In Regulation (EC) 1272/2008 Annex I section 3.1.3.6.2.2 it says:
In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known ingredients only, with the additional statement that “x percent of the mixture consists of ingredient(s) of unknown toxicity”
also in Annex I section 4.1.3.6.1 it says:
In the event that no useable information on acute (short term) and/or chronic (long term) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies). In this situation the mixture shall be classified based on the known components only, with the additional statement in the SDS that: “Contains x % of components with unknown hazards to the aquatic environment”
The highlighted statements, when required, must appear on the MSDS. I would suggest that the statements are shown in section 2.3 as they also have to be shown on any labels for the mixture.
From advice that we have received from the UK REACh Helpdesk, the environmental statement “Contains x% of components with unknown hazards to the aquatic environment” does not mean the percentage of unknown components within the mixture, but the percentage of the mixtures concentration that is unknown.
Using this table we will get the following statements:-
Contains 26% of components with unknown hazards to the aquatic environment
46 percent of the mixture consists of ingredient(s) of unknown toxicity
The environmental statement is calculated by adding together the concentration percentage of all substances that do not have either Aquatic Acute or Aquatic Chronic classifications (GHK & ILM), and, the toxicity statement will be calculated by adding together the concentration of all substances that do not have Acute Toxic classifications (DEF & ILM).
If we know that substance "DEF" is non-toxic to humans the toxicity statement will become:
11 percent of the mixture consists of ingredient(s) of unknown toxicity
This statement has calculated by adding together the concentration of all substances that do not have Acute Toxic classifications ((DEF & ILM)) less the concentration of the substance(s) that are known to be non-toxic to humans (DEF).
If we know that substance "ILM" is non-hazardous to the environment the statement will become:
Contains 15% of components with unknown hazards to the aquatic environment
This is calculated by adding together the concentration of all substances that do not have either Aquatic Acute or Aquatic Chronic classifications (GHK & ILM) less the concentration of the substance(s) which are known to be non hazardous to the environment (ILM).
In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known ingredients only, with the additional statement that “x percent of the mixture consists of ingredient(s) of unknown toxicity”
also in Annex I section 4.1.3.6.1 it says:
In the event that no useable information on acute (short term) and/or chronic (long term) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies). In this situation the mixture shall be classified based on the known components only, with the additional statement in the SDS that: “Contains x % of components with unknown hazards to the aquatic environment”
The highlighted statements, when required, must appear on the MSDS. I would suggest that the statements are shown in section 2.3 as they also have to be shown on any labels for the mixture.
From advice that we have received from the UK REACh Helpdesk, the environmental statement “Contains x% of components with unknown hazards to the aquatic environment” does not mean the percentage of unknown components within the mixture, but the percentage of the mixtures concentration that is unknown.
Example
| Substance | Concentration % | CLP Classifications |
|---|---|---|
| ABC | 39 | Acute Toxic 4 Aquatic Acute 1 |
| DEF | 35 | Aquatic Chronic 4 |
| GHK | 15 | Acute Toxic 3 |
| ILM | 11 |
Using this table we will get the following statements:-
Contains 26% of components with unknown hazards to the aquatic environment
46 percent of the mixture consists of ingredient(s) of unknown toxicity
The environmental statement is calculated by adding together the concentration percentage of all substances that do not have either Aquatic Acute or Aquatic Chronic classifications (GHK & ILM), and, the toxicity statement will be calculated by adding together the concentration of all substances that do not have Acute Toxic classifications (DEF & ILM).
If we know that substance "DEF" is non-toxic to humans the toxicity statement will become:
11 percent of the mixture consists of ingredient(s) of unknown toxicity
This statement has calculated by adding together the concentration of all substances that do not have Acute Toxic classifications ((DEF & ILM)) less the concentration of the substance(s) that are known to be non-toxic to humans (DEF).
If we know that substance "ILM" is non-hazardous to the environment the statement will become:
Contains 15% of components with unknown hazards to the aquatic environment
This is calculated by adding together the concentration of all substances that do not have either Aquatic Acute or Aquatic Chronic classifications (GHK & ILM) less the concentration of the substance(s) which are known to be non hazardous to the environment (ILM).
No comments:
Post a Comment