EU Regulatory Approval of Zinc Oxide - Research

I have been in discussion with the Vice-Chair of the EU Scientific Committee on Consumer Safety (SCCS), Dr. Qasim Chaudhry and also Natacha Grenier, the SCCS Secretariat regarding the status of Zinc Oxide approval and the scientific committee submissions surrounding the topic.

As I understand, and from my discussions with them, at the Standing Committee and Working Party on Cosmetic Products on 26 June, the Commission presented the legislative proposals based on SCCS opinions recommending the inclusion of Zinc Oxide to the Annex VI of EU Cosmetic Regulations for approved UV filters. [Source: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_q_108.pdf]

Following the June plenary a number of Member States requested a clarification of the meaning of ‘sprayable applications/products’ for the nano forms of Carbon Black CI77266, Titanium [Dioxide] and Zinc Oxide. There was a short review of the terms discussed at the 10 September meeting [Source: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_miwg_202.pdf].

At the 30 September meeting these terms were clarified and defined and comments were continuing to be accepted up until 10 November.

Experts in the SCCS determined that ‘the term ‘spray’ or ‘sprayable’ will mean that a formulation is either dispensed by the use of propellant gas as defined in Directive 75/324, or by a spray bottle with a pump dispenser that forces a liquid through a nozzle generating a spray stream or a mist of a liquid…the term ‘pump dispenser for dosing cream’ will mean a formulation is dispensed through a mechanical pump in the form of a single dose, where the process does not generate a significant quantity of airborne particles or droplets that are either respirable as such, or become respirable as a result of drying while airborne’. [Source: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf]

As most cosmetics products Antaria will be targeting are non-spray creams and powders, this is good news as they are deemed under the opinion to produce no danger of airborne particles.

The next meeting scheduled is 1 December which is a specific working group meeting on the topic of “nano in cosmetics” [Source: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_ag_025.pdf] with a further plenary meeting on 16 December. It is expected that these terms will be fully endorsed and that the adoption into regulation is imminent.

For further confidence in the process, BASF were already successful in achieving Tinosorb’s approval to the Annex VI of EU Cosmetic Regulations on 18 August [Source: https://www.basf.com/en/company/news-and-media/news-releases/2014/08/p-14-308.html] so this shows the changes can and will be implemented once they have cleared the appropriate hurdles.

From my research I don’t see much left standing in the way of Zinc Oxide’s approval, it seems the final question was indeed solely surrounding definition of “sprayables”. If approval isn’t by the end of 2014 as previously rumoured [Source: http://www.cosmeticsdesign-europe.c...lation-a-year-on-work-to-be-done#.VGgh2FeUd1R] it does not look far off into 2015 at all - I would say at the 20 January meeting if it isn’t 16 December.