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Philip A. Moffat(202) 789-6027

pmoffat@bdlaw.com

REACH: CORPORATE AND PRACTICE IMPACTS, LEGISLATIVE RESPONSES

Primer on REACH

January 28, 2009

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IntroductionIntroduction

• 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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Major REACH ProvisionsMajor 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 AdministrationREACH 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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Exclusions from REACHExclusions 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 RequirementsExemptions 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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Key TermsKey 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 TermsKey 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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Key Terms 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 (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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Registration (Title II)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 PhaseRegistration of Phase--In SubstancesIn 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) requiredbefore registrants can benefit from Phase-In provision

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PhasePhase--In Substances: Joint Registration In Substances: Joint Registration and Data Sharingand 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 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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Downstream Users (Title V)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 VIEVALUATION (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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AUTHORIZATION (Title VII)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 (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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ResourcesResources

ECHA website:http://echa.europa.eu/reach_en.html

EC websites:http://ec.europa.eu/environment/chemicals/reach/reach_intro.htmhttp://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/