Following on from our recent look at the current status of the Biocidal Products Regulation (BPR), in this article, Chris Vance discusses the errors and deficiencies in the regulation, together with some anticipated revisions.
BPR Amending and Implementing Regulations
Details of the BPR Amending Regulations can be found on the European Chemicals Agency (ECHA) website.
There are currently two Amending Regulations.
The first (Regulation (EU) No. 736/2013) extends the deadline for the work programme for the evaluation of all existing active substances from the previous target date of 14 May 2014 to 31 December 2024. This new deadline is only some 14 years later than that envisaged in the original Biocidal Products Directive. This timescale has consequences for the authorisation of biocidal products, as such an authorisation can only be initiated when all the active substances in a product have been approved for the particular product-type under the work programme.
It remains incumbent on the manufacturers of biocidal products to monitor the status under the work programme of the active substances they are using. Information and details of the active substance-specific Implementing Regulations can be found on the ECHA and Commission websites.
The second Amending Regulation (Regulation (EU) No. 837/2013) makes some changes to Annex III as regards the information requirements for authorisation of biocidal products with regard to establishing the “technical equivalence” of active substances from differing manufacturing locations, processes or starting materials.
Included among the Implementing Regulations is Regulation (EU) No. 564/2013 on the fees and charges payable to the ECHA. These include fees relating to active substances and for the Union authorisation of biocidal products. The list is rather substantial. For example, the standard fee for approval of an active substance for the first product-type is €120,000, while the additional fee per additional product-type is €40,000. Granting of Union authorisation for a biocidal product family will cost €150,000. The granting of Union authorisation for a single product, meanwhile, will be charged at €40,000 or €80,000 respectively depending on whether or not the product is identical to one of the representative products assessed for the purposes of active substance approval.
SMEs will be entitled to a 10–30% reduction of the standard fees depending on the size of the enterprise.
Note that for biocidal product authorisation at national level, charges are set by the national Competent Authority. In the UK, this is the HSE, which has published its estimated charges.
Cost will be charged at a daily rate of £393 and the total fee for the authorisation of a biocidal product dossier will vary on a case-by-case basis, but could be in the region of circa £15,000 per product.
At either Union or national level, the total cost of a biocidal product authorisation could be significantly higher than the fees element when other costs, including data generation and dossier preparation, are taken into account.
The legislative text amending Regulation (EU) No. 528/2012 was adopted by the European Parliament on 25 February and by the Council of the EU on 10 March 2014. A significant number of the articles in the original regulation are being modified or corrected. However, at the time of writing, the text of the Amending Regulation had not yet been published in the Official Journal. Publication had been expected for “early 2014”.
Among the changes anticipated, the amendments aim to remedy some unintended consequences of the wording of certain provisions of the current BPR. In particular, the transition rules have introduced an unintended market freeze of up to 11 years for articles treated with biocidal active substances which are legal on the EU market, but which have not yet been evaluated at EU level.
The amendment also intends to define a protection period for data relating to products with the most favourable risk profile, to amend some of the transitional rules and to correct other inconsistencies in the text of the regulation. For example, it is intended to make it unambiguously clear that the labelling of treated articles provisions apply from 1 September 2013.
It is a matter of regret that even though the BPR was subject to extensive consultation prior to its publication in June 2012, numerous errors and lack of clarity in the text were not identified and are still to be formally corrected nearly two years after publication, and some six months after the regulation came into force.
Watch this space…