The Federal Law for the Protection of Industrial Property, in force since the 5th of November of 2020, is distinguished from its predecessor, among other things, by the particularities in the claims of a compensation for damages caused by the infringement of industrial property rights.
Currently, individuals may claim a compensation for damages through the administrative venue, before the Mexican Institute of Industrial Property (IMPI), or through the civil venue before the corresponding Courts in the matter. This implies that the holder of infringed exclusive rights may opt for two procedures and authorities of different nature, which has its benefits and disadvantages.
Before the IMPI, the compensation action is exercised in an ancillary proceeding, provided that such authority has previously issued a declaration of administrative infringement that is enforceable. Alternatively, it is still possible for the action to be brought directly before the Civil Courts, once the resolution from IMPI is final.
Although the exercise of the action for compensation before the administrative authority implies that a specialized authority in the matter is to hear the case, it has the disadvantages that its ancillary proceeding requires the prior prosecution of an administrative infringement claim before the same administrative authority (IMPI) and the lack of experience to quantify damages and losses. Additionally, the time required for the enforcement of the resolution issued by the IMPI before the Federal Courts in Civil Matters must be added to the time required for the substantiation of the action.
Thanks to the entry into force of the new Law, individuals may also resort directly to the civil Courts to claim infringement of their industrial property rights and compensation for damages, without the need for a prior declaration of infringement by the IMPI. This implies that a Judge, an expert in civil law, will have to delve into complex, specialized and technical issues, specific to industrial property.
Additionally, it is provided that the proceeding of the civil action will be suspended if an invalidity claim is filed before the IMPI against the right basis the civil claim, as long as the administrative authority does not issue a final resolution to such nullity action. This counteracts the advantage of a civil proceeding whose resolution may be quicker than before IMPI.
The new landscape for the claim for damages requires a careful study of the particularities of each specific case to determine the suitability of each route, since this is influenced, among other factors, by the complexity, the sophistication of the counterparty, the causes and technical considerations of the violation caused, among others.
Cross-cultural differences and the misunderstandings that often arise from them play a powerful role in how businesses build relationships and conduct their commercial and legal affairs. At a time of expansive growth in transnational business, trade, and investment, a lack of knowledge about local culture, values, and customs in business and legal dealings are leading to ever more complex and tense international legal disputes.
As lawyers and arbitrators, it is critical to foster a deeper understanding of how cultural and emotional factors along with behavioral tendencies impact business decisions and the practice of arbitration worldwide. Addressing these issues in the context of business-to-business (B2B) relationships, a recent report by the International Chamber of Commerce, Jus Connect, and McCann Truth Central found that a new set of principles—based on emotional intelligence, cultural awareness, and cultural fluency—is required to create a cross-cultural playbook for arbitration and re-imagining dispute outcomes.
Global leaders surveyed said that arbitration is still the preferred way to resolve cross-border disputes over litigation. If a contract fails, 60% prefer arbitration to legal proceedings in a court. Overall, arbitration has increased significantly over the past decade, reaching an estimated $80 billion in 2022. Some 37,000 new cases were registered between 2018 and 2022, an increase of nearly 30% between 2013 and 2017. While this represents a mere fraction of the $121 trillion in international trade in 2022, arbitration is growing twice as fast as global trade as clients recognize the speed, efficiency, transparency, and flexibility it offers to resolve disputes compared to traditional litigation.
Cultural Miscues
In my travels as President of the ICC International Court of Arbitration, I have heard countless stories about the influence of cross-cultural differences on business and legal affairs, including arbitration. And with good reason: every country has unique and often contrasting attitudes about dispute resolution and misunderstanding them can add layers of difficulty during legal proceedings for both general counsel and arbitration lawyers.
Based on extensive interviews and quantitative data, the ICC report divides cultural attitudes and approaches into four generalized categories and suggests which countries fit into each one. The Innovative Explorer, for example, including France and Saudi Arabia, seeks collaboration and co-creation, looks for emotional chemistry, and tends to stretch goals. For their part, India and Nigeria can be seen as a Strategic Balancer, eager for collaboration and co-creation, along with emotional chemistry, and ready to stretch goals.
Brazil and Mexico are among the countries regarded as a Decisive Custodians, in that they tend to value structure and contracts as part of a more direct, yet discrete approach and in addition, prefer working with senior partners. Finally, as the name indicates, the Pragmatic Realist—including the U.K. and Switzerland—takes a reasoned and practical approach, with an appreciation for clear expectations meeting agendas, and giving parties a second chance.
These attitudes are reflected in the different approaches that countries have toward contracts. Some want a clear scope, set in stone. Others put more focus on outcomes and fluidity in delivery. For instance, while Mexico and Brazil prefer structured approaches in contract agreements, India and Saudi Arabia are open to collaboration and co-creation in a scope of work. France and China prefer to stretch sometimes-unrealistic goals, but India and Nigeria, want realistic and achievable ones.
Chameleon U.S.
Digging deeper into the analysis shows that in some ways, the U.S. has a lot in common with Brazil and China when considering the role of hierarchy and discretion in a business situation. If someone in business makes a mistake, Americans prefer to promptly resolve disputes, even if a party might get offended and are also unlikely to copy their boss on an email.
These categories help explain many business decisions and actions and can guide teams to recognize and overcome cultural differences. But they don’t always tell the whole story: cultural nuances add even more complexity to cross-border business and legal dealings.
The U.S., for example, can be described as a chameleon or shapeshifter that doesn’t always neatly fit any descriptor. In my experience, U.S. business representatives will typically revise their approach depending on what the customer or counterparty needs. This flexibility is likely due to the presence of diverse and multicultural U.S. business teams compared to some other countries. As one senior arbitrator said in the report, “In the U.S., the common denominator is understanding what the customer needs.”
Small Behavior, Big Impact
Mapping the world by culture rather than geographic positioning offers valuable insights that can improve cultural fluency and ensure that geography alone does not influence expectations and approaches. The report showed how small behaviors point to larger cultural priorities. Teams from France and Saudi Arabia don’t necessarily need an agenda to attend a meeting, but those from India and Nigeria would usually prefer a detailed agenda. Acknowledging these cultural differences, however small and seemingly inconsequential, provides a framework for anticipating and resolving friction and helping teams adapt.
One of the most interesting aspects of the study is that business teams and leaders say they want lawyers involved earlier in the B2B process—and more deeply integrated into the journey—with a focus on win-win outcomes. This is consistent with the changing role of in-house counsel, particularly in the U.S., where in house counsel work more closely with business teams to develop strategy and structure the deal. Given the growing complexity of today’s global regulatory environment, business teams can no longer negotiate the deal first and then bring the terms to the in-house team to document.
While the study focused on cultural differences, it also found a commonality across cultures: a growing preference for non-legal dispute resolution. Some 77% favored an amicable, interest-based resolution—through internal or contract review, or direct negotiations between legal teams—compared to 52% favoring a rights-based resolution using arbitration or legal proceedings in a court. Only about one-third chose a so-called power-based resolution, such as a canceled contract, a report to a regulator, a post on social media, or a leak to the press.
Key Truths
Understanding the diverse world of business culture reveals several truths about B2B relationships. One is that emotion and culture have a significant impact on business—perhaps more than many realize—because the B2B journey comprises the human experience. Contrary to the commonly held perceptions that B2B interactions are largely transactional or purely functional, and free of emotions, the report found that they are emotionally charged, from initial engagement with parties and contracts to long-term partnerships.
I have experienced this firsthand when representing a multinational company in a very complex arbitration involving the calculation of damages. I needed to prepare the CEO for cross-examination. Yet his analysis was not entirely data-driven decision-making: emotions were also a big part of his thinking. When describing his approach and his meeting with his CEO counterpart, he just kept telling me, “This is so emotional.”
Another truth is that by effectively navigating cultural differences and overcoming communication barriers, we can improve business relationships. In this context, business attitudes toward particulars such as contracts and meeting styles reflect cultural priorities and offer relevant cultural cues. At first, these may appear to be minor details but unveil deeper cultural attitudes concerning hierarchy, orderliness, adaptability, and creativity.
When I was in China earlier this year, I was surprised by the number of back-channel conversations that took place to determine how many people we could bring to a meeting and the level of seniority so that the Chinese delegation would have the same. There were also discussions about attire—including whether men should wear a tie—so that nobody would feel out of place.
Cross-Cultural Playbook
With these truths in mind, a new cross-cultural playbook for global arbitration should include the following actions. First, integrate legal teams as early as possible into the process and keep them engaged via partnerships with business teams. Train teams to understand emotional intelligence and be more culturally aware so they can become more adept at relationship building and managing shifting emotions during the B2B journey. Ensure teams can interpret subtle behavioral and cultural cues to make informed decisions and improve communications. Equally important, prioritize direct negotiation channels for dispute resolution, reserving legal action for failed negotiations.
More than ever, we must emphasize the role of emotion and human interaction in business and how important it is in building trust: the report noted that half of all B2B disputes are likely caused by the breakdown of human interaction rather than solely by contractual issues. With heightened sensitivity to cultural differences, we can better understand the complexities of the B2B journey, minimize business and legal disputes, and successfully apply these truths to resolving conflicts through arbitration.
This series will examine the issues stakeholders need to consider in connection with deep-sea mining. We first provide an introduction to deep-sea mining and its current status. Future articles will consider in greater detail the regulatory and contractual landscape, important practical considerations, and future developments, including decisions of the ISA Council.
POLYMETALLIC NODULES
Current technology for the generation of wind and solar power (as well as the batteries needed to store such power) requires scarce raw materials, including nickel, manganese, cobalt, and copper. The fact that these minerals are found in the millions of polymetallic nodules scattered on areas of the ocean floor gives rise to another debate on whether the deep-sea mining of these nodules should be pursued.
This issue attracted considerable attention over the summer of 2023, when the International Seabed Authority (ISA) Assembly and Council held its 28th Session and, in January 2024, when Norway’s parliament (the Storting) made Norway the first country to formally authorise seabed mining activities in its waters.
INTERNATIONAL REGULATION OF DEEP-SEA MINERALS: UNCLOS AND ISA
The United Nations Convention on the Law of the Sea (UNCLOS) provides a comprehensive regime for the management of the world’s oceans. It also established ISA.
ISA is the body that authorises international seabed exploration and mining. It also collects and distributes the seabed mining royalties in relation to those areas outside each nation’s exclusive economic zone (EEZ).
Since 1994, ISA has approved over 30 ocean-floor mining exploration contracts in the Atlantic, Pacific, and Indian oceans, with most covering the so-called ‘Clarion-Clipperton Zone’ (an environmental management area of the Pacific Ocean, between Hawaii and Mexico). These currently-approved contracts run for 15 years and permit contract holders to seek out (but not commercially exploit) polymetallic nodules, polymetallic sulphides, and cobalt-rich ferromanganese crusts from the deep seabed.
UNCLOS TWO-YEAR RULE AND ISA’S 28TH SESSION
Section 1(15) of the annex to the 1994 Implementation Agreement includes a provision known as the “two-year rule.” This provision allows any member state of ISA that intends to apply for the approval of a plan of work for exploitation of the seabed to request that the ISA Council draw up and adopt regulations governing such exploitation within two years.
In July 2021, the Republic of Nauru triggered the two-year rule, seeking authority to undertake commercial exploitation of polymetallic nodules under license. That set an operative deadline of 9 July 2023.
At meetings of the ISA Assembly and ISA Council in July 2023, the ISA Council determined that more time was needed to establish processes for prospecting, exploring, and exploiting mineral resources, and a new target was set for finalising the rules: July 2025.
The expiration of the two-year rule in July 2023 does allow mining companies to submit a mining license application at any time. However, the above extension gives the ISA Council direct input into the approval process, which will make approval of any application difficult.
NORWAY’S DEEP-SEA MINING PLAN
State legislation regulates deep-sea mining in different EEZs. Norway is one of the only countries that has its own legislation (the Norway Seabed Minerals Act of 2019) regulating the exploration and extraction of deep-sea minerals.
In December 2023, Norway agreed to allow seabed mineral exploration off the coast of Norway, ahead of a formal parliamentary decision. The proposal was voted 80-20 in favour by the Storting on 9 January 2024.
The proposal will permit exploratory mining across a large section of the Norwegian seabed, after which the Storting can decide whether to issue commercial permits.
The decision initially applies to Norwegian waters and exposes an area larger than Great Britain to potential sea-bed mining, although the Norwegian government has noted that it will only issue licenses after more environmental research has been done.
The Norwegian government has defended the plan as a way to seize an economic opportunity and shore up the security of critical supply chains. However, there is concern that this will pave the way towards deep-sea mining around the world. Green activists, scientists, fishermen, and investors have called upon Oslo to reconsider its position. They cite the lack of scientific data about the effects of deep-sea mining on the marine environment, as well as the potential impact on Arctic ecosystems. In November 2023, 120 European Union lawmakers wrote an open letter to Norwegian members of the Storting, urging them unsuccessfully to reject the project, and in February 2024, the European Parliament voted in favour of a resolution that raised concerns about Norway’s deep-sea mining regulations. This resolution carries no legal power, but it does send a strong signal to Norway that the European Union does not support its plans.
In May 2024, WWF-Norway announced it will sue the Norwegian government for opening its seabed to deep-sea mining. WWF-Norway claim that the government has failed to properly investigate the consequences of its decision, has acted against the counsel of its own advisors, and has breached Norwegian law.
METHODS OF POLYMETALLIC NODULE EXTRACTION
Should Norway, or any other nation, initiate commercial deep-seabed mining, one of the following methods of mineral extraction may be employed:
Continuous Line Bucket System
This system utilises a surface vessel, a loop of cable to which dredge buckets are attached at 20–25 meter intervals, and a traction machine on the surface vessel, which circulates the cable. Operating much like a conveyor belt, ascending and descending lines complete runs to the ocean floor, gathering and then carrying the nodules to a ship or station for processing.
Hydraulic Suction System
A riser pipe attached to a surface vessel “vacuums” the seabed, for example, by lifting the nodules on compressed air or by using a centrifugal pump. A separate pipe returns tailings to the area of the mining site.
Remotely Operated Vehicles (ROVs)
Large ROVs traverse the ocean floor collecting nodules in a variety of ways. This might involve blasting the seafloor with water jets or collection by vacuuming.
Recent progress has been made in the development of these vehicles; a pre-prototype polymetallic nodule collector was successfully trialed in 2021 at a water depth of 4,500 metres, and in December 2022, the first successful recovery of polymetallic nodules from the abyssal plain was completed, using an integrated collector, riser, and lift system on an ROV. A glimpse of the future of deep-sea ROVs perhaps comes in the form of the development of robotic nodule-collection devices, equipped with artificial intelligence that allows them to distinguish between nodules and aquatic life.
Key to all three methods of mineral extraction is the production support vessel, the main facility for collecting, gathering, filtering, and storing polymetallic nodules. Dynamically positioned drillships, formerly utilised in the oil and gas sector, have been identified/converted for this purpose, and market-leading companies active in deep-water operations, including drilling and subsea construction, are investing in this area. It will be interesting to see how the approach to the inherent engineering and technological challenges will continue to develop.
THE RISKS OF DEEP-SEA MINING
As a nascent industry, deep-sea mining presents risks to both the environment and the stakeholders involved:
Environmental Risks
ISA’s delayed operative deadline for finalising regulations has been welcomed by parties who are concerned about the environmental impact that deep-sea mining may have.
Scientists warn that mining the deep could cause an irreversible loss of biodiversity to deep-sea ecosystems; sediment plumes, wastewater, and noise and light pollution all have the potential to seriously impact the species that exist within and beyond the mining sites. The deep-ocean floor supports thousands of unique species, despite being dark and nutrient-poor, including microbes, worms, sponges, and other invertebrates. There are also concerns that mining will impact the ocean’s ability to function as a carbon sink, resulting in a potentially wider environmental impact.
Stakeholder and Investor Risks
While deep-sea mining doesn’t involve the recovery and handling of combustible oil or gas, which is often associated with offshore operations, commercial risks associated with the deployment of sophisticated (and expensive) equipment in water depths of 2,000 metres or greater are significant. In April 2021, a specialist deep-sea mining subsidiary lost a mining robot prototype that had uncoupled from a 5-kilometer-long cable connecting it to the surface. The robot was recovered after initial attempts failed, but this illustrates the potentially expensive problems that deep-sea mining poses. Any companies wishing to become involved in deep-sea mining will also need to be careful to protect their reputation. Involvement in a deep-sea mining project that causes (or is perceived to cause) environmental damage or that experiences serious problems could attract strong negative publicity.
INVESTOR CONSIDERATIONS
Regulations have not kept up with the increased interest in deep-sea mining, and there are no clear guidelines on how to structure potential deep-sea investments. This is especially true in international waters, where a relationship with a sponsoring state is necessary. Exploitative investments have not been covered by ISA, and it is unclear how much control investors will have over the mining process. It is also unclear how investors might be able to apportion responsibility for loss/damage and what level of due diligence needs to be conducted ahead of operations. Any involvement carries with it significant risk, and stakeholders will do well to manage their rights and obligations as matters evolve.
As an accompaniment to our biweekly series on “What Every Multinational Should Know About” various international trade, enforcement, and compliance topics, we are introducing a second series of quick-hit pieces on compliance best practices. Give us two minutes, and we will give you five suggested compliance best practices that will benefit your international regulatory compliance program.
Conducting an international risk assessment is crucial for identifying and mitigating potential risks associated with conducting business operations in foreign countries and complying with the expansive application of U.S. law. Because compliance is essentially an exercise in identifying, mitigating, and managing risk, the starting point for any international compliance program is to conduct a risk assessment. If your company has not done one within the last two years, then your organization probably should be putting one in motion.
Here are five compliance checks that are important to consider when conducting a risk assessment:
Understand Business Operations: A good starting point is to gain a thorough understanding of the organization’s business operations, including products, services, markets, supply chains, distribution channels, and key stakeholders. You should pay special attention to new risk areas, including newly acquired companies and divisions, expansions into new countries, and new distribution patterns. Identifying the business profile of the organization, and how it raises systemic risks, is the starting point of developing the risk profile of the company.
Conduct Country- and Industry-Specific Risk Factors: Analyze the political, economic, legal, and regulatory landscape of each country where the organization operates or plans to operate. Consider factors such as political stability, corruption levels, regulatory environment, and cultural differences. You should also understand which countries also raise indirect risks, such as for the transshipment of goods to sanctioned countries. You also should evaluate industry-specific risks and trends that may impact your company’s risk profile, such as the history of recent enforcement actions.
Gather Risk-Related Data and Information: You should gather relevant data and information from internal and external sources to inform the risk-assessment process. Relevant examples include internal documentation, industry publications, reports of recent enforcement actions, and areas where government regulators are stressing compliance, such as the recent focus on supply chain factors. Use risk-assessment tools and methodologies to systematically evaluate and prioritize risks, such as risk matrices, risk heat maps, scenario analysis, and probability-impact assessments. (The Foley anticorruption, economic sanctions, and forced labor heat maps are found here.)
Engage Stakeholders: Engage key stakeholders throughout the risk-assessment process to gather insights, perspectives, and feedback. Consult with local employees and business partners to gain feedback on compliance issues that are likely to arise while also seeking their aid in disseminating the eventual compliance dictates, internal controls, and other compliance measures that your organization ends up implementing or updating.
Document Findings and Develop Risk-Mitigation Strategies: Document the findings of the risk assessment, including identified risks, their potential impact and likelihood, and recommended mitigation strategies. Ensure that documentation is clear, concise, and actionable. Use the documented findings to develop risk-mitigation strategies and action plans to address identified risks effectively while prioritizing mitigation efforts based on risk severity, urgency, and feasibility of implementation.
Most importantly, you should recognize that assessing and addressing risk is an ongoing process. You should ensure your organization has established processes for the ongoing monitoring and review of risks to track changes in the risk landscape and evaluate the effectiveness of mitigation measures. Further, at least once every two years, most multinational organizations should be updating their risk assessment periodically to reflect evolving risks and business conditions as well as changing regulations and regulator enforcement priorities.
WEBINAR – Registration Is Open For “Harmonizing TSCA Consent Orders with OSHA HCS 2012”: Register now to join The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) for “Harmonizing TSCA Consent Orders with OSHA HCS 2012,” a complimentary webinar covering case studies and practical applications of merging the requirements for consent order language on the Safety Data Sheet (SDS). In this webinar, Karin F. Baron, MSPH, Director of Hazard Communication and International Registration Strategy, Acta, will explore two hypothetical examples and provide guidance on practical approaches to compliance. An industry perspective will be presented by Sara Glazier Frojen, Senior Product Steward, Hexion Inc., who will discuss the realities of managing this process day-to-day.
SAVE THE DATE – “TSCA Reform — 8 Years Later” On June 26, 2024: Save the date to join Acta affiliate B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health for a day-long conference reflecting on the challenges and accomplishments since the implementation of the 2016 Lautenberg Amendments and where the Toxic Substances Control Act (TSCA) stands today. This year, the conference will be held in person at the George Washington University Milken Institute School of Public Health (and will be livestreamed via YouTube). Continuing legal education (CLE) credit will be offered in select states for in-person attendees only. Please check ELI’s event page in the coming weeks for more information, including an agenda, CLE information, registration, and more. If you have questions in the meantime, please contact Madison Calhoun (calhoun@eli.org).
AUSTRALIA
Changes To Categorization, Reporting, And Recordkeeping Requirements For Industrial Chemicals Will Take Effect April 24, 2024: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced regulatory changes to categorization, reporting, and recordkeeping requirements will start April 24, 2024. For the changes to take effect, the Industrial Chemicals (General) Rules 2019 (Rules) and Industrial Chemicals Categorisation Guidelines will be amended. According to AICIS, key changes to the Rules include:
Written undertakings replaced with records that will make compliance easier;
Greater acceptance of International Nomenclature of Cosmetic Ingredients (INCI) names for reporting and recordkeeping;
Changes to the categorization criteria to benefit:
Local soap makers;
Introducers of chemicals in flavor and fragrance blends; and
Introducers of hazardous chemicals where introduction and use are controlled; and
Strengthening criteria and/or reporting requirements for health and environmental protection.
AICIS announced final changes to the Industrial Chemicals Categorisation Guidelines that will take effect April 24, 2024. According to AICIS, the changes include:
Refinement of the requirement to check for hazardous esters and salts of chemicals on the “List of chemicals with high hazards for categorisation” (the List);
Provision to include highly hazardous chemicals to the List based on an AICIS assessment or evaluation;
Expanded options for introducers to demonstrate the absence of skin irritation and skin sensitization; and
More models for in silico predictions and an added test guideline for ready biodegradability.
AICIS states that it will publish a second update to the Guidelines in September 2024 due to industry stakeholders’ feedback that they need more time to prepare for some of the changes. It will include:
For the List: add chemicals based on current sources and add the European Commission (EC) Endocrine Disruptor List (List I) as a source; and
Refined requirements for introducers to show the absence of specific target organ toxicity after repeated exposure and bioaccumulation potential.
CANADA
Canada Provides Updates On Its Implementation Of The Modernized CEPA: As reported in our June 23, 2023, memorandum, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, received Royal Assent on June 13, 2023. Canada is working to implement the bill through initiatives that include the development of various instruments, policies, strategies, regulations, and processes. In April 2024, Canada updated its list of public consultation opportunities:
Discussion document on the implementation framework for a right to a healthy environment under the Canadian Environmental Protection Act, 1999 (CEPA) (winter 2024);
Proposed Watch List approach (spring/summer 2024);
Proposed plan of chemicals management priorities (summer 2024);
Draft strategy to replace, reduce or refine vertebrate animal testing (summer/fall 2024);
Draft implementation framework for a right to a healthy environment under CEPA (summer/fall 2024);
Discussion document for toxic substances of highest risk regulations (winter 2025); and
Discussion document on the restriction and authorization of certain toxic substances regulations (winter/spring 2025).
EUROPEAN UNION (EU)
ECHA Checks More Than 20 Percent Of REACH Registration Dossiers For Compliance: The European Chemicals Agency (ECHA) announced on February 27, 2024, that between 2009 and 2023, it performed compliance checks of approximately 15,000 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrations, representing 21 percent of full registrations. ECHA states that it met its legal target for dossier evaluation, which increased from five percent to 20 percent in 2019. ECHA notes that for substances registered at quantities of 100 metric tons or more per year, it has checked compliance for around 30 percent of the dossiers.
According to ECHA, in 2023, it conducted 301 compliance checks, covering more than 1,750 registrations and addressing 274 individual substances. ECHA “focused on registration dossiers that may have data gaps and aim to enhance the safety data of these substances.” ECHA sent 251 adopted decisions to companies, “requesting additional data to clarify long-term effects of chemicals on human health or the environment.” ECHA states that during the follow-up evaluation process, it will assess the incoming information for compliance. ECHA will share the outcome of the incoming data with the EU member states and the EC to enable prioritization of substances. ECHA will work closely with the member states for enforcement of non-compliant dossiers. Compliance of registration dossiers will remain a priority for ECHA. In 2024, ECHA will review the impact of the Joint Evaluation Action Plan, aimed at improving REACH registration compliance, and, together with stakeholders, develop new priority areas on which to focus. More information is available in our March 29, 2024, blog item.
Council Of The EU And EP Reach Provisional Agreement On Proposed Regulation On Packaging And Packaging Waste: The Council of the EU announced on March 4, 2024, that its presidency and the European Parliament’s (EP) representatives reached a provisional political agreement on a proposal for a regulation on packaging and packaging waste. The press release states that the proposal considers the full life-cycle of packaging and establishes requirements to ensure that packaging is safe and sustainable by requiring that all packaging is recyclable and that the presence of substances of concern is minimized. It also includes labeling harmonization requirements to improve consumer information. In line with the waste hierarchy, the proposal aims to reduce significantly the generation of packaging waste by setting binding re-use targets, restricting certain types of single-use packaging, and requiring economic operators to minimize the packaging used. The proposal would introduce a restriction on the placing on the market of food contact packaging containing per- and polyfluoroalkyl substances (PFAS) above certain thresholds. The press release notes that to avoid any overlap with other pieces of legislation, the co-legislators tasked the EC to assess the need to amend that restriction within four years of the date of application of the regulation.
EP Adopts Position On Establishing System To Verify And Pre-Approve Environmental Marketing Claims: The EP announced on March 12, 2024, that it adopted its first reading position on establishing a verification and pre-approval system for environmental marketing claims to protect citizens from misleading ads. According to the EP’s press release, the green claims directive would require companies to submit evidence about their environmental marketing claims before advertising products as “biodegradable,” “less polluting,” “water saving,” or having “biobased content.” Micro enterprises would be exempt from the new rules, and small and medium-sized enterprises (SME) would have an extra year to comply compared to larger businesses. The press release notes that the EP also decided that green claims about products containing hazardous substances should remain possible for now, but that the EC “should assess in the near future whether they should be banned entirely.” The new EP will follow up on the file after the European elections that will take place in June 2024.
On April 3, 2024, a coalition of industry associations issued a “Joint statement in reference to ‘the ban of green claims for products containing hazardous substances’ in the Green Claims Substantiation Directive (GCD).” The associations “fully support the principle that consumers should not be misled by false or unsubstantiated environmental claims and share the EU’s objective to establish a clear, robust and credible framework to enable consumers to make an informed choice.” The associations express concern that the proposed prohibition of environmental claims for products containing certain hazardous substances “will run contrary to the objective of the Directive to enable consumers to make sustainable purchase decisions and ensure proper substantiation of claims.” According to the associations, for a number of consumer products, “the reference to ‘products containing’ would encompass substances that would have intrinsic hazardous properties,” implying that there would be a ban of making any environmental claim(s), “even if such trace amounts of unavoidable and unintentional impurities and contaminants are present in these products.” The signatories include the International Association for Soaps, Detergents and Maintenance Products; the European Brands Association; APPLiA; the Association of Manufacturers and Formulators of Enzyme Products; CosmeticsEurope; the European Power Tool Association; the Federation of the European Sporting Goods Industry; the International Fragrance Association; LightingEurope; the International Natural and Organic Cosmetics Association; Toy Industries of Europe; Verband der Elektro- und Digitalindustrie; and the World Federation of Advertisers.
ECHA Clarifies Next Steps For PFAS Restriction Proposal: ECHA issued a press release on March 13, 2024, to outline how the Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will progress in evaluating the proposal to restrict PFAS in Europe. As reported in our February 13, 2023, memorandum, the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a proposal to restrict more than 10,000 PFAS under REACH. The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks. Following the screening of thousands of comments received during the consultation, ECHA states that it is clarifying the next steps for the proposal. According to ECHA, RAC and SEAC will evaluate the proposed restriction together with the comments from the consultation in batches, focusing on the different sectors that may be affected.
In tandem, the five national authorities who prepared the proposal are updating their initial report to address the consultation comments. This updated report will be assessed by the committees and will serve as the foundation for their opinions. The sectors and elements that will be discussed in the next three committee meetings are:
March 2024 Meetings
Consumer mixtures, cosmetics, and ski wax;
Hazards of PFAS (only by RAC); and
General approach (only by SEAC).
June 2024 Meetings
Metal plating and manufacture of metal products; and
More information is available in our March 18, 2024, blog item.
ECHA Adopts And Publishes CoRAP For 2024-2026: On March 19, 2024, ECHA adopted and published the Community rolling action plan (CoRAP) for 2024-2026. The CoRAP lists 28 substances suspected of posing a risk to human health or the environment for evaluation by 11 Member State Competent Authorities. The CoRAP includes 11 newly allocated substances and 17 substances already included in the previous CoRAP 2023-2025 update, published on March 21, 2023. For 11 out of these 17 substances, ECHA notes that the evaluation year has been postponed, mainly to await submission of new information requested under dossier evaluation. Of the 28 substances to be evaluated, ten are to be evaluated in 2024, 13 in 2025, and five in 2026. The remaining substance of the 24 substances listed in the previous CoRAP was withdrawn as its evaluation is currently considered to be a low priority. According to ECHA, for this substance, a compliance check is needed first. ECHA states that the substance can be placed in the CoRAP list again, if after the conclusion of the dossier evaluation process, concerns remain beyond what can be clarified through dossier evaluation. ECHA has posted a guide for registrants that need to update their dossiers with new relevant information such as hazard, tonnages, use, and exposure.
Comments On Proposals To Identify New SVHCs Due April 15, 2025: A public consultation on proposals to identify two new substances of very high concern (SVHC) will close on April 15, 2024. The substances and examples of their uses are:
Bis(α,α-dimethylbenzyl) peroxide: This substance is used in products such as pH-regulators, flocculants, precipitants, and neutralization agents; and
Triphenyl phosphate: This substance is used as a flame retardant and plasticizer in polymer formulations, adhesives, and sealants.
UNITED KINGDOM (UK)
HSE Publishes UK REACH Work Programme For 2023/24: In February 2024, the Health and Safety Executive (HSE) published its UK REACH Work Programme 2023/24. The Work Programme sets out how HSE, with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. Alongside these activities, HSE and the Environment Agency will engage with stakeholders. The Work Programme includes the following deliverables and target deadlines:
Topic
Deliverable
Target
Substance evaluation
Evaluate substances in the Rolling Action Plan (RAP)
Evaluate one
Authorization
Complete the processing of received applications within the statutory deadline (this includes comments from public consultation and REACH Independent Scientific Expert Pool (RISEP) input)
100 percent
SVHC identification
Undertake an initial assessment of substances submitted for SVHC identification under EU REACH during 2022/23 and consider if they are appropriate for SVHC identification under UK REACH
Assess up to five
Regulatory management options analysis (RMOA)
Complete RMOAs initiated in 22/23
Initiate RMOAs for substances identified as priorities
Up to ten
Up to five
Restriction
Complete ongoing restriction opinions
Begin Annex 15 restriction dossiers
Initiate scoping work for restrictions
Two
One
Two
HSE Opens Call For Evidence On PFAS In FFFs: HSE is working with the Environment Agency to prepare a restriction dossier that will assess the risks of PFAS in firefighting foams (FFF). HSE will propose restrictions, if necessary, to manage any significant risks identified. To help compile the dossier, HSE opened a call for evidence. HSE states that it would like stakeholders to identify themselves as willing to engage in further dialogue throughout the restrictions process. In particular, it would like to hear from stakeholders with relevant information on PFAS (or alternatives) in FFFs, especially information specific to Great Britain (GB). Regarding relevant information, HSE is interested in all aspects of FFFs, including:
Manufacture of FFFs: Substances used, process, quantities;
Import of FFF products of all types: Quantities, suppliers;
Use: Quantities, sector of use, frequency, storage on site, products used;
Alternatives to PFAS in FFF: Availability, cost, performance in comparison to PFAS-containing foams, barriers to switching;
Hazardous properties: SDSs, new studies on intrinsic properties and exposure, recommended risk management measures;
Environmental fate: What happens to the FFF after it is used, where does it go;
Waste: Disposal requirements, recycling opportunities, remediation; and
Standards: Including product-specific legislation, performance, certification.
HSE states that the call for evidence targets companies (manufacturers, importers, distributors, and retailers) and professional users of FFFs, trade associations, environmental organizations, consumer organizations, and any other organizations and members of the public holding relevant information. HSE intends to publish the final dossier, including any restriction proposals, on its website in March 2025. Interested parties will also then be able to submit comments on any proposed restriction.
New GB BPR Data Requirements Will Apply To Applications Submitted In October 2025:The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of the GB Biocidal Products Regulation (BPR), were laid in Parliament on March 13, 2024, and came into force on April 6, 2024. The legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties that previously relied on animal testing. HSE held a public consultation on the proposed changes in 2023 and has posted a report on the outcome of the consultation. The new data requirements will apply to applications received 18 months after the legislation came into force (October 6, 2025) and do not apply to existing applications. HSE will provide further guidance on the changes in the future.
Welcome to the UK Regulation Round Up, a regular bulletin highlighting the latest developments in UK and EU financial services regulation.
Key developments in March 2024:
28 March
FCA Regulation Round-up: The FCA published its regulation round-up for March 2024.
26 March
AIFMD II: Directive (EU) 2024/927 amending the Alternative Investment Fund Managers Directive (2011/61/EU) (“AIFMD”) and the UCITS Directive (2009/65/EC) (“UCITS Directive”) relating to delegation arrangements, liquidity risk management, supervisory reporting, provision of depositary and custody services, and loan origination by alternative investment funds has been published in the Official Journal of the European Union (“EU”). Please refer to our dedicated article on this topic here.
ELTIFs: The European Commission published a Communication to the Commission explaining that it intends to adopt, with amendments, ESMA’s proposed regulatory technical standards (“RTS”) under Regulations 9(3), 18(6), 19(5), 21(3) and 25(3) of the Regulation on European Long-Term Investment Funds ((EU) 2015/760) as amended by Regulation (EU) 2023/606.
Financial Promotions: The FCA published finalised guidance (FG24/1) on financial promotions on social media.
Cryptoassets: The Investment Association (“IA”) published its second report on UK fund tokenisation written by the technology working group to HM Treasury’s asset management taskforce.
25 March
Cryptoassets: ESMA published a final report (ESMA75-453128700-949) on draft technical standards specifying requirements for co-operation, exchange of information and notification between competent authorities, European Supervisory Authorities and third countries under the Regulation on markets in cryptoassets ((EU) 2023/1114) (“MiCA”).PRIIPS Regulation: the European Parliament’s Economic and Monetary Affairs Committee (“ECON”) published the report (PE753.665v02-00) it has adopted on the European Commission’s legislative proposal for a Regulation making amendments to the Regulation on key information documents (“KIDs”) for packaged retail and insurance-based investment products (1286/2014) (“PRIIPs Regulation”) (2023/0166(COD)).
Alternative Investment Funds: The FCA published the findings from a review it carried out in 2023 of alternative investment fund managers that use the host model to manage alternative investment funds.
AIFMD: Four Delegated and Implementing Regulations concerning cross-border marketing and management notifications relating to the UCITS Directive and the AIFMD have been published in the Official Journal of the European Union (here, here, here, and here).
22 March
Smarter Regulatory Framework: HM Treasury published a document on the next phase of the Smarter Regulatory Framework, its project to replace assimilated law relating to financial services.
21 March
Market Transparency: ESMA published a communication on the transition to the new rules under the Markets in Financial Instruments Regulation (600/2014) (“MiFIR”) to improve market access and transparency.
Retail Investment Package: ECON published a press release announcing it had adopted its draft report on the proposed Directive on retail investment protection (2023/0167(COD)). The proposed Directive will amend the MiFID II Directive (2014/65/EU) (“MiFID II”), the Insurance Distribution Directive ((EU) 2016/97), the Solvency II Directive (2009/138/EC), the UCITS Directive and the AIFMD.
19 March
ESG: The Council of the EU proposed a new compromise text for the Corporate Sustainability Due Diligence Directive, on which political agreement had previously been reached in December 2023.
FCA Business Plan: The FCA published its 2024/25 Business Plan, which sets out its business priorities for the year ahead.
15 March
Customer Duty: The FCA announced that it is to conduct a review into firms’ treatment of customers in vulnerable circumstances.
PRIIPS Regulation: The Joint Committee of the European Supervisory Authorities published an updated version of its Q&As (JC 2023 22) on the key information document requirements for packaged retail and insurance-based investment products (“PRIIPs”), as laid down in Commission Delegated Regulation (EU) 2017/653.
14 March
FCA Regulatory Approach: The FCA published a speech given by Nikhil Rathi, FCA Chief Executive, on its regulatory approach to deliver for consumers, markets and competitiveness and its shift to outcomes-focused regulation.
11 March
AML: HM Treasury launched a consultation on improving the effectiveness of the Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017 (SI 2017/692). The consultation runs until 9 June 2024 and covers four distinct areas.
08 March
ESG: The IA published a report on insights and suggested actions for asset managers following the commencement of reporting obligations of climate-related disclosures under the ESG sourcebook.
ESG: The House of Commons Treasury Committee published a report on the findings from its “Sexism in the City” inquiry.
Cryptoassets: The EBA published a consultation paper (EBA/CP/2024/09) on draft guidelines on redemption plans under Articles 47 and 55 of the MiCA.
AML: The FCA published a Dear CEO letter sent to Annex I financial institutions concerning common control failings identified in anti-money laundering (AML) frameworks.
ESG: The European Commission adopted a delegated regulation supplementing the Securitisation Regulation ((EU) 2017/2402) with regard to regulatory technical standards specifying, for simple, transparent and standardised non-ABCP traditional securitisation, and for simple, transparent and standardised on-balance-sheet securitisation, the content, methodologies and presentation of information related to the principal adverse impacts of the assets financed by the underlying exposures on sustainability factors.
CRD IV: The European Commission adopted a Commission Implementing Regulation that amends Commission Implementing Regulation (EU) 650/2014 containing ITS on supervisory disclosure under the CRD IV Directive (2013/36/EU) (“CRD IV”).
01 March
Alternative Investment Funds: The FCA published a portfolio letter providing an interim update on its supervisory strategy for the asset management and alternatives portfolios.
Corporate Transparency: The Economic Crime and Corporate Transparency Act 2023 (Commencement No. 2 and Transitional Provision) Regulations 2024 (SI 2024/269) have been made and published.
Financial Sanctions: The Treasury Committee launched an inquiry into the effectiveness of financial sanctions on Russia.
EMIR: The FCA published a consultation paperin which it, together with the Bank of England, seeks feedback on draft guidance in the form of Q&As on the revised reporting requirements under Article 9 of UK EMIR (648/2012).
FCA Handbook: The FCA published Handbook Notice 116 (dated February 2024), which sets out changes to the FCA Handbook made by the FCA board on 29 February 2024.
FCA Handbook: the FCA published its 43rd quarterly consultation paper (CP24/3), inviting comments on proposed changes to a number of FCA Handbook provisions.
Amar Unadkat, Sulaiman Malik & Michael Singh also contributed to this article.
After extensive negotiations, the European Parliament, Commission, and Council came to a consensus on the EU Artificial Intelligence Act (the “AI Act”) on Dec. 8, 2023. This marks a significant milestone, as the AI Act is expected to be the most far-reaching regulation on AI globally. The AI Act is poised to significantly impact how companies develop, deploy, and manage AI systems. In this post, NM’s AI Task Force breaks down the key compliance timelines to offer a roadmap for U.S. companies navigating the AI Act.
The AI Act will have a staged implementation process. While it will officially enter into force 20 days after publication in the EU’s Official Journal (“Entry into Force”), most provisions won’t be directly applicable for an additional 24 months. This provides a grace period for businesses to adapt their AI systems and practices to comply with the AI Act. To bridge this gap, the European Commission plans to launch an AI Pact. This voluntary initiative allows AI developers to commit to implementing key obligations outlined in the AI Act even before they become legally enforceable.
With the impending enforcement of the AI Act comes the crucial question for U.S. companies that operate in the EU or whose AI systems interact with EU citizens: How can they ensure compliance with the new regulations? To start, U.S. companies should understand the key risk categories established by the AI Act and their associated compliance timelines.
I. Understanding the Risk Categories
The AI Act categorizes AI systems based on their potential risk. The risk level determines the compliance obligations a company must meet. Here’s a simplified breakdown:
Unacceptable Risk: These systems are banned entirely within the EU. This includes applications that threaten people’s safety, livelihood, and fundamental rights. Examples may include social credit scoring, emotion recognition systems at work and in education, and untargeted scraping of facial images for facial recognition.
High Risk: These systems pose a significant risk and require strict compliance measures. Examples may include AI used in critical infrastructure (e.g., transport, water, electricity), essential services (e.g., insurance, banking), and areas with high potential for bias (e.g., education, medical devices, vehicles, recruitment).
Limited Risk: These systems require some level of transparency to ensure user awareness. Examples include chatbots and AI-powered marketing tools where users should be informed that they’re interacting with a machine.
Minimal Risk: These systems pose minimal or no identified risk and face no specific regulations.
II. Key Compliance Timelines (as of March 2024):
Time Frame
Anticipated Milestones
6 months after Entry into Force
Prohibitions on Unacceptable Risk Systems will come into effect.
12 months after Entry into Force
This marks the start of obligations for companies that provide general-purpose AI models (those designed for widespread use across various applications). These companies will need to comply with specific requirements outlined in the AI Act.
Member states will appoint competent authorities responsible for overseeing the implementation of the AI Act within their respective countries.
The European Commission will conduct annual reviews of the list of AI systems categorized as “unacceptable risk” and banned under the AI Act.
The European Commission will issue guidance on high-risk AI incident reporting.
18 months after Entry into Force
The European Commission will issue an implementing act outlining specific requirements for post-market monitoring of high-risk AI systems, including a list of practical examples of high-risk and non-high risk use cases.
24 months after Entry into Force
This is a critical milestone for companies developing or using high-risk AI systems listed in Annex III of the AI Act, as compliance obligations will be effective. These systems, which encompass areas like biometrics, law enforcement, and education, will need to comply with the full range of regulations outlined in the AI Act.
EU member states will have implemented their own rules on penalties, including administrative fines, for non-compliance with the AI Act.
36 months after Entry into Force
The European Commission will issue an implementing act outlining specific requirements for post-market monitoring of high-risk AI systems, including a list of practical examples of high-risk and non-high risk use cases.
By the end of 2030
This is a critical milestone for companies developing or using high-risk AI systems listed in Annex III of the AI Act, as compliance obligations will be effective. These systems, which encompass areas like biometrics, law enforcement, and education, will need to comply with the full range of regulations outlined in the AI Act.
EU member states will have implemented their own rules on penalties, including administrative fines, for non-compliance with the AI Act.
In addition to the above, we can expect further rulemaking and guidance from the European Commission to come forth regarding aspects of the AI Act such as use cases, requirements, delegated powers, assessments, thresholds, and technical documentation.
Even before the AI Act’s Entry into Force, there are crucial steps U.S. companies operating in the EU can take to ensure a smooth transition. The priority is familiarization. Once the final version of the Act is published, carefully review it to understand the regulations and how they might apply to your AI systems. Next, classify your AI systems according to their risk level (high, medium, minimal, or unacceptable). This will help you determine the specific compliance obligations you’ll need to meet. Finally, conduct a thorough gap analysis. Identify any areas where your current practices for developing, deploying, or managing AI systems might not comply with the Act. By taking these proactive steps before the official enactment, you’ll gain valuable time to address potential issues and ensure your AI systems remain compliant in the EU market.
The foreign investment policy was ambiguous about space activities beyond satellites, leading to different interpretations.
Some companies made investments basis the view that investments in the activities not listed under the FDI policy in this sector could be made up to 100% without prior government approval.
The proposed FDI Space Policy addresses these concerns and allows 100% foreign investments under the automatic and governmental approval route.
Formal notification is awaited which will make this policy effective as law.
Background
India currently is home to more than 200 space start-ups, and the space sector in India has attracted USD 124.7 million investment in the year 2023. The existing foreign investment policy of India (“FDI Policy”) requires foreign investors to obtain prior government approvals for investing in the space sector, particularly for the establishment of satellites.
Considering the growth of this sector, the Indian government has been periodically releasing policies / notifications, establishing organizations, etc. with the intent to allow more private participation in this sector. This has led to the establishment of an organization to promote the sector called the Indian National Space Promotion and Authorization Centre in 2020, as well as the introduction of the National Geospatial Policy, 2022 followed by the Indian Space Policy, 2023.
On February 21, 2024, the Union Cabinet approved amendments to the Foreign Direct Investment (“FDI”) policy and communicated it in a press release (“FDI Space Policy”) which proposes to liberalize investments in the space sector. However, a formal notification from the relevant authorities is still awaited for the amendments to become enforceable as law.
Existing FDI Policy
Existing foreign investment limits in the space sector are provided under the Schedule I of Foreign Exchange Management Act (Non-Debt Instrument) Rules, 2019 (“NDI Rules”). The current norms do not recognize “space” as a sector in itself. Instead, the space related activities are primarily captured under the head – “satellites – establishment and operation”. 100% foreign investment is allowed in this sector but the same is subject to approval from the government along with compliance of sectoral guidelines from Department of Space / Indian Space Research Organisation. In essence, all foreign investments in companies undertaking the activities of satellites-establishment and operations require government approval.
Reforms – New FDI Space Policy
The proposed FDI Space Policy allows 100% foreign investment in the space sector and has also created sub-categories, entry route and investment thresholds for various space related activities, which are as follows:
S.no.
Activity
FDI Thresholds
1.
Satellites-manufacturing & operation, satellite data products and ground segment & user segment
Up to 74% under automatic route
and beyond 74% (up to 100%) under government route
2.
Launch vehicles and associated systems or subsystems, creation of spaceports for launching and receiving spacecraft
Up to 49% under automatic route and beyond 49% (up to 100%) under government route
3.
Manufacturing of components and systems/ sub-systems for satellites, ground segment and user segment
Up to 100% under automatic route
Analysis
(i) Status of existing investments
The existing FDI policy did not include space sector related activities (other than satellites-establishment and operation) such as launch vehicle business, ground segment, user segment, sub-component / sub-systems manufacturing, data products etc.
Various stakeholders argued that since the existing FDI policy did not specify certain activities such as launch vehicles, data sets, manufacturing of space systems / components etc. under the head of “satellites-establishment and operation”, foreign investments in such cases should be permitted up to 100% under the automatic route. This was based on the interpretation under the FDI policy that sectors / activities not specifically listed or prohibited, are permissible for foreign investment up to 100% under the automatic route, subject to sectoral conditionalities. Relying on the same, foreign investors made investments in space start-ups whose activities were not explicitly listed or regulated under the current FDI regime without obtaining government approval.
Some stakeholders interpreted “satellites” very broadly and took a more conservative view that all space related activities required government approval. Similarly, there were overlaps in activities / interpretation of the FDI policy under the sectors of defence, telecom and manufacturing.
The space liberalization norms under the proposed FDI Space Policy may have actually de-liberalized this sector for certain companies who received investments in allied space activities based on the understanding that sectors / activities not specifically listed or prohibited, should be eligible for foreign investments up to 100% under the automatic route. In such cases where the investment thresholds under the proposed FDI Space Policy may be breached, it would be interesting to see the government’s approach including granting approvals on a post-facto basis.
(ii) Sub- categorizations of activities within the Space Sector
While the government has acknowledged the sub-categories of activities within the space sector, it hasn’t clarified its rationale for providing different foreign investment thresholds for such activities. Relaxed thresholds for satellites (i.e., 74% under the automatic route (up to 100% under government route)) and its sub-components (i.e., 100% under the automatic route) encourage foreign participation in commercial aspects of space activities. In contrast, the 49% cap on foreign investments under the automatic route (up to 100% under government route) on launch vehicles acknowledge their dual-use potential for both civilian and defence purposes. This sensitivity, combined with the launching state’s heightened liability under Article II of the Convention on International Liability for Damage Caused by Space Objects (“Liability Convention”), may be viewed as necessitating greater government oversight.
However, industry players have also criticized the differential treatment provided to launch vehicles vis-a-vis satellites. They believe, in essence, both industries have similar sensitivity issues and hence should be treated at par from a foreign investment perspective. Hence, the difference in foreign investment thresholds require more explanation from the government.
(iii) Satellite Data Products
The term ‘satellite data products’ has not been defined under the proposed FDI Space Policy but investments in such activities would be permitted up to 74% under the automatic route (up to 100% under government route). This may lead to some conflict from a satellite imagery / data perspective read along with the liberalized Geospatial Guidelines, 2021. (“Geospatial Guidelines”).
The Geospatial Guidelines largely permit foreign investments up to 100% under the automatic route with limited foreign investment restrictions especially if the activity is for (i) creation / ownership / storage of geospatial data of a certain accuracy (as defined under the Geospatial Guidelines); (ii) terrestrial mobile survey, street view survey and surveying activities in Indian territorial waters. There seems to be no specific restriction on satellite generated data (other than the above) under the Geospatial Guidelines. Thus, the proposed FDI Space Policy may end up limiting foreign investments for activities relating to Satellite Data Products (which would include geo-spatial data) in which otherwise is viewed to be permissible up to 100% under the automatic route.
The government should also define what constitutes satellite data products and to the extent possible it would be recommended that foreign investment up to 100% should be permitted under the automatic route.
Additionally, the rationale for capping investments for satellite data products under the proposed FDI Space Policy seems unclear as these are data sets which could be regulated under the Geospatial Guidelines and the new Indian privacy law.
(iv) Where are sub-components for launch vehicles covered?
The proposed FDI Space Policy explicitly covers the manufacturing of components and systems / sub-systems for the satellite sector, ground & user segment, and permits 100% FDI under automatic route for the same. With the absence of similar language for components in launch vehicles, it could imply its inclusion under the broader launch vehicle category, hence falling under the 49% automatic route (up to 100% under government route). Alternatively, it could also be argued since it is not expressly specified, the same could be covered under the 100% automatic route category. However, considering the critical role of such components in the sector’s development, clarification from the government would provide much-needed comfort especially if the components are dual use (satellite and launch vehicle usage).
(v) What about ground segment and user segment for launch vehicles?
Following the pattern observed with the satellite and ground segment categories, the absence of specific mention for the “ground segment & user segment” in the launch vehicle section raises further questions. This omission could be an oversight or intentional, but the lack of clarity hinders transparency and predictability for potential investors. Further clarity on the inclusion from an industry perspective in the official amendment notification would ensure a comprehensive and consistent policy framework for the entire launch vehicle sector.
(vi) Were any sub-categories / activities missed?
As space activities may expand to include space mining, exploration, international space station construction, space tourism etc., India needs to proactively address these areas. Especially, if these should be interpreted for foreign investments up to 100% under the automatic route, as this would have a bearing on India’s ability to attract foreign investment while safeguarding national interests, technological competitiveness, and responsible stewardship of India in space.
Conclusion
While the proposed FDI Space Policy provides substantial liberalization, further clarity is awaited based on the formal notification which will make this effective as law. Ideally, the Government should provide definitions / explanations for the proposed categorization and sub-categorizations, and further clarity on the inclusions and omissions of activities which may be related to most space sector functions such as user and ground segments.
While the move towards liberalization significantly reduces government control over the space sector, its inherent interconnectedness with other regulated domains like telecommunications / geospatial cannot be ignored. Despite these challenges, the government’s willingness to open the space sector to foreign investments is a positive step offering greater confidence to foreign investors. Relaxation in the existing norms also signifies a supportive stance towards the industry, encouraging both domestic and international participation. Notably, India successfully attracted substantial foreign investment even during the era of full government control. Therefore, with the current reforms, a significant increase in foreign investments is expected.
Footnotes
[1] Rajya Sabha Questions, Department of Space, available at
https://sansad.in/getFile/annex/262/AU621.pdf?source=pqars
[2] Notification, Department of Space, available at https://pib.gov.in/PressReleasePage.aspx?PRID=1988864
[3] Notification, Ministry of Commerce & Industry, available at https://pib.gov.in/PressReleaseIframePage.aspx?PRID=2007876
[4] Article II of the Liability Convention provides that a launching State shall be absolutely liable to pay compensation for damage caused by its space object on the surface of the earth or to aircraft flight.
Nishith Desai Associates 2024. All rights reserved.
The U.S. State Department released the March Visa Bulletin Friday, showing little movement in the employment-based Final Action Dates and Dates for Filing charts. U.S. Citizenship and Immigration Services announced that in March it will use Final Action Dates to determine filing eligibility.
Because Dates for Filing are generally more progressive, the switch to Final Action Dates means that priority date cutoffs will move back next month—and fewer applicants will be eligible to file for employment-based green cards.
When comparing February’s Dates for Filing chart to March’s Final Action Date chart, the movement of cutoffs for being eligible to file for employment-based green cards is as follows:
EB-1
China EB-1 will move back 5½ months to July 15, 2022.
India EB-1 will move back three months to Oct. 10, 2020.
All other countries under EB-1 will remain current.
EB-2
China EB-2 will move back five months to Jan. 1, 2020.
India EB-2 will move back 2½ months to March 1, 2012.
All other countries under EB-2 will move back nearly three months to Nov. 22, 2022.
EB-3
China EB-3 will move back 10 months to Sept. 1, 2020.
India EB-3 will move back one month to July 1, 2012.
Philippines EB-3 will move back almost four months to Sept. 8, 2022.
All other countries under EB-3 will move back almost five months to Sept. 8, 2022.
Final Action Dates for Employment-Based Preference Cases:
Preference
All Other Countries
China
India
Mexico
Philippines
EB-1
Current
July 15, 2022
Oct. 1, 2020
Current
Current
EB-2
Nov. 22, 2022
Jan. 1, 2020
March 1, 2012
Nov. 22, 2022
Nov. 22, 2022
EB-3
Sept. 8, 2022
Sept. 1, 2020
July 1, 2012
Sept. 8, 2022
Sept. 8, 2022
Additional Information: The March Visa Bulletin and the switch to Final Action Dates come after employment-based priority date cutoffs advanced key categories in January and saw no movement in February. This is the first time this fiscal year that USCIS has used the Final Action Dates to determine filing eligibility for employment-based applicants. USCIS will continue using the Dates for Filing chart to determine family-based filing eligibility next month.
The World Health Organization (WHO) recently published “Ethics and Governance of Artificial Intelligence for Health: Guidance on large multi-modal models” (LMMs), which is designed to provide “guidance to assist Member States in mapping the benefits and challenges associated with the use of for health and in developing policies and practices for appropriate development, provision and use. The guidance includes recommendations for governance within companies, by governments, and through international collaboration, aligned with the guiding principles. The principles and recommendations, which account for the unique ways in which humans can use generative AI for health, are the basis of this guidance.”
The guidance focused on one type of generative AI, large multi-modal models (LMMs), “which can accept one or more type of data input and generate diverse outputs that are not limited to the type of data fed into the algorithm.” According to the report, LMMs have “been adopted faster than any consumer application in history.” The report outlines the benefits and risks of LLMs, particularly the risk of using LLMs in the healthcare sector.
The report proposes solutions to address the risks of using LMMs in health care during development, provision, and deployment of LMMs and ethics and governance of LLMs, “what can be done, and by who.”
In the ever-changing world of AI, this is one report that is timely and provides steps and solutions to follow to tackle the risk of using LMMs.
