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1. Communicating chemical hazard and risk information to consumers A Member State view Dr Robin Foster
International Chemicals Unit
Health & Safety Executive
4th AISE Information Day, 28 November 2007
3. Chemical products supplied to the public
4. Approaches to regulating marketing of chemicals Authorisation / licensing / approval
Highest level regulatory intervention
All prohibited unless regulator allows
Regulator does risk assessment
Expensive!
Positive listing of components
Regulator allows certain ingredients only
Registration
Inform regulator what is marketed
No marketing restrictions
5. Communicating information Product labels
Hazard, risk, directions for use, safety precautions
Safety data sheets
Usually for use at work
Available to public on request
Other means
Package inserts
internet
6. PPPs and Biocides Product-by-product approval system
Nothing allowed unless regulator agrees
Covers all PPPs and biocides, inc. those for consumers
Regulator does risk assessment based on huge data sets
Health, safety, environment, efficacy
Expensive!
Uses prescribed conditions of use imposed
Extensive labels include detailed information on hazard, risk, conditions for use
7. Biocide Label Example
8. Biocide Label Example
9. Biocide Label Example
10. Medicines Product-by-product approval system
Nothing allowed unless regulator agrees
Covers all medicines, including self-prescribed
Regulator does risk assessment based on huge data sets
Health, efficacy
Expensive!
Uses prescribed
Presumption of benefit generally intervention by doctor
Extensive labels / inserts with detailed information on risk, conditions for use
11. Medicines - example
13. Cosmetics Bans/Positive listing of certain ingredients system
Regulator specifies ingredients and any conditions
No other marketing restrictions
Consumer safety only
Regulator does limited risk assessment
Relevant health effects
Less expensive system than medicines, PPPs, biocides
Uses not prescribed
Limited hazard and risk information on product labels
14. Cosmetics - example
16. Foods Bans/Positive listing only for few ingredients, eg additives
No other marketing restrictions
For these ingredients, regulator does risk assessment
Relevant health effects
Relatively cheap for industry
Uses not prescribed
Presumption of wholesomeness
Requirements for hygiene in preparation and use
Extensive labelling - ingredients, nutritional value, cooking instructions, use by, etc
17. General chemicals REACH registration of ingredients (substances)
Regulator can intervene selectively, eg for substances of very high concern (SVHC)
Full coverage - workers and consumers
Mostly industry does risk assessment
Safety, health, environment
Uses generally not prescribed by regulators
Dialogue between suppliers & users
Exception for SVHC
Hazard and risk information on product labels
Existing EU system; in future GHS
18. General Chemical - example
20. General points (1) Regulators want users to have information about all potential harms, even if risk low right to know
Foreseeable use
Foreseeable misuse
Accident situations
Favour integrated schemes for all users (h/s/env; consumers & workers)
Boundary between consumer and worker increasingly fuzzy
Difficult to justify different standards
21. General points (2) Overall picture rationalising with REACH, but still compartmentalised. However,
Hazard and risk information unless additional safeguards and presumption of
Professional individual oversight (medicines)
Wholesomeness (cosmetics, food)
Regulators sometimes overlook
Comprehensibility / practicability of information
AISE work helpful
22. Observations on AISE approach to GHS (1) GHS is a hazard based system
GHS agreed on basis that doesnt directly force jurisdictions to change existing approaches
Annex V included for US (and for chronic consumer health hazards only)
23. Observations on AISE approach to GHS (2) Does the scheme AISE propose
Justify different information requirements in different circumstances?
Consumers vs workers
Health hazards vs safety / env hazards?
Cover foreseeable misuse?
Respect existing EU values and standards?
24. Ways forward Alternative approaches
Seek to amend hazard classification criteria at UN level?
Ask whether EU should adopt UN GHS skin corrosion / irritation building block now?
Use existing flexibilities in GHS for mixtures? [Needs data, preferably generated in validated in vitro test methods]