Current status of substances and products regulations for nanotechnologies

REACH is the E.U. Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008.  The purpose of REACH is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on internal market while enhancing competitiveness and innovation. REACH lays down provisions on substances, which apply to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. REACH is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.

Although there are no provisions in REACH referring specifically to nanomaterials, REACH deals with substances, in whatever size, shape or physical state. Substances at the nanoscale are therefore covered by REACH and its provisions apply. It thus follows that under REACH manufacturers, importers and downstream users have to ensure that their nanomaterials do not adversely affect human health or the environment.  The European Chemicals Agency (ECHA) receives the REACH registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.

Nanomaterials that fulfil the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures must be classified and labelled. This applies to nanomaterials as substances in their own right, or nanomaterials as special forms of the substance. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous should have been notified to ECHA by 3rd January 2011. Any further update to the classification must also be notified without undue delay. ECHA has made a classification and labelling inventory.

ECHA’s REACH Technical Guidance Documents implementation until recently gave no specific guidance concerning nanomaterials. There was a technical manual on how to include information on nanomaterial in a IUCLID dossier which is an integral part of every REACH registration. This manual describes possibilities and best practices to include nanomaterials and to structure the available nanomaterial information. The latter is particularly important when nanomaterials are additional forms of a substance rather than substances in their own right. Further guidance on the clarification and elaboration of the REACH information requirements and the Chemical Safety Assessment in case of nanomaterials is needed as registration dossiers for nanomaterials must be prepared or updated by companies and reviewed by ECHA.

Work in the scientific community as well as in international organisations has been ongoing for almost a decade on methodologies for assessing risks associated with nanomaterials. On this basis the Commission launched a comprehensive REACH Implementation Project on Nanomaterials (RIP-oN) in 2009 to provide advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements [pdf] and Chemical Safety Assessment [pdf]. 

Based on the scientific and technical state of the art recommendations in these reports, on the 30th April 2012 ECHA published three new appendices, updating Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA), providing recommendations for registering nanomaterials.

A third report of the RIP-oN project relates to Substance Identity. The final report [pdf] is available but as it was not possible to reach consensus amongst the experts on the recommendations, further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.

Further information on REACH & CLP can be found on the European Chemicals Agency (ECHA) website.

The mission of the US EPA is to protect human health and the environment. It accomplishes this via research activities (including internal research and a grant award system), sponsorship of partnerships, and provision of education. In relation to regulation, the EPA is charged with implementation of environmental laws passed by US congress via development and enforcement of Regulations. 

In October 2008, the EPA announced that carbon nanotubes were distinct from graphite and other forms of carbon listed on the Toxic Substances Control Act (TSCA) inventory (EPA, 2008). This announcement sparked much debate amongst stakeholders as to its potential impact on other nanomaterials, in particular whether:

• all NM may be listed as new substances (and hence subject to 90-day pre-manufacturing notices (PMN) prior to manufacture or importation in the US), or 
• the EPA may implement tools such as the Significant New Use Rules (SNURs) to restrict the uses of particular nanomaterials shown to pose risks to consumers or the environment. 

At the current time, it remains the case that for NMs other than CNT the original TSCA policy (which considers that a chemical's size doesn't affect its molecular identity) still stands. Thus, TSCA does not require registration and testing for nanoscale versions of materials already in its inventory, but considers nanoparticles with novel molecular structures as new materials (i.e. carbon nanotubes).

In 2008, the EPA created the Nanoscale Materials Stewardship Program (NMSP) to collect information about the EHS risks of nanomaterials on a voluntary basis from participating manufacturers. An interim report of this programme was published in january 2009. This stated that the EPA was approximately halfway through its data collection and development of well-characterized tests for risk assessment, and concluded that 'based on the current interim results, the NMSP can be considered successful'. However, the report also acknowledged that gaps in data do exist and that some unresolved risk concerns remained. 

It is expected that EPA officials will complete the data collection phase of the NMSP in 2010. Following this, they expect to be in a position to propose new rules and to open these for public comment (a legal requirement for any Significant New Use Rules (SNUR)). Based on evidence to date, it is possible that the EPA may implement new regulations for nanomaterials within 2011. 

Many nanoscale materials are regarded as "chemical substances" under the US Toxic Substances Control Act (TSCA). In order to ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, the US EPA is pursuing implementation of a comprehensive regulatory approach under TSCA, which encompasses: 

• Premanufacture notifications;
• Significant New Use Rules;
• Information gathering rules; and
• Test rules.

1. Premanufacture Notifications

Regulation EC 258/97 of 27 January 1997 of the European Parliament and the Council lays out detailed rules for the authorisation of novel foods and novel food ingredients (those that have not been used for human consumption to a significant degree within the European Community before 15th May 1997).  A draft update of this regulation, passed by the European Parliament in July 2010, included a stipulation to ban nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorised be clearly labelled as such.  However, the European Parliament and European Union Council have thus far failed to reach agreement on an update to the novel foods regulation to address several issues, including nanoscale ingredients in food.  The EP issued a statement on the 29th March 2011, statement, which notes that the failure to reach an agreement on the legislation means "[t]here will continue to be no special measures regarding nanomaterials in food".

The U.S. FDA regulates a wide range of products, including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilise nanotechnology or contain nanomaterials.

The FDA Nanotechnology Task Force, formed in August 2006, is charged with determining regulatory approaches that encourage the continued development of innovative, safe, and effective FDA-regulated products that use nanotechnology materials.

The FDA’s approach to the regulation of nanotechnology products is outlined on its website, where it is stated: 

"The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus evaluations of safety or effectiveness of FDA-regulated products that include nanomaterials or otherwise involve the application of nanotechnology should consider the unique properties and behaviors that nanomaterials may exhibit. However, FDA does not categorically judge all products containing nanomaterials or otherwise involving the application of nanotechnology as intrinsically benign or harmful. FDA will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction."

The FDA Nanotechnology Regulatory Science Research Plan lays out a framework and implementation plan to provide coordinated leadership on regulatory science activities and issues related to FDA-regulated products that either contain nanomaterial or otherwise involve the application of nanotechnology.  The goal of providing coordinated leadership of FDA’s regulatory science research helps to address key scientific gaps in knowledge, methods, or tools needed to make regulatory assessments of these products.  

For more information on current FDA regulatory guidance on nanotechnology, see Draft Guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.  In April 2012, FDA issued for public comment two product-specific draft guidance documents to address the use of nanotechnology by the foods and cosmetics industries.  These guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report. 

Further information regarding FDA’s nanotechnology related activities and policy developments can be found on the FDA website. 

All food supplied in Australia and New Zealand must comply with the Australia New Zealand Food Standards Code (the Code) and be safe for human consumption. Any new food substances that are manufactured using nanotechnologies that may present safety concerns will, as with any other substance, have to undergo a comprehensive scientific safety assessment under the appropriate Standard before they can be legally supplied in Australia and New Zealand.  An application must be submitted to FSANZ that meets the requirements set out in the FSANZ Application Handbook.

Using the best available scientific evidence, FSANZ states it has adopted a range of strategies to continually review and manage potential risks associated with nanotechnologies in foods to ensure the public are not exposed to any health or safety issues.  These strategies include:

• amending the FSANZ Application Handbook to support new food regulations and ensure applicants provide all the necessary information to help FSANZ conduct a risk assessment;
• advising the food industry about the amendments to the Application Handbook involving nanotechnology and asking industry for information about proposed nanotechnology applications;
• engaging with other national regulatory agencies, industry and the public to outline FSANZ’s regulatory responses.

Further information on FSANZ stance with regard to nanotechnology in food products is available on its website.

In November 2009, the European Union Council agreed to recast some 55 directives relating to cosmetics into a single regulation on cosmetic products, Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products.   As the first piece of national or supranational legislation to incorporate rules relating specifically to the use of nanomaterials in any products, this regulation is considered to be very significant (Bowman et al., 2010).  

For the purposes of this Regulation, the following definition applies to the term "nanomaterial": an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.  Adaptation of this definition, to bring it in line with the EU definition of the term 'nanomaterial', is understood to be underway.

 

In July 2012, the European Commission published Guidance on the Safety Assessment of Nanomaterials in Cosmetics [pdf].  The document was drafted by the Scientific Committee on Consumer Safety (SCCS) to help the cosmetics industry comply with article 16 of the Regulation on cosmetic products , which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013. 

From the 11th January 2013, the cosmetics industry will have to notify to the Commission, through the Cosmetic Products Notification Portal, all cosmetic products containing nanomaterials, six months prior to placing them on the market. They will also have to provide specific data relevant for risk assessment purposes, which the Commission will submit to the SCCS, in case it has concerns. A checklist of required data has been included in the new Guidance to help them do so.

In light of the rapid advances in the field of nanotechnology and the ever increasing scientific knowledge about the safety of nanomaterials, the present Guidance is likely to be updated regularly.

In addition to the notification requirement described above, the Cosmetics Regulation requires labelling of nanomaterials (name of the ingredient, followed by 'nano' in brackets) in the ingredients list. When there are concerns over the safety of a nanomaterial, the Commission will refer it to the Scientific Committee on Consumer Safety (SCCS) for risk assessment.

Further information on the EU Cosmetics Regulation is available here. 

The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency created in 1973. CPSC’s jurisdiction includes over 15,000 types of consumer products used in or around the home, except certain items excluded by statute, for example, motor vehicles, tobacco, food, drugs, cosmetics, most medical devices, and pesticides. Examples of products that are regulated by CPSC include clothing, hazardous household cleaners and substances, electronic devices, appliances, furnishings, building materials, toys and other juvenile products.

According to the CPSC nanotechnology statement [pdf]:  

"The potential safety and health risks of nanomaterials, as with other compounds that are incorporated into consumer products, can be assessed under existing CPSC statutes, regulations and guidelines. Neither the Consumer Product Safety Act (CPSA) nor the Federal Hazardous Substances Act (FHSA) requires the pre-market registration or approval of products. Thus, it is usually not until a product has been distributed in commerce that the CPSC would evaluate a product’s potential risk to the public."

"In the absence of an express regulation, as it does with other consumer products, the staff will look to see whether a defective product composed of or containing nanomaterials creates a substantial risk of injury to the public because of, among other factors, the pattern of the defect, the number of defective products distributed in commerce, and the severity of the risk."

Established in 1990, NICNAS:

i) Provides a national notification and assessment scheme to protect the health of the public, workers and the environment from the harmful effect of industrial chemicals and;

ii) Assesses all chemicals new to Australia and assesses those chemicals already used (existing chemicals) on a priority basis, in response to concerns about their safety on health and environmental grounds.

The regulation of industrial chemicals in Australia distinguishes between those listed on the Australian Inventory of Chemical Substances (AICS) (i.e. chemicals with a prior history of approval and use in Australia) known as 'existing' industrial chemicals, and those not listed on the AICS, known as 'new' industrial chemicals.

In January 2011, and following extensive consultations with stakeholders (both in industry and the public more generally) from 2006 to 2010, NICNAS changed the administrative arrangements for the regulation of 'new' industrial chemicals to provide that nanoforms of these chemicals must be notified and assessed for their safety before they can be marketed. Exemption is subject to very strict criteria. The arrangements are summarised in Guidance for Notifiers Handbook: New Chemical Requirements for Notification of Industrial Nanomaterials [pdf] - including a working definition of 'industrial nanomaterials' and advice on exemptions, permits, certificates, conditions and data requirements.

Since the arrangements were introduced, NICNAS has provided technical support to industry; implemented administrative changes to capture and monitor notifications of nanoforms of new industrial chemicals; and initiated compliance activities to ensure industry uptake.

A discussion paper proposing an arrangement suited to the regulation of nanoforms of 'existing' industrial chemicals is being developed by NICNAS and the NICNAS Nanotechnology Advisory Group as a basis for public consultations in 2011-12.

NICNAS continues to build its technical capacity in the identification of potential hazards and in risk assessment methodology, processes and practices to ensure that it takes a precautionary approach in making recommendations about risk mitigation.  NICNAS's specific areas of technical interest include:

• international best practice in the risk assessment of industrial nanomaterials;
• toxicity of selected nanomaterials that have been commercialised or are nearing commercialisation. 
• hazard assessment of titanium dioxide, zinc oxide, cerium oxide and silver nanoforms (a series of publications on these nanoforms is in development).

NICNAS has also established a Nanotechnology Advisory Group to advise on strategic directions NICNAS might take in addressing the potential impacts of nanomaterials as industrial chemicals.  Meetings of the Group are reported in NICNAS Nanotechnology Advisory Group Meetings, Statement of Outcomes.  

Further details of NICNAS's regulatory activity in regards to nanotechnology are available on its website.