Commission Delegated Regulation (EU) 2023/1656 of 16 June 2023 amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides and industrial chemicals (Text with EEA relevance)
Commission Delegated Regulation (EU) 2023/1656of 16 June 2023amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides and industrial chemicals(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicalsOJ L 201, 27.7.2012, p. 60., and in particular Article 23(4), point (a), thereof,Whereas:(1)Regulation (EU) No 649/2012 implements the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International TradeOJ L 63, 6.3.2003, p. 29. ("the Rotterdam Convention").(2)By Implementing Regulations (EU) 2021/1379Commission Implementing Regulation (EU) 2021/1379 of 19 August 2021 concerning the non-renewal of approval of the active substance famoxadone, 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 (OJ L 297, 20.8.2021, p. 32). and (EU) 2022/94Commission Implementing Regulation (EU) 2022/94 of 24 January 2022 concerning the non-renewal of the approval of the active substance phosmet, 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 16, 25.1.2022, p. 33)., the Commission decided not to renew the approval of the substances famoxadone and phosmet, respectively, as active substances under Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilRegulation (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 (OJ L 309, 24.11.2009, p. 1).. The effect of that decision is that famoxadone and phosmet are banned from all use in the category "pesticides", due to the fact that they have not been approved for any other use in that category. Therefore, famoxadone and phosmet should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(3)By Implementing Regulation (EU) 2021/2081Commission Implementing Regulation (EU) 2021/2081 of 26 November 2021 concerning the non-renewal of approval of the active substance indoxacarb, 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 (OJ L 426, 29.11.2021, p. 28)., the Commission decided not to renew the approval of the substance indoxacarb as an active substance under Regulation (EC) No 1107/2009. That decision amounts to a severe restriction of the use of that substance at the level of the category "pesticides", considering that indoxacarb is only approved for use in biocidal products under Regulation (EU) No 528/2012 of the European Parliament and of the CouncilRegulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). for product-type 18 in the subcategory "other pesticide including biocides". Therefore, indoxacarb should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(4)By Implementing Regulation (EU) 2021/795Commission Implementing Regulation (EU) 2021/795 of 17 May 2021 withdrawing the approval of the active substance alpha-cypermethrin 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 (OJ L 174, 18.5.2021, p. 2). the Commission decided to withdraw the approval of the substance alpha-cypermethrin as an active substance under Regulation (EC) No 1107/2009. The effect of that decision is that alpha-cypermethrin is banned from use in the subcategory "pesticide in the group of plant protection products". In addition, the harmonised classification of alpha-cypermethrin under Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilRegulation (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). is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, alpha-cypermethrin should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.(5)The active substance bromadiolone has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that bromadiolone is banned from use in the subcategory "pesticide in the group of plant protection products". In addition, the harmonised classification of bromadiolone under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, bromadiolone should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.(6)The active substance metam-sodium has been withdrawn by industry from the approval process under Regulation (EU) No 528/2012. The effect of that withdrawal is that metam-sodium is banned from all use in the subcategory "other pesticide including biocides". In addition, the harmonised classification of that substance under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, metam-sodium should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.(7)By Implementing Regulation (EU) 2022/782Commission Implementing Regulation (EU) 2022/782 of 18 May 2022 withdrawing the approval of the active substance isopyrazam 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, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012 (OJ L 140, 19.5.2022, p. 3). the Commission decided to withdraw the approval of the substance isopyrazam as an active substance under Regulation (EC) No 1107/2009. The effect of that decision is that isopyrazam is banned from all use in the category "pesticides", due to the fact that it has not been approved for any other use in that category. Therefore, isopyrazam should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(8)The active substance diuron has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that the use of diuron is severely restricted at the level of the category "pesticides", considering that diuron is only allowed to be used in biocidal products under Regulation (EU) No 528/2012 for product-types 7 and 10 in the subcategory "other pesticide including biocides". In addition, the harmonised classification of diuron under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, diuron should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(9)The active substances azimsulfuron, carbetamide, carboxin, cyproconazole, ethametsulfuron-methyl, etridiazole, fenbuconazole, fluquinconazole, lufenuron, metosulam, myclobutanil, pencycuron, prochloraz, profoxydim, spirodiclofen and triflumizole have been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that those substances are banned from all use in the category "pesticides", due to the fact that they have not been approved for any other use in that category. In addition, the harmonised classification of those substances under Regulation (EC) No 1272/2008 is sufficient evidence that the substances raise concerns for human health or the environment. Therefore, those substances should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(10)By Implementing Decisions (EU) 2018/622Commission Implementing Decision (EU) 2018/622 of 20 April 2018 not approving chlorophene as an existing active substance for use in biocidal products of product-type 3 (OJ L 102, 23.4.2018, p. 80)., (EU) 2020/1765Commission Implementing Decision (EU) 2020/1765 of 25 November 2020 not approving chlorophene as an existing active substance for use in biocidal products of product-type 2 (OJ L 397, 26.11.2020, p. 24). and (EU) 2021/98Commission Implementing Decision (EU) 2021/98 of 28 January 2021 not approving esbiothrin as an existing active substance for use in biocidal products of product-type 18 (OJ L 31, 29.1.2021, p. 214)., the Commission decided not to approve the substances chlorophene and esbiothrin as active substances under Regulation (EU) No 528/2012. The effect of that decision is that chlorophene and esbiothrin are banned from all use in the category "pesticides", due to the fact that the substances have not been approved for any other use in that category. Therefore, chlorophene and esbiothrin should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(11)The active substance fenoxycarb has been withdrawn by industry from the approval processes under Regulation (EC) No 1107/2009 and under Regulation (EU) No 528/2012. The effect of those withdrawals is that fenoxycarb is banned from use in the category "pesticides". In addition, the harmonised classification of fenoxycarb under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, fenoxycarb should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(12)By Commission Delegated Regulation (EU) 2018/172Commission Delegated Regulation (EU) 2018/172 of 28 November 2017 amending Annexes I and V to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L 32, 6.2.2018, p. 6)., the substance triflumuron has been added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012, based on a ban in the subcategory "other pesticide including biocides". In addition, the active substance triflumuron has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009 and the conclusions of the risk assessment under Regulation (EU) No 528/2012 constitute sufficient evidence that the substance raises concerns for human health or the environment, which amounts to a ban in the subcategory "pesticide in the group of plant protection products". Consequently, triflumuron is banned from all use in the category "pesticides" and should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.(13)By Commission Delegated Regulation (EU) No 1078/2014Commission Delegated Regulation (EU) No 1078/2014 of 7 August 2014 amending Annex I to Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (OJ L 297, 15.10.2014, p. 1)., the substance cyfluthrin has been added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012, based on a ban in the subcategory "pesticide in the group of plant protection products". That ban amounts to a severe restriction of the use of that substance at the level of the category "pesticides", considering that cyfluthrin is only approved for use in biocidal products under Regulation (EU) No 528/2012 for product-type 18 in the subcategory "other pesticide including biocides". Therefore, cyfluthrin should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.(14)The substances chlorfenvinphos and terbufos are not approved as active substances under Regulation (EC) No 1107/2009 and those substances are not approved as active substances under Regulation (EU) No 528/2012. Consequently, chlorfenvinphos and terbufos are banned from all use in the category "pesticides" and should be listed in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012. Since chlorfenvinphos and terbufos are already listed in Part 1 they should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.(15)The substances 1-bromopropane, diisopentyl phthalate, 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich, 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, 1,2-benzenedicarboxylic acid, dipentylester, branched and linear, bis(2-methoxyethyl) phthalate, dipentyl phthalate and n-pentyl-isopentyl phthalate are listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilRegulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). since they have been previously identified as substances of very high concern. Consequently, those substances are subject to authorisation in accordance with Title VII of Regulation (EC) No 1907/2006. Since no authorisations have been granted, those substances are severely restricted for industrial use. Therefore, those substances should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.(16)At its tenth meeting held from 6 to 17 June 2022, the Conference of the Parties to the Rotterdam Convention decided to include decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex III to that Convention, with the effect that those chemicals became subject to the prior informed consent procedure under that Convention. Consequently, those chemicals should be added to the list of chemicals set out in Part 3 of Annex I to Regulation (EU) No 649/2012. Since decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds are already listed in Part 2 of Annex I to that Regulation, those chemicals should be removed from the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.(17)The entries for bromoxynil, epoxiconazole and nonylphenol ethoxylates included in the lists of chemicals set out in Parts 1 and 2 of Annex I should be amended by clarifying the scope or adding additional numerical identifiers in order to facilitate implementation of Regulation (EU) No 649/2012.(18)Regulation (EU) No 649/2012 should therefore be amended accordingly.(19)It is appropriate to provide for a reasonable period of time for interested parties to take the measures necessary to comply with this Regulation and for Member States to take the measures necessary for its implementation,HAS ADOPTED THIS REGULATION:
Article 1Annex I to Regulation (EU) No 649/2012 is amended in accordance with the Annex to this Regulation.
Article 2This 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 November 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 16 June 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXAnnex I to Regulation (EU) No 649/2012 is amended as follows:(1)in Part 1, in the table, the following entries are added:
ChemicalCAS NoEC NoCN code(***)Subcategory (*)Use limitation (**)Countries for which no notification is required
"1-bromopropane (n-propyl bromide) (+)106-94-5203-445-0ex29036919i(1)-i(2)sr-b
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (+)71888-89-6276-158-1ex29173400i(1)-i(2)sr-b
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (+)68515-42-4271-084-6ex29173400i(1)-i(2)sr-b
1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear (+)84777-06-0284-032-2ex29173400i(1)-i(2)sr-b
Alpha-cypermethrin67375-30-8ex29269070p(1)b
Azimsulfuron (+)120162-55-2ex29359090p(1)b
Bis(2-methoxyethyl) phthalate (+)117-82-8204-212-6ex29173400i(1)-i(2)sr-b
Bromadiolone28772-56-7249-205-9ex29322090p(1)b
Carbetamide (+)16118-49-3240-286-6ex29242970p(1)b
Carboxin (+)5234-68-4226-031-1ex29349990p(1)b
Chlorophene (+)120-32-1204-385-8ex29081900p(2)b
Cyproconazole (+)94361-06-5ex29339980p(1)b
Diisopentyl phthalate (+)605-50-5210-088-4ex29173400i(1)-i(2)sr-b
Dipentyl phthalate (+)131-18-0205-017-9ex29173400i(1)-i(2)sr-b
Diuron (+)330-54-1206-354-4ex29242100p(1)b
Esbiothrin (+)260359-57-7ex29162000p(2)b
Ethametsulfuron-methyl (+)97780-06-8ex29359090p(1)b
Etridiazole (+)2593-15-9219-991-8ex29349990p(1)b
Famoxadone (+)131807-57-3ex29349990p(1)b
Fenbuconazole (+)114369-43-6406-140-2ex29339980p(1)b
Fenoxycarb (+)72490-01-8276-696-7ex29242970p(1)-p(2)b-b
Fluquinconazole (+)136426-54-5411-960-9ex29335995p(1)b
Indoxacarb (+)173584-44-6144171-61-9ex29349990p(1)b
Isopyrazam (+)881685-58-1ex29331990p(1)b
Lufenuron (+)103055-07-8410-690-9ex29242100p(1)b
Metam-sodium137-42-8205-293-0ex29302000p(2)b
Metosulam (+)139528-85-1410-240-1ex29359030p(1)b
Myclobutanil (+)88671-89-0410-400-0ex29339980p(1)b
n-pentyl-isopentyl phthalate (+)776297-69-9ex29173400i(1)-i(2)sr-b
Pencycuron (+)66063-05-6266-096-3ex29242100p(1)b
Phosmet (+)732-11-6211-987-4ex29309098p(1)b
Prochloraz (+)67747-09-5266-994-5ex29332990p(1)b
Profoxydim (+)139001-49-3ex29349990p(1)b
Spirodiclofen (+)148477-71-8ex29322090p(1)b
Triflumizole (+)68694-11-1ex29332990p(1)b"
(2)in Part 1, in the table, the entries for bis(pentabromophenyl) ether, bromoxynil, chlorfenvinphos, cyfluthrin, epoxiconazole, nonylphenol ethoxylates, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, terbufos and triflumuron are replaced by the following entries:
ChemicalCAS NoEC NoCN code(***)Subcategory (*)Use limitation (**)Countries for which no notification is required
"Bis(pentabromophenyl) ether (decabromodiphenyl ether) (#)1163-19-5214-604-9ex29093038i(1)-i(2)sr-b
Bromoxynil and its butyryl, heptanoyl and octanoyl esters (+)1689-84-53861-41-456634-95-81689-99-2216-882-7223-374-9260-300-4216-885-3ex29269070p(1)b
Chlorfenvinphos (+)470-90-6207-432-0ex29199000p(1)-p(2)b-b
Cyfluthrin (+)68359-37-5269-855-7ex29269070p(1)b
Epoxiconazole (+)135319-73-2133855-98-8406-850-2ex29349990p(1)b
Nonylphenol ethoxylates (C2H4O)nC15H24O (+)9016-45-926027-38-368412-54-437205-87-1127087-87-0and others500-024-6500-045-0500-209-1932-337-2500-315-8and othersex34024200ex39072911ex38249992i(1)-i(2)p(1)-p(2)sr-srb-b
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (#)335-67-1and others206-397-9and othersex29159070i(1)-i(2)sr-b
Terbufos (+)13071-79-9235-963-8ex29309098p(1)-p(2)b-b
Triflumuron (+)64628-44-0264-980-3ex29242100p(1)-p(2)b-b"
(3)in Part 2, in the table, the following entries are added:
ChemicalCAS NoEC NoCN code(***)Category (*)Use limitation (**)
"1-bromopropane (n-propyl bromide)106-94-5203-445-0ex29036919isr
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich71888-89-6276-158-1ex29173400isr
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters68515-42-4271-084-6ex29173400isr
1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear84777-06-0284-032-2ex29173400isr
Azimsulfuron120162-55-2ex29359090pb
Bis(2-methoxyethyl) phthalate117-82-8204-212-6ex29173400isr
Carbetamide16118-49-3240-286-6ex29242970pb
Carboxin5234-68-4226-031-1ex29349990pb
Chlorfenvinphos470-90-6207-432-0ex29199000pb
Chlorophene120-32-1204-385-8ex29081900pb
Cyfluthrin68359-37-5269-855-7ex29269070psr
Cyproconazole94361-06-5ex29339980pb
Diisopentyl phthalate605-50-5210-088-4ex29173400isr
Dipentyl phthalate131-18-0205-017-9ex29173400isr
Diuron330-54-1206-354-4ex29242100psr
Esbiothrin260359-57-7ex29162000pb
Ethametsulfuron-methyl97780-06-8ex29359090pb
Etridiazole2593-15-9219-991-8ex29349990pb
Famoxadone131807-57-3ex29349990pb
Fenbuconazole114369-43-6406-140-2ex29339980pb
Fenoxycarb72490-01-8276-696-7ex29242970pb
Fluquinconazole136426-54-5411-960-9ex29335995pb
Indoxacarb173584-44-6144171-61-9ex29349990psr
Isopyrazam881685-58-1ex29331990pb
Lufenuron103055-07-8410-690-9ex29242100pb
Metosulam139528-85-1410-240-1ex29359030pb
Myclobutanil88671-89-0410-400-0ex29339980pb
n-pentyl-isopentyl phthalate776297-69-9ex29173400isr
Pencycuron66063-05-6266-096-3ex29242100pb
Phosmet732-11-6211-987-4ex29309098pb
Prochloraz67747-09-5266-994-5ex29332990pb
Profoxydim139001-49-3ex29349990pb
Spirodiclofen148477-71-8ex29322090pb
Terbufos13071-79-9235-963-8ex29309098pb
Triflumizole68694-11-1ex29332990pb
Triflumuron64628-44-0264-980-3ex29242100pb"
(4)in Part 2, in the table, the entries for bromoxynil, epoxiconazole and nonylphenol ethoxylates are replaced by the following entries:
ChemicalCAS NoEC NoCN code(***)Category (*)Use limitation (**)
"Bromoxynil and its butyryl, heptanoyl and octanoyl esters1689-84-53861-41-456634-95-81689-99-2216-882-7223-374-9260-300-4216-885-3ex29269070pb
Epoxiconazole135319-73-2133855-98-8406-850-2ex29349990pb
Nonylphenol ethoxylates (C2H4O)nC15H24O9016-45-926027-38-368412-54-437205-87-1127087-87-0and others500-024-6500-045-0500-209-1932-337-2500-315-8and othersex34024200ex39072911ex38249992ipsrb"
(5)in Part 2, in the table, the following entries are deleted:
ChemicalCAS NoEC NoCN code(***)Category (*)Use limitation (**)
"Bis(pentabromophenyl) ether1163-19-5214-604-9ex29093038i(1)-i(2)sr-b
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1and others206-397-9and othersex29159070and othersi(1)-i(2)sr-b"
(6)in Part 3, in the table, the following entries are added:
ChemicalRelevant CAS number(s)HS codePure substance (**)HS codeMixtures containing substance (**)Category
"Bis(pentabromophenyl) ether (decabromodiphenyl ether)1163-19-52909.303824.99Industrial
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1and others2915.90and othersIndustrial"