EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10257/2018  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../...  
amending Annex III to Regulation (EC) 1107/2009 of the European Parliament and of 
the Council listing co -formulants which are not accepted for inclusion in plant 
protection products    
EN 1  EN ANNEX  
 
Annex III to Regulation (EC) No 1107/2009 is replaced by  the following:  
ʽANNEX III  
List of co -formulants which are not accepted for inclusion in plant protection products as referred to in Article 271 
No.  Name  EC names/Other names  CAS number  EC number  Classification/Other 
properties  
1.  1-Chloro -2,3-epoxypropane  Epychloridrine,  
2,3-Epoxypropyl chloride  106-89-8 203-439-8 Carcinogenic cat.1B  
2.  1, 2- Dichloroethane  Ethane, 1,2 -dichloro  107-06-2 203-458-1 Carcinogenic cat.1B  
3.  1-Ethylpyrrolidin -2-one N-ethyl -2-pyrrolidone  2687 -91-4 220-250-6 Reproductive toxicity cat.1B  
4.  2-Ethoxyethanol  Ethanol, 2 -ethoxy  110-80-5 203-458-1 Reproductive toxicity cat.1B  
5.  2-Ethoxyethanol acetate  Ethanol, 2 -ethoxy -, 1-acetate  111-15-9 203-839-2 Reproductive toxicity cat.1B  
6.  1-Methyl -2-pyrrolidone  2,pyrrolidinone, 1 -methyl  872-50-4 212-828-1 Reproductive toxicity cat.1B  
7.  2-Methoxyethanol  Ethanol, 2 -methoxy  109-86-4 203-713-7 Reproductive toxicity cat.1B  
8.  2-Methoxyethanol acetate  Ethanol, 2 -methoxy -, 1-acetate  110-49-6 203-772-9 Reproductive toxicity cat.1B  
9.  2-Methoxypropanol  1-Propanol, 2 -methoxy  1589 -47-5 216-455-5 Reproductive toxicity cat.1B  
10.  2-Nitropropane  Propane, 2 -nitro 79-46-9 201-209-1 Carcinogenic cat.1B  
11.  4-Nonylphenol, branched, ethoxylated  Poly(oxy -1,2-ethanediyl) , α-(4-
nonylphenyl) -ω-hydroxy -, branched  127087 -87-0 500-315-8 Endocrine disrupting 
properties (REACH Article 
57(f) - Environment)  
12.  2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol  Ethanol, 2 -[2-[2-[2-(4-nonylphenoxy)
ethoxy] ethoxy] ethoxy] - 7311 -27-5 230-770-5 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
13.  2-[2-(4-nonylphenoxy)ethoxy]ethanol  Ethanol, 2 -[2-(4-nonylphenoxy)
ethoxy] - 20427 -84-3 243-816-4 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
                                                 
1 The limit for the acceptable presence of the substances listed in the table as unintentional impurity is 0,01 % (weight by we ight (w/w)) except where stated otherwise in this Annex.    
EN 2  EN 14.  4-Nonylphenol, ethoxylated  Poly(oxy -1,2-ethanediyl) , α-(4-
nonylphenyl) -ω-hydroxy - 26027 -38-3 500-045-0 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
15.  20-(4-nonylphenoxy) -3,6,9,12,15,18 -hexaoxaicosan -1-ol 3,6,9,12,15,18-Hexaoxaeicosan -1-ol, 
20-(4-nonylphenoxy) - 27942 -27-4 248-743-1 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
16.  2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol  Ethanol, 2 -(4-nonylphenoxy) - 104-35-8  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
17.  2-[2-(4-nonylphenoxy)ethoxy]ethanol  3,6,9,12,15,18,21,24-
Octaoxahexacosan -1-ol, 26 -(4-
nonylphenoxy) - 14409 -72-4  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
18.  4-Nonylphenol, ethoxylated  3,6,9,12,15-Pentaoxaheptadecan -1-ol, 
17-(4-nonylphenoxy) - 34166 -38-6  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
19.  20-(4-nonylphenoxy) -3,6,9,12,15,18 -hexaoxaicosan -1-ol Poly(oxy -1,2-ethanediyl) , α-
(isononylphenyl) -ω-hydroxy - 37205 -87-1  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
20.  4-Nonylphenol, branched, ethoxylated  Ethanol, 2 -[2-(4-tert-nonylphenoxy)
ethoxy] - 156609 -10-8  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
21.  2-(2-[4-(1,1,3,3 -Tetramethylbutyl)phenoxy]ethoxy)ethanol  
 Ethoxylated octylphenol  
Polyethylene Glycol Octylphenyl 
Ether  
Poly(oxy -1,2-ethanediyl) , α-[(1,1,3,3-
tetramethylbutyl) phenyl] -ω-hydroxy - 9036 -19-5 618-541-1 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
22.  Acrylamide  2-propenamide  79-06-1 201-173-7 Carcinogenic cat.1B /  
Mutagenic cat.1B  
23.  Alkylarylpolyglycol ether   9016 -45-9 934-221-7 Endocrine disrupting 
properties (REACH Article 
57(f) - ENV)  
24.  Aluminium silicate  
containing > 0.1 % particles of crystalline silica with 
diameter below 50 um)2 Kaolin  1332 -58-7 310-194-1  
25.  Amines, tallow alkyl, ethoxylated (POE -tallowamine)  Amines, tallow alkyl, ethoxylated  61791 -26-2 500-153-8 Concerns or data gaps related 
to potential effects on human 
                                                 
2 The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).   
EN 3  EN health or the environment  
26.  Amines, tallow alkyl, ethoxylated propoxylated (POEP -
tallowamine)  Amines, tallow alkyl, ethoxylated 
propoxylated  68213 -26-3 614-378-5 Concerns or data gaps related 
to potential effects on human 
health or the environment  
27.  Asbestos fibres - Actinolite  Actinolite asbestos  77536 -66-4 616-471-6 Carcinogenic cat.1A  
28.  Asbestos fibres - Amosite  Amiosite asbestos  12172 -73-5 601-801-3 Carcinogenic cat.1A  
29.  Asbestos fibres - Anthophyllite  Antophyllite asbestos  77536 -67-5  Carcinogenic cat.1A  
30.  Asbestos fibres - Chrysotile  Chrysotile asbestos  12001 -29-5 
132207 -32-0-  Carcinogenic cat.1A  
31.  Asbestos fibres - Crocidolite  Crocidolite asbestos  12001 -28-4  Carcinogenic cat.1A  
32.  Asbestos - Tremolite  Tremolite asbestos  77536 -68-6  Carcinogenic cat.1A  
33.  Attapulgite  Palaygorskite  12174 -11-7  Carcinogenic cat.1A  
34.  Benzene  Benzole  71-43-2 200-753-7 Carcinogenic cat.1A /  
Mutagenic cat.1B  
35.  Benzo[def]chrysene  Benzo [a] pyrene  50-32-8 200-028-5 Carcinogenic cat.1B  
36.  Boric acid  Boric acid  10043 -35-3 233-139-2 Reproductive toxicity cat.1B  
37.  Buta -1,3-diene  1,3-butadiene  106-99-0 203-450-8 Carcinogenic cat.1A /  
Mutagenic cat.1B  
38.  Butane (containing ≥ 0,1 % butadiene (CAS No. 203-450-8) Butane  106-97-8 203-448-7 Carcinogenic cat.1A  
39.  Cristobalite (SiO2)   14464 -46-1 238-455-4 See  Silicium dioxide  
40.  Dibutyl phthalate  n-Butyl phthalate  84-74-2 201-557-4 Endocrine disrupting 
properties (REACH Article 
57(f) – Human Health) 
Reproductive toxicity cat.1B  
41.  Diisobutyl phthalate  bis(2 -methylpropyl) benzene -1,2-
dicarboxylate  84-69-5 201-553-2 Endocrine disrupting 
properties (REACH Article 
57(f) – Human Health) 
Reproductive toxicity cat.1B  
42.  Disodium octaborate  Disodium octaborate anhydrous  12008 -41-2 234-541-0 Reproductive toxicity cat.1B  
43.  Disodium; boron; oxygen(2 -); tetrahydrate  Boric acid,disodiumsalt,tetrahydrate  12280 -03-4 234-541-0 Reproductive toxicity cat.1B   
EN 4  EN 44.  Disodium tetraborate, anhydrous  Boron sodium oxide  1330 -43-4 215-540-4 Reproductive toxicity cat.1B  
45.  Disodium tetraborate, decahydrate  Borax  1303 -96-4 215-540-4 Reproductive toxicity cat.1B  
46.  Disodium tetraborate, pentahydrate  Boron sodium oxide, hydrated  12179 -04-3 215-540-4 Reproductive toxicity cat.1B  
47.  Distillates (petroleum), hydrotreated heavy naphthenic with 
a content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64742 -52-5 265-155-0 Carcinogenic cat.1B  
48.  Distillates (petroleum), hydrotreated heavy paraffinic with a 
content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64742 -54-7 265-157-1 Carcinogenic cat.1B  
49.  Distillates (petroleum), hydrotreated light naphthenic with a 
content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64742 -53-6 265-156-6 Carcinogenic cat.1B  
50.  Distillates (petroleum), hydrotreated light paraffinic with a 
content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64742 -55-8 265-158-7 Carcinogenic cat.1B  
51.  Distillates (petroleum), solvent -dewaxed heavy paraffinic 
with a content of ≥ 3.0 % DMSO -extract (measured by IP 
346)  64742 -65-0 265-169-7 Carcinogenic cat.1B  
52.  Distillates (petroleum), solvent -refined heavy paraffinic with 
a content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64741 -88-4 265-090-8 Carcinogenic cat.1B  
53.  Distillates (petroleum), solvent -refined light paraffinic with 
a content of ≥ 3.0 % DMSO -extract (measured by IP 346)   64741 -89-5 265-091-3 Carcinogenic cat.1B  
54.  Ethylene oxide  Oxyrane, Epoxyethane  75-21-8 200-849-9 Carcinogenic cat.1B  
55.  Formaldehyde  Formalin, Methanal,Formol  50-00-0 200-001-8 Carcinogenic cat.1B  
56.  Formamide  Methanamide  75-12-7 200-842-0 Reproductive toxicity cat.1B  
57.  Isobutane (containing ≥ 0,1 % butadiene (CAS No. 203 -450-
8) Propane, 2 -methyl  75-28-5 200-857-2 Carcinogenic cat.1A /  
Mutagenic cat. 1B  
58.  Lubricating oils (petroleum), C15 -30, hydrotreated neutral 
oil-based with a content of ≥ 3.0 % DMSO -extract 
(measured by IP  346)  72623 -86-0 276-737-9 Carcinogenic cat.1B   
EN 5  EN 59.  Lubricating oils (petroleum), C17 -32, solvent -extd., 
dewaxed, hydrogenated with a content of ≥ 3.0 %  DMSO -
extract (measured by IP  346)  101316 -70-5 309-875-6 Carcinogenic cat.1B  
60.  Lubricating oils (petroleum), C20 -50, hydrotreated neutral 
oil-based with a content of ≥ 3.0 % DMSO -extract 
(measured by IP  346)  72623 -87-1 276-738-4 Carcinogenic cat.1B  
61.  Lubricating oils (petroleum), C20 -50, hydrotreated neutral 
oil-based, high -viscosity with a content of ≥  3.0 % DMSO -
extract (measured by IP  346)  72623 -85-9 276-736-3 Carcinogenic cat.1B  
62.  N, N -dimethylformamide  Dimethyl formamide, DMF  68-12-2 200-679-5 Reproductive toxicity cat.1B  
63.  Naphtha (petroleum), heavy alkylate predominantly 
branched chain C9 -C12 with a content o f  ≥ 0.1 % benzene 
(CAS  No. 200-753-7)  64741 -65-7 265-067-2 Carcinogenic cat.1B /  
Mutagenic cat.1B  
64.  Naphtha (petroleum), hydrodesulfurized heavy 
predominantly C7 -C12 with a content of ≥ 0.1 % benzene 
(CAS No. 200 -753-7)  64742 -82-1 265-185-4 Carcinogenic cat.1A/  
Mutagenic cat.1B  
65.  Naphtha (petroleum), hydrodesulfurized light, dearomatized 
predominantly C7 paraffins and cycloparaffins with a 
content of ≥ 0.1 % benzene (CAS No. 200 -753-7)  92045 -53-9 295-434-2 Carcinogenic cat.1A /  
Mutagenic cat.1B  
66.  Naphtha (petroleum), hydrotreated heavy predominantly C6 -
C13 with a content of ≥ 0.1 % benzene (CAS No. 200 -753-
7)  64742 -48-9 265-150-3 Carcinogenic cat.1A /  
Mutagenic cat.1B  
67.  Naphta (petroleum), light arom. predominantly C8 -C10 with 
a content of ≥ 0.1% benzene (CAS N. 200 -753-7)  64742 -95-6 265-199-0 Carcinogenic cat.1A /  
Mutagenic cat.1B  
68.  Nitrobenzene  Benzene, nitro  98-95-3 202-716-0 Reproductive toxicity cat.1B/ 
Carcinogenic cat. 2  
69.  N-methylformamide  Formamide, N -methyl - 123-39-7 204-624-6 Reproductive toxicity cat.1B  
70.  Nonyl phenol, ethoxylated  2-[2-(4-nonylphenoxy)ethoxy]ethanol  9016 -45-9 500-024-6 Endocrine  disrupting 
properties (REACH Article 
57(f) - Environment)  
71.  Phenol, 4 -isononyl - p-isononylphenol  26543 -97-5 247-770-6 Endocrine disrupting  
EN 6  EN properties (REACH Article 
57(f) – Environment)  
72.  Phenol, 4 -nonyl - p-nonylphenol  104-40-5 203-199-4 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
73.  Phenol, 4 -nonyl -, branched  Phenol, 4 -nonyl -, branched  84852 -15-3 284-325-5 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
74.  Phenol, nonyl - Nonylphenol  25154 -52-3 246-672-0 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
75.  Phenol, nonyl -, branched  Phenol, nonyl -, branched  90481 -04-2 291-844-0 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
76.  Phenol, 4 -(1,1-dimethylheptyl) - p-(1,1-dimethylheptyl)phenol  30784 -30-6 250-339-5 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
77.  Phenol, 4 -(1-ethyl -1,3-dimethylpentyl) - 4-(1-Ethyl -1,3-dimethylpentyl)phenol  186825 -36-5 - Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
78.  Phenol, 4 -(1-ethyl -1,4-dimethylpentyl) - 4-(1-Ethyl -1,4-dimethylpentyl)phenol  142731 -63-3 - Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
79.  Phenol, 4 -(1-ethyl -1-methylhexyl) - 4-(1-ethyl -1-methylhexyl)phenol  52427 -13-1 257-907-1 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
80.  Phenol, 4 -(1-methyloctyl) - p-(1-methyloctyl)phenol  17404 -66-9 241-427-4 Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
81.  Octyl phenol ethoxylated  Octoxynol  9002 -93-1  Endocrine disrupting 
properties (REACH Article 
57(f) – Environment)  
82.  Orthoboric acid, sodium salt  Boric acid, sodium salt  7311 -27-5 237-560-2 Reproductive toxicity cat.1B  
83.  Pyridine, alkyl derivatives, with a content of ≥ 0.1 % 
benzene (CAS No. 200 -753-7)  68391 -11-7 269-929-9 Carcinogenic cat.1A /  
Mutagenic cat.1B  
84.  PHMB  
CoPoly(bisiminoimidocarbonyl, hexamethylene Guanidine, N, N'''-1,6-
hexanediylbis[N' -cyano -, polymer 27083 -27-8 and 
32289 -58-0 and   Not approved for use in 
biocidal products for product - 
EN 7  EN hydrochloride),(iminoimidocarbonyl, hexamethylene 
hydrochloride  
 with 1, 6-hexanediamine, 
hydrochloride  
Poly[iminocarbonimid
oyliminocarbonimidoy limino -1,6-
hexanediyl] , hydrochloride  
Cyanamide, N -cyano -, compd. with 
1,6-hexanediamine (2:1) , polymer 
with 1, 6-hexanediamine 
hydrochloride (1:2)  1802181 -67-4 type 6 (in -can preservatives).  
85.  Quinoline  Quinoline  91-22-5 202-051-6 Carcinogenic cat.1B  
86.  Quartz sand  
(containing > 0.1 % particles with diameter below 50 um)3 Quartz, Silicium dioxide, Silica, 
Silicon dioxide, SiO 2 14808 -60-7 238-878-4  
87.  Silicium dioxide  
containing > 0.1 % particles with diameter below 50 um)4 Kieselguhr  61790 -53-2 310-127-6 
 
88.  Tetraboron disodium heptaoxide, hydrate  Boron sodium oxide, hydrate  12267 -73-1 235-541-3 Reproductive toxicity cat.1B  
89.  Tetrahydrofurfuryl Alcohol  2-Furanmethanol -tetraydro  97-99-4 202-625-6 Reproductive toxicity cat.1B  
90.  Trydim ite (SiO2)   15468 -32-3 239-487-1 See Silicium dioxide  
ʼ. 
                                                 
3 The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).  
4 The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).