Substances which do not contain infectious substances or substances which are unlikely to cause
disease in humans or animals are not subject to the provisions of ADR unless they meet the criteria for
inclusion in another class.
Substances containing microorganisms which are non-pathogenic to humans or animals are not
subject to ADR unless they meet the criteria for inclusion in another class.
Substances in a form that any present pathogens have been neutralized or inactivated such that they no
longer pose a health risk are not subject to ADR unless they meet the criteria for inclusion in another
NOTE: Medical equipment which has been drained of free liquid is deemed to meet the requirements
of this paragraph and is not subject to the provisions of ADR.
Substances where the concentration of pathogens is at a level naturally encountered (including
foodstuff and water samples) and which are not considered to pose a significant risk of infection are
not subject to ADR unless they meet the criteria for inclusion in another class.
Dried blood spots, collected by applying a drop of blood onto absorbent material, are not subject to
Faecal occult blood screening samples are not subject to ADR.
Blood or blood components which have been collected for the purposes of transfusion or for the
preparation of blood products to be used for transfusion or transplantation and any tissues or organs
intended for use in transplantation as well as samples drawn in connection with such purposes are not
subject to ADR.
Human or animal specimens for which there is minimal likelihood that pathogens are present are not
subject to ADR if the specimen is carried in a packaging which will prevent any leakage and which is
marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate.
The packaging is deemed to comply with the above requirements if it meets the following conditions:
(a) The packaging consists of three components:
(i) a leak-proof primary receptacle(s);
(ii) a leak-proof secondary packaging; and
(iii) an outer packaging of adequate strength for its capacity, mass and intended use, and
with at least one surface having minimum dimensions of 100 mm × 100 mm;
(b) For liquids, absorbent material in sufficient quantity to absorb the entire contents is placed
between the primary receptacle(s) and the secondary packaging so that, during carriage, any
release or leak of a liquid substance will not reach the outer packaging and will not
compromise the integrity of the cushioning material;
(c) When multiple fragile primary receptacles are placed in a single secondary packaging, they are
either individually wrapped or separated to prevent contact between them.
NOTE 1: An element of professional judgment is required to determine if a substance is exempt under
this paragraph. That judgment should be based on the known medical history, symptoms and
individual circumstances of the source, human or animal, and endemic local conditions. Examples of
specimens which may be carried under this paragraph include the blood or urine tests to monitor
cholesterol levels, blood glucose levels, hormone levels, or prostate specific antibodies (PSA); those
required to monitor organ function such as heart, liver or kidney function for humans or animals with
non-infectious diseases, or for therapeutic drug monitoring; those conducted for insurance or
employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy test;
biopsies to detect cancer; and antibody detection in humans or animals in the absence of any concern
for infection (e.g. evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc.).
NOTE 2: For air transport, packagings for specimens exempted under this paragraph shall meet the
conditions in (a) to (c).
(a) Medical waste (UN No. 3291);
(b) Medical devices or equipment contaminated with or containing infectious substances in
Category A (UN No. 2814 or UN No. 2900); and
(c) Medical devices or equipment contaminated with or containing other dangerous goods that
meet the definition of another class,
medical devices or equipment potentially contaminated with or containing infectious substances
which are being carried for disinfection, cleaning, sterilization, repair, or equipment evaluation are not
subject to provisions of ADR other than those of this paragraph if packed in packagings designed and
constructed in such a way that, under normal conditions of carriage, they cannot break, be punctured
or leak their contents. Packagings shall be designed to meet the construction requirements listed in
6.1.4 or 6.6.4.
These packagings shall meet the general packing requirements of 126.96.36.199 and 188.8.131.52 and be capable of
retaining the medical devices and equipment when dropped from a height of 1.2 m.
The packagings shall be marked "USED MEDICAL DEVICE" or "USED MEDICAL
EQUIPMENT". When using overpacks, these shall be marked in the same way, except when the
inscription remains visible.
For the purposes of ADR, biological products are divided into the following groups:
(a) those which are manufactured and packaged in accordance with the requirements of
appropriate national authorities and carried for the purposes of final packaging or distribution,
and use for personal health care by medical professionals or individuals. Substances in this
group are not subject to the provisions of ADR;
(b) those which do not fall under paragraph (a) and are known or reasonably believed to contain
infectious substances and which meet the criteria for inclusion in Category A or Category B.
Substances in this group shall be assigned to UN Nos. 2814, 2900 or 3373, as appropriate.
NOTE: Some licensed biological products may present a biohazard only in certain parts of the world.
In that case, competent authorities may require these biological products to be in compliance with
local requirements for infectious substances or may impose other restrictions.
Genetically modified microorganisms and organisms
Genetically modified microorganisms not meeting the definition of infectious substance shall be
classified according to section 2.2.9.