Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Tag Archives: European

NGOs Call for “Nano Patch” for REACH, and EC Responds

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC Begins Public Consultation On Discussion Paper Addressing The New Challenges For Risk Assessment

Posted in International, Legal/Regulatory Issues, Research
On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a… Continue Reading

ECHA Will Hold Webinar on REACH Registration Dossiers for Nanomaterials and Creates Nanomaterials Working Group

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC Adopts Communication on Second Regulatory Review on Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC’s SCCS Scientific Opinion on Nano-Form Zinc Oxide Available for Comment

Posted in International, Legal/Regulatory Issues
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration… Continue Reading

SCCS Calls for Experts on the Safety Assessment of Nanomaterials in Cosmetic Products

Posted in International, Legal/Regulatory Issues
On August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on… Continue Reading

ISO Preparing Labeling Guidance for Manufactured Nano-Objects and Products Containing Manufactured Nano-Objects

Posted in International, Legal/Regulatory Issues
The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for… Continue Reading

EU-OSHA Posts Literature Review on Risk Perception and Communication on Nanomaterials in the Workplace

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that… Continue Reading

SCENIHR Issues Call for Information and Experts on Health Effects of Nanomaterials Used in Medical Devices

Posted in International, Legal/Regulatory Issues
On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials: Carbon nanotubes… Continue Reading

The Netherlands Publishes Report Examining the EC’s Recommended Definition of Nanomaterial

Posted in International, Legal/Regulatory Issues
The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider… Continue Reading

EC Scientific Committee Releases Guidance on Safety Assessment of Nanomaterials in Cosmetics

Posted in International, Legal/Regulatory Issues
On July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to… Continue Reading

ECHA Will Create Working Group on Nanomaterials

Posted in International, Legal/Regulatory Issues, State
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… Continue Reading

ECHA Updates Additional Guidance for Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

ECHA Announces Updated Guidance for Registering Nanomaterials

Posted in International, Legal/Regulatory Issues
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)… Continue Reading

ECHA Forwards Draft Guidance Concerning Nanomaterials to CARACAL

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EU OSHA Announces French Report on Feasibility of Epidemiological Surveillance System for Workers Exposed to Engineered Nanomaterials

Posted in International, Legal/Regulatory Issues, Occupational Health and Safety Issues
The European Agency for Safety and Health at Work (EU OSHA) posted an item on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported… Continue Reading

EC Scientific Committee Requests Information on Nanosilver

Posted in International, Legal/Regulatory Issues, Other
On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to… Continue Reading

EC Requests Scientific Opinion on Health Effects of Nanomaterials Used in Medical Devices

Posted in International, Legal/Regulatory Issues
On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials… Continue Reading

CoRAP Notes Nano Concerns for Two Substances

Posted in International, Legal/Regulatory Issues
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… Continue Reading

ECHA Announces Plans to Update Guidance for Registration of Nanoform Substances

Posted in International, Legal/Regulatory Issues
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… Continue Reading

CIEL Claims REACH Insufficient to Regulate Nanomaterials

Posted in International, Legal/Regulatory Issues
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: REACH does… Continue Reading

EP Passes Resolution Calling for Legislation to Protect Workers from Nanomaterials

Posted in International, Occupational Health and Safety Issues
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,… Continue Reading

Proposed EU Biocidal Products Regulation Addresses Nanomaterials

Posted in International, Legal/Regulatory Issues
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… Continue Reading

EC Requests SCENIHR for Scientific Opinion on Nanosilver

Posted in International, Legal/Regulatory Issues
The European Commission (EC) requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to humans,… Continue Reading