What are the UFI Code and CLP Regulations required for aromatic oils entering Europe?
Introduction.
In the European Union (EU), the application of the "CLP Regulation (Classification, Labelling and Packaging Regulation)" and the "UFI Code (Unique Formulation Identifier)" has been rapidly progressing since 2021, strengthening safety assurance for consumer products.
In particular, Japanese companies exporting aroma oils, room sprays, and other miscellaneous goods to the European market are required to comply with these CLP regulations and the UFI Code, and even test marketing and sample products are no exception.
In the EU, it is not the "presence or absence of sales" but the "distribution to the market itself" that is subject to regulation, so shipments without regulatory compliance may be illegal. This article provides an easy-to-understand explanation of the CLP Regulation and the UFI Code, which are indispensable for entering the European market, including practical aspects.
What are the CLP Regulations and UFI Code? Covered Products and Background
The CLP Regulation (Regulation (EC) No 1272/2008) is a regulation to classify the hazards of chemical substances and mixtures (preparations) sold in the EU and to label and package them appropriately.
Based on this regulation, the following products are required to be labeled with "hazard classification," "GHS pictogram," "warning statement," "UFI code," etc.
Examples of main products covered by the CLP Regulation
Aroma sprays, diffusers, air fresheners
Detergent for kitchen, toilet and residential use
Sterilization and disinfection sprays (other than cosmetics)
Adhesives, paints, solvents
Automotive chemicals and DIY products
Even if the product is sold as "general merchandise," if the ingredients are hazardous, it is subject to the CLP Regulations .
A Safety Data Sheet (SDS) must be prepared foreach product, a classification evaluation must be conducted, and a UFI code must be obtained if necessary.
Steps to obtain a UFI code
UFI (Unique Formula Identifier) is a 16-digit identification code used when submitting product information to EU toxicology centers.
Basic Flow of UFI Acquisition
Generate UFI code
PCN (Poison Center Notification) submissions based on product ingredients
UFI code displayed on product packaging
In practice, however, the following challenges exist in performing this task
Must be an EU operator (VAT holder) to submit a PCN on the ECHA (European Chemicals Agency) portal
Japanese companies alone do not have the authority to submit
Display of UFI code is illegal unless PCN submission is completed.
Therefore, it is very difficult for Japanese companies without a base in Europe to deal with this issue on their own, and the cooperation of a reliable local representative or submission agent is essential.
Appointment of a locally responsible person is required to obtain the UFI Code
In order to perform PCN submission and UFI management under the CLP Regulations, a **EU-based "responsible person "** must be formally appointed.
This responsible person will be expected to
PCN Submission of Product Information
Update and manage submission information
Confirmation of legal conformity of label description
Points to note
If you leave the PCN submission to the company with whom you are doing the initial transaction, all the ingredients of the product will be passed on to the other party. There is also the risk of incomplete submissions and violations if the counterparty does not properly understand the regulations.
Therefore, a practical choice is to first ask a third party who has a proper understanding of CLP rules and regulations and can respond in Japanese to temporarily assume local responsibility.
As an EU corporation, Swapsss provides comprehensive support for obtaining UFI codes, submitting PCNs, and labeling compliance. We can also provide support at the prototype level, including labels and promotional materials, prior to actual deployment in Europe. Please feel free to contact us for more information.
Failure to comply with the CLP Regulations and UFI Code
Legal Risks
Fines and product recall orders (thousands to tens of thousands of euros depending on the member country)
Sales injunctions and customs refusals
Blacklisting by ECHA and national authorities
Practical losses
Transactions with distributors are suspended/delayed
Re-printing and re-production of packages and labels after regulatory non-compliance is discovered.
Additional costs and reduced reliability due to sealing
Stop shipments just before an exhibition or export event, etc.
It is precisely in the early phases of European expansion that compliance with the CLP Regulation will prevent unnecessary costs and loss of trust in the future.
Watch for future regulatory tightening and trends.
The CLP Regulations and the UFI Code are expected to further expand the scope of application and tighten the content of obligations in the future. Particular attention should be paid to the following developments
Consideration of digital label support (QR-coding)
Tighter labeling requirements for online retailers
Implement real-time update requirements for PCN submission information
To respond flexibly to these changes, preparation for expansion in collaboration with a partner with expertise is the key to long-term success.
summary
In entering the European market, compliance with the CLP Regulations and the UFI Code is no longer a "you should do it" level, but an "obligation".
Even if the product is a sample for sales promotion or test marketing, if it is a product subject to CLP, it is necessary to obtain a UFI Code and submit it to a toxicology center (PCN).
Products treated as sundries are also subject to CLP depending on their ingredients
Submission by Japanese companies alone is not possible. Appointment of a locally responsible person is essential.
Completing regulatory compliance the first time around is advantageous in terms of reliability and cost.
Swapsss provides one-stop support for handling, regulatory classification, UFI issuance, and PCN submission in Japanese.
First of all, we welcome even a simple consultation, "Is our product eligible?" We welcome even a simple consultation. Please feel free to contact us as your first step to enter the European market.