Restriction of Hazardous Substances (Rohs) Regulations 2012 Government Guidance Notes For Rohs 2

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The key takeaways are that the document provides guidance on the Restriction of Hazardous Substances (RoHS) Regulations 2012 in the UK, including the scope, compliance requirements, and obligations of manufacturers, importers and distributors.

The main categories of electrical and electronic equipment covered are: large and small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools, toys and leisure equipment, medical devices, monitoring and control instruments.

Manufacturers' obligations under the RoHS Regulations include ensuring products comply with restricted substances limits, retaining documentation to demonstrate compliance, and providing information to enforcement authorities upon request.

RESTRICTION OF HAZARDOUS

SUBSTANCES (RoHS)
REGULATIONS 2012

GOVERNMENT GUIDANCE NOTES


FOR ROHS 2

JULY 2014
Contents
1. Introduction .................................................................................................... 3

2. RoHS – The Law in Brief ................................................................................ 4

Summary................................................................................................................... 4

Entry into force .......................................................................................................... 5

Requirements ............................................................................................................ 5

Enforcement .............................................................................................................. 5

3. Scope of the Regulations ............................................................................... 5

Assessing products to see if they are included in the scope ...................................... 6

Exclusions ................................................................................................................. 6

Exemptions ............................................................................................................... 7

Spare parts ............................................................................................................... 7

Possible future exemptions ....................................................................................... 8

Definitions ................................................................................................................. 8

Maximum concentration values ................................................................................. 9

4. Compliance .......................................................................................................... 9

5. Manufacturers’ Obligations ................................................................................ 9

6. Importers’ Obligations ...................................................................................... 11

7. Distributors’ Obligations .................................................................................. 11

8. Enforcement ...................................................................................................... 12

Offences and penalties............................................................................................ 13

9. Contact points ................................................................................................... 15

Annex A – Categories of electrical and electronic equipment covered by the


RoHS Regulations. ................................................................................................ 16

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1. Introduction
About This Guidance

1.1 This guidance applies from 2 January 2013. For product first
placed on the market under the 2008 RoHS Regulations implementing
the first RoHS Directive (2002/95/EC), please also refer to the earlier
guidance BIS guidance notes URN 11/526 1.

1.2 This guide is addressed to all businesses and individuals placing


electrical and electronic equipment on the UK market. It clearly
explains the requirements of the UK Restriction of the use of certain
Hazardous Substances in Electrical and Electronic Equipment (RoHS)
Regulations 2012 2 (as amended)3.

1.4 This guidance is aimed at the UK market to provide specific


advice over and above EU level guidance 4, which will need to be read
in conjunction with this document.

1.5 This guidance cannot cover every situation and, of course, it may
be necessary to carefully consider the relevant legislation to see how it
applies in your circumstances. However, if you do follow the guidance
it will help you to understand how to comply with the law.

1.6 This guidance has been designed to comply with the “Code of
Practice on Guidance on Regulation 2009”. This was published in
October 2009 and a copy can be downloaded from the www.gov.uk
website.

1.7 This is the July 2014 edition. The guidance is updated on a


regular basis as necessary.

1
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/31803/11-
526-rohs-regulations-government-guidance-notes.pdf

2
http://www.legislation.gov.uk/uksi/2012/3032/contents/made

3
http://www.legislation.gov.uk/uksi/2014/1771/made

4
http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm

3
2. RoHS – The Law in Brief
Summary

2.1 The Restriction of the Use of Certain Hazardous Substances in


Electrical and Electronic Equipment Regulations 2012 (SI 2012 No.3032)5 (as
amended), (“the RoHS Regulations 2012”) implements the provisions of the
European Parliament and Council Directive on the Restrictions of the use of
certain Hazardous Substances in electrical and electronic equipment
2011/65/EU6 (“RoHS 2”).

2.2 The Regulations are amended by the Waste Electrical and Electronic
Equipment and Restriction of the use of certain Hazardous
Substances in Electrical and Electronic Equipment (amendment) regulations
2014 no.1771 7 which transposes the Corrigendum to the Directive 8.

2.3 The original RoHS Regulations 9 have restricted the placing on the UK
market of new Electrical and Electronic Equipment (EEE) containing more
than the permitted levels of lead, cadmium, mercury, hexavalent chromium
and both polybrominated biphenyl (PBB) and polybrominated diphenyl ether
(PBDE) flame retardants in certain products since 1 July 2006. There are a
number of exempted applications for these substances and a number of
products which will have limits imposed in the future.

2.4 Since 1 July 2006, manufacturers have needed to ensure that their
products - and the components and subassemblies of such products - comply
with the requirements of the original RoHS Regulations in order to be put on
the single market. The Regulations have also had an impact on those who
import EEE into the European Union on a professional basis, those who
export to other Member States and those who rebrand other manufacturers’
EEE as their own.

2.5 The RoHS Regulations 2012 do not affect the application of existing
legal requirements for EEE, including those regarding safety, the protection of

5
http://www.legislation.gov.uk/uksi/2012/3032/contents/made

6
Directive 2011/65/EU of 1 July 2011, (OJ No. L174/88).

7
http://www.legislation.gov.uk/uksi/2014/1771/made

8
OJ L 4, 14.02.14, p.55

9
The RoHS Regulations 2006, (SI 2006 No. 1463); revoked and replaced by the RoHS
Regulations 2008 (SI 2008 No. 37), as amended by the Restriction of the Use of Certain
Hazardous Substances in Electrical and Electronic Equipment (Amendment) Regulations
2009 (SI 2009 No. 581).

4
health, existing transport requirements or provisions on hazardous waste. In
other words, existing legislation on EEE and hazardous substances must also
be complied with.

Entry into force

2.6 The RoHS Regulations came into force on 2 January 2013, replacing
the original Regulations that came into force on 1 February 2008.

Requirements

2.7 The RoHS Regulations 2012 impose obligations on economic


operators throughout the supply chain (as defined in the Regulations) in
relation to the placing and making available of EEE on the market.

2.8 The key restriction is that economic operators may not place, or make
available, EEE containing lead, mercury, cadmium, hexavalent chromium,
polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE),
in amounts exceeding the established maximum concentration values, on the
market. There are also requirements for finished EEE to be CE marked.

2.9 The Regulations outline what EEE are in scope, exclusions (EEE to
which these regulations do not apply) and makes reference to the specific
exemptions to the restricted substances. With the exception of some
categories (where certain parts of the regulation apply on special dates), EEE
that was outside the scope of the 2008 Regulations does not need to comply
with the new Regulations until 22 July 2019.

2.10 Economic operators must be able to demonstrate compliance by


submitting an EU Declaration of Conformity and technical documentation or
other information to the market surveillance authority on request and must
retain such documentation for a period of ten years after the EEE is placed on
the market.

Enforcement

2.11 Responsibility for the enforcement of the RoHS Regulations lies with
the Secretary of State for Business, Innovation & Skills, who has appointed
the National Measurement Office (NMO), an executive agency of the
Department, to act on his behalf.

3. Scope of the Regulations


3.1 The RoHS Regulations apply to all EEE put on the market in the UK
which falls into the broad categories listed. The RoHS Regulations define
“EEE” and although this point is covered later in this guidance it should be

5
noted that the definition has changed. In addition, the RoHS Regulations
apply both to electric light bulbs and to household luminaires.

3.2 The broad categories bring products into scope of the RoHS
Regulations at different times over a 6.5 year period starting from 2 January
2013. Details are provided below.

- Existing categories 1-7 and 10 remain in scope. All categories (1-11)


are subject to new exclusions listed separately (p5).

- Categories 8+9 Medical devices, monitoring and control instruments


enter into scope on the following timetable:

o From 22 July 2014: Medical devices and monitoring and control


instruments;

o From 22 July 2016: In vitro diagnostic medical devices;

o From 22 July 2017: Industrial monitoring and control


instruments.

- A new category 11, other electrical and electronic equipment not


covered by any of the categories above, comes into scope from 23 July
2019, as do two wheeled electric vehicles which are not type approved
and any products in categories 1-7 or 10 not covered by the 2002
RoHS Directive, which was most recently transposed into UK law by
the 2008 Regulations.

Assessing products to see if they are included in the scope

3.3 For many products, the decision on whether they are included within
the scope of these Regulations should be reasonably straightforward.
However there are a number of products (particularly in specialised or
industrial sectors), where there may be significant areas of doubt and
uncertainty.

3.4 The FAQ developed by the Commission for the previous Directive does
not apply to the new RoHS Directive as they are considered to have different
policy intentions. The Commission have issued a FAQ document for RoHS 2
which is available on the Commission website 10.

Exclusions

3.5 The RoHS Regulations do not apply to:

10
http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm

6
• Equipment which is necessary for the protection of the essential interest
of the security of member states, including arms, munitions and war
material intended for specifically military purposes;

• Equipment designed to be sent into space;

• Equipment which is specifically designed to be installed as part of


another type of equipment to which the RoHS 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;

• Large-scale stationary industrial tools;

• Large-scale fixed installations;

• means of transport for persons or goods, excluding electric two-wheeled


vehicles which are not type-approved;

• Non-road mobile machinery made available exclusively for professional


use;

• Active implantable medical devices;

• 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;

• Equipment specifically designed solely for the purposes of research and


development only made available on a business-to-business basis.

Exemptions

3.6 A list of specific exemptions agreed for items in any category is


provided in Annex III of the RoHS Directive. Additional exemptions for
categories 8 and 9 are contained in a separate list in Annex IV of the RoHS
Directive. The duration for the validity of these is considered in the
Commission’s FAQ document.

Spare parts

3.7 Furthermore:

• Until 1 July 2016, Reuse of spare parts recovered from EEE placed on
the market before 1 July 2006 in a business to business closed loop are
not subject to the substance restrictions;

7
• Please note the Regulations do not provide for exemptions for spare
parts for products in category 11 as this is not provided for in the
Directive (Article 4.4).

New and future exemptions

3.8 Two exemptions which were granted additionally to the original RoHS
Directive were not included in the text of RoHS 2. These have been applied
to RoHS 2 through Commission Delegated Directive 2012/50/EU and
2012/51/EU11 published in December 2012. A further two batches of
exemptions have since been published:

• 16 Commission Delegated Directives 2014/1/EU to 2014/16/EU, of 18


October 2013 12
• 8 Commission Delegated Directives 2014/69/EU to 2014/76/EU, of 13
March 2014 13

3.9 The European Commission expects to receive further requests from


industry for exemptions of additional specific applications of the hazardous
substances. These requests may further extend the list in the Annex to the
RoHS Directive, if agreed and adopted as Commission Decisions. Details on
applying for exemptions are contained within the RoHS Directive in Article 5
and Annex V.

3.10 The RoHS Regulations incorporate both December 2012 exemptions


which have already been adopted and any further exemptions which may be
agreed while they remain in force, as the Regulations use provisions so as to
refer to the exempt applications listed in the RoHS Directive Annex “as
amended from time to time”. This removes the need for further amendments
to the RoHS Regulations every time that new exemptions are agreed.

Definitions

3.11 The definitions of “electrical and electronic equipment”, “place on


the market” and “make available on the market” can be found within the
RoHS Regulations. It is worth noting these Regulations contain many more
definitions than the previous ones, covering in addition e.g. “homogeneous
material”, “conformity assessment”.

11
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2012:348:SOM:EN:HTML

12
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:004:TOC

13
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2014:148:TOC

8
Maximum concentration values

3.12 For the purposes of the RoHS Regulations, a maximum concentration


value of up to 0.1% by weight in homogeneous materials for lead, mercury,
hexavalent chromium, PBB and PBDE and of up to 0.01% by weight in
homogenous materials for cadmium will be permitted in EEE.

4. Compliance
4.1 The RoHS Regulations use self-declaration as the basis of the
compliance regime. The UK market surveillance authority also undertakes
market surveillance activities to detect non-compliant products and conducts
tests for this purpose. The new RoHS Regulations also have important
procedural obligations which must be complied with.

4.2 The RoHS Regulations now impose obligations on economic operators


at different stages in the supply chain (manufacturers, importers, distributors)
in relation to the placing and making available on the market of EEE. If you
fulfil more than one of these functions, you will pick up the obligations of that
part of the supply chain too.

4.3 The Regulations contain common definitions. This reflects the


changes that were made at EU level to align the new RoHS Directive with
Decision No 768/2008/EC on a common framework for the marketing of
products, which was adopted in July 2008 as part of (what has become known
as) the “Goods Package” with a view to introducing greater legislative
consistency among EC harmonising measures, and in particular among the
increasing number of members of the “New Approach” family of legislation
setting harmonised requirements for a range of products.

4.4 RoHS allows for the use of harmonised standards as a route to


supporting compliance. Where a standard exists and has been cited in the
OJEC as a harmonised standard for the purposes of RoHS2 then meeting
that standard will give a presumption of conformity for those requirements
covered by that standard.

5. Manufacturers’ Obligations
5.1 The RoHS Regulations require manufacturers to self-declare the
conformity of their products with the requirements of the RoHS Regulations.
Manufacturers are required to complete an internal production control
procedure in accordance with Module A of Annex II to Decision 768/2008/EC
of the European Parliament and of the Council on a common framework for

9
the marketing of products and repealing Council Decision 93/465/EEC 14.
Manufacturers must also draw up technical documentation.

5.2 Once the conformity assessment is complete, manufacturers must


prepare an “EU Declaration of Conformity” and affix the “CE marking”. The
RoHS Directive’s Annex VI sets out the requirements for the declaration of
conformity. In the absence of evidence to the contrary, it is assumed that EEE
bearing the CE mark is compliant with the RoHS Regulations. The term "not
possible" in Regulations (18(2)(b) and 24(2)) regarding affixing the CE
marking has been copied out from the Directive. An informed judgement
should be made on what is not possible in justifying the use of this provision
to the enforcement authority.

5.3 The technical documentation, and the EU Declaration of Conformity,


must be kept for a period of ten years after placing the product on the market.

5.4 Manufacturers also have other new obligations under the RoHS
Regulations. These include:

i. marking EEE with information identifying the EEE and the


manufacturer;

ii. putting procedures in place to ensure EEE manufactured by means of


series production will remain compliant;

iii. keeping a register, and advising distributors, of non-compliant EEE


which they have placed on the market, and any EEE which has been
recalled;

iv. taking appropriate corrective measures if the manufacturer becomes


aware that EEE placed on the market is non-compliant, and advising
market surveillance authorities of that non-compliance, and the
corrective measures taken;

v. co-operating with the market surveillance authority, including


providing it with the information necessary to demonstrate
compliance. This information must be provided in English in the
United Kingdom. Other EEA states can require it in a language
understood by their authority;

vi. Identifying to market surveillance authorities who has supplied the


manufacturer with EEE and to whom they have supplied EEE.

14
OJ L218, 13.8.2008 p.82

10
6. Importers’ Obligations
6.1 Importers have an obligation to ensure that EEE they place on the
market comply with the content restrictions. They must ensure that the
manufacturer has a register of non-conforming EEE and product recalls,
carried out a conformity assessment procedure, drawn up technical
documentation, affixed the CE mark, and marked the EEE with the required
information. Importers should also check that any documentation required is
present, and mark the EEE with the importer’s name, tradename or
trademark, and a contact postal address. If EEE which they intended to place
on the market is non-compliant, importers should inform the manufacturer,
and the market surveillance authority, of the non-compliance.

6.2 Importers have the following additional obligations under the RoHS
Regulations:

i. check that the manufacturer has indicated their name, registered


trade name or registered trade mark and the address at which they
can be contacted on the EEE or, where that is not possible, on its
packaging or in a document accompanying the EEE

ii. taking appropriate corrective measures if the importer becomes


aware that EEE placed on the market is non-compliant, and advising
market surveillance authorities of that non-compliance, and the
corrective measures taken;

iii. co-operating with the market surveillance authority, including


providing it with the information necessary (in English) to demonstrate
compliance;

iv. Identifying to market surveillance authorities who has supplied the


importer with EEE and to whom they have supplied EEE.

6.3 If an importer places EEE on the market under its own name or
trademark, it is required to comply with the duties imposed on manufacturers,
instead of the duties imposed on importers.

7. Distributors’ Obligations
7.1 Distributors’ obligations arise when they make EEE available on the
market. Distributors must not make EEE available if they have reason to
believe it does not comply with the substance restrictions contained in

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regulation 3 of the RoHS Regulations. They should also inform the importer
(or manufacturer if no importer exists), and the market surveillance authority.

7.2 Additional obligations for distributors under the ROHS Regulations


include:

i. taking appropriate corrective measures if the distributor becomes


aware that EEE placed on the market is non-compliant, and advising
market surveillance authorities of that non-compliance, and the
corrective measures taken;

ii. co-operating with the market surveillance authority, including


providing it with the information necessary to demonstrate
compliance;

iii. Identifying to market surveillance authorities who has supplied the


distributor with EEE and to whom they have supplied EEE.

8. Enforcement
8.1 It is the duty of the National Measurement Office, acting on behalf of
the Secretary of State for Business, Innovation & Skills, to enforce these
Regulations.

8.2 Various powers of enforcement are available, including:

• Making test purchases;

• Exercising powers of entry to business premises (this excludes premises


that are used wholly or mainly as a private dwelling);

• Obtaining warrants;

• Requiring the production of compliance documentation and other


information which may provide evidence as to whether or not the
Regulations have been complied with in a particular case or class of
cases;

• Inspecting processes, documents, goods, EEE etc;

• Seizing and detaining EEE, documents, information etc and performing


analytical tests, or retaining it for use as evidence in proceedings;

• Issuing a compliance or enforcement notice requiring certain action to be


taken, or requiring non-compliant goods to be withdrawn from the market

12
or prohibiting or restricting the placing of non-compliant goods on the
market;

• Issuing a recall notice requiring the economic operator to use reasonable


endeavours to organise the return of the EEE;

• The market surveillance authority can take an action that could have
been required under a compliance, enforcement or recall notice in
certain circumstances.

Offences and penalties

8.3 The RoHS Regulations carry the following offences:

i. Contravening or failing to comply with the prohibition on placing non-


compliant EEE on the market found in regulations 10, 23 and 29, or
with an enforcement or recall notice, could result in those held
responsible facing a fine up to the statutory maximum (currently
£5,000) on summary conviction or an unlimited fine on conviction on
indictment.

ii. The following offences could lead to a fine up to level five on the
standard scale (currently £5,000) on summary conviction:

a. failing to take corrective measures and notify the authorities


in cases of non-compliant EEE, in accordance with
regulations 20, 26 and 30;

b. failing to keep technical documentation or an EU declaration


of conformity in breach of regulations 15 and 27;

c. failing to keep a register of non-compliant and recalled EEE


in breach of regulations 19 and 25;

d. failing to co-operate with the authorities in breach of


regulations 21, 27(5) or 31;

e. contravening or failing to comply with the requirements of


regulation 33 regarding identification of economic operators
to the market surveillance authority.

f. contravening or failing to comply with the requirements of


regulation 34 regarding protection of CE marking.

iii. Procedural offences (obstruction of an enforcement officer, providing


false or misleading information to the enforcement authority) are also
punishable on summary conviction by a fine up to level five on the
standard scale.

13
8.4 As an alternative, or in addition, to any of the above penalties, the court
may, in certain circumstances, make an order requiring a person convicted of
the offences referred to in paragraph 36 (i) and (ii) above to remedy the
matters which have given rise to the commission of the offence. In addition,
the court may order a person convicted of the offences referred to in
paragraph 36 (i) above to reimburse the enforcement authority’s costs of
investigating the offence.

8.5 The defence of ‘due diligence’ is available where a person can show he
took all reasonable steps and exercised all due diligence to avoid committing
an offence. This may include reference to an act or default of, or reliance on
information given by, a third party, in which case it must be accompanied by
such information identifying the third party as is in the possession of the
defendant.

8.6 The RoHS Regulations also provide for the ‘liability of persons other
than the principle offender’, including a provision that where a company or
other body corporate commits an offence, those concerned in its management
and responsible (consciously or by negligence) for the commission of the
offence, may also be prosecuted.

14
9. Contact points
Department for Business, Innovation & Skills
Environmental Regulation Team
1 Victoria Street
London SW1H 0ET
Tel: +44 (0)20 7215 5000
Email: [email protected]
Website: https://www.gov.uk/rohs-compliance-and-guidance

The National Measurement Office - RoHS Enforcement Team


RoHS Enforcement Team
NMO
Stanton Avenue
Teddington
TW11 0JZ
Tel: +44 (0)20 8943 7227
Email: [email protected]
Website: https://www.gov.uk/rohs-compliance-and-guidance

European Commission FAQ

The European Commission has issued an FAQ document for RoHS 2.

Email: [email protected]
Website:
http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm

15
Annex A – Categories of electrical and electronic
equipment covered by the RoHS Regulations.
Existing categories continuing to be within scope:

1. Large household appliances

2. Small household appliances

3. IT and telecommunications equipment

4. Consumer equipment

5. Lighting equipment, (including electric light bulbs and household


luminaires)

6. Electrical and electronic tools (with the exception of large-scale stationary


industrial tools)

7. Toys, leisure and sports equipment

10. Automatic dispensers

New categories being added to the scope:

8+9 Medical devices, monitoring and control instruments

From 22 July 2014: Medical devices and monitoring and control


instruments

From 22 July 2016: In vitro medical devices

From 22 July 2017: Industrial monitoring and control instruments.

11. Any other EEE

From 23 July 2019: other electrical and electronic equipment not


covered by any of the categories above,

Other additions:

Two wheeled electric vehicles which are not type approved and any products
in categories 1-7 or 10 not covered by the original Directive come into scope
from 23 July 2019.

16
© Crown copyright 2014
You may re-use this information (not including logos) free of charge in any format or medium,
under the terms of the Open Government Licence. Visit
www.nationalarchives.gov.uk/doc/open-government-licence, write to the Information Policy
Team, The National Archives, Kew, London TW9 4DU, or email:
[email protected].

This publication is also available on our website at www.gov.uk/bis

Any enquiries regarding this publication should be sent to:


Department for Business, Innovation and Skills
1 Victoria Street
London SW1H 0ET
Tel: 020 7215 5000

If you require this publication in an alternative format, email [email protected], or call


020 7215 5000.

URN BIS/14/1007

17

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