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Article 57: Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation
Regulation (EC) No 1907/2006 shall be amended as from the entry into force of this Regulation as follows:
1.
Article 14(2) shall be amended as follows:
(a)
point (b) shall be replaced by the following:
‘(b)
the specific concentration limits that have been set in Part 3 of Annex VI to 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 (
*3
);
(ba)
for substances classified as hazardous to the aquatic environment, if a multiplying factor (hereinafter referred to as “M-factor”) has been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;
(b)
point (e) shall be replaced by the following:
‘(e)
the specific concentration limits given in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008;
(ea)
for substances classified as hazardous to the aquatic environment, if an M-factor has been set in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;’;
2.
Article 31 shall be amended as follows:
(a)
paragraph 8 shall be replaced by the following:
‘8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.’;
(b)
the following paragraph shall be added:
‘10. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.
From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.’;
3.
Article 56(6)(b) shall be replaced by the following:
‘(b)
for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Part 3 of Annex VI to Regulation (EC) No 1272/2008 which result in the classification of the mixture as dangerous.’;
4.
Article 59(2) and 3 shall be amended as follows:
(a)
in paragraph 2, the second sentence shall be replaced by the following:
‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
(b)
in paragraph 3, the second sentence shall be replaced by the following:
‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
5.
in Article 76(1)(c), the words ‘Title XI’ shall be replaced by ‘Title V of Regulation (EC) No 1272/2008’;
6.
Article 77 shall be amended as follows:
(a)
in paragraph 2, the first sentence of point (e) shall be replaced by the following:
‘(e)
establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list established in accordance with Regulation (EC) No 1272/2008;’;
(b)
in paragraph 3, point (a), the words ‘Titles VI to XI’ shall be replaced by ‘Titles VI to X’;
7.
Title XI shall be deleted;
8.
Annex XV, sections I and II shall be amended as follows:
(a)
section I shall be amended as follows:
(i)
the first indent shall be deleted;
(ii)
the second indent shall be replaced by the following:
‘—
the identification of CMRs, PBTs, vPvBs, or a substance of equivalent concern in accordance with Article 59,’;
(b)
in section II, point 1 shall be deleted;
9.
the table in Annex XVII shall be amended as follows:
(a)
the column ‘Designation of the substance, of the groups of substances or of the preparation’, shall be amended as follows:
(i)
entries 28, 29 and 30 shall be replaced by the following:
‘28.
Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:
—
Carcinogen category 1A (Table 3.1)/carcinogen category 1 (Table 3.2) listed in Appendix 1
—
Carcinogen category 1B (Table 3.1)/carcinogen category 2 (Table 3.2) listed in Appendix 2
29.
Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as germ cell mutagen category 1A or 1B (Table 3.1) or mutagen category 1 or 2 (Table 3.2) and listed as follows:
—
Mutagen category 1A (Table 3.1)/mutagen category 1 (Table 3.2) listed in Appendix 3
—
Mutagen category 1B (Table 3.1)/mutagen category 2 (Table 3.2) listed in Appendix 4
30.
Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:
—
Reproductive toxicant category 1A adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5
—
Reproductive toxicant category 1B adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 2 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 6’;
(b)
in the column ‘Conditions of restriction’, in entry 28, the first indent of point 1 shall be replaced by the following:
‘—
either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or’;
10.
Appendices 1 to 6 to Annex XVII shall be amended as follows:
(a)
the Foreword shall be amended as follows:
(i)
in the section entitled ‘Substances’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
(ii)
in the section entitled ‘Index number’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
(iii)
in the section entitled ‘Notes’, the words ‘the foreword of Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 1 of Annex VI to Regulation (EC) No 1272/2008’;
(iv)
Note A shall be replaced by the following:
‘Note A:
Without prejudice to Article 17(2) of Regulation (EC) No 1272/2008, the name of the substance must appear on the label in the form of one of the designations given in Part 3 of Annex VI to that Regulation.
In that Part, use is sometimes made of a general description such as “... compounds” or “... salts”. In this case, the supplier who places such a substance on the market is required to state on the label the correct name, due account being taken of Section 1.1.1.4 of Annex VI to Regulation (EC) No 1272/2008.
In accordance with Regulation (EC) No 1272/2008, where a substance is included in Part 3 of Annex VI to that Regulation, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation.
For substances belonging to one particular group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation.
For substances belonging to more than one group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by both entries in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation. In cases where two different classifications are given in the two entries for the same hazard class or differentiation, the classification reflecting the more severe classification shall be used.’;
(v)
Note D shall be replaced by the following:
‘Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier who places such a substance on the market must state on the label the name of the substance followed by the words “non-stabilised”.’;
(vi)
Note E shall be deleted;
(vii)
Note H shall be replaced by the following:
‘Note H:
The classification and label shown for this substance applies to the hazard or hazards indicated by the hazard statement or hazard statements in combination with the hazard classification shown. The requirements of Article 4 of Regulation (EC) No 1272/2008 on suppliers of this substance apply to all other hazard classes, differentiations and categories.
The final label shall follow the requirements of section 1.2 of Annex I to Regulation (EC) No 1272/2008.’;
(viii)
Note K shall be 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 of Annex VI to Regulation (EC) No 1272/2008.’;
(ix)
Note S shall be replaced by the following:
‘Note S:
This substance may not require a label according to Article 17 of Regulation (EC) No 1272/2008 (see section 1.3 of Annex I to that Regulation).’;
(b)
in Appendix 1, the title shall be replaced by the following:
‘Point 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
(c)
Appendix 2 shall be amended as follows:
(i)
the title shall be replaced by ‘Point 28 — Carcinogens: category 1B (Table 3.1)/ category 2 (Table 3.2)’;
(ii)
in the entries index Nos 024-017-00-8, 611-024-001, 611-029-00-9, 611-030-00-4 and 650-017-00-8, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Annex VI to Regulation (EC) No 1272/2008.’;
(d)
in Appendix 3, the title shall be replaced by the following:
‘Point 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
(e)
in Appendix 4, the title shall be replaced by the following:
‘Point 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)’;
(f)
in Appendix 5, the title shall be replaced by the following:
‘Point 30 — Reproductive toxicants: category 1A (Table 3.1)/category 1 (Table 3.2)’;
(g)
in Appendix 6, the title shall be replaced by the following:
‘Point 30 — Reproductive toxicants: category 1B (Table 3.1)/category 2 (Table 3.2)’;
11.
the word ‘preparation’ or ‘preparations’ within the meaning of Article 3 (2) of Regulation (EC) 1907/2006 shall be replaced by ‘mixture’ or ‘mixtures’ respectively throughout the text.