Commission Implementing Regulation (EU) 2022/782 of 18 May 2022 withdrawing the approval of the active substance isopyrazam 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, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012 (Text with EEA relevance)
Date: 2022-05-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: carcinogenic substance, market approval, plant health control, plant health product, toxic substance, withdrawal from the market








L_2022140EN.01000301.xml










19.5.2022   


EN


Official Journal of the European Union


L 140/3








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/782
of 18 May 2022
         
withdrawing the approval of the active substance isopyrazam 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, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012
(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 21(3) and Article 78(2) thereof,

Whereas:







(1)


Commission Implementing Regulation (EU) No 1037/2012 (2) approved isopyrazam as an active substance in accordance with Regulation (EC) No 1107/2009 and listed it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3).












(2)


On 10 December 2020, the Committee for Risk Assessment of the European Chemicals Agency adopted an opinion (4) in accordance with Article 37(4) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5) in which it concluded that isopyrazam meets the criteria to be classified as toxic for reproduction category 1B and carcinogenic category 2.












(3)


Commission Delegated Regulation (EU) 2022/692 (6) consequently amended Annex VI to Regulation (EC) No 1272/2008 and classified isopyrazam as toxic for reproduction category 1B.












(4)


Under point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 an active substance is only to be approved if it is not or has not to be classified in accordance with the provisions of Regulation (EC) No 1272/2008 as toxic for reproduction category 1B, unless the exposure of humans to that substance in a plant protection product under realistic proposed conditions of use is negligible.












(5)


For the representative uses of isopyrazam, residues of isopyrazam on food and feed exceed the default value within the meaning of Article 18(1), point (b), of Regulation (EC) No 396/2005 of the European Parliament and of the Council (7), therefore the condition of negligible exposure with respect to dietary exposure is not met.












(6)


Consequently, isopyrazam no longer fulfils the criterion for approval laid down in point 3.6.4 of Annex II to Regulation (EC) No 1107/2009.












(7)


In accordance with Article 21(1) of Regulation (EC) No 1107/2009, the Commission informed the Member States, the European Food Safety Authority and the applicant that it considered the approval criterion laid down in point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 may no longer be met given that isopyrazam meets the criteria to be classified as toxic for reproduction category 1B and invited the applicant to submit its comments.












(8)


The applicant neither provided any information to demonstrate negligible exposure nor any evidence that the conditions of Article 4(7) of Regulation (EC) No 1107/2009, concerning substances which are needed to control a serious danger to plant health that cannot be contained by other available means, are fulfilled.












(9)


Consequently, it is appropriate to withdraw the approval of isopyrazam.












(10)


The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly and Implementing Regulation (EU) No 1037/2012 should be repealed.












(11)


Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing isopyrazam.












(12)


For plant protection products containing isopyrazam, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and expire no later than 6 months from the date of entry into force of this Regulation.












(13)


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












(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

Withdrawal of approval

The approval of the active substance isopyrazam is withdrawn.


Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, row 27 on isopyrazam is deleted.


Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing isopyrazam as active substance by 8 September 2022.


Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 8 December 2022.


Article 5

Repeal

Implementing Regulation (EU) No 1037/2012 is repealed.


Article 6

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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 May 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) No 1037/2012 of 7 November 2012 approving the active substance isopyrazam, 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 (OJ L 308, 8.11.2012, p. 15).

(3)  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)  Committee for Risk Assessment, Opinion proposing harmonised classification and labelling at EU level of Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [>78% syn isomers <15% anti isomers relative content]; isopyrazam. EC Number: - CAS Number: 881685-58-1 CLH-O-0000006915-65-01/F, adopted on 10 December 2020.

(5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(6)  Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 129, 3.5.2022, p. 1).

(7)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).