HONG KONG--(BUSINESS WIRE)--In this era, plastic is a material that is ubiquitous and of crucial importance in our daily lives. Composed of a wide range of monomers, different plastics are endowed with various physical properties customized by their corresponding monomers and additives. The varying properties render plastic materials versatile for use in a huge variety of consumer products and daily necessaries.
Among the many types of plastic, one of the best-known is called nylon, which are polyamides made of repeating units linked by amide linkages. Nylon plastics are widely used in food contact materials (FCMs). One of the most common applications is for cooking utensils, including spatulas, barbeque tongs, turners, whisks, and so forth, because of nylon’s good heat and abrasion resistance and its durability. Simply look around a kitchen or a department store to feel the close bond between nylon and our daily lives, and see how our health hinges in part on the quality and safety of nylon-made FCMs.
Though a preferred choice for a multitude of FCM applications, nylon-made FCMs may not be as safe as you may have perceived. In the first seven months of this year (1/1/2019 – 31/7/2019), among 91 alert cases with respect to FCMs recorded in the Rapid Alert System for Food and Feed (RASFF) of the European Union (EU)1, at least 14 concerned nylon/polyamide products -- an extremely large number for nylon plastic if you compare this single material to many other types of material available for FCM products. It is anticipated that with the ever-growing attention of authorities to the safety of nylon-made FCMs, the relevant surveillance monitoring will become increasingly stricter and the requirements scope wider.
As a key international test service provider, TÜV Rheinland wishes to raise your level of concern regarding a group of substances for which official control may potentially be focused on for FCMs in the foreseeable future. These substances are present in FCMs but are not intentionally added in their manufacture, and are collectively called Non-intentionally Added Substances (NIAS). The sources of NIAS can be impurities, contaminants, and by-products in the manufacturing process. There was one recall of cyclic oligomers from nylon products recorded in Mar 2019. One example of possible NIAS, the group of cyclic oligomers are products of the undesired cyclic condensation reaction of two or more monomers utilized to manufacture nylon.
The NIAS are mentioned in EU regulation No. 10/2011, and it has been observed that awareness of the authorities regarding NIAS assessment is increasing. NIAS assessment will certainly become a common and formal requirement in the relevant food contact regulations. Therefore, it is highly recommended that NIAS assessment is incorporated into the assessment scope for FCM products in order to embrace this probable change.
Anticipating this trend, TÜV Rheinland wants to present you with our NIAS assessment service, through which you can understand what type of NIAS can potentially migrate from your FCM products into foodstuffs. Our NIAS assessment starts with simulation tests on the FCM sample to qualify and quantify NIAS released into the tested simulant. Based on the test results, our experts will conduct a risk assessment on the identified NIAS, which comprises several approaches: 1) literature study on detected substances with reference to current regulatory requirements; 2) safety evaluation based on literature toxicological data; and 3) derivation of critical dose for the substances based on Threshold of Toxicological Concern principle or other dose descriptors. An identified risk derived from the assessment can indicate the danger of the FCM product and its non-compliance with relevant regulations such as the EU’s Commission Regulation (EC) no. 1935/2004.
Apart from the potential dangers of NIAS, there are a number of parameters which you must not ignore when assessing the safety of your nylon FCM products. Primary aromatic amines (PAAs) are well-known carcinogens which can be easily found in nylon FCM products. Over 80% of nylon FCM alert cases (12 out of 14 cases) in the RASFF recorded so far this year (1/1/2019 – 31/7/2019) were attributed to the migration of PAAs. Additionally, depending on the nylon type (PA6, PA66…) or the monomer/ingredient information as provided by the client, the specific migrations of the concerned substances used in manufacture of the corresponding nylon materials are important for compliance verification. Examples include migration of caprolactam for nylon PA6 and migration of hexamethylenediamine for PA66. Both chemicals are controlled under EU regulations.
Finally, and importantly, although we provide comprehensive testing service for your food contact products, maintaining good manufacturing practice (GMP) must not be ignored. A GMP certification will ensure your client’s confidence in the safety and quality of your products, and secure your position in the international markets. As such, TÜV Rheinland also provides GMP audit service for clients in need. With a team of experts with in-depth knowledge on GMP, we can help you identify your needs and provide professional advice on how to improve and maintain quality manufacturing practices for your FCM products.
TÜV Rheinland hopes that through this brief introduction you can obtain a glimpse at upcoming trends regarding FCM product safety assessment, the potential and importance of NIAS assessment, and what services we can offer for your products. We are glad to be presenting you with more information on these topics in further articles to be issued soon, which we hope will help you gain appreciation and more in-depth understanding on our NIAS assessment service.
TÜV Rheinland is a global leader in independent inspection services, founded nearly 150 years ago. The group maintains a worldwide presence of more than 20,000 people; annual turnover is EUR 2 billion. The independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TÜV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TÜV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption.