Chemical products are available for a variety of uses to professionals and the general public. Unintentional human exposure to these products can pose significant health hazards under circumstances of misuse or accidents. When an accidental exposure takes place, emergency responders need access to accurate and relevant information about the chemical product in order to provide the best possible care.
According to current European Union (EU) legislation, member states must appoint a body responsible for receiving information relating to dangerous mixtures placed on the market. Many member states have implemented a system to collect this information and provide it to poison centers that will then give medical advice in health emergencies. Under this current legislation, a lack of member state harmonization has led to substantial variation in the existing national notification systems, data formats and information requirements. This is a challenge for companies selling hazardous mixtures in different member states because they must submit similar information multiple times in various formats in order to meet the individual requirements of each country. Poison centers have also reported difficulties matching products to the corresponding notification in up to 40% of emergency exposure calls, which can lead to devastating consequences. This system is flawed and regulators have taken action to implement change.
The new Annex VIII to the CLP (Regulation (EC) No 1272/2008 on the classification, labeling and packaging of substances and mixtures) was designed to harmonize the format and content of the notification requirements and correct the inconsistencies that emerged under the previous system. Importers of chemicals into the EU and downstream users placing hazardous mixtures on the market will be responsible for complying with the updated requirements established in Annex VIII to the CLP.
Notification Deadlines & State-specific Considerations
CLP regulated mixtures that are hazardous based on health or physical effects must be notified before they are placed on the market. The deadline for compliance with Annex VIII is Jan. 1, 2020 for consumer mixtures, Jan. 1, 2021 for professional mixtures and Jan. 1, 2024 for industrial mixtures. For mixtures that have been notified in a member state before 2020, there is a transition period for updated notification with a deadline of Jan. 1, 2025. However, if there is a change to the product composition or labeling, or if the mixture is placed on the market in another member state, then a new notification according to Annex VIII will have to be submitted in advance of the 2025 transitional period deadline.
Mixtures will still need to be notified in each separate member state where they are placed on the market. This is done either directly via a member state appointed body or via the European Chemicals Agency (ECHA) poison center notification (PCN) portal. Each member state will determine how products will be notified; some member states allow for either notification method to be used. The language of submission is the official language(s) of the member state unless the member state specifies otherwise. In many cases, this means that English submissions are not acceptable. Submission information includes the Globally Harmonized System for Classifying Hazardous Chemicals (GHS) hazard classification, toxicological information and the product composition.
Labels for hazardous mixtures placed on the market will now be required to carry a 16-digit Unique Formula Identifier (UFI). The UFI will enable poison centers to rapidly and unambiguously identify submitted information when called upon to provide advice when dealing with a poisoning incident. All products with the same UFI must have the same composition.
When a raw material used to formulate a product is a mixture, then it is called a Mixture in Mixture (MiM). If the supplier has notified the raw material to the PCN portal, then this MiM may be used in the notification for the overall product. All that is needed is the UFI of the MiM and the percentage of the MiM in the product. This allows the supplier to maintain confidentiality and saves the notifier time since they do not need to add the full composition to the notification. It is important to note that if the supplier of a MiM changes its formula, then its UFI will change. This means that any product containing the modified MiM will need to be re-notified and a new UFI must be generated for the overall product.
Another new feature of Annex VIII is the European product categorization system (EuPCS) which is used to describe the intended use of a mixture that is being notified. The purpose of the EuPCS is to support the reporting and monitoring of poisoning incidents in the EU as well as help to identify product risks for specific mixture categories when other information is unavailable. Some examples of product categories include “aerosol paints and coatings” and “floor cleaning products.”
How to prepare for the upcoming deadlines
ECHA has some helpful resources available for those who want to learn more about Annex VIII to CLP. Version 1.0 of the Guidance on Harmonized Information Relating to Emergency Health Response is currently available on the Guidance on CLP section of ECHA’s website (echa.europa.eu). If you have obligations under Annex VIII to CLP, this guidance document provides valuable information about the requirement to notify hazardous mixtures to the Member States’ appointed bodies.
We can expect to see an updated version of this document this year that will include clarification about the obligations of distributors placing hazardous mixtures on the market in the EU.
Additionally, the ECHA submission portal web page provides some key documents, including a guide to dossier preparation and submission as well as an overview of how Member States have implemented Annex VIII requirements so far.
Notifying now rather than waiting until the deadline can be beneficial for multiple reasons. Currently, most member states are not charging fees for notification. It is unclear how the fee structure will change in the future, so submitting notifications now is a good way to save on this anticipated cost. Companies that notify member states before the 2020 deadline may take advantage of the transition period, which means that there is no obligation to comply with new Annex VIII requirements until Jan. 1, 2025. Additionally, there is a moral obligation for companies to submit the relevant information so that in case of an exposure incident, emergency responders can give appropriate advice.
Some key factors to consider in preparation for the upcoming deadlines include determining which products require notification, to which Member States a submission is needed, and by when must the notifications be completed. EuPCS categories should be determined for each product; UFI codes must be generated and added to product labels and notification dossiers will need to be prepared. Once your hazardous mixtures have been notified, you will be able to rest easy knowing that emergency responders have the information they need to respond to any potential incident involving one of your products.
For more information about EU poison center notification, contact us at Nexreg Compliance by visiting nexreg.com. SPRAY