However the Biocidal Products Regulation (BPR), another piece of new legislation which came into effect only in September last year, could turn out to be an even bigger challenge than expected to the industry.
With REACH, which necessitates the drawing-up of safety dossiers on individual chemicals, coatings producers are already having to reformulate their products because of raw materials – at the moment relatively small in number – being withdrawn by their manufacturers or distributors due to the expense of gathering safety data.
With the BPR, the safety data to be submitted for the approval of biocides is far more rigorous and expensive to collect. Also, even after a dossier has been completed, there is no guarantee that a product will be authorized by the EU’s regulatory authorities, particularly those at the national level.
Some national agencies, mainly in northern Europe, are deeply sceptical about the safety of some chemicals used to harm or eliminating microorganisms in the environment.
Under the legislation biocides are defined as any substance “destroying, deterring, rendering harmless or exerting a controlling effect” on fungi, viruses, bacteria, yeasts, moulds, algae and other microscopic organisms.
“For industry, the BPR is a worse piece of legislation than REACH mainly because of political influence,” said Didier Leroy, technical director at the European Council of Paints, Printing Inks and Artists colours (CEPE), the main European trade association for coatings. “Decisions under the legislation are likely to be taken for political rather than scientific reasons.”
The biggest immediate danger is that key chemicals used as fungicides in waterborne paints could be banned under the legislation.
“The result could be that no water-based coatings could be used in or as consumer products,” Leroy warned. “A decision at the EU level on the future of waterborne coatings could be taken as early as the end of this year.”
In addition, the marketing of coatings combating microorganisms, such as anti-fouling paints, are being jeopardised by antagonism to the products among individual EU member states.
The EU legislators made the BPR extra strict because the 1998 Biocides Products Directive – the EU’s first legislation specifically on biocides, which it was designed to replace – was considered to be too lax. But they retained a decentralized system allowing authorizations to be made by the EU’s 28 member states because of their knowledge of local environments and public health issues.
The BPR fills in gaps by laying down rules on the safety of imports and on data to be provided on efficacy and on the impact of biocides on non-target organisms.
Under the new regulations, approvals are needed for active substances, biocidal products such as anti-microbial coatings which are intended to combat microorganisms, and ‘treated articles’, essentially finished products containing biocides.
Active substance have to be authorized at the EU level through the Helsinki-based European Chemicals Agency (ECHA) which makes recommendations to the European Commission, the EU executive so that it can take the final decision.
Biocidal products have to be approved by each of the EU’s 28 member states or through a mutual recognition scheme under which an approval of a product in one state is accepted by other countries.
“A company can make a mutual recognition application to cover the countries in which it wants to market a product,” explained Richard Roy, a toxicologist at REACHReady, a London-based consultancy which provides advice on the BPR. “The country carrying out the evaluation of the applicant’s dossier will usually co-ordinate closely with the other countries covering the submission so approval can take time.”
However, even within the process for approving active substances, countries can shape the recommendations made by ECHA, because the agency’s expert committees comprise member states specialists.
This is what is happening with two groups of fungicides – formaldehyde releasers and isothiazolinones – which are applied as preservatives in waterborne coatings. Individual EU countries have been calling for bans on their use on the grounds of their being health hazards.
Formaldehyde-releasing compounds which emit small amount of the chemicals are considered to be carcinogenic while isothiazolinones are regarded as skin sensitisers. ECHA is likely to make a recommendation on the approval of the two fungicides in the next few months for the Commission’s consideration.
“Under the BPR carcinogens have to be phased out in active substances while the same approach can be taken with skin sensitisers,” said Leroy. “Without these fungicides, waterborne coatings will rapidly degrade. The only alternative is to switch to solvents whose use is retricted by the EU’s regulations on emissions of volatile organic compounds. (VOCs). We’re hoping the Commission will rule out a ban because of its impact.”
With coatings like anti-fouling and other anti-microbial products, manufacturers face a difficult decision of deciding whether to seek approval state by state or through the mutual recognition route.
“Mutual recognition can be difficult because of the hostility to biocides in certain states,” said Leroy. “In some countries they can be regarded as dangerous to the environment no matter what the evidence is. In Scandinavia some experts say that, instead of using chemicals, fouling organisms can be scraped off the hulls of ships.”
CEPE’s tactic with anti-fouling paints is to concentrate the resources of its national associations on a minority of member states to persuade their health and safety agencies of the social and economic importance of the coatings.
“Long-haul cargo and other large ships which are served by shipyards in the main global centres of South Korea and China will still be able to enter EU waters with unauthorised anti-fouling coatings,” Leroy added.
It is not just inconsistencies in the BPR’s application which is annoying European industry but also small technical details which will be difficult to comply with. Active substances have to be tested, for example, to Good Laboratory Practice (GLP) standards to show that they are produced in batches of uniform quality and once incorporated in biocidal products are technically equivalent to the original.
“For SMEs, testing to GLP standards could be expensive,” said Nina McGrath, scientific advisor at Euro Chlor, the European association of chlorine and chlorine derivatives producers. “Also, some countries, even in the EU, do not have any GLP-certified laboratories.”
Already before the BPR was introduced the numbers of biocidal active substances on the market is estimated to have been reduced by around 60 percent to around 400 because of the requirements of the previous legislation.
With the new regulation being even more stringent, the number of active substances and consequently of biocidal products is likely to go down even further. “Coatings producers will have even less choice and will almost certainly have to pay more for biocides,” said commercial manager at one European distributor of coatings raw materials.