Impact of REACH on the Plastics and Packaging Supply Chain

88 Pages·0.331 MB·English

by  Pira International Ltd

Impact of REACH on the Plastics and
Packaging Supply Chains
Sean Milmo
Published by
Pira International Ltd
Cleeve Road, Leatherhead
Surrey kt22 7ru
UK
T [phone]
F [phone]
E [email protected]
W www.piranet.com
The facts set out in this publication Pira International Ltd acknowledges product, service and company names referred to
are obtained from sources which we in this report, many of which are trade names, service marks, trademarks or registered
believe to be reliable. However, we trademarks.
accept no legal liability of any kind
for the publication contents, nor any
information contained therein nor
conclusions drawn by any party from it.
No part of this publication may be
reproduced, stored in a retrieval
system, or transmitted, in any form or
by any means, electronic, mechanical,
photocopying, recording or otherwise
without the prior permission of the
Copyright owner.
ISBN 1 85802 565 6
© Copyright
Pira International Ltd 2006
Head of publications and events
Philip Swinden
[email protected]
Publisher
Rav Lally
[email protected]
Head of editorial
Adam Page
[email protected]
Global editor
Nick Waite
[email protected]
Head of US publishing
Charles E. Spear, Jr.
[email protected]
Assistant editor
Claire Jones
[email protected]
Customer services manager
Denise Davidson
[email protected]
T [phone]
Typeset in the UK by
Jeff Porter, Deeping St James,
Peterborough, Lincs
[email protected]
Contents
List of tables v The secretariat and executive director 27
List of figures vi The agency’s committees 28
1
Board of Appeal 29
4
Introduction to REACH 1
European Commission’s legislative Registration 31
proposals for REACH 2 Basic registration requirements 32
Amendments to REACH by the European
Pre-registration 32
Parliament and Council of Ministers 6
Steps for assessing data
The European Chemicals Agency 8
requirements 33
Registration 9
Information needed for a standard
Data sharing 11
technical dossier 34
Evaluation and authorisation 12
Hazard data requirements 34
Downstream users of chemicals 12
Full or partial exemptions from REACH 35
2
Polymers 36
Preparations and substances in
articles 37
Intermediates 38
Drivers behind REACH 15
Prioritisation and registration deadlines 39
International and EU political trends 15
Substances of 1 tonne or more 39
The influence of NGOs 16
Substances of 10 tonnes or more 39
Role of EU legislative institutions 17
Substances of 100 tonnes or more 40
Concerns about SMEs 19
Substances of 1,000 tonnes or more 41
Main issues affecting the finalisation and
Chemical safety assessments and chemical
implementation of REACH 20
safety reports (CSRs) 42
Substitution 20
Chemical safety assessments 42
Confidentiality 21
Exposure assessments 43
Duty of Care 21
3 Chemical safety report 44
Classification and labelling inventory 45
5
European Chemicals Agency
(ECHA) 23
The ECHA’s position within the REACH Data sharing 47
system 23 One Substance, One Registration
Specific responsibilities and tasks of the (OSOR) 47
agency 24 Sharing of test data 48
The management structure of the Opting out and issues of confidentiality 49
agency 26 Confidentiality 49
Management board 26 Sharing of information costs 51
Page iii © Copyright Pira International Ltd 2006
Impact of REACH on the Plastics and Packaging Supply Chains
Contents
6
Chemical safety report 68
8
Evaluation and authorisation 53
Evaluation procedure 53 Imports and trade 71
Dossier evaluations 53 REACH regulations on imports 71
Substance evaluations 54 Substances in articles and
Authorisation process 55 preparations 71
Criteria for candidate list 55 REACH as a possible barrier to trade 73
9
Comitology procedure 55
Prioritisation 56
Authorisation applications and
decisions 57
Authorisation reviews 57 Outlook 75
Controls and restrictions 58 Costs of REACH 75
Substitution 59 Implementation and enforcement of
Socio-economic analysis (SEA) 60 REACH 76
7
Strategic partnerships 77
Enforcement 78
Effects on competitiveness and
innovation 79
Downstream users 63 Innovation 79
Changes in the scope of safety data sheets Health, safety and environmental
(SDSs) 64 benefits 80
Uses and preparations 66 REACH as a global pace-setter in health
Chemical safety assessments by and safety 80
downstream users 67
Page iv © Copyright Pira International Ltd 2006
List of tables
2.1 Availability of various toxicity data 5.1 Information held by the European
on high production volume chemicals Chemicals Agency that will be
(HPVCs) with annual output above considered open, confidential or the
1,000 tonnes in the European Union, disclosure of which will be left to the
according to substance type 16 agency’s discretion 50
2.2 REACH legislation chronology 18 6.1 Health and safety risk assessment of
3.1 Responsibilities of different UV curing of printing inks 59
entities within the European 6.2 Environmental assessment 60
Chemicals Agency 26 7.1 Information sources for downstream
4.1 Pre-registration information 33 users on substances in articles 64
4.2 Registration deadlines 34 7.2 Environmental impact assessment of
4.3 Number and production volume UV and conventional printing 67
range of selected specialty 7.3 Risk assessment matrix 69
chemicals 40
Page v © Copyright Pira International Ltd 2006
List of figures
1.1 REACH timeline 2001–06 3 6.1 Steps to authorisations 56
1.2 REACH timeline 2006–18 6 7.1 REACH and the supply chain 63
2.1 Number of enterprises and sales 7.2 Sectoral breakdown of EU chemical
by employment size-class in EU industry, 2004 65
chemical industry 19 8.1 Breakdown of world chemical
2.2 REACH preparations checklist 20 sales 73
4.1 REACH recycling timeline 32 9.1 REACH regulation timetable 76
Page vi © Copyright Pira International Ltd 2006
1
Introduction to REACH
Politicians, industrialists, environmentalists and trade unionists in the EU have been
virtually unanimous in affirming the need for a single piece of new EU legislation to
govern chemicals. But there has been a lot of disagreement – particularly between
industry and environmentalists – about what type of single regulatory system is needed.
The European Commission, the EU’s executive, has drawn up a scheme called REACH for
the Registration, Evaluation and Authorisation of CHemicals. But it has turned out to be
one of the most controversial items of industrial legislation ever put forward by the EU.
Because of the size of the EU’s market, the introduction of the REACH project will affect
the marketing of pigments and other chemicals throughout the world.
Prior to REACH, the use of chemicals in the EU has been governed by 40 different
directives or laws incorporated into the statute books of all the EU’s 25 member states.
The Commission, member states, non-governmental organisations (NGOs), environmental
groups and other bodies were all agreed that a simplified form of regulatory control was
required.
However there have been sharp differences over what types of controls over chemicals
would be required. Environmentalists called for tighter restrictions than in the existing
rules. They in particular urged more application of the precautionary principle under
which action would be taken against chemicals when there are reasonable doubts about
their safety despite the lack of scientific proof. The environment campaigners won a
great deal of support among the general public in Europe who had become increasingly
concerned about the safety of chemicals after a series of industrial accidents, health
scares and studies showing a rising level of pollution. The chemical industry and its
customer sectors, on the other hand, warned about the dangers of precipitate and
unjustified measures.
The demand for new legislation was fuelled by the obvious failure of current EU
regulations to provide assurances on the safety of chemicals already on the market.
A directive from 1976 enables the EU to restrict the marketing and use of certain
dangerous substances and preparations. Restrictions have been imposed on around
100 substances, including their use in finished articles. In addition, controls have been
placed on the marketing to the general public of around 900 substances classified as
carcinogenic, mutagenic or toxic to reproduction (CMR).
Under a law introduced in 1981, new substances, even those for research purposes,
with volumes as low as 10kg, had to be tested and assessed for possible risks to human
health and the environment. But there was no provision for testing nearly 100,000 existing
chemicals. Public authorities were later given responsibility to undertake risk assessments of
chemicals considered potentially dangerous, with the possibility of imposing restrictions on
their use. By 2004 around 3,000 new chemicals had been authorised under the 1981 rules.
Of existing, possibly harmful, high-volume chemicals, only 141 had been identified for risk
assessment by authorities within individual member states, with a mere 27 completing the
process. As a result there has been a general lack of publicly available knowledge about the
properties and uses of over 99% of substances on the market.
Page 1 © Copyright Pira International Ltd 2006
Impact of REACH on the Plastics and Packaging Supply Chains
Introduction to REACH
Under current legislation, only manufacturers and importers of substances have been
required, if necessary, to provide safety and other data on their products. Downstream
industrial users and formulators have not been obliged to do the same. So information on
the uses of substances has been hard to obtain, with a scarcity of data about exposure
to chemicals from downstream applications. Generally, industry has to provide test data
only when a substance has been proved to pose a serious risk. But without test results, the
authorities have claimed that it has been almost impossible to supply such proof.
European In February 2001 the European Commission issued a White Paper on a future chemical
Commission’s policy for the EU. It was welcomed by environment groups, although some thought its
legislative proposals proposals were not tough enough. But it was strongly criticised by the chemical industry
for REACH and many of its customer sectors. It also had a mixed response from member states.
Scandinavian countries and those with relatively small chemical industries tended to
be the most supportive. Countries like Germany, the UK and France with large chemical
sectors were inclined to be the most sceptical. Many politicians were nervous about the
impact of the new policy on a chemical industry which is the third largest manufacturing
sector in Europe and employs 1.7 million directly while another 3 million people are
dependent on it for their jobs.
The Commission claimed that the overriding goal of the policy was sustainable
development, which depended on a number of objectives in order to be achieved in the
chemical industry. These were:
 Protection of human health and the environment;
 Maintenance and enhancement of the competitiveness of the EU chemical industry;
 Prevention of fragmentation of the EU’s internal market;
 Increased transparency by giving consumers access to information on chemicals;
 Integration with international efforts on safety of chemicals;
 Promotion of non-animal testing;
 Conformity with the EU’s international obligations within the World Trade
Organisation (WTO).
A key proposal of the Commission was that manufacturers and importers would have
to register all substances which they produce or supply in total annual amount of over
one tonne. These were estimated to total around 30,000 companies. The registration
dossier on each substance would include data on physicochemical, toxicological and
ecotoxicological properties. The information could be equivalent to that already required
for new chemicals. The Commission argued that it would fill the gap in knowledge about
the intrinsic properties of existing substances. Also, by having a volume threshold of one
tonne, many chemicals used in research and development would be exempted from the
scheme.
All the registered information on substances with an annual production of more than
100 tonnes and those of lower volumes with worries about their safety would be evaluated
by authorities with a view to undertaking further testing programmes on the effects of
Page 2 © Copyright Pira International Ltd 2006
1
Impact of REACH on the Plastics and Packaging Supply Chains
Introduction to REACH
FIGURE 1.1 REACH timeline 2001–06
(cid:18)(cid:15)(cid:1)(cid:49)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:66)(cid:77)(cid:1)(cid:71)(cid:83)(cid:80)(cid:78)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)
(cid:18)(cid:15)(cid:1)(cid:34)(cid:79)(cid:1)(cid:38)(cid:68)(cid:80)(cid:79)(cid:80)(cid:78)(cid:74)(cid:68)(cid:1)(cid:66)(cid:79)(cid:69)(cid:1)
(cid:52)(cid:80)(cid:68)(cid:74)(cid:66)(cid:77)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:85)(cid:85)(cid:70)(cid:70)(cid:1) (cid:20)(cid:15)(cid:1)(cid:34)(cid:78)(cid:70)(cid:79)(cid:69)(cid:70)(cid:69)(cid:1)(cid:81)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:66)(cid:77)
(cid:19)(cid:15)(cid:1)(cid:39)(cid:74)(cid:83)(cid:84)(cid:85)(cid:1)(cid:83)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:67)(cid:90)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:38)(cid:49)(cid:1)(cid:176)(cid:1)(cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79)
(cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79)(cid:15)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:85)(cid:85)(cid:70)(cid:1)(cid:80)(cid:71)(cid:1) (cid:71)(cid:83)(cid:80)(cid:78)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)
(cid:85)(cid:73)(cid:70)(cid:1)(cid:51)(cid:70)(cid:72)(cid:74)(cid:80)(cid:79)(cid:84)(cid:1)(cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79)
(cid:21)(cid:15)(cid:1)(cid:39)(cid:74)(cid:83)(cid:84)(cid:85)(cid:1)(cid:83)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:67)(cid:90)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)
(cid:56)(cid:73)(cid:74)(cid:85)(cid:70)(cid:1)(cid:49)(cid:66)(cid:81)(cid:70)(cid:83)(cid:1)(cid:176)(cid:1)(cid:39)(cid:70)(cid:67)(cid:83)(cid:86)(cid:66)(cid:83)(cid:90)(cid:1)(cid:19)(cid:17)(cid:17)(cid:18)
(cid:22)(cid:15)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)(cid:84) (cid:24)(cid:15)(cid:1)(cid:38)(cid:49)(cid:1)(cid:73)(cid:66)(cid:84)(cid:1)(cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)(cid:69) (cid:18)(cid:17)(cid:15)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:86)(cid:79)(cid:74)(cid:68)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)
(cid:26)(cid:15)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79)
(cid:66)(cid:77)(cid:77)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:38)(cid:49)(cid:181)(cid:84)(cid:1) (cid:85)(cid:73)(cid:70)(cid:1)(cid:81)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:66)(cid:77)(cid:1)(cid:88)(cid:74)(cid:85)(cid:73)(cid:80)(cid:86)(cid:85) (cid:71)(cid:83)(cid:80)(cid:78)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)
(cid:80)(cid:71)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)
(cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84)(cid:1) (cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84) (cid:80)(cid:79)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79)
(cid:23)(cid:15)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:68)(cid:66)(cid:79) (cid:25)(cid:15)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:68)(cid:66)(cid:79) (cid:18)(cid:84)(cid:85)(cid:1)(cid:49)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:66)(cid:77)(cid:1)(cid:176)(cid:1)(cid:34)(cid:81)(cid:83)(cid:74)(cid:77)(cid:1)(cid:19)(cid:17)(cid:17)(cid:20)
(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:66)(cid:68)(cid:85)
(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:66)(cid:68)(cid:85)
(cid:66)(cid:84)(cid:1)(cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:70)(cid:69)
(cid:18)(cid:18)(cid:15)(cid:1)(cid:52)(cid:70)(cid:68)(cid:80)(cid:79)(cid:69)(cid:1)(cid:83)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:67)(cid:90)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:38)(cid:49)
(cid:19)(cid:79)(cid:69)(cid:1)(cid:49)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:66)(cid:77)(cid:1)(cid:176)(cid:1)(cid:52)(cid:70)(cid:81)(cid:85)(cid:70)(cid:78)(cid:67)(cid:70)(cid:83)(cid:1)(cid:19)(cid:17)(cid:17)(cid:20)
(cid:18)(cid:19)(cid:15)(cid:1)(cid:38)(cid:49)(cid:1)(cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)(cid:84)(cid:1) (cid:18)(cid:21)(cid:15)(cid:1)(cid:38)(cid:49)(cid:1)(cid:83)(cid:70)(cid:75)(cid:70)(cid:68)(cid:85)(cid:84) (cid:18)(cid:23)(cid:15)(cid:1)(cid:38)(cid:49)(cid:1)(cid:81)(cid:83)(cid:80)(cid:81)(cid:80)(cid:84)(cid:70)(cid:84)(cid:1) (cid:18)(cid:24)(cid:15)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)
(cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:80)(cid:83) (cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79) (cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84)(cid:1)(cid:85)(cid:80) (cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79)(cid:1)(cid:80)(cid:79)(cid:1)(cid:38)(cid:49)(cid:181)(cid:84)
(cid:78)(cid:66)(cid:76)(cid:70)(cid:84)(cid:1)(cid:79)(cid:80)(cid:1)(cid:68)(cid:80)(cid:78)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84) (cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79) (cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79) (cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84)
(cid:18)(cid:20)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:74)(cid:84) (cid:18)(cid:22)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:74)(cid:84)(cid:1)(cid:69)(cid:70)(cid:70)(cid:78)(cid:70)(cid:69)
(cid:69)(cid:70)(cid:70)(cid:78)(cid:70)(cid:69) (cid:79)(cid:80)(cid:85)(cid:1)(cid:85)(cid:80)(cid:1)(cid:67)(cid:70)
(cid:18)(cid:84)(cid:85)(cid:1)(cid:51)(cid:70)(cid:72)(cid:86)(cid:77)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:176)(cid:1)(cid:48)(cid:68)(cid:85)(cid:80)(cid:67)(cid:70)(cid:83)(cid:1)(cid:19)(cid:17)(cid:17)(cid:20)
(cid:85)(cid:80)(cid:1)(cid:67)(cid:70)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69) (cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69)
(cid:18)(cid:25)(cid:15)(cid:1)(cid:52)(cid:70)(cid:68)(cid:80)(cid:79)(cid:69)(cid:1)(cid:83)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:67)(cid:90)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)
(cid:18)(cid:26)(cid:15)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)(cid:84)(cid:1)(cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:70)(cid:69)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79) (cid:19)(cid:18)(cid:15)(cid:1)(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:69)(cid:80)(cid:70)(cid:84)(cid:1)(cid:79)(cid:80)(cid:85)
(cid:18)(cid:84)(cid:85)(cid:1)(cid:51)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:176)(cid:1)(cid:47)(cid:80)(cid:87)(cid:70)(cid:78)(cid:67)(cid:70)(cid:83)(cid:1)(cid:19)(cid:17)(cid:17)(cid:22)
(cid:74)(cid:10)(cid:1)(cid:67)(cid:90)(cid:1)(cid:66)(cid:1)(cid:82)(cid:86)(cid:66)(cid:77)(cid:74)(cid:71)(cid:74)(cid:70)(cid:69)(cid:1)(cid:78)(cid:66)(cid:75)(cid:80)(cid:83)(cid:74)(cid:85)(cid:90)(cid:1)(cid:74)(cid:71)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)(cid:1)(cid:73)(cid:66)(cid:84)(cid:1)(cid:69)(cid:70)(cid:77)(cid:74)(cid:87)(cid:70)(cid:83)(cid:70)(cid:69)(cid:1)(cid:66) (cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:78)(cid:70)(cid:79)(cid:85)(cid:84)
(cid:81)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:87)(cid:70)(cid:1)(cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79) (cid:85)(cid:80)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:80)(cid:79)(cid:1)(cid:49)(cid:80)(cid:84)(cid:74)(cid:85)(cid:74)(cid:80)(cid:79)
(cid:74)(cid:74)(cid:10)(cid:1)(cid:86)(cid:79)(cid:66)(cid:79)(cid:74)(cid:78)(cid:80)(cid:86)(cid:84)(cid:77)(cid:90)(cid:1)(cid:74)(cid:71)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:36)(cid:80)(cid:78)(cid:78)(cid:74)(cid:84)(cid:84)(cid:74)(cid:80)(cid:79)(cid:1)(cid:73)(cid:66)(cid:84)(cid:1)(cid:69)(cid:70)(cid:77)(cid:74)(cid:87)(cid:70)(cid:83)(cid:70)(cid:69)(cid:1)(cid:66)(cid:1)(cid:79)(cid:70)(cid:72)(cid:66)(cid:85)(cid:74)(cid:87)(cid:70)
(cid:80)(cid:81)(cid:74)(cid:79)(cid:74)(cid:80)(cid:79)
(cid:19)(cid:17)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69)(cid:1)(cid:66)(cid:84)(cid:1)(cid:66)(cid:78)(cid:70)(cid:79)(cid:69)(cid:70)(cid:69) (cid:19)(cid:19)(cid:15)(cid:1)(cid:36)(cid:80)(cid:79)(cid:68)(cid:74)(cid:77)(cid:74)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:68)(cid:80)(cid:78)(cid:78)(cid:74)(cid:85)(cid:85)(cid:70)(cid:70)(cid:1)(cid:74)(cid:84)(cid:1)(cid:68)(cid:80)(cid:79)(cid:87)(cid:70)(cid:79)(cid:70)(cid:69)
(cid:19)(cid:79)(cid:69)(cid:1)(cid:51)(cid:70)(cid:66)(cid:69)(cid:74)(cid:79)(cid:72)(cid:1)(cid:176)(cid:1)(cid:37)(cid:70)(cid:68)(cid:70)(cid:78)(cid:67)(cid:70)(cid:83)(cid:1)(cid:19)(cid:17)(cid:17)(cid:23)
(cid:19)(cid:20)(cid:15)(cid:1)(cid:36)(cid:80)(cid:79)(cid:68)(cid:74)(cid:77)(cid:74)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:81)(cid:83)(cid:80)(cid:68)(cid:70)(cid:69)(cid:86)(cid:83)(cid:70)
(cid:19)(cid:21)(cid:15)(cid:1)(cid:36)(cid:80)(cid:79)(cid:68)(cid:74)(cid:77)(cid:74)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:68)(cid:80)(cid:78)(cid:78)(cid:74)(cid:85)(cid:85)(cid:70)(cid:70)(cid:1) (cid:19)(cid:26)(cid:15)(cid:1)(cid:36)(cid:80)(cid:79)(cid:68)(cid:74)(cid:77)(cid:74)(cid:66)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:68)(cid:80)(cid:78)(cid:78)(cid:74)(cid:85)(cid:85)(cid:70)(cid:70)(cid:1)(cid:69)(cid:80)(cid:70)(cid:84)(cid:1)(cid:79)(cid:80)(cid:85)(cid:1)
(cid:66)(cid:72)(cid:83)(cid:70)(cid:70)(cid:84)(cid:1)(cid:80)(cid:79)(cid:1)(cid:66)(cid:1)(cid:75)(cid:80)(cid:74)(cid:79)(cid:85)(cid:1)(cid:85)(cid:70)(cid:89)(cid:85) (cid:66)(cid:72)(cid:83)(cid:70)(cid:70)(cid:1)(cid:80)(cid:79)(cid:1)(cid:66)(cid:1)(cid:75)(cid:80)(cid:74)(cid:79)(cid:85)(cid:1)(cid:85)(cid:70)(cid:89)(cid:85) (cid:34)(cid:69)(cid:80)(cid:81)(cid:85)(cid:74)(cid:80)(cid:79)(cid:1)(cid:176)(cid:1)(cid:34)(cid:81)(cid:83)(cid:74)(cid:77)(cid:1)(cid:19)(cid:17)(cid:17)(cid:24)(cid:32)
(cid:19)(cid:22)(cid:15)(cid:1)(cid:49)(cid:66)(cid:83)(cid:77)(cid:74)(cid:66)(cid:78)(cid:70)(cid:79)(cid:85)(cid:1)(cid:66)(cid:79)(cid:69)(cid:1) (cid:19)(cid:24)(cid:15)(cid:1)(cid:49)(cid:66)(cid:83)(cid:77)(cid:74)(cid:66)(cid:78)(cid:70)(cid:79)(cid:85)(cid:1)(cid:66)(cid:79)(cid:69)(cid:1) (cid:20)(cid:17)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:74)(cid:84)(cid:1)(cid:79)(cid:80)(cid:85)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69)
(cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:66)(cid:68)(cid:85) (cid:36)(cid:80)(cid:86)(cid:79)(cid:68)(cid:74)(cid:77)(cid:1)(cid:69)(cid:80)(cid:1)(cid:79)(cid:80)(cid:85)(cid:1)(cid:66)(cid:81)(cid:81)(cid:83)(cid:80)(cid:87)(cid:70)
(cid:68)(cid:80)(cid:79)(cid:68)(cid:70)(cid:83)(cid:79)(cid:70)(cid:69)(cid:1)(cid:74)(cid:79)(cid:1)(cid:66)(cid:68)(cid:68)(cid:80)(cid:83)(cid:69)(cid:66)(cid:79)(cid:68)(cid:70) (cid:85)(cid:73)(cid:70)(cid:1)(cid:75)(cid:80)(cid:74)(cid:79)(cid:85)(cid:1)(cid:85)(cid:70)(cid:89)(cid:85)
(cid:88)(cid:74)(cid:85)(cid:73)(cid:1)(cid:85)(cid:73)(cid:70)(cid:1)(cid:75)(cid:80)(cid:74)(cid:79)(cid:85)(cid:1)(cid:85)(cid:70)(cid:89)(cid:85)
(cid:19)(cid:23)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:74)(cid:84)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69) (cid:19)(cid:23)(cid:15)(cid:1)(cid:34)(cid:68)(cid:85)(cid:1)(cid:74)(cid:84)(cid:1)(cid:79)(cid:80)(cid:85)(cid:1)(cid:66)(cid:69)(cid:80)(cid:81)(cid:85)(cid:70)(cid:69)
Source: Pira International Ltd
Page 3 © Copyright Pira International Ltd 2006
Impact of REACH on the Plastics and Packaging Supply Chains
Introduction to REACH
long-term exposure to them. An estimated 5,000 substances or 15% of the total would
have to be evaluated.
Authorisation would have to be obtained for substances with certain hazardous
properties. These could include chemicals classified as CMR substances or those likely
to be identified as CMRs after further testing. They would also include substances
categorised as persistent organic pollutants (POPs). Around 1,400 substances or 5% of the
total were likely to have to be authorised.
Responsibility for generating and assessing data on chemicals, as well as gauging
the risks of using them, would be shifted from the authorities to industry. Producers and
importers would have to ensure that only chemicals that are safe for their intended uses
are placed on the market.
Furthermore, downstream users of chemicals, such as formulators, would be
responsible for all aspects of the safety of their products. They would have to provide
information on the use of and exposure to chemicals so that they could be properly
assessed. When uses of chemicals by downstream operators differ from those originally
envisaged by manufacturers or importers, the downstream user would be obliged to carry
out additional tests.
The Commission argued that its proposed REACH scheme would stimulate
innovations in the chemical industry as it would encourage producers to develop safer
chemicals. It would also increase transparency in the industry and in the use of its
products because the public would have the right of access to information about the
chemicals to which they are exposed.
On the costs of the system, the Commission calculated that tests to meet the basic
registration requirements could cost around €85,000 per substance. With substances
needing more stringent testing the cost could be as high as €325,000. The total testing
costs would be about €2.1 billion over the 11 years during which the whole REACH
registration programme would be completed, according to the Commission.
During a consultation period extending over two years after the publication of the
White Paper, a number of conferences and workshops of stakeholders – the chemical
industry, downstream users, NGOs, trade unions and governments of EU member states
– took place. There was also an internet consultation which attracted over 6,000
contributions, 42% of which came from companies or trade associations.
The consultation showed a broad consensus on the need for a new European
chemicals policy, the main objectives of which would be sustainable development and
the safe use of chemicals. Stakeholders generally agreed on the necessity of a balance
of responsibilities between industry and authorities, on the need for international co-
ordination on chemical safety and for improved communications on chemical risks.
The main concerns, especially among chemical producers and their downstream
customers, were:
 The economic and social costs of the whole scheme, with the chemical industry in
particular expressing doubts about the accuracy of the Commission’s cost estimates.
Page 4 © Copyright Pira International Ltd 2006