The Recasts of EU RoHS and WEEE Directives - Update October 2009

09.28.2009 // Posted by: Ken Stanvick // Posted in: Articles, Supply Chain

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The recasts of the EU RoHS and WEEE Directives continue to unfold. Since the initial recast proposals were presented for adoption, ^{i ii} amended versions were proposed in September 2009 ^{iii iv} by the Environment Council of Ministers of the European Union. The latest schedule calls for a parliamentary review in April 2010 and, if approved, must be implemented into the national laws of the EU Member States no later than eighteen months after entry into the Official Journal of the European Union.

RoHS, Overview of “significant” proposed changes and their impact

Article 2 Scope

This Directive shall apply to electrical and electronic equipment.

"Electrical and electronic equipment" (hereinafter ^* ‘EEE’) means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current.

Impact

The inclusion of all EEE is often referred to as the “exclusionary principle”. To be considered “out of scope”, products must be specifically excluded from the scope of the Directive if they otherwise meet the definition of “EEE”. This a major change in philosophy from the current directive. If your products have been considered to be out of scope and are not specifically listed as out of scope you need to take action in order to continue selling into the EU should the recast as currently written be approved.

Category 8 and 9 included in the scope of the Directive

• Medical devices and monitoring and control instruments which are placed on the market from 1st January 2014
• In vitro medical devices which are placed on the market from 1st January 2016
• Industrial monitoring and control instruments which are placed on the market from 1st January 2017.
• Active implantable medical devices.
• By 2020 the Commission shall review the exclusion of active implantable medical devices with a view to propose inclusion.

Impact

The inclusion of Category 8 and 9, with the earliest projected implementation date of January 1 2014, should not present an undue hardship to producers. Many producers of this type of equipment are already in compliance or have plans in place to be in compliance in advance of these dates.

Article 5 (exemptions mechanism)

Measures adopted in accordance with point (b) of paragraph 1 shall have a maximum validity period of four years and may be renewed. The Commission shall decide in due time on any application for renewal that is submitted no later than 18 months before an exemption expires.

(b). Inclusion of materials and components of EEE in Annexes V and VI where either of the following conditions is fulfilled:

their elimination or substitution via design changes or materials and
components which do not require any of the materials or substances referred to
in Article 4(1) is scientifically or technically impracticable;

the availability and reliability of substitutes is not ensured or the negative
socio economic impacts caused by substitution are disproportionate
compared to the environmental, health, consumer safety or socio economic
benefits thereof;

the negative environmental, health, consumer safety impacts caused by
substitution are likely to outweigh the environmental, health or consumer
safety benefits thereof;

Impact

This is a significant change as it places a maximum time limit on exemptions and requires that requests for exemptions be submitted no later than 18 months prior to an exemption expiration date. The Directive in place today has no limit regarding the length of time an exemption is valid, only that exemptions must be reviewed every 4 years. A REACH Methodology will be implemented that will shift the burden of proof to the applicant and provide more detailed rules for exemption submissions.

Article 7 Obligation of Manufacturers

• Manufacturers shall draw up the required technical documentation and carry out the internal production control procedure set out in module A of Annex II to Decision No 768/2008/EC (“A common framework for the marketing of products”) or have it carried out.
• Where compliance of an EEE with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the CE Marking.
• Manufacturers keep the technical documentation and the EC declaration of conformity for ten years after the EEE has been placed on the market.
• Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of an EEE is declared shall be adequately taken into account.

Impact

Manufacturers will need to go beyond the simple premise that by having placed a finished product on the EU Market it is “assumed” to be compliant and that manufacturers have taken reasonable steps to insure compliancy which can be satisfactorily demonstrated to enforcement agencies. If you are a manufacturer of a finished product or you supply raw materials, components or subassemblies to finished product manufacturers you will need to provide objective evidence to validate your RoHS compliance statements.

WEEE, Overview of “significant” proposed changes and their impact

Article 2 Scope

• This Directive shall apply to electrical and electronic equipment falling under the categories set out in Annex IA. Annex IB contains an indicative list of products which fall under the categories set out in Annex IA.

Impact

The first recast submitted for discussion removed these annexes and referred to two new annexes which were to be added to the initial RoHS Recast. This would have provided a direct link to the RoHS Directive, provided a list of broad product categories and a binding list of products within each category. The following extracted from the initial WEEE recast, identified the problem, “there is lack of clarity on the products covered by the current WEEE Directive and their categorisation, with different interpretations of the current provisions made by different Member States and stakeholders”.

Unfortunately the new annexes were removed from the latest RoHS recast and Annex 1A and 1B were written back into the latest WEEE recast. This action will do nothing to address the clarity problem that is caused by inconsistent classification of products by EU Member States. As a producer of a product you will continue to face the very real possibility that your product would be considered to be in scope by the EPA in Member State “A” and not in scope by the EPA in Member State “B”.

Article 3 Definitions

• "placing on the market" means the first making available of a product on the market of a Member State”
• "making available on the market” means any supply of a product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge”

Impact

The initial recast used the more inclusive term “Community market”. This demonstrates that there seems to be a desire to harmonize national implementation of Directive legislation, versus what may ultimately be achievable.

The extensive analysis carried out as part of the WEEE review process led to the identification of the following problems related to the application of the WEEE Directive:

Article 16 Registration, information and reporting

1. Member States shall draw up a register of producers, including producers supplying electrical and electronic equipment by means of distance communication in accordance with paragraph 2. That register shall serve for monitoring compliance with the financing obligations under Articles 12 and 13.
2. Member States shall ensure that any producer on their territory can enter in their national register all relevant information online, including reporting requirements and fees, reflecting its activities.
3. The format for registration and reporting, including information on quantities of electrical and electronic equipment placed on the national market, categories and frequency of reporting, shall be established. Those measures designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(3).

Impact

This is probably the second most controversial change in the WEEE recast. The current directive requires producers to register and report in 27 different producer registration schemes in each Member State they place products on the market, causing significant administrative burden. To reduce the burden of implementing the WEEE Directive the Commission proposes to harmonize registration and reporting obligations for producers by making the registers inter-operational. In this way producers will need only register in one Member State for all their activities throughout the EU. This should be monitored closely.

Summary

The recast of both Directives is underway with the overall goal of improving the directives based upon what has been learned from past experience. I have identified those changes that I believe will or should have the largest impact to our industry. The definition of product scope, the exemption process, EC Declaration of conformity, CE Marking and producer registration are some of the biggest unresolved issues that are expected to delay the final approval of the amended Directives.

What manufacturers can expect to see as a result of the recasts will be an increase in requests for complete material disclosure, demonstration of proof that your products can be consistently manufactured to be RoHS compliant ( internal and external auditing data), a decrease in out of scope products, and a continued increase in enforcement activities.

ⁱ [1] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0809:FIN:EN:PDF
ⁱⁱ [1] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0810:FIN:EN:PDF
ⁱⁱⁱ [1] http://register.consilium.europa.eu/pdf/en/09/st12/st12847.en09.pdf
^iv [1] http://register.consilium.europa.eu/pdf/en/09/st12/st12848.en09.pdf

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