REACH
”NO DATA, NO MARKET”
Elin Simonsson
Lena Lundahl
Anna Johansson
”NO DATA, NO MARKET”

Art. 5 REACH; EC 1907/2006
OUTLINE
Introduction
 Provisions
 Controversy
 Status/Discussion

HISTORY BEHIND REGULATING
INFORMATION
Expensive and administratively heavy
 Internalizing cost of information
 Market failure
 Internal market – art. 114 TFEU

MARKET-BASED REGULATION

Compare with the EU ETS


International aviation
Global impact
ART. 5 REACH

[…] substances on their own, in preparations or in
articles, shall not be manufactured in the
Community or placed on the market unless they
have been registered […]
DEFINITIONS

Art. 3 REACH

3(1) Substance
[…] a chemical element and its compounds in the
natural state or obtained by any manufacturing
process […]

3(2) Article
[…] an object which during production is given a
special shape, surface or design which determines its
function to a greater degree than does its chemical
composition […]
OBLIGATION TO REGISTER
Art. 6 REACH
 General obligation to register substances
 If the quantity exceeds 1 tonne annually, per
manufacturer

REGISTRATION
Art. 7 REACH
 Criteria for registration of articles:

Quantity exceeding 1 tonne per year and producer
 Substance in article is intended to be released under
normal/reasonably foreseeable conditions of use

REGISTRATION (CONT’D)

Art. 10 REACH: Technical dossier


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Information about the manufacturer
Identity of the substance
Information on the manufacture and uses of the
substance
Classification and labeling
Guidance of use
Chemical safety report
Study summary
The tonnage range decides what information the
registrant needs to submit (Annexes VII-XI)
NOTIFICATION
Art. 7 REACH
 Basic information about the substance might
lead to an obligation to register
 Criteria for notification:

Substance concentration in article exceeds 0.1%, and
 The substance has been classified as:

Cancerogenic
 Mutagenic
 Toxic to reproduction
 Persistent, bioaccumulative and toxic, or
 Substances for which there is scientific evidence of probable
serious effects to human health or to the environment

JOINT SUBMISSION OF DATA
Art. 11 REACH
 The lead registrant shall notify the Agency about:

Classification and labeling
 Guidance on safe use
 Study summaries
 Proposals for testing

Every registrant submits information specific to
their own import/production
 Every single registrant responsible only for the
information of their own manufacture or import

SHARING OF COSTS
Rules dispensed in different parts of the
regulation
 Art. 27 REACH


”The previous registrant and potential registrant(s)
shall make every effort to ensure that the costs of
sharing the information are determined in a fair,
transparent and non-discriminatory way.”
CONTROVERSY
1.
Privatization of information provision



Obligation on private actors
Explicit responsibility for the industry for the
safety of its chemicals
Internalization of costs
CONTROVERSY (CONT’D)
2.
Perverse incentives for the industry?



Underestimation of risk
Key governance problem of REACH
Two principal mechanisms:


Hierarchical control
Peer review
I.
HIERARCHICAL CONTROL
Dossier evaluation
 Examination of testing proposals
 Compliance check of registration

II.
DATA SHARING/JOINT REGISTRATION
(PEER REVIEW)
Title III, articles 25-30 of REACH
 REACH requires multiple registrants of the same
substance to share data and to jointly submit
their registration dossier
 Core principle to avoid unnecessary animal
testing and reduce registration costs
 Mechanism differs depending on whether the
chemical is a new (non phase-in) or an existing
(phase-in) substance

A.
NON PHASE-IN SUBSTANCES: INQUIRY
Duty to inquire whether a registration has
already been submitted for that substance
 The Agency has to facilitate joint registration

B.
PHASE-IN SUBSTANCES: SIEF
Duty to pre-register and to join a Substance
Information Exchange Forum (SIEF)
 One joint submission for each substance

Cost reduction
 Unnecessary animal testing avoided


SIEFs have no prescribed legal form and are
independently managed by the industry

ECHA not involved
CONTROVERSY (CONT’D)
3.
Accountability
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4.
Risk assessment

5.
Is it a workable regulatory strategy?
Assessment of the quality of the data
Risk assessment rather than hazard assessment
Costs

Do the costs to private actors exceed the public
benefits?
CONTROVERSY (CONT’D)
6.
Practicalities

Decisions need to be made about different issues:


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Risk identification
Information quality
Publication and sharing of information
How is the information to be acted on?
REACH REVIEW 2012

”…special attention to the costs and
administrative burden and other impacts on
innovation.”
DISCUSSION

Is a focus on information a good way to regulate?
From a market perspective?
 From an environmental perspective?


Is it reasonable to put the obligation of
information provision on the industry? Is it safe?