Pesticide regulations and MRLs for food products: An overview
Pesticides are widely used around the world to protect agricultural crops against insects, rodents and other predatory pests, as well as bacteria, mould and fungus. However, residual amounts of pesticides in food products can be potentially harmful to human health. Children can be especially susceptible to adverse health effects attributable to residual pesticides in foods because their smaller size increases the potency of pesticide concentrations that might not pose a risk to adults.
For these reasons, regulators in most major industrialised economies have established requirements regarding the use of pesticides in connection with food products. These requirements often include an outright ban on the use of certain pesticides in the cultivation of food crops, as well as maximum residue levels (MRLs) for pesticides in food products. However, regulations and MRLs can differ significantly from country to country, complicating the compliance process for food producers and distributors.
In this article, we’ll provide a brief overview of the regulatory requirements and MRLs in key markets applicable to pesticides used in food products, as well as links to additional information about specific pesticide regulations and MRLs.
What are pesticides?
Pesticides are generally considered to be any substance or mixture of different substances designed for the purpose of destroying, suppressing or preventing of any pest that could interfere with agricultural products or animal livestock. Various types of pesticides include herbicides, insecticides, fungicides, biocides, acaricides and rodenticides.
The U.S. Environmental Protection Agency (EPA) has estimated that worldwide usage of pesticides is greater than 2.4 million tonnes (5.2 billion pounds) per year, with the agricultural sector accounting for approximately 80 percent of all pesticides used. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 17,000 individual pesticide products marketed in the U.S. alone.
In recent years, the introduction of new chemicals has helped to make modern pesticides safer for humans and more environmentally-preferable than older alternatives. At the same time, the increase in the number of chemicals used in pesticides has further complicated the process of evaluating their safety. As a result, regulators are forced to continually re-evaluate existing requirements and established MRLs for food products and update them as necessary.
A brief summary of regulations and MRL requirements
In the EU, pesticides must comply with the requirements of EU Regulation (EC) No 1107/2009, which replaced prior EU directives applicable to pesticides. The Regulation requires pesticide producers to perform extensive, scientifically-based testing to evaluate their products for physical and chemical properties, environmental and eco-toxicological effects, metabolism and toxicity prior to their being placed on the market.
A separate EU regulation, Regulation (EC) No 396/2005, establishes MRLs for pesticides permitted in food products of plant or animal origin and intended for human consumption. Each MRL represents the highest level of pesticide residue that is legally permitted in food or food products and that is consistent with the safety of consumers.
Enforcement under both regulations is managed by national authorities in EU member states, who conduct regular sampling and testing of products to ensure compliance.
The EU Commission maintains and regularly updates a database of pesticide products that have been approved for use in the EU under 1107/2009, as well as a central repository for updates to current MRLs applicable under 396/2005. The database and MRL repository can be accessed here.
The U.S. Environmental Protection Agency (EPA) is the government agency responsible for the regulation of pesticides used in agricultural crops intended for human food and animal feed. The EPA is also responsible for establishing limits (“tolerances”) on the residual amounts of pesticides that may remain in foods marketed in the U.S., regardless of their original source.
In the U.S., any pesticide must be reviewed by the EPA prior to its sale or distribution. Once the EPA has determined that the pesticide does not pose an unreasonable risk to human health or the environment, the pesticide is officially registered for use. A database of all U.S. registered pesticides is available through the National Pesticide Information Retrieval System, which is accessible here.
As part of the pesticide registration review process, the EPA also establishes specific tolerance limits for the amount of pesticide residue that is allowed to remain in or on food products. In establishing tolerances, the EPA considers:
the toxicity of the pesticide and its break-down products;
how much of the pesticide is applied and how often it is applied; and
how much pesticide residue is likely to remain on a food product by the time it is marketed and prepared.
The EPA maintains a dedicated website that enables visitors to search for tolerance levels for specific pesticide ingredients. The website is accessible here.
Enforcement of pesticide tolerances is the responsibility of the U.S. Department of Agriculture (USDA), which enforces tolerances for meat, poultry and some egg products, and the U.S. Food and Drug Administration (FDA), which enforces tolerances for all other food and food products.
The regulation of pesticides in China is governed by the provisions of that Country’s Regulations on Pesticide Administration, issued by China’s State Council in 1997. Under the Regulations, pesticide manufacturers seeking to register their pesticide products must undergo an extensive and complex process. Most importantly, any field and residual studies used in support of the application must be conducted in China, with data analysis completed only by laboratories authorised by China’s Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA). Further, final test reports must be submitted in Chinese.
Regarding MRLs, China’s national food safety standard No 4/2014 establishes MRLs for pesticides in food. The standard lists 371 pesticides and over 3600 MRLs, based on a number of criteria, and expands the number and variety of food groups covered over China’s prior regulation, GB 2763-2012.
An English translation of China’s Regulations on Pesticide Administration is available here. In addition, the ICAMA maintains a database for MRLs applicable in China, which is available here.
Japan’s Ministry of Health, Labour and Welfare (MHLW) utilises a different approach for addressing residual chemicals in food. Introduced in 2006, the MHLW adopted a positive list system for agricultural chemicals remaining in foods, including pesticides, feed additives and veterinary drugs. Under this system, a “uniform limit” of not more than 0.01 part per million (ppm) is applied to all chemicals for which MRLs have not previously been established.
The primary exception to this positive list system approach are chemicals which have been classified as “exempted substances,” that is those substances that do not pose a risk of adverse health effects. An additional exemption from the positive list system is applied to those chemicals for which MRLs had been previously established, but which have not yet received full review by Japan’s Food Safety Commission. These “provisional MRLs” are subject to change pending the completion of a full safety assessment.
A publically-accessible database of Japan’s pesticide MRLs is maintained by the Japan Food Chemical Research Foundation, and is available here.
Other resources on pesticides and MRLs for food producers
The Codex Alimentarius Commission (CAC) has worked to provide the food industry with internationally-accepted standards for food safety. As part of that effort, the Codex Committee on Pesticide Residues (CCPR) has established guidelines on pesticides and has set MRLs for more than 2400 different pesticide products.
CAC guidelines and MRLs are only recommendations, and individual jurisdictions often choose to establish their own mandatory MRLs. Nonetheless, the CAC MRLs may provide useful guidance for both pesticide manufacturers and food producers on acceptable MRLs in countries other than those discussed in this article. The CAC’s online MRL database is available here.
The United Nation’s Organisation for Economic Co-operation and Development maintains a webpage that provides direct access to national websites on pesticides for more than 20 countries and international organisations. The website is available here.
Finally, the Food and Agricultural Organisation (FAO) of the United Nations and the World Health Organisation (WHO) publishes its International Code of Conduct of Pesticide Management to assist government regulators and private sector companies on best practices for the management of pesticides. The 2014 edition of the Code is available here.
The presence of pesticide residue in food and food products is tightly regulated in most major markets around the world. Failure to comply with mandatory MRLs for pesticides in food products can have significant consequences for food producers and suppliers. However, the lack of MRL harmonisation means that food manufacturers must have a thorough understanding of the specific requirements that are applicable in their target markets. Given the expanded use of global supply chains to source food products and ingredients, food producers must also apply rigorous oversight to suppliers to ensure compliance.
 “Pesticide Industry Sales and Usage: 2006 and 2007 Market Estimates,” U.S. Environmental Protection Agency, February 2011. Available here (as of 7 November 2015).
 “Pesticide Illness & Injury Surveillance,” National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, updated 15 August 2015. Available here (as of 7 November 2015).
 “Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directive 79/17/EEC and 91/414/EEC,” Official Journal of the European Union, 24 November 2009, Available here (as of 7 November 2015).
 “Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 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,” (consolidated). Available here (as of 7 November 2015).