Already on 16 June 2020, the opinions of ECHA's Biocidal Products Committee (BPC) on the in-situ generated active substance "Active chlorine generated from sodium chloride by electrolysis" for product types 1 - 5 were adopted. On July 3, 2020, these were submitted to the European Commission with the recommendation for approval of the active substance.
On 14 July 2020, the BPC Opinions were published on ECHA's website:
- PT 1 - Human hygiene
- PT 2 - Disinfectants and algaecides not intended for direct application to humans or animals
- PT 3 - Veterinary hygiene
- PT 4 - Food and feed area
- PT 5 - Drinking water
A maximum of 2 years will then remain from the approval of the active substance to submit the relevant applications for authorisation of the biocidal product. The publication of the active substance approval is expected at the end of 2020.
Changes to the original BPC Opinions became necessary
It was originally assumed that the approval of the active substance for the in-situ system "Active chlorine generated from sodium chloride by electrolysis" would be granted in 2019. In the meantime, however, the authorising authority (ECHA – European Chemical Agency) had determined that the insufficient and excessively old data in the dossier of the applicant from Great Britain, which is now more than 10 years old, needed to be corrected. The requirements had meanwhile become more stringent.
In addition, due to the entry into force of Regulation (EU) 2017/21001, the Commission sent the BPC Opinion back to ECHA on 18 June 2018 with the request to revise the opinion already adopted by the Biocidal Products Committee (BPC) regarding the application of the criteria for endocrine disrupting properties as laid down in this Regulation.
Furthermore, at the initiative of industry, it has been possible to convey to both the European Commission and ECHA that the standard for salt, as well as that for water, as required by the BPC opinion of 25 April 2018, is far from any reality or practice. This is because the BPC opinion stated that for chlorine disinfection by electrolysis, a salt according to EU Pharmacopoeia (the reference work for the quality of medicines) and distilled water should have been used. In practice, this would have meant the end of chlorine electrolysis.
Therefore, the Commission asked ECHA for an opinion on the sodium chloride specifications and on the water quality for the generation of active chlorine by electrolysis according to Article 75(l)(g) of Regulation (EU) No 528/20122 . It was then decided within the working group consisting of industry representatives, MSCAs (Member State Competent Authorities) and ECHA to include further salt standards in addition to the Pharmacopoeia standard. If the water quality should have an influence on the composition of the generated active chlorine, then according to the BPC Opinion this would have to be considered in the context of disinfection by-products at the level of product approval.
Aqua Europa, as the European representative of figawa, has been instrumental in recent months in ensuring that the above-mentioned BPC Opinions were subject to appropriate revision.
All BPC Opinions published so far can be found here: