Corrigendum - REACH24H Consulting Group

Recommendations

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etween 20 °C and 30 °C but, in addition, one aerosol dispenser in 2 000 shall be tested at the higher temperature. 6.2.4.2.1.2 No leakage or permanent deformation of an aerosol dispenser may occur, except that a plastic aerosol dispenser may be deformed through softening provided that it does not leak. 6.2.4.2.2 Alternative methods With the approval of the competent authority alternative methods that provide an equivalent level of safety may be used provided that the requirements of 6.2.4.2.2.1, 6.2.4.2.2.2 and 6.2.4.2.2.3 are met. 6.2.4.2.2.1 Quality system Copyright@United Nations, 2011. All rights reserved. Aerosol dispenser fillers and component manufacturers shall have a quality system. The quality system shall implement procedures to ensure that all aerosol dispensers that leak or that are deformed are rejected and not offered for transport. The quality system shall include: (a) A description of the organizational structure and responsibilities; (b) The relevant inspection and test, quality control, quality assurance, and process operation instructions that will be used; (c) Quality records, such as inspection reports, test data, calibration data and certificates; (d) Management reviews to ensure the effective operation of the quality system; (e) A process for control of documents and their revision; (f) A means for control of non-conforming aerosol dispensers; (g) Training programmes and qualification procedures for relevant personnel; and (h) Procedures to ensure that there is no damage to the final product. An initial audit and periodic audits shall be conducted to the satisfaction of the competent authority. These audits shall ensure the approved system is and remains adequate and efficient. Any proposed changes to the approved system shall be notified to the competent authority in advance. 6.2.4.2.2.2 Pressure and leak testing of aerosol dispensers before filling Every empty aerosol dispenser shall be subjected to a pressure equal to or in excess of the maximum expected in the filled aerosol dispensers at 55 °C (50 °C if the liquid phase does not exceed 95% of the capacity of the receptacle at 50 °C). This shall be at least two-thirds of the design pressure of the aerosol dispenser. If any aerosol dispenser shows evidence of leakage at a rate equal to or greater than 3.3 × 10 -2 mbar.l.s -1 at the test pressure, distortion or other defect, it shall be rejected. 6.2.4.2.2.3 Testing of the aerosol dispensers after filling Prior to filling the filler shall ensure that the crimping equipment is set appropriately and the specified propellant is used. Each filled aerosol dispenser shall be weighed and leak tested. The leak detection equipment shall be sufficiently sensitive to detect at least a leak rate of 2.0 × 10 -3 mbar.l.s -1 at 20 °C. Any filled aerosol dispenser that shows evidence of leakage, deformation or excessive mass shall be rejected. - 220 -
Copyright@United Nations, 2011. All rights reserved. 6.2.4.3 With the approval of the competent authority, aerosols and receptacles, small, are not subject to 6.2.4.1 and 6.2.4.2, if they are required to be sterile but may be adversely affected by water bath testing, provided: (a) They contain a non-flammable gas and either (i) contain other substances that are constituent parts of pharmaceutical products for medical, veterinary or similar purposes; (ii) contain other substances used in the production process for pharmaceutical products; or (iii) are used in medical, veterinary or similar applications; (b) An equivalent level of safety is achieved by the manufacturer's use of alternative methods for leak detection and pressure resistance, such as helium detection and water bathing a statistical sample of at least 1 in 2000 from each production batch; and (c) For pharmaceutical products according to (a) (i) and (iii) above, they are manufactured under the authority of a national health administration. If required by the competent authority, the principles of Good Manufacturing Practice (GMP) established by the World Health Organization (WHO) 2 shall be followed. 2 WHO Publication: “Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume 2: Good manufacturing practices and inspection”. - 221 -
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Recommendations on the Transport of
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16. 4.1.4.1, P802 (1) After 4B, ins
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Copyright@United Nations, 2011. All
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Recommendations on the TRANSPORT OF
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2.8 Appearance at normal transport
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4.9 Does the substance have oxidizi
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CHAPTER 1.1 GENERAL PROVISIONS Intr
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1.2.1 Definitions CHAPTER 1.2 DEFIN
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Consignee means any person, organiz
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Open cryogenic receptacle means a t
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Remanufactured packagings include:
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Clarifying examples for certain def
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The decimal multiples and sub-multi
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CHAPTER 1.4 SECURITY PROVISIONS Int
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1.5.1 Scope and application Copyrig
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1.5.2.4 For occupational exposures
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2.0.0 Responsibilities CHAPTER 2.0
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2.0.4 Transport of samples Copyrigh
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CHAPTER 2.1 CLASS 1 - EXPLOSIVES In
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(e) Division 1.5 Very insensitive s
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NOTE 1: Articles of compatibility g
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2.1.3.6 Exclusion from Class 1 Copy
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2.2.1 Definitions and general provi
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2.2.3 Mixtures of gases Copyright@U
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2.3.2.6 Hazard grouping based on fl
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2.4.2.2.3.3 For solids which may ca
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SELF-REACTIVE SUBSTANCE Concentrati
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Figure 2.4.1: FLOW CHART SCHEME FOR
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2.4.3 Division 4.2 - Substances lia
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2.4.4.3 Assignment of packing group
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CHAPTER 2.5 CLASS 5 - OXIDIZING SUB
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2.5.2.3.1.2 The classification test
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- 101 - ORGANIC PEROXIDE Concentrat
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Notes on 2.5.3.2.4: 1) Diluent type
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Exit E Box 11 Figure 2.5.1: FLOW CH
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CHAPTER 2.6 CLASS 6 - TOXIC AND INF
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2.6.2.2.4.2 The criteria for inhala
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(a) Classify the formulation accord
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INDICATIVE EXAMPLES OF INFECTIOUS S
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2.6.3.2.3.7 Except for: Copyright@U
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CHAPTER 2.7 CLASS 7 - RADIOACTIVE M
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Gold (79) Radionuclide (atomic numb
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Radionuclide (atomic number) A1 A2
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Osmium (76) Radionuclide (atomic nu
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2.7.2.2.4 For mixtures of radionucl
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(b) SCO-II: A solid object on which
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2.7.2.3.3.8 For specimens which com
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For mixtures of radionuclides whose
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2.8.1 Definition CHAPTER 2.8 CLASS
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CHAPTER 2.9 CLASS 9 - MISCELLANEOUS
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Other substances or articles presen
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NOTE 1: The organisms fish, crustac
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2.9.3.4.2 The approach for classifi
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2.9.3.4.4.2 Dilution 2.9.3.4.4.2.1
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2.9.3.4.5.3 When applying the addit
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2.9.4 Lithium batteries Copyright@U
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3.1.1 Scope and general provisions
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3.1.2.8 Generic or “not otherwise
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UN No. Name and description Copyrig
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UN No. Name and description Class o
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(a) Fusee matches are matches the h
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308 Fish scrap or fish meal shall c
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Fuel cell cartridge design types us
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CHAPTER 3.4 DANGEROUS GOODS PACKED
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3.5.1 Excepted quantities CHAPTER 3
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(ii) Where the sample is in the sha
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Class or Division Subsidiary Risk C
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APPENDIX B GLOSSARY OF TERMS Cautio
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BOOSTERS BOMBS, PHOTO-FLASH; BOMBS
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CHARGES, SHAPED, without detonator
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EXPLOSIVE, BLASTING, TYPE D Substan
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IGNITERS Articles containing one or
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PROPELLANTS, LIQUID PROPELLANTS, SO
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Name and description Class UN No. N
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4.1.1.18 Use of salvage packagings
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sections 4.1.5, 4.1.6, 4.1.7, 4.1.8
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P114(a) PACKING INSTRUCTION (Solid
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P200 PACKING INSTRUCTION (cont'd) P
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P207 PACKING INSTRUCTION P207 This
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P502 PACKING INSTRUCTION P502 The f
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IBC520 PACKING INSTRUCTION IBC520 T
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IBC620 PACKING INSTRUCTION IBC620 T
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equirements. Copyright@United Natio
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4.2.1.9.6 Portable tanks shall not
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4.2.1.13.9 For insulated portable t
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(b) When leaking; (c) When damaged
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4.2.4.4 The periodic testing and in
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T23 PORTABLE TANK INSTRUCTION T23 T
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T50 PORTABLE TANK INSTRUCTION T50 T
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T50 PORTABLE TANK INSTRUCTION (cont
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4.2.5.3 Portable tank special provi
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(c) Substances shall not be allowed
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4.3.1 General provisions Copyright@
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4.3.1.16 Before a flexible bulk con
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5.1.1 Application and general provi
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5.2.1 Marking Copyright@United Nati
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5.2.1.6 Special marking provisions
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container except that on labels for
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5.2.2.2.2 Specimen labels CLASS 1 E
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CLASS 7 Radioactive material (No. 7
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5.3.1 Placarding 5.3.1.1 Placarding
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5.3.2 Marking 5.3.2.1 Display of UN
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CHAPTER 5.4 DOCUMENTATION Introduct
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5.4.1.4.2 Sequence of the dangerous
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5.4.1.5.7 Radioactive material Copy
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* FOR DANGEROUS GOODS: you must spe
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5.5.1 Deleted. CHAPTER 5.5 SPECIAL
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5.5.3 Special provisions applicable
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6.5.6.3 Preparation of IBCs for tes
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6.5.6.5.5 Criteria for passing the
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(b) For IBCs of types 31H1, 31H2, 3
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6.5.6.10 Tear test 6.5.6.10.1 Appli
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6.5.6.14 Test report Copyright@Unit
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6.6.1 General Copyright@United Nati
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6.6.3.2 Examples of the marking 50
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6.6.5.2.2 In the drop tests for liq
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6.6.5.3.4 Drop test 6.6.5.3.4.1 App
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CHAPTER 6.7 REQUIREMENTS FOR THE DE
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(b) A liquid tight closure at the e
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(d) Missing or loose bolts or nuts
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Figure 6.7.2.20.1: Example of ident
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(b) For steels with no clearly defi
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6.7.3.5 Service equipment Copyright
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where: 0. 82 FA Q = 12. 4 LC - 317
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There shall be no obstruction in an
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(f) Materials (i) Shell material(s)
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6.7.4.2.13 Under each of the forces
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(d) Pressures (i) MAWP (in bar gaug
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6.7.4.15.3 If a portable tank is de
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6.7.5.3.3 For filling and discharge
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6.7.5.10 MEGC supports, frameworks,
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the inspection and test, the test p
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CHAPTER 6.8 REQUIREMENTS FOR THE DE
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6.8.4.3 Vehicles shall comply with
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8. Characteristics of test contents
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oken, missing or otherwise inoperat
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(c) Inform the appropriate public h
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TS-R-1 UN 101 1.5.1.1 102 X 103 1.1
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TS-R-1 UN 667 6.4.10.1 668 6.4.10.2
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