International Regulatory Affairs
In today's global marketplace, an understanding of international trade, foreign laws and regulations, and international standards is a must. Members of Keller and Heckman's international regulatory affairs practice group have extensive experience in helping clients understand how foreign laws and regulations, international trade agreements, and standard setting organizations affect their interests, and in advocating on their behalf to promote open markets across a diverse array of governmental, quasi-governmental and private organizations. By combining a thorough understanding of trade and regulatory policymaking with a technical knowledge of diverse laws and regulations, we successfully promote our clients' interests in the global marketplace.
Global marketers must deal not only with traditional trade issues such as customs duties, but also with an array of complex laws that can affect market access around the world. For example, product standards, package labeling requirements, environmental protection mandates, privacy laws and other international, regional or national regulations can effectively restrict a client's ability to conduct business in international markets. We assist clients in developing global best practices and other strategies to effectively respond to these requirements, calling on the experience and knowledge of our other practice groups and our scientific and technical staff as needed.
Keller and Heckman attorneys are experienced in handling food, drug, cosmetic and commodity issues, as well as environmental and chemical control issues involving the U.S. government, European Union, Eastern and Central Europe and other trading blocs, the World Trade Organization, and various committees of the Codex Alimentarius Commission, as well as in counseling clients on how to comply with technical product regulatory requirements in these as well as Pacific Rim, mid-Eastern and Mercosur countries. We also have experience in employing the principle of free movement of goods (mutual recognition), as embodied in articles 30 and 36 of the Treaty of Rome and to assist clients in finding alternative routes to market products internationally that they could not otherwise place in certain national markets.
Since 1992, Keller and Heckman clients conducting business in the European Union have been assisted by attorneys in the firm's Brussels office who are actively involved in issues relating to the integration of the regulatory regimes of the European Union. Our knowledge of the internal workings of the EU institutions enables us to guide clients through the complex EU regulatory system and advise clients regarding the applicability of EU legislation to their products and materials. Our attorneys enjoy a close working relationship with the European Institutions, through daily contacts with officials in the European Commission, the European Parliament, and the Council. Moreover, given that the harmonization of the laws of the Member States remains incomplete in many areas, our attorneys also advise our clients on the applicability of national legislation to their products and materials and, to that end, have developed extensive contacts with national authorities. Our attorneys also have more than 10 years of regular contact with Eastern and Central European authorities to advise them on harmonizing their legislation with that of the EU, and are therefore uniquely positioned to help our clients identify and address legal and regulatory challenges and opportunities in the forthcoming enlargement of the European Union to 13 more Member States.
To meet the rising demand for global regulatory advice in Asia, Keller and Heckman opened an office in Shanghai in December 2004. Our Shanghai office provides advice to clients on the intricacies of international regulations in the areas of foods, food packaging, drugs, dietary supplements, medical devices, pesticides and industrial and fine chemicals. We assist clients with the legal status of ingredients in products; the effects of local Asian standards; the necessity for pre-market clearance and how to obtain it; regulation of labeling, nutrition and health claims; advertising; hygiene and inspection requirements; and import/export certifications. Many of our lawyers firmwide have built relations over the years with various government officials, industry associations, and market research and financial firms. The firm is also a member of the Chinese Food Additives Association, the International Life Sciences Institute Focal Point in China, and the American Chamber of Commerce in Shanghai.
Following are examples of the issues handled by our International Regulatory Affairs Group:
- Advise corporate clients on the full spectrum of global food legislation, including the regulation of food additives, novel food and novel food ingredients, food for particular nutritional uses and food supplements, fortified foods, the labeling of foodstuffs and food additives, food irradiation, and the rules applicable to the control and hygiene of foodstuffs;
- Assist clients in developing lists of product ingredients acceptable for use internationally;
- Prepare, submit, and obtain agency clearance for the use of food additives, novel foods, and novel food ingredients, both at EU and national levels;
- Advise clients on the status of ingredients, processing aids, and finished products (including labeling) under all of the Asian regulatory schemes;
- Advise on food labeling, GMO labeling, product claims, nutrition labeling, and advertising issues for all types of food products;
- Advise dietary supplement, nutraceutical, and functional food companies on whether registration or prior approval is need under Asian regulatory systems, and if so, how to obtain it; and
- Advise on compliance issues, including good manufacturing practice requirements and product recalls.
- Monitor policies on food-contact regulation and furnish legislative and strategic analysis on all food-packaging issues under U.S. laws, the laws of the EU and of the Member States, Canada, Asia, and other regions around the world, including Pacific Rim and Mercosur countries;
- Provide opinions on the status and compliance of food packaging materials, including plastics, coatings, paper and paperboard, rubber, and substances used in these materials under the relevant laws;
- Obtain clearances for substances used in the manufacture of food-contact materials;
- Obtain clearances for the use of recycled plastics and other materials in contact with foodstuffs and advise on the necessary data requirements to obtain these clearances; and
- Advise on product certificates, record keeping, and traceability issues.
- Submit comments to the International Trade Commission regarding the non-tariff trade barriers imposed by mandatory bioengineered labeling requirements;
- Provide comments on developing food industry strategies and biotech-related legislative and regulatory initiatives in international markets, including Canada, Mexico, Chile, Brazil, the European Union, Japan, Australia, New Zealand, Indonesia, Hong Kong, Saudi Arabia, and Kuwait; and
- Track international regulatory, scientific, and judicial developments regarding biotechnology for clients.
Drugs, Medical Devices, and Cosmetics
- Obtain marketing authorizations for medicinal products;
- Advise on the compositional and labeling requirements applicable to excipients, active drug ingredients, and packaging materials for medicinal products;
- Establish the status of monographs for drug ingredients and determining the compliance of given substances with existing monographs;
- Provide opinions on the proper classification of finished medical devices and on the conformity assessment procedures and other applicable requirements;
- Determine the classification of a product as a cosmetic, a drug, or a foodstuff based on product claims and other criteria; and
- Determine the labeling and compositional requirements applicable to cosmetic products.
- Determine data requirements, prepare testing protocols, and prepare dossiers for the notification of new chemical substances and preparations to the government agencies that administer chemical control laws and regulations;
- File petitions and exemptions for the authorization of research and development programs on chemical substances pending their notification;
- Advise on the marketing of "hazardous chemicals" and on the importation or exportation of "dangerous substances";
- Advise on the development of the REACH legislation and on conducting audits to prepare for the requirements of REACH;
- Prepare (or review) and submit new chemical notifications as well as exemption filings in the U.S., EU, Canada, Japan, Australia, and China, among others;
- Conduct negotiations with governmental authorities regarding new chemical testing requirements, protocols, the use of surrogate data, and waiver justifications in Canada, Europe, Asia, and Australia;
- Prepare and shepherd bona fide inquiries of national inventories including China, EU, and the U.S. and apply for TSCA Inventory corrections; and
- Determine whether polymers are grandfathered on the European Inventory of New and Existing Chemical Substances (EINECS) and the Chinese inventory.
- Evaluate the legal requirements applicable to the production, supply, and use of ozone-depleting substances and of equipment containing such substances and their impact on particular substances and equipment;
- Monitor the legislation on ozone-depleting substances and global warming adopted at international and national levels, particularly in the EU member states, U.S., and Canada;
- Identify the hazardous character of waste and counsel on the requirements regarding the treatment, storage, shipment, and disposal of hazardous waste;
- Provide opinions on the labeling of packaging and the requirements pertaining to the management, collection, reuse, recovery, and recycling of packaging waste and on the marketing and importation of packaging materials; and
- Advise clients on extended producer responsibility, integrated product policy, and related initiatives.
Privacy and Internet
- Provide comments on regional and national privacy laws;
- Draft global privacy policies;
- Counsel clients on global best practices for data privacy and security, including children's, consumer, and HR data;
- Provide opinions on the impact of proposed legal instruments on data collection and transfer activities; and
- Advocate sensible self-regulatory and legal frameworks to protect consumers online.
Advertising and Marketing
- Counsel clients on national and regional legal and self-regulatory requirements applicable to advertising, promotional, and marketing activities;
- Provide comments on various legal instruments, such as the proposed European regulation on sales promotions and revisions to the Television Without Frontiers Directive;
- Participate in advertising self-regulation initiatives; and
- Counsel clients on global strategies.
Other Regulatory Practices
- Determine the technical standards applicable to electrical or electromagnetic equipment, machinery, toys, and other industrial or consumer products;
- Monitor new restrictions on the advertising of products by different audio-visual means;
- Monitor legislation in the telecommunications and audio-visual sectors having an impact on our clients' products and services;
- Negotiate and draft transportation contracts for motor carriage services;
- Assist clients in managing their trademark portfolios worldwide; and
- Monitor corporate responsibility initiatives and assist clients in developing policy positions on corporate responsibility and implementing those initiatives.
Keller and Heckman's international regulatory affairs practice group has legal, technical, practical, political, and scientific experience in a broad range of international issues. From offices in the United States, Europe, and Asia, we help our clients identify and address legal and regulatory challenges in this fast-paced, ever changing global economy.