Sean Milmo04.03.07
The European Union's (EU) controversial scheme for the registration, evaluation and authorization of chemicals (REACH), will now start to come into effect in June this year with the prime aim of improving safeguards to human health and the environment.
However its implementation is likely also to have a major impact on relations between suppliers and customers, particularly in sectors like coatings.
The project was finally approved by EU legislators in December after eight years of discussions, during which many of its proposals were fiercely opposed by chemical producers and downstream users.
Approximately 30,000 chemicals or substances will have to be registered with safety data under the REACH scheme, of which approximately five to ten percent will have to be evaluated and, if necessary, authorized because of their potential danger. Some of the most hazardous substances will have to be replaced by safer alternatives.
REACH also gives extra legal responsibilities to manufacturers of preparations, which are defined in the legislation as being a mixture or solution of two or more substances, and of articles or finished products whose function is determined by their shape, surface and design.
Coatings supplied in tins or drums are categorized as preparations. Examples of articles would be a paint packaged as a spray and an inkjet cartridge.
As many as 10,000 chemicals are thought to be used in some way in Europe in coating formulations, even though the paint and ink segments account for only approximately six percent of EU chemical sales in volume terms.
Huge amounts of data covering areas like physicochemical properties, toxicological profiles and worker and consumer exposures will be collected for the registration of chemicals. But exactly how the work of gathering the information will be shared between chemical producers and downstream users, like paint companies, is at present unclear.
Not only will registrations of chemicals have to provide information on the safety of their physical characteristics but also of their various uses on which much of the key data is held by downstream customers.
"The legislation is vague about who in the supply chain should be responsible for putting together information for registration of uses of substances," complained one coatings company executive. "This lack of clear definition of responsibility would appear to give chemical producers the opportunity in certain circumstance to shift downstream the job of gathering data."
If REACH is to operate efficiently there will need to be a smooth exchange of information between chemical suppliers and customers. Otherwise the whole system could run into difficulties.
We are recommending that coatings companies ensure that they have a good level of co-operation with their chemical suppliers," said Jacques Warnon, technical director of the European Council of the Paint, Printing Ink and Artists' Colours Industry (Cepe). "If they don't have good communications with upstream suppliers, coatings manufacturers could find they will have problems with REACH."
For business reasons, coatings producers will want to do the registration of uses of some substances themselves. But on other occasions a switch in responsibility for the registration to the user may be triggered by the chemicals producer, which will inevitably strain supplier/customer relations.
Much of the information of registration of uses will be centerd on what is dubbed "exposure scenarios," covering aspects like production processes, exposure to humans and the environment and usage by consumers. With some coatings products containing as many as 50 different substances, the drawing-up of exposure scenarios could be a big task for paint manufacturers.
It could be a particularly heavy burden for small- and medium-sized coatings producers (SMEs), many of whom are unlikely to have the technically qualified staff to collate safety data. Instead they could have to hire at considerable expense outside specialists to do the work for them.
The position of coatings companies who buy chemicals directly from suppliers outside Europe could be especially complicated. Under the REACH legislation they will be� categorized as importers and as a result will be responsible for providing not only the data on the use of the substances but the information for their full registration.
Another difficulty for coatings companies is the prospect that relatively large numbers of chemicals may be withdrawn from the market because their producers feel that the gathering of data on their risks to human health and the environment is too costly.
Substitution of chemicals could also cause complications. For the EU legislators a key objective of REACH is the replacement of chemicals which are causing the highest concerns about their safety. "The substitution principle is clearly the cornerstone of the whole of this legislation on chemicals," said Guido Sacconi, a leading member of the European Parliament's environment committee who had a considerable influence on the final draft of the regulation.
As a result there will be considerable pressure on producers of the estimated 1,500 chemicals which are considered to be potentially the most dangerous chemicals and which are likely to go through the authorization procedure. They may be obliged to find safer alternatives.
Applicants for authorizations will have to provide a substitution plan with details of how they propose to replace the chemicals with safer alternatives.
Since producers will have to draw up a substitution plan even when they can demonstrate adequate control of individual chemicals within specific safety thresholds, the European Chemical Industry Council (Cefic) has claimed that the REACH requirements are the start of mandatory substitution.
Because of substitutions and withdrawals due to registration costs, producers of coatings and inks may no longer be able to use several hundred chemicals in their formulations, according to Cepe.
REACH aims to give chemical users plenty of time to prepare for the withdrawal of a substance due to its non-registration. After the scheme starts to be implemented in mid-2007, there will be a period of 12-18 months during which companies wishing to submit data on chemicals will have to pre-register them.
Pre-registration information will contain the name and identity code of the substance and details of a contact person, although not necessarily the name of the producer. However it will not include uses of substances.
From the point of view of coatings companies, a major drawback of the pre-registration procedure is that no details will have to be provided on what uses will be registered," explained Warnon. "So downstream users will not know from the pre-registration data whether the registration of the uses of a chemical will be covered by a supplier."
Within three and a half years of the introduction of REACH, substances which are produced or imported in amounts of 1,000 metric tons or more a year will have to be fully registered. In addition, registration will be required for all those with a tonnage of above one metric ton a year which are classified as carcinogenic, mutagenic or having reproductive toxicity (CMR) and most of those categorized as being persistent, bioaccumulative and toxic (PBT) or very persistent or very bioaccumulative (vPvB).
By June 2013, registration of chemicals in the 100-1,000 metric ton range will have to be completed and by June 2018, or 11 years after the start of the enforcement of REACH, all other chemicals above one metric ton a year.
Substances in the one to ten metric ton range, which account for two-thirds of the chemicals covered by REACH and the majority of those used in coatings formulations, will be subject to the least stringent registration rules, as long as they are not classified as CMR, PBT or vPvB substances.
With most low-volume chemicals only basic information on the identity of the manufacturer or importer, the substance itself, the method of manufacture and the substance's uses will be needed. Data will also have to be provided on a chemical's physicochemical properties, as well as all relevant and available test and toxicological information.
With substances in tonnage bands above ten metric tons, much more toxicological data and information on exposure to humans and the environment will be required. The demands for data become more onerous the higher the tonnage.
With the registration of uses of chemicals, which are reckoned to be hazardous and/or in a tonnage range of above ten metric tons, exposure scenarios will have to be drawn up with data on both risk assessments and risk management measures.
Considerable variations in data in exposure scenarios are likely even with the same substance. A single chemical can have a wide variety of uses, with each having its own risk management procedures.
Some use registrations may only necessitate the provision of a minimal amount of exposure data because the substances are applied in a closed production system, generate no discharges or emissions into the environment and are not available to consumers.
On the other hand many of the exposure scenarios will have to be highly detailed. They have to cover not only their inclusion in a finished product or article but also the whole life cycle through to the waste disposal of the article itself.
Chemical suppliers are expected to put details of the vast majority of uses in their own registrations. But in order to comply with the REACH registration rules, they will have to rely on downstream users providing adequate exposure information.
"We will work closely with our customers to generate the most accurate and complete picture possible of present uses," said Richard Punzar, head of the REACH implementation team at Ciba Speciality Chemicals, Basle, Switzerland, a supplier of pigments, photoinitiators, dispersants, biocides and other products for the coatings sector.
"In the majority of cases, we will seek to include all present and known uses of products in our registration of substances," Punzar continued. "We would expect downstream users to come back to us to make sure their usage is covered or to inform us of their need for data."
Nonetheless chemical companies have conceded that commercial considerations could determine what uses will be covered by their registrations. For the bigger customer there will be a greater certainty that its uses will be included.
However, chemicals suppliers may look less favourably on customers purchasing low volumes. SMEs buying small quantities of chemicals may find their uses being excluded from registrations by some chemical producers wishing to keep down the cost of implementing REACH. In addition, downstream operators with very specific and specialized uses may be liable to have them excluded from registrations.
Even major chemicals producers warn that in some cases they will have to weigh the cost of filling in gaps in data on uses against the commercial benefit of the business generated by them.
"With the registration of special uses, we would need to get confirmation from the customer that he will be buying the chemical from us," explained Matthias Meder, a member of the REACH implementation team at BASF. "We would take into account the commercial value in helping a customer with the registration of a specific use. That is the normal way of doing business when resources are invested in something in this way."
BASF, which despite being a coatings manufacturer itself, is one of biggest suppliers of chemicals to the European coatings sector, is expecting that it will have to register approximately 2,500 chemicals.
"We will be supporting our customers as much as possible," Meder added. "We will be in contact with them in order to discuss uses of chemicals and to help them calculate the amount of exposure data needed for registration."
For competitive reasons, such as the need to keep confidential the way a specific chemical is used in a formulation, some coatings producers may decide to register uses of substances themselves with the Helsinki-based European Chemicals Agency, which will be administering REACH. But for SMEs this could be a costly exercise, particularly if the chemicals are classified as being hazardous.
In order to help to reduce registration costs, REACH has arrangements for sharing of safety and test data. These are based on the principle of One Substance, One Registration (OSOR). Registration of single substances manufactured or imported by more than one producer or importer will have to be done jointly. Companies will have a right to opt out of the sharing of some data mainly on the grounds of confidentiality of information. The sharing of animal test data will, however, be obligatory.
The main vehicle for implementation of OSOR will be substance information exchange forums (SIEFs), whose members will share information on the same substances. In the original proposals for REACH, membership of SIEFs was going to be restricted to chemical producers and importers. But downstream users led by the Downsteam Users of Chemicals Co-ordination group (DUCC), comprising mainly representatives from the paints, detergents and cosmetics trade associations, lobbied successfully for chemical purchasers to be allowed to participate in the forums.
"Membership of SIEFs will give downstream users the opportunity to be much more deeply involved in the implementation of REACH," said a DUCC official.
With regard to exposure of workers and consumers to chemicals, coatings companies, which have already amassed a lot of data on the safety of their products will be able to bolster the effectiveness of SIEFs.
Due to the participation of downstream users, SIEFs will provide a vital link between the production of chemicals and their application. The forums will play a big role in the improvement of the flow of safety information through the supply chain, which is a major objective behind REACH.
The legislation is not only about registration, authorization and substitution of chemicals but also the dissemination of information about them so that they can be used safely.
As a result the rules on safety data sheets (SDSs), which provide summaries of information on the safe handling of chemicals as they pass along the supply chain, are being made stricter. Previously only chemical producers and importers were obliged to provide customers with an SDS on each chemical and preparation. REACH extends this obligation to downstream users.
Furthermore, the scope of the SDS is being expanded so that with hazardous substances and preparations they will also have to contain data on exposure scenarios, including waste management measures.
Since coatings are classified as preparations, REACH will extend the responsibilities of coatings producers and distributors in respect to the provision of safety information to customers. Coatings companies may have to carry out new assessments on the risks associated with their products so that they can recommend appropriate risk management actions to their customers, including consumers.
For importers of coatings chemicals and products, the distinctions between substances, preparations and various types of articles in REACH will be important. They will need to have safety data on the chemicals in paints they bring into the EU since all substances in preparations must be registered as long as they amount to one metric ton or more.
They will also require in some circumstances information on chemicals in coatings products in the form of articles or finished products. Substances exceeding the one metric ton threshold, which will be "intentionally released" from articles will have to be registered. Inks in inkjet cartridges and paints with sprays or packaging for direct application of the coating would be categorized as articles with substances for intentional release.
Exporters of coatings products to Europe will be able to collect REACH registration information themselves by using safety data from their own countries. The European Commission, the EU executive, envisages industrial associations outside Europe helping their members prepare registration dossiers.
"REACH registrations can be based on data generated in the U.S., for example, as long as it meets the quantitative and qualitative criteria in the legislation," said the DUCC official.
However the actual registration will have to be carried out by an importer or legal representative in the EU appointed by the exporting company.
Although REACH is a piece of European legislation, the largest in the history of the EU, the obligation to comply with it will extend well beyond Europe. It will inevitably have a ripple effect on the safety of chemicals in coatings across the world.
However its implementation is likely also to have a major impact on relations between suppliers and customers, particularly in sectors like coatings.
The project was finally approved by EU legislators in December after eight years of discussions, during which many of its proposals were fiercely opposed by chemical producers and downstream users.
Approximately 30,000 chemicals or substances will have to be registered with safety data under the REACH scheme, of which approximately five to ten percent will have to be evaluated and, if necessary, authorized because of their potential danger. Some of the most hazardous substances will have to be replaced by safer alternatives.
REACH also gives extra legal responsibilities to manufacturers of preparations, which are defined in the legislation as being a mixture or solution of two or more substances, and of articles or finished products whose function is determined by their shape, surface and design.
Coatings supplied in tins or drums are categorized as preparations. Examples of articles would be a paint packaged as a spray and an inkjet cartridge.
As many as 10,000 chemicals are thought to be used in some way in Europe in coating formulations, even though the paint and ink segments account for only approximately six percent of EU chemical sales in volume terms.
Huge amounts of data covering areas like physicochemical properties, toxicological profiles and worker and consumer exposures will be collected for the registration of chemicals. But exactly how the work of gathering the information will be shared between chemical producers and downstream users, like paint companies, is at present unclear.
Not only will registrations of chemicals have to provide information on the safety of their physical characteristics but also of their various uses on which much of the key data is held by downstream customers.
"The legislation is vague about who in the supply chain should be responsible for putting together information for registration of uses of substances," complained one coatings company executive. "This lack of clear definition of responsibility would appear to give chemical producers the opportunity in certain circumstance to shift downstream the job of gathering data."
If REACH is to operate efficiently there will need to be a smooth exchange of information between chemical suppliers and customers. Otherwise the whole system could run into difficulties.
We are recommending that coatings companies ensure that they have a good level of co-operation with their chemical suppliers," said Jacques Warnon, technical director of the European Council of the Paint, Printing Ink and Artists' Colours Industry (Cepe). "If they don't have good communications with upstream suppliers, coatings manufacturers could find they will have problems with REACH."
For business reasons, coatings producers will want to do the registration of uses of some substances themselves. But on other occasions a switch in responsibility for the registration to the user may be triggered by the chemicals producer, which will inevitably strain supplier/customer relations.
Much of the information of registration of uses will be centerd on what is dubbed "exposure scenarios," covering aspects like production processes, exposure to humans and the environment and usage by consumers. With some coatings products containing as many as 50 different substances, the drawing-up of exposure scenarios could be a big task for paint manufacturers.
It could be a particularly heavy burden for small- and medium-sized coatings producers (SMEs), many of whom are unlikely to have the technically qualified staff to collate safety data. Instead they could have to hire at considerable expense outside specialists to do the work for them.
The position of coatings companies who buy chemicals directly from suppliers outside Europe could be especially complicated. Under the REACH legislation they will be� categorized as importers and as a result will be responsible for providing not only the data on the use of the substances but the information for their full registration.
Another difficulty for coatings companies is the prospect that relatively large numbers of chemicals may be withdrawn from the market because their producers feel that the gathering of data on their risks to human health and the environment is too costly.
Guido Sacconi, a leading member of the European Parliament's environment committee who had a considerable influence on the final draft of the regulation. |
As a result there will be considerable pressure on producers of the estimated 1,500 chemicals which are considered to be potentially the most dangerous chemicals and which are likely to go through the authorization procedure. They may be obliged to find safer alternatives.
Applicants for authorizations will have to provide a substitution plan with details of how they propose to replace the chemicals with safer alternatives.
Since producers will have to draw up a substitution plan even when they can demonstrate adequate control of individual chemicals within specific safety thresholds, the European Chemical Industry Council (Cefic) has claimed that the REACH requirements are the start of mandatory substitution.
Because of substitutions and withdrawals due to registration costs, producers of coatings and inks may no longer be able to use several hundred chemicals in their formulations, according to Cepe.
REACH aims to give chemical users plenty of time to prepare for the withdrawal of a substance due to its non-registration. After the scheme starts to be implemented in mid-2007, there will be a period of 12-18 months during which companies wishing to submit data on chemicals will have to pre-register them.
Pre-registration information will contain the name and identity code of the substance and details of a contact person, although not necessarily the name of the producer. However it will not include uses of substances.
From the point of view of coatings companies, a major drawback of the pre-registration procedure is that no details will have to be provided on what uses will be registered," explained Warnon. "So downstream users will not know from the pre-registration data whether the registration of the uses of a chemical will be covered by a supplier."
Within three and a half years of the introduction of REACH, substances which are produced or imported in amounts of 1,000 metric tons or more a year will have to be fully registered. In addition, registration will be required for all those with a tonnage of above one metric ton a year which are classified as carcinogenic, mutagenic or having reproductive toxicity (CMR) and most of those categorized as being persistent, bioaccumulative and toxic (PBT) or very persistent or very bioaccumulative (vPvB).
By June 2013, registration of chemicals in the 100-1,000 metric ton range will have to be completed and by June 2018, or 11 years after the start of the enforcement of REACH, all other chemicals above one metric ton a year.
Substances in the one to ten metric ton range, which account for two-thirds of the chemicals covered by REACH and the majority of those used in coatings formulations, will be subject to the least stringent registration rules, as long as they are not classified as CMR, PBT or vPvB substances.
With most low-volume chemicals only basic information on the identity of the manufacturer or importer, the substance itself, the method of manufacture and the substance's uses will be needed. Data will also have to be provided on a chemical's physicochemical properties, as well as all relevant and available test and toxicological information.
With substances in tonnage bands above ten metric tons, much more toxicological data and information on exposure to humans and the environment will be required. The demands for data become more onerous the higher the tonnage.
With the registration of uses of chemicals, which are reckoned to be hazardous and/or in a tonnage range of above ten metric tons, exposure scenarios will have to be drawn up with data on both risk assessments and risk management measures.
Considerable variations in data in exposure scenarios are likely even with the same substance. A single chemical can have a wide variety of uses, with each having its own risk management procedures.
Some use registrations may only necessitate the provision of a minimal amount of exposure data because the substances are applied in a closed production system, generate no discharges or emissions into the environment and are not available to consumers.
On the other hand many of the exposure scenarios will have to be highly detailed. They have to cover not only their inclusion in a finished product or article but also the whole life cycle through to the waste disposal of the article itself.
Chemical suppliers are expected to put details of the vast majority of uses in their own registrations. But in order to comply with the REACH registration rules, they will have to rely on downstream users providing adequate exposure information.
"We will work closely with our customers to generate the most accurate and complete picture possible of present uses," said Richard Punzar, head of the REACH implementation team at Ciba Speciality Chemicals, Basle, Switzerland, a supplier of pigments, photoinitiators, dispersants, biocides and other products for the coatings sector.
"In the majority of cases, we will seek to include all present and known uses of products in our registration of substances," Punzar continued. "We would expect downstream users to come back to us to make sure their usage is covered or to inform us of their need for data."
Nonetheless chemical companies have conceded that commercial considerations could determine what uses will be covered by their registrations. For the bigger customer there will be a greater certainty that its uses will be included.
However, chemicals suppliers may look less favourably on customers purchasing low volumes. SMEs buying small quantities of chemicals may find their uses being excluded from registrations by some chemical producers wishing to keep down the cost of implementing REACH. In addition, downstream operators with very specific and specialized uses may be liable to have them excluded from registrations.
Even major chemicals producers warn that in some cases they will have to weigh the cost of filling in gaps in data on uses against the commercial benefit of the business generated by them.
"With the registration of special uses, we would need to get confirmation from the customer that he will be buying the chemical from us," explained Matthias Meder, a member of the REACH implementation team at BASF. "We would take into account the commercial value in helping a customer with the registration of a specific use. That is the normal way of doing business when resources are invested in something in this way."
BASF, which despite being a coatings manufacturer itself, is one of biggest suppliers of chemicals to the European coatings sector, is expecting that it will have to register approximately 2,500 chemicals.
"We will be supporting our customers as much as possible," Meder added. "We will be in contact with them in order to discuss uses of chemicals and to help them calculate the amount of exposure data needed for registration."
For competitive reasons, such as the need to keep confidential the way a specific chemical is used in a formulation, some coatings producers may decide to register uses of substances themselves with the Helsinki-based European Chemicals Agency, which will be administering REACH. But for SMEs this could be a costly exercise, particularly if the chemicals are classified as being hazardous.
In order to help to reduce registration costs, REACH has arrangements for sharing of safety and test data. These are based on the principle of One Substance, One Registration (OSOR). Registration of single substances manufactured or imported by more than one producer or importer will have to be done jointly. Companies will have a right to opt out of the sharing of some data mainly on the grounds of confidentiality of information. The sharing of animal test data will, however, be obligatory.
The main vehicle for implementation of OSOR will be substance information exchange forums (SIEFs), whose members will share information on the same substances. In the original proposals for REACH, membership of SIEFs was going to be restricted to chemical producers and importers. But downstream users led by the Downsteam Users of Chemicals Co-ordination group (DUCC), comprising mainly representatives from the paints, detergents and cosmetics trade associations, lobbied successfully for chemical purchasers to be allowed to participate in the forums.
"Membership of SIEFs will give downstream users the opportunity to be much more deeply involved in the implementation of REACH," said a DUCC official.
With regard to exposure of workers and consumers to chemicals, coatings companies, which have already amassed a lot of data on the safety of their products will be able to bolster the effectiveness of SIEFs.
Due to the participation of downstream users, SIEFs will provide a vital link between the production of chemicals and their application. The forums will play a big role in the improvement of the flow of safety information through the supply chain, which is a major objective behind REACH.
The legislation is not only about registration, authorization and substitution of chemicals but also the dissemination of information about them so that they can be used safely.
As a result the rules on safety data sheets (SDSs), which provide summaries of information on the safe handling of chemicals as they pass along the supply chain, are being made stricter. Previously only chemical producers and importers were obliged to provide customers with an SDS on each chemical and preparation. REACH extends this obligation to downstream users.
Furthermore, the scope of the SDS is being expanded so that with hazardous substances and preparations they will also have to contain data on exposure scenarios, including waste management measures.
Since coatings are classified as preparations, REACH will extend the responsibilities of coatings producers and distributors in respect to the provision of safety information to customers. Coatings companies may have to carry out new assessments on the risks associated with their products so that they can recommend appropriate risk management actions to their customers, including consumers.
For importers of coatings chemicals and products, the distinctions between substances, preparations and various types of articles in REACH will be important. They will need to have safety data on the chemicals in paints they bring into the EU since all substances in preparations must be registered as long as they amount to one metric ton or more.
They will also require in some circumstances information on chemicals in coatings products in the form of articles or finished products. Substances exceeding the one metric ton threshold, which will be "intentionally released" from articles will have to be registered. Inks in inkjet cartridges and paints with sprays or packaging for direct application of the coating would be categorized as articles with substances for intentional release.
Exporters of coatings products to Europe will be able to collect REACH registration information themselves by using safety data from their own countries. The European Commission, the EU executive, envisages industrial associations outside Europe helping their members prepare registration dossiers.
"REACH registrations can be based on data generated in the U.S., for example, as long as it meets the quantitative and qualitative criteria in the legislation," said the DUCC official.
However the actual registration will have to be carried out by an importer or legal representative in the EU appointed by the exporting company.
Although REACH is a piece of European legislation, the largest in the history of the EU, the obligation to comply with it will extend well beyond Europe. It will inevitably have a ripple effect on the safety of chemicals in coatings across the world.
