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Posted: Feb 07, 2014

German Federal Environment Agency supports European register of nanotechnology products

(Nanowerk News) Due to the particular uncertainties concerning evaluation of the possible risks of nanomaterials for human health and the environment, the German Federal Environment Agency (Umweltbundesamt – UBA) supports the establishment of a European register of products containing nanomaterials as a precautionary measure (download "Concept for a European Register of Products Containing Nanomaterials"; pdf).
The objective of such a product register is the creation of an overview of products containing nanomaterials that have applications in the consumer area and in an open environment. This enables public authorities to set priorities in enforcement and monitoring, to estimate exposure for humans and the environment and, in the case of adverse effects, to ensure traceability. For actors in the supply chain a product register creates transparency.
The establishment of such an electronic product register should take place at the EU level und be managed centrally. A national product register would result in overlaps with varied EU legislation and in varying obligations and regulations in individual EU Member States, which would mean increased costs for authorities and stakeholders subject to notification.
Elaboration of such a product register should have the objective of avoiding duplicate obligations and maintaining a reasonable cost-benefit ratio. At the same time, there are substance-related regulatory bases (REACH and CLP Regulation) and also product-related regulatory bases (Cosmetics Regulation and Novel Food Regulation) in European law. Both legal bases should be utilized for a product register, since both contain appropriate points of departure (for example, registration and notification requirements). For the purpose of consistent legal implementation, enactment of a European product register regulation is to be recommended, which would lay down general provisions in the form of an umbrella regulation, amend existing substance- and product-related provisions, adapt or create notification requirements and consolidate generated information.
Substances and mixtures (manufactured or imported) that comprise or contain nanomaterials are subject to notification. Furthermore, articles that intentionally or unintentionally release nanomaterials (analogous to Article 7 (2) in connection with (3) REACH) should be subject to notification. Notification should basically be restricted to product name / description, characterization and concentration of the respective substance, manufactured or imported tonnage bands as well as application and functionality. It has to be ensured that products that are no longer on the market are removed from the register, and that article variants do not have to be individually registered. The register comprises a "public" part that is generally accessible and a confidential part to which only authorities have access. In order to guarantee protection of confidential information, certain data is only contained in the confidential part.
Regarding the practicability of the product register, it has to be ensured that the cost for stakeholders subject to notification and for public authorities is limited. As far as concerns products with nanomaterials, according to industry representatives several hundred nanomaterials in up to 100,000 mixtures have to be expected with further development of nanotechnology. The number of articles containing nanomaterials that are subject to notification is unlikely to be greater than this figure, since with a large proportion of such articles the release of nanomaterials can be ruled out. Reliable figures on nanomaterials in products are presently not available, however, and should be established within the scope of an "impact study". Mechanisms have also to be developed for cost-effective monitoring of provisions, since experience shows that with imported articles, in particular, a significant rate of non-compliance with notification requirements is to be expected.
Products should be assigned a notification number, which should be displayed on the respective product in order to facilitate research, without it being regarded as a warning.
A product register substitutes neither further developments in the elaboration of the REACH Regulation nor necessary, nano-specific provisions in substance-, product- and environment-related legislation, which is currently being discussed; it is merely a component thereof.
Source: Umweltbundesamt
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