In a presentation at ACIs European Base Oils and Lubricants Summit in Warsaw last September, Sandra Meijer, the Centres director of business development, explained that government authorities transferred the responsibility for controlling hazardous substances to the chemical industry, comprised of manufacturers, importers and downstream users. The rationale for this move was that industry professionals know the products better than the authorities and can show how safe they are.

Evaluation

After a substance has been applied for registration, its evaluation is the next important step of the procedure. The evaluation is executed through the Community Rolling Action Plan (CoRAP). The aim is to clarify any concerns by asking registrants to perform further tests if needed, Meijer said. CoRAP is a rolling three-year program, and at any given time, quite a number of evaluations can be going on or waiting to be started.

Approximately 50 to 60 substances are added to the CoRAP each year, said Meijer. As of September, 49 substances had completed the evaluation process. For 38 substances, the evaluation is done and no further information is needed for them. Ninety-three substances require ongoing evaluation, and additional information has been requested for 76 materials. The procedure has not started for 99 substances, she revealed, and two evaluations were suspended.

The results of the evaluation process may lead to a change in hazard classification, which is listed in Annex VI of the regulatory framework for the Classification, Labeling and Packaging (CLP) of substances and mixtures. Meijer noted that the process may lead to proposals to classify a substance as a Substance of Very High Concern (SVHC), proposals for restrictions or other substance-specific legislation. In many cases, the evaluation could have implication on a registrants costs and operations.

Authorization

After the evaluation, the next step is authorization of the substance. The main target in this phase of the registration is to remove SVHCs from the market. A company must apply for authorization if it wants to continue to manufacture, import or use the substance.

After identification of the SVHCs, the substance can be placed on Annex XIV with a sunset date. After this date, it cannot be manufactured, imported or used, unless authorization has been granted, Meijer stated.

If a substance is identified as having properties of concern, the authorities need to decide the best way to manage its risk. This part of the procedure is called Risk Management Options Analysis (RMOA), according to Meijer. In this phase, typical questions for the registrants are:

• Will my substance be evaluated or become an SVHC?
• How can I get advance warning?
• How does the agency select these substances?

To answer these questions, the ECHA (European Chemicals Agency) sends the substance to RMOA for screening and follow-up actions, Meijer said. She added that for substance identified as SVHCs, a candidate list is formed that goes to the authorization process. The other option is restriction, classification change or other legislation. In some cases, no measures are to be taken.

Current Situation

The REACH Centre found that as of September, 31 substances on Annex XIV were subject to authorization. At that time, 155 authorization applications had been submitted, covering 22 substances, and 19 decisions were adopted. All 19 authorizations were granted. I guess it is good news because the authorizations cover a total of five substances that have multiple uses. In addition, only one application concerning a lubricant is under ongoing evaluation, Meijer said.

The Centre revealed that this substance is 1,2-dichloroethane, which is used in base oil production. On the other hand, several substances have been proposed for inclusion on the authorization list, including borates, trixylyl phosphate and nonyphenol. Some substances such as formaldehyde, short-chain chlorinated paraffins, perfluorooctanoic acid or perfluorononanoic acid could be identified as CMR (carcinogenic, mutagenic and reprotoxic), while approximately 40 substances are expected to be on the CoRAP list.

Meijer then presented a CoRAP case study for two substances used in the lubricants industry: butylated hydroxytoluene (BHT) and medium chain chlorine paraffin (MCCP). BHT is an antioxidant used in turbine and insulating oils. It faces concerns as a potential endocrine disruptor. Its evaluation was scheduled for completion in 2016, with France as the competent authority. The potential follow-up for BHT includes harmonized categorization and authorization.

MCCP is used in metalworking fluids, and the concern is that it is a potential persistent bioaccumulative toxic material. It was evaluated in the United Kingdom in 2012, and nine registrants appealed. The appeal was dismissed, and studies were requested to determine fish bioaccumulation and aerobic and anaerobic transformation in aquatic sediments.

The impact of REACH on a business can be tremendous, according to Meijer. The registrants have to expect the potential for further activities after registration. Every substance has to be evaluated, and it can be restricted, undergo a classification change, become an SVHC or be put on the candidate list. Ultimately, through authorization and restriction, the substance can be restricted and removed from the EU market. Alternatively, it can be authorized.

The REACH Centre recommends that companies use horizon scanning as the best tool for a successful application. It will allow you to always stay one step ahead, said Meijer. The tool can be accessed on the ECHA website, and we recommend our clients do a complete monitoring portfolio and compare it to other substances listed under the Public Activities Coordination Tool, CoRAP or proposal for harmonized classification and listing, she concluded, adding that the REACH Centre also recommends tracking other listings that might be used in ECHAs screening such as the International Agency for Research in Carcinogens.