Darling Ingredients Inc. and its subsidiaries (Darling) operate as a global developer and producer of sustainable natural ingredients from edible and inedible bio-nutrients, creating a wide range of ingredients and customized specialty solutions for customers in the pharmaceutical, food, pet food, animal feed, industrial, fuel, bioenergy and fertilizer industries.
The company owns significant rendering operations, Valley Proteins in North America and the FASA Group in South America and a signif...
Darling Ingredients Inc. and its subsidiaries (Darling) operate as a global developer and producer of sustainable natural ingredients from edible and inedible bio-nutrients, creating a wide range of ingredients and customized specialty solutions for customers in the pharmaceutical, food, pet food, animal feed, industrial, fuel, bioenergy and fertilizer industries.
The company owns significant rendering operations, Valley Proteins in North America and the FASA Group in South America and a significant collagen operation, Gelnex, with processing located in South America and North America.
With operations on five continents, the company collects and transforms all aspects of animal by-product streams into useable and specialty ingredients, such as collagen, edible fats, feed-grade fats, animal proteins and meals, plasma, pet food ingredients, organic fertilizers, yellow grease, fuel feedstocks, green energy, natural casings and hides. The company also recovers and converts recycled oils (used cooking oil and animal fats) into valuable feed ingredients, and collects and processes residual bakery products into feed ingredients. In addition, the company provides environmental services, such as grease trap collection and disposal services to food service establishments.
North America
The company is a leading provider of animal by-product processing, used cooking oil and bakery residual recycling and recovery solutions to the U.S. food industry. The company operates over 150 processing and transfer facilities in the United States to produce finished products, such as protein (primarily meat and bone meal (MBM) and poultry meal (PM)), meat products for the pet food industry, blood products (plasma and whole blood), collagen, fats (primarily bleachable fancy tallow (BFT), poultry grease (PG) and yellow grease (YG)), bakery by-products (BBP) and hides, as well as a range of branded and value-added products. Darling sells these products in North America and throughout the world, primarily to producers of animal feed, pet food, biodiesel, fertilizer and other consumer and industrial ingredients, including oleo-chemicals, soaps and leather goods, for use as ingredients in their products or for further processing. In the United States, Darling is a partner with Valero Energy Corporation in Diamond Green Diesel, a renewable diesel facility, which converts used cooking oils, animal fats and other feedstocks into valuable biofuel products. In Canada, the company is a leading recycler of animal by-products. Darling's Canadian ingredients business processes raw materials into finished fat and protein products for use in animal feed, pet food, fertilizer and other ingredients.
International
Darling Ingredients International, the company’s subsidiary, is a worldwide leader in the development and production of specialty ingredients from animal by-products for applications in the pharmaceutical, food, pet food, animal feed, industrial, fuel, bioenergy and fertilizer industries. Darling Ingredients International operates a global network of 80 production facilities across five continents, including Europe, Asia, Australia, South America and North America covering all aspects of animal by-product processing through seven brands: Rendac (fuel), Sonac (proteins, fats, edible fats and blood products), FASA (proteins and fats), Ecoson (bioenergy and fertilizer), Rousselot (collagen), Gelnex (collagen) and CTH (natural casings). Darling Ingredients International's specialized portfolio of over 345 products covers all animal origin raw material types and thereby offers a comprehensive, single source solution for suppliers. Darling Ingredients International’s rendering and specialties business has leading positions across Europe, China and South America, with European operations in the Netherlands, Belgium, Germany, Poland and Italy, under the Ecoson, Rendac, Sonac and FASA brand names. Value-added products include edible fats, blood products, bone products, protein meals and fats. Rousselot and Gelnex are global leading market providers of collagen for the food, pharmaceutical and technical industries with operations in Europe, the United States, South America and China. CTH is a leading natural casings company for the sausage industry with operations in Europe, China and the United States.
Segments
The company operates through three operating segments: Feed Ingredients, Food Ingredients and Fuel Ingredients.
The Feed Ingredients operating segment includes the company’s global activities related to the collection and processing of beef, poultry and pork animal by-products in North America, Europe and South America into non-food grade oils and protein meals; the collection and processing of bakery residuals in North America into Cookie Meal, which is predominantly used in poultry and swine rations; the collection and processing of used cooking oil in North America and South America into non-food grade fats; the collection and processing of porcine and bovine blood in China, Europe, North America and Australia into blood plasma powder and hemoglobin; the processing of selected portions of slaughtered animals into a variety of meat products for use in pet food in Europe, North America and South America; the processing of cattle hides and hog skins in North America; the production of organic fertilizers using protein produced from the company’s animal by-products processing activities in North America and Europe; the rearing and processing of black soldier fly larvae into specialty proteins for use in animal feed and pet food in North America; and the provision of grease trap services to food service establishments in North America. Non-food grade oils and fats produced and marketed by the company are principally sold to third-parties to be used as ingredients in animal feed and pet food, as an ingredient for the production of biodiesel and renewable diesel, or to the oleo-chemical industry to be used as an ingredient in a wide variety of industrial applications. Protein meals, blood plasma powder and hemoglobin produced and marketed by the company are sold to third-parties to be used as ingredients in animal feed, pet food and aquaculture.
The Food Ingredients operating segment includes the company’s global activities related to the purchase and processing of beef and pork bone chips, beef hides, pig skins, and fish skins into collagen in Europe, China, South America and North America, the collection and processing of porcine and bovine intestines into natural casings in Europe, China and North America, the extraction and processing of porcine mucosa into crude heparin in Europe, the collection and refining of animal fat into food grade fat in Europe, and the processing of bones to bone chips for the collagen industry and bone ash in Europe. Collagens produced and marketed by the company are sold to third-parties to be used as ingredients in the pharmaceutical, nutraceutical, food, pet food, and technical (e.g., photographic) industries. Natural casings produced and marketed by the company are sold to third-parties to be used as an ingredient in the production of sausages and other similar food products.
The Fuel Ingredients operating segment includes the company’s global activities related to its share of the results of its equity investment in Diamond Green Diesel Holdings LLC, a joint venture with Valero Energy Corporation (Valero) to convert animal fats, recycled greases, used cooking oil, inedible corn oil, soybean oil, or other feedstocks that become economically and commercially viable into renewable diesel (DGD or the DGD Joint Venture), the conversion of organic sludge and food waste into biogas in Europe, the collection and conversion of fallen stock and certain animal by-products pursuant to applicable EU regulations into low-grade energy sources to be used in industrial applications in Europe, and the processing of manure into natural bio-phosphate in Europe.
Operations
Feed Ingredients segment
Feed Ingredients segment consists principally of the company’s the U.S. ingredients and specialty products businesses, including its fats and proteins, used cooking oil, and trap grease collection business, its Canadian ingredients business, and the ingredients and specialty products businesses conducted by Darling Ingredients International under the Sonac and FASA names (proteins, fats and plasma products); and its bakery residuals business.
Animal By-Products
North American Operations
Processing operations: The company produces finished products primarily through the grinding, cooking, separating, drying, and blending of various raw materials. The process starts with the collection of animal by-products, including fat, bones, feathers, offal and other animal by-products. The animal by-products are ground and heated to evaporate water and separate fats from animal tissue, as well as to sterilize and make the material suitable as an ingredient for animal feed. The separated fats, tallows and greases are then centrifuged and/or refined for purity. The remaining solid product is pressed to remove additional oils to create protein meals. The protein meal is then sifted through screens and ground further if necessary to produce an appropriately sized protein meal. The primary finished products derived from the processing of animal by-products are MBM, PM (both feed grade and pet food), PG, tallow, feather meal and blood meal. In addition, at certain of its facilities, the company is able to operate multiple process lines simultaneously, which provides it with the flexibility and capacity to manufacture a line of premium and value-added products in addition to its principal finished products. Because of these processing controls, the company is able to produce premium products that typically have higher protein and energy content and lower moisture than standard finished products, and such products command premium prices.
International Operations
Darling Ingredients International’s ingredients and specialty products businesses are operated under the Sonac and FASA names by the company’s Sonac C3 and Sonac Blood business activities. The Sonac and FASA ingredients and specialty products businesses of Darling Ingredients International operate similarly to its North American ingredients division. However, the Sonac businesses, with the exception of Sonac C3, further separate raw material streams to add additional value to each stream.
Sonac C3 processes animal by-products collected primarily from slaughterhouses, into proteins and fats for applications used in the pet food, feed, technical, biofuels and oleo-chemical markets. Oleo-chemical producers use fats to produce specialty ingredients used in paint, rubber, paper, concrete, plastics and a variety of other consumer and industrial products.
Sonac Blood processes bovine, porcine and ovine blood by separating blood into plasma and hemoglobin and produces specialized end products for application in the feed and pet food markets. Sonac Blood’s end products include plasma, fibrimex, globin and hemin.
Used Cooking Oil
The company is a leading collector and processor of used cooking oil in North America for use as a valuable low carbon fuel and feed ingredient. The company estimates it collects used cooking oil from approximately 173,000 locations in the U.S. The company’s primary customer for this product is the DGD Joint Venture.
Processing Operations: The used cooking oil the company collects is heated, settled, and purified for use as a feedstock for biofuels or as an ingredient for animal feed.
Bakery Residuals
The company is a leading processor of bakery residuals in the United States. The bakery residuals division, which operates solely in the United States, collects bakery residual materials and processes the raw materials into BBP, including Cookie Meal, an animal feed ingredient primarily used in poultry and swine rations.
Other Products/Services
The company’s Feed Ingredients segment also includes its organic fertilizer business conducted under the Nature Safe name, insect protein business conducted under the EnviroFlight name, hides businesses and grease trap services business.
The company’s fertilizer operations utilize finished products from its animal by-products division to manufacture organic fertilizers from ingredients approved by the U.S. Department of Agriculture (USDA) to be used in organic farming which contain no waste by-products (i.e., sludge or sewage waste). The company's North American fertilizer products are predominantly sold to golf courses, sports facilities, organic farms and landscaping companies.
The company’s EnviroFlight business utilizes technologies which enable the rearing of non-pathogenic black soldier fly larvae, which larvae are then processed to produce specialty protein for use as an ingredient in animal feed and pet food.
The company’s hides operations process hides and skins from beef and hog processors, respectively, into outputs used in commercial applications, such as the leather industry. The company sells treated hides and skins to external customers, the majority of which are tanneries. Fresh and salted hides and fresh skins are sold to tanneries, automotive companies, leather processors and to the shoe and furniture industries in Italy, Germany and China.
The company’s grease trap services business provides its customers with a comprehensive set of solutions to their trap grease disposal needs, including manifests for regulatory compliance, computerized routing for consistent cleaning and comprehensive trap cleaning. The trap grease the company collects is transported to waste treatment centers.
Food Ingredients segment
Food Ingredients segment consists principally of the collagen business conducted by Darling Ingredients International under the Rousselot and Gelnex names, the natural casings and meat by-products business conducted by Darling Ingredients International under the CTH name and certain specialty products businesses conducted by Darling Ingredients International under the Sonac name.
Collagen
Rousselot and Gelnex are global leading market providers of collagen for the food, nutraceutical, pharmaceutical and technical (e.g., photographic) industries with operations in Europe, China, South America and the United States. Rousselot and Gelnex have a network of 16 production plants and 12 sales locations, covering sales into more than 80 countries. With the Rousselot and Gelnex collagen business, the company is part of the growing global collagen market. Collagen is a functional ingredient, which means that it has a role in the end product by adding a critical property to it that is largely non-substitutable. Collagen is used in a large variety of end products, but only small amounts are used in most products. Rousselot and Gelnex collagen products have higher sales prices relative to the company’s other end products. Rousselot and Gelnex market their hydrolyzed collagen under the Peptan and Peptinex brands; this fast-growing specialty ingredient is positioned specifically towards nutritional supplement customers focusing on improved bone, joint and skin health.
Other Specialty Products
In addition, the company’s Food Ingredients segment includes the Sonac bone, heparin and edible fat businesses operated by Darling Ingredients International under the Sonac name:
Sonac Fat primarily melts, refines and packages animal fat into food grade fat for the food markets.
Sonac Bone processes porcine bones into fat, bone protein, glue, bone ash and bone chips for the feed, pet food, food and collagen industries.
Sonac Heparin extracts crude heparin from hydrolyzed mucosa for application in the pharmaceutical industry.
Natural Casings and Meat By-Products
The CTH business of Darling Ingredients International is a leading natural casings company for the sausage business with operations in Europe, China and the United States. The activities of this business are divided into two categories:
CTH Casings harvests, sorts and sells hog and sheep casings for worldwide food markets, particularly sausage manufacturers, and harvests, processes and sells hog and beef bowel package items for global pharmaceutical, food and feed market segments. CTH holds a leading position in the highly fragmented global casings market.
CTH Meat By-Products harvests, purchases and processes hog, sheep and beef meat for customers in the global food and European pet food industries. In the meat by-products market, CTH is a major player with established sales networks in Europe and Asia.
Fuel Ingredients sSegment
The company’s Fuel Ingredients segment consists of its investment in the DGD Joint Venture and the bioenergy business conducted by Darling Ingredients International under the Ecoson and Rendac names.
Diamond Green Diesel
The DGD Joint Venture operates two renewable diesel plants, one located adjacent to Valero’s St. Charles Refinery in Norco, Louisiana (the DGD St. Charles Plant) and one located adjacent to Valero’s Port Arthur Refinery in Port Arthur, Texas (the DGD Port Arthur Plant and, together with the DGD St. Charles Plant, the DGD Facilities), with a combined renewable diesel production capacity of approximately 1.2 billion gallons per year. Renewable diesel is a low-carbon transportation fuel that is interchangeable with diesel produced from petroleum and is produced at the DGD Facilities using an advanced hydroprocessing-isomerization process licensed from UOP LLC, known as the Ecofining Process, and a pretreatment process developed by the Desmet Ballestra Group, to convert fats (animal fats, used cooking oils, distillers corn oil and vegetable oils) into renewable diesel, renewable naphtha and other light end renewable hydrocarbons. The DGD Joint Venture was formed in 2011 to design, engineer, construct and operate the DGD St. Charles Plant, which reached mechanical completion and began production of renewable diesel and certain other co-products in late June 2013. In 2021, the DGD Joint Venture completed an expansion of the DGD St. Charles Plant that increased its renewable diesel production capability to up to 750 million gallons per year of renewable diesel, as well as separating renewable naphtha (approximately 30 million gallons) and other light end renewable hydrocarbons for sale into low carbon fuel markets. Additionally, in November 2022 the DGD Joint Venture completed the construction of the DGD Port Arthur Plant, with a capacity to produce 470 million gallons per year of renewable diesel and 20 million gallons per year of renewable naphtha and having similar logistics flexibilities as those of the DGD St. Charles Plant. Furthermore, in January 2023, the DGD Joint Venture partners approved a capital project at the DGD Port Arthur Plant to provide the plant with the capability to upgrade approximately fifty percent (50%) of its 470 million gallon annual production capacity to sustainable aviation fuel (SAF).
The DGD Facilities receive feedstocks primarily by rail and trucks owned by third-parties, as well as imports via ships. The company is a party to a raw material supply agreement with the DGD Joint Venture pursuant to which it is obligated to offer to supply the DGD Joint Venture a portion of the feedstock requirements at the DGD St. Charles Plant at market rates. The DGD Joint Venture’s renewable diesel is sold under the Diamond Green Diesel brand primarily to obligated parties who produce or import petroleum-based fuels into areas subject to renewable fuels obligations. The DGD Joint Venture sells renewable diesel domestically and exports renewable diesel into global markets, primarily Canada and Europe. Renewable diesel is distributed primarily by rail and ships owned by third-parties. The company accounts for the DGD Joint Venture as an investment in an unconsolidated subsidiary.
Bioenergy
In Europe, Ecoson produces green power from biogas production out of organic sludge and food waste for combined heat plant installations. Ecoson is the largest industrial digestion operation in the Netherlands and Belgium. In addition, Ecoson's fat refinery produces refined fats and fatty acids. Ecoson also processes manure into natural biophosphate for use as fertilizer and green gas.
Rendac collects fallen stock and animal waste, also referred to as Category 1 and Category 2 material under EU Regulation 1069/2009, from farmers and slaughterhouses, and processes these materials into fats and meals, which can only be used as a low grade source of energy or fuel for boilers and cement kilns. With a specialized collection fleet of approximately 350 trucks, Rendac collects raw materials in the Netherlands, Germany, Luxembourg and Belgium. This business is a market leader in the countries of Belgium, the Netherlands and Luxembourg (the Benelux region) and certain parts of Germany, a predominantly regulated market with spare capacity requirements and long-term contracts with local governments. The market for the collection and processing of fallen stock in these regions is regulated, and government contracts provide for exclusivity of the service to the contracted partner.
Marketing, Sales and Distribution of Finished Products
The company sells its finished products worldwide. Finished product sales are primarily managed through the company’s commodity trading departments. With respect to its North American operations, the company has trading departments located at its corporate headquarters in Irving, Texas, at its regional office in Cold Spring, Kentucky and its regional office in Winchester, Virginia. Darling Ingredients International’s finished product sales are managed primarily through trading departments that are located in Son en Breugel, the Netherlands, and through various offices located in Europe, Asia, South America and North America. Where appropriate, the company coordinates international sales of common products in order to market them more efficiently. The company’s sales force is in contact with customers daily and coordinates the sale, and assists in the distribution of, most finished products produced at its processing plants. The company also sells its finished products internationally directly to customers or, in some cases, through commodities brokers and agents. The company markets certain of its finished products under its Dar Pro Ingredients brand, certain specialty products under the Sonac and FASA names, collagen products under the Rousselot and Gelnex names and natural casings and meat by-products under the CTH name.
The company sells finished products in North America and throughout the world, primarily to producers of animal feed, pet food, biofuel, fertilizer and other consumer and industrial products, including oleo-chemicals, soaps and leather goods, for use as ingredients in their products or for further processing. Certain of the company’s finished products are ingredients that compete with alternatives, such as corn, soybean oil, inedible corn oil, palm oils, soybean meal and heating oil, based on nutritional and functional values; therefore, the actual pricing for those finished products, as well as competing products, can be quite volatile.
Customers for the company’s premium, value-added and branded products include feed mills, pet food manufacturers, integrated poultry producers, the dairy industry and golf courses. Feed mills purchase meals, fats, blood products, and Cookie Meal for use as feed ingredients. Pet food manufacturers require stringent feed safety certifications and consistently demand premium additives that are high in protein and nutritional content. As a result, pet food manufacturers typically purchase only premium or value-added products under supply contracts with the company. Oleo-chemical producers use fats as feedstocks to produce specialty ingredients used in paint, rubber, paper, concrete, plastics and a variety of other consumer and industrial products. Darling Ingredients International’s premium, value-added and branded products also command higher pricing, including with respect to collagen, natural casings, meat by-products, edible fat, heparin and specialty plasma products.
The company obtains payment protection for most of its global export sales by requiring payment before shipment, either through bank letters of credit or cash against documents at the origin of the sale or guarantees of payment from government agencies.
Finished products produced by the company are shipped primarily by truck or rail from its plants shortly following production. While there can be some temporary inventory accumulations at various North American and international locations, particularly port locations for export shipments, with the exception of collagen and natural casings, inventories rarely exceed three weeks’ production and, therefore, the company uses limited working capital to carry those inventories.
The company operates a fleet of trucks, trailers and railcars to transport raw materials from suppliers and finished products to customers or ports for transportation by ship. Within its bakery and international by-products divisions, except for Rendac, substantially all inbound and outbound freight is handled by third-party logistics companies.
Competition
The company competes with a number of well capitalized companies across its business, such as Cargill, Inc., Tyson Foods, Inc. and JBS & Company in the U.S. products business.
Seasonality
Although the amount of raw materials made available to the company in each of its segments by its suppliers is relatively stable on a weekly basis, it is impacted by seasonal factors, including holidays, during which the availability of raw materials declines because major meat and poultry processors are not operating, and cold and other severe weather and natural disasters. The amount of bakery residuals the company processes generally increases during the summer from June to September. Collagen sales generally decline in the summer.
Intellectual Property
The company has registered or applied for registration of certain of its intellectual property, including the tricolor triangle used in its signage and logos and the names Darling, Darling Ingredients, Griffin Industries, Dar Pro Solutions, Dar Pro, Rousselot, Gelnex, Sonac, FASA, Ecoson, Rendac, Rothsay, Nature Safe, CleanStar, Peptan, Cookie Meal, and Bakery Feeds, and certain patents, both domestically and internationally, relating to the process for preparing nutritional supplements and the drying and processing of raw materials.
Regulations
The company is subject to the rules and regulations of various federal, state, local and foreign governmental agencies including, but not limited to, the following principal governmental agencies in the following countries:
The United States
The Food and Drug Administration (‘FDA’), which regulates pharmaceutical products and food and feed safety. The FDA is responsible for enforcement of rules (21 C.F.R. 589.2000 and 589.2001, referred to herein as the ‘BSE Feed Rule’) to prevent the spread of bovine spongiform encephalopathy (‘BSE’), which is commonly referred to as ‘mad cow’ disease. In addition, the FDA is responsible for implementing and enforcing the FDA Food Safety Modernization Act (‘FSMA’), which gives FDA a series of powers intended to better protect human and animal health by adopting a modern, preventive and risk-based approach to food safety regulation. In addition, to various authorities granted to the FDA by FSMA, the FDA has finalized major rules under FSMA affecting the production, importation and transport of human and animal food. These authorities and regulations include:
Mandatory recall authority for adulterated or misbranded foods where the use of or exposure to such foods is likely to cause serious adverse health consequences or death to humans or animals, if the responsible party fails to cease distribution and recall such adulterated or misbranded foods voluntarily.
Regulations that define the FDA’s administrative detention authority to include the authority to detain an article of food if there is reason to believe the food is adulterated or misbranded.
Section 306 of the FSMA provides that the FDA must refuse admission of food into the United States if a foreign food establishment or foreign government refuses to permit entry for an inspection.
Section 102 of the FSMA amended facility registration requirements in the Federal Food, Drug and Cosmetic (‘FD&C’) Act for domestic and foreign manufacturers, processors, packers or holders of food for human or animal consumption, to require that facility registrations be renewed during the fourth quarter of each even-numbered year, beginning October 1, 2012, and that additional information be included in such registrations. FSMA also provides that, if the FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the FDA may suspend the registration of a facility that created, caused, or was otherwise responsible for such reasonable probability, or knew or had reason to know of such probability and packed, received, or held the food.
The FDA has issued final rules for preventive controls (‘PCs’) for human food and animal feed (‘Human Food PC Rule’ and ‘Animal Food PC Rule,’ respectively), which apply to registered FDA facilities that manufacture, process, pack and hold human or animal food and require these facilities to establish and implement written food safety plans, which include hazard analyses, PCs to ensure that significant hazards that are identified as needing to be controlled will be significantly reduced or prevented, monitoring of PCs, supply-chain controls if appropriate to control a significant hazard, recall plans, corrective action procedures, verification activities and record keeping standards. The Human Food PC Rule also updates existing Current Good Manufacturing Practices (‘CGMPs’), and the Animal Food PC Rule establishes minimum CGMPs for the production, holding and distribution of the human or animal food.
The FDA has issued a regulation relating to Foreign Supplier Verification Programs (‘FSVP Rule’) requiring that importers of both human and animal food must develop, follow and maintain written procedures verifying that their foreign suppliers produce food in a manner that provides the same level of public health protection as the Human Food PC Rule, Animal Food PC Rule, or FDA’s regulations established under FSMA regarding produce safety, as appropriate, and must ensure that the suppliers’ food is not adulterated and is not misbranded with respect to allergen labeling of human food.
Under FSMA, the Sanitary Transportation Food Act of 2005, and FDA’s regulation, sanitary transportation practices must be used to transport human and animal foods to prevent such food from being adulterated during transport and applies to shippers, loaders, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food.
The FDA has finalized a rule that requires registered human food facilities to conduct a vulnerability assessment and implement mitigation strategies, including a written food defense plan, to prevent or mitigate potential acts of intentional adulteration of food that could harm the public health.
The FDA issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (‘LAAF’) program as required by FSMA section 202(a). Under the LAAF program, FDA will recognize accreditation bodies that will accredit laboratories to the standards established in this final rule. Laboratories accredited to the LAAF standard (‘LAAF-accredited laboratories’) are authorized to conduct certain food testing as described in the rule. In September 2022, FDA launched a LAAF Dashboard which maintains a list of FDA-recognized Accreditation Bodies for the LAAF Program.
The FDA has issued a final rule establishing additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods that appear on a list of ‘high risk’ foods. The list of high risk foods includes certain fruits and vegetables, shell eggs, and certain types of seafood, among other products. Entities that are subject to the rule will be required to establish and maintain traceability program records containing required information. The compliance date for all persons subject to the rule is January 20, 2026.
The FDA also has regulations governing food additives in animal feed and pet food, which could apply to the use of protein from black soldier fly larvae in such products. The FDA acknowledges that it considers the listing of animal feed and pet food ingredients in the Association of American Feed Control Officials (‘AAFCO’) Official Publication to permit marketing of such ingredients in interstate commerce, provided there are no safety concerns regarding the use or composition of the ingredients.
The United States Department of Agriculture (‘USDA’), which has authority over meat, poultry, and egg products and inspects producers to ensure compliance with applicable laws and regulations. Within the USDA, two agencies exercise direct regulatory oversight of the company’s activities:
Animal and Plant Health Inspection Service (‘APHIS’) certifies facilities and claims made for exported materials to meet importing country requirements and establishes and enforces import requirements for live animals and animal by-products, as well as plant products; and
Food Safety and Inspection Service (‘FSIS’) regulates sanitation and biosecurity of the company’s facilities and its food safety programs at plants producing edible fats and meats, among other things.
The U.S. Environmental Protection Agency (‘EPA’), which regulates air and water discharges and hazardous and solid waste requirements among other environmental requirements, as well as local and state environmental agencies with jurisdiction over environmental matters affecting the company’s operations. The EPA also administers the National Renewable Fuel Standard Program (‘RFS2’).
The Association of American Feed Control Officials (‘AAFCO’), which is a voluntary membership association of state, and federal agencies that regulate the sale and distribution of animal feeds and animal drug remedies. Although, AAFCO has no regulatory authority, it brings together stakeholders and works to develop and implement uniform and equitable laws, regulations, standards, definitions, and enforcement polices for regulating the manufacture, labeling, distribution and sale of animal feeds.
State Departments of Agriculture, which regulate animal by-product collection and transportation procedures and animal feed quality.
The United States Department of Transportation (‘USDOT’), as well as local and state transportation agencies, which regulate the operation of the company’s commercial vehicles.
The U.S. Occupational Safety and Health Administration (‘OSHA’), which is the main federal agency charged with the enforcement of worker safety and health legislation.
The Securities and Exchange Commission (‘SEC’), which regulates securities and information required in annual, quarterly and other reports filed by publicly traded companies.
European Union and EU Member States
The European Union, which has competence to adopt legislation, which is binding on the EU Member States and, as regards regulations, their citizens, related to inter alia, employment and social affairs, agriculture, environment, consumer protection and public health.
EU Member States must correctly transpose EU Directives in their national legislation and apply EU Regulations, and in particular ensure adequate and effective enforcement, control and supervision of the relevant principles such as minimum safety and health requirements for the workplace and use of work equipment by workers. The EU Directives may allow EU Member States to maintain or establish more stringent measures in their own legislation. In general, each EU Member State is responsible for regulating health and safety at work and labor inspection services and is in charge of controlling compliance with applicable legislation and regulations.
The European Commission, which is the European Union’s executive arm and is responsible for drawing up proposals for new EU legislation and implementing the decisions of the European Parliament and the Council of the EU. Relevant Directorate Generals include, but are not limited to:
Directorate-General for Health and Food Safety, which is responsible for EU policy on food safety and health and for monitoring the implementation of related EU legislation, including but not limited to food, feed, human and animal health, technical uses of animal by-products and packaging.
Directorate-General for the Environment, which is responsible for EU policy on the environment and for monitoring the implementation of related EU legislation, including but not limited to Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control) and, together with other Directorate-Generals of the European Commission, the Best Available Techniques Reference Document on the Slaughterhouses and Animal By-products Industries.
Relevant Agencies and Authorities include, but are not limited to:
The European Medicines Agency, which is responsible for the scientific evaluation, supervision and safety monitoring of medicinal products for human and veterinary use in the EU and establishes guidance amongst others for bovine-containing medicinal products for human or veterinary use, and maximum residue limits.
The European Chemicals Agency, which is responsible for the implementation of Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals.
The European Food Safety Authority, which advises the European Commission, the European Parliament and the EU Member States on food safety matters, including on animal feed, animal health and welfare, biological hazards and contaminants.
The Council of Europe's, European Directorate for the Quality of Medicine and Healthcare, which establishes quality standards for safe medicinal products for human and veterinary use in Europe by developing guidance and standards in the areas of blood transfusion, organ, cell and tissue transportation and consumer health issues.
The EU Member States’ national competent authorities responsible for, including but not limited to, human and animal medicinal products, issuing permits, approvals and registrations to establishments or plants engaged in certain activities related to the handling of animal by-products and food and feed production, human and animal health and feed production, environmental regulation, including waste management, collection and transport of animal by-products, as well as health and safety of workers.
The United Kingdom
The Medicines and Healthcare products Regulatory Agency (‘MHRA’), is an executive agency of the Department of Health and Social Care and is responsible for, inter alia, ensuring the safety of medicinal products for human and veterinary use.
The Animal and Plant Health Agency (‘APHA’) is an executive agency of the Department for Environment, Food and Rural Affairs and is responsible for protecting the health and welfare of the general public and animals from disease. The APHA issues permits, approvals and registrations to plants carrying out certain activities related to the handling of animal by-products. Feed businesses need to be approved or registered with their local authority trading standards office.
The Food Standards Agency (‘FSA’), which is responsible for safeguarding public health, including in relation to food and feed. The FSA supports the control of BSE. Local authorities are responsible for delivering activities such as inspections, audits and surveillance, sampling in most food and feed establishments.
The United Kingdom’s Health and Safety Executive is the government body responsible for enforcing health and safety at work legislation, such as the Health and Safety at Work Act 1974, and enforcing health and safety law in industrial workplaces, together with local authorities.
Canada
The Canadian Food Inspection Agency (‘CFIA’), which regulates animal health and the disposal of animals and their products or by-products.
Canadian provincial ministries of agriculture and the environment, which regulate food safety and quality, air and water discharge requirements and the disposal of deadstock.
The Canadian Department of the Environment (‘Environment Canada’), which ensures compliance with Canadian federal air and water discharge and wildlife management requirements and the various provincial and local environmental ministries and agencies.
The Canadian Technical Standards and Safety Authority (‘TSSA’), a non-profit organization that regulates the safety of fuels and pressure vessels and boilers.
China
The General Administration of Quality Supervision, Inspection and Quarantine, which supervises the import and export of food and feed.
The Ministry of Health of the People’s Republic of China, which establishes standards for food and pharmaceutical products.
The Chinese Pharmacopeia, which establishes standards for pharmaceutical products.
Ministry of Environmental Protection of the People's Republic of China, which regulates the environmental protection standards.
Ministry of Labor and Social Security of the People's Republic of China, which establishes the regulations of labor, welfare and health insurance.
State Administration of Work Safety, which establishes the work safety standards and regulations.
Brazil
The Ministry of Agriculture, Cattle and Supply (Ministerio da Agricultura, Pecuária e Abastecimento), which regulates the production of collagen.
Ministry of Labor (Ministerio do Trabalho), which regulates labor health and safety.
The Ministry of the Environment and Climate Change (Ministerio do Meio Ambiente e Mudança do Clima - MMA), which regulates and supervises the implementation of the national policy for the environment.
Federal Environmental Agency (Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis - IBAMA), which regulates and supervises the development of potentially pollutant activities in Brazil as well as is responsible for the Federal Technical Registry (Cadastro Tecnico Federal – CTF), required for all the enterprises which develop potentially pollutant activities and/or use of natural resources.
Various local and State environmental agencies responsible for the State-Level and local-level control, supervision, monitoring and licensing process for pollution generating activities in the areas in which the company operates.
Brazilian Federal Police, responsible for regulating and inspecting controlled chemical industrial products.
Brazilian Army, responsible for regulating and inspecting controlled chemical industrial products.
Federal Council of Veterinary Medicine (CFMV), and its regional counterparts (Reginal Councils of Veterinary Medicine – CRMV), which guide, control, inspect, and regulate the exercise of certain professional categories, and issue the registration of companies (i.e., the Legal Entity Registration Certificate issued by the competent professional council – CRPJ) and the annotation of legally qualified professionals in charge of them (i.e., the Technical Responsibility Note issued by the competent professional council – ART).
Federal Council of Chemistry (CFQ), and its regional counterparts (Regional Councils of Chemistry – CRQ), which guide, control, inspect, and regulate the exercise of certain professional categories, and issue the CRPJ and the ART.
Brazilian Oil, Gas & Biofuels Regulatory Agency (ANP), responsible for the regulation of the operation of biofuel production plants, an activity that one of the company’s subsidiaries is engaged with.
National Land Transport Agency (ANTT), which issues subscriptions on the National Register of Road Freight Transporters (RNTRC) and regulates road cargo transportation, an activity that one of the company’s subsidiaries is engaged with.
Australia
The Australian Quarantine and Inspection Service, which regulates the import and export of agricultural products, including animal by-products.
The Department of Agriculture, Fisheries and Forestry, which administers meat and animal by-product legislation.
PrimeSafe, which is the principal regulator of meat and animal by-product businesses in the State of Victoria.
The Australian Competition and Consumer Commission, which regulates Australia’s competition and consumer protection law.
The Australian Securities and Investments Commission, which regulates Australia’s company and financial services laws.
Worksafe Victoria, which is the regulator responsible for administering and enforcing occupational health and safety laws and regulations in the State of Victoria.
Environment Protection Authority Victoria, which administers environmental protection laws in Victoria.
Goulburn-Murray Rural Water Corporation, which manages allocation and use of water under local water laws in Victoria.
Rules and regulations promulgated by these and other agencies may influence the company’s operating results at one or more facilities.
History
The company was founded in 1882. It was incorporated in Delaware in 1962. The company was formerly known as Darling-Delaware Company, Inc. and changed its name to Darling International Inc. in 1993. Further, the company changed its name to Darling Ingredients Inc. in 2014.
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