Meaning
Legislative requirements that mandate a risk assessment for non-intentionally added substances to ensure that migrants from plastic materials do not endanger human health. This specific section of the law governs the safety of chemicals that are not part of the intentional formulation but may still be present in the final product. The regulation eu 10 2011 article 19 applies to the entire supply chain, from resin producers to the final manufacturers of food contact materials.
It requires a proactive approach to identifying and evaluating potential hazards that could leach into food. The responsibility ends only when the safety of the material has been demonstrated through scientific assessment.
Substance Assessment
Identifying every chemical that might be present in a finished plastic part is a complex analytical task. These substances can include breakdown products from additives, impurities in the raw materials or contaminants from the recycling process. Under regulation eu 10 2011 article 19, the manufacturer must assess the risk of any substance that is not listed on the official union list of approved monomers and additives.
This assessment involves determining the chemical identity of the migrant and estimating the amount that could potentially reach the consumer. If the identity is unknown, the assessment must be based on a worst-case scenario using standardized safety thresholds. This process is necessary to ensure that the final packaging is as safe as the individual components used to make it.
Purity Obligation
Maintaining high standards for the purity of raw materials is a primary focus for compliance with this article. Resin suppliers must provide information about the potential presence of side products and impurities to the companies that use their materials. When using regrind or recycled plastics, the challenge becomes even greater because the history of the material is not always known.
The regulation eu 10 2011 article 19 forces companies to implement strict quality controls to minimize the presence of these unwanted substances. This might include more frequent testing of incoming resin or the use of higher-grade additives with lower impurity levels. By reducing the source of potential migrants, the manufacturer simplifies the final risk assessment and ensures a higher level of safety for the end user.
Compliance Proof
Demonstrating that a plastic product meets the requirements of the law is a mandatory part of the declaration of compliance. Every risk assessment performed under regulation eu 10 2011 article 19 must be documented and kept available for inspection by national authorities. This documentation should describe the reasoning behind the assessment, the analytical methods used and the toxicological data that supports the safety of the substances.
If a company cannot provide this proof, they may face fines or be forced to withdraw their products from the market. This transparency is essential for maintaining consumer trust and ensuring a fair playing field in the industry. As the analytical technology for detecting trace chemicals improves, the requirements for this assessment continue to become more detailed.
Manufacturers must stay updated on the latest scientific guidance to remain in full compliance.
