Commission Implementing Regulation (EU) 2020/653 of 14 May 2020 correcting Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 as regards the CAS number of the active substance carvone (Text with EEA relevance)
Date: 2020-05-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, plant health control, plant health product








L_2020152EN.01000101.xml










15.5.2020   


EN


Official Journal of the European Union


L 152/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2020/653
of 14 May 2020
         
correcting Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 as regards the CAS number of the active substance carvone
(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 Implementing Regulation (EU) 2019/706 (2) renewed the approval of the active substance carvone and included it in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3).












(2)


After Implementing Regulation (EU) 2019/706 entered into force, an error was noted concerning the CAS number (Chemical Abstracts Number of the American Chemical Society) used for the active substance carvone in the Annexes to Implementing Regulation (EU) 2019/706.












(3)


The CAS number is a unique chemical substance identifier, which is also used for an active substance contained in plant protection products; it is used as reference for the purpose of trade and regulatory activities for chemicals globally and not limited to pesticidal substances. The column on common name and identification numbers erroneously mention ‘carvone 244-16-8’. This specification should be replaced by ‘carvone 2244-16-8’.












(4)


The active substance Carvone has several CAS numbers. However, only one has been granted the approval as a plant protection product. The CAS numbers as mentioned in Union implementing acts authorising active substances are taken over in international databases and references are used for the purpose of subsequent authorisation of plant protection products in Member States and outside the Union. CAS number 244-16-8 does not correspond to any existing registered chemical substance; the active substance therefore would not be properly identified for the purpose of the approval of the plant protection products. Therefore, as confusion about the substance identity may arise in chemicals management and trade, a correction of the CAS number mentioned in the Annexes to Implementing Regulation (EU) 2019/706 and consequently in Implementing Regulation (EU) No 540/2011 is necessary.












(5)


For reasons of clarity, it is appropriate to replace Annex I to Implementing Regulation (EU) 2019/706 and the relevant entry 135 in the Annex to Implementing Regulation (EU) No 540/2011.












(6)


In the interest of clarity and legal certainty for economic operators and enforcement authorities, this Regulation should enter into force as a matter of urgency.












(7)


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

Correction to Implementing Regulation (EU) 2019/706

Annex I to Implementing Regulation (EU) 2019/706 is corrected in accordance with Annex I to this Regulation.


Article 2

Correction to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is corrected in accordance with Annex II to this Regulation.


Article 3

Entry into force

This Regulation shall enter into force on the day 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, 14 May 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) 2019/706 of 7 May 2019 renewing the approval of the active substance carvone 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 120, 8.5.2019, p. 11).

(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).




ANNEX I
Annex I to Implementing Regulation (EU) 2019/706 is replaced by the following:











‘Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




carvone
2244-16-8 (d-carvone = S-carvone = (+)-carvone)
Carvone: 602
d-carvone: not allocated


(S)-5-isopropenyl-2-methylcyclohex-2-en-1-one
or
(S)-p-mentha-6,8-dien-2-one


923 g/kg d-carvone


1 August 2019


31 July 2034


For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.




Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:






—


the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.




The applicant shall submit that information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.







(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.’
         





ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, entry 135 on carvone is replaced by the following entry:












No


Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Expiration of approval


Specific provisions




‘135


carvone
2244-16-8 (d-carvone = S-carvone = (+)-carvone)
Carvone: 602
d-carvone: not allocated


(S)-5-isopropenyl-2-methylcyclohex-2-en-1-one
Or
(S)-p-mentha-6,8-dien-2-one


923 g/kg d-carvone


1 August 2019


31 July 2034


For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:






—


the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.




Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:






—


the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.




The applicant shall submit that information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’







(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.