Recent update of SANCO/10473/2003 rev.6 regarding phys-chem requirements for PPP’s
Recent update of SANCO/10473/2003 rev.6 regarding phys-chem requirements for PPP’s
The latest update of the Guidance Document SANCO/10473/2003 will come into effect from the 20th of July 2026. It revises reference methods for physical hazard testing, aligning them with the CLP Regulation (EC) No 1272/2008 and the UN Manual of Tests and Criteria. Older EC methods for oxidizing properties (EC A.17/A.21), flashpoint (EC A.9), flammability (EC A.10/A.11/A.12), and self-heating (EC A.15/A.16) are now invalid, while EC A.14 for explosive properties remains valid. CIPAC MT methods are cited without version numbers to accommodate ongoing updates (e.g., ‘MT 47’ instead of ‘MT 47.3’). The latest Guidance Document also introduces new methods for assessing the relative density and corrosive properties of both liquids and solids.
In the new revision, persistent foam must be measured before and after storage; if foam exceeds 60 mL after one-minute, the use of anti-foam agents or adjuvants are recommended, with follow-up testing as needed.
The Guidance clarifies that data submission should require points 4.2, 4.3, and 4.5 under Regulation (EU) No. 284/2013. In many cases, referencing the product’s safety data sheet (SDS) is sufficient. However, the draft Registration Report (dRR, section B4) must include at least the physical hazard information from the SDS, which may not be evident from physico-chemical tests or from tests conducted under Regulation (EC) No. 1272/2008, as presented in the dRR section B2.
The revised Guidance Document also specifies that for containers larger than 20L of non-homogeneous or complex formulations (e.g., EC, SC etc), Member States should require labelling instructions that the contents be thoroughly re-homogenized before use. It must be shown that the product can be mixed with appropriate devices or homogenizers prior to application. This labelling requirement may be waived if storage stability tests in the corresponding bulk containers (>20 L) confirm that all technical properties remain within acceptable limits. However, for suspension concentrate (SC) formulations, sedimentation in larger volumes is difficult to predict, so the labelling requirement should always apply. Finally, methods of testing for trigger packaging are available.
As the revised Guidance introduces notable changes from previous requirements, careful consideration should be given to whether existing data and methods remain compliant.
Navigating evolving physico‑chemical requirements can be complex; contact our regulatory experts at info@kerona.ie to ensure your PPP submissions meet the latest EU and UK requirements.