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Article 59: Amendments to Regulation (EC) No 1907/2006 from 1 June 2015
Regulation (EC) No 1907/2006 shall be amended from 1 June 2015 as follows:
1.
Article 14(2) shall be replaced by the following:
‘2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than
(a)
the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;
(b)
0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.’;
2.
Article 31 shall be amended as follows:
(a)
in paragraph 1, point (a) shall be replaced by the following:
‘(a)
where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or’;
(b)
paragraph 3 shall be replaced by the following:
‘3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:
(a)
in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or
(b)
in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or
(c)
paragraph 4 shall be replaced by the following:
‘4. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.’;
3.
Article 56(6)(b) shall be replaced by the following:
‘(b)
for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.’;
4.
in Article 65 the words ‘and Directive 1999/45/EC’ shall be deleted;
5.
Annex II shall be amended as follows:
(a)
point 1.1 shall be replaced by:
The term used for identification of a substance shall be identical to that provided on the label in accordance with Article 18(2) of Regulation (EC) No 1272/2008.
The term used for identification of a mixture shall be identical to that provided on the label in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008.’;
(b)
footnote 1 to point 3.3(a), first indent, shall be deleted;
(c)
point 3.6 shall be replaced by:
‘3.6.
Where, in accordance with Article 24 of Regulation (EC) No 1272/2008, the Agency has agreed that the chemical identity of a substance may be kept confidential on the label and in the safety data sheet, their chemical nature shall be described under heading 3 in order to ensure safe handling.
The name used on the safety data sheet (including for the purposes of paragraphs 1.1, 3.2, 3.3 and 3.5) shall be the same as that used on the label, agreed in accordance with the procedure set out in Article 24 of Regulation (EC) No 1272/2008.’;
6.
in Annex VI section 4.3 shall be replaced by the following:
‘4.3
Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.’;
7.
Annex XVII shall be amended as follows:
(a)
in the column ‘Designation of the substance, of the groups of substances or of the mixture’ of the table in entry 3, the words ‘which are regarded as dangerous in accordance with Directive 1999/45/EC or are’ shall be deleted;
(b)
in the column ‘Conditions of restriction’ of the table, entry 28 shall be amended as follows:
(i)
the second indent of point 1 shall be replaced by the following:
‘—
the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.’;
(ii)
point 2 (d) shall be replaced by the following:
‘(d)
artists’ paints covered by Regulation (EC) No 1272/2008.’.