On 19 January 2012, the European Parliament approved in Second Reading the Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (the “BPR”). The final text is expected to be published in the Official Journal around the summer break, with an entry into force later this year (20 days following publication). The new regime is expected to be fully applied as of 1 September 2013. While the BPR maintains the concept of the harmonized authorization system for active substances used in biocidal products set up under Directive 98/8/EC, important changes are introduced. This client alert highlights the main issues manufacturers and formulators should be aware of.
Harmonized authorisation system
The placing on the market of biocidal products is still subject to a two-step process whereby active substances are approved at EU-level (with the inclusion into a Union list of authorized active substances – Article 9), while formulated products remain in principle authorized at the Member State level. Important novelties involve a simplified authorization procedure, amendments to the mutual recognition system, and the possibility to obtain EU wide authorizations of biocidal products. In addition, the procedure and criteria underlying each of these two steps have changed substantially.
Procedure - the role of the European Chemicals Agency
The European Chemicals Agency ("Agency") will become increasingly involved in the review of active substance dossiers. The Agency shall have a "coordinating" role for the evaluation of dossiers submitted after 1 September 2012 (i.e., 1 year before the date of application of the BPR – Article 90(1)) and for which the review under Directive 98/8/EC is not completed by 1 September 2013 (Article 90(2)). From 1 September 2013 onwards, applicants for approval of active substances will need to apply to the Agency, and choose a Member State authority accepting to review their dossier, after which the Agency will prepare an opinion on the application for the Commission. Also applications for EU authorizations of biocidal products must be submitted to the Agency, whereas for national authorizations this must be done to a “receiving competent authority”.
New hazard-based “cut-off criteria"
The BPR introduces new hazard-based “cut-off criteria” for the approval based on the intrinsic properties of active substances. For example, active substances that are a carcinogen, mutagen or reproductive toxicant ("CMR") of Category 1A or 1B under Regulation 1272/2008, a persistent-bioaccumulative-toxic substance (“PBT”), or a very persistent and very bio-accumulative substance (“vPvB”), cannot in principle be approved and if they are exceptionally approved they shall become candidates for “substitution".
Substitution criteria also apply for substances that are a respiratory sensitizer, or have an ADI, ARfD or AOEL which is significantly lower than those of other approved active substances, or meet two of the PBT criteria, or contain a significant proportion of non-active isomers or impurities, or for which the combination of critical effects/use patterns still causes concern.
Active substances that are nanomaterials are normally not approved “except where explicitly mentioned” (Article 4(4)) and the biocidal products containing them can only be authorized if “the risk to the environment and to health has been assessed separately” (Article 19(1)(f)).
Broadening of the concept of comparative assessment
Where the predecessor to the BPR, Directive 98/8/EC, was the first Community measure ever to introduce “comparative assessment”, this concept has been maintained and significantly broadened in Article 23 of the BPR. Contrary to Directive 98/8/EC (which applied comparative assessment at the active substance approval stage), it now applies to authorized biocidal products which may be subject to a comparative assessment and substitution where there are other products presenting significantly lower risks for human health or the environment without entailing significant economic or practical disadvantages, or which minimize the risk of resistance occurring in the target organism.
Treated articles and in-situ generated active substances
The BPR introduces rules for treated articles and in-situ generated biocidal products which up to now were not covered or, at least, remained in a gray zone under Directive 98/8/EC. A treated article will be considered as a biocidal product where it has "a primary biocidal function". No definition is given of in-situ generated products, but the combined reading of recital 70 and the transitional rule in Article 93, transitioning products that were previously not covered, leads to the conclusion that these too will now be covered (this also follows from the Common Principles in Annex VI).
Data protection, data sharing and confidentiality
Article 60 of the BPR generally mirrors the data protection periods of Directive 98/8/EC. For active substance/product type combinations in the review programme that are not yet approved under the BPR, Article 95(1), last subparagraph, provides that data protection will “universally” end on 31 December 2025.
Data owners will be made subject to the data sharing obligations laid down in Articles 62 and 63 of the BPR. These provisions are mandatory as regards vertebrate animal data. Should the parties concerned fail to reach an agreement on vertebrate animal studies, the Agency is entitled to use the studies to the benefit of the prospective applicant, provided it demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner(s) a share of cost incurred. Thereafter the data owner will have a claim before national courts for a fair share of the costs.
As regards data confidentiality, Article 66(2) of the BPR contains a short list of information which is “deemed to undermine the protection of the commercial interests or privacy or safety of the persons concerned” and which, therefore, will normally not be disclosed unless this is urgently needed for health, safety or environmental reasons. The list of information that can be disclosed in Article 66(3) is much longer.
Transitional measures – list of authorized sources : mandatory data sharing of all toxicological and ecotoxicological studies (including those not involving vertebrate animals)
Article 95 de facto puts an end to the situation under Directive 98/8/EC whereby non-participating companies in the biocide review programme can remain costless on the market on the basis of the participation of notifiers. All manufacturers or importers of biocide active substances (or products) are required to submit an active substance dossier (or a letter of access) to the Agency as a condition for remaining on the market. On that basis, the Agency will publish a list of “authorized sources”. Non-compliant biocidal products will be withdrawn 2 years later. While this measure is to be welcomed questions can be raised regarding the practical implications and timing.
Importantly, under Article 95, data-owning participants in the review programme will be obliged to share all toxicological and ecotoxicological studies in their dossier (including those not involving vertebrate animals) with non participating companies making an application with the Agency to be on the list of authorized sources. Assessing technical equivalence (with the specification and dossier of participants in the review) is not a condition in Article 95.
The BPR has significantly tightened the rules and procedures for the placing on the market of biocidal products. The measure goes further than any comparable EU chemical regulation enacted during the last decade. The new hurdles and variable parameters introduced will require a close coordination of business, scientific and legal considerations of all players on the market, be they manufacturers or formulators.
For more information, please contact us.
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