Meeting the reporting requirement
By Dr Dieter Reiml and Rupert Scherer, TÜV Süd Industrie Service
Not only end users come into contact with paints and varnishes, but these mixed products are also used in trade and industry. The hazard potential ranges from physical hazards (e.g. fire hazard) to health hazards (acute and chronic poisoning) and environmental hazards (poisoning of water bodies). In medical emergencies, poison control centres or ECHA offer advice by telephone: they provide information on necessary measures such as detoxification, examinations and further steps. To ensure that doctors and experts from a wide range of fields can provide this information, manufacturers and importers must classify and label the dangers arising before placing dangerous products on the market in the EU and provide information on their chemical composition and toxicological properties.
In the past, there were no uniform rules for notifying poison control centres about chemical products. Now the EU has standardised the notification to poison control centers with an amendment to the CLP regulation (Classification, Labelling and Packaging). There are staggered notification deadlines for those placing products on the market in the EU, depending on their area of application: For products for end consumers, the initial deadline was 1 January 2020 – but this deadline was extended by one year to 1 January 2021. The same applies to commercially used products. For industrial use, the deadline is 1 January 2024. By 2025, all products must be notified, including products that were previously on the market under national laws.
Classification and labelling of products is not a simple matter. On the one hand, consumers have difficulty understanding the information on product labels and, on the other hand, companies often do not know exactly how to label chemicals and classify their hazards. The Federal Institute for Occupational Safety and Health (BAuA) in Germany provides information on this. Detailed information and instructions can also be found on the pages of the ECHA poison control centres. Before hazardous substances are reported, however, they must first meet the requirements of the REACH Regulation. This further chemicals regulation primarily serves to protect human health and minimise environmental risks.
Notifications to poison control centres are only made electronically via the harmonised PCN format (Poison Centre Notification) – in accordance with the CLP Regulation. Among other things, this format ensures that discrepancies between EU member states and the European Economic Area are reduced. Based on defined criteria, companies determine hazardous properties of chemical products and assign them to hazard categories. A European Product Categorisation System (EuPCS) has been established for this purpose. For classification, companies can refer to the ECHA’s Classification and Labelling Inventory (C&L Inventory) and consult already harmonised classifications of substances or carry out a self-assessment of the expected hazards. If substances are assigned to at least one hazard category, they are considered hazardous and must be notified. Labelling is done using standardised elements such as hazard statements, safety instructions and contact information. In addition, marketers must create a UFI code (Unique Formula Identifier) and affix it to the product label.
Confidentiality and targeted assistance
The UFI code, the unique recipe identifier, is a 16-digit alphanumeric code consisting of, among other things, the VAT number of the company and a number from 0 to 268,435,455. As the exact composition of a mixture is a trade secret, it is deposited confidentially with the poison control centres. The UFI allows the product and its chemical composition and toxicological properties to be precisely identified in medical emergencies. In the case of industrial products without a label, the UFI must be stated in the safety data sheet. The advantage of a UFI is that it ensures data protection: The poison control centres know the chemical composition and at the same time manufacturers avoid product piracy. For easier and more economical administration, a UFI can also be used across products if the chemical composition does not differ or as long as deviations or tolerance limits are not exceeded in the dosage – even for products with a different trade name or different packaging.
Trustees protect sensitive product data
Anyone wishing to place mixtures from manufacturers outside the EU on the EU market needs information on the chemical composition. As there is no obligation to report outside the EU under the CLP Regulation, manufacturers are usually reluctant to disclose their trade secrets for reasons of business strategy. A trustee can be appointed to counteract this problem. A manufacturer outside the EU entrusts the data to a trustee, who passes them on to the poison control centres of all EU member states. In this way, business relationships can be maintained without neglecting reporting obligations.
Expertise and reliability are fundamental
Trustees must treat all data with absolute confidentiality and must never pass it on for their own purposes. This also includes keeping data secure. Furthermore, trustees must be competent in the field of chemistry as well as in the field of chemicals legislation. In order for trustees to fulfil the task of notifying poison control centres of products to be imported, they must have the necessary computer skills to handle the software instruments. Furthermore, reliability means that trustees carry out their task with the utmost care and attention.
Sense and purpose
A uniform product notification system for hazardous mixtures in Europe ensures that chemicals legislation is harmonised. A further advantage is that all poison emergency call centres in the EU can be notified with a central notification. In medical emergencies, poison control centres can also provide qualified assistance. At the same time, companies protect their business secrets.Trustees such as TÜV Süd help with questions relating to the notification obligation or the translation of the PCN into the respective national language.