SYNAPSE and SIMMBAD: changes in 2023
SYNAPSE and SIMMBAD: changes in 2023
jeudi 12 janvier 2023
◾SYNAPSE Before a mixture is placed on the European market by an importer or downstream user and when it meets the criteria in Article 45 of Regulation (EC) 1272/2008 (CLP), it must be declared to the Poison Control Centres in each country where it is placed on the market so they can provide an adequate response in case of accidental exposure.
Regulation (EU) 2017/542, applicable since 1st January 2020, harmonised the information contained in the declaration to be provided to the poison centres (Annex VIII of the CLP Regulation). The European Union has set up a portal to carry out this declaration in a centralised and harmonised form: the European portal for notifications to poison centres, known as the “PCN portal”. This portal allows the notification of hazardous mixtures in all countries of the European Economic Area (EEA), where it was necessary to submit a declaration according to the national system.
With the introduction of this new system for the declaration of hazardous mixtures, all EEA countries have committed themselves to connect to the PCN. Currently, Bulgaria and Slovakia are the last Member States not connected to the PCN portal, with Iceland having recently connected in August 2022.
The switch to reporting via the PCN portal is followed by transitional periods until 1st January 2025, during which notifications made according to national requirements will still be valid, provided, among other criteria, that the composition of the mixture has not changed. The obligation to comply with the harmonised declarations is progressive and depends on the type of use:
- Consumers and professional use: 1st January 2021
- Industrial use: 1st January 2024
The first January 2025 will mark the end of the transitional period. All declarations will then have to be made in accordance with Annex VIII of the CLP Regulation.
In France, the SYNAPSE portal, a national tool for submitting a notification, has been phased out in January 2023. Today, the notification of hazardous mixtures is necessarily made through the PCN portal. However, it will still be possible to consult your SYNAPSE declarations until 30 June 2023.
Please note that the notification of a hazardous mixture can only be made by an entity based in the EEA. However, it is possible for a foreign company to have an EEA trustee submit a voluntary notification on its behalf. Lisam Telegis can help you to notify your hazardous mixtures, whether you are subject to the obligation to submit the information yourselves or whether you intend to submit it voluntarily.
◾SIMMBAD
The placing on the market and use of biocidal products is subject to Regulation (EU) 528/2012. Therefore, it is necessary to make the necessary formalities with the European Chemicals Agency (ECHA) but also with each national authority.
In France, the SIMMBAD portal ("Information system for the marketing of biocides: authorisation and declaration") is the tool used to declare biocidal products to the National Agency for Food, Environmental and Occupational Health Safety (Anses) so that they can be added to the French biocidal product inventory. It also allows you to declare the annual quantities placed on the market in order to comply with the requirements of the French authority.
The SIMMBAD portal, initially created in 2010, has been totally revised in January 2023 in order to better adapt to the needs of professionals. It is now called BioCID, a tool for the Catalogue, Inventory and Declarations of biocidal products. Thus, since 1st January 2023, it is no longer possible to submit your declarations on the SIMMBAD portal. Now you will have to go through the BioCID application, which has become available on 10th January. New login details have been sent by email to SIMMBAD account holders.
The BioCID tool aims to simplify the user experience for submitting declarations but also to provide a better readability of the status of biocidal products listed in the French catalogue. Declarations made on SIMMBAD will be automatically migrated to BioCID. Please note that the management of “certibiocides” will not be done with BioCID, as the General Directorate for Risk Prevention (DGRP) is working on a dedicated tool.