The European Chemicals Agency has just released a significant update to the APCP Technical Agreement for Biocides
Navigating the Latest APCP TAB 4.0 Update
Key Changes You Need To Know
- Sections 3.4.4 and 3.4.5:
Clearer guidelines on naming active substances based on their dry form and physicochemical testing for active substances with solvents that cannot be removed to obtain the dry form.
- Section 4.3:
Introduction of the requirement for test data using specific methods to address the physical state of active substances when there is doubt.
- Section 188.8.131.52:
Enforcement of CG-53-2022-07 AP 14.1 Shelf-life setting at PA-vf. Shelf-life of products now requires long-term storage stability test results before draft PAR for a 30-day commenting phase. Any changes afterward necessitate new data submission for extended shelf-life.
- Section 184.108.40.206:
Accelerated storage tests may no longer be necessary if products will not be exposed to temperatures exceeding 30°C during storage.
- Section 220.127.116.11:
Shelf-life determination relies on available long-term storage stability data. Accelerated storage stability tests no longer grant provisional 2 years of shelf-life.
- Section 7.4:
Updates on the classification of products containing hydrogen peroxide as oxidising liquid. The classification from transportation overrules the test result.
- Section 7.5:
Update on the the criteria for waiving flashpoint tests. Flashpoint can only be waived if the water content is above 80% and no flammable components are present in the formula. As content of flammable components are irrelevant, even if flammable components are present at very low concentration, test is required.
At ARCHE Consulting, we are dedicated to ensuring our clients are well-prepared to navigate these changes and comply with the latest regulations. Do not hesitate to reach out if you have any questions or need assistance in understanding and implementing these updates.