Date: 2018-01-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/113 of 24 January 2018 renewing the approval of the active substance acetamiprid 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. )
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2018/113 renews the approval of acetamiprid as an active substance in accordance with Regulation (EC) No 1107/2009. The regulation amends Implementing Regulation (EU) No 540/2011 and takes effect on March 1, 2018. The approval of acetamiprid is renewed until February 28, 2033.
**Key Points / Main Content:**
* **Renewal of Approval:**
* The active substance acetamiprid's approval is renewed.
* The expiration date for the renewed approval is February 28, 2033.
* The renewed approval is based on the satisfaction of criteria in Article 4 of Regulation (EC) No 1107/2009.
* **Amendments to Implementing Regulation (EU) No 540/2011:**
* The Annex to Implementing Regulation (EU) No 540/2011 is amended as detailed in Annex II of this regulation.
* Entry 91 on acetamiprid in Part A of the Annex is deleted.
* A new entry for acetamiprid is added to Part B of the Annex.
* **Specific Provisions for Implementation:**
* Member States must consider the conclusions of the renewal report on acetamiprid, particularly Appendices I and II, when implementing uniform principles as per Article 29(6) of Regulation (EC) No 1107/2009.
* Member States should pay particular attention to risks concerning aquatic organisms, bees and other non-target arthropods, birds and mammals, consumers, and operators.
* Conditions of use must include risk mitigation measures, where appropriate.
* **Entry into Force:**
* The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union and applied from March 1, 2018.
**Impact Analysis**
**Member States:**
* *Impact:* Required to implement the renewed approval of acetamiprid, considering the specific provisions and risk mitigation measures. Must pay particular attention to the identified risks during their overall assessment.
* *Action Required:* Incorporate the conclusions of the renewal report into their assessment, focusing on the specified risks and implementing appropriate risk mitigation measures in the conditions of use.
**Plant Protection Product Manufacturers/Applicants:**
* *Impact:* Can continue to place plant protection products containing acetamiprid on the market, subject to the conditions and provisions outlined in the regulation.
* *Action Required:* Ensure compliance with the conditions of the renewed approval, including risk mitigation measures, and provide necessary information to Member States for their assessment.
**European Food Safety Authority (EFSA):**
* *Impact:* EFSA's renewal assessment report and conclusions serve as the basis for the renewed approval.
* *Action Required:* Ensure the availability of the renewal report and related documents for Member States and other stakeholders.
**Consumers:**
* *Impact:* Affected by the safety and regulation of plant protection products containing acetamiprid, particularly regarding potential risks.
* *Action Required:* No direct action required, but should be aware of the measures taken to ensure the safe use of acetamiprid in plant protection.
**Operators:**
* *Impact:* Directly affected by the conditions of use of plant protection products containing acetamiprid, including required risk mitigation measures.
* *Action Required:* Implement risk mitigation measures as outlined in the conditions of use.
Key Entities Referenced
Acetamiprid: An active substance used in plant protection products, the approval of which is being renewed.
Regulation EC No 1107/2009: 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: Commission Implementing Regulation implementing Regulation EC No 1107/2009 as regards the list of approved active substances.
European Parliament: One of the legislative branches of the European Union.
Council of the European Union: One of the legislative branches of the European Union.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice on food-related risks.
Commission Implementing Regulation EU No 844/2012: Commission Implementing Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances.
Brussels: The location where the regulation was adopted.
25.1.2018 EN Official Journal of the European Union L 20/7
COMMISSION IMPLEMENTING REGULATION (EU) 2018/113
of 24 January 2018
renewing the approval of the active substance acetamiprid 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) thereof,
Whereas:
(1) Commission Directive 2004/99/EC (2) included acetamiprid 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).
(3) The approval of the active substance acetamiprid, as set out in Part A of the Annex to Implementing Regulation
(EU) No 540/2011, expires on 30 April 2018.
(4) An application for the renewal of the approval of acetamiprid 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.
(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
27 November 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 supple
mentary summary dossier available to the public.
(8) On 19 October 2016 the Authority communicated to the Commission its conclusion (6) on whether acetamiprid
can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The
Commission presented the draft renewal report for acetamiprid to the Standing Committee on Plants, Animals,
Food and Feed on 23 January 2017.
(9) The applicant was given the opportunity to submit comments on the draft renewal report.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid
as active substances (OJ L 309, 6.10.2004, p. 6).
(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).
(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).
(5) 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).
(6) EFSA Journal 2016;14(11):4610. Available online: www.efsa.europa.euL 20/8 EN Official Journal of the European Union 25.1.2018
(10) It has been established with respect to one or more representative uses of at least one plant protection product
containing acetamiprid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are
satisfied. It is therefore appropriate to renew the approval of acetamiprid.
(11) The risk assessment for the renewal of the approval of acetamiprid is based on a limited number of representative
uses, which however do not restrict the uses for which plant protection products containing acetamiprid may be
authorised. It is therefore appropriate to remove the restriction to use only as an insecticide.
(12) The Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(13) Commission Implementing Regulation (EU) 2016/2016 (1) extended the approval period of acetamiprid to
30 April 2018 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 renewal has been taken ahead of that extended expiry date, this
Regulation should apply from 1 March 2018.
(14) 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
Renewal of the approval of the active substance
The approval of the active substance acetamiprid is renewed as set out in Annex I.
Article 2
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3
Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 1 March 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 January 2018.
For the Commission
The President
Jean-Claude JUNCKER
(1) Commission Implementing Regulation (EU) 2016/2016 of 17 November 2016 amending Implementing Regulation (EU) No 540/2011
as regards the extension of the approval periods of the active substances acetamiprid, benzoic acid, flazasulfuron, mecoprop-P,
mepanipyrim, mesosulfuron, propineb, propoxycarbazon, propyzamide, propiconazole, Pseudomonas chlororaphis Strain: MA 342,
pyraclostrobin, quinoxyfen, thiacloprid, thiram, ziram, zoxamide (OJ L 312, 18.11.2016, p. 21).ANNEX I
Common Name, Expiration of
IUPAC Name Purity(1) Date of approval Specific provisions
Identification Numbers approval
Acetamiprid (E)-N1-[(6-Chloro-3-pyr ≥ 990 g/kg 1 March 2018 28 February 2033 For the implementation of the uniform principles, as referred to in
idyl)methyl]-N2-cyano- Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 135410-20-7
N1-methylacetamidine the renewal report on acetamiprid, and in particular Appendices I
CIPAC No 649 and II thereof, shall be taken into account.
In their overall assessment Member States shall pay particular
attention to:
— the risk to aquatic organisms, bees and other non-target
arthropods,
— the risk to birds and mammals,
— the risk to consumers,
— the risk to operators.
Conditions of use shall include risk mitigation measures, where
appropriate.
(1) Further details on identity and specification of active substance are provided in the renewal report.
25.1.2018
EN
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Journal
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20/9ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, entry 91 on acetamiprid is deleted;
(2) in Part B, the following entry is added:
Common Name, Date of Expiration of
Number IUPAC Name Purity(1) Specific provisions
Identification Numbers approval approval
‘119 Acetamiprid (E)-N1-[(6-Chloro-3-pyr ≥ 990 g/kg 1 March 28 February For the implementation of the uniform principles, as referred
idyl)methyl]-N2-cyano- 2018 2033 to in Article 29(6) of Regulation (EC) No 1107/2009, the
CAS No 135410-20-7
N1-methylacetamidine conclusions of the renewal report on acetamiprid, and in
CIPAC No 649 particular Appendices I and II thereof, shall be taken into
account.
In their overall assessment Member States shall pay particular
attention to:
— the risk to aquatic organisms, bees and other non-target
arthropods,
— the risk to birds and mammals,
— the risk to consumers,
— the risk to operators.
Conditions of use shall include risk mitigation measures, where
appropriate.’
(1) Further details on identity and specification of active substance are provided in the renewal report.
L
20/10
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Official
Journal
of
the
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Union
25.1.2018