5 Globally harmonised system of classification
and labelling of chemicals
(28756)
11497/07
+ ADDs 1-6
COM(07) 355 | Draft Regulation on classification, labelling and packaging of substances and mixtures and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006
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| Legal base | Article 95 EC; co-decision; QMV
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| Document originated | 27 June 2007
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| Deposited in Parliament | 5 July 2007
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| Department | Work and Pensions
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| Basis of consideration | EM of 17 July 2007
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| Previous Committee Report | None, but see footnote 15
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| To be discussed in Council | Late 2007/early 2008
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information awaited
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Background
5.1 It has long been recognised that certain chemicals can cause
serious damage to human health and the environment. Consequently,
along with a broad range of other substances, their production,
marketing and use within the Community is governed by a number
of legal instruments, notably the Dangerous Substances Directive
(67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).
These regulate testing, determine risk reduction measures, and
establish duties regarding the safety information provided to
users through safety data sheets drawn up in accordance with Directive
(91/155/EEC) and labelling incorporating symbols ("pictograms"),
and the use of standard phrases indicating the nature of the risk
and providing safety advice. In addition to providing a basis
for self-classification, these measures have resulted in the harmonised
classification of the most dangerous substances (chemical elements
or compounds) and preparations (mixtures or solutions of chemicals)
into different classes of hazard,[14]
and these are in turn divided into categories according to the
severity of the hazard in question. Currently, about 8,000 of
the most dangerous substances are classified in this way (and
hence included in Annex I of Directive 67/548/EEC).
5.2 Despite this, concerns that the system in operation
did not provide sufficient protection, particularly as regards
substances on the market in September 1981,[15]
led to the adoption of Regulation (EC) No. 1907/2006, which introduces
with effect from 1 June 2008 a new system (REACH) based on the
registration, evaluation and authorisation of all chemicals. In
effect, this sets out the basic requirements for the testing of
substances so as to allow them to be classified, but the classification
criteria remain those contained in Directives 67/548/EEC and 1999/45/EC.
5.3 Although similar arrangements are in place in
many other countries, these are not identical, and the Rio Earth
Summit in 1992 included a commitment to develop and implement
a globally harmonised system, a commitment which was reaffirmed
at the World Summit on Sustainable Development in 2002. This has
resulted in the United Nations Globally Harmonised System (GHS),
which is a non-binding agreement establishing the definitions
and criteria for classification and hazard communication for the
supply of chemicals and their transportation, with the aim of
protecting human health and the environment, whilst also reducing
trade barriers. The purpose of this draft Regulation — which
follows extensive consultation by both the Commission and the
UK Government following publication of a draft measure in August
2006 — is to incorporate the main elements of that System
into Community law.
The current proposal
5.4 In putting forward its proposal, the Commission
notes that the arrangements within the Community were a major
influence in the drawing up of the GHS agreement, and that there
are many similarities between the two (although there are also
some differences —
for example, in the terminology used to describe potential hazards
and risks, and the precautions needed to avoid these, the warnings
symbols ("pictograms"), and the approach to classifying
mixtures). It also points out that, because of the wide range
of different classification and labelling systems around the world,
the GHS allows governments (or entities such as the Community)
to select appropriate parts for local implementation under the
so-called "building block" approach. This proposal accordingly
selects those blocks which most closely reflect the present Community
system, and will in fact adopt all of the 27 hazard classes, and
77 of the 83 hazard categories included within the GHS. In doing
so, it will maintain a number of existing duties on chemical suppliers.
These include ensuring that chemicals are correctly classified,
appropriately labelled, and properly packaged, and it would also
incorporate all the harmonised classifications currently contained
in Annex I of Directive 67/948/EEC. It does not, however, deal
with the transport of chemicals, which is already covered by existing
Community measures: likewise, it does not extend to pharmaceuticals,
cosmetics, waste (as defined in the relevant Regulation), or to
food and feedingstuffs.
5.5 At the same time, however, the Commission has
undertaken a study of the proposal's impact on other "downstream"
legislation relating to chemicals, particularly that arising in
some way or other from their classification under the Dangerous
Substances Directive and the Dangerous Preparations Directive.
It says that, in most cases, there will be little or no impact
because of the direct correlation between the existing Community
classification and the GHS, but that, in a limited number of instances,
care will be needed to ensure that the latter does not unduly
extend the downstream requirements. In particular, it notes that
there could be a potentially significant impact on the measures
in place under the Seveso II Directive (96/82/EC) dealing with
major accidents, if it led to additional sites becoming subject
to these controls.
5.6 In view of this, the Commission has proposed
that the Regulation should be implemented in two stages, applying
to substances as from 1 December 2010 and to preparations from
1 June 2015. It has also proposed that, as at present, amendments
to the Annexes should be made through Adaptations to Technical
Progress (ATPs), but that this procedure should in future be extended
to include amendments to specific Articles in the body of the
Regulation dealing with "non-essential" elements, in
order to reflect any corresponding changes made to the GHS from
time to time.
The Government's view
5.7 In his Explanatory Memorandum of 17 July 2007,
the Parliamentary Under-Secretary of State (Health and Safety)
at the Department of Work and Pensions (Lord McKenzie) says that
the UK continues to support the GHS, and its contribution to achieving
global sustainable development. However, he points out that, since
the Community already has a well-developed classification and
labelling system, the main improvements to health and the environment
will be felt in those countries which do not at present have such
a system. The Government's main aim, therefore, will be to secure
trade benefits whilst limiting the costs to industry by keeping
the scope of the new system in line with the present one, and
by maintaining workable transitional arrangements. It will also
wish to consider whether the use of ATPs to amend certain Articles
in the Regulation (as opposed to its technical Annexes) would
set an unwelcome precedent.
5.8 The Minister has sought to amplify some of these
points in an initial RIA, and to quantify the potential costs
and benefits of adopting the GHS. The Assessment notes that, for
the Community as a whole, exports of chemicals to third countries
account for 25% of all sales,[16]
whilst for the UK the equivalent figure is about 40%. It confirms
that, since the Community already has in place a mature classification
system, it is unlikely to see any significant environmental or
health benefits, and that the main benefit will be the effect
of the GHS in facilitating international trade (though, in the
short term, the main impact is likely to be in relation to countries
such as the USA, Canada, Japan and Australia, with the full benefits
being felt only a good deal later as other countries adopt the
necessary measures).
5.9 As to the possible costs, the Assessment suggests
that the Commission may have under-estimated the down-stream effects,
and that the UK will accordingly wish to explore further a number
of detailed issues where the proposal appears to go beyond the
provisions of the GHS and current Community requirements, notably
whether classification relates to the state in which a product
is placed on the market or in which it is subsequently used; the
conditions associated with the derogations proposed for research
and development; and the duties imposed on different parts of
the supply chain.
5.10 The Assessment goes on to consider the effects
on the various sectors involved, which it identifies as being
chemical manufacturers, downstream businesses using chemicals
as an input to production, wholesalers and retailers, and consumers.
In general, it says that any such costs are likely to be transitional
rather than long-term, and would arise in such areas as the need
to re-classify products not covered by the current harmonised
system, update IT systems, provide training for staff, and ensure
that subsequent users fully understand the new system. More specifically,
it says that, although the precise number of substances and mixtures
produced in the UK is not known,[17]
the 3,000 or so chemical manufacturers in the UK would (depending
on the assumptions made) face transitional costs of between £26
million and £144 million, of which £15 million to £130
million would relate the reclassification of mixtures; that downstream
businesses[18] would
face equivalent costs of £63 million, of which agriculture
would account for £47 million; that wholesalers' and retailers'
costs (of staff familiarisation and training) would be £600,000
and £2.6 million respectively; that the public sector involvement
by the Health and Safety Executive and local authorities enforcement
officers would give rise to additional costs of about £2
million; and that, based on the average wage, the cost incurred
by the 25 million or so households in familiarising themselves
with the new classifications and labelling requirements could
be assessed at about £3.5 million.
Conclusion
5.11 We are grateful to the Minister for his Explanatory
Memorandum, and for the comprehensive Regulatory Impact Assessment
which he has provided. To the extent that the proposal seeks to
extend on a global basis the sort of arrangements which currently
apply within the Community for the classification and labelling
of chemicals, it is to be welcomed in principle, even though the
main benefits arising from enhanced trade may not be realised
for some time.
5.12 Having said that, we note that the Government
had a number of detailed concerns, particularly as regards the
possible down-stream effects of the proposal, which it intended
to pursue in discussion, and that it also wished to consider the
way in which it was proposed that Adaptations to Technical Progress
should be used. Furthermore, it is the Government's stated intention
to produce a full Regulatory Impact Assessment in the light of
its current consultation exercise. In view of this, we think it
would be sensible to await that Assessment, and any further information
on the other points we have highlighted, before taking a final
view. In the meantime, we are drawing the document to the attention
of the House.
14 These include explosiveness, flammability, toxicity,
carcinogenicity, mutagenicity, toxicity to reproduction, sensitisation,
irritation, corrosiveness, and harmfulness to the aquatic environment. Back
15
(25115) 15409/03: see HC 42-ix (2003-04), para 2 (4 February 2004),
HC 42-xviii (20003-04), para 1 (28 April 2004) and HC 34-ix (2005-06),
para 12 (9 November 2005). Back
16
By comparison, 26% of such sales are to domestic markets, and
the remaining 49% to other Member States. Back
17
On the basis of extrapolating figures at a European level, the
Assessment suggests that between 3,000 and 4,000 substances and
between 200,000 and 300,000 mixtures could be produced in the
UK. Back
18
The numbers involved depend crucially on the definition used.
However, if the term is applied to those sectors which obtain
at least 10% of inputs from the chemical industry, there are about
148,000 such businesses, of which nearly 131,000 are in agriculture. Back
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