International Issues
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.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-557-3800 • 202-557-3836 (fax) | lawbc.com
Contact • Twitter
Privacy Policy | Terms of Use | Cookie Policy | Attorney Advertising | Trademarks
©2023 Bergeson & Campbell, P.C.
All Rights Reserved.