Chapter 38 Regulation of Electrical and Electronic ... · Regulation of Electrical and Electronic...

Chapter 38

Regulation of Electrical andElectronic Equipment and Chemicalsin the European Union

By: Bettina Schmitt-Rady*

§ 38:1 Introduction§ 38:2 The WEEE and RoHS Directives§ 38:3 —De�nition of EEE§ 38:4 —The scope of the WEEE Recast§ 38:5 The WEEE and RoHS Directives–The scope of the

WEEE Recast—Transitional period§ 38:6 The WEEE and RoHS Directives—The scope of the

WEEE Recast—Open Scope as of 15 August 2018§ 38:7 — —Liable Parties§ 38:8 — —Placing on the Market§ 38:9 — —Producer Obligations—Providing information

to treatment and recovery facilities§ 38:10 — — —Information to users§ 38:11 — — —Collecting, treating, reusing, recovering,

and recycling WEEE§ 38:12 — — —Labeling§ 38:13 — — —Financing the take back of WEEE§ 38:14 — — —Shipment§ 38:15 The scope of RoHS 2§ 38:16 —Maximum concentration values in restricted

substances§ 38:17 —Homogeneous material

*Dr. Bettina Schmitt-Rady is a partner with the German law �rm Grafvon Westphalen mbB (GvW), Frankfurt o�ce. She regularly advisesinternational and national clients in environmental matters including onrules and restrictions for industry and importers placing products and EEEon the Union market under European and German law. She was a visitingscholar at the University of California at Berkeley, USA, and lectured at theCollegium Falconis in Leuven, Belgium, on the EU emissions trading scheme.

Cándido García Molyneux drafted the previous version of this Chapter.

38-1K 2014 Thomson Reuters, 12/2014

§ 38:18 —Covered Categories of EEE§ 38:19 — —Categories not included§ 38:20 — —What does “Large Scale” mean?§ 38:21 — —Open Scope§ 38:22 —Exemptions§ 38:23 —Liable Parties under RoHS 2§ 38:24 —EU Declaration of Conformity§ 38:25 Enforcement§ 38:26 Recommendations to limit liability§ 38:27 The ErP Directive§ 38:28 The REACH Regulation: General overview§ 38:29 The REACH Regulation: Compliance with RoHS§ 38:30 —De�nition of placing on the market§ 38:31 —Validity for imported articles§ 38:32 —SVHCs: Concentration limits§ 38:33 —Granting exemptions§ 38:34 —Classi�cation, labeling and packaging of

substances (CLP)

KeyCiteL: Cases and other legal materials listed in KeyCite Scope can beresearched through the KeyCite service on WestlawL. Use KeyCite to checkcitations for form, parallel references, prior and later history, andcomprehensive citator information, including citations to other decisionsand secondary materials.

§ 38:1 Introduction

The European Union (“EU”) is establishing the globalenvironmental standards for the electronics industry. Over thelast decade, Brussels has adopted sweeping requirements onelectrical and electronic equipment (EEE) and chemicals.Waste of electrical and electronic equipment (WEEE) such ascomputers, TV-sets, fridges and cell phones is one the fastestgrowing waste streams in the EU, with some 9 million tonsgenerated in 2005, and expected to grow to more than 12 mil-lion tons by 2020.1 To improve the environmental managementof WEEE and to enhance resource e�ciency by improving col-lection, treatment and recycling of electronics at the end oftheir life two pieces of legislation have been put in place: TheDirective on waste electrical and electronic equipment (WEEE

[Section 38:1]1See http://ec.europa.eu/environment/waste/weee/index�en.htm.

International Contract Manual

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Directive) that controls how WEEE is handled and recycled,2

and the Directive on the restriction of the use of certain haz-ardous substances in electrical and electronic equipment (RoHSDirective),3 which bans the use of certain substances in EEE,in particular heavy metals and �ame retardants.

Most businesses that must ensure RoHS compliance mustalso ensure WEEE compliance as well. Anyone who is involvedwith the production of an a�ected article—is it for purposes ofputting such equipment onto the market, for research activi-ties concerning substitutes or for (legal) services around theseissues—should be aware of the Directives.

Moreover, in 2007 the EU legislators introduced the ambi-tious new legal framework for chemicals, so-called “REACH,”which ranks among the strictest legislations on chemicalsworldwide. REACH stands for Registration, Evaluation,Authorisation and Restriction of Chemicals.4 In principle,REACH applies to all chemical substances during their entirelife cycle, not only to those used in industrial processes butalso to household goods, clothes, furniture and electricalappliances. Thus, the regulation has an impact on mostcompanies across the EU.

REACH places the burden of proof on companies. To complywith the regulation, companies must identify and manage therisks linked to the substances they manufacture and market inthe EU. They have to demonstrate to the newly establishedEuropean Chemicals Agency in Helsinki, Finland (“ECHA”)how the substance can be safely used, and they must com-

2Directive 2012/19/EU of the European Parliament and of the Councilof 4 July 2012 on waste electrical and electronic equipment (WEEE) recast,OJ L197 of 24 July 2012.

3Directive 2011/65/EU of the European Parliament and of the Councilof 8 June 2011 on the restriction of the use of certain hazardous substancesin electrical and electronic equipment, OJ L 174 of 1 July 2011.

4Regulation (EC) No 1907/2006 of the European Parliament and of theCouncil of 18 December 2006 concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH), establishing aEuropean Chemicals Agency, amending Directive 1999/45/EC and repealingCouncil Regulation (EEC) No 793/93 and Commission Regulation (EC) No1488/94 as well as Council Directive 76/769/EEC and Commission Directives91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006,p.1. Entry into force: 1 June 2007. Last amended by Council Regulation (EU)No 517/2013 of 13 May 2013, OJ L 158/1.

§ 38:1Regulation of Electrical and Chemicals in the EU


municate the risk management measures to the users.5 If therisks cannot be managed, authorities can restrict the use ofsubstances in di�erent ways. In the long run, it is intended tosubstitute the most hazardous substances with less dangerousones.

REACH is accompanied by requirements on the classi�ca-tion, labeling and packaging of substances (CLP).6 The CLPRegulation implements the 2nd edition of the United NationsGlobally Harmonised System of classi�cation and labeling ofchemicals (GHS) into EU law. The CLP Regulation enteredinto force on January 20, 2009.

As a general rule several pieces of legislation may have to betaken into consideration for one product, since the makingavailable on the Union market or putting into service can onlytake place when a product complies with all applicable provi-sions and when the conformity assessment has been carriedout in accordance with all applicable EU legislation.

Given the complexity of European regulations with overlap-ping schemes plus national regulatory diversity in theimplementation process counsel must never assume a totalharmonization of the rules. The EU's political complexity tendsto crystallize in unclear implementation rules that, in mostcases, leave the 28 EU Member States7 with a certain degree ofdiscretion to control the access to their national markets byenforcing their own interpretation of the rules and even apply-ing stricter requirements. With regard to REACH and CLP,the new agency ECHA aims to ensure the consistent implemen-tation of these regulations across the EU and the countries in

5See ECHA Guidance on registration, version 2.0, May 2012 as guid-ance for the implementation of REACH. All guidance documents are draftedand discussed within the REACH Implementation Projects (RIPs) led by theEuropean Commission services, involving all stakeholders such as MemberStates, industry and non-governmental organizations. These guidance docu-ments can be obtained via the website of the European Chemicals Agency(ECHA) (http://echa.europa.eu/). Further guidance documents are constantlypublished on this website upon �nalization or updates.

6Regulation (EC) No 1272/2008 on classi�cation, labeling and packag-ing of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006(REACH). The CLP Regulation is replacing the Dangerous Substances Direc-tive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD) in a stepwise approach during a transitional period until 2015.

728 Member States as of July 1, 2013.

§ 38:1 International Contract Manual

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the European Economic Area Iceland, Lichtenstein andNorway.8

This chapter reviews the main requirements and legal issuesarising from principal pieces of this EU legislation a�ectingEEE.

§ 38:2 The WEEE and RoHS Directives

The Directive on waste electrical and electronic equipment(WEEE Directive) and the Directive on the restriction of theuse of certain hazardous substances in electrical and electronicequipment (RoHS Directive) have similar, but not identicalscopes. Both apply to EEE that falls within a list of di�erentcategories as set forth below. Unless your products are speci�-cally listed as one of the exemptions, with time the restrictionswill apply to every manufacturer and distributor of EEE.

Both Directives have been subject to extensive amendmentsand were recently revised to accelerate e�ectiveness. The newWEEE Directive 2012/19/EU entered into force on 13 August

8ECHA is responsible for further implementation and enforcementprocedures such as of the Rotterdam Convention on the Prior InformedConsent Procedure for Certain Hazardous Chemicals and Pesticides inInternational Trade (PIC), which entered into force in 2004. The EU-PriorInformed Consent Regulation (PIC-Regulation (EU) 649/2012) implementsthe Rotterdam Convention at EU level and sets guidelines for the import andexport of various very hazardous industrial chemicals, biocides or pesticides.It requires industry to notify their intention to import or export thesechemicals. The PIC Regulation applies to a list of entries (for individualchemicals or groups of chemicals), which are included in Annex I, and tomixtures containing such chemicals in a concentration that triggers labelingobligations under the CLP Regulation (EC) No 1272/2008 (irrespective of thepresence of any other substance), as well as to articles containing thesechemicals in an unreacted form. This list is updated regularly as a result ofregulatory actions under EU legislation, and developments under the Rot-terdam Convention. Export of these chemicals cannot take place until thereceiving country has been informed. In some cases, an ‘explicit consent’ isneeded from the importing country outside the EU and its designatednational authority. The recast PIC Regulation applies for industry fromMarch 1, 2014, onwards. ECHA's main task as of 2014 will be to transmitthe noti�cations to the importing (non-EU) countries, to manage all relatedcommunication and to keep a database of the noti�cations. Under the previ-ous legislation until 2014, these tasks were the responsibility of the EuropeanCommission's Joint Research Centre (JRC). The new regulation is consistentwith the REACH and CLP regulations. It also follows the GloballyHarmonised System of classi�cation and labelling. It introduces �xedtimelines for all actors to perform their tasks.



2012 and became e�ective on February 14, 2014 (“WEEERecast”).1

The RoHS recast Directive 2011/65/EU entered into force onJuly 21, 2011 (“RoHS 2”).2 Member States had to transpose theprovisions into their respective national laws by January 2,2013 (RoHS) and February 14, 2014 (WEEE). So far Bulgaria,Denmark, Ireland, Italy, Luxemburg, the Netherlands and theUK have transposed the WEEE Recast. Most Member Statesdid not meet this deadline. Draft legislation to transpose theWEEE Recast has been released by 18 Member States,3 interalia Germany, Austria, France, Croatia and Italy.

Counsel should note that as a matter of principle, the origi-nal requirements under the Directives will remain in e�ectand apply directly on a national level if a Member State failsto transpose the provisions of European Directives into nationallaw in time. As a consequence, the absence of applicablenational transposition law does not mean that no restrictionsapply.

§ 38:3 The WEEE and RoHS Directives—De�nition ofEEE

As a starting point, counsel needs to check whether its prod-uct is quali�ed as EEE under European law.

Under both Directives, “Electrical and electronic equipment”or “EEE” is de�ned as “equipment which is dependent onelectric currents or electromagnetic �elds in order to workproperly and equipment for the generation, transfer andmeasurement of such currents and �elds and designed for use

[Section 38:2]1Directive 2012/19/EU of the European Parliament and of the Council

of 4 July 2012 on waste electrical and electronic equipment (WEEE) (1), OJL197 of 24 July 2012, recast of Directive 2002/96/EC of 27 January 2003 onWEEE upon a number of substantial changes.

2Directive 2011/65/EU of the European Parliament and of the Councilof 8 June 2011 on the restriction of the use of certain hazardous substancesin electrical and electronic equipment, OJ L 174 of 1 July 2011. Directive2002/95/EC of the European Parliament and of the Council of 27 January2003 on the restriction of the use of certain hazardous substances in electri-cal and electronic equipment—OJ L of 13 February 2003 is repealed as fromJanuary 3, 2013.

3As of April 25, 2014, source: Business Information Group, http://www.ept.ca/news/weee-recast-directive-update.


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with a voltage rating not exceeding 1,000 volts for alternatingcurrent and 1,500 volts for direct current.”1

RoHS 2 adds a de�nition of “dependent” to cover themultipurpose character of certain products. “Dependent” means“EEE needing electric currents or electromagnetic �elds to ful�llat least one intended function,”2 meaning that if equipmentcannot ful�ll its primary function if the electric current is o� itwill not qualify as EEE. This is di�erent from the WEEERecast and the original RoHS Directive because it expands thescope of products covered by RoHS 2.

RoHS 2 adds also a de�nition of “Cables” to be incorporated,meaning “all cables with a rated voltage of less than 250V thatserve as a connection or an extension to connect EEE to theelectrical outlet or to connect two or more EEE to each other.”3

If the product quali�es as EEE under these de�nitionscounsel must check whether it is excluded from or within thescope of either the WEEE Recast and/or RoHS 2.

§ 38:4 The WEEE and RoHS Directives—The scope ofthe WEEE Recast

The WEEE-Directive controls how EEE is handled andrecycled. This Directive a�ects all producers, retailers, distancesellers, distributors of EEE, local authorities, waste manage-ment companies and treatment operators of WEEE and re-useorganizations specializing in the refurbishment and reuse ofEEE.

The main targets are prevention of WEEE falling under thecategories as set out in Annex I of the Directive incl. allcomponents, subassemblies and consumables. Moreover, theDirective imposes re-use, recycling and recovery liabilities onproducers and obliges Member States to ensure that producersmeet certain minimum recovery targets.1

The WEEE Recast increases the range of products coveredwithin its scope. The former Directive applied a “closed” scope

[Section 38:3]1Art. 3(1) Directive 2011/65/EU and Art. 3(1)a Directive 2012/19/EU.2Art. 3(2) Directive 2011/65/EU.3Art. 3(5) Directive 2011/65/EU.

[Section 38:4]1The minimum recovery targets are set out in Art. 11 and Annex V as

applicable from August 13, 2012, in a stepwise approach until August 15,



by providing a list of products and equipment split into ten dif-ferent categories in former Annexes 1A and B of the Directive,with speci�c examples of the products falling into eachcategory. The WEEE Recast introduces an “open” scope fromAugust 15, 2018. “Open scope” assumes that every EEE prod-uct is covered by the Directive, apart from a list of speci�callyexcluded products.

§ 38:5 The WEEE and RoHS Directives–The scope ofthe WEEE Recast—Transitional period

There is a transitional period from August 13, 2012 to August14, 2018, before the open scope approach will become e�ective.Annex I of the WEEE Recast contains the list of categories ofcovered products during this period:

1. Large household appliances2. Small household appliances3. IT and telecommunications equipment4. Consumer equipment and photovoltaic panels such as

solar arrays5. Lighting equipment6. Electrical and electronic tools (with the exception of

large-scale stationary industrial tools, de�nition see be-low)

7. Toys, leisure and sports equipment8. Medical devices (with the exception of all implanted and

infected products, de�nition see below)9. Monitoring and control instruments10. Automatic dispensersThe immediate inclusion of photovoltaic panels into Cate-

gory 4 even before the open scope will apply was subject toextensive discussion because the EU and the Member Statesaim to reach their objectives for renewable energy and energye�ciency. It was thus �rst intended to exclude them fromscope. Since this has �nally failed Member States such as theUK intend to apply a less strict scheme for photovoltaic panels

2018. The European Parliament and the Council shall, by August 14, 2016,re-examine the recovery targets.


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in order to lessen the burden for producers. The UK will createa new 14th category for them.1

Annex II contains an indicative list of products falling intothe categories of Annex I, inter alia refrigerators, washingmachines, air conditioner appliances, vacuum cleaners, clocks/watches, personal computer and notebooks, printers,telephones/cell phones, radios, TV, luminaires, tools, video-games, dialysis equipment, to name just a view in order toshow the vast range of a�ected products.

Since this list is non-exhaustive, Member States may inprinciple include other products in national legislationimplementing the WEEE Directive. Counsel is thus also obligedto check national law of the Member State where the productis going to be put on the market.2

§ 38:6 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Open Scope as of 15 August2018

As of August 15, 2018, after the transitional period from the“closed” to the “open scope” scheme has been lapsed, all EEEwill be covered (i.e. “open scope”). EEE will then be classi�edwithin the categories set out in Annex III.

Annex III contains the following six categories:1. Temperature exchange equipment

[Section 38:5]1WEEE Consultation Document of the Department for Business, In-

novation and Skills, April 2013, p.13; now transposed into The Waste Electri-cal and Electronic Equipment Regulations 2013, Sl 2013 No. 3113.

2For example Germany: “Gesetz über das Inverkehrbringen, dieRücknahme und die umweltverträgliche Entsorgung von Elektro- undElektronikgeräten (ElektroG)” of 24 March 2005 (BGBl. I S. 762). Upon thestakeholder consultation the Act is currently in the enactment process; entryinto force will probably be in Fall 2014. UK: The Waste Electrical andElectronic Equipment Regulations 2013, Sl 2013 No. 3113; The WEEERegulations 2006 (SI 2006 No. 3289, as amended by SIs 2007 No. 3454, 2009No. 2957, 2009 No. 3216 and 2010 No. 1155) are revoked with the exceptionof some speci�c provisions. The UK use the “copy out” principle to transposethe WEEE Recast, i.e. will not go further than implementing the minimumrequirements of the Directive. The current UK Regulations (and the amend-ing Regulations) have been repealed and the new Regulations were put inplace to implement the changes brought about by the recast, see WEEEConsultation Document of the Department for Business, Innovation andSkills, April 2013, p.5.



2. Screens, monitors, and equipment containing screens hav-ing a surface greater than 100 cm2

3. Lamps4. Large equipment (any external dimension more than 50

cm) including, but not limited to:Household appliances; IT and telecommunication equip-ment; consumer equipment; luminaires; equipment repro-ducing sound or images, musical equipment; electrical andelectronic tools; toys, leisure and sports equipment; medicaldevices; monitoring and control instruments; automaticdispensers; equipment for the generation of electriccurrents. This category does not include equipment includedin categories 1—3.

5. Small equipment (no external dimension more than 50cm) including, but not limited to:

Household appliances; consumer equipment; luminaires;equipment reproducing sound or images, musical equip-ment; electrical and electronic tools; toys, leisure and sportsequipment; medical devices; monitoring and control instru-ments; automatic dispensers; equipment for the generationof electric currents. This category does not include equip-ment included in categories 1—3 and 6.

6. Small IT and telecommunication equipment (no externaldimension more than 50 cm)

Annex IV contains a non-exhaustive list of EEE which fallswithin the categories set out in Annex III; counsel must beaware again that national deviation is permissible.

Permanently excluded will remain all equipment:E which is necessary for the protection of the essential

interests of the security of Member States, including arms,munitions and war material intended for speci�callymilitary purposes such as missiles and battle�eld comput-ers;

E which is speci�cally designed and installed as part of an-other type of equipment that is excluded from or does notfall within the scope of the WEEE Recast, which can ful�llits function only if it is part of that equipment;

E �lament bulbs.1

From August 15, 2018, the Directive shall not apply to the fol-lowing EEE:

[Section 38:6]1Art. 2(3)(a) to (c).


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1. equipment designed to be sent into space such as satel-lites and space probes;

2. large-scale stationary industrial tools which are de�nedas large size assembly of machines, equipment, and/orcomponents, functioning together for a speci�c applica-tion, permanently installed and de-installed by profes-sionals at a given place, and used and maintained byprofessionals in an industrial manufacturing facility orresearch and development facility. Examples are cranesor production and processing lines;

3. large-scale �xed installations, meaning a large-sizecombination of several types of apparatus and, where ap-plicable, other devices, which (i) are assembled, installedand de-installed by professionals, (ii) are intended to beused permanently as part of a building or a structure at apre-de�ned and dedicated location; and (iii) can only bereplaced by the same speci�cally designed equipment,except any equipment which is not speci�cally designedand installed as part of those installations. Examples areelevators or conveyor transport systems;

4. means of transport for persons or goods, excluding electrictwo-wheel vehicles which are not type-approved such ascars, aircraft, trains and boats;

5. non-road mobile machinery made available exclusively forprofessional use, meaning machinery with on-board powersource, the operation of which requires either mobility orcontinuous or semi-continuous movement between a suc-cession of �xed working locations while working, forexample fork-lifts or harvesters;

6. equipment speci�cally designed solely for the purposes ofresearch and development that is only made available ona business-to-business basis, such as watt balances (onlyif custom made for a speci�c client, NOT standard equip-ment such as monitoring devices or instruments for chemi-cal analysis);

7. medical devices and in vitro diagnostic medical devices,where such devices are expected to be infective prior toend of life, and active implantable medical devices, suchas pacemakers.2

No later than August 14, 2015, the Commission is asked to

2Art. 2(4)(a) to (g) with de�nitions in Art. 3(1)(b), (c) and (d); examplesacc. to RoHS 2 FAQ guidance document of the Commission as of 12 December



review the scope of the Directive, including the parameters todistinguish between large and small equipment in Annex III,and shall present a report thereon to the European Parliamentand to the Council.3 Counsel must therefore be on the lookoutfor further upcoming amendments.

§ 38:7 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Liable Parties

The provisions of the WEEE Recast apply to products andproducers irrespective of selling technique, including distanceand electronic selling. The legislator makes clear that theobligations of producers and distributors using distance andelectronic selling channels should, as far as is practicable, takethe same form, and should be enforced in the same way, as forother distribution channels, in order to avoid those other dis-tribution channels having to bear the costs resulting from thisDirective arising from WEEE for which the equipment wassold by distance or electronic selling.1

“Producer” is de�ned as any natural or legal person who, ir-respective of the selling technique used, is:

i. established in a Member State and manufactures EEEunder his own name or trademark, or has EEE designedor manufactured and markets it under his name ortrademark within the territory of that Member State;

ii. established in a Member State and resells within the ter-ritory of that Member State, under his own name ortrademark, equipment produced by other suppliers, areseller not being regarded as the “producer” if the brandof the producer appears on the equipment, as providedfor in point (i);

iii. established in a Member State and places on the marketof that Member State, on a professional basis, EEE froma third country or from another Member State; or

iv. sells EEE by means of distance communication directlyto private households or to users other than privatehouseholds in a Member State, and is established in an-other Member State or in a third country.

2012 that applies also to the WEEE Recast, http://ec.europa.eu/environment/waste/rohs�eee/pdf/faq.pdf.

3Art. 1(5).

[Section 38:7]1Recital no. 7.


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The WEEE Recast indeed changes the de�nition of “pro-ducer” by stipulating that an entity must be established in aMember State to qualify as a producer who can register there.The legislator intended to harmonize di�erent approachesunder the previous WEEE regime. In the UK for example, enti-ties that are not actually present (established) in the UK arealso de�ned as “producers.”

However, for these cases where products are imported fromcountries outside the EU, the WEEE Recast has introducedthe concept of an Authorised Representative.2 The AuthorisedRepresentative may carry out a number of tasks on behalf ofthe producer once appointed by the producer and accepted bythe national register. He represents the producer in mattersrelating to, inter alia, registration, reporting and enforcement.The idea of appointing an Authorised Representative in theWEEE Recast is not new as other EU Directives know andinstalled them already.3 The Commission has issued a “Guide-line for Authorised Representatives” that clari�es its role.4

Counsel may refer to this guideline.The di�erence of the Authorised Representative under the

WEEE Recast is that it must be appointed in each MemberState where the producer places EEE on the market otherthan the Member State where he is established.5 Please notthat if, however, the Authorised Representative of a thirdcountry manufacturer supplies a product to a distributor or aconsumer within the EU, he then no longer acts as a mereAuthorised Representative but becomes the importer and issubject to the obligations of importers.6

Whoever exclusively provides �nancing under or pursuant toany �nance agreement shall not be deemed to be a “producer”unless he also acts as a producer within the meaning of points(i) to (iv).7

A “distributor” is de�ned as any natural or legal person in

2Art. 17; see also preamble Recital no. 8, Art. 16 and Annex X.3For example Council Directive 93/42/EEC of 14 June 1993 (Medical

Devices Directive), OJ L 169, 12 July 1993, p. 1.4EU Commissions, DG Health& Consumers, Guideline for Authorised

Representatives, MEDDEV 2.5/10, January 2012.5Art. 17 and Art. 3(1)(f).6The Blue Guide on the implementation of EU product rules 2014, EU

Commission, Ref. Ares(2014)1025242—02/04/2014, page 19.7Art. 3(1)(f).



the supply chain, who makes an EEE available on the market.This de�nition does not prevent a distributor from being, atthe same time, a producer within the meaning of the WEEERecast.8

§ 38:8 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Placing on the Market

EU legislation applies when the product is placed on theUnion market and to any subsequent operation which consti-tutes making available until it reaches the end-user. Productsmust comply with the applicable EU legislation at the momentof placing on the market for the �rst time.1

“Placing on the market” means the �rst making available ofa product on the Union market within the territory of aMember State on a professional basis.2

“Making available on the market” means any supply of aproduct for distribution, consumption or use on the market of aMember State in the course of a commercial activity, whetherin return for payment or free of charge.3 This includes “placingon the market,” i.e. the �rst making available on the marketand all secondary market operations such as resale. Such sup-ply includes any o�er for distribution, consumption or use onthe Union market which could result in actual supply based onany type of legal instrument (e.g. an invitation to purchase,advertising campaigns, and gifts).4

Supplying a product is only considered as making availableon the Union market, when the product is intended for end useon the market. The supply of products for further distribution,for incorporation into a �nal product, for further processing orre�nement with the aim to export the �nal product outside theUnion market is not considered as making available. More-over, the concept of making available refers to each individual

8Art. 3(1)(g).

[Section 38:8]1The Blue Guide Id., page 15.2Art. 3(1)(k).3Art. 3(1)(j).4Blue Guide 2014, Id., page 17.


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product, not to a type of product, and whether it was manufac-tured as an individual unit or in series.5

Counsel should note that stockpiling is no easy way out. Tostockpile non-compliant EEE for sale after the new obligations,in particular open scope entered into force, is not a way to eas-ily circumvent the WEEE Directive's ban on certain productsas special provisions of other applicable EU regulations and inparticular the national laws and regulations of Member Statesmust be taken into account, which are free to impose stricterrequirements and take di�erent views. However, according tothe EC Commission's “Blue Guide,”6 placing on the market isconsidered not to take place where a product is

E manufactured for one's own use. Some EU legislationhowever covers products manufactured for own use in itsscope, e.g. the Directives on Machinery, Measuring Instru-ments, ATEX and Civil Explosives;7

E bought by a consumer in a third country while physicallypresent in that country;

E transferred from the manufacturer in a third country toan authorised representative in the EU whom the manu-facturer has engaged to ensure that the product complieswith the EU legislation;

E introduced from a third country in the EU customs terri-tory and has not been released for free circulation. Thisincludes the cases of products in transit, placed in freezones, warehouses or temporary storage;8

E manufactured in a Member State with a view to exportingit to a third country (this includes components supplied to

5Blue Guide 2014, Id., page 17.6The Blue Guide on the implementation of EU product rules 2014, EU

Commission, Ref. Ares(2014)1025242—02/04/2014.7Blue Guide 2014, Id., page 17. Directive 2006/42/EC on machinery;

Directive 2004/22/EC of 31 March 2004 on measuring instruments; the newATEX Directive (2014/34/EU) will come into force on April 20, 2016; Direc-tive 94/9/EC will be repealed; Directive 93/15/EEC on the harmonization ofthe provisions relating to the placing on the market and supervision ofexplosives for civil uses.

8Blue Guide, Id., page 18 footnote 50 referring to Council Regulation(EEC) No 2913/92 establishing the Community customs code. In accordancewith this Regulation, non-Community goods placed under a suspensivecustoms procedure or in a free zone are subject to customs supervision anddo not bene�t from the free circulation in the internal market. Before bene�t-ing from the free circulation, these goods must be declared for release for freecirculation. That entails application of commercial policy measures, comple-



a manufacturer for incorporation into a �nal product to beexported into a third country);

E transferred for testing or validating pre-production unitsconsidered still in the stage of manufacture;

E displayed or operated under controlled conditions9 at tradefairs, exhibitions or demonstrations, however, a visiblesign must clearly indicate that the product may not beplaced on the market or put into service until it has beenmade to comply;10 or

E in the stocks of the manufacturer (or the authorised rep-resentative established in the Union) or the importer,where the product is not yet made available, unlessotherwise provided for in the applicable EU legislation.

§ 38:9 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Providing information to treatment andrecovery facilities

The WEEE Recast requires Member States to ensure thatproducers provide treatment, reuse, and recover information totreatment and waste-management facilities. The informationmust be provided for each type of new EEE that is put on themarket and within one year of such marketing free of charge.1

Usually, the national laws require that the informationprovided cover the di�erent components and materials of theappliance, the location of dangerous substances and prepara-tions, and the means to comply with recycling and recoverytargets. In line with the Directive, most national laws also al-low producers to supply this information in the form of manu-als or by means of electronic media, such as CD-ROM andInternet sites. In practice, many producers have opted forincluding in their websites an email address to which treat-ment and recycling facilities may address their requests forinformation.

tion of the other formalities laid down in respect of the importation of goodsand the charging of any duties legally due.

9Blue Guide, Id., page 18 footnote 51: The prototype must be safe andunder complete control and supervision. Controlled conditions would meanexpert operators, restrictions to public contact with the product, avoidinginappropriate interaction with other neighboring products etc.

10Blue Guide, Id., page 18 footnote 52.

[Section 38:9]1Art. 15(1)(2).


38-16

§ 38:10 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Information to users

The WEEE Recast also requires Member States to ensurethat users of private household EEE are given the followingWEEE information:

E the requirement not to dispose of WEEE as unsorted mu-nicipal waste and to collect such WEEE separately

E the return and collection systems available to them; therole of contributing to reuse, recycling, and other forms ofrecovery of WEEE

E the potential e�ects on the environment and humanhealth resulting from the presence of hazardous sub-stances in the EEE

E the meaning of the crossed-out wheeled bin symbolSome Member States have implemented this obligation by

requiring producers to accompany the EEE they market withthis information. For example, Belgium requires that thisWEEE information be provided in the instructions for usemanuals of private household EEE. Similarly, Denmark,France, Ireland, Poland, and Spain require that the informa-tion be included in documents or manuals accompanyingmarketed private household EEE.

The Italian law goes even further and provides that theWEEE information must also be included in the instructionsmanuals of both private household and professional EEE. TheItalian law, however, also provides that where no manual isprovided, the information must be supplied at the points ofsale or by means of other information materials.

§ 38:11 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Collecting, treating, reusing, recovering, andrecycling WEEE

Most importantly, the Directive imposes obligations of WEEEcollection, treatment, reuse, recovery, and recycling onproducers. These obligations distinguish between privatehousehold and professional WEEE.

The distinction between WEEE from private households andprofessional use (i.e., “professional WEEE”) is important to al-locate the take back requirements of the Directive. The WEEERecast also uses this distinction to distinguish between private



household and professional EEE and, in some cases, to imposedi�erent requirements on them.

The WEEE Recast de�nes WEEE from private households asWEEE which comes from private households and WEEE whichcomes from commercial, industrial, institutional and othersources which, because of its nature and quantity, is similar tothat from private households. Waste from EEE likely to beused by both private households and users other than privatehouseholds shall in any event be considered to be WEEE fromprivate households.1 Thus, for example, computers that areusually used in private households result in private householdWEEE even if they were sold to a law �rm, unless the numberof computers sold clearly exceeds that used in a privatehousehold.

The Directive's take back requirements apply only to WEEEand not to products. In accordance with the EC waste legisla-tion, WEEE is de�ned as “electrical or electronic equipmentwhich is waste within the meaning of Article 3(1) of Directive2008/98/EC, including all components, sub-assemblies andconsumables which are part of the product at the time ofdiscarding.”2 Thus, where a consumer returns defective EEEunder a product warranty scheme, the equipment should notbe considered as WEEE.

For private household WEEE, the Directive requires thatMember States ensure that holders and distributors can returnfree of charge the WEEE to collection systems. Member Statesmay also require distributors to accept, free of charge, thereturn of WEEE from holders when supplying equipment thatis of equivalent type and ful�lls the same functions as thediscarded EEE. The Directive also allows producers to set upschemes collecting WEEE free of charge from privatehouseholds.

For professional WEEE, the Directive requires producers toensure the collection of such waste, arguably from the premisesof the professional customer. As explained below, however, pro-ducers of professional EEE may negotiate otherwise the alloca-tion of these obligations with their customers.

From 2016, the minimum collection rate for EEE at the endof life shall be 45% calculated on the basis of the total weight

[Section 38:11]1Art. 3.1(h).2Art. 3(1)(e).


38-18

of WEEE collected and expressed as a percentage of the aver-age weight of EEE placed on the market in the three precedingyears in that Member State. This collection rate needs to beachieved annually, for the �rst time in 2016 by producers.Member States shall ensure that the volume of WEEE col-lected evolves gradually during the period from 2016 to 2019,unless the collection rate has already been achieved.

From 2019, the minimum collection rate to be achieved an-nually shall be 65% of the average weight of EEE placed onthe market in the three preceding years in the Member Stateconcerned, or alternatively 85% of WEEE generated on the ter-ritory of that Member State.3 Member States may havetransitional arrangement granted through comitology in casethey have di�culties meeting the rate due to speci�c nationalcircumstances.4

The aim to reduce administrative burden by stipulating anew provision to harmonize the registration of producers andreporting by producers in the EU including by making thenational registers interoperable unfortunately failed duringthe process.

In the UK, for example, the �nancing of the costs of the col-lection, treatment, recovery and environmentally sound dis-posal of WEEE from private households, that is deposited at adesignated collection facility or is returned but is not depositedat a designated collection facility, will be the responsibility ofall producers or their authorised representatives, who placedEEE onto the market in the UK, unless they have registeredas small producers. They will be held liable for �nancing thecosts of the collection, treatment, recovery and environmentallysound disposal of a speci�ed amount of WEEE. The nationalauthority will calculate the amount of WEEE in tons to be col-lected by each producer or authorised representative in each

3Art. 7(1). Art. 7(3) grants Bulgaria, the Czech Republic, Latvia, Lithu-ania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia an exemp-tion because of their lack of the necessary infrastructure and their low levelof EEE consumption. They may decide to (a) achieve, from August 14, 2016,a collection rate that is lower than 45% but higher than 40% of the averageweight of EEE placed on the market in the three preceding years; and (b)postpone the achievement of the set collection rate until a date of their ownchoice which shall not be later than August 14, 2021.

4Art. 7(4).



category of EEE.5 All producers or their authorised representa-tives who are established in the UK are obliged to become amember of a WEEE scheme.6

Retailers with sales areas relating to EEE exceeding 400 m2

in any single store are now under the new obligation to takeback very small WEEE (no external dimension over 25cm) freeof charge with no obligation on the consumer to purchase EEEof an equivalent type.7 The WEEE Recast provides for an opt-out from this obligation, however, where it can be shown thatexisting collection schemes are likely to be at least as e�ectiveas the “take-back” method of collection.

Speci�c rules apply to particular types of components. Thetake-back requirements of the WEEE Recast apply to batteriesthat are part of the appliance at the time of discarding withthe exception of batteries used in equipment connected withthe protection of Member States' essential security interestand batteries in equipment designed to be sent to space. If thebatteries are discarded separately, in most cases, they will besubject to the requirements of the EC Batteries Directives.8

The WEEE Recast requires Member States to ensure that allWEEE is transported to facilities where the WEEE must betreated, reused, recovered, recycled, and disposed in accor-dance with the requirements of the Directive. In practice, mostMember States have imposed these obligations on producerswhile allowing them to do this independently or through collec-tive compliance schemes. Producers are, therefore, free todecide whether they wish to ful�ll their obligations on theirown, in agreement with other producers, or by joining a collec-

5Part 3 Regulation11 (1) of The Waste Electrical and Electronic Equip-ment Regulations 2013, Sl 2013 No. 3113, p. 15.

6Part 3 Regulation14 (1) of The Waste Electrical and Electronic Equip-ment Regulations 2013, Sl 2013 No. 3113, p. 17 Existing schemes e.g. inGermany: Stiftung Elektro-Altgeräte Register (EAR); in the UK: DistributorTakeback Scheme (DTS).

7Art. 5(2)(c).8Directive 2013/56/EC on batteries and accumulators and waste batter-

ies and accumulators as regards the placing on the market of portable bat-teries and accumulators containing cadmium intended for use in cordlesspower tools, and of button cells with low mercury content, repealing Commis-sion Decision 2009/603/EC; Directive 2006/66/EC on batteries and accumula-tors and waste batteries and accumulators, repealing Directive 91/157/EEC.


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tive compliance scheme; however, they must ensure that theyoperate within the limits of the EU anti-trust rules.9

Treatment and recycling facilities must meet certain mini-mum requirements. In particular, they must hold a wastepermit, meet the technical requirements of Annex VIII to theDirective, use the best available treatment, recovery andrecycling techniques, and treat the WEEE in accordance withthe requirements of Annex VII. The Directive requires MemberStates to encourage these facilities to be certi�ed under theEuropean eco-management and audit scheme (EMAS).

§ 38:12 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Labeling

Already the previous WEEE Directive required that all EEEput on the market after August 13, 2005, had to be labeledwith marks clearly identifying the producer and making clearthat the EEE was put on the market after that date. The label-ing requirement applies to both private household and profes-sional EEE.

EEE put on the market must be marked with a crossed-outwheeled bin symbol. While the Directive is unclear on this,most Member States have tended to implement this require-ment as applying to both private household and professionalEEE. In line with the Directive, Member States exempt fromthis requirement only EEE that is too small or the function ofwhich prevents it from being labeled. In such cases, while someMember States require that the label be put on the packaging,the instructions for use, and on the warranty accompanyingthe equipment, other countries, such as Austria, Denmark, andGermany, allow producers to choose where to put the mark onany of these three materials.

The Directive requires Member States to establish registersof manufacturers of EEE with which all producers should reg-ister and provide information. The Directive does not establishan EU register and, thus, producers must register in each andevery Member State where they market their products.

9See, for example, “DG Competition Paper Concerning Issues of Compe-tition in Waste Management Systems.”



§ 38:13 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Financing the take back of WEEE

Probably one of the most discussed issues during the legisla-tive procedure of the �rst WEEE Directive was who is going topay for all these WEEE take back obligations and how. In theend, the WEEE Directive established the principle of producer-individual responsibility; producers are required to pay for thecosts of the take back operations of WEEE, but only the costsfor managing the waste resulting from their EEE. Theoreti-cally, this means that where a producer is capable of designingEEE in a way that results in less WEEE than those of itscompetitors, it should be entitled to pay less.

Nevertheless, the Directive allocates the �nancing obliga-tions di�erently on the basis of whether the WEEE is fromprivate households or from professionals, and whether theWEEE results from EEE put on the market before or afterentry into force.

For private household WEEE, producers must pay for themanagement of the WEEE resulting from their own products.As explained above, in order to ensure this �nancing, the Direc-tive requires Member States to require producers to provide aguarantee when placing a product on the market. The guaran-tee may take the form of a recycling insurance, a blocked bankaccount, or the producer participating in a collective compli-ance scheme. As indicated, Member States have tended toimplement this requirement by requiring producers to providea guarantee if they do not show proof of membership of a col-lective compliance scheme at the time of registration or in theannually required reports.

For professional WEEE, the Directive imposes the principleof individual responsibility.

§ 38:14 The WEEE and RoHS Directives—The scope ofthe WEEE Recast—Producer Obligations—Shipment

A new Annex I has been added to the WEEE Recast,establishing minimum monitoring requirements for shipmentsof WEEE in order to avoid illegal exports to third countries,among which are non-OECD countries. The monitoring aims toclearly distinguish between new and still used EEE and WEEE.

The competent authorities of the Member States shall be


38-22

entitled to request evidence from the party that ships the EEE(e.g. invoice, testing, proof of functionality, records). In theabsence of the appropriate documentation required and packag-ing, Member State authorities shall presume that an item ishazardous WEEE and presume that the load comprises an ille-gal shipment.

§ 38:15 The scope of RoHS 2

The RoHS 2 Directive imposes obligations on economic opera-tors throughout the supply chain in relation to the placing andmaking available of EEE on the market.

RoHS 2 provides for extensive changes compared to theprevious RoHS Directive. These refer to scope, de�nitions,mechanisms for including new substances and mechanisms forde�ning exemptions, as well as conformity assessment.

The original RoHS regulations have already restricted theplacing on the market of new EEE containing lead (Pb),cadmium (Cd), mercury (Hg), hexavalent chromium (Hex-Cr)and the �ame retardants, Polybrominated biphenyls (PBB),and Polybrominated diphenyl ethers (PBDE) in amountsexceeding the established maximum concentration values incertain products.

Since July 1, 2006, manufacturers have needed to ensurethat their products—and the components and subassemblies ofsuch products—comply with the requirements of the originalRoHS regulations in order to be put on the Union market. Theregulations have also had an impact on those who import EEEinto the EU on a professional basis, those who export to otherMember States and those who rebrand other manufacturers'EEE as their own.

RoHS 2 entered into force on July 21, 2011, and had to betransposed into national laws by January 2, 2013. At that timethe previous RoHS provisions were repealed. The new RoHS 2provisions do not a�ect the application of existing legal require-ments for EEE, including those regarding safety, the protec-tion of health, existing transport requirements or provisions onhazardous waste.

RoHS 2 continues to ban lead, mercury, cadmium, hexavalentchromium and the �ame retardants PBB and PBDE. MemberStates must ensure that EEE placed on the Union market,including cables and spare parts for its repair, its reuse, updat-



ing of its functionalities or upgrading of its capacity, does notcontain these substances as listed in Annex II.1

§ 38:16 The scope of RoHS 2—Maximum concentrationvalues in restricted substances

No more than the maximum concentration value by weightin homogeneous materials as speci�ed in Annex II will betolerated:

E For cadmium and hexavalent chromium, there must beless than 0.01% of the substance by weight at rawhomogeneous materials level.

E For lead, PBB, and PBDE, there must be no more than0.1% of the material, when calculated by weight at rawhomogeneous materials.

E Any RoHS compliant component must have 100 ppm orless of mercury and the mercury must not have beenintentionally added to the component.

Any RoHS compliant component is tested for the presence ofthese banned substances. The Commission is obliged to adoptdetailed rules for complying with these maximum concentra-tion values taking into account, inter alia, surface coatings.1

This means that Annex II can be amended through so-called“comitology.”

Comitology means that the European Parliament and theCouncil of the European Union may delegate detailed imple-menting measures to the executive, i.e. they can confer suchpowers on the Commission to reach better harmonization.However, the Commission must act in conjunction with com-mittees of representatives of Member States. The respectivecompetent committee is the one on waste. The procedure is setout in the new Articles 17 to 22.

This procedure shall also serve as a mechanism for introduc-ing new substance bans in line with the REACH methodologyto ensure coherence and maximize synergy with the work car-ried out under the chemicals' legislation (regarding REACHsee infra).

It remains to be seen which detailed rules on compliance

[Section 38:15]1Art. 4(1)

[Section 38:16]1Art. 4(2)


38-24

with the maximum concentration values, including for surfacecoatings, and coherence with REACH the Commission and thecompetent committee will enact. The detailed rules will mostlikely also provide for harmonized laboratory methodology, un-less the REACH methods will be transferred, which is not yetclear. Under REACH there are already harmonized standards.2

The review of the list of banned substances started by July2014 and will be carried out periodically thereafter; so again,counsel needs to check the latest updates on a regular basis.The current proposals to be added to the “black list” includePVC, chlorinated plasticisers, organohalogens, other �ameretardants and the phthalates BBP, DBP and DEHP.

§ 38:17 The scope of RoHS 2—Homogeneous material

The maximum tolerated concentration value of the bannedsubstances as listed in Annex II refers to the amount in anyhomogenous material from which the application is comprisedby weight.

“Homogenous material” is de�ned as “one material ofuniform composition throughout or a material, consisting of acombination of materials that cannot be disjointed or separatedinto di�erent materials by mechanical actions such as unscrew-ing, cutting, crushing, grinding and abrasive processes.”1

This de�nition already created extensive discussions underthe previous RoHS Directive. According to the Commission thefollowing examples would qualify as “homogenous material”:

E A plastic cover if it consists of one type of plastic that isnot coated with or has attached to it or inside it any otherkinds of materials. In this case the maximum concentra-tion values would apply to the plastic.

E A semi-conductor package contains many homogeneousmaterials which include: plastic moulding material, tin-electroplating coatings on the lead frame, the lead framealloy and gold-bonding wires.

An electric cable that consists of metal wires surrounded bynon-metallic insulation materials is an example of a “non-homogeneous material” because the di�erent materials could

2Council Regulation No 440/2008 of 30 May 2008 laying down testmethods pursuant to Regulation No 1907/2006 (REACH).

[Section 38:17]1Art. 3(20).



be separated by mechanical processes. In this case themaximum concentration values would apply to each of theseparated materials individually.2

§ 38:18 The scope of RoHS 2—Covered Categories ofEEE

Counsel needs to check compliance with RoHS 2 thoroughlyas various criteria need to be taken into account before youknow whether its restrictions apply to your product orappliance.

§ 38:19 The scope of RoHS 2—Covered Categories ofEEE—Categories not included

If one of the restricted substances is present in a product,counsel needs to check whether the product is initially excludedfrom the scope of RoHS via Art. 2(4). RoHS 2 does NOT applyto the following EEE:

a) equipment which is necessary for the protection of the es-sential interests of the security of Member States, includ-ing arms, munitions and war material intended forspeci�cally military purposes;

b) equipment designed to be sent into space;c) equipment which is speci�cally designed, and is to be

installed, as part of another type of equipment that isexcluded or does not fall within the scope of this Direc-tive, which can ful�l its function only if it is part of thatequipment, and which can be replaced only by the samespeci�cally designed equipment;

d) large-scale stationary industrial tools;e) large-scale �xed installations;f) means of transport for persons or goods, excluding electric

two-wheel vehicles which are not type-approved;g) non-road mobile machinery made available exclusively

for professional use;h) active implantable medical devices;i) photovoltaic panels intended to be used in a system that

is designed, assembled and installed by professionals forpermanent use at a de�ned location to produce energy

2Examples are cited from: European Commission Directorate GeneralEnvironment, 2006, “Frequently Asked Questions Document on Directive2002/95/EC (RoHS) and Directive 2002/96/EC on WEEE,” cf. under http://ec.europa.eu/environment/waste/pdf/faq�weee.pdf.


38-26

from solar light for public, commercial, industrial andresidential applications;

j) equipment speci�cally designed solely for the purposes ofresearch and development only made available on abusiness-to-business basis.

§ 38:20 The scope of RoHS 2—Covered Categories ofEEE—What does “Large Scale” mean?

“Large scale” stationary industrial tools and �xed installa-tions bene�t from exclusion. Counsel should note that themeaning of “large-scale” in absolute terms may be a di�erentone for tools and installations, as there are di�erences betweentools and installations.

According to the Commission's interpretation “tools” are es-sentially machines, stand-alone or assemblies, often with mov-ing parts, and used for example for the treatment or manufac-turing of materials and work pieces. The Machinery Directive1

can be used as guidance. Typical machine tools can also bepart of �xed installations.

In order to bene�t from either exclusion the tool or installa-tion must meet all the respective requirements. As statedbelow, it has to be:

1. “Tool”- an assembly of machines, equipment and/or compo-

nents, functioning together for a speci�c application;- permanently installed and de-installed by profession-

als at a given place;- used and maintained by professionals in an industrial

manufacturing facility or R&D facility;- and it has to be large-scale.

2. “Installation”- a combination of several types of apparatus and,

where applicable, other devices;- assembled, installed and de-installed by professionals;- with the intention to be used permanently in a pre-

de�ned and dedicated location;

[Section 38:20]1Directive 2006/42/EC on machinery, OJ L 157/24 of 09.06.2006; entry

into force June 29, 2006, as applicable since December 29, 2009. The MemberStates had to transpose the provisions until June 29, 2008.



- and it has to be large-scale.2

“Large-scale” is part of both sets of requirements and thusdecisive for exemption. “Large-scale” refers to dimensional orsimilar criteria, although this is not speci�ed in RoHS 2. Ac-cording to the Commission, one possible way of introducing adirect size criterion relates to transportation. The indicativelist as published in the RoHS 2 FAQ comprises the followingguidance metrics and qualitative criteria. If the installationexceeds the minimum requirements for one of the followingcriteria, it can be considered large-scale:

- If, when installing or de-installing the installation, it istoo large to be moved in an ISO 20 foot container becausethe total sum of its parts as transported is larger than5,71m x 2,35m x 2,39m, it can be considered large-scale.

- The maximum weight of many road trucks is 44 tons. Thusif, when installing or de-installing the installation, it is tooheavy to be moved by a 44 ton road truck, because thetotal sum of its parts as transported weighs more than thetruck's load capacity, it can be considered large-scale.

- If heavy-duty cranes are needed for installation or de-installation, the installation can be considered large-scale.

- An installation that does not �t within a normal industrialenvironment, without the environment needing structuralmodi�cation, can be considered large-scale. Examples formodi�cations are modi�ed access areas, strengthenedfoundations etc.

- If an installation has a rated power greater than 375 kW,it can be considered large-scale.3

Tools that are large-scale in comparison to smaller industrialtools, however, can be signi�cantly smaller than large-scaleinstallations. Therefore, tools do not need to match the abovelisted criteria for installations. However if they do, they are inany case large-scale. According to the Commission the follow-ing criteria being indicators can be applied to tools as installed,but speci�c guidance metrics need still to be developed:

- Dimensions (for guidance see above listed examples oftools);

2European Commission Directorate General Environment, FrequentlyAsked Questions Document on the new RoHS Directive 2011/65/EU (RoHS 2)(“RoHS 2 FAQ”), Q3.1, http://ec.europa.eu/environment/waste/rohs�eee/pdf/faq.pdf.

3All criteria cited according to RoHS 2 FAQ, Id., Q3.1, p. 12.


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E Tool size;E Size, movement or force of moving parts;

- Weight (for guidance see above listed examples of tools).4

It is the responsibility of the manufacturer, importer, or anyother economic operator involved to assess whether the tool orinstallation bene�ts from either exclusion. The burden of proofis with the responsible economic operator.

Decisions are to be taken on a case-by-case basis consideringall criteria in each de�nition. Where a tool or installation doesbene�t from exclusion, all its constituent components beingpart of it when placed on the market are also excluded.5

Examples of large-scale �xed installations bene�ting fromexclusion:

- Production and processing lines, including robots andmachine tools (industrial, food, print media etc.);

- Passenger lifts;- Conveyor transport systems;- Automated storage systems;- Electrical distribution systems such as generators;- Railway signaling infrastructure;- Fixed installed cooling, air conditioning and refrigerating

systems or heating systems designed exclusively for non-residential use.

Examples of large-scale stationary industrial tools bene�tingfrom exclusion:

- Machines for the industrial production and processing ofmaterials and goods, such as:

E CNC lathes;E Bridge-type milling and drilling machines;E Metal forming presses;E Newspaper printing presses;

- Machines for the testing of work pieces, such as:E Electron beam, laser, bright light, and deep ultra vio-

let defect detection systems;E Automated integrated circuit board and printed wir-

ing board testers;- Cranes;

4All criteria cited according to RoHS 2 FAQ, Id., Q3.1, p. 12.5RoHS 2 FAQ, Id., Q3.1.



- Other machinery of similar size, complexity and weight.6

Buildings and sites, chemical plants etc. are not installa-tions; however they may contain various subsystems that canbe addressed as installations or tools.

§ 38:21 The scope of RoHS 2—Covered Categories ofEEE—Open Scope

Apart from these listed above, the ban on heavy metals andother dangerous chemicals in EEE has now been extended to amuch wider range of products. RoHS 2 applies to EEE fallingwithin the categories set out in Annex I1 and an entirely neweleventh category has been added to Article 2 of the Directive,which serves as a catch-all:

“Other electrical and electronic equipment not covered by anyof the categories 1-10.”

This very broad categorization is related to the existing de�-nition of “Electrical and Electronic Equipment” as set forthabove in this Chapter under Sec 38:3.1 and means that allEEE will be subject to RoHS unless explicitly excluded.

With this 11th category the legislator introduced the “openscope” principle contrary to the previous RoHS provisionswhich followed the vice-versa approach covering merely listedEEE. Now both, the WEEE Recast and RoHS 2 Directives, fol-low the open scope approach.

Under Annex I the following categories of EEE are nowcovered:

1. Large household appliances2. Small household appliances3. IT & Telecommunications equipment (infrastructure

equipment is exempt in some countries)4. Consumer equipment5. Lighting equipment—including light bulbs6. Electronic and electrical tools7. Toys, leisure, and sports equipment (video games to ap-

parel requiring batteries)8. Medical devices (NOT if placed on the market before

July 22, 2014)

6All examples cited from RoHS 2 FAQ, Id., Q3.1.

[Section 38:21]1Art. 2(1), Annex I.


38-30

9. Monitoring and control instruments (NOT if placed onthe market before July 22, 2014)

10. Automatic dispensers11. Other EEE not covered by any of the categories aboveThe substance restrictions will gradually be extended to new

product categories in a step wise approach, resulting in theopen scope at the end:2

E 22 July 2014 extension to: medical devices (Category 8)and monitoring and control instruments (Category 9) asset out above already

E 22 July 2016 extension to: in vitro diagnostic medical de-vices (Category 8)

E 22 July 2017 extension to: industrial monitoring andcontrol instruments (Category 9)

E 23 July 2019 extension to: all EEE except for the onesexplicitly excluded

Cables, spare parts for the repair, the reuse, the updating offunctionalities or upgrading of capacity for a speci�c productcategory, must comply from the same date as their respectiveproduct category.3

Thus, non-compliant EEE that were outside the scope of theprevious RoHS Directive but inside the scope of RoHS 2 mustbe granted full market access until 22 July 2019, unless thegranted transition period is limited, which is the case for thedevices as is set out above.4 The Commission con�rms that allcategory 11 products may bene�t from this transitional periodof Article 2(2), but also products in other categories that onlynow fall within the scope of RoHS 2 due to a new scope relatedprovision, such as the clari�ed de�nition of EEE, whichcomprises any piece of equipment that needs electric currentsor electromagnetic �elds for at least one intended function.5

For example, the electric bicycles sector has signi�cant compli-ance issues and the Commission is currently assessing whetherit should be exempted from scope.6

Counsel should be aware, however, that these are legal

2Art. 4(3).3Art. 4(4).4Art. 2(2), Art. 4(3) and Art. 4(4).5RoHS 2 FAQ, Id., Q2.1 and Q2.2.6Commission Impact Assessment due in Summer/Fall 2014, see

Roadmap for the Legislative proposal amending the scope of the new RoHSDirective, 05/2013.



enforcement dates but commercially, importers start asking forcompliant product at least six months prior to the legaldeadline as they are forced to ensure compliant products intheir stock. Each manufacturer's individual implementationtimelines should take this into account.

The Commissions does give guidance on the question what“making available on the market” does mean in the transitionperiod. Under the current interpretation which is, however,subject to review, “making available on the market” includesthe placing on the market, i.e. the �rst making available (onthe market) and all secondary market operations, for exampleresale. This means that the products bene�ting from the transi-tion period will have full market access until July 22, 2019.However, after that date none of these products will be allowedto remain on the market even if they have been placed therebefore that date. This means that the distribution chain withinthe EU must be clear of these non-compliant products by July22, 2019.7

The Commission is aware that this has signi�cant unin-tended retroactive side-e�ects. Non-compliant products thathave been placed on the market between January 2013 andJuly 2019 cannot be resold or refurbished after July 22, 2019,i.e. no secondary market operations are possible. This side ef-fect is currently under review by the Commission's impact as-sessment and it will propose necessary adaptations to the scopeprovisions in the RoHS Directive, i.e. exclusions from the scopeand adjustments to Article 2(2), 4(3) and 4(4), if proven neces-sary by the results of the assessment.8

Following the principle of “repair as produced,” spare partsfor the speci�c products already on the market before thetransitional dates mentioned above are exempted.9 However,since these products are only addressed in Article 2(2), Article4(4) does not provide a transitional spare parts provision forproducts newly in scope (other than medical devices and moni-toring and control instruments) past July 22, 2019. As a result,products falling within this category and placed on the market

7RoHS 2 FAQ, Id., Q2.3. The Commission is addressing this issue inthe Commission impact assessment of 2013 that forms the basis for the Com-mission proposal scheduled in the �rst half of 2014 under the RoHS 2 Article24(1) mandate which is, however, delayed.

8See Roadmap for the Legislative proposal amending the scope of thenew RoHS Directive, Id., p. 2.

9Art. 4(4); RoHS 2 FAQ of 12 December 2012, Q1.3.


38-32

lawfully in July 2019, cannot be repaired anymore in August2019. Again, the Commission is aware of this side e�ect andwill propose necessary adaptations.10

If it is unclear whether an individual application falls underthe RoHS 2 scope, counsel may �nd some further guidancewithin the Frequently Asked Questions (FAQ) guidance docu-ment of December 12, 2012.11 Further questions on individualcases may be referred to the European Commission by e-mailor post or to the national authorities of Member States.12

§ 38:22 The scope of RoHS 2—Exemptions

Annexes III and IV specify current applications which are al-ready exempted from the substance ban.1 The exact scope anddate of applicability is set forth in the two Annexes in greatdetail. Counsel needs to check the criteria of the Annexesthoroughly whether its product or appliance falls under one ofthe exemptions and for how long.

Further exemptions can still be granted in cases where nosatisfactory alternative is available and further use of therestricted substance can be justi�ed.2 In case the application orproduct is not exempted and falls under the scope of RoHS 2,counsel may thus want to check if the criteria for exemptionare applicable.

RoHS 2 introduced clearer and more transparent rules forgranting exemptions from the substance ban.3 A new Annex Vprovides the information required on an application for exemp-tion and for an application for renewal of an existing exemp-tion due to expire within 18 months. An application may alsomake sense in cases where a change of wording to cover ad-ditional similar applications is needed or where counsel wouldlike to apply for the revoke of an exemption, due to recent sci-enti�c or technical developments. Under speci�c circumstances,temporary permission for placing non-consistent EEE on the

10Roadmap, Id., p. 2.11ec.europa.eu/environment/waste/rohs�eee/. . ./faq.pdf.12A list of national authorities can be found here: http://ec.europa.eu/env

ironment/waste/weee/pdf/contacts�ms�rohs.pdf.

[Section 38:22]1Art 4(6) in conjunction with Annex III and Annex IV.2Art. 5(3) to (8).3Art. 5(3) to (8) in conjunction with Annex V.



Union market may be granted. Such exemptions will then alsobe added to the Annexes III and IV of the Directive.

Counsel must know that exemptions without a speci�c dateof expiration will expire after �ve years (general application) orseven years (medical devices and monitoring and controlinstruments), unless an extension is applied for.

The grounds and procedure for submitting a request forexemption are explained in detail in a guidance document forRoHS exemption requests of 2012 that had to be issued underArt. 5(8).4 Counsel may refer to this document for further guid-ance, in particular the application checklist, and for the ap-plication form. Once counsel has decided to either request anexemption or the renewal, the amendment or the deletion of anexisting exemption, it must send the application form alongwith further documentation to the European Commission bye-mail or standard mail.5 The Commission will then acknowl-edge receipt of an application in writing within 15 days of itsreceipt and will inform the Member States of the applicationwithout delay. It will provide them with the application andany supplementary information and shall make a summary ofthe application available to the public. The Commissions willthen evaluate the application and its justi�cation. It may takeup to one and a half years before the procedure has beencompleted.6

On May 20, 2014, eight new exemptions with respect to leadand mercury have been published as Delegated Directives inthe O�cial Journal of the EU.7 The exemptions allow a higherthreshold of substances restricted in the current Annex II forspeci�c uses in EEE and two exemptions will be included intoAnnex III (general application). Six exemptions will be includedinto Annex IV (medical devices and monitoring and control

4Öko-Institut e.V./Fraunhofer IZM, Standard application format andguidance document for RoHS exemption requests on the basis of Article 5(8)Directive 2011/65/EU, 30 August 2012.

5Contact details RoHS Policy O�cer, European Commission, DGENVIRONMENT, Unit ENV/A2 Waste Management & Recycling, Avenue deBeaulieu(BU)9 05/106, B-1160 Brussels/Belgium, Email: [email protected].

6Annex V, see Standard application format and guidance document, Id.,Sec. 1.5, p.12, Sec. 1.6, p.13

7OJ L 148/57 of 20 May 2014.


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instruments).8 Member States that included the list of exemp-tions into their national legislation (not linked to the Annexesof the Directive directly) will have to update their list accord-ingly by the end of 2014.

§ 38:23 The scope of RoHS 2—Liable Parties underRoHS 2

Compliance with RoHS 2 is the responsibility of the eco-nomic operators:

1. Manufacturer2. Authorized Representative3. Importers4. DistributorsRoHS 2 stipulates each party's speci�c responsibilities in

Articles 7, 8, 9, and 10.For the de�nitions of these economic operators please refer

to Sec. 38:3.2.3 of this Chapter.In practice, most Member States are likely to �rst consider

manufacturers and professional importers that are present intheir national territories as liable under the WEEE and RoHSDirectives. However, manufacturers that are not present in aMember State or even the EU territory should not assume thatthey will be shielded from liability, in particular, where theEEE carries their trademark. Where importers fail to meettheir requirements, it is likely that national authorities willalso hold liable these foreign manufacturers.

The manufacturer is any natural or legal person who isresponsible for designing or manufacturing a product and

8Lead in solders and termination �nishes of electrical and electroniccomponents and �nishes of printed circuit boards used in ignition modulesand other electrical and electronic engine control systems (Annex III); Leadin dielectric ceramic in capacitors for a rated voltage of less than 125 V ACor 250 V DC for industrial monitoring and control instruments; (Annex IV);Lead in micro-channel plates containing speci�c properties (Annex IV); Leadin solder in one interface of large area stacked die elements (Annex IV); Leadin platinized platinum electrodes used for conductivity measurements underspeci�c conditions (Annex IV); Lead used in other than C-press compliant pinconnector systems for industrial monitoring and control instruments (AnnexIV); Mercury in hand-crafted luminous discharge tubes (HLDTs) used forsigns, decorative or architectural and specialist lighting and light-artworkunder certain limitations (Annex III); Mercury in cold cathode �uorescentlamps (CCFLs) for back-lighting liquid crystal displays, not exceeding 5mgper lamp, used in industrial monitoring and control instruments placed onthe market before 22 July 2017 (Annex IV).



places it on the market under his own name or trademark. Thede�nition contains two cumulative conditions: the person hasto manufacture (or have a product manufactured) and to mar-ket the product under his own name or trademark. So, if theproduct is marketed under another person's name or trade-mark, this person will be considered as the manufacturer.

The responsibilities of the manufacturer apply also to anynatural or legal person who assembles, packs, processes orlabels ready-made products and places them on the marketunder his own name or trademark. Further, the responsibilityof the manufacturer is placed on any person who changes theintended use of a product in such a way that di�erent essentialor other legal requirements will become applicable, or substan-tially modi�es or re-builds a product (thus creating a new prod-uct), with a view to placing it on the market. The manufacturermay design and manufacture the product himself. As analternative, he may have it designed, manufactured, as-sembled, packed, processed or labeled with a view to placing iton the market under his own name or trademark, and thuspresenting himself as a manufacturer. Where subcontractingtakes place, the manufacturer must retain the overall controlfor the product and ensure that he receives all the informationthat is necessary to ful�ll his responsibilities according to therelevant.

The manufacturer who subcontracts some or all of his activi-ties may in no circumstances discharge himself from his re-sponsibilities, for example to an authorised representative, adistributor, a retailer, a wholesaler, a user or a subcontractor.

The manufacturer has sole and ultimate responsibility forthe conformity of the product to the applicable Union harmoni-zation legislation, whether he designed and manufactured theproduct himself or is considered as a manufacturer because theproduct is placed on the market under his name or trademark.Thus, when a product is transferred to a manufacturer for fur-ther measures such as assembling, packaging, processing orlabeling, when placing the product on the market, he has thesole and ultimate responsibility for ensuring the conformity ofthe product to the applicable legislation, and must be able todo so.

Thus, foreign manufacturers wishing to limit their liabilityshould agree on the responsibility for compliance with theirdistributors in the di�erent Member States. For example,contracts with national distributors may specify that distribu-


38-36

tors are liable for compliance with the requirements of theWEEE Directive, such as registration, reporting, and take-back. However, some obligations under the WEEE Directive,such as marking, and compliance with the RoHS ban will bemore di�cult to delegate to national distributors.

§ 38:24 The scope of RoHS 2—EU Declaration ofConformity

Manufacturers are required to complete an internal produc-tion control procedure in accordance with Module A of AnnexII to Decision 768/2008/EC of the European Parliament and ofthe Council on a common framework for the marketing ofproducts and repealing Council Decision 93/465/EEC.1 Manu-facturers must also draw up technical documentation.2

Generally, RoHS 2 and the Member States use self-declaration as the basis of the compliance regime. An e�ectiveRoHS compliance and enforcement regime is intended to bebased on a presumption of conformity for all products put onthe market and a self-declaration from producers. The nationalauthorities such as the UK market surveillance authority alsoundertake market surveillance activities to detect non-compliant products and conducts tests for this purpose.3 Thisapproach follows the �rst draft RoHS Enforcement GuidanceDocument of May 2006 which was created by the EU RoHSEnforcement Authorities Informal Network of Member Statesthat was run under the leadership of the UK.4

A step-by-step procedure by which national authorities mayverify RoHS compliance is applied. Producers must �rst submitdocumentation proving compliance and only in case of doubtneed to carry out testing and sampling procedures. SomeMember States may be inclined to engage in nondestructivetesting (e.g., through an XRF analyzer) at the very beginningof the enforcement procedure, however.

Once the conformity assessment is complete, manufacturersmust prepare an “EU Declaration of Conformity” and a�x the

[Section 38:24]1OJ L218, 13.8.2008 p.82; UK Government.2BIS guidance notes for RoHS 2, September 2013, 5.1.3UK Government—BIS guidance notes for RoHS 2, September 2013,

4.1.4EU RoHS Enforcement Authorities Informal Network, “RoHS Enforce-

ment Guidance Document” (Version 1—May 2006).



“CE marking” on �nished EEE. Annex VI of RoHS 2 stipulatesthe requirements for the declaration of conformity. Economicoperators must be able to demonstrate compliance by submit-ting an EU Declaration of Conformity (“DoC”) and technicaldocumentation or other information to the market surveillanceauthority on request and must retain such documentation for aperiod of ten years after the EEE is placed on the market. AllEEE within scope must be CE marked and include a referenceto RoHS 2 (2011/65/EU) on the DoC from the date when thesubstance restrictions apply. The DoC must ensure that therequirements have been satis�ed, i.e. that the EEE is in compli-ance with the substance restrictions of RoHS 2.

Where EEE falling within the scope of RoHS 2 and meetingthe substance restrictions, procedural requirements and otherrequirements is placed on the market on or after the Directive'sentry into force date July 21, 2011, it may be CE marked andinclude RoHS 2 on its DoC even if the substance restrictions donot yet apply.5

In the absence of evidence to the contrary, it is assumed thatEEE bearing the CE mark is compliant with the RoHS provi-sions under national law.

The Commission aims for improved coherence between allEU harmonization rules, i.e. between RoHS 2 with the REACHRegulation and other applicable EU laws and regulations.6

Thus, all EU legislation requiring a DoC shall provide that asingle declaration shall be drawn up in respect of all relevantEU laws that apply.7 In light of this, single declarations areencouraged by the Commission.8

Moreover, RoHS 2 allows for the use of harmonized stan-dards to prove compliance. Where a standard exists and hasbeen cited in the OJEC as a harmonized standard for thepurposes of RoHS2 then meeting that standard will give apresumption of conformity for those requirements covered bythat standard.9

5RoHS 2 FAQ, Id., Q8.4.6See also The Blue Guide on the implementation of EU product rules

2014 Ref. Ares(2014)1025242—02/04/2014.7Article 5 of Commission Decision 768/2008/EC (common framework for

the marketing of products).8RoHS 2 FAQ, Id., Q8.2.9BIS guidance notes for RoHS 2, Id., 4.4.


38-38

§ 38:25 Enforcement

The Directive requires Member States to impose e�ective,proportionate, and dissuasive penalties for infringements, butdoes not prescribe speci�c compliance procedures, testingmethods, or levels of penalties that Member States mustenforce. Instead, Member States are responsible for establish-ing their own approaches to compliance and testing, and theseapproaches vary signi�cantly per national jurisdiction.

In general, counsel should expect the following nationalenforcement practices:

E Enforcement may take place at customs premises, distri-bution warehouses, or retail outlets. During the �rstmonths, in particular, enforcement is likely to take placeat customs premises and focus on high-risk products andshipments

E Enforcement authorities are likely to �rst focus ondocumentation, but nondestructive sample testing is alsopossible

E National authorities are expected to share informationwith other Member States through the EU RoHS Enforce-ment Authorities Informal Network and other discussiongroups. Thus, once an enforcement action begins in oneMember State, counsel should prepare for a pan-Europeandefense

E In practice, authorities have a wide margin of discretionwhen imposing the total amount of the �nes, and counselshould assume that, in most cases, the penalties are pernoncompliant item. In addition, the laws of some MemberStates (e.g., Germany) allow enforcement authorities toimpose �nes that absorb the totality of the pro�t obtainedfrom noncompliance

E Enforcement measures will also include seizure of goods,product recalls, market withdrawals, consumer noti�ca-tions, and publication of enforcement actions

E In some Member States (e.g., the UK), enforcement willnecessarily have to take place through criminal prosecu-tion rather than the administrative imposition of �nes

E In Member States such as Germany, enforcement is alsolikely to take place by means of private litigation. Counselshould expect that producers or associations of producerstarget speci�c competitors or shipments from speci�c coun-tries



§ 38:26 Recommendations to limit liability

The RoHS Directive does not require producers to certify thecompliance of their EEE. The Directive imposes certain restric-tions on the use of hazardous substances in EEE, and produc-ers and importers are simply expected to comply with suchrestrictions.

However, national enforcement authorities may take into ac-count the fact that a producer has taken all due diligencemeasures to ensure compliance with the RoHS Directive. Thisis, for example, explicitly stated in the RoHS Regulations ofthe United Kingdom, which provide for a due diligence defensefor producers showing that they took all reasonable steps andexercised all due diligence to ensure compliance.

For an o�ence the prosecution has to prove an intention todo something wrong and if e�orts were made to comply withits demands the prosecutors will take this into account. Toprove such e�orts, a person must show that all reasonablesteps or precautions were taken and all due diligence to avoidcommitting the o�ence was carried out. If they can prove thisso they are entitled to be acquitted. Whether or not a defensewill be successful depends on the circumstances surroundingeach case.1

In terms of RoHS, this means that production and materialsupply must be controlled and series of appropriate checks toprevent any problems occurring must have been put in place.Once this is done it must be ensured that the system of checksis really being carried out. Due diligence means ensuring thatthe installed system of checks works and that the a�ected partycan prove it.2

Large companies should be able to show documentation prov-ing that they have a Compliance Assurance System (“CAS”) inplace, and that they follow procedures to actively control theCAS. Small and medium sized companies, instead, are expectedto be able to provide certi�cates of compliance provided bytheir suppliers.

Thus, counsel would be well advised to develop a RoHS

[Section 38:26]1UK Government—BIS guidance notes for RoHS 2, September 2013,

8.5.2UK Government—BIS guidance notes for RoHS 2, September 2013,

8.5.


38-40

compliance program to reduce any liability in case of noncom-pliance and, in general, also ensure a high-level compliance.

The program could inter alia consist of the followingelements:

E The company should create a RoHS-compliance team thatwill work together to ensure compliance and also todevelop a pan-European strategy where the company �ndsthat a batch of products put on the EU market isnoncompliant. This team should also include employeeswho regularly deal with suppliers and contract manufac-turers and are responsible for the procurement of compo-nents

E The company should identify all the stages of the supplychain and its own manufacturing process where there is arisk that the prohibited substances may be introducedinto the equipment. This requires details on the sources ofall components of the equipment (and of the equipmentitself if it is contract manufactured) and on whichsuppliers/contract manufacturers/components/equipmentare at a higher risk of not complying with the restrictionsof the Directive.

E The company should obtain assurances from all its suppli-ers and contract manufacturers that all of the materials,components, or �nal equipment supplied comply with therequirements of RoHS 2. This could be done by introduc-ing appropriate language into the contracts requiring thefollowing: (1) all supplied components and equipmentcomply with the RoHS 2 restrictions; (2) suppliers andcontract manufacturers develop adequate complianceprograms and allow the company access to their premisesto conduct audits; (3) suppliers and contract manufactur-ers perform sample testing for each batch of equipment orcomponents supplied; and (4) all supplied batches of equip-ment and components are accompanied by declarations ofconformity or material composition declarations. Thecontracts may also specify that each declaration ofconformity or material composition declaration be ac-companied by proof of sample testing for the batch.

Merely relying on assurances from suppliers and contractmanufacturers will, however, not relieve the company from li-ability in case of noncompliance. Thus, the company shouldadopt its own procedures to ensure that all its equipment soldin the EU complies with the RoHS 2 restrictions. For example,



the company could adopt a procedure to sample test batches ofequipment sold. The sample testing procedures could, forexample, focus on batches of components and equipment and/orsuppliers that were identi�ed as being of high risk.

The compliance program should be well documented and alldocuments must be kept for a minimum period of 10 years.The company should keep documentation describing its compli-ance program, the di�erent procedures and the personsresponsible, details of contracts with suppliers and contractmanufacturers, records of audits of suppliers and contractmanufacturers, copies of all declarations of conformity or mate-rial declarations provided, records of sample testing performedby the company, and records of cases where noncompliancewas identi�ed and the remediation and prevention measuresthat were adopted

The company should also audit its compliance program fromtime to time and keep records of such audits and the measuresit took to improve the program.

The company should also make sure that the contracts withsuppliers or contract manufacturers allow it to recover dam-ages caused by noncompliance of �nished equipment as a resultof using infringing components or equipment. Recovered dam-ages should at least include any penalties or loss of sales suf-fered due to noncompliance.

Finally, counsel should bear in mind that while a complianceprogram may reduce the risk, it will not grant absolute im-munity where national enforcement authorities establish thata batch of EEE is non-RoHS compliant. Furthermore, if theauthorities decide, on the basis of the company's due diligence,not to take enforcement action against a �rst or second in-fringement, this leniency is likely to be disappear in case ofsuccessive infringements. Thus, counsel should try to ensurethat the company chooses RoHS liable partners and suppliers.

Even after all precautions are taken, mistakes can happen.Where the company �nds out that a batch of EEE that it hasput on the EU market is non-RoHS compliant, counsel shouldmake sure that the company is capable of providing a uniformmessage with the di�erent national enforcement authoritiesinvolved. One important issue is whether the company shouldnotify its noncompliance to the authorities. Some MemberStates such as Ireland require such noti�cation. Comingforward may mitigate liability, but also carries the risk thatenforcement authorities may share the information with those


38-42

of other Member States. Whatever approach the companydecides to take, it is more likely to succeed if counsel ensuresthat the company agrees with its national distributors andretailers in advance on how to proceed in case of noncompliance.

§ 38:27 The ErP DirectiveOn 21 October 2009, the EU adopted the Directive 2009/

125/EC on ecodesign1 as a recast to the EUP Directive.2

Ecodesign aims at reducing the environmental impact ofproducts, including the energy consumption throughout theirentire life cycle. This Directive is complementary to the WEEE,RoHS and REACH Directives and CPL Regulation as set outherein.

This framework Directive de�nes the principles, conditionsand criteria for setting environmental requirements for energy-using appliances (“ecodesign”) but makes no direct provisionfor mandatory requirements for speci�c products and does notimpose any speci�c requirements on manufacturers andimporters of equipment. This will be done at a later stage forgiven products via implementing measures which will applyfollowing consultations with interested parties and an impactassessment. However, the Directive establishes a fast-track“comitology procedure” for the adoption of implementingmeasures that will probably have a signi�cant impact on allequipment marketed in the EU.

An energy-related product (a “product”), is de�ned as anygood that has an impact on energy consumption during usewhich is placed on the market and/or put into service, andincludes parts intended to be incorporated into energy-relatedproducts covered by this Directive which are placed on themarket and/or put into service as individual parts for end-users and of which the environmental performance can be as-sessed independently.3

All energy sources are covered, in particular electricity and

[Section 38:27]1Directive 2009/125/EC of 21 October 2009 establishing a framework

for the setting of ecodesign requirements for energy-related products (ErP),OJ L 285/10.

2Directive 2005/32/EC establishing a framework for the setting of eco-design requirements for energy-using products and amending Council Direc-tive 92/42/EEC and Directive 96/57 and 2000/55/EC OJ [2005] L191/29.

3Art 2 (1).



solid, liquid and gaseous fuels. It applies to all products placedon the EU market and to imported products.

Means of transport (vehicles) for people or goods areexcluded.4

“Product design” means the set of processes that transformlegal, technical, safety, functional, market or other require-ments to be met by a product into the technical

speci�cation for that product.5

The implementing measures will set out the conformity at-testation procedure for products subject to ecodesign require-ments (generally self-declaration by the manufacturer with nothird-party intervention); CE marking is required for apresumption of conformity.

The manufacturer or authorized representative or, in theirabsence, the importer is responsible for guaranteeing that theproduct complies with the relevant implementing measures.They must keep the EC declaration of conformity and thetechnical data on the appliance.

Under the implementing measures, the manufacturer maybe required to inform the consumer of:

E the characteristics and environmental performance of theproduct;

E how to minimize the environmental impact when usingthe product.

Once binding implementing directives are adopted, produc-ers will no longer be able to put equipment on the EU marketthat is not marked with a “CE” conformity marking and ac-companied by a declaration of conformity whereby the pro-ducer ensures that the product complies with all environmentalrequirements of the implementing directives.

§ 38:28 The REACH Regulation: General overviewOn June 1, 2007 the REACH chemicals regulation entered

into force.1 Restrictions under REACH can be used to regulatethe manufacturing, placing on the market, or use of certain

4Art. 1(3).5Art. 2(10).

[Section 38:28]1Regulation (EC) No.1907/2006 of the European Parliament and of the

Council of 18 December 2006 concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals (REACH)) establishing a


38-44

substances if they pose an unacceptable risk to human healthor the environment. This Regulation places greater responsibil-ity on industry to manage the risks from chemicals and toprovide safety information on almost all substances used andsold.

Under REACH Substances of Very High Concern (“SVHC”)are subject to restrictions. A chemical quali�es as a SVHC as aresult of being: (1) carcinogenic, mutagenic, or a reproductivetoxicant (CMR), (2) being persistent, bioaccumulative and toxic(PBT), (3) being very persistent and very bioaccumulative(vPvB), or (4) being found to “give rise to an equivalent level ofconcern.”

Whereas RoHS and WEEE restrict hazardous substances inEEE that falls within the scope (under the Recasts after thetransitional periods all EEE unless explicitly exempted),REACH Regulations restrict the use of any substance in itsown, in a preparation and/or in an article (also beyond theEEE industry).

There are two options under the REACH Regulation (i) theauthorisation, i.e. the option of a ban on the use with the pos-sibility to apply for exemptions, and (ii) the restriction withoutthe possibility to apply for exemptions later.

Substances subject to authorisation are listed in the List ofSubstances Subject to Authorisation (Annex XIV of REACH)(the “Authorisation List”). Conditions for being granted anauthorisation include a safe use, lack of alternatives andpredominant socio-economic advantages.

All banned substances being subject to restriction are listedin Annex XVII to the REACH Regulation.

Unlike RoHS 2 and the WEEE Recast the REACH Regula-tions did not need to be transposed into Member State law.They apply directly although they need to be enforced on thenational level. The restriction of banned substances appliesdirectly without any national divergences.

Enforcement of REACH is a national responsibility, thereforeeach EU Member State, Norway, Iceland and Liechtensteinmust ensure that there is an o�cial system of controls and laydown legislation specifying penalties for non-compliance withthe provisions of REACH.

The newly incorporated agency ECHA located in Finland has

European Chemicals Agency, OJ L 396 of 30 December 2006, corrigendumOJ L 136/3 of 29 May 2007.



no enforcement responsibilities, since it is a Community-levelinstitution. However, ECHA does host the Forum for Exchangefor Information on Enforcement and manages all REACH andCLP tasks by carrying out or co-coordinating the necessaryactivities. It also ensures a consistent implementation at Com-munity level and provides Member States and the Europeaninstitutions with the scienti�c advice on questions related tothe safety and the socio-economic aspects of the use ofchemicals.

For example, in the framework of the authorisation process,the ECHA (or Member States' competent authorities) preparesthe decisive “Annex XV dossiers” for the identi�cation ofSVHCs. The outcome of this identi�cation procedure is a list ofsubstances (“the Candidate List”), which are candidates foreventual inclusion in the Authorisation List. ECHA organizesa public consultation on proposed restrictions. The consultationstarts when the REACH Annex XV restriction report ispublished on the ECHA website and is open for six months.Interested parties may comment on the proposed restrictionand the Annex XV restriction report.

In about 20 months as of publication of an Annex XV dossierat the ECHA website the restriction is adopted and needs to beobeyed European wide. The average timeline under RoHS forrestrictions to be adopted by the European bodies is longer (inaverage two—three years).

REACH imposes on chemical manufacturers, importers, anddownstream users requirements on registration, data sharing,evaluation, downstream use reporting, authorization, restric-tions, and the provision of information through the supplychain and to consumers.2 The Regulation also imposes speci�crules for substances contained in articles, such as electricaland electronic equipment.

A manufacturer of equipment may be subject to REACH asan importer of chemicals to be used in the manufacturer ofequipment in the EU, as a downstream user purchasingchemicals from EU suppliers, as an importer of equipmentwith substances into the EU, or as supplier of equipment inthe EU. Both, REACH and CLP only apply to legal entitiesestablished in the European Union and the other MemberStates of the European Economic Area, i.e. Norway, Iceland

2See also Candido Garca Molyneux, “Chemicals Survey 2006” in theYearbook of European Environmental Law (Volume 8).


38-46

and Liechtenstein. Companies established outside of the EUare not bound by the obligations of REACH and CLP, even ifthey export their products to the EU. The responsibility forful�lling the requirements of REACH and CLP, such asregistration or labeling, lies with the importers established inthe EU, or for REACH obligations, with the only representa-tive of a non-EU manufacturer established in the EuropeanUnion.

ScopeREACH applies to virtually all substances and goods. A

“substance” is de�ned in very broad terms as “a chemical ele-ment and its compounds in the natural state or obtained byany manufacturing process, including any additive necessaryto preserve its stability and any impurity deriving for the pro-cess used, but excluding any solvent which may be separatedwithout a�ecting the stability of the substance or changing itscomposition.”3 Virtually all goods are made of such substances,and the Regulation does not provide for any general exceptionsfor electrical and electronic products.

The Regulation, however, excludes from its scope radioactivesubstances, substances under special customs proceduresprovided there is no treatment or processing, non-isolatedintermediates, and the carriage of dangerous substances orsubstances in dangerous preparations.

Waste is also excluded because the Regulation provides thatwaste, as de�ned in Directive 2006/12/EC on waste,4 “is not asubstance, preparation or article.”5 Recycled substances andsubstances contained in recycled materials, however, will besubject to at least some of the REACH requirements. Article2(6)(d) of the Regulation also provides that substances on theirown, in preparations, or in articles that have been registeredand recovered in the Community are exempted from registra-tion (but not authorisation) if they meet the following twostringent requirements: (1) the substances resulting from therecovery process are the same as those that have already beenregistered, and (2) the recycler has available the informationon the substances provided in a safety data sheet or the infor-mation required by Article 32 for substances where a safetydata sheet is not required.

3Article 3(1) of the REACH Regulation.4Directive 2006/12/EC on waste OJ [2006] L114/9.5Article 2(2) of the REACH Regulation.



The Regulation also allows Member States to grant, on acase-by-case basis, exemptions for substances on their own, inpreparations, or articles “where necessary in the interest ofdefence.”6

RegistrationAs of June 2008, manufacturers and importers of substances

will be required to register those substances that theymanufacture or import in quantities of one ton or more. Therequirement of registration applies to “substances on their ownor in preparations,”7 and therefore, importers of preparationsare required to register each and every substance contained inthe imported products should they import one ton or more peryear in the same or other preparations or in bulk. In the caseof corporations, the quantities must be calculated on the basisof each di�erent legal entity rather than the corporate groupas a whole.

Only EU manufacturers and importers, but not foreignmanufacturers, may comply with the di�erent REACH require-ments, including registration. However, foreign manufacturersmay register and comply with the other REACH requirementsby appointing an “only representative” in the Community. Therepresentative must have, among others, su�cient backgroundin the practical handling of substances and the information re-lated to them.8 In this case, the representative, and not theforeign manufacturer, is likely to be liable under REACH.

The Regulation exempts polymers from registration, but itrequires the Commission to review this exemption and presentthe necessary legislative proposals “as soon as a practicableand cost-e�cient way of selecting polymers for registration onthe basis of sound technical and valid scienti�c criteria can beestablished.”9 The monomers or other substances contained inthe polymers, however, may be subject to registration if: (1)they have not already been registered by an actor up the sup-ply chain, (2) the polymer consists of 2% or more of suchmonomer or other substance in the form of monomeric unitsand chemically bound substances, and (3) the total quantity ofsuch monomer or substance makes up one ton or more per

6Article 2(3) of the REACH Regulation.7Article 5 of the REACH Regulation.8Article 8(2) of the REACH Regulation.9Article 138(2) of the REACH Regulation.


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year. An actor up the supply chain is an EU manufacturer,importer or downstream user; therefore, all foreign suppliers ofpolymers meet the �rst threshold, triggering the registration ofmonomers or other substances contained in their polymers un-less they or their suppliers have registered them through anonly representative in the Community.

On-site and transported isolated intermediates are alsosubject to limited registration requirements if their manufac-turer can con�rm that the substance is rigorously contained bytechnical means during its whole life cycle.10 Intermediates arede�ned as substances that are “manufactured for and consumedin or used for” chemical processing in order to be transformedinto another substance.11 On-site isolated intermediates areintermediates that, during synthesis, are intentionally removedfrom the equipment in which the synthesis takes place butwhere the manufacture of the intermediate and the synthesissubstance take place on the same site. Transported isolatedintermediates are those where the manufacture of the interme-diate and the synthesis substance take place at di�erent sites.Monomers that are used as on-site isolated intermediates ortransported isolated intermediates to manufacture polymersmay not bene�t from the limited registration requirementsthat apply to intermediates.12

The Regulation also exempts from registration (but not fromother REACH requirements, such as authorisation) substanceslisted in Annex IV or falling within the categories listed in An-nex V.

As stated above, generally since June 2008, manufacturers,and importers are required to register their substances.

Registration will require the submission of a technical dos-sier and may also require the submission of a chemical safetyreport where the registrant manufactures or imports thesubstance in quantities above 10 tons per year. A chemicalsafety report, however, need not be submitted where thesubstance is present in concentrations below speci�edthresholds.13

The technical dossier must include all physico-chemical,toxicological and ecotoxicological information that “is relevant

10Articles 17 and 18 of the REACH Regulation.11Article 3(15) of the REACH Regulation.12Article 6(2) of the REACH Regulation.13Article 14(2) of the REACH Regulation.



and available” to the registrant.14 In addition, the Regulationrequires the submission of data sets on the basis of the volumesof the substance, which are de�ned in Annex VII to XI to theRegulation. Annex VII lists physico-chemical and basic toxicityand eco-toxicity information requirements; Annex VIII listsshort term toxicity and eco-toxicity information requirements;while Annexes IX and X require long term chronic toxicity andeco-toxicity information. Particularly low data requirementsapply to phase-in substances in volumes below 10 tons permanufacturer or importer per year. The Annexes also establishthe general rule that, before carrying new tests, manufacturersshould �rst assess all available in vitro data, historical humandata, data valid from (Q)SARs, and data from structurally re-lated substances. Annex IX and X also specify that theregistrant must �rst include a testing proposal in its registra-tion in order to obtain the information required in suchAnnexes. Annex XI provides additional guidance on the gather-ing and submission of required data. The Commission isrequired to adopt a Regulation on test methods, which it mustamend regularly with a view to reducing testing on vertebrateanimals.15

Where the registrant must submit a chemical safety report,it must include at least an assessment of human healthhazards, physicochemical hazards, environmental hazards, andwhether the substance is persistent, bioaccumulative and toxic(“PBT”) or very persistent and very bioaccumulative (“vPvB”).If the assessment concludes that the substance should be clas-si�ed as dangerous under Directive 67/548 or is a PBT or avPvB, the chemical safety report must also include: (1) anexposure assessment including the generation of exposurescenarios and exposure estimation; and (2) a riskcharacterisation.

All pre-registrants of a same phase-in substance will berequired to join a substance information exchange forum(“SIEF”) where participants will be required to share data onthe substance.16 Manufacturers and importers of the substancein quantities below one ton (who therefore need not register),downstream users, and any third party holding information onthe substance may also join the SIEF of a substance. Parties

14Article 12(1) of the REACH Regulation.15Article 13 of the REACH Regulation.16The data sharing requirements are in addition to the OSOR rule.


38-50

that are not required to register may still decide to join a SIEFin order to in�uence the data that is submitted to the EuropeanChemical Agency.

All participants of a SIEF will be required to share the datathey own where requested by another SIEF member even ifthey are not yet required to register themselves. Before carry-ing out any testing for the purposes of registration, a SIEFmember must request the data from other SIEF members if itinvolves testing on vertebrate animals; where the data doesnot involve testing on vertebrate animals, the member maydecide not to request it from other SIEF members.

Where the holder of data involving animal testing isrequested to share it, it will not be able to continue with itsregistration and will be �ned if it does not share the data or itdoes not provide proof of its costs. In that case, the othermember may also proceed with the registration without thedata. In contrast, where the data holder agrees to share thedata and provides proof of its costs, the Regulation indicatesthat the costs must be shared in a “fair, transparent and non-discriminatory way.” However, where no agreement is reached,the costs must be “shared equally.”17 Still, in cases where thecosts are shared equally, it is unclear whether the recipient ofthe data may only refer to it for the purposes of registration ormay also have full access to the study.

In contrast, if a registration containing the data has alreadybeen submitted by a third party, the Agency must give the newregistrant permission to refer to the data in that registration.The data owner will then have a claim for an equal share ofthe costs “provided that he makes the full study report avail-able to the other participant.”18

If a study involving testing on vertebrate animals is notavailable in the SIEF, the study must be conducted by only oneSIEF participant acting on behalf of all others. All participantsof the SIEF requiring the study must contribute to the costs ofthe study with a share corresponding to the number ofparticipating potential registrants. The Regulation also speci-�es that all those participants will have the right to receive thefull study report.19

The Regulation provides for similar data sharing rules for

17Article 30(1) of the REACH Regulation.18Article 30(3) of the REACH Regulation.19Article 30(2) of the REACH Regulation.



the registration of non-phase in substances and phase-in sub-stances that have not been pre-registered.20

Information Through the Supply Chain and Downstream UserRequirements

The obligations on downstream users will largely depend onthe obligations of their suppliers and the information that theysupply to each other; generally, downstream users will onlyhave obligations where the registration dossiers of their suppli-ers do not cover the substance usage of the downstream users.Only those using substances in the Community (or the EEAcountries) and purchasing substances from EU suppliers orforeign suppliers with an only representative in the EU/EEAmay be considered downstream users.21 Importers of chemicalsin preparations are not considered downstream users butimporters of substances (and therefore, are subject to theregistration requirements), unless their foreign suppliers regis-ter the substances through an only representative in theCommunity.22

The requirements for downstream users are linked to theobligation of their suppliers to pass information down the sup-ply chain. The Regulation requires suppliers of substances ontheir own or in preparations to provide their customers with asafety data sheet (“SDS”) if the substance or preparation isdangerous under the criteria of the Dangerous SubstancesDirective and the Dangerous Preparations Directive, or wherethe substance is a PBT, vPvB, or a substance raising an equiv-alent level of concern.23 The Regulation also requires suppliersof preparations, upon request of their customers, to providethem with a SDS if the preparation contains, above speci�edconcentration levels, substances that are classi�ed as danger-ous, PBTs or vPvBs, substances identi�ed as raising an equiv-alent level of concern, or substances for which there are Com-munity workplace exposure limits. Where the supplier mustinclude a chemical safety report in its registration dossier, itmust include the report's exposure scenarios covering theidenti�ed uses in an annex to the safety data sheet.

Downstream users (i.e. customers) are entitled to identify

20Articles 26 and 27 of the REACH Regulation.21Article 3(13) of the REACH Regulation.22Article 8(3) of the REACH Regulation.23Article 31 of the REACH Regulation.


38-52

their uses of the substance to the supplier, who must includethem in the exposure scenarios unless it is unable to do so forreasons of protection of human health or the environment.Upon receipt of the SDS, the downstream users must checkwhether the exposure scenarios cover their uses. If their use isnot included in the SDS (because they have not identi�ed theuse to the supplier or the supplier has refused to include it),downstream users must prepare a chemical safety reportand/or notify the European Chemicals Agency.

Downstream users, however, are not required to draft achemical safety report and/or notify the Agency if their sup-plier is not required to supply a SDS, their supplier was notrequired to prepare a chemical safety report, or they use thesubstance in quantities below one ton per year, among others.Thus, in practice, downstream users will not be required toprepare chemical safety reports and/or notify the Agencywhere, among others, they are supplied with substances thatare not classi�ed as dangerous or where their suppliersmanufacture or import the substance in quantities below tentons. Downstream users can always shift their procurementamong suppliers in order to get the best “REACH deal.”

EvaluationThe rules on evaluation, in e�ect, lay down three evaluation

procedures. First, the Agency must decide on testing proposalsincluded in registration dossiers or downstream user reports toprovide the information speci�ed in Annexes IX and X. TheAgency must give priority to substances that have, or mayhave, PBT, vPvB, sensitising, or CMR properties, or substancesthat are classi�ed as dangerous under the Dangerous Sub-stances Directive and manufactured or imported in quantitiesabove 100 tons per manufacturer or importer per year.

Second, the Agency must check the compliance of at least 5%of all registration dossiers submitted.24 Within 12 months ofthe evaluation of the dossier, the Agency must draft a decisionrequiring the registrant to submit additional information in or-der to comply with the registration requirements and specify-ing the time limits for doing so.

Third, Member States are to evaluate substances on the basisof all relevant information submitted. By December 2011, andthereafter, the Agency is to draft a Community rolling action

24Article 41 of the REACH Regulation.



plan covering the substances that should be evaluated withinthe following three years. This plan must prioritize substanceson a risk-based approach by taking into account the substance'shazard information, exposure information, and tonnage.

The competent authorities of Member States may choosesubstances from the rolling action plan in order to become thecompetent authority for the evaluation of such substances.They may draft decisions, which must be adopted by theAgency or, where no agreement can be reached, the Commis-sion, and require the registrant to submit additional informa-tion, including information not required in Annexes VII to X.The competent authorities must review the informationsubmitted and draft a decision.

This draft decision must be noti�ed to the registrant, whichmust be allowed to comment. The competent authority mustthen circulate the draft decision and any comments of theregistrant among the Agency and other Member States. If otherMember States do not propose amendments, the decision mustbe adopted. If Member States propose amendments, the draftmust be discussed by the Member State Committee. If thisCommittee agrees by unanimity on the draft decision, theAgency must adopt it. Where no agreement can be reached, theEuropean Commission must adopt a decision through thecomitology regulatory procedure. As with the prior evaluationprocedures, registrants may appeal the decision to the Agency'sBoard of Appeals only if the Agency (and not the Commission)adopts the decision (i.e., there is unanimity within the MemberState Committee).

AuthorisationUnder the Authorisation procedure, manufacturers are

required to apply for the prior authorisation of the marketingand use of certain substances, on their own or in preparations.This procedure is designed to ensure that producers progres-sively phase out substances that are considered to be of partic-ular concern.

The authorisation procedure applies to substances on theirown or in preparations but not to substances in articles, suchas electrical and electronic equipment. This is because Article56 provides that prior authorisation is required for “the use(s)of that substance on its own or in preparation on the incorpora-


38-54

tion of the substance into an article,”25 but not the use of thesubstance “in an article.” This interpretation is also con�rmedby Article 69(2), which provides that, after a substance is listedas subject to authorisation, “the Agency must consider whetherthe use of that substance in articles poses a risk to humanhealth or the environment that is not adequately controlled”and make proposals under the Restrictions procedure.

The authorisation procedure may apply to substances that(1) meet the criteria for classi�cation as Category 1 or 2 CMRs;(2) are PBTs; (3) are vPvBs; or that do not meet the criteria of(1), (2) or (3) but for which “there is scienti�c evidence of prob-able serious e�ects to human health or the environment whichgive rise to an equivalent level of concern [. . .] and which areidenti�ed on a case-by-case basis.”26 These four categories ofsubstances are generally referred to as substances of very highconcern. The identi�cation of PBTs and vPvBs must be done onthe basis of the criteria of Annex XIII to the Regulation, whichthe European Commission must amend.

Yet, the procedure is not likely to apply to all substancesmeeting the criteria described above. The Agency, upon requestof the Commission or on the basis of a Member State proposal,must �rst identify the substances of very high concern thatwill become candidates for inclusion within the list of sub-stances subject to authorisation of Annex XIV to the Regulation.The identi�cation of substances must be done on the basis of adossier following criteria contained in Annex XV and must al-low all interested parties to comment. Decisions identifyingsubstances are adopted by the Agency if the Member StatesCommittee can reach a unanimous agreement; where no una-nimity can be reached, the Commission must adopt the deci-sion through the regulatory comitology procedure.27

The Commission must thereafter decide to include sub-stances identi�ed as candidates within the list of substancessubject to authorisation of Annex XIV. It must do so on thebasis of a proposal of the Agency, which must prioritize sub-stances with PBT or vPvB properties, wide dispersive use, orhigh volumes. Before sending its recommendation to the Com-mission, the Agency must publish the draft on its web site and

25Article 56(1) of the REACH Regulation.26Article 57 of the REACH Regulation.27Article 59 of the REACH Regulation.



allow all interested parties to comment. The Agency must putforward its �rst recommendation by June 2009.28

The Commission decision listing substances in Annex XIVmust provide any applicable exceptions, the date after whichthe substance may not be marketed or used unless an authori-sation is granted or an application for authorisation has beensubmitted (so called “sun-set date”), and the date within whichall application must be submitted, among others.29

Applications may be submitted by importers, manufacturers,or downstream users.30 Where manufacturers or importersobtain an authorisation, this can also cover the uses of theirdownstream users. There are, however, at least two reasonswhy downstream users should consider applying themselvesfor authorisation. First, after the application deadline, no moreapplications may be submitted; thus, where the supplier failsto obtain the authorisation, the downstream will have to �nd asupplier with authorisation or stop using the substance.Second, where a downstream user obtains an authorisation forits use, it will be free to choose any supplier even if it the lat-ter does not have an authorisation of its own.

All applications for authorisation must include, among oth-ers, an analysis of alternatives considering their risks andtechnical economic feasibility of substitution, and, wherealternatives are available, a substitution plan including atimetable. The European Commission “must” grant authorisa-tions for uses of substances if the risk to human health or theenvironment of the use of a substance [. . .] “is adequatelycontrolled.” However, authorisation may be granted only if it isshown that socio-economic bene�ts outweigh the risk to humanhealth or the environment arising from the use of the substanceand if there are no suitable alternative substances or technolo-gies in the following four cases: (1) where it cannot be shownthat the risks are adequately controlled, (2) the substances areCategory 1 or 2 CMRs and it is not possible to establish anexposure threshold, (3) the substances are PBTs or vPvBs, or(4) the substance is identi�ed as raising an equivalent level of

28Article 58(4) of the REACH Regulation.29Article 58 of the REACH Regulation.30Article 62(1) of the REACH Regulation.


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concern to PBTs or vPvBs. The Commission must adopt its de-cision through the regulatory comitology procedure.31

All authorisations are time limited and subject to review.Authorisation holders wishing to extend the authorisation mustsubmit a review report at least 18 months prior to the deadlinespeci�ed in the authorisation. The review report must includean update of alternative substances or technologies and asubstitution plan if alternatives are available. Only authorisa-tion holders, and not latecomers, are likely to be able to requestthe extension.32

The Commission may also decide to review an authorisationat any time if: (1) the circumstances of the original authorisa-tion have changed so as to a�ect the risk to human health orthe environment or the socio-economic; or (2) new informationon possible substitutes becomes available.33

RestrictionsThe REACH Regulation also provides for a restrictions pro-

cedure through which the Commission may restrict themanufacture, marketing, or use of substances that pose “anunacceptable risk to human health or the environment.”34 Thus,under this procedure, the adoption of new chemical restrictionswill no longer require its legislative adoption by the Parlia-ment and the Council through the EC Treaty co-decisionprocedure.

The restrictions must be adopted on the basis of opinions ofthe Agency's Committees for Risk Assessment and Socio-Economic Analysis and after allowing interested parties tocomment. The procedure can be initiated by a dossier preparedby the Agency, upon the Commission's request, or a MemberState. As indicated above, where a substance is listed as subjectto authorisation, the Agency must consider whether the use ofthat substance in articles must be restricted. The restrictionsmust be listed in Annex XVII to the Regulation.

While the Regulation includes a free movement clause forsubstances meeting the requirements of the REACH Regula-

31Article 60 of the REACH Regulation.32Article 61(1) of the REACH Regulation.33Article 61(2) of the REACH Regulation.34Title VIII of the REACH Regulation.



tion,35 it also allows Member States to keep their own restric-tions in place until 1 June 2013 provided those restrictionshave been noti�ed to the Commission in accordance with theEC Treaty.36

ArticlesThe Regulation imposes less stringent requirements on sub-

stances contained in articles, such as electrical and electronicequipment, than on substances on their own or in preparations.In practice, the real impact of this will be on imported articlesbecause, for the purposes REACH, EU/EEA manufacturers ofarticles are downstream users of the substances they use intheir manufacturing processes and may even be substanceimporters as well.

An article is de�ned as “an object which during production isgiven a special shape, surface or design which determines itsfunction to a greater degree than does its chemicalcomposition.” Thus, an article must meet two conditions: (1) itmust be an object with a special shape, surface or design, and(2) the shape, surface or design must determine the article'sfunction to a greater degree than its chemical composition.37

While in most cases it will be relatively easy to identify anarticle (e.g., a chair, a wheel, a teething ring), there are likelyto be many borderline cases where it will be di�cult to make adistinction between an article and a container of a preparation.This distinction will have important regulatory implicationsbecause, as stated above, the REACH Regulation imposes lessstringent requirements on articles than on preparations incontainers. For example, if ink cartridges are considered asarticles rather than containers of preparations, the substancesin the imported ink cartridges will not be subject to the priorauthorisation requirement even if they are intended to bereleased from the ink cartridge. Another important regulatorydi�erence results from the di�erent method for calculatingvolumes for substances/preparations in containers than forsubstances/preparations in articles. For example, the volume ofa substance imported in bulk must be added to the volumes ofthe same substance that is part of a preparation in an imported

35Article 128 of the REACH Regulation.36Article 67(3) of the REACH Regulation.37DHI Water & Environment, Danish Toxicology Center, kopol, GmbH,

et al, Draft Technical Guidance Document on requirements for substances inarticles: Reach Implementation Project 3.8 Final Report (May 26. 2006).


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container. In contrast, the volumes of the substance importedin bulk, or even as part of a preparation in a container, mustnot be added to the volume of a substance contained in animported article. This di�erent method of calculating thevolumes may have important regulatory implications because,among others, the amount of data to be submitted in theregistration of the substance and its timing depends on thevolumes of the substance per manufacturer or importer peryear. Another important regulatory di�erence is that while inthe case of substances on their own or in preparations all theirmanufacturers and importers must register the substance ifthey meet the volume thresholds, producers and importers ofarticles are not required to register or notify the substances intheir articles if the use of the substance in the article has al-ready been registered by any other third party.

The evolution of the discussions on guidance for borderlinecases between articles and containers of preparations in theREACH Implementation Project (“RIP”) 3.8 on substances inarticles re�ect a u-turn in the approach of stakeholders andthe Commission towards a much stricter interpretation of thede�nition of articles. The latest discussions indicate that mostMember States and the Commission view as containers ofpreparations rather than articles spray cans, ink cartridges,carbon papers, printed ribbons, �re crackers, and car batteries.In contrast, thermometers with liquid in them, smelling eras-ers and adhesive tapes tend to be perceived as articles.38 Thesediscussions also suggest that for borderline cases useful criteriacould be: (1) the primary and an ancillary function of the prod-uct (i.e., is the object merely acting as a container or carrier todeliver the substance?); and (2) whether the preparation is anintegral part of the article, and therefore, they are used and,where relevant, discarded concurrently.

The Regulation requires producers and importers of articles,(e.g., equipment) to register the substances contained in themif the following three conditions are met: (1) the substance ispresent in “those articles” in quantities over one ton per pro-ducer or importer per year; (2) the substance is intended to bereleased under normal reasonably foreseeable conditions of

38European Commission, Draft Summary of Meting of the Sub-GroupCommission Working Group on Substances in Articles of 9 February 2007(Brussels, 19 February 2007); European Commission.



use;39 and (3) the substance has not already been registered“for that use” by a third party.40 The use of the term of “thosearticles” when referring to the volumes per producer orimporter per year suggests that the threshold should apply tothe entire article output of a producer or importer rather thanto individual article types. For example, it is likely that thevolumes of the substance in di�erent models of a computer ofthe same producer should be added. Furthermore, an interpre-tation of the three di�erent thresholds for registration as wholewould suggest that the volumes of substances in articlesimported or produced by the same person should be addedprovided that the substances in the articles have the same use.Thus, the volumes of a substance in personal computers andnetwork servers should be added provided that the substancehas the same use in those articles. Not surprisingly, the conceptof use of a substance is subject to much debate within the RIPdiscussions.41

The data to be submitted during the registration of sub-stances in articles and their timing is the same as that ap-plicable to the registration of substances on their own or inpreparations. Registrants of substances in articles are alsosubject to the REACH Regulation's requirements on datasharing.

Producers and importers of articles are also required to notifythe substances contained in their articles if the following �veconditions are met: (1) the substance has already been identi-�ed as a substance of very high concern and as a candidate tobe subject to the prior authorisation requirement; (2) thesubstance is present in those articles in quantities over one tonper producer or importer per year; (3) the substance is presentin those articles above a concentration of 0.1% weight byweight;42 (4) the substance has not already been registered forthat use by a third party;43 and (5) the producer or importer

39Article 7(1) of the REACH Regulation.40Article 7(6) of the REACH Regulation.41CEFIC, DHI, BfR, et al., RIP 3.2-2 (Task IV) Work Package 2—Task

A5 (Task Group 1) Proposal for a Common Descriptor System with Regard toUses (January 23, 2007).

42Article 7(2) of the REACH Regulation.43Article 7(6) of the REACH Regulation.


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cannot exclude human or environmental exposure duringnormal or reasonably conditions of use, including disposal.44

Not surprisingly, the RIP 3.8 discussions indicate that thereis a debate on how to measure the concentration limit of 0.1%in order to decide whether a substance in an article should benoti�ed. For example, where a substance is contained in thewheel of an imported car, should the concentration be calcu-lated on the basis of the wheel or of the whole car? Or shouldthe concentration limit be calculated on the basis of the ho-mogenous material? While the original interpretation of theCommission was that the concentration threshold should bemeasured on the basis of the article as a whole,45 as a result ofconcerns raised by NGOs and Scandinavian countries the Com-mission has asked its legal services to review this question.

The noti�cation requirement is likely to a�ect many moreproducers and importers of electrical and electronic equipmentthan the requirement of registration. Noti�cations of sub-stances in articles require the submission of limited informa-tion, such as the contact details of the producer or importer,the substance's identity, classi�cation and tonnage, and a briefdescription of its uses.46 Noti�cations will be due within sixmonths from the moment that the substance is identi�ed as asubstance of very high concern and a candidate for theauthorisation procedure, starting as of June 2011.47

In addition, the European Chemicals Agency may requireproducers and importers of articles to submit a registration ifthe following four conditions are met: (1) the substance is pres-ent in the articles in quantities over one ton per producer orimporter per year; (2) the Agency has grounds for suspectingthat the substance is released from the articles; (3) the Agencyhas grounds for suspecting that the release of the substancefrom the articles presents a risk to human health or theenvironment;48 and (4) the substance has not already been

44Article 7(3) of the REACH Regulation.45European Commission, Draft Summary of Meeting of the Sub-Group

of Commission Working Group on Substances in Articles of 9 February 2007(19 February 2007).




registered for that use by a third party.49 Arguably, the Agencyshould be allowed to require the registration of these sub-stances not earlier than the registration deadline for the par-ticular substances on their own or in preparations.

The Regulation also requires the Agency to consider whetherthe use of a substance that has been subject to authorisationposes risks human and environmental risks that are notadequately controlled and that merit a restriction under theRegulation's restrictions procedure once the authorisationsunset deadline for those substances has passed.50 Thus, theRegulation envisions that the Agency use the informationobtained during the noti�cation and registration of substancesin articles to restrict the use in articles of those substancesthat have been subject to the authorisation requirement. Theadoption of restrictions for the use of substances in articles,however, would still be limited to those cases where there are“unacceptable risks” to humans or the environment.51 Onlytime will tell the extent to which this restrictions procedurerenders irrelevant the RoHS Directive and other similarlegislation.

A producer of an article is de�ned as any natural or legalperson who makes or assembles an article within the EU/EEA.Thus, where an EU producer of equipment assembles compo-nents made by others, it is likely that in case of non-compliancewith the registration and noti�cation requirements or themarketing and use restrictions, regulatory authorities mayhold liable both the producer of the component and that of theassembled product. Importers of equipment are wholly liablefor the substances in the equipment they import unless theirchemical suppliers have appointed an only representative inthe EU/EEA.

Finally, an important innovation of the REACH Regulationis that it requires all persons engaged in the trade of articles toinform their customers of the presence in their articles of sub-stances identi�ed as being of very high concern. All suppliers—and not only producers or importers—of equipment containingsubstances that have been identi�ed as being of very highconcern and candidates for the authorisation procedure inconcentrations above 0.1% weight per weight must provide



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their professional customers, including distributors, wholesal-ers and professional end users, with su�cient information toallow the safe use of the article.52 Suppliers are also requiredto provide the same information to consumers within 45 daysof the receipt of their request.53 In both cases, the informationto be supplied must include at a minimum the name of thesubstance that has been identi�ed as being of very high concernand a candidate for authorisation and is present in theequipment.

§ 38:29 The REACH Regulation: Compliance withRoHS

Horizontal legislation such as REACH and product-speci�cvertical EU legislation such as the RoHS Directive areconsidered to be complementary. Whereas REACH aims toensure that the risks presented by substances are adequatelycontrolled throughout their whole life cycle, including those oc-curring in the waste stream. RoHS contributes to the soundmanagement of waste EEE. The EU legislator wanted bothpieces of legislation to work together and decided they shouldapply without prejudice to each other.1

This approach sounds easy but creates considerable di�cul-ties for manufacturers, importers and distributers in practice.In cases where a substance is considered under both legalinstruments—for example if a substance is subject to authori-sation under the REACH Regulation and banned in EEE underRoHS 2- the ban under RoHS 2 will have priority and applyonly to EEE. An authorisation under the REACH Regulationwill apply to all other �elds of application. It cannot overrule arestriction under the RoHS 2 Directive. Therefore, exemptionfrom a restriction under RoHS 2 can only be obtained by meansof the procedure stipulated in the RoHS 2 Directive.

The European Commission is aiming to achieve a betteralignment of the instruments of the REACH Regulation andthe RoHS 2 Directive. However, the RoHS 2 Recast is stilllacking a concrete speci�cation of the interface with REACH; afull merger between RoHS and REACH has not been considered

52Article 33(1) of the REACH Regulation.53Article 33(2) of the REACH Regulation.

[Section 38:29]1EU Commission Directorate General, REACH and Directive 2011/

65/EU (RoHS)—A common understanding, Doc. CA/36/2014.



immediately possible. This is why they will continue to remainvalid in parallel.

From this, the following inconsistencies occur that are notyet solved by the legislator:

E a restriction is proposed under REACH for the placing onthe market of articles containing a substance1 (includingEEE) and the substance is already listed in Annex II toRoHS;

E a new substance is proposed for inclusion in Annex II toRoHS and a restriction relating to articles containing thatsubstance (including EEE) is already in Annex XVII toREACH;

E the placing on the market of articles containing a particu-lar substance is not yet restricted at Union level under ei-ther instrument but a proposal for a restriction underREACH is imminent and so it has to be clari�ed howRoHS should be taken into account.2

Further issues remain still unsettled.

§ 38:30 The REACH Regulation: Compliance withRoHS—De�nition of placing on the market

The concept of “placing on the market” in the RoHS Direc-tive refers to the �rst making available of an EEE on theEuropean Market. In contrast, the concept has been assigned abroader meaning under REACH by including each instance ofmaking available, i.e. for example also the transfer of (asubstance in) used products to a third party. This broaderconcept is also included in the WEEE-Recast now, see above,but not yet agreed upon.

§ 38:31 The REACH Regulation: Compliance withRoHS—Validity for imported articles

Substance restrictions under the RoHS Directive applydirectly also to imported articles from non-EU regions. This isthe case under REACH only if a restriction has been imposedin Annex XVII but not in case a substance has been includedas being subject to authorisation under Annex XIV.

An authorisation requirement under REACH means that asubstance may not be used in the EU without an authorisationgranted upon application. The authorisation requirement refers

2REACH and RoHS common understanding, Id., p. 2.


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only to the placing on the market and the use of substances,respectively, but not to that of articles. Hence, articles producedoutside of Europe are not subject to authorisation. Moreover,substances being (an integral) part of imported articles cannotbe subject to authorisation.

Please note, an article is de�ned within ECHA guidancedocuments as an object with physical properties more impor-tant to its function than any chemical properties.1 The exactclassi�cation of an article needs a detailed assessment on acase-by-case basis. Under RoHS the general restriction of sub-stances contained in products applies to all new products onthe European market irrespective of their place of manufacture.

§ 38:32 The REACH Regulation: Compliance withRoHS—SVHCs: Concentration limits

RoHS 2 and REACH use di�erent reference levels for theconcentration limits in articles. The maximum concentrationvalues of 0.1% by weight stated in the RoHS Directive refer toa homogeneous material. The REACH Regulation, based onthe interpretation by ECHA's guidance of 2008, applies thesubstance concentration threshold of 0.1% weight by weight tothe article as such as produced or imported.

§ 38:33 The REACH Regulation: Compliance withRoHS—Granting exemptions

The two options under the REACH Regulation of (i) authori-zation (option of a ban on the use with the possibility to applyfor exemptions) and of (ii) restriction without the possibility toapply for exemptions later—are not compatible with the proce-dure under the RoHS Directive. The RoHS Directive combinestwo procedures whose combination is not envisaged underREACH, namely a general restriction of substances containedin products—applying to all new products on the Europeanmarket irrespective of their place of manufacture—with a pro-cedure for granting temporary exemptions. On principle,(temporary) exemptions also exist for restriction under theREACH Regulation. However, there is no established mecha-

[Section 38:31]1Article means “an object which during production is given a special

shape, surface or design which determines its function to a greater degreethan its chemical composition”; (REACH, Article 3(3)). An article is to beunderstood as the article as produced or imported.



nism to apply for such exemptions after entry into force of therestriction ruling. The exemptions are already de�ned whenimposing the restriction.

The restriction of the use or placing on the market of asubstance in articles under REACH does not provide for exemp-tion applications by industry and applies both to articlesproduced in the EU and imported articles. Applications, towhich the restrictions as listed in Annex XVII apply, as well aspossible exemptions, are laid down in a binding way by theMembers States in advance.

In RoHS 2 the Commission had proposed that in the futurean exemption granted under the RoHS Directive shall implyan exemption from the authorisation requirement laid down inthe REACH Regulation. As a consequence, a substance subjectto authorization under REACH could then be used again forthe production of EEE in the EU, in the �eld of application towhich the exemption refers, without imposing any furtherrequirements. This suggestion is subject to controversy. Ger-many for example is of the opinion that the European Commis-sion should abandon the automatism. In particular, it shouldbe taken into account that the question of exposure duringmanufacturing and processing is not comprehensively consid-ered by the RoHS Directive, and the REACH Regulationprovides for strict requirements for the handling of a substance,which then would perhaps not exist under the RoHS Directive.

§ 38:34 The REACH Regulation: Compliance withRoHS—Classi�cation, labeling and packagingof substances (CLP)

In parallel to REACH, the Globally Harmonised System forclassi�cation and labeling of sub-stances and preparations hasbeen implemented in the EU (Regulation (EC) No 1272/2008 of16 December 2008), which applies in respect of substancesfrom December 1, 2010, and in respect of mixtures from June1, 2015. The CLP Regulation entered into force on January 20,2009.

This replaces the classi�cation and labeling provisions of theDangerous Substances Directive (67/548/EEC) and the Danger-ous Preparations Directive (99/45/EC), which shall be repealedwith e�ect from June 1, 2015.

Instead, the supplier shall provide the information todownstream users or distributors by means of the safety datasheet to be set up in accordance with REACH Regulations (Sec.1.3.4.2 of Annex I to the CLP Regulation).


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