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)Text with EEA relevance

• Published date: 05 May 2017
• Official Gazette Publication: Official Journal of the European Union, L 116, 5 May 2017

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:

		Official Journal
		No	page	date
►M1	COMMISSION REGULATION (EU) 2018/1480 of 4 October 2018	L 251	1	5.10.2018

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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)

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.

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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...