Biological products
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 ofappropriate 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 thisgroup are not subject to the provisions of ADR;
(b) those which do not fall under paragraph (a) and are known or reasonably believed to containinfectious substances and which meet the criteria for inclusion in Category Aor Category B.Substances in this group shall be assigned to UNNos.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.
Medical or clinical wastes
Medical or clinical wastes containing Category A infectious substances shall be assigned to UNNo. 2814or UNNo. 2900 as appropriate. Medical or clinical wastes containing infectious substances in CategoryB shall be assigned to UNNo. 3291.
NOTE:Medical or clinical wastes assigned to number 180103 (Wastes from human or animal health care and/or related research – wastes from natalcare, diagnosis, treatment or prevention of disease in humans – wastes whose collection and disposal is subject to special requirements in order to prevent infection) or 180202 (Wastes from human or animal health care and/or related research – wastes from research, diagnosis, treatment or prevention of disease involving animals – wastes whose collection and disposal is subject to special requirements in order to prevent infection) according to the list of wastes annexed to the Commission Decision 2000/532/EC4as amended, shall be classified according to the provisions set out in this paragraph, based on the medical or veterinary diagnosis concerning the patient or the animal.
Medical or clinical wastes which are reasonably believed to have alow probability of containing infectious substances shall be assigned to UN No. 3291. For the assignment, international, regional or national waste catalogues may be taken into account.
NOTE 1:The proper shipping name for UN No. 3291 is "CLINICAL WASTE,UNSPECIFIED, N.O.S." or "(BIO) MEDICAL WASTE, N.O.S". or "REGULATED MEDICAL WASTE, N.O.S.".
NOTE 2:Notwithstanding the classification criteria set out above, medical or clinical wastes assigned to number 1801 04 (Wastes from human or animal health care and/or related research – wastes from natal care, diagnosis, treatment or prevention of disease in humans – wastes whose collection and disposal is not subject to special requirements in order to prevent infection) or 180203 (Wastes from human or animal health care and/or related research – wastes from research, diagnosis, treatment or prevention of disease involving animals – wastes whose collection and disposal is not subject to special requirements in order to prevent infection) according to the list ofwastes annexed to the Commission Decision 2000/532/EC5as amended, are not subject to the provisions of ADR.
Decontaminated medical or clinical wastes which previously contained infectious substances are not subject to the provisions of ADRunless they meet the criteria for inclusion in another class.
Medical or clinical wastes assigned to UN No. 3291 are assigned to packing groupII.
Infected animals
Unless an infectious substance cannot be consigned by any other means, live animals shall not be used to consign such a substance. A live animal which has been intentionally infected and is known or suspected to contain an infectious substance shall only be carried under terms and conditions approved by the competent authority.NOTE:The approval of the competent authorities shall be issued on the basis of the relevant rules for the carriage of live animals, taking into consideration dangerous goods aspects. The authorities
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4 Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste (replaced by the Directive 2006/12/EC of the European Parliament and of the Council (Official Journal of the European Union No. L114 of 27 April 2006, page 9)) and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (Official Journal of the European Communities No. L 226 of 6 September 2000, page3).
that are competent to lay down these conditions and rules for approval shall be regulated at national level.
If there is no approval by a competent authority of a Contracting Party to ADR, the competent authority of a Contracting Party to ADR may recognize an approval issued by the competent authority of a country that is not a Contracting Party to ADR.
Rules for the carriage of livestock are, for example, contained in Council Regulation (EC) No1/2005 of 22December 2004 on the protection of animals during transport (Official Journal of the European UnionNo L3 of 5January 2005) as amended.
Substances not accepted for carriage
Live vertebrate or invertebrate animals shall not be used to carry an infectious agent unless the agent cannot be carried by other means or unless this carriage has been approved by the competent authority (see 2.2.62.1.12.1).
List of collective entries
General
Unless otherwise provided for in Chapter 2.2 or in this Chapter, the test methods to be used for the classification of dangerous goods are those described in the Manual of Tests and Criteria.