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Nanomaterials Regulations Present Challenges



By Sean Milmo, European Correspondent



Published August 13, 2013
Related Searches: Nanotechnology
Despite the current slowdown in the European economy, the region’s regulators have not been easing up on the application of health, safety and environmental rules in the markets for coatings and its raw materials.  Even new rules are being introduced to make compliance tougher for coatings producers and their suppliers.

The regulatory challenge for the coatings sector has tended to come from European Union legislation whose main objective is to ensure that the EU’s single market in products and services is not hampered by trade barriers.
However, a growing number of EU governments are posing problems for the European coating sector by introducing their own regulations, which are threatening to undermine the single market.

The main objective of these regulations is the control of nanomaterials whose safety has been an issue  of growing concern among NGOs, politicians and some groups of consumers in Europe. 

But these national initiatives are worrying some European coatings companies and their raw material suppliers that have become technological leaders in the application of nanomaterials.

The European Commission, the EU’s Brussels-based executive that is responsible for putting forward EU legislation for approval by the European Parliament and the governments of the EU’s 28 member states, has been taking a cautious line on  nanomaterials.
Two years ago the Commission decided on a definition of nanomaterials that was criticized by NGOs and some politicians for not being tight enough or for being too imprecise.  Under the definition nanomaterials would have to contain 50 percent or more of nanoparticles sized between one nanometers and 100 nm, although with some nanomaterials of specific health and safety concerns, this percentage could be reduced.

In a review of nanomaterials issued in October, 2012, the Commission concluded that a case-by-case approach should be adopted for their risk assessment.  But it did acknowledge the need for more public information to be made available through facilities like registries of nanomaterials on a national or sector level.

Some national governments have now introduced or are drawing up their own regulations on the registration of  nanomaterials in the belief that the Commission has been moving too slowly on the issue.

The French government has been implementing since May a new law which requires producers, users and distributors to submit annual declarations to its Environment Ministry  on the identity, quantity and uses of nanomaterials supplied to other businesses, including  professional painters.

“The objective of the French decree is to ensure traceability of nanomaterials (and)  greater transparency of information available to the public on nanomaterials,”  said Veronique Garny, product stewardship director at the European Chemical Industry Council (Cefic), Brussels, the chemicals sector’s main EU trade association.

“One difficulty with the regulation is that substances must have been intentionally manufactured as a nanomaterial to be defined as a nanomaterial,” she added. “The decree leaves it to the manufacturer to decide whether something has been manufactured for the purposes of functioning as a nanomaterial.”

However, nanomaterials producers and users currently have no standardized measuring method for general application with nanomaterials. This makes identification of nanomaterials particularly complicated for coatings formulators using a wide range of chemicals.

“There are accepted methods for measuring specific nanomaterials but these cannot necessarily be applied to other nanomaterials,” explained Sonia Benacquista, a products management specialist at the French chemicals industries trade association (UIC)  “This regulation is a national initiative which discriminates against French companies  because of the additional burden it creates. It could also  hamper innovation.”

Belgium has been following the example of the French government by issuing draft legislation last month (July) for a national registry of nanomaterials, which would start to come into effect at the beginning of 2015. 
In addition to information about the identity and characteristics of nanomaterials, producers, users and distributors may also have to provide information on the possible dangers and exposures of certain nanomaterials if they are considered to be a risk to health or the environment.

Compliance with the legislation could be a big challenge to Belgian coatings companies who buy their raw materials from outside the country.

“Many of our members are SMEs who will have to rely heavily on  information received from their suppliers,” said Theo de Jaegher, regulations, safety and environment advisor to the Belgian federation of paint and ink manufacturers (IVP). “Obtaining this information could prove to be a complicated and difficult exercise. At the moment it is extremely hard  to calculate or even give an estimate of the extra  administrative costs.”

Denmark has just started a public consultation on the creation of  a national registry of products and mixtures like formulations containing nanomaterials,  while the Netherlands and Sweden have been making similar moves.

In Germany the government has been finalizing a draft regulation on food materials that mainly applies to chemicals in inks and coatings on food packaging. But it also covers coatings on household equipment and appliances, which have the potential to contaminate food.

The regulation potentially severely restricts the use of nanomaterials in coatings. These will effectively be permitted only if their producers and distributors can provide evidence that the nanomaterials  cannot migrate in potentially dangerous amounts into food.
“With France already having a regulation on nanomaterials and other EU countries now planning to do the same, selling products containing nanomaterials in the EU is going to become a nightmare,” said Garny. “It will have a very negative effect on the single market.”

The European Commission has  been tentatively preparing to establish an EU-wide nanomaterials register.   Its research arm, the Italy-based Joint Research Centre (JRC), has also started developing a standardizing measuring method in parallel with the activities of a nanotechnology working party at the Paris-based Organisation for Economic Co-operation and Development (OECD). “All this will take some time,” said Benacquista.

Meanwhile there are signs that companies are delaying the introduction of innovative nano-based products partly because of the regulatory uncertainties.  Bayer MaterialScience  (BMS) of  Germany, a major supplier of coatings materials, has halted production of and research into carbon nanotubes  (CNTs).

“Our CNTs business has been discontinued,” Patrick Thomas, BMS chief executive, told a recent press conference at the company’s headquarters.  “There is not a big enough market for CNTs. But, we have the knowledge and the infrastructure to restart the business, if we want, when there is sufficient demand.”

The European coatings industry will be hoping that regulatory confusion does not lead to a general standstill in R&D in performance-enhancing nanomaterials for the sector.


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