Online mixture classification calculator

Carcinogenicity

Non-additivity approach

The additivity approach is not applicable for calculation of Carcinogenicity.

If a single ingredient classified as carcinogen is present in the mixture above the generic or specific concentration limit the mixture must be classified for that hazard. Other hand, if the mixture contains two or more ingredients each below the generic or specific concentration limit, even if the sum of their concentrations is above generic concentration limit, the mixture will not be classified.

The mixture is classified as a carcinogen if at least one ingredient is classified as a Category 1A, Category 1B or Category 2 carcinogen and is present at or above the appropriate generic concentration limit as shown in Table 3.6.2 of Annex I to CLP for Category 1A, Category 1B and Category 2 respectively.

Component classified as

Generic concentration limits triggering classification of a mixture as

Component classified as	Carc. 1A	Carc. 1B	Carc. 2
Carc. 1A	≥ 0.1 %
Carc. 1B		≥ 0.1 %
Carc. 2			≥ 1.0 % (note 1)

Note.

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

Note 1.

If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0.1 % a safety data sheet shall be available for the mixture upon request.

Hierarchy of hazard categories

Hazard

➔

−	Carcinogenicity, category 1A (Carc. 1A: H350 or H350i *)
−	Carcinogenicity, category 1B (Carc. 1B: H350 or H350i *)
−	Carcinogenicity, category 2 (Carc. 2: H351)

* To carcinogenicity sub-categories 1A and 1B one of the following H statement is applied.

−	H350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
−	H350i: May cause cancer by inhalation. (see CLP, Annex I, 1.1.2.1.2)

Where there is conclusive proof that cancer is caused only by certain route(s), then this route may be stated in the hazard statement. In case of sub-category 1A or 1B carcinogens where there is conclusive proof that cancer is caused only by inhalation, the hazard phrase H350i applies (CLP, Annex VII, Table 1.1).

A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as carcinogenicity sub-category 1A (Carc. 1A) and carcinogenicity sub-category 1B (Carc. 1B) the sub-category 'Carc. 1A' must be selected. If both H350i and H350 are applied for a mixture the statement H350 must be selected.

To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.6.3 of Regulation (EC) no 1272/2008 (CLP).

If mixture is not intended for the general public and is not classified as hazardous but contains ≥ 0.1 % of a substance classified as Carc. 2 the label on the packaging must bear the statement EUH210 - 'Safety data sheet available on request' (CLP, Annex II, 2.10).

Additional labelling provisions

There are provisions resulted from point 28 of Annex XVII to Regulation (EC) no. 1907/2006 (REACH). Mixture containing substance classified as Carcinogen and listed in Appendix 1 or 2 of Annex XVII to REACH, when the individual concentration of such a substance equals to or greater than specific or generic concentration limit:

−	mixture is prohibited for supply to the general public and
−	packaging of such mixture 'must be marked visibly, legibly and indelibly as follows: "Restricted to professional users".'. Derogations from this obligation are outlined in the same provision and are related to the use in: medicinal or veterinary products, cosmetic products, some types of fuels and oil products, artists' paints, etc.

See also answer of European Chemical Agency in section Q&As, ID: 0156 .

Example 1

Example 2

Example 3

Example 4

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	0.2	Carc. 1A: H350
Substance B	5.0	Carc. 1B: H350
Substance C	10.0	Carc. 2: H351
Water	84,.8	−

Cut-off limits

−	There is no generic cut-off limit for Carcinogenicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

−	Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Carc. 1A'

−	Concentration of substance A is above the generic concentration limit 0.1 %. This leads to classification Carc. 1A .

Calculation of 'Carc. 1B'

−	Concentration of substance B is above the generic concentration limit 0.1 %. This leads to classification Carc. 1B .

Calculation of 'Carc. 2'

−	Concentration of substance C is above the generic concentration limit 1.0 %. This leads to classification Carc. 2 .

Selection of hazard category

−	Classification sub-category 'Carc. 1A' is more severe than 'Carc. 1B' and 'Carc. 2', therefore, mixture is classified as 'Carc. 1A'.

Selection of hazard statements

−	H350 corresponds to 'Carc. 1A'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1A'.

Selection of precautionary statements

−	For H350 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Carc. 1A
Hazard statements:	H350
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance D	1.0	Carc. 1A: H350i
Substance B	1.0	Carc. 1B: H350
Water	98.0	−

Cut-off limits

−	There is no generic cut-off limit for Carcinogenicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

−	Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Carc. 1A'

−	Concentration of substance D is above the generic concentration limit 0.1 %. This leads to classification Carc. 1A .

Calculation of 'Carc. 1B'

−	Concentration of substance B is above the generic concentration limit 0.1 %. This leads to classification Carc. 1B .

Selection of hazard category

−	Classification sub-category 'Carc. 1A' is more severe than 'Carc. 1B', therefore, mixture is classified as 'Carc. 1A'.

Selection of hazard statements

−	Both substances D and B have influence on mixture's classification, therefore, a choice between H350i and H350 should be made. Because H350 indicates that inhalation is not the only route of exposure, the statement H350 must be selected.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1A'.

Selection of precautionary statements

−	For H350 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Carc. 1A
Hazard statements:	H350
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	0.09	Carc. 1A: H350
Substance E	0.09	Carc. 1A: H350
Substance G	0.12	Carc. 1B: H350i
Substance C	10.0	Carc. 2: H351
Water	89.7	−

Cut-off limits

−	There is no generic cut-off limit for Carcinogenicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

−	Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Carc. 1A'

−	Concentration of substance A is below the generic concentration limit 0.1 %. This does not lead to classification 'Carc. 1A'.
−	Concentration of substance E is below the generic concentration limit 0.1 %. This does not lead to classification 'Carc. 1A'.

Calculation of 'Carc. 1B'

−	Concentration of substance G is above the generic concentration limit 0.1 %. This leads to classification Carc. 1B .

Calculation of 'Carc. 2'

−	Concentration of substance C is above the generic concentration limit 1.0 %. This leads to classification Carc. 2 .

Selection of hazard category

−	Classification sub-category 'Carc. 1B' is more severe than 'Carc. 2', therefore, mixture is classified as 'Carc. 1B'.

Selection of hazard statements

−	H350i corresponds to 'Carc. 1B' because of substance G.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1B'.

Selection of precautionary statements

−	For H350i are applied the same precautionary statements as for H350: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Carc. 1B
Hazard statements:	H350i
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance A	0.08	Carc. 1A: H350	−
Substance B	0.08	Carc. 1A: H350	−
Substance C	0.5	Carc. 2: H351	Carc. 2: H351: C ≥ 0.2 %
Substance H	0.5	Carc. 2: H351	−
Water	98.84	−	−

Cut-off limits

−	There is no generic cut-off limit for Carcinogenicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

−	Substance C has a specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of C must be compared to SCL.
−	Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits.

Calculation of 'Carc. 1A'

−	Concentration of substance A is below the generic concentration limit 0.1 %. This does not lead to classification 'Carc. 1A'.
−	Concentration of substance B is below the generic concentration limit 0.1 %. This does not lead to classification 'Carc. 1A'.

Calculation of 'Carc. 2'

−	Concentration of substance C is above specific concentration limit (0.2 %). This leads to classification Carc. 2 .
−	Concentration of substance H is below the generic concentration limit 1.0 %. This does not lead to classification 'Carc. 2'.

Selection of hazard category

−	The mixture is classified as 'Carc. 2'.

Selection of hazard statements

−	H351 corresponds to 'Carc. 2'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Warning' correspond to 'Carc. 2'.

Selection of precautionary statements

−	For H351 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Carc. 2
Hazard statements:	H351
Pictogram:
	GHS08
Signal word:	Warning
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501