Government Decree on the conformity assessment of packaging, tanks and bulk containers used for the transport of dangerous goods

NB: Unofficial translation; legally binding only in Finnish and Swedish Ministry of Transport and Communications of Finland Government Decree on the conformity assessment of packaging, tanks and bulk containers used for the transport of dangerous goods (326/2005) (302/2001, amendments up to 265/2009 included) ————— Section 1 Scope of application (1) This Decree issues more detailed provisions on the assessment of conformity of packagings, tanks and bulk containers used for the transport of dangerous goods than the Act on the Transport of Dangerous Goods (719/1994) as well as on the inspection bodies performing the tasks relating to the assessment and on their tasks. (326/2005) (2) The provisions of this Decree on transportable pressure equipment, including valves and other accessories, shall also apply to transportable pressure equipment, including valves and other accessories, used in waterway transport or air transport of dangerous goods. Section 2 (326/2005) Definitions (1) For the purposes of this Decree: 1) an inspection body means the inspection body referred to in section 3 (1) (9) of the Act on the Transport of Dangerous Goods; 2) the Ministry means the Ministry of Transport and Communications; 3) the Directive on transportable pressure equipment means Council Directive 1999/36/EC on transportable pressure equipment; 4) transportable pressure equipment means tanks and packagings which are transportable pressure equipment referred to in the Directive on transportable pressure equipment, including their valves and other accessories; 5) the ADR Agreement means the European Agreement concerning International Carriage of Dangerous Goods by Road (Treaty Series of the Statutes of Finland 23/1979) as in force and binding on Finland; (265/2009) 2 6) the RID Regulations mean the regulations concerning the international carriage of dangerous goods by rail provided in Appendix C to the Convention concerning International Carriage by Rail (COTIF) (Treaty Series of the Statutes of Finland 52/2006) as in force and binding on Finland; (265/2009) 7) the IMDG Regulations mean the provisions defined in Appendix VII, Chapter A, Part 1 of the International Convention for the Safety of Life at Sea adopted in 1974 (Treaty Series of the Statutes of Finland 11/1981), which contains provisions on the transport of dangerous goods by sea in packaged form; 8) the ICAO-TI mean the technical instructions published as standards under the Convention on International Civil Aviation (Treaty Series of the Statutes of Finland 11/1949); 9) Member States mean Member States of the European Union and the States belonging to the European Economic Area; 10) the CSC Convention means the International Convention for Safe Containers adopted in 1972 (Treaty Series of the Statutes of Finland 111/1999); 11) a bulk container means a bulk container referred to in Chapter 6.11 of Annex A of the Decree of the Ministry of Transport and Communications on the Transport of Dangerous Goods by Road (171/2009) and in Chapter 6.11 of the Annex to the Decree of the Ministry of Transport and Communications on the Transport of Dangerous Goods by Rail (172/2009) or a corresponding container meant for waterway transport of goods in packaged form; (265/2009) 12) a UN pressure receptacle means a UN-approved cylinder, tube, pressure drum, closed cryogenic receptacle or bundle of cylinders. (2) Information on the regulations referred to in subsection 1 (7) shall be issued by the Finnish Maritime Administration and on the instructions referred to in subsection (1) (8) by the Civil Aviation Administration. Section 3 (326/2005) Conformity assessment of a packaging, a tank and a bulk container (1) Conformity of a packaging and a tank used for the transport of dangerous goods shall be assessed by testing the packaging and tank and by approving its structure type unless otherwise provided for in a Decree of the Ministry on the transport of dangerous goods by road or by rail or in a Decision of the Civil Aviation Administration or the Finnish Maritime Administration or in international conventions binding on Finland. 3 (2) In derogation from subsection 1, the conformity of transportable pressure equipment shall be assessed by conformity assessment or reassessment. (3) In addition to the provisions of subsections 1 and 2, the continuous conformity of a packaging and a tank put into service shall be established, where necessary, with periodic inspections performed at set intervals and provided for by a Decree of the Ministry or by a Decision of the Civil Aviation Administration or the Finnish Maritime Administration and with other inspections. (4) The right to use a package and a tank in Finland approved abroad shall be governed by the provisions of Government Decree on the Transport of Dangerous Goods (194/2002), Government Decree on the Transport of Dangerous Goods by Rail (195/2002), the Decree on the Transport of Dangerous Goods in Packaged Form by Sea (666/1998) and the Decree on the Transport of Dangerous Goods by Air (210/1997). (5) The conformity of a bulk container other than one in accordance with the CSC Convention shall be assessed by approving its structure type unless otherwise provided for by the Decrees referred to in section 2 (1) (11) or by a Decision of the Finnish Maritime Administration. A bulk container in accordance with the CSC Convention shall be approved in accordance with the CSC Convention. Section 4 Pressure equipment meant for waterway and air transport The obligations of the party placing equipment on the market referred to in section 13 b (1) of the Act on Transport of Dangerous Goods and others referred to in subsection 2 of the said section shall also apply to transportable pressure equipment meant for waterway and air transport. Section 5 (326/2005) Conformity marking of a packaging, a tank and a bulk container The conformity markings of a packaging, a tank and a bulk container shall, with regard to road and rail transport, be in compliance with the Decrees referred to in section 2 (1) (11), with regard to waterway transport of goods in packaged form, with the IMDG Regulations and, with regard to transport 4 by air, with the ICAO-TI Instructions. Section 6 Conformity marking of transportable pressure equipment (1) The conformity of a receptacle and a tank belonging to transportable pressure equipment shall be indicated, in addition to the requirements of section 5, by affixing visibly and immovably to the equipment the mark referred to in Annex VII of the Directive on transportable pressure equipment accompanied by the identification number of the notified body which has performed the conformity assessment procedure or, in the event of reassessment of equipment, the identification number of the notified body or, in the case referred to in section 11, paragraph 2, of the approved body. (2) New valves and other accessories having a direct safety function shall bear either the mark provided for in Annex VII referred to in subsection 1 or the CE mark referred to in section 2, paragraph 2 of the Act on Pressure Equipment (869/1999), which may be accompanied by the identification number of the notified body. (3) For the assessment of continuous conformity of transportable pressure equipment, the equipment shall bear the number of the inspection body that performed the periodic inspection indicating that it has undergone periodic inspection. (4) If the conformity assessment of transportable pressure equipment has been performed by an inspection body referred to in section 13 d (2) of the Act on Transport of Dangerous Goods, the mark provided for in Annex VII referred to in subsection 1 may not be affixed to the equipment. (5) If the transportable pressure equipment, with regard to its technical requirements, corresponds to any technical requirements set out in the IMDG Regulations or in the ICAO-TI instructions that are not in compliance with the provisions issued for the implementation of Directive 2008/68/EC of the European Parliament and of the Council on the inland transport of dangerous goods, the mark provided for in Annex VII referred to in subsection 1 may not be affixed to the transportable pressure equipment. (265/2009) (6) The affixing of markings on transportable pressure equipment, which misleadingly resemble the markings to be affixed to the equipment in 5 accordance with provisions and regulations, shall be prohibited. Section 7 Declaration of conformity of transportable pressure equipment The manufacturer or its authorised representative established within the Member States shall draw up a written declaration of conformity to ensure and declare that the transportable pressure equipment is in compliance with the provisions issued therefore. The declaration of conformity shall include the information required of a declaration of conformity in Standard SFS-EN 45014. Section 8 Inspection bodies The inspection bodies are the VAK inspection body, the VAK inspection body for periodic inspections, an inspection body recognised by the Finnish Centre for Radiation and Nuclear Safety, a notified body and an approved body. Section 9 The tasks of the VAK inspection body and the VAK inspection body for periodic inspections (1) With the exception of tasks relating to packagings and tanks used for the transport of gases belonging to class 2, substances belonging under UN numbers 1051, 1052 and 1790 as well as of radioactive materials, the VAK inspection body shall perform the tasks for which it has been recognised: 1) approvals of packagings; 2) approvals of tanks; 3) periodic inspections of packagings and tanks; 4) inspections required of packagings and tanks other than those referred to in paragraph 3 and other tasks required of conformity assessment; 5) approvals, inspections and other tasks required of the conformity assessment of bulk containers other than those in accordance with the CSC Convention; 6) approvals, inspections and other tasks required of the conformity assessment of packagings, tanks and bulk containers other than those in 6 accordance with the CSC Convention referred to in the annexes of the ADR Agreement; 7) approvals, inspections and other tasks required of the conformity assessment of packagings, tanks and bulk containers other than those in accordance with the CSC Convention referred to in the annex of the RID Regulations; 8) approvals, inspections and other tasks required of the conformity assessment of packagings, tanks and bulk containers other than those in accordance with the CSC Convention referred to in the IMDG Regulations; 9) approvals, inspections and other tasks required of the conformity assessment of packagings and tanks referred to in the ICAO-TI. (326/2005) (2) With the exception of tasks relating to gases of class 2, substances of UN numbers 1051, 1052 and 1790 or to packaging and tanks used for the transport of radioactive substances, the VAK inspection body for periodic inspections may perform periodic inspections of packaging as well as other inspections provided for packaging, for which it has been recognised. (282/2003) Section 10 (326/2005) Tasks of a notified body The notified body shall perform the tasks for which it has been recognised such as: 1) conformity assessments of transportable pressure equipment as well as related assessments and approvals of the quality system as well as related control; 2) conformity reassessment of transportable pressure equipment; 3) reassessment of conformity to type of receptacles manufactured in series, including their valves and other accessories; 4) periodic inspections of transportable pressure equipment; 5) inspections provided for transportable pressure equipment other than those referred to in paragraph 4; 6) assessments and approvals of the quality system relating to the periodic inspection of transportable pressure equipment as well as related control; 7) approvals and inspections of pressure receptacles and pressurized tanks other than transportable pressure equipment used for the transport of class 2 gases as well as substances belonging under UN numbers 1051, 1052 and 1790 as well as approvals of the quality system of the manufacture of these 7 receptacles and tanks with the exception of the recognition of the inspection body; 8) periodic inspections of UN pressure receptacles used for the transport of class 2 gases. Section 11 (326/2005) Tasks of an approved body The approved body shall perform the tasks for which it has been recognised such as: 1) periodic inspections of receptacles, including their valves and other accessories, belonging to transportable pressure equipment; 2) periodic inspections of UN pressure receptacles used for the transport of class 2 gases; 3) conformity reassessment of receptacles manufactured in series, including their valves and other accessories, belonging to transportable pressure equipment if a notified body has performed the reassessment of conformity to type of the equipment. Section 12 Packaging and tanks used for the transport of radioactive substances (1) The Finnish Centre for Radiation and Nuclear Safety shall, with regard to packaging and tanks used for the transport of radioactive substances, perform the following: 1) the approvals required; 2) the approvals required in the annexes of the ADR Agreement; 3) the approvals required in the annex of the RID Regulations; 4) the approvals required in the IMDG Regulations; 5) the approvals required in the ICAO-TI. (2) The testing, periodic inspections and other examinations required of packaging and tanks used for the transport of radioactive substances shall be carried out by the Finnish Centre for Radiation and Nuclear Safety or an inspection body recognised by it. 8 Section 13 Detailed criteria for the recognition of an inspection body (1) The criteria for the recognition of an inspection body shall be governed by the provisions of section 13 e of the Act on Transport of Dangerous Goods. In addition, the inspection body shall have appropriate procedures to be applied when handling rectification requests relating to refusal of conformity. (2) The criteria set out in Annexes 1 and 2 shall be complied with in the recognition of an inspection body as well as the criteria set out in Annexes 1 and 3 in the recognition of an approved body. If the notified body performs the periodic inspections referred to in section 10 (8) or if the approved body performs the periodic inspections referred to in section 11 (2), the inspection body shall have a quality system approved by an authority recognized by the body provided for further in the Decrees of the Ministry referred to in section 2 (1) (11) or regulated further by a Decision of the Civil Aviation Administration or the Finnish Maritime Administration. (326/2005) (3) The criteria set out in Annexes 4 and 5 shall be complied with in the recognition of the VAK inspection body as well as the criteria set out in Annexes 4 and 6 in the recognition of the VAK inspection body for periodic inspections. (4) The recognition of an inspection body recognised by the Finnish Centre for Radiation and Nuclear Safety shall be governed, where applicable, by the criteria set out in Annexes 4 and 6. Section 14 Application for recognition of an inspection body (1) The recognition of an inspection body shall be applied for in writing from the authority to the competence of which the recognition falls. The application shall be appended with the documents evidencing compliance with the criteria referred to section 13 e of the Act on Transport of Dangerous Goods and in section 13 of this Decree. A certificate or a statement of the Centre for Metrology and Accreditation or a corresponding organisation or another certificate or statement indicating compliance with the criteria deemed sufficient by the authority recognising the body shall be 9 appended to the documents. (2) If the inspection body has already been recognised for the tasks relating to the conformity assessment of packaging and tanks used for the transport of dangerous goods, the certificates, statements and other accounts presented in connection with the recognition may be taken into account in recognising the inspection body for new tasks. Section 15 Recognition of an inspection body (1) The Ministry shall recognise an inspection body as a notified body for the purpose of carrying out the tasks referred to in section 10 or as an approved body for the purpose of carrying out the tasks referred to in section 11 if the body meets the criteria provided therefore. (2) If an inspection body meets the criteria provided therefor, the Safety Technology Authority shall: 1) recognise the inspection body as a VAK inspection body to carry out the tasks referred to in section 9 (1) within the scope of the application on packagings, tanks and bulk containers other than those in accordance with the CSC Convention; 2) recognise the inspection body as a VAK inspection body for periodic inspections to carry out the inspections referred to in section 9 (2) within the scope of the application on packagings. (326/2005) Section 16 Performance of inspections (1) The inspection body and its staff shall carry out the assessments and other inspections with the highest degree of professional integrity and technical competence. (2) The inspection body shall itself perform the inspections which it contracts to undertake. It may, however, sub-contract a part of the tasks relating to conformity assessment to be performed by a sub-contractor. If the inspection body sub-contracts any part of its tasks, it shall ensure and be able to demonstrate that its sub-contractor is competent to perform the said task. 10 Section 17 Supervision of the operations of the inspection bodies (1) The inspection body shall submit an annual report of its operations to the authority responsible for the recognition of the said body. (2) If the Safety Technology Authority observes that a notified or approved body acts in violation of provisions, the Safety Technology Authority shall inform the Ministry of its observations. Section 18 Communications by the Ministry The Ministry shall be responsible to communicate to the European Commission as we as to the Member States of the European Union and the States belonging to the European Economic Area the bodies notified and approved in compliance with the Directive on transportable pressure equipment as well as their identification numbers issued by the Commission and any withdrawals of recognition. Section 19 Co-operation between the authorities If the supervisory authority prohibits the transport of dangerous goods under section 15 of the Act on Transport of Dangerous Goods because the transportable pressure equipment does not meet the requirements provided for in the said Act or the provisions or orders issued thereunder, the authority shall, without delay, inform the Safety Technology Authority thereof, which shall, where necessary, undertake the measures referred to in the said Act. Section 20 Entry into force (1) This Decree shall enter into force on 1 July 2001. Sections 13-15 and section 18 thereof shall, however, enter into force on 6 April 2001. (2) With regard to tanks, pressure drums and bundles of cylinders belonging to 11 transportable pressure equipment, including their valves and other accessories, section 3 (2) as well as sections 4, 6, 7, 10 and 11 shall, however, enter into force on 1 July 2005. (326/2005) (3) This Decree repeals the Decision of the Ministry of Transport on the authorities competent for the type-approval of packaging required in the international transport of dangerous goods by road of 23 February 1990 (201/1990) with later amendments. Section 21 Transitional provisions (1) Tanks and packaging complying with the provisions in force upon the entry into force of this Decree may continue to be used in Finland. (2) Gas cylinders, tubes and cryogenic receptacles, including their valves and other accessories, complying with the provisions in force upon the entry into force of this Decree may be placed on the market in Finland until 30 June 2003 as well as put into service here also thereafter if they have been placed on the market at the latest on the said date. (3) If a packaging or a tank belonging to transportable pressure vessels, including their valves and other accessories, referred to in subsections 1 and 2 is not made subject to conformity reassessment, the conformity marking must be in accordance with the provisions in force upon the entry into force of this Decree. Degree 326/2005; 19 May 2005: (1) This Decree enters into force on 1 June 2005. (2) Tanks, packagings and bulk containers complying with the provisions in force upon the entry into force of this Decree may continue to be used in Finland. (3) Tanks, pressure drums and bundles of cylinders belonging to transportable pressure equipment, including their valves and other accessories, complying with the provisions in force upon the entry into force of this Decree may be 12 placed on the market in Finland until 30 June 2007 as well as put into service here also thereafter if they have been placed on the market at the latest on the said date. (4) If a tank, a pressure drum or a bundle of cylinders belonging to transportable pressure equipment or their valves and other accessories, referred to in subsections 2 and 3, is not made subject to conformity reassessment, the conformity marking must be in accordance with the provisions in force upon the entry into force of this Decree. (5) If a notified body or an approved body begins to perform the periodic inspections of UN pressure receptacles referred to in section 10 (8) or section 11 (2), it shall, prior to commencing the operations, apply from the authority recognising the body for an extension of recognition for the said task. Decree 265/2009, 23 April 2009: This Decree enters into force on 1 May 2009.