Aug. 5, 2014 deadline for European Union public consultation on measures to increase transparency on nanomaterials on the market

A May 14, 2014 news item on Nanowerk announces a new ‘nanomaterials’ consultation (Public Consultation  on Impact Assessment on Possible Measures to Increase Transparency on Nanomaterials on the Market) in Europe,

As part of the Communication on the Second Regulatory Review on Nanomaterials, the European 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.

The text of the May 14, 2014 news item can be found on this announcement page, which explains the background leading up to this consultation and the role of the companies  engaged to hold the study and the consultation, on the Risk Policy Analysts website,

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

  1. Recommendation on how to implement a “best practice model” for Member States wishing to establish a national system (soft law approach)
  2. Structured approach to collect information (“Nanomaterials Observatory”)
  3. Regulation creating an EU nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor
  4. 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.

The description of the terms for the public consultation follows,

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.

Complete the questionnaire for non-industry stakeholders

(preview in pdf or in Word)

Complete the questionnaire for industry stakeholders

(preview in pdf or in Word)

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.

I wonder what it means when the Cosmetic Products Notification Portal does not participate. This nonparticipation adds a level of intrigue I hadn’t anticipated when I caught sight of this announcement. Are the ‘cosmetics portal’ people boycotting the consultation for some reason?

* Upper case ‘M” changed to lower case ‘m’ in head on May 16, 2014 at 9:47 am PDT.

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