April 2002.
New Strategy for Future EU Chemical PolicyEURATEX StatementFinal
WHITE PAPER
FOR A FUTURE EU CHEMICALS POLICY
- Statement -
In the field of European environment policy, EURATEX is closely following the development of the White Paper "Strategy for Future EU Chemical Policy". The White Paper represents an important step towards the protection of the environment and health. It addresses the issues of concern already identified by the textile sector as a downstream user and takes the risk as basis for chemical regulation rather than hazard alone.
Accordingly, EURATEX recognises the need for a new Community system for the management of chemicals but unfortunately, these positive elements do not remove our industry's core concerns.
The textile and clothing industry is an important downstream user of chemical products. It requires a wide variety of dyestuffs and pigments, lubricating agents and oils, solvents and other substances. Best use of these products enables the industry to continue to compete effectively against growing competition from Asia. As a result we attach particular importance to those aspects of the White Paper which relate to these areas.
Requirements of the White Paper
The White Paper for a future policy on chemicals establishes that the volume-related notification system for new substances led to a considerable build-up of data about these substances but the level of knowledge about existing substances remains extremely low. For this reason, it is a challenge to set up a system that guarantees the storage of sufficient information accessible to the public and a corresponding risk management for a large number of existing substances.
The White Paper proposes that every manufacturer or importer of chemicals (substances & preparations) must register all chemicals of more than one tonne per year. This applies to all chemical substances, regardless of whether or not they are constituent of a formulation, and includes natural and complex substances. The proposal according to the White Paper also covers the entire life cycle of chemicals, right through to its disposal stage.
The White Paper also refers to substances in products. Substances used and placed on the market as constituents of products i.e. textiles, other than preparations are exempted under the current notification system. Products where the whole manufacturing process has been carried out outside the EU may contain untested and unregistered substances. Substances in products, which may be released during use and disposal in significant amounts causing human and environmental exposure, according to the White Paper cannot be neglected.
Costs of the European action
A cost appraisal has been carried out further to the White Paper for a future EU policy on chemicals. Above all, attention is drawn to the difficulties involved in being able to assess the costs for this action at all. Nevertheless, figures are set out. The Commission assesses the auditing costs for old substances at around € 2,100 million (2.1 billion) for industry alone over the next 11 years.
The industry is unable to agree with these estimates. According to a statement made by European companies that manufacture organic dyes and pigments, the audit costs for this sector alone will be € 1,000 million (1 billion). The latter underlines that about 2000 -2500 existing colorants and about the same number of intermediates mainly used for colorants will be affected according to a survey made by ETAD .
We should also note that the base set testing cost for a new dyestuff according to the 7th amendment is equivalent to 1.25 year's turnover in the EU on average . The same would inevitably apply to low volume existing dyes under the proposed framework.
According to ETAD the additional cost burden would be hard to recover for the majority of products in the range of 10 to 100 t/a. This additional exorbitant financial burden on European companies that manufacture organic dyes and pigments as suppliers to the textile industry, will lead to the phasing out of a large number of substances and preparations. For the remaining substances and preparations, the costs will be passed on to the users in addition to the necessity to reformulate speciality products from more limited choices of dyes with some effects which no longer can be achieved. Moreover, the textile industry's use of chemicals is not simply limited to dyestuffs. Hence, the overall impact is even greater.
Consternation of the European Textile Industry
The European textile industry, in particular the textile finishing industry, is largely dependent on the use of special chemical products that are predominantly marketed by European manufacturers. These products can be divided into the following main groups:
1. Organic dyes and pigments
2. Optical bleaches (fluorescent whitening agents)
3. Textile auxiliaries etc. i.e. Pre-treatment, Dyeing, Printing, Finishing, Laminating
Apart from the necessary base chemicals such as salts, organic and inorganic acids or alkaline solutions, all other processing materials for textile finishing are in the broadest sense preparations that consist of 2 or more components. As described above, this means that the individual active substances of a preparation are subject to the extensive process for defining environmental relevance, as well as auxiliary products, which have become a constituent part of the preparation by way of the synthesis of the individual components. For these reasons, it is not possible to rule out that a large number of tests may be necessary in order to achieve approval or registration of a preparation for an actual application.
Consequences for the European Textile Industry
The unwarranted expenditure in the eyes of the European textile industry as a "downstream user" could result in specific finishing processes being given up and, consequently, specific performances no longer being provided or only provided to a limited extent.
If manufacturers of special chemical products for the textile industry see the market chances for their products endangered by testing procedures that cannot be paid for, they will have to cease production in Europe. This applies equally to organic dyes, pigments and the large number of application products. Even companies in the middle-of-the-range chemical industry that purchase base and intermediate products from all over Europe as a basis for the production of special products would be affected.
If suppliers were to cease production for the aforementioned economic reasons, this would lead to a very large restriction in the choice of products for the European textile industry. This in turn impacts on the competitiveness of the textile and clothing industry in general by pushing the prices for the remaining used substances and preparation sky high (cost for compliance + supply and demand). The formation of consortia of producers for product testing can enhance this effect. Agreements can be made, leading to the creation of a monopolistic situation. The latter will be detrimental to downstream users in general and in particular sectors, which are dominated by SME's.
Given that the textile and clothing industry is largely dominated by SME's (95%) which, by their nature are less equipped to face such burdens, would lead to some closures. For the remaining larger companies, emerging markets may sound a better and economically viable environment. Needless to mention the social consequences, the cost effect on the price of the final products and competitiveness in the world markets.
Equally important, the current system effectively excludes substances used and placed on the market as constituents of products other than preparations i.e. textiles. So far the task was left to other legislative instruments such as the Marketing and Use and General Product Safety Directives.
Moreover, in the EU a large percentage of substances included in textiles are covered as they are marketed either as such or as components of preparations before being included into articles (notification requirements).
However, articles where the manufacturing process has been carried out outside the EU contain to a large extent untested and unregistered substances. Although the Marketing and Use and General Product Safety Directive's, among others, primary objective is to ban and/or restrict the placing on the market of products containing harmful substances whether they are imported or produced within the Community, these instruments, arguably show their limits in addressing the safety of imports.
We should also point out that the aim of the proposal is to revise the current legislative framework on chemicals in order to provide a high level of protection for human health and the environment. This includes the concept of reversal of burden of proof. Although we agree that this is an important step in the protection for the environment and health and recognise the need of a new Community system for the management of chemicals, we equally stress that the scope and the boundaries of the future legislation must be clear and well defined and no space must be left for different interpretations. Consequently, the use of the term "product" must be put in its context.
"Product" is a generic term, applicable to substances, preparations and articles. Directive 67/548/EEC on Dangerous Substances provide in Article 2 a definition of "substances" and "preparations" but does not contain a definition of "articles". We therefore suggest the following definition, which is consistent with the definition of the Chemical Acts of Australia and Germany.
Definition:
An "article" is an item, which during manufacture has been given a specific shape, surface or form which determine its function to a greater degree than does its chemical composition. Examples of articles include batteries, brake linings, chips, fabrics, filaments, films, flares, glasswool, leather, paper, pencils, rock wool, chromatographic supports and yarns.
Given that:
- The present system covers a large percentage of substances included in textile articles as they are marketed either as such or as components of preparations.
- The proposed new chemical strategy will cover all substances produced or imported either as such or as components of preparations and their inclusion in articles via the risk assessment required at registration and where appropriate via authorisation.
- The "acquis communautaire" in the area of articles/products is already impressive and existing legislation must be carefully considered,
it must be made clear that the concerns are about substances and not articles. Therefore, the question must be asked whether it is necessary to regulate articles within the proposed framework.
Articles where manufacturing process has been carried out outside the EU, which may contain untested and unregistered substances, will necessitate measures to be taken within the proposed framework to ensure their compliance with the REACH system.
Reference can be made to the outcome of the working group "substances in products" in which a general duty requirement resembling that of General Product Safety Directive has been proposed. The latter symbolises an important step toward addressing the challenge the issue of imported articles represents.
However, in doing so we must not brush aside the question of compliance with the requirement. Although this is the responsibility of member states, the Commission must give clear suggestions and guidelines on how it can be done i.e. random checks, fines for not complying etc.
Substances, which may be released during normal handling and use and final disposal in quantities sufficient to cause concern to human health and environment, cannot be neglected and therefore require additional action.
One should not forget that at the present time there is abundant evidence among experts that the gathering of exposure data represents a major bottleneck. There are enormous existing deficiencies in this field. The resources needed to fill the gap are vast and difficult to be made available and / or even operational. Common test procedures to derive exposure data are lacking and need to be developed, demonstrated and validated. The levels at which exposure may be considered as dangerous are also missing and need to be identified in addition to the substances that may be released and the relevant exposure situations, which may give rise to concern.
With the above in mind we believe that although human and environmental exposure cannot be neglected, the current environment in which the question can be addressed effectively is not appropriate. We should first aim at setting a more favourable environment.
Equally important, the registration phase would require data / information on the identity of the substances, its physical chemical and toxicological properties, preliminary risk assessment, intended uses and exposure. This must be provided by the chemical producer and /or importer except for the intended uses.
It is important for the textile industry as a downstream user to be involved in deciding which "intended use" should be submitted in the registration dossier to avoid that producers and importers of chemicals decide on their own. The textile industry, in previous communications, expressed its total commitment to co-operate with the producers /importers in this area. Failure to do so would lead to a situation in which producer/importer of chemicals could decide to remove some "intended uses" if they foresee that this use could create additional work and cost at the risk assessment or evaluation phase.
It is obvious that such unilateral decisions would create major problems for the textile industry as a downstream user. Industry simply does not have the human and financial resources to generate additional data and risk assessment on its own. The requirement cannot be met properly unless all manufacturers / importers and downstream users alike are involved.
It must be borne in mind that the European textile and clothing industry, which is predominately made up of SME's, currently employs around 2.2 million people in about 113.800 operating units.
These companies face increased competitive pressures from manufacturers in Asia, whose share of the EU market continues to grow in the period until the end of quantitative restrictions in 2005. Yet thanks to their innovative and creative abilities, they have also proved able to increase their own exports by 40% since 1995 in spite of a world market in which many countries choose to keep their domestic markets resolutely closed. A large part of their success is due to new products and processes, particularly in the area of technical and industrial textiles as well as fashion in all of which, Europe has a clear lead over the rest of the world.
To maintain this leadership the textile and clothing industry is largely dependent on the use of special chemical products that are predominantly marketed by European manufacturers. As a downstream user, the textile industry is vulnerable to the direct and indirect effects of the Commission's proposal.
As a result of our assessment of the impact of the proposals on our sector, EURATEX foresees substantial closures of companies, in particular SME's, accompanied with the inevitable job losses.
The closure of companies in one part of the textile industry would naturally also have effects on up and downstream stages of the textile sector. Among those affected would be companies and institutions such as manufacturers of textile machinery, chemical industry, manufacturers of functional textiles, manufacturers of heavyweight textiles, automotive engineering (road and rail vehicles, shipping and aircraft sectors and their system suppliers), structural engineering and the health service. It is not possible to even begin to estimate the expected overall negative impact on the European economy.
New Strategy for Future EU Chemical PolicyEURATEX StatementFinal
WHITE PAPER
FOR A FUTURE EU CHEMICALS POLICY
- Statement -
In the field of European environment policy, EURATEX is closely following the development of the White Paper "Strategy for Future EU Chemical Policy". The White Paper represents an important step towards the protection of the environment and health. It addresses the issues of concern already identified by the textile sector as a downstream user and takes the risk as basis for chemical regulation rather than hazard alone.
Accordingly, EURATEX recognises the need for a new Community system for the management of chemicals but unfortunately, these positive elements do not remove our industry's core concerns.
The textile and clothing industry is an important downstream user of chemical products. It requires a wide variety of dyestuffs and pigments, lubricating agents and oils, solvents and other substances. Best use of these products enables the industry to continue to compete effectively against growing competition from Asia. As a result we attach particular importance to those aspects of the White Paper which relate to these areas.
Requirements of the White Paper
The White Paper for a future policy on chemicals establishes that the volume-related notification system for new substances led to a considerable build-up of data about these substances but the level of knowledge about existing substances remains extremely low. For this reason, it is a challenge to set up a system that guarantees the storage of sufficient information accessible to the public and a corresponding risk management for a large number of existing substances.
The White Paper proposes that every manufacturer or importer of chemicals (substances & preparations) must register all chemicals of more than one tonne per year. This applies to all chemical substances, regardless of whether or not they are constituent of a formulation, and includes natural and complex substances. The proposal according to the White Paper also covers the entire life cycle of chemicals, right through to its disposal stage.
The White Paper also refers to substances in products. Substances used and placed on the market as constituents of products i.e. textiles, other than preparations are exempted under the current notification system. Products where the whole manufacturing process has been carried out outside the EU may contain untested and unregistered substances. Substances in products, which may be released during use and disposal in significant amounts causing human and environmental exposure, according to the White Paper cannot be neglected.
Costs of the European action
A cost appraisal has been carried out further to the White Paper for a future EU policy on chemicals. Above all, attention is drawn to the difficulties involved in being able to assess the costs for this action at all. Nevertheless, figures are set out. The Commission assesses the auditing costs for old substances at around € 2,100 million (2.1 billion) for industry alone over the next 11 years.
The industry is unable to agree with these estimates. According to a statement made by European companies that manufacture organic dyes and pigments, the audit costs for this sector alone will be € 1,000 million (1 billion). The latter underlines that about 2000 -2500 existing colorants and about the same number of intermediates mainly used for colorants will be affected according to a survey made by ETAD .
We should also note that the base set testing cost for a new dyestuff according to the 7th amendment is equivalent to 1.25 year's turnover in the EU on average . The same would inevitably apply to low volume existing dyes under the proposed framework.
According to ETAD the additional cost burden would be hard to recover for the majority of products in the range of 10 to 100 t/a. This additional exorbitant financial burden on European companies that manufacture organic dyes and pigments as suppliers to the textile industry, will lead to the phasing out of a large number of substances and preparations. For the remaining substances and preparations, the costs will be passed on to the users in addition to the necessity to reformulate speciality products from more limited choices of dyes with some effects which no longer can be achieved. Moreover, the textile industry's use of chemicals is not simply limited to dyestuffs. Hence, the overall impact is even greater.
Consternation of the European Textile Industry
The European textile industry, in particular the textile finishing industry, is largely dependent on the use of special chemical products that are predominantly marketed by European manufacturers. These products can be divided into the following main groups:
1. Organic dyes and pigments
2. Optical bleaches (fluorescent whitening agents)
3. Textile auxiliaries etc. i.e. Pre-treatment, Dyeing, Printing, Finishing, Laminating
Apart from the necessary base chemicals such as salts, organic and inorganic acids or alkaline solutions, all other processing materials for textile finishing are in the broadest sense preparations that consist of 2 or more components. As described above, this means that the individual active substances of a preparation are subject to the extensive process for defining environmental relevance, as well as auxiliary products, which have become a constituent part of the preparation by way of the synthesis of the individual components. For these reasons, it is not possible to rule out that a large number of tests may be necessary in order to achieve approval or registration of a preparation for an actual application.
Consequences for the European Textile Industry
The unwarranted expenditure in the eyes of the European textile industry as a "downstream user" could result in specific finishing processes being given up and, consequently, specific performances no longer being provided or only provided to a limited extent.
If manufacturers of special chemical products for the textile industry see the market chances for their products endangered by testing procedures that cannot be paid for, they will have to cease production in Europe. This applies equally to organic dyes, pigments and the large number of application products. Even companies in the middle-of-the-range chemical industry that purchase base and intermediate products from all over Europe as a basis for the production of special products would be affected.
If suppliers were to cease production for the aforementioned economic reasons, this would lead to a very large restriction in the choice of products for the European textile industry. This in turn impacts on the competitiveness of the textile and clothing industry in general by pushing the prices for the remaining used substances and preparation sky high (cost for compliance + supply and demand). The formation of consortia of producers for product testing can enhance this effect. Agreements can be made, leading to the creation of a monopolistic situation. The latter will be detrimental to downstream users in general and in particular sectors, which are dominated by SME's.
Given that the textile and clothing industry is largely dominated by SME's (95%) which, by their nature are less equipped to face such burdens, would lead to some closures. For the remaining larger companies, emerging markets may sound a better and economically viable environment. Needless to mention the social consequences, the cost effect on the price of the final products and competitiveness in the world markets.
Equally important, the current system effectively excludes substances used and placed on the market as constituents of products other than preparations i.e. textiles. So far the task was left to other legislative instruments such as the Marketing and Use and General Product Safety Directives.
Moreover, in the EU a large percentage of substances included in textiles are covered as they are marketed either as such or as components of preparations before being included into articles (notification requirements).
However, articles where the manufacturing process has been carried out outside the EU contain to a large extent untested and unregistered substances. Although the Marketing and Use and General Product Safety Directive's, among others, primary objective is to ban and/or restrict the placing on the market of products containing harmful substances whether they are imported or produced within the Community, these instruments, arguably show their limits in addressing the safety of imports.
We should also point out that the aim of the proposal is to revise the current legislative framework on chemicals in order to provide a high level of protection for human health and the environment. This includes the concept of reversal of burden of proof. Although we agree that this is an important step in the protection for the environment and health and recognise the need of a new Community system for the management of chemicals, we equally stress that the scope and the boundaries of the future legislation must be clear and well defined and no space must be left for different interpretations. Consequently, the use of the term "product" must be put in its context.
"Product" is a generic term, applicable to substances, preparations and articles. Directive 67/548/EEC on Dangerous Substances provide in Article 2 a definition of "substances" and "preparations" but does not contain a definition of "articles". We therefore suggest the following definition, which is consistent with the definition of the Chemical Acts of Australia and Germany.
Definition:
An "article" is an item, which during manufacture has been given a specific shape, surface or form which determine its function to a greater degree than does its chemical composition. Examples of articles include batteries, brake linings, chips, fabrics, filaments, films, flares, glasswool, leather, paper, pencils, rock wool, chromatographic supports and yarns.
Given that:
- The present system covers a large percentage of substances included in textile articles as they are marketed either as such or as components of preparations.
- The proposed new chemical strategy will cover all substances produced or imported either as such or as components of preparations and their inclusion in articles via the risk assessment required at registration and where appropriate via authorisation.
- The "acquis communautaire" in the area of articles/products is already impressive and existing legislation must be carefully considered,
it must be made clear that the concerns are about substances and not articles. Therefore, the question must be asked whether it is necessary to regulate articles within the proposed framework.
Articles where manufacturing process has been carried out outside the EU, which may contain untested and unregistered substances, will necessitate measures to be taken within the proposed framework to ensure their compliance with the REACH system.
Reference can be made to the outcome of the working group "substances in products" in which a general duty requirement resembling that of General Product Safety Directive has been proposed. The latter symbolises an important step toward addressing the challenge the issue of imported articles represents.
However, in doing so we must not brush aside the question of compliance with the requirement. Although this is the responsibility of member states, the Commission must give clear suggestions and guidelines on how it can be done i.e. random checks, fines for not complying etc.
Substances, which may be released during normal handling and use and final disposal in quantities sufficient to cause concern to human health and environment, cannot be neglected and therefore require additional action.
One should not forget that at the present time there is abundant evidence among experts that the gathering of exposure data represents a major bottleneck. There are enormous existing deficiencies in this field. The resources needed to fill the gap are vast and difficult to be made available and / or even operational. Common test procedures to derive exposure data are lacking and need to be developed, demonstrated and validated. The levels at which exposure may be considered as dangerous are also missing and need to be identified in addition to the substances that may be released and the relevant exposure situations, which may give rise to concern.
With the above in mind we believe that although human and environmental exposure cannot be neglected, the current environment in which the question can be addressed effectively is not appropriate. We should first aim at setting a more favourable environment.
Equally important, the registration phase would require data / information on the identity of the substances, its physical chemical and toxicological properties, preliminary risk assessment, intended uses and exposure. This must be provided by the chemical producer and /or importer except for the intended uses.
It is important for the textile industry as a downstream user to be involved in deciding which "intended use" should be submitted in the registration dossier to avoid that producers and importers of chemicals decide on their own. The textile industry, in previous communications, expressed its total commitment to co-operate with the producers /importers in this area. Failure to do so would lead to a situation in which producer/importer of chemicals could decide to remove some "intended uses" if they foresee that this use could create additional work and cost at the risk assessment or evaluation phase.
It is obvious that such unilateral decisions would create major problems for the textile industry as a downstream user. Industry simply does not have the human and financial resources to generate additional data and risk assessment on its own. The requirement cannot be met properly unless all manufacturers / importers and downstream users alike are involved.
It must be borne in mind that the European textile and clothing industry, which is predominately made up of SME's, currently employs around 2.2 million people in about 113.800 operating units.
These companies face increased competitive pressures from manufacturers in Asia, whose share of the EU market continues to grow in the period until the end of quantitative restrictions in 2005. Yet thanks to their innovative and creative abilities, they have also proved able to increase their own exports by 40% since 1995 in spite of a world market in which many countries choose to keep their domestic markets resolutely closed. A large part of their success is due to new products and processes, particularly in the area of technical and industrial textiles as well as fashion in all of which, Europe has a clear lead over the rest of the world.
To maintain this leadership the textile and clothing industry is largely dependent on the use of special chemical products that are predominantly marketed by European manufacturers. As a downstream user, the textile industry is vulnerable to the direct and indirect effects of the Commission's proposal.
As a result of our assessment of the impact of the proposals on our sector, EURATEX foresees substantial closures of companies, in particular SME's, accompanied with the inevitable job losses.
The closure of companies in one part of the textile industry would naturally also have effects on up and downstream stages of the textile sector. Among those affected would be companies and institutions such as manufacturers of textile machinery, chemical industry, manufacturers of functional textiles, manufacturers of heavyweight textiles, automotive engineering (road and rail vehicles, shipping and aircraft sectors and their system suppliers), structural engineering and the health service. It is not possible to even begin to estimate the expected overall negative impact on the European economy.