RoHS2 DIRECTIVE 2011/65/EU

What Manufacturers Need To Know And Do Updated 23 June 2014

RoHS2 Directive Officially in Effect The most important change

July 2011 the Recast RoHS Directive was published in The Recast RoHS Directive is now a CE-marking directive.
the Official Journal by the European Commission, which In plain English, what this means is that if you manufacture
now makes it a legal document you need to comply with. an electrical/electronic product, device or equipment, you
can no longer CE-mark in accordance with just the Medical
Unless your products are specifically listed as one of the
Device, Machinery, EMC or Low Voltage Directive. Compli-
exemptions, with time it will apply to every manufacturer
ance with the RoHS Directive is required before you can
of electrical and electronic equipment.
place the CE mark on the product. This should be obvious
Products already covered by the original 8 categories on your Declaration of Conformity.
have a transition period of 2 January 2013 to meet the
requirements of the Recast Directive.
RoHS2 Directive And Definitions
New categories formerly excluded but now included:
Medical Devices – 3 Years – 22 July 2014. Please download the new RoHS2 Directive officially titled:
In-vitro Diagnostic Medical Devices – 5 Years – 22 July Directive 2011/65/EU of the European Parliament and of
2016. the Council of 8 June 2011 on the restriction of the use of
Monitoring and Control Instruments – 3 Years – 22 July certain hazardous substances in electrical and electronic
2014. equipment. Here is the link:
Industrial Monitoring and Control Instruments – 6 Years http://www.ce-mark.com/Rohs%20final.pdf
– 22 July 2017. The RoHS2 Directive refers to a secondary document
Active Implantable Medical Devices – Will be reviewed where you can locate the procedures for assessing the
in 2020 for inclusion. conformity of EEE, it is Decision no. 768/2008/EC on a
All other electrical and electronic equipment not covered Common framework for the marketing of products.
by any of the categories above – 22 July 2019. Please download this document from the following link:
http://www.ce-mark.com/7682008EC.pdf
As a first step in the compliance process you need to know
QNET LLC if the RoHS2 Directive applies to your products, let’s start
PO Box 527 with the definition below:
Elk River, MN 55330
The definition of “EEE” or Electrical and Electronic Equip-
763-441-0899
ment is: ”Electrical and electronic equipment” means
equipment which is dependent on electrical currents or
http://www.CE-Mark.com
electromagnetic fields in order to work properly and equip-
http://www.CE-Authorizedrepresentative.eu ment for the generation, transfer and measurement of such
currents and fields and designed for use with a voltage not
exceeding 1000 Volts for Alternating Current and 1500
Volts for Direct Current.
Additional definitions you may want to read can be found
as follows in the RoHS2 Directive: Article 3- definitions.
Pages L174/91 and 92, (1) through (28).

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 RoHS2 DIRECTIVE 2011/65/EU
What Manufacturers Need To Know And Do
Here are a few examples: January 2013. All EU States must have adopted and
(3) ‘large-scale stationary industrial tools’ published RoHS2 into National Law by the same date.
(4) ‘large-scale fixed installations’ See article 25: Transposition on page L174/98.
(5) ‘cables’ After the recast, RoHS2 adds 3 product categories with
(6) ‘manufacturer’ specific deadlines, they are:
(7) ‘authorized representative’
8) Medical devices – deadline 22 July 2014, including
Etc.
In-Vitro Diagnostic medical devices – deadline 22 July
2016.
Substances and Product 9) Monitoring and Control Instruments – deadline 22 July
Categories 2014, including Industrial Monitoring and Control Instru-
A) The six hazardous and restricted substances in the ments – deadline 22 July 2017.
RoHS2 directive are outlined in Annex II (page 11) All other electrical and electronic equipment not
L174/100) with maximum concentration values tolerat- covered by any of these categories – deadline 22 July
ed by weight to homogeneous materials. 2019.
They are:
An observation about the deadlines. They are legal en-
1) Lead (0.1%)
forcement dates, however, commercially, importers start
2) Mercury (0.1%)
asking for compliant product at least 6 months prior to the
3) Cadmium (0.01%)
legal deadline, in order not to end up with non-compliant
4) Hexavalent chromium (0.1%)
product in inventory. You may want to consider this in your
5) Polybrominated biphenyls (0.1%)
implementation timeline.
6) Polybrominated diphenyl ethers (PBDE) (0.1%)
The good news is that these are the same substances
listed in the RoHS Directive prior to RoHS2. Exemptions
Update- Next four proposed substances: Exemptions to the RoHS2 Directive can be divided into 3
● Hexabromocyclododecane (HBCDD) (a brominated groups:
Flame Retardant)
● Bis (2-ethylhexyl) phthalate (DEHP) ( a commonly I) Equipment and products this directive does not apply to,
uses plasticizer) in Article 2 Point 4 (page L174/91) and Article 4 Points 4
● Butyl benzyl phthalate (BPP) ( a commonly used and 5 Page L174/93
plasticizer) II) General exemptions listed in Annex III (pages L174/101
● Dibutyl phthalate (DBP) ( a commonly used through 105)
plasticizer)
III) Exemptions specific to medical devices and monitoring
B) Before the recast there were 8 categories of prod- and control instruments in Annex IV (page L174/106)
ucts as follows:
1) Large Household appliances
Recommendation
2) Small Household appliances
3) IT and Communications equipment We strongly recommend that you read all exemptions as
4) Consumer Equipment stated in the Directive plus Article 5 point 3 (page L174/93)
5) Lighting equipment combined with Annex V (page L174/107) where you can
6) Electrical and electronic tools find the information and details on how to apply for an
7) Toys, leisure and sports equipment exemption.
10) Automatic Dispensers
These 8 product categories must implement the chang-
es published in the RoHS2 directive no later than 2
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 RoHS2 DIRECTIVE 2011/65/EU
What Manufacturers Need To Know And Do
Module A of Annex II in Decision 768-2008/EC point 2.
Who Is responsible For What Technical documentation (read technical file)
The manufacturer shall establish the technical documenta-
Compliance with the RoHS2 directive is the responsi- tion.
bility of the Economic Operators, they are: The documentation shall make it possible to assess the
1) Manufacturer product's conformity to the relevant requirements and shall
2) Authorized Representative include an adequate analysis and assessment of the risk(s).
3) Importers The technical documentation shall specify the applicable
4) Distributors
requirements and cover, as far as relevant for the assess-
RoHS2 outlines each parties specific responsibilities in
ment, the design, manufacture and operation of the product.
Articles 7,8,9, and 10.
The technical documentation shall, where applicable, con-
tain at least the following elements:
Compliance - Including Supply - a general description of the product,
Chain - conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.
The manufacturer shall in accordance with Article 7: - descriptions and explanations if necessary of those draw-
(a) Ensure that the product has been designed and ings and schemes and the operation of the product,
manufactured in accordance with Article 4. - a list of the harmonized standards and/or other relevant
(b) Draw up the required technical documentation (tech- technical specifications the references of which have been
nical file) and carry out the internal production control published in The Official Journal of the European Union,
procedure in accordance with Module A of Annex II in applied in full or in part, and descriptions of the solutions
Decision 768/2008/EEC. adopted to meet the essential requirements of the legisla-
(c) Ensure that procedures are in place for series pro- tive instrument where those harmonized standards have
duction to remain in conformity. not been applied. In the event of partly applied harmonized
(d) Keep a register of non-conforming EEE and product standards, the technical documentation shall specify the
recalls, and keep distributors informed thereof.
parts which have been applied, results of design calcula-
(e) Ensure that their EEE bears a type, batch or serial
tions made, examinations carried out, etc., and
number.
- test reports
(f) Follow specific labeling requirements.
(g) Take corrective measures to bring the EEE into
Module A of Annex II in Decision 768/2008/EC point 1,
conformity, withdraw it from the market or recall it if they
3 and 4 Internal Production Control (Quality Product
have a reason to believe that it is not in compliance with System)
the RoHS2 Directive AND inform the Competent Au-
1. Internal production control is the conformity assessment
thorities in all Member States where the EEE is available.
procedure whereby the manufacturer fulfills the obligations
(h) Respond to a reasoned request from a Competent
laid down in points 2,3 and 4, and ensures and declares on
National Authority; provide all information and docu-
his sole responsibility that the products concerned satisfy
mentation to demonstrate conformity in a language
the requirements of the legislative instrument that apply to
which can be easily understood, through your Autho-
them.
rized Representative. And cooperate with that authority
2.Technical documentations (see above).
on taking any action to ensure compliance with this
Directive.

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 RoHS2 DIRECTIVE 2011/65/EU
What Manufacturers Need To Know And Do
3. Manufacturing Example 1: If you manufacture machinery with
The manufacturer shall take all measures necessary so electrical/electronics (EEE) and in the past you CE-marked
that the manufacturing process and its monitoring en- in accordance with the Machinery Directive + EMC Direc-
sure compliance of the manufactured products with the tive, starting 2 January 2013 you need to comply with:
technical documentation referred to in point 2 and with Machinery + EMC + RoHS2. All three directives must be
the requirements of the legislative instruments that ap- on your Declaration of Conformity.
ply to them. Example 2: If you manufacture electrical/electronic (EEE)
4. Conformity marking and declaration of conformity.
medical devices and in the past you CE-marked in accor-
The CE- Mark shall be affixed visibly, legibly and indeli-
dance with the Medical Device Directive, starting 22 July
bly to the finished EEE or to its data plate.
2014 you need to comply with the Medical Device Directive
4.1 The manufacturer shall affix the required conformity
+ RoHS2. Both directives must appear on your Declaration
marking set out in the legislative instrument to each
of Conformity.
individual product that satisfies the applicable require-
(Unless your products fall under one of the exemp-
ments of the legislative instrument. tions)
4.2 The manufacturer shall draw up a written declara-
tion of conformity for a product model and keep it to- III. All EEE Importers and Distributors:
gether with the technical documentation at the disposal Must ensure that all EEE products they import and place
of the national authorities for 10 years (through its on the EU market complies with RoHS2.
authorized representative) after the product has been IV. All Authorized Representatives:
placed on the market. The declaration of conformity Must keep the Declaration of Conformity and technical
shall identify the product for which it has been drawn up. documentation demonstrating compliance with RoHS2 at
A copy of the declaration of conformity shall be made the disposal of the national surveillance authorities for 10
available to the relevant authorities upon request. years following the placing on the market of EEE.
Special Note: Enforcement – Better Known as
Notified Body assessment and certification is not a Market Surveillance
requirement of this directive.
The Surveillance Authority in each EU Member State:
Enhanced Legal Standing In article 18 of the RoHS2 Directive the European Commis-
The statement you will hear most in the future is: RoHS2 sion instructs all EU Member States to carry out market
is now a CE-marking directive. surveillance in accordance with Articles 15 to 29 of Regu-
Here is what it means to: lation (EC) No. 765/2008 relating to Community Market
I. All EU Countries: Surveillance Framework and Control of Products entering
Each EU country must adopt the RoHS2 directive into the Community Market. You can download a copy of the
National law by 2 January 2013. This is the date they document here:
are obliged to start enforcement which is referred to as http://www.ce-mark.com/Regulation%20765%202008.pdf
market surveillance. A few examples of the activities the Surveillance Authority
II. All EEE Manufacturers: are obliged to carry out are:
In order to place a CE-mark on your EEE products you - Must ensure that products which do not comply with
must meet the requirements of all applicable directives, applicable directives to be withdrawn, prohibited or restrict-
this now includes RoHS2. ed from the EU market.

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 RoHS2 DIRECTIVE 2011/65/EU
What Manufacturers Need To Know And Do
- Must have procedures to: 1) follow up on complaints Authorized Representative:
or reports; 2) monitor accidents and harm to health; 3) Must provide the Market Surveillance Authority with all the
verify that corrective action has been taken; 4) follow up information and documentation (including Declaration of
scientific and technical knowledge concerning safety Conformity) necessary to demonstrate conformity with
issues. RoHS2 on behalf of the manufacturer.

- Shall perform appropriate checks by means of docu- Standards:

mentary checks, physical and laboratory checks based
Every European CE-marking Directive comes with a list of
on adequate samples. Taking into account risk assess-
references of harmonised standards.
ments, complaints and other information.
- May require the economic operators to provide docu- Harmonised standards that have been published and
mentation and information, and where is necessary and provide some useful guidance relating to material
justified they may enter the premises and take neces- restrictions:
sary samples. EN 50581:2012 Technical documentation for the assessment
of electrical and electronic products with respect to the
- May destroy products presenting a serious risk, restriction of hazardous substances.
·
- Shall observe confidentiality in order to protect com- Describes three kinds of documents that may be used to
mercial secrets or personal data. demonstrate conformity with the RoHS requirements:
- Supplier declarations and/or signed contractural
- Work with the EU Commission to place the information agreements
· - Materials declarations
on the Community Rapid Information System, notifying
- Analytical test results (Requires the use of EN 62321:
all EU Countries where products have been sold.
2009
- Must cooperate with external border control authori-
IEC/TR 62476 Edition 1.0 2010-02 -"Guidance for
ties. (Customs). evaluation of products with respect to substances -
·
- Shall lay down the rules on penalties applicable to use restrictions in electrical and electronic products.
infringements and shall make sure that they are imple-
IEC/PAS 62596:2009 Electrotechnical products – determina-
mented. They must be effective, proportionate, and
dissuasive. tion of restricted substances – Sampling procedure –
Guidelines.
Economic Operators: EN 62321: 2009 Electrotechnical products – Determination of
Importers: levels of six regulated substances (lead, mercury, cadmi-
If they have reason to believe that an EEE is not in um, Hexavalent chromium, Polybrominated biphenyls,
conformity with RoHS, they must 1) not place it on the
Polybrominated diphenyl ethers). IEC 62321:2008 is the same
market until it has been brought into conformity; 2) Must standard.
inform the manufacturer and the market surveillance
EN 62474:2012 Material declaration for
authority.
products of and for the Electrotechnical Industry
Distributors:
If they have reason to believe that an EEE is not in
conformity with RoHS, they must 1) not place it on the
market until it has been brought into conformity; 2) Must © 2013 QNET LLC. All rights reserved. This material
inform the manufacturer or the importer and the market may not be reproduced, displayed, modified or
surveillance authority. distributed without the express prior written
permission of the copyright holder.
For permission, contact [email protected].

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