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Chemical Regulation in the Middle East

Overview:
 
The Middle East is incorrectly thought to be at a relatively nascent stage of developing comprehensive programs for managing chemicals.  There may be a variety of reasons for this perception, ranging from a lack of fluency in Arabic, Hebrew, or Urdu, to a somewhat insular culture within the region, to the tendency to focus on geographic regions with more robust commercial and business operations. There are, however, emerging chemical regulatory initiatives underway in the region, and a thorough understanding of these programs and those agencies and entities involved, the legislation in force, and the key areas of concern is vital for compliant and commercially successful operations across the region.
 
The Middle East region is comprised of countries at varying stages of chemical substance regulation implementation, forming a “compliance patchwork” of sorts, and requiring careful evaluation on a country-by-country basis. In addition to individual national legislation, many of the countries are members of the Cooperation Council for the Arab States of the Gulf, originally (and still colloquially) known as the Gulf Cooperation Council, or GCC.  The GCC functions in loose parallel to the European Union and the South Common Market (Mercado Comum do Sul, or MERCOSUR) as it has the stated goals of establishing a common currency, harmonizing regulations across a variety of fields, such as trade, customs, and finance, and establishing a common national defense force. All of the Arab states of the Persian Gulf, except for Iraq, are members. Thus, there are “trade bloc” regulations that must be observed as well. Compounding the confusion, not all regulations promulgated by the GCC are mandatory, so one country may implement the legislation, but another GCC Member State may elect not to.
 
Virtually none of the Middle Eastern countries 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, where such programs exist in national law. Throughout the region, a country’s defined legislative priorities, as well as its economic drivers, results in various areas of focus specific to chemical substance regulation. Israel, a world leader in the manufacture of generic drugs, has some of the most substantial and comprehensive drug regulations of any Middle Eastern country. Kuwait has had a national monitoring system for chemical substances in place since 1987, and has specifically introduced the “polluter pays” concept into its natural law, while Egypt has seven different Ministries with varying roles and responsibilities for issuing chemical substance permits. Bahrain’s chemical substance regulations cover a wide range of categories as pesticides, cleaning materials, pharmaceutical drugs, and food additives, while several cities and provinces in both Pakistan and Saudi Arabia have their own -- often separate -- substance regulations.
 
The Acta Group (Acta®) is active and knowledgeable in assisting its clients in dealing with the complexities of chemical management regulations in the Middle East. Thanks to our significant scientific, legal, and policy knowledge base and our familiarity with agencies across the globe, we are uniquely qualified to help client companies commercialize their products in the region.
 
Our Experience:
 
Acta maintains a deep and expansive understanding of the regulatory landscape in multiple countries of the Middle East. 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 international team of seasoned scientific and regulatory professionals includes regulatory consultant Michael Wenk, M.S., a recognized industry expert on chemical substance regulation in the Middle East with over 20 years’ experience managing global regulatory affairs and product stewardship for Fortune 500 companies.  Mr. Wenk is author of “Chemical Regulation in the Middle East,” 2018, John Wiley & Sons Ltd.  Acta President Lynn Bergeson has earned an international reputation for her deep and expansive understanding of chemical regulatory programs worldwide, and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies.  Ms. Bergeson assists multinational entities develop and maintain sophisticated, business-sensitive, global chemical compliance and stewardship strategies focused on getting to market faster and more efficiently than the competition.  Jane Vergnes, Ph.D., DABT®, has managed toxicology, hazard communication, and regulatory affairs programs for a wide array of industrial and specialty chemical products.  Richard E. Engler, Ph.D., assists clients with properly identifying chemicals under various global nomenclature schemes, including complicated substances such as Unknown or Variable Composition, Complex Reaction Products, or Biological Materials (UVCB). Brian Xu, M.D., Ph.D., DABT®, is a board-certified toxicologist, fluent in English and Mandarin, with an M.D. in pathology, a Ph.D. in pharmacology and toxicology, and over 15 years of experience developing and managing international safety testing, risk assessment, product safety, and regulatory compliance.  Scott J. Burya, Ph.D., assists clients in all stages of product development, from prototype development and regulatory approvals, to end of life product management. 
 
Karin Baron, MSPH offers clients expert advice and guidance in the assessment and application of GHS globally, including comprehensive knowledge of classification criteria, SDS development and templates, and labeling requirements.  Lara Hall, M.S., RQAP GLP, has a wide array of technical and quality assurance experience well-suited to assisting clients in the development of effective testing strategies and ensuring scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide. Sheryl Dolan assists clients with chemical notification and submission support, compliance counseling, management system support, auditing, and testing placement. Kathleen Roberts, an affiliate of Acta, is a well-recognized expert on chemical control regulations, and is highly regarded as a leader in domestic and international science and policy program management for industry groups engaged in legislative and regulatory advocacy, research, and public outreach and communications.  Molly Blessing assists with dossier preparation and data assessment for chemical product approval under global chemical control programs. She is experienced with assessing chemicals for risk of regulation to help companies minimize business risk from manufacture or use of hazardous products and processes.  Heather Collins, M.S., has an extensive project management background developing and managing Environmental Health and Safety (EHS) compliance matters. She has managed global product safety and hazard communication groups and established training programs to ensure applicable laws and regulations were followed, while supporting new chemical submissions. 
 
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

 
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