Analysts reckon that many producers and distributors have decided not to register possibly thousands of chemicals with the European Chemical Agency (ECHA), responsible for administering REACH, by a deadline of May 31, 2018 mainly because of the cost.
The chemicals which are low volume products make up the third and final group of substances which have to be registered under the REACH rules, a process which started in 2010 with high-volume chemicals.
Under REACH – which stands for the registration, evaluation, authorisation and restriction of chemicals – substances which are not registered on time cannot stay on the European market.
Registrants, who are mainly chemical manufacturers, importers and distributors, also include coatings producers who make or import some of their own ingredients. The final group of chemicals to be registered which covers the 1-100 tons per-year range of a registrant’s annual supplies includes many speciality, niche products of the type used in coatings formulations.
Preliminary figures from ECHA show that on average for each chemical on the European market there are 4-5 producers, importers and distributors. This seems to indicate that it is unlikely that many chemicals will disappear from the market. More probably with fewer suppliers of individual chemicals scarcities will occur which will push up prices.
Low margins on chemicals seems to have a major reason why prospective registrants have not registered their products under REACH. The expense of drawing up safety dossiers with registrations can narrow margins to such an extent that their registration becomes economically unviable.
Dossiers are drawn up by groups of registrants called Substance Information Exchange Forums (SIEFs) each of which collects safety data for individual chemicals. The major expense of SIEFs is the amount their members have to pay larger companies, often fellow SIEF members, for proprietary data from their own safety studies.
“The costs of preparing registration dossiers have, in particular, been a problem for SMEs,” said Janice Robinson, product regulations director at the European Council of the Paint, Printing Ink and Artists Colours Industry (CEPE), Europe’s coatings trade association. We had been lobbying for measures to be taken to encourage data sharing among registrants, which we hope will have reassured SME.”
CEPE believes that the extent of non-registration of chemicals on the European market will not become clear for at least a few months when ECHA is due to complete a preliminary check of the registration dossiers for items like completeness and accuracy.
“Well before the deadline, we have been advising our members to keep in close contact with their chemical suppliers,” said Robinson. “This would have enabled suppliers to warn their coatings and other customers well in advance of any plans not to register chemicals so that coatings producers could stockpile supplies if necessary. So far we have not received any feedback from our members of any warnings from suppliers. So at the moment no news is good news.”
ECHA has revealed that by the May 31 deadline, there had been 33, 363 registrations of 11,114 substances in the 1-100 tons range.
“(We don’t ) have information whether substances have been withdrawn from the market,” said an agency spokesperson. “We have not had any signs from our industry stakeholders that substances important to European businesses and supply chains would not be registered. At the same time it is too early to say whether that’s the reality. We’ll continue to monitor the situation in collaboration with industry associations.”
ECHA claims that it has a relatively clear idea of the numbers and volumes of chemicals on the market in the 10-100 ton range because of data from chemicals directories and inventories before REACH was implemented over 10 years ago.
“Under existing chemicals legislation before REACH entered into force, reliable estimates were available only for (chemicals of) tonnages down to 10 tons,” the ECHA spokesperson explained. “There was a high level of uncertainty on the 1-10 tonnage band.”
Partly due to this unreliability of information on the identity of low-volume chemicals and the pre-REACH estimates by the European Commission, the EU’s executive, of the totals of chemicals to be registered, some industrial associations believe that the number of non-registered chemicals could amount to at least several thousand.
According to a Brussels-based association representing SMEs in Europe (UEAPME), whose members include small chemical and coatings producer, the numbers of non-registered chemicals could be as high as 10,000-15,000. This is a calculation based on the European Commission’s pre-REACH estimate of 30,000 already on the market which would need to be registered under the legislation. This figure would exclude certain intermediates and new chemicals.
Marko Susnik, a REACH expert advising UEAPME, estimated that at most only half of the original estimate of 30,000 chemicals had now been registered under REACH. “Such a gap is considerable,” he said, adding that it is “hard to believe” that the market for speciality chemicals had changed so radically over the last 10-15 years that large numbers of chemicals had been withdrawn.
The 10,000-15,000 figures also ties in with the 135,000 individual substances notified to ECHA since 2011 for categorizing under the EU’s Classification, Labelling and Packaging (CLP) regulation, according to Susnik. This determines how hazardous chemicals should be labelled but, unlike with REACH, does not have the same minimum volume threshold.
Susnik is hoping that some companies will realize in the coming months the need to register their products and that at the same time the authorities will exercise “some pragmatism” in the way they enforce REACH rules. This could allow greater leeway for late registrations.
ECHA has revealed that a relatively high proportion of the registrations made by the May 31 deadline this year were for chemicals in the tonnage range above 100 tons which had a 2013 registration deadline. Their registrants had originally planned to register them by the 2018 deadline but because of increased demand the volume of supplies had exceeded the 100-ton threshold between 2013 and 2018.
The agency has indicated that after the checking of the May 31 registration dossier and an enforcement exercise next year to ensure compliance with the REACH registration rules, there may be room for flexibility on late registrations.
“We encourage customers using chemicals to clarify whether substances which are crucial for their businesses are registered,” the ECHA spokesperson said. “If they find that potentially they are not (registered) we would encourage them to contact their industry association or ourselves so that actions can be taken.”
To enable even late registrations to take place, measures will have to be taken by the EU to lower the cost of preparing registration safety dossiers for SMEs. That could turn out to be a big challenge for REACH but also coatings producers facing the threat of shortages of vital chemicals.