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Commission Regulation (EU) No 1297/2014 of 5 December 2014 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)
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THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006(1), and in particular Article 53(1) thereof,
Whereas:
(1) Regulation (EC) No 1272/2008 harmonises the criteria for the classification and the rules on labelling and packaging for hazardous substances and mixtures. It sets an obligation for suppliers to label and package substances and mixtures classified as hazardous in accordance with that Regulation before placing them on the market. It provides for rules to avoid accidental exposure and poisoning of consumers, in particular young children, to hazardous chemicals supplied to the general public.
(2) Liquid consumer laundry detergents in soluble packaging for single use are placed on the market in the Member States, and the market share of this product is rising in the Union. The existing provisions for soluble packaging containing hazardous chemicals for single use do not provide sufficient protection. A uniform and more efficient approach to ensure better protection of the general public and especially young children and other vulnerable groups while maintaining free circulation of chemical products contained in soluble packaging is therefore warranted.
(3) A significant number of severe incidents of poisoning and eye damage involving infants have been reported by Poison Centres in several Member States in regard to liquid consumer laundry detergents in soluble packaging for single use, with a higher accident rate compared to consumer laundry detergents in other packaging systems.
(4) Although information campaigns in some Member States have shown some positive effects, it is necessary to lower the attractiveness to young children and to protect them by making this type of product less visible by using opaque outer packaging, by including an aversive agent (such as a bittering agent) in the soluble packaging to cause an immediate repulsive effect when in contact with the mouth and by rendering access to this type of product more difficult. Supplemental information should be included and highlighted on the label of the outer packaging of liquid consumer laundry detergents in soluble packaging for single use.
(5) To rapidly address the severe consequences related to incidents with these products, while taking account of the necessary minimum time needed by economic operators to adapt to the new rules, an adequate transitional period should be provided.
(6) Recourse to the urgency procedure under Article 54(4) of Regulation (EC) No 1272/2008 is warranted.
(7) Without undue delay, further studies on relevant incidents will be carried out and further measures including the widening of the scope of the rules to other consumer products contained in soluble packaging and the review of the proposed rules will be considered.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(2),
HAS ADOPTED THIS REGULATION:
Regulation (EC) No 1272/2008 is amended as follows:
in the second subparagraph of Article 35(2), the following sentence is added:
‘Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council(3), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.’;
Annex II is amended as set out in the Annex to this Regulation.
1.By way of derogation from the second paragraph of Article 3, substances subject to Article 1, classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before 1 June 2015 shall not be required to be relabelled and repackaged in accordance with Regulation (EC) No 1272/2008, as amended by this Regulation, until 31 December 2015.
2.By way of derogation from the second paragraph of Article 3, mixtures subject to Article 1, classified, labelled and packaged in accordance with Directive 1999/45/EC of the European Parliament and of the Council(4) or Regulation (EC) No 1272/2008 and placed on the market before 1 June 2015 shall not be required to be relabelled and repackaged in accordance with Regulation (EC) No 1272/2008, as amended by this Regulation, until 31 December 2015.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 June 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 December 2014.
For the Commission
The President
Jean-Claude Juncker
In Part 3 of Annex II to Regulation (EC) No 1272/2008 the following section 3.3 is added:
Where a liquid consumer laundry detergent in dosages for single use is contained in a soluble packaging, the following additional provisions shall apply:
Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.
The outer packaging shall:
be opaque or obscure so that it impedes the visibility of the product or individual doses;
without prejudice to Article 32(3), bear the precautionary statement P102 “Keep out of reach of children” at a visible place and in a format that attracts attention;
be an easily reclosable, self-standing container;
without prejudice to the requirements of section 3.1, be fitted with a closure that:
impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;
maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.
The soluble packaging shall:
contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;
retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;
resist mechanical compressive strength of at least 300 N under standard test conditions.’
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).’
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).
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