The DDAC approved by the European Commission
The European Commission has approved DDAC (Didecyl(dimethyl)ammonium chloride | CAS No.: 7173-5165 | EC No.: 230-525-2) for TP01 and TP02 as an active substance, in accordance with Regulation (EU) No. 528/2012. The date of approval is February 1, 2024. From this date, an authorization for your biocidal products containing only DDAC will be mandatory for the market of your products. As a reminder, TP03 and TP04 were approved on November 1st 2022.
For DDAC, the European Commission requires that the authorization dossiers for Product Type 1 (TP01) contain an assessment of the product on exposure, risk and efficacy related to all uses covered by an application for authorization, but which have not been taken into account in the risk assessment of the active substance within the Union. For Product Type 2 (TP02) authorization dossiers, the same assessments are required together with an assessment related to exposure and potential risks to professional users.
History of DDAC
DDAC is a biocidal substance used as a disinfectant (Group 1 type of biocides).
In 2012, this substance was under evaluation by the German Federal Institute for Risk Assessment (BfR). Background levels of DDAC were assessed to be above the default maximum residue limit (MRL) applicable in the majority of products. At that time, the institute recommended the development of guidelines for cleaning and washing procedures for all food contact equipment.
In 2013, Switzerland added DDAC (TP08) to the list of active substances in the national regulation on biocidal products.
It was in 2018, that ECHA's BPC (Biocidal Products Committee) supported the approval of quaternary ammoniums including DDAC.
In 2021, Product Types 1 and Product Types 2 containing DDAC have been evaluated by the Italian authorities, under Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 (Annex V to Directive 98/8/EC) on the market and use of biocidal products.
Use of TP01 and TP02:
- Type 1 products are biocidal products intended for human hygiene.
- Type 2 products are disinfectants and algicides not intended for direct application to humans or animals.
Support of EcoMundo
Combining consulting services and biocides consortium (EQuaC consortium), EcoMundo accompanies you for the realization of your authorization dossiers for TP01, TP02, TP03 and TP04 products containing DDAC. The objective of this consortium is to allow you to anticipate and reduce your costs and deadlines, while establishing different strategies for the constitution of your dossiers and during their submission.
For more information on the EQuaC consortium (EcoMundo Quats Consortium - Quaternary Ammonium Compounds Dossier), watch the free replay of our webinar "which strategy for a successful biocide dossier" or contact our experts directly.
The DDAC approved by the European Commission
The European Commission has approved DDAC (Didecyl(dimethyl)ammonium chloride | CAS No.: 7173-5165 | EC No.: 230-525-2) for TP01 and TP02 as an active substance, in accordance with Regulation (EU) No. 528/2012. The date of approval is February 1, 2024. From this date, an authorization for your biocidal products containing only DDAC will be mandatory for the market of your products. As a reminder, TP03 and TP04 were approved on November 1st 2022.
For DDAC, the European Commission requires that the authorization dossiers for Product Type 1 (TP01) contain an assessment of the product on exposure, risk and efficacy related to all uses covered by an application for authorization, but which have not been taken into account in the risk assessment of the active substance within the Union. For Product Type 2 (TP02) authorization dossiers, the same assessments are required together with an assessment related to exposure and potential risks to professional users.
History of DDAC
DDAC is a biocidal substance used as a disinfectant (Group 1 type of biocides).
In 2012, this substance was under evaluation by the German Federal Institute for Risk Assessment (BfR). Background levels of DDAC were assessed to be above the default maximum residue limit (MRL) applicable in the majority of products. At that time, the institute recommended the development of guidelines for cleaning and washing procedures for all food contact equipment.
In 2013, Switzerland added DDAC (TP08) to the list of active substances in the national regulation on biocidal products.
It was in 2018, that ECHA's BPC (Biocidal Products Committee) supported the approval of quaternary ammoniums including DDAC.
In 2021, Product Types 1 and Product Types 2 containing DDAC have been evaluated by the Italian authorities, under Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 (Annex V to Directive 98/8/EC) on the market and use of biocidal products.
Use of TP01 and TP02:
- Type 1 products are biocidal products intended for human hygiene.
- Type 2 products are disinfectants and algicides not intended for direct application to humans or animals.
Support of EcoMundo
Combining consulting services and biocides consortium (EQuaC consortium), EcoMundo accompanies you for the realization of your authorization dossiers for TP01, TP02, TP03 and TP04 products containing DDAC. The objective of this consortium is to allow you to anticipate and reduce your costs and deadlines, while establishing different strategies for the constitution of your dossiers and during their submission.
For more information on the EQuaC consortium (EcoMundo Quats Consortium - Quaternary Ammonium Compounds Dossier), watch the free replay of our webinar "which strategy for a successful biocide dossier" or contact our experts directly.
