Article 95: which processes to simplify the procurement of biocidal active substances?
ECHA�s measures to speed up the commercialisation of disinfectants and sanitizers in the Covid-19 context
National derogations to procure active substances
With the emergency of the Covid-19 health crisis, and in order to increase the quantity of active substances required for the formulation of hand sanitizers and disinfectants, ECHA recommends togrant temporary exemptions from the usual processes. These exemptions are granted by Member States which are free to agree or not with ECHA�s recommendations.
Regarding national exemptions, France for example has already implemented one via the 17th April directive modifying the 13th March 2020 directive. It authorises, for already registered and marketed products and when the supplier is facing a shortage, to temporarily use new sources of active substances through suppliers listed on the pharmacopoeia or operators of the agribusiness. More precisely the exact references are:
- agricultural ethylic alcohol in the definition of Annex 1 of the regulation (CE) n� 110/2008,
- natural ethanol produced according to the standard EN 15376 : 2014.
However, companies will need to take care of being compliant at the end of the crisis and of the exemption periods (on 1st September for France).
ECHA�s participation to the effort in the fight against Covid-19
ECHA's goal is to quickly launch disinfectants on the European market. The agency has therefore decided to accelerate the process of inclusion to the approved suppliers list of Article 95: the evaluation can now start before the fees are paid, instead of after, as it is usually the case.
Furthermore, ECHA also speeds up the processes of technical equivalence. For marketing authorisation (MA) dossiers already submitted, if the active substance�s source has to change because of a shortage on the supplier�s part, it is possible to submit a technical equivalence for a new source.
Article 95 and biocidal active substances
Article 95 of the BPR aims at overseeing active substances (AS) suppliers and put through industrialists using the same active substance. This article gives a list of approved suppliers and the inclusion on this list is carried out with the couple AS/PT (Active substance/Product Type). It is essential to know of this list, because a biocidal product cannot be placed on the market if its active substance supplier is not registered on it for the product type of this specific biocide.
Article 95 allows to share test data on AS. It allows to have less tests carried out on vertebrates and a fairer cost-sharing for AS data.
To be included in the approved suppliers list, a company has to submit its request on the R4BP platform. The normal process is as follows:
- ECHA checks the request and sends the fee invoice
- The payment must be done in the next 30 days, then the request is placed on a waiting list
- ECHA processes the request, checks its compliance, and sends a pre-acceptation of the request
- The company then has a month to answer and add information.
- At the end of this period, ECHA takes the final decision as to the inclusion of the company to the Article 95 list.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
ECHA�s measures to speed up the commercialisation of disinfectants and sanitizers in the Covid-19 context
National derogations to procure active substances
With the emergency of the Covid-19 health crisis, and in order to increase the quantity of active substances required for the formulation of hand sanitizers and disinfectants, ECHA recommends togrant temporary exemptions from the usual processes. These exemptions are granted by Member States which are free to agree or not with ECHA�s recommendations.
Regarding national exemptions, France for example has already implemented one via the 17th April directive modifying the 13th March 2020 directive. It authorises, for already registered and marketed products and when the supplier is facing a shortage, to temporarily use new sources of active substances through suppliers listed on the pharmacopoeia or operators of the agribusiness. More precisely the exact references are:
- agricultural ethylic alcohol in the definition of Annex 1 of the regulation (CE) n� 110/2008,
- natural ethanol produced according to the standard EN 15376 : 2014.
However, companies will need to take care of being compliant at the end of the crisis and of the exemption periods (on 1st September for France).
ECHA�s participation to the effort in the fight against Covid-19
ECHA's goal is to quickly launch disinfectants on the European market. The agency has therefore decided to accelerate the process of inclusion to the approved suppliers list of Article 95: the evaluation can now start before the fees are paid, instead of after, as it is usually the case.
Furthermore, ECHA also speeds up the processes of technical equivalence. For marketing authorisation (MA) dossiers already submitted, if the active substance�s source has to change because of a shortage on the supplier�s part, it is possible to submit a technical equivalence for a new source.
Article 95 and biocidal active substances
Article 95 of the BPR aims at overseeing active substances (AS) suppliers and put through industrialists using the same active substance. This article gives a list of approved suppliers and the inclusion on this list is carried out with the couple AS/PT (Active substance/Product Type). It is essential to know of this list, because a biocidal product cannot be placed on the market if its active substance supplier is not registered on it for the product type of this specific biocide.
Article 95 allows to share test data on AS. It allows to have less tests carried out on vertebrates and a fairer cost-sharing for AS data.
To be included in the approved suppliers list, a company has to submit its request on the R4BP platform. The normal process is as follows:
- ECHA checks the request and sends the fee invoice
- The payment must be done in the next 30 days, then the request is placed on a waiting list
- ECHA processes the request, checks its compliance, and sends a pre-acceptation of the request
- The company then has a month to answer and add information.
- At the end of this period, ECHA takes the final decision as to the inclusion of the company to the Article 95 list.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
