February 1, 2013 by Peter Simpson

This week (30th of January 2013) I had the pleasure of attending a one-day workshop on the European Commission’s 2nd review of nanomaterial regulation. As well as setting out the conclusions of the review (which can be downloaded via the commission’s website) the workshop was intended as an opportunity for stakeholders to feedback on the review’s conclusions. The whole meeting was streamed live over the internet and a recording of the meeting and the presentations can be viewed here.

The key highlights of the review were as follows:

  1. Pre-registration of nanomaterials in cosmetics via the EU Cosmetic Products Notification Portal (CPNP) is now mandatory six months prior to placing a product on the market.
  2. REACH Annexes are being reviewed to make provisions for nanomaterials during registration clearer. There will be public consultation about this later this year (from as early as February). These won’t affect 2013 registrations.
  3. There are unlikely to be any specific provisions under REACH for nanomaterials below the current minimum tonnage threshold for manufacture/import of 1 tonne per year, although they may be covered by an EU-wide registry (see point below).
  4. An EU-wide registry for nanomaterials is being discussed (an impact assessment is being done). In part this has been prompted by the myriad of different Member State schemes on nanomaterial registration that are being developed (i.e. the French Déclaration des Substances à l’état nanoparticulaire).

Industry stakeholders were generally supportive of the review, which asserts that nanomaterials should not be considered as inherently dangerous and their hazardous properties reviewed, as necessary, on a case-by-case basis. It was stressed that nanomaterials should not always be considered as novel technology as some nanomaterials have been used in large tonnages for many years without concerns for either human health or the environment (e.g. carbon black and synthetic amorphous silica). Of particular note, however, was the response of the European Green Party / European Free Alliance faction of the European Parliament. They were deeply critical of the review and think that the Commission haven’t considered some of the European Parliaments’ specific requests regarding the regulatory review, such as the development of an EU-wide registry. They advocate the development of specific legislation for nanomaterials. sometimes termed “MINI-REACH”.

We have recently been involved in the registration of a nanomaterial substance under REACH and await the outcome of the review of the REACH annexes with interest.