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 to be sold or distributed in the United States, a pesticide product must be registered with the US Environmental Protection Agency (EPA).
The Toxic Substances Control Act (TSCA) gives the Environmental Protection Agency (EPA) the authority to regulate new and existing chemicals. As a result, there are deadlines for manufacturers and importers of chemical substances to meet in 2018.
Different federal agencies including the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) and the US Environmental Protection Agency's (EPA) Office of Pesticide Program (OPP) are tasked with regulating a given product’s registration, use, and sale.
The Consumer Products Safety Act (CPSA) and the Consumer Product Safety Improvement Act (CPSIA) give the Consumer Products Safety Commission (CPSC) the authority to develop standards and institute product bans or recalls if a consumer product poses harm to the public.
US government agencies, including the US Environmental Protection Agency (EPA), have not yet agreed on how to define biostimulants. They are working with industry organizations and nonprofits to provide guidance on how biostimulant production, sale, and use is being handled.
Prior to entry into the US marketplace, many devices require premarket submissions so the FDA can evaluate the safety and efficacy characteristics of the device in question.
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. Each state has its own laws and regulation and most states regulate fertilizers through their Department of Agriculture.
Animal feed is regulated at the state level in cooperation with FDA and AAFCO. Each state has a different set of laws and regulations in place to ensure compliance. This includes each state having its own procedure for registering products, overseeing their renewal, developing label requirements, and collecting 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.
Prior to additions or changes going live on the CDMS and/or Agrian 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 France, Spain, Germany and the UK 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.
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).
Click below to view more detail about some of the countries in which we operate.
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.
The Canadian Environmental Protection Act (CEPA) was passed in 1999 to promote sustainable development by preventing pollution and protecting human health and the environment from risks associated with toxic substances.