Date: 2020-07-14Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/1018 of 13 July 2020 approving ferric pyrophosphate as low-risk active substance 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 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) 2020/1018 approves ferric pyrophosphate as a low-risk active substance, in accordance with Regulation (EC) No 1107/2009, and amends Commission Implementing Regulation (EU) No 540/2011. The regulation, effective August 3, 2020, establishes that ferric pyrophosphate meets the approval criteria and is considered a low-risk substance due to its negligible additional exposure to humans, animals, and the environment.
Key Points / Main Content:
Approval of Ferric Pyrophosphate:
* Ferric pyrophosphate is approved as a low-risk active substance.
* The approval is based on the satisfaction of criteria outlined in Article 4 of Regulation (EC) No 1107/2009, particularly regarding representative uses detailed in the review report.
* The substance is not considered a substance of concern and fulfills conditions set out in point 5 of Annex II to Regulation (EC) No 1107/2009
Amendment to Implementing Regulation (EU) No 540/2011:
* Implementing Regulation (EU) No 540/2011 is amended to include ferric pyrophosphate in the list of approved active substances, as detailed in Annex II of this regulation.
* Annex I specifies that for the implementation of uniform principles as referred to in Article 296 of Regulation (EC) No 1107/2009, the conclusions of the review report on ferric pyrophosphate shall be taken into account.
* Impurities of toxicological and environmental concern must not exceed specified levels in the technical material.
Effective Date:
* The regulation came into force on August 3, 2020, which is the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
European Commission:
Impact: The Commission has adopted a regulation approving ferric pyrophosphate and amending existing regulations.
Action Required: Ensure the implementation and enforcement of the new regulation across Member States.
Member States:
Impact: Member States must apply the provisions of the regulation, including the approval conditions for ferric pyrophosphate.
Action Required: Incorporate the changes into their national regulations and ensure compliance with the specified conditions for ferric pyrophosphate use.
Plant Protection Product Manufacturers/Applicants:
Impact: Manufacturers of plant protection products containing ferric pyrophosphate benefit from its approval as a low-risk active substance.
Action Required: Adhere to the specific provisions outlined in Annex I regarding purity, impurities, and the implementation of uniform principles in accordance with Regulation (EC) No 1107/2009.
European Food Safety Authority (EFSA):
Impact: EFSA's conclusion on the peer review of ferric pyrophosphate's risk assessment supports the Commission's decision.
Action Required: Continue to provide scientific advice and risk assessments related to active substances in plant protection products.
BROS Sp. z o.o. Sp.k. (Applicant):
Impact: The applicant's submission led to the approval of ferric pyrophosphate.
Action Required: Comply with all conditions and specifications outlined in the approval.
Standing Committee on Plants, Animals, Food and Feed:
Impact: The measures were in accordance with the opinion of the committee.
Action Required: Continue to provide opinions on implementing regulations.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Regulation EU 2020/1018: A regulation approving ferric pyrophosphate as a low-risk active substance.
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 regarding the list of approved active substances.
European Parliament: Legislative branch of the European Union.
Council Directives 79/117/EEC: Council Directive related to placing of plant protection products on the market.
Council Directives 91/414/EEC: Council Directive concerning the placing of plant protection products on the market.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on risks associated with the food chain.
14.7.2020 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 L 225/9
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1018
of 13 July 2020
approving ferric pyrophosphate as low-risk active substance 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 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 13(2) in conjunction with Article 22(1) thereof,
Whereas:
(1) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, BROS Sp. z o.o. Sp.k. submitted to Poland on
28 December 2015 an application for the approval of the active substance ferric pyrophosphate.
(2) In accordance with Article 9(3) of that Regulation, Poland, as rapporteur Member State, notified the applicant, the
other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility
of the application on 24 June 2016.
(3) On 21 August 2018, the rapporteur Member State submitted a draft assessment report to the Commission with a
copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria
provided for in Article 4 of Regulation (EC) No 1107/2009.
(4) The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of
Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States,
the Commission and the Authority. The assessment of the additional information by the rapporteur Member State
was submitted to the Authority in the format of an updated draft assessment report on 9 August 2019.
(5) On 17 December 2019, the Authority communicated to the applicant, the Member States and the Commission its
conclusion(2) on whether the active substance ferric pyrophosphate can be expected to meet the approval criteria
provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the
public.
(6) On 23 and 24 March 2020, the Commission presented to the Standing Committee on Plants, Animals, Food and
Feed the review report for ferric pyrophosphate and on 19 May 2020, the draft of this Regulation providing that
ferric pyrophosphate is approved.
(7) The applicant was given the possibility to submit comments on the review report.
(8) It has been established with respect to one or more representative uses of at least one plant protection product
containing the active substance, and in particular the uses which were examined and detailed in the review report,
that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(9) The Commission further considers that ferric pyrophosphate is a low-risk active substance pursuant to Article 22 of
Regulation (EC) No 1107/2009. In fact, ferric pyrophosphate is not a substance of concern and it fulfils the
conditions set out in point 5 of Annex II to Regulation (EC) No 1107/2009, including the second subparagraph of
point 5.1.2. More specifically, even though ferric pyrophosphate is considered persistant, it eventually dissociates
into ions which are a natural constituent of the human diet, that are ubiquitous in the environment, and essential
for animal and plant functions. Consequently, the additional exposure of humans, animals and the environment by
the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure
expected through realistic natural situations
(1) OJ L 309, 24.11.2009, p. 1.
(2) EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of the pesticide risk assessment of the active substance
ferric pyrophosphate. EFSA Journal 2020;18(1):5986, 25 pp. doi:10.2903/j.efsa.2020.5986.L 225/10 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 14.7.2020
(10) It is therefore appropriate to approve ferric pyrophosphate as a low-risk substance.
(11) In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU)
No 540/2011(3) should be amended accordingly.
(12) 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
Approval of the active substance
The active substance ferric pyrophosphate, as specified in Annex I, is approved subject to the conditions laid down in that
Annex.
Article 2
Amendments to Implementing Regulation (EU) No 540/2011
mplementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3
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, 13 July 2020.
For the Commission
The President
Ursula VON DER LEYEN
(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
Common Name, Date of Expiration of
IUPAC Name Purity (1) Specific provisions
Identification Numbers approval approval
Ferric pyrophosphate iron(3+) diphosphate ≥ 802 g/kg 3.8.2020 3.8.2035 For the implementation of the uniform principles as
CAS No: 10058-44-3 referred to in Article 29(6) of Regulation (EC)
CIPAC No: — The following impurities are of toxicological and No 1107/2009, the conclusions of the review re
enviromental concern and must not exceed the fol port on ferric pyrophosphate, and in particular
lowing levels in the technical material: Appendices I and II thereto, shall be taken into ac
count.
— Lead: 3 mg/kg
— Mercury: 0,1 mg/kg
— Cadmium: 1 mg/kg
(1) Further details on identity and specification of active substance are provided in the review report.
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In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Common Name,
Date of Expiration of
No Identification IUPAC Name Purity (1) Specific provisions
approval approval
Numbers
‘20 Ferric pyropho iron(3+) diphosphate ≥ 802 g/kg 3.8.2020 3.8.2035 For the implementation of the uniform principles
sphate as referred to in Article 29(6) of Regulation (EC)
CAS No: 10058- The following impurities are of toxicological and No 1107/2009, the conclusions of the review re
44-3 enviromental concern and must not exceed the port on ferric pyrophosphate, and in particular
CIPAC No: — following levels in the technical material: Appendices I and II thereto, shall be taken into
account.’
— Lead: 3 mg/kg
— Mercury: 0,1 mg/kg
— Cadmium: 1 mg/kg
(1) Further details on identity and specification of active substance are provided in the review report.
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