May 31 was the European Unions final deadline to register substances under the Registration, Evaluation, Authorization and Restriction of Chemicals regulation for substances manufactured or imported into the region. But some products may still be unregistered-specifically those made in small volumes by producers with a market focus outside the EU, such as lubricant additives-potentially creating supply disruptions for lube companies, an industry conference heard in May.
Companies should now have registered substances-whether they are an ingredient or a product unto themselves-if annual volumes that they handle exceed 1 metric ton. For lubricating oils, this means the base oils and all components of the additives, emphasized Andreas Dodos of Greek lube manufacturer Eldons S.A. He reiterated the oft-repeated slogan of the European Chemicals Agency, the regulatory body created to enforce REACH: No registration equals no market. Because of this, lubricant blenders and marketers doing business in the EU should ensure continuity of their supply chain by verifying the registration of their additive products, he advised attendees at GBCs CIS Base Oils and Lubricants conference.
For post-2018 exports to the EU, marketers should expect not all base stocks to be REACH registered. Please verify the CAS [Chemical Abstracts Service] and registration number of your supplier, Dodos urged attendees in Moscow. He also warned that not all local additive manufacturers will have registered their products if the European market is not in their focus.
The May deadline-which applied to most chemicals made or imported in volumes of 1 to 10 metric tons per year-capped eight years of registration deadlines.
The European Chemicals Agency listed 21,323 unique substances in the registration database in mid-September, and the agency expects to complete all pending registrations by May 2019. Next year, the ECHA and the EU Customs Union will begin an enforcement initiative to ensure that companies have fulfilled their registration obligations.
Registration remains open for new imports to the EU, new manufacturers and their legal entities, and new substances that exceed the 1 metric ton per year threshold, said Dodos, who is technical service, research and development, and regulatory compliance manager at Eldons and chairs the European REACH Grease Thickener Consortium, a group of companies cooperating to develop joint registrations for chemicals used as grease thickeners.
Costs a Burden
For registrants, the biggest issue remains the compliance cost, which in many instances is addressed with joint registration.
Depending on tonnage, dossiers must contain a certain number of what ECHA calls endpoints. These data points include physiochemical, toxicological and ecotoxicological information. A greater number of required endpoints increases registration costs.
For example, the tonnage band over 1,000 metric tons per year requires 70 endpoints, covered in Annex X of the regulation. Calculated under the Fleischer formula, which estimates prices for laboratory testing of chemical substances, the cost would be over 2.4 million euros. The tonnage band from 100 to 1,000 metric tons per year (Annex IX) includes 62 endpoints, and the testing costs involved in registration would be about 1 million euros. For 10 to 100 metric tons per year (Annex VIII) 42 endpoints bring an estimated cost of 170,000 euros. The smallest volumes (1 t/y to 10 t/y, Annex VII) must include only 28 endpoints costing about 58,000 euros.
But more expenses loom for companies that have already registered in the higher tonnage bands. The higher-tier toxicological and ecotoxicological tests required by Annex IX and Annex X include studies conducted on vertebrate animals, Dodos told LubesnGreases. Registrants in these tonnage bands have submitted test proposals, but will await approval from the ECHA before carrying out the tests, in order to minimize animal testing. A lot of this feedback has not yet been provided by the ECHA, which means that these tests originally submitted only as proposals will need to be carried out in the future, he said.
Following registration, ECHA evaluates the submitted dossiers. Eighty-five percent of dossiers submitted in 2016 received a quality observation letter, which requests that the registrant revise their dossier to address shortcomings or inconsistencies. The majority of compliance checks that resulted in denial had to do with the testing proposals and the requirement for additional testing or support of the testing strategy, Dodos revealed.
But of the 33,363 dossiers submitted this year before the May 31 deadline, ECHA said it has rejected only 1 percent. Registration numbers were granted to 32,515 dossiers; the remaining dossiers are incomplete and ECHA is awaiting updated information.
Industry players have been working together over the past several years to lighten the load, Dodos pointed out. Suppliers of specialty base fluids or additives have gotten in touch with their customers and asked them if they really want to continue using a specialty fluid or additive that has been developed, and they are asked to contribute toward the cost. Companies that have contributed toward REACH registration may receive preferential treatment from the supplier.
Some companies have expressed frustration with lead registrants, which arrange testing for substances that multiple companies produce or import. The idea is for companies to share costs for that testing, but cost and data sharing disputes have arisen between co-registrants.
Supply Disruptions
Dodos recommended that marketers importing to the EU assure the continuity of their supply chain. Most additive manufacturers have already announced discontinuation or formulation changes of products affected, he acknowledged. In fact, Dodos reported that industry sources with both additive and specialty base fluid companies say all major additive manufacturers have announced changes in their product range.
Very-low-volume additives, such as those used in food-grade lubricants, are being discontinued to avoid the registration burden, he noted. Specialty products such as metalworking fluids are very much affected. Metalworking fluid formulations are often highly customized and have the added challenge of the EUs biocides directive, which severely limits the types of biocides available, particularly in water based formulations, Dodos said.
Discontinued products include ester base stocks and additives with highly customized chemistry and antioxidants such as those based on phenolic and aminic acids. We have the situation where a lot of antioxidant additives coming from the U.S. have been replaced because the U.S. companies are not willing to pay the extra cost of REACH registration, Dodos said.
Other affected chemistries include antiwear and extreme pressure additives, solubilizers and emulsifier systems, amine derivatives and biocides. Again, Dodos pointed to companies based in the United States that have been exporting small volumes of additives. We have been in touch with a lot of American companies that have difficulties maintaining a viable market in Europe with their additives because of REACH.
Customers in the EU also have a heightened sensitivity about substances classified as hazardous or toxic under Europes CLP labeling regulation. People dont like to use products where theres a man with an exploding heart on the label, he observed, referring to the health hazard pictogram in the Globally Harmonized System of chemical classification and labeling. Companies are striving to produce products that are not classified, so you might have the case where additive packages have not been discontinued, but the formulation has changed significantly to impact the classification of these products.
Formulators are also working to eliminate substances of very high concern in terms of toxicology and biokinetics, which face a sunset date and will eventually be unavailable for use in Europe. In its 2017 report, the ECHA listed 181 such substances, including boric acid and borate derivatives used in grease manufacturing, metalworking fluids and coolants. There is a lot of discussion of whether boric acid derivatives need to be classified in the same category as boric acid, Dodos explained, in which case they will need to be replaced in the supply chain by a certain date.
REACH was brought into Europe to protect the health of the citizens and the environment, Dodos reminded the group. He cited a series of studies conducted by the European Commission, which estimated the cost to industry will range from 3 to 5 billion euros, but the savings in healthcare, for example, will be upwards of 30 billion euros by 2030. So the advantages severely outweigh the cost of this regulation.
Further, while REACH does present a barrier to importing chemicals into Europe, other countries and markets-including South Korea, China, Thailand, the Philippines, Turkey, Japan and the U.S. state of California-are implementing similar registration programs. Companies that have dealt with REACH in Europe will be better prepared to deal with such legislation in other countries, Dodos encouraged his audience.
Work will continue with REACH, including registration of new substances and substances that breach the tonnage threshold in the future. Efforts to regulate nanomaterials, which are sometimes used in lubricants, are also part of REACH. There is some talk about implementing REACH for mixtures after 2020, he warned.