PRACTICES

Chemical Regulation in Central and South America

Overview:

The Central and South American chemical regulatory environment is particularly challenging to understand, as there is relatively little consistency, even among neighboring countries. The region is home to two major trading blocs, MERCOSUR (Mercado Común del Sur), and the Andean Community of Nations (Comunidad Andina). Similar in basic concept to the European Union (EU), these blocs impose overarching regulation and legislation on the individual member countries that often do not exist locally. As such, countries in Central and South America often face an ever-changing mix of local, national, and regional regulatory requirements. It is critical for a company to understand its intended markets, its proposed marketing and labeling claims, and its supply chain to ensure compliance.

While most Central and South American countries do not currently possess formal chemical inventories, and generally have not adopted the Globally Harmonized System of Classification and Labeling (GHS) for their respective Safety Data Sheet (SDS) programs, many have made significant progress in developing regulations that are similar to those in the United States, the EU, and Canada. Perhaps the most robust is Brazil, which has introduced its national inventory of chemical substances and the Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais), has established a variety of regulations pertaining to food contact materials (Resolução - RDC nº 88, 89, and 90), and has implemented GHS (ABNT 14.725-4: 2014 (SDS)). Even more progressively, the country has established regulations concerning biodiversity, substances banned in personal care products, cosmetics, perfumes for children, and organic products, among others.

Other Central and South American countries are developing regulatory programs that are expected to have a significant impact on entities doing business in the region. Among these are Argentina (GHS for mixtures -- January 1, 2017), Chile (Proposed Regulation on antimicrobial products), and Costa Rica (Costa Rican Technical Regulation (RTCR) No. 484:2016, regulations governing the registration, use, and control of formulated synthetic pesticides, technical grade active ingredients, processing aids, and related substances for agricultural use).

Our Experience:

The Acta Group (Acta®) maintains a deep and expansive understanding of the regulatory landscape in Central and South America. This is reflected in the many publications that quote our professionals on legislative developments in the region, and the seminars that request our participation as expert speakers.

Our team of seasoned scientific and regulatory professionals includes regulatory consultant Michael Wenk, M.S., a recognized industry expert on chemical and biocidal substance regulation in Central and South America with over 20 years’ experience managing global regulatory affairs and product stewardship for Fortune 500 companies. In addition to maintaining direct authority contacts in key Ministries in virtually every country of the region, Mr. Wenk has hands-on expertise with a wide range of regulations throughout the area.

Acta President Lynn Bergeson has earned an international reputation for her deep and expansive understanding of the complex legal, commercial, and scientific challenges presented by globalized chemical management programs, and especially how these regulatory programs pertain to nanotechnology, biotechnology, and other emerging transformative technologies. Ms. Bergeson assists multinational corporations, innovative start-ups, business consortia, and industry trade groups develop efficient and sophisticated pathways to commercialization for new chemicals.

Karin Baron, MSPH, a regulatory consultant with more than 15 years’ experience developing, implementing, and managing complex regulatory chemical compliance matters for some of the largest industrial and specialty chemical companies in the world, offers expert advice and guidance in a broad range of chemical-specific regulatory matters.

Sheryl Dolan is a product regulatory specialist with nearly 25 years' experience in environmental regulatory consulting. Ms. Dolan addresses regulatory approval and compliance management issues for pesticides and chemicals with industrial, commercial, and consumer applications.

What We Do:

Acta professionals can provide strategic, cost-effective, and timely assistance in the following areas:

Services:

  • Registration
  • Confidential Business Information (CBI) Management and Protection
  • Data Search, Evaluation, Validation, and Gap Analysis
  • Review of Data Validation and Gap Analysis
  • Business Planning
  • Supply Chain Management Considerations and Communications
  • Registration Dossier Preparation
  • Preparation and Review of Hazard Data
  • SDS Preparation
 
THE ACTA GROUP, L.L.C.
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