Clarity still needed for EU Cosmetics Regulation
This was the feeling at the Global Cosmetics Compliance summit organised by IQPC and chaired by CosmeticsDesign-Europe.com as many in attendance raised questions over the Cosmetic Products Notification Portal as well as with other aspects.
Laura Kirkbride, technical and development director at Orean Personal Care, addressed these concerns in her presentation looking at processes to ensure compliance using a case study from Orean, which is a UK contract manufacturer.
Kirkbride highlighted differences between EU member states as a concern, as it may mean the Regulation is having the opposite effect of what it was set out to do.
Harmony?
“One of the objectives of the Regulation was to harmonise the existing system, but there are more differences noticeable between the member states,” she said in her talk.
This was reiterated in a later presentation in the same session by John Hayes, chief technology officer at H2 Compliance, who said that in some ways it is the “’non-harmonised’ harmonised regulation.”
Both Hayes and Kirkbride spoke about how compliance can be an issue with regards to compiling a correct Product Information File as well as using the CPNP, which can also be troublesome.
The H2 Compliance man highlighted that it is a drain on resources, particularly for SMEs as they do not have the staffing or budget to deal with the new requirements compared to larger organisations, who are also finding it tough as it is.
“The CPNP can be a problem as notifications can take a long time, which is a problem when choosing formulations as it gets in the way of their commercial plans,” added Kirkbride.
This notification system can take months according to the Orean director, which is a problem impacted by confusion over which nanomaterials are defined as such.
Nanomaterials
This was another area addressed at the event, as it sought to try and clear confusion over the definition of nanomaterials with a presentation from Dr Steffi Friedrichs, director general at the Nanotechnology Industries Association.
She discussed the definition of nanomaterials in cosmetic products, which she admitted ‘remains a problem’, and also spoke about labelling these in the list of ingredients with the word 'nano' in brackets following the name of the substance.
She also reiterated that the European Commission must be notified of all cosmetic products containing nanomaterials six months prior to placing on the market.
“The Commission's [definition of nanomaterials] is based on the potential hazard of a material; it seeks to identify such material and guide it through a risk assessment,” explained Friedrichs.
“It also aims to inform the regulators of the economic impact and spread of nanomaterials on the market, and this will be heavily distorted by conducting it against the background of a hazard-based definition.”
