For those of you with import chemicals or mixtures into the EU for the Consumer market, you probably are breathing a sigh of relief that the Poison Centre Notification deadline of Jan 1, 2020 has been extended to January 1, 2021. And I’m thinking that most of you probably shelved this off and started attending to more pressing issues. Prioritization of EU REACH and CLP compliance is a juggling trick these days. I’m here to try and help simplify what you will need so you can quickly address the Poison Center Notifications once you finally get around to it, hopefully not December 28.
For a quick recent history lesson, in January 2009, Article 45 of the CLP Regulation (EC No 1272/2008) entered into force requiring member states to create bodies for receiving and dispensing information on hazardous preparations for the utilization by medical personal in the case of emergencies. However, the directive did not harmonize requirements and thus led to inconsistencies in product and hazard information across the EU. In 2017 Commission Regulation (EU) 2017/542 was adopted, which aligned reporting requirements, formats and ultimately the consolidation of data submissions into a central repository now known as the EU Poison Centre.
The Poison Centre notification deadlines differ for various chemical products by their use. As mentioned above hazardous products marketed for the public consumer now have the Jan 1, 2021 notification deadline. Additionally, products that apply to professionals must also have their notifications submitted by Jan 1, 2021. The last grouping of products, those marketed for industrial use, have a notification deadline of Jan 1, 2024. If your product has multiple uses – consumer, professionals or industrial – the earliest deadline would apply.
What Information is required?
With the deadlines now established, let’s talk about the products (mixtures) and the type of information you will need to submit. Since notification is only required for products (mixtures) that are classified as hazardous, you should confirm its classification to include any updates and alignment with any GHS harmonized classifications. Other information required for the notification is as follows:
- Product identifier such as trade and brand name, product number etc.
- Details of Submitter
- Telephone number
- Email address
- Contact info for rapid access (only for limited submissions)
- Classification of the mixture – health and physical hazards
- Label elements – hazard pictograms, signal word, hazard statements, precautionary statement codes
- Toxicological information of the mixture – Section 11 of the mixtures SDS in accordance with Annex II to Regulation (EC) No 1907/2006
- Chemical identity (CAS, EC or other well-known unambiguous identifier) of the product or mixture and their concentrations
- Size and type of packaging
- Color and physical state of the product
- pH where applicable
- Product categorization
- Use (consumer, industrial or professional)
- Unique formula identifier (UFI) – prescribed in more detail below
What about very hazardous substances?
Of course, the reporting of just the information above is not as straightforward as one would hope. For example, for components that meet at least one of the below hazard classifications, you must list their exact concentrations in descending order by mass or volume.
- Acute toxicity, Category 1, 2 or 3
- Specific target organ toxicity – single exposure, Category 1 or 2
- Specific target organ toxicity – repeated exposure, Category 1 or 2
- Skin corrosion, Category 1, 1A, 1B or 1C
- Serious eye damage, Category 1
Another nuance is the unique formula identifier or UFI. The UFI is a unique 16-digit alphanumeric code that can be used by emergency personal to identify your specific product. ECHA has created tools to help generate UFIs. The tool uses the company’s VAT number and other inputs that generate a coded number utilized in the notification. Additionally, the UFI is to be placed on the products label. The number is to be preceded by the letters UFI in capital letters and clearly visible, legible and indelibly marked.
For the majority of the notification the format is straightforward, but there is one exception – the toxicological Information. This section includes any data that is relevant and available on the toxicologic effects related to the health hazards covered in Annex1 of CLP. This information is the same information that should be found in Section 11 of a CLP-compliant SDS. This section of the notification process is a free field and thus may require editing and potential translations depending on the product’s marketed countries.
To facilitate implementation, ECHA provided multiple pathways and resources for information upload. The first method is utilization of the online portal itself. The portal has step-by-step instructions to guide the user through the process. The system will save each step so one can progressively enter data as it becomes available prior to final submission. The second method of PCN allows for system-to-system integration. Via this method submitters can utilize their in-house systems to create submission into IUCLID (i6z) format. For those with large volumes of submissions, this may be the method of choice. The last method uses the ECHA-designed IUCLID 6 software. This is a manual data entry off-line solution. It too creates an i6z file for submission via the portal. Additionally, on the Poison Centre website, there are numerous guidance documents and webinars referenced to provide detailed assistance.
While the responsibility for notification appears to be complicated, this new process is meant to replace having to submit to each and every member state where your product is sold. With the proper preparation, the new PCN process will be beneficial in the long run, not only to those who must submit, but also to those who require the data when the emergency arises.
Contact us today to learn more.