The Danish Environmental Protection Agency (Miljøstyrelsen) launched on 4 July a public consultation related to a draft executive order for a register for mixtures and products that contain or releases nanomaterials and the duty of manufacturers and importers to provide information to the register.
Manufacturers and importers would annually have to provide a range of information about mixtures and products that contain nanomaterials that were sold to private users (i.e. consumers) in the previous year. The registeration requirement is conditioned to nanomaterials that are released during the use of the product, or if the nanomaterial is the cause of hazardous materials being released from the nanoproduct. The definition of nanomaterials in the executive order follows the European Commission definition.
A range of exemptions are indicated that exclude certain activities or products from registration. Firstly nanoproducts sold between businesses do not require registration. Secondly products that fall under areas where specific regulations are already in place are also excluded (e.g. food, feed, pharmaceuticals, medical devices, cosmetics, pesticides and waste). Thirdly a number of specific products, in which nanomaterials are used, are also excluded:
- Nanosized products of substances in REACH Annex V
- Products where the material is not consciously produced in nanosize
- Products where the nanomaterial is in a fixed matrix
- Products where the nanomaterial is used as printing ink directly on the product or on labels on the product
- Textiles where the nanomaterial is used as printing ink or to colouring of the textile
- Paints and wood protection products containing titaniumdioxide where the sole purpose for the titanium dioxide is to colour the product
- Products of rubber or rubber parts that contain the nanomaterials carbon black or silicondioxide.
- Products imported for private use
- Products used for research and development
The executive order acknowledges that manufacturers and producers that are already required to notify the same product to the Danish product registry can avoid reporting the same information to the nano register. Confidential information reported to the register will be protected and therefore the register will not be publicly available, but it is also acknowledges that the Danish act on public access would be applicable. The Danish Environmental Protection Agency will public an annual report with the collected results.
The draft executive order prescribes that the first reporting (for the year 2014) should be done at the latest 31 January 2015.
Information to be provided to the register has both a compulsory part and a voluntary part. The required information (stipulated in Annex I) includes e.g. general information such as the name and address of the registrant, name of the product, amount of products, professional use and description of the use. The required nanospecific information includes the name of the nanomaterial, information on whether the nanomaterial or the substance is registered in REACH and the form the nanomaterial is in the product (e.g. solid, dispersion, aerosol etc) as well as IUPAC name, CAS number and EC-number (EINECS, ELINCS, INCI) and the formula.
In annex II, voluntary information that can be provided is outlined. This information includes the chemical product and article category following REACH, the content of the nanomaterial per product reported in grams or in percent as well as physicochemical information (e.g. particle size, size distribution, aggregation/agglomeration, form, crystalline form, surface area, surface chemistry and surface charge).
A guidance will be made available later in 2013 to support the executive order. The guidance will describe how the registration will be performed, and provide a number of examples to facilitate what products should be registered. The deadline to provide input to the public consultation to the Danish Environmental Protection Agency (Miljøstyrelsen) is 16 August 2013. The link to the Danish public consultation is http://hoeringsportalen.dk/Hearing/Details/16910 (in Danish).
NIA has started an NIA Exclusive Members Consultation on the topic with the aim to provide a reply to the Danish Environmental Protection Agency.