TSG provides federal, state and international expertise on a wide range of scientific and regulatory issues. With experts in regulatory affairs, toxicology, ecotoxicology, residue and metabolism, environmental fate, efficacy, and risk assessment, TSG supports the registration, compliance, and defense of chemically related products. Our federal services support chemical products that are regulated and registered at the federal level under key federal acts and by federal agencies such as EPA.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the federal statute governing US pesticide regulation. In order for a pesticide product to be sold or distributed in the US, it must be pre-approved and registered with the U.S. Environmental Protection Agency (EPA), and in each individual state and US territory.
The Toxic Substances Control Act (TSCA) grants EPA authority to collect data on chemicals used to evaluate, assess, mitigate and control risks that might be posed by their manufacture, processing and use. TSCA provides a variety of control methods to prevent chemicals from posing unreasonable risks.
Regulated separately from antimicrobial and biopesticides, conventional pesticide products are considered those that control, repel, mitigate, or destroy pests through traditional synthetic chemistry. They can include products used in the crop protection industry, insect vector control, professional pest control operations, home & garden pest control, insect control, and livestock and companion animal care, among others.
Intergeneric organisms are ‘‘new’’ microorganisms formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. Considered a microbial product of biotechnology, intergeneric microorganisms require notification under section 5 of the Toxic Substances Control Act (TSCA).
Biopesticide products require pre-approval from US EPA before being offered for sale and are evaluated based on their chemistry, toxicology and product performance (if pests are considered public health) using guidelines established under FIFRA.
A pesticide device is an instrument or contrivance that is used to destroy, repel, trap or mitigate pests such as insects, weeds, rodents, birds, bacteria, viruses, and fungi that are not on living humans or animals.
US EPA regulates antimicrobial pesticides separately from conventional pesticides and biopesticides. Antimicrobial pesticides are substances or mixtures of substances that prevent, destroy, repel or mitigate microorganisms on inanimate objects and surfaces.
US EPA requires that all antimicrobials intended to kill or minimize microorganisms must provide efficacy data to support product label claims. Antimicrobial efficacy is inclusive of disinfection, sanitization, and preservation among other product claims.
Eco-label regulatory support for the antimicrobial industry.
US - State
TSG offers state registration and renewal services for chemical products. Products, such as pesticides, are regulated federally but also need to be registered in each state that they are to be marketed and TSG can manage the registration process and then the renewal processes to ensure products remain compliant. Conversely, there are some products which are regulated solely at the state level (such as fertilizers and animal feed) with which we can assist. Additionally, there are some state-specific initiatives, such as Proposition 65 in California, which you may need assistance in addressing.
Obtaining state registrations is a necessary step in bringing your federally registered product to market. Before a pesticide may be offered for sale, the product must be registered in each state where it will be sold.
Fertilizers and amending materials are regulated at the state level rather than by the Federal Government. The Association of American Plan Food Control Officials (AAPFCO) is an independent organization of state control officials that work together to develop a degree of uniformity between states on their regulatory guidelines. Due to the nature of guidelines, each state still maintains its own laws and regulations.
Animal feed, which includes food for dogs, cats and other pets, is regulated at the state level in cooperation with FDA and AAFCO. Each state has its own procedures for registering products, product renewals, labeling requirements, and collection of tonnage fees based on sales.
California's Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, requires the state to publish a list of chemicals known to cause cancer or birth defects. Businesses face issues if they fail to label products that contain listed substances appropriately under Proposition 65.
CDMS and Agrian are product databases providing critical agro-chemical product information to the agricultural industry. Prior to additions or changes going live on the databases, a registrant must double-check all of the inputs made on the systems.
TSG provides regulatory and scientific support on the use and approval of a wide range of chemical substances and products. We have strong teams of regulatory experts and scientists focused on the regulatory initiatives across the EU which determine safety and market access. Whilst most regulations stem from the EU, some approval processes are dealt with in the Member States. To meet the challenges this represents we have established a network of offices across Europe.
We have offices in Spain, Germany and the UK, as well as a presence in France, offering local knowledge, language and forging relationships with government authorities and agencies. The model is straightforward and has proven to work well on behalf of our clients for many years.
REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals EC/1907/2006) is one of two key areas of regulation governing chemicals in the European Union. Introduced to mitigate risk of hazardous chemical substances to human health and the environment, its rules may apply to any company that imports, manufactures or uses chemicals or articles in the European Economic Area.
Substances, on their own or in mixtures, that are imported into the UK in quantities greater than 1 metric tonne per year will need to be registered with the UK Health and Safety Executive (UK HSE) unless an exemption applies.
The other key regulation that governs chemicals in the European Union is CLP Regulation (Classification, Labelling and Packaging). CLP legislation requires all importers, manufacturers and downstream users to classify, label and package substances and mixtures adequately before they can be placed on the market.
The Plant Protection Products Regulation (EU) No. 1107/2009 came into force on June 14, 2011, and lays down the rules and procedures for the placing of protection products onto the market within the EU and introduces many new regulatory challenges.
The Biocidal Products Regulation 528/2012 (EC) concerns market access and use of biocidal products in the European Union. The regulation covers a very diverse group of products including disinfectants, non-agricultural pest control products, and preservatives.
The introduction of Regulation (EC) No 1223/2009 which came into force on July 11, 2013, imposes stringent procedures on organizations involved in cosmetics and personal care products. All cosmetic products being marketed within the European Union have to be registered on the new Cosmetic Products Notification Portal (CPNP).
In Europe, Framework Regulation (EC) No 1935/2004 lays down the general rules covering all food contact materials, whilst the Good Manufacturing Practice (GMP) Regulation (EC) 2023/2006 covers the methods and procedures under which the materials are produced.
TSG assists clients in the Asia-Pacific region, through relationships with third-party partners, with regulatory matters for pesticides, foods, pharmaceuticals, and chemicals. We coordinate new chemical notifications and pesticide registrations in a number of countries in the Asia-Pacific region, including China, Japan, Malaysia, Indonesia, Thailand, Taiwan, Singapore, the Philippines, Vietnam, India, Pakistan, Australia and New Zealand.
We also assist clients with sourcing products by locating, inspecting and auditing manufacturing facilities, including performing Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) audits. Furthermore, TSG’s consultants conduct due diligence audits for companies interested in acquiring a business in a different region/jurisdiction from their own.
The Ministry of Agriculture (MOA) regulates all agrochemicals, including pesticides and biopesticides, that are registered and sold in China, as well as products manufactured in China and sold in other countries.
The National Health and Family Planning Commission (NHFPC) regulates all disinfectants in China. Registering disinfectant products intended for public health use requires data to be generated to support efficacy and safety.
China Food and Drug Administration (CFDA) regulates all consumer products including food, food additives, drugs, cosmetics and medical devices.
TSG acts as a liaison for western companies doing business in China including technical communication between companies, connecting with relevant Chinese companies, finding qualified Chinese registration agents, coordinating business relationships and visits, and establishing relations with industry trade associations.
TSG provides clients with regulatory, scientific and compliance assistance on a broad spectrum of chemical-related issues to help companies market and use products in Canada.
Antimicrobial products such as sterilants and disinfectants intended for use on environmental surfaces, inanimate objects, and to reprocess medical devices are regulated as drugs under Health Canada’s Food and Drugs Act because they decrease the chance of transmitting disease.
Health Canada requires that all antimicrobials intended to kill or minimize microorganisms must provide efficacy data to support product label claims. Antimicrobial efficacy is inclusive of disinfection, sanitization, and preservation among other product claims.
Under the Canadian Environmental Protection Act (CEPA), all chemical substances new to Canada must be assessed for human health and environmental risks before manufacture or import to Canada and may require Notification under the New Substances Notification Regulations (NSNR).
The Cosmetic Regulations of the Food and Drugs Act require that cosmetics sold in Canada be manufactured, prepared, preserved, packed and stored under sanitary conditions. Manufacturers must also notify Health Canada that they are selling the product and provide a list of its ingredients.
We work in various different markets, including agriculture, industrial, consumer and medical.
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