PCN Poison Centres Notification of chemical mixture

How have regulations changed and how important is the role of PCNs?

Many substances to be placed on the European market require appropriate testing. Of course, it must not be forgotten that it is crucial to ensure, first and foremost, that they are safe for use, but it is also important to respond to situations of potential danger. In this case, PCN poison centres play a very important role. Such a centre collects relevant information about hazardous mixtures. The aim is to put in place medical advice in case of poisoning. This means that in the case of medical emergencies and unexpected cases, i.e. poisonings, the recommendations for handling will be known and the procedures will be readily available. At the same time, it will probably not surprise you to learn that the regulations in many countries were very different, so the marketing, import or use of hazardous mixtures was not uniform. This translated into problems, so there were inconsistencies in the notification systems. At the same time, the State in question had to carry out tests again, which entailed further costs. This is why a proper procedure was implemented in the countries belonging to the European Union, namely Annex VIII of the CLP Regulation.

In this way, the format itself is standardised, but also the hazard information is immediately known, hence it can be submitted immediately to the designated authorities, and thus the emergency response at the poison centre is not only rapid, but also greatly improved. This is the general outline of the introduction of hazardous substances considered toxic on the market. But we are about to give you an overview of how the regulation affects the structures of the various authorities and how PCN poison centres work to implement solutions even more quickly to provide possible protection in the event of a potential poisoning.


PCNs - poison centres as a new formula for reporting chemical mixtures.

Poison Centres Notification

A proper system and harmonisation of the rules significantly reduces and costs and increases safety, this fact seems obvious. At the same time, the implementation of legislative measures also affects the clarity of the rules and the possibility and speed of enforcement. But let us start from the beginning. Here, it is important to know that this legislation takes into account the Treaty on the Functioning of the European Union and also takes into account Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (1 ), in particular Article 45, paragraph 4 and Article 53, paragraph 1. The application of the legislation undoubtedly brings many benefits. So it is time to know what has changed ( and it has changed quite a lot) and for the better. European Union Commission Regulation 2017/542 of 22 March 2017 on the classification, labelling and packaging of substances and mixtures by adding an annex on harmonised information related to health emergency assistance. Probably everyone knows that the use of certain substances is dangerous and carries a high risk. It is so important to react quickly so that appropriate action can be implemented, which will obviously translate into health protection.

First and foremost, the most important change is that all necessary information on mixtures that are placed on the market and declared hazardous must be provided immediately to the relevant authorities at national level by importers and downstream users. The information must cover what the product is, what hazards it may present, but also its composition. It is this information that toxicology centres rely on. The European Commission carried out a review of the methods for obtaining information on the toxicity of substances and, interestingly enough, the results clearly showed that the system does not work very well, but that this can be changed by implementing uniform rules throughout the European Union. So importers no longer have to submit the same information in different formats, which often led to inconsistencies and errors, but also entailed higher costs. In addition to the fact that the information is uniform, the emphasis is also on the scope of the information and the scope must be the same in every country. It is known that individual mixtures can contain unclassified ingredients, so all units must have information on the therapeutic measures that must be put in place, but also on the use of prophylaxis itself. The format of the information itself must be uniform. It should always be done electronically in the harmonised XML format maintained by the European Chemicals Agency and, of course, made available free of charge. The European Chemicals Agency must develop a product classification system to be used when transmitting the information. The Commission also analysed the costs, but also the benefits, associated with substance identification. As many as 40% of the notifications related to problems with the correct identification of a given mixture, which could lead to inadequate treatment. In order to prevent this, as well as inappropriate treatment, it is necessary to introduce the requirement to identify a mixture by means of an alphanumeric code which is unique. It must be placed on the label.

How is information transmitted to the PCN?

We have already mentioned that the system for inputting information must be uniform. It should be noted that the current rules are indeed very simple to apply. So even before mixtures are placed on the market, it must be done in the same way throughout the EU. The information must be transmitted to the relevant bodies. But the extent of the information itself is important. It must relate to the physical health risks involved. Of course, the entity that has received this information still has the right to request clarification of the information, but it can also request an explanation of the effects of the mixture in question. And such information must be provided immediately and without undue delay. Language is important here. The legislation also specifies this aspect and so the information shall be provided in “the official language of the Member State in which the mixture is placed on the market, unless the Member State concerned provides otherwise”. It is important to remember to use the product categorisation system provided by the Agency. This ensures that poison centres have the necessary information and can take appropriate action, which translates into safety for all consumers.

Unique Formula Identifier

Reporting to the UFI or group submission.

The system is so standardised that information can be communicated collectively, which is called group communication. This applies to all mixtures belonging to a group classified in the same way in terms of health and physical hazards and belonging to the same product category . The provision may seem moderately self-explanatory, but it is actually very easy to understand. So, a group submission can take place when all the mixtures in the group contain the same components and, at the same time, for each component the reported concentration range is the same 100%. But you must also know that there are some exceptions to this standard. Namely, the submission of information is also permitted if there are differences in the composition of the various mixtures in the group, but these only relate to the fragrances or aromas, but on the condition that the concentration of the fragrances or aromas contained in each mixture does not exceed 5%. So it must not affect the performance of the substance concerned.

The Unique Formula Identifier (UFI) applies. Here you also need to know that it is the submitter of this data who creates the unique form identifier using electronic means provided by the agencies. The Unique Formula Identifier (UFI) is nothing more than a unique alphanumeric code that links the transmitted information on the composition of a mixture or group of mixtures to a specific mixture or group of mixtures. The assignment of a UFI is free of charge. A new UFI shall be created whenever there is a change in the composition of a mixture or group of mixtures. The submitter shall print or place the UFI on the label of the hazardous mixture. The UFI must always be preceded by the abbreviation UFI in capital letters , but must also be clearly visible, legible and indelibly affixed. The UFI may also be included in the safety data sheet.


What data must be included in the information provided?

The full trade name(s) of the mixture should always be provided, as should the trademark, the product name and variants of the name on the label, without abbreviations and allowing rapid but also unambiguous identification of the mixture. It is also always important to remember that the UFI is stated in the information provided. The details of the submitter, i.e. the entity, are also important and the full name, but also the full address, telephone number and e-mail address of the submitter must always be given. Of course, all information must be consistent with the data provided on the label. Article 17(1)(a) applies here. The telephone number and e-mail address are intended to facilitate rapid contact and access to necessary and important information about the product in question. At the same time, the telephone number must be available 24 hours a day, 7 days a week.

The hazards must be communicated clearly and legibly. It is imperative that the class, but also the hazard category itself is specified. The EU has also determined the elements of the label itself and Article 17 applies. In this case, the pictogram codes are to indicate the entire type of hazard. The label must include a warning word, phrase codes that indicate the type of hazard, but also phrase codes that indicate the preventive measures to be taken. Another important element is the toxicological information. This must cover all the toxicological effects of the entire mixture or its components. The additional information section is also important . In this case, we will use a quotation. This information is to include: “the type and size of packaging used to market the mixture for consumer or professional use, the colour and physical state of the mixture as supplied, the pH, if applicable, the categorisation of the product, the use (consumer, professional, industrial or a combination of any of these three).” So the whole description has to be very precise, only so that appropriate measures can be put in place. But the EU still sets out general requirements in the legislation. These concern the chemical identity and the concentration of the ingredients that are contained in the mixture. This means that ingredients that are not present cannot be notified. But remember still that, in the case of group submissions, it is imperative that the entire list of mixtures and the fragrances or flavourings they contain must be drawn up, together with their classification. So we come to know …

Learn about the mixtures affected by the new requirements.

The obligation to provide information applies to all mixtures that are not only recognised, but also classified as hazardous to human health or classified due to the physical hazard present. This obligation applies to biocidal products and plant protection products. Here, it is still important to remember that these requirements are necessary for use, even if other provisions in the Biocides Regulation still apply. But there are also exemptions. Exemptions make it unnecessary to submit information to PCN centres. Here we can mention: radioactive mixtures, but also mixtures subject to customs supervision or mixtures used in scientific research and development. The provision also applies to medicinal or veterinary products, cosmetic products, medical devices, but also all food or feed products. Interestingly, it also applies to mixtures classified only as gases under pressure or explosives. The required information should always be submitted to PCN poison centres before a product is placed on the EU market. Companies should be aware of the upcoming notification deadlines for their products. Compounds for professional and consumer use have to be notified by the first of January 2021, compounds for industrial use have to be notified by the first of January 2024 and all other products that are included in the regulation have to be notified by the first of January 2025. Failure to provide the required information by the specified deadlines will result in penalties or potential exclusion from the market.

Categorisation regarding the concentration and its range of all components of mixtures.

In order for PCN poison centres to be able to introduce specific prophylaxis, it is important to know that data submitters must also provide the information specified in Sections 3.4.1 and 3.4.2, which refers to the concentrations of the components of mixtures (substances and MwM) identified according to Section 3.3. Thus, this applies to all hazardous components of high concern for health emergencies, but also for the application of prophylactic measures. You have to specify the percentages what concerns mass or volume. So, acute toxicity is category 1, 2 or 3, target organ toxicity, including single exposure, is category 1 or 2, target organ toxicity with repeated exposure is category 1 or 2. There can also be skin corrosion, category 1, 1A, 1B or 1C or serious eye damage, category 1. So, what needs to be specified? The class and hazard category must be stated, as well as the pictogram codes that indicate the type of hazard. There must also be the signal word, the phrase codes that indicate the type of hazard. Another important element is the info. toxicity, including a description of the toxicity of the mixture or its components. The colour, ph, physical state, packaging including type and size, product category code, i.e. use, should be described. This may be consumer, professional or industrial.

Thus, the role of PCN poison centres is very important. Of course, it is only on the basis of strictly defined information that preventive measures can be prepared. At the same time, the regulations introduced by the EU considerably facilitate the provision of information, but also reduce the costs themselves and have a major impact on safety.