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Posted: May 5, 2010
Publication of the Report of the Questionnaire on Regulatory Regimes on Manufactured Nanomaterials
(Nanowerk News) One of the objectives of the WPMN project on Co-operation on Voluntary Schemes and Regulatory Programmes is to identify applicable (current and proposed) regulatory regimes and how they address information requirements, hazard identification, exposure mitigation, risk assessment and risk management measures for manufactured nanomaterials.
The current document presents the information obtained from the WPMN Questionnaire on Regulatory Regimes for Manufactured Nanomaterials issued July 28, 2008. Responses received are summarized in the Tables (see Annexes).
Twenty-four responses were received from nine jurisdictions for Legislations covering a wide variety of chemical substances and/or products including industrial chemicals, pesticides, fertilizers, agricultural compounds, fuels and fuel additives, food and food additives and veterinary medicines. Other Legislations reported included those covering occupational health and safety, consumer products, control of major accidents and labelling and packaging. Although a wide variety of sectors are represented in the data obtained, it is noted that responses from the industrial chemical sector were in the majority for those Legislations reporting pre-market and/or post-market registration/notification and assessment.
None of the respondents reported having legislation specific to nanomaterials, however most respondents indicated that the authority to regulate substances that are nanomaterials, or products containing nanomaterials, exists in current Legislation. Since nanomaterials and products containing nanomaterials are currently being regulated under existing Legislations, and given the qualitative nature of the survey itself, the results of this analysis have been limited to identifying the number of legislations with various features that may be of use in the registration/notification and assessment of nanomaterials. Readers are cautioned that the features mentioned may not be relevant for all Legislative mandates, nanomaterials or products, and that response from the industrial chemical sector dominate.
Of the twenty-four (24) Legislations reported, fourteen (14) have pre-market registration/notification and assessment of substances. Of these fourteen (14), seven (7) represent the industrial chemical sector, three (3) represent the agricultural sector, two (2) represent the labelling sector, one (1) represents the occupational health and safety sector and one (1) represents the fuel and fuel additives sector. Of these fourteen (14) Legislations, eight (8) do not have trigger quantities for registration/notification, allowing these jurisdictions to assess nanomaterials imported, manufactured, used or disposed of in any quantity. The other six (6) Legislations however, do have trigger quantities ranging from 10-1000 kg/year. Depending on the substance identification and conditions of manufacturing, registration/notification based on trigger quantities may present a problem for these jurisdictions wanting to assess nanomaterials when it is manufactured, imported, used or disposed of at quantities below the trigger volume for registration/notification.
Of the fourteen (14) Legislations reported to have pre-market registration/notification and assessment of substances, ten (10) were reported to have a tiered or graduated assessment approach based on volumes, substance type4 and/or substance hazard. The presence of a tiered or graduated assessment approach that can be based on substance type is promising for jurisdictions planning to amend their Legislations to include specific provisions for nanomaterials.
Although none of the fourteen (14) Legislations with pre-market registration/notification and assessment of substances have specific information requirements for nanomaterials, nine (9) Legislations were reported to have a mechanism to require new information and/or testing for the assessment or as part of a risk management measure.
Of the twenty-four (24) Legislations reported, fifteen (15) have registration/notification, and/or assessment and/or management of substances already in commerce. Of these fifteen (15), eight (8) represent the industrial chemical sector, three (3) represent the agricultural sector, two (2) represent the worker protection sector, one (1) represents the labelling sector and one (1) represents the fuel and fuel additives sector. The ability to assess substances already in commerce is beneficial in order to be able to assess those nanomaterials which may not have received pre-market assessment, either because they exist below trigger quantities for pre-market assessment, or because their molecular composition is indistinguishable from their larger counterparts. The requirement to re-register whenever there is a change to the substance, hazard or classification is also beneficial if assessment is triggered because of the manufacture, import or use of the substance in a nano-sized form. Some registrations/notification and assessments are triggered by volume, which may limit the usefulness of these provisions for those nanomaterials imported, manufactured or used at low volumes.
Eleven (11) of fifteen (15) Legislations are reported to have an inventory of chemicals in commerce, but only the EU indicated that nanomaterials could be identified in the inventory when the properties of the nanomaterial results in a different hazard classification. The ability to distinguish nanomaterials from their larger counterparts with the same molecular composition would assist regulatory agencies with their assessments and help the public and workers identify which form of a substance is in use. As well, the inability to identify a nanomaterial from its larger counterpart also limits the usefulness of non-CBI registration, assessment and risk management information available to the public, workers and companies in the supply chain.
In conclusion, nanomaterials and their associated products are currently being regulated under existing Legislations in many countries. As the work and science of the various steering groups within the OECD WPMN progresses, various jurisdictions may wish to amend existing regulations, or develop new provisions for the regulation of nanomaterials and their products based on project findings. Section IV of this report presents a summary of legislative features identified in legislations currently providing regulatory oversight of nanomaterials and their products. It is noted that not every feature was present in every Legislation, nor is it assumed that every feature listed is relevant for all Legislations. It is further noted that the effectiveness of the identified Legislative features in protecting the environment and human health has not been determined.