REACH Annex XVII 附錄17之法規沿革與規範內容最新更新至

REACH Annex XVII 17 : Commission Regulation (EU) 2021/1297 of 04 August
#
1
82/828/EEC
85/467/EEC
89/677/EEC
1.
2.()0.005%
2
Directive 1999/45/EC
following hazard classes or categories set out
in Annex I to Regulation (EC) No 1272/2008:
(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8
types A and B, 2.9, 2.10, 2.12, 2.13 categories
1 and 2, 2.14 categories 1 and 2, 2.15 types A
to F;
development, 3.8 effects other than narcotic
effects, 3.9 and 3.10;
(c) hazard class 4.1;
(d) hazard class 5.1.
1“”

#
5
Benzene
2. 1
2. 1 2005 1 1 /

2011/06/01
Appendix 7
2. 1
2. 1
#
9
containing saponines
and Helleborus niger
and Veratrum nigrum
CAS No 92-87-5
EC No 202-199-1
)
nigrum(/)
2.1
2.1
#
11
(a) Methyl bromoacetate
CAS No 96-32-2
EC No 202-499-2
(b) Ethyl bromoacetate
CAS No 105-36-2
EC No 203-290-9
(c) Propyl bromoacetate
CAS No 35223-80-4
(d) Butyl bromoacetate
CAS No 18991-98-5
EC No 242-729-9
2.1
13
14
4-Nitrobiphenyl
15
CAS No 92-67-1
#
16
CAS No 598-63-0
EC No 209-943-4
(b) Trilead-bis(carbonate)-dihydroxide 2Pb
#
18a
Mercury
1. : (a) ; (b) (: , , , )
2. 1 2009/4/3
4. (EC 847/2012 )
5. 2014/4/10, : (a) ; (b) ; (c) ; (d) ; (e)
; (f) ; (g)
(a)~(g) ,
8. 57: (a) 2007/10/350; (b)
19
-
#
20
()b); c)

b)(a)201071
5.DBT
PVC DBT PVC -
d)(a) (b)EC NO.1935/2004
6.DOT
------
b)(a)201211
0.1%
CAS No 87-86-5
EC No 201-778-6

#
24

76/769/EEC
0.01% 2012111969XV

[3208][3209]0.01%
[3208][3209]10%0.1%
, 0.1%,
4. - PVC (PVC), -PVC ()
PVC 0.1%(a) ; (b) ; (c) ; (d)
; (e) PVCPVC
PVC PVC
5. ,
8. 0.01%()0.01%
450
11. 10 2011 12 10 2012 1 10 50
EC 552/2009
EC 494/2011
EC 835/2012
EU 2016/217
#
26
#
28
to Regulation (EC) No 1272/2008 classified as
carcinogen category 1A or 1B (Table 3.1) or
carcinogen category 1 or 2 (Table 3.2)
Regulation(EC)No. 1272/2008
- 2008/1272 VI Part 31999/45/EC
, ”
germ cell mutagen category 1A or 1B (Table
3.1) or mutagen category 1 or 2 (Table 3.2)
toxic to reproduction category 1A or 1B (Table
3.1) or toxic to reproduction category 1 or 2
(Table 3.2)
#
1.
2. :
CAS No 8001-58-9
EC No 232-287-5
CAS No 61789-28-4
EC No 263-047-8
naphthalene oil
oil
(e) Distillates (coal tar), upper; heavy
anthracene oil
CAS No 65996-85-2
EC No 266-019-3
(h) Creosote, wood
CAS No 8021-39-4
EC No 232-419-1
residues (coal), low temperature coal tar
alkaline
#
32
Chloroform

#
40
classified as flammable, highly flammable or
extremely flammable regardless of whether
they appear in Part 3 of Annex VI to Regulation
(EC) No 1272/2008 or not.
67/548/EEC,
,
(EC)No.1272/2008IV3

users only.
4. 1 2
41 Hexachloroethane
chlorinated paraffins)
a)
b)
c) ;
3. 9 (List of azo dyes)(Navy blue)0.1 wt%

#
45
2. 0.1%
3. 20048152002/95/EC (RoHS)
46

)
#
47
EU 126/2013
EU 301/2014
3. 1 2
4. CEN -
5. 3 mg/kg()
6. 3 mg/kg()
48
Toluene
49
Trichlorobenzene
-
-
#
EC 552/2009
EU 1272/2013
EU 2015/326
EU 2021/1199
CAS No 50-32-8
CAS No 192-97-2
CAS No 56-55-3
(d) Chrysen (CHR)
CAS No 218-01-9
CAS No 205-99-2
CAS No 205-82-3
CAS No 207-08-9
CAS No 53-70-3
BaP1mg/kg
PAHs10mg/kg
”EN 16143:2013 (Petroleum products - Determination of content of Benzo(a)pyrene (BaP) and selected polycyclic aromatic hydrocarbons (PAH) in
extender oils - Procedure using double LC cleaning and GC/MS analysis) "
2016/9/23IP 346:1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl
sulphoxide extraction refractive index method)PCAPolycyclic aromatics (PCA)3%
6BaPPAHsPCA
2. 2010 1 1 (tyres and treads for reteading) 1
0.35% Bay protons ( ISO21461 )
3. 1 2
4.
PAHs0.5 mg/kg

(b) mulches4 - 130 mm10 - 15 mm

(c) infill material in synthetic turf pitches
(d) use in loose form on playgrounds or in sport applications

#
EC 552/2009
EU 2015/326
EU 2018/2005
(a) Bis(2-ethylhexyl) phthalate (DEHP)
(b) Dibutyl phthalate (DBP)
(d) Diisobutyl phthalate (DIBP)
(g) Directives 90/385/EEC93/42/EEC98/79/EC

B. 1030
51
Phthalates
CAS No 117-81-7
EC No 204-211-0
CAS No 85-68-7
EC No 201-622-7
#
52
Phthalates
(c) Di-n-octyl phthalate (DNOP)
53
halide, amide, and other derivatives including
polymers)
54
55
2. 20101227
“Do not use in paint spraying equipment”
#
56

- (diisocyanates)
2. 1(a) (hot melt adhesives)
57
Cyclohexane

0.1%
(EC) No 2003/2003III

3. 2 201471/20%(w/w)

#
60 Acrylamide
61
Dimethylfumarate
Dichloromethane
2010126(c) 201266
2. 1

(a)
; (b)

; (c) ; (d)
89/686/EEC ; (e)

‘Restricted to industrial use and to professionals approved in certain EU Member States — verify where use is allowed.’

59
76/769/EEC
455/2009/EC
#
62
2. 20171010 0.01%
63
Lead
(i)
(a)
(ii) (any individual part)
3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making.
4. 1
(b)
(d) 500

#
63
Lead
be placed in the mouth by children
5 cm
(c)
(iii)(Directive 2009/48/EC)
#
65
3 ppm (2.12 mg/m3)

4. 11CEN/TS 16516
67
Bis(pentabromophenyl)ether
2.
(a)
(b)
(b)
#
1.202074PFOA

(c)20327493/42/EEC
(c)REACH (transported isolated intermediate)
3. C9-C14 PFCA10 ppm6
18(4)(a)(f)22023825
i.
ii.
iii.
25C9-C14 PFCA100 ppb
C9-C14 PFCA2(c)
2024825
PTFE C9-C14 PFCA
2024825
Perfluorooctanoic acid (PFOA)
CAS No 335-67-1
EC No 206-397-9
and its salts.
polymers) having a linear or branched
perfluoroheptyl group with the formula C7F15-
directly attached to another carbon atom, as one of
the structural elements.
perfluorooctyl group with the formula C8F17- as
one of the structural elements.
The following substances are excluded from this
designation:
— C8F17-C(=O)OH, C8F17-C(=O)O-X′ or
C8F17-CF2-X′ (where X′ = any group,
including salts).
2020
the formula CnF2n +1-C(=O)OH where n = 8, 9,
10, 11, 12, or 13 (C9-C14 PFCAs), including their
salts, and any combinations thereof;
Any C9-C14 PFCA-related substance having a
perfluoro group with the formula CnF2n +1-
directly attached to another carbon atom, where n
= 8, 9, 10, 11, 12, or 13, including their salts and
any combinations thereof;
perfluoro group with the formula CnF2n +1- that
it is not directly attached to another carbon atom,
where n = 9, 10, 11, 12, 13 or 14 as one of the
structural elements, including their salts and any
combinations thereof.
designation
- CnF2n +1-X, where X = F, Cl, or Br where n =
9, 10, 11, 12, 13 or 14, including any
combinations thereof,
group, including salts
CAS No 335-67-1
EC No 206-397-9
C8F17-CF2-X′ X′ =
12,13

n = 9, 10, 11, 12, 1314

#
69 Methanol -- (EU) 2018/589 2019590.6 % ()
70 Octamethylcyclotetrasiloxane (D4)
2., wash-off cosmetic productsRegulation (EC) No 1223/2009Article 2(1)(a)

1.202074PFOA

(c)20327493/42/EEC
(c)REACH (transported isolated intermediate)
3. C9-C14 PFCA10 ppm6
18(4)(a)(f)22023825
i.
ii.
iii.
25C9-C14 PFCA100 ppb
C9-C14 PFCA2(c)
2024825
PTFE C9-C14 PFCA
2024825
CAS No 335-67-1
EC No 206-397-9
and its salts.
perfluoroheptyl group with the formula C7F15-
directly attached to another carbon atom, as one of
the structural elements.
perfluorooctyl group with the formula C8F17- as
one of the structural elements.
The following substances are excluded from this
designation:
— C8F17-C(=O)OH, C8F17-C(=O)O-X′ or
C8F17-CF2-X′ (where X′ = any group,
including salts).
2020
the formula CnF2n +1-C(=O)OH where n = 8, 9,
10, 11, 12, or 13 (C9-C14 PFCAs), including their
salts, and any combinations thereof;
Any C9-C14 PFCA-related substance having a
perfluoro group with the formula CnF2n +1-
directly attached to another carbon atom, where n
= 8, 9, 10, 11, 12, or 13, including their salts and
any combinations thereof;
perfluoro group with the formula CnF2n +1- that
it is not directly attached to another carbon atom,
where n = 9, 10, 11, 12, 13 or 14 as one of the
structural elements, including their salts and any
combinations thereof.
designation
- CnF2n +1-X, where X = F, Cl, or Br where n =
9, 10, 11, 12, 13 or 14, including any
combinations thereof,
group, including salts
CAS No 335-67-1
EC No 206-397-9
C8F17-CF2-X′ X′ =
12,13

n = 9, 10, 11, 12, 1314

#
71 1-methyl-2-pyrrolidone (NMP) N- -- (EU) 2018/588 1. 202059(CSR)(SDS)
14.4 mg/m34.8 mg/kg/day(Derived No-Effect Levels, DNELs)
0.3%
#
Cadmium and its compounds
Chromium VI compounds
Benzene
Benz[a]anthracene [a]
Benz[e]acephenanthrylene [e]
benzo[a]pyrene; benzo[def]chrysene [a];[d,e,f]
Benzo[e]pyrene [e]
Benzo[j]fluoranthene [j]
Benzo[k]fluoranthene [k]
Chrysene
α, α,α,4-tetrachlorotoluene; p-chlorobenzotrichlorideα,α,α,4-;p-
Bis(2-methoxyethyl) phthalate (2-)

Appendix 12
3. 1
(a)
(b)

(a)
-

-()
()

Regulation (EU) 2016/425()Regulation (EU) 2017/745()

#
Diisopentylphthalate
Benzenamine, 4,4′-(4-iminocyclohexa-2,5- dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
[4-[4,4′-()]

#
73 (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)
(TDFAs)
(3,3,4,4,5,5,6,6,7,7,8,8,8-

trigger sprays
Fatal if inhaledGHS06 ()
4. SDS2.3mixtures of (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and/or
any of its mono-, di- or tri-O-(alkyl) derivatives in a concentration equal to or greater than 2 ppb and organic solvents in spray
products, are for professional users only (3,3,4,4,5,5,6,6,7,7,8,8,8-)/
2 ppb, , - O - ()Fatal if
inhaled

(EU)
2020/1149
(a) 0.1()
(b) 1(b)
“As from 24 August 2023 adequate training is required before industrial or professional use”
3. “industrial and professional user(s)”

(b)
10.
#
Substances falling within one or more of the
following points:
in Part 3 of Annex VI to Regulation (EC) No
1272/2008:
excluding any such substances classified due
to effects only following exposure by
inhalation
but excluding any such substances classified
due to effects only following exposure by
inhalation
—skin corrosive category 1, 1A, 1B or 1C or
skin irritant category 2
irritant category 2
and of the Council (*1)
(c)substances listed in Annex IV to Regulation
(EC) No 1223/2009 for which a condition is
specified in at least one of the columns g, h
and i of the table in that Annex
(d)substances listed in Appendix 13 to this
Annex.

(b) CLP1A, 1B20.001()
(c) CLP1, 1A1B0.001()
(d) CLP1, 1A, 1B1C212

(e) Regulation (EC) No 1223/20090.00005()
(f) Regulation (EC) No 1223/2009g(Product type, Body parts)
0.00005()
i. Rinse-off products ii. Not to be used in products applied on mucous membranes iii.
Not to be used in eye products
(g) Regulation (EC) No 1223/2009h(Maximum concentration in ready
for use preparation) i(Other)
(h) 13
permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation
3. 131(a)(g)13
4. 2023141
(a) Pigment Blue 15:3 (CI 74160, EC No 205-685-1, CAS No 147-14-8); (b) Pigment Green 7 (CI 74260, EC No 215-524-7, CAS No
1328-53-6).
#
6. 202114IIIV1
(e)(f)(g)1
(c) (IUPACCASEC)IngredientIngredient
CLP
(f) 13"Contains chromium (VI). Can cause allergic reactions."
(g) CLP
(a)

8. “Mixture for use in tattoos or permanent make-up”
9. 20°C101.3 kPa50°C300 kPaCAS no. 50-00-0EC
no. 200-001-8
(EU) 2017/745

4238
75

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REACH Annex XVII 附錄17之法規沿革與規範內容 最新更新至

REACH Annex XVII 附錄17之法規沿革與規範內容最新更新至