1. INTRODUCTION

The usage of nanomaterials and nanotechnology in many sectors of industry is becoming more common. Therefore, the total quantity of nanomaterials placing on the market is increasing rapidly year by year. The industry is attracted by the wide range of benefits and possibilities offered by these materials.[1] However, because of lack of definite answer whether the use of nanomaterials is safe or not, in 2008, the European Commission decided to launch the first regulatory review of the EU legislation concerning nanomaterials.

2. REGULATORY REVIEW IN THE AREA OF NANOMATERIALS

2.1. Definition

As a result of the first review, in 2011, new definition of nanomaterial has been introduced by the European Commission. It is based solely on the size of the constituent particles of a material, without regard to hazard or risk [2]. The definition engendered a wide discussion among stakeholders and will be reviewed in 2014. European Commission plans to implement the new definition in the EU legislation, however, in justified cases sector specific solutions may also still apply [1].

2.2. Regulation No 1907/2006 (REACH)

Nanomaterials are covered by the provisions of the Regulation No 1907/2006 (REACH) concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. Therefore nanomaterials that are produced or imported outside the Community in quantities over 1 tonne anually per relevant producer/importer must be registered.  Registrants decide whether their nanomaterial is a form of a bulk substance (then nano form is included in a dossier for the bulk substance) or a separate nanosubstance (then it is registered on its own). In opinion of some NGOs, REACH in current state is not able to provide sufficient control over these materials and changes in the legal text and annexes or even a separate legislation are needed [3].  The European Commission has published public consultation on potential changes in REACH Regulation to better cover substances in nanoscale. Respondents have 6 options to consider, for example: no policy actions, changes in certain annex provisions, guidance updates or introducing revised or additional endpoints. The consultation runs until 13 September 2013. [4]

2.3. Regulatory initiatives on national level

In opinion of several Member States current regulations are not sufficient to provide safety of nanomaterials. France has published a decree on the annual declaration on substances at nanoscale. It requires companies, private and public research laboratories to declare the quantities and uses of substances produced, distributed or imported in France at nanoscale. The declaration is mandatory for substances produced, imported or distributed during the previous year in a quantity greater than 100 g and must be submitted before the 1st May each year. [5].

Similar decree regarding placing on the market substances in nanoscale is planning to be published in Belgium. Draft decree has been already submitted to the Commission. The declaration will have to include: identification of the declarer, identification of the substance, quantity of substance manufactured at the nanoscale placed on the market during the reporting period, uses of the substance and identity of the professional users. [6]

Denmark  has launched a public consultation, related to a draft executive order for a national register of products and mixtures containing nanomaterials. The order is expected to come into force by 1 January 2014. [7]

There is also a group of Member States that suggest introducing European Registry of such products rather than national ones. As the result of these claims European Commission has issued a call for tender to help it prepare an impact assessment for a nano registry. The information required to be gathered includes: costs and administrative burden of such registry, possible effects on competiveness and potential benefits. [8]

REFERENCES

[1] Second Regulatory Review on Nanomaterials, COM(2012) 572 final;

[2] Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU);

[3] Azoulay D.: Just out of REACH, The Center for International Environmental Law (CIEL);

[4] Public consultation relating to the REACH Annexes on Nanomaterials;

[5]Decree no. 2012-232 of 17 February 2012 on the annual declaration on substances at nanoscale in application of article R. 523-4 of the Environment code;

[6]Draft - Royal decree regarding the placement on the market of substances manufactured at the nanoscale;

[7] V. Zainzinger, Denmark consults on nanomaterial product register, ChemicalWatch,10 July 2013;

[8]EU Commission tenders nano-registry impact assessment, ChemicalWatch, 27 June 2013.

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1. Regulacje prawne w nanotechnologii