Tiskové zprávy
ELS-ED: REACH: Požadavky na data musí být založeny na hodnocení rizik
4. května 2005 | ELS-ED, tel: +32 228 473 61
The EPP-ED rapporteur in the European Parliament's Committee on Internal Market, Hartmut Nassauer (EPP-ED/CDU) today announced a modified approach for the registration of chemical substances within the REACH regulation. Nassauer suggests the introduction of categories for exposure and use, which are to lead to significant savings and less bureaucracy for the economy, without prejudicing safety levels of humans and the environment. Nassauer declared in Brussels:
"Since the commission published its draft regulation on 29 October 2003, there has been a need to agree on a new proposal for the use of chemical substances in the EU. Nonetheless the draft met with considerable criticism in a series of points. The criticism focuses on the commission's proposed method to register chemical substances according to the amount produced or imported.
The draft legislation will affect not only the chemicals industry and users of chemical products, but also, for example, the metal-working and car industries. Not only producers of substances are affected, but also traders, users of substances and importers, i.e. all industries, which deal in chemical substances, including large companies and small and medium-sized business.
Weak points of the Commission draft
The commission met significant criticism with its system to register substances. The commission establishes a connection between the data a user has to supply and the amount of a substance produced. The information requirements start with the production of a substance or its import and increase in levels according to production or import of 10 tons per year, 100 tons per year and 1.000 tons per year.
The crucial weakness of the commission proposal is the lack of relationship to a concrete risk. The data requirements increase when certain thresholds are crossed, without a complementary increase in the risk a substance might pose to humans or the environment.
This amount-based approach leads to unwanted results. The direct costs to supply information for a substance range from 20.000 to 400.000 Euro depending on data requirements. As a consequence, especially in the low-volume sector the costs for registration would be disproportionate to the revenue generated by the substance. A significant number of substances - estimates speak of 20 per cent or more - might have to be taken off the market. This amount-based approach with its thresholds gives the wrong selection incentives, which is oriented at registration costs, not risk.
The proposal: a risk-based registration
I thus want to supplement the amount-based approach with risk-based factors. Starting point for this modification is the system of registration. Here, the following procedure is recommended:
• Pre-registration: all producers or importers have to register all produced or imported substances with 18 months.
• Supplying core information for all produced or imported substances of more than 1 ton per year within a further 3.5 years after pre-registration. The data required for this procedure can be found in a new annex V, which is essentially the old annex V plus two more tests. Data on use and exposure of the substance is also required, so that a first assessment of the risk is possible.
• Prioritising substance registration by using lists with registration limits of 7, 9 and 11 years. This prioritisation will be done by the agency on the basis of the core information and the risk a substance poses. Exceptions are to apply for CMR- and vPvB substances as well as substances of which more than 1000 tons per year are produced, whose registration should be finished within the five year timeframe for other substances.
• Further data demands, including additional test, are to be dependent on the exposure situations. Increasing levels of exposure require stricter timeframes and additional data requirements for registration. These are described in annex IV.
• 11 years after the regulation came into force, just as in the commission proposal, the registration for all 30.000 substances is to be finished.
The new concept does not any more consider every possible use for a substance, but combines the uses into categories (industrial, commercial and private use) and links them to typical exposure categories for humans and the environment. In the case of humans, these are oral, inhaled or dermal absorption, and in the case of the environment, by air, water and soil, each supplemented by the length of the exposure (once or short-term, from time-to-time, repeated, long-term). The combination of both categories leads to typical risk situations requiring the same protective measures and which serve as the basis for specific data requirements. This concept is laid out in annex IXa.
Advantages of the modified approach
The approach is based on the risk, not the amount produced or imported. The burdens in connection with the registration will thus be significantly reduced without prejudicing health and safety or the protection of the environment.
• The pre-registration offers more planning security for producers and users of a substance and delivers early information on animal tests already conducted.
• For the registration, producers and users do not have to take into account a large number of individual uses, but benefit from the introduction of categories of uses. This reduces the obligation of follow-up information by users and allows easier flow of information. At the same time, confidential business information will be protected.
• Due to the prioritisation with lists there is generally only one particular time for registering a particular substance. In conjunction with the pre-registration this allows for better co-operation in the registration.
• Overall, the flexibility of use and availability of substances is increased, while the possibility that substances disappear from the market because the costs for testing and registration cannot be borne, will be lower. Animal testing can also be reduced by these measures.
The combination of exposure categories and categories for use in connection with a set of core data is an efficient instrument to protect humans and the environment more efficiently whilst at the same time decreasing the need for resources and the administrative burden on companies and administrations.
The use of good laboratory practice (GLP) should be limited to new tests with vertebrates (article 12, paragraph 3). As each system for registration tends to put a disproportionate burden on producers of small amounts of a substance, it seems appropriate to introduce registration fees for more than 100 tons per year (article 95, paragraph 1a new). Both measures lead to a lower financial burden which will benefit small and medium-sized industries.
Conclusion
Overall, the proposal makes the draft regulation easier to handle for industry, and less expensive, without giving up the targeted level of protection for humans and the environment.
If the commission wants to reach its goal of keeping and strengthening the competitiveness of the chemical industry in the EU, the REACH draft has to be more practical, cheaper and systematically more plausible. The new chemicals policy has to serve the protection of the human health and the environment, but it also has to offer a framework for investment and innovations, which can lead to new jobs and new business opportunities. This requires a REACH approach based on the risk posed by a substance, not the potential lack of different information. The report tries to achieve this aim with a modified method for the registration of substances."
"Since the commission published its draft regulation on 29 October 2003, there has been a need to agree on a new proposal for the use of chemical substances in the EU. Nonetheless the draft met with considerable criticism in a series of points. The criticism focuses on the commission's proposed method to register chemical substances according to the amount produced or imported.
The draft legislation will affect not only the chemicals industry and users of chemical products, but also, for example, the metal-working and car industries. Not only producers of substances are affected, but also traders, users of substances and importers, i.e. all industries, which deal in chemical substances, including large companies and small and medium-sized business.
Weak points of the Commission draft
The commission met significant criticism with its system to register substances. The commission establishes a connection between the data a user has to supply and the amount of a substance produced. The information requirements start with the production of a substance or its import and increase in levels according to production or import of 10 tons per year, 100 tons per year and 1.000 tons per year.
The crucial weakness of the commission proposal is the lack of relationship to a concrete risk. The data requirements increase when certain thresholds are crossed, without a complementary increase in the risk a substance might pose to humans or the environment.
This amount-based approach leads to unwanted results. The direct costs to supply information for a substance range from 20.000 to 400.000 Euro depending on data requirements. As a consequence, especially in the low-volume sector the costs for registration would be disproportionate to the revenue generated by the substance. A significant number of substances - estimates speak of 20 per cent or more - might have to be taken off the market. This amount-based approach with its thresholds gives the wrong selection incentives, which is oriented at registration costs, not risk.
The proposal: a risk-based registration
I thus want to supplement the amount-based approach with risk-based factors. Starting point for this modification is the system of registration. Here, the following procedure is recommended:
• Pre-registration: all producers or importers have to register all produced or imported substances with 18 months.
• Supplying core information for all produced or imported substances of more than 1 ton per year within a further 3.5 years after pre-registration. The data required for this procedure can be found in a new annex V, which is essentially the old annex V plus two more tests. Data on use and exposure of the substance is also required, so that a first assessment of the risk is possible.
• Prioritising substance registration by using lists with registration limits of 7, 9 and 11 years. This prioritisation will be done by the agency on the basis of the core information and the risk a substance poses. Exceptions are to apply for CMR- and vPvB substances as well as substances of which more than 1000 tons per year are produced, whose registration should be finished within the five year timeframe for other substances.
• Further data demands, including additional test, are to be dependent on the exposure situations. Increasing levels of exposure require stricter timeframes and additional data requirements for registration. These are described in annex IV.
• 11 years after the regulation came into force, just as in the commission proposal, the registration for all 30.000 substances is to be finished.
The new concept does not any more consider every possible use for a substance, but combines the uses into categories (industrial, commercial and private use) and links them to typical exposure categories for humans and the environment. In the case of humans, these are oral, inhaled or dermal absorption, and in the case of the environment, by air, water and soil, each supplemented by the length of the exposure (once or short-term, from time-to-time, repeated, long-term). The combination of both categories leads to typical risk situations requiring the same protective measures and which serve as the basis for specific data requirements. This concept is laid out in annex IXa.
Advantages of the modified approach
The approach is based on the risk, not the amount produced or imported. The burdens in connection with the registration will thus be significantly reduced without prejudicing health and safety or the protection of the environment.
• The pre-registration offers more planning security for producers and users of a substance and delivers early information on animal tests already conducted.
• For the registration, producers and users do not have to take into account a large number of individual uses, but benefit from the introduction of categories of uses. This reduces the obligation of follow-up information by users and allows easier flow of information. At the same time, confidential business information will be protected.
• Due to the prioritisation with lists there is generally only one particular time for registering a particular substance. In conjunction with the pre-registration this allows for better co-operation in the registration.
• Overall, the flexibility of use and availability of substances is increased, while the possibility that substances disappear from the market because the costs for testing and registration cannot be borne, will be lower. Animal testing can also be reduced by these measures.
The combination of exposure categories and categories for use in connection with a set of core data is an efficient instrument to protect humans and the environment more efficiently whilst at the same time decreasing the need for resources and the administrative burden on companies and administrations.
The use of good laboratory practice (GLP) should be limited to new tests with vertebrates (article 12, paragraph 3). As each system for registration tends to put a disproportionate burden on producers of small amounts of a substance, it seems appropriate to introduce registration fees for more than 100 tons per year (article 95, paragraph 1a new). Both measures lead to a lower financial burden which will benefit small and medium-sized industries.
Conclusion
Overall, the proposal makes the draft regulation easier to handle for industry, and less expensive, without giving up the targeted level of protection for humans and the environment.
If the commission wants to reach its goal of keeping and strengthening the competitiveness of the chemical industry in the EU, the REACH draft has to be more practical, cheaper and systematically more plausible. The new chemicals policy has to serve the protection of the human health and the environment, but it also has to offer a framework for investment and innovations, which can lead to new jobs and new business opportunities. This requires a REACH approach based on the risk posed by a substance, not the potential lack of different information. The report tries to achieve this aim with a modified method for the registration of substances."
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