When the European Unions Registration, Evaluation, Authorization and Restriction of Chemicals regulation was adopted in 2007, the European Chemicals Agencys aim was the protection of human health and the environment from dangerous chemicals, while enhancing the competitiveness of the administrating organization European market. The legislation may have made headway with the former, but progress on the latter is up for debate.

Europes small and mid-size enterprises trade body, the European Association of Craft, Small and Medium-Sized Enterprises said that its calculations based on the latest data from the ECHA show that not even half of the number of registrations predicted have been attained.

The agency has assumed that by the final registration deadline on June 1, 2018, up to 20,000 chemicals would be registered for volumes traded in less than 100 metric tons. (Deadlines were staggered in bands depending on the traded volumes of each chemicals.) Meanwhile, the number of registrations of lower-volume substances available on the European market has been staying low, with some lubricant companies – part of the wider chemicals market – citing troubles with reformulation and registration costs of new substances. Instead, they have withdrawn products from sale.

The lubricant industry in general, and the metalworking fluids market specifically, did not escape these impacts. Industry insiders confirmed that a number of specialty lubricant products, such as metalworking fluids, additives and food-grade lubricants have been discontinued. In a few instances, ester-based additives and formaldehyde release agents (a chemical binder that slowly releases formaldehyde) used in metalworking fluids were abandoned or reformulated because of REACH.

REACH is an all-encompassing regulative system for the control and safe handling of all chemicals manufactured in and imported into Europe. It requires that chemical components of a product be tested, registered and have their hazards evaluated in a lengthy and expensive process. Responsibility for doing so falls upon the producer.

One group of products is metalworking fluids, which cool, lubricate, rinse and prevent corrosion during cutting, drilling, grinding, lathing and routing of metals. These specialty fluids consist of a mixture water and/or oil plus surface-active compounds, corrosion inhibitors, biocides, defoamers and numerous other compounds, which all must be registered on REACH and with other EU-wide schemes.

As of Jan. 9, 2018, the latest iteration of the Biocidal Product Regulation – the ECHAs list of active biocidal products – contains such substances as isothiazolines, formaldehyde releasers, iodopropynyl butylcarbamate biocides and boric acid. All of these are used in metalworking fluid formulations.

Before June 1, 2015, many metalworking fluids were allowed to contain such substances, but now the Classification, Labeling and Packaging Regulation – a packaging and labelling harmonization regulation that complements REACH and BPR – stipulates that they have to be reported and labeled as carcinogenic, which means some marketers shy away from them or would face more costs for their safe handling.

Customers are not happy to see these labels, let alone other requirements, such as keeping formaldehyde releasers locked [away] separately, said an industry insider.

Agent of Change

Indeed, the most important market development for water-soluble metalworking fluids is the classification of these formaldehyde release agents as biocides, according to Vladimir Bernard, a senior formulation scientist for metalworking fluids and industrial lubricants at the Czech lube company Aknel.

In a December update of the CLP, three of several formaldehyde releasers used in metalworking fluids – methylenedimorpholine, oxazolidine and hydroxypropylamine – were newly classified as carcinogenic. This means that all metalworking fluids containing at least 0.1 percent of these three formaldehyde releasers in their formulation must be labeled as carcinogenic, too. The update was enforced earlier this year and instantly shunted some metalworking fluid products off the market.

Now there is no difference between a free formaldehyde and a chemically bound one in a compound – everything higher or equal to 0.1 percent total formaldehyde must be classified and labeled as carcinogenic, Bernard said. He added that in the past, formaldehyde releasers were available at a reasonable price whereas now the pool of approved biocides is very limited and costly.

In my opinion, most companies did not withdraw their products, but replaced this biocide for another one – usually more expensive – so that the coolant was bio-stable, had a low skin irritation level, did not cause rusting of steel or gray iron and was easy to blend. This seems easy to say, but more difficult to accomplish, Bernard said.

Formaldehyde is a controversial substance. It is a naturally occurring biocide with myriad uses in a wide range of industries, including healthcare, resins, textiles and preservatives. Its vapor is toxic and a number of studies have indicated that prolonged excessive exposure may cause myeloid leukemia. It is also a common and cost effective biocide in metalworking fluids.

Liljana Pedisic, a products developer at Ina-Maziva, a Croatian lubricant company, said that for water-miscible metalworking fluids there are safer alternatives to formaldehyde and formaldehyde releasing agents. These include biocide- and boron-free emulsions with low oil content, finer droplets, good stability and sufficient lubricity.

Biocide- and boron-free metalworking fluids have more or less good resistance to micro-organism attack. If that is a route to replacing biocide we should also avoid biocide [in the] tank, she said.

A non-chemical alternative to biocide could be ultra-violet light devices for fluid purification. UV light destroys the DNA of microorganisms, preventing them from multiplying, and is safe for users.

If someone chooses an alternative technology to biocides, it should also have a different approach to the microorganism content. The high bacterial peaks that damage the fluid in the system are cut down, but a constant level of bacteria control is necessary, Pedisic said.

Range Anxiety

Pedisic added that as a result of the regulation, formulation of a number of current metalworking fluids has to experience changes – formulators have to use other components, considered less harmful for humans and animals.

For example, alkylbenzene sulfonates, which are widely used as emulsifiers and surfactants in metalworking fluids, can be replaced with fatty acid esters and carboxylates, which are less harmful for humans and animals. In some cases, these products can be obtained from renewable substances such as polyglycerol esters. However, industry insiders confirmed that these changes, among others, could be expensive and put a burden on companies operational budgets.

Ward Huybrechts, business manager at Belgian esters and fatty acids producer Oleon, confirmed that the company has discontinued a few of its products from the market.

Oleon has a very wide product range, which involved a lot of registrations under REACH. We discontinued a few products, and the reason is that we were unable to achieve enough sales to justify the registration cost and effort, Huybrechts said.

The company sees much bigger issue with REACH procedures in the limitation of developing of new products.

REACH is now quite severe on registrations even in the upscaling phase. While in this phase, the final economics and interest of the market is not confirmed yet. All the products that our company produces are generally recognized as safe, and we find the limitations set by REACH on products in the R&D phase [to be] too strict, Huybrechts revealed.

Giant Steps

The German chemicals giant BASF said that it had not stopped marketing products solely because of REACH but the regulations requirements are still a contributing factor to such decisions.

To stop the marketing of certain products is certainly a multi-factorial decision. Costs or earnings are an important factor during such decisions, but even there, REACH is only one of several parameters, said BASF spokesperson Ursula von Stettin.

That may be, but representatives of all sizes of companies have said that REACH significantly increased the costs that must be weighed in making such decisions. In doing so, it raised the profitability necessary to justify a companys offering – be that an alternative approach to purify and eliminate bacteria or setting a course for developing new formulations. Naturally that increases the number of products that fail to reach that bar. Whether it is an alternative approach to purify and eliminate bacteria or setting a course for developing new formulations, it takes operators resources and efforts, which translate into more expensive finished products with not enough sales to justify the costs of development and product registration.