EUROPE- EU-27

KEEP YOUR PRODUCTS ON THE SHELF!

Stringent requirements for Cosmetic companies to sell products in Europe and other countries are being strictly enforced! The latest development in Europe is the interruption of incoming product being held by government. What is at the bottom of this?? Mostly BREXIT and the lack of EU RP registrations and labeling.

EU Regulation 1223/2009

EU Regulation 1223/2009, which went into effect July 2013, mandates that all products being sold in the European Union must comply with this regulation. Products must meet all three requirements:

1. Cosmetic Product Safety Report (CPSR) with Safety Assessment for the Product Information File (PIF)
2. Responsible Person (RP)
3. Cosmetic Product Notification Portal (CPNP) submission

We’re on the forefront of the changes for implementation. Ingredients become restricted from time to time requiring an update to your file.

We give you advance notice of these changes that impact your formulations.

Step 1: Cosmetic Product Safety Report (CPSR)

How do we spell success? Start with a Qualifified Safety Assessor. The Technical file is what satisfies the Europe governments. Toxicological reports are not all the same. A great Safety Assessor will have 1. Formulation knowledge of cosmetic products and ingredients; 2. Education from European Master Classes; 3. Recognition as an authority in cosmetic regulatory and compliance by industry leaders.

The CPSR consists of:

• Technical documents
• Preservative Effectiveness Test
• Stability Testing
• Safety Assessment

Avoid unnecessary testing while still meeting the requirements. For basic formulations, there are only two mandatory tests required for the PIF: Stability Testing and Preservative Testing.

A legal, qualified and competent Safety Assessor is the key to your success for this requirement. Don’t be fooled by Toxicologists who do not have the EU background, and in most cases lack of cosmetic formulation. This requirement is very specialized and can cost you time and money. The Safety Assessor is key to meeting all of the technical requirements under the 1223/2009 EU Cosmetic Regulation. We maintain strictest confidentiality so your proprietary information is always safe and secure with us.

Safety Assessment

When marketing in the EU-27, the PIF must be linked with a qualified Safety Assessment and Cosmetic Product Safety Report. The PIF is completed y the Responsible Person per 1223/2009 EC Regulation International Cosmetics will ensure recognition of all 27 EU Authorities to the legitimacy and qualification of this document.

Our highly skilled and experienced staff has attended universities on both sides of the Atlantic, including Belgium, the UK. and the US. As a result, we understand the approach by both American and European companies. Our qualifications and EU contacts provide the best insurance and safety to keep your supply chain permanently uninterrupted.

Product Information File (PIF)

The Product Information File (PIF) must meet EU requirements for essential content before placing the product on the market per 1223/2009 EU Regulation. It is in a company’s best interest to avoid superficial and obscure content. This process is pivotal to forming a strong foundation for inquiries from the EU Authorities.

Each product placed on the EU-27 Market must have a PIF. The European Authorities recognize technical knowledge and Qualified Safety Assessors, especially when relationships, such as ours, have been established at European events. Our relationships with these authorities have been well received and we have unique support from the European Cosmetic Associations.

Our Safety Assessors have attended Master Classes in Europe to ensure the intent of the regulation is met. Our staff has a background in product formulation, Quality Assurance and Regulatory Affairs to bring unparalleled expertise and practicality to the PIF.

Companies who do not comply risk having a complete interruption of supply chain with the product pulled from the shelf.

Step 2: Responsible Person

Let us be your RP!

Our RP service provides the required notifications, compliance and regulatory services to place and keep your existing cosmetic products in the 27 European Member State countries. Your company does not have any membership obligations thereby allowing you to control how your product is represented. Our European location in Dublin, Ireland, as required, holds the Product Information File and Safety Assessment and is the address for product labeling. We understand Safety Assessment and technical criteria under the EU Regulation.

As your EU-27 RP, we will provide:

• Our English-speaking central location for all 27 EU Member States Authorities to contact
• A response to all technical issues for products and ingredients
• Accurate representation to avoid creating additional concerns from authorities when audited, protecting confidentiality
• A label review by our RP to ensure format and content have been provided.
• Representation for your EU Distributors at no additional cost

Labeling & Claims Compliance

The label and what you say about your product can define your success in more than one way. It is often the first view the government authorities see of your company and products. First impressions are the most important; it applies not only to people, but products as well.

Your label and claims make your product unique. Your product label is important to the legality of your product. Simple claims can backfire by changing the classification for the product making it a medicinal product. EU requirements can work to your advantage in some cases.

For example, UV claims in the US make the product a drug, while a UV claim in Europe may still be classified as a cosmetic.

ISO 22716 GMP

The RP requires manufacturers to adhere to Good Manufacturing Practices (GMP). The 1223/2009 EC Regulation requires GMP compliance. International Standards Organization (ISO) has established a cosmetic GMP standard. ISO GMP 22716 satisfies this requirement for Europe.

Many other countries have adopted this standard as a requirement. International Cosmetics participated in the creation and finalizing of ISO 22716 and continues to be involved with updates and the ISO meetings Internationally. ISO 22716 is widely recognized and used worldwide.

Step 3: Cosmetic Product Notifications (CPNP)

Congratulations! This is the last step of compliance. This is what will get your product through customs, and assures your EU distributors that you have followed the requirements under 1223/2009 EC Regulations. This provides electronic proof to each EU-27 Member State government authorities. Don’t get caught with a CPNP registration without proof of Product Information File (PIF) by a Qualified Responsible Person (EU RP), or conversely a PIF and no CPNP.

OTHER EUROPEAN REGULATIONS

International Cosmetics provides the following EU Regulatory Compliance Services to US companies seeking to expand their cosmetic-product business in Europe.

REACH Only Representative

The Only Representative (OR) for REACH chemical compliance must be a legal entity in Europe. International Cosmetics has satisfied this requirement in all aspects since 2007. Any non-EU company marketing goods, including cosmetics, may be subject to the requirements of REACH. REACH regulates ingredients even if contained in a finished cosmetic product.

Retailers in Europe often require non-EU companies to have an Only Representative to qualify the products under REACH. International Cosmetics Chemical Services has been providing this service since 2007.

CLP (Classification, Labeling & Packaging)

This requirement must be considered by all companies marketing products in the EU. CLP regulations impact finished cosmetic product labeling as well as the
technical documents used for the EU Product Information Files. The Safety Data Sheets are required to meet the CLP requirements as of 2010.