Date: 2018-01-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2018/112 of 24 January 2018 renewing the approval of the low-risk active substance laminarin 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:
Commission Implementing Regulation (EU) 2018/112 renews the approval of laminarin as a low-risk active substance for plant protection products, in accordance with Regulation (EC) No 1107/2009. The regulation amends Implementing Regulation (EU) No 540/2011 and takes effect on March 1, 2018. It is binding in its entirety and directly applicable in all Member States.
Key Points / Main Content:
Renewal of Laminarin Approval:
* The approval of laminarin as a low-risk active substance is renewed, as detailed in Annex I.
* The expiration date of the renewed approval is February 28, [year after publication].
* Conditions of use must include risk mitigation measures.
Amendments to Implementing Regulation (EU) No 540/2011:
* The Annex to Implementing Regulation (EU) No 540/2011 is amended according to Annex II of this regulation.
* In Part A, the original entry for laminarin (entry 95) is deleted.
* In Part D, a new entry for laminarin is added, specifying its properties and conditions for use.
Entry Into Force:
* The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* It applies from March 1, 2018.
Impact Analysis:
European Commission:
Impact: Responsible for implementing and enforcing the regulation.
Action Required: Ensure the regulation is properly integrated into relevant frameworks and monitor its application.
Member States:
Impact: Directly bound by the regulation and responsible for its application within their territories.
Action Required: Amend national regulations and practices to align with the renewed approval of laminarin and the amended Implementing Regulation (EU) No 540/2011.
Plant Protection Product Manufacturers/Applicants:
Impact: Can continue to use laminarin in their products, subject to the conditions outlined in the renewed approval.
Action Required: Ensure that plant protection products containing laminarin comply with the specific provisions and risk mitigation measures outlined in the regulation and renewal report.
European Food Safety Authority (EFSA):
Impact: Responsible for providing scientific opinions and assessments related to laminarin.
Action Required: Continue to provide scientific support and expertise as needed for the ongoing evaluation and monitoring of laminarin.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
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 implementing Regulation EC No 1107/2009 as regards the list of approved active substances.
laminarin: A low-risk active substance, a polysaccharide found in brown algae, used in plant protection products.
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.
Commission Implementing Regulation EU No 844/2012: Commission Implementing Regulation setting out the provisions necessary for the implementation of the renewal procedure for active substances.
Standing Committee on Plants, Animals, Food and Feed: A committee of the European Union that provides opinions on measures relating to plant health, animal health, food and feed safety.
Brussels: The de facto capital city of the European Union, located in Belgium, where the regulation was adopted.
25.1.2018 EN Official Journal of the European Union L 20/3
COMMISSION IMPLEMENTING REGULATION (EU) 2018/112
of 24 January 2018
renewing the approval of the low-risk active substance laminarin 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 22(1) in conjunction with Article 20(1) thereof,
Whereas:
(1) Commission Directive 2005/3/EC (2) included laminarin as 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 laminarin, as set out in Part A of the Annex to Implementing Regulation
(EU) No 540/2011, expires on 31 July 2018.
(4) An application for the renewal of the approval of laminarin was submitted in accordance with Article 1 of
Commission Implementing Regulation (EU) No 844/2012 (5) 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 complete by the rapporteur Member State.
(6) The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur
Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on
22 April 2016.
(7) The Authority communicated the renewal assessment report to the applicant and to the Member States for
comments and forwarded the comments received to the Commission. The Authority also made the supple
mentary summary dossier available to the public.
(8) On 3 May 2017 the Authority communicated to the Commission its conclusion (6) on whether the active
substance laminarin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC)
No 1107/2009. The Commission presented the draft renewal report for laminarin to the Standing Committee on
Plants, Animals, Food and Feed on 5 October 2017.
(9) The applicant was given the possibility to submit comments on the renewal report.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Directive 2005/3/EC of 19 January 2005 amending Council Directive 91/414/EEC to include imazosulfuron, laminarin,
methoxyfenozide and s-metolachlor as active substances (OJ L 20, 22.1.2005, p. 19).
(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 implemen
tation 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).
(6) EFSA Journal 2014;12(10):3868.L 20/4 EN Official Journal of the European Union 25.1.2018
(10) It has been established with respect to one or more representative uses of at least one plant protection product
containing laminarin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are
satisfied. It is therefore appropriate to renew the approval of laminarin.
(11) The risk assessment for the renewal of the approval of laminarin is based on a limited number of representative
uses, which however do not restrict the uses for which plant protection products containing laminarin may be
authorised. It is therefore appropriate to remove the restriction for use only as an elicitor.
(12) The Commission further considers that laminarin is a low-risk active substance pursuant to Article 22 of
Regulation (EC) No 1107/2009. Laminarin is not a substance of concern and fulfils the conditions set in point 5
of Annex II to Regulation (EC) No 1107/2009. Laminarin is a polysaccharide found in brown algae and naturally
ocurring in the environment. 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 natural exposure.
(13) It is therefore appropriate to renew the approval of laminarin as a low-risk substance.
(14) In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof,
the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(15) Commission Implementing Regulation (EU) 2017/841 (1) extended the approval period of laminarin in order to
allow the renewal process to be completed before the expiry of the approval of that substance. However, given
that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from
1 March 2018.
(16) 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
Renewal of the approval of active substance
The approval of the low-risk active substance laminarin is renewed as set out in Annex I.
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 March 2018.
(1) Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10,
benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459
(flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foramsulfuron, Gliocladium catenulatum strain: j1446,
imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl-m, methoxyfenozide, milbemectin, oxasulfuron, pendimethalin,
phenmedipham, pymetrozine, s-metolachlor, and trifloxystrobin (OJ L 125, 18.5.2017, p. 12).25.1.2018 EN Official Journal of the European Union L 20/5
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 January 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX I
Common Name, Expiration of
IUPAC Name Purity(1) Date of approval Specific provisions
Identification Numbers approval
Laminarin (1!3)-β-D-glucan ≥ 860 g/kg on dry 1 March 2018 28 February For the implementation of the uniform principles, as referred to in
matter (TC) 2033 Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
CAS No 9008-22-4 (according to IUPAC-IUB
the renewal report on laminarin, and in particular Appendices I
Joint Commission on Bio
CIPAC No 671 and II thereto, shall be taken into account.
chemical Nomenclature)
Conditions of use shall include risk mitigation measures, where ap
propriate.
(1) Further details on identity and specification of active substance are provided in the renewal report.
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, the entry 95 on laminarin is deleted;
(2) in Part D, the following entry is added:
Common Name, Expiration of
Number IUPAC Name Purity(1) Date of approval Specific provisions
Identification Numbers approval
‘12 Laminarin (1!3)-β-D-glucan ≥ 860 g/kg on 1 March 2018 28 February For the implementation of the uniform principles, as referred to
dry matter (TC) 2033 in Article 29(6) of Regulation (EC) No 1107/2009, the conclu
CAS No 9008-22-4 (according to IUPAC-IUB
sions of the renewal report on laminarin, and in particular
Joint Commission on
CIPAC No 671 Appendices I and II thereto, shall be taken into account.
Biochemical
Nomenclature) Conditions of use shall include risk mitigation measures, where
appropriate.’
(1) Further details on identity and specification of active substance are provided in the renewal report.
L
20/6
EN
Official
Journal
of
the
European
Union
25.1.2018