Quaternary ammonium compounds in infant nutrition

New limit values in China: regulatory background and analytical implementation

April 2023. The group of quaternary ammonium compounds (often referred to as QAC), describes a large group of industrial chemicals which can be classified as surfactants. For infant food, the maximum residue level (MRL) of 0.01 mg/kg applies in the EU^[1]. Since 1 January 2022, the Chinese authorities require certificates with a negative QAC detection for imported baby food products. Negative in this context means "lower than LOQ", which was set to 1ppb (0.001 mg/kg)^[2].

Legal regulation in the EU

The legal regulation of QAC is based on the sum regulation of benzalkonium chloride (BAC) with chain lengths between C8 and C18 and didecylmethylammonium chloride (DDAC) with chain lengths between C8 and C12. Both substance groups are no longer approved for use in plant protection products within the European Union^[3,4,6]. They are subject to Regulation (EC) No. 396/2005^[5]. According to Regulation (EC) No. 1119/2014^[6] the current MRL for plant and animal products for the respective sums of BAC and DDAC is 0.1 mg/kg. As of 14 September 2023, the MRL for the sum of DDAC in plant food products will be lowered to 0.05 mg/kg according to Regulation (EC) No. 2023/377^[7].

Legal regulation in China

The Chinese regulation covers the substances BAC C12 - C16, benzalkonium bromide, DDAC C10, and tetrabutylammonium hydrogen sulfate (TBAHS) in powdered baby food products, cereal-based complementary foods, and fruit and vegetable purees intended for baby food.

Background of QAC entry into food

QAC are cationic surfactants and are soluble in both water and fat due to their chemical properties. As a result, dirt and grease can be bound very well in water.

Depending on their structure, some of these compounds have cleansing as well as germicidal properties. The best-known substance classes with germicidal properties include the BACs and DDACs. They can impair and damage the function of the cell membrane of living organisms and are therefore used as biocides in cleaning agents or disinfectants, and are also applied for surface treatments.

Besides, QAC are also surface active and adhere well to treated surfaces after their application. If the treated surfaces, e.g. cutting equipment, are not adequately rinsed with hot water after disinfection, residues of QAC can transfer, especially into foods rich in fat and protein. This can lead to problems in cleaning-intensive industries that produce and process e.g. meat, fish, dairy or cheese products.

Another route of transmission to food can be hand sanitizers that contain QAC. Especially during the pandemic period, disinfection measures massively increased as protection against SARS-CoV-2 viruses.

Our experts working at the competence center for baby food of Eurofins Laboratories for Food and Feed Testing laboratories in Germany have many years of experience with these contaminants and can assess your baby food products and foodstuffs according to both EU legislation and Chinese requirements. The underlying analytical methods are based on the extraction of the analytes and simultaneous separation of the matrix components with subsequent measurement by high-performance liquid chromatography (UHPLC)-tandem mass spectrometry (MS/MS).

Are you interested in further information?

Would you like to know more about QAC or work out concrete test strategies for your products with us? Please feel free to contact your personal account manager or our expert Oliver Schwöbel.

Relevant Souces

[1] Regulation on Dietetic Food in the version published on April 28, 2005 (Federal Law Gazette I p. 1161), last amended by Article 2 of the Ordinance of June 2, 2021 (Federal Law Gazette I p. 1362) – document in German language
[2] “BJS 202007 Determination of Disinfectant Residue in Baby Food”; official notice No.2020-50; China SAMR (State Administration for Market Regulation) – document in Chinese language
[3] COMMISSION REGULATION (EC) No 2076/2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances
[4] COMMISSION DIRECTIVE 2009/70/EC amending Council Directive 91/414/EEC to include difenacoum, didecyldimethylammonium chloride and sulphur as active substances
[5] REGULATION (EC) NO 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
[6] COMMISSION REGULATION (EU) No 1119/2014 amending Annex III to Regulation (EC) No 396/2005 as regards maximum residue levels for benzalkonium chloride and didecyldimethylammonium chloride in or on certain products
[7] COMMISSION REGULATION (EU) 2023/377 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, quizalofop-P, sodium aluminium silicate, thiabendazole and triadimenol in or on certain products