The European Commission is clarifying the definition of nanomaterials in a new Recommendation. A deliverable of the Chemicals Strategy for Sustainability, the new Recommendation supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors. The new definition should be used in EU and national legislation, policy or research programmes.
Nanomaterials consist of differently shaped small particles no larger than one hundred nanometers, or about one thousand times smaller than the thickness of a human hair. As a result, nanomaterials have specific properties and some are exploited by industry and in products. Because of these properties, nanomaterials are subject to specific regulatory scrutiny, both by general chemicals legislation (REACH) and by sectoral legislation addressing their use in certain products, such as biocides, cosmetics or food.
The new definition replaces the initial definition of 2011. The changes were developed following a comprehensive review, and should allow easier and more efficient implementation, but will not significantly affect the scope of identified nanomaterials.
The specific properties of nanomaterials are a great driver for innovation, but may also increase the toxicity of the material or require different procedures for safe use. Therefore, several EU laws include additional nanomaterial provisions to ensure adequate data collection, risk assessment and, in selected cases, labelling of products to inform consumers on the presence of nanomaterials. The decision to trigger all these provisions is based on the applied definition of nanomaterial.
Individual definitions of nanomaterials still exist in EU legislation in the food and cosmetics sector, while other EU laws (e.g. REACH, Biocidal Products Regulation, Medical Devices Regulation) and some national legislation already use the common definition from the Commission Recommendation 2011/696/EU, making it legally binding within their scope. Following this update, the Commission will now strive to use the revised definition to align legislation across all sectors.
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- 10 birželis 2022
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