Pre-Market Review and Product Registration
Government authorities in many countries require pre-market review or registration of products in advance of sales. Beveridge & Diamond assists clients to monitor developments, evaluate the applicability of requirements to particular products, and prepare the required submissions. Some examples of how we have helped clients are the following.
- For governmental review of new chemicals (those not on the Toxic Substances Control Act Inventory or comparable national inventories), we have assisted with:
- Determination of whether products are subject to premanufacture notification requirements or significant new use rules under TSCA or are covered by exemptions; preparation of premanufacture and significant new use notices where needed; and defense of enforcement actions for manufacture of chemicals not on the TSCA Inventory.
- Resolution of allegations of non-compliance with the new chemical provisions of the Canadian Environmental Protection Act, and counseling on other foreign programs
- Pre-registration of products under the European Union’s regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and preparation for registration to maintain market access.
- For pesticides and antimicrobials regulated under the Federal Insecticide, Fungicide, and Rodenticide Act and its foreign counterparts, we have helped with:
- Obtaining pesticide registrations from EPA; advice on compliance with exemptions from registration requirements; defense of challenges to registrations brought by competitors or advocacy groups; and bringing challenges to competitors’ applications and registrations.
- Advice on the potential need to register consumer products with antimicrobial or pest repellant properties with EPA and with its counterparts in Europe, Latin America, and Asia, and favorable settlements in cases in several jurisdictions alleging that products were not properly registered.
- For food additives, dietary supplements, and other products regulated under the Federal Food, Drug, and Cosmetic Act and its counterparts, we have assisted clients with:
- Advice on whether new components of food contact materials were covered by existing clearances for indirect food additives, and assisted in obtaining FDA approval of food contact notifications for new indirect food additives.
- Obtaining favorable FDA review of notifications that certain food components are generally recognized as safe, including a bioengineered enzyme preparation.