HET COLLEGE
VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN
EN BIOCIDEN
1
TOELATING
Gelet op de aanvraag d.d. 9 december 2010 (20101069 TBR) van
tot verkrijging van een toelating op basis van de werkzame stof(fen) formaldehyde,
gelet op artikel 121, eerste lid, jo. artikel 44, Wet
gewasbeschermingsmiddelen en biociden,
BESLUIT HET COLLEGE als volgt:
1.1 Toelating
Het middel SYN-Formaline 37% is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13525 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.
De toelating geldt tot 1 november 2021.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.
1.4 Classificatie en etikettering
Gelet op artikel 31 en artikel 65 van de
Verordening EG/1107/2009 worden voorschriften gegeven.
Gelet op artikel 50 Wet
gewasbeschermingsmiddelen en biociden worden voorschriften gegeven.
Dit leidt tot de volgende voorschriften:
PICTOGRAM(MEN)
GHS05 |
|
GHS06 |
|
GHS08 |
|
SIGNAALWOORD
Gevaar
GEVARENAANDUIDINGEN
H302 Schadelijk bij inslikken.
H311 Giftig bij contact met de huid.
H314 Veroorzaakt ernstige brandwonden.
H317 Kan een allergische huidreactie veroorzaken.
H331 Giftig bij inademing.
H351 Verdacht van het veroorzaken van kanker.
H371 Kan schade aan organen veroorzaken.
VOORZORGSMAATREGELEN (CVM)
P202 Pas gebruiken nadat u alle
veiligheidsvoorschriften gelezen en begrepen heeft.
P260 Gas/nevel/damp/spuitnevel niet
inademen.
P280D Beschermende handschoenen/beschermende kleding en oogbescherming dragen.
P284 Adembescherming dragen.
P303+P361+P353 BIJ CONTACT MET DE HUID (of het haar): verontreinigde kleding onmiddellijk uittrekken - huid met water afspoelen/afdouchen.
P403 +
P233 Op een goed geventileerde plaats bewaren. In goed
gesloten verpakking bewaren.
aard van het preparaat: Met water mengbaar concentraat
werkzame stof: |
gehalte: |
formaldehyde |
37 % |
letterlijk en zonder enige
aanvulling:
andere zeer giftige, giftige, bijtende of schadelijke stof(fen):
methanol
1)
Behalve de onder 1. bedoelde en de overige bij
de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding
milieugevaarlijke stoffen en preparaten voorgeschreven aanduidingen en
vermeldingen moeten op de verpakking voorkomen:
§
letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder
A.
§
hetzij
letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing
is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
De vervaldatum (2
jaar na de productiedatum van SYN-Formaline 37%) dient op het etiket te worden
vermeld.
2 DETAILS VAN DE AANVRAAG
Het betreft een aanvraag tot verkrijging van een toelating van het middel SYN-Formaline 37% (13525 N), een middel op basis van de werkzame stof formaldehyde.
De aanvrager heeft een adequaat aanvraagdossier ingediend. Het Ctgb is in de
beoordeling uitgegaan van de wetenschappelijk gezien beste eindpunten.
HET COLLEGE VOOR
DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
dr. D. K. J. Tommel
voorzitter
HET COLLEGE VOOR DE
TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I bij het besluit d.d. 14 oktober 2011 tot toelating van het middel
SYN-Formaline 37%, toelatingnummer 13525 N
A.
WETTELIJK
GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als middel ter bestrijding van
bacteriën (incl. mycobacteriën, maar excl. bacteriesporen), gisten, schimmels
en virussen
1.
door middel van vernevelen, zoals beschreven in de
gebruiksaanwijzing, in:
A. lege ruimten
bestemd voor de kweek van consumptie- en siergewassen en paddestoelen.
B. dierverblijfplaatsen
met bijbehorende stallen en materialen (machines en gereedschappen)
en als middel ter bestrijding van bacteriën (incl.
mycobacteriën, maar excl. bacteriesporen)
2.
op hoeven van rundvee en schapen door middel van
hoefbaden.
De dosering zoals aangegeven in de
gebruiksaanwijzing moeten worden aangehouden.
De desinfectie moet worden uitgevoerd volgens de gebruiksaanwijzing.
Vernevelen van het middel is niet toegestaan in ruimten waarin zich
mensen, dieren, sier- en/of consumptiegewassen bevinden.
Het middel niet in direct contact met dieren
laten komen, met uitzondering van de hoeven.
Om verminderd functioneren van een Individuele Behandeling Afvalwater
(IBA) te voorkomen, dienen afvalresten die het middel bevatten geloosd te
worden op de mestkelder of op de gemeentelijk riolering.
Het middel is uitsluitend bestemd voor professioneel gebruik.
Desinfectie door middel van vernevelen mag uitsluitend worden uitgevoerd
door professionals, die een opleiding voor ruimtedesinfectie hebben gevolgd.
B.
GEBRUIKSAANWIJZING
1. Desinfectie uitsluitend middels
vernevelen m.b.v. straalmotorapparatuur gebruikt volgens onderstaande
instructie
De te
desinfecteren ruimten, oppervlakken en apparatuur eerst grondig reinigen. Een
daarbij gebruikt reinigingsmiddel wegspoelen met schoon water. Overtollig water
verwijderen.
Materialen die in contact kunnen komen met diervoer of drinkwater voor
dieren na behandeling grondig afspoelen met schoon water.
Algemene instructies voor vernevelen:
.
1A. Lege
ruimten bestemd voor de kweek van consumptie- en siergewassen en paddestoelen
Dosering: 2% (
Gebruik 5 tot
1B. Dierverblijfplaatsen en bijbehorende stallen en
materialen (machines en gereedschappen)
Dosering: onverdund middel, 1,3 tot
2. Desinfectie
middels hoefbaden
Het
middel is bestemd voor het desinfecteren van hoeven van rundvee en schapen. De
te desinfecteren hoeven eerst grondig reinigen met schoon water. Vul een schone
bak, eventueel voorzien van een voetenmat, met water en voeg het middel toe.
Plaats de bak zodanig dat het vee er doorheen loopt.
Dosering: 4% (
De oplossing
gedurende maximaal 24 uur, na het vullen van de bak, gebruiken.
Bij routinematig gebruik: iedere 2 á 3 weken
herhalen.
Bij ad-hoc behandeling: 1 á 2 keer per week.
N.B.: Het middel wordt onwerkzaam wanneer het in
contact komt met zeep of synthetische wasmiddelen en wanneer het vervuild is
met organisch materiaal.
HET COLLEGE VOOR DE
TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II bij het besluit d.d. 14 oktober 2011 tot toelating van het middel
SYN-Formaline 37%, toelatingnummer 13525 N
RISKMANAGEMENT
|
|
Page |
1. |
Introduction |
2 |
2. |
Identity |
2 |
3. |
Physical and chemical properties |
4 |
4. |
Efficacy |
5 |
5. |
Human toxicology |
8 |
6. |
Environment |
18 |
7. |
Conclusion |
23 |
8. |
Classification and labelling |
25 |
9. |
References |
26 |
Formaldehyde 37%
Brenntag en SYN-Formaline 37%
This assessment
concerns two biocidal products based on the active substance formaldehyde. The
applications for authorisation of these products have been submitted under the
differentiated enforcement policy of biocides of the Ministry of I&M.
The assessment includes the following products:
Product |
Applicant |
Product type (PT) |
Application number |
Formaldehyde 37% Brenntag |
Brenntag Nederland BV |
2,3 |
20101101 TBR |
SYN-Formaline 37% |
Synerlogic B.V. |
2,3 |
20101069 TBR |
The active
substance formaldehyde has
been notified for product types 2, 3, 20
and 22. formaldehyde has
not been included in annex 1, 1A or 1B of Directive 98/8/EC yet.
General
Active substance (ISO
Common Name) |
Formaldehyde (non-ISO) |
Name in Dutch |
Formaldehyde |
Identity
Chemical name (IUPAC) |
Methanal |
Chemical name (CA) |
Methanal |
CAS No |
50-00-0 |
EC No |
200-001-8 |
Other substance No. |
CIPAC no. 156 |
Molecular formula |
CH2O |
Molecular mass |
30.0 |
Structural
formula |
The active substance
formaldehyde is not yet included in annex I of Directive 98/8/EC.
A draft CAR of the active
substance is available.
Physical and chemical properties relevant to the risk assessment
Technical formaldehyde is
an aqueous solution (50-55%).
Appearance |
Colourless
gas (pure) |
Surface tension |
N/A |
Vapour pressure (Pa) |
4378 – 5185 hPa |
Henry’s law constant (Pa
m3 mol -1) |
0.034
at |
Solubility in water (g/L
or mg/L) |
Theoretically 95% (w/w) at Aqueous
solutions become cloudy at concentrations >30% due to polymerisation. |
Partition coefficient
(log POW) |
0.35
at |
Hydrolytic stability (DT50) |
N/A |
Dissociation constant |
No
dissociation within an environmentally relevant pH range. |
UV/VIS absorption (max.)
(if absorption > 290 nm state e at wavelength) |
No
significant absorption > 290 nm |
Photolysis (DT50)
and quantum yield |
N/A |
Hazard identification for classification and labelling
Flammability |
Non-flammable
gas TK
(gas in water): Not flammable Auto-flammability:
Not self-igniting (> |
Oxidising properties |
Not oxidising |
Explosive properties |
Not explosive |
Adequate analytical
methodology is available to determine the content of active substance and
significant and/or relevant impurities in the technical active substance.
The identity, physical and
chemical properties and analytical methods of the active substance are
sufficiently described.
Formaldehyde 37% Brenntag
Name |
Formaldehyde
37% Brenntag |
Content active
substance |
37%
formaldehyde |
Formulation type |
SL |
Packaging |
HDPE can,
drum or IBC: 5 – 1000L |
Appearance |
Clear liquid with pungent odour |
Explosive properties |
Not explosive |
Oxidising properties |
Not oxidising |
Auto-flammability |
Not self-igniting |
Flashpoint |
FP: |
pH 1% solution |
2.8 – 4.0 Acidity: 0.01 – 0.05% as acetic acid |
Relative density |
1.0925 |
Storage stability/ Shelf
life |
1
year |
Technical characteristics |
No data. Not required. |
Physical and chemical
compatibility |
Not applicable |
Viscosity |
Not applicable |
Surface tension |
Not applicable |
Preparation (principle of
method) |
ISO /
ASTM method |
Adequate residue analytical
methodology is available to monitor residues of the biocide taking into account
all possible exposure scenarios and the toxicity of the active substance.
The identity, the physical
and chemical properties and the analytical methods of the biocidal product are
sufficiently described.
SYN-Formaline 37%
Name |
SYN-Formaline
37% |
Content active
substance |
37%
formaldehyde |
Formulation type |
SL |
Packaging |
HDPE: 1 –
1000L |
Appearance |
Clear liquid with pungent odour |
Explosive properties |
Not explosive |
Oxidising properties |
Not oxidising |
Auto-flammability |
Not self-igniting |
Flashpoint |
FP: 64 – |
pH 1% solution |
2.8 – 4.0 |
Relative density |
1.0925 |
Storage stability/ Shelf
life |
2
years in HDPE |
Technical characteristics |
No data. Not required. |
Physical and chemical
compatibility |
Not applicable |
Viscosity |
Not applicable |
Surface tension |
Not applicable |
Preparation (principle of
method) |
ISO /
ASTM method |
Adequate residue analytical
methodology is available to monitor residues of the biocide taking into account
all possible exposure scenarios and the toxicity of the active substance.
The identity, the physical
and chemical properties and the analytical methods of the biocidal product are
sufficiently described.
Formaldehyde 37% Brenntag
Formaldehyde 37% Brenntag
is an disinfectant (PT 2 and PT3) based on 37% w/w formaldehyde.
The proposed field of use of Formaldehyde 37% Brenntag is the control of bacteria, yeasts, fungi and viruses
a.
In
empty rooms intended for the growing of mushrooms/plants for consumption and
ornamental plants
b.
In
animal housing including stables and materials
c.
In
vehicles for transport of animals
d.
On
hoofs to prevent the spread of hoof diseases
These uses are included in PT2 and PT3.
The product is intended for professional use only.
The available information
was sufficient to evaluate the efficacy of Formaldehyde 37% Brenntag,
considering that the authorisation is done under article 121 of the WGB and
that the product has already been on the market for some time.
Data of several literature studies demonstrated that Formaldehyde 37%
Brenntag, when used in accordance with the proposed label (WG/GA), is expected
to be effective in controlling bacteria
(including mycobacteria, excluding bacterial spores), yeasts, viruses and fungi
in
Also
efficacy against bacteria (including
mycobacteria, excluding bacterial spores) on hoofs of ungulates has been
demonstrated. However, the concentration applied in this use is not sufficient
for the control of yeast, fungi and viruses.
Efficacy
has not been demonstrated for use in the animal transport sector since for this
use a virucidal claim is mandatory. The viral claim can not be accepted as the
required target organisms (classical swine fever, Aujeszki and foot and mouth
disease ) have not been tested in efficacy tests.
The
applicant has provided a Dutch WG/GA. This has been adapted to the standards.
For the
field of use of hoof disinfection only the bacterial claim (including mycobacteria, excluding
bacterial spores) is accepted on the WG/GA, as sufficient efficacy has been
demonstrated only for the control of bacteria.
The
intended use in the animal transport sector has been removed since the
mandatory virucidal efficacy has not been substantiated for the required target
organisms (Classical Swine fever, Aujeszki and Foot and Mouth disease).
The biocidal action of
formaldehyde is caused by the interaction with macromolecules on cell
membranes, in body tissues and fluids (e.g., proteins and DNA) and the
disruption of cellular functions.
No
data was submitted on the possible occurrence of resistance of target organisms
to Formaldehyde 37% Brenntag. Considering the
authorisation is done under article 121 of the WGB this is acceptable.
Based on the data submitted and considering that the evaluation is done
under article 121 of the WGB and that the product has already been on the
market for some time, it can be concluded that Formaldehyde 37% Brenntag, when
used in accordance with the proposed label (WG/GA), is expected to be effective
in controlling
1. bacteria (including mycobacteria, excluding bacterial spores), yeasts,
viruses and fungi in:
2. and in controlling bacteria (including mycobacteria, excluding bacterial spores)
SYN-Formaline 37%
SYN-Formaline 37% is a disinfectant (PT 2 and PT3)
based on 37% w/w formaldehyde.
The proposed field of use of SYN-Formaline 37% is the control of bacteria, yeasts, fungi and viruses
a.
On
hoofs of cattle and sheep
b.
On
footwear of men that enter farms, cleaning devices for shoes and footbaths
c.
In
empty rooms intended for the accommodation, care and transport of animals
d.
In
empty rooms intended for the growing of mushrooms/plants for consumption and
ornamental plants
e.
On
the outside and inside of machines
f.
On
equipment
These uses are included in PT2 and PT3.
The product is intended for professional use
only.
The available information
was sufficient to evaluate the efficacy of SYN-Formaline 37%, considering that the authorisation is done
under article 121 of the WGB and that the product has already been on the
market for some time.
Data of several literature studies demonstrated
that SYN-Formaline 37% can be expected to be effective against bacteria
(including mycobacteria, excluding bacterial spores), yeasts, fungi and viruses
in empty rooms intended for the growing of plants for consumption and
ornamental plants, in animal housing including stables and materials, and on
surfaces and equipment in these rooms, when used in accordance with the
proposed label (WG/GA). Moreover, SYN-Formaline 37% can be expected to be
effective against bacteria (including mycobacteria, excluding bacterial spores)
on hoofs of cattle and sheep when used in accordance with the proposed label
(WG/GA). However, the concentration applied in hoof disinfection did not
demonstrate sufficient control of yeast, fungi and viruses. Efficacy has not
been demonstrated for the claimed target organisms for footwear disinfection
and equipment by treatments with a short contact time using the product in low
concentrations. Efficacy has not been demonstrated for use in the animal
transport sector since for this use a virucidal claim is mandatory. The viral
claim can not be accepted as the required target organisms (classical swine
fever, Aujeszki and foot and mouth disease ) have not been tested in efficacy
tests.
The applicant has provided
a Dutch WG/GA. This has been adapted to the standards.
The field of use of
footwear disinfection and equipment disinfection has been eliminated from the
WG/GA as efficacy has not been demonstrated for the intended concentrations and
contact times. For the field of use of hoof disinfection only the bacterial
claim (including mycobacteria, excluding bacterial spores) is accepted on the
WG/GA, as sufficient efficacy has been demonstrated only for the control of
bacteria.
The intended use in the
animal transport sector has been removed since the mandatory virucidal efficacy
has not been substantiated for the required target organisms (Classical Swine
fever, Aujeszki and Foot and Mouth disease).
The biocidal action of
formaldehyde is caused by the interaction with macromolecules on cell
membranes, in body tissues and fluids (e.g., proteins and DNA) and the
disruption of cellular functions.
No
data was submitted on the possible occurrence of resistance of target organisms
to SYN-Formaline 37%. Considering the authorisation
is done under article 121 of the WGB this is acceptable.
Based on the data submitted and considering that the evaluation is done
under article 121 of the WGB and that the product has already been on the market
for some time, it can be concluded that SYN-Formaline 37%, when used in
accordance with the proposed label (WG/GA), is expected to be effective in
controlling
1. bacteria (including mycobacteria,
excluding bacterial spores), yeasts, fungi and viruses in/on
2. bacteria (including mycobacteria, excluding bacterial
spores)
Formaldehyde 37%
Brenntag and SYN-Formaline 37%
Human health effects assessment active substance
Formaldehyde is an existing
active substance, not included in Annex I of 98/8/EC. An application for
inclusion is submitted, for which
In addition an OECD
Screening Information Data Sets (SIDS) on formaldehyde (March 2002), published
by the United Nations Environment Programme (UNEP) is available. Furthermore,
the information provided in the IARC monograph on formaldehyde (Volume 88,
2006), and the Reregistration Eligibility Decision (RED) report on formaldehyde
and praformaldehyde (June 2008), published by the US Environmental Protection
Agency (US EPA) might be considered.
This assessment is based on
the List of Endpoints (LoEP) from the draft concept CA-report (June 2010) for
which
List of Endpoints
Formaldehyde is a corrosive
substance. Formaldehyde causes toxic effects only in the tissues of direct
contact after inhalation, oral or dermal exposure characterised by local
cytotoxic destruction. Toxic effects in the target tissues are dependent upon
concentration rather than cumulative dose, and are highly non-linear. The
typical locations of lesions in experimental animals are the nose after
inhalation, the stomach after oral administration and the skin after dermal
application.
In de concept CAR of
formaldehyde the following AEL/AEC’s were derived:
-
EU-AEL
acute/medium/longterm (systemic internal acceptable exposure level): 0.15 mg/kg
bw/day, based on 28-day, 90-day and 2-year studies in rats, an assessment
factor of 100, and no correction for oral absorption.
-
AEC acute/medium/longterm,
inhalation: 0.12 µg/L, based on human eye irritation, human respiratory
irritation and studies with rats and monkeys.
Since the active substance
is not included in Annex I of 98/8/EC, a NL-AEL was derived for systemic
effects:
Based on a NOAEL of 15
mg/kg bw/day, an assessment factor of 36 (3*4 for interspecies and 3 for
intraspecies), and no correction for oral absorption, and a body weight of
Besides, a 8-hour tolerable
limit value (TLV) of 0.15 mg/m3 and a 15-minutes TLV of 0.5 mg/m3
were established for formaldehyde.
Carcinogenic effects were
observed in the respiratory system of rats and mice at exposure concentrations
not lower than 7.2 μg/L formaldehyde gas in air. Based on dose-response
and mechanistic considerations linking local carcinogenicity of formaldehyde to
cytotoxic insult and/or proliferative response of the exposed tissue, it is
concluded that the proposed AEC will provide adequate protection.
No specific local
acceptable exposure level was established in the CAR for dermal exposure.
It was stated that the
availability of data on toxicity after repeated dermal exposure to
formaldehyde-containing solutions is limited. A NOAEC of 0.1 % has been
previously derived based on skin irritation following 2-3 weeks administration
to mice (OECD, 2002). It must be noted, however, that formaldehyde is also
regarded as a skin sensitizer and that no reliable NOAEC can be derived for
this possibly more sensitive endpoint based on the submitted data. In an LLNA a
possible threshold of 0.35 % formaldehyde in an acetone/olive oil vehicle was
established. Previous considerations suggested a threshold concentration for
induction below 5 % in solution (OECD, 2002) and a low probability for positive
reactions in humans below 0.025-0.05 % (ATSDR, 1999). However, the currently available
methodology as well as the submitted database is not suitable for derivation of
a NOAEC for sensitisation by formaldehyde which is relevant to human health
(from draft CAR formaldehyde, 2010).
To have an indication on
the possible risks for skin sensitization, the concentration of 0.1% from the
repeated dose toxicity study is used as an AEL local dermal.
Local effects
See above.
Data requirements active substance
No additional data
requirements are identified.
Formaldehyde 37% Brenntag
is a liquid and contains formaldehyde as active substance (343 g/L). The
proposed field of use is in PT2 and PT3.
SYN-Formaline 37% is a
liquid and contains formaldehyde as active substance (343 g/L). The proposed
field of use is in PT2 and PT3.
An assessment of uses and
exposure scenarios was made for the three products. A summary of uses is given
in Table T.1 below.
Table T.1 Summary
of uses Formaldehyde 37% Brenntag and SYN-Formaline 37%
|
Concentration
a.s. in product |
Use
concentration |
PT |
Application
method |
Frequency |
Potential
secondary exposure |
Formaldehyde
37% Brenntag |
||||||
disinfection of equipment/ surfaces |
343
g/L |
25.2
g/L (7.5%) |
2 |
Mix/load, low pressure spraying |
2 times/year |
None (surfaces rinsed, rooms ventilated, no
crops present) |
Disinfection of mushroom cells |
343
g/L |
6.7
g/L (2%) |
2 |
Mix/load, low pressure spraying |
1 time/ 4-6 weeks |
None (empty cells only) |
disinfection of animal housing or
transportation |
343
g/L |
53.8
g/L (16%) |
3 |
Mix/load, low pressure spraying |
1 time/6 weeks |
None (rooms ventilated, no animals present) |
disinfection animal hoofs |
343
g/L |
16.8
g/L (5%) |
3 |
Mix/load of hoof-bath |
1 time/ 1-4 weeks |
None |
SYN-Formaline
37% |
||||||
disinfection animal hoofs |
343
g/L |
13.4
g/L (4%) |
3 |
Mix/load of hoof-bath |
1 time/ 2-3 weeks |
None |
disinfection foot wear |
343
g/L |
6.7
g/L (2%) |
3 |
Mix/load of foot bath |
When necessary |
None |
disinfection of greenhouses and mushroom cells |
343
g/L |
6.7
g/L (2%) |
2 |
Puls-fog |
1 time/ 4-6 weeks |
None (rooms empty, and ventilated) |
disinfection of animal housing or
transportation |
343
g/L |
336
g/L (100%) |
3 |
Puls-fog |
1 time/ 6 weeks (assumed) |
None (rooms ventilated, no animals present) |
disinfection of animal housing or
transportation |
343
g/L |
67
g/L (20%) |
3 |
Mix/load, low pressure spraying |
1 time/ 6 weeks (assumed) |
None (rooms ventilated, no animals present) |
disinfection equipment |
343
g/L |
6.7
g/L (2%) |
3 |
Mix/load, dipping |
Several times/day, 5 days/week |
None (material rinsed with water) |
As also systemic effects
were observed after exposure to formaldehyde, a quantitative exposure
assessment was performed.
In addition, a comparison
of non-irritating/sensitizing concentrations and the use concentrations was
made.
Based on the corrosive
properties of the active substance, personal protection equipment will be
prescribed on the label.
The products are intended
for professional use. All uses are dealt with in paragraph 6.1.2.
For both products, the
inhalation exposure during low pressure spraying with the undiluted formulation
might be considered worst case. For dermal exposure, a comparison of the
concentration formaldehyde in the formulation and in-use concentration versus
the non-irritating concentration was made.
The professional user of
Formaldehyde 37% Brenntag and SYN-Formaline 37% can be exposed to the products
during:
To calculate professional
exposure during spraying (as a worst-case application method and
concentrations) to formaldehyde, the User Guidance for the Technical notes for
Guidance on Human Exposure to Biocidal Products is applied. The following
points have been taken into consideration:
-
Spraying Model 1 is used: mixing
and loading liquids in compression sprayers, and applying 1 to 3 bar pressure
as a coarse or medium spray, indoors and outdoors, overhead and downwards.
-
A task duration of 6 hours
-
A body weight of
-
The highest use concentration
for spraying of 67 g/L
Spraying model 1 describes
mixing and loading and applying at 1 to 3 bar pressure in compression sprayers
as a coarse or medium spray, indoors and outdoors, overheads and downward. From
the WG/GA it can be concluded that this model fits the use of Formaldehyde 37%
Brenntag and SYN-Formaline 37%. Spraying
model 1 is based on a small dataset for which the exposure is measured
underneath a glove; therefore the potential dermal hand exposure is with high
factor of uncertainty.
Table T.2 Internal operator exposure to formaldehyde
and risk assessment for the use of Formaldehyde 37% Brenntag and SYN-Formaline
37%, spraying
|
Route |
Estimated internal exposure a (mg /day) |
Systemic NL-AEL (mg/day) |
Risk-index b |
Manual upward/downward
spraying on surfaces (67 g/L) |
||||
Low pressure spraying
(incl. mixing/loading) |
Respiratory |
523 |
29.1 |
18.0 |
Dermal |
65847 |
29.1 |
2263 |
|
|
Total |
66370 |
29.1 |
2281 |
On the basis of the above
considerations, it can be concluded that the risk for the professional user is
not acceptable. Dermal absorption data were already present in the dossier.
Furthermore, considering the corrosive and skin sensitizing properties of the
active substance, and taking into consideration the classification as and acute
inhalation toxicant, personal protection equipment should be prescribed.
Therefore, calculations were made with PPE (coverall, gloves and respiratory
protection equipment).
Table T.3 Internal operator exposure to formaldehyde
and risk assessment for the use of Formaldehyde 37% Brenntag and SYN-Formaline
37%, with PPE, spraying
|
Route |
Estimated internal exposure a (mg /day) |
Systemic NL-AEL (mg/day) |
Risk-index b |
Manual upward/downward
spraying on surfaces (67 g/L) |
||||
Low pressure spraying
(incl. mixing/loading) |
Respiratory |
52.3 |
29.1 |
1.80 |
Dermal |
4800 |
29.1 |
165 |
|
|
Total |
4852 |
29.1 |
167 |
On the basis of the above
considerations, it can be concluded that the risk for the professional user is
not acceptable for spraying concentrations of 67 g/L.
Considering a lower in-use
concentration of 6.7 g/L (the lowest concentration for spraying for both
products), will also results in non-safe use (systemic dermal exposure with
PPE, gloves and coverall, of 480 mg/day, systemic inhalation exposure with
respiratory protection equipment 5.2 mg/day, total 485.2 mg/day resulting in a
RI of 16.7).
For SYN-Formaline 37%,
fogging is included in the PGB for both PT2 and PT3. Fogging (puls-fog) is not
a standard use for surfaces in veterinary accommodations/means of
transport/public area. Furthermore, to include fogging special apparatuses are
needed and additional information on how to use the product in combination with
the apparatuses. The applicant provided a description of the equipment and a
specific protocol for area disinfection by fogging. In this protocol specific
personal protection measures are prescribed for fogging including mixing and
loading. These personal protection measures include:
-
Wear a respiratory
protection (B2 grey)
-
Wear suitable gloves
-
Wear specific protective
clothing for spraying (spray suit)
In addition, the applicant
of SYN-Formaline 37% includes the following in the protocol:
-
The fogger should be filled
and started and the operator should immediately leave the area.
-
Ventilation should be shut
down and ventilation openings should be closed.
-
Keep the treated area
closed for 24 hours.
-
Heat the area above
-
Re-entry of treated areas
is only allowed it the area concentration is below the occupational exposure
limits (MAC TGG, 15 min: 0,5 mg/m3, MAC TGG, 8 hours: 0.15 mg/m3).
-
If the treated area is
entered, taking in considering the MAC values, personal protection as indicated
for application should be worn.
-
It is advised to wear
personal samplers in case of re-entry (gas tubes for formaldehyde with a lower
measuring limit of 0.1 ppm and above (> 0.12 mg/m3).
There is no suitable model
to estimate exposure during fogging. Based on the hazard properties of
formaldehyde, the reduction of exposure through the risk reduction measures,
above protocol is considered acceptable. When the product is used according to
the proposed instruction for use.,it is concluded that no adverse health
effects are expected for the protected (gloves, spray suit, respiratory protection)
professional after dermal and respiratory exposure to formaldehyde as a result
of the use of SYN-Formaline 37% during fogging.
Risk assessments were also
made for the dipping instruments and hoof-bath applications.
For an hoof-bath
application, for the professional user, only mixing and loading is considered.
Dermal and inhalation
exposure were calculated using EUROPOEM (in accordance with the User guidance
version 1, for TNsG 2002). Hoof-baths can be filled with 200 L/bath, and are
therefore considered fixed receiving vessels.
Table T.4 Internal operator exposure to formaldehyde
and risk assessment for the use of Formaldehyde 37% Brenntag and SYN-Formaline
37% - mixing and loading for hoof-baths
|
Route |
Estimated internal exposure a (mg /day) |
Systemic NL-AEL (mg/day) |
Risk-index b |
Manual mixing and loading
for hoof-baths (4-7.5% product concentration) |
||||
Mixing/loading |
Respiratory |
0.006 |
29.1 |
< 0.01 |
Dermal |
18.56 |
29.1 |
0.64 |
|
|
Total |
18.57 |
29.1 |
0.64 |
|
|
Estimated internal exposure a (mg /m3) |
MAC-15 min (mg/m3) |
Risk-index b |
Mixing/loading |
Respiratory |
0.018 |
0.5 |
0.036 |
a External exposure was estimated with EUROPOEM.
Internal exposure was calculated with 100%
bioavailability for the dermal and respiratory route.
b The risk-index is calculated by dividing the internal
exposure by the systemic AOEL or MAC.
Based on the risk
assessment, it can be concluded that no adverse health effects are expected for
the unprotected professional after dermal and respiratory exposure to
formaldehyde as a result of the use of Formaldehyde 37% Brenntag and
SYN-Formaline 37% for hoof-baths.
Considering the corrosive
properties of formaldehyde, personal protection equipment should be worn (see
paragraph 6.5) during mixing and loading. The exposure will we lowered with a
factor 10, by using personal protection equipment.
For foot baths, the above
risk assessment is considered applicable, since a lower concentration is used
(2%) and dermal and respiratory exposure is only considered during mixing and
loading.
As a safe use was
calculated for hoof-bath application, a safe use is also calculated for foot
bath application of SYN-Formaline 37%.
For the dipping of
instrumentation, the mixing and loading scenario applies. For the exposure
estimation during mixing and loading, EUROPOEM is used. In addition, dermal and
inhalation exposure during dipping is considered. For the exposure calculation,
dipping model 4 from the TNsG is used. Body exposure was not considered
applicable for the anticipated use of the products under consideration, since
only small instruments are disinfected, and only hand exposure is expected.
Table T.5 Internal operator exposure to formaldehyde
and risk assessment for the use of SYN-Formaline 37% - dipping instruments
|
Route |
Estimated internal exposure a (mg /day) |
Systemic NL-AEL (mg/day) |
Risk-index b |
Manual dipping of
instruments (2% product concentration) |
||||
Mixing/loading |
Respiratory |
< 0.01 |
29.1 |
< 0.01 |
Dermal |
1.23 |
29.1 |
0.04 |
|
Dipping |
Respiratory |
0.96 |
29.1 |
0.03 |
|
Dermal |
92.69 |
29.1 |
3.19 |
|
Total |
94.88 |
29.1 |
3.26 |
|
|
Estimated internal exposure a (mg /m3) |
MAC-15 min (mg/m3) |
Risk-index b |
Mixing/loading |
Respiratory |
0.0012 |
0.5 |
0.024 |
Dipping |
Respiratory |
0.2 |
0.5 |
0.4 |
a External exposure was estimated with EUROPOEM and
dipping model 4. Internal exposure was calculated with 100% bioavailability for
the dermal and respiratory route.
b The risk-index is calculated by dividing
the internal exposure by the systemic AOEL or MAC.
For the unprotected professional operator, adverse
health effects after dermal exposure to formaldehyde as a result of manual
disinfection of instruments cannot be excluded. Correct use of personal
protective equipment will reduce the dermal exposure and results in a
sufficient reduction of the exposure to formaldehyde for the application of
SYN-Formaline 37% in during manual disinfection of instruments.
No adverse health effects are expected after
respiratory exposure to formaldehyde as a result of manual disinfection of
instruments.
Local effects
For dermal and respiratory
tract exposure to formaldehyde for hoof-bath and dipping applications the
following concentrations are considered: 18.35 g/L (5%) for Formaldehyde 37%
Brenntag and 6.7 (2%) and 13.4 g/L (4%) for SYN-Formaline 37%. For fogging of
SYN-Formaline 37%, concentrations of 2 and 100% are considered.
The AEL for local dermal
effects is set at 0.1% from a the repeated dose toxicity study. The maximum use
concentrations of both products exceed the AEL for local dermal effects.
Although application of the
standard factor for reduction of exposure through PPE will not reduce the
exposure sufficiently, for local effects it is assumed that correct use of
personal protective equipment (layer of clothing (coverall or spray suit) and
gloves) will result in a sufficient reduction of the exposure to formaldehyde
during the application.
The professional can be
inhalatory exposed to formaldehyde.
An AEC
acute/medium/long-term for respiratory exposure was established at 0.12 µg/L
(0.12 mg/m3), based on human eye irritation, human respiratory
irritation and studies with rats and monkeys.
The maximum inhalatory
exposure to formaldehyde during mixing and loading of hoof-baths is 0.018 mg/m3.
Therefore, for Formaldehyde 37% Brenntag and SYN-Formaline 37%, it can be
concluded that no adverse health effect are expected for the unprotected
professional user after inhalatory exposure to formaldehyde during mixing and
loading of hoof-baths.
The professional
respiratory exposure during dipping of instruments will be 0.2 mg/m3.
This exceeds the maximum inhalatory exposure to formaldehyde with a factor
(0.2/0.12) 1.7. However, correct use of personal protective equipement
(respiratory protection) will result in sufficient reduction of the respiratory
exposure to formaldehyde during dipping of instruments for SYN-Formaline 37%.
Formaldehyde 37% Brenntag
and SYN-Formaline 37% are used for the disinfection of accommodations and
annexes for animals. Furthermore, both products are also used for the
disinfection of means of transport for animals. This means that livestock can
be exposed to formaldehyde and that humans can be exposed indirectly by
consumption of animal products containing formaldehyde. However if it is indicated
in the WG/GAs that all products should be kept out of reach from animals
(animals should not be in the area during application and areas ventilated
before entering), it is not expected that humans can be indirectly exposed to
formaldehyde residues by the use of these products in as a animal hygiene
product (PT3).
Formaldehyde 37% Brenntag
and SYN-Formaline 37% are used for the disinfection of cells for mushroom
culture. As cells should empty during disinfection and ventilated before
re-use, consumer exposure through mushroom culture is not considered,
For hoofbath applications,
workers might be exposed to formaldehyde. However, since the hoof bath is only
of a limited area, animal housings are normally ventilated well, and
formaldehyde will react with the hoofs and dirt, respiratory exposure of
workers to formaldehyde is considered negligible.
Exposure of workers during
re-entry or bystanders during or after fogging should be considered. For worker
personal protection equipment can be prescribed, for bystanders not.
However, one should
consider the proposed instruction for fogging of SYN-Formaline 37%.
Since re-entry of the
treated area is only allowed 24 hours after application, only if the area
concentration is below the occupational exposure limit, there is no risk for
the worker during re-entry. For initial concentration measurements, the same
PPE as during application is prescribed.
Since fogging takes place
in closed areas, the treated area should be closed for minimally 24 hours and
the ventilation openings should be closed, there is no risk for the
bystander.
Animal exposure to
formaldehyde after disinfection of instruments is considered negligible, since
instruments are rinsed with water after disinfection.
However, animals will be
exposed by use of the hoof-baths. Systemic exposure to formaldehyde through
dermal exposure by hoof-bath is considered negligible. Formaldehyde will not
become systemically available through the horn layer. In addition, local
effects are not anticipated, considering the intrinsic properties of the horn
layer.
Systemic and local
respiratory exposure cannot be excluded. However, possible residues following
application of hoof-bath are considered to be negligible since the applied
in-use concentrations formaldehyde in air will be highly diluted in the
stables.
Secondary exposure after
foot bath disinfection is not to be expected.
No studies with
Formaldehyde 37% Brenntag and SYN-Formaline 37% were submitted.
Classification will be
based on CLP calculation method.
No
additional data requirements are identified.
For direct application of
Formaldehyde 37% Brenntag and SYN-Formaline 37% by spraying (PT2 and PT3), it
can be concluded that adverse health effects cannot be excluded for the
unprotected and protected professional after dermal and respiratory exposure to
formaldehyde.
For application of
Formaldehyde 37% Brenntag and SYN-Formaline 37% in hoof-baths, it can be
concluded that no adverse health effects are expected for the unprotected
professional after dermal and respiratory exposure to formaldehyde.
For application of
SYN-Formaline 37% in manual disinfection of instruments by dipping, it can be
concluded that adverse health effects after dermal exposure to formaldehyde
cannot be excluded. Correct use of personal protective equipment (gloves) will
reduce the dermal exposure and results in a sufficient reduction of the
exposure to formaldehyde.
For application of
SYN-Formaline 37% in area disinfection by fogging (PT2 and PT3), it can be
concluded that adverse health effects are not to be expected, when the product
is used according to the proposed instruction for use for the protected
professional after dermal and respiratory exposure to formaldehyde. The
following personal protection equipment has to be used during fogging: gloves,
spray suit and respiratory protection (B2 grey).
Considering the corrosive
and skin sensitizing properties of formaldehyde, personal protection equipment
will be prescribed on the label.
On the basis of the above
considerations, it can be concluded that the risk for the protected
professional user is acceptable for the hoof-baths, instrument disinfection and
fogging. Risk management measures should be taken.
The applications by
low-pressure spraying are not acceptable.
The products are intended
for professional use.
Animal and human indirect
exposure through application in accommodations and means of transport can be
excluded since it is indicated on the label that people, animals and food and
feed products should not be in the area during application and areas should be
ventilated before entering.
Consumer exposure through
mushroom culture is not considered, since only empty rooms will be disinfected.
Culture of mushroom in treated rooms will start after thorough ventilation.
Animal exposure to
formaldehyde after disinfection of instruments is considered negligible, since
instruments are rinsed with water after disinfection.
Systemic and local exposure
of animals after hoof-bath applicable is considered negligible and will not
result in indirect exposure of humans.
When used according to the
WG/GA, it can be concluded that no adverse health effects are expected from
indirect exposure to formaldehyde a result of the application of Formaldehyde
37% Brenntag and SYN-Formaline 37%.
Formaldehyde 37% Brenntag
and SYN-Formaline 37% contain only one active substance and it is not described
that it should be used in combination with other formulations.
Formaldehyde 37% Brenntag
For direct application of
Formaldehyde 37% Brenntag by spraying (PT2 and PT3), it can be concluded that
adverse health effects cannot be excluded for the unprotected and
protected professional after dermal and
respiratory exposure to formaldehyde.
For application of
Formaldehyde 37% Brenntag in hoof-baths, it can be concluded that no adverse
health effects are expected for the unprotected professional after dermal and
respiratory exposure to formaldehyde.
Considering the corrosive
and skin sensitizing properties of formaldehyde, personal protection equipment
will be prescribed on the label.
On the basis of the above
considerations, it can be concluded that the risk for the protected
professional user is acceptable for the hoof-bath disinfection only. However,
risk management measures should be taken. These should include gloves and
respiratory protection. No safe use with was concluded for the spray
applications.
SYN-Formaline 37%
For direct application of
SYN-Formaline 37% by spraying (PT2 and PT3), it can be concluded that adverse
health effects cannot be excluded for the unprotected and protected
professional after dermal and respiratory exposure to formaldehyde.
For application of
SYN-Formaline 37% in hoof-baths, it can be concluded that no adverse health
effects are expected for the unprotected professional after dermal and
respiratory exposure to formaldehyde.
For application of
SYN-Formaline 37% in manual disinfection of instruments by dipping, it can be
concluded that adverse health effects after dermal exposure to formaldehyde
cannot be excluded. Correct use of personal protective equipment (gloves) will
reduce the dermal exposure and results in a sufficient reduction of the
exposure to formaldehyde.
For application of
SYN-Formaline 37% in area disinfection by fogging (PT2 and PT3), it can be
concluded that adverse health effects are not to be expected for the protected
professional after dermal and respiratory exposure to formaldehyde. For application of SYN-Formaline 37% in area
disinfection by fogging (PT2 and PT3), it can be concluded that adverse health
effects are not to be expected, when the product is used according to the
proposed instruction for use for the protected professional after dermal and
respiratory exposure to formaldehyde. The following personal protection
equipment should be considered during fogging: gloves, spray suit, respiratory
protection (B2 grey).
Considering the corrosive
and skin sensitizing properties of formaldehyde, personal protection equipment
will be prescribed on the label.
On the basis of the above
considerations, it can be concluded that the risk for the protected
professional user is acceptable for the hoof-bath, instrument disinfection and
fogging. However, risk management measures should be taken. These should
include protective clothing (spray suit), gloves and respiratory protection. No
safe use was concluded for the spray applications.
Formaldehyde 37%
Brenntag and SYN-Formaline 37%
Authorisation is requested
for two products containing formaldehyde as active substances. These biocidal
products are private and public health area disinfectants (PT02) and veterinary
hygiene disinfectants (PT03). The products are for professional use. The
intended uses are described in table E.1.
Table
E.1. Intended use(s)
Product / area
of use envisaged |
Use concentration active substance (g/L) |
Dosage product. |
PT02: Private
and public health area disinfectants |
||
Disinfection of industrial
areas - Disinfection of empty rooms for the production of crops and
ornamental plants |
||
Formaldehyde
37% Brenntag |
25.2 |
1 L/300m² |
Disinfection of industrial
areas - Disinfection of empty rooms for the production of edible mushrooms |
||
Formaldehyde
37% Brenntag |
6.7 |
1 L/300m² |
Disinfection of industrial
areas - Disinfection of empty rooms and hard surfaces for the production of
crops, edible mushrooms, and ornamental plants - fumigation |
||
SYN-Formaline
37% |
6.7 |
13-25 mL/m³ |
PT03:
Veterinary hygiene biocidal products |
||
Disinfection of stables |
||
Formaldehyde
37% Brenntag |
53.8 |
0.4 L/m² |
SYN-Formaline
37% |
67 |
0.3 L/m² |
Disinfection of stables by
fogging |
||
SYN-Formaline
37% |
336 |
25 mL/m³ |
Disinfection of transport
vehicles |
||
Formaldehyde
37% Brenntag |
53.8 |
0.4 L/m² |
SYN-Formaline
37% |
67 |
0.3 L/m² |
Disinfection of transport
vehicles by fogging |
||
SYN-Formaline
37% |
336 |
25 mL/m³ |
Disinfection of footwear
and paws – disinfection of animals’ hoofs |
||
Formaldehyde
37% Brenntag |
16.8 |
105 L1 |
SYN-Formaline
37% |
13.4 |
200 L2 |
Disinfection of footwear
and paws – disinfection of personnel footwear |
||
SYN-Formaline
37% |
6.7 |
20 L3 |
Disinfection of footwear
and paws – disinfection of veterinary machinery and tools |
||
SYN-Formaline
37% |
6.7 |
4 |
1 Disinfection of hoofs is
applied every 1-4 weeks with a fresh solution;
2 Disinfection of hoofs is
applied every 2-3 weeks with a fresh solution;
3 Solution is refreshed every 3
days;
4 Tools are completely
submerged in the solution. Use amounts depends therefore on the size of the
tools to be disinfected.
Formaldehyde is one of the
simplest aldehydes and is a colourless gas at room temperature. The compound is
highly soluble in water. Once dissolved in water, formaldehyde almost completely
hydrates into methanediol; less than 0.1% of formaldehyde exists non-hydrated.
Disinfectants containing formaldehyde are actually solutions of methanediol in
water to which small amounts of methanol (0.5-15%) is added which prevent
polymerization into oligomers. Aldehydes in general are highly reactive
compounds that react with carboxyl, sulfhydryl and
hydroxyl groups and readily undergo polymerisation. Formaldehyde is readily
biodegradable, meeting the 10 day criteria. The current environmental risk assessment
is focussing on formaldehyde only as degradation and polymerisation products
are considered as low risk chemicals. Furthermore, possible pH effects
on the environment were not considered, because the receiving compartments are
expected to have sufficient buffering.
Releases into the
environment can take place at any stage of the life cycle of a product. The major routes of entry into the
environment during the application, in-service, and waste phase for the active
substance and/or its metabolites are listed in Table E.2. The relevant exposure
routes are discussed below.
Table
E.2. Potentially exposed environmental
compartments based on the intended use
Main scenario |
Environmental compartments and groups of organisms exposed |
|||||
STP1 |
Fresh-water2 |
Marine-water2 |
Soil3 |
Air |
Birds and mammals |
|
PT02: Private and public health area
disinfectants |
||||||
Disinfection of industrial areas |
++ |
- |
- |
- |
++ |
-4 |
PT03: Veterinary hygiene biocidal products |
||||||
Disinfection of stables |
- |
- |
- |
- |
++ |
-4 |
Disinfection of transport |
++ |
+ |
- |
- |
++ |
-4 |
Disinfection of personnel footwear |
- |
- |
- |
+ |
(+) |
-4 |
Disinfection of animals’ hoofs |
- |
- |
- |
+ |
++ |
-4 |
Disinfection of veterinary machinery and tools |
- |
- |
- |
+ |
++ |
-4 |
++ Compartment primarily exposed
+ Compartment
secondarily exposed (surface water from STP discharge, vertebrates eating
contaminated fish)
(+) Compartment potentially exposed
- Compartment not exposed
1 Sewage treatment plant
2 Including sediment
3 In the
4 Exposure to birds and mammals indirectly via the food chain is
considered as not relevant due to the compound’s low hydrophobicity (log Kow
0.35).
Environmental exposure of public health area disinfectants
Surfaces used during the
production of crops, ornamental plants, and edible mushrooms are disinfected by
means of fumigation, spraying, or foaming. When the products are applied by
fumigation, rooms and surfaces are well ventilated between 2 and 24 hours after
the incubation. Emission to air is therefore significant. Waste water is
emitted to the STP when the products are applied by spraying and foaming.
Environmental exposure of veterinary hygiene biocidal products
In the
Considering that professional use of
biocides for the disinfection of veterinary transport vehicles is legally
controlled (Ontwerpbesluit milieubeheer
– agrarisch, Wet bodembescherming), direct
exposure of soils and surface water is prevented as vehicles have to be
disinfected above liquid-tight floors. Disinfection of vehicles usually takes
place on the premises of slaughterhouses where waste water is collected and
purified in an on-site or municipal STP before being discharged to the surface
water.
Formaldehyde is a very
reactive compound. During and after application of the products, the
concentration strongly decreases when they go through a chain of reactions and
degrade while forming water and carbon dioxide. Residues will directly react
with the excess organic matter present in the sewer pipeline system that
discharges to the STP, thus resulting in very low amounts of active substance
at the STP’s influent. The remaining part of the active compounds, including
methanediol that is formed when formaldehyde dissolves in water, will be
further degraded quickly in a STP as decomposition in activated sludge is
completed within 48-72 hours. Therefore, the effluent of the STP will contain
very low concentrations of formaldehyde. Also in surface waters, formaldehyde
will be further quickly degraded (half lives 1 - 7 days (US EPA RED
formaldehyde).
In
view of this, a low risk for aquatic organisms, sediment organisms and
micro-organisms in the STP, surface water, and sediments is expected. The
proposed applications, when used in compliance with the directions for use
(WG/GA), therefore, meet the standards for aquatic organisms, sediment
organisms and micro-organisms in the STP. However, peak loads to an on-site STP
(In Dutch: Individuele Behandeling van Afvalwater (IBA)) may result in
decreasing microbiological activity and subsequent malfunction as such systems
are usually small (
There are no data available
in the Pesticide Atlas regarding the presence of formaldehyde in surface water.
Authorized biocidal products with formaldehyde have been on the Dutch market
for > 3 years. From the general scientific knowledge collected by the Ctgb
about the product and its active substance, the Ctgb concludes that there are
in this case no concrete indications for concern about the consequences of this
product for surface water from which drinking water is produced, when used in
compliance with the directions for use. The Ctgb does under this approach
expect no exceeding of the drinking water criterion. The standards for surface
water destined for the production of drinking water are met.
Criteria for the
examination of environmental risks to air are not specified by a numerical
standard. The present assessment of potential impacts on air quality, is aimed
to minimize the risk for stratospheric ozone depletion.
In the atmosphere,
formaldehyde is expected to be indirectly photodegraded by reaction with
OH-radicals, with a half life of 1.71 days. This half life is below the trigger
of < 2 days that is used as cut off value to identify chemicals that could
be of potential concern for long range transport through the atmosphere. Furthermore,
formaldehyde is a natural gas occurring in the atmosphere as a result of the
degradation of methane. As methane is widely distributed naturally and has a
half-live of several years, formaldehyde is formed on a global scale
continuously.
The active substances are
not listed as controlled substances according to European Council’s Regulation
no 1005/2009 and therefore not classified as ozone depleting compounds. The
proposed applications meet the standards for air.
Soils are indirectly
exposed via fertilization with manure that holds biocides when used product are
discharged to the slurry pit. Due to formaldehyde’s strong oxidizing potential,
the compounds will rapidly react with organic material. Manure contains
moreover a large active microbiological community which completely degrades
formaldehyde during storage. It is therefore expected that concentrations of
formaldehyde will be very low in the manure when applied as an fertilizer.
Exposure of soil and flowering plants is therefore considered negligible.
The exposure of bees is
considered negligible as bees are not considered to forage in animal housings.
The exposure of bees to formaldehyde on manure treated land is considered
negligible as the compound is expected to fully degrade already before manure
is applied to agricultural soils. Soil dwelling arthropods are considered to be
covered by the risk assessment for soil organisms as the active substance is assumed
to have a non-specific mode of action. All other uses as described in table E.1
are not expected to result in exposure of non-target arthropods (including
bees).
The
proposed applications, when used in compliance with the directions for use
(WG/GA), therefore, meet the standards for soil organisms, non target
arthropods and bees.
Assessment
of the drinking water criterion defines that the concentration of the active
substance and the relevant metabolites in groundwater for the preparation of
drinking water needs to be < 0.1 µg/L.
Considering the application
of the products and the biochemical profile of the compound, environmental
concentrations in soil and soil pore water are expected to be low. Leaching and
concentrations in shallow groundwater will be negligible. Hence, the risk for groundwater is considered
acceptable.
Formaldehyde is chemically
instable, highly reactive, and readily biodegradable. Hence, formaldehyde is not
persistent and the standards for persistence are met.
As the log Kow
is below 3 risk for bioconcentration in aquatic organisms is considered low.
Bioconcentration and biomagnification is not expected (conform the
biomagnification trigger value proposed for Kow in the TGD). Hence, the standards for bioaccumulation are
met.
For
the proposed use of the active substances direct or indirect exposure of birds and mammals to the active substance or contaminated
aquatic and terrestrial organisms is considered negligible.
As the active substance is
not bioaccumulative and the concentrations in surface water are negligible, the
risk for secondary poisoning is considered acceptable. Primary poisoning is not expected with the
intended use.The
proposed application meets the standards for birds and mammals.
There are existing risk
mitigations on the WG/GA that does not allow fumigation of the product in rooms
were animals and humans are present, except for the professional user, and
direct contact to animals, except animal hoofs.
Although formaldehyde is
highly reactive and readily biodegradable, risks for micro-organisms in on-site
STPs (IBA’s in Dutch) and subsequent malfunction of the water treatment are
expected when high amounts of formaldehyde enter the system. Therefore, the
following risk mitigation measure is included to prevent inhibition in
functioning of the IBA:
- “To
prevent the inhibition in functioning of an on-site wastewater treatment system
(IBA) possible residues containing the product must be discharged to the slurry
pit or to a municipal STP.”
- “Om verminderd functioneren van een Individuele Behandeling Afvalwater
(IBA) te voorkomen, dienen afvalresten die het middel bevatten geloosd te
worden op de mestvoorraad of op de gemeentelijk riolering.”
Considering
that the disinfection of veterinary transport vehicles has to be done on
liquid-tight floors (Besluit landbouw milieubeheer, Wet bodembescherming) and
therefore direct exposure of soils and surface water is prevented, it is not
necessary to add this as a restriction on the WG/GA.
It can be concluded that
the products Formaldehyde 37% Brenntag and SYN-Formaline 37% when used in accordance
with the proposed label (WG/GA), comply with the environmental standards and
will not cause unacceptable effects on the environment.
There are no additional
data required.
Reference list |
Ontwerpbesluit
milieubeheer – agrarisch |
Screening Information Dataset (SIDS) for High Volume Chemicals for
Formaldehyde (CAS nr. 50-00-0) available via the United Nations Environment
Programme (UNEP, http://www.chem.unep.ch/); |
|
Environmental Health criteria 89 Formaldehyde. WHO. IPCS (International Programme On Chemical Safety) INCHEM. 1989.
(http://www.inchem.org/documents/ehc/ehc/ehc89.htm) |
Formaldehyde 37% Brenntag
The proposed field of use of Formaldehyde 37% Brenntag is the control of bacteria, yeasts, fungi and viruses
a.
In
empty rooms intended for the growing of mushrooms /plants for consumption and
ornamental plants
b.
In
animal housing including stables and materials
c.
In
vehicles for transport of animals
d.
On
hoofs to prevent the spread of hoof diseases
The product is intended for professional use only.
For
Formaldehyde 37% Brenntag it can be concluded
that adverse health effects cannot be excluded for the unprotected and
protected professional after dermal and
respiratory exposure to formaldehyde for applications a. till c. as mentioned
above. As a result the proposed uses
a. till c. can not be authorised.
Safe use
and efficacy is demonstrated for the other proposed use.
SYN-Formaline 37%
The proposed field of use of SYN-Formaline 37% is the control of bacteria, yeasts, fungi and viruses
a.
On
hoofs of cattle and sheep
b.
On
footwear of men that enter farms, cleaning devices for shoes and footbaths
c.
In
empty rooms intended for the accommodation, care and transport of animals and
the out- and inside of machines and equipment by spraying and fogging.
d.
In
empty rooms intended for the growing of mushrooms/plants for consumption and
ornamental plants
e.
Of
equipment by dipping
The product is intended for professional use only.
For direct application of
SYN-Formaline 37% by spraying, it can be concluded that adverse health effects
cannot be excluded for the unprotected and protected professional after dermal
and respiratory exposure to formaldehyde.
Considering the corrosive
and skin sensitizing properties of formaldehyde, personal protection equipment
will be prescribed on the label.
For application of
SYN-Formaline 37% in area disinfection by fogging, it can be concluded that
adverse health effects are not to be expected, when the product is used
according to the proposed instruction
for use for the protected professional after dermal and respiratory
exposure to formaldehyde.
The following personal
protection equipment has to be used during fogging: gloves, spray suit and
respiratory protection (B2 grey).
The application of footwear
disinfection and equipment disinfection including dipping has not been
demonstrated efficacious for the intended concentrations and contact times. For
the application of hoof disinfection only the efficacy against bacteria
(including mycobacteria, excluding bacterial spores) is demonstrated.
The application of
disinfection of vehicle for animal transport has not been demonstrated
efficacious against for the required viruses (Classical Swine fever, Aujeszki
and Foot and Mouth disease).
As a result of the
assessment :
·
uses
b. and e., as mentioned above can not be authorised
·
Disinfection
of vehicle for animal transport as mentioned under c. can not be
authorised.
·
Disinfection
of empty rooms intended for the accommodation and care of animals and the out-
and inside of machines and equipment by spraying as mentioned under c. can not
be authorised
Safe use
and efficacy is demonstrated for all the other proposed uses, provided that
personal protection equipment is used.
It has been demonstrated
that the use of Formaldehyde 37% Brenntag used as disinfectant to control
bacteria (including mycobacteria,
excluding bacterial spores) on hoofs of ungulates, as described in the
Legal Conditions for Use and the Directions for Use (WG/GA), is sufficiently
effective and presents no unacceptable risks to human health, to users or to
the environment (Art.121 jo art. 49 first paragraph Dutch 2007 Plant Protection
Products and Biocides Act).
It has been demonstrated that the use of SYN-Formaline 37% used as
disinfectant to control
1. bacteria (including
mycobacteria, excluding bacterial spores ), yeasts, fungi and viruses by fogging:
2. bacteria (including mycobacteria, excluding bacterial
spores)
as described in the Legal
Conditions for Use and the Directions for Use (WG/GA), is sufficiently
effective and presents no unacceptable risks to human health, to users or to
the environment (Art.121 jo art. 49 first paragraph Dutch 2007 Plant Protection
Products and Biocides Act).
Formaldehyde 37%
Brenntag
Proposed for
classification and labelling for the formulation
Based on Reg. (EC)
1272/2008:
The identity of all substances in the mixture that contribute to the
classification of the mixture *: |
|||
methanol |
|||
Pictogram: |
GHS06 |
Signal word: |
Danger |
|
GHS05 |
||
|
GHS08 |
||
H-statements: |
H302 |
Harmful if swallowed. |
|
|
H311 |
Toxic in contact with skin. |
|
|
H314 |
Causes severe skin burns and eye damage. |
|
|
H317 |
May cause an allergic skin reaction. |
|
|
H331 |
Toxic
if inhaled. |
|
|
H351 |
Suspected
of causing cancer. |
|
|
H371 |
May cause damage to organs. |
|
P-statements: |
P260 |
Do not breath mist/vapour/spray. |
|
|
P280 |
Wear protective gloves, protective
clothing, eye protection and face protection. |
|
|
P403+P233 |
Store in a well-ventilated place. Keep container tightly closed. |
|
|
P303+P361+P353 |
IF ON SKIN (or hair): Remove / Take off
immediately all contaminated clothing. Rinse skin with water/shower. |
|
Supplemental Hazard
information: |
- |
- |
|
Child-resistant
fastening obligatory? |
|
||
Tactile warning of danger obligatory? |
|
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
SYN-Formaline 37%
Proposed for
classification and labelling for the formulation
Based on Reg. (EC)
1272/2008:
The identity of all substances in the mixture that contribute to the
classification of the mixture *: |
|||
methanol |
|||
Pictogram: |
GHS06 |
Signal word: |
Danger |
|
GHS05 |
||
|
GHS08 |
||
H-statements: |
H302 |
Harmful if swallowed. |
|
|
H311 |
Toxic in contact with skin. |
|
|
H314 |
Causes severe skin burns and eye damage. |
|
|
H317 |
May cause an allergic skin reaction. |
|
|
H331 |
Toxic
if inhaled. |
|
|
H351 |
Suspected
of causing cancer. |
|
|
H371 |
May cause damage to organs. |
|
P-statements: |
P202 |
Do not handle until all safety precautions have been read and
understood. |
|
|
P260 |
Do not breath mist/vapour/spray. |
|
|
P280 d |
Wear protective gloves, protective
clothing, eye protection. |
|
|
P284 |
Wear respiratory protection. |
|
|
P403+P233 |
Store in a well-ventilated place. Keep container tightly closed. |
|
|
P303+P361+P353 |
IF ON SKIN (or hair): Remove / Take off
immediately all contaminated clothing. Rinse skin with water/shower. |
|
Supplemental Hazard
information: |
- |
- |
|
Child-resistant
fastening obligatory? |
|
||
Tactile warning of danger obligatory? |
|
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
9. References
No references.
[1]
Distant farms and houses are usually provided with a local wastewater treatment
system (In Dutch: Individuele Behandeling Afvalwater (IBA)). These are however
meant to purify domestic waste water and due to their size (usually