Poison Centre Notification (PCN)
−− Its Implications on Mixtures
Nov. 20, 2020
There has been a new development on the European Union’s Classification, Labelling and Packaging (CLP) regulation which has now added the new requirements within Annex VIII of the regulation for the hazardous mixtures placed into EU market.
Poison centres answer more than half a million calls yearly for support in case of incidents. Roughly half of the calls are related to accidental exposure involving children. Children are particularly vulnerable to hazardous chemicals, which are often found in everyday products. There has been very limited information is available on the mixtures which are in market with poison centre. Also, many times it takes time to respond on emergency health response or they don’t have the composition details of the mixture which has caused the emergency.
Considering this EU has harmonised the information requirements on mixtures classified as hazardous for human health or physical effects as of 2021. Importers or downstream users have to submit this information to Member States, to be used by their poison centres for emergency health response. With these new requirements poison centres will have more updated information about the mixtures and will be in better position to respond to all emergency health requests.
If you are placing hazardous mixtures on the market, you will have to prepare information in an EU-harmonised Poison Centres Notification (PCN) format. You will then have the option of submitting this information centrally through European Chemicals Agency’s (ECHA’s) submission portal.
Mixtures in Scope
All mixtures including mixtures in biocidal products and plant protection products are within the scope of this obligation, and the information submission requirements apply in addition to other obligations under the Biocidal Products Regulation and Plant Protection Products Regulation.
The obligation to submit information does not apply to mixtures considered hazardous only due to environmental hazards. Mixtures exempted from the submission requirements include also:
• Radioactive mixtures;
• Mixtures subject to customs supervision;
• Mixtures used in scientific research and development;
• Medicinal and veterinary products, cosmetic products, medical devices and food and feeding stuffs; and
• Mixtures only classified as gases under pressure and explosives.
Timelines for Compliance
There have been different compliance deadlines has been identified by the authorities as mentioned below
PCN data requirements?
All the requirements are detailed in the Guidance, most notable new elements include:
• Provide the full chemical composition of the mixture – this means both the hazardous and non-hazardous components. In this case it is mandatory to provide the 100% compositional details of the mixtures. This enables to do the correct classification of the mixtures and this can be further verified based on the data available for the components in mixtures.
• Label your product with a unique formula identifier (UFI) – the UFI allows poison centres to rapidly identify the product or update the UFI into section 1 of your SDS.
• Assign a product category according to the European Product Categorisation System (EuPCS).
With this UFI, poison centres would be able to trace back the composition and classification of the mixtures used in product and will be able to respond to the queries in timely manner.
Types of submissions
There are three different types of submission available for mixtures with PCN notification and the details of the same are mentioned below
For mixtures used at industrial sites only, a limited submission is an option that allows you to provide information that, regarding the composition, is limited to what is contained in the safety data sheet. Note that a safety data sheet in either a standard or limited submission is not an information requirement and the harmonised format must still be respected. However, if you use the limited submission option, you must provide a 24/7 phone number for rapid access to information in case of an incident.
You may be able to opt for a group submission, which brings multiple mixtures together under a single submission. All mixtures in the group submission must have the same classification for human health and physical hazards and have the same mixture composition (though this can differ with regard to fragrances and perfumes under specific conditions).
Consider a voluntary submission for mixtures where there is no obligation to submit information, namely, non-hazardous mixtures or mixtures classified for the environment only. A voluntary submission may be useful if your product will be incorporated in a mixture that is classified as hazardous for human health and physical hazards. In this way, a voluntary submission can help protect your confidential business information such as the composition of your mixture, by allowing you to provide this information to your customers through the UFI only. Placing the UFI on the label would, however, be optional.
Stepwise Actionable point for the Industry
• Identify & verify if you are manufacturing / exporting only mixtures or Mixtures in Mixtures (MiM’s)
• Get familiar with new PCN requirements and terminology involved into it
• Prepare inventory of the mixtures manufactured and exported to EU
• Verify & compile the classification of the mixtures as per CLP notification and verify available SDS
• Compile the data required for PCN notification
• Identify the EU based competent person/ consultant to do the notification on behalf of your company
Thus, now industry has to gear up with these new requirements and prepare themselves to meet this upcoming challenge to keep up to date information related to mixtures or Mixtures in Mixtures which are landing in EU for any uninterrupted issue.
For any help of information related to PCN, please visit our site https://gpcgateway.com/
The article is from 2020 INDIA PESTICIDE SUPPLIERS GUIDE magazine.
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