This is another tricky concept of the Dangerous Preparations Directive. In essence, when totalling the TFVs (Click here to find out more about TFVs) for a cumulative hazard, you must only consider ingredients present at a concentration at or above a specified limit for the particular hazard – the “Lower Limit of Concentration” – ignore ingredients with a lower concentration.
Here is what Article 3 of the DPD legislation says:
3. For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in Annex I to Directive 67/548/EEC, or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive
|
Category of Danger of the Substance |
Concentration to take into consideration for |
|
|
|
Gaseous Preparations |
Other preparations |
|
Very Toxic |
>0.02 |
≥0.1 |
|
Toxic |
≥0.02 |
≥0.1 |
|
Carcinogenic Category 1 or 2 |
≥0.02 |
≥0.1 |
|
Mutagenic Category 1 or 2 |
≥0.02 |
≥0.1 |
|
Toxic for Reproduction Category 1 or 2 |
≥0.02 |
≥0.1 |
|
Harmful |
≥0.2 |
≥1 |
|
Corrosive |
≥0.02 |
≥1 |
|
Irritant |
≥0.2 |
≥1 |
|
Sensitising |
≥0.2 |
≥1 |
|
Carcinogenic Category 3 |
≥0.2 |
≥1 |
One complication that sometimes occurs is that the Specific Concentration Limit for a hazard of a chemical is below the Lower Limit of Concentration for that hazard. In that case, you assume that the Lower Limit of Concentration for that hazard of that particular chemical is reduced to the same value as the Specific Concentration Limit.
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