16th and 17th ATP to CLP

Caroline Raine outlines in this feature article the changes introduced to the Regulation on the classification, labelling and packaging of substances and mixtures (CLP) through the 16th and 17th Adaptation to Technical Progress (ATPs).

Background

The 16th ATP was published on 20 April 2021 and includes updates to notes J to R in point 1.1.3.1, and notes 8 and 9 in 1.1.3.2. The 16th ATP came into force on 10 May 2021.

The 17th ATP was published on 28 May 2021 and includes new harmonised classifications and amended harmonised classifications. The amendments add 63 substances to the list of harmonised classification and labelling of hazardous substances; Part 3 of Annex VI. These additions include 14 biocides, 10 copper compounds, 4 boron compounds, 1 nickel compound, benzyl salicylate, citric acid and 1,4-dioxane. In addition, the entry for tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate has been removed. The 17th ATP came into force on 17 June 2021 and will apply from 17th December 2022.

16th ATP

16th ATP — COMMISSION DELEGATED REGULATION (EU) 2021/643

Several Member States and stakeholders requested that a number of the notes set out in subsection 1.1.3 of Part 1 of Annex VI to Regulation (EC) No 1272/2008 be amended; the Commission agreed and so the 16th ATP was born.

The Commission stated that: “some of the notes related to substances are inaccurate and bring in some uncertainty as to the correct interpretation of legal obligations. In particular, some of those notes could be interpreted as not requiring the substances with respect of which those notes apply to be classified at all under certain conditions, whereas, in fact, they should not be covered by the harmonised classification and labelling but should still be subject to classification in accordance with Title II of Regulation (EC) No 1272/2008 (self-classification).”

The notes in 1.1.3.1 have been updated as follows:

“Note J:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes.

“Note K:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w 1,3- butadiene (Einecs No 203-450-8), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 shall apply.

“Note L:

The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 3 % of dimethyl sulphoxide extract as measured by IP 346 (“Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions – Dimethyl sulphoxide extraction refractive index method” Institute of Petroleum, London), in which case, a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

“Note M:

The harmonised classification as a carcinogen applies unless it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5), in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

“Note N:

The harmonised classification as a carcinogen applies unless the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen, in which case a classification in accordance with Title II of this Regulation shall be performed also for that hazard class.

“Note P:

The harmonised classification as a carcinogen or mutagen applies unless it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7), in which case a classification in accordance with Title II of this Regulation shall be performed also for those hazard classes. Where the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

“Note Q:

The harmonised classification as a carcinogen applies unless one of the following conditions is fulfilled:

  • a short term biopersistence test by inhalation has shown that fibres longer than 20 μm have a weighted half-life less than 10 days; or

  • a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted half-life less than 40 days; or

  • an appropriate intra-peritoneal test has provided no evidence of excess carcinogenicity; or

  • no relevant pathogenicity or neoplastic changes are noted in a suitable long term inhalation test.

“Note R:

The harmonised classification as a carcinogen applies except in the case of fibres with a Length Weighted Geometric Mean Diameter (LWGMD) minus two geometric standard errors greater than 6 μm, as measured in accordance with Test method A.22 in the Annex to Commission Regulation (EC) No 440/2008 (*).”

In addition, the notes in 1.1.3.2 are updated as follows:

“Note 8:

The classification as a carcinogen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.

“Note 9:

The classification as a mutagen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.’

17th ATP

17th ATP — Commission Delegated Regulation (EU) 2021/849 of 11 March 2021

The 17th ATP to CLP adds the following substances to Table 3 of Part 3 of Annex VI.

Chemical name

EC no

CAS no

1,4-dimethylnaphthalene

209-335-9

571-58-4

1-isopropyl- 4-methylbenzene; p-cymene

202-796-7

99-87-6

p-mentha-1,3-diene; 1-isopropyl- 4-methylcyclohex- a-1,3-diene; alpha-terpinene

202-795-1

99-86-5

Tetrafluoroethylene

204-126-9

116-14-3

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

204-327-1

119-47-1

(5-chloro-2-methoxy- 4-methyl-3-pyridyl) (4,5,6-trimethoxy-o- tolyl)methanone; pyriofenone

688046-61-9

2,2-dibromo-

2-cyanoacetamide; [DBNPA]

233-539-7

10222-01-2

[S-(Z,E)]-

5-(1-hydroxy-2,6,6-tri- methyl-4-oxocyclohex- 2-en-1-yl)-

3-methylpenta-2,4-die- noic acid;

S-abscisic acid

244-319-5

21293-29-8

methyl salicylate

204-317-7

119-36-8

citric acid

201-069-1

77-92-9

ethametsulfuron-methyl (ISO);

methyl 2-({[4-ethoxy- 6-(methylami-

no)-1,3,5-triazin-2-yl] carbamoyl}sulfamoyl) benzoate

97780-06-8

trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl (hydroxy)

methylene]-3,5-dioxocy- clohexanecarboxylate

95266-40-3

(3aS,5S,6R,7aR,7bS,9a-S,10R,12aS,12bS)-10-[(2S,3R,4R,5R)-3,4--)-3,4-dihydroxy-5,6-dime- thylheptan-2-yl]-5,6-dihydrox- y-7a,9a- dimethylhexadecahy-dro-3H-benzo[c]indeno [5,4-e]oxepin-3-one; 24-epibrassinolide

78821-43-9

benzyl salicylate

204-262-9

118-58-1

(RS)-1-{1-ethyl- 4-[4-mesyl-

3-(2-methoxyethoxy)-o- toluoyl]pyrazol-5-yloxy} ethyl methyl carbonate; tolpyralate

1101132-67-

-5

prothioconazole (ISO); 2-[2-(1-chlorocyclopro- pyl)-3-(2-chlorophenyl)-

2-hydroxypropyl]-2,4-di- hydro-3H-1,2,4-triazole- 3-thione

178928-70-6

azamethiphos (ISO); S- [(6-chloro-2-oxooxazolo [4,5-b]pyridin-3(2H)-yl) methyl] O,O-dimethyl thiophosphate

252-626-0

35575-96-3

3-methylpyrazole

215-925-7

1453-58-3

clomazone (ISO); 2-(2-chloroben-

zyl)-4,4-dimethyl-1,2-ox- azolidin-3-one

81777-89-1

emamectin benzoate (ISO); (4"R)-4"-deoxy-4"-

(methylamino) avermectin B1 benzoate

155569-91-8

N-methoxy-N- [1-methyl-

2-(2,4,6-trichlorophe- nyl)-ethyl]-

3-(difluoromethyl)- 1-methylpyrazole- 4-carboxamide; pydiflumetofen

1228284-64-

-7

N-{2-[[1,1'-bi

(cyclopropyl)]-2-yl] phenyl}-

3-(difluoromethyl)-

1-methyl-1H-pyrazole-

4-carboxamide; sedaxane

874967-67-6

The following existing entries have been updated.

boric acid [1]

boric acid [2]

233-139-2 [1]

234-343-4 [2]

10043-35-3 [1]

11113-50-1 [2]

diboron trioxide

215-125-8

1303-86-2

tetraboron disodium heptaoxide, hydrate; [1] disodium tetraborate, anhydrous; [2]

orthoboric acid, sodium salt [3]

235-541-3 [1]

215-540-4 [2]

237-560-2 [3]

215-540-4 [4]

215-540-4 [5]

12267-73-1 [1]

1330-43-4 [2]

13840-56-7 [3]

1303-96-4 [4]

12179-04-3 [5]

disodium tetraborate decahydrate [4] disodium tetraborate pentahydrate [5]

thiophanate-methyl (ISO); dimethyl

(1,2-phenylenedicarbamo- thioyl)biscarbamate; dimethyl 4,4′-(o-phenylene) bis(3-thioallophanate)

245-740-7

23564-05-8

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

8018-01-7

tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl) O,O-dimethyl thiophosphate

260-515-3

57018-04-9

trinickel disulfide; nickel subsulfide; [1]

heazlewoodite [2]

234-829-6 [1]

- [2]

12035-72-2 [1]

12035-71-1 [2]

dicopper oxide; copper (I) oxide

215-270-7

1317-39-1

copper thiocyanate

214-183-1

1111-67-7

copper(II) oxide

215-269-1

1317-38-0

dicopper chloride trihydroxide

215-572-9

1332-65-6

tetracopper hexahydroxide sulphate; [1]

tetracopper hexahydroxide sulphate hydrate [2]

215-582-3 [1]

215-582-3 [2]

1333-22-8 [1]

12527-76-3 [2]

copper flakes (coated with aliphatic acid)

-

copper(II) carbonate— copper(II) hydroxide (1:1)

235-113-6

12069-69-1

copper dihydroxide; copper(II) hydroxide

243-815-9

20427-59-2

bordeaux mixture;

reaction products of copper sulphate with calcium dihydroxide

8011-63-0

copper sulphate pentahydrate

231-847-6

7758-99-8

dipentene; limonene [1]

(S)-p-mentha-1,8-diene; l-limonene [2]

trans-1-methyl-

4-(1-methylvinyl) cyclohexene; [3] (±)-1-methyl-

4-(1-methylvinyl) cyclohexene [4]

205-341-0 [1]

227-815-6 [2]

229-977-3 [3]

231-732-0 [4]

138-86-3 [1]

5989-54-8 [2]

6876-12-6 [3]

7705-14-8 [4]

(R)-p-mentha-1,8-diene; d-limonene

227-813-5

5989-27-5

1,4-dioxane

204-661-8

123-91-1

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

203-437-7

106-87-6

2-phenoxyethanol

204-589-7

122-99-6

4-methylpentan-2-one; isobutyl methyl ketone

203-550-1

108-10-1

cypermethrin (ISO);

α-cyano-3-phenoxybenzyl 3-(2,2-dichlorovi-

nyl)-2,2-dimethylcyclopro- panecarboxylate; cypermethrin cis/trans +/- 40/60

257-842-9

52315-07-8

trifloxystrobin (ISO); methyl (E)-methoxyimino-

{(E)-α-[1-(α,α,α-trifluoro-m- tolyl)

ethylideneaminooxy]-o- tolyl}acetate

141517-21-7

mecoprop-P (ISO) [1] and its salts;

(R)-2-(4-chloro-

2-methylphenoxy) propionic acid [1] and its salts

240-539-0 [1]

16484-77-8 [1]

esfenvalerate (ISO); (S)-α-cyano-

3-phenoxybenzyl-(S)- 2-(4-chlorophenyl)- 3-methylbutyrate

66230-04-4

3-aminomethyl-3,5,5-tri- methylcyclohexylamine

220-666-8

2855-13-2

imidacloprid (ISO); (E)-1-(6-chloro-

3-pyridylmethyl)-N- nitroimidazolidin-

2-ylideneamine;

(2E)-1-[(6-chloropyridin- 3-yl) methyl]-N- nitroimidazolidin-2-imine

428-040-8

138261-41-3

carbendazim (ISO); methyl benzimidazol-

2-ylcarbamate

234-232-0

10605-21-7

dimethomorph (ISO); (E,Z)- 4-(3-(4-chlorophenyl)-

3-(3,4-dimethoxyphenyl) acryloyl)morpholine

404-200-2

110488-70-5

1,2,4-triazole

206-022-9

288-88-0

flumioxazin (ISO);

N-(7-fluoro-3,4-dihydro- 3-oxo-4-prop-

2-ynyl-2H-1,4-benzoxazin- 6-yl)cyclohex-

1-ene-1,2-dicarboximide

103361-09-7

imazamox (ISO); (RS)-2-(4-isopropyl- 4-methyl-5-oxo-

2-imidazolin-2-yl)-

5-methoxymethylnicotinic acid

114311-32-9

thiamethoxam (ISO); 3-(2-chloro-thiazol- 5-ylmethyl)-5-methyl [1,3,5]oxadiazinan-

4-ylidene-N-nitroamine

428-650-4

153719-23-4

triticonazole (ISO); (RS)-(E)-

5-(4-chlorobenzylide- ne)-2,2-dimethyl-

1-(1H-1,2,4-triazol-

1-methyl)cyclopentanol

138182-18-0

diflufenican (ISO);

N-(2,4-difluorophenyl)- 2-[3-(trifluoromethyl) phenoxy]-

3-pyridinecarboxamide; 2′,4′-difluoro-2-(α,α,α- trifluoro-m-tolyloxy) nicotinanilide

83164-33-4

phenmedipham (ISO); methyl

3-(3-methylcarbaniloyloxy) carbanilate

237-199-0

13684-63-4

desmedipham (ISO); ethyl

3-phenylcarbamoyloxyphe- nylcarbamate

237-198-5

13684-56-5

The following entry has been deleted.

tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate; tetrakis(2,6-dimethylphenyl) 1,3-phenylene bis(phosphate)

EC Number: 432-770-2

CAS Number: 139189-30-3

Index Number: 015-192-00-1

Conclusions

  • While the 16th ATP does not make any changes to substances it is important to check the notes and make sure there is no impact to you as a business.

  • The 17th ATP makes changes to a number of substances and adds new entries.

  • As it must be applied by 17 December 2022, check your substances lists carefully and ensure that all hazard communication (labels, safety data sheets, etc) are updated in a timely manner.