Dodos is also chairman of the European REACH Grease Thickener Consortium (ERGTC), a trade group that helps its members navigate the complicated and potentially costly joint registration process.

Regulation Landscape

In force since 2007, REACH is the main European Union regulation that aims to protect people and the environment from chemicals. It mandates that all substances produced or imported into the EU in quantities of more than 1 metric ton per year per legal entity be registered by mid-2018. (Many substances previously had to be registered and the new deadline applies only to those that are low volume.)

Only EU-registered entities can submit registration dossiers to the Amsterdam-based European Chemicals Agency (ECHA) for assessment. Non-EU manufacturers that import into the EU must appoint a REACH only representative to act on their behalf.

The ECHA sets registration fees that entities must pay in order to continue producing and marketing substances in the EU. These fees are determined by the size of the entity and the volumes they intend to import or produce. Fees for quantities between 1 and 10 tons are 1,739 for an individual submission and 1,304 for a joint submission, ranging up to 33,699 and 25,274 for quantities greater than 1,000 tons. There are also a range of discounts for small and micro enterprises.

There were two earlier deadlines – in 2010 for producers in the 100-1,000 t/y volume band and in 2013 producers the 10-100 t/y band – and the quantity of information to be supplied depends on the tonnage placed on the market.

There are also costs incurred by testing substances, acquiring letters of access, consultancy fees and maintaining dossiers after submission.

Cooperative Efforts

Since 2007, REACH has been amended numerous times, with the latest being in 2016 – EC No 2016/9 on cost and data sharing. With the 2016 update, the ECHA devised a one-substance, one-registration principle that requires a data-sharing agreement between registrants of the same substance. The costs of the registration are also shared between the co-registrants, which also nominate a lead registrant.

The ERGTC found that REACH has a significant cost impact for grease manufacturers, one that grows proportionally larger as produced volumes get smaller. To alleviate the costs, consortium members have established a testing program for 11 substance groups and have a data set ready when the substance is registered. For each substance group, the required testing program ranges between 300,000 to 450,000, but the cost of registration under REACH is much higher, Dodos said.

If a grease producer applies individually, the costs can be higher still depending on the tonnage band and the ECHAs draft decision for more information. Applicants also have to pass a complex administrative procedure that involves inventory review; sameness testing needed when co-registrants have to determine if their substances are the same as the lead registrant; exposure scenarios to set out risk controls during manufacture and to human health and the environment; dossier submission and maintenance; and a risk premium that some consortia charge to compensate data owners for their development risks. The consortium can streamline this procedure using its management, substance grouping and developed communication and administration capabilities, Dodos said.

The ERGTCs 42 members have identified more than 500 substances that could be used as grease thickeners. According to the ERGTC, an estimated 40 of them will be REACH registered, nine had been registered by the 2010 deadline and six were registered by 2013.

In a grease formulation, one or more thickeners can be present that should be isolated in order to be registered, Dodos said, adding that thickeners vary significantly in complexity and chemistry. They can be highly water soluble to practically insoluble. Stability outside the oil matrix can be an issue, and concentration in the base oil can vary significantly. Thickeners can be mixed to produce the finished product ready for the market.

Registration Steps

Co-registrants need to take several detailed steps on the way to REACH registration. First, they need to identify the substances and join the substance information exchange forum, where they can find shared data and other information on a given substance. Then they should generate a substance identification profile for verification of the product, obtain a letter of access and generate and submit an electronic dossier entered into the REACH system. The last step is to follow-up with the agency for additional requirements when the dossier is reviewed.

Every registrant needs to obtain a so-called letter of access to register its chemicals, which is a further cost. A letter of access is a document that grants you the right to refer to the REACH-registration dossier of a lead registrant, and it grants entities the right to participate in a joint-submission.

Following registration, the ECHA evaluates the submitted dossiers, which contain information on substance identification, manufacturing processes, testing results, an evaluation of the impact on humans and the environment and safe use. One scenario is the agency challenges the dossiers content and requires changes or additions. This could also include additional testing, and the lead registrant is responsible for updating the dossier, in addition to the co-registrants, who need to contribute their share or otherwise they
can lose the right to use the letter of access, Dodos said, adding that in this case the costs could be significant.

When the registration is completed, the ECHA carries out manual checks on the dossiers already submitted in the following period. A long time is needed to review each dossier, Dodos said.

The consortium found that for substances registered in 2013 the final decision was received in 2017 after the backlog of manual checks were done. These updates are one of the requirements for REACH, and even when a dossier is submitted, the responsibility of the lead registrant is to maintain it with the latest available information. The updates could range from guidance on safe use to classification alternations.

Another part of the 2016 update was a letter of cost sharing, which can be constantly reviewed and depends on the number of actual registrants, the way the data set is used, provided for non-REACH purposes, Dodos said. The ERGTC said it would set up a mechanism for charging or reimbursing co-registrants for each substance.

Brexit Stage Right

If all the above wasnt costly and complicated enough, things could get potentially much worse for entities originating from and operating in the United Kingdom. According to the ECHA website, by 2017, 1,597 U.K. companies had made 9,135 applications for 6,103 substances, some of which of which could be used in greases.

After the British leave the 28-member bloc, some industry insiders fear companies will experience much higher costs. Since Britain would be no longer in the EU, all companies operating there need to appoint a REACH representative. This could increase their costs, and they will look ways to minimize losses, Thomas Norrby, senior technical advisor for lubricants at the Swedish refiner Nynas, told LubesnGreases in November.

The double whammy of Brexit and REACH will lead or has already led hundreds of companies to register in Dublin, as the Republic of Ireland is part of the EU. Others may leave permanently, Norrby said.

Whatever the outlook for EU and non-EU companies, entities must submit dossiers before the deadline or face fines, which adds even more costs. As Dodos urged, grease manufacturers must act in a timely manner because the June deadline is looming. Follow the roadmap and submit your dossiers as early as possible to avoid surprises. Be prepared for additional work, he said. No registration equals no market.