SCHEDULE 3Amendment of the Annexes and Appendices to the REACH Regulation
PART 1The Annexes
Annex 1I11
1
Annex 1 (general provisions for assessing substances and preparing chemical safety reports) is amended as follows.
2
In point 0.5, in the first paragraph, for “Community” substitute “F5domestic or European Union”
.
3
In point 1.1.2, for the words from “test methods laid down” to “Article 13(3)” substitute “Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to REACH”
.
4
In point 1.3.1, in the first paragraph, omit “and Articles 4 to 7 of Directive 1999/45/EC”.
5
Annex 2I22
1
Annex 2 (requirements for the compilation of safety data sheets) is amended as follows.
2
In point 0.2.2, after “set out in” insert “
retained EU law that transposed
”
.
3
In point 1.1—
a
in the first paragraph, for the words from “the official language(s)” to the end of the paragraph substitute “
English
”
;
b
in the third paragraph, in point (b), omit the words “Member State”.
4
In point 1.3—
a
omit the second paragraph;
b
in the fourth paragraph, for “non-Union” substitute “F8non-Great British”
.
5
In point 1.4, omit from “in the Member State” to “on the market”.
6
In point 2.1, in the first paragraph, omit “to the classification and labelling inventory”.
7
In point 3.2.2(a)(ii), omit “Union”.
8
In point 3.2.3, omit “Union”.
9
In point 3.2.4, in point (b), omit the words “Member State”.
10
In point 7, in the second paragraph, after “measures according to” insert “
retained EU law that transposed
”
.
11
In point 8.1.1, omit “in the Member State in which the safety data sheet is being provided”.
12
For points 8.1.1.1 to 8.1.1.5 substitute—
F98.1.1.1
the workplace exposure limit within the meaning of the Control of Substances Hazardous to Health Regulations 2002 (S.I. 2002/2677);
8.1.1.2
the occupational exposure limit within the meaning of the Control of Lead at Work Regulations 2002 (S.I. 2002/2676).
13
In point 8.2.1, after “in accordance with” insert “
the retained EU law that transposed
”
.
14
In point 8.2.2.2, for “Council Directive 89/686/EEC” substitute “
Regulation (EU) 2016/425 M1
”
.
15
In point 8.2.3, omit “Union”.
16
In point 13, in the first paragraph—
a
after “the requirements of” insert “
the retained EU law that transposed
”
;
b
omit “by the Member State in which the safety data sheet is being supplied”.
17
In point 13.1, in the second paragraph, for the words from “Union” to “force” substitute “
legislation relating to waste
”
.
18
In point 14, omit from “, all three” to “of the Council”.
19
In point 15.1, in the first paragraph—
a
omit “Union”;
b
for “for example,” substitute “
including relevant EU provisions transposed through retained EU law, such as the
”
;
c
for “Council Directive 96/82/EC” substitute “
Directive 2012/18/EU
”
;
d
omit the second sentence.
Annex 5I33
In Annex 5 (exemptions from the obligation to register in accordance with Article 2(7)(b)), in paragraph 8, for “dangerous” substitute “
hazardous
”
.
Annex 7I44
In Annex 7 (standard information requirements for substances manufactured or imported in quantities of one tonne or more), in footnote (2), for the words from “the appropriate” to “specified in” substitute “
regulations under
”
.
Annex 8I55
In Annex 8 (standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more), in footnote (2), for the words from “the appropriate” to “specified in” substitute “
regulations under
”
.
Annex 9I66
1
Annex 9 (standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more) is amended as follows.
2
In footnote (2), for the words from “the appropriate” to “specified in” substitute “
regulations under
”
.
3
In point 8.7.2, in the first column, for “as specified in” substitute “
made under
”
.
4
In point 8.7.3, in the first column, for “as specified in” substitute “
made under
”
.
Annex 10I77
1
Annex 10 (standard information requirements for substances manufactured or imported in quantities of 1,000 tonnes or more) is amended as follows.
2
In footnote (2), for the words from “the appropriate” to “specified in” substitute “
regulations under
”
.
3
In point 8.7.3, in the first column, for “as specified in” substitute “
made under
”
.
Annex 11I88
1
Annex 11 (general rules for adaptation of the standard testing regime set out in Annexes 7 to 10) is amended as follows.
2
In point 1.2, in the second paragraph, omit “the Commission or”.
3
In point 1.3, in the second paragraph, omit “the Commission, Member States and”.
4
In point 1.4, in the first paragraph—
a
omit “(e.g. the European Centre for the Validation of Alternative Methods (ECVAM)) criteria”;
b
for “process)” substitute “
process
”
.
5
In point 1.5, in the first paragraph, omit “sufficiently in advance of the first registration deadline for phase-in substances”.
Annex 12I99
In Annex 12 (general provisions for downstream users to assess substances and prepare chemical safety reports), in the introduction, in the second paragraph, for “Community” substitute “
other
”
.
Annex 14I1010
In Annex 14 (list of substances subject to authorisation), in entry Nr 4, in the entry for the column headed “exempted (categories of) uses”, for “Directive 2001/82/EC, and/or Directive 2001/83/EC” substitute “
the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012
”
.
Annex 15I1111
1
Annex 15 (dossiers) is amended as follows.
2
In Part 1 (introduction and general provisions), in the first paragraph, in the second indent, omit “within the Community”.
3
In Part 2 (content of dossiers), in section 3 (Dossiers for restrictions proposal)—
a
in the heading “Justification for Restrictions at Community Level”, omit “at Community level”;
b
in the paragraph that follows that heading—
i
in the first indent omit “on a Community-wide basis”;
ii
in the second indent omit “Community wide”.
Annex 17I1212
Annex 17 (restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles) is amended as follows.
I1313
Immediately before the Table insert—
1
In this Annex “competent appropriate authority”, in relation to the exercise of a function under this Annex, means—
a
the Secretary of State if, or to the extent that, the exercise of the function—
i
relates to England;
ii
relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);
iii
relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006);
F10iv
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
b
the Scottish Ministers if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998);
c
the Welsh Ministers if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006);
F10d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F112
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
I1414
1
In entry 3 in the table (liquid substances or mixtures regarded as dangerous or fulfilling the criteria for certain hazard classes or categories), the second column is amended as follows.
2
In paragraph 4, for the words from “European Standard” to “(CEN)” substitute “
British Standard Specification on Decorative oil lamps (BS EN 14059) adopted by the British Standards Institute
”
.
3
In paragraph 5, for “Community provisions” substitute “
legislation
”
.
4
Omit paragraph 6.
5
In paragraph 7, for the words from “competent” to “Commission” substitute “
Agency
”
.
I1515
I1616
1
In entry 6 in the table (asbestos fibres), the second column is amended as follows.
2
In paragraph 1, omit the second, third and fourth subparagraphs.
3
In paragraph 2—
a
in the first subparagraph, for “Member States may” substitute “
the competent appropriate authority may, after having consulted the other appropriate authorities
”
;
b
in the second subparagraph—
i
for “Member States may” substitute “
The competent appropriate authority may, after having consulted the other appropriate authorities,
”
;
ii
omit the second and third sentences.
4
In paragraph 3, for “Community provisions” substitute “
legislation
”
.
I1717
In entries 16 (lead carbonates) and 17 (lead sulphates) in the table, in the second column—
a
for “Member States may” substitute “
the competent appropriate authority may, after having consulted the other appropriate authorities
”
;
b
omit “on their territory”;
c
omit the final sentence.
I1818
In entry 18a in the table (mercury), in the second column, in paragraph 2, for “Member States may” substitute “
the competent appropriate authority may, after having consulted the other appropriate authorities,
”
.
I1919
1
In entry 19 in the table (arsenic compounds), the second column is amended as follows.
2
In paragraph 4—
a
in point (a), for “Article 5(1) of Directive 98/8/EC” substitute “
Articles 19 or 26 of Regulation (EU) No 528/2012
”
;
b
in point (c), for “Community provisions” substitute “
legislation
”
.
3
In paragraph 7, for “Member States may” substitute “
The competent appropriate authority may, after having consulted the other appropriate authorities,
”
.
I2020
In entry 23 in the table (cadmium), in the second column—
a
in the first paragraph, after “2658/87” insert “
, as it has effect in EU law immediately before F13IP completion day. For the purposes of this entry that Regulation has effect as if the references to Euratom were omitted
”
;
b
in paragraph 1—
i
omit the penultimate subparagraph (which begins “The first and second subparagraphs”);
ii
omit the final subparagraph (which begins “By 19 November 2012,”);
c
in paragraph 4, omit the final subparagraph (which begins “In accordance with Article 69”).
I2121
In entry 24 in the table (monomethyl – tetrachlorodiphenyl methane), in the second column, in paragraph 2, in the second subparagraph, for “Member States may” substitute “
the competent appropriate authority may, after having consulted the other appropriate authorities
”
.
I2222
1
In entries 28 to 30 of the table (certain substances that are carcinogens, cell mutagens or toxic to reproduction) the second column is amended as follows.
2
In paragraph 1, in the second subparagraph, for “Community provisions” substitute “
legislation
”
.
3
In paragraph 2—
a
for point (a) substitute—
a
medicinal or veterinary medicinal products as defined by the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012;
b
in point (b), for “Directive 76/768/EEC” substitute “
Regulation 1223/2009
”
;
c
in point (c), in the first indent, for “Directive 98/70/EC” substitute “
the Motor Fuel (Composition and Content) Regulations 1999
”
.
I2323
In entry 31 of the table (creosotes etc.), in the second column, in paragraph 2(a)—
a
in the first subparagraph omit “Community”;
b
in the third subparagraph, for “Community provisions” substitute “
legislation
”
.
I2424
In entries 32 to 38 of the table (chloroform etc.), in the second column, in paragraph 2—
a
for “Community provisions” substitute “
legislation
”
;
b
for point (a) substitute—
a
medicinal or veterinary medicinal products as defined by the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012;
c
in point (b), for “Directive 76/768/EEC” substitute “
Regulation 1223/2009
”
.
I2525
In entry 40 of the table (certain flammable substances etc.), in the second column, in paragraph 2, for “Community provisions” substitute “
legislation
”
.
I2626
In entry 45 of the table (diphenylether, octabromo derivative), in the second column, in paragraph 3, for “Directive 2002/95/EC” substitute “
the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 M3
”
.
I2727
In entry 47 of the table (chromium VI compounds), in the second column, in paragraph 2, for “Community provisions” substitute “
legislation
”
.
I2828
1
In entry 50 of the table (polycyclic-aromatic hydrocarbons), the second column is amended as follows.
2
In paragraph 1, in the second subparagraph, for “EN” substitute “
BS EN
”
.
3
For paragraph 4 substitute—
4
For the purpose of this entry ‘tyres’ shall mean tyres for vehicles covered by:
— F1Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles;
— Regulation (EU) No 167/2013 of the European Parliament and of the Council on the approval and market surveillance of agricultural and forestry vehicles M4;
— Regulation (EU) No 168/2013 of the European Parliament and of the Council on the approval and market surveillance of two- or three-wheel vehicles and quadricycles M5.
I38F328A
1
In entry 51 of the table (Bis(2-ethylhexyl) phthalate (DEHP) etc.), the second column is amended as follows.
2
In paragraph 4(c), for “Directive 2007/46/EC” substitute “Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles”
.
3
In paragraph 4(g), for “Directives 90/385/EEC, 93/42/EEC or 98/79/EC” substitute “The Medical Devices Regulations 2002 ”
.
4
In paragraph 4(h), for “Directive 2011/65/EU” substitute “
the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 ”
.
5
In paragraph 4(i), for the words from “Regulation (EC) No 726/2004” to the end substitute “
the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012 ”
.
6
In paragraph 6(a), for “Regulation (EC) No 216/2008” substitute “
Regulation (EU) 2018/1139
”
.
I2929
In entry 55 of the table (2-(2-butoxyethoxy)ethanol), in the second column, in paragraph 3, omit “Community”.
I3030
1
In entry 56 of the table (methylenediphenyl diisocyanate), the second column is amended as follows.
2
In paragraph 1(a), for “Council Directive 89/686/EEC” substitute “
Regulation (EU) 2016/425
”
.
3
In paragraph 1(b)—
a
omit “Community”;
b
in the third indent, for “EN” substitute “
BS EN
”
.
I3131
In entry 57 of the table (cyclohexane), in the second column, in paragraph 3, omit “Community”.
I3232
1
In entry 58 of the table (ammonium nitrate), the second column is amended as follows.
2
3
In paragraph 2(b)—
a
in the definition of “farmer”—
i
omit “by national law”;
ii
for the words from “Community” to “Treaty” substitute “F12Great Britain”
;
b
in the definition of “agricultural activity”, omit from “as established” to the end of the definition.
4
Omit paragraph 3.
I3333
1
In entry 59 of the table (dichloromethane), the second column is amended as follows.
2
In paragraph 2—
a
in the first subparagraph—
i
for “Member States may” substitute “
the competent appropriate authority may, after having consulted the other appropriate authorities,
”
;
ii
omit “on their territories and”.
b
in the second subparagraph—
i
for “Member States making use of this” substitute “
A
”
;
ii
omit “and shall inform the Commission thereof”;
c
in the third subparagraph—
i
omit “that is accepted by the Member State in which that professional operates”;
ii
omit “or be otherwise approved by that Member State,”;
d
omit the fourth subparagraph.
3
In paragraph 3, in the first subparagraph—
a
omit the first sentence;
b
in point (c), for “Directive 89/686/EEC” substitute “
Regulation (EU) 2016/425
”
.
4
In paragraph 4—
a
omit “Community”;
b
in point (d), for “Directive 89/686/EEC” substitute “
Regulation (EU) 2016/425
”
.
5
In paragraph 5—
a
for “Community provisions” substitute “
legislation
”
;
b
in the text in quotation marks—
i
after “industrial use and to” insert “
approved
”
;
ii
omit “approved in certain EU Member States”.
I3434
1
In entry 63 of the table (lead), the second column is amended as follows.
2
In paragraph 4(a), for the words from “Annex I” to “69/493/EEC” substitute “
the Crystal Glass (Descriptions) Regulations 1973 M7
”
.
3
In paragraph 4(c), after “2658/87” insert “
as it has effect in EU law immediately before F13IP completion day
”
.
4
Omit paragraph 6.
5
In paragraph 8(b), for the words from “Annex I” to “69/493/EEC” substitute “
the Crystal Glass (Descriptions) Regulations 1973
”
.
6
In paragraph 8(c), after “2658/87” insert “
as it has effect in EU law immediately before F13IP completion day
”
.
7
In paragraph 8(k)—
a
in point (i), before “Directive” insert “
the retained EU law that transposed
”
;
b
for point (iii) substitute—
iii
the Toys (Safety) Regulations 2011 M8;
c
for point (iv) substitute—
iv
the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012.
8
In paragraph 9—
a
for “Commission” substitute “
Agency
”
;
b
for “modify this entry accordingly” substitute “
make recommendations to the Secretary of State
”
.
I3535
In entry 65 of the table (inorganic ammonium salts), in the second column—
a
omit paragraph 3;
b
in paragraph 4, for “CEN/TS 16516” substitute “
BS EN 16516: 2017
”
.
I3636
1
In entry 67 (Bis(pentabromophenyl)ether), the second column is amended as follows.
2
In paragraph 3(b)(ii)—
a
for “Directive 2007/46/EC” substitute “F2Regulation (EU) 2018/858 of the European Parliament and of the Council”
;
b
for “Directive 2006/42/EC of the European Parliament and of the Council” substitute “
the Supply of Machinery (Safety) Regulations 2008 M9
”
.
3
In paragraph 4(d), for “Directive 2011/65/EU” substitute “
the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
”
.
4
In paragraph 5, for “Regulation (EU) No 216/2008 of the European Parliament and of the Council” substitute “
Regulation (EU) 2018/1139 of the European Parliament and of the Council
”
.
I3737
In entry 68 (Perfluorooctanoic acid), in the second column, in paragraphs 3(c) and 4(d)(i), for “Directive 93/42/EEC” substitute “
the Medical Devices Regulations 2002
”
.
I39F437A
1
In entry 72 of the table (the substances listed in column 1 of the table in Appendix 12), the second column is amended as follows.
2
In paragraph 4, for “Regulation (EU) 2017/745” to the end substitute “The Medical Devices Regulations 2002”
.
3
In paragraph 6, omit “Union”.
4
In paragraph 7—
a
for “Commission” substitute “
Secretary of State
”
;
b
omit “and, if appropriate, modify that point accordingly”.