F18SCHEDULE A1Restricted substances referred to in regulation 3 and maximum concentration values tolerated by weight in homogeneous materials

Regulation 3

Annotations:
Amendments (Textual)

  • Lead (0.1%)

  • Mercury (0.1%)

  • F7Cadmium (0.01%)

  • Hexavalent chromium (0.1%)

  • Polybrominated biphenyls (PBB) (0.1%)

  • Polybrominated diphenyl ethers (PBDE) (0.1%)

  • Bis (2-ethylexyl) phthalate (DEHP) (0.1%)

  • Butyl benzyl phthalate (BBP) (0.1%)

  • Dibutyl phthalate (DBP) (0.1%)

  • Diisobutyl phthalate (DIBP) (0.1%)

  • The restriction of DEHP, BBP, DBP and DIBP does not apply to—

    1. a

      F17...

    2. b

      F13...

    3. c

      cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22nd July 2019.

  • The restriction of DEHP, BBP and DBP does not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex 17 to Regulation (EC) No 1907/2006.

C1F20SCHEDULE A2Applications exempted from the restriction in regulation 3(1)

Regulation 3

Annotations:
Amendments (Textual)
Modifications etc. (not altering text)

The tables of exempted applications1

In this Schedule—

a

Table 1 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in EEE, F8...

b

Table 2 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in spare parts for EEE F11with no expiry date.

Interpretation of the tables

2

The following provisions apply for the purposes of interpreting Tables 1 and 2.

3

In Table 1, in the column headed “corresponding EU exemption”, a reference to a numbered Annex, followed by another number, is a reference to the exemption with that number in that Annex to Directive 2011/65/EU.

4

In Tables 1 and 2, in the column headed “categories of EEE to which exemption applies”, the entries indicate the categories of EEE to which an exemption applies, as follows—

a

a number from 1 to 11, which is not followed by any letters, means the category of EEE with that number in Part 1 of Schedule 1;

b

“8iv” and “8x” are sub-categories of category 8 (medical devices) with the following meanings—

i

8iv means in vitro diagnostic medical devices;

ii

8x means medical devices, other than in vitro diagnostic medical devices;

c

“9ind” and “9x” are sub-categories of category 9 (monitoring and control instruments) with the following meanings—

i

9ind means industrial monitoring and control instruments;

ii

9x means monitoring and control instruments, other than for industrial use.

5

In Table 1, in the column headed “expiry date or status”—

a

a date, in relation to an exemption and a category of EEE, is the expiry date of the exemption for that category of EEE, that is, the date on which the exemption expires subject to regulation 5(8) of the 2020 Regulations;

b

“transitional case”, in relation to an exemption and a category of EEE, means that the exemption for that category of EEE is a transitional case for the purposes of regulation 10 of the 2020 Regulations.

6

For the purposes of entries 1 to 9 in Table 1 (entries related to lighting) a lamp is for “general lighting purposes” if it is designed for the purpose of illuminating a room or space in order to provide or improve visibility, and it is for “special purposes” if it is designed for any other purpose.

7

In paragraph 5, “the 2020 Regulations” means the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020.

Table 1Table of exempted applications

No.

Application

Maximum quantity exempted (if any)

Corresponding EU exemption

Categories of EEE to which exemption applies

Expiry date or status

1

Mercury in single capped (compact) fluorescent lamps:

1.1

For general lighting purposes < 30 W

2.5 mg per burner

Annex 3, 1(a)

all categories

transitional case

1.2

For general lighting purposes ≥ 30 W and < 50 W

3.5 mg per burner

Annex 3, 1(b)

all categories

transitional case

1.3

For general lighting purposes ≥ 50 W and < 150 W

5 mg per burner

Annex 3, 1(c)

all categories

transitional case

1.4

For general lighting purposes ≥ 150 W

15 mg per burner

Annex 3, 1(d)

all categories

transitional case

1.5

For general lighting purposes with circular or square structural shape and tube diameter ≤ 17 mm

7 mg per burner

Annex 3, 1(e)

all categories

transitional case

1.6

For special purposes

5 mg per burner

Annex 3, 1(f)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

1.7

For general lighting purposes < 30 W with a lifetime equal or above 20,000 h

3.5 mg per burner

Annex 3, 1(g)

all categories

transitional case

2

Mercury in double-capped linear fluorescent lamps for general lighting purposes:

2.1

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter < 9 mm (e.g. T2)

4 mg per lamp

Annex 3, 2(a)(1)

all categories

transitional case

2.2

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5)

3 mg per lamp

Annex 3, 2(a)(2)

all categories

transitional case

2.3

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 17 mm and ≤ 28 mm (e.g. T8)

3.5 mg per lamp

Annex 3, 2(a)(3)

all categories

transitional case

2.4

Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 28 mm (e.g. T12)

3.5 mg per lamp

Annex 3, 2(a)(4)

all categories

transitional case

2.5

Tri-band phosphor with long lifetime (≥ 25,000 h)

5 mg per lamp

Annex 3, 2(a)(5)

all categories

transitional case

3

Mercury in other fluorescent lamps:

3.1

Non-linear tri-band phosphor lamps with tube diameter > 17 mm (e.g. T9).

15 mg per lamp

Annex 3, 2(b)(3)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

3.2

Lamps for other general lighting and special purposes (e.g. induction lamps).

15 mg per lamp

Annex 3, 2(b)(4)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4

Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for special purposes:

4.1

Short length (≤ 500 mm)

3.5 mg per lamp

Annex 3, 3(a)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4.2

Medium length (> 500 mm and ≤ 1500 mm)

5 mg per lamp

Annex 3, 3(b)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

4.3

Long length (> 1500 mm)

13 mg per lamp

Annex 3, 3(c)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

5

Mercury in other low pressure discharge lamps.

15 mg per lamp

Annex 3, 4(a)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

6

Mercury in High Pressure Sodium (vapour) lamps for general lighting purposes in lamps with improved colour rendering index Ra > 60:

6.1

P ≤ 155 W

30 mg per burner

Annex 3, 4(b)-I

all categories

transitional case

6.2

155 W < P ≤ 405 W

40 mg per burner

Annex 3, 4(b)-II

all categories

transitional case

6.3

P > 405 W

40 mg per burner

Annex 3, 4(b)-III

all categories

transitional case

7

Mercury in other High Pressure Sodium (vapour) lamps for general lighting purposes:

7.1

P ≤ 155 W

25 mg per burner

Annex 3, 4(c)-I

all categories

transitional case

7.2

155 W < P ≤ 405 W

30 mg per burner

Annex 3, 4(c)-II

all categories

transitional case

7.3

P > 405 W

40 mg per burner

Annex 3, 4(c)-III

all categories

transitional case

8

Mercury in metal halide lamps.

Annex 3, 4(e)

1–7, 10

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

9

Mercury in other discharge lamps for special purposes not specifically mentioned in another entry in this Table.

Annex 3, 4(f)

1-7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

10

Lead in glass of cathode ray tubes.

Annex 3, 5(a)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

11

Lead in glass of fluorescent tubes.

0.2% lead by weight

Annex 3, 5(b)

1–7, 10

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

12

Lead as an alloying element in steel for machining purposes and in galvanised steel.

0.35% lead by weight

Annex 3, 6(a)

8, 9

transitional case

11

21st July 2024

13

Lead as an alloying element in steel for machining purposes.

0.35% lead by weight

Annex 3, 6(a)-I

1-7, 10

transitional case

14

Lead as an alloying element in batch hot dip galvanised steel components.

0.2% lead by weight

Annex 3, 6(a)-I

1-7, 10

transitional case

15

Lead as an alloying element in aluminium.

0.4% lead by weight

Annex 3, 6(b)

8, 9

transitional case

11

21st July 2024

16

Lead as an alloying element in aluminium, provided it stems from lead-bearing aluminium scrap recycling.

0.4% lead by weight

Annex 3, 6(b)-I

1-7, 10

transitional case

17

Lead as an alloying element in aluminium for machining purposes.

0.4% lead by weight

Annex 3, 6(b)-II

1-7, 10

transitional case

18

Copper alloy containing lead.

4% lead by weight

Annex 3, 6(c)

1-10

transitional case

11

21st July 2024

19

Lead in high melting temperature type solders, i.e. lead-based alloys containing 85% by weight or more lead.

This entry does not apply to applications covered by entry 42.

Annex 3, 7(a)

1-10

transitional case

11

21st July 2024

20

Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission, and network management for telecommunications.

Annex 3, 7(b)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

21

Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound.

This entry does not apply to applications covered by entry 49.

Annex 3, 7(c)-I

1-10

transitional case

11

21st July 2024

22

Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher.

This entry does not apply to applications covered by entry 21 or 23.

Annex 3, 7(c)-II

1 – 10

transitional case

11

21st July 2024

23

Lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors.

Annex 3, 7(c)-IV

1-7, 8x, 9x, 10

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

24

Cadmium and its compounds in electrical contacts.

Annex 3, 8(b)

8, 9

transitional case

11

21st July 2024

25

Cadmium and its compounds in electrical contacts used in:

— circuit breakers,

— thermal sensing controls,

— thermal motor protectors (excluding hermetic thermal motor protectors),

— AC switches rated at:

  1. a

    6 A and more at 250 V AC and more, or

  2. b

    12 A and more at 125 V AC and more,

— DC switches rated at 20 A and more at 18 V DC and more, and

— switches for use at voltage supply frequency ≥ 200 Hz.

Annex 3, 8(b)-I

1-7, 10

transitional case

26

Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75 % by weight in the cooling solution.

Annex 3, 9

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

27

Lead in bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications.

Annex 3, 9(b)

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

28

Lead in white glasses used for optical applications.

Annex 3, 13(a)

all categories

transitional case

29

Cadmium and lead in filter glasses and glasses used for reflectance standards.

Annex 3, 13(b)

8, 9, 11

transitional case

30

Lead in ion coloured optical filter glass types.

Annex 3, 13(b)-(I)

1-7, 10

transitional case

31

Cadmium in striking optical filter glass types.

Annex 3, 13(b)-(II)

1-7, 10

transitional case

32

Cadmium and lead in glazes used for reflectance standards.

Annex 3, 13(b)-(III)

1-7, 10

transitional case

33

Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages.

Annex 3, 15

8, 9

transitional case

11

21st July 2024

34

Lead in solders to complete a viable electrical connection between the semiconductor die and carrier within integrated circuit flip chip packages where at least one of the following criteria applies:

— a semiconductor technology node of 90 nm or larger;

— a single die of 300 mm² or larger in any semi-conductor technology node;

— stacked die packages with die of 300 mm² or larger, or silicon interposers of 300mm2 or larger.

Annex 3, 15(a)

1–7, 10

transitional case

35

Lead halide as radiant agent in high intensity discharge (HID) lamps used for professional reprography applications.

Annex 3, 17

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

36

Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used as sun tanning lamps.

1% lead by weight or less

Annex 3, 18(b)

1–7, 8x, 9x, 10

transitional case

8iv

21st July 2023

9ind, 11

21st July 2024

37

Lead as activator in the fluorescent powder of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment.

This entry does not apply to applications covered by entry 88.

1% lead by weight or less

Annex 3, 18(b)-I

5, 8

transitional case

38

Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.

Annex 3, 21

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

39

Cadmium when used in colour printed glass to provide filtering functions, used as a component in lighting applications installed in displays and control panels of EEE.

Annex 3, 21(a)

1–7, 10

21st July 2021

40

Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.

Annex 3, 21(b)

1–7, 10

21st July 2021

41

Lead in printing inks for the application of enamels on other than borosilicate glasses.

Annex 3, 21(c)

1–7, 10

21st July 2021

42

Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors.

Annex 3, 24

1–10

transitional case

11

21st July 2024

43

Lead oxide in surface conduction electron emitter displays (SED) used in structural elements, notably in the seal frit and frit ring.

Annex 3, 25

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

44

Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC(1).

Annex 3, 29

1–7, 10, 11

transitional case

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

45

Cadmium alloys as electrical/mechanical solder joints to electrical conductors located directly on the voice coil in transducers used in high-powered loudspeakers with sound pressure levels of 100 dB (A) and more.

Annex 3, 30

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

46

Lead in soldering materials in mercury free flat fluorescent lamps (which e.g. are used for liquid crystal displays, design or industrial lighting).

Annex 3, 31

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

47

Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes.

Annex 3, 32

1–7, 8x, 9, 10

transitional case

8iv

21st July 2023

11

21st July 2024

48

Lead in solders for the soldering of thin copper wires of 100 μm diameter and less in power transformers.

Annex 3, 33

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

49

Lead in cermet-based trimmer potentiometer elements.

Annex 3, 34

1–10

transitional case

11

21st July 2024

50

Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass body.

Annex 3, 37

1–7, 8x, 9x, 10

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

51

Cadmium and cadmium oxide in thick film pastes used on aluminium bonded beryllium oxide.

Annex 3, 38

8x, 9x

21st July 2021

8iv

21st July 2023

9ind, 11

21st July 2024

52

Cadmium selenide in downshifting cadmium-based semiconductor nanocrystal quantum dots for use in display lighting applications (< 0.2 μg Cd per mm² of display screen area).

Annex 3, 39(a)

all categories

transitional case

53

Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (category NRSh in Regulation (EU) 2016/1628 of the European Parliament and of the Council(2)).

Annex 3, 41

1–7, 10, 11

31st March 2022

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

54

Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:

— with engine total displacement ≥ 15 litres; or

— with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.

This entry does not apply to applications covered by entry 18.

Annex 3, 42

8x, 9x

transitional case

11

21st July 2024

55

Bis(2-ethylhexyl) phthalate in rubber components in engine systems, designed for use in equipment that is not intended solely for consumer use and provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin.

This entry applies where the concentration value of bis(2-ethylhexyl) phthalate does not exceed:

30 % by weight of the rubber for:

gasket coatings;

solid-rubber gaskets; or

rubber components included in assemblies of at least three components using electrical, mechanical or hydraulic energy to do work, and attached to the engine.

10% by weight of the rubber for rubber-containing components not referred to in point (a).

For the purposes of this entry, ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.

Annex 3, 43

9ind

15th July 2023

11

21st July 2024

56

Lead in solder of sensors, actuators, and engine control units of combustion engines within the scope of Regulation (EU) 2016/1628 of the European Parliament and of the Council, installed in equipment used at fixed positions while in operation which is designed for professionals, but also used by non-professional users.

Annex 3, 44

11

21st July 2024

57

Lead, cadmium and mercury in detectors for ionising radiation.

Annex 4, 1

8x, 9x, 9ind

transitional case

8iv

21st July 2023

58

Lead bearings in X-ray tubes.

Annex 4, 2

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

59

Lead in electromagnetic radiation amplification devices:

micro-channel plate and capillary plate.

Annex 4, 3

8, 9

transitional case

60

Lead in glass frit of X-ray tubes and image intensifiers and lead in glass frit binder for assembly of gas lasers and for vacuum tubes that convert electromagnetic radiation into electrons.

Annex 4, 4

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

61

Lead in shielding for ionising radiation.

Annex 4, 5

8x, 9

transitional case

8iv

21st July 2023

62

Lead in X-ray test objects.

Annex 4, 6

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

63

Lead stearate X-ray diffraction crystals.

Annex 4, 7

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

64

Radioactive cadmium isotope source for portable X-ray fluorescence spectrometers.

Annex 4, 8

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

65

Lead and cadmium in ion selective electrodes including glass of pH electrodes.

Annex 4, 1a

8x, 9

transitional case

8iv

21st July 2023

66

Lead anodes in electrochemical oxygen sensors.

Annex 4, 1b

8x, 9

transitional case

8iv

21st July 2023

67

Lead, cadmium and mercury in infra-red light detectors.

Annex 4, 1c

8, 9

transitional case

68

Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate and mercury oxide.

Annex 4, 1d

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

69

Cadmium in helium-cadmium lasers.

Annex 4, 9

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

70

Lead and cadmium in atomic absorption spectroscopy lamps.

Annex 4, 10

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

71

Lead in alloys as a superconductor and thermal conductor in MRI.

Annex 4, 11

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

72

Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors.

Annex 4, 12

8x, 9

transitional case

8iv

30th June 2021

73

Lead in counterweights.

Annex 4, 13

8x, 9x

transitional case

38iv

21st July 2023

9ind

21st July 2024

74

Lead in single crystal piezoelectric materials for ultrasonic transducers.

Annex 4, 14

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

75

Lead in solders for bonding to ultrasonic transducers.

Annex 4, 15

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

76

Mercury in very high accuracy capacitance and loss measurement bridges and in high frequency RF switches and relays in monitoring and control instruments.

20mg of mercury per switch or relay

Annex 4, 16

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

77

Lead in solders in portable emergency defibrillators.

Annex 4, 17

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

78

Lead in solders of high performance infrared imaging modules to detect in the range 8-14 μm.

Annex 4, 18

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

79

Lead in liquid crystal on silicon (LCoS) displays.

Annex 4, 19

8x, 9x

21st July 2021

8iv

21st July 2023

9ind

21st July 2024

80

Cadmium in X-ray measurement filters.

Annex 4, 20

8x, 9x

transitional case

8iv

21st July 2023

9ind

21st July 2024

81

Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment.

Annex 4, 22

8, 9

30th June 2021

82

Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation.

Annex 4, 23

8, 9

30th June 2021

83

Lead in the surface coatings of pin connector systems. requiring nonmagnetic connectors which are used durably at a temperature below –20 °C under normal operating and storage conditions.

Annex 4, 25

8, 9

30th June 2021

84

Lead in the following applications that are used durably at a temperature below –20 °C under normal operating and storage conditions:

  1. a

    solders on printed circuit boards;

  2. b

    termination coatings of electrical and electronic components and coatings of printed circuit boards;

  3. c

    solders for connecting wires and cables;

  4. d

    solders connecting transducers and sensors.

Lead in solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below –150 °C.

Annex 4, 26

8x, 9

transitional case

8iv

30th June 2021

85

Lead in:

— solders,

— termination coatings of electrical and electronic components and printed circuit boards,

— connections of electrical wires, shields and enclosed connectors,

which are used in:

  1. a

    magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or

  2. b

    magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.

Annex 4, 27

8, 9x

transitional case

86

Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices or in industrial monitoring and control instruments.

Annex 4, 29

8x

transitional case

8iv, 9ind

30th June 2021

87

Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer.

Annex 4, 31a

8, 9x

transitional case

9ind

21st July 2024

88

Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors.

Annex 4, 34

8, 9

22nd July 2021

89

Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017.

Annex 4, 35

9ind

21st July 2024

90

Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:

  1. a

    wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0.1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations;

  2. b

    measurements of solutions where an accuracy of +/– 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following:

    1. i

      solutions with an acidity < pH 1;

    2. ii

      solutions with an alkalinity > pH 13;

    3. iii

      corrosive solutions containing halogen gas;

  3. c

    measurements of conductivities above 100 mS/m that must be performed with portable instruments.

Annex 4, 37

8, 9

31st December 2025

91

Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:

  1. a

    a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;

  2. b

    a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:

    1. i

      a response time shorter than 25 ns;

    2. ii

      a sample detection area larger than 149 mm² ;

    3. iii

      a multiplication factor larger than 1.3 × 10³ .

  3. c

    a response time shorter than 5 ns for detecting electrons or ions;

  4. d

    a sample detection area larger than 314 mm² for detecting electrons or ions;

  5. e

    a multiplication factor larger than 4.0 × 107.

Annex 4, 39

8, 9

transitional case

92

Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.

Annex 4, 41

8iv

31st March 2022

93

Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.

Annex 4, 42

8x, 9x

F1230th June 2026

94

Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required.

Annex 4, 43

9ind

15th July 2023

95

Cadmium in radiation tolerant video camera tubes designed for cameras with a centre resolution greater than 450 TV lines which are used in environments with ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy.

Annex 4, 44

8x, 9

31st March 2027

F2196

Lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide in electric and electronic initiators of explosives for civil (professional) use and barium chromate in long time pyrotechnic delay charges of electric initiators of explosives for civil (professional) use

Annex 3, 45

11

20th April 2026

F197

Bis(2-ethylhexyl) phthalate (DEHP) in ion selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids.

Annex 4, 45

8

21st July 2028

98

Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils.

Annex 4, 46

8

1st January 2024

99

Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer.

Annex 4, 47

8

21st July 2028

(1)

OJ No L 326, 19.12.1969, p.36, as last amended by Council Directive 2006/96/EC (OJ No L 363, 20.12.2006, p.81).

(2)

EUR 2016/1628.

Table 2Table of exemptions for spare parts for EEE with no expiry date

No.

Application

Categories of EEE to which exemption applies

1

Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for EEE placed on the market before 1st January 2013.

all categories

2

Cadmium and its compounds in one shot pellet type thermal cut-offs, where used in spare parts for EEE placed on the market before 1st January 2012.

all categories

3

Lead used in C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

4

Lead used in other than C-press compliant pin connector systems, where used in spare parts for EEE placed on the market before 1st January 2013.

all categories

5

Lead as a coating material for the thermal conduction module C-ring, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

6

Lead in solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80% and less than 85% by weight, where used in spare parts for EEE placed on the market before 1st January 2011.

all categories

7

Lead in finishes of fine pitch components other than connectors with a pitch of 0.65 mm and less, where used in spare parts for EEE placed on the market before 24th September 2010.

all categories

8

Cadmium in phosphor coatings in image intensifiers for X-ray images, in spare parts for X-ray systems placed on the market before 1st January 2020.

8, 9

9

Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers, where used in spare parts for X-ray systems placed on the market before 1st January 2020.

8, 9

10

Lead used in other than C-press compliant pin connector systems, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021.

9ind

11

Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, where used in spare parts for industrial monitoring and control instruments placed on the market before 1st January 2021.

9ind

SCHEDULE 1

Regulation 5(1), (2) and (3)F15and regulation 12(1)

Annotations:
Amendments (Textual)

PART 1Categories of EEE to which these Regulations apply

1

Large household appliances.

2

Small household appliances.

3

IT and telecommunications equipment.

4

Consumer equipment.

5

Lighting equipment.

6

Electrical and electronic tools.

7

Toys, leisure and sports equipment.

8

Medical devices.

9

Monitoring and control instruments including industrial monitoring and control instruments.

10

Automatic dispensers.

11

Other EEE not covered by any of the categories above.

PART 2EEE to which these Regulations do not apply

E212

Equipment which is necessary for the protection of the essential interests of the security of F23the United Kingdom, including arms, munitions and war material intended for specifically military purposes.

E112

Equipment which is necessary for the protection of the essential interests of the security of F24the United Kingdom or member States, including arms, munitions and war material intended for specifically military purposes.

13

Equipment designed to be sent into space.

14

Equipment which is specifically designed, and is to be installed, as part of another type of equipment to which these Regulations do not apply, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment.

15

Large-scale stationary industrial tools being a large-scale assembly of machines, equipment, and/or components—

a

functioning together for a specific application;

b

permanently installed and de-installed by professionals at a given place; and

c

used and maintained by professionals in an industrial manufacturing facility or research and development facility.

16

Large-scale fixed installations being a large-scale combination of several types of apparatus and, where applicable, other devices, which are—

a

assembled and installed by professionals;

b

intended to be used permanently in a pre-defined and dedicated location; and

c

de-installed by professionals.

17

Means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved.

18

Non-road mobile machinery made available exclusively for professional use, being machinery, with an on-board power source F4or with a traction drive powered by an external power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use.

19

Active implantable medical devices.

20

Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications.

21

Equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

F1921A

Pipe organs.

PART 3Categories of EEE with special rules of application

22

Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply—

a

to medical devices and monitoring and control instruments placed on the market before 22nd July 2014;

b

to in vitro diagnostic medical devices placed on the market before 22nd July 2016; F14...

c

to industrial monitoring and control instruments placed on the market before 22nd July 2017; F6and

d

to all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019.

23

1

Regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following—

a

EEE placed on the market before 1st July 2006;

b

medical devices placed on the market before 22nd July 2014;

c

in vitro diagnostic medical devices placed on the market before 22nd July 2016;

d

monitoring and control instruments placed on the market before 22nd July 2014;

e

industrial monitoring and control instruments placed on the market before 22nd July 2017;

F2ea

all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019;

f

EEE which benefited from an exemption listed in the Directive or the F92002 Directive and which was placed on the market before that exemption expired, provided that the specific exemption concerned those cables or spare parts.

F52

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1624

Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer, regulations 3(1), 10, 15, 19, 20, 21, 22, 23, 25, 26, 27 and 28 do not apply to reused spare parts—

a

recovered from EEE placed on the market before 1st July 2006 and used in EEE placed on the market before 1st July 2016;

b

recovered from medical devices or monitoring and control instruments placed on the market before 22nd July 2014 and used in EEE placed on the market before 22nd July 2024;

c

recovered from in vitro diagnostic medical devices placed on the market before 22nd July 2016 and used in EEE placed on the market before 22nd July 2026;

d

recovered from industrial monitoring and control instruments placed on the market before 22nd July 2017 and used in EEE placed on the market before 22nd July 2027;

e

recovered from all other EEE that was outside the scope of the 2002 Directive and which is placed on the market before 22nd July 2019, and used in EEE placed on the market before 22nd July 2029.

F3PART 4Internal Production Control Procedure

Annotations:
Amendments (Textual)

25

The internal production control procedure is a conformity assessment procedure whereby a manufacturer must ensure EEE is manufactured in compliance with the technical documentation and with the applicable requirements of these Regulations.

26

The technical documentation must—

a

make it possible to assess the EEE's conformity with the applicable requirements of these Regulations, and must include an adequate analysis and assessment of the risks;

b

specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the EEE;

c

contain, where applicable, at least the following elements—

i

a general description of the EEE;

ii

conceptual design and manufacturing drawings and schemes of components, sub-assemblies;

iii

descriptions and explanations necessary for the understanding of those drawings and schemes, and the operation of the EEE;

iv

a list of the designated standards applied in full or in part (where applicable specifying the parts which have been applied);

v

where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied;

vii

results of design calculations made, examinations carried out and

viii

test reports.

F22SCHEDULE 1ADeclaration of conformity

Regulation 14(2)

Annotations:
Amendments (Textual)

1

Declaration of conformity (unique identification of the EEE):

2

Name and address of the manufacturer or, where applicable, authorised representative:

3

This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4

Object of the declaration (identification of EEE allowing traceability: it may include a photograph, where appropriate):

5

The object of the declaration described above is in conformity with relevant statutory requirements:

6

Where applicable, references to the relevant designated standards used or references to the technical specifications in relation to which conformity is declared:

7

Additional information:

Signed for and on behalf of:

place and date of issue:

name, function) (signature:

SCHEDULE 2Test purchases, powers of entry etc and warrants

Regulation 36(a)

Test purchases1

1

The market surveillance authority may purchase EEE for the purpose of ascertaining whether the requirements of these Regulations have been complied with in respect of it.

2

If—

a

EEE which has been purchased under sub-paragraph (1) or seized under paragraph 3(1)(c) of this Schedule is submitted to a test;

b

the test leads to the bringing of proceedings for an offence under regulation 37 or the serving of a compliance, enforcement or recall notice; and

c

a person—

i

from whom the EEE was purchased;

ii

who is a party to the proceedings; or

iii

who has an interest in EEE which is identified as an infringing EEE in a compliance enforcement or recall notice,

requests the market surveillance authority to allow that person to have the EEE tested,

the authority must, if it is practicable for such a test to be carried out, allow that person to have the EEE tested.

Power to enter premises2

1

An authorised person may enter premises, except any premises used wholly or mainly as a private dwelling, at any reasonable hour, for the purpose of enforcing these Regulations.

2

Before entering the premises an authorised person must give reasonable notice, unless the authorised person has a reasonable suspicion of a failure to comply with these Regulations.

3

An authorised person must, if requested to do so, produce a written authorisation document.

4

An authorised person may—

a

be accompanied by—

i

such other persons as the authorised person considers necessary,

F10ii

any representative of the European Commission; and

b

bring on to the premises such equipment as the authorised person considers necessary.

Power to inspect, seize and detain EEEetc3

1

An authorised person may—

a

in order to ascertain if any provision of these Regulations has not been complied with—

i

inspect any EEE, products, goods, substances, records, documents or information;

ii

on entering any premises whether under a power of entry under paragraph 2 or under a warrant under paragraph 4, make such examination or investigation as is necessary;

b

in order to ascertain if any provision of these Regulations has not been complied with, require any person carrying on or employed in connection with a business to produce any EEE, products, goods, substances, records, documents or information and take copies of—

i

any document or record; or

ii

any entry in any document or record;

c

in order to ascertain by testing or otherwise if any provision of these Regulations has not been complied with, and reasonably suspecting such non-compliance, seize and detain any EEE, products, goods, substances, records, documents or information;

d

seize and detain any EEE, products, goods, substances, records, documents or information which may be required as evidence in any proceedings under these Regulations;

e

for the purposes of exercising any powers or duties under these Regulations or RAMS, but only if and to the extent reasonably necessary in order to secure that the provisions of these Regulations are complied with, require any person having authority to do so to break open any container and, if that person does not comply or if there is no person present having authority to open it, break it open using reasonable force.

2

An authorised person may require information stored electronically to be made available in printed form.

3

An authorised person entering any premises whether under a power of entry under paragraph 2 or under a warrant under paragraph 4 must, if the occupier is present, give to the occupier or, if the occupier is absent, leave in a prominent place a notice—

a

summarising the authorised person’s powers of seizure and detention of EEE, products, goods, substances, records, documents and information;

b

disclosing at which office of the market surveillance authority and within which hours a copy of these Regulations is available to be consulted.

4

An authorised person entering any premises which are unoccupied or from which the occupier is temporarily absent must leave them as effectively secured against unauthorised entry as they were before entry.

5

An authorised person exercising any power of seizure and detention must—

a

give to the person against whom the power has been exercised a notice stating what has been seized and detained;

b

detain those things only for as long as is necessary for the market surveillance authority to ascertain whether any provision of these Regulations has not been complied with and, if required, to present the evidence at court.

6

Nothing in this paragraph compels the production by any person of a document which that person would be entitled to withhold production of in any proceedings in any court on the grounds that it is the subject of legal professional privilege or, in Scotland, that it contains a confidential communication made by or to an advocate or solicitor in that capacity.

Warrants4

1

A justice of the peace may by signed warrant permit an authorised person or any other person to enter any premises in the exercise of the powers and duties under these Regulations or Article 19 of RAMS, if necessary by reasonable force, if the justice in England and Wales on sworn information in writing, in Northern Ireland on a complaint on oath, or in Scotland by evidence on oath is satisfied—

a

that there are reasonable grounds to enter those premises for the purposes of enforcing these Regulations; and

b

that any of the conditions in sub-paragraph (3) is met.

2

Reference to a justice of the peace—

a

in Scotland includes a sheriff;

b

in Northern Ireland is a reference to a lay magistrate.

3

The conditions are—

a

entry to the premises has been, or is likely to be, refused and notice of the intention to apply for a warrant has been given to the occupier;

b

asking for admission to the premises, or giving such a notice, would defeat the object of the entry;

c

entry is required urgently;

d

the premises are unoccupied or the occupier is temporarily absent.

4

A warrant under sub-paragraph (1) is valid for one month.

SCHEDULE 3Compliance, enforcement and recall notices

Regulation 36(b)

Compliance notice1

1

The market surveillance authority may serve a notice under this paragraph on an economic operator who makes EEE available on the market if the authority has reasonable grounds for believing—

a

the EEE is an infringing product; or

b

the economic operator has failed to comply with its obligations under regulation 15, 19, 25 or 27(1).

2

A compliance notice must—

a

describe the alleged infringing EEE (the “specified EEE”) or alleged failure to comply with the obligations set out in sub-paragraph 1(b) (the “alleged breach”) in a manner sufficient to identify it; and

b

state the exact grounds on which the notice is based.

3

A compliance notice may—

a

require the economic operator in an appropriate case, and having regard to the economic operator’s ability to take the measures in light of that person’s position in the supply chain, to remedy the situation or matters which gave rise to the authority’s belief that the specified EEE was an infringing EEE or an alleged breach had occurred; or

b

where it is not possible for the specified EEE to cease to be an infringing EEE, require the economic operator to secure that the specified EEE is withdrawn or that its being made available on the market is prohibited or restricted.

4

A compliance notice must tell the economic operator—

a

what compliance is required and the period within which it must be completed;

b

to give the authority evidence that the economic operator has complied with the notice;

c

the consequences of failing to comply with the notice; and

d

the rights of appeal against the notice under these Regulations and any time limits for their exercise.

5

Proceedings must not be commenced against a person under regulation 37 in respect of an alleged contravention of a requirement of these Regulations where—

a

a compliance notice has been served on that person in respect of the alleged contravention; and

b

the specified compliance period in that notice has not come to an end.

Enforcement notice2

1

Where the market surveillance authority serves a compliance notice on an economic operator and, at the end of the compliance period specified in the notice—

a

it appears to the authority that that person has failed to comply with the notice; and

b

the authority has reasonable grounds for considering that the specified EEE is an infringing EEE or that an alleged breach has occurred,

the authority may serve an enforcement notice on that person.

2

An enforcement notice must—

a

describe the specified EEE or alleged breach in a manner sufficient to identify it; and

b

state the exact grounds on which the notice is based.

3

An enforcement notice may—

a

require the economic operator in an appropriate case, and having regard to the economic operator’s ability to take the measures in light of that person’s position in the supply chain, to remedy the situation or matters which gave rise to the authority’s belief that the specified EEE was an infringing EEE or that an alleged breach has occurred; or

b

require the economic operator to secure that the specified EEE is withdrawn or that its being made available on the market is prohibited or restricted.

4

An enforcement notice must tell the economic operator—

a

what compliance is required and the period within which it must be completed;

b

to give the authority evidence that the economic operator has complied with the notice;

c

the consequences of failing to comply with the notice; and

d

the rights of appeal against the notice under these Regulations and any time limits for their exercise.

5

Proceedings must not be commenced against a person under regulation 37 (Offences) in connection with any specified EEE which it is alleged is an infringing EEE where—

a

an enforcement notice has been served on that person in respect of the specified EEE; and

b

the compliance period specified in that notice has not come to an end.

6

In this paragraph “specified EEE” means the alleged infringing EEE that has been identified in a compliance notice in accordance with paragraph 1(2)(a).

Supplementary provisions in relation to compliance and enforcement notices3

1

The market surveillance authority must comply with the provisions of Article 21 of RAMS in relation to the serving of a compliance or enforcement notice which imposes any requirements to secure that EEE is withdrawn from the market or that its being made available on the market is prohibited or restricted.

2

Where the market surveillance authority has served a compliance notice or enforcement notice under this Schedule, the authority—

a

must keep the notice under review and may withdraw or revoke it at any time;

b

may vary the notice, provided it is not made more restrictive for the economic operator or more onerous for that person to comply with.

Recall notices4

1

The market surveillance authority may serve a recall notice on an economic operator if the authority has reasonable grounds for believing that EEE is—

a

an infringing EEE presenting a serious risk by reason of that infringement; and

b

that it has already been supplied or made available to end users.

2

A recall notice is a notice which requires the economic operator to use reasonable endeavours to organise the return of the EEE from end users to the economic operator or another person specified in the notice.

3

The provisions of—

a

regulation 15 of the General Product Safety Regulations 200516 (“GPSR”); and

b

Article 21 of RAMS,

apply in relation to the serving of a recall notice under these Regulations.

4

For the purposes of serving a recall notice under this paragraph, regulation 15 of the GPSR applies as if—

a

references to the provisions of the GPSR were references to those provisions as modified by this paragraph and to these Regulations;

b

references to an “enforcement authority” were references to the market surveillance authority;

c

references to the product being “a dangerous product” were references to the EEE being an infringing EEE presenting a serious risk by reason of that infringement;

d

references to risks to the health and safety of persons were references to the serious risk presented by the EEE;

e

paragraphs (9) and (10) were omitted.

5

In this paragraph—

a

“serious risk” means a serious risk to health, safety, the environment, consumers, or security, requiring rapid intervention, including a serious risk the effects of which are not immediate;

b

The decision whether or not an EEE presents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of an occurrence;

c

The feasibility of obtaining higher levels of safety or the availability of other EEEs presenting a lesser degree of risk shall not constitute grounds for considering that an EEE presents a serious risk.

Action by the market surveillance authority5

1

The market surveillance authority may itself take action which an economic operator could have been required to take by a compliance, an enforcement or recall notice where the conditions for serving such a notice are met and either—

a

the authority has been unable to identify any economic operator on whom to serve such a notice; or

b

the person on whom such a notice has been served has failed to comply with it.

2

If the market surveillance authority has taken action under paragraph (1) following the failure of an economic operator to comply with a compliance, enforcement or recall notice, the authority may recover from that person as a civil debt any costs or expenses reasonably incurred by the authority in taking the action.

3

A civil debt recoverable under the preceding paragraph may be recovered summarily—

a

in England and Wales by way of complaint pursuant to section 58 of the Magistrates’ Courts Act 198017;

b

in Northern Ireland in proceedings under article 62 of the Magistrates’ Court (Northern Ireland) Order 198118.

Compensation provisions relating to compliance, enforcement and recall notices6

Where the market surveillance authority serves a compliance, enforcement or recall notice, the authority is liable to pay compensation to a person in respect of any loss or damage suffered by that person by reason of the notice if—

a

the EEE is not an infringing EEE or the alleged breach is not a breach; and

b

the exercise by the authority of the power to serve the notice was not attributable to neglect or default by the person.

Appeals against compliance, enforcement and recall notices7

1

An application for an order to vary or set aside the terms of a compliance, enforcement or recall notice may be made—

a

in the case of a compliance, enforcement or recall notice, by the economic operator on whom the notice has been served; and

b

in the case of a compliance or enforcement notice, by a person having an interest in the product in respect of which that notice has been served.

2

An application must be made before the end of the period of 21 days beginning with the day on which the notice was served.

3

The appropriate court (as determined in accordance with paragraph 8) may only make an order setting aside a compliance, enforcement or recall notice if satisfied—

a

that the EEE is not an infringing EEE;

b

that the alleged breach is not a breach; or

c

that the serving of the notice was not proportionate.

4

On an application to vary the terms of a compliance, enforcement or recall notice, the appropriate court may vary the terms of the notice as it considers appropriate.

Appropriate court for appeals against notices etc and further appeals8

1

In England and Wales or Northern Ireland the appropriate court for the purposes of paragraph 7 is—

a

the court in which proceedings have been brought for an offence under regulation 37(1)(a), (2)(a) or (3)(a) or paragraph 9 of this Schedule; or

b

in any other case a magistrates’ court in England and Wales or Northern Ireland.

2

In Scotland the appropriate court for the purposes of paragraph 7 is the sheriff for a sheriff court district in which a compliance, enforcement or recall notice has been served on an economic operator.

3

A person aggrieved by an order made by a magistrates’ court in England, Wales or Northern Ireland19 pursuant to an application under paragraph 7(1), or by a decision of such a court not to make such an order, may appeal against that order or decision—

a

in England and Wales, to the Crown Court;

b

in Northern Ireland, to the county court.

Offences and penalties9

1

It is an offence for any person to contravene or fail to comply with any of the requirements of—

a

an enforcement notice; or

b

a recall notice.

2

A person convicted of an offence under sub-paragraph (1) is liable—

a

on summary conviction, to a fine not exceeding the statutory maximum;

b

on conviction on indictment, to a fine.