First Report for Denmark Nano Product Register is due August 30th, 2015
The Danish Order on a register of mixtures and articles that contain nanomaterials as well as the requirement for producers and importers to report to the register entered into force on June 18, 2014. It establishes a Nano Product Register of mixtures and articles, which contain nanomaterials, and are intended for sale to the general public. The Danish Environmental Protection Agency (EPA) will create and maintain the Nano Product Register. The first reports from manufacturers and importers are due by August 30, 2015, for the period of June 20, 2014 to June 20, 2015, and the first report by the Danish EPA will be issued in 2016.
The reporting requirement includes mixtures and articles that are intended for sale to the general public that contain nanomaterials where: (1) the nanomaterial is released under normal use of the mixture or article, or (2) where substances in soluble form that are classified as CMR (carcinogenic, mutagenic, or toxic for reproduction) or environmentally dangerous are released from the nanomaterial.
The definition provided for nanomaterials, subject to reporting follows the European Commission Recommendation 2011/696/EU for defining nanomaterials: “a natural, incidental, or manufactured material that contains particles in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm (nanometres).”
Article three of the Order lists items that will not be included in the Nano Product Register. These items are:
- medicinal products;
- medical devices;
- mixtures and articles in which the nanomaterial includes nanoscale substances listed in Annex IV or V to Regulation (EC) No 1907/2006;
- mixtures and articles for which the nanomaterial is not intentionally produced at the nanoscale;
- articles in which the nanomaterial is part of a fixed matrix, unless wear and tear, washing, breaking, and similar normal use of the article leads to the release of free nanomaterials;
- articles on which the nanomaterial is used as ink directly on the article or on the labels on the article, including newspapers, periodicals, magazines, packaging that is not coloured in the mass or dyed, etc.;
- textiles with nanomaterial used as ink or for dyeing;
- paint, wood preservative, glue and filler that contains pigments in the nanoscale where the pigments are added solely for the purpose of colouring the mixture;
- articles of rubber, or rubber parts of articles, that contain the nanomaterials carbon black (EINECS No 215-609-9) or silicon dioxide (EINECS Nos. 231-545-4, 262-373-8, 238-455-4, 238-878-4 and 239-487-1 or CAS Nos. 13778-37-5, 13778-38-6, and 17679-64-0).
Mandatory and option information to be included in the reports is provided in the Annexes to the Order. However, those who submit reports may indicate that certain information is confidential, but must justify why the information is a trade secret. In addition, the following information will be regarded as confidential without being specifically listed as confidential:
- Details of the full composition of a mixture;
- The precise use, function, or application of a substance or mixture, including information about its use as an intermediate;
- The tonnage of the substance or mixture; and
- Links between a manufacturer or importer and its distributors or downstream users.
The above information may only be disclosed if urgently needed for the protection of human health or environmental safety.
The Danish Order allows a foreign manufacturer to report certain required information on behalf of the importer. The importer must then reference the reporting numbers of the reports made on his behalf. Failure to report is subject to fines and may trigger criminal liability.
The Nano Product Register will not be publicly accessible, and access to it by Danish authorities will be restricted. The Order specifies that only the Danish EPA and the Danish Working Environment Authority will have exclusive, direct access to the Register. Furthermore, only designated employees will have direct access to the Register. Each year, the Danish EPA will publish a report on data submitted the previous year.
For further details, please click here for an unofficial English translation of the Danish Order on a register of mixtures and articles that contain nanomaterials as well as the requirement for producers and importers to report to the register. For additional information, please contact Rachida Semail at Semail@khlaw.com.