Classification for category Acute 1
First, allingredients classified as Acute 1areconsidered. If the sum of the concentrations (in %) ofthese ingredients is greater than or equal to 25% the whole mixture shall be classified as Acute 1. If the result of the calculation is a classification of the mixture as Acute1, the classification process is completed.
The classification of mixtures for acute hazards based on this summation of the concentrations of classified ingredients is summarized in Table 2.2.9.1.10.4.6.2.2 below.
Table 2.2.9.1.10.4.6.2.2: Classification of a mixture for acute hazards based on summation of the concentrations of classified ingredients
|
Sum of the concentrations (in %) of ingredients classified as: |
Mixture classified as: |
|
|
Acute 1 x M a ≥ %25 |
Acute 1 |
a For explanation of the M factor, see 2.2.9.1.10.4.6.4.
Classification for categories Chronic 1 and 2
First, all ingredients classified as Chronic 1are considered. If the sum of the concentrations (in %) ofthese ingredients is greater than or equal to 25% the mixture shall be classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1the classification procedure is completed.
In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2is considered. A mixture shall be classified as Chronic 2if 10 times the sum of the concentrations (in %) ofall ingredients classified as Chronic 1plus the sum of the concentrations (in %) ofallingredients classified as Chronic 2is greater than or equal to 25%. If the result of the calculation is classification of the mixture as Chronic 2, the classification process is completed.
The classification of mixtures for long-term hazards based on this summation of the concentrations of classified ingredients is summarized in Table 2.2.9.1.10.4.6.3.3 below.
Table 2.2.9.1.10.4.6.3.3: Classification of a mixture for long-term hazards based on summation of the concentrations of classified ingredients
|
Sum of the concentrations (in %) of ingredients classified as: |
Mixture classified as: |
|
|
Chronic 1 x M a |
≥ %25 |
Chronic 1 |
|
(M x 10 x Chronic 1) + Chronic 2 |
≥ %25 |
Chronic 2 |
a For explanation of the M factor, see 2.2.9.1.10.4.6.4.
Mixtures with highly toxic ingredients
Acute 1 or Chronic 1 ingredients with acute toxicities well below 1 mg/l and/or chronic toxicities well below 0.1 mg/l (if non-rapidly degradable) and 0.01 mg/l (if rapidly degradable) may influencethe toxicity of the mixture and are given increased weight in applying the summationmethod. When a mixture contains ingredients classified as acute or Chronic 1, the tiered approach described in 2.2.9.1.10.4.6.2 and 2.2.9.1.10.4.6.3 shall be applied using a weighted sum by multiplying the concentrations of Acute 1and Chronic 1 ingredients by a factor, instead of merely adding up the percentages. This means that the concentration of "Acute 1" in the left column of Table 2.2.9.1.10.4.6.2.2 and the concentration of "Chronic1" in the left column of Table 2.2.9.1.10.4.6.3.3 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied tothese ingredients are defined using the toxicity value, as summarised in Table2.2.9.1.10.4.6.4 below. Therefore, in order to classify a mixture containing Acute 1and/or Chronic 1ingredients, the classifier needs to be informed of the value of the M factor in order to apply the summation method. Alternatively, the additivity formula (see2.2.9.1.10.4.5.2) may be used when toxicity data are available for all highly toxic ingredients in the mixture and there is convincing evidence that all other ingredients, including those for which specific acuteand/or chronictoxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture.
Table 2.2.9.1.10.4.6.4: Multiplying factors for highly toxic ingredients of mixtures
|
Acute toxicity |
M factor |
Chronic toxicity |
M factor |
|
|
L(E)C50 value |
NOEC value |
NRD a ingredients |
RD b ingredients |
|
|
0,1 < L(E)C50 ≤ 1 |
1 |
0,01 < NOEC ≤ 0,1 |
1 |
- |
|
0,01 < L(E)C50 ≤ 0,1 |
10 |
0,001 < NOEC ≤ 0,01 |
10 |
1 |
|
0,001 < L(E)C50 ≤ 0,01 |
100 |
0,0001 < NOEC ≤ 0,001 |
100 |
10 |
|
0,0001 < L(E)C50 ≤ 0,001 |
1 000 |
0,00001 < NOEC ≤ 0,0001 |
1 000 |
100 |
|
0,00001 < L(E)C50 ≤ 0,0001 |
10 000 |
0,000001 < NOEC ≤ 0,00001 |
10 000 |
1 000 |
|
(continue in factor 10 intervals) |
(continue in factor 10 intervals) |
|||
a Non-rapidly degradable.
b Rapidly degradable.
Classification of mixtures with ingredients without any useable information
In the event that no useable information on acute and/or chronic aquatic toxicityis available for one or more relevant ingredients, it is concluded that the mixture cannot be attributed (a) definitive hazard category(ies). In this situation the mixture shall be classified based on the known ingredients only.
Substances or mixtures classified as environmentally hazardous substances (aquatic environment) on the basis of Regulation 1272/2008/EC3
If data for classification according to the criteria of 2.2.9.1.10.3 and 2.2.9.1.10.4 are not available, a substance or mixture:
(a)Shall be classified asan environmentally hazardous substance (aquatic environment) if it has tobe assigned category(ies) Aquatic Acute 1, Aquatic Chronic 1 or Aquatic Chronic 2 accordingto Regulation 1272/2008/EC3;
(b)May be regarded as not being an environmentally hazardous substance (aquatic environment) ifit does not have to be assigned such a category according to the said Regulation.
Assignment of substances or mixtures classified as environmentally hazardous substances (aquatic environment) according to the provisions in 2.2.9.1.10.3, 2.2.9.1.10.4 or 2.2.9.1.10.5
Substances or mixtures classified as environmentally hazardous substances (aquatic environment), not otherwise classified under ADR shall be designated:
UN No. 3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.; or
UN No. 3082 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.
They shall be assigned to packing group III.
Genetically modified microorganisms or organisms
Genetically modified microorganisms (GMMOs) and geneticallymodified organisms (GMOs) are microorganisms and organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally. They are assigned to Class 9 (UN No. 3245) if they do not meet the definition of toxic substances orof infectious substances, but are capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction.
NOTE 1: GMMOs and GMOs which are infectious are substances of Class 6.2, UN Nos. 2814, 2900 or3373.
NOTE 2:GMMOs or GMOs are not subject to the provisions of ADR when authorized for use by the competent authorities of the countries of origin, transit and destination14.
NOTE 3:Genetically modified live animals which,in accordance with the current state of scientific knowledge, have no known pathogenic effect on humans, animals and plants and are carried in receptacles that are suitable for safely preventing both the escape of the animals and unauthorized access to them, are not subject to the provisions of ADR. The provisions specified by the International Air Transport Association (IATA) for air transport “Live Animals Regulations, LAR” can be drawn on as guidelines for suitable receptacles for the transport of live animals.
NOTE 4:Live animals shall not be used to carry genetically modified microorganisms classified in Class 9 unless the substance can be carried no other way. Genetically modified live animals shall be carried under terms and conditions of the competent authorities of the countries of origin and destination.
________________
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC; and amending Regulation (EC) No 1907/2006, published in the Official Journal of the European Union, L353, 31December 2008, p 1-1355.14See Part C of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal of the EuropeanCommunities,No.L 106,of17April2001,pp8-14)andRegulation(EC)No.1829/2003oftheEuropean Parliament and of the Council on genetically modified food and feed (Official Journal of the European Union, No. L 268, of 18 October 2003, pp 1-23), which set out the authorization procedures for the European Union.
Elevated temperature substances
Elevated temperature substances include substances which are carried or handed over for carriage in the liquid state at or above 100 °C and, in the case of those with a flash-point, below their flash-point. They also include solids which are carried or handed over for carriage at or above 240 °C.
NOTE: Elevated temperature substances may be assigned to Class 9 only if they do not meet the criteria of any other class.
Other substances and articles presenting a danger during carriage but not meeting the definitions of another class
The following other miscellaneous substances not meeting the definitions of another class are assigned to Class 9:
Solid ammonia compounds having a flash-point below 60 °C;
Low hazard dithionites;
Highly volatile liquids;
Substances emitting noxious fumes;
Substances containing allergens;
Chemical kits and first aid kits;
Electric doublelayer capacitors (with an energy storage capacity greater than 0.3Wh);
Vehicles, engines and machinery, internal combustion;
Articles containing miscellaneous dangerous goods.
NOTE:UN No. 1845 carbon dioxide, solid (dry ice)15,UN No. 2216 fish meal (fish scrap), stabilized, UN No. 2807 magnetized material, UN No. 3334 aviation regulated liquid, n.o.s.and UN No. 3335 aviation regulated solid, n.o.s.listed in the UN Model Regulations, are not subject to the provisions of ADR.