What is the RoHS2

[Ganimedes Reveley]

What is the RoHS2

EU RoHS 2 - New EU RoHS Directive

Five years after the introduction of RoHS, a new European Union RoHS Directive (known as RoHS2) was adopted by the European Council on 27 May 2011.  The new Member State RoHS2 Regulations will take effect 18 months after its adoption. However, many companies are not aware of the new RoHS2 scope, the obligations of distributors and the associated sample testing requirements.

RoHS

The original RoHS is an EU Directive (2002/95/EC) pertaining to the Restriction of Hazardous Substances in Electrical and Electronic Equipment (EEE). It was adopted by the EU in February 2003 and brought into force 1st of July 2006.

This directive was brought into force in order to limit the component concentration of six hazardous substances found in EEE as they are harmful to the environment, mainly through the pollution of landfills.
RoHS Directive covers a wide range of products, including not only integrated electrical and electronic products but also individual parts, raw materials and packing cases.

This directive is very closely related to the WEEE directive, Waste from Electrical and Electronic Equipment (2002/96/EC) except RoHS regulates hazardous substances in EEE while WEEE regulates the disposal of the same equipment.
RoHS 2

RoHS2 is an updated / recast version of RoHS. There are no additions to or difference in the six restricted substances, as can be viewed in table below. However, there is a proposed inclusion of Category 8 (medical devices from 2014) and Category 9 (control and monitoring instruments from 2014) and also a new Category 11, which captures all other 'grey area' electrical equipment(from 2019), and encorporates new CE Marking requirements. The date of this proposed inclusion is 2012 or later.



RoHS does not require any specific product labeling, however many manufacturers have adopted their own compliance marks. Examples of the visual indicators in use today include explicit "RoHS compliant" labels, green leaves, check marks, and "PB-Free" markings. Chinese RoHS labels use a lower case "e" within a circle with arrows, which can also designate compliance.

[Ganimedes Reveley]

RoHS2

Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (known as RoHS2) became European Law on 21 July 2011 and will take effect in EU Member States from 2 January 2013. RoHS2 brings a much wider range of equipment into scope but does not introduce any new substance restrictions. Another very important difference is that RoHS2 is a CE Marking Directive - this is discussed in detail in the ENVIRON Guide to Using BOMcheck and EN 50581 to Comply with RoHS2 Technical Documentation Requirements.

RoHS2 requires Manufacturers to produce technical documentation which demonstrates that their products are RoHS compliant, in line with Module A of Decision 768/2008/EC. This is a significant difference compared to the RoHS1 Directive which does not prescribe any requirements for Manufacturers to maintain compliance documentation. RoHS2 also includes obligations for all EU Member States to perform systematic market surveillance including "appropriate checks on product compliance on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples". In contrast, RoHS1 did not prescribe any enforcement procedures that Member States were required to implement.

There are many different approaches that companies can use to draw up the required technical documentation to demonstrate that their products are RoHS compliant. Many companies already have established compliance processes and quality management systems for RoHS1 compliance and for other product regulatory requirements. Each company has to decide the best approach for drawing up the RoHS2 technical documentation which makes best use of their existing compliance processes and quality management systems.

In October 2011 the European Commission issued a Mandate to CENELEC to develop a European Standard that Manufacturers can choose to follow to comply with the RoHS2 technical documentation requirements. European Standard EN 50581:2012 "Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances" was approved on 11 June 2012 by all CENELEC National Committees and, as per the Mandate, will be published in the Official Journal of the European Union as a RoHS2 Harmonised Standard. Under Article 16 (2) of the RoHS2 Directive, a Manufacturer who demonstrates compliance with EN 50581:2012 will automatically be deemed to be compliant to the RoHS2 technical documentation requirements.

The ENVIRON Guide to Using BOMcheck and EN 50581 to Comply with RoHS2 Technical Documentation Requirements provides a step-by-step practical approach that Manufacturers can choose to adapt and implement in their supply chains to generate the required RoHS2 technical documentation for a product model and provide an EU Declaration of Conformity. This practical approach explains how Manufacturers can choose to use the EN 50581:2012 European Standard and the BOMcheck system to comply with the RoHS2 technical documentation requirements.

How BOMcheck supports the process specified in EN 50581 for Manufacturers to comply with RoHS2 Technical Documentation

requirements



The above diagram summarises the process specified in EN 50581 and highlights how using BOMcheck to collect the documents from suppliers (Clause 4.3.3) enables the Manufacturer to save time and effort to comply with the Clause 4.3.4 document evaluation requirements. ENVIRON held a webinar on 19 July 2012 which demonstrates how the standardised process that suppliers follow to create materials declarations in BOMcheck ensures that these declarations already meet the Clause 4.3.4 quality and trustworthiness requirements (i.e. the Manufacturer does not need to carry out any additional document evaluation). If the Manufacturer's assessment in Clause 4.3.2 determines that the supplier is also required to provide test reports to support their materials declarations, then the standardised process that suppliers follow to attach a test report to a declaration in BOMcheck requires the supplier to evaluate that the test report meets the Clause 4.3.4 quality and trustworthiness requirements (i.e. this reduces the time and effort for the Manufacturer to evaluate test reports). For further details please see recorded webinar on using BOMcheck and EN 50581 to comply with RoHS2 Technical Documentation Requirements and the slides from the webinar.

source: You are not allowed to view links. Register or Login

[Ganimedes Reveley]

RoHS 2: New Obligations for Manufacturers, Importers and Distributors from 2 January 2013

On 2 January 2013, the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (RoHS 2) came into force in the UK. As previously reported on our blog of 18 May 2012, RoHS 2 implements Directive 2011/65/EU1 and repeals and replaces the RoHS 2008 Regulations2. RoHS 2 places new and extended duties on manufacturers, importers and distributors of electrical and electronic equipment (EEE), with immediate effect.

Like its predecessor, RoHS 2 continues to prohibit EEE containing certain substances (as outlined below) in the specified concentrations, from being placed/made available on the market in the EU on or after 2 January 2013: lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ethers (PBDE), in concentrations above 0.1%; and cadmium in concentrations above 0.01%.

However, RoHS 2 makes substantial changes to the regime, including a number of new obligations and a different classification of obligated parties, with consequent changes for each of them. The key changes are set out below.

Scope

The definition of EEE now includes cables and spare parts for their repair, reuse, and updating of functionalities or upgrading of capacity of EEE. However, certain obligations of manufacturers and importers will not apply in respect of cables and spare parts for EEE placed on the market before 1 July 2006, or before the relevant applicable date for new categories of EEE as described below.

RoHS 2 has excluded the following EEE from its scope: equipment necessary for the protection of the essential interests of the security of Member States; equipment designed to be sent into space; large-scale stationary industrial tools; large-scale fixed installations; active implantable medical devices; photovoltaic panels; means of transport for persons or goods (excluding electric two-wheeled vehicles); non-road machinery for professional use and equipment designed for the purposes of research and development.

RoHS 2 continues to apply to the categories of EEE previously covered by the RoHS 2008 Regulations3. Additionally new categories of EEE have been included; most of these new categories have a deferred date of application in respect of their compliance obligations, as set out below:

    (i) Automatic dispensers (placed on the market on or after 2 January 2013)
    (ii) Medical devices (placed on the market after 22 July 2014)4
    (iii) Monitoring and control instruments (placed on the market after 22 July 2014)
    (iv) Industrial monitoring and control instruments (placed on the market after 22 July 2016)
    (v) Other EEE not covered by any of the categories above (placed on the market on or after 2 January 2013)

In addition to the above deferred deadlines, EEE that was outside the scope of the RoHS 2008 Regulations and has already been placed on the market will be able to be made available on the market until 22 July 2019, even if it does not comply with the requirements of RoHS 2.

Obligations

A pervasive change under RoHS 2, is its imposition of obligations on parties in the supply chain. Previously, all obligations were imposed on "producers" even though this definition included different actors in the supply chain. RoHS 2 however, identifies and classifies different parties in the supply chain and imposes distinct obligations accordingly. The following parties are defined under RoHS 2: manufacturer, distributor, importer and authorised representatives.

The bulk of the obligations under RoHS 2 are imposed on manufacturers, however under certain circumstances importers and distributors could also be obligated to comply with manufacturer-specific obligations.

Under RoHS 2, manufacturers (and their authorised representatives) have to comply with the following new obligations with immediate effect from 2 January 2013.

    Draw up technical documentation, in line with Module A of Annex II to Decision 768/2008 on a common framework for the marketing of products.
    Draw up an EU declaration of conformity, which must be translated into the language required by the Member State where the EEE will be made available.
    Affix a CE marking to the EEE.
    Ensure that the EEE is able to be identified by type, batch, serial number or other element and indicate the manufacturer's name, registered trade name or trademark and a single contact address.

The following new obligations also apply to manufacturers but only in respect of in-scope EEE with immediate effect from 2 January 2013:

    Keep a register of non-compliant EEE which has been placed on the market or which has been recalled.
    Keep technical documentation for 10 years.
    Where a manufacturer has reason to believe that provisions of RoHS 2 have not been complied with in respect of the EEE it has placed on the market, a manufacturer must immediately take the necessary corrective measures to withdraw or recall the EEE as appropriate, and inform the market surveillance authority and competent national authorities of the relevant Member States.

Importers must comply with the requirement set out below, with immediate effect from 2 January 2013:

    Ensure that the EEE is marked with the importer's name, registered trade name or trademark and its contact address.

Additionally, importers' obligations that apply with immediate effect from 2 January 2013 to in-scope EEE include the following:

    Not to place non-compliant EEE on the market.
    Ensure that manufacturers have complied with their respective obligations before placing the EEE on the market.
    Keep a register of non-compliant EEE which has been placed on the market or which has been recalled.
    Inform the manufacturer and the marker surveillance authority if it has reason to believe that the EEE it was intending to place on the market does not comply with RoHS 2. Additionally it has the same obligation as a manufacturer in respect of the EEE it has already placed on the market and which it believes is non-compliant, e.g. take corrective measures and inform the market surveillance and competent national authorities.
    Where an importer places EEE on the market under its name or trademark it must comply with all the duties of manufacturers.

Distributors' obligations apply with immediate effect from 2 January 2013 and include the following:

    "Act with due care" when making EEE available on the market by verifying that the requirements of RoHS 2 have been complied with, such as that the CE marking has been affixed on the EEE, information identifying the manufacturer or importer has been included and that the EEE is accompanied by the required documentation in the relevant language.
    Inform the importer or manufacturer and the market surveillance authority if it has reason to believe that the EEE it intends to make available to the market does not comply with RoHS 2. It must also take corrective measures or recall the EEE that it suspects is non-compliant and that has been made available to the market, as well as inform the market surveillance authorities and the relevant national competent authority.
    In circumstances where a distributor has modified the EEE already placed on the market so that compliance with the general prohibition may be affected, it will have to comply with all duties of a manufacturer.

Penalties

Non-compliance with the overarching prohibition on placing non-compliant EEE on the market is a criminal offence punishable by up to an unlimited fine. Non-compliance with other obligations under RoHS 2 is an offence punishable by a fine not exceeding £5,0005.



    Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
    Restriction of the use of certain hazardous substances in electrical and electronic equipment regulations 2008 (SI 2008/37).
    Large and small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electrical and electronic tools and toys, leisure and sports equipment.
    Obligations apply to in vitro diagnostic devices after 22 July 2016
    In respect of England and Wales.


source : You are not allowed to view links. Register or Login

[Ganimedes Reveley]

RoHS 2 FAQ guidance document

The new RoHS Directive 2011/65/EU (RoHS 2) entered into force on 21 July 2011 and requires Member States to transpose the provisions into their respective national laws by 2 January 2013. The FAQ document was drafted by a Member States working group under a mandate from the RoHS/WEEE Technical Adaptation Committee and takes account of stakeholder input from a consultation on an earlier version.

The FAQs are intended to help economic operators interpret the provisions of RoHS 2 in order to ensure compliance with the Directive's requirements. They are considered a 'living document' and may be revised again in the future.
The existing Commission FAQ document related to 2002/95/EC will remain valid until that Directive is repealed on 3 January 2013.

You are not allowed to view links. Register or Login

[Ganimedes Reveley]

[img width=800https:You are not allowed to view links. Register or Login[/img]http://



You are not allowed to view links. Register or Login