They are also examining carefully the activities of their suppliers with respect to the European Union’s REACH legislation on the registration, evaluation and authorisation of chemicals.
The legislation, which started to come into effect in mid-2007, will be implemented over a 11-year period ending in 2018 when all chemicals produced or imported into the EU with an annual output of one ton or more should have been registered with the Helsinki-based European Chemicals Agency (ECHA) with details of their health and safety profiles.
The main impact of the regulation will be on thousands of producers and importers of more than 30,000 substances above the one ton threshold. The repercussions of REACH have become evident only a few months after the end of a six-month phase during which all substances above the one ton threshold had to be pre-registered with ECHA. If a chemical has not been pre-registered, it cannot legally be marketed into the EU.
Pre-registration has comprised only the provision of details of the identity of each chemicals, of its manufacturer or importer and of its tonnage.
The identity of individual substances has become the platform for the next stage of REACH under which producers and importers of the same chemical form groups in order to share the responsibility and cost of gathering safety data for its registration dossier. The groups are called Substance Information Exchange Forums (SIEFs).
The deadlines for registrations have been set on the basis of annual production volumes. Chemicals with an output of 1,000 tons or more will have to be registered by the beginning of December next year, of 100 tons or more by mid-2013, and the remainder by mid-2018.
Substances which are considered to dangerous to health or the environment will have to be registered by the end of next year – whatever their volume. The aim is that these substances of very high concern (SVHC) will eventually have to be authorized to stay on the market on condition, in most cases, that their producers or importers make efforts to find safer alternatives.
The Challenges of Implementing REACH
Critics of REACH have warned since legislation on the scheme was first drafted around 10 years ago that it would be extremely difficult to implement because of its complexity. Already these critics are being proved to be right.
ECHA was expecting around 100,000 to 150,000 pre-registrations. By the deadline of Dec. 1, approximately 2.6 million pre-registrations had been submitted. Well over 100,000 “different” substances were pre-registered, although it is still unclear how many of those are in fact the same chemicals.
Even ink makers decided to pre-register substances they use in their formulations because of fears that their suppliers may not have done so with the risk that the chemicals may be taken off the market.
Now there is confusion about the responsibilities of ink producers and other purchasers of chemicals in ensuring that the substances they buy have been pre-registered.
Trade associations are telling their members that they are not legally required to verify that chemicals from their suppliers have been pre-registered, but that it would nonetheless be sensible to investigate the matter.
“It is the producer or importer of substances who are legally obliged to market in the European Union only chemicals which have been pre-registered,” said Martin Schless, technical and regulatory affairs manager at the German paints and printing inks association (VdL).
“There is no legal obligation on ink producers to check that chemicals they purchase for the making of their products have been pre-registered,” he added. “On the other hand, it would be good business practice to check because if they have not been pre-registered, the supplier runs the risk of being forced to take them off the market by the authorities.”
Some lawyers believe that because the legislation is not completely clear on the issue, formulators should be extremely cautious about handling chemicals which might not have been pre-registered.
“The law is less clear about companies which buy chemical substances but which are not the actual importers of the substance concerned,” explained Giles Chappell, a lawyer at the legal firm of Crowell & Moring in Brussels. “Depending on the national authority (with the responsibility for enforcing REACH within each EU member state), such companies may find themselves subject to enforcement action if they use or market in the EU substances that have not been pre-registered.
“Furthermore, there is a real risk of damage to a company’s reputation if that company is found to be marketing in the EU substances that have not been pre-registered, especially if it results from inadequate checking procedures,” he continued. “Moreover, a company may find itself liable under other applicable EU or national laws, if the non-pre-registered substances cause any harmful effects to humans or the environment.”
Some REACH consultants are advising their clients to ensure that imported substances and preparations – such as inks and coatings – carry REACH-compliance letters or certificates after shipment have been inspected in northern European ports.
The Dutch authorities, for example, are reported to been asking to see evidence of pre-registration for imported products before allowing them through customs.
Resins and Pigments
Registration will be a particularly convoluted procedure for the two main ingredients in ink formulations – resins and pigments.
Inks themselves are categorized under the REACH legislation as preparations, defined as “mixtures or solutions composed of two or more substances.” But many pigments and resins are also classified as preparations because they are considered to be mixtures of substances rather than single chemicals or compounds.
Companies which have pre-registered their substances according to European and U.S. numbering systems for chemicals identification have been directed by the European Chemicals Agency to join what are called pre-SIEFs.
At this stage, producers and importers decide which SIEFs should be formed to deal with specific substances on the basis of their similarity.
There are now around 146,000 pre-SIEFs, according to ECHA. About 93,000 of them have between one and nine companies while two have more than 5,000 participating companies.
However the task of determining the “sameness” of substances in order to create SIEFs for them is proving to be more difficult that expected. “Sameness” should ensure that a SIEF can draw up a single registration dossier to provide an adequate safety profile for an individual chemical.
Pigments will be one of the most complicated product categories within REACH for establishing “sameness” because of the relatively high level of impurities within them.
Under REACH, there are three ways of categorizing substances. There are mono constituents, in which at least 80 percent is the same substance with the remainder consisting of by-products or impurities. There are multi-constituent substances where, as a result of reactions during synthesis within the production process, there are several components amounting to 10 to 80 percent of the product.
The third category are substances of unknown or variable composition or complex reaction products or biological materials (UVCB). They are effectively products in which the exact properties of its constituents, for example in biological materials or oils, are unclear.
Most pigments are classified as mono-constituents but there are many which fall into the other two categories.
“A pigment may be given the same generic name such as Blue 15 or Yellow 13 but the actual constituents of it can vary, depending on the range of substances within it and how it is made,” said Christophe Bulliard, REACH project manager at the coating effects segment of Ciba Specialty Chemicals, Basel, a leading suppler of pigments to the inks sector.
“Under the REACH rules, for one substance to be similar to another it has to contain at least 80 percent of the same constituent if it is to be registered as a mono-constituent substance, ” he added. “Within the registration dossier, each producer of a mono constituent substance must provide individual data on the 20 percent containing by-products or impurities. But as a mono constituent they will be considered to be the same substance with normally the same toxicological and ecotoxicological profile.”
Mono-constituents, whose impurities have markedly different safety profiles, may have to join separate SIEFs because of the need for registration dossiers to cover chemicals with same toxicological and ecotoxicological properties. With recent developments of new analytical technologies, these differences in profiles have become more evident.
“Analytical methods have advanced so much that what was previously considered to be similar is in fact different,” said Mr. Bulliard. “For example, with trichlorinated phthalocyanine pigments, there are differences in the substitution level and chlorination level on each individual molecule.”
The European association for paints and printing ink producers (Cepe) is drawing up a list of usage descriptors which will contain data covering most uses by coatings and printing ink formulators. The list should be published this summer.
“We reckon it will cover over 90 percent of uses of substances used in the coatings and printing inks sectors,” said Jacques Warnon, Cepe’s technical director. “We have tried to make the descriptors as broad as possible so that only users in very specialist sectors will have to draw up their own data on uses. We are also ensuring that the descriptors meet the needs of downstream customers such as printers.”