The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page provides information about the transitional measures for nano active substances that are under the scope of the EU Biocides Regulations 528/2012 (EU BPR).
As the nanomaterial industry has grown and developed, it is possible that some nanomaterial forms of biocidal active substances may be being used within biocidal products. The EU Biocidal Products Directive 98/8/EC (BPD) did not distinguish between nano and non-nano versions of active substances, so where a named active substance had been notified for review under the BPD, that notification would have covered both nano and non-nano versions of the active.
The EU Biocides Regulation 528/2012 (EU BPR) introduced specific provisions for nanomaterials, which will require that nanomaterial versions of active substance are individually assessed for their safety.
Under the EU BPR, nanomaterials are now defined as:
- ‘nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
- ‘particle’ means a minute piece of matter with defined physical boundaries,
- ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,
- ‘aggregate’ means a particle comprising strongly bound or fused particles’
Following the review of an active substance under EU BPR, the Approval Decision will only cover a nanomaterial form of an active substance if that nanomaterial is specifically mentioned in that Approval Decision.
Supporting nanomaterials through review
As active substances in nanomaterial form will now need a specific assessment and Approval under EU BPR, the EU Commission have introduced a process to allow such substances to be supported for review by industry.
The EU Commission contacted all existing participants in the review programme to confirm if the dossier for the substance they are currently supporting for review covers a nanomaterial form of that active substance. The EU Commission has clarified that only two of the active substances notified for review are the nano form of those active substances, these are entries 1017 and 1019 in Part 1 of Annex II to the EU BPR Review Regulation (Regulation 1062/2014). For all other active substances listed in Part 1 of Annex II to the EU BPR Review Regulation nano-forms of those active substance are not considered to be included in the review programme. Similarly, active substances already on the EU BPR list of Approved actives substances will be considered to only be Approved for non-nano forms of those active substances. However the EU BPR Review Regulation introduces a time-limited opportunity for interested parties to support such nano-forms of active substances for review.
Anyone wishing to take over the role of participant for nano-forms of those active substance/product type combinations should complete the notification procedure in Article 17 of the EU BPR Review Regulation by 30 October 2015.
Any person may submit via R4BP an application to support the active substance/product-type combination they are interested in by 30 October 2015.
The application must be in IUCLID format and must contain the following information.
- evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of EU BPR i.e. the substance’ was on the market on 14 May 2000 as an active substance in a biocidal product;
- an indication of the product-type(s) concerned by the notification;
- information on any studies that have been commissioned for the purpose of application for Approval under EU BPR or for inclusion in Annex I to EU BPR, as well as the expected date of completion;
- the information referred to in Sections
- 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to EU BPR for chemical substances;
- 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to EU BPR for micro-organisms;
Where there isn’t an evaluating competent authority listed in Annex II of the EU BPR Review Regulation for the active substance (e.g. active substance isn’t listed as being evaluated by a competent authority for a different product type) the applicant should include the details of the competent authority they would like to evaluate their dossier and provide evidence that the competent authority agrees to do so.
Fees and ECHA verification
Upon receipt of the application ECHA will inform the notifier of the fees payable to ECHA and these fees must be paid with 30 days. If the ECHA fees aren’t paid, ECHA will reject the notification.
If the ECHA fees are paid, ECHA will verify within 30 days that notification has been submitted in the correct format and contains all the required information.
Where the notification hasn’t been submitted in the correct format and/or doesn’t contains all the required information the notifier will be give 30 days to complete or correct the notification. After the expiry of the 30 days to complete or correct the notification ECHA will declare the notification complete or reject it and inform the EU Commission.
The EU Commission will include the active substance/product type combination in the review programme upon receipt of the confirmation from ECHA that the notification is complete. The notifier must apply to ECHA for approval under EU BPR or for inclusion in Annex I to EU BPR of the active substance/product type combination within two years of this date. The process for submitting and evaluating these dossier applications can be found in Article 3 to 9 of the Review Regulation. ECHA and the Competent Authority will change the relevant fees for evaluating the dossier.
Rejected notification/notification not submitted
ECHA will publish details of the active substance/product type combinations where no notification is received within the time limit referred to in Article 16 (5) of the Review Regulation, or where a notification has been submitted and subsequently rejected.
Biocidal products containing these active substance/product type combinations can be
- made available on the UK market for 12 months; and
- existing stocks of the biocidal product may used in the UK for 18 months
after the date of publication that the notification wasn’t received or the notification has been rejected.