The objective of REACH is the elimination of substances of very high concern (SVHC) from the EU marketplace, Brearley said. These substances meet one or more of the following criteria:

Class 1A or 1B carcinogen, mutagen or toxic for reproduction

Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with REACH Annex XIII

Demonstrate a similar level of concern, for example, endocrine disruptors

The candidate list currently comprises 155 substances, said Brearley, including 15 potentially used in metalworking fluids. SVHCs included in the Authorization List (Annex XIV) cannot be put on the market or used after a given date, unless an authorization is granted for their use, or the use is exempted from authorization.

Annex XIV currently includes 31 substances, including five that may be present in metalworking fluids, Brearley noted. For example, disodium tetraborate, a corrosion inhibitor, is on the candidate list as toxic for reproduction. Restrictions can be applied to any hazardous substance, he added. The restrictions can be very specific, but also can be a complete ban. Many additives used in metalworking fluids have a restriction placed on them; however, relatively few of the restrictions apply to their use in metalworking fluids.

For example, short-chain chlorinated paraffins are restricted from use in metalworking fluids, and these substances are now discontinued, Brearley said. Also, pentachlorophenol [a fungicide] is restricted to a concentration of less than 0.1 percent.

Another substance under severe scrutiny is boric acid, previously widely used as a corrosion inhibitor. Boric acid was included on the Candidate List in 2010, and in September 2014, it was proposed for inclusion in Annex XIV, said Brearley. A decision is expected in the summer of 2016.

Several substances can be used as substitutes for boric acid, including lactic acid and boric acid-based compounds. However, mixtures with boric acid-based compounds currently must maintain a level of free boric acid under 5.5 percent to avoid being classified and labeled as toxic for reproduction he added.

Managing the Future

Brearley then covered the various means of tracking developments on restrictions and authorization protocols, including the Registry of Intentions, the Public Activities Coordination Tool/Risk Management Option analysis and the community rolling action plan.

According to the ECHA website, the organization issues a Registry of Intentions periodically to make interested parties aware of the substances for which a harmonized classification and labeling document (CLH), SVHC or restriction dossier is intended to be submitted. This action gives interested parties time to prepare comments for later in the process. It also avoids duplication of work and encourages cooperation between potential dossier submitters.

Public consultation follows dossier submission, and concerned parties can comment on the proposal. Based on these comments, the proposals are discussed in the relevant committees – Risk Assessment Committee for CLH and restrictions, Committee for Socio-Economic Analysis for restrictions and member state committee for SVHCs. The ECHA encourages interested parties to consult the RoI regularly to follow the processing of the dossier.

The Public Activities Coordination Tool lists the substances for which a Risk Management Option Analysis is either under development or has been completed. Available documents include the RMOA conclusion document and the full RMOA if the authority wishes to publish them. RMOAs and their conclusions are compiled on the basis of available information and may change in light of new information or further assessment.

The community rolling action plan (CoRAP) specifies the substances that are to be evaluated over a three-year period. After the first year, the plan is updated to include additional substances as well as any revision to the substances that were included in the second and third years of the original plan.

Substances subject to immediate evaluation are listed in the first year of the plan. However, a member state may notify at any time that it has information suggesting that a substance is a priority for evaluation, even though it is not included in the CoRAP list. In these situations, the CoRAP may be amended to include this substance prior to an annual update.

For example, in November, GHS Resources Howell reported that ECHA published a CoRAP update on the status of substances already on the list and identifying new substances proposed by member states for inclusion. Per its webpage, ECHA plans to finalize the plan in March 2015.

Of interest to metalworking fluid producers, Howell noted, is the continued inclusion of triazine (used as a biocide) and 2-amino-2-methyl-propanol (used to neutralize acids). Triazine is included because of its high usage and the serious health effect of being fatal if inhaled. AMP is suspected of being a reproductive toxin, said Howell. The ultimate action on AMP through the CoRAP process may include further restrictions on its use as a substance subject to authorization.

Regulations Impact

The impact of the REACH registration has been varied. For example, said Brearley, Some additives are being withdrawn from the market, such as boric acid, which is being progressively substituted by [other] substances. Also, many new additives have been developed such as nanomaterials, which are under evaluation by both industry and authorities.

He added, REACH has had the negative impact of making many metalworking formulations less effective, more costly or both. And their conditions of use have become more proscriptive.

Brearley went on to describe the impact of the Classification, Labeling and Packaging Regulation, which requires all mixtures to be classified beginning in June 2015. This presents the potential for more severe classifications and continuing review as additional substances are registered, and classification is based on more data, cautioned Brearley. The goal is a globally harmonized classification system; however, reclassification of some substances may lead to more proscriptive conditions of use.

For example, formaldehyde was reclassified in December 2014 such that mixtures containing more than a 0.1 percent concentration are considered a Class 1B carcinogen. As a consequence of this reclassification, the current workplace exposure level of 2 parts per million will have to be reduced, said Brearley.

He added that of the currently notified substances, about 35 percent are formaldehyde releasers. Potential alternatives include methylisothiazolinone (MIT), benzisothiazolinone (BIT) and certain phenolics. However, these substances are likely to be more specialized in their application.

What about Biocides?

Brearley concluded his presentation by reviewing the status of the Biocidal Products Regulation, EU 528/2012, which went into effect in September 2013. The BPR has a few features that directly affect metalworking fluid formulations.

For example, only biocide products containing approved active substances included on the Union List can be placed on the market, said Brearley. The Union List comprises substances for which approval decisions have been made for their use in biocidal products.

All biocide products have to be authorized according to the requirements of the BPR, he noted, and as of 1 September 2015, active substances on their own or in a biocide product must be sourced from a supplier on the list of active substance suppliers the so-called Article 95 list.

Twenty-six active substances have been notified for use in metalworking fluids. But as of August 2014, only two, MIT and N, N methylenebismorphaline (MBM), have received a positive recommendation. Eventually, all biocide products on the market will have to be authorized according to the BPR, Brearley explained. However, transitional arrangements allow for biocidal products contained in the review program to continue to be placed on the market under individual member state rules. The target date for submission of opinions is the end of 2020.

If MIT is approved as an active substance in biocidal products, it will need to be added directly to the sump to prevent worker contact because it has skin sensitizing properties, said Brearley. Also, the opinion of the commission issued in October recommends approval of MBM and its inclusion on the Union List for use in enclosed chambers and with local exhaust ventilation.

The impact of the BPR on metalworking fluids will build over time, Brearley said, but active substance approval and biocidal product authorization is expensive. Industry will carry the financial cost either directly or indirectly.

He cautioned that some active substances may not be approveddue to their hazard classification, or they may potentially be substituted. Also, the number of available biocides may be reduced due to withdrawal of actives from the market or lack of approval. Therefore, the efficacy of biocides may be reduced as more hazardous [and more effective] substances are removed from the marketplace, said Brearley.

Finally, formulators of biocides will need to ensure that they or their active substance supplier is listed on the approved supplier list, Brearley concluded. And with transitional arrangements in place and ongoing review, the regulation needs careful monitoring to effectively manage its impact.