Staying Abreast of Potential Regulation Changes Regarding Bis (2,4-dichlorobenzoyl) Peroxide
By Mayte Alvarenga and Xiaoyi Fang
As many readers already know, the materials that come into contact with food (called “food contact materials” or “FCMs”) are heavily regulated around the world. Regulations ensure food products are not impacted by harmful chemicals, therefore creating safe consumption conditions for the general public.
Regulators impose extra precautions in the selection of materials used by manufacturers with the intention of safeguarding food products. Manufacturers of FSMs must meet regulatory requirements applicable to their products and be able to address the safety concern of the chemicals used in an FCM to ensure brand integrity and consumer loyalty.
While the existence of these regulations ensure consumers’ peace of mind, they can complicate manufacturing activities as the regulatory environment can be both challenging and prone to constant changes.
Regulatory bodies vary by country, posing yet another challenge for manufacturers. While these agencies have the same goal—which is to safeguard the health and safety of consumers—the perception toward certain chemicals and additives can vary based on geography.
In the United States, the U.S. Food and Drug Administration (FDA) is responsible for the safety of FCMs. Any substance that may come into contact or become part of the end food product must be approved by the FDA unless it is generally recognized as safe.
Jumping over the pond to Europe—where the regulatory body is the European Commission—the Framework Regulation, Good Manufacturing Practices, and materials-specific measures are in place to minimize any potential health risks from FCMs.
How Can Regulations Impact the Use of Silicone in Food Transfer Applications?
Silicone is a great choice for FCM manufacturers due to its flexible and tear-resistance properties, but most importantly, for its safety. Plasticizers, which are usually used at high levels in FCMs, among other additives, are not used in silicone tubing extrusion, thus reducing the risk of contamination of the food that passes through the tubing. However, silicone tubing must be cured prior to use. Manufacturers have two choices: peroxide- or platinum-cured silicones.
Bis (2,4-dichlororbenzoyl) peroxide (CAS 133-14-2) is used frequently in silicone products and has been positively listed in many food contact regulations cross the EU, U.S., and China. This substance is allowed for use as a crosslinking agent during the silicone curing stage. The limit of use is 0.2 percent (EU/China) and 1.5 percent (U.S.) in the final products. Residual peroxide should not exceed 0.08 percent in the final product.
Tubing cured with peroxide is long lasting, especially when used in pumping operations. The most important consideration for food manufacturers, however, is that the use of peroxide as a curing agent may result in residual chemical and breakdown products. These chemicals may potentially impact the quality of the food passing through the tube.
Platinum, the other curing agent, is not prone to extractables or other byproducts. The downside to platinum is its high cost when compared to peroxide curing.
The reclassification of bis (2,4-dichlororbenzoyl) peroxide as “Toxic for Reproduction, Category 1B” under the Global Harmonized System of Classification and Labeling of Chemicals, indicating the reproductive toxicity of this substance, will result in concerns over the safety of its use in FCMs.
In the EU, the positive list in the materials-specific measures has not been revised in light of the current state of knowledge and in the context of the Classification, Labelling, and Packaging Regulation, also referred to as the REACH Regulation. Further, FDA does not ban a cleared FCM or further restrict its permitted use unless the agency views the continued use of the substance as an imminent health threat. In the short term, this reclassification may have minimal impact in the current status of food contact regulations in the U.S. and EU. However, close monitoring of the current regulation may be necessary to stay abreast of potential changes.
What Can be Done?
Manufacturers can avoid regulatory-related disruptions by partnering with a provider that actively tracks regulations and has the infrastructure for quick turnarounds in the case of a regulation change. Saint-Gobain Performance Plastics’ regulatory affairs expertise is maintained by a dedicated team of professionals that closely tracks this space and anticipates changes. Our team proactively adjusts product offerings to meet and comply with regulatory standards on behalf of our customers. Suppliers and manufacturers can be assured that Saint-Gobain actively investigates and researches the latest standards and regulations, updating products to meet compliance. This is done through continuous evaluation and analysis of the regulatory environment, as well as the development and establishment of appropriate regulatory strategies and tactics. Our regulatory groups are also kept updated with new regulatory changes by many external resources, including law firms and research institutes that specialize in food contact regulations. Saint-Gobain supports and follows compliance work performed by functions according to procedures and checklists.
Mayte Alvarenga is a marketing specialist and Xiaoyi Fang is a global food and beverage regulatory affairs specialist.
Saint-Gobain designs, manufactures, and distributes materials and solutions that are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure, and in many industrial applications. They provide comfort, performance, and safety while addressing the challenges of sustainable construction, resource efficiency, and climate change. With 2017 sales of more than $50 billion, Saint-Gobain operates in 67 countries and has more than 172,000 employees.
Saint-Gobain’s Performance Plastics business is headquartered in Solon, Ohio, and employs 6,000 people in 22 countries. It is a world leader in high-performance plastics, including flexible tubing, seals, coated fabrics, foams, window film, barrier/release films, tapes, medical components, fluid handling systems, and bearings.
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