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Commission Implementing Regulation (EU) No 402/2013Show full title
Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance)
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- 2013 No. 402
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Changes to legislation:
There are outstanding changes not yet made to Commission Implementing Regulation (EU) No 402/2013. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the affected provisions when you open the content using the Table of Contents below.
Changes and effects yet to be applied to :
- Art. 1 omitted by S.I. 2019/837 reg. 16(2)
- Art. 1 omitted by S.I. 2019/837 reg. 21(2)
- Art. 2(1) words substituted by S.I. 2019/837 reg. 16(3)(a)
- Art. 2(1) words substituted by S.I. 2019/837 reg. 21(3)(a)
- Art. 2(3) words substituted by S.I. 2019/837 reg. 16(3)(b)(i)
- Art. 2(3) words substituted by S.I. 2019/837 reg. 21(3)(b)(i)
- Art. 2(4) word substituted by S.I. 2019/837, reg. 16(3)(c)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(a)
- Art. 2(4) word substituted by S.I. 2019/837, reg. 21(3)(c)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(a)
- Art. 2(4) words substituted by S.I. 2019/837 reg. 16(3)(c) (This amendment not applied to legislation.gov.uk. Reg. 16(3)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(a))
- Art. 2(4) words substituted by S.I. 2019/837 reg. 21(3)(c) (This amendment not applied to legislation.gov.uk. Reg. 21(3)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(a))
- Art. 2(4) words substituted by S.I. 2019/837, reg. 16(3)(c)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(a)
- Art. 2(4) words substituted by S.I. 2019/837, reg. 21(3)(c)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(a)
- Art. 2(5) omitted by S.I. 2019/837 reg. 16(3)(d)
- Art. 2(5) omitted by S.I. 2019/837 reg. 21(3)(d)
- Art. 2(6) omitted by S.I. 2019/837 reg. 16(3)(d)
- Art. 2(6) omitted by S.I. 2019/837 reg. 21(3)(d)
- Art. 3 substituted by S.I. 2019/837 reg. 16(4)
- Art. 3 substituted by S.I. 2019/837 reg. 21(4)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(i)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(ii)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(iii)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(iv)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(i)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(ii)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(iii)
- Art. 3 words inserted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(iv)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(v)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(vi)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(viii)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(v)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(vi)
- Art. 3 words omitted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(viii)
- Art. 3 words substituted in earlier amending provision S.I. 2019/837, reg. 16(4) by S.I. 2019/1310 reg. 7(4)(b)(vii)
- Art. 3 words substituted in earlier amending provision S.I. 2019/837, reg. 21(4) by S.I. 2019/1310 reg. 7(7)(b)(vii)
- Art. 4(1) words substituted by S.I. 2019/837 reg. 16(6)
- Art. 4(1) words substituted by S.I. 2019/837 reg. 21(6)
- Art. 6 words omitted by S.I. 2019/837 reg. 16(7)(j) (This amendment not applied to legislation.gov.uk. Reg. 16(7)(j) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(ii))
- Art. 6 words omitted by S.I. 2019/837 reg. 21(7)(j) (This amendment not applied to legislation.gov.uk. Reg. 21(7)(j) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(ii))
- Art. 6 words omitted by virtue of S.I. 2019/837, reg. 16(7)(j)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(c)(ii)
- Art. 6 words omitted by virtue of S.I. 2019/837, reg. 21(7)(j)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(c)(ii)
- Art. 6 words substituted by S.I. 2019/837, reg. 16(7)(j)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(c)(ii)
- Art. 6 words substituted by S.I. 2019/837, reg. 21(7)(j)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(c)(ii)
- Art. 6(1) words omitted by S.I. 2019/837 reg. 16(7)(a)
- Art. 6(1) words omitted by S.I. 2019/837 reg. 21(7)(a)
- Art. 6(4) word substituted by S.I. 2019/837 reg. 16(7)(d)
- Art. 6(4) word substituted by S.I. 2019/837 reg. 21(7)(d)
- Art. 7 words omitted by S.I. 2019/837 reg. 16(8)(a)
- Art. 7 words omitted by S.I. 2019/837 reg. 21(8)(a)
- Art. 7 words substituted by S.I. 2019/837 reg. 16(8)(b)
- Art. 7 words substituted by S.I. 2019/837 reg. 21(8)(b)
- Art. 8(1) words inserted by S.I. 2019/837 reg. 21(9)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 21(9)(a) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(d)(i))
- Art. 8(1) words substituted by S.I. 2019/837 reg. 16(9)(a) (This amendment not applied to legislation.gov.uk. Reg. 16(9)(a) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(d)(i))
- Art. 8(1) words substituted by S.I. 2019/837 reg. 21(9)(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 21(9)(a) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(d)(i))
- Art. 8(1) words substituted by S.I. 2019/837, reg. 16(9)(a)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(d)(i)
- Art. 8(1) words substituted by S.I. 2019/837, reg. 16(9)(a)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(d)(i)
- Art. 8(1) words substituted by S.I. 2019/837, reg. 21(9)(a)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(d)(i)
- Art. 8(1) words substituted by S.I. 2019/837, reg. 21(9)(a)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(d)(i)
- Art. 8(2) omitted by S.I. 2019/837 reg. 21(9)(b)
- Art. 8(2) words inserted by S.I. 2019/837 reg. 16(9)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 16(9)(b)(ii) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(d)(ii))
- Art. 8(2) words substituted by S.I. 2019/837 reg. 16(9)(b)(i)
- Art. 8(2) words substituted by S.I. 2019/837, reg. 16(9)(b) (as substituted) by S.I. 2019/1310 reg. 7(4)(d)(ii)
- Art. 9(2) omitted by S.I. 2019/837 reg. 16(10)(d)
- Art. 9(2) omitted by S.I. 2019/837 reg. 21(10)(d)
- Art. 10(1) words substituted by S.I. 2019/837 reg. 16(11)(a)
- Art. 10(1) words substituted by S.I. 2019/837 reg. 21(11)(a)
- Art. 10(3) omitted by S.I. 2019/837 reg. 21(11)(c)
- Art. 12-14 omitted by S.I. 2019/837 reg. 16(12)
- Art. 12-14 omitted by S.I. 2019/837 reg. 21(12)
- Art. 15(3) word substituted by S.I. 2019/837 reg. 16(13) (This amendment not applied to legislation.gov.uk. Reg. 16(13) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(e))
- Art. 15(3) word substituted by S.I. 2019/837 reg. 21(13) (This amendment not applied to legislation.gov.uk. Reg. 21(13) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(e))
- Art. 15(3) word substituted by S.I. 2019/837, reg. 16(13)(a) (as substituted) by S.I. 2019/1310 reg. 7(4)(e)
- Art. 15(3) word substituted by S.I. 2019/837, reg. 21(13)(a) (as substituted) by S.I. 2019/1310 reg. 7(7)(e)
- Art. 15(4) words substituted by S.I. 2019/837, reg. 16(13)(b)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(e)
- Art. 15(4) words substituted by S.I. 2019/837, reg. 16(13)(b)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(e)
- Art. 15(4) words substituted by S.I. 2019/837, reg. 21(13)(b)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(e)
- Art. 15(4) words substituted by S.I. 2019/837, reg. 21(13)(b)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(e)
- Art. 17(1) words substituted by S.I. 2019/837 reg. 16(14)(a)
- Art. 17(1) words substituted by S.I. 2019/837 reg. 21(14)(a)
- Art. 17(2) words substituted by S.I. 2019/837 reg. 16(14)(b)
- Art. 17(2) words substituted by S.I. 2019/837 reg. 21(14)(b)
- Art. 17(3) word substituted by S.I. 2019/837 reg. 16(14)(c)(i)
- Art. 17(3) word substituted by S.I. 2019/837 reg. 21(14)(c)(i)
- Art. 17(3) words omitted by S.I. 2019/837 reg. 21(14)(c)(ii)
- Art. 17(3) words substituted by S.I. 2019/837 reg. 16(14)(c)(ii)
- Art. 17(4) omitted by S.I. 2019/837 reg. 21(14)(d)
- Art. 17(4) words substituted by S.I. 2019/837 reg. 16(14)(d)
- Art. 18(1) words substituted by S.I. 2019/837 reg. 16(15)(a)
- Art. 18(1) words substituted by S.I. 2019/837 reg. 21(15)(a)
- Art. 18(2) omitted by S.I. 2019/837 reg. 16(15)(b)
- Art. 18(2)-(6) omitted by S.I. 2019/837 reg. 21(15)(b)
- Art. 18(3) words omitted by S.I. 2019/837 reg. 16(15)(c)(ii)
- Art. 18(3) words substituted by S.I. 2019/837 reg. 16(15)(c)(i)
- Art. 18(4) omitted by S.I. 2019/837 reg. 16(15)(d)
- Art. 18(5) omitted by S.I. 2019/837 reg. 16(15)(d)
- Art. 18(6) omitted by S.I. 2019/837 reg. 16(15)(d)
- Art. 19 omitted by S.I. 2019/837 reg. 16(16)
- Art. 19 omitted by S.I. 2019/837 reg. 21(16)
- Art. 20 words omitted by S.I. 2019/837 reg. 16(17)
- Art. 20 words omitted by S.I. 2019/837 reg. 21(17)
Changes and effects yet to be applied to the whole legislation item and associated provisions
- Sch. 10 para. 31 word substituted in earlier amending provision S.I. 2019/837, Sch. by S.I. 2019/1310 reg. 7(8)(a)
- Annex 1 point 2.5.10 omitted by S.I. 2019/837 reg. 16(18)(h)
- Annex 1 point 2.5.10 omitted by S.I. 2019/837 reg. 21(18)(h)
- Annex 1 point 2.5.2-2.5.8 word omitted by S.I. 2019/837 reg. 16(18)(f)
- Annex 1 point 2.5.5-2.5.8 word omitted by S.I. 2019/837 reg. 21(18)(f)
- Annex 1 point 2.3.3 word omitted by virtue of S.I. 2019/837, reg. 16(18)(c)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(g)(iii)
- Annex 1 point 1.2.1 word substituted by S.I. 2019/837, reg. 16(18)(bb) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(ii)
- Annex 1 point 2.3.3 word substituted by S.I. 2019/837, reg. 16(18)(c)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(g)(iii)
- Annex 1 point 1.2.1 word substituted by S.I. 2019/837, reg. 21(18)(bb) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(ii)
- Annex 1 point 2.3.3 word substituted by S.I. 2019/837, reg. 21(18)(c)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(g)(iii)
- Annex 1 point 2.3.3 word substituted by S.I. 2019/837, reg. 21(18)(c)(iii) (as substituted) by S.I. 2019/1310 reg. 7(7)(g)(iii)
- Annex 1 point 2.3.3 word substituted byS.I. 2019/837, reg. 16(18)(c)(iii) (as substituted) by S.I. 2019/1310 reg. 7(4)(g)(iii)
- Annex 1 point 2.3.3 words omitted by S.I. 2019/837 reg. 16(18)(c) (This amendment not applied to legislation.gov.uk. Reg. 16(18)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(iii))
- Annex 1 point 2.5.6 words omitted by S.I. 2019/837 reg. 16(18)(g)(i)
- Annex 1 point 2.5.6 words omitted by S.I. 2019/837 reg. 16(18)(g)(ii)
- Annex 1 point 2.5.11 words omitted by S.I. 2019/837 reg. 16(18)(i)(iii)
- Annex 1 point 2.3.3 words omitted by S.I. 2019/837 reg. 21(18)(c) (This amendment not applied to legislation.gov.uk. Reg. 21(18)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(iii))
- Annex 1 point 2.5.6 words omitted by S.I. 2019/837 reg. 21(18)(g)(i)
- Annex 1 point 2.5.6 words omitted by S.I. 2019/837 reg. 21(18)(g)(ii)
- Annex 1 point 2.5.11 words omitted by S.I. 2019/837 reg. 21(18)(i)(iii)
- Annex 1 point 2.3.4 words omitted by virtue of S.I. 2019/837, reg. 16(18)(cc) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(iv)
- Annex 1 point 2.3.3 words omitted by virtue of S.I. 2019/837, reg. 21(18)(c)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(g)(iii)
- Annex 1 point 2.3.4 words omitted by virtue of S.I. 2019/837, reg. 21(18)(cc) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(iv)
- Annex 1 point 1.1.4(a) words substituted by S.I. 2019/837 reg. 16(18)(a)
- Annex 1 point 1.1.5 words substituted by S.I. 2019/837 reg. 16(18)(b)
- Annex 1 point 2.4.2(a) words substituted by S.I. 2019/837 reg. 16(18)(d)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837 reg. 16(18)(e) (This amendment not applied to legislation.gov.uk. Reg. 16(18)(e) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(v))
- Annex 1 point 2.5.11 words substituted by S.I. 2019/837 reg. 16(18)(i)(i)
- Annex 1 point 2.5.11 words substituted by S.I. 2019/837 reg. 16(18)(i)(ii)
- Annex 1 point 1.1.4(a) words substituted by S.I. 2019/837 reg. 21(18)(a)
- Annex 1 point 1.1.5 words substituted by S.I. 2019/837 reg. 21(18)(b)
- Annex 1 point 2.4.2(a) words substituted by S.I. 2019/837 reg. 21(18)(d)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837 reg. 21(18)(e) (This amendment not applied to legislation.gov.uk. Reg. 21(18)(e) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(v))
- Annex 1 point 2.5.11 words substituted by S.I. 2019/837 reg. 21(18)(i)(i)
- Annex 1 point 2.5.11 words substituted by S.I. 2019/837 reg. 21(18)(i)(ii)
- Annex 1 point 1.1.4(b) words substituted by S.I. 2019/837, reg. 16(18)(aa)(i) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(i)
- Annex 1 point 1.1.4(b) words substituted by S.I. 2019/837, reg. 16(18)(aa)(ii) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(i)
- Annex 1 point 1.2.6 words substituted by S.I. 2019/837, reg. 16(18)(bc) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(ii)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837, reg. 16(18)(e)(i) (as substituted) by S.I. 2019/1310 reg. 7(4)(g)(v)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837, reg. 16(18)(e)(ii) (as substituted) by S.I. 2019/1310 reg. 7(4)(g)(v)
- Annex 1 point 2.5.5 words substituted by S.I. 2019/837, reg. 16(18)(ff) (as inserted) by S.I. 2019/1310 reg. 7(4)(g)(iv)
- Annex 1 point 1.1.4(b) words substituted by S.I. 2019/837, reg. 21(18)(aa)(i) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(i)
- Annex 1 point 1.1.4(b) words substituted by S.I. 2019/837, reg. 21(18)(aa)(ii) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(i)
- Annex 1 point 1.2.6 words substituted by S.I. 2019/837, reg. 21(18)(bc) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(ii)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837, reg. 21(18)(e)(i) (as substituted) by S.I. 2019/1310 reg. 7(7)(g)(v)
- Annex 1 point 2.5.2 words substituted by S.I. 2019/837, reg. 21(18)(e)(ii) (as substituted) by S.I. 2019/1310 reg. 7(7)(g)(v)
- Annex 1 point 2.5.5 words substituted by S.I. 2019/837, reg. 21(18)(ff) (as inserted) by S.I. 2019/1310 reg. 7(7)(g)(vi)
- Annex 2 para. 2 word substituted by S.I. 2019/837 reg. 16(19)
- Annex 2 para. 2 words omitted by S.I. 2019/837 reg. 21(19)
- Art. 2(3)(a) omitted by S.I. 2019/837 reg. 16(3)(b)(ii)
- Art. 2(3)(a) omitted by S.I. 2019/837 reg. 21(3)(b)(ii)
- Art. 2(3)(b) words omitted by S.I. 2019/837 reg. 16(3)(b)(iii)
- Art. 2(3)(b) words omitted by S.I. 2019/837 reg. 21(3)(b)(iii)
- Art. 3A inserted by S.I. 2019/837 reg. 16(5)
- Art. 3A inserted by S.I. 2019/837 reg. 21(5)
- Art. 3A(1)(a) words inserted by 2020 c. 29 Sch. 4 para. 21(a)
- Art. 3A(3A) inserted by 2020 c. 29 Sch. 4 para. 21(b)
- Art. 3A(5) word inserted by 2020 c. 29 Sch. 4 para. 21(c)(i)
- Art. 3A(5) words inserted by 2020 c. 29 Sch. 4 para. 21(c)(ii)
- Art. 6(3)(a) words substituted by S.I. 2019/837 reg. 16(7)(b)
- Art. 6(3)(a) words substituted by S.I. 2019/837 reg. 21(7)(b)
- Art. 6(3)(b) words substituted by S.I. 2019/837 reg. 16(7)(c) (This amendment not applied to legislation.gov.uk. Reg. 16(7)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(i))
- Art. 6(3)(b) words substituted by S.I. 2019/837 reg. 21(7)(c) (This amendment not applied to legislation.gov.uk. Reg. 21(7)(c) substituted immediately before IP completion day by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(i))
- Art. 6(3)(b) words substituted by S.I. 2019/837, reg. 16(7)(c) (as substituted) by S.I. 2019/1310 reg. 7(4)(c)(i)
- Art. 6(3)(b) words substituted by S.I. 2019/837, reg. 21(7)(c) (as substituted) by S.I. 2019/1310 reg. 7(7)(c)(i)
- Art. 6(4)(a) words omitted by S.I. 2019/837 reg. 16(7)(e)
- Art. 6(4)(a) words omitted by S.I. 2019/837 reg. 21(7)(e)
- Art. 6(4)(b) words omitted by S.I. 2019/837 reg. 16(7)(e)
- Art. 6(4)(b) words omitted by S.I. 2019/837 reg. 21(7)(e)
- Art. 6(4)(c) words omitted by S.I. 2019/837 reg. 16(7)(f)
- Art. 6(4)(c) words omitted by S.I. 2019/837 reg. 21(7)(f)
- Art. 6(4)(d) words omitted by S.I. 2019/837 reg. 16(7)(g)
- Art. 6(4)(d) words omitted by S.I. 2019/837 reg. 21(7)(g)
- Art. 6(4)(e) words omitted by S.I. 2019/837 reg. 16(7)(h)
- Art. 6(4)(e) words omitted by S.I. 2019/837 reg. 21(7)(h)
- Art. 6(4)(f) words omitted by S.I. 2019/837 reg. 16(7)(i)
- Art. 6(4)(f) words omitted by S.I. 2019/837 reg. 21(7)(i)
- Art. 9(1)(a) words inserted by S.I. 2019/837 reg. 16(10)(a)
- Art. 9(1)(a) words inserted by S.I. 2019/837 reg. 21(10)(a)
- Art. 9(1)(c) omitted by S.I. 2019/837 reg. 21(10)(b)
- Art. 9(1)(c) words omitted by S.I. 2019/837 reg. 16(10)(b)
- Art. 9(1)(d) words substituted by S.I. 2019/837 reg. 16(10)(c)
- Art. 9(1)(d) words substituted by S.I. 2019/837 reg. 21(10)(c)
- Art. 10(2)(a) words substituted by S.I. 2019/837 reg. 16(11)(b)
- Art. 10(2)(a) words substituted by S.I. 2019/837 reg. 21(11)(b)
- Art. 10(3)(a) words substituted by S.I. 2019/837 reg. 16(11)(c)
Article 12.Relaxed criteria where a significant change is not to be mutually recognised
Article 14.Support from the Agency to accreditation or recognition of the assessment body
1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS
1.1. General principles and obligations
1.1.1. The risk management process shall start from a definition of...
1.1.2. The risk management process shall include appropriate quality assurance activities...
1.1.3. The proposer in charge of the risk management process shall...
1.1.4. The actors who already have in place methods or tools...
1.1.5. Without prejudice to civil liability in accordance with the legal...
1.1.6. The first step of the risk management process shall be...
1.1.7. Evaluation of the correct application of the risk management process...
1.2.1. For each interface relevant to the system under assessment and...
1.2.2. If, in order to fulfil a safety requirement, an actor...
1.2.3. For the system under assessment, any actor who discovers that...
1.2.4. The actor implementing the safety measure shall then inform all...
1.2.5. When agreement cannot be reached between two or more actors...
1.2.6. When a requirement in a notified national rule cannot be...
1.2.7. Independently from the definition of the system under assessment, the...
2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS
2.1.1. The risk assessment process is the overall iterative process that...
2.1.2. The system definition shall address at least the following issues:...
2.1.3. A hazard identification shall be carried out on the defined...
2.1.4. The risk acceptability of the system under assessment shall be...
2.1.5. The proposer shall demonstrate in the risk evaluation that the...
2.1.6. The application of these risk acceptance principles shall identify possible...
2.1.7. The iterative risk assessment process is considered to be completed...
2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a...
2.2.2. To focus the risk assessment efforts upon the most important...
2.2.3. As a criterion, risks resulting from hazards may be classified...
2.2.4. During the hazard identification, safety measures may be identified. They...
2.2.5. The hazard identification only needs to be carried out at...
2.2.6. Whenever a code of practice or a reference system is...
2.3. Use of codes of practice and risk evaluation
2.3.1. The proposer, with the support of other involved actors, shall...
2.3.2. The codes of practice shall satisfy at least the following...
2.3.3. Where compliance with TSIs is required by Directive 2008/57/EC and...
2.3.4. National rules notified in accordance with Article 8 of Directive...
2.3.6. Where an alternative approach is not fully compliant with a...
2.3.7. If the risk for a particular hazard cannot be made...
2.3.8. When all hazards are controlled by codes of practice, the...
2.4. Use of reference system and risk evaluation
2.4.1. The proposer, with the support of other involved actors, shall...
2.4.2. A reference system shall satisfy at least the following requirements:...
2.4.3. If a reference system fulfils the requirements listed in point...
2.4.4. If the system under assessment deviates from the reference system,...
2.4.5. If at least the same safety level as the reference...
2.5. Explicit risk estimation and evaluation
2.5.2. The acceptability of the estimated risks shall be evaluated using...
2.5.3. If the risk associated with one hazard or a combination...
2.5.4. The proposer shall not be obliged to perform additional explicit...
2.5.5. Where hazards arise as a result of failures of functions...
2.5.6. Without prejudice to points 2.5.1 and 2.5.4, the harmonised design...
2.5.7. The risk associated with the failures of functions of technical...
2.5.8. The following specific definitions shall apply in reference to the...
2.5.9. Where the failure of a function of the technical system...
2.5.10. Without prejudice to either the procedure specified in Article 8...
2.5.11. Where a technical system is developed on the basis of...
2.5.12. The explicit risk estimation and evaluation shall satisfy at least...
5. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS
CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY
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