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ECHA Guidance on technical equivalence for active chlorine released from hypochlorous acid

Advice on information requirements for the technical equivalence application recently published by ECHA

Different active substances require different practical approaches when technical equivalence needs to be demonstrated with respect to another source.
ECHA proposed a tailored approach for the active substance: "Active chlorine released from hypochlorous acid".

Technical equivalence is a process aimed at assessing the chemical similarity of an alternative source of active substance in relation to the one already registered. It consists of two tiers, which are described in document ECHA-18-G-08-EN. The current guidance document on active chlorine released from hypochlorous acid refers to Tier I only.

The requirements included in the document are:
1) A 5-batch analysis (performed under GLP) should be submitted for the following parameters:
     a. Active chlorine
     b. Chlorate
     c. Sodium
    d. Chloride
    e.  Chlorite (if applicable)
    f. Perchlorate (if applicable)
   g. pH value

If any other impurity ≥ 0,1 % (w/w on dry weight) is present, it must be identified and quantified. If it is < 0.1 % (w/w on dry weight), it should be addressed if it has (eco)toxicological relevance.

2) Absorption spectra are not required.

3) The minimum purity of the active substance and the maximum concentration of impurities must be indicated based on both the substance as manufactured and on dry weight. If a large amount of sodium chloride is present (due to the manufacturing process), it must be excluded from the dry weight calculation.

Read more about technical equivalence on the ECHA website

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