 2018.
For the Commission
The President
Jean-Claude JUNCKERL 34/12 EN Official Journal of the European Union 8.2.2018
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in the sixth column, expiration of approval, of row 307, Sulfuryl fluoride, the date is replaced by ‘31 October 2023’;
(2) in the sixth column, expiration of approval, of row 308, FEN 560 (also called fenugreek or fenugreek seed powder),
the date is replaced by ‘31 October 2021’.