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Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024, Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU “identifies the challenges and barriers and proposes to tackle them, in line with the Communication on the long-term competitiveness of the EU.” According to the...

By Lynn L. Bergeson and Carla N. Hutton   According to a January 24, 2023, item published by the U.S. International Trade Administration (ITA), the demand for new bioplastic materials and innovative processing technologies is high, contributing to the European and Italian plastics circular economy policy. According to ITA, European demand for bioplastics (compostable, bio-attributed, and bio-based) grew more than 23 percent annually from 2019 to 2021, increasing from 210,000 to 320,000...

On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate.  One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI).  The second decision (Hautala et al. v. EFSA, Case T-329/17)...

On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an...

On January 13, 2015, the Court of Justice (Grand Chamber) of the European Union (EU) overturned a judgment of the General Court of the European Union (General Court) in Stichting Natuur en Milieu and Pesticide Action Network Europe v. Commission. The case concerned the non-governmental organizations’ (NGO), the Plaintiffs, interest in having the European Commission review Regulation (EC) 149/2008 amending Regulation (EC) 396/2005 of the European Parliament and of the European Council by...

During a summit in Brussels on October 23-24, 2014, European Union (EU) leaders agreed to a blueprint to guide climate and energy policy through 2030. The overall goals of the blueprint are to achieve a 40 percent emissions reduction by 2030, relative to 1990 emissions levels, as well as a target of 27 percent for total energy consumption in the EU being provided by renewable sources by 2030. The EU already has a 20 percent...

In a July 9, 2014, press release, the European Union (EU) announced the launch of seven public-private partnerships, established under the EU's new research funding program Horizon 2020. They represent a total investment of € 19.5 billion into research and innovation over the next seven years, where the EU contribution of € 7.3 billion will unlock a € 12.2 billion investment from the private sector and the Member States. The press release is available online....

The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration,...

On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in...

The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation: CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that...

The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15 abstentions, also calls for the assessment of the effects of new technologies on health. The EP calls for legislation to ensure that nanomaterials...

On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for...

The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition...

The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”: 2.         “Nanomaterial” means a natural, incidental or...

The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:...

The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk assessment criteria should be used to assess and minimize potential risks, which the EC...

The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the precautionary principle. The notice specifically states that these “other hazardous substances” include “any substances of...

The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU).  The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in...

The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment’s (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17,...

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports.  Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to...

The European Parliament (EP) and European Union (EU) Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labeling food from cloned animals and their descendents, as well as nanotechnology. The draft legislation passed by the EP in July 2010 would have banned nanoscale...

According to a March 10, 2011, press release, the risks connected with nanomaterials are one of the areas on which the Swedish Chemicals Agency (KemI) will focus in its national action plan, which will apply from 2011-2014. The press release states that the objective is for Sweden “to become one of the leading member states in the [European Union (EU)] in proposing new bans and restrictions.” Sweden expects the action plan to “lead to intensified cooperation and...

On February 11, 2011, the European Union (EU) Regulatory Committee voted to adopt revised environmental criteria for hand dishwashing detergents and all-purpose cleaners and cleaners for sanitary facilities. The Committee supported a European Commission (EC) proposal not to exclude nanomaterials from products awarded the voluntary EU ecolabel, despite concerns from members states, including Austria, Germany, France, Denmark, Slovakia, and Poland, as well as Norway. The EC proposed that the...

On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new...

On October 21, 2010, the European Commission (EC) began a consultation on its proposal for a definition of the term “nanomaterial” that the it intends to use as “an overarching, broadly applicable reference term” for any European Union (EU) communication or legislation addressing nanomaterials. The EC states that the definition of the term “nanomaterial” should be based on available scientific knowledge and should be used for regulatory purposes.  The definition...

During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette, the next European Environment and...

On July 12, 2010, the European Commission (EC) opened a public consultation on the pre-consultation opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) entitled “Scientific Basis for the Definition of the Term ‘Nanomaterial.’” The EC states that its services need a working definition for the term “nanomaterial” to ensure the consistency of forthcoming regulatory developments, to guide the effective implementation of existing...

On July 7, 2010, the European Parliament (EP) voted that nanoscale ingredients should be banned from food in the European Union (EU) until the health and environmental risks they might pose are better understood, and that any nanoscale ingredients that are eventually authorized should be clearly labeled as such. The EP voted on several amendments to draft legislation concerning the authorization of novel foods, including a provision that would prohibit food from cloned animals or their...

On July 2, 2010, the European Commission’s (EC) Joint Research Centre (JRC) announced the availability of a reference report entitled Considerations on a Definition of Nanomaterial for Regulatory Purposes. JRC prepared the report in response to a request from the European Parliament (EP). JRC states that the aim of the report is to review and discuss issues and challenges related to a definition of “nanomaterial,” and to provide practical guidance for a definition for...

On June 6, 2010, the European Commission (EC) Joint Research Center Institute for Health and Consumer Protection (JRC-IHCP) and the Chinese Academy of Inspection and Quarantine signed a Memorandum of Understanding (MOU) at the European Union (EU)-China Food Safety Scientific Seminar held at the Shanghai World Expo.  According to JRC-IHCP, “[b]oth institutions provide technical support for policy makers and aim to reinforce their co-operation in scientific research for consumer...

On May 4, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety voted on draft legislation regarding “novel foods,” which are defined as those that have not been consumed to a significant degree in the European Union (EU) before May 1997. Under the legislation, foods produced by nanotechnology processes would be required to undergo risk assessment before being approved for use, and approved products would be subject to labeling...

On March 16, 2010, the EP Environment Committee approved draft legislation intended to modernize, simplify, and clarify food labeling within the EU. The legislation would make minor changes to existing rules on required labeling information, such as name, list of ingredients, “best before” or “use by” date, specific conditions of use, and add a requirement to list key nutritional information. The Committee added that showing the country of origin should also be...

On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The...

In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted...

The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S.,...

The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review — Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does...

On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1,...

During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program,...

The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching...

On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials,...

On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the...

On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies — tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with...

In a January 28, 2008, report entitled EU Nanotechnology R&D in the Field of Health and Environmental Impact of Nanoparticles, the European Commission (EC) provides an overview of past and ongoing research projects funded by the Framework Programmes (FP), EU member states, candidate countries, and countries associated to FP6 or FP7 in the area of possible impacts in health, environment, and safety of nanoparticles. The report has information on 106 projects, 14 of which are from...

According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a...

On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.” The potential risks and opportunities, according to...

The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology — Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover...

On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental...

On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special...

On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of...