Toelatingsnummer 13525 N

SYN-Formaline 37%  

 

13525 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 TOELATING

 

Gelet op de aanvraag d.d. 9 december 2010 (20101069 TBR) van

 

Synerlogic B.V.

Graafsingel 22

6921 RT  DUIVEN

 

 

 

tot verkrijging van een toelating op basis van de werkzame stof(fen) formaldehyde,

 

SYN-Formaline 37%

 

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.

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 14 oktober 2011

 

 

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:

  • Behandeling uitvoeren bij een temperatuur boven 15ºC, indien nodig de ruimte eerst verwarmen.
  • Ventilatie van de betreffende ruimte uitzetten en ventilatieopeningen dichtmaken.
  • Draag de volgende persoonlijke beschermingsmiddelen: adembescherming (B2 grijs), handschoenen en een goed sluitend spuitpak.
  • Vul geschikte apparatuur met de juiste hoeveelheid middel, zet de apparatuur aan en verlaat direct de ruimte.
  • Houd vervolgens de ruimte gedurende 24 uur gesloten.
  • Verwarm de ruimte tot boven 15ºC, ventileer de restdampen uit de ruimte totdat de ruimte volledig droog is.
  • Indien de behandelde ruimte betreden moet worden voor eventuele tussentijdse bemonstering, moeten dezelfde persoonlijke beschermingsmiddelen als hierboven voorgeschreven gedragen worden.
  • Voor bemonstering worden Dräger adsorptiebuisjes, meetbereik 0,2 – 2,5 mg/m3 geadviseerd.
  • Als grenswaarde voor het betreden van de ruimte worden de beroepsmatige blootstellinglimieten voor formaldehyde gehanteerd (MAC-TGG 15 minuten: 0,5 mg/m3,  MAC-TGG 8 uur: 0,15 mg/m3)

      .

1A. Lege ruimten bestemd voor de kweek van consumptie- en siergewassen en paddestoelen

Dosering: 2% (2 liter middel aanvullen met water tot 100 liter),

Gebruik 5 tot 6 liter oplossing per 100 m3 ruimte.

     

1B. Dierverblijfplaatsen en bijbehorende stallen en materialen (machines en gereedschappen)

Dosering: onverdund middel, 1,3 tot 2,5 liter middel per 100 m3. Het is ook mogelijk om het middel verdund in water toe te passen. Hierbij moet een vergelijkbare hoeveelheid Formaline37% (1,3 tot 2,5 liter onverdund middel/100 m3) toegepast worden.

           

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% (4 liter middel aanvullen met water tot 100 liter).

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

 

 

 

 

 


1.                  Introduction

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.

2.                  Identity

2.1       Identity of the active substance formaldehyde

 

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

 

Bestand:Formaldehyde-2D.svg

 

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.


 

2.2       Physical and chemical properties of the active substance formaldehyde

 

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 25 °C

Solubility in water (g/L or mg/L)

Theoretically 95% (w/w) at 120 °C.

Aqueous solutions become cloudy at concentrations >30% due to polymerisation.

Partition coefficient (log POW)

0.35 at 20 °C

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 (> 300 °C)

Oxidising properties

Not oxidising

Explosive properties

Not explosive

 

2.3       Analytical methods for the technical active substance

 

Adequate analytical methodology is available to determine the content of active substance and significant and/or relevant impurities in the technical active substance.

 

2.4       Overall conclusions active substance

The identity, physical and chemical properties and analytical methods of the active substance are sufficiently described.


 

3.                  Physical and chemical properties

 

Formaldehyde 37% Brenntag

 

3.1 Identity of the biocidal product

Name

Formaldehyde 37% Brenntag

Content active substance

37% formaldehyde

Formulation type

SL

Packaging

HDPE can, drum or IBC: 5 – 1000L

 

3.2 Physical and chemical properties of the biocidal product

 

Appearance

Clear liquid with pungent odour

Explosive properties

Not explosive

Oxidising properties

Not oxidising

Auto-flammability

Not self-igniting

Flashpoint

FP: 67 °C

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

 

3.3       Analytical methods for detection and identification

3.3.1    Analytical methods for analysis of the biocidal product

 

Preparation (principle of method)

 ISO / ASTM method

3.3.2    Residue analytical methods

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.

3.4       Overall conclusions biocidal product

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

 


 

SYN-Formaline 37%

 

3.1 Identity of the biocidal poduct

Name

SYN-Formaline 37%

Content active substance

37% formaldehyde

Formulation type

SL

Packaging

HDPE: 1 – 1000L

 

3.2 Physical and chemical properties of the biocidal product

 

Appearance

Clear liquid with pungent odour

Explosive properties

Not explosive

Oxidising properties

Not oxidising

Auto-flammability

Not self-igniting

Flashpoint

FP: 64 – 85°C

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

 

3.3       Analytical methods for detection and identification

3.3.1    Analytical methods for analysis of the biocidal product

 

Preparation (principle of method)

 ISO / ASTM method

 

3.3.2    Residue analytical methods

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.

3.4       Overall conclusions biocidal product

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

 

4.                  Efficacy

Formaldehyde 37% Brenntag

4.1       Function

Formaldehyde 37% Brenntag is an disinfectant (PT 2 and PT3) based on 37% w/w formaldehyde.

4.2       Field of use envisaged

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.

4.3       Effects on target organisms and efficacy

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

  • empty rooms intended for the growing of plants for consumption and ornamental plants
  • animal housing including stables and materials

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.

4.3.1    Evaluation of the WG/GA

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).

4.3.2 Mode of action

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.

4.3.3    Resistance

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.

4.4       Overall conclusions

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:

  • empty rooms intended for the growing of plants for consumption and ornamental plants
  • animal housing including stables and materials

 

2. and in controlling bacteria (including mycobacteria, excluding bacterial spores)

  • on hoofs of ungulates

 

 

SYN-Formaline 37%

4.1       Function

SYN-Formaline 37% is a disinfectant (PT 2 and PT3) based on 37% w/w formaldehyde.

4.2       Field of use envisaged

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.

4.3       Effects on target organisms and efficacy

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.

4.3.1    Evaluation of the WG/GA

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).

4.3.2 Mode of action

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.

4.3.3    Resistance

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.

4.4       Overall conclusions

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

  • empty rooms intended for the growing of plants for consumption, ornamental plants and mushrooms
  • empty rooms intended for the accommodation and care of animals and materials
  • hard surfaces in empty rooms intended for the accommodation and care of animals

2. bacteria (including mycobacteria, excluding bacterial spores)

  • on hoofs of cattle and sheep

 

5.                  Human toxicology

 

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 Germany is the Reporting Member State. A draft concept CA-report is available for formaldehyde (PT6).

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 Germany is the Reporting Member State. Since the active substance is still in the process of evaluation/discussion, no final endpoints are set yet.

 

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 70 kg, a NL-AEL of 29.1 mg/day is calculated.

 

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.

 

5.1 Human exposure assessment active substance

5.1.1 General aspects

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.

5.1.2 Identification of main paths of professional exposure towards active substance from its use in biocidal product

 

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.

 

5.1.3 Identification of main paths of non-professional exposure towards active substance from its use in biocidal product

 

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:

  • Mixing and loading
  • Application through: dipping, hoof-bath, low-pressure spraying and fogging. The highest use concentration for spraying is 100% (undiluted).

 

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 60 kg for the professional user

-          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 15°C and turn on the ventilation, until the area is completely dry.

-          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%.

5.1.4 Indirect exposure as a result of use of the active substance in biocidal product

 

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.

5.2 Human health effects assessment product

5.2.1 Toxicity of the formulated product

 

No studies with Formaldehyde 37% Brenntag and SYN-Formaline 37% were submitted.

Classification will be based on CLP calculation method.

5.2.2 Data requirements formulated product

No additional data requirements are identified.

5.3 Risk characterisation for human health

5.3.1      Professional users

 

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.

5.3.2 Non-professional users, including the general public

 

The products are intended for professional use.

5.3.3 Indirect exposure as a result of 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%.

5.3.4    Combined exposure

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.

5.4       Overall conclusions

 

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.

 

6.                  Environment

Formaldehyde 37% Brenntag and SYN-Formaline 37%

6.1       Introduction

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.

6.2.1    Environmental profile of active substance

Chemistry and/or metabolism

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.

6.2.2 Distribution in the environment

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 Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Therefore, exposure of soil and groundwater via STP surplus sludge application is not part of the risk assessment.

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 Netherlands, discharge of industrial waste water from farms to the sewer is not allowed when it contains animal manure (Besluit landbouw milieubeheer). Discharge to the sewer is moreover unlikely, because the majority of farming buildings are not connected to the sewage system as they are > 40 meters from the nearest sewer. As it is prohibited to disperse waste water on agricultural land or directly to surface water when it contains (residues of) biocides (Lozingenbesluit bodembescherming, Lozingenbesluit open teelt en veehouderij), waste water from disinfection of footwear, and animals’ hoofs, and tools and machinery is therefore usually discharged to the slurry pit (Voorlopige richtlijnen agrarische afvalwaterlozingen)[1]. Biocides may subsequently enter the environment when agricultural soils are fertilized with manure from the slurry pit. Because manure is injected in soils, exposure to air and adjacent surface water during fertilization is limited. Exposure to air is however expected when formaldehyde solutions in baths is disturbed during disinfection of personal footwear or, animals’ hoofs, or by evaporation. These amounts are however considered small, although most of the times enough to detect the typical formaldehyde odour, and therefore emission to air is considered as potential for this application. Exposure to air during disinfection of tools is relevant when stables including tools and machinery present there, and transport vehicles are disinfected by means of fumigation.

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.

6.3       Risk characterisation for the environment

6.3.1  Aquatic compartment (incl. sediment) and STP

6.3.1.1 Water and sediment organisms and micro-organisms in the STP

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 (6 m³) and exposure concentrations are high as products are insufficient diluted. Therefore, emission to an IBA have to be avoided and waste products have to be discharged to the slurry pit instead (see sections 0 and 0).

 

6.3.1.2 Surface water intended for the abstraction of drinking water

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.

6.3.2    Atmosphere

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.

6.3.3    Terrestrial compartment

6.3.3.1 Soil organisms and non target arthropods (including bees)

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.

 

6.3.3.2    Groundwater

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.

 

6.4.3.3    Persistence in soil

Formaldehyde is chemically instable, highly reactive, and readily biodegradable. Hence, formaldehyde is not persistent and the standards for persistence are met.

 

6.3.4    Non compartment specific effects relevant to the food chain

6.3.4.1.   Bioconcentration

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.

 

6.3.4.2    Primary and secondary poisoning of birds and mammals

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.

 

6.4       Measures to protect the environment (risk mitigation measures)

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.

6.5 Overall conclusion

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.

6.5.1 Data requirements

There are no additional data required.


6.6 Consulted literature sources

Reference list

Voorlopige richtlijnen voor het bevoegd gezag ten aanzien van agrarische afvalwaterlozingen. Circulaire 6 maart 1997/DBO/97085822, Staatscourant nr. 60, ’s Gravenhage.

Artikel 25 Lozingenbesluit bodembescherming

Artikel 10 Lozingenbesluit open teelt en veehouderij

Reregistration Eligibility Decision for Formaldehyde and Paraformaldehyde (Case 0556). U.S. Environmental Protection Agency, Washington, DC, EPA739/R-08/004, 2008. (www.epa.gov).

Ontwerpbesluit milieubeheer – agrarisch

Ontwerpbesluit houdende wijziging van het Besluit algemene regels voor inrichtingen milieubeheer (agrarische activiteiten in het Besluit algemene regels voor inrichtingen milieubeheer)

Artikelen 6-13 Wet Bodembescherming

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/);

U.S. EPA. IRIS Toxicological Review of Formaldehyde-Inhalation Assessment (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-10/002A, 2010 (http://www.epa.gov/iris);

Environmental Health criteria 89 Formaldehyde. WHO. IPCS (International Programme On Chemical Safety) INCHEM. 1989. (http://www.inchem.org/documents/ehc/ehc/ehc89.htm)

 

7.                  Conclusion

7.1       Overview

 

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.

 

7.2       Overall conclusion

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:

  • empty rooms intended for the growing of mushrooms/plants for consumption and ornamental plants
  • empty rooms intended for the accommodation and care of animals and materials

2. bacteria (including mycobacteria, excluding bacterial spores)

  • on hoofs of cattle and sheep,

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).

8.      Classification and labelling

 

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 6 m³) not suitable for industrial uses.