Date: 2020-05-15Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/653 corrects errors in Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 concerning the Chemical Abstracts Service (CAS) number for the active substance carvone. The incorrect CAS number (244168) is replaced with the correct number (2244168) to ensure proper identification and regulatory compliance for plant protection products. This regulation entered into force on the day of its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Correction of CAS Number for Carvone:**
* The CAS number for the active substance carvone in Implementing Regulations (EU) No 540/2011 and (EU) 2019/706 is corrected from 244168 to 2244168.
* Annex I to Implementing Regulation (EU) 2019/706 is replaced with a corrected version as outlined in Annex I of this regulation.
* The entry for carvone (entry 135) in the Annex to Implementing Regulation (EU) No 540/2011 is replaced with a corrected version as outlined in Annex II of this regulation.
* **Basis for the Correction:**
* The original CAS number (244168) does not correspond to any existing registered chemical substance, leading to potential confusion in chemicals management and trade.
* The correction ensures the active substance is properly identified for the approval of plant protection products.
* **Specific Provisions for Member States and Applicants:**
* Member States must consider the renewal report on carvone, particularly Appendices I and II, when implementing uniform principles as per Article 29(6) of Regulation (EC) No 1107/2009.
* Member States shall pay particular attention to the protection of operators, ensuring adequate personal protective equipment is used.
* Conditions of use should include risk mitigation measures and consideration for the necessary time period before entry into storage rooms after application.
* The applicant must submit confirmatory information regarding the effect of water treatment processes on residues in surface and groundwater within two years of the publication of a guidance document by the Commission.
Impact Analysis:
* Economic Operators and Enforcement Authorities:
* Impact: Ensures clarity and legal certainty in trade and regulatory activities related to plant protection products containing carvone.
* Action Required: Take note of the corrected CAS number and ensure compliance in trade and regulatory activities.
* Member States:
* Impact: Must consider the renewal report on carvone when implementing uniform principles and pay particular attention to operator protection.
* Action Required: Implement the specific provisions outlined, including ensuring adequate personal protective equipment and considering risk mitigation measures.
* Applicants (Manufacturers/Producers of Carvone-Based Products):
* Impact: Required to submit confirmatory information regarding the effect of water treatment processes on residues in water sources.
* Action Required: Submit the required information to the Commission, Member States, and the Authority within two years of the publication of the relevant guidance document.
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, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union.
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.
European Parliament: The directly elected parliamentary body of the European Union.
Council of the European Union: A part of the legislative branch of the EU
Carvone: An active substance used in plant protection products, the regulation addresses errors concerning its CAS number.
Implementing Regulation (EU) No 540/2011: A Commission Implementing Regulation regarding the list of approved active substances.
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II
(Non-legislative acts)
REGULATIONS
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.
(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).L 152/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 15.5.2020
(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 LEYENANNEX I
Annex I to Implementing Regulation (EU) 2019/706 is replaced by the following:
‘Common Name, Identification
IUPAC Name Purity (1) Date of approval Expiration of approval Specific provisions
Numbers
carvone (S)-5-isopropenyl-2- 923 g/kg d-carvone 1 August 2019 31 July 2034 For the implementation of the uniform principles, as referred
2244-16-8 (d-carvone = S-car methylcyclohex-2-en-1- to in Article 29(6) of Regulation (EC) No 1107/2009, the con
vone = (+)-carvone) one clusions of the renewal report on carvone, and in particular
Carvone: 602 or Appendices I and II thereto, shall be taken into account.
d-carvone: not allocated (S)-p-mentha-6,8-dien-
In this overall assessment Member States shall pay particular
2-one
attention to:
— the protection of operators, ensuring that conditions of
use include the application of adequate personal protec
tive equipment.
Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be gi
ven to the necessary time period before entry into storage
rooms after the application of plant protection products con
taining 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 gui
dance 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.’
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152/3ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, entry 135 on carvone is replaced by the following entry:
Common Name,
No IUPAC Name Purity (1) Date of approval Expiration of approval Specific provisions
Identification Numbers
‘135 carvone (S)-5-isopropenyl-2- 923 g/kg d-carvone 1 August 2019 31 July 2034 For the implementation of the uniform principles, as
2244-16-8 (d-carvone = methylcyclohex-2-en-1- referred to in Article 29(6) of Regulation (EC)
S-carvone = (+)-carvone) one No 1107/2009, the conclusions of the renewal report
Carvone: 602 Or on carvone, and in particular Appendices I and II there
d-carvone: not allocated (S)-p-mentha-6,8-dien-2- to, shall be taken into account.
one
In this overall assessment Member States shall pay par
ticular attention to:
— the protection of operators, ensuring that condi
tions of use include the application of adequate
personal protective equipment.
Conditions of use shall include risk mitigation mea
sures, 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 infor
mation as regards:
— the effect of water treatment processes on the nat
ure 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 Com
mission, 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.
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