Public Consultation on Impact Assessment on
Possible Measures to Increase Transparency
on Nanomaterials on the Market
As part of the Communication on the Second Regulatory Review on Nanomaterials, the Commission has announced to launch “an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight [on nanomaterials], including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”
More information on the background, methodology and planned timing of this impact assessment can be found in the working document - CASG(Nano)/02/14 (an updated version including a final version of the problem definition, objectives and policy options will be published in the second half of May). This document also contains a draft problem definition, policy objectives and a more detailed description of the following policy options that are under consideration:
0. Baseline scenario
- Recommendation on how to implement a "best practice model" for Member States wishing to establish a national system (soft law approach)
- Structured approach to collect information ("Nanomaterials Observatory")
- Regulation creating an EU nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor
- Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release)
The European Commission (DG Enterprise and Industry) has commissioned Risk & Policy Analysts Ltd. (RPA) and BiPRO GmbH to undertake a study to support the Commission on the preparation of this impact assessment. The terms of reference and the resulting reports are available here.
This public consultation is an integral part of this study. The objective of the public consultation is to obtain stakeholder views on the currently available information on nanomaterials on the market (as defined here), the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of the aforementioned policy options.
Please be aware that within the European Union, France has already established a mandatory reporting scheme for manufactured nanomaterials produced, imported or distributed in its territory. The Interministerial decree No. 2012-232 entered into force in January 2013. Moreover, at European level, when cosmetic products containing nanomaterials are put on the EU market, Article 16 of Regulation (EC) No 1223/2009 requires the responsible persons to submit information on the nanomaterial(s) contained through the Cosmetic Products Notification Portal. Further information on these and other proposed schemes is available here.
Please note that, if your company/organisation is registered in the Transparency Register, you will be requested to indicate your Register ID number. Your contribution will then be considered as representing the views of your organisation. If your organisation is not registered, you have the opportunity to learn more and/or register now.
Please note that if your company has to notify to the French Notification System and/or to the Cosmetic Products Notification Portal but did not participate in the consultation undertaken by RPA/BiPRO for the European Commission in early 2014, please take the time to fill in the questionnaire on the administrative burden of the notification schemes which is available here.
Further detail on the definitions applicable to SMEs is available here.
Some of the acronyms used are presented in the glossary.
** Responses to the public consultation must be submitted by 5 August 2014 **
Practical questions on the consultation can be sent to the Project Manager, Marco Camboni, or, alternatively, to Craig Hawthorne, BiPRO project manager. Substantive questions may be directed to the Commission (Maurits-Jan.Prinz@ec.europa.eu).
Please note that responses to the questionnaires may be published by the European Commission, subject to your agreeement. In dealing with your personal data, we can confirm that we will comply with personal data protection rules as established by Regulation (EC) 45/2001.
If you have specific concerns about how your views will be treated, you can contact Dr Pete Floyd and we will be happy to discuss your concerns.