New European Union cosmetic regulations will have a major impact on all U.S. manufacturers of cosmetics that export to the EU now, and after July 2013. This is when the new regulations will go into full effect. The regulations were first implemented in 2009, but the old 1976 regulations will be fully replaced on July 11, 2013. There has been a gradual implementation of these new regulations since then.

What products does this cover exactly? The EU Cosmetic Regulation EC 1223/2009 defines cosmetics as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs),  or with the teeth or mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odors, and/or protecting them or keeping them in good condition. ”

This includes, but is not limited to: cosmetics, shampoos, conditioners, skin lotions, sunscreen, lipsticks, deodorants, toothpastes, fragrances, perfumery products and soaps.

So what does this mean to U.S. manufacturers of these kinds of products exporting to the European Union after July, 2013? It will mean a number of things.

Here is a list of the new EU Cosmetics Directive & other requirements:

• Check to see if your product is a cosmetic under EU law.
• Determine if your product ingredients are allowed or banned in the EU.
• Prepare a Product Information File (PIF).
• Must have a Product Safety Assessment Report.
• Must have a Responsible Person located in the EU.
• Label products according to EU rules.
• Before placing products in the market, the proper EU authority must be notified.
• Be very careful when making product claims.
• Animal testing is not allowed.
• There are EU Directive rules covering marketing & sales strategies.
• Protect your IPR, Trademarks & Service Marks.

Check to see if your product is a cosmetic under EU law

The EU looks at certain cosmetics as borderline products. These are products that may also be considered a medicine or biocide. Examples of these are certain types of toothpaste, sunscreen, and insect repellant. A U.S. manufacturer may classify a product one way, and  then be challenged by an EU member or court.

Determine if your product ingredients are allowed or banned in the EU

There are special restrictions on certain ingredients, some prohibited outright, others having restrictions and conditions. Be aware of the permitted and/or allowed colorants, preservatives and UV filters.

Prepare a Product Information File (PIF)

Each cosmetic product must have a Product Information File or PIF prepared and readily available for inspection by the EU authorities. It has all the required documents including the safety assessment report.

Must have a Cosmetic Product Safety Assessment Report (CPSR)

The PIF must contain the CPSR. The CPSR must be completed by a qualified safety assessor.  The safety assessor must be “a person in possession of a diploma or evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course as equivalent by a Member State”.

Must have a “Responsible Person” located in the EU

There must be a “responsible person” that is a legal or responsible person within the EU. This legal or responsible person maintains the PIF and serves as the product’s primary contact for compliance. The name and contact information for the “responsible person” must be on the label. The “responsible person” can be the importer, distributor, or a third-party. There are organizations in the EU with representatives in the USA that for a fee can act as the “responsible person”, and help with the Cosmetic Product Safety Report (CPSR).

Product must be labeled according to EU rules

EU regulations require the container and packaging be labeled in a way that is indelible, easily legible and visible. The label must also include the following:

• Name and address in the EU of the Responsible Person/Location of PIF.
• Nominal Content – by weight or volume (metric), dual labeling is allowed.
• Date of durability First is the “Open Jar” symbol that is for the period after opening. Only used for products that have a shelf life of 30 months or more. The number used with the “Open Jar” symbol shows the durability of the contents once opened.

The “Hour Glass” symbol, new to the regulations, is for products that last
less than 30 months. The date must be in the form of month and year, or
day,  month and year.

• Any warning or conditions of use.
• Batch number.
• Product function-overt/clear product presentation may suffice.
• List of ingredients-listed in descending order by weight at time of packaging using common ingredient names used by INCI, International Nomenclature of Cosmetic Ingredients.
• New to the label is indicating the presence of any nanomaterials with the term nano in brackets after the ingredient’s name. When using nanomaterials, there are other requirements.
• Country of origin-also new to labeling is where the article was manufactured or produced.
• Wherever marketing or selling a product, the label must have all the information in that country’s language. The only exception is the ingredients list which must use the INCI ingredient names.
• If the product is too small or where it is not practical, printed labeling only for warnings, ingredients, and product use information can be on a separate leaflet label or card. When using this method, a “Hand inside an open book” symbol must be printed on the container or package as well as the rest of the labeling requirements not on the leaflet or card.

Proper EU authority must be notified before placement of products  in the market.

Before any cosmetic product can be entered into the EU market, notification must be made to the proper authority. Although cosmetic products do not need CE marking (indicates conforming to EU standards), there is still a notification system cosmetics must go through before they can be sold in the EU market. The important thing to note is that after July, 2013 a new system known as Cosmetics Products Notification Portal, (CPNP) will go into effect. The CPNP is a central electronic notification system at the EU level. The Responsible Person must make the notification.

Be very careful when making product claims.

If the claim is not proven, then do not make the claim. Wording must be acceptable and not imply more than what the product is or is capable of. The PIF must document the claim. This goes for the label, marketing, advertising, texts, names, trademarks, pictures, and figurative and other signs indicating more than what the product is capable of . They cannot be used to imply characteristics or functions they do not have.

An EU commission is developing guidance on common issues.

Animal testing is not allowed

Testing on animals was banned in the EU in 2009, with the exception until March, 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics.

The “Bunny” symbol on the label shows there was no animal testing. Need I say more?

There are EU Directive rules covering marketing & sales strategies

The EU is strict when it comes to internet marketing, internet sales, and direct sales. Take care to consider all requirements and obligations.

Protect your IPR,Trademarks & Service Marks

If you want protection for a patent, trademark, or service mark, then register your IPR in the country or countries you plan on exporting to. Registration and enforcement always take place in the country of import, and it is the IPR holder’s responsibility to make sure they have the legal protection before entering those products into a foreign commerce.

So what do we do?

Are you a U.S. manufacturer that exports products effected by these new rules? How does your company expect to get over this hump? It seems like a lot, but it can be done.
Bailey Trading Company, LLC would like to help you. It is important to note that
EU companies must also comply with all the same rules and regulations.

While at Cosmoprof 2012 in Las Vegas, I attended ECORE, a seminar on the new EU cosmetic regulations. It was surprising to see so few people from U. S. manufacturers at this seminar to learn how to deal with exporting  cosmetics, shampoos, and every other effected item to the European Union after July, 2013. I am not sure why there were so few in attendance. I have spoken with a number of private label and other cosmetic manufacturers that seemed unaware of these new requirements. Some said they were aware, but still did not seem to be prepared for the compliance required after July, 2013.

The Export Trading Company Act of 1982 comes to mind . It provides for “experimentation in the development of innovative export programs”.  It also “promotes the formation of export trading associations and export trading companies”…

The term “export trading company” means any person, partnership, association, or similar organization, whether operated for profit or as a nonprofit organization, which does business under the laws of the United States or any State, and which is organized and operated principally for the purpose of exporting goods and services produced in the United States; or facilitating the exportation of goods or services produced in the United States by unaffiliated persons by providing one or more export trade services…

I believe many U.S. cosmetic manufacturers have a dilemma that must be resolved sooner than later, because July, 2013 is right around the corner.

For many the  new rules and costs will make exporting to the European Union prohibitive.

If U.S. cosmetic manufacturers band together under one trading company, they will all be better positioned to negotiate rates with the EU Responsible Person, air and ocean carriers, air and marine insurers, and other costs associated with the supply chain.

Please feel free to contact Bailey Trading Company, LLC for additional information. Any and all comments, thoughts and feedback will be appreciated.

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