CA-July13-Doc.8.4
Question on in situ generated CO2
French Competent Authorities
May 2013 CA meeting
Abstract
France is in charge of the assessment of a dossier for CO2 as a PT19 substance. CO2 is either generated from combustion of butane/propane or emitted directly from dry ice or CO2 container. France gives in this paper its approach to carry out AS and BP authorization dossiers.
Like in the BPD framework, in the case of an AS generated in situ, we propose to consider only one kind of generation of the AS in order to carry out the assessment and approve the AS. The other ways of generating the active substance must be evaluated latter, during the authorization product stage.
Moreover, article 3 of the BPR considers precursors as “biocidals products”. As a consequence, they will need one product authorization and will also fall under the provisions of article 93 : they can benefit from the transitory measures for submitting an authorization product dossier.
A market distortion for generating devices put on the market between 2013 and 2017 has also been identified. Finally, it seems there is a caveat in the BPR as there is no provision for submitting an AS dossier when this AS was not in the scope of the BPD: article 93 refers only to product authorization.
According to article 3 of the Biocidal Product Regulation, in situ generated biocidal active substances and precursors that generate biocidal active substances are covered by this regulation.
France is in charge of the assessment of a dossier for CO2 as a PT19 substance, in order to attract mosquitoes. In this dossier, CO2 is either generated from combustion of butane/propane or emitted directly from dry ice or CO2 container. Although the latters uses fall under the scope of the BPD, the former is out of the BPD scope (as the butane/propane container has no specific biocidal claim) but will fall within the BPR scope.
France would like to have Member States and Commission’s views on the way it understands the additional provisions introduced by the BPR, either about the AS approval, and the BP authorization process.
1/ AS dossier
Context: in case of in situ generation, like in BPD framework, generated active substance must has been notified in the review program or be authorized via an approval regulation. In our case, CO2 is in the review program for assessment as a PT19.
French approach : like in the BPD framework, we consider that the active substance can be approved if the assessment concludes that one of the different kinds of in situ generation listed above is acceptable. The different ways of generating CO2 must be evaluated latter, during the authorization product stage.
For the CO2/PT19AS dossier: some additional information will be required in order to precise the in situ generation process concerned.
The regulation would mention that “in-situ generated CO2” is approved, allowing the placing on the market of all kind of CO2 generating devices as long as product authorizations are not delivered.
Question : As France, would you consider that an AS can be approved if the assessment concludes that the AS generated with one kind of generation (eg: butane/propane or dry ice) is acceptable?
Proposed answer: Yes. However CO2 would then be included as 'CO2 generated from butane/propane' or as 'CO2 released from dry ice', or both, depending on what would have been assessed. As all ways of generating CO2 will eventually have to be approved, the task force members may have an interest to support all the ways already included in the current application.
2/ Product authorization
Context: article 3 of the BPR introduces new provisions on in situ generation. It’s indeed mentioned that precursors are now considered like “biocidals products”
French approach: in order to be made available on the market and to be used, precursors therefore need one product authorization and also fall under the provisions of article 93: they can benefit from the transitory measures, and the applicant concerned must submit a product dossier before the 1st of September 2017 for products already on the market on the 1st of September 2013.
The precursors authorization dossiers will have an additional value by giving a risk assessment of the preliminary operations (mixture, combustion…) needed to generate the active substance.
In our case, with the hypothesis that the assessment will lead at an approval regulation:
generation from combustion of butane/propane :
One product authorization dossier for the precursor (butane/propane mix) must be submitted to the competent authorities. According to the discussions held during the last PA & MRFG meeting, only the devices generating active substance from natural elements (air, sea water…) need one authorization for the placing on the market (authorization holder = device’s provider): so the combustion device generating CO2 from butane/propane mix is not in the scope of the BPR.
Release of CO2 directly from dry ice or container :
Two differents product authorization dossiers must be submitted: one for the dry ice, one for the container. No precursors are interfering, so the dossiers must deal with CO2 as an active substance / biocidal product.
The three product authorization dossiers foreseen must describe the whole risks identified during the preparation, generation… of CO2. Applications must benefit from transitory provisions of the BPR, and the application could be done until the 1st of September 2017.
Question : Do you agree that precursors effectively fall under article 93 provisions and that no authorization is needed for combustion device generating CO2?
Proposed answer: Products that were already in the scope of the BPD, as they were placed on the market with a biocidal intention (in most cases CO2 containers and dry ice), cannot benefit from the transitional provisions under Article 93, and shall already follow the normal procedures. Products that were not already in the scope of the BPD, such as precursors placed on the market with no biocidal intention (propane/butane containers), can on the other hand benefit from the provisions of Article 93.
No authorization is needed for placing on the market the device when it uses precursors placed on the market, as it is the precursors that will be subject to the authorisation for placing on the market and use in the device.
Moreover, two problems are highlighted with our approach:
With the current wording of article 93, it appears that precursors or device put on the market after the 1st of September 2013 won’t benefit from the transitory provisions and couldn’t be placed on the market until the dossier review will be done: it could lead to a market distortion.
The timing for (in situ generated) active substance dossier submission is not mentioned in article 93, as this article only refers to products which were not in the scope of the BPD. In the case of an active substance generated in situ and not in the review program, we would like a confirmation that both dossiers, active substance and product authorizations should be submitted within the same timeframe, ie before the 1st of september 2017. The product authorizations dossiers will of course be frozen until a decision has been taken on the active substance dossier.
Comments: these issues will hopefully be addressed through the new wording of Article 93.
Thank you in advance for your comments/positions about our approaches.