19th Amendment
We've made a considerable effort to be able to help customers become compliant. Our experts have assessed the supplied information and have only approved raw materials that meet the strict requirements of the new amendment. On this page you'll learn more about how we tackled these requirements.
The 19th Amendment
It is the unofficial term for Regulation 2025/351, which is the 19th amendment to Regulation 10/2011 which regulates plastic food contact materials. We are currently in the transition phase, which will end on 16th of December for new products and on the 16th of September 2026 for existing products.
There are new purity requirements for all used materials, as listed in the newly added Article 3a of the regulation. These requirements are demanding, but the interpretation of these requirements is different per raw material supplier. Suppliers are performing analyses to screen for Non-Intentionally Added Substances (NIAS). Holland Colours will have to assess each case individually and deem whether the requirements are met.
Requirements
In short, the 19th Amendment mainly revolves around the newly established purity standards in Article 8 and the newly added Article 3a. These purity requirements are in place for all materials used in food contact under the Regulation, and demand that:
- All constituents of a substance must correspond to its stated identity
- The substance must only contain a minimal amount of Non-Intentionally Added Substances (NIAS)
- These NIAS must be risk assessed; their toxicological profile should be known by the supplier, and their actual presence in finished products must be considered. In short, the composition shall be known to the manufacturer of the substance, and a risk assessment needs to be performed so boundaries for intended and foreseeable use can be defined.
Demands and information exchange
Holland Colours’ food contact products are still compliant with Regulation (EU) 10/2011, up to and including the 18th Amendment of said regulation (Regulation (EU) 2024/3190). Naturally, we will keep you up to date about any developments from either Holland Colours or its suppliers.
Further steps we took
- Informing relevant stakeholders, both internal and external
- Systematically requesting and processing new DoC’s from our suppliers (in progress)
- If the documentation is incomplete, or when the supplier does not understand the scope of the new Amendment, the supplier will be assisted with their compliance work
- Performing risk assessments based on the newly provided data for each raw material
- Performing analyses, if required to guarantee compliance
- Making decisions on raw materials that can no longer be considered compliant. Reformulations,
substitutions, or dropping food contact support for said materials may occur - Proactively informing customers about any products that might be affected by the raw materials’
compliance status - Systematically updating DoC’s with compliance to the new 19th Amendment
Customer support
Holland Colours gladly aids customers with their compliance, providing personal support based on requests. Additionally, we also are prepared to help customers with specific questions about impurities, process contributions or interpretation of the legislation.
Customers can contact their sales representatives if there are follow-up questions. If needed, Product Stewardship is more than happy to provide more detailed information via a call.