In the modern world, the development of agricultural and food trade between countries raises the question of global food safety. In response to this global concern, governments have initiated strict import regulations that assure the safety of imported food and impedes access to global markets for certain food suppliers, especially those from developing and transitional economies. An understanding of the import regulations in the EU and the US, the main food importers from developed countries, allows for a proper analysis of the potential effect these have on the various concerned parties.
Under the EU's general food law, Regulation (EC) No 178/2002, food imported to European markets shall comply with:
The relevant requirements of food law, or conditions recognized by the Community to be at least equivalent thereto, or where a specific agreement exists between the Community and the exporting country, with requirements contained therein.In other words, the EU requires imported food to meet the same standards that the EU requires for food produced within the EU. EU food importers bear responsibility for the safety of imported food. The regulation states that if a food business operator considers or has reason to believe that food that it has imported is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food from the market and inform the competent authorities thereof.
There are different import systems for different food commodities, in particular for food of animal origin and food of non-animal origin. With regard to food of animal origin, only a country that appears on a list established by the Community can export to the EU. An establishment that would like to start exporting to the EU should contact the relevant authorities in their country. If the competent authority finds the establishment fulfills the requirements set out by EU legislation, then the authority can submit an application for approval to the European Commission. The legal basis for this procedure is provided in Article 11 and 12 of Regulation (EC) No 854/2004. With regard to food of non-animal origin, third-party countries do not need to appear on an approved list in order to be eligible to export to the EU. There are also specific rules that govern the import of various types of meat, poultry and seafood products, among others.
The EU rules on food hygiene confirm that all food businesses after primary production must establish, implement and maintain a procedure that incorporates the Hazard Analysis and Critical Control Points (HACCP) principles. Foodstuffs imported into the Community are submitted to official controls to ensure that the relevant provisions of the food hygiene rules are followed, including the requirement of putting in place, implementing and maintaining HACCP-based procedures.
In the US, under the Food Safety Modernization Act (FSMA), the requirements for imported foods have increased considerably. The act intends to ensure that imported foods meet US standards and are as safe for consumers as foods produced domestically. To reach this aim, the FSMA contains significant requirements for importers. In particular, they must verify the safety of the food offered for import using the new Foreign Supplier Verification Program (FSVP). This program requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated or misbranded and is produced in compliance with the FDA's preventive controls requirements and produce safety standards where applicable. In other words, importers will have explicit responsibility to verify the safety of their supplier chain. However, the requirement does not apply to firms that import products from foreign suppliers subject to low-acid canned food regulations, seafood or juice, as they have their own HACCP procedures. The FSMA states that verification activities may include monitoring records for shipments, lot-by-lot certification compliance, annual on-site inspections, checking the hazard analysis and risk-based preventative control plan of the foreign supplier and periodically testing and sampling shipments.
The FSVP program is mandatory unlike the Voluntary Qualified Importer Program (VQIP), which is entirely voluntary and provides the importers with a green light for imported foods from trustful suppliers. Non-compliance with the FSVP is a ground for refusal of an imported article. The FDA is required to publish and maintain a list of FSVP participants. Foreign suppliers are also included during the process of registration of their facilities. Currently, food facilities, both foreign and domestic, must register with the FDA once, unless there is a relevant change in status. This rule is effective since the passage of the Bioterrorism Act of 2002. The FSMA requires renewing this registration every two years; however, farms, restaurants, retailers and some other entities are exempt from the rule. The FSMA also includes other provisions for imported foods. For instance, the act authorizes the FDA to require that high-risk imported foods, based on health consequences, be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the US. It is worth noting that the FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products, which are regulated by the USDA.
As a result of the scope of the FSMA and the FSVP, members of the food industry were eager to learn about the FDA's proposed regulations for the FSVP, which were due January 4, 2012. The FDA missed the deadline, but stated that it will update the food industry soon. If there is no specific regulation, then the original provisions of the FSMA will automatically be effective on January 4, 2013.
All of the EU and US import rules help to ensure that consumers in these respective areas have access to safe food products, both imported and produced domestically. At the same time, these regulations demand certain efforts from the US and EU importers, foreign suppliers and foreign governments. At the FDA's public meeting on the food import safety provisions of the FSMA, the following challenges have been highlighted: tight statutory deadlines, ambiguous statutory terms, potential adverse effects on small and medium size business and an adverse impact on competitiveness and efficiency. As for importers, the strict rules of food laws force the companies to spend additional resources to comply with EU and US import provisions. This situation can make small- and medium-size companies less competitive in comparison to large retailers that have a developed supply chain. However, from a long term perspective, these businesses can benefit from these rules by having "greater confidence in the supply chain and a reduction in the risk of brand damage because of the increased accountability throughout the supply chain."
As for foreign suppliers and governments, they also have several concerns about import requirements, specifically about HACCP or HACCP-based preventive control systems, which are becoming a must in international trade. HACCP implementation at foreign facilities will require adequate funding, increase the costs of imported food and may even restrain access for certain food suppliers to the EU and US market. For example, small- and medium-size food suppliers from developing and transitional economies may not be able to afford the implementation of these expensive preventive control systems at their facilities. In this regard, the role of technical assistance increases. In accordance with the World Trade Organization's Agreement on the Application of Sanitary and Phytosanitary Measures, the European Commission and the US provide technical assistance and facilities for institutional capacity building. Moreover, international organizations, such as the World Bank, provide support for implementing food safety standards. These instruments can help developing countries comply with EU and US import conditions, but also create questions of dependency. Thus, it is obvious that the largest economies are ready to spend more money, but not to compromise over food safety rules.
Volha Samasiuk holds a Diploma and a Doctor of Philosophy in Law from the Belarusian State University. She was an Associate Professor of law at the Belarusian State University, a Visiting Scholar at the University of Washington School of Law and a Curriculum Research Fellow at the Central European University in Budapest, Hungary.
Suggested citation: Volha Samasiuk, Strict Food Import Regulations and their Impact on Exporters, JURIST - Dateline, Apr. 6, 2012, http://jurist.org/dateline/2012/04/volha-samasiuk-food-import.php.
This article was prepared for publication by Elizabeth Imbarlina, an assistant editor for JURIST's student commentary service. Please direct any questions or comments to her at firstname.lastname@example.org