HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Directorate E – Food and feed safety, innovation
E4 - Pesticides and Biocides
70th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Subject:Inclusion of Powdered corn cob into Annex I to the BPR
At the occasion of the discussion on the active substances currently listed in Annex I to Regulation (EU) No 528/2012 (BPR), the Commission received a question in relation with the status of powdered corn cob, which was previously included by Directive 2013/44/EU[1]into Annex I and IA to the Directive 98/8/EC(BPD) for use in PT14 biocidal products.
The objective of the document is to provide some highlight on the situation of this substance, and propose a way forward with the view to its listing into Annex I to the BPR.
1- Background
(1)Powdered corn cob has been assessed and included into Annex I and IA to the BPD. In particular, this substance was considered as eligible for use in low risk products under the BPD, and was therefore also included into Annex IA to the BPD.
(2)The decision-making process on this substance took place late 2012/beginning of 2013, after the adoption of the new Regulation (EU) No 528/2012 (BPR) on May 2012 and was finalized before its entry into application on 1st September 2013. ECHA's BPC, in charge of delivering opinions on the inclusion of active substances into Annex I to the BPR was not operating before 1st September 2013.
(3)Due to this calendar, it was not discussed whether powdered corn cob had to be listed or not into Annex I to the BPR.
(4)As provided under article 28(1) of the BPR, new inclusion of an active substance into Annex I to the BPR has to be made by means of delegated acts on the basis of an ECHA opinion.
(5)It is currently not possible for companies to obtainan authorisation via the simplified authorisation procedure for products containing powdered corn cob, as such procedure is only possible when the active substances is listed in Annex I to the BPR.
2- Proposal
(6)In the light of this particular situation, the Commission's services proposeto request an Article 75(1)(g) to ECHA in order to define whether or not powdered corn cob give rise to concern in accordance with Article 28(2) of the BPR.
(7)If the ECHA's BPC opinion concludes that this substance does not give rise to concern, the Commission will prepare a draft delegated act in order to include powdered corn cobinto Annex I, category 6 "Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC". The listing into category 6 ensures that the provisions of Article 95 of the BPR continue to apply to the suppliers of powdered corn cob; as provided under Article 95(6).
(8)Such listing in Annex I to the BPR would allow companies to pass via the simplified authorisation procedure for future applications for products which meet the conditions of eligibility (ie. no need to use PPE etc…). Other products will continue to pass via the normal authorisation procedure.
3- Actions requested
The Commission invites Member States' Competent authorities to reflect on this topic in order to have a discussion and reach an agreement during the 70th CA meeting.
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