Primer on the EU’s chemicals regulation known as REACh.

1. REACH: CORPORATE AND PRACTICE IMPACTS,
LEGISLATIVE RESPONSES
Primer on REACH
January 28, 2009
Philip A. Moffat
(202) 789-6027
pmoffat@bdlaw.com
Introduction
• New chemical regulatory scheme in the EU:
- Adopted in December 2006
- Entered in Force June 2007
• Prior to REACH, approximately 40 different
regulations and directives comprised chemical
regulatory framework in EU
• Concern about a lack of information on many
chemicals on market
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2. Major REACH Provisions
• Registration (Title II)
• Data sharing (Titles III)
• Supply chain communication (Title IV)
• Downstream users (Title V)
• Evaluation (Title VI)
• Authorization (Title VII)
• Restriction (Title VIII) of
• Chemicals
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REACH Administration
European Chemicals Agency (ECHA) is the newly
established agency responsible for managing
REACH, including registration, communication with
EU Commission, coordinating technical resources
and reviews.
Member States Competent Authorities are
responsible for enforcement, including inspections,
as well as establishment and assessment of
penalties.
• Some discretion with interpretation of requirements
• Potential for inconsistency between various Member States
• Priorities for enforcement probably risk-based (high
hazard/low exposure or lower hazard/significant exposure)
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3. Exclusions from REACH
Key Exclusions:
- Radioactive substances
- Substances subject to customs supervision/free
zone that do not undergo processing and are
intended for re-exportation or are in transit
- Non-isolated intermediates
- Carriage of dangerous substances and
dangerous preparations
- Waste
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Exemptions from Certain REACH Requirements
• REACH includes a number of exemptions for different
activities, uses, or categories of substances
• Eligibility criteria must be carefully evaluated
- Guidance available
- When in doubt, rely on regulatory text
• Selection of a particular exemption may have
consequences vis-à-vis other provisions
• Examples:
- Substances used in medicinal products
- Annex IV and V substances
- Substances in Product and Process Oriented R&D activities
- Recycled/Recovered substances
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4. Key Terms
• Substance: a chemical element and its
compounds in natural state or obtained by any
manufacturing process, including any additive
necessary to preserve its stability and any
impurity deriving from the process used
• Preparation: a mixture or solution of two or
more substances
• Article: an object which during production is
given a special shape, surface or design which
determines its function to a greater extent than
does its chemical composition
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Key Terms
• Manufacturer: any natural or legal person
established within the Community who
manufactures a substance within the
Community
- Manufacturing: production or extraction of
substances in the natural state
• Importer: any natural or legal person
established within the Community who is
responsible for import
- Import: the physical introduction into the
customs territory of the Community
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5. Key Terms
• Downstream User: any natural or legal person
established within the Community, other than the
manufacturer or importer, who uses a substance,
either on its own or in a preparation, in the course of
his industrial or professional activities
- Use: any processing, formulation, consumption, storage,
keeping, treatment, filling into containers, transfer from one
container to another, mixing, production of an article or any
other utilization
• Only Representative: undefined in REACH, but
Article 8 establishes that it is a natural or legal
person established within the Community that fulfills
the role of importer for non-EU manufacturers,
formulators, or article producers
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Registration (Title II)
• Registration ensures that persons who manufacture,
import, place on the market, or professionally use
substances have the data to evaluate and manage risks.
• EU-based Manufacturers, Importers, Only
Representatives, and certain Article Producers/Importers
have registration obligations
• 1 tonne/year threshold
• Applies to substances whether alone, in preparations, or articles
(intentionally released under normal/reasonably foreseeable use)
• Registration Types
• Full registration – most “new” and “phase-in” substances
• Light registration – certain intermediates
• “Deemed” registered – certain active substances in biocides/plant
protection products, and ELINCS substances
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6. Registration (Title II)
• Registration Deadlines:
- Non-phase-in substances: June 1, 2008 or before exceeding
1 tonne threshold
- Phase-in substances: pre-registered by December 1, 2008;
otherwise full registration by June 1, 2008
• Full Registration Dossier Generally Includes:
- Technical Dossier:
• Physicochemical, Toxicological, Environmental Data (increasing
with volume)
• Classification and Labeling
• Guidance on Safe Use
• Use/Exposure
- Chemical Safety Report (for substances > 10 tonnes/year):
• Hazard/PBT Assessment
• Exposure Assessment and Risk Characterization if “Dangerous,”
PBT, vPvB
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Registration of Phase-In Substances
• “Phase-in” substances are:
- EINECS-listed substances;
- Substances produced “within the fence line” and never placed on
the EU market after May 31, 1992; or
- No Longer Polymers.
- (On-site and transported isolated intermediates may qualify)
• 3 Phase-In Waves (over 11 years):
- Nov. 30, 2010: Highly hazardous substances (CMRs, Risk Phrase
50/53) or >1,000 tonnes/annum
- May 31, 2013: substances between 100 and 1,000 t/y
- May 31, 2018: substances in volumes between 1100 t/y
• Pre-registration (June 1 – Dec. 1, 2008) required
before registrants can benefit from Phase-In provision
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7. Phase-In Substances: Joint Registration
and Data Sharing
• Multiple registrants of “same” substance must submit
one registration with:
- Agreement on Classification and Labeling
- Data on hazardous properties of substance and proposals for any
necessary testing
• Possible to opt-out and register individually
• Sharing of existing data, and joint development and
ownership of new data, through a Substance
Information Exchange Forum (SIEF) to avoid
duplicate animal testing
- SIEFs operate until 2018
- Separate consortia may also be formed
- REACH provides minimal protection for CBI – Third Party
Representatives and private arrangements contemplated in SIEF
process
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Information in the Supply Chain (Title IV)
• Information necessary for the management of risk
associated with the use of a substance must be
communicated along the Supply Chain.
• Information to be communicated based on Chemical Safety
Assessment (CSA) when quantities exceed 10 t/y.
• Safety Data Sheet (SDS) is the primary tool for
communicating information on properties and risk
management measures for “Dangerous” and PBT / vPvB
substances.
- Exposure scenarios from CSA must be attached to SDS
• The SDS will be governed by REACH and will need to
conform with the recently enacted Globally Harmonized
System (GHS) regulation.
• Suppliers of articles with SVHCs above 0.1% (w/w) must
provide available information re safe use; name of
substance is minimum
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8. Downstream Users (Title V)
• Required to consider safety of uses and apply
appropriate risk management measures
• Required to communicate with suppliers to
“identify” uses so that they are covered in any
exposure scenarios that supplier generates and
attaches to SDS
• Allowed to develop CSA and risk management
measures for uses outside of supplier’s
exposure scenario
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EVALUATION (Title VI)
▪ The Dossier Evaluation process allows the
European Chemicals Agency (ECHA) to evaluate
testing proposals, compliance with registration
requirements and request additional data
▪ ECHA in coordination with Member States will
perform Substance Evaluation for substances
with chemical structures similar to problematic
substances, potentially resulting in requests for
additional data
▪ Data and information submitted can be used to
propose substances for Authorization (Title VII) or
Restriction (Title VIII)
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9. AUTHORIZATION (Title VII)
• Substances of “Substances of Very High Concern” (SVHC):
- Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2)
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and
very Bioaccumulative (vPvB)
- Causing probable serious effects to human health or the environment
(e.g. Endocrine Disruptors)
• Added to “Candidate List” for possible inclusion in Annex XIV
• Once included on Annex XIV, certain uses subject to Authorization
- Persons using or making substance available must apply for
authorization within prescribed deadline seeking approval of non-
exempt uses & include an analysis of possible substitutes
• Authorization granted for a period of time, if:
- Risk adequately controlled (except non-threshold CMR, and
PBT/vPvB), or
- Socio-economic benefits outweigh risks and no suitable
alternatives
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Restrictions (Title VIII)
▪ Restrictions may include a “Community Wide”
market ban on, or conditions on use(s) of, a
substance that poses an “unacceptable risk to
human health or the environment”:
- Proposal initiated by Member State, or European
Commission with ECHA coordination
- Evaluated in light of risk, socio-economic impact of
restriction, and availability of alternatives
▪ Many restrictions currently included in Annex
XVII, which will become effective in July 2009
- Based on currently enforceable restrictions in
Marketing Directive (76/769/EEC)
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10. Resources
ECHA website:
http://echa.europa.eu/reach_en.html
EC websites:
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
http://ec.europa.eu/enterprise/reach/reach_guidance_helpdesks_en
.htm
UK Helpdesk:
http://www.hse.gov.uk/press/2006/e06101.htm
Ireland Helpdesk:
http://www.hsa.ie/eng/Sectors/Chemicals/REACH/
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