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(1)

Risks at the Workplace

that will influence Annex I - Inclusion

Dr. Sabine Darschnik

(2)

Biocidal product directive RL 98/8/EC

In accordance with Article 5(1)(b) of the Directive Member States

shall only authorise a biocidal product if ...

... the product

has no unacceptable effects on human

or animal health directly or indirectly ...

(3)

Occupational diseases Germany 2004

others 37%

respiratory obstructive 4%

skin 36%

respiratory dusts

23%

23.600 recognised (1)

(4)

Professional use of biocides

registered products in Germany ~ 13.000

active substances ~ 300

active substances: professional use only 20 of 41 (1st list)

products used by non-professionals ~ 10 %

„workers are the first

and often the only ones to be directly exposed“

(5)

Positive list

Annex I

active substance biocidal product

authorisation risk assessment

Annex I

risk assessment ...

...

...

...

(6)

Existing active substances

Priorities for the evaluation

product type professional use (e.g.)

1. wood preservatives carpenter,

rodenticides pest control operator 2. disinfectants, ... nurse, butcher

3. insecticides, ... gardener, farmer

. .

(7)

Examples of workplaces

(8)

Prerequisites for Annex I- Inclusion

•••

all relevant data available

efficacy

one safe use

•••

(9)

Safe use

exposure < reference value: no concern exposure > reference value: concern

in case of concern:

• protection measures

• restrictions

(10)

Topics

potential actual OEL AOEL

already applied additional

exposure assessment

reference value

risk reduction

common understanding

identification of problems

ideas for a way forward

(11)

Exposure data provided

dermal inhalation

level of exposure

duration

frequency

mg/cm 2 mg/m 3

mg/person/day

(12)

Source of exposure information

models literature

field studies

tools

(13)

Example for field studies

(14)

Actual exposure

e.g. dermal exposure of potassium sorbate ( szenario bathing or dipping )

potential

• mixing loading: 90 % PPE

• application: 70 % clothing 45 % footwear

• post-application + 70 % clothing

disposal: 90 % PPE hand

7.300 mg/p/d

(15)

Specific questions exposure

how to bridge missing information (defaults) ?

which uncertainties exist?

which model is applicable?

how to derive actual exposure?

(16)

Reference value

NOAEL

interspecies intraspecies Safety factors

AOEL acceptable operator

exposure level

(17)

Different Technical Guidance

intraspecies interspecies

TNsG ( AOEL) 10 10

TGD (MOE) 2.5 x metabolic rate 5 (worker)

(18)

Additional considerations

Internal / external value

• absorption data

• route specific toxicity

• combined exposure

Different exposure length

• acute reference dose

• short-term reference dose

(19)

Specific questions reference values

different reference values from the same data ?

how to calculate internal values?

shall reference values refer to exposure duration ?

(20)

Risk reduction measures ...

... already applied

good practice

safety data sheet regulations

personal factors

(21)

Example

(22)

Additional measures

potential exposure

measures as already applied actual exposure

if concern additional measures to reduce exposure

S ubstitution

T echnique

(23)

Conditions as result of concern

no annex I listing (Diamin)

(specialised) professional use only (Anticoagulants)

to be used with applicator (Al-phosphide)

intermittent period necessary (Sulfurylfluoride)

daily change of gloves (Dichlofluanid)

(24)

Specific questions measures

which measures are already applied?

which protection factors shall be assigned?

how to deal with compliance?

which additional measures appear feasible?

•••

(25)

Benefits for occupational safety and health

pool of information available for practical use at the workplace

substance regulation classification/ OEL

comparative assessment restrictions

product development inherently safe products ☺

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