Saturday, July 20, 2013

New European Cosmetics Law and Implications for the Nail Industry

New European Cosmetics Law and Implications for the Nail Industry

Smaller distributors and brands may find it too expensive to comply

On July 11th 2013 the new European Cosmetics Directive (EC) 1223 / 2009 came into effect. This updates and extends the previous Directive  76/768/EEC. Unfortunately, at least in Sweden, many manufacturers and distributors were unaware of the new law and it’s consequences until the national authority (L√§kmedelsverket) issued a newsletter mid-June. 

So what requirements are new?
No cosmetic products or ingredients can be sold that have been tested on animals and additional substances have been banned due to safety concerns.

However, the major change for manufacturers is the need to provide a Product Information File (PIF) for each product. This replaces the previous Safety and Risk Assessments with a document that now also includes:

  • a detailed toxicology analysis of the product by a qualified person (European based toxicologist or medical qualification)
  • list of ingredients
  • chemical formula
  • manufacturing process

Some of this information is clearly intellectual knowledge and proprietary to the product manufacturer, that in many cases will be the factory that supplies the gel, acylic, gel polish, nail polish, spa product or liquid products to the “manufacturer” who private labels them. A complication can arise where the factory may not be willing to give this information to smaller private labellers.  Companies who have developed their own products with the assistance of an internal or external chemist, would have access to this intellectual property and therefore be able to produce the PIF.

New European database: CPNP

All European manufacturers and first-importers into Europe for each brand, now need to appoint a Responsible Person who will register all products on a central European database, the Cosmetic Product Notification Portal (CPNP). The RP can be the company, or a nominated consultant. The RP is also responsible for warning the authorities or any observed negative health effects due to product use, and ensuring that the products continue to meet the European legislation.

The information that the RP has to enter into the database for every product includes:
  • Product name
  • Name of Responsible Person
  • Country of Manufacture
  • Country where first placed on the European market
  • Notification if the product is carcinogenic, mutagenic or toxic for reproduction (CMR)
  • Notification if the product contains nano materials
  • Product categories
  • Ingredients and percentages
  • Photograph of the product container
  • Photograph of the product label (in the language of the market where placed for the first time – usually the same country as the RP)

The national product distributor also needs to register their company on CPNP. They then have to upload a photograph of the product label (in the language of their country) for every product. Many smaller distributors have not produced local labels in the past, although this has always been a legal requirement. Now the cost of doing this and then applying the labels to every product may force them to reconsider if it is worthwhile to continue to sell the products. 

Illegal Products and Consequences for Nail Salons
Only those products registered on CPNP and correctly labelled can be legally sold in Europe. If a nail salon buys an illegal product, it could very likely invalidate their salon insurance in the event that a customer develops a health problem. Ignorance is not usually an accepted defence in the event that the customer sues the nail salon. 

Will this lead to safer products?

During 2010 and 2011, the Swedish Medical Product Agency which is also responsible for cosmetic safety, carried out an inspection of the professional nail products in the Swedish market. Unfortunately, many companies and particularly those that had not registered their company with MPA, were not inspected. 

In the report published 20th April 2012, MPA stated:

  • 108 products tested from 33 manufacturers and distributors
  • 83% had incorrect labelling
  • 15% had products with ingredients that exceeded the legal amount
  • One company had two products removed as dangerous.

Let's consider that again for a moment. More than 15% of products inspected of this small sample were unsafe. And this number does not consider those "back door" suppliers who failed to register their products with MPA and who were not inspected or the many thousands of different products on the market. Surely  many more unsafe products would have been found with a wider inspection.

A similar inspection by CVUA in Germany in 2012 found that:

  • 42 nail products tested
  • 66% did not meet the legal requirements. Most failed due to incorrect labelling and specifically, not including all ingredients on the label. 
  • 16.7% of the product tested there were found higher levels of hydroquinone than are permitted by law
Hydroquinone is one of three ingredients whose maximum amount is limited by law for safety reasons. Products containing these ingredients must only be sold to trained professionals - this includes all acrylic (polymer) nail products.

The responsibility of professional manufacturers and distributors

All European cosmetic manufacturers and first importers, and national distributors must register with the CPNP by law. Failure to register, register all products, or supply products that are incorrectly labelled, face prosecution with a penalty of either a monetary fine or imprisonment. This is the first time that such penalties have existed, prior to the introduction of this new law the penalty only meant products would be removed from the market. 

So now the authorities have the power to force cosmetic suppliers to comply with the law - but do they have the resources to make investigations and will they prosecute? 

Update November 2014
It is now more than two years since the new cosmetics law was introduced. It is clear that not all distributors have registered on CPNP. Visit trade shows, it is also apparent that the majority of professional nail products are not labelled according to the law. In both cases, the products are illegal. 

It seems that the authorities have neither the interest or resources to implement the law in the nail industry. 

Few professional nail technicians are aware what is a legal or illegal product, and many also choose to buy products from eBay and import these without understanding the legal risks and consequences. 

Earlier this year, the Swedish MPA removed a retail gel polish from the market after receiving more than 80 reports of customers who had developed serious allergies, including painful skin blistering. The same gel polish is continues to be sold by professional brands. 

More information
EC 1223/2009:


Product labelling: