According to Article 7 of Chapter 2 of Law No. 5/2013 ‘Food Safety Law’, the production and operation of food, as well as the use of food additives and food-related products during processing, must comply with food safety standards. The establishment of food safety standards are the important regulatory specifications derived from the Food Safety Law to safeguard food safety in Macao.
Presently, the food safety standards of Macao are promulgated in the form of legally binding administrative regulations. The existing food safety standards can be divided into six categories, namely food additives, prohibited substances in food, residues in food, contaminants and toxins in food, microorganisms in food and nutritional composition of food products. These food safety standards will be updated and emerging continuously in response to dietary trends and developments on scientific research, for enhancing Macao’s capacity for prevention and control of food safety risks.
Food Safety Standards in Macao
What are the reference sources for formulating food safety standards?
The food safety standards of Macao are based on internationally recognised scientific evidence, with standards laid down by the Codex Alimentarius Commission (CAC) serving as the core. References are made to the research results of risk assessment of hazardous substances in food conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in addition to the analysis of international standards and those of neighbouring regions. Moreover, comprehensive considerations are given to the practical application of the standards and outcomes of food surveillance in Macao. All these are taken into account to establish the food safety standards that are suitable for the general public of Macao.
How are the food safety standards established?
After the standards are initially drafted, they are sent to experts and concerned executive departments to seek for their views then be passed on the legal department for drafting the legal provisions. The draft provisions are submitted to the Executive Council for analysis. Afterwards, the food safety standards are promulgated in the form of a legally binding administrative regulation by the Chief Executive. Furthermore, Macao government makes notification to the World Trade Organization (WTO) about the food safety standards so as to inform its member countries and fulfil international obligations.
Food safety standards established by Macao are a set of measures for controlling food safety risks. They serve as the administrative management guidelines in assessing whether the food trade adheres to good manufacturing practices, and helping the supervisory department to maintain food safety in Macao. Besides the overarching principle of food safety, it also takes into account that the launched standards will not affected the stability of food supply in Macao so as to ensure the safety, supply and demand of food.
How can the substandard food products be found in Macao? What are the follow-up actions taken on the suspected food products?
The food supervisory department performs day-to-day food inspections through Routine Food Surveillance, Seasonal Food Surveillance, Targeted Food Surveillance and Food Incident Monitoring System to oversee whether food products in the market comply with the food safety standards in Macao. When certain food products are found to pose food safety risk, the regulatory authority takes immediate actions to control the spread of risks. Food alerts are notified to relevant importers and retailers in order to remind and instruct them for recall all affected food products in the local market. Furthermore, press releases are issued to inform the public and food trade for stop consuming and selling the affected food products at once if they possess the suspected products. The authority conducts continuous inspection on the retail outlets so as to remove the affected products from distribution and safeguard food safety in Macao.
Will Consumption of Foodstuffs Not Complying With Food Safety Standards Pose Acute Hazard to Human Health?
When a certain substance in a food product fails to meet food safety standards, it means the food product has violated the “Food Safety Law” enforced in Macao; but, it does not imply that consumption of such product poses acute hazard to human health. The extent of harm to human body is determined by a variety of factors and related data, including the quantity of harmful substance present in the food, the frequency of food intake, the amount of food consumption, as well as the toxicity of substance. Through a systematic and scientific analysis is required for assessing the risk level in order to determine its adverse effects and severity on human body.
The Municipal Affairs Bureau (IAM) once detected 440 mg/kg of benzoic acid in a carbonated beverage, which exceeded the maximum permitted level of 250 mg/kg in “Carbonated Water-Based Flavoured Beverages” as prescribed by Administrative Regulation No. 7/2019 “Standards for Use of Preservatives and Antioxidants in Foodstuffs”. Nowadays, benzoic acid is widely used as a preservative in foods and beverages by food industry. It has the best effectiveness especially at acidic condition, such as carbonated drinks, pickled vegetables and fruits, meat products, cheese and soy sauce, to inhibit the growth of micro-organisms like yeasts and moulds, and extend the shelf life of product. Moreover, benzoic acid occurs naturally in trace amounts of some plant and animal species. When a small amount of benzoic acid enters human body, it is readily metabolised and excreted through urine. As long as benzoic acid is utilized at a reasonable and legally permitted level, it does not have negative impacts on human health.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has established the health-based guidance values for a variety of food additives and chemical contaminants through their toxicological evaluation based on long-term studies in humans and animals. The Acceptable Daily Intake (ADI) of benzoic acid recommended by JECFA is 0 to 5 mg/kg body weight. So, for an adult weighing 60 kg, the maximum daily intake of benzoic acid is 300 mg. Only if the adult drinks 2 cans of the non-compliant benzoic acid-containing carbonated beverage (350 ml each can) daily over a lifetime, the ingested amount of benzoic acid exceeds the respective health-based guidance value. Hence, consumption of foodstuffs that fails to meet the food safety standards does not necessarily cause acute hazard to human health. But even so, consumers should not underestimate the sugar content of carbonated beverages. Excessive sugar intake over extended periods of time is associated with increased risk of obesity and dental caries. That is more harmful to the body than the exposure to small amounts of low toxic benzoic acid.
It is apparent that a foodstuff violated the food safety standards of Macao must be removed from the shelves and recalled, but it does not entail that consuming this food poses immediate negative effects on the human body. It merely indicates that there is a food safety concern with this food. Consumers do not need overly worried if they accidentally consume non-compliant foodstuffs. It is because the additional aforesaid factors take into consideration in risk assessment. As long as we maintain a balanced diet, eating more fresh foods and less processed foods, we can avoid excessive intake of food additives and contaminants. Since the level of dietary reference intake of food additives is based on body weight, children in particular should not eat too much processed foods in order to reduce the health risks of food additives.
Why only some substances are subject to have limits in the food safety standards for food additives whereas others are not?
Currently, the Codex Alimentarius Commission (CAC) and most countries use the ‘Maximum Use Level’ and ‘Good Manufacturing Practice (GMP)’ in determining the amount of use of food additives. For some food additives that have been evaluated and assigned a maximum ‘Acceptable Daily Intake (ADI)’ by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), or their maximum use level in different food categories are defined. On the other hand, some food additives evaluated and determined by JECFA generally recognized as safe and their ‘Recommended Maximum Intake’ (namely safe limit) are not set or required. Since there is no defined maximum use level, the food trade is required to use them under certain conditions based on good manufacturing practice, using in an appropriate amount as desired in the food production process.
When the food trade uses food additives at reasonable levels as needed in the various stages of food production, the additives do not pose health risks. In addition, certain food additives have their ‘self-limiting’ levels of use in food. When used in excessive amount, the properties of food additives will be affected, such as food colourings.
Among the different food safety standards for food additives, which one does not have a stated maximum limit?
The Administrative Regulation No. 30/2017 ‘Standards for Use of Food Colourings in Food’ does not stipulate the limits of use of food colourings in food. However, it does not mean that entities engaged in the production and operation of food can add the food colourings as much as they want. The Administrative Regulation has clearly stated that the conditions of good manufacturing practice which the food trade is required to strictly follow. The principle of GMP is a general rule commonly used internationally to regulate food additives.
What is Good Manufacturing Practice?
Good Manufacturing Practice (GMP) is an autonomous management system to control the quality, safety and hygiene of food products during their production. It is an important principle for the food trade to handle food products. The GMP for the use of food additives includes that the quality must be in food grade, and the quantity added to food should be limited to the minimum dosage required to achieve the desired effect. Moreover, the amount of food additives, whether they are originally present in food ingredients, supplementary substances or added during food packaging, should be reduced to minimum level and controlled within a reasonable range to ensure the safety of food for sale and protect the consumers’ health.
How are the reference values setting for the substances regulated by food safety standards?
For chemical compounds assigned with use limits, their reference values are based upon the health-based guidance values recommended by international authorities so that ensuring the intake of specific substances from food would not have adverse effects on health.
The health-based guidance values established by JECFA or other international authorities are developed on the basis of results of safety tests, including toxicity studies in laboratory animals. These values are then integrated with test data to derive the dose of the tested substances which is administered to experimental animals over a long period of time without causing any adverse effects on their health. This benchmark dose (BMD) is known as ‘No Observed Adverse Effect Level (NOAEL)’. It serves as a reference value for determining the safety of ingredients in food.
How are the test data applied to the health-based guidance values for human?
Since the test results are derived from experimental animals and there are differences among human beings, it is necessary to adjust the test results as applied to humans. The NOAEL is divided by a safety factor and set variously depending on the situations, generally in 100 (a factor of 10 for the differences between test animals and human, then another factor of 10 for differences among humans). The value obtained by dividing NOAEL over the safety factor is known as the ‘Acceptable Daily Intake (ADI)’ or ‘Tolerable Daily Intake (TDI)', which is the amount of a specific substance that can be ingested over extended periods without adverse health effects. It can be taken as the health-based guidance value for the specific substance. ADI is applied in food additives, pesticides, veterinary drugs and other substances that are intentionally added to food; conversely, TDI is applied to food contaminants such as heavy metals and plasticisers and other substances that are present in food due to contamination.
NOAEL / Safety factor = ADI or TDI (mg/kg body weight/day)
How is the ‘Maximum Use Level’ or ‘Maximum Residue Limit’ of a substance to be established?
When establishing the ‘Maximum Use Level’ or ‘Maximum Residue Limit (MRL)’ in food safety standards, it is necessary to consider which categories of food contain the substances and their dosage. By the summation of the maximum use level or maximum residue limit of a specific substance in the various food categories, the value of total intake of the substance in everyday life exposed is derived. This value must be less than the ADI or TDI of the corresponding substance.
Maximum Use Level (Maximum Residue Limit) x Intake from Various Food Categories = Total Intake < ADI
Since almost all food in Macao is imported, it is necessary to ensure that the limits of the food safety standards are scientific, served to protect public’s consumption safety with strong practicability, convenient for the management by regulatory departments as well as adherence by the food trade. At the same time, it has to ensure that these established limits do not adversely affect the stable food supply for Macao, and they are in line with international standards to avoid creating trade barriers.
023/DIR/DSA/2019
