European Commission

International Symposium on Chemicals Managementin the Context of Global Trends
Latest Trends of Chemicals Management in north America,
Europe and Asia

Chemicals Management in the European Union andits application to industrial products
Wolfgang Hehn
Deputy Head of Che micals Unit
Directorate–General
Enterprise and Industry
European Commission
1.

Objectives of this Presentation


Introduction into the set
set--up of chemicals management in the European Union
Structure of the system
Content of the most important acts from an industrial and international
trade perspectiveDescription of the main policy drivers which led to the system in its currentform

Description of the political and technical reasons which led to the new
REACH regulation

Short personal assessment of the expected developments in the years to comeThis presentation is not a technical or legal guidance to RoHS or REACH;
however,, it provides information where such guidance can be foundhowever2.

1General Outline
1.

Introduction to the European context

2.

Current legislation for chemicals management in the European
Union- Structure and general outline of its content- The Directive on Restrictions of Hazardous Substances(RoHS)RoHS) in electrictal and electonic products as an example for
product legislation

3.

The new REACH legislation

4.

Outlook – Challenges and future efforts
3.

Context (1)Sectoral breakdown of EU chemical industry

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Context (2)The production of chemicals in a global perspective

5.

Context (3)The European Union – A community inthe making
27 Member states
2 Candidate countries
several countries requesting membershipmore than 20 languages, 500 million inhabitants

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Context (4)Main factors influencing the developmentof European chemicals legislation
Main objectives of European chemicals legislation


Need to harmonise provisions on chemicals of themember states in order to ensure the finctioning of theinternal market



Need to protect public healthoriginally mainly workers’ healthlater general population – consumers
nowadays increasing focus on vulnerable groups

Increasingly and with a widening scopeprotection of the environment – no longer just classicalsubjects like water and air pollution but items like
protection of the ozone layer, climate change, biodiversity

7.

Context (5)Main factors influencing the development ofEuropean chemicals legislation

Important other policy drivers:








High rank of concerns on the environment and health in the
public debate
A very strong influence of civil society / NGO’s
Requirement to move from a reactive approach to aprecautionary approach
Strong call for a life-cycle-approach (integration of consumerof final product and waste management)
Strong call for a substitution of hazardous substances in
products
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Current legislation for chemicals management in theEuropean Union (1)General Structure of the legislation on chemical substances
Horizontal rules applying to all (industrial) chemicals--

Chemical rules applying to specific product groups (e.g. explosives, cosmetics,
detergents, fertilisers, pesticides, biocides, etc.)
Environmental legislation addressing directly the use of specific chemical
substances in certain products (e.g. refrigerants containing ozone depleting
substances, restriction of hazardous substances in electrical and electronic
products (RoHS), End of life vehicles)

Main challenge: coherence
Large numbe r of governme nt departments involved and wide variety of
9.
objectives

Current legislation for chemicals management in theEuropean Union (2)Horizontal rules applying to all chemicals
The Directive on Dangerous Substances (Directive 667/548/EEC) and the
Directive of classification labelling of Dangerous Preparations

Main subject:Classification, packaging and labelling of dangerous substancesand preparations

These Directives are the key element and foundation of chemical management rules in the
EU. The rules of the Dangerous Substances Directive define which substances are to beconsidered as dangerous, because of which hazards and the classification and labellingprovides the basic information for any subsequent risk management.
For substances of special concern harmonised classifications are established which are
Legally binding. Harmonised classifications cover at present about 8000 substances andthe Directive is under permanent revision to take account of scientific and technicalprogress.
The two Directives will be replaced by a regulation implementing the Globally
Harmonised System (GHS) in 2008 (subject to completion of the legislative process)10.

5Current legislation for chemicals management in the European
Union (3)Horizontal rules applying to all che micals
The Safety Datasheet Directives (Directives 93/112/EEC and 2001/58/EC)
2001/ 58/EC) andthe Directive on the protection of the health and safety of workers from the risks ofchemical agents at work (Directive 98/24/EC)
The supplier of a dangerous substance or certain preparation has to provide a safety data which in essence contains
all the specified information and hazards, appropriate uses and risk management measures. Safety data sheets are ofvery high importance for risk management by professional users.
The workplace legislation requires employers to determine whether hazardous substances are present at theworkplace and to asses the related risks. He has to do so based on the information in the safety data sheets.
The employer has to take all necessary risk reduction measures and he is obliged to take measures for
substitution of hazardous by non- or less hazardous substances or to reduce exposure.
Alas empirical studies have shown that many safety data sheets are deficient and of little use. This one of thereasons that risk reduction measures taken by the downstream users of chemicals are frequently not fully up
to standards either.

11.

Current legislation for chemicals management in the European
Union (4)Horizontal rules applying to all chemicals

Risk assessment of Existing Substances (Regulation793/93/EEC)
and New Substances (6th and 7th Amendment of
Directive 67/548)
Under the current legislation very different rules apply for “Existing Substances” and “New
Substances”. “New” substances (those which entered the market after 1981) need to be notified tothe authorities with a fixed set of testing data from very low quantities.
“Existing Substances” are those registered in “EINECS” (European Inventory of Existing
Commercial Substances). All substances registered in EINECS can be put on the market unless there
are specific restrictions. For most EINECS substances only very limited data on production andtoxicity are available
In order to generate more information at least on high volume Existing Sustances specific rules forthe risk assessment of those substances were introduced in 1993
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Current legislation for chemicals management in the European
Union (5)Horizontal rules applying to all che micals

Existing Substances Regulation (cont.)

The basic structure of the Existing S ubstances Regulation is simple: Industry submits the data for substances incertain volume brackets, Community authorities take a decision on which substances warrant a Community risk
assessment, designated Member S tates undertake the risk assessments which are then discussed and endorsed on EU
level with recommendations how to address the identified risks.
13.

Current legislation for chemicals management in the European
Union (5)Horizontal rules applying to all che micals

Existing Substances Regulation (cont.)
In practice, this system worked rather slow. In more than ten years
only 141 substances have been prioritised and production andagreement on the respective risk assessments has taken a very longtime. Consequently, the results the results for risk reduction comevery late, sometimes too late from a political perspective.
This was one of the main reasons for the reform by means of the
new REACH system.
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Current legislation for chemicals management in the European
Union (6)Horizontal rules applying to all che micals

The Restrictions of Marketing and Use Directive or„Limitations Directive
Directive“(“( 76/769/EC)
This Directive compiles marketing and use restrictions for a wide
variety of priority substances, preparations and products (e.g. abestos,arsenic, certain phtalates, certain brominated flame retardents).

The prohibition to put a product on the market is the most severe risk
reduction measure existing. It is therefore generally based on a risk
assessment and an economic impact assessment.

As an exception to this principle carcinogenic, mutagenic andreprotoxic substances are generally prohibited for sale to the generalpublic (with some rare exceptions when no suitable subststitute isavailable)

15.

Current legislation for chemicals management in the European
Union (7)Legislation on specific product groups
Apart from the so-called ‚horizontal legislation‘ which applies in principle to all industries
and applications there is quite a number of sector-specific legislation.
The most important areas are:-Pharmaceuticals (totally separate)
Cosmetics
Plant protection products (pesticides)
Biocidal products
Food contact materials
Detergents
Explosives

In general this sector-specific legislation is partly based on the horizontal che mical legislationand sets stricter specific rules for the specific product group in conside ration of the specificrisks of the respective application.
The EU is party to virtually all international che mical conventions, which are thenimple mented by specific acts of Community law.
Finally, the re are substance manage ment provisions in certain acts of Community waste
legislation. Most known, the restrictions on the use of heavy metals in vehicles and electricaland electronic products.

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Current legislation for chemicals management in the European
Union (8)Legislation on specific product groups
The example of the RoHS Directive

The Restriction of Hazardous Substances (« RohS ») in electrical and electronicequipme nt Directive (2002/95/EC) is an example of environmental legislationinfluencing directly the use of certain hazardous substances in a group ofindustrial products

Prime objective is to address proble ms in waste manage ment caused by thepresence of hazardous substances in the waste streamLinked to this is the objective to push producers of electrical and electronic
articles to design their products in a more environmentally friendly way

Restricted are mercury, cadmium, lead, hexavalent chromium and two groups ofpolybrominated flame retardents; other substances can be added on a proposal
from the Commission



The Directive requires a substitution of the hazardous materials when technicalalternatives are available unless negative effects of the substitution on
environment, health or consume r protection outweigh the benefits (compare
Article 5);17.

Current legislation for chemicals management in the European
Union (9)Legislation on specific product groups
The example of the RoHS Directive (cont.)

Practical problems in application of the RoHS Directive
The RoHS Directive can be regarded as the first Directive in Europe which set a
general substitution requirement for a wide group of complex industrial products(until then, marketing and use restrictions had a very narrow scope). This caused anumber of implementation problems:








A high number of derogations has been proven to be necessary, high work load
for industry and the European Commission
Methodological problems to measure compliance, especially with theconcentation limit of 0.1% (0.01% for Cd), this limit applies to « homogeneousmaterial ». A product can consist of many homogenious materials.
EU Member States are responsable for the implementation of the RoHS Directive.
The rules for compliance are not harmonised and therefore somewhat different,
although Member States cooperate.
To address the practical problems the Commission is reviewing the RoHS
Directive (for further informationcompare:
http://ec.europa.eu/environment/waste/weee_index.htm)
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Current legislation for chemicals management in the European
Union (10)Legislation on specific product groups
The example of the RoHS Directive (cont.)

RoHS Directive, conclusions:

The Directive addresses an important global waste problem (compare current
international discussions on e-waste in the framework of the Basle
convention)



Basic approach to push producers to considers the full life cycle of theirproducts when they decide to use hazardous substances is generally
acknowledged

Approach to regulate specific hazardous substances in individual products or
product groups is only feasable in some few cases (other examples are « endof life vehicles » or the « batteries directive »).

In future, hazardous substances in products are to be addressed under the
new REACH legislation
19.

The new REACH Regulation(1) Reasons for the new legislation
Problems with the existing system
Current chemicals management system is inefficient Current system is a patchwork developed over time Difficult to identify risks – difficult to address risks: Lack of information about most substances on themarket Burden of proof on public authorities No efficient instrument to deal with problematic
substances Lack of incentives for innovation
 Disproportionately high demands for new substances

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The new REACH regulation (2)Main features and objectives
REACH stand for: Regulation on the Registration, Evaluation and
the Authorisation of CHemicals
 Scope:-

manufacture, import, placing on market and use of substances:on their own
in preparations
in articles

Overall aims:

-











Improving health and safety of workers and the general public.
Environmental protection – avoiding chemical contamination of air, water, soil
and damage to biodiversity
Maintaining a competitive/innovative chemicals industry
Integration with international efforts (SAICM, GHS, etc)
21.

The new REACH Regulation(3)Key Elements (cont.) One single and coherent system
for new and existing chemicals
 Core elements:
Registration of substances ≥ 1 tonne/yr (staggered deadlines)
Information in the supply chainEvaluation of some substances by Member States
Authorisation only for substances of very high concern
Restrictions - the safety net
European Chemicals Agency to manage system
 Focus on priorities:high volumes(as a proxy for potential risk)
greatest concern (substances & uses with highest risk)
 Shift of responsibilities:
from public authorities towards industry
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The new REACH regulation(4) Key elements as regards the scope REACH applies to the manufacturing, import, placing on the market
market and use of
substances However, as in the current legislation there are exemptions for certain:
 Substances (e.g. ores, certain common natural substances) Uses of substances (mainly those regulated by special legislation)
 In comparison to the current legislation reduced obligations for R&D (research,
product and process related research and development (PPORD)), polymers andintermediates
 Note that substance definition includes metals, as has been the case in the EU for thelast decades

23.

The new REACH regulation (5)Registration: obligations of
Manufacturers/Importers
 Registration requirement for substances ≥ 1 tonne per year (permanufacturer/importer, in practice over a three year average)
 Imports: registration to be effected by EU-importer or the “only representative” ofthe non-EU company
 Chemical Safety Report (CSR) for all substances ≥ 10 t per year;
CSRs document the hazard and classification of the substance, potential exposuresof humans and the environment during the life cycle of the substances are describedin ‘exposure scenarios’ for all foreseen uses, CSRs contain a risk assessment andrisk management measures for these uses
 In the absence of available information, tests may have to be conducted Data sharing (obligatory for vertebrate tests)
 Substance Information Exchange Fora (SIEFs) in order to limit duplication of24.
testing

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The new REACH regulation (6)Registration: obligations of
Manufacturers/Importers (cont.)
 Timetable: Non phase-in substances: A 67/548/EEC notification for a ‘new substance’ in the current system automatically becomes aregistration
 When not already notified by the company:
registration required before production or import can take place (= new substances under
REACH)
 Phase-in (of forme r ‘existing’) s ubstances:
benefit from transition periods if pre-registered Pre-registration: 1 June 2008 – 30 November 2008
(except where newly manufactured / imported) Identify substance, manufacturer, tonnage band/deadline
 European Chemicals Agency will publish list
 Registration: Transition period depending on the tonnage band

25.

The new REACH regulation (7)Registration: Timelines
Timeline REACH phasephase-in period (not in scale)Note that phasephase-in registration requires
prepre-registration!
Pre--registrationPre
1 June 2008 – 1 Dec. 2008
EIF
1 June 2007

EIO Agency
1 June 2008

Agency publishes List
1 January 2009

≥ 1000 t/a

Prepare testing strategies, CSA

CMR ≥ 1 t/a
R50/53 ≥ 100 t/a30 Nov.
2010

Registration of‘newnew’’ substances≥ 1t/a31 May2018

100 - 1000t/a
31 May2013

SIEF
C&L notification(independent of tonnage)
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The new REACH regulation (8)Downstream User Rights and Obligations
One of the main differences between the curre nt system and REACH is the integration of
Downstream Users. Downstream Users are users of che mical substances that are neithe r
manufactured nor imported by the company itself.


CSRs and Safety Data sheets usually have to address uses of the chemicals by the Downstream
Users. Therefore, Downstream Users have to make their uses known to manufacturers/importers.
However, to enable the suppliers to prepare the corresponding exposure scenario and support of
the use they need to provide the relevant data

Downstream Users are entitled carry out their own CSA(e.g. for confidentiality reasons) In case input che mical is directly imported from outside the EU without “onlyrepresentative” of the exporting manufacturer:
The Downstream User is regarded as importe r and has the registration obligations!
27.

The new REACH regulation (9)Substances in Articles (Article 7)> 1 tonne / year per Manufacturer / Importer

Substance not registered for that use

Intended to be released(regardless of hazard)



Substance of Ve ry High Concern(CMRs, PBTs and vPvBs, etc.)Placed on candidate list for authorisation

Concentration of > 0.1 % weight-by-weight

General obligation to registerTimeline in accordance with(phase-- in) deadlines(phaseObligation to notify the Agency


except where there is no exposure

At the earliest 1 June 2011, and6 months after SVHC placed on candidate list

Agency may require registration

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The new REACH regulation (10)Authorisation/Restriction
 Authorisation:for Substances of Very High Concern (“SVHC”, essentially CMR category
1 and 2, PBT, vPvB substances) Identification of SVHC (compare Art 58 of REACH Regulation)
 “Sunset date” after which manufacturing and use is only allowed when
covered by an authorisation
 Uses or use categories can be exempted from authorisation if the risk isadequately controlled (i.e. if no emissions are expected)
Note: although the number of SVHC is relatively high, authorisation will bealong term process as a strict priority setting will be needed Restriction:

only minor changes compared to existing system (Directive 76/769/EEC) In addition to “marketing & use”, now also manufacturing covered

29.

The new REACH regulation (11)Authorisation and Substitution (Art. 62)

A manufacturer applying for authorisation of a SVHC needs to provide
provide ananalysis of the alternatives “considering their risks and the technicaltechnical andeconomic feasibility of substitution”
If the mandatory “Analysis of alternatives” finds suitable alternatives,
alternatives, theapplication must also include a substitution plan with timetable When no such alternatives are found, the application must provide
provide information on
any relevant R&D activities, if appropriate
 During a review, the Commission may require a substitution plan when it decides
that there are suitable alternatives available
 PBT substances cannot invoke the “adequate control route”
 By 1 June 2013, the Commission to consider whether to exclude Endocrine
Disruptive Substances from the scope of the “adequate control route”


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The new REACH regulation (12)Imminent implementing goals of the Commission
Intensify the preparation to implement REACH
smoothly:
Drafting the Technical Guidance Documents,
 Preparing the necessary software tools(IUCLID 5 and REACH IT),
 Setting up ECHA: the Chemicals Agency in Helsinki Important: to provide key elements of the guidance by entry into force
 to make REACH workable for SMEs
 to get the Agency operational on time31.

The new REACH regulation (13)
Network of helpdesks
trade associations, industry organisations, experts

AgencyCommittees
Committees
Committees
(MSC,
RAC,
(MSC,RAC,
RAC,
(MSC,
SEAC)
SEAC)
SEAC)
Support to helpdesks
Q&A database
FAQ document

Agency“helpdesk”

Network•Helpdesk exchange forum(IT based)

Industry
Industry
Industry
helpdesks
helpdesks
helpdesks•Correspondents network
Agency acting as
focal point

MemberMemberMember
State
State
State
helpdesk
helpdesk
helpdesks

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The new REACH regulation (14)Points of immediate relevancefor non-EU companies•

PrePre-registration required for (phase(phase-in) registration:
Your EUEU-importer or your “only representative”
must participate in the SIEF•

Avoid uncoordinated testing:Testing can only be carried out once agreed in the
SIEF
For higher volumes: Before testing can start,
Agency must approve testing proposal•

Agency helpdesk takes up questions from outside
the EU•

Substances intended to be released from articles:
Also fall under obligation to register

33.

The new REACH regulation (15)Conclusions from a policy perspective
REACH builds largely on the existing system of European chemicals legislation
legislation..
It is not a revolution
revolution.. Virtually all elements have been applied in parts of thechemical legislation before
before..

The main differences are:--

Much more information is to be collected on existing substances
New requirement of registration of substances as a prepre--condition for
placing them on the market (Article 5: No data, no market
market))Strong involvement of downstream users
A further step in addressing chemical substances in articles.

None of these ideas are new, neither in the European nor in theinternational debate
debate..
The challenges are implementation and cost.
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Outlook
Challenges and further efforts








REACH defines to a large extent the work programme
for chemicals management in Europe for the next
decade;decade;GHS will be a complement to REACH;
adoption of the legislative proposal imminent;
start of the legislative discussions expected for firstsemester 2007
Growing importance of regulatory convergence and of
the work of international bodies (eg(eg OECD, SAICM) as
globalisation of the industry will continue
International coco-operation strongly desirable inemerging issues (e.g. nanotechnology)
nanotechnology)
35.

Further Information
Further information is available on the followinginternet pages of the Commission:
1. Policy Information and Text of the Legislation
Environment Directorate General:

http://ec.europa.eu/environment/chemicals/index.htm
http://ec.europa.eu/environment/chemicals/index.htm
Enterprise Directorate General

http://ec.europa.eu/enterprise/chemicals/index_en.htm
2. Technical information (technical guidance documents, risk assessments):
European Chemicals Bureau
http://ecb.jrc.it/

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European Commission

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