Harmonised notifications
Information to provide
Following the amendment adding Annex VIII to CLP regulation, information in a European harmonised format (or PCN format) will need to be provided by importers and downstream users (including formulators). The required information is as follows:
- the full chemical composition
- toxicological information of the mixture (SDS Section 11)
- product category
- the safety data sheet and label in the country’s language
- the Unique Formula Identifier, or UFI
On this last point, ECHA implemented a UFI generation tool on its dedicated website for poison centres. The UFIs will be generated from the company’s VAT number and a formulation number specific to the mixture. UFIs will need to appear on labels and should ideally be linked to the corresponding submissions on the notification portal.
EcoMundo will soon make available a detailed article on UFIs.
ECHA’s submission portal
On last 24th April, ECHA set up an online harmonised submission portal, so as to centralise both the submission and verification of notifications by industry and authorities.
However, all member states have not yet declared their intentions of connecting to this new portal. Meaning that, for some time, companies might need to have a double notification, depending on the countries where their mixture is sold: one through ECHA’s portal, PCN format, and one notification to the corresponding local poison centre.
Exemptions
There are some exemptions to Annex VIII:
- mixtures used for scientific research and development
- mixtures classified only for one or more of the following hazards
- Pressurised gas
- Explosives
- Environmental hazards
Deadlines to get compliant
The implementation deadlines for Annex VIII are as follow:
- consumer use: 1st January 2021
- professional use: 1st January 2021
- industrial use: 1st January 2024
However, local notifications to national poison centres for products already on the market will still be valid until 2025. From 1st January 2025, all products must be notified in the harmonised format.
On the other hand, this transitional period does not apply if changes are made to the product by 2025. For instance, if the composition of the mixture changes, or its toxicological properties, etc., triggering an update of the notification, or if it is marketed in a new country, in these cases the notification will need to be made in the harmonised format.
The dates at which each member state will connect its local notification system to ECHA’s European platform are not known yet. Each member state’s decision at this time is listed on this page.
At the moment, no member state accepts notifications submitted through ECHA’s platform only. Some of them however have already announced they would be connected quickly.
Context
Many European countries have required for several years that companies notify to poison centres the mixtures deemed hazardous that are sold on their territory. This declaration serves the purpose of giving the best health response, be it to consumers or to health professionals, in cases of exposure to hazardous mixtures.
In order to provide the best response in case of emergency, the European Union decided to standardise the required information to submit to poison centres and its format by voting in 2017 a regulation. The (EU) 2017/542 Regulation amends the CLP Regulation by adding Annex VIII.
Harmonised notifications
Information to provide
Following the amendment adding Annex VIII to CLP regulation, information in a European harmonised format (or PCN format) will need to be provided by importers and downstream users (including formulators). The required information is as follows:
- the full chemical composition
- toxicological information of the mixture (SDS Section 11)
- product category
- the safety data sheet and label in the country’s language
- the Unique Formula Identifier, or UFI
On this last point, ECHA implemented a UFI generation tool on its dedicated website for poison centres. The UFIs will be generated from the company’s VAT number and a formulation number specific to the mixture. UFIs will need to appear on labels and should ideally be linked to the corresponding submissions on the notification portal.
EcoMundo will soon make available a detailed article on UFIs.
ECHA’s submission portal
On last 24th April, ECHA set up an online harmonised submission portal, so as to centralise both the submission and verification of notifications by industry and authorities.
However, all member states have not yet declared their intentions of connecting to this new portal. Meaning that, for some time, companies might need to have a double notification, depending on the countries where their mixture is sold: one through ECHA’s portal, PCN format, and one notification to the corresponding local poison centre.
Exemptions
There are some exemptions to Annex VIII:
- mixtures used for scientific research and development
- mixtures classified only for one or more of the following hazards
- Pressurised gas
- Explosives
- Environmental hazards
Deadlines to get compliant
The implementation deadlines for Annex VIII are as follow:
- consumer use: 1st January 2021
- professional use: 1st January 2021
- industrial use: 1st January 2024
However, local notifications to national poison centres for products already on the market will still be valid until 2025. From 1st January 2025, all products must be notified in the harmonised format.
On the other hand, this transitional period does not apply if changes are made to the product by 2025. For instance, if the composition of the mixture changes, or its toxicological properties, etc., triggering an update of the notification, or if it is marketed in a new country, in these cases the notification will need to be made in the harmonised format.
The dates at which each member state will connect its local notification system to ECHA’s European platform are not known yet. Each member state’s decision at this time is listed on this page.
At the moment, no member state accepts notifications submitted through ECHA’s platform only. Some of them however have already announced they would be connected quickly.
Context
Many European countries have required for several years that companies notify to poison centres the mixtures deemed hazardous that are sold on their territory. This declaration serves the purpose of giving the best health response, be it to consumers or to health professionals, in cases of exposure to hazardous mixtures.
In order to provide the best response in case of emergency, the European Union decided to standardise the required information to submit to poison centres and its format by voting in 2017 a regulation. The (EU) 2017/542 Regulation amends the CLP Regulation by adding Annex VIII.
