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The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of...

On March 3, 2021, Representatives Frank Lucas (R-OK), Ranking Member of the House Science, Space, and Technology Committee; Stephanie Bice (R-OK), Ranking Member of the Environment Subcommittee; and Jay Obernolte (R-CA), Ranking Member of the Investigations and Oversight Subcommittee, sent a letter to the U.S. Environmental Protection Agency (EPA) urging EPA to expedite any reevaluation of the Toxic Substances Control Act’s (TSCA) systematic review methods.  As reported in our...

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 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier for a substance with nanoform(s). In addition, on...

The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in registration dossiers. Currently, according to ECHA, the...

On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment.  ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned aspects such as occupational exposure estimation and dose-response characterization for human...

On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track...

The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials...

On February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the initial grounds for concern are “Substance...

On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate...

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...

On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances.  REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to...

The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and...

During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of...

The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that...

In February 2011, the Dutch Environmental Safety and Risk Management Directorate sent a letter to the Directorate General (DG) Enterprise and DG Environment expressing concern regarding delays in the work of the Competent Authorities Sub-Group on Nanomaterials (CASG Nano) and the European Commission’s (EC) progress regarding clarifying the definition and status of nanomaterials. The Dutch Directorate states that an essential first step is to define what nanomaterials are and asks that the EC...

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two...

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 June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.” The...

On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be...

During the Helsinki Chemicals Forum 2010, Jukka Malm, European Chemicals Agency (ECHA) Assessment Director stated that ECHA is revising its Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) guidance documents to include technical instructions to help companies include nanomaterials in their registration dossiers and other compliance obligations for substances they make or import. According to Malm, ECHA is following “international developments,” particularly work...

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...

On June 25, 2009, the Norwegian Board of Technology announced that the Norwegian Pollution Control Authority (SFT) has established “a scheme for Norwegian businesses to report their use of nanomaterials in chemical products.”  According to a spokesperson for the Board, until now the Norwegian market has “lacked oversight of nanomaterials.”  Under the scheme, information about nanomaterials in chemical products will be incorporated as a separate topic in declarations to the...

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,...

In an April 24, 2009, press release, the European Parliament (EP) calls for the provision of information to consumers on the use of nanomaterials in consumer products. According to the EP, all ingredients present in the form of nanomaterials in substances, mixtures, or articles should be clearly indicated in the product labeling. The press release also specifically calls for the European Commission (EC) to evaluate the need to review the Registration, Evaluation, Authorization and...

During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them so that FDA can learn more about the effects of nanotechnology. Sackner-Bernstein acknowledged that the...

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 26, 2008, the European Trade Union Confederation (ETUC) passed a resolution on nanotechnologies and nanomaterials, which calls for the application of the precautionary principle. The resolution states that application of the precautionary principle is necessary to avoid “past mistakes [made] with putatively ‘miracle’ technologies and materials. According to ETUC, the number of workers coming into contact with nanomaterials will increase sharply as nanotechnologies...

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...

Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new...