REGULATION OF CHEMICALS IN EUROPE – REACH

BEFORE 2008- EC 793/93Existing chemicals - substances on the market 010171-180981 – European Inventory of Excisting Commercial Chemical Substances EINECS New chemicals – compounds on the

CHALLENGES – SAFETY OF CHEMICALS

BEFORE 2008- EC 793/93

Existing chemicals - substances on the market

010171-180981 – European Inventory of Excisting Commercial

Chemical Substances (EINECS)

New chemicals – compounds on the market after 180981

Responsibilities – Public authorities for existing chemicals –

141 high volume chemicals (MS RAR, ECB, SCHER, EC)New chemicals to be tested at volumes as low as 10 kg/yr

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i There is a need for further information

and/or testing

ii There is at present no need for further

information and/or testing and for risk reduction measures beyond those which are being

Regulation (EC) No 178/2002

• Article 7 - Precautionary principle

– 1 In specific circumstances where, following

an assessment of available information, the

possibility of harmful effects on health is

identified but scientific uncertainty persists,

provisional risk management measures

necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment

DGSANCO

HEALTH AND CONSUMER PROTECTION

SCIENTIFIC COMMITTEES:

CONSUMER PRODUCTS (SCCP)

HUMAN AND ENVIRONMENTAL RISK (SCHER)

EMERGING AND NEWLY IDENTIFIED HEALTH

RISKS (SCENIR)

EFSA (Parma, IT)

EMEA (London, UK) 9

OBJECTIVES of REACH

 Protection of human health and the environment

 Maintenance and enhancement of the

competitiveness of the EU chemical industry

 Prevention of fragmentation of the internal market

 Increased transparency

 Integration with international efforts

 Promotion of non-animal testing

HOW WILL REACH WORK ?

 All substances are covered by the regulation

 Registration – manufacturers/importers obtain relevant informations

 Reduce testing on vertebrate animals – data sharing

 Better information on hazards and risks

 Evaluation - ECHA (Helsinki)

 Authorisation – risk adequately controlled,

socio-economic benefits outweigh risk, no suitable alternative substitute

 Registration

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Products or commodities, where the form is more

important than the chemical composition

Excempted compounds: Annex 4

ANNEX 4 and 5 EXEMPTIONs

Radioactive substances

Substances in transit

Non-isolated intermediates

Polymers

Substances which occur in nature

and not chemically modified –

minerals, ores, crude oil, vegetable

oil

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Technical dossier – 1 tonne or more

Chemical safety report – 10 tonne or more

Responsibility of manufacturer og importer to collect

information on the substance, assessment of the risk and

to ensure that the risk is properly managed.

TECHNICAL DOSSIER

 Properties – physiochemical & toxicological

(requirement depends on tonnage)

Substances that are dangerous to health

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CHEMICAL SAFETY REPORT

 Classification of substanse

 Describes exposure scenarios, manufacturing,

use and life-cycle

risk management procedures, including safety data sheets

CSR should be developed for all uses, by

importer/producer as well as downstream users

CLASSIFICATION – safe levels

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GLOBAL HARMONIZED SYSTEM

Acute toxicity – oral (LD50)

Category 2 (same label) Substances which should be

regarded as they are carcinogenic to man

Category 3 (Xn R40) Substances which cause

EXPOSURE SCENARIOS

1 Identify uses of chemical

Manufacturing, industrial use, service life, waste

2 Identify routes of potential exposure

for each use

3 Develop exposure scenario for each

EXPOSURE SCENARIOS-WORKERS

• Work process – descriptor

• Time of activity

• % of substance used

• Form of substance (gas, liquid, solid)

• Vapour pressure, dustiness

Worker exposure – methanol (Tier 1)

Generic processing – closed system (PROC 2)

Type of setting – industrial

Form of substance – liquid

Duration of exposure > 4 hrs (default)

Location indoor without ventilation

Inhalation exposure 66.8 mg/m3

Dermal exposure 1.4 mg/kg/day

Other worker functions – 267-333 mg/m3 og 6.9

mg/kg/day

8 hrs TWA 260 mg/m3 and IRIS RfD= 0.5 mg/kg/day21

EXPOSURE SCENARIO - CONSUMER

• Select sentenial product (PC/AC)

• Select sub product category

Frequency event/day

Fraction relased

Room volume

Conversion factor

Exposure air conc mg/m3

Body weight

Expos ure dose

ISOLATED INTERMEDIATES

”Light” registration when manufactured under strictly controlled conditions not likely to be present in final

product

If product leaves the production site – transported

between sites under controlled conditions

Hazard classificationInformation on risk managements

If more than 1000 tonnes is transported full dossier is

REDUCE ANIMAL TESTING

Data sharing

3R principles

reducerefinereplace

ECVAM – European Center for Validation of

Alternative Methods

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SUBSTANCES 1 to 10 T per year

Toxicological data on skin and eye irritation in

vitro, skin sensitation and bacterial mutagenicity

Skin/eye test donot need to be conducted if

chemical is corrosive

If positive bacterial mutagenicity test then

additional mutagenicity tests

SUBSTANCES 10-100 T YEAR

Same as for 1-10 T + in vivo skin and eye test

Genotoxicity in vitro mammalian cells

Repeated dose toxicity 28 days – exemption if

compound is immediately degraded and relevant human exposure can be excluded

Reproductive toxicity – exemption if compound is genotoxic and appropriate risk management can

be implemented and if human exposure can be

SUBSTANCES >100 Tons per Year

90 days chronic toxicity study

Excemption: If 28-days study show severe toxicity R48

NOAEL is calculated from NOAEL-28 with UF

No evidence of absorption and

no toxicity in 28-day study

SUBSTANCE IN ARTICLES

REACH requies all substances that are intended to be released from articles during norml and foreseeable

conditions of use to be used according to normal and

reasonable foreseable conditions to be registered

Substances of very high concern present in articles

above the concentration limit of 0.1% weight by weight (

< 1 tonne per year)

exemption: where exposure to human and the

Dossier evaluation:

Compliance testChecking of testing proposals

Substance evaluation: in collaboration with MS

development of action plan – MS to evaluate priority substances

Scientific evidence – case-by-case basis

ECHA will publish list annually based upon scientific

data (committee) – uses exempted

Granted if adequately controlled, socioeconomic benefits outweigh risk, no sutiable alternative

If safe level cannot be defined, substance cannot be authorized

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Key actor: European Chemical Agency

Registration of chemical compounds:

Deadline 3 yrs for >1000 t, and for compounds with carcinogenic, mutagenic

properties and those toxic for reproduction (CMR compounds)

Deadline 6 years for 100-1000 t Deadline 11 years for 10-100 t and 1-10 t

REACH - DEADLINES

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Substitute a compound with an less toxic alternatives

No special criteria – substances requiring an authorization

Based upon NOEL/ MOS

Alternatives may be associated with risk

A substance banned in Europe can re-enter the

European Market in finish articles

MOE APPROACH

• Selection of the appropriate reference point from the dose response curve for

comparison with human intake

• Estimation of human exposure

• Calculation of an MOE

MARGIN OF EXPOSURE (MOE)

Definition:

The ratio between the defined point on the

dose-response curve for the adverse effect and the human intake

No implicit assumption about a ”safe” intake

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INTERPRETATION OF MARGIN OF

EXPOSURE

• Inter-species and intra-species differences

• 100 would be sufficient

• Nature of the carcinogenic process

• Type of reference point

BENEFITS of REACH

Positive occupational impact

Positive public health impact

(employment opportunities for toxicologist)

Economic benefits:

World bank estimate:

Chemicals account for 1% of all diseasesAssuming a 10% reduction as a consequence of REACH - 4500 death due to cancer

Value of human life 1 M€

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