EU｜BPR見直しプログラムの対象物質更新－附属書IIの刷新

2022.06.06

EU｜BPR見直しプログラムの対象物質更新－附属書IIの刷新

見直しプログラム対象物質更新

2022年05月30日、欧州官報で殺生物性製品規則に基づく見直しプログラム（レビュープログラム）について定める委任規則(EU) No 1062/2014の附属書IIを修正する規則(EU) 2022/825が公布されました。

見直しプログラム（レビュープログラム）とは？

見直しプログラム（レビュープログラム）は、殺生物製品に含まれる既存の殺生物性の活性物質を審査するための作業プログラムで、殺生物性製品指令（BPD）の下で欧州委員会によって設置され、殺生物性製品規則（BPR）の下で継続されている取り組みです。対象となるのは、「既存活性物質」です。

「既存活性物質」とは、2000年5月14日に殺生物製品の活性物質として上市されていた物質（科学的または製品・プロセス指向の研究開発（PPORD）以外の目的）をいいます。見直しプログラムの審査対象として認められた既存活性物質は、欧州委員会規則(EU) No 1062/2014の附属書IIに規定されているように、そのように特定され、届出が受理されたものを指します。

BPR第89条に規定された経過措置により、審査プログラムに含まれる活性物質を含む殺生物製品は、特定の製品タイプについて、承認の日から3年後まで、各国の規則に従って上市および使用することができます。承認されなかった場合は、より短い期間が適用されることになります。

見直しプログラム規則の附属書IIには既存活性物質の見直しプログラムに含まれる活性物質と製品タイプの組み合わせのリストが含まれています。

見直しプログラムは、2024年までに完了する予定として案内されています。

改正内容

今回、2018年11月6日以降に1つ以上の製品タイプについて承認または不承認の決定が採択された活性物質や、BPR附属書Iへ収載された活性物質など、もはや見直しプログラムの対象になっていないものについての削除、ならびに附属書IIに含まれるべき活性物質の追加などを反映した修正がなされています。附属書IIは次の内容に置き換えられます。

附属書II 2022 年 3 月 17 日の見直しプログラムに含まれる物質/製品タイプの組み合わせ

2022 年 3 月 17 日に認証された活性物質/製品タイプの組み合わせで、項目 1017 で明示的に言及されているもの以外のナノ材料を除外し、認証された前駆体を明示的に言及する場合を除き、活性物質の原位置での生成を除外しているもの。

Entry number

Substance name

Rapporteur Member State

EC number

CAS number

Formaldehyde

200-001-8

50-00-0

Bronopol

200-143-0

52-51-7

Ethanol

200-578-6

64-17-5

Formic acid

200-579-1

64-18-6

1025

Performic acid generated from formic acid and hydrogen peroxide

Salicylic acid

200-712-3

69-72-7

Ethylene oxide

200-849-9

75-21-8

Glycolic acid

201-180-5

79-14-1

1026

Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxide

1027

Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide

L-(+)-lactic acid

201-196-2

79-33-4

(2R,6aS,12aS)-1,2,6,6a,12,12a-Hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one (Rotenone)

201-501-9

83-79-4

Symclosene

201-782-8

87-90-1

Biphenyl-2-ol

201-993-5

90-43-7

113

3-Phenyl-propen-2-al (Cinnamaldehyde)

203-213-9

104-55-2

117

Geraniol

203-377-1

106-24-1

122

Glyoxal

203-474-9

107-22-2

133

Hexa-2,4-dienoic acid (Sorbic acid)

203-768-7

110-44-1

171

2-Phenoxyethanol

204-589-7

122-99-6

180

Sodium dimethylarsinate (Sodium Cacodylate)

204-708-2

124-65-2

185

Tosylchloramide sodium (Chloramin T)

204-854-7

127-65-1

187

Potassium dimethyldithiocarbamate

204-875-1

128-03-0

188

Sodium dimethyldithiocarbamate

204-876-7

128-04-1

227

2-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole)

205-725-8

148-79-8

235

Diuron

206-354-4

330-54-1

239

Cyanamide

206-992-3

420-04-2

283

Terbutryn

212-950-5

886-50-0

292

(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Tetramethrin)

214-619-0

1166-46-7

321

Monolinuron

217-129-5

1746-81-2

330

N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)

219-145-8

2372-82-9

336

2,2′-Dithiobis[N-methylbenzamide] (DTBMA)

219-768-5

2527-58-4

339

1,2-Benzisothiazol-3(2H)-one (BIT)

220-120-9

2634-33-5

341

2-Methyl-2H-isothiazol-3-one (MIT)

220-239-6

2682-20-4

346

Sodium dichloroisocyanurate dihydrate

220-767-7

51580-86-0

345

Troclosene sodium

220-767-7

2893-78-9

348

Mecetronium ethylsulfate (MES)

221-106-5

3006-10-8

359

Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))

222-720-6

3586-55-8

365

Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)

223-296-5

3811-73-2

368

Methenamine 3-chloroallylochloride (CTAC)

223-805-0

4080-31-3

377

2,2′,2″-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT)

225-208-0

4719-04-4

382

Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD)

226-408-0

5395-50-6

392

Methylene dithiocyanate

228-652-3

6317-18-6

393

1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH)

229-222-8

6440-58-0

397

Didecyldimethylammonium chloride (DDAC)

230-525-2

7173-51-5

401

Silver

231-131-3

7440-22-4

405

Sulfur dioxide generated from sulfur by combustion

424

Active bromine generated from sodium bromide and sodium hypochlorite

1030

Active bromine generated from sodium bromide and calcium hypochlorite

1031

Active bromine generated from sodium bromide and chlorine

1032

Active bromine generated from sodium bromide by electrolysis

1033

Active bromine generated from hypobromous acid and urea and bromourea

1034

Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acid

434

Tetramethrin

231-711-6

7696-12-0

439

Hydrogen peroxide

231-765-0

7722-84-1

1036

Hydrogen peroxide released from sodium percarbonate

444

7a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO)

231-810-4

7747-35-5

450

Silver nitrate

231-853-9

7761-88-8

453

Disodium peroxodisulfate

231-892-1

7775-27-1

432

Active chlorine released from sodium hypochlorite

455

Active chlorine released from calcium hypochlorite

457

Active chlorine released from chlorine

458

Monochloramine generated from ammonium sulfate and a chlorine source

1016

Silver chloride

232-033-3

7783-90-6

1076

Silver-polyethylenimine-chloride

491

Chlorine dioxide

233-162-8

10049-04-4

1037

Chlorine dioxide generated from sodium chlorite by electrolysis

1038

Chlorine dioxide generated from sodium chlorite by acidification

1039

Chlorine dioxide generated from sodium chlorite by oxidation

1040

Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid

494

2,2-Dibromo-2-cyanoacetamide (DBNPA)

233-539-7

10222-01-2

1022

Dialuminium chloride pentahydroxide

234-933-1

12042-91-0

1075

Reaction products of aluminium trihydroxide and hydrochloric acid and aluminium and water

515

Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochlorite

522

Pyrithione zinc

236-671-3

13463-41-7

524

Dodecylguanidine monohydrochloride

237-030-0

13590-97-1

529

Active bromine generated from bromine chloride

531

(Benzyloxy)methanol

238-588-8

14548-60-8

550

D-Gluconic acid, compound with N,N”-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG)

242-354-0

18472-51-0

554

p-[(Diiodomethyl)sulphonyl]toluene

243-468-3

20018-09-1

559

(Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB)

244-445-0

21564-17-0

562

2-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin)

245-387-9

23031-36-9

566

Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT)

571

2-Octyl-2H-isothiazol-3-one (OIT)

247-761-7

26530-20-1

577

Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride

248-595-8

27668-52-6

588

Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH)

251-171-5

32718-18-6

590

3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon)

251-835-4

34123-59-6

599

S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos)

252-626-0

35575-96-3

608

Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride

255-451-8

41591-87-1

1045

Eucalyptus citriodora oil, hydrated, cyclized

1245629-80-4

1046

Cymbopogon winterianus oil, fractionated, hydrated, cyclized

Not available

619

3-Iodo-2-propynylbutylcarbamate (IPBC)

259-627-5

55406-53-6

620

Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)

259-709-0

55566-30-8

648

4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3-one (DCOIT))

264-843-8

64359-81-5

656

Reaction products of paraformaldehyde and 2- hydroxypropylamine (ratio 3:2) (MBO)

667

Alkyl (C_12-18) dimethylbenzyl ammonium chloride (ADBAC (C_12-18))

269-919-4

68391-01-5

671

Alkyl (C_12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C_12-C₁₆))

270-325-2

68424-85-1

673

Didecyldimethylammonium chloride (DDAC (C_8-10))

270-331-5

68424-95-3

690

Quaternary ammonium compounds, benzyl-C_12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)

273-545-7

68989-01-5

691

Sodium N-(hydroxymethyl)glycinate

274-357-8

70161-44-3

693

Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS)

274-778-7

70693-62-8

939

Active chlorine generated from sodium chloride by electrolysis

1049

Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate)

1050

Active chlorine generated from seawater (sodium chloride) by electrolysis

1051

Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis

1054

Active chlorine generated from sodium N- chlorosulfamate

701

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP)

279-013-0

84665-66-7

1024

Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide

724

Alkyl (C₁₂-C₁₄) dimethylbenzylammonium chloride (ADBAC (C₁₂-C₁₄))

287-089-1

85409-22-9

725

Alkyl (C₁₂-C₁₄) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C₁₂-C₁₄))

287-090-7

85409-23-0

1057

Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvent

1058

Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide

744

Lavender, Lavandula hybrida, ext./Lavandin oil

294-470-6

91722-69-9

779

Reaction products of: glutamic acid and N-(C₁₂-C₁₄-alkyl)propylenediamine (Glucoprotamin)

403-950-8

164907-72-6

785

6-(Phthalimido)peroxyhexanoic acid (PAP)

410-850-8

128275-31-0

791

2-Butyl-benzo[d]isothiazol-3-one (BBIT)

420-590-7

4299-07-4

792

Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification

811

Silver sodium hydrogen zirconium phosphate

422-570-3

265647-11-8

797

cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC)

426-020-3

51229-78-8

1014

Silver zeolite

Not available

152

Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)

Not available

459

Reaction mass of titanium dioxide and silver chloride

Not available

777

Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH)

Not available

810

Silver phosphate glass

Not available

308069-39-8

1077

Silver borophosphate glass

1078

Silver phosphoborate glass

824

Silver zinc zeolite

Not available

130328-20-0

1013

Silver copper zeolite

Not available

130328-19-7

1017

Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale)

Not available

854

(RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) (d-Allethrin)

Plant protection product

231937-89-6

843

4-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)

Plant protection product

122453-73-0

859

Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer)

Polymer

25988-97-0

869

Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26)

Polymer

94667-33-1

872

N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine)

Polymer

214710-34-6

1070

Orange, sweet, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, Rutaceae.

232-433-8

8028-48-6

1071

Garlic, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae.

232-371-1

8008-99-9

1072

Brandy

tbd

Not available

1073

Peanut butter

Not available

1074

Copper, powder

231-159-6

7440-50-8

参考

■　改正規則(EU) 2022/825／欧州官報
■　見直しプログラム規則(EU) No 1062/2014

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