The ink sector in Europe is starting to get down to the serious work of collecting data for the registration
It is already becoming evident that for certain ink makers and raw materials suppliers, the task may be more difficult and hence more expensive than expected. There is even a danger that costs will be so high that certain ink materials may have to be taken off the market.
The biggest problem area could be certain pigments on which a lot of expensive safety testing may be necessary in order to prove they do not need to be replaced by safer alternatives.
REACH, which started to be implemented on June 1, initiates an 11-year program for the registration of approximately 30,000 chemicals with annual sales of one metric ton or more. Nearly 5 to 10 percent of these, which are categorized as being of high concern because of their potential to be harmful to human health and the environment, will have to be further evaluated and if necessary be authorized to remain on the market.
Some chemicals may be allowed to remain commercially available only if the producer is able to show there are no suitable safer replacements available.
There are fears among pigment producers that some of their products could be categorized as being very persistent and very bioaccumulative (vPvB). This will mean that the collection of safety data for these pigments will be particularly expensive. It would also result in some of them having to go through REACH’s costly authorization procedure with the threat of enforced substitution.
The first key stage of the REACH process will be in the second half of next year, when producers and importers will have to register basic details of the substance or chemicals they plan to register. This pre-registration will enable producers and importers with identical or similar products to form consortia or groups called substance information exchange forums (SIEFs) for the sharing of safety data.
Since REACH was finally approved after eight years of wrangling at the end of 2006, companies have not been so willing to pass on safety information.
“It is now becoming difficult to obtain safety information which would normally be freely available because, due to REACH, safety data has now got a value,” complained an R&D executive in one ink company. “Within the SIEFs, companies will be buying and selling information to put in the registration dossiers for their products.”
The procedure for the full registration of substances will stretch over 11 years, with three deadlines for different tonnage and hazard groups. November 2010 will be the first deadline – for substances of 1,000 tons and above and for those chemicals which are carcinogenic, mutagenic and toxic to reproduction (CMRs) and very toxic to aquatic organisms.
Substances in quantities of 100 tons or more will have to be registered by mid-2013 and all remaining chemicals in amounts of one ton or more by mid-2018. The Helsinki-based European Chemicals Agency, a new organization, will have the task of running REACH, including the registration process. Final decisions will be taken by the Brussels-based European Commission, the EU executive.
The lowest tonnage group of one to 10 tons, comprising the majority of chemicals covered by REACH and the vast majority of those used by inks makers, have the least demanding of data requirements. This is as long as they are not classified as CMRs or have other hazards of high concern, such as being persistent, bioaccumulative and toxic (PBT) or vPvB, in which case the data their producers or importers will have to provide will be as onerous as that for higher tonnages.
Pigment producers, led by the Swiss-based Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), have been stepping up their efforts to find ways of demonstrating that their products are not bioaccumulative.
In a report which was published last year and co-funded by ETAD and the UK Environment Agency, Atkins Environment, a UK-based consultancy, suggested an improved method for categorizing pigments for their potential for bioaccumulation.
It decided that an existing technique based on the solubility of pigments in octanol, a fatty acid, was insufficient and needed to be complemented by two other parameters of molecular size and/or weight and dietary/uptake studies. The octanol solubility test has been resulting in some organic pigments being classified as bioaccumulative.
The broader testing method would then be used for the preliminary screening of pigments to exclude those with no apparent potential for bioaccumulation. The rest would be subject to further investigation.
However the report warned that “actual levels of bioaccumulation are difficult to determine as the very low solubilities of pigments present experimental difficulties in both fish accumulation tests and in the measurement of (solubility levels).”
ETAD member companies have been carrying out their own tests to find a standard system for measuring the bioaccumulation potential of all pigments. They will then have to persuade the EU authorities that this standard is an acceptable way of demonstrating that organic pigments are not PBT or vPvB substances.
“We are still in the assessment phase,” said Walther Hofheer, ETAD’s deputy executive director. “We are working out a strategy on how to get further down the road with the testing of pigments. We have a number of options, but so far we have not come up with any information which gives us any real cause for concern.”
Another complication with pigments in REACH is that some pigments will have to be registered in terms of their individual components rather than as single entities as a result of a distinction in the legislation between substances and preparations.
A substance is defined as a “chemical element and its compounds in the natural state or obtained by any manufacturing process.” It includes, for example, additives to preserve stability and impurities as long as they do not exceed certain limits. It excludes solvents and other auxiliaries like surfactants.
A preparation is defined as a “mixture or solution composed of two or more substances.” Therefore, coatings and inks are classified as preparations. But since certain pigments are combinations of substances or hybrids of two or more colorants they are categorized as preparations as well.
The difference between a substance and a preparation is important. Only substances have to be registered. But the registration also covers the uses or applications of substances within preparations, including details about their behavior and potential for harming human health and the environment.
Data on the use of preparations will also have to be included in safety data sheets (SDS), which provide information on the safety of products as they are applied through the supply chain. Under the REACH legislation the scope of SDS is being widened so that they can provide more information on the potential risks of substances and recommended risk management measures.
Pigment producers and importers will want to avoid the expense of having to draw up chemical safety reports (CSRs) on their products, which will have to be attached to the safety data sheets. The report would be based on chemical safety assessments (CSA) which include drawing up exposure scenarios or details of how workers or other users of pigments and inks could be exposed to certain health dangers. The assessments would also cover the environmental impact of pigments.
The marketing of a growing proportion of organic pigments in dispersions means that pigments producers may have to register more than just the substance which make up the pigments themselves.
“With dispersions there could be quite a few substances which have to be registered besides those in the pigment itself,” explained Erwin Dietz, head of product safety at Clariant’s Pigments and Additives Division. “Within the dispersion there will be solvents and biocides, which are already covered by separate safety legislation, and then auxiliaries to improve the properties of the pigment, such as surfactants and resins and polymers on the pigment’s surface.
“If many safety tests have to be done for the registration of the substances, registrations will then become really expensive,” he added. “Obviously the extra costs of registration will influence the prices being charged by producers and importers for pigments.”
Combinations of pigments, an increasing trend in colorants to achieve optical variations, could cause problems because they will have to be registered as separate substances, yet will also be classified as preparations.
With effect inorganic pigments there will be additional complications. Since some of them comprise minerals, they may be exempted from registration as substances.
“Minerals which are not chemically modified are exempt from registration – for example, mica,” said Robert Fischer, director of Eurocolour, the trade association for makers of colorants, including both organic and inorganic pigments.
However, since many pearlescent pigments now comprise flakes and particles of mica and other materials coated with metal oxides, silicas and other chemicals, they can comprise at least one substance if not several, all of which will have to be registered. At the same time they will also classified as preparations in their finished form.
Some resins are in a similar position to pigments. With polymers, only monomers have to be registered, but safety details of the application of the polymers are required. Binders comprising a mix of polymers and other substances will be categorized as preparations.
Anxiety is mounting among raw material suppliers that the cost of registration, especially the conducting of safety tests, will become so expensive that certain chemicals may have to be taken off the market.
“Withdrawal of products must be expected when you look at today’s small profit margins,” said Mr. Dietz. “In some cases, the profit on pigments is so low that after taking into account the costs of REACH there will be no profit left.”