Source: http://crossborder.practicallaw.com/5-508-5987
Timestamp: 2013-05-20 01:11:05
Document Index: 201087725

Matched Legal Cases: ['§ 2601', '§ 57018', '§ 2', '§ 3', '§ 707', '§ 5', '§ 720', '§ 720', '§ 721', '§ 5', '§ 721', '§ 8', '§ 136']

PLC - The regulation of nanomaterial products
Law stated as at 01-Aug-2011
Nanomaterials have recently seen wide application to a diverse array of products. The regulatory regimes in various countries are struggling to catch up with the pace of this technological advancement. The chapter below considers recent international developments (particularly in the US and the EU) regarding the regulation of nanomaterials in commercial products to provide some clarity on the direction regulation may take in this field and to suggest a path forward for such regulation.
This chapter is part of the PLC multi-jurisdictional guide to environment. For a full list of jurisdictional Q&As visit www.practicallaw.com/environment-mjg.
Tzvi Levinson, Dario Hunter and Gil Dror, The Levinson Environmental Law Firm
Contents USThe TSCAImportingPMN requirements for nanomaterialsProcedureConsent ordersSNURSection 8(e)FIFRAA shift in policyEUThe Novel Food RegulationREACHRoHSOther EU legislationThe path forwardRegulation of nanomaterials in France: a step closerGuidance for manufacturers and importersContributor detailsTzvi LevinsonDario HunterGil DrorNanomaterials are substances that have an extremely small particulate size, typically (although not definitively) less than 100 nanometres. (For the sake of comparison, a human hair is about 80,000 nanometres wide.) Nanomaterials have recently seen wide application to a diverse array of products, including sunscreen, clothing, household appliances, cosmetics and even food packaging. The regulatory regimes in various countries are struggling to catch up with the pace of this technological advancement. So much is still unknown about the potential risks to humans and the environment posed by the use of nanomaterials. In the void caused by a lack of thorough and conclusive scientific evidence, two regulatory approaches have emerged:Refraining from tight regulation on the specific use of nanomaterials until further evidence is produced.Imposing substantial requirements on manufacturers and importers in the absence of proof of the safety of nanomaterials. This chapter surveys recent international developments (particularly in the US and the EU) regarding the regulation of nanomaterials in commercial products to provide some clarity on the direction regulation may take in this field and to suggest a path forward for such regulation. It also provides some guidance to manufacturers and importers of nanomaterials on complying with current regulation (see box, Guidance for manufacturers and importers). USThe Environmental Protection Agency (EPA) enforces US environmental legislation at a federal level. A piece of legislation of primary importance to manufacturers and importers of products containing nanomaterials is the Toxic Substances Control Act of 1976 (Toxic Substances Control Act, 15 USC § 2601) (TSCA). Individual states may produce and enforce their own legislation regulating substances in manufactured or imported commercial products, as long as it does not conflict with federal law. California, for example, has implemented a Chemical Information Call-In programme in regards to six nanomaterials (California Health and Safety Code, Ch. 699, § 57018-57020): Nano cerium oxide.Nano silver.Nanotitanium dioxide.Nanovalent iron.Nano zinc oxide.Quantum dots. This call for information from manufacturers and importers is designed to fill information gaps and aid in the regulation and management of potential risks from these substances.The Safe Chemicals Act, in its most recent form as the Safe Chemicals Act of 2011, is a repeatedly proposed and long overdue revision to the over 30 year old TSCA. Among its innovations are some provisions of particular applicability to nanomaterials. For example, under the proposed legislation, "notwithstanding molecular identity, the Administrator [of the EPA] may determine that a variant of a chemical substance is a new chemical substance…".The issue of whether a nanomaterial is another form of an existing substance, already listed in the inventory under the TSCA, or a new substance therefore subject to various filing requirements is of great importance to manufacturers and importers in regards to the expense and time exerted in readying products for the US market.The remainder of this section explains:How the TSCA operates.The impact the TSCA has on importers of substances, mixtures and articles.Pre-manufacture notice (PMN) requirements imposed by the TSCA in relation to new substances.The procedure involved in submitting a PMN.When an importer might be required to enter into a consent order, which allows for manufacture or import of a substance subject to conditions.When the significant new use rule (SNUR) applies.The specific reporting requirements of section 8(e) of the TSCA in relation to certain nanomaterials.How the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) is being used to regulate anti-bacterial uses of nanomaterials.The recent shift in government policy concerning nanomaterials, which could result in the implementation of a less burdensome regulatory regime in the future.The TSCAThe TSCA gives the EPA the authority to track and regulate production and import of chemicals into the US (TSCA § 2(c)). If chemical substances, mixtures or articles are imported, the TSCA requires that certain documentary requirements be met (similar to a local US manufacturer) (TSCA § 3(7)). The TSCA covers any new or existing substances, mixtures or articles unless specifically exempted. Existing chemicals are listed in the TSCA's Chemical Substance Inventory. Before producing or importing a new substance, manufacturers or importers must comply with PMN requirements (section 5, TSCA). The new substance is then added to the list. Some substances are assigned generic names on the list to protect the confidentiality of their identity.ImportingSection 13 of the TSCA indicates that entry to the US will be refused for substances, mixtures or articles that fail to comply with any rule under the TSCA. Importers must certify that imported substances or mixtures are in compliance with sections 5, 6 and 7 of the TSCA at import or that they are not subject to the TSCA (40 CFR § 707.20). Certification is not required for articles. US Customs can refuse entry to any shipment that does not have the required TSCA certification. Certification is provided by a signed statement on the invoice or in the entry documents indicating either that the TSCA does not apply or that the chemicals in the shipment comply with the TSCA (the exact required wording can be found in the EPA publication, Introduction to the Chemical Import Requirements of the Toxic Substances Control Act, http://www.epa.gov/compliance/resources/publications/assistance/sectors/chemimport.pdf).PMN requirements for nanomaterialsThe landscape in regards to the classification of nanomaterials as "new" or existing is changing (particularly as it applies to the enforcement of FIFRA (see below, FIFRA)). However, it is recommended that manufacturers prepare for the possibility that they will be subject to documentary requirements for a "new" substance in regards to the nanomaterials in their products. For example, in 2007, the EPA decided to treat carbon nanotubes (a material that can be used in anything from tennis balls to boating equipment) as new chemical substances, determining that "their molecular identities are different from the carbon allotropes currently listed on the TSCA inventory" (US Environmental Protection Agency, TSCA Nanoscale Materials Inventory Paper: Public Comments with EPA Responses (Dec. 20, 2007) at 11, Docket EPA-HQ-OPPT-2004-0122).Examining the example of carbon nanotubes further, an additional question has arisen regarding the scope covered by a single inventory entry, that is, whether it includes all carbon nanotube substances, only that specific instance (thus requiring PMN for others), merely all single walled carbon nanotubes or merely all multi-walled carbon nanotubes. The unique nature of nanomaterials has prompted the EPA to suggest that specific guidelines for the nomenclature of nanomaterials be developed to bring certainty to the determination of whether such materials are to be considered "new" or existing (US EPA, Consideration Relevant to Toxic Substances Control Act (TSCA) Application to Nanoscale Materials (2005), at 5-6, Docket OPPT-2004-0122). The EPA has not established clear, general standards for the identification and naming of nanomaterials. (The International Standards Organisation (ISO) is currently working on standards for the nomenclature of nanomaterials). In practice, the EPA has required all carbon nanotubes to be registered individually as new substances. According to the EPA, "no manufacturer or importer has been able to demonstrate that their carbon nanotubes are chemically identical to another manufacturer's carbon nanotubes, hence the agency has treated all carbon nanotubes as unique chemical substances" (Government Accountability Office, Nanotechnology: Nanomaterials Are Widely Used in Commerce, But EPA Faces Challenges, GAO-10549 (2010)). Based on this reasoning, the importer or manufacturer is advised not to rely on prior listings in the TSCA and to prepare for the potential necessity of filing a PMN for each nanomaterial, even if filing has already occurred for a "similar" substance. Importers are advised to question manufacturers or suppliers as to the content of supplied products, perhaps by providing a pre-printed questionnaire with specific questions about nanomaterial content.ProcedureThe manufacturer or importer must submit a pre-manufacture notice to the EPA 90 days before manufacture or importation of a new substance (TSCA § 5). This gives the EPA the allotted amount of time to determine if the substance may present unreasonable risk to human health or the environment for the uses stated in the notice. If the PMN is approved and the substance imported, a notice of commencement (NOC) must be filed within 30 days of importation (40 CFR § 720.102). After the NOC is received, the substance is then added to the TSCA inventory (40 CFR § 720.102).Consent ordersUpon reviewing the PMN, if the EPA finds that certain uses of the substance pose an unreasonable risk, the manufacturer or importer may be required to enter into a section 5(e) consent order allowing manufacture or import of the substance if the manufacturer or importer agrees to comply with certain conditions (for example, protective equipment for workers, hazard communication, testing and so on). For example, if the EPA considers a substance to contain "respirable, poorly soluble particulates" and finds that they may pose an unreasonable health risk to the lungs, a 90-day inhalation toxicity test (performed on rats) might be required (US EPA, TSCA New Chemicals Program (NCP) Chemical Categories (Aug. 2010) at 124, http://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf). The EPA may also recommend a recovery period of 60 days as a part of testing to check for the "progression of lesions". If the particles are indicated to be potentially carcinogenic, a two-year inhalation bioassay (test) may be called for. As a result, in the case of some nanomaterials, a significant amount of time may be added to the process of importation to account for testing. Once again, since the EPA has not treated individual instances of the "same" nanomaterials in prior PMNs as necessarily indicative of the properties of future cases, the possibility of testing in each case should be considered and prepared for. Obtaining thorough information from suppliers and perhaps conducting third party testing in advance may help to expedite the process of vetting nanomaterial substances.SNURA consent order is binding only on the specific PMN submitter (that is, for example, the manufacturer or importer). If the EPA has designated a use of a substance as a "significant new use" under section 5 of the TSCA, it may require, through the issuance of a SNUR, that certain information be submitted before the manufacture, import or processing of that substance for that use. The SNUR will mirror the consent order and will require the manufacturer or importer (or processor) to notify the EPA at least 90 days before commencing any activity the EPA has designated as a "significant new use". A special expedited process allows the EPA to publish a direct final rule consistent with the consent order without prior notice and comment (40 CFR § 721.160). If a stakeholder submits notice of intent to submit adverse comments during a 30-day review period, the EPA withdraws the direct final rule and issues a notice of proposed rulemaking.The SNUR also requires submission of a significant new use notice (SNUN) 90 days before commencing manufacture that does not conform to the conditions of the SNUR (TSCA § 5(a); 40 CFR § 721). The agency may also create a SNUR without a prior consent order (called a "Non-5(e) SNUR") when it identifies potential new uses different from those identified in the PMN that could result in increased exposure or releases of the substance and may result in unreasonable risk to health or the environment. The new and unique nature of nanomaterials presents some unique challenges in regards to implementation and compliance with SNURs. The size of nanomaterials is not the only consideration as they may be used in some rather surprising and novel applications. Carbon nanotubes, for example, have been used in everything from epoxy to cancer treatment. Such wide ranging uses provide a wide range of considerations concerning approval of the uses of a nanomaterial. For example, the EPA proposed and published (following public consultation) SNURs in regards to carbon nanotubes on 17 September 2010 (75 Fed. Reg. 56880 (Sept. 17, 2010)). A lack of clear criteria makes it difficult to determine if the SNURs apply in each instance, for example, to downstream users who may have changed the molecular identity of the substance through additional processing. While the EPA has released guidance, it has also re-asserted its position that the EPA would continue to determine on a case-by-case basis when carbon nanotubes made by different manufacturers and processes would be considered different chemical substances (US EPA, Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination and Nomenclature (June 2010), Docket No. EPA-HQ-OPPT-2009-0686). For downstream users, the distinguishing factor in determining whether it is a new chemical is whether the processing has caused a chemical reaction that has formed new chemical bonds. Section 8(e)Section 8(e) of the TSCA requires that manufacturers or importers report to the EPA "information which reasonably supports the conclusion" that a chemical or mixture "presents substantial risk of injury to health or the environment". The EPA has proposed specific reporting requirements for certain nanomaterials (US EPA, Spring 2010 Regulatory Agenda (Apr. 26, 2010) at 265, RIN 2070-AJ54). These proposed requirements would include reporting information on production volume, manufacturing methods, exposure and release information as well as health and safety data. Small manufacturers and processors are likely to be exempted from these requirements (TSCA § 8(a)(1)).FIFRAUnder FIFRA, products that are intended to kill or repel bacteria or germs are considered pesticides and must be registered with the EPA before sale or distribution (Federal Insecticide, Fungicide and Rodenticide Act, 7 USC § 136). A burgeoning area for the use of nanomaterials is in products claimed to have anti-microbial features due to the inclusion of nano silver (for example, air filters, washing machines and so on). Such products come under FIFRA and must comply with its provisions to be imported and sold on the US market. In December 2010, the EPA fined a manufacturer of an air purifier US$82,400 (as at 1 August 2011, US$1 was about EUR0.7) for its claims that the product could control various types of bacteria by the use of nano silver (US EPA, Hefty Fine for So Cal Company's Untested 'Nano' Claims (15 December 2010), http://yosemite.epa.gov/opa/admpress.nsf/0/3DB62E7E695B684A852577FA005948DC). The EPA cited the failure of the company to register this pesticide under FIFRA (which must occur prior to sale) as well as the unfounded claims as to its effectiveness. The purifiers also failed to list an EPA establishment number, as required by FIFRA. This active effort to regulate anti-bacterial uses of nanomaterials under existing FIFRA policy has been engaged in alongside a concerted effort to establish a specific policy targeting such materials. As published in the 17 June 2011 Federal Register, the EPA has proposed a number of possible approaches to regulation of nanomaterials in pesticide products (76 Fed. Reg. 35383-35395 (June 17, 2011)). Under the first approach, through section 6(a)(2) of FIFRA, the EPA would require those registering the pesticides to submit adverse effects information. The EPA may send a notice to the registrant requiring additional info or data. An alternative proposal involves determining on a case-by-case basis whether a nanomaterial is a "new" active or inert ingredient in a product (according to FIFRA) where a non-nanoscale form of the same substance is already registered. Comments on the proposed policy were accepted up until 17 August 2011 and an official response will be forthcoming.A shift in policyA yet to be published document from the EPA, signed 8 June 2011, indicates a shift in policy regarding how the EPA classifies and treats nanomaterials for the purpose of enforcing FIFRA. The EPA has indicated that it will engage in a case-by-case analysis in determining whether a nanomaterial in a pesticide is "new" for the purposes of regulation (76 Fed. Reg. 35383-35395 (June 17, 2010)). The EPA had previously treated all nanomaterials as new, whether or not a non-nanoscale form of the "same" substance was already registered under FIFRA. This shift in policy accords with a recent memo from the White House urging federal agencies to avoid generalising about nanomaterials and to base their administrative decisions on scientific evidence (Executive Office of the President (US), Memorandum for the Heads of Executive Departments and Agencies (9 June 2011), http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf). In future, this may result in a less burdensome regulatory regime for manufacturers and importers by potentially eliminating the need for what some in the industry see as duplicative submissions for nano-scale forms of already registered substances. TopEUThere are a few notable areas of EU regulation that address nanomaterials specifically. However, some of the most wide-ranging (in scope) EU legislation affecting substances in commercial products, for example Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS), have yet to conclusively address the issue of nanomaterials. Of the individual EU member states, France is currently closest to adopting a regulatory regime specifically governing nanomaterials (see box, Regulation of nanomaterials in France: a step closer).This section explains the extent to which nanomaterials are regulated in the EU by:Regulation (EC) No. 258/97 on novel foods and novel food ingredients (Novel Food Regulation).REACH.RoHS.Other EU legislation.The Novel Food RegulationNovel foods or food ingredients are those that have not previously "been used for human consumption to a significant degree within the European Community" (Article 1(2), Novel Food Regulation). Foods or ingredients that come under that definition (with a few exceptions) must be authorised according to a procedure set out in the regulation. This may involve a full application or a simplified application. The simplified application is available where an EU member state's competent authority believes the novel food or ingredient is substantially equivalent to an existing food or food ingredient (Article 1(2), Novel Food Regulation).In 2008, the European Parliament, European Commission and the Council of the EU began negotiations over the revision or "recast" of the Novel Food Regulation. The proposed regulation would have contained a legal definition of nanomaterial as "an intentionally manufactured material with one or more existing dimensions or an internal structure of under 10 nm or less" (European Parliament, Position of the European Parliament adopted at first reading on 25 March 2009 with a view to the adoption of Regulation (EC) No .../2009 of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 (March 25, 2009)). The proposal also contained an authorisation procedure for approval of novel foods and/or ingredients with nanomaterials as well a requirement to place the word "nano" on the labelling for food products containing nanomaterials. On 28 March 2011, the three EU institutions involved failed to reach a consensus on the issue of cloning and whether or not food from cloned animals and their descendants should be subject to a ban (European Parliament, Novel Foods talks collapse on Council refusal to label clone-derived products (March 29, 2011), http://www.europarl.europa.eu/en/pressroom/content/20110328IPR16525/html/Novel-Foods-talks-collapse-on-Council-refusal-to-label-clone-derived-products). As a result, the future of the proposed revision is uncertain. However, since the primary reason for the failure of the proposal was not the issue of nanomaterials, manufacturers and importers should expect that the proposed provisions in relation to nanomaterials may resurface in the future. REACHREACH controls the production, use and distribution of chemicals. It requires that all companies manufacturing or importing chemical substances into the EU (in quantities more than one tonne per year) register the substances with the European Chemicals Agency (ECHA). REACH applies to some substances in articles, potentially affecting some manufacturers who import manufactured articles into the EU.REACH and the REACH guidance documents put out by the EU apply to nanomaterials. However, the current regulation and guidance do not give specific advice on nanomaterials. As a result, the EU has initiated REACH implementation projects on nanomaterials (RIP-oNs) to provide scientific and technical advice on bringing nanomaterials under REACH compliance (The European Chemical Industry Council (CEFIC), Nano and REACH Workshop − Presentations: RIP-oN 1 Overview, http://www.cefic.org/Documents/IndustrySupport/REACH%20Implementation/REACH%20and%20Nano%20Workshop/2011-06-23/Nano%20REACH%20Workshop%20-%20RIP-oN1%20overview%20-%20Birgit%20Sokull-Kluettgen.pdf). Three reports will be developed:RIP-oN 1: on substance identification (SI).RIP-oN 2: on information requirements.RIP-oN 3: on chemical safety assessment.Under REACH, generally a substance is identified by its chemical composition, chemical identity and the content of each constituent in the substance. In some cases, additional identifying substance information may be required. Different REACH substances can be distinguished from each other by "identifiers" and the forms of the same substance by "characterisers". RIP-oN 1 aimed to evaluate how existing guidance for identifying and naming substances under REACH applies to nanomaterials. Where necessary, it also sought to develop specific advice on how to establish the SI of nanomaterials. The participants in the process included EU institutions, member states, industry organisations and environmental non-government organisations. The resulting report did not conclude with a single cohesive approach; instead it provided a range of options. Operating under a working definition of nanomaterials as "particles and tubes with at least one dimension < 100 nm", the group debated whether size should be used as an "identifier" or perhaps merely a "characteriser". Another proposed approach included considering size in combination with significant changes in properties (that is, distinguishing the nano-forms).The issue of surface treatment as an identifier was also addressed. Section 6.3.8 of the REACH FAQ states that "chemically surface treated substances should not be registered as such under REACH". While ECHA has indicated that it does not consider this to apply to nanomaterials, the industry view is that it does apply and that registering the different nanomaterials based on this distinguishing feature (that is, of surface treatment) would be unnecessarily (and expensively) duplicative. The finalised recommendations for RIP-oN 1 were issued in an advisory report in March 2011.RIP-oN 2 is tasked with developing advice on how REACH requirements regarding nanomaterials may be met and the information needed for safety evaluation and risk management. RIP-oN 3 is tasked with developing advice on how to conduct exposure assessments for nanomaterials within the context of REACH. Both of these ongoing processes have yet to conclude and produce finalised recommendations.The lack of regulation and guidance specifically addressing REACH obligations in relation to nanomaterials may be remedied after a scheduled review process is completed. By June 2012, the Commission must conduct a review of various aspects of REACH including a review of the scope of REACH. It is expected that, as part of this review process, there may be a proposal of legislative provisions specifically addressing the regulation of nanomaterials.RoHSRoHS regulates the use of certain hazardous substances in electronic and electrical equipment (EEE). The six substances regulated are: Lead.Mercury.Cadmium.Hexavalent chromium.PBB.PBDE.For each of the substances other than cadmium, the established limit for these substances is 0.1% or 1,000 ppm by weight of homogenous materials; for cadmium it is 0.01% or 100 ppm.A recast (that is, amended) version of RoHS came into force on 21 July 2011. Although prior drafts of the proposed legislation took a more proactive approach to regulating nanomaterials in EEE, the final version, due in part to comments from industry stakeholders, is measured in its approach. Article 16 states that "as soon as scientific evidence is available… the restriction of other hazardous substances, including any substance of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous… should be examined". In reviewing the list of restricted substances, the Commission will consider whether such substances could (Article 6, RoHS):Have a negative impact on EEE waste management operations.Produce uncontrolled or diffuse release of hazardous materials into the environment.Leave hazardous residues.Expose workers to unacceptable risks in EEE waste management. The Commission will also consider whether such substances could be substituted with those of a lesser negative impact. The recast directive sets out to study and evaluate nanomaterials as nanomaterials, a distinct "class" of substances, for future consideration. The result of further evaluation may involve regulation of the uses of certain nanomaterials deemed hazardous in EEE and possible further amendments to RoHS to reflect the body of currently developing scientific research on nanomaterials.Other EU legislationThe following regulations have an impact on nanomaterials:Regulation (EC) No. 1223/2009 on cosmetic products, which requires manufacturers of cosmetic products containing nanomaterials to notify the relevant competent authorities six months before placing them on the market. Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with food, which indicates that the usage of new technology such as nanomaterials in active materials (that is, materials intended to extend the shelf life or to maintain or improve the condition of packaged food), intelligent materials (that is, materials and articles that monitor the condition or environment of packaged food), as well as other articles intended to come into contact with food, will be evaluated for risks on a case-by-case basis (section 14).The development and implementation of these provisions demonstrate the application of the precautionary principle in EU nanomaterial regulation, opting for a "wait and see" approach to the current lack of scientific certainty on the risks of nanomaterials. TopThe path forwardPerhaps the largest variable concerning the issue of regulating nanomaterials is clearly identifying and classifying the various substances considered to fall under that class of substances. There are a number of similar working definitions for nanomaterials (for example, compare the definition used in recent proposed French legislation to that of the RIP-oN 1 working group (see box, Regulation of nanomaterials in France: a step closerandabove, EU: REACH). However, the exact definition of a "nanomaterial" has yet to be completely clarified.The widespread usage of nanomaterials is a relatively new development. However, it is not the first instance in which regulation of chemicals has been hampered by a lack of common standards. When it became apparent that the various standards for classifying chemical hazards from country to country would hamper the identification and regulation of hazardous materials, the United Nations devised the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). The GHS system classifies the substances or mixtures based on the nature of the hazards presented, as determined through tests, scientific literature and practical experience. As such it reduces the amount of duplication in regards to technical filings and testing for individual substances. There is a need for a GHS-like system of standards for identifying and classifying nanomaterials and their possible hazards. The active participation of various supranational organisations and stakeholders in the process of formulating the GHS as well as the wide adoption and application of the standards indicates that the development of such common standards is indeed possible. It would be preferable if the various working groups studying the issue on behalf of various international organisations (for example, the Organisation for Economic Co-operation and Development, the EU, ISO and so on) expressed a clear will to orient their work towards the development of a common effort in classifying nanomaterials. TopRegulation of nanomaterials in France: a step closerOf all of the EU member states, France appears to be closest to establishing a regime imposing specific requirements on manufacturers and importers of nanomaterials into its internal market. Under Article 185 of France's Environmental Commitment Bill (12 July 2010), "[p]ersons who manufacture, import or distribute nanoscale substances, either in pure form or contained in loose mixtures, or materials that will discharge such substances under normal or reasonably foreseeable conditions of uses, shall periodically declare to the administrative authority… the identity, quantities and uses of those substances, as well as the identity of the professional users to whom they were sold or given free of charge". An enabling decree was drafted and made available to the public for commentary by stakeholders. The period of consultation ended on 28 February 2011; a resulting final draft of the decree is yet to be produced. In the proposal made available to the public, "a substance in a nanoparticulate state" was defined as a substance that meets at least one of the following criteria:The particles of which it consists have one or more dimensions between 1 and 100 nanometres for at least 1% of the distribution of their numbers according to their size.Its internal structure and its surface structure have included one or more dimensions between 1 and 100 nanometres.Its specific surface area per volume is greater than 60 metres squared per centimetre cubed, excluding substances consisting of particles whose size is less than 1 nanometre. (Minister of Ecology, Sustainable Development, Transport and Housing (France), Projet de décretrelatif à la déclarationannuelle des substances à l'étatnanoparticulairemisessur le marché (Dec. 2010), www.developpement-durable.gouv.fr/IMG/pdf/DecretNano_consultation.pdf.)Manufacturers, importers and distributers would have to report on an annual basis regarding the nanomaterials made available on the French market if they exceed the threshold of 10 grams per year. The report would have to be submitted electronically by 1 May each year, in a form and manner yet to be described (but which will be in accordance with a joint order of the Ministers of the Environment, Agriculture, Health and Labour). The registrant may request that certain information made in the declaration be kept confidential to protect trade secrets. Importers will want to keep informed of the developments concerning this regulation to ensure that any expected future reporting requirements are complied with in a full and timely fashion.TopGuidance for manufacturers and importersImporters and manufacturers should enquire of suppliers whether or not their products contain nanomaterials. Reliance on suppliers, however, may not be enough: where deemed necessary, third-party testing should be undertaken to identify the chemical nature of supplied substances or mixtures, as well as any potential hazards. The production of such information in advance will assist compliance with regulations and minimise the amount of time it takes for national authorities to vet the safety of manufactured or imported products.Importers and manufacturers should keep well informed of the ongoing developments in the process of developing nanomaterial legislation. There will often be public consultation on proposed rules; these consultations provide a valuable opportunity to voice practical concerns about proposed legislation that may affect the final draft or cause the proposal to be dropped altogether. The resulting impact may be crucial to the amount of time and expense required to make manufactured or imported goods ready for market.Finally, an international harmonised standard is necessary to clear up confusion from country to country over the identification and potential hazards of nanomaterials (see main text, The path forward). One of the ways industry can aid in this potential development is by voicing the need for such collaboration in any public consultation over nanomaterial regulation.TopContributor detailsTzvi LevinsonThe Levinson Environmental Law FirmT +972 4 852 5246F +972 4 864 3827E tzvi@environment.co.ilW www.environment.co.ilQualified. Israeli Bar, 1990Areas of practice. Environmental regulation; environmental consultancy; environmental litigation.Recent transactions. Engaged in preventative and compliance counselling as well as environmental litigation (civil, administrative and criminal) for various high profile international companies. For more details of recent transactions, publications, and so on, see full PLC Which lawyer? profile here.Dario HunterThe Levinson Environmental Law FirmT +972 4 852 5246F +972 4 864 3827E dario@environment.co.ilW www.environment.co.ilQualified. Law Society of Upper Canada, 2009Areas of practice. Environmental regulation; environmental consultancy; environmental litigation.Recent transactions. Engaged in preventative and compliance counselling as well as environmental litigation (civil, administrative and criminal) for various high profile international companies.Gil DrorThe Levinson Environmental Law FirmT +972 4 852 5246F +972 4 864 3827E gil@environment.co.ilW www.environment.co.ilQualified. Israeli Bar, 2004Areas of practice. Environmental regulation; environmental consultancy; environmental litigation.Recent transactions. Engaged in preventative and compliance counselling as well as environmental litigation (civil, administrative and criminal) for various high profile international companies.
Resource ID: 5-508-5987
Law stated date: 01-Aug-2011
Products: Environment multi-jurisdictional guide, PLC Cross-border, PLC UK Corporate, PLC UK Environment, PLC UK Law Department, PLC UK Public Sector, PLC US Environmental, PLC US Law Department
{ "siteName" : "PLC", "objType" : "PLC_Doc_C", "objID" : "1247532989843",
"objName" : "The regulation of nanomaterial products",
"objUrl" : "http://crossborder.practicallaw.com/cs/Satellite/5-508-5987?null",
"analyticsPermCookie" : "26e711cc7:13ebe720f59:-379e",
"analyticsSessionCookie" : "26e711cc7:13ebe720f59:-379d", "statisticSensorPath" : "http://analytics.practicallaw.com/sensor/statistic"