Commission Implementing Regulation (EU) 2017/1273 of 14 July 2017 approving active chlorine released from sodium hypochlorite as an existing active substance for use in biocidal products of product-types 1, 2, 3, 4 and 5 (Text with EEA relevance. )

Article 1

Active chlorine released from sodium hypochlorite is approved as an active substance for use in biocidal products of product-types 1, 2, 3, 4 and 5, subject to the specifications and conditions set out in the Annex.

Article 2

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

ANNEX

ANNEX
Common Name
IUPAC Name
Identification Numbers
Minimum degree of purity of the active substance  ( 1 )
Date of approval
Expiry date of approval
Product type
Specific conditions
Active chlorine released from sodium hypochlorite (hereafter referred to as ‘sodium hypochlorite’).
IUPAC Name:
Sodium hypochlorite
EC No: 231-668-3
CAS No: 7681-52-9
Minimum purity of the releaser sodium hypochlorite: aqueous solution with an active chlorine concentration ≤ 180 g/kg (i.e. ≤ 18 % w/w).
1 January 2019
31 December 2028
1
The authorisations of biocidal products are subject to the following condition:
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
2
The authorisations of biocidal products are subject to the following conditions:
(1)
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
(2)
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:
(a)
professional users and non-professional users;
(b)
surface water and sediment for disinfection of sewage / waste water in the effluent stream of the sewage treatment plant (post-chlorination).
3
The authorisations of biocidal products are subject to the following conditions:
(1)
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
(2)
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users and non-professional users.
(3)
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council  ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
4
The authorisations of biocidal products are subject to the following conditions:
(1)
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
(2)
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.
(3)
For products that may lead to residues in food or feed, the need to set new or to amend existing MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
5
The authorisations of biocidal products are subject to the following conditions:
(1)
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
(2)
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.
(3)
For products that may lead to residues in food or feed, the need to set new or to amend existing (MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
( 1 )   The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
( 2 )   Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ).
( 3 )   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).

Commission Implementing Regulation (EU) 2017/1273 of 14 July 2017 approving active chlorine released from sodium hypochlorite as an existing active substance for use in biocidal products of product-types 1, 2, 3, 4 and 5 (Text with EEA relevance. )

Schedules & Appendices

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