EU law

In the European Union (EU), nanomaterials fall within the scope of various regulations and directives. Some of these already contain nano-specific provisions, while amendments are being discussed for others.

EU law

The following table contains the nano-specific regulations in various EU regulations. A proposal for a European framework definition of the term nanomaterial (11 October 2011) is currently being reviewed. Specific requirements for nanomaterials in the annexes of the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are being prepared (European Commission, 2012).

Nano-specific regulations in the EU

  Authorisation

Registration

Labelling

Foods

Nano-sized additives and ingredients for food and plastics that come into contact with food must be evaluated and authorised as such. 1, 2, 3

 

Nanomaterials must be labelled (nano) in the list of ingredients for foods 7

Cosmetic products 4

 

Nano-cosmetics: must specify the NMs they contain and provide information on their safety

Nanomaterials must be labelled (nano) in the list of ingredients

Biocidal products 5

Nano-sized active ingredients must be evaluated and authorised as such

 

Hazard classification and labelling in accordance with CLP 8

Nanomaterials must be labelled (nano) in the list of ingredients

Chemicals 6

 

NM to be registered as a separate substance or as a specific form of the bulk material

Hazard classification and labelling in accordance with CLP 8

1 Food additives regulation (EC) No.1333/2008, 16 December 2008
2 Regulation on plastic materials and articles intended to get into contact with food (EU) No. 10/2011, 14 January 2011
3 Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
4 Regulation on cosmetic products (EC) No. 1223/2009, 30 November 2009
5 Biocidal products regulation (EU) No. 528/2012, 22 May 2012
6 REACH does not yet have any specific requirements for nanomaterials. However, there are recommendations on how nanomaterials are to be handled under REACH: Nanomaterials in REACH, CA/59/2008 rev.1, December 2008
7 Regulation on the provision of food information to consumers (EU) No. 1169/2011, 25 October 2011
8 Regulation on the classification, labelling and packaging of substances and mixtures (EU) No. 1272/2008, 16 December 2008

Last modification 18.12.2018

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