# L_2021446EN.01003401.xml

| 14.12.2021 | EN | Official Journal of the European Union | L 446/34 |
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14.12.2021

EN

Official Journal of the European Union

L 446/34

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COMMISSION REGULATION (EU) 2021/2204

of 13 December 2021

amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (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 (1), and in particular Article 68(2) thereof,

Whereas:

| (1) | Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B, and listed in Appendices 1 to 6 to that Annex and of mixtures containing such substances above specified concentrations. |
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(1)

Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B, and listed in Appendices 1 to 6 to that Annex and of mixtures containing such substances above specified concentrations.

| (2) | Substances classified as CMR are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). |
| --- | --- |

(2)

Substances classified as CMR are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2).

| (3) | Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006, as last amended by Commission Regulation (EU) 2020/2096 (3), do not yet reflect the new classifications of substances as CMR under Regulation (EC) No 1272/2008, as amended by Commission Delegated Regulations (EU) 2020/1182 (4) and (EU) 2021/849 (5). It is therefore appropriate to add the newly classified CMR substances of categories 1A or 1B listed in Delegated Regulations (EU) 2020/1182 and (EU) 2021/849 to Appendices 2, 4 and 6 to Annex XVII to Regulation (EC) No 1907/2006. |
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(3)

Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006, as last amended by Commission Regulation (EU) 2020/2096 (3), do not yet reflect the new classifications of substances as CMR under Regulation (EC) No 1272/2008, as amended by Commission Delegated Regulations (EU) 2020/1182 (4) and (EU) 2021/849 (5). It is therefore appropriate to add the newly classified CMR substances of categories 1A or 1B listed in Delegated Regulations (EU) 2020/1182 and (EU) 2021/849 to Appendices 2, 4 and 6 to Annex XVII to Regulation (EC) No 1907/2006.

| (4) | The classification of substances listed in Delegated Regulation (EU) 2020/1182 will apply from 1 March 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2020/1182 should therefore apply from 1 March 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2020/1182 earlier. |
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(4)

The classification of substances listed in Delegated Regulation (EU) 2020/1182 will apply from 1 March 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2020/1182 should therefore apply from 1 March 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2020/1182 earlier.

| (5) | The classification of substances listed in Delegated Regulation (EU) 2021/849 will apply from 17 December 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2021/849 should therefore apply from 17 December 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2021/849 earlier. |
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(5)

The classification of substances listed in Delegated Regulation (EU) 2021/849 will apply from 17 December 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2021/849 should therefore apply from 17 December 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2021/849 earlier.

| (6) | Regulation (EC) No 1907/2006 should therefore be amended accordingly. |
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(6)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133(1) of Regulation (EC) No 1907/2006, |
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(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133(1) of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Point (1) of the Annex shall apply as follows:

| — | rows concerning silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), dibenzo[def,p]chrysene; dibenzo[a,l]pyrene, m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether, 2,2-bis(bromomethyl)propane-1,3-diol, sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate], butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime and N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] shall apply from 1 March 2022, |
| --- | --- |

—

rows concerning silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), dibenzo[def,p]chrysene; dibenzo[a,l]pyrene, m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether, 2,2-bis(bromomethyl)propane-1,3-diol, sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate], butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime and N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] shall apply from 1 March 2022,

| — | rows concerning tetrafluoroethylene, 1,4-dioxane and 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide shall apply from 17 December 2022. |
| --- | --- |

—

rows concerning tetrafluoroethylene, 1,4-dioxane and 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide shall apply from 17 December 2022.

Point (2) of the Annex shall apply from 1 March 2022.

Point (3) of the Annex shall apply as follows:

| — | rows concerning tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, dichlorodioctylstannane, dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs. [2], ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme, 2-(4-tert-butylbenzyl)propionaldehyde, diisooctyl phthalate, 2-methoxyethyl acrylate, pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc, flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one and bis(α,α-dimethylbenzyl) peroxide shall apply from 1 March 2022, |
| --- | --- |

—

rows concerning tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, dichlorodioctylstannane, dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs. [2], ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme, 2-(4-tert-butylbenzyl)propionaldehyde, diisooctyl phthalate, 2-methoxyethyl acrylate, pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc, flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one and bis(α,α-dimethylbenzyl) peroxide shall apply from 1 March 2022,

| — | rows concerning mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt, 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide, 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC], dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine, 1,2,4-triazole and 3-methylpyrazole shall apply from 17 December 2022. |
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—

rows concerning mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt, 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide, 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC], dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine, 1,2,4-triazole and 3-methylpyrazole shall apply from 17 December 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 December 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 396, 30.12.2006, p. 1.

1

(2)  Regulation (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).

2

(3)  Commission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants (OJ L 425, 16.12.2020, p. 3).

3

(4)  Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 261, 11.8.2020, p. 2).

4

(5)  Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 188, 28.5.2021, p. 27).

5

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ANNEX

Annex XVII is amended as follows:

| (1) | in Appendix 2, the following entries are inserted in the table in the order of the index numbers set out therein:









  Substances | Index No | EC No | CAS No | Notes |
| --- | --- | --- | --- | --- | --- |
| ‘silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 014-048-00-5 | 206-991-8 | 409-21-2
  308076-74-6’ | |
| ‘dibenzo[def,p]chrysene; dibenzo[a,l]pyrene | 601-092-00-0 | 205-886-4 | 191-30-0’ | |
| ‘tetrafluoroethylene | 602-110-00-X | 204-126-9 | 116-14-3’ | |
| ‘1,4-dioxane | 603-024-00-5 | 204-661-8 | 123-91-1’ | |
| ‘m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether | 603-065-00-9 | 202-987-5 | 101-90-6’ | |
| ‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide | 603-066-00-4 | 203-437-7 | 106-87-6’ | |
| ‘2,2-bis(bromomethyl)propane-1,3-diol | 603-240-00-X | 221-967-7 | 3296-90-0’ | |
| ‘sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate] | 607-746-00-1 | 274-357-8 | 70161-44-3’ | |
| ‘butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime | 616-014-00-0 | 202-496-6 | 96-29-7’ | |
| ‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 616-230-00-5 | 213-103-2 | 924-42-5’; | |

(1)

in Appendix 2, the following entries are inserted in the table in the order of the index numbers set out therein:

Substances

Index No

EC No

CAS No

Notes

‘silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)

014-048-00-5

206-991-8

409-21-2

308076-74-6’

‘dibenzo[def,p]chrysene; dibenzo[a,l]pyrene

601-092-00-0

205-886-4

191-30-0’

‘tetrafluoroethylene

602-110-00-X

204-126-9

116-14-3’

‘1,4-dioxane

603-024-00-5

204-661-8

123-91-1’

‘m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether

603-065-00-9

202-987-5

101-90-6’

‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide

603-066-00-4

203-437-7

106-87-6’

‘2,2-bis(bromomethyl)propane-1,3-diol

603-240-00-X

221-967-7

3296-90-0’

‘sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]

607-746-00-1

274-357-8

70161-44-3’

‘butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime

616-014-00-0

202-496-6

96-29-7’

‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]

616-230-00-5

213-103-2

924-42-5’;

| (2) | in Appendix 4, the following entries are inserted in the table in the order of the index numbers set out therein:









  Substances | Index No | EC No | CAS No | Notes |
| --- | --- | --- | --- | --- | --- |
| ‘2,2-bis(bromomethyl)propane-1,3-diol | 603-240-00-X | 221-967-7 | 3296-90-0’ | |
| ‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 616-230-00-5 | 213-103-2 | 924-42-5’; | |

(2)

in Appendix 4, the following entries are inserted in the table in the order of the index numbers set out therein:

Substances

Index No

EC No

CAS No

Notes

‘2,2-bis(bromomethyl)propane-1,3-diol

603-240-00-X

221-967-7

3296-90-0’

‘N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]

616-230-00-5

213-103-2

924-42-5’;

| (3) | in Appendix 6, the following entries are inserted in the table in the order of the index numbers set out therein:









  Substances | Index No | EC No | CAS No | Notes |
| --- | --- | --- | --- | --- | --- |
| ‘mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt | 006-076-00-1 | - | 8018-01-7’ | |
| ‘tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane | 014-050-00-6 | 213-934-0 | 1067-53-4’ | |
| ‘dichlorodioctylstannane | 050-021-00-4 | 222-583-2 | 3542-36-7’ | |
| ‘dioctyltin dilaurate; [1]
  stannane, dioctyl-, bis(coco acyloxy) derivs. [2] | 050-031-00-9 | 222-883-3 [1]
  293-901-5 [2] | 3648-18-8 [1]
  91648-39-4 [2]’ | |
| ‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide | 603-066-00-4 | 203-437-7 | 106-87-6’ | |
| ‘ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | 603-237-00-3 | - | 125225-28-7
  115850-69-6
  115937-89-8’ | |
| ‘bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 603-238-00-9 | 205-594-7 | 143-24-8’ | |
| ‘6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC] | 604-095-00-5 | 204-327-1 | 119-47-1’ | |
| ‘2-(4-tert-butylbenzyl)propionaldehyde | 605-041-00-3 | 201-289-8 | 80-54-6’ | |
| ‘diisooctyl phthalate | 607-740-00-9 | 248-523-5 | 27554-26-3’ | |
| ‘2-methoxyethyl acrylate | 607-744-00-0 | 221-499-3 | 3121-61-7’ | |
| ‘dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine | 613-102-00-0 | 404-200-2 | 110488-70-5’ | |
| ‘1,2,4-triazole | 613-111-00-X | 206-022-9 | 288-88-0’ | |
| ‘pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc | 613-333-00-7 | 236-671-3 | 13463-41-7’ | |
| ‘flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one | 613-334-00-2 | 262-661-3 | 61213-25-0’ | |
| ‘3-methylpyrazole | 613-339-00-X | 215-925-7 | 1453-58-3’ | |
| ‘bis(α,α-dimethylbenzyl) peroxide | 617-006-00-X | 201-279-3 | 80-43-3’ | |

(3)

in Appendix 6, the following entries are inserted in the table in the order of the index numbers set out therein:

Substances

Index No

EC No

CAS No

Notes

‘mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt

006-076-00-1

-

8018-01-7’

‘tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane

014-050-00-6

213-934-0

1067-53-4’

‘dichlorodioctylstannane

050-021-00-4

222-583-2

3542-36-7’

‘dioctyltin dilaurate; [1]

stannane, dioctyl-, bis(coco acyloxy) derivs. [2]

050-031-00-9

222-883-3 [1]

293-901-5 [2]

3648-18-8 [1]

91648-39-4 [2]’

‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide

603-066-00-4

203-437-7

106-87-6’

‘ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

603-237-00-3

-

125225-28-7

115850-69-6

115937-89-8’

‘bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme

603-238-00-9

205-594-7

143-24-8’

‘6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC]

604-095-00-5

204-327-1

119-47-1’

‘2-(4-tert-butylbenzyl)propionaldehyde

605-041-00-3

201-289-8

80-54-6’

‘diisooctyl phthalate

607-740-00-9

248-523-5

27554-26-3’

‘2-methoxyethyl acrylate

607-744-00-0

221-499-3

3121-61-7’

‘dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine

613-102-00-0

404-200-2

110488-70-5’

‘1,2,4-triazole

613-111-00-X

206-022-9

288-88-0’

‘pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc

613-333-00-7

236-671-3

13463-41-7’

‘flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one

613-334-00-2

262-661-3

61213-25-0’

‘3-methylpyrazole

613-339-00-X

215-925-7

1453-58-3’

‘bis(α,α-dimethylbenzyl) peroxide

617-006-00-X

201-279-3

80-43-3’

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