Steptoe's global chemical regulation practice covers the United States, European Union, and China. With offices in these three key jurisdictions, our clients are able to seamlessly benefit from Steptoe's knowledge of their products and issues globally. Through our longstanding work for the chemical industry, we have built a reputation for constructive dialogue with regulators, policy makers, legislators, and enforcement authorities, including regulatory advocacy before the EPA and other US agencies, the European Commission and EU agencies, and national competent authorities.
Steptoe also provides exceptional regulatory litigation capability, concentrating on challenges to regulations, enforcement defense, and preemption before US appellate and trial courts as well as administrative agencies. We help clients integrate regulatory, litigation, and government relations strategies to optimize results.
We represent and advise clients who manufacture, import, distribute, use, and transport products on a broad spectrum of regulatory programs and policy including:
- REACH/CLP (including China & Korea REACH)
- Toxic Substances Control Act (TSCA)
- Antimicrobials & biocides
- Agrochemicals
- Chemicals in consumer products and children’s products
- Nanotechnology
- California's multiple programs applicable to chemicals and products
- Consortium, data rights, & trade association management
- Emerging cannabis regulations
- Occupational Health & Safety Act (OSHA)
We cover the complete lifecycle of chemical regulation:
Regulatory Requirements
- Pre-market authorization and re-authorization of products
- Data valuation, sharing and compensation negotiations, and arbitrations (for mandatory and voluntary data sharing)
- Export and import requirements (including the Prior Informed Consent requirements under the Rotterdam Convention)
- Data requirements (regulatory negotiation) and risk assessment
- Classification, labeling, and marketing requirements
- Testing requirement implementation
- Maximum residue limits/tolerances
Commercial Issues
- Task force and consortia establishment, management, and antitrust compliance
- Letters of access
- Supply agreements
- Commercial due diligence for acquisitions and divestitures
Compliance, Enforcement & Litigation
- Regulatory challenges
- Environmental liabilities
- Enforcement defense
- Compliance audits and non-compliance response strategies
- Strategic advocacy
- International trade issues
Noteworthy
- Legal 500 US, Environment: Litigation (2017-2021)
Steptoe has the largest dedicated EU chemical and environment regulatory practice in Brussels, consistently ranked in the top tier for chemicals and environment work by legal directories. Chambers Europe recently declared Steptoe's environmental capabilities to be "stellar." Our EU team's work concerns chemicals regulation, mainly: REACH, biocides, agrochemicals, food contact materials, classification, labelling, packaging, and nanomaterials, as well as the regulation of chemicals in a range of consumer products such as cosmetics, toys, disinfectants, medical devices, etc.
We have been active in all these areas since the respective EU regimes were first proposed and worked at all stages of their implementation. The size and depth of experience of our EU team enables us to meet the requirements of our clients promptly, whilst ensuring a consistently high quality end product.
We are lawyers, scientists, and policy advisers who serve clients with an in-depth legal, scientific, and technical knowledge of the requirements. Our practice achieved success in proceedings related to EU chemical and environmental regulation before the European courts (Court of Justice of the EU and EU General Court); the Board of Appeal (BoA) of the ECHA; and preliminary references from national courts. Our litigation docket, the largest in Brussels with unparalleled track record of success, includes primarily REACH-related disputes (on substance and dossier evaluation, SVHC listings and restrictions, data sharing, etc.), biocides (data sharing), agrochemicals, and requests for access to confidential business information.
Steptoe's Washington-based US practice interacts daily with the EPA to assist clients in a broad range of issues that arise under US chemical regulations. In particular, our practitioners assist clients with TSCA regulatory and litigation matters, including compliance assistance and enforcement defense. We are at the forefront of the developing issues under TSCA, including the implementation of key elements of the Lautenberg Chemical Safety Act (LCSA), PMN requirements, and implications of non-animal testing requirements under Section 4. We have longstanding experience in nanotechnology regulation in the US, EU, and China; as well as data generation protection. Steptoe has substantial experience in assisting clients on a wide array of issues arising under TSCA, including TSCA compliance audits and self-reporting of TSCA violations; Section 8(a), (d), and (e) recordkeeping and reporting requirements; Section 5 Significant New Use Rules (SNUR); TSCA exemptions; the interface among TSCA, FIFRA, and FFDCA regulation for multi-use products; the use of REACH data under TSCA; TSCA preemption; and CDR Rule.
Steptoe professionals interact daily with the EPA Office of Pesticide Programs (OPP), regularly working together with the OPP Antimicrobials, Registration, and BioPesticides divisions to guide applications through EPA's application/registration and amendment processes. We assist companies, groups of companies, and trade associations in addressing the broad range of issues that arise under US pesticide regulation, such as FIFRA, the powerful regulatory statute applicable to all pesticides, and the relationship to FFDCA and allowable residue levels of pesticides on certain foods. We also assist clients with re-registrations and registration review, data requirements and data call-ins, data compensation, regulatory development and policy, and enforcement and compliance audits.
Agrochemicals for crop protection and pest management have been a core part of our practice for more than 25 years, and Steptoe is counsel to companies supporting some of the most high profile agrochemical products on the market. We also advise regional and international trade associations operating in the agribusiness sector. The details of the regimes we work in differs in each jurisdiction and our clients turn to us regularly for strategic guidance and support.
Our California team includes dedicated professionals active in San Francisco and Los Angeles where we are able to assist our clients with a broad range of California specific regulations, including California's Safe Drinking Water and Toxic Enforcement Act (Proposition 65), California's Safer Consumer Products Law (Green Chemistry Initiative), SB-258 Cleaning Products Right to Know Act of 2017, California Organic Products Act (COPA), and California medical waste regulation.
Steptoe advises multinational companies on interpreting and ensuring compliance with the challenging and increasingly high profile Chinese regulatory systems for hazardous chemicals, China REACH, biocides, food safety, and cosmetics. As Chinese regulatory reforms continue, Steptoe combines in-house technical knowledge and deep experience with global regulatory regimes to advise our international clients and to assist our clients in creatively overcoming regulatory and market challenges in China. Steptoe’s presence in Beijing enables us to assist our clients in Chinese regulatory development and implementation.
Steptoe is also working on projects relating to the emerging regulation of antimicrobials and biocides. In both the food contact and non-food contact categories, we are uniquely positioned with the most up to date information on changing regulatory and technical requirements. In the consumer products category, Steptoe can determine if a product requires registration or approval and if it contains restricted or banned substances, register products and ingredients as necessary, and review labeling to ensure compliance with Chinese GHS requirements.
News & Publications
Media Mentions
Chemical Watch Quotes Michael Boucher on Industry Groups Challenging TSCA Reporting Rule
April 8, 2025
Regulatory Pulse: Chemicals and Sustainability Newsletter
Welcome to the Inaugural Issue of Regulatory Pulse: Chemicals and Sustainability Newsletter
April 8, 2025
Publications
The new EU Packaging and Packaging Waste Regulation and its application in Northern Ireland
April 2, 2025
Publications
Environment & Climate Change Laws and Regulations 2025
International Comparative Legal Guides
March 2025
Media Mentions
The ENDS Report Quotes Tom Gillett in Article About UK REACH Work Programme
March 25, 2025
Client Alerts
United States v. Regeneron: Where "But-For" Art Thou, Romeo?
March 14, 2025
By: Ciara Davis, Patrick F. Linehan, Nicholas P. Silverman, Kane Smith
Regulatory Pulse: Pharma and Medical Devices Newsletter
Regulatory Pulse Pharma and Medical Devices Newsletter: Issue #2
March 2025
Media Mentions
March 6, 2025
Events
Webinars
Oxidative Substances Coalition - Introductory Session
May 15, 2025
Speaker: Eléonore Mullier
Webinars
EU Omnibus Proposal: Proposed Changes to the Sustainability Requirements
March 27, 2025
Speakers: Ruxandra Cana, Jonathan C. Drimmer, Eléonore Mullier
Webinars
Food Contact Regulation: What to Expect in 2025 with the Change in Administration
March 18, 2025
Speakers: Joan Baughan, Joseph Dages, Daniel C. Rubenstein
Webinars
PFAS Litigation in the US and the EU:
February 4, 2025
Speakers: Anthony G. Hopp, Eléonore Mullier, George Desh
Seminars & Events
EU Chemicals and Sustainability Conference
November 13, 2024
Speakers: Eléonore Mullier, Ruxandra Cana, Michael Boucher, Dennis Raglin
Webinars
Consumer Products and Chemicals with Scary Names: Know the Legal Risks and How to Manage Them
November 6, 2024
Speakers: Anthony J. Anscombe, Joseph Dages, Jessica Cooper, Ph.D.
Seminars & Events
Chemical Reactions: UK Chemicals Conference
September 24, 2024
Speakers: Darren Abrahams, Tom Gillett, Zanda Romata
Webinars
Part Two - REACH Improvement Proposals on Restrictions, Agency Reporting, Animal Testing and More
June 11, 2024
Speakers: Darren Abrahams, Tom Gillett
Resources
Biocides News & Briefs
Endocrine Disruptors: Confronting the New Criteria
November 15, 2017
Biocides News & Briefs
Harmonising the Process for Biocidal Products Authorisations
May 30, 2017
By: Darren Abrahams
Biocides News & Briefs
Adoption of Endocrine Disruptor Criteria: Plain Sailing Ahead?
ChemicalWatch
August 31, 2016
By: Darren Abrahams
Biocides News & Briefs
Biocides and the Board of Appeal: A First Assessment
ChemicalWatch
April 9, 2016
By: Darren Abrahams
Biocides News & Briefs
Masterbatches Under the BPR: A Riddle Resolved?
ChemicalWatch
January 8, 2016
By: Darren Abrahams