More than a regulatory pressure with associated penalties, authorisation poses a serious threat of supply disruption. For this reason, it should be seen as an issue with long-term consequences for your company�s ability to remain innovative. What is at stake is both the economic strategy of your company, and the scientific assessment of the associated health and environmental risks.
Therefore, companies using SVHCs should consider the following:
Become knowledgeable about your substance.
You must know the real risks associated with the substance and ensure that the CSR is good enough to demonstrate that risk is controlled under the authorisation process; you must be sure of authorisation�s unique necessity for your activity; revise your R&D programmes to include a possible alternatives analysis and substitution plan; and define the scope of a potentially needed economic analysis (SEA). This preliminary work will save you time, especially with long-term programmes (for example, in the aerospace, marine or train industries) for which you may have to partially rebuild knowledge. It will also help you define your authorisation strategy.
Integrate the different sections of the dossier in a strategic way.
All sections must complement each other and stick to the same objective. Authorisation differs from registration in that it must win over experts who all, more or less, agree on the fact that your substance must be banned from the market. In this sense, authorisation is more of a statement of defence than just administrative work. As much as possible, you must be clear and forceful while protecting your confidentiality, and what to say, and when to say it, should be part of your strategy. Finally, each authorisation is specific to a company, or under certain circumstances, to a group of companies. Therefore, grouping ought to be a major part of your strategic reflection.
Organise early.
Experience shows that many people, perhaps working from different offices with different business cultures, will be involved in the process. Tasks and documentation should be attributed to all stakeholders as early as possible, and a lead team should coordinate the entire process.
Remember that working on your authorisation strategy does not necessarily mean submitting an authorisation application dossier.
Alternatives and exemptions are worth considering. Deciding what should be the best risk management option (RMO), as set out in the Commission�s recent SVHC roadmap, (CW 11 February 2013) could be a useful strategy to prevent an SVHC being added to Annex XIV. The annex is not always the most appropriate way to protect health and the environment, especially when other solutions exist that do not jeopardise a company� chances of survival, and EcoMundo is trying to persuade some member states to accept that the risks associated with some SVHC uses can be adequately controlled by other means. Restriction is one possibility, but a broader discussion on whether candidate list status is the satisfactory RMO, possibly backed up by other pieces of legislation, could also be initiated.
EcoMundo strictly protects the confidentiality of its clients and hence, will not disclose any details that may affect their competitiveness, notably their names, goals and strategies. The two cases discussed below illustrate how authorisation work does not always lead to the submission of authorisation dossiers, but, rather, is a way of selecting and building a strong set of arguments through flexibility and innovation. The first deals with the exemption of monomers, the second with an exemption in the interest of defence. Both were developed in parallel with full authorisation dossiers.
MONOMER EXEMPTION
Substances used as monomers in polymers are exempt from authorisation as they are, by definition, intermediates (REACH Art2(8)b).
Although a dossier does not have to be submitted to ECHA, it is necessary to retain all information that proves the relevance of the exemption. In addition, as the context is still the authorisation of an SVHC, demonstration that risk is adequately managed is also expected. A dossier demonstrating that the substance meets the definition of a monomer, and that risks are controlled, is the best way to answer any questions from, or inspection by, a competent authority. This dossier should be scientifically rigorous, but readable and with all the evidence attached in annexes.
However, monomer uses can be very specific and hard to demonstrate. In this particular case, it was demonstrated by writing a chemical description of the complex and multistage reaction and its stoichiometry, and also by measuring the concentration of the substance at different stages of its use, such as during polymerisation, and in the final article. This helped describe the real risk: the less there is of a substance, the lower the risk.
Unlike a registration dossier for an intermediate, an application for an authorisation exemption for a monomer does not have to demonstrate that strictly controlled conditions are applied during its use. However, it would unrealistic to seek an exemption for a hazardous substance with known exposures at your site and think national authorities will allow it because you abided by what some might see as a shortfall of the REACH Regulation. You can be authorised to use your substance under REACH and still have your site closed because you did not respect local laws for the safety of workers or the surrounding environment. This may force you to revise some parts of the substance�s chemical safety report in order to refine the exposure levels that may arise at your site and the risk management measures in place. This may include risk management improvements and monitoring programs.
In a recent case in which inhalation was first identified as the concern and measures, including a dedicated depressurised room and inhalation apparatus, were introduced to protect workers from this route of exposure, a risk assessment and biomonitoring programme revealed that the dermal route was a possible exposure pathway. Additional measures, as described in the �exemption report�, were therefore put in place for reinforcing undressing procedures.
Regarding exposure via environment, classical assessment is made by considering the atmospheric, food and drinking water routes. However, in this case, we decided to assess exposure for workers on site around the dedicated room in which the SVHC is processed, as standard assessment was not relevant and the exposure was limited in terms of spatial area. The solution was thus for us to develop a specific but conservative model that could demonstrate the absence of concern.
Similarly, other authorisation dossiers or exemption from authorisation dossiers will have to use risk assessment as a basis for demonstrating adequate control of risk, but also because it is the foundation of other parts of an authorisation application, such as a comparison with substitution, or the cost/benefit analysis.
DEFENCE EXEMPTION
Article 2(3) of REACH says member states may allow for exemptions from the Regulation in specific cases for certain substances, where necessary in the interests of defence. It is one of the few provisions (Article 126 on penalties is another example) which allow member states to retain some power. An exemption can apply to any of REACH�s provisions.
The way in which defence exemption dossiers are compiled varies according to the member state. In the UK, for instance, the Ministry of Defence is responsible for issuing these exemptions, although the process is subject to scrutiny from the Health and Safety Executive. However, in France the Ministry of Ecology is an equal partner with the defence ministry (except in case of emergency). The applicable law in each Member State can be found on the European Defence Agency REACH portal.
In France, the exemption from authorisation can be compared, on many points, to a full authorisation dossier with, on the one hand, the need to focus on a few strong arguments that are mostly specific to your business and, on the other hand, possible shortcomings of the chemical safety report developed for the purpose of �simple� registration.
The line of defence should be clear: one argument completed by discussion with one or two alternatives. Again, although the documents necessary for an authorisation are well described by ECHA, they are not only a collection of data, as may be the case with registration: here, the objective is to assemble the elements into a reasoning that demonstrates the applicability of authorisation or exemption of authorisation to your substance use. This should, right from the start, be sufficiently clear and demonstrated to avoid extra requests from competent authorities and loss of precious time for your business. In our case, the core demonstration became an in-depth discussion of the technical difficulties associated with the available or in-development alternatives, and with economic figures, including the �defence cost� associated with the substitution plan.
The challenge is often first and foremost to demonstrate the time needed for technical and economic substitution. It is from there that discussions really start on the technical description of how the substance is used and what the difficulties are in finding alternatives. This, then, allows for cost/benefit values that can justify some delays in substitution.
By:
Olivier Le Curieux-Belfond, Head of Toxicology & Ecotoxicology Department, EcoMundo
Pierrick Drapeau, Authorisation Projects Manager, EcoMundo
Article published in The Molecule 8
More than a regulatory pressure with associated penalties, authorisation poses a serious threat of supply disruption. For this reason, it should be seen as an issue with long-term consequences for your company�s ability to remain innovative. What is at stake is both the economic strategy of your company, and the scientific assessment of the associated health and environmental risks.
Therefore, companies using SVHCs should consider the following:
Become knowledgeable about your substance.
You must know the real risks associated with the substance and ensure that the CSR is good enough to demonstrate that risk is controlled under the authorisation process; you must be sure of authorisation�s unique necessity for your activity; revise your R&D programmes to include a possible alternatives analysis and substitution plan; and define the scope of a potentially needed economic analysis (SEA). This preliminary work will save you time, especially with long-term programmes (for example, in the aerospace, marine or train industries) for which you may have to partially rebuild knowledge. It will also help you define your authorisation strategy.
Integrate the different sections of the dossier in a strategic way.
All sections must complement each other and stick to the same objective. Authorisation differs from registration in that it must win over experts who all, more or less, agree on the fact that your substance must be banned from the market. In this sense, authorisation is more of a statement of defence than just administrative work. As much as possible, you must be clear and forceful while protecting your confidentiality, and what to say, and when to say it, should be part of your strategy. Finally, each authorisation is specific to a company, or under certain circumstances, to a group of companies. Therefore, grouping ought to be a major part of your strategic reflection.
Organise early.
Experience shows that many people, perhaps working from different offices with different business cultures, will be involved in the process. Tasks and documentation should be attributed to all stakeholders as early as possible, and a lead team should coordinate the entire process.
Remember that working on your authorisation strategy does not necessarily mean submitting an authorisation application dossier.
Alternatives and exemptions are worth considering. Deciding what should be the best risk management option (RMO), as set out in the Commission�s recent SVHC roadmap, (CW 11 February 2013) could be a useful strategy to prevent an SVHC being added to Annex XIV. The annex is not always the most appropriate way to protect health and the environment, especially when other solutions exist that do not jeopardise a company� chances of survival, and EcoMundo is trying to persuade some member states to accept that the risks associated with some SVHC uses can be adequately controlled by other means. Restriction is one possibility, but a broader discussion on whether candidate list status is the satisfactory RMO, possibly backed up by other pieces of legislation, could also be initiated.
EcoMundo strictly protects the confidentiality of its clients and hence, will not disclose any details that may affect their competitiveness, notably their names, goals and strategies. The two cases discussed below illustrate how authorisation work does not always lead to the submission of authorisation dossiers, but, rather, is a way of selecting and building a strong set of arguments through flexibility and innovation. The first deals with the exemption of monomers, the second with an exemption in the interest of defence. Both were developed in parallel with full authorisation dossiers.
MONOMER EXEMPTION
Substances used as monomers in polymers are exempt from authorisation as they are, by definition, intermediates (REACH Art2(8)b).
Although a dossier does not have to be submitted to ECHA, it is necessary to retain all information that proves the relevance of the exemption. In addition, as the context is still the authorisation of an SVHC, demonstration that risk is adequately managed is also expected. A dossier demonstrating that the substance meets the definition of a monomer, and that risks are controlled, is the best way to answer any questions from, or inspection by, a competent authority. This dossier should be scientifically rigorous, but readable and with all the evidence attached in annexes.
However, monomer uses can be very specific and hard to demonstrate. In this particular case, it was demonstrated by writing a chemical description of the complex and multistage reaction and its stoichiometry, and also by measuring the concentration of the substance at different stages of its use, such as during polymerisation, and in the final article. This helped describe the real risk: the less there is of a substance, the lower the risk.
Unlike a registration dossier for an intermediate, an application for an authorisation exemption for a monomer does not have to demonstrate that strictly controlled conditions are applied during its use. However, it would unrealistic to seek an exemption for a hazardous substance with known exposures at your site and think national authorities will allow it because you abided by what some might see as a shortfall of the REACH Regulation. You can be authorised to use your substance under REACH and still have your site closed because you did not respect local laws for the safety of workers or the surrounding environment. This may force you to revise some parts of the substance�s chemical safety report in order to refine the exposure levels that may arise at your site and the risk management measures in place. This may include risk management improvements and monitoring programs.
In a recent case in which inhalation was first identified as the concern and measures, including a dedicated depressurised room and inhalation apparatus, were introduced to protect workers from this route of exposure, a risk assessment and biomonitoring programme revealed that the dermal route was a possible exposure pathway. Additional measures, as described in the �exemption report�, were therefore put in place for reinforcing undressing procedures.
Regarding exposure via environment, classical assessment is made by considering the atmospheric, food and drinking water routes. However, in this case, we decided to assess exposure for workers on site around the dedicated room in which the SVHC is processed, as standard assessment was not relevant and the exposure was limited in terms of spatial area. The solution was thus for us to develop a specific but conservative model that could demonstrate the absence of concern.
Similarly, other authorisation dossiers or exemption from authorisation dossiers will have to use risk assessment as a basis for demonstrating adequate control of risk, but also because it is the foundation of other parts of an authorisation application, such as a comparison with substitution, or the cost/benefit analysis.
DEFENCE EXEMPTION
Article 2(3) of REACH says member states may allow for exemptions from the Regulation in specific cases for certain substances, where necessary in the interests of defence. It is one of the few provisions (Article 126 on penalties is another example) which allow member states to retain some power. An exemption can apply to any of REACH�s provisions.
The way in which defence exemption dossiers are compiled varies according to the member state. In the UK, for instance, the Ministry of Defence is responsible for issuing these exemptions, although the process is subject to scrutiny from the Health and Safety Executive. However, in France the Ministry of Ecology is an equal partner with the defence ministry (except in case of emergency). The applicable law in each Member State can be found on the European Defence Agency REACH portal.
In France, the exemption from authorisation can be compared, on many points, to a full authorisation dossier with, on the one hand, the need to focus on a few strong arguments that are mostly specific to your business and, on the other hand, possible shortcomings of the chemical safety report developed for the purpose of �simple� registration.
The line of defence should be clear: one argument completed by discussion with one or two alternatives. Again, although the documents necessary for an authorisation are well described by ECHA, they are not only a collection of data, as may be the case with registration: here, the objective is to assemble the elements into a reasoning that demonstrates the applicability of authorisation or exemption of authorisation to your substance use. This should, right from the start, be sufficiently clear and demonstrated to avoid extra requests from competent authorities and loss of precious time for your business. In our case, the core demonstration became an in-depth discussion of the technical difficulties associated with the available or in-development alternatives, and with economic figures, including the �defence cost� associated with the substitution plan.
The challenge is often first and foremost to demonstrate the time needed for technical and economic substitution. It is from there that discussions really start on the technical description of how the substance is used and what the difficulties are in finding alternatives. This, then, allows for cost/benefit values that can justify some delays in substitution.
By:
Olivier Le Curieux-Belfond, Head of Toxicology & Ecotoxicology Department, EcoMundo
Pierrick Drapeau, Authorisation Projects Manager, EcoMundo
Article published in The Molecule 8
