THE UK IS NOW REQUIRING UK RESPONSIBLE PERSON
DON’T LET YOUR SUPPLY CHAIN GET INTERRUPTED!!
Labeling deadline was January 01, 2021!
Look for BREXIT to march into your Supply Chain and cause challenges starting at Import Customs all the way to Retail products on the shelf.
Let us untangle these concerns BEFORE they snag your products.
UK (current version) of EU Regulation 1223/2009
Effective 01/01/2021, the UK will have separate regulations similar to EU Regulation 1223/2009, which went into effect July 2013. All cosmetic products being sold in the United Kingdom must comply with this regulation. Products must meet all three requirements:
- Cosmetic Product Safety Report (CPSR) with Safety Assessment for the Product Information File (PIF)
- UK Responsible Person (RP)
- UK Cosmetic Product Notification 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.
How do we spell success? Start with a UK-qualified Safety Assessor. The Technical file is what satisfies the UK government. Toxicological reports are not all the same.
A great Safety Assessor will have
- Formulation knowledge of cosmetic products and ingredients;
- Education from European Master Classes;
- 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 a UK 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.
When marketing in the UK, the PIF must be linked with a qualified Safety Assessment and Cosmetic Product Safety Report. The PIF is completed by the UK 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 differences in the approach by both American and UK companies. Our qualifications and UK contacts provide the best insurance and safety to keep your supply chain permanently uninterrupted.
The technical file, PIF, is the first step to compliance required by 1223/2009 EU Regulations. Each product placed on the UK Market must have one. The UK Authorities recognize technical knowledge and Qualified Safety Assessors, especially when relationships, such as ours, have been established at UK and European events. Our relationships with these authorities have been well received and we have unique support from the UK and European Cosmetic Associations.
The PIF must meet the UK requirements for essential content. Our Safety Assessors have attended Master Classes in Europe to ensure the intent of the regulation is met for this essential content.
Our staff is highly experienced in corporate Product Formulation, Quality Assurance and Regulatory Affairs to bring unparalleled expertise and practicality to the PIF. With this experience, we’ve been helping clients for over 20 years.
A technical file is required before every cosmetic product is placed on the UK market. The PIF must meet UK requirements for essential content. 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 UK Authorities.
Companies who do not comply risk having a complete interruption of supply chain with the product pulled from the shelf. Our staff has a background in product formulation, Quality Assurance and Regulatory Affairs to bring unparalleled expertise and practicality to the PIF.
Let us be your UK and EU RP!
Our RP service provides the required notifications, compliance and regulatory services to place and keep your existing cosmetic products in the UK and 27 European Member State countries. Your company does not have any membership obligations thereby allowing you to control how your product is represented. Our UK location in London, England and our European location in Dublin, Ireland, as required, hold the Product Information Files. We provide these addresses for your product labeling.
As your UK and EU-27 RP, we will provide:
- Our English-speaking central locations for the UK and all 27 EU Member States for 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 UK Distributors at no additional cost
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. UK 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 UK’s version of 1223/2009 EC Regulation requires GMP compliance. International Standards Organization (ISO) has established a cosmetic GMP standard. ISO GMP 22716 satisfies this requirement for the UK.
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.
Congratulations! This is the last step of compliance. This is what will get your product through customs, and assures your UK distributors that you have followed the requirements under the UK’s version of 1223/2009 EC Regulations.
This provides electronic proof to the UK Government Authorities.
The UK will continue to require compliance to their version of 1223/2009 EU Cosmetic Regulations after BREXIT. This is the last step that confirms compliance and provides electronic proof specifically to the UK government authorities. Don’t get caught with a UK registration without proof of a Product Information File (PIF) with a Qualified Responsible Person (UK RP).
DON’T TAKE THE RISK OF NON-COMPLIANCE!
Companies who do not comply risk having a complete interruption of supply chain with the product pulled from the shelf. In addition to supply chain disruption, the UK can levy heavy fines for products that are not compliant. If your product is not compliant with any of the three steps listed above, you are at risk. Keep your product on the shelf!
OTHER UK AND EUROPEAN REGULATIONS
International Cosmetics provides the following UK and EU Regulatory Compliance Services to US companies seeking to expand their cosmetic-product business in Europe.
The Only Representative (OR) for UK REACH chemical compliance must be a legal entity in the UK. The original EU REACH regulation requires a legal entity in the EU. International Cosmetics can provide both.
This includes ingredients even if only contained in finished cosmetic products.
Retailers in the UK and Europe often require non-UK and 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.
This requirement must be considered by all companies marketing products in the UK. CLP regulations impact finished cosmetic product labeling as well as the technical documents used for the UK Product Information Files. The Safety Data Sheets are required to meet the CLP requirements as of 2010.
The service you don’t think you need…until you do!