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Poison Centre Notification – 6 Steps for a Successful PCN

Download our comprehensive guide about Poison Centre Notification here!

A large number of chemical products are placed on the EU market and used both by the general public in their everyday lives as well as by professionals in their working environments. Chemical products are, in general, considered to be safe when their use instructions are followed. Nevertheless, unintentional exposure to chemicals can occur, for example, due to their inappropriate use or accidents. When this happens, immediate access to relevant information on the chemical product is crucial for medical staff and those who provide emergency responses. Poison centres play an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents.

The companies that place hazardous mixtures on the market are obliged to provide information to the poison centres in each EU member state the placing occur. The placing on the market happens when the company, e.g. formulates or imports a mixture and either sells it or uses it in its own operations. This requirement is set by law in article 45 of the Classification, Labelling and Packaging (CLP)regulation ((EC) No 1272/2008). This obligation is applicable to mixtures,e.g. to detergents, paints, glues or biocides. Substances, e.g. ethanol, hydrogen peroxide, or copper sulphate, are not in the scope of this obligation as poison centres have the required information of substances available in their databases. The information provided enables poison centres to advise the citizens or medical personnel in an emergency.

PCN plays an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents

Our guide gives an overview of Poison Centre Notification (PCN) that play an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poison incidents.

Do you want to know what a Poison Centre Notification (PCN) is? Are you curious about which mixtures require information to be submitted and how to submit a Poison Centre Notification dossier? These are just some of the questions our guide answers as well as presenting the 6 steps for a successful PCN.

Download our guide here.

Ecobio helps you to fulfil your obligations

Do you need help or wish to know more about your obligations or the poison centre notifications (PCNs)? Ecobio can help you to make Poison centre notifications and to collect the information required in notifications. Our experts will help you to meet your PCN obligations quickly and efficiently.

Get in touch with us! We are very pleased to help you.

Ecobio Oy asiantuntija Anne KallioinenAnne Kallioinen

Senior Consultant

anne.kallioinen@ecobio.fi

Tel.: +358 20 756 2303


Picture: Shutterstock

Blog: REACH – ripple effects on the whole supply chain

An important milestone for the European chemical industry has been reached as the final REACH registration deadline for substances passed in 31.5.2018. The European REACH Regulation ((EC) No 1907/2006), however, continues to set high standards for the whole industry, from manufacturers, importers, formulators and distributors all the way down to downstream and end users.

Effects on the supply chain

Whilst the REACH registration deadline passed in 31.5.2018 already, it can take up to 3 months for the European Chemicals Agency ECHA to make a registration decision; your supplier might be fully REACH compliant if they have submitted their dossier on time, but might not yet have received a registration decision, i.e. a registration number, from ECHA. In complex cases where an extension might have been received from ECHA and the Director’s Contact Group, receiving a registration decision will take even longer than that.

This also means that the potential effects of the last registration deadline that mainly dealt with SMEs and their substances might affect supply chains with a delay. Whether or not the registering company had enough assets and know-how to pull through the registration might become evident only later on. If a company has decided to cease their manufacture by 31.5.2018, they are still allowed to sell all their supply gathered before the deadline to downstream users as distributors. Whether or not some companies or some products might be dropping out, or the market become more homogenized, will most likely be found out only after the dust of the final registration deadline has settled.

Communicating REACH compliance to authorities and stakeholders

In terms of supply chains and their continuance, it is important to notice that pre-registration numbers are no longer valid. It is also important to notice that either a generic or a company-specific version of the actual REACH Registration number can be put forward. The company-specific version always consists of four parts of numbers, e.g. 01-2119458769-17-0003, whereas the generic form might only consist of three (e.g. 01-2119458769-17 or 01-2119458769-17-XXXX). Make sure that your suppliers have actually registered the substance in their name, and are not just giving you a generic number to keep you content for a while.

A good way to communicate a company’s adherence to REACH and its many requirements is a REACH declaration of compliance. Such a statement can serve as a testimony to the authorities or as communication to customers and other stakeholders to show that your company is indeed REACH compliant in all the relevant aspects of the REACH Regulation. Such a statement is a hard asset outside of Europe as well.

A shift in focus towards formulators

As the burden of REACH has previously been mainly on substance manufacturers and EU importers, the focus of the regulation is now shifting towards formulators. The safe use of mixtures is a topic that will need to be addressed by operators in the coming years in the form of unique formula identifiers (UFI) and poison centre notifications (PCN). This will require a thorough knowledge of the composition and hazardous properties of the supplied mixtures as well. Exposure scenarios and their utilization in communicating the safe use of mixtures will surely be giving formulators some gray hair.

Increasing amount of regulation

As ECHA is now the holder of the world’s largest open database of substance information, plans on how to best utilize the gathered information on the registered substances are big. On a general level this might mean more substance restrictions and harmonized classifications. Manufacturers of highly hazardous substances or those who have submitted incomplete information, on the other hand, might become a target for even more scrutiny.

Reaching the legislative deadline will also most definitely result in increased supervision from national authorities on whether or not companies have fulfilled their various requirements under the REACH Regulation, with regard to substance restrictions and registrations especially. A more scrutinized assessment of SDS’s and of the responsibilities that downstream users have regarding exposure scenarios and their assessment against their own conditions could also result.

Harmonized classifications under the CLP Regulation ((EC) No 1272/2008) themselves can also be a source of restriction, as is now happening with titanium dioxide. A common chemical used as a pigment and thickener in a wide variety of applications for consumer use, including foodstuff, is about to receive a category 2 carcinogen classification, meaning heavy restrictions on its use in many of its current applications.

Competitive edge for European companies

One of the main original aims and visions of the comprehensive chemical legislation that is REACH is to ensure a high level of health and environmental protection. Another aim of the regulation has been to stimulate innovation and enhance the competitiveness of European brands on international markets. As chemical legislation is getting stricter all around the globe, REACH is indeed serving as an important example for other countries striving for increased chemical safety. This is one of the reasons why being REACH compliant is an asset all over the world; still today, REACH is the most advanced chemical legislation in the world.

Consumer image – a threat or a possibility?

An increasing amount of portals and sources for consumers on how to use chemicals safely and on how to find relevant safety information on chemicals have also emerged. Whilst a huge amount of scientifically-based information on chemicals and their safe use is now publicly available, what should never be underestimated is the opinion and views of the general public. Companies should therefore have an understanding of what the data gathered by them actually means and how it can be translated into facts and to transparent stakeholder communication.

Registration in the future

Now that all the three major deadlines for the REACH registration of chemicals in different tonnage bands have passed, the registration of future substances will require more planning in advance; as of now substances will need to be registered before manufactured or imported into the EU in amounts above 1 tonne per year. Make sure to make use of all the relevant exemptions to registration requirements. For R&D substances, for example, a PPORD notification will give your company a 5-year period of reflection before deciding on whether to continue with the substance or not. For substances produced in circular economy processes, further exemptions also apply.

 

For more of the concrete results that REACH keeps delivering, see the press release of the European Commission on the matter: http://europa.eu/rapid/press-release_IP-18-1362_en.htm

 

Leea Ojala, Senior consultant

20.6.2018, Helsinki

 

In case you have any questions about your obligations under the REACH Regulation or are interested in a REACH Declaration of Compliance or a screening of substance restrictions on your chemicals, contact Ecobio’s experts at: info@ecobio.fi or tel. +358 20 756 9450.