General regulations

© Gina Sanders - Fotolia.com
© Gina Sanders - Fotolia.com

The legislation on occupational health and safety does not currently include specific regulations for nanoparticular substances. Adjustments to the legal framework are discussed at European and national level. In order to ensure adequate protection of health and the environment as a whole, the NanoKommission recommends a comprehensive application of the European Commission's precautionary principle to minimize potential risks (DGUV Positionspapier 2010).

REACH

In the European Union and its member countries, chemicals, and thus nanomaterials, are encompassed by the EU REACH Regulation (No. 1907/2006 ). REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals and entered into force on June 1st, 2007. REACH requires that all substances imported into the EU or produced in the EU have to be used safely and that they have to be registered by ECHA (EC 2012). All chemicals have to undergo a test procedure (MLR 2011). Thus, REACH is also applicable to nanomaterials, although these are not explicitly mentioned (EC 2012). Chemical substances can come in different forms such as solids, powders or nanomaterials. According to REACH, one registration for the different forms of a chemical substance is sufficient (EC 2012). REACH stipulates that the assessment and limitation of risks of chemicals to be the manufacturers’ responsibility. In addition, industry has to ensure that the users are provided with appropriate safety information (EC 2013). REACH is based on the precautionary principle (Art. 1) (precautionary principle for nanomaterials).

Cosmetics regulation

On January 1st 2010, the new cosmetics regulation (no. 1223/2009 ) came into force. The cosmetics regulation contains specific guidelines on the safety and labeling of nanomaterials and nanotechnologies: Only nanomaterials that are safe are allowed to be used in products. Additionally, they have to be labeled with "nano" (art. 16). Nanotechnology used in cosmetics has to be labeled with "nano" as well (Article 19) (Eisenberger et al. 2010). Nano-ingredients in cosmetics have to be approved separately. Nano-substances already in use have to be approved in a new safety-test.

Biocidal products regulation

Another EU regulation, which contains explicit provisions on nanomaterials, is the biocidal products regulation (no. 528/2012 ). Authorizations for an active substance do not cover nanomaterials unless explicitly mentioned. According to the biocidal products regulation, a separate dossier has to be compiled for nanomaterials. In addition, the ingredients that are used in its nanoform have to be labeled with "nano". According to the biocidal products regulation, the simple authorization procedure for products containing nanomaterials is not approved ( ECHA ).

Food regulation

As of December 2014, according to the regulation 1169/2011 of the European Commission, nanomaterials used in food have to be labelled with the suffix "nano". The European regulations on food additives 1333/2008 and the "novel foods" regulation 258/97 (LUBW 2012) are both legally relevant in Germany. Regulation (G) no. 1333/2008 concerning food additives requires a re-examination of substances when they are used in nanoform. The revision of the novel foods regulation failed in early 2011. 2013/0435 (COD) is a proposal of the European Parliament and of the Council for the Regulation on Novel Foods.

Voluntary measures

In addition to the legally binding regulation, there are also voluntary measures which go beyond state rules or supplement them. For example, companies can voluntarily commit themselves to stricter safety standards.

There are various approaches to the voluntary measures related to nanotechnologies. First of all, there are various so-called Codes of Conduct (CoC). In addition to the codes of conduct, there are also voluntary systems for risk management: systems with (e.g. CENARIOS ®) or without certificates as well as voluntary reporting procedures to disclose relevant data on nanomaterials and nanoproducts.

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