Active chlorine soon to be approved: what to do?
The European Commission published on 26th February 2021 the implementing regulations 2021/364 and 2021/365 approving active chlorine. Electrolytically generated active chlorine and active chlorine released from hypochlorous acid will therefore be officially approved on 1st July 2022 for PT2, PT3, PT4, PT5 and on 1st July 2021 for PT1.
For these types of disinfectant products, it will therefore be necessary to submit a Marketing Authorisation Application (MA) before the approval date in order to market these products.
Active chlorine can be found in products for water treatment, swimming pools or for general disinfection.
Active chlorine is the active form of chlorine, effective against bacteria, viruses and algae.
Both active substances will be approved if they meet certain conditions :
- Active chlorine released from hypochlorous acid is approved if it has a dry weight of at least 90.87% w/w and is the predominant species at pH 3.0 - 7.4.
- For electrolytically produced active chlorine, it is approved if the sodium chloride complies with the purity requirements of one of the standards listed in Annex I of Regulation 2021/364.
As the approval date of this substance is quite close, companies marketing these products must complete their Marketing Authorisation (MA) dossiers as soon as possible. In order to complete this dossier, it is necessary to undertake procedures to assess the substance and various tests to demonstrate the risks associated with its use. This dossier can be quite costly and time consuming to complete. If the dossier is not submitted before the approval date (July 2022), the products will have to be withdrawn from the market within 180 days.
The MA dossier can be compiled by the company alone, with the help of a consultant, or within a consortium dedicated to the substance. The latter allows the exchange of information on the biocidal product and minimises the costs of the dossier.
If you wish to reduce the cost of the application and save time on testing, you can join the Active Chlorine Consortium led by EcoMundo. Don’t hesitate to contact us or if you want to know more, join our webinar !
The purpose of the consortium is not to share technology or formulas, but to exchange information on substance hazards and risk assessment. Within the EcoMundo Active Chlorine Consortium (ACC), your data is protected: as a neutral entity, we guarantee the confidentiality of all your information.
Date of approval and product type
The approval of a biocidal active substance, the completion of the marketing authorisation dossier for the biocidal product and its approval by the competent authorities is a lengthy process for companies.
Active substances are first evaluated by the competent evaluation authority of a Member State and the results of these evaluations are forwarded to ECHA, whose Biocidal Products Committee delivers an opinion within 270 days. The opinion is the basis for the approval decision adopted by the European Commission. The approval of an active substance is granted for a fixed number of years not exceeding 10 years but renewable.
Active substances must be approved before an authorisation for a biocidal product containing them can be granted.
The MA dossier is quite complex to complete and takes at least a year to do so.
In order to continue to market products, it is necessary to be compliant and aware of the deadlines around the active substances but also according to their product type.
Ultimately, active chlorine will be approved for the following product types:
- PT1 Human hygiene: biocides in contact with the skin or scalp, with the main purpose of disinfecting the skin or scalp.
- PT2 Disinfectants and algaecides not intended for direct use on people or animals: for disinfecting surfaces, materials, equipment and furniture or swimming pools, aquariums, air conditioning systems, air, waste water, hospital waste, textiles.
- PT3 Veterinary hygiene: disinfectants, products for oral and body hygiene, products with antimicrobial functions, or for the disinfection of materials and surfaces related to the housing or transport of animals.
- PT4 Food and Feed: for the disinfection of equipment, containers, eating utensils, surfaces and pipes related to the production, transport, storage and consumption of animal feed.
- PT5 Drinking water: used for the disinfection of drinking water, both for humans and animals.
Knowledge of the type of product and the hazards of substances in biocidal products is essential to be marketed in compliance.
Wish to know more about risk management?
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts!
