1. International and State Chemical Policy Update
Rachel Massey
TUR Planners Continuing Education Conference,
April 12, 2007

2. Policy Updates 1. Update on REACH 2. China RoHS
3. State level chemicals policy initiatives
4. Canada – DSL categorization
5. Regulation of nanomaterials

3. 1. Update on REACH Registration Evaluation and Authorization of
Chemicals
Final regulation published December 2006
Replaces or incorporates about 40 pieces of existing legislation
New regulatory structure for chemicals

4. REACH ENTERS INTO FORCE LEGISLATION ADOPTED
Stakeholder consultation
Council Conclusions
WHITE PAPER
Cardiff Council meeting
Proposal DG Env DG ENT
Parliament’s Opinion
2001
1998
Internet consultation
Council Common Position
July 2003
COMMISSION PROPOSAL
Opinion Commission
Parliament’s 1st reading
Oct 03
Parliament’s 2nd reading
Final regulation published December 2006
At this point, emphasize that many of the materials and specifics are still in progress, so you’ll probably have some questions that don’t yet have answers. …
REACH ENTERS INTO FORCE
LEGISLATION ADOPTED
Conciliation process
Dec 06
June 1, 2007
Adapted from: International Chemical Secretariat

5. REGISTRATION
Manufacturers and importers must submit information on health and environmental effects of the chemicals they sell.
Testing requirements depend on annual production volume per company.
Companies join consortia to share testing costs.
Phase-in period of 11 years.
Applies to chemicals produced or imported at > 1 tonne/year per producer/importer.
For chemicals > 10 tpa, requires a Chemical Safety Report documenting hazard classification of a substance and whether it’s PBT or vPvB.
For chemicals classified as dangerous, PBTs, or vPvBs, manufacturer must explain how risks from known uses can be ‘adequately controlled’.

6. REGISTRATION: Time Line
Source: International Chemical Secretariat

7. EVALUATION
Review of information in registration; completeness check; possible requests to fill data gaps.
Dossier evaluation (individual registration)
Substance evaluation (per substance)
Substance evaluation applies when there is reason to believe a substances presents a risk to health or the environment.
Dossier evaluation (individual registration)
Prevent unnecessary animal testing and require additional tests
Compliance check (5%)
Substance evaluation (per substance)
Agency / Member State will evaluate safety data for certain chemicals, especially those at high volumes and those of particular concern.
This may lead to:
Requests for further information to clarify risks, or ensure compliance with the requirements
Substance proposed for ‘authorisation’ or ‘restrictions’

8. AUTHORIZATION
Substances of Very High Concern (SVHC) cannot be sold without an authorization.
“Adequate control”
Impossible by definition for some chemicals
Socioeconomic benefit
An authorization applies to specific uses.
Socioeconomic value that outweighs the risks. [OR: Submit a case for continued use based on risks, socio economic impacts, alternatives and substitutes]
No set schedule for authorization - chemicals will be added on a chemical by chemical basis but the list of chemicals potentially subject will be published earlier.

9. Substances of Very High Concern
Carcinogenic, Mutagenic, Reproductive toxicity (CMR) 1 & 2
Persistent, Bioaccumulative, and Toxic (PBT)
Very Persistent, very Bioaccumulative (vPvB)
Substances of “equivalent concern,” e.g. endocrine disrupting chemicals

10. RESTRICTION Safety net Incorporates current restrictions
Can include conditions for use, or prohibition
Dossier must show risk to health or the environment that needs to be addressed at the European Community level, and explore options for managing risk.
Safety net: chemicals that pose “unacceptable risks” to human health or the environment that need to be addressed at a community level. Similar to current EU restrictions process, but faster. Existing EU marketing and use restrictions are brought forward into REACH.

11. SUBSTANCES IN ARTICLES
Registration requirements and deadlines apply to substances in articles > 1 tonne/yr if intended to be released.
If substance is not intended to be released,
for SVHCs, must provide a notification
European Chemicals Agency may request registration of a notified substance in an article if it poses a risk to health or the environment.
If present above 1 tonne per M/I per year,
If substance is not intended to be released,
for SVHCs, must provide a notification to the European Chemicals Agency

12. Substance in Article: Present at > 1 tonne per year?No
Yes
Substance of Very High Concern?
Intended to be released? No
Yes No
Yes
No registration requirement
No registration requirement
Registration required
Notification required
Chemicals Agency may request registration
if risk posed to health or environment

13. REACH Exemptions Radioactive materials Pharmaceuticals Polymers
Pesticides
Some byproducts
Some minerals, ores, and fuels
Some familiar, commonly used substances

14. What’s Ahead? REACH Time Line
June 1, 2007: REACH enters into force
June 1, 2008:
European Chemicals Agency becomes operational
“New” substances can now be registered;
Preregistration of “phase-in” substances begins (until November 2008)

15. What’s Ahead? REACH Time Line
Dec. 1, 2010: First registration deadline
Substances > 1,000 tonne/yr
Substances classified as very toxic to aquatic organisms > 100 tonne/yr
CMR (category 1 & 2) substances > 1 tonne/yr

16. European Chemicals Agency
The new European Chemicals Agency will be established in Helsinki, Finland.
Executive Director
Secretariat
In charge of administering REACH, including maintaining databases and organizing decision making processes.
Secretariat is planned to grow in a year from around 80 to 220, and then gradually to a full staff of about 450.

17. Substance: Imported to the EU at more than 1 tonne per year?
No: No registration requirement.
Yes: registration required.
Check registration deadline and
data requirements for your volume tier.
Check any restrictions.
Apply for authorization if necessary.
Are other companies registering? No
Yes
Join a consortium
Check data availability and carry out any necessary tests,
or pay fee to use test data already collected.
Communicate with downstream users to identify relevant uses.

18. Submit registration, including chemical safety report
Evaluation
May need to submit
additional data
Subject to authorization?
Yes No
Submit authorization request
including analysis of substitutes
Product remains on market

19. Submit authorization request including analysis of substitutes
Is “adequate control” possible?
(Can a safe threshold be defined?)
Yes: some CMR
No: PBT, vPvB, some CMR
Substance adequately controlled?
Does a safer alternative exist?
No market
Yes No
Yes No
Sell substance for authorized uses only.
Socioeconomic importance
that outweighs risk?
Yes No
No market

20. RESOURCES European Commission Lowell Center for Sustainable Production
Directorate General for Enterprise:
Directorate General for Environment
Lowell Center for Sustainable Production
Chemicals Policy Initiative:
International Chemical Secretariat (NGO)

21. Policy Updates 2. China RoHS 1. Update on REACH
3. State level chemicals policy initiatives
4. Canada – DSL categorization
5. Regulation of nanomaterials

22. CHINA RoHS
“Measures for the Administration of the Control of Pollution Caused by Electronic Information Products”
Promulgated February 2006
In force as of March 1, 2007
Review the basics of RoHS in the EU before going into details

23. CHINA RoHS Lead Mercury Cadmium Hexavalent chromium PBBs PBDEs
“other toxic and hazardous substances or elements specified by the State”
Review information about EU RoHS:
The EU directive covers the same six classes of substances. It specifies that NEW EQUIPMENT SHALL NOT CONTAIN MORE THAN THE MAXIMUM SPECIFIED CONCENTRATIONS OF THESE TOXIC SUBSTANCES AS OF JULY 1, 2006.

24. CHINA RoHS Phase 1 Phase 2 Labelling Catalog
Compliant
Noncompliant
Phase 2
Catalog
Testing by accredited laboratories
Prohibition on sale of non-compliant products

26. Also mention the need for a check-box showing which chemicals are present.

27. Phase 2
Catalog
Laboratory testing
Prohibition on sales

28. Comparison: EU vs. China
Labeling provisions
Catalog
Laboratory testing vs. self-declaration
Testing may be required for every part, down to homogeneous materials
Exemptions
EU RoHS exempts medical equipment, servers and networking equipment. It allows mercury lamps (in laptop computers) because they’re highly energy efficient.
Also: The EU directive applies to NEW equipment, whereas the Chinese legislation applies to ALL equipment.
Other differences:
The concept of "Put on the market" is different
The penalties are different
Material testing may be required in every part you use to build your product, down to the homogeneous materials
Firms must design labels and issue change orders in order to comply
Finalized standards just became available

29. Policy Updates 3. State level policy initiatives 1. Update on REACH
2. China RoHS
3. State level policy initiatives
4. Canada – DSL categorization
5. Regulation of nanomaterials

30. STATE POLICY INITIATIVES
Right to Know
Chemical restrictions
Procurement policies
TUR/safer alternatives
Right to Know (labeling, toxics use data collection, biomonitoring)
Chemical restrictions (PBTs, mercury, PBDEs, Perc)
Procurement policies
TUR/safer alternatives

31. Source: Center for International Environmental Law

32. State level initiatives: Recent examples
Connecticut: Mercury; proposals re: deca and safer alternatives
Illinois: BFRs; Governor’s letter to Illinois EPA re: Deca
Maryland: Mercury; BFRs; phthalates, bisphenol A in toys
Michigan: Mercury; BFRs; Executive order: Green Chemistry
New Hampshire: Mercury; Dioxin
New York: BFRs; Executive order on deca submitted 12/06; new Pollution Prevention & Green Chemistry Institute proposed
Plus: Buffalo: PBTs; Erie County & NYC: environmentally preferable purchasing; proposed state action on phthalates, lead paint & jewelry, EPP, & environmental health tracking.
Rhode Island: Mercury; BFRs
… and more!

33. CHEMICAL RESTRICTIONS
Example: Brominated flame retardants
Maine
Bans sale of products containing >1% penta- and octa-BDEs as of January 2006.
Products containing BFRs must be registered with the state.
Specify type and amount.
Products containing BFRs must be labeled, with a summary of health hazards. 
Ban deca-BDE by 2008 if safer alternatives are available.
New deca bill pending
Tetrabromobisphenol-A or hexabromocyclododecane or any other brominated flame retardant is banned as of January 1, 2010.
The Legislature is considering a proposal from the state Department of Environmental Protection to ban the sale of televisions and other electronics equipment containing Deca beginning in Maine already has banned two related flame retardants.Research conducted by staff at the Maine Center for Disease Control and Prevention and the University of Southern Maine found that newborn lab mice exposed to Deca exhibited brain development problems, including lower grip strength, decreased thyroid levels and learning problems

34. CHEMICAL RESTRICTIONS
Example: Brominated flame retardants
Washington –first deca ban, April ’07
Prohibits use in mattresses starting 2008
Prohibits use in TVs, computers and residential upholstered furniture starting 2011
Contingent on safer substitute

35. SAFER ALTERNATIVES Executive orders Example: Maine, February 2006
Outlines need for information on safer alternatives;
Names lead, mercury, BFRs, and pesticides as priorities;
Commits to environmentally preferably preferable purchasing;
Creates task force to promote safer chemicals in consumer products.

36. California Proposition 65 Biomonitoring BFRs
Hazardous Chemicals: Testing Methods
Mercury
Right to Know
Phase-out of perc; + South Coast Air Quality Management District perc regulation
Municipal:
Berkeley: Precautionary principle and environmentally preferable purchasing
Berkeley: Nanoparticles
Oakland: Dioxin
San Francisco: Bisphenol A, phthalates
San Francisco: Precautionary principle and environmentally preferable purchasing

37. Massachusetts TURA Mercury Boston: Dioxin
Proposed: Asthma/Cleaning Products
Proposed: Act for a Healthy Massachusetts
Safer Alternatives to Toxic Chemicals
Initial focus on: lead, formaldehyde, TCE, Perc, dioxins and furans, hexavalent chromium, organophosphate pesticides, PBDEs, DEHP, and 2,4-D.

38. Policy Updates 4. Canada – DSL Categorization
1. Update on REACH
2. China RoHS
3. State level policy initiatives
4. Canada – DSL Categorization
5. Regulation of nanomaterials

39. CANADA
Domestic Substances List (DSL) Categorization, mandated by law in 1999
Examined information available on about 23,000 chemicals in commerce
Identified more than 4,300 warranting further scrutiny

40. Source: Environment Canada

41. Regulation of Nanomaterials
Special characteristics of nanomaterials
Challenges for regulation
Government initiatives – first steps
EPA – intention to regulate nanosilver
Voluntary programs
US EPA UK
Municipal
Berkeley
Cambridge

42. Environmental Defense and DuPont Nanorisk Framework
Describe material and application.
Profile lifecycle(s).
Evaluate risks.
Assess risk management.
Decide, Document, and Act.
Review and adapt.