Consequently, over the next several years producers and importers of coatings in Europe face the prospect of being forced to reformulate their products because many biocides are no longer available.
The legislation is the latest example of how the EU and European governments are continuing to press on with introducing tighter controls on chemicals in coatings and other products.
The Biocidal Products Regulation (BPR), which came into operation on September 1, is “another step towards ensuring that only safe, authorized products are made available throughout the EU,” said Janez Potocnik, environment commissioner at the European Commission, the Brussels-based EU executive.
He also asserted that the legislation is a “simplification of authorization procedures (which) will bring significant economic benefits” to producers, importers and users of biocides. But his claims have been greeted with much scepticism by the coatings and other industries.
The regulation, approved last year by the European Parliament and Council of Minister representing EU governments, replaces a biocides directive which was introduced only in 1998 but was found to be ineffective in helping the review of the safety of hundreds of biocidal active substances.
Under the EU’s legislative system regulations are binding in their entirety and enforced simultaneously in all of the Union’s 28 member states. Directives are binding in their objectives while it is left to the member states to decide how to achieve these through their own laws.
The Commission and the national regulatory authorities in the EU believe that the regulation is a distinct improvement on the directive because of the streamlining of authorization procedures at the EU and national levels and moves to greater uniformity of risk controls throughout the Union.
However, these advances are offset by drawbacks such as the complexity of the legislation, particularly in the requirements for safety data to be included in dossiers submitted by companies for approvals of their products. Coatings requiring authorization as biocidal products include anti-foulants, anti-bacterial paints and various preservatives, such as wood preservatives.
The authorization of existing active substances which is being done centrally and under the directive was supposed to be completed in 2010 has now been set to be finished in 2024 because of the difficulties of evaluating their safety. New active substances are effectively having to go through an even more rigorous authorization procedure.
The Helsinki-based European Chemicals Agency (ECHA), which is accountable to the Commission, has taken over the task of dealing with evaluations of active substances and centrally approved biocidal products. This should lead to greater consistency and efficiency in the assessment of safety dossiers.
“Although the new regulation is supposed to be an improvement on the directive, overall it isn’t,” said Didier Leroy, technical director at the European Council of Paint, Printing Ink and Artists’ Colours industry (CEPE), Brussels. “The demands for proof of safety are more severe in the new legislation. Furthermore providing the data to make this proof of safety is very costly. There is a real threat that a lot of products will be taken off the market.”
SMEs, particularly in the coatings market, will be the hardest hit by the expense of gaining authorization so they are the most likely to pull products off the market or to move out of the sector altogether.
“The European Commission has reduced the authorization fees for SMEs—by 60 percent for micro-organizations, 40 percent for small ones and 20 percent medium-sized companies,” explained Marko Susnik, a spokesperson on biocides for the European association of small and medium-sized businesses (UEAPME). “But it fails to realize that much of the cost of authorization for companies is in the preparation of the safety dossiers.”
While authorization of biocidal products can be done centralled through ECHA, they can also be approved by national authorities—either individually or through a mutual recognition system under which an evaluation by a single country will be accepted by groups of other states.
“There should be greater use of mutual recognition schemes which will help to harmonize the whole European market,” said An Ghekiere, a biocides specialist at Arche Consulting, Leuven, Belgium.
Nonetheless, the market will still be liable to fragmentation as a result of individual states retaining powers to prohibit or restrict individual biocidal products.
Consequently biocides can be banned in one or more countries but permitted in others. The Swedish Chemical Agency (Kemi) last year banned anti-fouling coatings containing high levels of zinc oxide. The agency decided they were pesticides, rejecting claims by their producers that they had a physical rather than chemical effect and thus were exempt from biocidal regulatory controls.
Companies have been opting to have new biocidal products approved by a single national authority in the hope that this would be cheaper and quicker.
However I-Tech, a Swedish startup, is still waiting for an approval around 7-8 years after submitting a dossier to the UK Health & Safety Executive (HSE) on a new anti-foulant medetomidine, which prevents barnacle larvae attaching themselves to the surfaces of ships.
“The authority seems to have no idea what delays like this mean for a company like ours,” said Lena Lindblad, R&D manager of I-Tech. “Fortunately we have a very faithful Swedish venture capital company backing us, otherwise we could have had to go out of business.”
The longer companies have to wait for approvals the greater the danger they will not obtain it because of new requirements.
“The authorities are in the early stages of working out how to evaluate mixtures of more than one active substance in a biocidal product,” said Ghekiere. “Also, under the regulation active substances and biocidal products should not contain endocrine disrupting chemicals (EDCs). Yet the Commission has still not decided what will be the criteria for identifying EDCs. When it does, previously approved substances found to contain EDCs may have to be withdrawn.”
Even large companies, let alone SMEs, are being cautious about developing new biocidal products when the approval process is so fraught with uncertainties.
“(Cost) will be a potential barrier to genuinely new biocides entering the market, especially when you consider that having the data does not guarantee that the active substance will be authorized for use,” said Gareth Prowse, AkzoNobel’s product regulatory affairs manager, marine and protective coatings. “We expect that increasingly we would likely see the transfer of pharmaceutical/agrochemical products into the biocide market where significant data sets already exist, and therefore risk of rejection from the process is less severe.”
Overall with innovation rates lagging well behind those of withdrawals, there will be fewer products and fewer companies producing or importing them. “With less companies in the market there will be less choice and competition but higher prices,” warned Susnik.