Determination and communication of safe use conditions of lubricants Steven Van de Broeck svb@essenscia.be LAB/VSN 12/12/2014
Introduction Manufacturers of lubricants are formulators of mixtures according to REACh Legal obligations related to mixtures under REACh Classify, label and package mixtures Until 1/6/2015 in accordance with the Dangerous Preparations Directive (DPD 1999/45/EC) and and addition by choice in accordance with the CLP regelation before that date After 1/6/2015 in accordance with the CLP-regulation Comply with obligations relating to down stream users Use substances according the information received from suppliers Communicate up the supply chain on uses of mixtures Communicate information on the safe use of mixtures to customers 2
Introduction In general obligations already existed under previous legislation But REACh introduced the concept of extended SDS Extended SDS = SDS + exposure scenario s Exposure scenario s are the result of the chemical safety assessment that is part of the registration process of substances Exposure scenario s describe for each identified use the conditions under which a substance (as such or in a mixture) can be used safely operational conditions and risk management measures conditions related to humans and environment conditions related to workers and consumers Applying and communicating the conditions of safe use contained in exposure scenario s is a challenge! 3
FORMULATOR Dealing with extsds as a formulator general overview suppliers of ingredients extsds extsds extsds check if own use (formulation) is covered check if own use (formulation) is covered check if own use (formulation) is covered check if usemix is covered check if usemix is covered check if usemix is covered extsds extsds identify and communicate relevant safety information users of mixtures extsds own assessments 4
Checking if uses are covered Own use formulation Is formulation an identified use in the SDS of the ingredients? Do you meet the operational conditions that are mentioned in the ES related to formulation? Have you implemented the risk management measures mentioned in the ES related to formulation? Use of the product Are all intended uses of your product identified uses? Meets your product the product characteristics as mentioned in the relevant ES? Are assumed/foreseenable conditions of use of your product in line with those mentioned in the relevant ES? Zie voorbeeld. 5
Communicating information on mixtures Mixture intended for: Industrial use? Professional use? Consumer use? Industrial and/or professional uses Communication requirements depend on the properties of the mixture (see next slide) No SDS need to be provided If your mixture is classified as hazardous*: provide sufficient information for safe use (eg. via the label) consumers uses / sold into the consumer/domestic market If your mixture constains hazardous substances for which an (ext)sds is supplied : verify if the SDS of the ingredients contain information on safe use related or relevant to consumer use (eg. recommended use of PPE) Note that distributors or down stream users (eg. retailers carrying out an activitity defined as a use ) that are part of the supply chain, can request a SDS in such case same elements apply as for a SDS supplied to an industrial or professional user * According to DPD or CLP (CLP mandatory as from 1/6/2015) 6
Communicating information on mixtures industrial and/or professional uses mixture classified as hazardous*? no Mixture contains at least 1 substance above specified concentration limits and/or for which an OEL is established? yes yes Provide a SDS to your customers Provide a SDS to your customers on request SDS must be compiled in accordance to annex II of REACh In case you have received an extsds for substances contained in your mixture: include safe use info exposure scenarios several options are possible no No SDS need to be provided - Provide any information related to authorisation and restriction - Provide any information to ensure safe use - Provide registration numbers for substances subject to authorisation or restriction or for which implementation of safe use conditions are necessary * According to DPD or CLP (CLP mandatory as from 1/6/2015) 7
Options to include ESinfo in SDS mixtures Forward (relevant) ES ingredients attach ES ingredients to SDSmix option 1 (ext)sdsmix option 2 consolidation safe use information OR attach safe use info to SDSmix include safe use info in main body SDSmix option 3 MIXTURE compostion uses Intermediate / combined approaches Mixture use based approach OR SAFE USE assessment of lead / risk driving substances uses / use conditions Simple editorial approach Worst case approach (by endpoint / exposure route) Lead / critical substance approach (by endpoint / exposure route) attach safe use info to SDSmix include safe use info in main body SDSmix If safe use info is the result of an DU-CSA, it shall be annexed to the SDS And mentioned in section 15 of the SDS 8
Atiel / ATC approach for lubricants Atiel / ATC have choosen to use option 3 for lubricants, more specific the development of Generic Exposure Scenario s (GES) Why? simplify communication of safe use information to DU information on safe use in line with common conditions of use of lubricants significantly reduction of the complexity and workload for lubricants industry players to comply with REACH ES may be applied to all classified mixtures that are within the boundary of application Estimate most classified lubricants mixtures are covered information on safe use easily accessible to the customer/supplier in a familiar format 9
Atiel / ATC approach for lubricants GES developped for Human Health and environment Different approach Different way of using it Detailed guidance on how to apply the ATIEL/ATC GES Process by formulators on the ATIEL-website 0: Guidance for applying the GES Process 1: GES Process Flow Chart 2: Lubricant Applications Table 3: Lubricants DUCC Table 4: Health Boundary Conditions Matrix 5a: GES - Use Group A 5b: GES Use Groups B-F 6: Environmentally Classified Substances table 7: Environmental GES Values Table 8: Health GES Explanation of Fields 9: Environmental GES Explanation of Fields 10: Checking Environmental Conditions of Use & Scaling 11: New Standard Phrases http://www.atiel.org/reach/formulators 10
Example Finished lubricant Classified as R20 and R52/53 Used in vehicles and machinery Contains: 11
Applying the GES process 0, 2 and 3 Step 1: Allocate your product to use groups 0, 1 (flowchart 1a), 4, 5a, 5b Step 1a: define the human health contents of your product SDS 0, 1 (flowchart 1b), 5a, 5b, 6, 7 Step 1b: define the environmetal contents of your product SDS Step 2: Allocate your raw materials to use groups 0, 1 (flowchart step 2) 0, 1 (flowchart step 3) Step 3: Check raw material extsds is compatible with required uses Step 7 [Continue next slide] Refers to documents available on www.atiel.org/reach/formulators 12
Applying the GES process Step 3 Refers to documents available on www.atiel.org/reach/formulators raw material extsds is compatible RM classified for human health? RM classified for environment? yes RM not classified yes 0, 1 (flowchart step 4), 4, 8 Step 4: confirm raw material extsds is consistent with the human health GES 0, 1 (flowchart step 5), 9, 10 Step 5: confirm raw material extsds is consistent with the environmental GES incosistency detected at step 4 and 5? yes NO Process is finished Incorperate information on safe use as determined in step 1a and/or 1B into the SDS of your product and document the process Step 6 13
Applying the GES process incosistency detected at step 4 or 5 0, 1 (step 6) Step 6: explore various options to solve the issue Step 7: what to if the RM is not used as an intermediate under SCC, but this is the only identified use? 0, 1 (step 7) Refers to documents available on www.atiel.org/reach/formulators 14
Applying the GES process: step 1 and 1a 0, 2 and 3 Allocate the use of your product to a use group determine (possible) applicable GES More details: see ref doc 1 flowchart 1a If product contains substances listed in section 3 of the SDS that are classified for HH: check if SDS is consistent with risk management measures GES NOT classified for HH classify your product for human health endpoints according to DPD determine max. concentration of sensitising substances (R43) contained in your product (if relevant) classified for HH Verify if your product is within the boundaries of the GES NOT within bounderies Operational conditions and risk management measures GES can NOT be used 4 5a and 5b within bounderies Derive information on safe use from ES ingredients (especially risk determine substances) Look up operational conditions and risk management measures GES Depending on the product classification appropriate advice to be included in section 8 of the SDS 15
Applying the GES process: step 1b 6 and 7 classify your product for environmental endpoints according to DPD NOT classified for env. If product contains substances listed in section 3 of the SDS that are classified for env: check if SDS is consistent with risk management measures GES classified for env. Determine the risk determining substances and coresponding RDScode Look up GES-values 7 No RDS-code can be determined No data available or no inclusion of environmental data at all Allocate the use of your product to a use group determinate (possible) applicable GES 16
Applying the GES process: steps 4 and 5 Revised or new ext- SDS for Raw Material (RM) received by formulator Is RM ES consistent with the GES for products in which the RM is used? E.g. is the RM (as shown by its classification, DNEL, PNEC) =/less hazardous than the RDS used to construct the GES? Are OCs and RMMs in the RM ES =/less stringent than those in the GES? Max. conc. haz. subtances < conc. health boundery matrix? No Does scaling show that the product GES is applicable? E.g. concentration of RDS in the product Yes Yes No action required Current GES for product remains appropriate No Undertake a CSA for the individual mixture stringent also includes other forms of RMM and/or OC that are materially different from those contained in existing ES advice 17
Use groups ATIEL/ ATC Use Group Description of Use Sectors Covered A Formulation of lubricant additives, lubricants and greases. Includes material transfers, mixing, large and small scale packing, sampling, maintenance and associated laboratory activities. i EXAMPLE B General use of lubricants and greases in vehicles or machinery. Includes filling and draining of containers and enclosed machinery (including engines) i, p, c C Use in open systems. Application of lubricant to work pieces or equipment by dipping, brushing or spraying (without exposure to heat), e.g. mould releases, corrosion protection, slideways i, p, c D Use of lubricants in open high temperature processes, e.g. quenching fluids, glass release agents i E Handling and dilution of metalworking fluid concentrates i F Use of lubricants in high energy open processes, e.g. in high speed machinery such as metal rolling / forming or metalworking fluids for machining and grinding i, p 18
Use groups Use groups are linked to lubricant applications, taking into account typical operational conditions and applied risk mangement measures 19
Verification if substance is within bounderies Total overview in document 4: Health Boundary Conditions Matrix C&L of mixture Concentration of skin sensitisers in mixture (if relevant) 20
RDS-codes RDSs each described as a set of key properties Log Kow, vapour pressure, biodegradability and PNEC FW aqua 40 different profiles created, identified by RDS code Determined for ± 50 raw materials If not on doc 6: to be determined according to key properties RDS codes assigned according to key properties 21
RDS-codes 22
Conlusions Delivers sound, understandable advice to DUs now No need to wait until 2018 Registrations for key information Enables formulators to provide useful safe use advice in a consistent manner to their customers Constrains the length of the ext-sds to a manageable size Complements the nature of SH&E advice already being offered by lubricant suppliers e.g. technical advisory notes 23
Disclaimer Alle gegevens op dit document worden door essenscia vzw/essenscia vlaanderen met de grootste zorgvuldigheid samengesteld. Voor deze informatie worden enkel betrouwbare bronnen aangewend. Ondermeer door de snelle evolutie van de behandelde materie blijft de mogelijkheid bestaan dat de gegevens toch niet volledig accuraat zijn, daarom wijst essenscia vzw/essenscia vlaanderen elke aansprakelijkheid voor fouten of onvolkomenheden af. 24