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Nail Polish, a combination of volatile solvents, pigments and additives is considered as a Cosmetics Finished Product globally. Due to ongoing regulatory changes and consumer health concerns, local regulatory Authorities all over the world are looking for stricter laws for the flammable industries like Nail Polish.

Below, we have tried to summarize the Regulatory concerns and laws related to Nail Polish industry briefly in major parts of the world.

USA - FDA

Nail Polish and other nail care products for home and salon are regulated by the Food and Drug Administration (FDA). These products are considered Cosmetics under the Federal Food, Drug, and Cosmetic Act[FD&C Act, Section 201].

By law, nail products sold in United States must be free of poisonous ingredients which could harm the end consumers if used at home. Many of the ingredients used in the nail products are hazardous, but still allowed to be used at a controlled percentage recommended and allowed by the FDA. There are few ingredients which are harmful, only when ingested.

One significant aspect of selling nail products in United States is the labelling of the product to consumers or salons. It must include a warning statement wherever necessary to prevent a probable health hazard to the end consumer, which is covered under 21 CFR 740.1 of the FDA in United States.

The licensing of the technicians in salon are regulated directly by state and local authorities. In addition, Occupational Safety and Health Administration also help address the safety of the employees working professionally with nail products in salons.

In case of any adverse reaction, all the consumers, nail technicians and healthcare providers are advised to immediately report reactions of the products to the FDA onBad Reaction to Cosmetics? Tell FDA.

EU - REACH

As per the European Union Parliament of 22nd December 2009, a new Cosmetics Regulation (EC) No. 1223/2009 has replaced the old Directive 76/768/EEC on 11th July, 2013.

As per the above stated regulation, Nail Polish and related products are categorized under the category Cosmetics.These changes have been implemented in order to have a uniform and transparent system throughout all member states of EU. The significant changes brought along include:

  • The Responsible person located in EU for any product made out of EU Region
  • To place the product on the market, there are certain set of conditions to be completed:
  • Register the products on Cosmetics Product Notification Portal (CPNP).
  • Get the Cosmetic Product Safety Report (CPSR) for each product from a Safety Regulator.
  • Get the Safety Data Sheet, generally needed for Transportation, but also considered important for storing and handling bulk products by local distributors.
  • You need to have the Product Information File (PIF) which would include all the above a, b and c included as well as other few documents ready to submit to the Border Authorities within limited time granted.
  • Poison centres have been created all over EU in order to check adultering and misbranding cosmetics in any state in EU

There are certain amendments being constantly worked on to the above described Regulation still. EU is considered as one of the toughest markets to crack right now, especially for new companies.