Background
EU member states are required to establish poison centers to receive information on the composition of hazardous mixtures and inform medical personnel and the general public of such information as well as recommendations for medical treatment in cases of poisoning. Companies which place hazardous mixtures on the EU market should notify poison centers of information of their mixtures.
However, as the information requirements of poison centers vary from country to country, companies have to submit similar information in different formats separately, which adds to their compliance difficulties and leads to inconsistencies in information available to poison centers and medical personnel. For instance, according to the European Commission, EU poison centers answer at least 600,000 calls per year, and in roughly 40% of calls poison centers find problems in identifying hazardous mixtures.
On March 22, 2017, in response to increased demands for harmonized information of hazardous mixtures, the EU Commission Regulation 2017/542 [1] was adopted to lay out unified Poison Center Notification (PCN) requirements concerning hazardous mixtures, so that well-clarified and consistent information of such mixtures can be available to all poison centers of EU countries. It amends the regulation concerning classification, labelling, and packaging (CLP) of substances and mixtures (EC Regulation 1272/2008 [2]) by adding an Annex on harmonized information relating to emergency health response and requiring the addition of a unique formula identifier (UFI) on the label of hazardous mixtures.
Scope of PCN Requirements
Basically, mixtures which are placed on the EU market and classified as hazardous on the basis of their health and physical effects should be subject to PCN requirements. Products exempt from the PCN requirements majorly include:
Substances
Mixtures not covered by CLP
Mixtures classified only for environmental effects
Mixtures used for R&D and PPORDs
Gases under pressure
Explosives (unstable explosives and divisions 1.1 to 1.6)
The PCN submissions of products listed above can be conducted on a voluntary basis. Such submissions will enable suppliers to protect their confidential business information and help emergency responders obtain necessary information to avoid unnecessary hospitalization.
Who Should Submit PCNs
Importers and downstream users placing hazardous chemical mixtures on the EU market need to submit PCNs. For distributors which solely store and place mixtures on the market, they are principally not required to submit information to appointed bodies as long as they do not engage in other activities of mixtures. However, for distributors which modify the label of hazardous mixtures or repackage hazardous mixtures, or launch products to member state markets where upstream users have not submitted notifications, they should notify appointed bodies as well.
In addition, a duty holder can entrust a third party (e.g. parent companies/headquarters and consultancies) to notify appointed bodies, but the use of a third party does not relieve them from their responsibilities or obligations.
Phased Deadlines of PCN
The deadlines of PCN requirements are determined based on the intended use of hazardous mixtures, as shown below:
Hazardous mixtures for consumer use: January 1, 2020 (a proposed delay until January 1, 2021 [3])
Hazardous mixtures for professional use: January 1, 2021
Hazardous mixtures for industrial use: January 1, 2024
Enterprises may find it difficult to identify the end use of mixtures when submitting PCNs, and should collect as much usage information as possible from downstream users. Where any change occurs to the use of mixtures after PCN submissions, such submissions should be promptly updated as needed.
How to Submit PCNs
The PCN system is aimed at harmonizing notifications of hazardous mixtures in all EU member states. The essentials of the system are shown below:
PCNs submitted in a unified format [4]
Categorization under the European Product Categorization System (EuPCS) [5]
Submit notifications to appointed bodies of member states via the ECHA submission portal [6]
Unified content in notifications
Basic information | Hazard information of mixtures | Composition information of mixtures | Additional information |
Identification of mixtures; identification of composition of mixtures (CAS/EC); UFI; and contact information of submitters | Classification of mixtures; label elements; and toxicological information | Composition of mixtures (100%); Exact concentration or concentration ranges of components; and Classification of components | Packaging type, size, color, physical state, pH, product categorization (EuPCS), use (consumer/professional/industrial |
New Addition to PCN Requirements: UFI
The unique formula identifier (UFI), consisting of 16 alpha-numerical characters, is generated based on an enterprise’s VAT number and an internal formulation number assigned to a product. A UFI is assigned to only one mixture composition (but one mixture composition may have multiple UFIs assigned to it), and the same UFI can be used in the supply chain as long as no change occurs to the composition. A UFI can be used to protect confidential formulas, and submitted as known components.
The UFI is developed using software called the “UFI Generator” (see the picture below).
One must fill in a UFI when submitting a notification, and only after the notification is approved will the UFI become valid and explicitly link the submitted mixture information with medical information and specific products placed on the market.
The UFI must be printed on, or affixed (e.g. by a sticker) to the label of products containing hazardous mixtures (see the picture below). Where any product has no label, the UFI can be specified in the safety data sheet (SDS) of the product.
Fig. Implementation of PCN requirements in EU nations
Implementation of PCN Requirements in EU Member States
ECHA has been releasing supporting regulations and software tools to flesh out the system. It has also investigated the implementation of Annex VIII to CLP regulations in each member state, and concluded that by October 3, 2019, 19 member states will accept notifications only via ECHA submission portal, 4 member states will accept notifications via ECHA submission portal or their national submission system, and 8 member states have not made a decision in this regard [8].
Meanwhile, member states which currently charge no fees may collect certain fees for administrative approval. Enterprises should stay tuned with relevant updates so as to make cost-efficient compliance decisions.
What should Enterprises Do?
Identify your role in the supply chain and understand you compliance obligations
Sort out a list of mixtures or products you have placed or will place on the market and assess whether they are classified as hazardous based their health and physical effects or exempt from PCN requirements
Collect information concerning EU member state markets, importers and end use of your products
Assign and manage UFIs based on business decisions
Prepare SDSs and labels and collect information concerning the packaging size, type, etc. of products
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