Quaternary ammoniums are a group of substances that stand out for their biocidal properties and are often used in the most common disinfectant cleaning products. Among them are DDAC and BKC. Are you ready for BPR approval?
DDAC and ADBAC/BKC C12-C16 are two of the most widely used quaternary ammoniums and are included in the Active Substances Review Programme established by the European Commission.
| DDAC | Didecyldimethylammonium chloride | CAS 7173-51-5 EC 230-525-2 |
| ADBAC/BKC C12-C16 | Alkyl (C12-16) dimethylbenzyl ammonium chloride | CAS 68424-85-1 EC 270-325-2 |
Companies wishing to place biocidal products containing DDAC or ADBAC/BKC C12-C16 on the market must ensure that they comply with the BPR and have the relevant marketing authorisation.
On the publication date of this article, the evaluation status of DDAC and ADBAC/BKC C12-C16 is as follows:
| Active substance | Product types | |
| Approved and approval date | Under evaluation | |
| DDAC | PT1 – 01/02/2024 PT2 – 01/02/2024 PT3 – 01/11/2022 PT4 – 01/11/2022 PT8 – 01/02/2015 | PT6 PT10 PT11 PT12 |
| ADBAC/BKC C12-C16 | PT1 – 01/07/2024 PT3 – 01/11/2022 PT4 – 01/11/2022 PT8 – 01/02/2015 | PT2 PT10 PT11 PT12 PT22 |
Companies marketing or wishing to market biocidal products containing at least one of these two active substances must ensure that the following applies to their product prior to the final approval date:
- They have an authorisation granted in accordance with the transitional measures.
- They have submitted an application for BPR authorisation.
The approval dates for these two substances vary depending on the type of product, and some product types are still under evaluation, therefore, companies are sometimes in doubt as to which steps they need to take and by which dates.
Some cases and the steps to be taken by companies wishing to market these products are detailed below:
A. A company is currently marketing a biocidal product with DDAC, such as PT2 and PT4:
- DDAC will be approved for PT2 on 1 February 2024.
- DDAC was approved for PT4 on 1 November 2022.
- The company has authorisation for that biocidal product according to the transitional measures for PT2 and PT4, in each of the countries where it is placing the product on the market.
✔ The company must submit an application for BPR authorisation for that biocidal product by 1 February 2024 in order to be able to continue to market the product without interruption after the approval date.
B. A company is marketing a biocidal product with DDAC, such as PT2 and PT4:
- DDAC will be approved for PT2 on 1 February 2024.
- DDAC was approved for PT4 on 1 November 2022.
❌The company does not have an authorisation for that biocidal product in accordance with the transitional measures.
The company must submit an application for authorisation for that biocidal product under the transitional measures, such as PT2 and PT4, in each of the countries where it is placing the product on the market before 1 February 2024, and
The company must submit an application for BPR authorisation before 1 February 2024 in order to be able to continue to market the product without interruption.
C. A company wants to start marketing a product with DDAC and ADBAC/BKC C12-C16, such as PT2 and PT4:
- DDAC will be approved for PT2 on 1 February 2024.
- DDAC was approved for PT4 on 1 November 2022
❌ADBAC/BKC C12-C16 is still under evaluation for PT2.
- ADBAC/BKC C12-C16 was approved for PT4 on 1 November 2022.
❌The company does not have an authorisation in accordance with the transitional measures.
The company must submit an application for authorisation in accordance with the transitional measures in each of the countries where it wants to market the product as soon as possible.
It must also periodically review the approval status of ADBAC/BKC C12-C16 for PT2, as once the approval date for this PT is published, it must start work on submitting its application for BPR authorisation in time.
D. A company wants to start marketing a product with DDAC and ADBAC/BKC C12-C16 for PT4:
- DDAC was approved for PT4 on 1 November 2022.
- ADBAC/BKC C12-C16 was approved for PT4 on 1 November 2022.
The approval date for both substances and product types has already expired, therefore, the company must submit an application for BPR authorisation as soon as possible and wait to receive the authorisation decision before starting to market the product.
As mentioned in another article, the costs of applying for authorisation under the BPR are high, so in order to reduce these costs, companies opt to:
- Submit applications for authorisation of families of biocidal products, grouping, as far as possible, several similar products into the same authorisation.
- Submit applications for authorisation of families of biocidal products, grouping, as far as possible, several similar products into the same authorisation.
- Accept the proposal of an authorised active substance supplier that has its own application for authorisation for a number of generic formulations and offers its customers access to this application under a commercial agreement.
The strategy for marketing biocidal products based on DDAC and/or ADBAC/BKC C12-C16 must be studied case by case, assessing not only the costs of the authorisation application, but also the viability of marketing in different European countries, the links of the agreements signed with other groups of companies, consortia or even suppliers of the active substance.
At ServiREACH, we can help you to assess your situation, evaluate the pros and cons of each option, and come up with the most appropriate strategy for your specific case.
