Fees worry downstream users as BPR comes into force
Treated articles also top list of concerns
2 September 2013 / Europe, Biocides
One of the largest sectoral users of biocides is the detergents industry. It is in two minds about the new BPR legislation. On the one hand, “in comparison to the existing regulatory framework for biocidal products, the new Regulation provides industry with a harmonised and more predictable authorisation system in terms of processes and timelines,” says the International Association of Soaps, Detergents and Maintenance Products (Aise).
“Provided that they are fully implemented, we believe that some concepts introduced by the Regulation have the potential to partly reduce administrative and cost burden for both authorities and industry,” says the trade group. Examples include the introduction of union authorisation and the biocidal product family concept.
However, it insists that for the these benefits to be fully realised, the legislation must be implemented properly. Aise warns that the biocides legislation is “a complex and expensive programme for industry”. Therefore, if not correctly managed and if guidance is insufficient, it could be “detrimental to the competitiveness of the biocides industry in Europe and disproportionately affect SMEs”. This is a particular worry in the case of the recently adopted regulation for fees payable to ECHA, comments Aise (CW 21 June 2013).
Speaking for SMEs, Mark Susnik, advisor to UEAPME, says: “At the moment, it is a bit hard to say how things will develop.” He agrees that “in principle, the idea of a community authorisation is good.” However, he is concerned that it will take until 2020 for all products to be covered by it and by the size of the fees. “The reduction for SMEs certainly helps a bit, but the annual fee is a problem,” he states (CW 8 May 2013). “We don’t see any basis for this annual fee, since no workload is required by ECHA, except storing data on a hard-drive. For additional work, such as updates, they will ask for extra fees.”
The immediate challenge, though, is how to deal with treated articles, according to Mr Susnik. “This is a totally new obligation, but there is not much information around about it and, accordingly, awareness is very low.” He compares it to Article 33 under REACH and says the latter “caused a lot of misunderstandings, and lots of resources were used for often unnecessary communication within supply chains”. Mr Susnik is concerned that a similar situation could arise with treated articles.
Uta Jensen-Korte, director general of the European Association of Chemical Distributors (Fecc), believes that the BPR “will cause problems, especially for smaller distributors”. One reason is the failure to link the authorisation of biocidal products to a specific tonnage. “Whether a company is selling a small or large quantity of a substance, it will have to pay the full price of the authorisation,” says Ms Jensen-Korte. “This will be very expensive and companies selling lower volumes will be at a disadvantage.” She adds that in addition to the fees, “the overall cost of preparing dossiers is extremely high.” According to her, these costs may make it “economically unfeasible” to continue the distribution of some biocidal products.
“In general, the information requirements under the BPR are quite demanding and distributors will probably have to buy in technical knowledge,” adds Ms Jensen-Korte. “This means an additional cost. And, for example, if you have already bought a letter of access or study under REACH, it does not necessarily cover the right to use the data in the biocidal product dossier, and so you will have to buy the data twice.” Moreover, Iuclid under REACH and the BPR is different, and so companies will have to handle the dossiers twice, she says.
Cosmetics Europe points out that cosmetic and biocidal products are regulated separately; as a result finished cosmetic products and their ingredients are exempted from the BPR. However, there is a grey area for cosmetic ingredients that have a secondary function as a biocide – such cases include products with an anti-bacterial action as a secondary function of a hand-washing soap, or anti-dandruff active for a shampoo. The association says the assessment of whether a product is a cosmetic product or not is made on a case-by-case basis, taking into account all its characteristics, including composition, presentation, intended main purpose, its claims, and so on.
Philippa Nuttall Jones