Date: 2022-09-07Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/1474 of 6 September 2022 renewing the approval of the low-risk active substance sheep fat 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:
This Commission Implementing Regulation (EU) 2022/1474 renews the approval of sheep fat as a low-risk active substance used in plant protection products, in accordance with Regulation (EC) No 1107/2009. It amends Implementing Regulation (EU) No 540/2011 to reflect this renewal. The regulation takes effect on November 1, 2022, and the approval of sheep fat expires on October 30, 2037.
Key Points / Main Content:
Approval Renewal:
* The active substance sheep fat's approval is renewed as specified in Annex I, subject to the conditions laid down therein.
* Sheep fat is considered a low-risk active substance.
* Minimum purity of sheep fat is set at 100.
* The approval of sheep fat expires on October 30, 2037.
Amendments to Implementing Regulation (EU) No 540/2011:
* Entry 249 on sheep fat in Part A of the Annex is deleted.
* A new entry for sheep fat is added to Part D of the Annex, entry 39.
General Provisions:
* The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union and applies from November 1, 2022.
* Conditions of use must include risk mitigation measures, where appropriate.
* The conclusions of the renewal report on sheep fat shall be taken into account.
Impact Analysis:
Member States:
* Impact: The regulation is binding and directly applicable in all Member States.
* Action Required: Implement the renewed approval and the amended Annex to Implementing Regulation (EU) No 540/2011.
Plant Protection Product Manufacturers/Applicants:
* Impact: Can continue to use sheep fat in plant protection products, subject to the conditions and purity standards outlined in the regulation.
* Action Required: Ensure compliance with the minimum purity of sheep fat and the conditions of use, including risk mitigation measures.
European Food Safety Authority (EFSA):
* Impact: Their renewal report and conclusions on sheep fat are referenced and considered in the implementation of the regulation.
* Action Required: No specific action required, but their findings are integral to the regulation's application.
Commission:
* Impact: Responsible for the renewal report on Sheep Fat.
* Action Required: Implement the regulation and ensure compliance.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
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.
Sheep fat: An active substance used in plant protection products, the approval of which is being renewed by this regulation.
Czech Republic: A Member State of the European Union, acting as the rapporteur Member State for the renewal of the approval of sheep fat.
France: A Member State of the European Union, acting as the co-rapporteur Member State for the renewal of the approval of sheep fat.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
7.9.2022 EN Official Journal of the European Union L 232/3
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1474
of 6 September 2022
renewing the approval of the low-risk active substance sheep fat 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) in conjunction with Article 22(1) thereof,
Whereas:
(1) Commission Directive 2008/127/EC(2) included sheep fat 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 sheep fat, as set out in Part A of the Annex to Implementing Regulation (EU)
No 540/2011, expires on 31 August 2023.
(4) An application for the renewal of the approval of the active substance sheep fat was submitted to the Czech
Republic, the rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU)
No 844/2012(5)and 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 admissible by the rapporteur Member State.
(6) The Czech Republic prepared a draft renewal assessment report in consultation with France, the co-rapporteur
Member State, and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on
10 September 2020. In its draft renewal assessment report the Czech Republic proposed to renew the approval of
sheep fat as a low-risk substance.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active
substances (OJ L 344, 20.12.2008, p. 89).
(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
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). This
Regulation was replaced by Regulation (EU) 2020/1740, however, it shall continue to apply to the procedure for the renewal of the
approval of active substances: (1) whose approval period ends before 27 March 2024; (2) for which a Regulation, adopted in
accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March
2024 or a later date.L 232/4 EN Official Journal of the European Union 7.9.2022
(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the
draft renewal assessment report to the applicant and to the Member States for comments and launched a public
consultation on it. The Authority forwarded the comments received to the Commission.
(8) On 16 December 2021, the Authority communicated to the Commission its conclusion(6) which indicated that
sheep fat can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
The Commission presented a renewal report on 30 March 2022and a draft of this Regulation regarding sheep fat
to the Standing Committee on Plants, Animals, Food and Feed on 17 May 2022.
(9) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in
accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the
renewal report. The applicant submitted its comments, which have been carefully examined and taken into
consideration where appropriate.
(10) It has been established with respect to one or more representative uses of at least one plant protection product
containing the active substance sheep fat that the approval criteria provided for in Article 4 of Regulation (EC)
No 1107/2009 are satisfied.
(11) The Commission further considers that sheep fat is a low-risk active substance pursuant to Article 22 of Regulation
(EC) No 1107/2009. Sheep fat is not a substance of concern and fulfils the conditions set in point 5 of Annex II to
Regulation (EC) No 1107/2009.
(12) It is therefore appropriate to renew the approval of sheep fat as a low-risk substance.
(13) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the
light of current scientific and technical knowledge, it is, however, necessary to set a minimum purity of the active
substance as manufactured in order to underpin the safety of the active substance to be used in plant protection
products.
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(15) Commission Implementing Regulation (EU) 2022/708(7) extended the approval period of sheep fat to
31 August 2023in order to allow the renewal process to be completed before the expiry of the approval period of
that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date,
this Regulation shall apply as soon as possible.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(6) EFSA (European Food Safety Authority), 2022. Conclusion on the peer review of the pesticide risk assessment of the active substance
sheep fat. EFSA Journal 2022;20(1):7073, 43 pp. doi:10.2903/j.efsa.2022.7073. Available online: www.efsa.europa.eu
(7) Commission Implementing Regulation (EU) 2022/708 of 5 May 2022 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aclonifen,
aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, beflubutamid, benthiavalicarb, boscalid, calcium carbide,
captan, cymoxanil, dimethomorph, dodemorph, ethephon, ethylene, extract from tea tree, fat distillation residues, fatty acids C7 to
C20, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, magnesium
phosphide, metam, metamitron, metazachlor, metribuzin, milbemectin, phenmedipham, pirimiphos-methyl, plant oils/clove oil, plant
oils/rape seed oil, plant oils/spear mint oil, propamocarb, proquinazid, prothioconazole, pyrethrins, quartz sand, fish oil, repellents by
smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, sulcotrione, tebuconazole and urea
(OJ L 133, 10.5.2022, p. 1).7.9.2022 EN Official Journal of the European Union L 232/5
HAS ADOPTED THIS REGULATION:
Article 1
Renewal of the approval of the active substance
The approval of the active substance sheep fat, as specified in Annex I to this Regulation, is renewed subject to the
conditions laid down in that Annex.
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 November 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 September 2022.
For the Commission
The President
Ursula VON DER LEYENANNEX I
Common Name,
IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions
Identification Numbers
Sheep fat Sheep fat Minimum purity of sheep 1 November 2022 30 October 2037 For the implementation of the uniform principles, as
fat: 100 % referred to in Article 29(6) of Regulation (EC)
CAS No: 98999-15-6
No 1107/2009, the conclusions of the renewal
CIPAC No: 919 No relevant impurity report on sheep fat, and in particular Appendices I
and II thereof, shall be taken into account.
Conditions of use shall include risk mitigation
measures, where appropriate.
(1) Further details on the identity and the specification of the active substance are provided in the renewal report.
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7.9.2022ANNEX II
The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, entry 249 on sheep fat is deleted;
(2) in Part D, the following entry is added:
Common Name,
Number IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions
Identification Numbers
‘39 Sheep fat Sheep fat Minimum purity of sheep 1 November 2022 30 October 2037 For the implementation of the uniform
fat: 100 % principles, as referred to in Article 29(6) of
CAS No: 98999-15-6
Regulation (EC) No 1107/2009, the
CIPAC No: 919 No relevant impurity conclusions of the renewal report on sheep fat,
and in particular Appendices I and II thereof,
shall be taken into account.
Conditions of use shall include risk mitigation
measures, where appropriate.’
(1) Further details on the identity and the specification of the active substance are provided in the renewal report.
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