The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether ‘neat’ (pure) chemicals, formulations or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media as effluent, emissions, fugitive releases or waste, as well as quantifying the potential for such releases to pose litigation risks or regulatory enforcement, or require costly remediation. Increasingly, parties to corporate transactions now continue to focus on these liabilities and on the compositional elements of chemical products themselves as potential sources of liability and commercial disruption. This article explains why the transition to chemical product due diligence has been slow and offers a few tips to help assess what diligence is due in corporate transactions involving chemical products.

In February 2022, France and the United States announced their commitment to protect our shared environment for future generations against the harm resulting plastic pollution.Both nations stated their united recognition of the transboundary impacts of plastic pollution and the importance of mitigating plastic waste at its source. On March 2, 2022, as reported by the 5th UN Environment Assembly (UNAE-5.2) in Nairobi, both France and the United States, along with 173 other nations, adopted a Resolution to End Plastic Pollution with an international legally binding agreement by 2024, with discussions beginning in 2022. Significantly, the Resolution to End Plastic Pollution defines “plastic waste” to include “microplastic.” Building upon the historic collaboration between France and the United States regarding plastic waste and learning from the contrasts in their governmental structures and approaches to environmental regulation, this French and United States Comparative Law Analysis and Recommendations Regarding Plastic Waste is offered for use by policy makers in the upcoming negotiations regarding the global plastic waste treaty.

The Chemicals Strategy for Sustainability, adopted by the European Commission in October 2020, calls on the Commission to ensure that Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation) is the central legislation for hazard classification and allows the Commission to initiate harmonised classifications. This article examines the effect of possible CLP amendments.

To help achieve the ambitious goals of the European Green Deal, the European Commission adopted the chemicals strategy for sustainability in October 2020. The strategy suggests that the Commission can address pressing human health and environmental concerns by reinforcing Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures – one of the EU’s cornerstones for regulating chemicals.

Two developments in the European Union in 2020 involving chemical regulations will almost certainly impact U.S. chemical stakeholders, according to Lynn L. Bergeson, managing partner of Bergeson & Campbell P.C. One initiative restricts certain chemicals in order to comply with the European Green Deal, while the other amends chemical disclosure requirements, she explains.

On February 25, 2021, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on "Assessing the dispersion stability and dissolution (rate) of nanomaterials in the environment" to discuss the scope, content, and use of Test Guideline No. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media and its accompanying guidance document. 

There has been remarkable consolidation in the analytical services sector in the US and elsewhere globally over the past few years. Make no mistake; the need for analytical and related testing services is growing significantly. Because of the legal and regulatory frameworks that demand such services, however, there is considerable need for attendant technical expertise to staff these laboratories, and the need for specialised expertise is also growing exponentially. This article summarises mergers and acquisitions (M&A) trends and explains why skilled help is essential to avoid liability. A PDF of this article can be downloaded here. 

Effective 1 January 2022, household cleaning, cosmetic and personal care products containing quantities of 1,4-dioxane over specified trivial levels will be prohibited from sale in the state of New York. The law imposing these restrictions, signed by governor Andrew M. Cuomo on 9 December 2019, is intended to protect drinking water supplies from contamination by the chemical. This product ban falls on the heels of the 15 March 2019 final rule issued by the US Environmental Protection Agency (EPA) banning the manufacture, import, processing and distribution, including e-commerce, of methylene chloride for consumer paint and coating removal. The EPA’s determination that the use of methylene chloride in consumer paint and coating removal presents an ‘unreasonable risk’ of injury to health prompted this decision. These commercial bans are not anomalies; they are the new normal. This article explains why, and the reasons corporate leaders, brand managers, investors and others in this commercial space need to understand this trend and plan accordingly.

Manufacturers and importers should weigh in on China’s planned changes to registration requirements for new chemical substances, write Brian Xu and Jane Vergnes of The Acta Group, and Carla Hutton of Bergeson & Campbell.

The registration deadlines for pre-registered “phase-in” chemical substances under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation presented for the chemicals industry a wide range of demanding tasks requiring substantial expertise from scientists, consultants, lawyers, and others. The transitional phase of REACH ended on 31 May 2018, and companies of all shapes and sizes are now engaged in a wide range of ongoing compliance activities. This column addresses certain important REACH-related activities being undertaken by numerous entitites in the ongoing post-deadline era, and provides comments on their significance. 

Global chemical substance notification deadlines continue to populate the regulatory horizon. For companies active in worldwide markets, it’s crucial to review and meet all important notification and registration deadlines in each country. This article focuses on South Korea’s policy and explains why it’s essential to meet these deadlines.

The International Estimated Short-Term Intake IESTI equations are used during the establishment of Codex Maximum Residue Limits. A recent proposal to revise the equations sparked international debate regarding selection of residue inputs and the appropriate level of consumer protection. The 49th Codex Committee on Pesticide Residues meeting recommended benchmarking the IESTI equations against distributions of actual exposures. Using publicly available data and models, this work compares dietary exposures for strawberries, tomatoes, and apples at five levels of refinement to place these equations into context relative to real-world exposures. Case studies were based on availability of robust USDA PDP monitoring data, which is uniquely suited to refine dietary exposures for a population. Benchmarking dietary exposure involves several decision points. Alternate methodology choices are not expected to impact the large margins observed between the probabilistic estimates and the IESTI equations or to change the overall conclusion that existing IESTI equations are conservative and health-protective.

Brexit is a moving target from a political viewpoint, but many matters for regulatory compliance and product stewardship teams globally appear clearer than before. This article suggests timely REACH compliance strategies companies should adopt and implement that account for wide-ranging Brexit repercussions.

This article reviews the Trump Administration’s engagement, to date, in key industrial chemical matters, domestically and internationally.  Topics include the Toxic Substances Control Act (TSCA), the UN’s Strategic Approach to International Chemicals Management (SAICM) and 2030 Agenda for Sustainable Development, and Ratification of the Stockholm Convention on Persistent Organic Pollutants.

As a candidate and now as president, President Trump has been uncharacteristically predictable in systematically dismantling signature environmental policies of prior administrations and ceding the United States’ leadership in combating climate change to other global powers. The administration’s industrial chemicals management policy has been less transparent and predictable, however. Some may have interpreted candidate Trump’s notable silence on the campaign trail as support for Toxic Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment on June 22, 2016. Others may have assumed that candidate Trump was simply unaware of the enactment of the most sweeping legislative changes to our domestic chemical management law in four decades and the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). President Trump has kept his TSCA cards close to his vest, and the administration’s broader engagement in chemicals management on the world stage is similarly unclear. Some trends can be discerned, or at least inferred, as discussed in this article.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. 

On 23 June 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should ‘Leave’ or ‘Remain’ in the European Union (EU). The referendum turnout was 71.8 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry.

Between then and now, there have been significant developments in case law and statute, culminating in the triggering of Article 50 of the Lisbon Treaty and the issuing of a White Paper setting out the UK’s strategy for repealing the European Communities Act 1972 (ECA 1972) and ending the supremacy of EU law. The Brexit process and potential outcomes, including ‘knowns and unknowns’, are subject to change and are evolving at an exceptionally rapid pace, and will likely continue to do so. Terminology utilised for important documents and events has changed since the start of the Brexit story in June 2016. Many Brexit-related issues depend significantly or entirely on outcomes of political negotiations, and making any predictions has become a challenging endeavour. The global chemicals industry is well advised, as part of an effort to support regulatory and legal compliance, to monitor regularly news and consultations regarding Brexit

Climate change watchers know that October, 15, 2016, was a historic day for international climate action. On that day, nearly 200 countries reached an agreement to phase down use of hydrofluorocarbons (HFCs) at the 28th Meeting of the Parties to the Montreal Protocol in Kigali, Rwanda. The meeting to discuss the Amendment took place from July 15-23, 2016. This seemingly impossible alignment of international interests reflects years of effort. This column summarizes this historic event and its implications.

In July 2017, the European Commission's (EC) Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials: Final report of the Nanocomput project.

The U.S. Environmental Protection Agency (EPA) made available on May 16, 2017, and requested comment on a draft guidance document, “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” This column discusses the draft guidance.

A major change, brought about by the November elections, is the uptick in citizen suit litigation, and lawsuits brought by third parties against the government. Given the current administration’s position on climate change, environmental regulation generally, and the perception that regulations impede economic growth and job development, there has been a significant slowdown in regulatory and administrative activity and the initiation of enforcement actions. NGOs and third-party activists will continue to fill this void by private lawsuits as citizen litigants.

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use.

On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. See http://www.environment.gov.au/protection/chemicals-management/national-standard/draft-national-standard-environmental-risk-management-industrial-chemicals  According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard. 

October 15, 2016, was a historic day for international climate action: nearly 200 countries reached an agreement to phase out use of hydrofluorocarbons (HFC) at the 28th meeting of the parties to the Montreal Protocol in Kigali, Rwanda. This column summarizes this historic event and its implications.

The Montreal Protocol is the international treaty designed to protect the earth’s ozone layer by requiring the phasing out of production and use of chlorofluorocarbons (CFC), substances believed to contribute to ozone depletion, many of which also contribute to greenhouse gas (GHG) production. By many accounts, the Montreal Protocol is one of the most successful international agreements ever implemented.

Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference.

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).

The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation.

On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. The petition summary states: "Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible."

The global chemicals industry has been presented with significant, often unfamiliar, challenges by the concept and functioning of SIEFs under REACH.  Through years of experience in SIEF participation on our clients’ behalf, Acta has identified the following questions to consider when participating in a SIEF.

On May 3, 3016, Mexico's Ministry of Economy published a notice beginning a public consultation on two draft nanotechnology standards. ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology. It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, non-governmental organizations (NGO), consumer organizations, members of the public, and others.

On May 31, 2016, the European Chemicals Agency (ECHA) began a public consultation on a harmonized classification and labeling (CLH) proposal submitted by France for titanium dioxide. The CLH report states: "Based on available evidence and information in the registration dossier (e.g. mechanism of carcinogenicity, characterization of the particles), the proposed scope for the Annex VI entry is: ‘Titanium dioxide in all phases and phase combinations; particles in all sizes/morphologies.'"

On April 29, 2016, Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. See https://www.nicnas.gov.au/about-nicnas/nicnas-reforms/consultation-paper-3 and https://www.nicnas.gov.au/about-nicnas/nicnas-reforms Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial. The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS).

The European Chemicals Agency (ECHA) announced on March 23, 2016, a new publication co-authored with the Dutch National Institute for Public Health and the Environment (RIVM) and Joint Research Center (JRC) that illustrates how to use data for different nanoforms within the same substance registration.

The February 24, 2016, Official Journal of the European Union includes the opinion of the European Economic and Social Committee (EESC) on "Nanotechnology for a competitive chemical industry."

This week, Belgium's Federal Public Service for Health, Food Chain Safety and Environment created an online portal for companies to register nanomaterials they put on the market.

The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Nano Task Force published an article in Regulatory Toxicology and Pharmacology entitled "A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping)."

As all chemical companies doing business in the European Union (EU) should know, the "A" in REACH stands for Authorisation, the last of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) processes to be implemented since the regulation entered into force in 2008. This article reviews the path to Authorisation and reports on key developments shared during the "Lessons Learnt on Applications for Authorisation" ECHA conference held 11 February, 2015. 

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission. 

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes. See http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=4BCC7425-1 Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures.

“On November 24, 2014, the European Parliament (EP) Committee on Environment, Public Health and Food Safety (ENVI) considered draft legislation concerning novel foods. See http://www.europarl.europa.eu/news/en/news-room/content/20141125IPR80424/html/Novel-foods-MEPs-call-for-moratorium-on-nano-foods-and-labelling-of-cloned-meat. The Committee amended the draft legislation, proposing a moratorium on the use of nanomaterials in food based on the precautionary principle. The Committee approved the amended draft legislation by a vote of 57-4, with two abstentions. EP Member James Nicholson (ECR, UK), who is steering the legislation through the EP, stated that he was not completely satisfied with the vote. ”

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). See http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2014)536293. The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor vehicles. 

Chemicals play a central role in our personal and professional lives. As consumers, we focus keenly on the chemicals in the products we use and with which we come into contact. Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. These challenges extend far beyond compliance questions that, by comparison, seem now nostalgically straightforward. Understanding these programs and their evolution can only help inform our judgment as lawyers, consultants, and educated consumers.

On August 9, 2014, Canada published a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). GHS compliance is a big issue for just about all manufacturers, and understanding the approach of our neighbor to the north is important. This column summarizes the highlights.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. See http://apvma.gov.au/node/11191 APVMA states that it "has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products." APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines.

Nano product registries in Europe are the newest twist to satiating the public’s relentless “right to know.” Nominally intended to prevent hazards, facilitate monitoring, and promote consumer choice, nano product registries also risk stigmatizing nano products, diverting limited government and private resources, and potentially creating commercial barriers to a promising technology. This article in the American Bar Association’s Natural Resources & Environment magazine focuses on efforts of multiple European countries that are presently at varying stages of establishing product registries to keep track of nanomaterials and the products that contain them. After outlining the stated purposes of these registries and explaining how they operate, the article explores whether they are achieving their stated goals or inadvertently inviting unintended consequences.

The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). See http://echa.europa.eu/documents/10162/21680461/bpc_opinion_heiq_ags-20_en.pdf.

On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterization of nanomaterials: Best practice for REACH registrants.

According to the study, Impact of REACH on SMEs in the Netherlands, commissioned by the Dutch Ministry for Infrastructure and the Environment, 23% of SMEs belonging to the chemical industry are not aware that they do, in fact, have obligations under REACH. A company does not need to be an SME, however, to have the false impression that it has no obligations under REACH. This article outlines frequent misconceptions regarding REACH obligations and provides guidance to help confirm whether companies have responsibilities under REACH.

On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate.

The European Union Biocidal Products Regulation dramatically changes the way biocidal active substances and biocidal products are regulated under European law. This new regulatory system is subtly different from those in other jurisdictions and EU neighboring countries, and fundamentally redefines biocidal products and treated articles. Companies exporting to the EU as a component of their global business must ensure that their supply chains and product designs are compliant with the regulation. This article presents a snapshot of existing industry norms and anticipates how these standard practices will be affected by the regulation.

The German Federal Environment Agency (UBA) has posted an English translation of a 2012 document entitled Concept for a European Register of Products Containing Nanomaterials. See http://www.umweltbundesamt.de/en/publikationen/concept-for-a-european-register-of-products The document states that, due to the particular uncertainties concerning evaluation of the possible risks of nanomaterials for human health and the environment, UBA supports the establishment of a European register of products containing nanomaterials as a precautionary measure.

Japan's National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces.

On October 8, 2013, Sweden issued a report proposing a national action plan for the safe use and management of nanomaterials. An English summary of the report’s recommendations is available at http://nanotech.lawbc.com/uploads/file/00125741.PDF

The U.S. International Trade Commission (ITC) published a notice in the July 30, 2013, Federal Register announcing that, following receipt of a letter from the United States Trade Representative (USTR), it instituted investigation No. 332-541, "Trade Barriers that U.S. Small and Medium-sized Enterprises Perceive as Affecting Exports to the European Union."

On June 21, 2013, the European Commission (EC) began a consultation on the modification of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed.

In May 2013, the European Commission (EC) posted a January 2013 report entitled Examination and assessment of consequences for industry, consumers, human health and the environment of possible options for changing the REACH requirements for nanomaterials. According to the report, 12 of the 21 originally suggested options are considered already implemented with existing legislation and guidance. The other nine options were considered relevant for an adaptation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and thus build the basis for the assessment.

On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled "Building Blocks for Completing EU Regulation of Nanomaterials." The conference was intended to identify areas where current European Union (EU) legislation on nanomaterials is insufficient. Participants included representatives from Member States, the European Commission (EC), European Parliament (EP), industry, and a number of non-governmental organizations.

It is entirely appropriate to consider how REACH may influence reconsideration of the U.S. chemical regulatory environment, and the report provides some critical insights. But REACH is not the only consideration — Canada’s Chemical Management Plan should be considered as well. Further, REACH should be considered from a practitioner’s, not an academic’s, perspective to learn lessons relevant to U.S. chemicals management 

Most would agree that legislative reform of the U.S. Toxic Substances Control Act (TSCA) is long overdue. Few agree on what to change and how best to proceed. If you throw in the 2012 presidential election, you have gridlock. Commerce marches on, however, and with the Environmental Protection Agency reinventing TSCA implementation in innovative and effective ways, Reach setting the new global tone, and California creating a new template for sustainable consumer products, TSCA reform is at risk of becoming a distracting afterthought. Stakeholders must develop new strategies to survive and flourish in these fast-changing times.

On December 19, 2011, the European Chemicals Agency (ECHA) announced that it added 20 substances of very high concern (SVHC) to the Candidate List, which now includes 73 substances.

In addition to the definition of nanomaterials, at the REACH Conference on the 23rd September 2011 held in Brussels, the participants discussed the implications of REACH as concerns nanomaterials.

The European Union's REACH regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). It also creates a data compensation scheme for entities that must rely upon studies another entity generated to complete their registration for a particular chemical substance. This article provides background on REACH registration, data compensation and sharing procedures, and compares REACH's data compensation principles with how similar issues are addressed in the context of FIFRA data compensation arbitrations.

The United Nations' Strategic Approach to International Chemicals Management (SAICM) urges each nation to make efforts to reduce hazards associated with the use of chemicals. In response to this request, South Korea recently has taken steps to implement a process for the management of chemicals with the objective of minimizing the harmful effects that substances have on human health and the environment.

In December 2008, Turkey enacted the Inventory and Control of Chemicals Regulation, a scaled-down version of the European Union’s REACH regulation to establish an inventory of chemicals produced and imported into Turkey and to better control potential risks posed by those chemical substances. Adoption of the regulation is one of many steps Turkey is required to take to secure membership in the European Union. The authors of this article advise chemical manufacturers and importers to obtain as much information as possible on the regulation and its implementation and to stay abreast of forthcoming clarifications.