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Focusing on Impact Chemicals
Authorization
Substances with certain hazardous properties that give rise to very high concern
will have to be given use-specific permission before they can be employed in particular uses. Evidence demonstrating that the specific use only presents a negligible
risk or, in other cases, that the use is acceptable will be considered before granting an authorization. This evidence includes taking into account socioeconomic
benefits; lack of “safer” chemicals for the same task; and measures minimizing the
exposure of consumers, workers, the general public, and the environment.
An authorization would be granted if the risk to human health or the environment
from the use of a substance arising from the intrinsic properties specified in Annex
XIV (list of substances subjected to the authorization procedure in the REACH
pro gram) is adequately controlled; it is shown that socioeconomic benefits outweigh
the risk to human health or the environment; and if there are no suitable alternative
substances or technologies.
One goal of authorization is to ensure the good functioning of the internal market
while ensuring that the risks from substances of very high concern are properly
controlled. Another goal is to ensure that these substances are eventually replaced
by suitable alternative substances or technologies if these are economically and
technically viable.
The EU recognizes that the authorization program will require considerable
resources for industries to comply with the program and for the regulatory community to review applications. It is expected that about 5 or 10 chemicals will be selected
each year for the authorization process. The system is also organized such that one
application should be prepared by interested parties for each chemical and use.
The following substances may be included:
• Category 1 or 2 carcinogens (Tables 11.4 and 11.5)
• Category 1 or 2 mutagens (Table 11.6)
• Category 1 or 2 substances that are toxic for reproduction (Tables 11.7 and
11.8)
• Substances that are PBTs
The following information is included in an authorization for a substance:
1. The persons to whom the authorization is granted
2. The identity of the substance
3. The use for which the authorization is granted
4. Any conditions under which the authorization is granted
5. The time-limited review period
6. Any monitoring arrangement
Notwithstanding any conditions of an authorization, the holder should ensure that
the exposure is reduced to as low a level as is technically and practically possible.
Focusing on Impact Chemicals
Authorization
Substances with certain hazardous properties that give rise to very high concern
will have to be given use-specific permission before they can be employed in particular uses. Evidence demonstrating that the specific use only presents a negligible
risk or, in other cases, that the use is acceptable will be considered before granting an authorization. This evidence includes taking into account socioeconomic
benefits; lack of “safer” chemicals for the same task; and measures minimizing the
exposure of consumers, workers, the general public, and the environment.
An authorization would be granted if the risk to human health or the environment
from the use of a substance arising from the intrinsic properties specified in Annex
XIV (list of substances subjected to the authorization procedure in the REACH
pro gram) is adequately controlled; it is shown that socioeconomic benefits outweigh
the risk to human health or the environment; and if there are no suitable alternative
substances or technologies.
One goal of authorization is to ensure the good functioning of the internal market
while ensuring that the risks from substances of very high concern are properly
controlled. Another goal is to ensure that these substances are eventually replaced
by suitable alternative substances or technologies if these are economically and
technically viable.
The EU recognizes that the authorization program will require considerable
resources for industries to comply with the program and for the regulatory community to review applications. It is expected that about 5 or 10 chemicals will be selected
each year for the authorization process. The system is also organized such that one
application should be prepared by interested parties for each chemical and use.
The following substances may be included:
• Category 1 or 2 carcinogens (Tables 11.4 and 11.5)
• Category 1 or 2 mutagens (Table 11.6)
• Category 1 or 2 substances that are toxic for reproduction (Tables 11.7 and
11.8)
• Substances that are PBTs
The following information is included in an authorization for a substance:
1. The persons to whom the authorization is granted
2. The identity of the substance
3. The use for which the authorization is granted
4. Any conditions under which the authorization is granted
5. The time-limited review period
6. Any monitoring arrangement
Notwithstanding any conditions of an authorization, the holder should ensure that
the exposure is reduced to as low a level as is technically and practically possible.