Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution  Text with EEA relevance
Date: 2015-03-11
Institutions: European Commission
Subjects: chemical product, plant health control, plant health product








L_2015067EN.01001801.xml










12.3.2015   


EN


Official Journal of the European Union


L 67/18








            COMMISSION IMPLEMENTING REGULATION (EU) 2015/408
of 11 March 2015
         
on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution
(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 78(2) thereof,

Whereas:







(1)


Active substances are to be identified as candidates for substitution if they meet one or more criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009.












(2)


Pursuant to Article 80(7) of Regulation (EC) No 1107/2009, the Commission has to establish a list of substances included in Annex I to Council Directive 91/414/EEC (2) which satisfy the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009, hereinafter: ‘list of candidates for substitution’.












(3)


To ensure the consistency of the policy of the Union as regards active substances that have properties identifying them as candidates for substitution and to apply equal treatment to such substances, the Commission should also include in that list active substances approved under Regulation (EC) No 1107/2009 pursuant to the transitional provisions of Article 80(1).












(4)


From the information contained in either the review report, or the conclusions of the European Food Safety Authority (3) or the Draft Assessment Report and related addenda and peer review reports, or from the classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4), it was possible to identify the substances which satisfy the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009. These documents provide information, where relevant, concerning the applicable Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD) or Acceptable Operator Exposure Level (AOEL), the information concerning persistent, bio-accumulative and toxic (PBT) properties of the substances, information concerning critical effects referred to in the third indent of point 4 of Annex II to Regulation (EC) No 1107/2009, the proportion of non-active isomers, the classification in accordance with Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B and toxic for reproduction category 1A or 1B, the endocrine disrupting properties. Based on that information, the substances set out in the Annex to this Regulation were identified as satisfying one or more criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009. The information has been consolidated and can be found in a support tool for the establishment of the list of candidates for substitution, which is available on the Commission website (5).












(5)


The Acceptable Daily Intake (ADI) of the active substances 1-methylcyclopropene, amitrole, diclofop, dimethoate, ethoprophos, fenamiphos, fipronil, fluometuron, haloxyfop-P, metam, oxamyl, sulcotrione and triazoxide is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. The Acute Reference Dose (ARfD) of the active substances dimoxystrobin, fenamiphos, methomyl and oxamyl is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. The Acceptable Operator Exposure Level (AOEL) of the active substances amitrole, bromadiolone, difenacoum, dimethoate, diquat, ethoprophos, fenamiphos, fluquinconazole, metam, sulcotrione, triazoxide and warfarin is significantly lower than that of the majority of the approved active substances within their respective groups of substances/use categories. It is therefore appropriate to include those active substances in the list of candidates for substitution.












(6)


The active substances lufenuron, oxyfluorfen and quinoxyfen meet the criteria to be considered a persistent and bioaccumulative substance. The active substances amitrole, bifenthrin, bromuconazole, chlorotoluron (unstated stereochemistry), copper compounds (variants copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture and tribasic copper sulphate), cyproconazole, cyprodinil, difenoconazole, diflufenican, dimoxystrobin, diquat, epoxiconazole, fenbutatin oxide, fludioxonil, flufenacet, fluopicolide, fluquinconazole, haloxyfop-P, imazamox, imazosulfuron, isoproturon, isopyrazam, lenacil, lufenuron, metconazole, metribuzin, metsulfuron-methyl, myclobutanil, nicosulfuron, oxadiazon, oxyfluorfen, paclobutrazol, pirimicarb, prochloraz, propiconazole, propoxycarbazone, prosulfuron, quinoxyfen, tebuconazole, tebufenpyrad, tepraloxydim, tri-allate, triasulfuron and ziram meet the criteria to be considered a persistent and toxic substance. The active substances aclonifen, difenacoum, esfenvalerate, etofenprox, etoxazole, famoxadone, lambda-cyhalothrin, lufenuron, oxyfluorfen, pendimethalin and quinoxyfen meet the criteria to be considered a bioaccumulative and toxic substance. It is therefore appropriate to include those active substances in the list of candidates for substitution.












(7)


The active substances mecoprop and metalaxyl contain a significant proportion of non-active isomers. It is therefore appropriate to include those active substances in the list of candidates for substitution.












(8)


The active substances carbendazim, epoxiconazole, flumioxazine, glufosinate, linuron, oxadiargyl, quizalofop-P (variant quizalofop-P-tefuryl) and warfarin are or are to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B. It is therefore appropriate to include those active substances in the list of candidates for substitution.












(9)


Since measures concerning specific scientific criteria for the determination of endocrine disrupting properties, as referred to in the first paragraph of point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, have not yet been adopted, it was to be established in accordance with the third paragraph thereof whether a substance is to be considered as having such properties. In accordance with that provision the active substances chlorotoluron (unstated stereochemistry), dimoxystrobin, epoxiconazole, molinate, profoxydim, tepraloxydim and thiacloprid are to be considered as having endocrine disrupting properties that may cause adverse effects in humans. It is therefore appropriate to include those active substances in the list of candidates for substitution.












(10)


Member States and interested parties should be provided with a reasonable period to adapt to the provisions of this Regulation.












(11)


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

Candidates for substitution

Active substances included in Annex I to Directive 91/414/EEC which fulfil the criteria set out in point 4 of Annex II to Regulation (EC) No 1107/2009 shall be as set out in the list in the Annex to this Regulation.
The first paragraph shall also apply to active substances approved under Regulation (EC) No 1107/2009 pursuant to the transitional measures of Article 80(1).


Article 2

Transitional measures

Article 1 and the Annex shall not apply to applications for the authorisation of plant protection products submitted before 1 August 2015.


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, 11 March 2015.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  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).

(3)  http://www.efsa.europa.eu/en/publications/efsajournal.htm

(4)  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).

(5)  http://ec.europa.eu/food/plant/pesticides/index_en.htm




ANNEX






 


1-methylcyclopropene










 


aclonifen










 


amitrole










 


bifenthrin










 


bromadiolone










 


bromuconazole










 


carbendazim










 


chlorotoluron (unstated stereochemistry)










 


copper compounds (variants copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture and tribasic copper sulphate)










 


cyproconazole










 


cyprodinil










 


diclofop










 


difenacoum










 


difenoconazole










 


diflufenican










 


dimethoate










 


dimoxystrobin










 


diquat










 


epoxiconazole










 


esfenvalerate










 


ethoprophos










 


etofenprox










 


etoxazole










 


famoxadone










 


fenamiphos










 


fenbutatin oxide










 


fipronil










 


fludioxonil










 


flufenacet










 


flumioxazine










 


fluometuron










 


fluopicolide










 


fluquinconazole










 


glufosinate










 


haloxyfop-P










 


imazamox










 


imazosulfuron










 


isoproturon










 


isopyrazam










 


lambda-cyhalothrin










 


lenacil










 


linuron










 


lufenuron










 


mecoprop










 


metalaxyl










 


metam










 


metconazole










 


methomyl










 


metribuzin










 


metsulfuron-methyl










 


molinate










 


myclobutanil










 


nicosulfuron










 


oxadiargyl










 


oxadiazon










 


oxamyl










 


oxyfluorfen










 


paclobutrazol










 


pendimethalin










 


pirimicarb










 


prochloraz










 


profoxydim










 


propiconazole










 


propoxycarbazone










 


prosulfuron










 


quinoxyfen










 


quizalofop-P (variant quizalofop-P-tefuryl)










 


sulcotrione










 


tebuconazole










 


tebufenpyrad










 


tepraloxydim










 


thiacloprid










 


tri-allate










 


triasulfuron










 


triazoxide










 


warfarin










 


ziram