Sean Milmo, European Correspondent 01.15.13
The European Union’s controversial REACH legislation on the safety of chemicals has been challenging chemical producers and their raw material suppliers since it came into effect five years ago.
Initially the major concern was that REACH—the registration, evaluation and authorisation of chemicals—would lead to market withdrawals of key chemicals for some coatings producers because of the cost of gathering safety data for their registration.
The final number of chemicals being taken off the market may not be clear until after 2018 when the registration process under REACH, which is being done in three phases, is due to be completed.
Now coatings formulators and their downstream users are having to deal with an even bigger anxiety under REACH – the requirement to communicate down the supply chain as precisely and comprehensively as possible all relevant safety data on registered chemicals in formulations.
The main vehicle for conveying the safety information to users will be through expanded safety data sheets (SDS). These will include ‘exposure scenarios’ describing how a substance or mixture of chemicals may be safely handled to ensure that exposure to them does not adversely affect human health and the environment.
Over 30,000 chemicals – a large proportion of them used in coatings – will have to be registered with safety profiles under REACH with some of the most hazardous being subject to special authorization. The obligation for downstream communication should result in Europe having one of the world’s best informed coatings markets on the safety of its chemicals.
It will be a massive and complex task, as was made clear at a workshop in November on the issue at the headquarters in Helsinki, Finland, of the European Chemicals Agency (ECHA), which is responsible for administering REACH.
“Full implementation (of the requirements for exposure scenarios) will take time,” said Sophie Mathieu, an environment issue manager, at the meeting where she spoke on behalf of the Downstream Users of Chemicals Co-ordination Group (DUCC), which represents the coatings and other downstream sectors.
A major difficulty with the drawing-up of exposure scenarios for the coatings sector is that the safety data in REACH registrations refers only to individual substances and not to mixtures of two or more chemicals as in dispersions, pigment preparations and other types of coatings formulations.
Although the REACH regulation stresses that formulators must pass on to downstream users information about individual substances through exposure scenarios it does not give much detail about how this should be done with mixtures.
The regulation merely states that with substances on their own or in mixtures recommended risk management or control measures “should systematically be conveyed through supply chains to prevent adverse effects” on human health or the environment.
“The legal text does not prescribe how to transmit exposure scenario information for substances in mixtures,” said Mathieu. It does not stipulate, for example, whether the information should be added as an annex to the SDS or integrated into the body of the text.
In a draft version of the REACH regulation there was a requirement for safety assessment of preparations or mixtures. But EU government representatives decided to delete it on the grounds that scientific methodologies for assessing combinations of chemicals were still under development.
Another source of confusion is that REACH is not the only piece of EU legislation demanding that safety information be disseminated down the supply chain.
Eva Lechtenberg-Auffarth of the hazardous substances management unit of the German Federal Institute for Occupational Safety and Health (BAuA), pointed out that a professional coatings applicator, for example, has also to take precautions under occupational health and safety (OSH), environmental and product specific regulations. “REACH applies without prejudice of (existing) OSH and environmental legislation,” she told the meeting.
She also highlighted the dangers of inconsistent safety information being sent through to end-users mainly because of lack of knowledge about downstream working conditions. Chemical producers cannot properly assess the behaviour of their substances in ‘real’ mixtures because they do not know what the other mixtures are nor do they have detailed information on how they are used.
Despite knowing about the performance of their mixtures and typical application methods, formulators are often not aware of specific on-site conditions, she said.
Another dilemma discussed at the Helsinki meeting was the different information needs of different operators in the chain. A coatings producer will, for example, want detailed data about substances and risk management measures from upstream dispersion suppliers. But an end-user will desire from a coatings manufacturer concise, understandable and more risk management-focused information.
Anita Hillmer, a REACH specialist at the car manufacturer Volkswagen AG, complained that extended SDSs are already becoming too complex and too long because of large quantities of superfluous information.
The European coatings sector, through its Brussels-based trade association CEPE, has been working on a more practical and simplified approach to exposure scenarios.
Sets of standardized exposure scenarios with the focus on what amounts to safe use in generic conditions were an option, Thomas May of DuPont Performance Coatings, Wuppertal, Germany, and a CEPE representative, told the workshop.
He gave as an example a car refinish bodyshop using 300 products from multiple suppliers with users mixing up to 10,000 color shades. “All products are used under similar operational conditions and users will probably not vary (them) and the risk management measures from product to product,”May said.
Jon Birger Aarnes of Jotun, Norway, outlined a CEPE case study on a mixture exposure scenario for a protective coating based on information on all “critical” substances in the formulation. Critical substances are defined as those “that determine the risk for one or more adverse effects via one or more exposure pathways,” such as dermal contact or inhalation.
Such an exposure scenario can be used for approximately 30 similar products, Birger Aarnes said. Among its advantages was its user friendliness and that it could be fitted on a single page in a SDS while a disadvantage was that, since it was based on dominant substances, the whole mixture was not assessed.
ECHA is now working on a guidance on exposure scenario information for mixtures, based to a certain extent on the discussions in the workshop. Bridget Ginnity of the agency’s risk management identification unit indicated that the key guidelines in the document would include the use as far as possible of standardized methods and that information could be communicated in “several ways.”
But she warned that exposure scenario information would have to be updated as new data relating to risk management measures and hazards became available.
With research on the safety risks of mixtures still at a relatively early stage, the European coatings sector faces the prospect of having to update continually information in exposure scenarios in SDSs. It is hoping that this need for regular revisions will be met through the introduction of software enabling the job to be done automatically.
Initially the major concern was that REACH—the registration, evaluation and authorisation of chemicals—would lead to market withdrawals of key chemicals for some coatings producers because of the cost of gathering safety data for their registration.
The final number of chemicals being taken off the market may not be clear until after 2018 when the registration process under REACH, which is being done in three phases, is due to be completed.
Now coatings formulators and their downstream users are having to deal with an even bigger anxiety under REACH – the requirement to communicate down the supply chain as precisely and comprehensively as possible all relevant safety data on registered chemicals in formulations.
The main vehicle for conveying the safety information to users will be through expanded safety data sheets (SDS). These will include ‘exposure scenarios’ describing how a substance or mixture of chemicals may be safely handled to ensure that exposure to them does not adversely affect human health and the environment.
Over 30,000 chemicals – a large proportion of them used in coatings – will have to be registered with safety profiles under REACH with some of the most hazardous being subject to special authorization. The obligation for downstream communication should result in Europe having one of the world’s best informed coatings markets on the safety of its chemicals.
It will be a massive and complex task, as was made clear at a workshop in November on the issue at the headquarters in Helsinki, Finland, of the European Chemicals Agency (ECHA), which is responsible for administering REACH.
“Full implementation (of the requirements for exposure scenarios) will take time,” said Sophie Mathieu, an environment issue manager, at the meeting where she spoke on behalf of the Downstream Users of Chemicals Co-ordination Group (DUCC), which represents the coatings and other downstream sectors.
A major difficulty with the drawing-up of exposure scenarios for the coatings sector is that the safety data in REACH registrations refers only to individual substances and not to mixtures of two or more chemicals as in dispersions, pigment preparations and other types of coatings formulations.
Although the REACH regulation stresses that formulators must pass on to downstream users information about individual substances through exposure scenarios it does not give much detail about how this should be done with mixtures.
The regulation merely states that with substances on their own or in mixtures recommended risk management or control measures “should systematically be conveyed through supply chains to prevent adverse effects” on human health or the environment.
“The legal text does not prescribe how to transmit exposure scenario information for substances in mixtures,” said Mathieu. It does not stipulate, for example, whether the information should be added as an annex to the SDS or integrated into the body of the text.
In a draft version of the REACH regulation there was a requirement for safety assessment of preparations or mixtures. But EU government representatives decided to delete it on the grounds that scientific methodologies for assessing combinations of chemicals were still under development.
Another source of confusion is that REACH is not the only piece of EU legislation demanding that safety information be disseminated down the supply chain.
Eva Lechtenberg-Auffarth of the hazardous substances management unit of the German Federal Institute for Occupational Safety and Health (BAuA), pointed out that a professional coatings applicator, for example, has also to take precautions under occupational health and safety (OSH), environmental and product specific regulations. “REACH applies without prejudice of (existing) OSH and environmental legislation,” she told the meeting.
She also highlighted the dangers of inconsistent safety information being sent through to end-users mainly because of lack of knowledge about downstream working conditions. Chemical producers cannot properly assess the behaviour of their substances in ‘real’ mixtures because they do not know what the other mixtures are nor do they have detailed information on how they are used.
Despite knowing about the performance of their mixtures and typical application methods, formulators are often not aware of specific on-site conditions, she said.
Another dilemma discussed at the Helsinki meeting was the different information needs of different operators in the chain. A coatings producer will, for example, want detailed data about substances and risk management measures from upstream dispersion suppliers. But an end-user will desire from a coatings manufacturer concise, understandable and more risk management-focused information.
Anita Hillmer, a REACH specialist at the car manufacturer Volkswagen AG, complained that extended SDSs are already becoming too complex and too long because of large quantities of superfluous information.
The European coatings sector, through its Brussels-based trade association CEPE, has been working on a more practical and simplified approach to exposure scenarios.
Sets of standardized exposure scenarios with the focus on what amounts to safe use in generic conditions were an option, Thomas May of DuPont Performance Coatings, Wuppertal, Germany, and a CEPE representative, told the workshop.
He gave as an example a car refinish bodyshop using 300 products from multiple suppliers with users mixing up to 10,000 color shades. “All products are used under similar operational conditions and users will probably not vary (them) and the risk management measures from product to product,”May said.
Jon Birger Aarnes of Jotun, Norway, outlined a CEPE case study on a mixture exposure scenario for a protective coating based on information on all “critical” substances in the formulation. Critical substances are defined as those “that determine the risk for one or more adverse effects via one or more exposure pathways,” such as dermal contact or inhalation.
Such an exposure scenario can be used for approximately 30 similar products, Birger Aarnes said. Among its advantages was its user friendliness and that it could be fitted on a single page in a SDS while a disadvantage was that, since it was based on dominant substances, the whole mixture was not assessed.
ECHA is now working on a guidance on exposure scenario information for mixtures, based to a certain extent on the discussions in the workshop. Bridget Ginnity of the agency’s risk management identification unit indicated that the key guidelines in the document would include the use as far as possible of standardized methods and that information could be communicated in “several ways.”
But she warned that exposure scenario information would have to be updated as new data relating to risk management measures and hazards became available.
With research on the safety risks of mixtures still at a relatively early stage, the European coatings sector faces the prospect of having to update continually information in exposure scenarios in SDSs. It is hoping that this need for regular revisions will be met through the introduction of software enabling the job to be done automatically.
