REACH 2018 and beyond how the EU legislation is shaping the future of metalworking fluids globally

Transcription

1 REACH 2018 and beyond how the EU legislation is shaping the future of metalworking fluids globally 5 th International Conference on Metal Removal Fluids, September 27-30, 2015 Mick Wragg Agenda Impact of EU legislation on Metalworking fluid (MWF) formulators REACH CLP BPR Endocrine Disrupting Chemicals Impact of EU regulations elsewhere in world 2 1

2 REACH - Registration May 31, 2018 is the end of the 10-year transition period for phase-in substances All substances imported and/or manufactured at MT/annum/legal entity From June 1, 2018 a registration will need to be in place for any nonregistered substance before starting or continuing supply at 1 MT Higher tier testing can uncover previously unknown hazards Unclear how many substances in common use in MWFs in EU are not yet registered Registration cost per substance can be highly variable ~ 140,000 (~$158,000) for 1-10 MT or ~ 480,000 (~$540,000) for MT as worst-case scenario How many of the raw materials/products used by EU MWF formulators today will disappear? Early planning is key 3 REACH - Evaluation Two types = Dossier evaluation & Substance evaluation Known as the Community Rolling Action Plan (CoRAP) Contains numerous substances that are known to be in use by MWF formulators Published annually and schedule can change year-to-year 12-month review period Carried out by Member State Competent Authority (MSCA) based on existing information in registration dossier Several outcomes No further action needed Additional information required Harmonized classification & labeling Identification as Substance of Very High Concern (SVHC) Restriction Other regulatory action outside of REACH Early warning that substance may be undesirable or unavailable to MWF formulators in future 4 2

3 REACH - Authorization One objective of REACH is the elimination of Substances of Very High Concern (SVHCs) SVHCs possess one or more of following hazards Carcinogen, Mutagen or Toxic for Reproduction (CMR) Category 1A or 1B Persistent, Bioaccumulative and Toxic (PBT) Very Persistent and very Bioaccumulative (vpvb) Equivalent concern (e.g., Endocrine Disrupting Chemical) Identification as SVHC is primarily hazard based No consideration of exposure.but that is changing Consultation underway to add respiratory and skin sensitizers to SVHC criteria 5 REACH - Authorization List of SVHCs ( Candidate List ) updated twice each year by Commission (June and December) Currently contains 163 substances Several used in MWFs Certain substances on Candidate List are then prioritised for Authorization BUT intent is for all SVHCs to go through to Authorization at some stage REACH Annex XIV ( Authorization list ) contains the Sunset date use prohibited beyond this date unless it has been authorized 5 years (typical) from addition to Annex XIV until removal from market for non-supported uses Boric acid is a candidate for Authorization (July 2015). Growing concern about boric acid is driving a global trend towards boron-free MWFs 6 3

4 REACH - Restriction REACH Annex XVII Alternative method of controlling exposure to substances of concern No administrative cost to EU Industry Faster way of eliminating substances from EU marketplace Provides authorities with wider scope for control Imported articles containing hazardous substances (as well as those produced in EU) Use in EU manufacturing processes Substances formerly used in MWFs have already been eliminated from this application by a Restriction Short-Chain Chlorinated Paraffins (SCCPs) Pentachlorophenol Nonylphenol ethoxylate (NPEs) Just when you think you ve ducked the jab a right hook comes over the top.! 7 Monitoring substances of concern Public Activities Coordination Tool (PACT) Advance notice of the substances that are on an authority's radar Risk Management Option Analysis (RMOA) Registry of Intentions (SVHC, Harmonized Classification & Labeling, Restrictions) CoRAP list (3 year plan) Third-party online tools/databases Your suppliers Trade associations Concern that REACH activities could lead to blacklisting of substances that are only under review at this stage 8 4

5 Classification, Labelling & Packaging Regulation (CLP) UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) adopted by EU in 2008 as CLP Regulation December 1, 2010 for substances and June 1, 2015 for mixtures More severe hazard classifications are more common Revised hazard criteria Lower regulatory cut offs for certain hazard end points REACH registration testing is resulting in frequent reclassifications ingredients and products Harmonized classification and labeling can be proposed/imposed Annex VI of CLP Harmonized classification must be used from specific date Hazard classification of a substance can significantly affect its existing or future use by MWF formulators 9 Biocidal Products Regulation (BPR) Replaced Biocidal Products Directive (98/8/EU) Entered into force September 1, 2013 From September 1, 2015 active substances must be purchased from approved suppliers (Article 95 list) Biocidal products will have to be authorized.eventually Within 2 years of approval of active substance Treated articles defined Products treated with a biocide Ongoing discussion whether imported treated articles have to contain a biocide that is approved in EU 10 5

6 Product Type 13 working or cutting fluid preservatives EU formulators must use biocidal products containing approved active substances 26 active substances have been proposed for PT13 Several active substances already approved IPBC MBM MIT No new active substances to be developed due to high cost? Most of active substances for bacterial control are formaldehyde-releasing biocides (11/18) Harmonized classification proposal for three formaldehyde-releasing biocides Carcinogen Category 1B and Mutagen Category 2 (among other hazards) All formaldehyde-releasers will inevitably be classified in same way Automatic candidates for substitution and elimination unless risk can be controlled Probable classification of all formaldehyde-releasing biocides as Carcinogen Category 1B is driving trend towards more bio-stable metalworking fluids 11 Endocrine Disrupting Chemicals (EDCs) Significant debate underway in EU Complementary to work underway in USA and Canada on EDCs EDC criteria for Pesticides and Biocides required by Dec but still not developed EU consultation has finished 29,000 comments received Industry seeking a satisfactory definition of EDC and hazard criteria Clear association between activity and adverse effects on an organism or ecosystem Screening study on ~700 substances is underway/planned Pesticide active ingredients Biocide active ingredients REACH registered substances Will this create another blacklist of undesirable substances that MWF formulators will want to avoid? 12 6

7 Impact of EU legislation elsewhere New toxicology data is resulting in revised hazard classifications Can apply globally unless alternative information exists UN global list of harmonized classification and labeling being developed China is considering a REACH-like initiative Gathering data on existing substances and assessing their risk Korean regulatory scheme is very REACH-like Known as K-REACH First Priority Substance list influenced by CLP Annex VI hazard classifications? Turkey will implement their own version of EU REACH shortly Scandinavian missionaries are spreading the word in developing countries Will TSCA Reauthorization result in chemical control in USA becoming more REACH-like? 13 Summary A challenging, complicated regulatory landscape exists in EU. Downstream legislation in EU is affecting the use of certain substances in MWFs. The chemicals management policy of individual companies will reduce the choice of substances available to the MWF formulator. New toxicology data is revealing previously unknown hazards. EU regulations and decisions taken by EU regulators are having a global impact on MWF formulators. As EU regulations increase their REACH it is becoming more and more challenging to assure the global sustainability of certain legacy MWF chemistry 14 7

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