Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Evaluation of active substances Assessment Report Active chlorine released from sodium hypochlorite Product-type 5 (Drinking water) January 2017 IT Active chlorine released Product-type 5 January 2017 from sodium hypochlorite CONTENTS 1. STATEMENT OF SUBJECT MATTER AND PURPOSE ............................................... 3 1.1. Procedure followed .............................................................................................................................. 3 1.2. Purpose of the assessment report ................................................................................................ 3 2. OVERALL SUMMARY AND CONCLUSIONS ................................................................... 4 2.1. Presentation of the Active Substance ......................................................................................... 4 2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis ................................................... 4 2.1.2. Intended Uses and Efficacy ..................................................................................................................... 9 2.1.3. Classification and Labelling ................................................................................................................... 12 2.2. Summary of the Risk Assessment ............................................................................................... 14 2.2.1. Human Health Risk Assessment .......................................................................................................... 14 2.2.1.1. Hazard identification and effects assessment ........................................................................ 14 2.2.1.2. Exposure assessment and risk characterisation ................................................................... 25 2.2.2. Environmental Risk Assessment ......................................................................................................... 40 2.2.2.1. Hazard identification and effects assessment ........................................................................ 41 2.2.2.2. Exposure assessment and risk characterisation ................................................................... 43 2.2.2.3. Fate and distribution in the environment ................................................................................ 46 2.2.2.4. PBT and POP assessment .............................................................................................................. 47 2.2.3. Assessment of endocrine disruptor properties .............................................................................. 47 2.3. Overall conclusions ............................................................................................................................ 48 2.4. Requirement for further information related to the reference biocidal product ... 48 2.5. List of endpoints .................................................................................................................................. 48 APPENDIX I: LIST OF ENDPOINTS ..................................................................................... 49 Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling ... 49 Chapter 2: Methods of Analysis ............................................................................................................ 53 Chapter 3: Impact on Human Health .................................................................................................. 55 Chapter 4: Fate and Behaviour in the Environment ..................................................................... 63 Chapter 5: Effects on Non-target Species ......................................................................................... 65 Chapter 6: Other End Points ................................................................................................................... 66 APPENDIX II: LIST OF INTENDED USES ........................................................................ 67 APPENDIX III: LIST OF STUDIES ........................................................................................ 69 2 Active chlorine released Product-type 5 January 2017 from sodium hypochlorite 1. STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1. Procedure followed This assessment report has been established as a result of the evaluation of the active substance active chlorine released from sodium hypochlorite as product-type 5 (Drinking water), carried out in the context of the work programme for the review of existing active substances provided for in Article 89 of Regulation (EU) No 528/20121, with a view to the possible approval of this substance. Active chlorine released from sodium hypochlorite (releaser CAS no.: 7681-52-9) was notified as an existing active substance, by the Euro Chlor Sodium Hypochlorite Registration Group at Euro Chlor, hereafter referred to as the applicant, in product-type 5. Commission Regulation (EC) No 1062/2014 of 4 August 20142 lays down the detailed rules for the evaluation of dossiers and for the decision-making process. On 31st July 2007, Italian competent authorities received a dossier from the Euro Chlor Sodium Hypochlorite Registration Group at Euro Chlor. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 2nd April 2008. On 17th May 2010, the Rapporteur Member State submitted to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the "Agency” (ECHA). Revisions agreed upon were presented at the Biocidal Products Committee and its Working Groups meetings and the competent authority report was amended accordingly. 1.2. Purpose of the assessment report The aim of the assessment report is to support the opinion of the Biocidal Products Committee and a decision on the approval of active chlorine released from sodium hypochlorite for product-type 5, and, should it be approved, to facilitate the authorisation of individual biocidal products. In the evaluation of applications for product-authorisation, the provisions of Regulation (EU) No 528/2012 shall be applied, in particular the provisions of Chapter IV, as well as the common principles laid down in Annex VI. For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available from the Agency web-site shall be taken into account. However, where conclusions of this assessment report are based on data protected under the provisions of Regulation (EU) No 528/2012, such conclusions may not be used to the benefit of another applicant, unless access to these data for that purpose has been granted to that applicant. 1 Replace by Article 90(2) for a new active substance submitted under Article 11 of the BPD 2 COMMISSION DELEGATED REGULATION (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council. OJ L 294, 10.10.2014, p. 1 3 Active chlorine released Product-type 5 January 2017 from sodium hypochlorite 2. OVERALL SUMMARY AND CONCLUSIONS 2.1. Presentation of the Active Substance 2.1.1. Identity, Physico-Chemical Properties & Methods of Analysis The active substance covered by this assessment is ‘active chlorine released from sodium hypochlorite’ (3). Upon use for MAIN GROUP 1 – Disinfectants (PT5), sodium hypochlorite aqueous solutions release ‘active chlorine’, i.e. efficacious chlorine or available/releasable chlorine that is disinfectant, algaecide, fungicide and microbiocide. Namely, in water sodium hypochlorite (NaClO) hydrolyzes to hypochlorous acid (HClO) according to: + ─ 4 NaClO + H2O ↔ Na + HClO + OH ( ) Furthermore, hypochlorous acid participates in the following equilibrium with chlorine (Cl2): + ─ 5 HClO + H3O + Cl ↔ Cl2 + 2H2O ( ) ─ The ratio of Cl2/HClO/ClO is pH and temperature dependent. The pH-dependence is displayed in the following figure, where the percentage of the different species at the equilibrium is showed as a function of pH. Hypochlorous acid is predominant in the pH range 4 to 5.5, whereas the hypochlorite anion predominates at pH >10. Chlorine can be present at pH < 4 only. (3) As in CA-March15-Doc.5.1-Final, Revised on 23 June 2015, Annex II – Releasers 4 ─ -8 3 ( ) Khydrolysis(ClO ) = Kw/Ka, where Ka(HClO)= 3.5 x 10 mol/dm at 20°C (Solvay, International Research Document, 1979) 5 -4 3 ( ) Khydrolysis(Cl2) = 3.2 x 10 mol/dm at 20°C (Solvay, International Research Document, 1979) 4 Active chlorine released Product-type 5 January 2017 from sodium hypochlorite Identification of the active substance releaser The following information attains to the active substance releaser, i.e. sodium hypochlorite Active substance releaser CAS-No. 7681-52-9 EINECS-No. 231-668- 3 Other No. 017-011-00-1 (Index number) IUPAC Name Sodium hypochlorite CAS name Hypochlorous acid, sodium sa lt Common name, synonyma Sodium hypochlorite Molecular formula CIHO.Na Structural formula Na+ Cl - O- Molecular weight 74.44 g/ mol Purity Aqueous solut ion with an available (active) chlorine concentration ::; 18% w/w (6 ) , in compliance with the EN