NGOs Call for "Nano Patch" for REACH, and EC Responds

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, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.

The EC’s Environment and Enterprise Directorate-Generals (DG) issued separate statements in response to the NGOs’ proposal. DG Environment stated: “We regard the NGO proposal . . . as a reaction to the Commission’s recent regulatory review on nanomaterials. We are looking forward to discussing our review with all the stakeholders.” DG Enterprise released a more detailed statement, noting that the EC “does not consider appropriate at present to change the basic registration rules under REACH and the rules for when a chemical safety assessment is required under REACH.” In addition, DG Enterprise stated: “[T]he highest volume substances such as carbon black and synthetic amorphous silica, as well as the most debated substances such as titanium dioxide, zinc oxide and carbon nanotubes, have already been registered under REACH. Together, they represent the vast majority of nanomaterials on the market in terms of tonnage and sales value.”

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

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 October 17, 2012, ECHA announced publication of a new web page on nanomaterials under REACH and the Classification, Labeling, and Packaging (CLP) regulation. According to ECHA, the page “will provide advice to registrants that wish to register nanomaterials and inform about” ECHA’s latest activities concerning nanomaterials. The web page states that, in October 2012, ECHA created a nanomaterials working group “to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues.” The working group is an informal advisory group consisting of experts from Member States, the European Commission, ECHA, and accredited stakeholder organizations, “with the mandate to ‘Provide informal advice on any scientific and technical issues regarding implementation of REACH and CLP legislation in relation to nanomaterials.’” ECHA states that the working group also “aims to facilitate discussions with industry regarding its experience gained in documenting intrinsic properties of the nano-forms of substances using recent methodologies and its obligations towards fulfilling REACH requirements.”

ECHA Will Create Working Group on Nanomaterials

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 scope of the registration (i.e., whether and how many nano-forms are included) is often unclear and the level of nano-specific information provided (e.g., substance characterization, hazards, exposure, and risks) shows “significant room for improvement.” ECHA agreed with MSCA representatives on a common approach to addressing the current information requirements in nanomaterial dossiers, taking into account the scientific uncertainties and legislative framework provided by REACH. ECHA states that it will implement the EC’s recommendation on the definition of a nanomaterial as a benchmark in assessing substances, and “invites registrants to proactively characterise their substances in light of this definition.” Workshop participants discussed creating a working group on nanomaterials that would provide advice on scientific and technical principles related to nanomaterials under REACH. The working group on nanomaterials would act independently, but report to the relevant ECHA committees. According to ECHA, the mandate of this working group will be further consolidated with the MSCAs. In addition, ECHA intends to disseminate the best practices that it has collected from relevant stakeholders that registered nanomaterials and that were discussed in the first “Group Assessing Already Registered Nanomaterials” meeting prior to the workshop. ECHA intends to post the best practices on its website by this summer.

ECHA Updates Additional Guidance for Nanomaterials

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 health and for environment. According to ECHA, the updated appendices “will further enhance the advice to registrants of substances in the nanoform a full year in advance of the next REACH registration deadline,” May 31, 2013.

ECHA Announces Updated Guidance for Registering Nanomaterials

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 procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update “needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline,” May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform.

ECHA Forwards Draft Guidance Concerning Nanomaterials to CARACAL

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 (RIPoN).  The draft appendices are available at:

 

CoRAP Notes Nano Concerns for Two Substances

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 characterization/Nanoparticles, toxicity of different forms of the substance.” Silicon dioxide is scheduled to be evaluated in 2012, by the Netherlands, and silver is scheduled to be evaluated in 2013, also by the Netherlands. ECHA notes that, when the substances are included in the CoRAP, “they have yet not been evaluated and thus the concern is indicative and not exhaustive or conclusive.”

Following the evaluation, further information may be requested from the registrants of the substances when additional data are considered necessary to clarify the suspected risk. From the publication of the CoRAP, the respective Member States have one year to evaluate substances specified for the year 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The decision will be taken by ECHA after consultation of the Member State Competent Authorities and the Member State Committee, or by the European Commission (EC) if there is no unanimity at the Member State Committee. For other evaluation decisions, registrants of the substances listed on the CoRAP will have opportunities to comment before any final decision is taken.

ECHA Announces Plans to Update Guidance for Registration of Nanoform Substances

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 compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.”

CIEL Claims REACH Insufficient to Regulate Nanomaterials

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 not define nanomaterials, and contains no nano-specific provisions;
  • Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
  • REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
  • REACH test guidelines fail to consider the special properties of nanomaterials.

CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”

 

ECHA Begins Consultation on Testing Proposal for Multi-Wall Carbon Nanotubes

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 ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH.  After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint.  ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.

EC Publishes Final RIPoN Reports

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 technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA.  The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”

REACH Conference Participants Discuss Nanomaterials

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 June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular -- we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”

ECHA Preparing Nano Inventory from REACH and CLP Submissions

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 detailed results from the inventory would be available towards the end of 2011, and the inventory may be disseminated at a later date, but this has not yet been discussed. According to the spokesperson, ECHA has found three registration dossiers and 14 CLP notifications in which “nanomaterial” was selected as the form of the substance. The spokesperson stated that ECHA will be able to identify 50-60 REACH registration dossiers that include information on nanomaterials that will be sent to the Joint Research Centre for assessment under a separate project to address if and how information on nanomaterials is included in REACH registration dossiers.

Dutch Urge EU to Act on Nanomaterials

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 propose a common definition to member states as soon as possible, and in time for it to be discussed at the Competent Authorities for REACH and Classification and Labeling (CARACAL) meeting scheduled for mid-2011. According to the Directorate, the definition should be sufficiently broad to ensure all substances that present a nano-related risk are covered. The Directorate also asks that the three Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) implementation projects on nanomaterials be completed before the CARACAL meeting and that the EC provide greater clarity on the criteria necessary to assess whether nanomaterials pose specific risks. The Dutch competent authority is considering which substances to propose for substance evaluation under REACH and intends to include a nanomaterial. While the evaluation would not begin until 2012, the Dutch competent authority states that it would still be valuable to provide information on which elements of REACH remain problematic in terms of assessing hazards and risks associated with nanomaterials.

ECHA Publishes Technical Manual for Including Nanoforms in an IUCLID Dossier

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 Manual introduces a book-keeping principle, where each form gets a specific label that enables it to be tracked throughout the dossier. Instructions are given on how to create labels for form-specific reference substances, composition blocks, endpoint study records, and analytical data. In particular, the Manual “gives instructions that will enable registrants to consistently create and label Endpoint study records such that it is clear which composition or form was used as the test substance for that study.”

The Manual states:

Nanomaterials are covered under the substance definition in REACH and may be considered to be distinct substances or forms of a substance (CA/59/2008). The sole purpose of this document is to provide registrants with information on how to technically prepare their IUCLID dossiers for nanomaterials. It is the responsibility of the registrant to identify the substance and this document does not provide any information that will aid the registrant deciding when a nanomaterial can be considered to be a distinct substance or a nanoform. Moreover, following the technical advice given in this document does not imply that a dossier would be compliant with REACH requirements should it be selected for evaluation.

The Manual notes that, although there are no specific information requirements for nanomaterials under REACH, it encourages registrants “to include any information they consider relevant to better describe the substance and to demonstrate its safe use.” The Manual suggests that registrants take advantage of the preliminary guidance of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) on testing, exposure measurements, and mitigation of nanomaterials.

 

ECHA Revising REACH Guidance Documents to Include Nanomaterials

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 by the Organization for Economic Cooperation and Development (OECD) concerning nanomaterial safety and testing. Malm stated: “As results become available, we are trying to introduce them into our guidance documents for steering industry on how to implement REACH in practice in their registration dossiers and other obligations.”

EC Will Review Legislation to Ensure Safety of Nanomaterials

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 by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials.  Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules.  We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH.  We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

Norway Asks Businesses to Report Presence of Nanomaterials

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 Norwegian Product Register, which is administered by the SFT. The initiative will supplement Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) due to its “focus on how substances are marketed and used in real life.”

The process is not completely mandatory. According to the Board, “a legal commitment to declare a product arises only if a significant risk has been identified. . . . [f]ew nanomaterials will qualify under this criterion in the short term.”  The Board advocates a mandatory scheme as soon as it is feasible, and urges industry “to embrace the initiative right away.”

UN Committee Will Discuss Ongoing Work on the Safety of Nanomaterials

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, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

  • Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
  • Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
  • How can this be done? Should new endpoints be determined?
  • To which extent information about nanomaterials need be provided?
  • What kind of information is needed?
  • What kind of communication tool is needed for this purpose?
  • What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

 

European Parliament Urges the Labeling of Nanomaterials in Consumer Products

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 Restriction of Chemicals (REACH) concerning:

  • Simplified registration for nanomaterials manufactured or imported below one tonne;
  • Consideration of all nanomaterials as new substances;
  • A chemical safety report with exposure assessment for all registered nanomaterials; and
  • Notification requirements for all nanomaterials placed on the market on their own, in preparations, or in articles.

The EP also calls for the EC to evaluate the need to review worker protection legislation concerning:

  • The use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to detect reliably and control exposure;
  • A clear assignment of liability to producers and employers arising from the use of nanomaterials; and
  • Whether all exposure routes (inhalation, dermal, and other) are addressed.