Online mixture classification calculator

Specific and Generic concentration limits

Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance ... in a mixture ... leads to the classification of ... mixture as hazardous (CLP, Article 10(1)).

Generic concentration limit (GCL) is the minimum concentration of an ingredient (in case of non-additivity method) or sum of relevant ingredients (in case of additivity method) in a mixture, when mixture becomes classified.

Specific Concentration Limits (SCLs) apply to individual substance and are given in Table 3 of Annex VI to CLP. If mixture contains a substance at concentration above SCL for specific hazard the mixture becomes classified for this hazard.

Example 1

Example 2

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits (SCLs)
Substance A	10.0	Repr. 1B: H360FD	Repr. 1B: H360FD: C ≥ 3.1 %
Water	90.0	−	−

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits (SCLs)
Substance B	12	Skin Corr. 1B: H314	Skin Corr. 1B: H314: C ≥ 25 % Skin Irrit. 2: H315: 10 % ≤ C < 25 % Eye Irrit. 2: H319: 10 % ≤ C < 25 %
Water	88	−	−

Specific Concentration Limits have precedence over the Generic Concentration Limits (CLP, Article 10(6)).

In case if Additivity method is used to calculate the category of a hazard class of the mixture and at least one of ingredients influencing on such hazard has SCL(s) the following formula is applied (Guidance on the Application of the CLP Criteria, Part 1: General Principles for Classification and Labelling, Version 5.0, Nov 2024, section 1.6.3.3.3):

Conc. A

ConcLimit. A

Conc. B

ConcLimit. B

+ ... +

Conc. Z

ConcLimit. Z

≥ 1

where:

Conc. A, Conc. B ... Conc. Z	-	concentrations of substances A, B ... Z in the mixture,
ConcLimit. A, ConcLimit. B ... ConcLimit. Z	-	concentration limit (specific or generic) for substances A, B ... Z.

The above formula is applied for calculation of the following hazard classes:

●	Skin corrosion/irritation (see examples 5 and 6 in section: Classification Skin corrosion / Irritation)
●	Serious eye damage/eye irritation (see examples 6, 7 and 8 in section: Classification Serious damage to eyes / Eye irritation)
●	Specific target organ toxicity, single exposure Category 3 (respiratory tract irritation (H335)) (see example 5 in section: Classification Specific target organ toxicity - single exposure)
●	Specific target organ toxicity, single exposure Category 3 (narcotic effects (H336)).
●	Aspiration.

Where no ingredient of a mixture have SCLs for appropriate classification class the above formula is not applied. Then classification is based on GLCs from Annex I (CLP, Annex VI, 1.1.2.3).

Type of hazard	Source
Acute toxicity	Neither SCLs no GCLs are applicable.
Skin corrosion / Irritation	Additivity approach is applicable - Annex I, Table 3.2.3. Non-additivity approach is applicable - Annex I, Table 3.2.4.
Serious damage to eyes / Eye irritation	Additivity approach is applicable - Annex I, Table 3.3.3. Non-additivity approach is applicable - Annex I, Table 3.3.4.
Respiratory / skin sensitisation	Non-additivity approach is applicable - Annex I, Table 3.4.5.
Germ cell mutagenicity	Non-additivity approach is applicable - Annex I, Table 3.5.2.
Carcinogenicity	Non-additivity approach is applicable - Annex I, Table 3.6.2.
Reproductive toxicity	Non-additivity approach is applicable - Annex I, Table 3.7.2.
Specific target organ toxicity - single exposure (STOT-SE)	Non-additivity approach is applicable - Annex I, Table 3.8.3. Additivity approach is applicable
Specific target organ toxicity - repeated exposure (STOT-RE)	Non-additivity approach is applicable - Annex I, Table 3.9.4.
Aspiration	Additivity approach is applicable - Annex I, section 3.10.3.3.1.
Endocrine disruption for human health	Non-additivity approach is applicable - Annex I, Table 3.11.2.
Hazardous to the aquatic environment	Neither SCLs no GCLs are applicable. M-factors concept is applied.
Endocrine disruption for the environment	Non-additivity approach is applicable - Annex I, Table 4.2.2.
Persistent, Bioaccumulative and Toxic or very Persistent, very Bioaccumulative	Non-additivity approach is applicable - Annex I, section 4.3.3.1.
Persistent, Mobile and Toxic or very Persistent, very Mobile	Non-additivity approach is applicable - Annex I, section 4.4.3.1.
Hazardous to the ozone layer	Non-additivity approach is applicable - Annex I, Table 5.1.