Aus der Praxis für die Praxis 1 Introduction Biocides - more specifically: microbicides or antimicrobial pesticides - are commercial products used to prevent the biodeterioration of products. Although most biocides are chemical formulations, they can also be physical agents, such as ultraviolet light or heat. Prior to 1998, each member country of the EU had its own regulations for the registration and use of biocides. Although many countries have retained the sovereign right of final decision authority over biocide use, in 1998 EU’s members adopted the Biocidal Products Directive (BPD; EU Directive 98/ 8/ EC) as a means of harmonizing biocide regulations. Under the 1998 Directive, biocides were divided into 23 Product Types among four Main Groups. Manufacturers were required to submit product dossiers that included toxicology, environmental fate and persistence, and performance efficacy data. In many circles, the BPD was seen as a pilot version of REACH. After a decade’s experience, the EU determined that the BPD needed to be revised. In 2009, a commission was chartered to undertake the revision effort. The result of their labors was the 2012 Biocidal Products Regulation (BPR; Regulation (EU) 528/ 2012). The BPR became effective as of September 2013. This presentation explains the impact of the BPR on microbicides used to control microbial contamination in MWF. 2 Definitions Typical of most regulations, BPR is loaded with arcane terms and acronyms. The definitions of the technical terms used in this paper will be provided on their first use. In this section, we provide a list of acronyms (Table 1). 44 Tribologie + Schmierungstechnik 64. Jahrgang 3/ 2017 * Dr. Frederick J. Passman CFMS, Fellow ASTM, Fellow STLE Biodeterioration Control Associates, Inc., Princeton New Jersey, USA Dr. Alan C. Eachus, Dr. Alan C. Eachus Consulting. CFMS, Independent Consultant, Villa Park, IL, USA Impact of Biocidal Products Regulation on microbial contamination control in metalworking fluids F. J. Passman, A. C. Eachus* Table 1: Biocidal Products Regulation Acronyms Acronym Meaning BPD Biocidal Products Directive BPR Biocidal Products Regulation CLP Classification, labelling and packaging - CLP regulation (REGULATION (EC) No 1272/ 2008) CMR Carcinogenicity, mutagenicity and reproductive toxicity GHS Globally Harmonized System IARC International Agency for Research on Cancer OPP US EPA’s Office of Pesticide Programs PBT Persistent, bioaccumulative and toxic PRIA Pesticide Registration Improvement Act SDS Safety Data Sheet The European Union’s new Biocidal Products Regulation ((EU) No 528/ 2012; BPR) became effective as of September 2013. The new regulation’s very broad definitions of biocidal products and treated articles are having an unprecedented adverse impact on microbial contamination control in water-miscible metalworking fluids (MWF). Given the increased costs associated with maintaining product registrations, and relatively small volumes relative to other biocide market segments, a number biocide manufacturers are choosing not to support product registrations. Consequently, the options available to both MWF compounders and endusers for microbial contamination control are shrinking. The resulting costs are likely to be measured in both increased operational costs and respiratory disease risk. This presentation will analyze the new regulations and their impact on the MWF industry. Keywords Biocide, microbicide, metalworking fluids, MWF, Biocidal Products Regulation, BPR Abstract T+S_3_17 03.04.17 15: 13 Seite 44 Aus der Praxis für die Praxis 3 Globally Harmonized System Both BPR and REACH are part of a larger effort to harmonize the regulation of chemicals that enter into commerce around the world. In 1992 GHS was conceived as “A globally harmonized hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000.” Final GHS standards were issued in 2014 with a 01 June 2015 deadline for compliance with the CLP regulation requiring implementation of GHS in the EU. This included the creation of standardized Safety Data Sheets (SDS). Theoretically, by now, everyone in this audience is using the new CLP-compliant SDS. However, keep in mind that the U.S. has adopted modified versions of the SDS and GHS labels, so that harmonization has not been as harmonious as had been hoped. Pay no attention to the 15-year gap between the aspirational date articulated in 1992 and the actual implementation date. 4 Biocidal Products Regulation; foundational concepts As noted above, BPR was approved in May 2012 and became effective in September 2013. One of the issues that provided impetus for revising the BPD was the complexity of the processes by which product dossiers were to be completed. Member countries did not necessarily agree on what constituted a sufficient battery of toxicological tests - either in the parameters to be tested or the methods to be used. Consequently, chemical manufacturers could never be certain that BPD registration would be sufficient to permit sales into all EU countries. Moreover, in the BPD, terms such as persistence had not been defined precisely and were subject to being interpreted differently by individual countries’ regulatory agencies. Under the BPR, companies who invest in developing toxicological, persistence and performance data are required to permit subsequent registration applicants to use those data. Compensation can and should be provided, potentially subject to binding arbitration. The initial BPD objective was to complete active substance dossier reviews by 2010. The BPR extends the review period through 2025. There are currently tens of thousands of total biocidal products formulated from approximately 2,500 active substances, with dossiers awaiting review. As of the end of 2014, fewer than 500 products had been reviewed. The BPR has harmonized data requirements (although the US has slightly different requirements) and has provided detailed criteria for both CMR and PBT thresholds. One major difference between the BPR and OPP’s registration requirements under PRIA is that the former assesses products based on hazard and the latter assesses products based on risk. 5 Hazard versus risk Canada’s Center for Occupational Health and Safety defines Hazard as “any source of potential damage, harm or adverse health effects on something or someone under certain conditions ….” Risk is a function of hazard x exposure. For example, sulfuric acid is a hazardous chemical. If you pour 2 N sulfuric acid onto your hand, it will do a very nice job of dissolving the tissue. However, if you avoid direct exposure to the acid, the risk is negligible. In mathematical terms: R = H x E (1) In the case of our example: Where R is risk, H is hazard and E is exposure. If you are not exposed to sulfuric acid, R = 0. If you are exposed, R = 1.0 (or 100 %; i. e.: no individual on whom 2 N sulfuric acid is poured will escape harm). Thus, regardless of the value of H, if E = 0, then R = 0. When hazard is the basis for product acceptability evaluations, then R & E become moot. 6 Hazard-based risk assessment implications The BPR can disqualify active substances/ products based on hazard-based exclusion criteria. If a biocidal active substance/ product has certain properties, it will not receive BPR registration. For example, products that contain ≥ 0.1 % chemicals that are classified as category 1A (known to cause heritable mutations based on clinical or epidemiological studies) or 1B (regarded as though they cause heritable mutations, based on in vivo studies) carcinogen/ mutagens or ≥ 0.3 % chemicals that are reprotoxic, will likely be denied registration. Similarly, chemicals known to be endocrine disruptors, PBT or vPvB (very persistent, very bioaccumulative or both) are normally excluded from registration. BPR article 5 paragraph 2 provides for certain exemptions to these restrictions. Table 2 summarizes the persistence threshold levels in different environments. Note that these criteria are based on data generated by standard test methods. Tribologie + Schmierungstechnik 64. Jahrgang 3/ 2017 45 Table 2: Persistence criteria for BPR hazard-based exclusionEnvironment T ½max (days) Marine Sediments 180 Fresh Water & Estuarine Sediments 120 Soil 120 Marine Water 60 Fresh Water 40 T+S_3_17 03.04.17 15: 13 Seite 45 Aus der Praxis für die Praxis The criterion for product exclusion based on bioaccumulative properties is if its bioconcentration factor (BCF) is >2,000, where: BCF = mg kg -1org ÷ mg L -1water (2) and mg kg -1org is the substance’s concentration in the test organism (fish) and mg L -1water is its concentration in the surrounding water. The exclusion criteria for toxicity are summarized in Table 3. Unlike the finite criteria provided for persistence and bioaccumulation, the list for toxicity includes a vague qualifier: “other evidence of chronic toxicity.” Presumably, entities performing biocidal product risk assessments can decide to exclude a product based on any evidence of chronic toxicity. According to BPR (Article 3), a biocidal product is: “Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.” Before defining treated products, let us deconstruct this definition. Any substance or mixture: what is a MWF concentrate, if not a mixture? “…in the form in which it is supplied to the user,”: presumably this differentiates supplied forms from those created by the user. “…containing or generating one or more active substances,”: the implication here is that if two or more components of your MWF formulation individually have no antimicrobial activity, but in the formulation do, your MWF could be a biocidal product. “…with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism”: the phrase “otherwise exerting a controlling effect” can be open to broad interpretation. It calls to mind a sign posted throughout the San Diego Zoo: “Please do not annoy, torment, pester, plague, worry, badger, harry, harass, heckle, persecute, irk, vex, disquiet, grate, beset, bother, tease, nettle, tantalize, or ruffle the animals.” This kind of broad statement leaves the reader wondering: “what’s left? ” Well, BPR as an answer. As amplification to the basic definition of a biocidal product, BPR offers: “Any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.” This definition can be interpreted to mean that regardless of whether you had any intention of formulating a MWF that could be construed as a biocidal product as defined by the first paragraph of BPR, Article 3, it is likely to be trapped by the broad net cast by the second paragraph. Just in case these two paragraphs, combined, don’t exert a sufficiently chilling effect on the MWF industry, BPR considers Treated Articles: “ ‘Treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. It shall be noted that a treated article that has a primary biocidal function shall be considered a biocidal product.” 46 Tribologie + Schmierungstechnik 64. Jahrgang 3/ 2017 Table 3: Toxicity criteria for BPR hazard-based exclusion Parameter Criterion NOEC a <0.01 mg L -1 Carcinogen Category 1A or 1B Mutagen Category 1A or 1B Reprotoxin Category 1A, 1B or 2 Fresh Water 40 days Note: a) NOEC - no observable effect concentration; threshold is the same for marine and freshwater organisms. 7 Critical BPR language As mentioned above, under the BPR, biocidal products are classified as Product Types within four Main Groups: • Main Group 1: Disinfectants (Product Types 1 through 5) • Main Group 2: Preservatives (Product Types 6 through 13) • Main Group 3: Pest Control (Product Types 14 through 20) • Main group 4: Other Biocidal Products (Product Types 21 and 22). Microbicides used in MWF are within Product Type 13: Working or cutting fluid preservatives: “Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.” Notwithstanding the introductory definition of a biocide provided in the introduction to this paper, the BPR has very detailed and specific definition for biocidal products and for treated articles. T+S_3_17 03.04.17 15: 13 Seite 46 Aus der Praxis für die Praxis A MWF compounder is again left wondering what is left? It might be comforting (or not) to learn that the decision of whether to classify microbicide-containing products - whose primary function is metalworking; not biocidal performance - is left up to the individual EU member nations. 8 BPR implications for the MWF industry Only time will tell how BPR will impact MWF formulation specifically and the metalworking industry in general. The most benign impact will be the proliferation of ignored warnings on labels. Returning to the sulfuric acid example above, few companies who use sulfuric acid switched to alternative strong acids after the skull and crossbones and partially dissolved hand labels started showing up on containers. If MWF are consistently classified as treated products, the additional labeling requirements might have no measurable effects on product usage. It remains to be seen what impact BPR will have on the replacement of microbicides with so-called bioresistant additives. For example, will bioresistant products be scrutinized for otherwise exerting a controlling effect on, any harmful organism? If they are, will this inhibit industry’s search for bioresistant alternatives to biocidal additives? How will companies who market their products in the EU and US harmonize their product lines? Presently, only approximately one-third of products registered as microbicides for use in MWF in the US are also listed in BPR Annex I. Presumably, international companies will harmonize their product lines so that they include only biocides that are approved for use in both the EU and the US. Hopefully, other countries will harmonize their regulations with either BPR or the US pesticide regulations. Beyond the regulatory and commercial issues that remain to be sorted out as biocide manufacturers, MWF compounders and end-users work through BPR implementation, there is the potential impact on MWF. Prior to the mid-1980’s, operators routinely discarded and replaced used MWF at 8 to 12 week intervals. As one plant manager observed, he never had a microbial contamination problem until he started to do microbiological condition monitoring. He simply dumped his systems each time the odor became so noxious that his machinists refused to enter the plant. As an industry, are we going to return to the days of frequent drain, clean and recharge events? How will this impact manufacturing costs and initiatives to reduce waste generation from industrial systems? Although there are few reports of MWF being vectors of communicable disease, the literature on the relationship between MWF microbial contamination, bioaerosols and respiratory disease is substantial. In particular, endotoxins - lipopolysaccharide molecules associated with the cell wall of Gram-negative bacteria - are well known to cause dose-related respiratory disease. Among allergic individuals, at low concentrations (10μg m -3 to 100 μg m -3 ) endotoxin exposure causes symptoms ranging from mild eye irritation to allergic rhinitis. At moderate concentrations (100μg m -3 to 1,000 μg m -3 ), endotoxin causes symptoms ranging from allergic rhinitis to asthma. At concentrations >10,000μg m -3 , endotoxin can cause fatal toxic shock syndrome. It has been demonstrated that aldehydes, such as formaldehyde-condensate microbicides, denature endotoxins, but non-aldehyde microbicides do not. Conflating formaldehyde-condensate biocides with formaldehyde, regulators in a number of countries have either banned or severely restricted the use of formaldehyde-condensate products. In their zeal to protect machinists from formaldehyde exposure (zero documented incidence of formaldehyde-related adverse health effects over a 60-year history of use), regulators are unintentionally creating a substantially increased risk of endotoxin exposure (hundreds of documented cases of allergic disease victims suffering symptoms ranging from eye irritation to industrial asthma). It will be interesting to see how regulators respond to the increased incidence of respiratory disease among machinists. 9 Conclusions Implementation of the EU’s Biocidal Products Regulation is already having a pronounced impact on the number of biocidal products available for use as preservatives in MWF. Biocide manufacturers have had to weigh the cost of completing the toxicological, environmental and performance tests and registering an active substance dossier (expected to average > 5million € to 12million € per product) against the MWF microbicide market opportunity estimated at 200 million €. The MWF microbicide market has always been an orphan segment - representing < 1 % of the total industrial microbicide market. Historically, few microbicides have been developed specifically for MWF treatment. Looking forward, it is unlikely that the MWF sector will receive much attention from biocide manufacturers. At this point, it is unclear whether MWF compounders - regardless of whether they include microbicides in their formulations - will have to seek BPR registration for their MWF. Assuming that BPR registration won’t be required, compounders will still have to create CLPcompliant labels and SDS and will have to comply with the Treated Articles provisions of BPR. Moreover, compounders will face greater challenges in developing MWF that provide long-term performance and protect workers from exposure to allergenic and toxic bioaerosols. Tribologie + Schmierungstechnik 64. Jahrgang 3/ 2017 47 T+S_3_17 03.04.17 15: 13 Seite 47 Aus der Praxis für die Praxis References European Chemicals Agency, Biocidal Products Regulation, 1998. Directive 98/ 8/ EC of the European Parliament and of the council of 16 February 1998 concerning the placing of biocidal products on the market (BPD). European Chemicals Agency, Biocidal Products Regulation, 2012. Regulation (EU) No 528/ 2012 of the European Parliament and of the council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR). European Parliament, 2008. Regulation (EC) No 1272/ 2008, OJ L 353 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures - amending and repealing Directive 67/ 548/ EEC and 1999/ 45/ EC, and Regulation (EC) No 1907/ 2006 (CLP Regulation). 48 Tribologie + Schmierungstechnik 64. Jahrgang 3/ 2017 expert verlag GmbH: Wankelstr. 13, 71272 Renningen Postfach 20 20, 71268 Renningen Tel. (0 71 59) 92 65 - 0, Fax (0 71 59) 92 65 -20 E-Mail expert@expertverlag.de Vereinigte Volksbank AG, Sindelfingen BIC GENODES1 BBV, IBAN DE51 6039 0000 0032 9460 07 Postbank Stuttgart BIC PBNKDEFF, IBAN DE87 6001 0070 0022 5467 07 USt.-IdNr. DE 145162062 Anzeigen: Sigrid Hackenberg, expert verlag Tel. 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