02017R0776 — EN — 25.10.2018 — 001.001

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►B COMMISSION REGULATION (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance) (OJ L 116 5.5.2017, p. 1)

Amended by:









▼B

COMMISSION REGULATION (EU) 2017/776

of 4 May 2017

amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

(Text with EEA relevance)







Article 1

Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.

Article 2

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

2. This Regulation shall apply from 1 December 2018.

▼M1

In the Annex, point (1), point (2) and points (a), (b) and (c) of point (3) shall apply from 1 June 2017.

▼B

3. By way of derogation from paragraph 2, substances and mixtures may, before 1 December 2018, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

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









ANNEX

Annex VI to Regulation (EC) No 1272/2008 is amended as follows:

(1) the introductory paragraphs are replaced by the following:

‘Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3.

Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Union level.

Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Union level. In Table 3 the classification and labelling are based on the criteria in Annex I to this Regulation.’;

(2) Part 1 is amended as follows:

(a) the title of Section 1.1.2 is replaced by the following:

Information related to the classification and labelling of each entry in Table 3’;

(b) Section 1.1.2.3 is replaced by the following:

‘1.1.2.3. Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE)

Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of table 3. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.

In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, that M-factor is given in Table 3 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see Section 4.1.3.5.5.5 of Annex I.’;

(c) Section 1.1.3.1 is amended as follows:

(i) Note E is deleted;

(ii) Note K is replaced by the following:

‘Note K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3.’;

(iii) Note P is replaced by the following:

‘Note P:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

This note applies only to certain complex oil-derived substances in Part 3.’;

(iv) Note S is replaced by the following:

‘Note S:

This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).’;

(v) in Note U, the title is replaced by the following:

‘Note U (Table 3):’;

(d) Section 1.1.3.2 is amended as follows:

(i) Note 1 is replaced by the following:

‘Note 1:

The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.’;

(ii) Note 8 is added as follows:

‘Note 8:

The classification as a carcinogen need not apply if 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 %.’;

(iii) Note 9 is added as follows:

‘Note 9:

The classification as a mutagen need not apply if 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 %.’;

(e) Section 1.1.4 is deleted;

(f) The Title of Section 1.2 is replaced by the following:

Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC’;

(g) Section 1.2.1 is replaced by the following:

‘1.2.1. Minimum classification

For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled:

— the manufacturer or importer has access to data or other information, as specified in Part 1 of Annex I, that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied,

— the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in this Annex if it differs from it.

Minimum classification for a category is indicated by the reference * in the column “Classification” in Table 3.

The reference * can also be found in the column “Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE)” where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be “translated” into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern.’;

(h) Section 1.2.2 is replaced by the following:

‘1.2.2. Route of exposure cannot be excluded

For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available.

These hazard statements are indicated by the reference ** in Table 3.’;

(i) Section 1.2.3 is replaced by the following:

‘1.2.3. Hazard statements for reproductive toxicity

Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: “May damage/Suspected of damaging fertility or the unborn child”. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation.

In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive.

These hazard statements are indicated by the reference *** in Table 3.’;

(j) Section 1.2.4 is replaced by the following:

‘1.2.4. Correct classification for physical hazards could not be established

For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing.

The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.’;

(3) Part 3 is amended as follows:

(a) the header of Part 3 is replaced by the following:

PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE’;

(b) the introductory paragraphs are deleted;

(c) the title of Table 3.1 is replaced by the following:

‘Table 3

List of harmonised classification and labelling of hazardous substances’;

(d) Table 3 is amended as follows:

(i) the title of the penultimate column is replaced by ‘Specific Conc. Limits, M-factors and ATE’;

(ii) the entries corresponding to index numbers 006-046-00-8, 604-057-00-8, 605-023-00-5, 606-041-00-6, 607-123-00-4, 608-055-00-8, 612-150-00-X, 613-318-00-5, 614-001-00-4, 615-013-00-2, 616-006-00-7, 616-094-00-7 and 650-032-00-X are replaced by the following corresponding entries:







Index No International Chemical Identification EC No CAS No Classification Labelling Specific Conc. Limits, M-factors and ATE Notes Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Hazard statement Code(s) Suppl. Hazard statement Code(s) ‘006-046-00-8 bendiocarb (ISO); 2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate; 2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate 245-216-8 22781-23-3 Acute Tox. 3 Acute Tox. 3 Acute Tox. 2 Aquatic Acute 1 Aquatic Chronic 1 H331 H311 H300 H400 H410 GHS06 GHS09 Dgr H331 H311 H300 H410 M = 10 M = 100’ ‘604-057-00-8 reaction mass of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n = 5 or 6 401-680-5 — Aquatic Chronic 4 H413 H413’ ‘605-023-00-5 5-chloro-2-(4-chlorophenoxy)phenol; [DCPP] 429-290-0 3380-30-1 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H318 H400 H410 GHS05 GHS09 Dgr H318 H410 M = 10 M = 10’ ‘606-041-00-6 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one 400-600-6 71868-10-5 Repr. 1B Acute Tox. 4 * Aquatic Chronic 2 H360FD H302 H411 GHS08 GHS07 GHS09 Dgr H360FD H302 H411’ ‘607-123-00-4 2,3-epoxypropyl methacrylate; glycidyl methacrylate 203-441-9 106-91-2 Carc. 1B Muta. 2 Repr. 1B Acute Tox. 3 Acute Tox. 4 STOT SE 3 STOT RE 1 Eye Dam. 1 Skin Corr. 1C Skin Sens. 1 H350 H341 H360F H311 H302 H335 H372 (respiratory tract) (inhalation) H318 H314 H317 GHS08 GHS06 GHS05 Dgr H350 H341 H360F H311 H302 H335 H372 (respiratory tract) (inhalation) H314 H317 D’ ‘608-055-00-8 fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile 424-610-5 120068-37-3 Acute Tox. 3* Acute Tox. 3* Acute Tox. 3* STOT RE 1 Aquatic Acute 1 Aquatic Chronic 1 H301 H311 H331 H372* H400 H410 GHS06 GHS08 GHS09 Dgr H301 H311 H331 H372* H410 M = 1 000 M = 10 000 ’ ‘612-150-00-X spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine — 118134-30-8 Repr. 2 Acute Tox. 4 Acute Tox. 4 Acute Tox. 4 STOT RE 2 Skin Irrit. 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H361d H332 H312 H302 H373 (eye) H315 H317 H400 H410 GHS08 GHS07 GHS09 Wng H361d H332 H312 H302 H373 (eye) H315 H317 H410 M = 100 M = 100’ ‘613-318-00-5 fenpyrazamine (ISO); S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate; S-allyl 5-amino-2-isopropyl-4-(2-methylphenyl)-3-oxo-2,3-dihydropyrazole-1-carbothioate — 473798-59-3 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 10 M = 1’ ‘614-001-00-4 nicotine (ISO); 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine 200-193-3 54-11-5 Acute Tox. 2 Acute Tox. 2 Acute Tox. 2 Aquatic Chronic 2 H330 H310 H300 H411 GHS06 GHS09 Dgr H330 H310 H300 H411 inhalation: ATE = 0.19 mg/L (dusts or mists) dermal: ATE = 70 mg/kg oral: ATE (*1) = 5 mg/kg’ ‘615-013-00-2 cyanamide; carbamonitril 206-992-3 420-04-2 Carc. 2 Repr. 2 Acute Tox. 3 Acute Tox. 3 STOT RE 2 Skin Corr. 1 Skin Sens. 1 Eye Dam. 1 Aquatic Chronic 3 H351 H361fd H311 H301 H373 (thyroid) H314 H317 H318 H412 GHS08 GHS06 GHS05 Dgr H351 H361fd H311 H301 H373 (thyroid) H314 H317 H412’ ‘616-006-00-7 dichlofluanid (ISO); N-[(dichlorofluoromethyl)thio]-N′,N′-dimethyl-N-phenylsulfamide 214-118-7 1085-98-9 Acute Tox. 4 Eye Irrit. 2 Skin Sens. 1 Aquatic Acute 1 H332 H319 H317 H400 GHS07 GHS09 Wng H332 H319 H317 H400 M = 10’ ‘616-094-00-7 3,3′-dicyclohexyl-1,1′-methylenebis(4,1-phenylene)diurea 406-370-3 58890-25-8 Aquatic Chronic 4 H413 H413’ ‘650-032-00-X cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol — 94361-06-5 Repr. 1B Acute Tox. 3 STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1 H360D H301 H373 (liver) H400 H410 GHS08 GHS06 GHS09 Dgr H360D H301 H373 (liver) H410 M = 10 M = 1’ (*1) Converted acute toxicity point estimate according to Table 3.1.2 of Annex I.

(iii) the following entries are inserted in accordance with the order of the entries set out in Table 3: