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The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

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Regulation 3

[F1SCHEDULE A1E+W+SRestricted substances referred to in regulation 3 and maximum concentration values tolerated by weight in homogeneous materials

  • Lead (0.1%)

  • Mercury (0.1%)

  • [F2Cadmium (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—

    (a)

    F3...

    (b)

    F4...

    (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.]

Regulation 3

[F5SCHEDULE A2E+W+SApplications exempted from the restriction in regulation 3(1)

The tables of exempted applicationsE+W+S

1.  In this Schedule—

(a)Table 1 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in EEE, F6...

(b)Table 2 sets out exemptions from the restriction in regulation 3(1) for applications of restricted substances in spare parts for EEE [F7with no expiry date].

Interpretation of the tablesE+W+S

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 1

Table of exempted applications

No.ApplicationMaximum quantity exempted (if any)Corresponding EU exemptionCategories of EEE to which exemption appliesExpiry date or status
(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.

1Mercury in single capped (compact) fluorescent lamps:
1.1For general lighting purposes < 30 W2.5 mg per burnerAnnex 3, 1(a)all categoriestransitional case
1.2For general lighting purposes ≥ 30 W and < 50 W3.5 mg per burnerAnnex 3, 1(b)all categoriestransitional case
1.3For general lighting purposes ≥ 50 W and < 150 W5 mg per burnerAnnex 3, 1(c)all categoriestransitional case
1.4For general lighting purposes ≥ 150 W15 mg per burnerAnnex 3, 1(d)all categoriestransitional case
1.5For general lighting purposes with circular or square structural shape and tube diameter ≤ 17 mm7 mg per burnerAnnex 3, 1(e)all categoriestransitional case
1.6For special purposes5 mg per burnerAnnex 3, 1(f)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
1.7For general lighting purposes < 30 W with a lifetime equal or above 20,000 h3.5 mg per burnerAnnex 3, 1(g)all categoriestransitional case
2Mercury in double-capped linear fluorescent lamps for general lighting purposes:
2.1Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter < 9 mm (e.g. T2)4 mg per lampAnnex 3, 2(a)(1)all categoriestransitional case
2.2Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5)3 mg per lampAnnex 3, 2(a)(2)all categoriestransitional case
2.3Tri-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 categoriestransitional case
2.4Tri-band phosphor with normal lifetime (< 25,000 h) and a tube diameter > 28 mm (e.g. T12)3.5 mg per lampAnnex 3, 2(a)(4)all categoriestransitional case
2.5Tri-band phosphor with long lifetime (≥ 25,000 h)5 mg per lampAnnex 3, 2(a)(5)all categoriestransitional case
3Mercury in other fluorescent lamps:
3.1Non-linear tri-band phosphor lamps with tube diameter > 17 mm (e.g. T9).15 mg per lampAnnex 3, 2(b)(3)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
3.2Lamps for other general lighting and special purposes (e.g. induction lamps).15 mg per lampAnnex 3, 2(b)(4)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
4Mercury in cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFL and EEFL) for special purposes:
4.1Short length (≤ 500 mm)3.5 mg per lampAnnex 3, 3(a)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
4.2Medium length (> 500 mm and ≤ 1500 mm)5 mg per lampAnnex 3, 3(b)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
4.3Long length (> 1500 mm)13 mg per lampAnnex 3, 3(c)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
5Mercury in other low pressure discharge lamps.15 mg per lampAnnex 3, 4(a)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
6Mercury in High Pressure Sodium (vapour) lamps for general lighting purposes in lamps with improved colour rendering index Ra > 60:
6.1P ≤ 155 W30 mg per burnerAnnex 3, 4(b)-Iall categoriestransitional case
6.2155 W < P ≤ 405 W40 mg per burnerAnnex 3, 4(b)-IIall categoriestransitional case
6.3P > 405 W40 mg per burnerAnnex 3, 4(b)-IIIall categoriestransitional case
7Mercury in other High Pressure Sodium (vapour) lamps for general lighting purposes:
7.1P ≤ 155 W25 mg per burnerAnnex 3, 4(c)-Iall categoriestransitional case
7.2155 W < P ≤ 405 W30 mg per burnerAnnex 3, 4(c)-IIall categoriestransitional case
7.3P > 405 W40 mg per burnerAnnex 3, 4(c)-IIIall categoriestransitional case
8Mercury in metal halide lamps.Annex 3, 4(e)1–7, 10transitional case
8x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
9Mercury in other discharge lamps for special purposes not specifically mentioned in another entry in this Table.Annex 3, 4(f)1-7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st July 2024
10Lead in glass of cathode ray tubes.Annex 3, 5(a)8x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
11Lead in glass of fluorescent tubes.0.2% lead by weightAnnex 3, 5(b)1–7, 10transitional case
8x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
12Lead as an alloying element in steel for machining purposes and in galvanised steel.0.35% lead by weightAnnex 3, 6(a)8, 9transitional case
1121st July 2024
13Lead as an alloying element in steel for machining purposes.0.35% lead by weightAnnex 3, 6(a)-I1-7, 10transitional case
14Lead as an alloying element in batch hot dip galvanised steel components.0.2% lead by weightAnnex 3, 6(a)-I1-7, 10transitional case
15Lead as an alloying element in aluminium.0.4% lead by weightAnnex 3, 6(b)8, 9transitional case
1121st July 2024
16Lead as an alloying element in aluminium, provided it stems from lead-bearing aluminium scrap recycling.0.4% lead by weightAnnex 3, 6(b)-I1-7, 10transitional case
17Lead as an alloying element in aluminium for machining purposes.0.4% lead by weightAnnex 3, 6(b)-II1-7, 10transitional case
18Copper alloy containing lead.4% lead by weightAnnex 3, 6(c)1-10transitional case
1121st 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)1-10transitional case
1121st July 2024
20Lead 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, 9x21st July 2021
8iv21st July 2023
9ind, 1121st 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)-I1-10transitional case
1121st 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)-II1 – 10transitional case
1121st July 2024
23Lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors.Annex 3, 7(c)-IV1-7, 8x, 9x, 1021st July 2021
8iv21st July 2023
9ind, 1121st July 2024
24Cadmium and its compounds in electrical contacts.Annex 3, 8(b)8, 9transitional case
1121st 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:

(a)

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

(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)-I1-7, 10transitional case
26Hexavalent 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, 98x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
27Lead in bearing shells and bushes for refrigerant-containing compressors for heating, ventilation, air conditioning and refrigeration (HVACR) applications.Annex 3, 9(b)8x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
28Lead in white glasses used for optical applications.Annex 3, 13(a)all categoriestransitional case
29Cadmium and lead in filter glasses and glasses used for reflectance standards.Annex 3, 13(b)8, 9, 11transitional case
30Lead in ion coloured optical filter glass types.Annex 3, 13(b)-(I)1-7, 10transitional case
31Cadmium in striking optical filter glass types.Annex 3, 13(b)-(II)1-7, 10transitional case
32Cadmium and lead in glazes used for reflectance standards.Annex 3, 13(b)-(III)1-7, 10transitional case
33Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages.Annex 3, 158, 9transitional case
1121st 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, 10transitional case
35Lead halide as radiant agent in high intensity discharge (HID) lamps used for professional reprography applications.Annex 3, 178x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
36Lead 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 lessAnnex 3, 18(b)1–7, 8x, 9x, 10transitional case
8iv21st July 2023
9ind, 1121st 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 lessAnnex 3, 18(b)-I5, 8transitional case
38Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.Annex 3, 218x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
39Cadmium 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, 1021st July 2021
40Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses.Annex 3, 21(b)1–7, 1021st July 2021
41Lead in printing inks for the application of enamels on other than borosilicate glasses.Annex 3, 21(c)1–7, 1021st July 2021
42Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors.Annex 3, 241–10transitional case
1121st July 2024
43Lead oxide in surface conduction electron emitter displays (SED) used in structural elements, notably in the seal frit and frit ring.Annex 3, 258x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
44Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC(1).Annex 3, 291–7, 10, 11transitional case
8x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
45Cadmium 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, 308x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
46Lead in soldering materials in mercury free flat fluorescent lamps (which e.g. are used for liquid crystal displays, design or industrial lighting).Annex 3, 318x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
47Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes.Annex 3, 321–7, 8x, 9, 10transitional case
8iv21st July 2023
1121st July 2024
48Lead in solders for the soldering of thin copper wires of 100 μm diameter and less in power transformers.Annex 3, 338x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
49Lead in cermet-based trimmer potentiometer elements.Annex 3, 341–10transitional case
1121st July 2024
50Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass body.Annex 3, 371–7, 8x, 9x, 1021st July 2021
8iv21st July 2023
9ind, 1121st July 2024
51Cadmium and cadmium oxide in thick film pastes used on aluminium bonded beryllium oxide.Annex 3, 388x, 9x21st July 2021
8iv21st July 2023
9ind, 1121st July 2024
52Cadmium 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 categoriestransitional case
53Lead 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, 411–7, 10, 1131st March 2022
8x, 9x21st July 2021
8iv21st July 2023
9ind21st 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, 428x, 9xtransitional case
1121st 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, 439ind15th July 2023
1121st July 2024
56Lead 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, 441121st July 2024
57Lead, cadmium and mercury in detectors for ionising radiation.Annex 4, 18x, 9x, 9indtransitional case
8iv21st July 2023
58Lead bearings in X-ray tubes.Annex 4, 28x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
59

Lead in electromagnetic radiation amplification devices:

micro-channel plate and capillary plate.

Annex 4, 38, 9transitional case
60Lead 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, 48x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
61Lead in shielding for ionising radiation.Annex 4, 58x, 9transitional case
8iv21st July 2023
62Lead in X-ray test objects.Annex 4, 68x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
63Lead stearate X-ray diffraction crystals.Annex 4, 78x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
64Radioactive cadmium isotope source for portable X-ray fluorescence spectrometers.Annex 4, 88x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
65Lead and cadmium in ion selective electrodes including glass of pH electrodes.Annex 4, 1a8x, 9transitional case
8iv21st July 2023
66Lead anodes in electrochemical oxygen sensors.Annex 4, 1b8x, 9transitional case
8iv21st July 2023
67Lead, cadmium and mercury in infra-red light detectors.Annex 4, 1c8, 9transitional case
68Mercury in reference electrodes: low chloride mercury chloride, mercury sulphate and mercury oxide.Annex 4, 1d8x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
69Cadmium in helium-cadmium lasers.Annex 4, 98x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
70Lead and cadmium in atomic absorption spectroscopy lamps.Annex 4, 108x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
71Lead in alloys as a superconductor and thermal conductor in MRI.Annex 4, 118x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
72Lead 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, 128x, 9transitional case
8iv30th June 2021
73Lead in counterweights.Annex 4, 138x, 9xtransitional case
38iv21st July 2023
9ind21st July 2024
74Lead in single crystal piezoelectric materials for ultrasonic transducers.Annex 4, 148x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
75Lead in solders for bonding to ultrasonic transducers.Annex 4, 158x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
76Mercury 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 relayAnnex 4, 168x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
77Lead in solders in portable emergency defibrillators.Annex 4, 178x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
78Lead in solders of high performance infrared imaging modules to detect in the range 8-14 μm.Annex 4, 188x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
79Lead in liquid crystal on silicon (LCoS) displays.Annex 4, 198x, 9x21st July 2021
8iv21st July 2023
9ind21st July 2024
80Cadmium in X-ray measurement filters.Annex 4, 208x, 9xtransitional case
8iv21st July 2023
9ind21st July 2024
81Lead 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, 228, 930th June 2021
82Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation.Annex 4, 238, 930th June 2021
83Lead 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, 258, 930th June 2021
84

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

(c)

solders on printed circuit boards;

(d)

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

(e)

solders for connecting wires and cables;

(f)

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, 268x, 9transitional case
8iv30th 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:

(g)

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

(h)

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, 278, 9xtransitional case
86Lead 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, 298xtransitional case
8iv, 9ind30th June 2021
87Lead, 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, 31a8, 9xtransitional case
9ind21st July 2024
88Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors.Annex 4, 348, 922nd July 2021
89Mercury 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, 359ind21st July 2024
90

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

(i)

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;

(j)

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:

(i)

solutions with an acidity < pH 1;

(ii)

solutions with an alkalinity > pH 13;

(iii)

corrosive solutions containing halogen gas;

(k)

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

Annex 4, 378, 931st December 2025
91

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

(l)

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;

(m)

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

(i)

a response time shorter than 25 ns;

(ii)

a sample detection area larger than 149 mm² ;

(iii)

a multiplication factor larger than 1.3 × 10³ .

(n)

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

(o)

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

(p)

a multiplication factor larger than 4.0 × 107.

Annex 4, 398, 9transitional case
92Lead 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, 418iv31st March 2022
93Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.Annex 4, 428x, 9x [F830th June 2026]
94Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required.Annex 4, 439ind15th July 2023
95Cadmium 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, 448x, 9

31st March 2027

[F996 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, 451120th April 2026]
[F1097 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, 45821st July 2028
98Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils.Annex 4, 4681st January 2024
99Bis(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, 47821st July 2028]

Table 2

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

No.ApplicationCategories of EEE to which exemption applies
1Lead 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
2Cadmium 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
3Lead 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
4Lead 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
5Lead 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
6Lead 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
7Lead 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
8Cadmium 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
9Hexavalent 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
10Lead 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
11Lead 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]

Regulation 5(1), (2) and (3) [F11and regulation 12(1)]

SCHEDULE 1U.K.

PART 1U.K.Categories of EEE to which these Regulations apply

1.  Large household appliances.U.K.

2.  Small household appliances.U.K.

3.  IT and telecommunications equipment.U.K.

4.  Consumer equipment.U.K.

5.  Lighting equipment.U.K.

6.  Electrical and electronic tools.U.K.

7.  Toys, leisure and sports equipment.U.K.

8.  Medical devices.U.K.

9.  Monitoring and control instruments including industrial monitoring and control instruments.U.K.

10.  Automatic dispensers.U.K.

11.  Other EEE not covered by any of the categories above.U.K.

PART 2U.K.EEE to which these Regulations do not apply

12.  Equipment which is necessary for the protection of the essential interests of the security of [F12the United Kingdom], including arms, munitions and war material intended for specifically military purposes.E+W+S

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

12.  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.N.I.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

13.  Equipment designed to be sent into space.U.K.

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.U.K.

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

(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—U.K.

(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.U.K.

18.  Non-road mobile machinery made available exclusively for professional use, being machinery, with an on-board power source [F13or 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.U.K.

19.  Active implantable medical devices.U.K.

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.U.K.

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

[F1421A.  Pipe organs.]U.K.

PART 3U.K.Categories 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—U.K.

(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; F15...

(c)to industrial monitoring and control instruments placed on the market before 22nd July 2017; [F16and

(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—U.K.

(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;

[F17(ea)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 [F182002 Directive] and which was placed on the market before that exemption expired, provided that the specific exemption concerned those cables or spare parts.

F19(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F2024.  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—U.K.

(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.]

[F21PART 4E+W+SInternal Production Control Procedure

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.]

Regulation 14(2)

[F22SCHEDULE 1AE+W+SDeclaration of conformity

1.  Declaration of conformity (unique identification of the EEE):E+W+S

2.  Name and address of the manufacturer or, where applicable, authorised representative:E+W+S

3.  This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):E+W+S

4.  Object of the declaration (identification of EEE allowing traceability: it may include a photograph, where appropriate):E+W+S

5.  The object of the declaration described above is in conformity with relevant statutory requirements:E+W+S

6.  Where applicable, references to the relevant designated standards used or references to the technical specifications in relation to which conformity is declared:E+W+S

7.  Additional information:E+W+S

Signed for and on behalf of:

place and date of issue:

name, function) (signature:]

Regulation 36(a)

SCHEDULE 2U.K.Test purchases, powers of entry etc and warrants

Test purchasesU.K.

1.—(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 premisesU.K.

2.—(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,

[F23(ii)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 EEE etcU.K.

3.—(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.

WarrantsU.K.

4.—(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.

Regulation 36(b)

SCHEDULE 3U.K.Compliance, enforcement and recall notices

Compliance noticeU.K.

1.—(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 noticeU.K.

2.—(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 noticesU.K.

3.—(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 noticesU.K.

4.—(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 2005(1) (“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 authorityU.K.

5.—(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 1980(2);

(b)in Northern Ireland in proceedings under article 62 of the Magistrates’ Court (Northern Ireland) Order 1981(3).

Compensation provisions relating to compliance, enforcement and recall noticesU.K.

6.  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 noticesU.K.

7.—(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 appealsU.K.

8.—(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 Ireland(4) 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 penaltiesU.K.

9.—(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.

(1)

S.I. 2005/1803, as amended by S.I. 2012/1848.

(4)

In Scotland the making of, or refusal to make, an order by a sheriff is subject to appeal in accordance with sections 27 and 28 of the Sheriff Courts (Scotland) Act 1907 (c.51), as amended.

Yn ôl i’r brig

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Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
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Llinell Amser Newidiadau

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

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Rhagor o Adnoddau

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