Do You Want To Import Chemical Products To The USA? Chemsafe USA Can Help You!

The North American regulation on the import of chemical products, whether they are substances or mixtures (Biocides, Fertilizers, Pesticides) or of a medical type (Drugs as Active Finished Ingredients, Cosmetics, Medical Devices) is quite complex. For each of these product categories, there are specific provisions (called “ACTS”) that indicate the regulatory ROAD MAP to be adopted. Although the categories are defined at the US level, Federal and State Regulations must always be considered before taking any action.

In brief, the main regulatory players are:

1.???? FDA (Food & Drug Administration) defines the rules for placing Food Products, Drugs, Medical Devices, and Cosmetics on the US market through chapters of the Code of Federal Regulation (CFR).

2.???? EPA (Environmental Protection Agency) defines through a series of acts, also included in the CFR, the import and export of chemical products in the USA. Primarily, the TSCA (Toxic Substances and Control Act) regulates the control and management of industrial chemical products, identifying and regulating the risks they pose and their toxicity to both public health and the environment. Secondly, the FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) regulates the market placement of pesticide substances and products. These products are divided into four more specific categories:

o??? Antimicrobials (disinfectants, sanitizers, preservatives, virucidals, fungicides)

o??? Biopesticides (derived from natural materials such as biochemicals, microbial, and Plant Incorporated Protectants – PIPs)

o??? Conventional pesticides (synthetically produced)

o??? Pesticides device registration (devices)

As mentioned earlier, at the state level, there are various laws and interpretations of laws that need to be carefully evaluated, especially concerning the national market one aims to reach. An example is the so-called PROPOSITION 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) regulated by the California Office of Environmental Health Hazard Assessment (OEHHA). This law specifically deals with maintaining and updating a list of chemical substances considered carcinogenic and toxic for reproduction (development and fertility).

The list contains about 900 substances. For all products (existing or new) on the California market, companies must verify if they comply with the law to ensure market access in California. Non-compliance can result in civil penalties of up to $2500 per day for each violation.

For every substance and/or chemical product, it is also crucial to verify its safety profile, the related safety classification according to US GHS criteria, and the presence of the SDS (Safety Data Sheet) prepared according to the US model.

CHEMSAFE USA CORP (our American subsidiary) can help you define the ROAD MAP to the USA through the following actions:

• Identification of the product usage indication (CLAIM) for the North American market
• Verification of the safety profile and classification
• Verification of the reference standard in the USA
• Verification of the Competent Authority of reference in the USA
• Identification of the regulatory pathway to adopt with an indication of the economic budget
• Identification of any experimental tests to be carried out
• Identification of the GLP laboratory in the USA for the necessary experimental tests
• Preparation of registration dossiers
• FDA Agent
• Liaison with Competent Authorities, calls, and visits on demand
• Customs compliance verification activities, warehouse needs, legal practices in collaboration with EXPORT USA, our partner.

Do not hesitate to contact us: [email protected]