A Starter's Guide to CLP Art. 45, Annex VIII on Harmonizing Information Relating to Emergency Health Response
This introduction provides you everything you need to know about CLP Art. 45, Annex VIII. For companies that are affected by the requirement, this guide also covers solution options.
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This guide is a great starting point to learn about the CLP Art. 45, Annex VIII. It answers the following questions to help you get started:
- Why harmonize information relating to emergency health response?
- Is my company affected?
- What is UFI? How do to generate UFIs?
- What are the data requirements for poison centre notifications?
- How to create and submit PCN notifications?
- How to start preparing for PCN notifications?
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Why harmonize information relating to emergency health response?
Did you know that half a million calls are made annually to national poison centres? In about half of these cases, they relate to accidental exposure of hazardous mixtures involving children. This is because hazardous mixtures are prevalent in our everyday lives – from laundry detergent to household cleaners.
The EU Commission Regulation (EU) 2017/542 amends the regulation (EC) No 1272/2008 of the European Parliament and of the European Council regulation on classification, labeling and packaging substances and mixtures (CLP). It calls for an EU-wide regulation harmonizing information relating to emergency health response that is provided to national poison centres in the EU and the European Economic Area (EEA). All mixtures that are classified for human health and physical effects are required to submit a notification in the poison centre notification (PCN) format via the ECHA Submission Portal.
- For a detailed look, see ECHA's official site on Poison Centres https://poisoncentres.echa.europa.eu/home
- For the legal text of the CLP Art. 45, see https://eur-lex.europa.eu/eli/reg_del/2020/1677/oj
Is my company affected?
If you fall in any of the following categories, you are obliged to submit a notification:
- Importers of hazardous mixtures to the EU
- Downstream users (formulator, re-packager, re-filler, toll formulator)
*If the mixture is distributed in states other than the ones included in the original PCN submission.
What is a UFI? How to generate them?
With the harmonization of information on hazardous mixtures, ECHA introduced a new element - the UFI or unique formula identifier. This 16-digit alphanumeric code is used to ensure an unambiguous link between the information provided to poison centers about the mixture that is placed on the market. Products, or more precisely, the chemical mixture of the product, is considered hazardous if it is classified for health or physical hazards. Therefore, the UFI will enable a better medical response, adds a level of certainty when treating poisoning cases, thus reducing unnecessary over-treatment.
There are two parts to creating a UFI - the VAT number of your company (or ECHA company key) and the formulation number of the mixture. You can use the following tools to generate UFIs for mixtures:
- ECHA's UFI Generator (see https://ufi.echa.europa.eu/#/create)
- Develop your own UFI generator in your company's IT system. See the UFI developer's manual.
- Use the opesus UFI generator (only applicable to companies using SAP) as a standalone. The UFI generator is included in our end-to-end solution that creates notifications in the PCN format. See opesus EPN for PCN.
However, handling UFI is a lot more complex. You need to take into account if yo use the same chemical composition for several products placed on the EEA market. Additionally, you need to consider how to manage formulation changes, updates of formula, and entering new markets, etc.
Do you use the same mixture for several products?
Check out the linked blog article that covers the various options on managing UFIs.
Data Requirements for CLP Art. 45
Mixtures that meet the following criteria must be notified:
- classified for human health and/or physical effects
- placed on the EEA market, i.e., the EU, Norway, Iceland and Liechtenstein
Exemptions: mixtures used for purposes of research and development and mixtures that are only classified as gases under pressure or explosives.
The following information is required in a PCN notification:
- Contact details of the importer or downstream user submitting the notification
- Trade name of the mixture
- Packaging type and size of the mixture
- Hazard information
- Toxicological information
- Phys-chemical properties of the mixture (color, pH value, state)
The PCN format brings with it new data elements. Namely:
- Full chemical composition
- Unique formula identifier (UFI) that has to be included in the labeling of your product
- European Categorization System (EuPCS) that has to be assigned to your product
How to Create & Submit PCN Notifications
ECHA provides different methods for companies to prepare their submissions:
- online in IUCLID cloud
- offline in IUDCLID software
- using a IUCLID-compatible dedicated format for PCN submissions from the company's system
After preparing the information, you can submit the PCN notification manually by uploading it directly in the ECHA submission portal or automatically via system-to-system (S2S) submission. This is only possible if you use a IUCLID-compatible software in your company's system and enable the S2S communication between your system and the ECHA submission portal.
If you are not sure which tool is best suited for your needs, check out the article linked below.
- January 1st, 2021
for mixtures intended for consumer and professional use
- January 1st, 2024
mixtures for industrial use only
- Unique Formula Identifier (UFI)
It is a 16-character alphanumeric code that has to appear on labels of products that are considered hazardous under CLP Art. 45.
- EU Product Categorisation System (EuPCS)
A system used to describe the intended use of a mixture for which a submission has to be made according to Article 45 and Annex VIII of the CLP Regulation.
- Poison Centres Notification Format
An XML-based format defined by the harmonized requirements laid out in Annex VIII to the CLP Regulation. The PCN aims to structure the information on hazardous mixtures classified for health or physical hazards.
Notifying to Various Countries in the EEA?
Where to begin?
Steps to Preparing Poison Centre Notifications
We get asked this question a lot. Before you explore various software solutions such as opesus EHS Product Notification for EU Poison Centre Notification (PCN) Format, here are a few steps that you can start with:
- Analyze your portfolio for affected products.
Check the total number of products or articles that are affected by the CLP Art. 45, Annex VIII. Generally, mixtures that have been classified for their physical and health effects require submission in the PCN format. Having this number in mind gives you a better estimation of the effort required.
- Evaluate the completeness of data.
Check the data that you have on your articles and products against the data required for poison centre notifications notifications. You may have to reach out to your suppliers and to get additional information about particular parts, etc. There are several advantages to reaching out to your supply chain such as being able to submit a limited submission (as opposed to a standard submission). If you're considering doing limited submissions, you should bear in mind these caveats.
- Decide how to handle UFIs and notifications.
With the information that you've collected, estimate the total effort required in terms of time and resources. A good question to ask is: How can you best handle notifications with the available resources? If you only have a handful of affected products, you might choose to handle PCN notifications manually. If these products are updated or changed frequently, getting an IT system is probably the most efficient way to handle these changes.
- Evaluate solution providers.
There are a few solution providers on the market for creating poison centre notifications. This is a good time to get someone from your IT department involved to find out which solution provider best fits into your company's IT system landscape and security requirements. If you have an approved budget at this point - even better! You should definitely check out our end-to-end solution, opesus EHS Product Notification for the EU PCN Format. It's the market-leading solution for SAP customers and is used by several large chemical companies!
- Implementation timeline.
The compliance requirement for PCN kicked in on January 1st, 2021. If you are just getting started, work with your team to create a prioritization list of articles in your portfolio. Your IT solution provider should work with you on the best strategy for managing and submitting poison centre notifications as efficiently as possible. If you already started submitting notifications, you probably are looking at improving the process using IT solutions. There are several solutions out there with various capabilities. For example, opesus EPN for PCN has the most process automation features that allow you to easily manage change management and stay on top of your notifications.
Check out how Biesterfeld use SAP EH&S and opesus EPN
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